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-aDOSALVL Actual Dosing Level 5bDOSALVLNActual Dosing Level (N) BEST  6cDOSPLVL Planned Dosing Level >dDOSPLVLNPlanned Dosing Level (N) BEST  ?eDS30KFL Phase 3 30k Subjects Flag GfPHASE Study Phase HgPHASEN Study Phase (N) BEST  O hAGEGR4 Pooled Age Group 4 WiAGEGR4N Pooled Age Group 4 (N) BEST  bjHIVFL HIV Positive Subjects Flag jkPEDIMMFLPop for Non-inferiority Assessement klPEDREAFLPhase 2/3 Pop for 12-25 Reacto Subset lmDS3KFL FU to 6MPD2 mnAGETR01 Age at Vaccination 01 BEST  noAGETRU01Age Units at Vaccination 01 v HEADER RECORD*******OBS HEADER RECORD!!!!!!!000000000000000000000000000000 C4591001C4591001 1005 10051328100513281005A0PRE-MENARCHE Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr^DVDHr{BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr^DVDHr{......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1005 10051328100513281005A ENVIRONMENTAL ALLERGIES Hypersensitivity FImmune system disorders F4Environmental allergy FTAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-3945 N DV 10.8 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr^DVDHr{BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr^DVDHr{......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1005 10051328100513281005AANXIETY Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1023 N DV 2.8 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr^DVDHr{BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr^DVDHr{......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1005 10051410100514101005APREMENARCHAL Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWD(Hs(Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDdHrdDWDҴHsu4DWD(Hs(Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1005 10051412100514121005A0POLYCYSTIC OVARIES Polycystic ovaries F#QReproductive system and breast disorders F-LPolycystic ovaries F#QOvarian and fallopian tube cysts and neoplasms FOvarian and fallopian tube disorders FReproductive system and breast disorders F-LGENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1809 N DV 4.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD Hr,DW DHr& BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD Hr,DW DHr& ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1005 10051412100514121005AANXIETY Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1078 N DV 2.95 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD Hr,DW DHr& BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD Hr,DW DHr& ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1005 10051412100514121005A DEPRESSION Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2018M-1078 N DV 2.95 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD Hr,DW DHr& BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD Hr,DW DHr& ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1005 10051414100514141005AASPERGERS Autism spectrum disorder FPsychiatric disorders F'Asperger's disorder FPervasive developmental disorders NEC F4Developmental disorders NEC FǒPsychiatric disorders F'GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2010M-4000 N DV 10.95 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD HrEDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD HrEDW DHrDWDHs}"tDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1005 10051414100514141005A ENVIRONMENTAL ALLERGIES Hypersensitivity FImmune system disorders F4Environmental allergy FTAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4000 N DV 10.95 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD HrEDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD HrEDW DHrDWDHs}"tDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1005 10051417100514171005Aacne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-715 N DV 1.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWD HsFPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDHrŅDWDHsƶxDWD HsFPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1005 10051418100514181005AASTHMA Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1080 YChronic pulmonary disease DV 2.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrHDWDHrņBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrHDWDHrņ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1005 10051419100514191005AANXIETY Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2013M-2906 N DV 7.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDLHr%DWTD(Hs"(Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDLHr%DW DHrDW?DHsf\DWTD(Hs"(Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DW?DWT.DW6DV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1005 10051419100514191005A ATTENTION DEFICIT DISORDER Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2013M-2906 N DV 7.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDLHr%DWTD(Hs"(Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDLHr%DW DHrDW?DHsf\DWTD(Hs"(Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DW?DWT.DW6DV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1005 10051420100514201005A0PREMENARCHAL Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDިHr$(DW DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDިHr$(DW DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1005 10051420100514201005AATTENTION DEFICIT DISORDER Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019M-715 N DV 1.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDިHr$(DW DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDިHr$(DW DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1005 10051420100514201005A ENVIRONMENTAL ALLERGIES Hypersensitivity FImmune system disorders F4Environmental allergy FTAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-715 N DV 1.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDިHr$(DW DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDިHr$(DW DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1005 10051422100514221005A tree nut allergy Food allergy FزImmune system disorders F4Allergy to nuts Fm/Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2014M-2542 N DV 6.96 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVDHrwDWDhHshPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrwDWDHr"XDWDHHssHDWDhHshPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1005 10051422100514221005Amigraines without aura Migraine without aura FdNervous system disorders FMigraine without aura FdMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1081 N DV 2.96 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVDHrwDWDhHshPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrwDWDHr"XDWDHHssHDWDhHshPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1005 10051425100514251005A ENVIRONMENTAL ALLERGIES Hypersensitivity FImmune system disorders F4Environmental allergy FTAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4004 N DV 10.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrLDWDHrCBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrLDWDHrC......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1005 10051425100514251005AASTHMA Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1447 YChronic pulmonary disease DV 3.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrLDWDHrCBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrLDWDHrC......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1005 10051429100514291005ASHORT STATURE Short stature F5Musculoskeletal and connective tissue disorders FkShort stature F5Musculoskeletal and connective tissue conditions NEC FMusculoskeletal and connective tissue disorders NEC FiMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2019-10 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Oct2019D-447 N DV 1.23 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD Hr DWDHrq@BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD Hr DWDHrq@......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1005 10051431100514311005A ERYTHROMYCIN ALLERGY Drug hypersensitivity FImmune system disorders F4Allergic reaction to antibiotics F8Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2006M-5469 N DV 14.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrpDWDHr̈́BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrpDWDHr̈́......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1005 10051431100514311005A0PENICILLIN ALLERGY Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2006M-5469 N DV 14.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrpDWDHr̈́BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrpDWDHr̈́......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1005 10051431100514311005ADEPRESSION Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2019M-721 N DV 1.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrpDWDHr̈́BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrpDWDHr̈́......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1005 10051436100514361005AANXIETY Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2011M-3643 N DV 9.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrXDWDʼHrͨBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrXDWDʼHrͨ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1005 10051437100514371005AACNE Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-721 N DV 1.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDpHrDWDHs!Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDpHrDWDHrͨDWD@HsjDWDHs!Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1005 10051438100514381005ALACTOSE INTOLERANCE Lactose intolerance FMetabolism and nutrition disorders FLactose intolerance FSugar intolerance (excl glucose intolerance) FDWD<HsmPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDʀHr>DWDHrDWD(Hss(DWD<HsmPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1006 10061214100612141006A Sulfa Antibiotic Allergy Drug hypersensitivity FImmune system disorders F4Sulfonamide allergy FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2006M-5451 N DV 14.93 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVDߘHrSDWDՄHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDߘHrSDWDڬHrZDWDHssݤDWDՄHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061214100612141006AAttention Deficit Disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2013-03-27 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 27Mar2013 -2809 N DV 7.69 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVDߘHrSDWDՄHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDߘHrSDWDڬHrZDWDHssݤDWDՄHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061219100612191006APfacial acne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019-12 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Dec2019D-372 N DV 1.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDtHrtDWD$HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDtHrtDWDHrSDWDHHsoHDWD$HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061219100612191006A Benign Generalized Moles Melanocytic naevus FNeoplasms benign, malignant and unspecified (incl cysts and polyps)F0Mole of skin FSkin neoplasms benign F6BCutaneous neoplasms benign F6CNeoplasms benign, malignant and unspecified (incl cysts and polyps)F0GENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2006M-5454 N DV 14.93 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDtHrtDWD$HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDtHrtDWDHrSDWDHHsoHDWD$HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061219100612191006AAmoxicillin Allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2009M-4358 N DV 11.93 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDtHrtDWD$HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDtHrtDWDHrSDWDHHsoHDWD$HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061219100612191006A0Insomnia Insomnia F%Psychiatric disorders F'Insomnia F%Disturbances in initiating and maintaining sleep FFSleep disorders and disturbances F6Psychiatric disorders F'GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2016M-1802 N DV 4.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDtHrtDWD$HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDtHrtDWDHrSDWDHHsoHDWD$HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061219100612191006A@Intermittent abdominal pain Abdominal pain FGastrointestinal disorders FܛAbdominal pain FGastrointestinal and abdominal pains (excl oral and throat) F܆Gastrointestinal signs and symptoms FGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2017M-1436 N DV 3.93 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDtHrtDWD$HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDtHrtDWDHrSDWDHHsoHDWD$HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061220100612201006A Amoxicillin Allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2008M-4724 N DV 12.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD8Hr8DWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD8Hr8DWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DW7DV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1006 10061220100612201006A@Penicillin Allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2008M-4724 N DV 12.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD8Hr8DWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD8Hr8DWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DW7DV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1006 10061220100612201006APseasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2016M-1802 N DV 4.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD8Hr8DWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD8Hr8DWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DW7DV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1006 10061220100612201006AAcne-facial Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-706 N DV 1.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD8Hr8DWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD8Hr8DWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DW7DV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1006 10061220100612201006A0Groin Pull Muscle strain FYInjury, poisoning and procedural complications FGroin strain F߱Muscle, tendon and ligament injuries FInjuries NEC FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2020-11 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Nov2020D-36 N DV 0.1 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD8Hr8DWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD8Hr8DWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DW7DV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1006 10061221100612211006A0Seasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2009M-4358 N DV 11.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr4BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr4......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061221100612211006AIrregular Menstrual Bleeding Menstruation irregular FKReproductive system and breast disorders F-LMenstruation irregular FKMenstruation and uterine bleeding NEC FGMenstrual cycle and uterine bleeding disorders FʎReproductive system and breast disorders F-LGENERAL MEDICAL HISTORY2019-01-03 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 03Jan2019 -704 N DV 1.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr4BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr4......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061221100612211006A@Temporomandibular Pain Temporomandibular joint syndrome F?TMusculoskeletal and connective tissue disorders FkTemporomandibular joint arthralgia F?OJoint related disorders NEC FJoint disorders F-Musculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2019-09-12 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 12Sep2019 -452 N DV 1.24 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr4BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr4......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061221100612211006A Scoliosis Scoliosis F1Musculoskeletal and connective tissue disorders FkScoliosis F1Spine and neck deformities FMusculoskeletal and connective tissue deformities (incl intervertebral disc disorders)FYMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2018-07-20 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 20Jul2018 -871 N DV 2.39 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr4BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr4......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061223100612231006AAsthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2167 YChronic pulmonary disease DV 5.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr*DWDDHsGPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr*DWDHr|DWD{ Hsr$DWDDHsGPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061223100612231006A Environmental allergies Hypersensitivity FImmune system disorders F4Environmental allergy FTAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1071 N DV 2.93 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr*DWDDHsGPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr*DWDHr|DWD{ Hsr$DWDDHsGPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061224100612241006AAllergic Rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2167 N DV 5.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHHr=HDWDHHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHHr=HDWDHHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061224100612241006APintolerance to cat hair Allergy to animal FNImmune system disorders F4Allergic to cats FCAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2015M-2167 N DV 5.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHHr=HDWDHHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHHr=HDWDHHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061224100612241006A Chronic sinusitis Chronic sinusitis F1Infections and infestations FChronic sinusitis F1Upper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2019-11-13 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 13Nov2019 -390 N DV 1.07 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHHr=HDWDHHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHHr=HDWDHHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061224100612241006A0Deviated septum Nasal septum deviation FRespiratory, thoracic and mediastinal disorders F-Nasal septum deviation FNasal disorders NEC FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2019-11-13 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 13Nov2019 -390 N DV 1.07 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHHr=HDWDHHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHHr=HDWDHHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061224100612241006A@hypertrophy nasal turbinates Nasal turbinate hypertrophy FRespiratory, thoracic and mediastinal disorders F-Hypertrophy of nasal turbinates FNasal disorders NEC FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2019-11-13 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 13Nov2019 -390 N DV 1.07 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHHr=HDWDHHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHHr=HDWDHHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061227100612271006AAcne-Facial Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1802 N DV 4.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrPDWDHr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrPDWDHr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1006 10061227100612271006A temporomandibular joint syndrome Temporomandibular joint syndrome F?TMusculoskeletal and connective tissue disorders FkTemporomandibular joint syndrome F?TJoint related disorders NEC FJoint disorders F-Musculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2020-03 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Mar2020D-281 N DV 0.77 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrPDWDHr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrPDWDHr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1006 10061228100612281006A dysmenorrhea Dysmenorrhoea FReproductive system and breast disorders F-LDysmenorrhea FMenstruation and uterine bleeding NEC FGMenstrual cycle and uterine bleeding disorders FʎReproductive system and breast disorders F-LGENERAL MEDICAL HISTORY2019-12 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Dec2019D-373 N DV 1.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrS@DWD4Hs/Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrS@DWDHHr/HDWD$HsnT$DWD4Hs/Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061228100612281006Aallergy to sulfa Drug hypersensitivity FImmune system disorders F4Sulfonamide allergy FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2013M-2898 N DV 7.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrS@DWD4Hs/Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrS@DWDHHr/HDWD$HsnT$DWD4Hs/Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061229100612291006ABilateral extremity hyperhidrosis Hyperhidrosis F"Skin and subcutaneous tissue disorders F5Hyperhidrosis F"Apocrine and eccrine gland disorders F&Skin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2017-04 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Apr2017D-1347 N DV 3.69 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrpPDWNDHs=Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrpPDWD$Hr$DW9DHrhDWNDHs=Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DW9DWN.DW6DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061229100612291006A Iron deficiency anemia Iron deficiency anaemia F<Blood and lymphatic system disorders FQIron deficiency anemia F>Anaemia deficiencies FzAnaemias nonhaemolytic and marrow depression FBlood and lymphatic system disorders FQGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1072 N DV 2.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrpPDWNDHs=Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrpPDWD$Hr$DW9DHrhDWNDHs=Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DW9DWN.DW6DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061230100612301006AAttention Deficit Hyperactive Disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit/hyperactivity disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1072 N DV 2.94 YEARSAYEARS12-15 YearsAFA MULTIPLE A`MULTIRACIAL A`YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrpDWD0Hr0BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrpDWD0Hr0......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1006 10061230100612301006A Mild Anxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2018M-1072 N DV 2.94 YEARSAYEARS12-15 YearsAFA MULTIPLE A`MULTIRACIAL A`YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrpDWD0Hr0BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrpDWD0Hr0......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1006 10061230100612301006A0Mild Depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1072 N DV 2.94 YEARSAYEARS12-15 YearsAFA MULTIPLE A`MULTIRACIAL A`YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrpDWD0Hr0BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrpDWD0Hr0......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1006 10061231100612311006APremenarchal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrLDWDHr<BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrLDWDHr<......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1006 10061231100612311006A Anxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3264 N DV 8.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrLDWDHr<BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrLDWDHr<......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1006 10061231100612311006ApObstructive Sleep Apnea Sleep apnoea syndrome F6Respiratory, thoracic and mediastinal disorders F-Obstructive sleep apnea syndrome FoBreathing abnormalities F>Respiratory disorders NEC F-Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2012 2014-08-08BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2012M-3264 08Aug2014 -2314 N DV 8.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrLDWDHr<BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrLDWDHr<......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1006 10061231100612311006A@Depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2013M-2898 N DV 7.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrLDWDHr<BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrLDWDHr<......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1006 10061231100612311006A0Attention deficit hyperactive disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit/hyperactivity disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2017M-1437 N DV 3.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrLDWDHr<BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrLDWDHr<......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1006 10061231100612311006A`Obsessive compulsive disorder Obsessive-compulsive disorder F JPsychiatric disorders F'Obsessive-compulsive disorder F JObsessive-compulsive disorders and symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1437 N DV 3.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrLDWDHr<BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrLDWDHr<......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1006 10061231100612311006AAdenoidectomy Adenoidectomy FNSurgical and medical procedures F<Adenoidectomy FNTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2014-08-082014-08-08BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.07 08Aug2014 -2314 08Aug2014 -2314 N DV 6.34 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrLDWDHr<BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrLDWDHr<......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1006 10061231100612311006APNasal Turbinate reduction Turbinectomy FFSurgical and medical procedures F<Trimming of turbinate bones FENasal therapeutic procedures FHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2014-08-082014-08-08BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.08 08Aug2014 -2314 08Aug2014 -2314 N DV 6.34 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrLDWDHr<BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrLDWDHr<......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1006 10061232100612321006ATibial Plateau Surgery Bone operation FSurgical and medical procedures F<Bone operation FBone therapeutic procedures NEC FBone and joint therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2019-10-062019-10-06BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 06Oct2019 -429 06Oct2019 -429 N DV 1.18 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD0HrDWDHs<Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD0HrDWDHrgDWD@Hss@DWDHs<Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061234100612341006AMild scoliosis Scoliosis F1Musculoskeletal and connective tissue disorders FkScoliosis F1Spine and neck deformities FMusculoskeletal and connective tissue deformities (incl intervertebral disc disorders)FYMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2019-02-05 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 05Feb2019 -673 N DV 1.85 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD~THrTDWD}(Hr7BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD~THrTDWD}(Hr7......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1006 10061235100612351006AGluten intolerance Gluten sensitivity FMMetabolism and nutrition disorders FGluten intolerance FޜFood malabsorption and intolerance syndromes (excl sugar intolerance) FطFood intolerance syndromes FضMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-3995 N DV 10.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD~HrDWD~Hs)Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD~HrDWD}dHr7DWDɐHsuDWD~Hs)Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061235100612351006A insomnia Insomnia F%Psychiatric disorders F'Insomnia F%Disturbances in initiating and maintaining sleep FFSleep disorders and disturbances F6Psychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019M-708 N DV 1.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD~HrDWD~Hs)Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD~HrDWD}dHr7DWDɐHsuDWD~Hs)Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061236100612361006A Hay Fever Seasonal allergy FUImmune system disorders F4Hay fever FbAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2016M-1804 N DV 4.94 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD`Hr`DWDȠHr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD`Hr`DWDȠHr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061236100612361006A0Migraines Migraine FONervous system disorders FMigraine FOMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1073 N DV 2.94 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD`Hr`DWDȠHr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD`Hr`DWDȠHr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061236100612361006AConstipation Constipation FGastrointestinal disorders FܛConstipation FGastrointestinal atonic and hypomotility disorders NEC F܍Gastrointestinal motility and defaecation conditions FܹGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-708 N DV 1.94 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD`Hr`DWDȠHr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD`Hr`DWDȠHr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061237100612371006A`Migraines Migraine FONervous system disorders FMigraine FOMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2015M-2169 N DV 5.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWD\HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDHrlDWD Hsn DWD\HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061237100612371006AAttention Deficit Hyperactivity Disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01001Jan2016M-1804 N DV 4.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWD\HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDHrlDWD Hsn DWD\HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061237100612371006ApMyopia Myopia FkEye disorders FԯMyopia FkRefractive and accommodative disorders F+Vision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.08 01Jan2016M-1804 N DV 4.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWD\HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDHrlDWD Hsn DWD\HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061237100612371006A0Generalized anxiety disorder Generalised anxiety disorder FPsychiatric disorders F'Generalized anxiety disorder F9Anxiety disorders NEC FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-03 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Mar2020D-283 N DV 0.78 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWD\HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDHrlDWD Hsn DWD\HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061237100612371006A@Major depressive disorder Major depression FxpPsychiatric disorders F'Major depressive disorder FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019-11 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Nov2019D-404 N DV 1.11 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWD\HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDHrlDWD Hsn DWD\HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061237100612371006ASeasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2020-09 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.09 01Sep2020D-99 N DV 0.27 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWD\HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDHrlDWD Hsn DWD\HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061237100612371006APMaxillary fracture Jaw fracture FInjury, poisoning and procedural complications FFractured maxilla FSkull fractures, facial bone fractures and dislocations F6Bone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2013-08-042013-08-08BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 04Aug2013 -2684 08Aug2013 -2680 N DV 7.35 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWD\HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDHrlDWD Hsn DWD\HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061237100612371006ANasal Septal fracture Facial bones fracture F*Injury, poisoning and procedural complications FFractured nose FSkull fractures, facial bone fractures and dislocations F6Bone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2013-08-042013-08-08BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.06 04Aug2013 -2684 08Aug2013 -2680 N DV 7.35 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWD\HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDHrlDWD Hsn DWD\HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061237100612371006Anasal fracture Facial bones fracture F*Injury, poisoning and procedural complications FFractured nose FSkull fractures, facial bone fractures and dislocations F6Bone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2013-08-042013-08-08BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.05 04Aug2013 -2684 08Aug2013 -2680 N DV 7.35 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWD\HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDHrlDWD Hsn DWD\HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061237100612371006A Fracture repair- facial Fracture treatment FSurgical and medical procedures F<Fracture treatment FFracture treatments (excl skull and spine) FDBone and joint therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2013-08-082013-08-08BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.07 08Aug2013 -2680 08Aug2013 -2680 N DV 7.34 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWD\HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDHrlDWD Hsn DWD\HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061239100612391006A Premenarchal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) 2020-12-12BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6)12Dec2020 4 N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDHre DWD`HsrDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061239100612391006AMild facial acne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2020-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2020D-343 N DV 0.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDHre DWD`HsrDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061241100612411006AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1438 N DV 3.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061241100612411006A seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1073 N DV 2.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061242100612421006AAcne Facial Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1073 N DV 2.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWD~THrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWD~THr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061248100612481006ASeasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2014M-2536 N DV 6.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD$Hr/$DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD$Hr/$DWDHrMtDWDHstDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1006 10061249100612491006AObesity Obesity F ;Metabolism and nutrition disorders FObesity F ;General nutritional disorders NEC FAppetite and general nutritional disorders FJMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1806 N DV 4.95 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrHDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrHDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1006 10061250100612501006Amigraines Migraine FONervous system disorders FMigraine FOMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2171 N DV 5.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDdHrIdDWDHs Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDdHrIdDWDHrDWDPHsv PDWDHs Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061252100612521006ACat Dandruff Intolerance Allergy to animal FNImmune system disorders F4Allergy to animal dander FOAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4728 N DV 12.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr`DWDDHrDBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr`DWDDHrD......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061252100612521006A Environmental Allergies Hypersensitivity FImmune system disorders F4Environmental allergy FTAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2008M-4728 N DV 12.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr`DWDDHrDBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr`DWDDHrD......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061252100612521006APrat dandruff allergies Allergy to animal FNImmune system disorders F4Allergy to animal dander FOAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2008M-4728 N DV 12.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr`DWDDHrDBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr`DWDDHrD......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061252100612521006A`white chocolate intolerance Food intolerance FMetabolism and nutrition disorders FFood intolerance FFood malabsorption and intolerance syndromes (excl sugar intolerance) FطFood intolerance syndromes FضMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2010M-3997 N DV 10.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr`DWDDHrDBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr`DWDDHrD......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061252100612521006A0anxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1440 N DV 3.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr`DWDDHrDBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr`DWDDHrD......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061252100612521006A@depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2017M-1440 N DV 3.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr`DWDDHrDBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr`DWDDHrD......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061253100612531006A seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1075 N DV 2.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDdHrvdDWDHsCPPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDdHrvdDWD Hr]DWD~Hsr'DWDHsCPPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061253100612531006Abroken right wrist Wrist fracture FR1Injury, poisoning and procedural complications FBroken wrist FyLimb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2020-05 2020-07 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01May2020D-224 31Jul2020D-133 N DV 0.62 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDdHrvdDWDHsCPPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDdHrvdDWD Hr]DWD~Hsr'DWDHsCPPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061254100612541006A@Obesity Obesity F ;Metabolism and nutrition disorders FObesity F ;General nutritional disorders NEC FAppetite and general nutritional disorders FJMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2017M-1440 N DV 3.95 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrrDWDtHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrrDWDtHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061254100612541006AInsomnia Insomnia F%Psychiatric disorders F'Insomnia F%Disturbances in initiating and maintaining sleep FFSleep disorders and disturbances F6Psychiatric disorders F'GENERAL MEDICAL HISTORY2020-07 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jul2020D-163 N DV 0.45 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrrDWDtHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrrDWDtHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061254100612541006A Intermittent Headaches Headache FNervous system disorders FIntermittent headache F~ Headaches NEC FHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2020-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jun2020D-193 N DV 0.53 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrrDWDtHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrrDWDtHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061254100612541006APanxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jun2020D-193 N DV 0.53 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrrDWDtHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrrDWDtHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061254100612541006A`depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jun2020D-193 N DV 0.53 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrrDWDtHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrrDWDtHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061254100612541006A0Intermittent Stomach Aches Abdominal pain upper FGastrointestinal disorders FܛStomach ache F:Gastrointestinal and abdominal pains (excl oral and throat) F܆Gastrointestinal signs and symptoms FGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2020-06-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 06Jun2020 -188 N DV 0.52 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrrDWDtHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrrDWDtHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061256100612561006A0Situational depression Adjustment disorder with depressed mood FPsychiatric disorders F'Situational depression FAdjustment disorders FAdjustment disorders (incl subtypes) FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-04 2020-07 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Apr2020D-254 31Jul2020D-133 N DV 0.7 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWD\HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWD\Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1006 10061256100612561006AAdenoidectomy Adenoidectomy FNSurgical and medical procedures F<Adenoidectomy FNTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2008 2008 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2008M-4728 31Dec2008M-4363 N DV 12.95 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWD\HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWD\Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1006 10061256100612561006A Recurrent tonsillitis Tonsillitis FBhInfections and infestations FTonsillitis recurrent FBlUpper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2008 2008 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2008M-4728 31Dec2008M-4363 N DV 12.95 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWD\HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWD\Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1006 10061256100612561006A@Tonsillectomy Tonsillectomy FBfSurgical and medical procedures F<Tonsillectomy FBfTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2008 2008 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2008M-4728 31Dec2008M-4363 N DV 12.95 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWD\HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWD\Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1006 10061256100612561006APfacial acne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1075 N DV 2.95 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWD\HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWD\Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1006 10061257100612571006AAttention Deficit Hyperactive Disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit/hyperactivity disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2015M-2171 N DV 5.95 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DVDHrDWODŔHslPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDHr|DW:D\Hr\DWODŔHslPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DW:DWO.DW6DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061257100612571006A0Tourette's Syndrome Tourette's disorder FBCongenital, familial and genetic disorders FTourette's syndrome FBNeurological disorders congenital NEC FNeurological disorders congenital FCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2016M-1806 N DV 4.95 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DVDHrDWODŔHslPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDHr|DW:D\Hr\DWODŔHslPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DW:DWO.DW6DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061257100612571006A Menstrual Cramping Dysmenorrhoea FReproductive system and breast disorders F-LMenstrual cramps F<Menstruation and uterine bleeding NEC FGMenstrual cycle and uterine bleeding disorders FʎReproductive system and breast disorders F-LGENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1440 N DV 3.95 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DVDHrDWODŔHslPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDHr|DW:D\Hr\DWODŔHslPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DW:DWO.DW6DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061258100612581006AAttention Deficit Hyperactive Disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit/hyperactivity disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1443 N DV 3.95 YEARSAYEARS12-15 YearsAMANATIVE HAWAIIAN OR OTHER PACIFIC ISLANDERAPNATIVE HAWAIIAN OR OTHER PACIFIC ISLANDERAPYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr$DW D}Hr!\BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr$DW D}Hr!\......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061258100612581006A Seasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1078 N DV 2.95 YEARSAYEARS12-15 YearsAMANATIVE HAWAIIAN OR OTHER PACIFIC ISLANDERAPNATIVE HAWAIIAN OR OTHER PACIFIC ISLANDERAPYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr$DW D}Hr!\BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr$DW D}Hr!\......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061259100612591006AHeadaches Headache FNervous system disorders FHeadache FHeadaches NEC FHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1443 N DV 3.95 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDxHr8DWoDlHsEZPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDxHr8DW DHr3,DWVDHs$hDWoDlHsEZPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWVDWo.DW@DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061259100612591006A Right hand 4th finger sprain Ligament sprain FInjury, poisoning and procedural complications FFinger sprain FױMuscle, tendon and ligament injuries FInjuries NEC FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2020-08-24 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 24Aug2020 -112 N DV 0.31 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDxHr8DWoDlHsEZPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDxHr8DW DHr3,DWVDHs$hDWoDlHsEZPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWVDWo.DW@DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061260100612601006APre-menarchal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr9pDWD8Hs8Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr9pDW DHr3hDWDHsr14DWD8Hs8Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061261100612611006A0Bicuspid aortic valve Bicuspid aortic valve FHCongenital, familial and genetic disorders FBicuspid aortic valve FHCardiac valve disorders congenital F>Cardiac and vascular disorders congenital FCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD HrDW D$Hr3BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD HrDW D$Hr3......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1006 10061261100612611006A Attention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2011M-3635 N DV 9.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD HrDW D$Hr3BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD HrDW D$Hr3......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1006 10061261100612611006AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2019M-713 N DV 1.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD HrDW D$Hr3BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD HrDW D$Hr3......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1006 10061262100612621006ACystic Acne, Facial Acne cystic FwSkin and subcutaneous tissue disorders F5Cystic acne FnAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2020-07 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jul2020D-166 N DV 0.46 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDpHrDWD\Hsz\Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDpHrDWD<Hr<DWDHs}.hDWD\Hsz\Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061263100612631006A Premenarcheal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDW D\Hr@\BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDW D\Hr@\......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1006 10061263100612631006AHeadaches Headache FNervous system disorders FHeadache FHeadaches NEC FHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-713 N DV 1.95 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDW D\Hr@\BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDW D\Hr@\......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1006 10061265100612651006AAsthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4735 YChronic pulmonary disease DV 12.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHru DWD{ Hrp BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHru DWD{ Hrp ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1006 10061265100612651006A@WHEY INTOLERANCE Food intolerance FMetabolism and nutrition disorders FFood intolerance FFood malabsorption and intolerance syndromes (excl sugar intolerance) FطFood intolerance syndromes FضMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2008M-4735 N DV 12.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHru DWD{ Hrp BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHru DWD{ Hrp ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1006 10061265100612651006A0Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2012M-3274 N DV 8.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHru DWD{ Hrp BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHru DWD{ Hrp ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1006 10061265100612651006A Growth delay Growth retardation FhMusculoskeletal and connective tissue disorders FkGrowth retardation FhMusculoskeletal and connective tissue conditions NEC FMusculoskeletal and connective tissue disorders NEC FiMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2014M-2543 N DV 6.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHru DWD{ Hrp BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHru DWD{ Hrp ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1006 10061266100612661006ADysmenorrhea Dysmenorrhoea FReproductive system and breast disorders F-LDysmenorrhea FMenstruation and uterine bleeding NEC FGMenstrual cycle and uterine bleeding disorders FʎReproductive system and breast disorders F-LGENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1810 N DV 4.96 YEARSAYEARS12-15 YearsAFA MULTIPLE A`MULTIRACIAL A`YYPlacebo PLACEBO Placebo PLACEBO DVD4Hr4DWTDtHs!tPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD4Hr4DWDdHrŐdDW?DHs-hDWTDtHs!tPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DW?DWT.DW>DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061269100612691006A0guided growth plate of bilateral knees Epiphysiodesis F&Surgical and medical procedures F<Epiphysiodesis F&Bone therapeutic procedures NEC FBone and joint therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2020-12-012020-12-01BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Dec2020 -14 01Dec2020 -14 N DV 0.04 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061269100612691006A bilateral bow legs Knee deformity FMusculoskeletal and connective tissue disorders FkBow legs FExtremity deformities FMusculoskeletal and connective tissue deformities (incl intervertebral disc disorders)FYMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2008M-4732 N DV 12.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061269100612691006ASeasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4001 N DV 10.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061270100612701006A Latex allergy Rubber sensitivity F/Immune system disorders F4Latex allergy FrAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2005 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2005M-5828 N DV 15.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr@DWNDHs=Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr@DWDTHrłTDW9DXHr.DWNDHs=Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DW9DWN.DW6DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061270100612701006AAloe allergy Allergy to plants FmImmune system disorders F4Allergy to plants FmAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1445 N DV 3.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr@DWNDHs=Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr@DWDTHrłTDW9DXHr.DWNDHs=Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DW9DWN.DW6DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061271100612711006A0Meningitis Meningitis FInfections and infestations FMeningitis FCentral nervous system and spinal infections FInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2011 2011 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2011M-3637 31Dec2011M-3273 N DV 9.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr4DW DHrnxBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr4DW DHrnx......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061271100612711006AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2016M-1811 N DV 4.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr4DW DHrnxBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr4DW DHrnx......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061271100612711006A Attention Deficit Hyperactive Disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit/hyperactivity disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1811 N DV 4.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr4DW DHrnxBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr4DW DHrnx......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061271100612711006A@right hand wart Skin papilloma F6KNeoplasms benign, malignant and unspecified (incl cysts and polyps)F0Wart FQQSkin neoplasms benign F6BCutaneous neoplasms benign F6CNeoplasms benign, malignant and unspecified (incl cysts and polyps)F0GENERAL MEDICAL HISTORY2019-11 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Nov2019D-411 N DV 1.13 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr4DW DHrnxBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr4DW DHrnx......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061272100612721006A@Attention Deficit Hyperactivity Disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4002 N DV 10.96 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDdHrDWDHsrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDdHrDWDHsr......BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) DV.DW...DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061272100612721006ASeparation Anxiety Disorder Separation anxiety disorder F2Psychiatric disorders F'Separation anxiety disorder F2Anxiety disorders NEC FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.07 01Jan2010M-4002 N DV 10.96 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDdHrDWDHsrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDdHrDWDHsr......BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) DV.DW...DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061272100612721006A`Disruptive Mood Dysregulation Disorder Disruptive mood dysregulation disorder FjPsychiatric disorders F'Disruptive mood dysregulation disorder FjAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2012M-3272 N DV 8.96 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDdHrDWDHsrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDdHrDWDHsr......BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) DV.DW...DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061272100612721006A0Asthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2013M-2906 YChronic pulmonary disease DV 7.96 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDdHrDWDHsrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDdHrDWDHsr......BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) DV.DW...DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061272100612721006A Anxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2014M-2541 N DV 6.96 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDdHrDWDHsrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDdHrDWDHsr......BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) DV.DW...DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061272100612721006APDepression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2014M-2541 N DV 6.96 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDdHrDWDHsrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDdHrDWDHsr......BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) DV.DW...DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061272100612721006ARecurring Insomnia Insomnia F%Psychiatric disorders F'Insomnia exacerbated F(Disturbances in initiating and maintaining sleep FFSleep disorders and disturbances F6Psychiatric disorders F'GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.08 01Jan2014M-2541 N DV 6.96 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDdHrDWDHsrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDdHrDWDHsr......BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) DV.DW...DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061272100612721006ARecurring Nightmares Nightmare F dPsychiatric disorders F'Nightmares F fParasomnias FSleep disorders and disturbances F6Psychiatric disorders F'GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01001Jan2015M-2176 N DV 5.96 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDdHrDWDHsrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDdHrDWDHsr......BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) DV.DW...DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061272100612721006AAggressive Behaviors Aggression FPPsychiatric disorders F'Aggressive behaviour FRBehaviour and socialisation disturbances FPersonality disorders and disturbances in behaviour F&Psychiatric disorders F'GENERAL MEDICAL HISTORY2017 2017 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.09 01Jan2017M-1445 31Dec2017M-1081 N DV 3.96 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDdHrDWDHsrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDdHrDWDHsr......BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) DV.DW...DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061272100612721006ApPost Traumatic Stress Disorder Post-traumatic stress disorder F$\Psychiatric disorders F'Post-traumatic stress disorder F$\Stress disorders F;cAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2015-11-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 06Nov2015 -1867 N DV 5.11 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDdHrDWDHsrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDdHrDWDHsr......BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) DV.DW...DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061273100612731006A0mild asthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2014 2017 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2014M-2541 31Dec2017M-1081 YChronic pulmonary disease DV 6.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD,Hr'DWDLHs<Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD,Hr'DWDHrjDWDְHssѰDWDLHs<Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061273100612731006A Headache, intermittent Headache FNervous system disorders FIntermittent headache F~ Headaches NEC FHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2016M-1811 N DV 4.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD,Hr'DWDLHs<Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD,Hr'DWDHrjDWDְHssѰDWDLHs<Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061273100612731006AAcne, Facial Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-715 N DV 1.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD,Hr'DWDLHs<Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD,Hr'DWDHrjDWDְHssѰDWDLHs<Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061274100612741006A@Insomnia Insomnia F%Psychiatric disorders F'Insomnia F%Disturbances in initiating and maintaining sleep FFSleep disorders and disturbances F6Psychiatric disorders F'GENERAL MEDICAL HISTORY2019-08 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Aug2019D-503 N DV 1.38 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDPHr?DWDHr1BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDPHr?DWDHr1......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1006 10061274100612741006A0Facial Acne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2020-08 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Aug2020D-137 N DV 0.38 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDPHr?DWDHr1BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDPHr?DWDHr1......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1006 10061274100612741006APSeasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2010M-4002 N DV 10.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDPHr?DWDHr1BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDPHr?DWDHr1......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1006 10061274100612741006A Attention Deficit Hyperactivity Disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2014M-2541 N DV 6.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDPHr?DWDHr1BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDPHr?DWDHr1......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1006 10061274100612741006AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019M-715 N DV 1.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDPHr?DWDHr1BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDPHr?DWDHr1......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1006 10061276100612761006ASeasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2177 N DV 5.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrKDWDHs(Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrKDWDHrִDWDHst8DWDHs(Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061277100612771006A@attention deficit hyperactive disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit/hyperactivity disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2015M-2177 N DV 5.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrpDWD Hs8 Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrpDWDHrpDWDHssDWD Hs8 Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061277100612771006APseasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1812 N DV 4.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrpDWD Hs8 Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrpDWDHrpDWDHssDWD Hs8 Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061277100612771006A Migraines Migraine FONervous system disorders FMigraine FOMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2018M-1081 N DV 2.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrpDWD Hs8 Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrpDWDHrpDWDHssDWD Hs8 Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061277100612771006AFarsightedness Hypermetropia FCEye disorders FԯFarsighted FxRefractive and accommodative disorders F+Vision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2019M-716 N DV 1.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrpDWD Hs8 Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrpDWDHrpDWDHssDWD Hs8 Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061277100612771006A0anxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019M-716 N DV 1.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrpDWD Hs8 Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrpDWDHrpDWDHssDWD Hs8 Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061279100612791006A@Premenarchal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) 2020-12-29BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 (b)(6) (b)(6)29Dec2020 13 N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDTHrTDWDHsJPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDTHrTDW DtHrėDWDHHsrBDWDHsJPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061279100612791006A Asthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2011M-3638 YChronic pulmonary disease DV 9.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDTHrTDWDHsJPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDTHrTDW DtHrėDWDHHsrBDWDHsJPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061279100612791006APSeasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2013M-2907 N DV 7.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDTHrTDWDHsJPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDTHrTDW DtHrėDWDHHsrBDWDHsJPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061279100612791006AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2014M-2542 N DV 6.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDTHrTDWDHsJPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDTHrTDW DtHrėDWDHHsrBDWDHsJPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061279100612791006A0Difficulty Sleeping Insomnia F%Psychiatric disorders F'Difficulty sleeping FȄDisturbances in initiating and maintaining sleep FFSleep disorders and disturbances F6Psychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2017M-1446 N DV 3.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDTHrTDWDHsJPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDTHrTDW DtHrėDWDHHsrBDWDHsJPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061280100612801006AAsthma Moderate Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4003 YChronic pulmonary disease DV 10.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr6DBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr6D......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1006 10061280100612801006A Obesity Obesity F ;Metabolism and nutrition disorders FObesity F ;General nutritional disorders NEC FAppetite and general nutritional disorders FJMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2016M-1812 N DV 4.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr6DBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr6D......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1006 10061282100612821006ASeasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1447 N DV 3.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD\HrDWDtHr2tBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD\HrDWDtHr2t......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1006 10061283100612831006A0Attention Deficit Hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4004 N DV 10.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDPHrDWDŔHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDPHrDWDؐHrpDWDxHsvxDWDŔHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061283100612831006AAppendectomy Appendicectomy FBSurgical and medical procedures F<Appendectomy F@Large intestine therapeutic procedures F{Gastrointestinal therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2009-09-302009-09-30BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 30Sep2009 -4097 30Sep2009 -4097 N DV 11.22 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDPHrDWDŔHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDPHrDWDؐHrpDWDxHsvxDWDŔHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061283100612831006A Appendicitis Appendicitis FCInfections and infestations FAppendicitis FCAbdominal and gastrointestinal infections FܯInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2009-09-302009-09-30BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 30Sep2009 -4097 30Sep2009 -4097 N DV 11.22 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDPHrDWDŔHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDPHrDWDؐHrpDWDxHsvxDWDŔHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061286100612861006APPTOSIS LEFT EYE Eyelid ptosis FEye disorders FԯEyelid ptosis FEyelid movement disorders FOcular neuromuscular disorders F Eye disorders FԯGENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2007M-5103 N DV 13.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHrytBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHryt......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061286100612861006Apseasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2014M-2546 N DV 6.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHrytBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHryt......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061286100612861006AALLERGY TO ANIMAL DANDER Allergy to animal FNImmune system disorders F4Allergy to animal dander FOAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2015M-2181 N DV 5.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHrytBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHryt......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061286100612861006A@INSOMNIA Insomnia F%Psychiatric disorders F'Insomnia F%Disturbances in initiating and maintaining sleep FFSleep disorders and disturbances F6Psychiatric disorders F'GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.07 01Jan2015M-2181 N DV 5.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHrytBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHryt......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061286100612861006A`allergic rhinitis due to dust mite Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2015M-2181 N DV 5.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHrytBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHryt......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061286100612861006A0Attention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1450 N DV 3.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHrytBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHryt......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061286100612861006A ANXIETY Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2018M-1085 N DV 2.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHrytBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHryt......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061287100612871006AAttention Deficit Hyperactive Disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit/hyperactivity disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2014M-2546 N DV 6.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHr̄xPlacebo A .Placebo A .DVDHrDWDHr̄x......Placebo Placebo DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061288100612881006A@Recurrent pharyngitis Pharyngitis FInfections and infestations FPharyngitis FUpper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2006 2008 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2006M-5468 31Dec2008M-4373 N DV 14.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr̄<BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr̄<......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DW@DV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061288100612881006AAdenoidectomy Adenoidectomy FNSurgical and medical procedures F<Adenoidectomy FNTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2008 2008 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2008M-4738 31Dec2008M-4373 N DV 12.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr̄<BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr̄<......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DW@DV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061288100612881006A`Tonsilectomy Tonsillectomy FBfSurgical and medical procedures F<Tonsillectomy FBfTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2008 2008 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2008M-4738 31Dec2008M-4373 N DV 12.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr̄<BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr̄<......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DW@DV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061288100612881006APSeasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1816 N DV 4.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr̄<BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr̄<......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DW@DV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061288100612881006A0Recurrent Paronychia of great right toe Paronychia F`Infections and infestations FParonychia F`Bacterial infections NEC FOBacterial infectious disorders F2Infections and infestations FGENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2017M-1450 N DV 3.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr̄<BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr̄<......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DW@DV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061288100612881006A Osteomyelitis Osteomyelitis FInfections and infestations FOsteomyelitis FBone and joint infections FInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2007-11 2007-12 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.06 01Nov2007D-4799 31Dec2007D-4739 N DV 13.14 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr̄<BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr̄<......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DW@DV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061289100612891006A Asthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2015M-2182 YChronic pulmonary disease DV 5.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrHDWD|HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrHDWD|Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061289100612891006AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2016M-1817 N DV 4.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrHDWD|HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrHDWD|Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061289100612891006APSEASONAL ALLERGIES Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2016M-1817 N DV 4.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrHDWD|HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrHDWD|Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061289100612891006A@GASTRO ESOPHAGEAL REFLUX DISEASE Gastrooesophageal reflux disease F]Gastrointestinal disorders FܛGastroesophageal reflux disease FGastrointestinal atonic and hypomotility disorders NEC F܍Gastrointestinal motility and defaecation conditions FܹGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-721 N DV 1.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrHDWD|HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrHDWD|Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061289100612891006A0Attention Deficit Hyperactive Disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit/hyperactivity disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-10 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Oct2020D-82 N DV 0.23 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrHDWD|HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrHDWD|Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061290100612901006AAsthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4739 YChronic pulmonary disease DV 12.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr8BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr8......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061290100612901006A@Seasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2010M-4008 N DV 10.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr8BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr8......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061290100612901006A0Depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2015M-2182 N DV 5.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr8BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr8......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061290100612901006A Bruised Facet (back) Contusion F\Injury, poisoning and procedural complications FContusion of back FSkin injuries NEC FInjuries NEC FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2019M-721 N DV 1.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr8BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr8......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061291100612911006ACholesteatoma of right ear Cholesteatoma FBNeoplasms benign, malignant and unspecified (incl cysts and polyps)F0Cholesteatoma FBAural neoplasms benign FPMiscellaneous and site unspecified neoplasms benign FNeoplasms benign, malignant and unspecified (incl cysts and polyps)F0GENERAL MEDICAL HISTORY2011 2018 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2011M-3643 31Dec2018M-722 N DV 9.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD@HrDWDHs~XPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD@HrDWDHrtDWDHs{ذDWDHs~XPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061291100612911006A Environment Allergies Hypersensitivity FImmune system disorders F4Environmental allergy FTAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1451 N DV 3.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD@HrDWDHs~XPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD@HrDWDHrtDWDHs{ذDWDHs~XPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061291100612911006A0right ear canal removal Ear operation FSurgical and medical procedures F<Ear operation FHead, neck and oral cavity therapeutic procedures NEC FdsHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2018 2018 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2018M-1086 31Dec2018M-722 N DV 2.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD@HrDWDHs~XPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD@HrDWDHrtDWDHs{ذDWDHs~XPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061292100612921006Aspinal kyphosis Kyphosis FUMusculoskeletal and connective tissue disorders FkKyphosis FUSpine and neck deformities FMusculoskeletal and connective tissue deformities (incl intervertebral disc disorders)FYMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2019-08 2019-10-14BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Aug2019D-509 14Oct2019 -435 N DV 1.4 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD<HrDWDHsAxPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD<HrDWDHr`DWD|Hsn8|DWDHsAxPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061292100612921006A@dairy intolerance Dairy intolerance FMetabolism and nutrition disorders FDairy intolerance FFood malabsorption and intolerance syndromes (excl sugar intolerance) FطFood intolerance syndromes FضMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2020-08 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Aug2020D-143 N DV 0.39 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD<HrDWDHsAxPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD<HrDWDHr`DWD|Hsn8|DWDHsAxPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061292100612921006A Insomnia Insomnia F%Psychiatric disorders F'Insomnia F%Disturbances in initiating and maintaining sleep FFSleep disorders and disturbances F6Psychiatric disorders F'GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4008 N DV 10.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD<HrDWDHsAxPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD<HrDWDHr`DWD|Hsn8|DWDHsAxPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061292100612921006ADepression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.08 01Jan2014M-2547 N DV 6.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD<HrDWDHsAxPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD<HrDWDHr`DWD|Hsn8|DWDHsAxPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061292100612921006A0anxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2014M-2547 N DV 6.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD<HrDWDHsAxPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD<HrDWDHr`DWD|Hsn8|DWDHsAxPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061292100612921006APnasal trauma Nasal injury FɻInjury, poisoning and procedural complications FNose injury FlSite specific injuries NEC F5Injuries NEC FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2020-06 2020-06-04BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.07 01Jun2020D-204 04Jun2020 -201 N DV 0.56 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD<HrDWDHsAxPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD<HrDWDHr`DWD|Hsn8|DWDHsAxPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061292100612921006A`septorhinoplasty Rhinoplasty F/;Surgical and medical procedures F<Septorhinoplasty F@Nasal therapeutic procedures FHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2020-06-042020-06-04BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.05 04Jun2020 -201 04Jun2020 -201 N DV 0.55 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD<HrDWDHsAxPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD<HrDWDHr`DWD|Hsn8|DWDHsAxPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061292100612921006Apspinal fusion Spinal fusion surgery F[Surgical and medical procedures F<Spinal fusion F8Spine and spinal cord therapeutic procedures F8Nervous system, skull and spine therapeutic procedures FxSurgical and medical procedures F<GENERAL MEDICAL HISTORY2019-10-142019-10-14BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 14Oct2019 -435 14Oct2019 -435 N DV 1.19 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD<HrDWDHsAxPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD<HrDWDHr`DWD|Hsn8|DWDHsAxPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061293100612931006AInsomnia Insomnia F%Psychiatric disorders F'Insomnia F%Disturbances in initiating and maintaining sleep FFSleep disorders and disturbances F6Psychiatric disorders F'GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4008 N DV 10.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr`BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr`......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061294100612941006Aheadache, intermittent Headache FNervous system disorders FIntermittent headache F~ Headaches NEC FHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1086 N DV 2.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDԔHrͲDWDHsvgDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061295100612951006A0Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2014M-2549 N DW 6.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrc DWD4HsAPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrc DWDHraDWDHsn8DWD4HsAPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061295100612951006AAsthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2184 YChronic pulmonary disease DW 5.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrc DWD4HsAPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrc DWDHraDWDHsn8DWD4HsAPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061295100612951006A Pet dander allergy Allergy to animal FNImmune system disorders F4Allergy to animal dander FOAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2015M-2184 N DW 5.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrc DWD4HsAPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrc DWDHraDWDHsn8DWD4HsAPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061296100612961006A0Intermittent Oral Pain Oral pain FGastrointestinal disorders FܛOral pain FOral soft tissue signs and symptoms FOral soft tissue conditions FGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2020-10 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Oct2020D-89 N DW 0.25 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD8Hr8DWDHrpPlacebo A .Placebo A .DWD8Hr8DWDHrp......Placebo Placebo DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061296100612961006AAppendectomy Appendicectomy FBSurgical and medical procedures F<Appendectomy F@Large intestine therapeutic procedures F{Gastrointestinal therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2016-11-182016-11-18BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 18Nov2016 -1502 18Nov2016 -1502 N DW 4.11 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD8Hr8DWDHrpPlacebo A .Placebo A .DWD8Hr8DWDHrp......Placebo Placebo DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061296100612961006A Appendicitis Appendicitis FCInfections and infestations FAppendicitis FCAbdominal and gastrointestinal infections FܯInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2016-11-182016-11-18BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 18Nov2016 -1502 18Nov2016 -1502 N DW 4.11 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD8Hr8DWDHrpPlacebo A .Placebo A .DWD8Hr8DWDHrp......Placebo Placebo DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061298100612981006APeanut, Cashew Allergy Food allergy FزImmune system disorders F4Allergy to nuts Fm/Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2009M-4380 N DW 11.99 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr9DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr9DWDHr DWD@HstDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061298100612981006A Viral Induced Asthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Infection induced asthma FcBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2013M-2919 YChronic pulmonary disease DW 7.99 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr9DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr9DWDHr DWD@HstDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1006 10061299100612991006AATTENTION DEFICIT HYPERACTIVITY DISORDER Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1095 N DW 3 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDLHrLDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDLHrLDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1006 10061300100613001006AAcne-facial Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1467 N DW 4.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr1DW$DHr޼BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr1DW$DHr޼......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1007 10071409100714091007A Simple febrile seizure Febrile convulsion FNervous system disorders FFebrile seizure F"Seizures and seizure disorders NEC F2hSeizures (incl subtypes) F2gNervous system disorders FGENERAL MEDICAL HISTORY2007 2014 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2007M-5043 31Dec2014M-2122 N DV 13.81 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD|Hrad|DWDHsnBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD|Hrad|DWDHsn......BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) DV.DW...DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071409100714091007AAsthma-like condition Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma-like condition FVBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2009 2009 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2009M-4312 31Dec2009M-3948 YChronic pulmonary disease DV 11.81 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD|Hrad|DWDHsnBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD|Hrad|DWDHsn......BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) DV.DW...DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071417100714171007ASeasonal allergy Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2007M-5043 N DV 13.81 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDPHraPDVDHr}#tBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDPHraPDVDHr}#t......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DW@DV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1007 10071429100714291007ASeasonal allergy Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1025 N DV 2.81 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHraDVD`Hr}\Placebo A .Placebo A .DVDHraDVD`Hr}\......Placebo Placebo DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071469100714691007AAchondroplasia Chondrodystrophy FCongenital, familial and genetic disorders FAchondroplasia FDNon-site specific cartilage disorders congenital F Musculoskeletal and connective tissue disorders congenital FlCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2006M-5447 N DV 14.92 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrXDVDHr|BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrXDVDHr|......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1007 10071469100714691007A Allergy to penicillin Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1064 N DV 2.92 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrXDVDHr|BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrXDVDHr|......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1007 10071471100714711007AEnlarged tonsil Tonsillar hypertrophy FBcRespiratory, thoracic and mediastinal disorders F-Tonsillar hypertrophy FBcPharyngeal disorders (excl infections and neoplasms) FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2006 2011 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2006M-5447 31Dec2011M-3257 N DV 14.92 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDVD0Hr0BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDVD0Hr0......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1007 10071471100714711007A Tonsillectomy Tonsillectomy FBfSurgical and medical procedures F<Tonsillectomy FBfTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2011 2011 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2011M-3621 31Dec2011M-3257 N DV 9.92 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDVD0Hr0BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDVD0Hr0......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1007 10071472100714721007AMigraine Migraine FONervous system disorders FMigraine FOMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1429 N DV 3.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD,HrDWDhHs,hPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD,HrDVDHrjDWDHsr_`DWDhHs,hPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071480100714801007AThalassemia minor Thalassaemia minor F@Congenital, familial and genetic disorders FThalassemia minor FlHaemoglobinopathies congenital FWBlood and lymphatic system disorders congenital FRCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2006M-5447 N DV 14.92 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr!|DWD$HsIPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr!|DVDHrDWDxHsrlDWD$HsIPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071483100714831007A Eczema Eczema FSkin and subcutaneous tissue disorders F5Eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2008M-4718 N DV 12.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD`Hr`DWvD$HsN$Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD`Hr`DVD4Hr۴DWaDHs3ILDWvD$HsN$Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWaDWv.DWKDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071483100714831007AAttention deficit/hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit/hyperactivity disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1430 N DV 3.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD`Hr`DWvD$HsN$Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD`Hr`DVD4Hr۴DWaDHs3ILDWvD$HsN$Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWaDWv.DWKDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071484100714841007A Allergy to amoxicillin Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2007M-5083 N DV 13.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDpHrpDWD Hs Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDpHrpDVDHrhDWDHsulDWD Hs Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071484100714841007AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1430 N DV 3.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDpHrpDWD Hs Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDpHrpDVDHrhDWDHsulDWD Hs Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071485100714851007A Serum sickness due to drug Serum sickness F4PImmune system disorders F4Serum sickness F4PAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2013M-2891 N DV 7.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDDVD,Hr,BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDDVD,Hr,......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1007 10071485100714851007AIrregular menstrual cycle Menstruation irregular FKReproductive system and breast disorders F-LIrregular menstrual cycle FOMenstruation and uterine bleeding NEC FGMenstrual cycle and uterine bleeding disorders FʎReproductive system and breast disorders F-LGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-700 N DV 1.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDDVD,Hr,BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDDVD,Hr,......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1007 10071488100714881007ABlepharitis Blepharitis FEye disorders FԯBlepharitis FLid, lash and lacrimal infections, irritations and inflammations FOcular infections, irritations and inflammations FEye disorders FԯGENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2006M-5448 N DV 14.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr_DVDHr@BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr_DVDHr@......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1007 10071488100714881007A Seasonal allergy Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-3987 N DV 10.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr_DVDHr@BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr_DVDHr@......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1007 10071492100714921007AMigraine Migraine FONervous system disorders FMigraine FOMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3257 N DV 8.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD8Hrs8DVD|Hr|Placebo A .Placebo A .DVD8Hrs8DVD|Hr|......Placebo Placebo DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071492100714921007A0Vestibular disorder NOS Vestibular disorder FOEar and labyrinth disorders F)Vestibular disorder NOS FOInner ear disorders NEC FInner ear and VIIIth cranial nerve disorders FEar and labyrinth disorders F)GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2013M-2891 N DV 7.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD8Hrs8DVD|Hr|Placebo A .Placebo A .DVD8Hrs8DVD|Hr|......Placebo Placebo DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071492100714921007A Postural orthostatic tachycardia syndrome Postural orthostatic tachycardia syndrome FCardiac disorders FPostural orthostatic tachycardia syndrome FRate and rhythm disorders NEC F*Cardiac arrhythmias FCardiac disorders FGENERAL MEDICAL HISTORY2020-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2020D-335 N DV 0.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD8Hrs8DVD|Hr|Placebo A .Placebo A .DVD8Hrs8DVD|Hr|......Placebo Placebo DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071495100714951007ASeasonal allergy Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2006M-5449 N DV 14.92 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr|DWDtHs<Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr|DVD HrDWDݸHs}8DWDtHs<Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071497100714971007AAttention deficit/hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit/hyperactivity disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1431 N DV 3.92 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD8HrĸDVDHHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD8HrĸDVDHHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1007 10071499100714991007ADrug allergy Amoxicillin Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2009M-4354 N DV 11.92 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDVD(HrPlacebo A .Placebo A .DVDHrDVD(Hr......Placebo Placebo DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071500100715001007AAttention deficit-hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit-hyperactivity disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2011M-3624 N DV 9.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDVDHr8BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDVDHr8......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DW>DV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1007 10071500100715001007A Seasonal allergy Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2014M-2528 N DV 6.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDVDHr8BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDVDHr8......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DW>DV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1007 10071504100715041007APenicillin allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2005 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2005M-5819 N DV 15.93 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD,Hr,DWDHrOTBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD,Hr,DWDHrOT......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DW>DV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1007 10071505100715051007A Cerebral palsy Cerebral palsy FACongenital, familial and genetic disorders FCerebral palsy FACerebral disorders congenital FdNeurological disorders congenital FCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) YHemiplegia or paraplegia DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD`Hr`DWDˆHs3Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD`Hr`DWDHr,DWDHs_<DWDˆHs3Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071505100715051007A0Hydrocephalus Hydrocephalus FNervous system disorders FHydrocephalus FHydrocephalic conditions FIncreased intracranial pressure and hydrocephalus F"Nervous system disorders FGENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD`Hr`DWDˆHs3Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD`Hr`DWDHr,DWDHs_<DWDˆHs3Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071505100715051007AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2010M-3993 N DV 10.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD`Hr`DWDˆHs3Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD`Hr`DWDHr,DWDHs_<DWDˆHs3Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071505100715051007APMigraine Migraine FONervous system disorders FMigraine FOMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.07 01Jan2015M-2167 N DV 5.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD`Hr`DWDˆHs3Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD`Hr`DWDHr,DWDHs_<DWDˆHs3Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071505100715051007ApSeizure Seizure F2bNervous system disorders FSeizure F2bSeizures and seizure disorders NEC F2hSeizures (incl subtypes) F2gNervous system disorders FGENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2015M-2167 N DV 5.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD`Hr`DWDˆHs3Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD`Hr`DWDHr,DWDHs_<DWDˆHs3Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071505100715051007A@Menorrhagia Heavy menstrual bleeding F/Reproductive system and breast disorders F-LMenorrhagia F1Menstruation with increased bleeding FNMenstrual cycle and uterine bleeding disorders FʎReproductive system and breast disorders F-LGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2019M-706 N DV 1.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD`Hr`DWDˆHs3Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD`Hr`DWDHr,DWDHs_<DWDˆHs3Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071505100715051007A`Portacaval shunt Portal shunt procedure F'Surgical and medical procedures F<Portacaval shunt F#Hepatic therapeutic procedures FxHepatobiliary therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2019M-706 N DV 1.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD`Hr`DWDˆHs3Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD`Hr`DWDHr,DWDHs_<DWDˆHs3Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071511100715111007A Appendectomy Appendicectomy FBSurgical and medical procedures F<Appendectomy F@Large intestine therapeutic procedures F{Gastrointestinal therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2011 2011 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2011M-3628 31Dec2011M-3264 N DV 9.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrTDWDHs7\Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrTDWDHrDWD Hss DWDHs7\Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071511100715111007A0Appendicitis Appendicitis FCInfections and infestations FAppendicitis FCAbdominal and gastrointestinal infections FܯInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2011 2011 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2011M-3628 31Dec2011M-3264 N DV 9.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrTDWDHs7\Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrTDWDHrDWD Hss DWDHs7\Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071511100715111007AAdenoidectomy Adenoidectomy FNSurgical and medical procedures F<Adenoidectomy FNTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2012 2012 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2012M-3263 31Dec2012M-2898 N DV 8.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrTDWDHs7\Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrTDWDHrDWD Hss DWDHs7\Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071511100715111007A@Chronic tonsillitis Chronic tonsillitis F@Infections and infestations FChronic tonsillitis F@Upper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2012 2012 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2012M-3263 31Dec2012M-2898 N DV 8.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrTDWDHs7\Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrTDWDHrDWD Hss DWDHs7\Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071512100715121007AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2014M-2532 N DV 6.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDXHrZXDWDHrHBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDXHrZXDWDHrH......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DW>DV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1007 10071514100715141007AAttention deficit/hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit/hyperactivity disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3263 N DV 8.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrYDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrYDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1007 10071515100715151007AAllergy to amoxicillin Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4725 N DV 12.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHHrCDWDHrPlacebo A .Placebo A .DVDHHrCDWDHr......Placebo Placebo DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071515100715151007A seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2011M-3629 N DV 9.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHHrCDWDHrPlacebo A .Placebo A .DVDHHrCDWDHr......Placebo Placebo DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071516100715161007ASeasonal allergy Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-3994 N DV 10.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrB$DWDLHs?Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrB$DWDPHr PDWDԔHssϔDWDLHs?Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071517100715171007AAllergy to drug Amoxicillin Drug hypersensitivity FImmune system disorders F4Allergy to antibiotic FxAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-3994 N DV 10.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD,HrPDWDHrHBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD,HrPDWDHrH......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1007 10071518100715181007Aheadaches Headache FNervous system disorders FHeadache FHeadaches NEC FHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2020-10-12 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 12Oct2020 -57 N DV 0.16 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD`HrXDWDxHrxBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD`HrXDWDxHrx......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DW>DV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1007 10071520100715201007Aseasonal allergy Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2009M-4359 N DV 11.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDtHrbDWD(Hs(Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDtHrbDWD|Hr |DWD@Hs@DWD(Hs(Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071521100715211007ASeasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1803 N DV 4.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDˆHr|DWDLHr:LBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDˆHr|DWDLHr:L......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1007 10071522100715221007AAttention Deficit Disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-707 N DV 1.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrXDWDHs `Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrXDWD|Hr7|DWD0Hs~)0DWDHs `Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071524100715241007AFactor V Leiden carrier Factor V Leiden carrier FCongenital, familial and genetic disorders FFactor V Leiden carrier FAbnormal gene carriers FdChromosomal abnormalities, gene alterations and gene variants F(Congenital, familial and genetic disorders FGENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2168 N DV 5.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrdDWUDHs#rPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrdDWDHr DW@DLHsLDWUDHs#rPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DW@DWU.DW1DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071525100715251007AFactor V Leiden carrier Factor V Leiden carrier FCongenital, familial and genetic disorders FFactor V Leiden carrier FAbnormal gene carriers FdChromosomal abnormalities, gene alterations and gene variants F(Congenital, familial and genetic disorders FGENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3264 N DV 8.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD@HrDWD@Hr @BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD@HrDWD@Hr @......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1007 10071527100715271007AAsthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3264 YChronic pulmonary disease DV 8.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD,HrDWDǰHs0Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD,HrDWDXHr.XDWDHsDWDǰHs0Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071531100715311007A0seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2016M-1804 N DV 4.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDhHrhDWD\HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDhHrhDWDHrSDWDdHs|DWD\HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071531100715311007AGastroesophageal reflux disease Gastrooesophageal reflux disease F]Gastrointestinal disorders FܛGastroesophageal reflux disease FGastrointestinal atonic and hypomotility disorders NEC F܍Gastrointestinal motility and defaecation conditions FܹGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1073 N DV 2.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDhHrhDWD\HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDhHrhDWDHrSDWDdHs|DWD\HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071531100715311007A right ear pain Ear pain FDEar and labyrinth disorders F)Ear pain FDEar disorders NEC FAural disorders NEC FEar and labyrinth disorders F)GENERAL MEDICAL HISTORY2020-12-05 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 05Dec2020 -4 N DV 0.01 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDhHrhDWD\HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDhHrhDWDHrSDWDdHs|DWD\HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071533100715331007Aseasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-3995 N DV 10.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDxHrxDWDdHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDxHrxDWDHrbPDWDHs~$DWDdHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071535100715351007Aacne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1073 N DV 2.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD Hr DWD<HrnBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD Hr DWD<Hrn......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DW>DV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1007 10071536100715361007Amigraines Migraine FONervous system disorders FMigraine FOMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2011M-3630 N DV 9.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDߘHrHBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDߘHrH......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1007 10071537100715371007AMigraines Migraine FONervous system disorders FMigraine FOMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1438 N DV 3.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDǰHrҰDWDHr\BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDǰHrҰDWDHr\......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1007 10071539100715391007AEosinophilic esophagitis Eosinophilic oesophagitis FTGastrointestinal disorders FܛEosinophilic esophagitis F\Oesophagitis (excl infective) Ff3Gastrointestinal inflammatory conditions FܱGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2005 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2005M-5821 N DV 15.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDTHrTDWDˬHs<Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDTHrTDWDʀHrDWD4HsDWDˬHs<Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071539100715391007A Food allergies to milk dairy Milk allergy FqImmune system disorders F4Milk allergy FqAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2006M-5456 N DV 14.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDTHrTDWDˬHs<Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDTHrTDWDʀHrDWD4HsDWDˬHs<Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071539100715391007A0Food allergies tree nuts peanuts Food allergy FزImmune system disorders F4Allergy to nuts Fm/Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2006M-5456 N DV 14.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDTHrTDWDˬHs<Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDTHrTDWDʀHrDWD4HsDWDˬHs<Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071541100715411007ASeasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-3995 N DV 10.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWED8HsMPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDhHrDW0DۜHrDWED8HsMPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DW0DWE.DW/DV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1007 10071542100715421007AADD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1804 N DV 4.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1007 10071543100715431007A kidney removal R side Nephrectomy F<Surgical and medical procedures F<Nephrectomy F<Renal therapeutic procedures FRenal and urinary tract therapeutic procedures F,]Surgical and medical procedures F<GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2007M-5091 N DV 13.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD<Hr<DWDHHrPlacebo A .Placebo A .DVD<Hr<DWDHHr......Placebo Placebo DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071543100715431007AWilms tumor Nephroblastoma FYNeoplasms benign, malignant and unspecified (incl cysts and polyps)F0Wilms tumor FQRenal neoplasms malignant FRenal and urinary tract neoplasms malignant and unspecified F,\Neoplasms benign, malignant and unspecified (incl cysts and polyps)F0GENERAL MEDICAL HISTORY2007 2007 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2007M-5091 31Dec2007M-4727 YAny malignancy DV 13.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD<Hr<DWDHHrPlacebo A .Placebo A .DVD<Hr<DWDHHr......Placebo Placebo DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071544100715441007A Seasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1073 N DV 2.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD,Hr,DWDHrlBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD,Hr,DWDHrl......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1007 10071544100715441007AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-708 N DV 1.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD,Hr,DWDHrlBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD,Hr,DWDHrl......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1007 10071546100715461007APenicillin allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2005 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2005M-5822 N DV 15.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD8HrDWDHrPBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD8HrDWDHrP......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DW>DV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1007 10071546100715461007A Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2005 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2005M-5822 N DV 15.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD8HrDWDHrPBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD8HrDWDHrP......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DW>DV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1007 10071546100715461007A0Sinus infection Sinusitis F5Infections and infestations FSinus infection F5Upper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2020-11-092020-11-13BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 09Nov2020 -31 13Nov2020 -27 N DV 0.09 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD8HrDWDHrPBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD8HrDWDHrP......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DW>DV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1007 10071547100715471007AAttention Deficit Hyperactive Disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit/hyperactivity disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2011M-3631 N DV 9.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDtHrDWDHs Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDtHrDWDHrX<DWDĤHsvbDWDHs Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071550100715501007A Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2007M-5092 N DV 13.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDנHr4 DWDHr|BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDנHr4 DWDHr|......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1007 10071550100715501007AAsthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1074 YChronic pulmonary disease DV 2.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDנHr4 DWDHr|BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDנHr4 DWDHr|......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1007 10071551100715511007ASeasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3266 N DV 8.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr1PDWD\HscPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr1PDWDHr/DWDHs{DWD\HscPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071552100715521007A Allergy to antibiotic Amoxicillin Drug hypersensitivity FImmune system disorders F4Allergy to antibiotic FxAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2007M-5092 N DV 13.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD`HrFDWDшHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD`HrFDWDƄHr/DWDlHs~VlDWDшHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071552100715521007AAllergy to animal dander Allergy to animal FNImmune system disorders F4Allergy to animal dander FOAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2008M-4727 N DV 12.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD`HrFDWDшHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD`HrFDWDƄHr/DWDlHs~VlDWDшHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071552100715521007A0Environmental allergies Hypersensitivity FImmune system disorders F4Environmental allergy FTAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2008M-4727 N DV 12.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD`HrFDWDшHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD`HrFDWDƄHr/DWDlHs~VlDWDшHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071557100715571007AAcne cosmetica Acne cosmetica FvSkin and subcutaneous tissue disorders F5Acne cosmetica FvAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-713 N DV 1.95 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDhHr*DW DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDhHr*DW DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1007 10071558100715581007AAttention deficit-hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit-hyperactivity disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3270 N DV 8.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr-|DW DLHrLBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr-|DW DLHrL......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1007 10071558100715581007A Seasonal allergy Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2012M-3270 N DV 8.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr-|DW DLHrLBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr-|DW DLHrL......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1007 10071560100715601007A Seasonal allergy Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2014M-2539 N DV 6.95 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrlLDWDHs+Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrlLDW DHHr-DWD<Hsr]DWDHs+Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1007 10071560100715601007AAcne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019-05 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01May2019D-593 N DV 1.63 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrlLDWDHs+Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrlLDW DHHr-DWD<Hsr]DWDHs+Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1007 10071561100715611007AHyperlipidemia Hyperlipidaemia FMetabolism and nutrition disorders FHyperlipidemia F;Hyperlipidaemias NEC F:Lipid metabolism disorders FʅMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1078 N DV 2.95 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrwPDW DHr%BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrwPDW DHr%......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1007 10071563100715631007Aallergy to Kiwi Food allergy FزImmune system disorders F4Fruit allergy FvAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2011M-3635 N DV 9.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrlDWDHs Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrlDW DHr@DWDHsrJDWDHs Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071567100715671007ASeasonal allergy Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2011M-3636 N DV 9.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDW DHr%XBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDW DHr%X......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1007 10071570100715701007A@O/E - impulsive behavior Impulsive behaviour FPsychiatric disorders F'Impulsive behavior FmImpulse control disorders FImpulse control disorders NEC FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019-08 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Aug2019D-502 N DV 1.38 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDPHrPDWD0Hs0Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDPHrPDW DLHreDWDHsDWD0Hs0Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071570100715701007APobesity Obesity F ;Metabolism and nutrition disorders FObesity F ;General nutritional disorders NEC FAppetite and general nutritional disorders FJMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2020-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2020D-349 N DV 0.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDPHrPDWD0Hs0Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDPHrPDW DLHreDWDHsDWD0Hs0Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071570100715701007A Depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019-03 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Mar2019D-655 N DV 1.8 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDPHrPDWD0Hs0Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDPHrPDW DLHreDWDHsDWD0Hs0Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071570100715701007A0Insomnia Insomnia F%Psychiatric disorders F'Insomnia F%Disturbances in initiating and maintaining sleep FFSleep disorders and disturbances F6Psychiatric disorders F'GENERAL MEDICAL HISTORY2019-03 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Mar2019D-655 N DV 1.8 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDPHrPDWD0Hs0Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDPHrPDW DLHreDWDHsDWD0Hs0Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071570100715701007AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-03 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Mar2020D-289 N DV 0.79 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDPHrPDWD0Hs0Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDPHrPDW DLHreDWDHsDWD0Hs0Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071573100715731007AEczema Eczema FSkin and subcutaneous tissue disorders F5Eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3271 N DV 8.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDXHrXDW DHr'Placebo A .Placebo A .DVDXHrXDW DHr'......Placebo Placebo DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071574100715741007Afracture of right knee Lower limb fracture FInjury, poisoning and procedural complications FKnee fracture FhLimb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2020-08 2020-09 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Aug2020D-137 30Sep2020D-77 N DV 0.38 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr DWDHrŲBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr DWDHrŲ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DW>DV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1007 10071575100715751007ATree nut allergy Food allergy FزImmune system disorders F4Allergy to nuts Fm/Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4733 N DV 12.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDՄHrDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDՄHrDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DW>DV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1007 10071577100715771007AAsthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4733 YChronic pulmonary disease DV 12.96 YEARSAYEARS12-15 YearsAMAMULTIPLE A`MULTIRACIAL A`YYPlacebo PLACEBO Placebo PLACEBO DVDHr<DWDHsjO<Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr<DWDHrDWuDHsMPDWDHsjO<Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWuDW.DWpDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071577100715771007A Attention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2011M-3637 N DV 9.96 YEARSAYEARS12-15 YearsAMAMULTIPLE A`MULTIRACIAL A`YYPlacebo PLACEBO Placebo PLACEBO DVDHr<DWDHsjO<Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr<DWDHrDWuDHsMPDWDHsjO<Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWuDW.DWpDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071581100715811007AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3273 N DV 8.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDlHrulDWDHs3Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDlHrulDWDlHr$DWDdHs{dDWDHs3Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071581100715811007A Migraine Migraine FONervous system disorders FMigraine FOMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1081 N DV 2.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDlHrulDWDHs3Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDlHrulDWDlHr$DWDdHs{dDWDHs3Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071583100715831007ASeasonal allergy Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2014M-2542 N DV 6.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDxHsxPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDLHr&DWD(Hss(DWDxHsxPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071584100715841007AAllergy cats Allergy to animal FNImmune system disorders F4Allergic to cats FCAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4003 N DV 10.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr}DWDHr*PBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr}DWDHr*P......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1007 10071585100715851007AADHD, predominantly inattentive type Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD, predominantly inattentive type FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1081 N DV 2.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDTHr~TDWDHslPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDTHr~TDWDHr'DWDHsr@DWDHslPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071586100715861007AAttention deficit-hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit-hyperactivity disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1081 N DV 2.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWD HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWD0Hr$DWDHsDWD HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071587100715871007ASeasonal allergy Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3273 N DV 8.96 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr+@BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr+@......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1007 10071590100715901007APrecocious puberty Precocious puberty FydEndocrine disorders FPrecocious puberty FydEndocrine abnormalities of puberty FEndocrine disorders of gonadal function FEndocrine disorders FGENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1457 N DW 3.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr,DWDlHrHlBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr,DWDlHrHl......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1007 10071590100715901007A Tourette syndrome Tourette's disorder FBCongenital, familial and genetic disorders FTourette's syndrome FBNeurological disorders congenital NEC FNeurological disorders congenital FCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1457 N DW 3.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr,DWDlHrHlBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr,DWDlHrHl......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1007 10071591100715911007ATourette's disorder Tourette's disorder FBCongenital, familial and genetic disorders FTourette's disorder FBNeurological disorders congenital NEC FNeurological disorders congenital FCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1457 N DW 3.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr`DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr`DWDHr֛HDWDHsb DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071592100715921007AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2013M-2918 N DW 7.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDxHrDWD\Hr֝BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDxHrDWD\Hr֝......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1007 10071592100715921007A0Seasonal allergy Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2013M-2918 N DW 7.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDxHrDWD\Hr֝BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDxHrDWD\Hr֝......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1007 10071592100715921007A Hearing loss Deafness FEar and labyrinth disorders F)Hearing loss FHearing losses FHearing disorders FEar and labyrinth disorders F)GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2017M-1457 N DW 3.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDxHrDWD\Hr֝BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDxHrDWD\Hr֝......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1007 10071593100715931007AType I Diabetes mellitus Type 1 diabetes mellitus FMetabolism and nutrition disorders FType I diabetes mellitus FG,Diabetes mellitus (incl subtypes) FǺGlucose metabolism disorders (incl diabetes mellitus) FxMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2011M-3649 YDiabetes without chronic complication DW 9.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr͜DWDHr͜Placebo A .Placebo A .DWDHr͜DWDHr͜......Placebo DW.....DW3DW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071594100715941007AMigraine Migraine FONervous system disorders FMigraine FOMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-727 N DW 1.99 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrLDWDHrdBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrLDWDHrd......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1007 10071596100715961007AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2188 N DW 5.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDHs5tPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDWDpHrDpDWDHs{DWDHs5tPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071599100715991007AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3284 N DW 8.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD`HrDWD(Hr¨BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD`HrDWD(Hr¨......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1007 10071599100715991007A Allergy to cats Allergy to animal FNImmune system disorders F4Allergic to cats FCAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2012M-3284 N DW 8.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD`HrDWD(Hr¨BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD`HrDWD(Hr¨......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1007 10071599100715991007A0Allergy to dogs Allergy to animal FNImmune system disorders F4Allergic to dogs FDAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2012M-3284 N DW 8.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD`HrDWD(Hr¨BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD`HrDWD(Hr¨......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1007 10071599100715991007A@Anxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1092 N DW 2.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD`HrDWD(Hr¨BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD`HrDWD(Hr¨......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1007 10071599100715991007APDepression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2018M-1092 N DW 2.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD`HrDWD(Hr¨BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD`HrDWD(Hr¨......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1007 10071600100716001007ACyst of kidney Renal cyst F,Renal and urinary disorders F,WCyst of kidney F`Renal neoplasms F,Renal disorders (excl nephropathies) F,Renal and urinary disorders F,WGENERAL MEDICAL HISTORY2020-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jun2020D-210 N DW 0.58 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDPHrDWDHs(Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDPHrDWD8HrDWDlHslDWDHs(Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071601100716011007A Seasonal allergy Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2010M-4014 N DW 10.99 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DWDHr(DWD4HrPlacebo A .Placebo A .DWDHr(DWD4Hr......Placebo Placebo DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071601100716011007AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1457 N DW 3.99 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DWDHr(DWD4HrPlacebo A .Placebo A .DWDHr(DWD4Hr......Placebo Placebo DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071603100716031007AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2017M-1458 N DW 3.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDHr Placebo A .Placebo A .DWDHrDWDHr ......Placebo Placebo DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071603100716031007A0Type 1 diabetes mellitus Type 1 diabetes mellitus FMetabolism and nutrition disorders FType 1 diabetes mellitus FDiabetes mellitus (incl subtypes) FǺGlucose metabolism disorders (incl diabetes mellitus) FxMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2018-12-17 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 17Dec2018 -743 YDiabetes without chronic complication DW 2.04 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDHr Placebo A .Placebo A .DWDHrDWDHr ......Placebo Placebo DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071603100716031007A Hypothyroidism Hypothyroidism FEndocrine disorders FHypothyroidism FThyroid hypofunction disorders FA]Thyroid gland disorders FA[Endocrine disorders FGENERAL MEDICAL HISTORY2020-11-30 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 30Nov2020 -29 N DW 0.08 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDHr Placebo A .Placebo A .DWDHrDWDHr ......Placebo Placebo DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071605100716051007AAllergies to tree nuts Food allergy FزImmune system disorders F4Allergy to nuts Fm/Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3285 N DW 9 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD\Hr\DWDHr֥\BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD\Hr\DWDHr֥\......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1007 10071605100716051007A Allergy to food seeds Food allergy FزImmune system disorders F4Food allergy FزAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2020-03 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Mar2020D-303 N DW 0.83 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD\Hr\DWDHr֥\BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD\Hr\DWDHr֥\......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1007 10071606100716061007AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-09 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Sep2020D-119 N DW 0.33 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDDHrDDWDpHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDDHrDDWDpHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1007 10071608100716081007AAttention deficit-hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit-hyperactivity disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2189 N DW 6 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr2DWD HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr2DWDTHrDWDHssDWD HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071609100716091007A Seasonal allergy Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2015M-2189 N DW 6 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD\Hr9\DWDHrHBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD\Hr9\DWDHrH......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1007 10071609100716091007AHypothyroidism Hypothyroidism FEndocrine disorders FHypothyroidism FThyroid hypofunction disorders FA]Thyroid gland disorders FA[Endocrine disorders FGENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1458 N DW 3.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD\Hr9\DWDHrHBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD\Hr9\DWDHrH......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1007 10071613100716131007ASolitary kidney Single functional kidney FRenal and urinary disorders F,WSolitary kidney FgRenal disorders NEC FRenal disorders (excl nephropathies) F,Renal and urinary disorders F,WGENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD HrM DWDHslPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD HrM DWDϨHr(DWDHs|4DWDHslPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071617100716171007A Drug allergy PCN Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2005 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2005M-5841 N DW 15.99 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDXHr[XDWDHsi^Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDXHr[XDWDhHrLhDWuDhHsMGDWDHsi^Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWuDW.DWjDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071617100716171007AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1093 N DW 3 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDXHr[XDWDHsi^Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDXHr[XDWDhHrLhDWuDhHsMGDWDHsi^Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWuDW.DWjDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071617100716171007A0Obsessive-compulsive disorder Obsessive-compulsive disorder F JPsychiatric disorders F'Obsessive-compulsive disorder F JObsessive-compulsive disorders and symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2018M-1093 N DW 3 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDXHr[XDWDHsi^Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDXHr[XDWDhHrLhDWuDhHsMGDWDHsi^Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWuDW.DWjDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071618100716181007AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1458 N DW 3.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr[DWD0Hr֜Placebo A .Placebo A .DWDHr[DWD0Hr֜......Placebo Placebo DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071618100716181007A Attention deficit-hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit-hyperactivity disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1458 N DW 3.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr[DWD0Hr֜Placebo A .Placebo A .DWDHr[DWD0Hr֜......Placebo Placebo DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071619100716191007AAttention deficit-hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit-hyperactivity disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1094 N DW 3 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrCDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrCDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1007 10071620100716201007AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1094 N DW 3 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrM8DWDHrRBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrM8DWDHrR......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1007 10071620100716201007A Attention deficit disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1094 N DW 3 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrM8DWDHrRBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrM8DWDHrR......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1007 10071621100716211007AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016-12-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Dec2016 -1490 N DW 4.08 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD,HrQDWDHrRPlacebo A .Placebo A .DWD,HrQDWDHrR......Placebo Placebo DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071622100716221007AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2015-12-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Dec2015 -1856 N DW 5.08 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrPDDWDHrPDBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrPDDWDHrPD......BNT162b2 (30 (*ESC*){unicode 03BC}g) DW.....DW6DW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071623100716231007AJuvenile RA Juvenile idiopathic arthritis F}Musculoskeletal and connective tissue disorders FkJuvenile RA FbRheumatoid arthropathies F/&Joint disorders F-Musculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2020-12-22 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 22Dec2020 -8 YRheumatic disease DW 0.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDtHrTDWDHslPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDtHrTDWDTHr٢DWDHsLDWDHslPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071624100716241007AAttention deficit disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-729 N DW 2 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHre DWD4Hs$4Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHre DW"DdHrdDWDHsuXDWD4Hs$4Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW".DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071625100716251007AAllergy to antibiotic penicillin Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2007-11 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Nov2007D-4808 N DW 13.17 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrg<DWDHs"Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrg<DW"DtHrtDWD$HsuDWDHs"Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW".DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071627100716271007AAsthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2008-12-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Dec2008 -4412 YChronic pulmonary disease DW 12.08 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD̜HrDWD~HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD̜HrDWD~Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1007 10071628100716281007ADepression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019-10 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Oct2019D-456 N DW 1.25 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDXHrDWDƄHr0BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDXHrDWDƄHr0......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1007 10071629100716291007AEczema Eczema FSkin and subcutaneous tissue disorders F5Eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2006M-5477 N DW 15 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DWD|HrDWDHsτPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD|HrDWD@Hr@DWD̜Hs<DWDHsτPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071629100716291007A0Seasonal allergy Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4016 N DW 11 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DWD|HrDWDHsτPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD|HrDWD@Hr@DWD̜Hs<DWDHsτPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071629100716291007A Exercise-induced asthma Asthma exercise induced FeRespiratory, thoracic and mediastinal disorders F-Exercise induced asthma FӡBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1094 YChronic pulmonary disease DW 3 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DWD|HrDWDHsτPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD|HrDWD@Hr@DWD̜Hs<DWDHsτPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071630100716301007AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2014-12-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Dec2014 -2221 N DW 6.08 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDHs(Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDWDHrDWDHs>DWDHs(Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071630100716301007A Seasonal allergy Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2014-12-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Dec2014 -2221 N DW 6.08 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDHs(Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDWDHrDWDHs>DWDHs(Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071634100716341007A Seasonal allergy Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1464 N DW 4.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHrDW!DHrޜlBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHrDW!DHrޜl......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1007 10071634100716341007AAttention deficit disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1099 N DW 3.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHrDW!DHrޜlBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHrDW!DHrޜl......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1007 10071635100716351007AAsthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2015M-2195 YChronic pulmonary disease DW 6.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DHrDW!DHrPPlacebo A .Placebo A .DW DHrDW!DHrP......Placebo Placebo DW DW!....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071635100716351007A Seasonal allergy Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1099 N DW 3.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DHrDW!DHrPPlacebo A .Placebo A .DW DHrDW!DHrP......Placebo Placebo DW DW!....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071638100716381007ASeasonal allergy Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2009M-4386 N DW 12.01 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW D<Hr<DW!DHrއBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW D<Hr<DW!DHrއ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1007 10071641100716411007AEczema Eczema FSkin and subcutaneous tissue disorders F5Eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1830 N DW 5.01 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW D(Hr(DW"DHr-BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW D(Hr(DW"DHr-......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW"....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1007 10071641100716411007A allergy to food milk protein Milk allergy FqImmune system disorders F4Milk protein allergy FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1464 N DW 4.01 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW D(Hr(DW"DHr-BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW D(Hr(DW"DHr-......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW"....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1007 10071642100716421007AMigraine Migraine FONervous system disorders FMigraine FOMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2018-01-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018 -1099 N DW 3.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW D,Hr%,DWDθHs8BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW D,Hr%,DWDθHs8......BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) DW .DW...DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071647100716471007AAsthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4021 YChronic pulmonary disease DW 11.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHrEDW!DHrlBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHrEDW!DHrl......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1007 10071650100716501007A Attention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2013M-2926 N DW 8.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DHr@LDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DHr@LDW"DHrDWDpHs}DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW".DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071650100716501007AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2020D-370 N DW 1.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DHr@LDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DHr@LDW"DHrDWDpHs}DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW".DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071651100716511007APenicillin allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010-01-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010 -4022 N DW 11.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHr=DW"DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHr=DW"DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW"....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1007 10071653100716531007A Seasonal allergy Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2008M-4753 N DW 13.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DʼHrn<DW"DθHr!BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DʼHrn<DW"DθHr!......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW"....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1007 10071653100716531007AAttention deficit-hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit-hyperactivity disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2011M-3657 N DW 10.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DʼHrn<DW"DθHr!BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DʼHrn<DW"DθHr!......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW"....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1007 10071654100716541007AAttention deficit disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-735 N DW 2.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW D(HrkDW"DHr"Placebo A .Placebo A .DW D(HrkDW"DHr"......Placebo Placebo DW DW"....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071656100716561007AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2014M-2562 N DW 7.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrńDW#DHrvBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrńDW#DHrv......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1007 10071658100716581007AAllergy to cat dander Allergy to animal FNImmune system disorders F4Allergy to animal dander FOAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2020-04 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Apr2020D-280 N DW 0.77 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDHs-Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDW#DHr9DWDHsrlDWDHs-Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071658100716581007A Anxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-11-11 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 11Nov2020 -56 N DW 0.16 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDHs-Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDW#DHr9DWDHsrlDWDHs-Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1007 10071658100716581007A0Depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-12-24 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 24Dec2020 -13 N DW 0.04 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDHs-Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDW#DHr9DWDHsrlDWDHs-Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081751100817511008A@Gastroesophageal reflux disease Gastrooesophageal reflux disease F]Gastrointestinal disorders FܛGastroesophageal reflux disease FGastrointestinal atonic and hypomotility disorders NEC F܍Gastrointestinal motility and defaecation conditions FܹGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2007M-5083 N DV 13.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWD0Hr0DWDǰHsn|DWDDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081751100817511008AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2008M-4718 N DV 12.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWD0Hr0DWDǰHsn|DWDDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081751100817511008A`Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2012M-3257 N DV 8.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWD0Hr0DWDǰHsn|DWDDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081751100817511008A Chronic headaches Headache FNervous system disorders FChronic headaches FhHeadaches NEC FHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2013M-2891 N DV 7.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWD0Hr0DWDǰHsn|DWDDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081751100817511008A0Face acne Acne FpSkin and subcutaneous tissue disorders F5Acne NOS F~Acnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-700 N DV 1.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWD0Hr0DWDǰHsn|DWDDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081751100817511008APHyperhidrosis Hyperhidrosis F"Skin and subcutaneous tissue disorders F5Hyperhidrosis F"Apocrine and eccrine gland disorders F&Skin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2020-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Jun2020D-183 N DV 0.5 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWD0Hr0DWDǰHsn|DWDDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081752100817521008A seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2007M-5083 N DV 13.92 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DVDHrXDWDˆHs'Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrXDVDHrPDWDHslDWDˆHs'Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081752100817521008AAcne on face Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1065 N DV 2.92 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DVDHrXDWDˆHs'Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrXDVDHrPDWDHslDWDˆHs'Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081753100817531008ASeasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2007M-5083 N DV 13.92 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDDHrXDDVDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDDHrXDDVDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081755100817551008AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-08 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Aug2020D-123 N DV 0.34 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD,HrDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD,HrDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWoDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081755100817551008A0Depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-08 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Aug2020D-123 N DV 0.34 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD,HrDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD,HrDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWoDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081755100817551008A`Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2006M-5449 N DV 14.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD,HrDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD,HrDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWoDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081755100817551008A@Migraines Migraine FONervous system disorders FMigraine FOMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1066 N DV 2.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD,HrDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD,HrDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWoDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081755100817551008A Contact dermatitis Dermatitis contact FSkin and subcutaneous tissue disorders F5Contact dermatitis FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2019M-701 N DV 1.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD,HrDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD,HrDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWoDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081755100817551008APNeomycin allergy Drug hypersensitivity FImmune system disorders F4Allergic reaction to antibiotics F8Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2019M-701 N DV 1.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD,HrDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD,HrDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWoDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081756100817561008A0Sulfa allergy Drug hypersensitivity FImmune system disorders F4Sulfonamide allergy FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2007M-5084 N DV 13.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDʼHr<DWDHskPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDʼHr<DVDְHr0DWxD8HsQ8DWDHskPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWxDW.DWwDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081756100817561008AAsthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2013M-2892 YChronic pulmonary disease DV 7.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDʼHr<DWDHskPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDʼHr<DVDְHr0DWxD8HsQ8DWDHskPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWxDW.DWwDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081756100817561008A Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2013M-2892 N DV 7.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDʼHr<DWDHskPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDʼHr<DVDְHr0DWxD8HsQ8DWDHskPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWxDW.DWwDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081757100817571008AAttention deficit disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1066 N DV 2.92 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDVDHr|DWDôHsrm4DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081757100817571008A Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1066 N DV 2.92 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDVDHr|DWDôHsrm4DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081758100817581008AFace acne Acne FpSkin and subcutaneous tissue disorders F5Acne NOS F~Acnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1431 N DV 3.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081761100817611008ASeasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-3993 N DV 10.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr:DW}DHsXPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr:DWDHrtDWgDHs;"DW}DHsXPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWgDW}.DWgDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081763100817631008A Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-3993 N DV 10.93 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrODWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrODWDHrr|DWDĤHsu$DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081763100817631008AAttention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2013M-2897 N DV 7.93 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrODWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrODWDHrr|DWDĤHsu$DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081764100817641008ASeasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-3993 N DV 10.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDdHrNdDWDHr[HBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDdHrNdDWDHr[H......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1008 10081767100817671008A0von willebrand disease Von Willebrand's disease FPCongenital, familial and genetic disorders FVon Willebrand's disease FPCoagulation disorders congenital FBlood and lymphatic system disorders congenital FRCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2009M-4359 N DV 11.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHsϬPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDHrDWDHsmO DWDHsϬPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081767100817671008AAttention deficit disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2011M-3629 N DV 9.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHsϬPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDHrDWDHsmO DWDHsϬPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081767100817671008A Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2011M-3629 N DV 9.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHsϬPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDHrDWDHsmO DWDHsϬPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081768100817681008AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2168 N DV 5.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHr&Placebo A .Placebo A .DVDHrDWDHr&......Placebo Placebo DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081768100817681008A0Obsessive compulsive disorder Obsessive-compulsive disorder F JPsychiatric disorders F'Obsessive-compulsive disorder F JObsessive-compulsive disorders and symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2015M-2168 N DV 5.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHr&Placebo A .Placebo A .DVDHrDWDHr&......Placebo Placebo DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081768100817681008A Depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2016M-1803 N DV 4.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHr&Placebo A .Placebo A .DVDHrDWDHr&......Placebo Placebo DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081769100817691008AAsthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2006M-5455 YChronic pulmonary disease DV 14.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrPDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrPDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWvDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081769100817691008A Bilateral arm eczema Eczema FSkin and subcutaneous tissue disorders F5Eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2006M-5455 N DV 14.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrPDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrPDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWvDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081769100817691008A0Bilateral leg eczema Eczema FSkin and subcutaneous tissue disorders F5Eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2006M-5455 N DV 14.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrPDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrPDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWvDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081769100817691008APZithromax allergy Drug hypersensitivity FImmune system disorders F4Allergic reaction to antibiotics F8Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2008M-4725 N DV 12.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrPDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrPDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWvDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081769100817691008A@Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2009M-4359 N DV 11.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrPDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrPDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWvDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081770100817701008AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2013M-2899 N DV 7.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr]dBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr]d......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1008 10081770100817701008A Attention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2014M-2534 N DV 6.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr]dBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr]d......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1008 10081770100817701008A0Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1804 N DV 4.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr]dBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr]d......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1008 10081771100817711008ASeasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1438 N DV 3.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDXHrXDWDHr^BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDXHrXDWDHr^......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081777100817771008AAmoxicillin allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2006M-5457 N DV 14.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrXDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrXDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081777100817771008A Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2170 N DV 5.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrXDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrXDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081780100817801008AFacial acne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-709 N DV 1.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr.DDWDhHshPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr.DDWDHrDWDHsr4|DWDhHshPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081781100817811008ASeasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1074 N DV 2.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDhHr/DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDhHr/DWD8Hr8DWDHsv/DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081785100817851008AGastroesophageal reflux disease Gastrooesophageal reflux disease F]Gastrointestinal disorders FܛGastroesophageal reflux disease FGastrointestinal atonic and hypomotility disorders NEC F܍Gastrointestinal motility and defaecation conditions FܹGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2171 N DV 5.95 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD͌Hr{DWD\HrNBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD͌Hr{DWD\HrN......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081788100817881008AAttention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1443 N DV 3.95 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr3DWDLHsLPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr3DW D Hr DWDTHslDWDLHsLPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081789100817891008A Attention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2013M-2904 N DV 7.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr4DW D8Hr 8BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr4DW D8Hr 8......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081789100817891008AAdderall allergy Drug hypersensitivity FImmune system disorders F4Specific allergy (drug) F8OAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2014M-2539 N DV 6.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr4DW D8Hr 8BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr4DW D8Hr 8......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081789100817891008A0Concerta allergy Drug hypersensitivity FImmune system disorders F4Specific allergy (drug) F8OAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2014M-2539 N DV 6.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr4DW D8Hr 8BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr4DW D8Hr 8......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081789100817891008A@Facial acne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1078 N DV 2.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr4DW D8Hr 8BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr4DW D8Hr 8......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081790100817901008A Premenarchal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) 2021-06-12BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 (b)(6) (b)(6)12Jun2021 181 N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrlDWDHs͐Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrlDW DxHrxDWD`HslDWDHs͐Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081790100817901008A0Reactive Airway Disease Bronchial hyperreactivity FRespiratory, thoracic and mediastinal disorders F-Reactive airways disease F*Bronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2010M-4000 N DV 10.95 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrlDWDHs͐Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrlDW DxHrxDWD`HslDWDHs͐Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081790100817901008AAcne(face) Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1078 N DV 2.95 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrlDWDHs͐Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrlDW DxHrxDWD`HslDWDHs͐Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081791100817911008AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1809 N DV 4.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDՄHrxDW DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDՄHrxDW DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081791100817911008A Attention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2016M-1809 N DV 4.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDՄHrxDW DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDՄHrxDW DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081792100817921008AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2015M-2174 N DV 5.95 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDtHrxDW DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDtHrxDW DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1008 10081792100817921008A Attention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2174 N DV 5.95 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDtHrxDW DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDtHrxDW DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1008 10081794100817941008APremenarcheal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DVDHr{DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr{DW DHrDWD͌Hsm1 DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081795100817951008A0Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2011M-3636 N DV 9.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDLHrLDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDLHrLDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1008 10081795100817951008ADecreased Height age related percentile Body height decreased FtlInvestigations FBody height decreased FtlPhysical examination procedures and organ system status FPhysical examination and organ system status topics FInvestigations FGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2019M-714 N DV 1.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDLHrLDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDLHrLDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1008 10081795100817951008A Decreased weight age related percentile Weight decreased FQInvestigations FWeight decreased FQPhysical examination procedures and organ system status FPhysical examination and organ system status topics FInvestigations FGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019M-714 N DV 1.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDLHrLDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDLHrLDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1008 10081798100817981008A Asthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2009M-4366 YChronic pulmonary disease DV 11.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDְHrʰDWDXHs)Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDְHrʰDW D4Hr}DWD4Hsnb4DWDXHs)Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081798100817981008A0Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2014M-2540 N DV 6.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDְHrʰDWDXHs)Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDְHrʰDW D4Hr}DWD4Hsnb4DWDXHs)Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081798100817981008AAmoxicillin allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2016M-1810 N DV 4.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDְHrʰDWDXHs)Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDְHrʰDW D4Hr}DWD4Hsnb4DWDXHs)Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081799100817991008A Premenarcheal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) 2021-03-11BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 (b)(6) (b)(6)11Mar2021 87 N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDW DHr5HBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDW DHr5H......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081799100817991008AFacial acne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2020-09 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Sep2020D-105 N DV 0.29 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDW DHr5HBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDW DHr5H......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081800100818001008AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2015M-2176 N DV 5.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD`HrDWDDHrŰDBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD`HrDWDDHrŰD......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1008 10081800100818001008A@Depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2015M-2176 N DV 5.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD`HrDWDDHrŰDBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD`HrDWDDHrŰD......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1008 10081800100818001008A Asthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2016M-1811 YChronic pulmonary disease DV 4.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD`HrDWDDHrŰDBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD`HrDWDDHrŰD......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1008 10081800100818001008APFace acne Acne FpSkin and subcutaneous tissue disorders F5Acne NOS F~Acnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1080 N DV 2.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD`HrDWDDHrŰDBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD`HrDWDDHrŰD......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1008 10081800100818001008A0Attention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2019M-715 N DV 1.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD`HrDWDDHrŰDBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD`HrDWDDHrŰD......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1008 10081801100818011008A Asthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2014M-2542 YChronic pulmonary disease DV 6.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD(Hr2(DWDlHslPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD(Hr2(DWDHrDWDHsrn`DWDlHslPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081801100818011008A0Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2014M-2542 N DV 6.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD(Hr2(DWDlHslPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD(Hr2(DWDHrDWDHsrn`DWDlHslPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081801100818011008A@Supraventricular tachycardia Supraventricular tachycardia F<Cardiac disorders FSupraventricular tachycardia F<Supraventricular arrhythmias F<Cardiac arrhythmias FCardiac disorders FGENERAL MEDICAL HISTORY2014 2019 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2014M-2542 31Dec2019M-352 N DV 6.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD(Hr2(DWDlHslPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD(Hr2(DWDHrDWDHsrn`DWDlHslPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081801100818011008AAmoxicillin allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2016M-1812 N DV 4.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD(Hr2(DWDlHslPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD(Hr2(DWDHrDWDHsrn`DWDlHslPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081801100818011008APSupraventricular tachycardia ablation Cardiac ablation FXSurgical and medical procedures F<Cardiac ablation FXCardiac therapeutic procedures NEC FCardiac therapeutic procedures F)Surgical and medical procedures F<GENERAL MEDICAL HISTORY2019 2019 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2019M-716 31Dec2019M-352 N DV 1.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD(Hr2(DWDlHslPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD(Hr2(DWDHrDWDHsrn`DWDlHslPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081803100818031008A Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4003 N DV 10.96 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVDHr^DWkDxHs@SPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr^DWDHr4DWVDŔHs$DWkDxHs@SPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWVDWk.DWKDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081803100818031008AObesity Obesity F ;Metabolism and nutrition disorders FObesity F ;General nutritional disorders NEC FAppetite and general nutritional disorders FJMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1081 N DV 2.96 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVDHr^DWkDxHs@SPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr^DWDHr4DWVDŔHs$DWkDxHs@SPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWVDWk.DWKDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081804100818041008ASeasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2014M-2542 N DV 6.96 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DVDθHreDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDθHreDWDؐHrDWD@Hsm1DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081805100818051008APremenarchal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) 2021-02-04BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6)04Feb2021 50 N DV (b)(6)YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDڬHrqDWDpHr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDڬHrqDWDpHr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1008 10081806100818061008AFace acne Acne FpSkin and subcutaneous tissue disorders F5Acne NOS F~Acnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1446 N DV 3.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD|Hrt|DWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD|Hrt|DWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081806100818061008A Migraines Migraine FONervous system disorders FMigraine FOMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1081 N DV 2.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD|Hrt|DWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD|Hrt|DWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081807100818071008ASeasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2178 N DV 5.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD|HrzDWDHs4Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD|HrzDWDHr?DWDHsnCDWDHs4Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081808100818081008ASeasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-717 N DV 1.97 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DVDHr~DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr~DWDHr>DWDHsr3DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1008 10081809100818091008A Face acne Acne FpSkin and subcutaneous tissue disorders F5Acne NOS F~Acnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1082 N DV 2.97 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DVD HrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD HrDWD0HrI0DWD@HsmODWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081809100818091008AChronic constipation Constipation FGastrointestinal disorders FܛConstipation chronic FGastrointestinal atonic and hypomotility disorders NEC F܍Gastrointestinal motility and defaecation conditions FܹGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2020-10 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Oct2020D-78 N DV 0.22 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DVD HrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD HrDWD0HrI0DWD@HsmODWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081809100818091008A0Gastroesophageal reflux disease Gastrooesophageal reflux disease F]Gastrointestinal disorders FܛGastroesophageal reflux disease FGastrointestinal atonic and hypomotility disorders NEC F܍Gastrointestinal motility and defaecation conditions FܹGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2020-10 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Oct2020D-78 N DV 0.22 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DVD HrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD HrDWD0HrI0DWD@HsmODWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081810100818101008AAttention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-09 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Sep2020D-108 N DV 0.3 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrPDWD$Hr7$BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrPDWD$Hr7$......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1008 10081812100818121008AAttention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1813 N DV 4.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDɐHrDWDHs$Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDɐHrDWDHrfDWDtHsmHDWDHs$Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081814100818141008ALatex allergy Rubber sensitivity F/Immune system disorders F4Latex allergy FrAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2010M-4004 N DV 10.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr@DWDHrmBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr@DWDHrm......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1008 10081814100818141008A0metabolic myopathy Metabolic myopathy FdCongenital, familial and genetic disorders FMetabolic myopathy FdInborn errors of carbohydrate metabolism (excl glucose) FMetabolic and nutritional disorders congenital FCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY2019-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019D-717 N DV 1.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr@DWDHrmBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr@DWDHrm......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1008 10081814100818141008A Syncope(stable) Syncope F=Nervous system disorders FSyncope F=Disturbances in consciousness NEC FENeurological disorders NEC FNervous system disorders FGENERAL MEDICAL HISTORY2020-10 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Oct2020D-78 N DV 0.22 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr@DWDHrmBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr@DWDHrm......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1008 10081816100818161008AAttention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1813 N DV 4.97 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDdHrDWDHriBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDdHrDWDHri......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081818100818181008A Asthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2007M-5100 YChronic pulmonary disease DV 13.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDިHr(DWDpHrcpBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDިHr(DWDpHrcp......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1008 10081818100818181008AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2014M-2543 N DV 6.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDިHr(DWDpHrcpBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDިHr(DWDpHrcp......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1008 10081818100818181008A0Attention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2014M-2543 N DV 6.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDިHr(DWDpHrcpBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDިHr(DWDpHrcp......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1008 10081819100818191008ASeasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2020-03 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Mar2020D-295 N DV 0.81 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDpHrlpDWD Hs/Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDpHrlpDWD,Hr_DWDHss{DWD Hs/Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081820100818201008AOmnicef allergy Drug hypersensitivity FImmune system disorders F4Allergic reaction to antibiotics F8Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3277 N DV 8.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrmDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrmDWDHrHDWD0Hs|DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081821100818211008ASeasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4738 N DV 12.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHruDWDӤHrͱBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHruDWDӤHrͱ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081822100818221008A0Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3277 N DV 8.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrxDWD4HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrxDWDHrb|DWDHsncDWD4HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081822100818221008AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019M-720 N DV 1.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrxDWD4HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrxDWDHrb|DWDHsncDWD4HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081822100818221008A Depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2019M-720 N DV 1.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrxDWD4HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrxDWDHrb|DWDHsncDWD4HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081823100818231008AAmoxicillin allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4738 N DV 12.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrzDWD}dHr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrzDWD}dHr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081824100818241008A Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1450 N DV 3.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD<Hr<DWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD<Hr<DWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081824100818241008AAttention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019M-720 N DV 1.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD<Hr<DWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD<Hr<DWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081825100818251008APremenarchal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDƄHrDWD4Hs4Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDƄHrDWDHrMdDWDxHsm&DWD4Hs4Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081826100818261008APenicillin allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2008M-4738 N DV 12.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWD|Hr͝|BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWD|Hr͝|......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081826100818261008A Sulfa allergy Drug hypersensitivity FImmune system disorders F4Sulfonamide allergy FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4738 N DV 12.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWD|Hr͝|BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWD|Hr͝|......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081827100818271008AZithromax allergy Drug hypersensitivity FImmune system disorders F4Allergic reaction to antibiotics F8Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4007 N DV 10.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDԔHrDWDHr]BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDԔHrDWDHr]......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081828100818281008ABilateral hand eczema Hand dermatitis F|Skin and subcutaneous tissue disorders F5Hand eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4007 N DV 10.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWD,HsnPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDlHrlDWD\HsnX\DWD,HsnPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081828100818281008A Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2010M-4007 N DV 10.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWD,HsnPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDlHrlDWD\HsnX\DWD,HsnPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081830100818301008ASeasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-721 N DV 1.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDPHrDWDHsupDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081831100818311008AFace acne Acne FpSkin and subcutaneous tissue disorders F5Acne NOS F~Acnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2020-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jun2020D-204 N DV 0.56 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDhHrDWD{HrYBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDhHrDWD{HrY......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081832100818321008APSeasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2182 N DV 5.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrʘDWDHr`BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrʘDWDHr`......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081832100818321008A Gastroesophageal reflux disease Gastrooesophageal reflux disease F]Gastrointestinal disorders FܛGastroesophageal reflux disease FGastrointestinal atonic and hypomotility disorders NEC F܍Gastrointestinal motility and defaecation conditions FܹGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1451 N DV 3.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrʘDWDHr`BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrʘDWDHr`......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081832100818321008A0Insomnia Insomnia F%Psychiatric disorders F'Insomnia F%Disturbances in initiating and maintaining sleep FFSleep disorders and disturbances F6Psychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2018M-1086 N DV 2.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrʘDWDHr`BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrʘDWDHr`......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081832100818321008A@Polycystic ovary syndrome Polycystic ovaries F#QReproductive system and breast disorders F-LPolycystic ovaries F#QOvarian and fallopian tube cysts and neoplasms FOvarian and fallopian tube disorders FReproductive system and breast disorders F-LGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2018M-1086 N DV 2.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrʘDWDHr`BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrʘDWDHr`......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081832100818321008AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2020D-356 N DV 0.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrʘDWDHr`BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrʘDWDHr`......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081836100818361008AFace acne Acne FpSkin and subcutaneous tissue disorders F5Acne NOS F~Acnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1086 N DV 2.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDҴHr4DWDxHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDҴHr4DWD}(Hr[(DWDHsnKDWDxHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081837100818371008AAttention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1817 N DV 4.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDPHr DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDPHr DWDDHrͷDDWDHsuPDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081838100818381008AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2013M-2912 N DV 7.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD@Hr DWDTHrͶTBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD@Hr DWDTHrͶT......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081838100818381008A Attention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2013M-2912 N DV 7.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD@Hr DWDTHrͶTBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD@Hr DWDTHrͶT......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081838100818381008A0Autism spectrum disorder Autism spectrum disorder FPsychiatric disorders F'Autism spectrum disorder FPervasive developmental disorders NEC F4Developmental disorders NEC FǒPsychiatric disorders F'GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2013M-2912 N DV 7.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD@Hr DWDTHrͶTBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD@Hr DWDTHrͶT......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081838100818381008A@Depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2013M-2912 N DV 7.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD@Hr DWDTHrͶTBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD@Hr DWDTHrͶT......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081839100818391008AFace acne Acne FpSkin and subcutaneous tissue disorders F5Acne NOS F~Acnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2020-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2020D-356 N DV 0.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDިHr (DWDpHrͩpBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDިHr (DWDpHrͩp......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081841100818411008AAttention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2013M-2913 N DW 7.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDWDHrxBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDWDHrx......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081841100818411008A Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1087 N DW 2.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDWDHrxBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDWDHrx......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081842100818421008A Premenarchal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr DWDyHrWDWDHsu DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081842100818421008ANeurofibromatosis type II Neurofibromatosis FCongenital, familial and genetic disorders FNeurofibromatosis, type 2 (acoustic neurofibromatosis) FNeurological disorders congenital NEC FNeurological disorders congenital FCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2012M-3279 N DW 8.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr DWDyHrWDWDHsu DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081842100818421008A0Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1452 N DW 3.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr DWDyHrWDWDHsu DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081843100818431008AAsthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2007M-5105 YChronic pulmonary disease DW 13.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDWDӤHr$BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDWDӤHr$......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081843100818431008A Attention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2010M-4009 N DW 10.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDWDӤHr$BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDWDӤHr$......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081843100818431008A0Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2010M-4009 N DW 10.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDWDӤHr$BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDWDӤHr$......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081843100818431008A@Tree nut allergy Food allergy FزImmune system disorders F4Allergy to nuts Fm/Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2015M-2183 N DW 5.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDWDӤHr$BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDWDӤHr$......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081846100818461008A Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2013M-2913 N DW 7.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDPHr PDWDHrHBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDPHr PDWDHrH......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081846100818461008AFacial acne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1452 N DW 3.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDPHr PDWDHrHBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDPHr PDWDHrH......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081847100818471008AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1087 N DW 2.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDWDHrDBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDWDHrD......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081847100818471008A Depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1087 N DW 2.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDWDHrDBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDWDHrD......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081847100818471008A0Tic disorder Tic FAPsychiatric disorders F'Tic FATic disorders FAChanges in physical activity FQPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-10 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Oct2020D-83 N DW 0.23 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDWDHrDBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDWDHrD......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081850100818501008A Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2015M-2183 N DW 5.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHHr(HDWDHrIBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHHr(HDWDHrI......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWVDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081850100818501008AAsthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-722 YChronic pulmonary disease DW 1.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHHr(HDWDHrIBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHHr(HDWDHrI......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWVDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081851100818511008A Autism Autism spectrum disorder FPsychiatric disorders F'Autism F]Pervasive developmental disorders NEC F4Developmental disorders NEC FǒPsychiatric disorders F'GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2009M-4374 N DW 11.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr2DWDHs-HPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr2DWDHrь DWD4Hss{4DWDHs-HPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081851100818511008AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018-10 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Oct2018D-814 N DW 2.23 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr2DWDHs-HPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr2DWDHrь DWD4Hss{4DWDHs-HPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081852100818521008AAutism Autism spectrum disorder FPsychiatric disorders F'Autism F]Pervasive developmental disorders NEC F4Developmental disorders NEC FǒPsychiatric disorders F'GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2007M-5105 N DW 13.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr3DWD@Hs-Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr3DWDHrэLDWDHss{DWD@Hs-Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081852100818521008A Depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017D-1452 N DW 3.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr3DWD@Hs-Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr3DWDHrэLDWDHss{DWD@Hs-Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081853100818531008A Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1092 N DW 2.99 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrXDWD Hs Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrXDWDHrNDWDhHsrmDWD Hs Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081853100818531008AGilberts syndrome Gilbert's syndrome FCongenital, familial and genetic disorders FGilbert's syndrome FInborn errors of bilirubin metabolism FMetabolic and nutritional disorders congenital FCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY2019-03 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Mar2019D-668 N DW 1.83 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrXDWD Hs Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrXDWDHrNDWDhHsrmDWD Hs Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081854100818541008ASeasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2011M-3649 N DW 9.99 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr\DWDtHrRtBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr\DWDtHrRt......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081855100818551008ABack eczema Eczema FSkin and subcutaneous tissue disorders F5Eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2011M-3649 N DW 9.99 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrHDWDHrՙBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrHDWDHrՙ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081855100818551008A0Bilateral arm eczema Eczema FSkin and subcutaneous tissue disorders F5Eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2011M-3649 N DW 9.99 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrHDWDHrՙBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrHDWDHrՙ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081855100818551008APBilateral leg eczema Eczema FSkin and subcutaneous tissue disorders F5Eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2011M-3649 N DW 9.99 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrHDWDHrՙBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrHDWDHrՙ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081855100818551008A Back psoriasis Psoriasis F'Skin and subcutaneous tissue disorders F5Psoriasis F'Psoriatic conditions FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2015M-2188 N DW 5.99 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrHDWDHrՙBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrHDWDHrՙ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081855100818551008A@Bilateral arm psoriasis Psoriasis F'Skin and subcutaneous tissue disorders F5Non-scalp psoriasis FhPsoriatic conditions FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2015M-2188 N DW 5.99 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrHDWDHrՙBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrHDWDHrՙ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081855100818551008A`Bilateral leg psoriasis Psoriasis F'Skin and subcutaneous tissue disorders F5Non-scalp psoriasis FhPsoriatic conditions FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2015M-2188 N DW 5.99 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrHDWDHrՙBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrHDWDHrՙ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081855100818551008ApMigraines Migraine FONervous system disorders FMigraine FOMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.07 01Jan2016M-1823 N DW 4.99 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrHDWDHrՙBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrHDWDHrՙ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081856100818561008A0Penicillin allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2009M-4379 N DW 11.99 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrTDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrTDWDLHrMLDWDʀHsuDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081856100818561008AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2015M-2188 N DW 5.99 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrTDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrTDWDLHrMLDWDʀHsuDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081856100818561008A Obsessive compulsive disorder Obsessive-compulsive disorder F JPsychiatric disorders F'Obsessive-compulsive disorder F JObsessive-compulsive disorders and symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2015M-2188 N DW 5.99 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrTDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrTDWDLHrMLDWDʀHsuDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081856100818561008A@Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2188 N DW 5.99 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrTDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrTDWDLHrMLDWDʀHsuDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081857100818571008APremenarchal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDӤHr$DWDHr\BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDӤHr$DWDHr\......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081858100818581008ASeasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2013M-2918 N DW 7.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrpDWKDИHs1Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrpDWDנHr DW8DlHrlDWKDИHs1Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DW8DWK.DW7DW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081860100818601008A Bilateral elbow eczema Eczema FSkin and subcutaneous tissue disorders F5Eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2007M-5110 N DW 13.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDְHr0DWD HrՍ BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDְHr0DWD HrՍ ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081860100818601008AAsthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2010M-4014 YChronic pulmonary disease DW 10.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDְHr0DWD HrՍ BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDְHr0DWD HrՍ ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081860100818601008A0Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2010M-4014 N DW 10.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDְHr0DWD HrՍ BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDְHr0DWD HrՍ ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081864100818641008Apremenarchal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD|Hr |DWDHrdBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD|Hr |DWDHrd......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081865100818651008A Bilateral hand eczema Hand dermatitis F|Skin and subcutaneous tissue disorders F5Hand eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2008M-4746 N DW 13 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr DWDИHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr DWDИHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081865100818651008A0Face eczema Eczema FSkin and subcutaneous tissue disorders F5Eczema facial FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4746 N DW 13 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr DWDИHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr DWDИHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081865100818651008AAsthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2009M-4380 YChronic pulmonary disease DW 11.99 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr DWDИHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr DWDИHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081866100818661008AAttention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2014M-2554 N DW 7 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr8DWDHsPPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr8DWDHr{DWDHsnEDWDHsPPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081867100818671008A Attention deficit disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1458 N DW 3.99 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr9DWD HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr9DWDHr{DWDHsnFDWD HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081867100818671008AAcne vulgaris(facial) Acne FpSkin and subcutaneous tissue disorders F5Acne vulgaris FAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019M-728 N DW 2 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr9DWD HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr9DWDHr{DWDHsnFDWD HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081869100818691008A`Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2015M-2189 N DW 6 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr>DWDHsc8Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr>DWD|tHr֔DWDHsnIDWDHsc8Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081869100818691008AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2016M-1824 N DW 5 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr>DWDHsc8Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr>DWD|tHr֔DWDHsnIDWDHsc8Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081869100818691008A Attention deficit disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2016M-1824 N DW 5 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr>DWDHsc8Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr>DWD|tHr֔DWDHsnIDWDHsc8Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081869100818691008APMigraines Migraine FONervous system disorders FMigraine FOMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2018M-1093 N DW 3 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr>DWDHsc8Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr>DWD|tHr֔DWDHsnIDWDHsc8Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081869100818691008A0Back acne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2020-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2020D-363 N DW 1 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr>DWDHsc8Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr>DWD|tHr֔DWDHsnIDWDHsc8Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081869100818691008A@Face acne Acne FpSkin and subcutaneous tissue disorders F5Acne NOS F~Acnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2020-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jun2020D-211 N DW 0.58 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr>DWDHsc8Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr>DWD|tHr֔DWDHsnIDWDHsc8Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081870100818701008APenicillin allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1824 N DW 5 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDڬHrCDWDHrsBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDڬHrCDWDHrs......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081871100818711008A0Naproxen allergy Drug hypersensitivity FImmune system disorders F4Allergic reaction to analgesics FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2015M-2190 N DW 6 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrPDWDDHsDPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrPDWDHrPDWD0Hsm2DWDDHsDPlacebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW..DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081871100818711008AAsthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1825 YChronic pulmonary disease DW 5 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrPDWDDHsDPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrPDWDHrPDWD0Hsm2DWDDHsDPlacebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW..DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081871100818711008A Migraines Migraine FONervous system disorders FMigraine FOMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1094 N DW 3 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrPDWDDHsDPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrPDWDHrPDWD0Hsm2DWDDHsDPlacebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW..DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081872100818721008AAttention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2014M-2555 N DW 7 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrXDW~DHsYmPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrXDWD$Hr$DWkDHs@bDDW~DHsYmPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWkDW~.DWiDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081872100818721008A seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2020 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2020M-364 N DW 1 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrXDW~DHsYmPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrXDWD$Hr$DWkDHs@bDDW~DHsYmPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWkDW~.DWiDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081873100818731008ASeasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2190 N DW 6 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDpHrXDWDHrJBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDpHrXDWDHrJ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081875100818751008AAppendectomy Appendicectomy FBSurgical and medical procedures F<Appendectomy F@Large intestine therapeutic procedures F{Gastrointestinal therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2020-07 2020-07 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jul2020D-182 31Jul2020D-152 N DW 0.5 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD,Hr`DWD$Hs$Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD,Hr`DWDHrDWDHsl8DWD$Hs$Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081875100818751008A Appendicitis Appendicitis FCInfections and infestations FAppendicitis FCAbdominal and gastrointestinal infections FܯInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2020-07 2020-07 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jul2020D-182 31Jul2020D-152 N DW 0.5 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD,Hr`DWD$Hs$Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD,Hr`DWDHrDWDHsl8DWD$Hs$Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081877100818771008A0Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1459 N DW 4 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDPHrDWD$Hs$Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDPHrDWDHr6DWDôHsrm4DWD$Hs$Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081877100818771008AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-03 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Mar2020D-304 N DW 0.84 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDPHrDWD$Hs$Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDPHrDWDHr6DWDôHsrm4DWD$Hs$Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081877100818771008A Depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-03 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Mar2020D-304 N DW 0.84 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDPHrDWD$Hs$Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDPHrDWDHr6DWDôHsrm4DWD$Hs$Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081878100818781008AFacial acne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-729 N DW 2 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDθHr8DWD$Hr6$BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDθHr8DWD$Hr6$......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081879100818791008A@Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4747 N DW 13 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrdDWDHrPlacebo A .Placebo A .DWDHrdDWDHr......Placebo Placebo DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081879100818791008A0Growth hormone deficiency Growth hormone deficiency FrEndocrine disorders FGrowth hormone deficiency FrAnterior pituitary hypofunction F Hypothalamus and pituitary gland disorders FEndocrine disorders FGENERAL MEDICAL HISTORY2020-07 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jul2020D-182 N DW 0.5 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrdDWDHrPlacebo A .Placebo A .DWDHrdDWDHr......Placebo Placebo DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081879100818791008AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jun2020D-212 N DW 0.58 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrdDWDHrPlacebo A .Placebo A .DWDHrdDWDHr......Placebo Placebo DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081879100818791008A Depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jun2020D-212 N DW 0.58 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrdDWDHrPlacebo A .Placebo A .DWDHrdDWDHr......Placebo Placebo DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081880100818801008APremenarchal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrPDWD4HsuPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrPDWDhHrDWDHssDWD4HsuPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081881100818811008APremenarchal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr@DWDpHsuPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr@DWDԔHrDWDXHssXDWDpHsuPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081883100818831008A@Back acne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2020-04 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Apr2020D-274 N DW 0.75 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDWD<HrٍBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDWD<Hrٍ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081883100818831008Aface acne Acne FpSkin and subcutaneous tissue disorders F5Acne NOS F~Acnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2020-04 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Apr2020D-274 N DW 0.75 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDWD<HrٍBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDWD<Hrٍ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081883100818831008A0Attention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2010-08 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.08 01Aug2010D-3805 N DW 10.42 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDWD<HrٍBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDWD<Hrٍ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081883100818831008ApHypothyroid Hypothyroidism FEndocrine disorders FThyroid function decreased FAOThyroid hypofunction disorders FA]Thyroid gland disorders FA[Endocrine disorders FGENERAL MEDICAL HISTORY2018-08 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Aug2018D-883 N DW 2.42 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDWD<HrٍBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDWD<Hrٍ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081883100818831008AZithromax allergy Drug hypersensitivity FImmune system disorders F4Allergic reaction to antibiotics F8Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.09 01Jan2006M-5478 N DW 15 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDWD<HrٍBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDWD<Hrٍ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081883100818831008APConcerta allergy Drug hypersensitivity FImmune system disorders F4Specific allergy (drug) F8OAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01001Jan2017M-1460 N DW 4 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDWD<HrٍBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDWD<Hrٍ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081883100818831008AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2019M-730 N DW 2 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDWD<HrٍBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDWD<Hrٍ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081883100818831008A Aspergers autism Autism spectrum disorder FPsychiatric disorders F'Asperger's disorder FPervasive developmental disorders NEC F4Developmental disorders NEC FǒPsychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2019M-730 N DW 2 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDWD<HrٍBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDWD<Hrٍ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081883100818831008A`Depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.07 01Jan2019M-730 N DW 2 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDWD<HrٍBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDWD<Hrٍ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081883100818831008AInsomnia Insomnia F%Psychiatric disorders F'Insomnia F%Disturbances in initiating and maintaining sleep FFSleep disorders and disturbances F6Psychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2019M-730 N DW 2 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDWD<HrٍBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDWD<Hrٍ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081884100818841008APenicillin allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2006M-5478 N DW 15 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDWDHrDWD(HsmIDWDHsPlacebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW..DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081884100818841008A Right hand eczema Hand dermatitis F|Skin and subcutaneous tissue disorders F5Hand eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1095 N DW 3 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDWDHrDWD(HsmIDWDHsPlacebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW..DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081886100818861008APremenarchal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDXHrXDWDHrEPBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDXHrXDWDHrEP......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081887100818871008A Premenarchal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DHrDWD4Hs4Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DHrDW!D\HrDWDHsmKDWD4Hs4Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081887100818871008AAttention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1464 N DW 4.01 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DHrDWD4Hs4Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DHrDW!D\HrDWDHsmKDWD4Hs4Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081889100818891008AScoliosis Scoliosis F1Musculoskeletal and connective tissue disorders FkScoliosis F1Spine and neck deformities FMusculoskeletal and connective tissue deformities (incl intervertebral disc disorders)FYMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2020-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jun2020D-217 N DW 0.6 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DPHrPDW!DpHrށBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DPHrPDW!DpHrށ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081890100818901008ABilateral hand eczema Hand dermatitis F|Skin and subcutaneous tissue disorders F5Hand eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3291 N DW 9.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHrDW!D}Hr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHrDW!D}Hr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081890100818901008A Left leg eczema Eczema FSkin and subcutaneous tissue disorders F5Eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2012M-3291 N DW 9.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHrDW!D}Hr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHrDW!D}Hr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081890100818901008A0Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2017M-1464 N DW 4.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHrDW!D}Hr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHrDW!D}Hr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081891100818911008A0Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2011M-3656 N DW 10.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DHrDWD|8Hs&Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DHrDW!D`HrނDWD4Hss{4DWD|8Hs&Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081891100818911008AAttention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2014M-2560 N DW 7.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DHrDWD|8Hs&Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DHrDW!D`HrނDWD4Hss{4DWD|8Hs&Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081891100818911008A Facial acne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2020-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jun2020D-217 N DW 0.6 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DHrDWD|8Hs&Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DHrDW!D`HrނDWD4Hss{4DWD|8Hs&Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081892100818921008A Attention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2014M-2560 N DW 7.01 YEARSAYEARS12-15 YearsAMAAMERICAN INDIAN OR ALASKA NATIVE A0AMERICAN INDIAN OR ALASKA NATIVE A0YYPlacebo PLACEBO Placebo PLACEBO DW D`Hr`DWD|8Hsa8Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW D`Hr`DW!DИHrDWD~Hs|DWD|8Hsa8Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081892100818921008A0Cetaphil allergy Dermatitis contact FSkin and subcutaneous tissue disorders F5Dermatitis contact FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2014M-2560 N DW 7.01 YEARSAYEARS12-15 YearsAMAAMERICAN INDIAN OR ALASKA NATIVE A0AMERICAN INDIAN OR ALASKA NATIVE A0YYPlacebo PLACEBO Placebo PLACEBO DW D`Hr`DWD|8Hsa8Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW D`Hr`DW!DИHrDWD~Hs|DWD|8Hsa8Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081892100818921008AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1099 N DW 3.01 YEARSAYEARS12-15 YearsAMAAMERICAN INDIAN OR ALASKA NATIVE A0AMERICAN INDIAN OR ALASKA NATIVE A0YYPlacebo PLACEBO Placebo PLACEBO DW D`Hr`DWD|8Hsa8Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW D`Hr`DW!DИHrDWD~Hs|DWD|8Hsa8Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081893100818931008A@Bilateral hand eczema Hand dermatitis F|Skin and subcutaneous tissue disorders F5Hand eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2007M-5117 N DW 14.01 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW D͌HrDW!DdHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW D͌HrDW!DdHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081893100818931008AAmoxicillin allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2008M-4752 N DW 13.01 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW D͌HrDW!DdHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW D͌HrDW!DdHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081893100818931008A`Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2009M-4386 N DW 12.01 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW D͌HrDW!DdHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW D͌HrDW!DdHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081893100818931008A Asthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2016M-1830 YChronic pulmonary disease DW 5.01 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW D͌HrDW!DdHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW D͌HrDW!DdHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081893100818931008A0Attention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2020M-369 N DW 1.01 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW D͌HrDW!DdHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW D͌HrDW!DdHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081893100818931008APDysfunctional uterine bleeding Abnormal uterine bleeding F0Reproductive system and breast disorders F-LDysfunctional uterine bleeding FMenstruation and uterine bleeding NEC FGMenstrual cycle and uterine bleeding disorders FʎReproductive system and breast disorders F-LGENERAL MEDICAL HISTORY2020 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2020M-369 N DW 1.01 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW D͌HrDW!DdHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW D͌HrDW!DdHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081894100818941008ASeasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2011M-3656 N DW 10.01 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHr)DW#DHr2BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHr)DW#DHr2......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081895100818951008APremenarcheal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DـHr+DW!DlHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DـHr+DW!DlHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081897100818971008ASeasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1831 N DW 5.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHHr<DW"DHrߠBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHHr<DW"DHrߠ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW"....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081898100818981008A Premenarchal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DHr?\DWD@HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DHr?\DW!DxHrވDWD$HslDWD@HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081898100818981008AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-735 N DW 2.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DHr?\DWD@HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DHr?\DW!DxHrވDWD$HslDWD@HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081901100819011008ARocephin allergy Drug hypersensitivity FImmune system disorders F4Allergic reaction to antibiotics F8Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2005 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2005M-5848 N DW 16.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DИHrtDWKDXHs%Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DИHrtDW"DLHr$LDW6D8HrK8DWKDXHs%Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW".DW6DWK.DW3DW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081902100819021008ASeasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4022 N DW 11.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DhHrvDWD<Hs<Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DhHrvDW"DHrDWDHsmHDWD<Hs<Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW".DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081903100819031008A Bilateral bend of arm eczema Eczema FSkin and subcutaneous tissue disorders F5Eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4753 N DW 13.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DԔHrxDW"DHHrHBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DԔHrxDW"DHHrH......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW"....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081903100819031008A0Bilateral bend of knee eczema Eczema FSkin and subcutaneous tissue disorders F5Eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2008M-4753 N DW 13.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DԔHrxDW"DHHrHBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DԔHrxDW"DHHrH......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW"....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081903100819031008A@Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2010M-4022 N DW 11.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DԔHrxDW"DHHrHBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DԔHrxDW"DHHrH......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW"....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081903100819031008AAttention deficit disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2017M-1465 N DW 4.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DԔHrxDW"DHHrHBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DԔHrxDW"DHHrH......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW"....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081904100819041008A Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2009M-4387 N DW 12.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DHr|LDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DHr|LDW"DHrDWD$Hsm>DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW".DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081904100819041008AAsthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2196 YChronic pulmonary disease DW 6.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DHr|LDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DHr|LDW"DHrDWD$Hsm>DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW".DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081905100819051008AFacial acne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2020 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2020M-371 N DW 1.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD0Hrň0DW%D̜HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD0Hrň0DW%D̜Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081906100819061008ACephalexin allergy Drug hypersensitivity FImmune system disorders F4Allergic reaction to antibiotics F8Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1466 N DW 4.02 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD8Hrŏ8DW#DLHr9BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD8Hrŏ8DW#DLHr9......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081906100819061008A Facial acne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1101 N DW 3.02 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD8Hrŏ8DW#DLHr9BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD8Hrŏ8DW#DLHr9......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081907100819071008ADysmenorrhea Dysmenorrhoea FReproductive system and breast disorders F-LDysmenorrhea FMenstruation and uterine bleeding NEC FGMenstrual cycle and uterine bleeding disorders FʎReproductive system and breast disorders F-LGENERAL MEDICAL HISTORY2020-09 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Sep2020D-127 N DW 0.35 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrŔDWD Hs*Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrŔDW#DHr6HDWD$Hsn$DWD Hs*Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081908100819081008Apremenarchal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrœDW#DPHr5BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrœDW#DPHr5......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081910100819101008ASeasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4754 N DW 13.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDϨHrĨDW#DHr`<BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDϨHrĨDW#DHr`<......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081911100819111008ASeasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2014M-2562 N DW 7.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDW$DHr⍤DWDHsnDDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081912100819121008AAttention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2013M-2927 N DW 8.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD4Hr4DW$D,Hr,BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD4Hr4DW$D,Hr,......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081912100819121008A Sleep apnea Sleep apnoea syndrome F6Respiratory, thoracic and mediastinal disorders F-Sleep apnea F6Breathing abnormalities F>Respiratory disorders NEC F-Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1101 N DW 3.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD4Hr4DW$D,Hr,BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD4Hr4DW$D,Hr,......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081913100819131008AAzithromycin allergy Drug hypersensitivity FImmune system disorders F4Allergic reaction to antibiotics F8Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2008M-4754 N DW 13.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDנHr̠DWD|Hs|Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDנHr̠DW$D@Hr@DWDHsr4DWD|Hs|Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081913100819131008A Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1832 N DW 5.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDנHr̠DWD|Hs|Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDנHr̠DW$D@Hr@DWDHsr4DWD|Hs|Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081914100819141008A Asthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2009M-4388 YChronic pulmonary disease DW 12.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDtHrtDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDtHrtDW3DHrZxDWDHsm?DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW3.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081914100819141008A0Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2010M-4023 N DW 11.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDtHrtDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDtHrtDW3DHrZxDWDHsm?DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW3.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081914100819141008AAcanthosis nigricans Acanthosis nigricans FSkin and subcutaneous tissue disorders F5Acanthosis nigricans FSkin hyperplasias and hypertrophies F6"Cornification and dystrophic skin disorders FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2020-07 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jul2020D-189 N DW 0.52 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDtHrtDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDtHrtDW3DHrZxDWDHsm?DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW3.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081915100819151008AAsthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2009M-4389 YChronic pulmonary disease DW 12.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr|DW$D|Hr|BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr|DW$D|Hr|......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081916100819161008AFace acne Acne FpSkin and subcutaneous tissue disorders F5Acne NOS F~Acnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2020-07 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jul2020D-190 N DW 0.52 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr<DW$DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr<DW$DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081917100819171008A Bilateral ankle psoriasis Psoriasis F'Skin and subcutaneous tissue disorders F5Non-scalp psoriasis FhPsoriatic conditions FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2012M-3294 N DW 9.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWD{HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDW$D`Hr`DWD4Hst۴DWD{HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081917100819171008A0Bilateral finger psoriasis Psoriasis F'Skin and subcutaneous tissue disorders F5Psoriasis F'Psoriatic conditions FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3294 N DW 9.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWD{HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDW$D`Hr`DWD4Hst۴DWD{HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081917100819171008A@Bilateral knee psoriasis Psoriasis F'Skin and subcutaneous tissue disorders F5Non-scalp psoriasis FhPsoriatic conditions FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2012M-3294 N DW 9.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWD{HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDW$D`Hr`DWD4Hst۴DWD{HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081917100819171008AAttention deficit disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2015M-2198 N DW 6.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWD{HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDW$D`Hr`DWD4Hst۴DWD{HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081918100819181008APremenarchal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDlHrDW$DƄHr⼄BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDlHrDW$DƄHr⼄......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081919100819191008A Sulfa allergy Drug hypersensitivity FImmune system disorders F4Sulfonamide allergy FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1833 N DW 5.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD<HrDWDHs <Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD<HrDW%DHrTDWD<HsuDWDHs <Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081919100819191008AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-10 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Oct2020D-98 N DW 0.27 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD<HrDWDHs <Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD<HrDW%DHrTDWD<HsuDWDHs <Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081920100819201008Anocturnal enuresis Enuresis FPsychiatric disorders F'Nocturnal enuresis F Psychiatric elimination disorders F'Psychiatric disorders NEC F'Psychiatric disorders F'GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1833 N DW 5.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrlDW$DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrlDW$DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081921100819211008AAttention deficit disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3294 N DW 9.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr#HDWD͌Hsrw Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr#HDW%DϨHr(DW|DlHsVlDWD͌Hsrw Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DW|DW.DWyDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081921100819211008A Intermittent nose bleeds Epistaxis FrRespiratory, thoracic and mediastinal disorders F-Nose bleeds F Nasal disorders NEC FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1467 N DW 4.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr#HDWD͌Hsrw Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr#HDW%DϨHr(DW|DlHsVlDWD͌Hsrw Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DW|DW.DWyDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081922100819221008AAttention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2013M-2929 N DW 8.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD0Hr+0DW%DθHr8BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD0Hr+0DW%DθHr8......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081922100819221008A Migraines Migraine FONervous system disorders FMigraine FOMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1834 N DW 5.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD0Hr+0DW%DθHr8BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD0Hr+0DW%DθHr8......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081923100819231008A Premenarcheal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr-DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr-DW%DxHrDWDĤHsm($DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081923100819231008AAttention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2014M-2564 N DW 7.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr-DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr-DW%DxHrDWDĤHsm($DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081924100819241008AAttention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2014M-2564 N DW 7.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr0DWDXHs Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr0DW%DHrlDWDHsnHDWDXHs Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081924100819241008A Bicuspid aortic valve Bicuspid aortic valve FHCongenital, familial and genetic disorders FBicuspid aortic valve FHCardiac valve disorders congenital F>Cardiac and vascular disorders congenital FCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1468 N DW 4.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr0DWDXHs Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr0DW%DHrlDWDHsnHDWDXHs Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081928100819281008A0Sulfa allergy Drug hypersensitivity FImmune system disorders F4Sulfonamide allergy FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2014M-2564 N DW 7.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDTHrpTDW%DHrxBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDTHrpTDW%DHrx......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081928100819281008A Attention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1834 N DW 5.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDTHrpTDW%DHrxBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDTHrpTDW%DHrx......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081928100819281008AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1103 N DW 3.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDTHrpTDW%DHrxBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDTHrpTDW%DHrx......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081929100819291008APremenarchal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDۜHrsDW%D͌Hr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDۜHrsDW%D͌Hr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081930100819301008A Premenarchal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD<Hr"DWDHs PPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD<Hr"DW(D8Hr8DWDXHsm(DWDHs PPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081930100819301008AAsthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2011M-3663 YChronic pulmonary disease DW 10.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD<Hr"DWDHs PPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD<Hr"DW(D8Hr8DWDXHsm(DWDHs PPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081931100819311008A Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2013M-2932 N DW 8.03 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DWDHr$`DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr$`DW(DHr罜DWDHstDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081931100819311008AAsthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2016M-1837 YChronic pulmonary disease DW 5.03 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DWDHr$`DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr$`DW(DHr罜DWDHstDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081932100819321008AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019-02 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Feb2019D-710 N DW 1.95 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DWDHr%PDWDTHsTPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr%PDW(D`Hr`DWDHstڈDWDTHsTPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081934100819341008A@Premenarchal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD4HrWDW(DшHr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD4HrWDW(DшHr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081934100819341008A Attention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2016M-1837 N DW 5.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD4HrWDW(DшHr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD4HrWDW(DшHr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081934100819341008A0Celiac disease Coeliac disease FGastrointestinal disorders FܛCeliac disease F8Malabsorption syndromes FMalabsorption conditions FGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2019M-741 N DW 2.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD4HrWDW(DшHr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD4HrWDW(DшHr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081934100819341008APseasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019M-741 N DW 2.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD4HrWDW(DшHr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD4HrWDW(DшHr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081934100819341008AAlopecia areata Alopecia areata FaSkin and subcutaneous tissue disorders F5Alopecia areata FaAlopecias FiSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2020 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2020M-376 N DW 1.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD4HrWDW(DшHr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD4HrWDW(DшHr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081935100819351008AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2202 N DW 6.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD<Hr^DW*D(Hr(BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD<Hr^DW*D(Hr(......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW*....DWFDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081937100819371008ASeasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4028 N DW 11.03 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDDHreDW(D\Hr \BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDDHreDW(D\Hr \......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081938100819381008A Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2009M-4393 N DW 12.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD`HrgDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD`HrgDW)D̜HrZDWDHsr4|DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW).DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081938100819381008AAmoxicillin allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2015M-2202 N DW 6.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD`HrgDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD`HrgDW)D̜HrZDWDHsr4|DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW).DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081940100819401008AAsthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2007M-5125 YChronic pulmonary disease DW 14.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD,Hr̈́,DW)DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD,Hr̈́,DW)DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW)....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081940100819401008A Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2012M-3299 N DW 9.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD,Hr̈́,DW)DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD,Hr̈́,DW)DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW)....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1008 10081941100819411008A Premenarchal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DWDHrͪDWDHs(pPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrͪDW)D4HrXDWDƄHsn{DWDHs(pPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW).DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081941100819411008AAsthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2011M-3664 YChronic pulmonary disease DW 10.03 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DWDHrͪDWDHs(pPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrͪDW)D4HrXDWDƄHsn{DWDHs(pPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW).DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081941100819411008A0Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2011M-3664 N DW 10.03 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DWDHrͪDWDHs(pPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrͪDW)D4HrXDWDƄHsn{DWDHs(pPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW).DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081942100819421008A Facial acne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2020-08 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Aug2020D-164 N DW 0.45 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DWDHrͫDWDxHs'Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrͫDW)DˬHrY,DWDHsn{DWDxHs'Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW).DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081942100819421008AAsthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2007M-5125 YChronic pulmonary disease DW 14.03 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DWDHrͫDWDxHs'Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrͫDW)DˬHrY,DWDHsn{DWDxHs'Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW).DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081942100819421008A0Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2007M-5125 N DW 14.03 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DWDHrͫDWDxHs'Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrͫDW)DˬHrY,DWDHsn{DWDxHs'Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW).DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1008 10081943100819431008APenicillin allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4760 N DW 13.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD@Hrͬ@DW)DҴHr`4BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD@Hrͬ@DW)DҴHr`4......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW)....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091204100912041009Aseasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1018 N DV 2.79 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrXxDWDߘHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrXxDVDHrqnDWDHsDWDߘHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091208100912081009A Penicillin Allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2006M-5401 N DV 14.79 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDpHrXDDW\DxHs,xPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDpHrXDDVDHruDWHDDHsDDW\DxHs,xPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWHDW\.DW=DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091208100912081009AAllergic Rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2012M-3210 N DV 8.79 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDpHrXDDW\DxHs,xPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDpHrXDDVDHruDWHDDHsDDW\DxHs,xPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWHDW\.DW=DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091208100912081009A0Seasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3210 N DV 8.79 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDpHrXDDW\DxHs,xPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDpHrXDDVDHruDWHDDHsDDW\DxHs,xPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWHDW\.DW=DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091209100912091009A0Premenarchal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD0HrXuDVDHrr\BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD0HrXuDVDHrr\......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091209100912091009A ATTENTION DEFICIT HYPERACTIVITY DISORDER Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017-09 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Sep2017D-1140 N DV 3.12 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD0HrXuDVDHrr\BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD0HrXuDVDHrr\......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091209100912091009AANXIETY Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018-09 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Sep2018D-775 N DV 2.12 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD0HrXuDVDHrr\BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD0HrXuDVDHrr\......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091212100912121009Aringworm Tinea infection FYInfections and infestations FRingworm NOS F/Tinea infections FAFungal infectious disorders FInfections and infestations FGENERAL MEDICAL HISTORY2020-09-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 06Sep2020 -40 N DV 0.11 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrYcDWDټHs'<Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrYcDVD4HrDWDHswlDWDټHs'<Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091218100912181009A AMBLYOPIA RIGHT EYE Amblyopia FEye disorders FԯAmblyopia unilateral FpAmblyopic vision impairment FVision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDtHrYtDVDHru.BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDtHrYtDVDHru.......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091218100912181009ASTRAMBIUS BILATERAL EYES Strabismus F;/Eye disorders FԯStrabismus F;/Ocular nerve and muscle disorders F Ocular neuromuscular disorders F Eye disorders FԯGENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDtHrYtDVDHru.BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDtHrYtDVDHru.......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091218100912181009AMulti Directional Joint Instability Joint instability F#Musculoskeletal and connective tissue disorders FkJoint instability F#Joint related disorders NEC FJoint disorders F-Musculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01101Jan2007M-5037 N DV 13.79 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDtHrYtDVDHru.BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDtHrYtDVDHru.......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091218100912181009A0AMOXICILLIN ALLERGY Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2008M-4672 N DV 12.79 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDtHrYtDVDHru.BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDtHrYtDVDHru.......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091218100912181009A`CEPHALOSPORINS ALLERGY Drug hypersensitivity FImmune system disorders F4Allergic reaction to antibiotics F8Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.07 01Jan2008M-4672 N DV 12.79 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDtHrYtDVDHru.BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDtHrYtDVDHru.......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091218100912181009ApCODEINE INTOLERANCE Drug intolerance FGeneral disorders and administration site conditions FDrug intolerance NOS FTTherapeutic and nontherapeutic responses F@Therapeutic and nontherapeutic effects (excl toxicity) FCGeneral disorders and administration site conditions FGENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.09 01Jan2008M-4672 N DV 12.79 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDtHrYtDVDHru.BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDtHrYtDVDHru.......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091218100912181009AOXYCODONE INTOLERANCE Drug intolerance FGeneral disorders and administration site conditions FDrug intolerance FTherapeutic and nontherapeutic responses F@Therapeutic and nontherapeutic effects (excl toxicity) FCGeneral disorders and administration site conditions FGENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01001Jan2008M-4672 N DV 12.79 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDtHrYtDVDHru.BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDtHrYtDVDHru.......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091218100912181009APENICILLIN ALLERGY Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.08 01Jan2008M-4672 N DV 12.79 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDtHrYtDVDHru.BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDtHrYtDVDHru.......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091218100912181009AALLERGIC RHINITIS Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2009M-4306 N DV 11.79 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDtHrYtDVDHru.BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDtHrYtDVDHru.......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091218100912181009APATTENTION DEFICIT HYPERACTIVITY DISORDER Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2014M-2480 N DV 6.79 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDtHrYtDVDHru.BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDtHrYtDVDHru.......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091218100912181009A@ASTHMA Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2011-09-16 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 16Sep2011 -3318 YChronic pulmonary disease DV 9.09 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDtHrYtDVDHru.BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDtHrYtDVDHru.......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091220100912201009Aanxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1022 N DV 2.8 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD<Hr]DVDHrvxPlacebo A .Placebo A .DVD<Hr]DVDHrvx......Placebo Placebo DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091220100912201009A0depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2018M-1022 N DV 2.8 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD<Hr]DVDHrvxPlacebo A .Placebo A .DVD<Hr]DVDHrvx......Placebo Placebo DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091220100912201009APpost concussive syndrome Post concussion syndrome FvInjury, poisoning and procedural complications FPost concussion syndrome FvNon-site specific injuries NEC F Injuries NEC FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2019-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jun2019D-506 N DV 1.39 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD<Hr]DVDHrvxPlacebo A .Placebo A .DVD<Hr]DVDHrvx......Placebo Placebo DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091220100912201009A chronic daily headache Headache FNervous system disorders FChronic headaches FhHeadaches NEC FHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2017-05-05 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 05May2017 -1263 N DV 3.46 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD<Hr]DVDHrvxPlacebo A .Placebo A .DVD<Hr]DVDHrvx......Placebo Placebo DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091220100912201009A@migraines, chronic Migraine FONervous system disorders FChronic migraine FMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2017-05-05 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 05May2017 -1263 N DV 3.46 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD<Hr]DVDHrvxPlacebo A .Placebo A .DVD<Hr]DVDHrvx......Placebo Placebo DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091220100912201009A`seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017-06-12 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 12Jun2017 -1225 N DV 3.36 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD<Hr]DVDHrvxPlacebo A .Placebo A .DVD<Hr]DVDHrvx......Placebo Placebo DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091221100912211009A`premenarchal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDhHr]DVDHrvxBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDhHr]DVDHrvx......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1009 10091221100912211009APfacial acne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2020-02 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Feb2020D-261 N DV 0.72 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDhHr]DVDHrvxBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDhHr]DVDHrvx......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1009 10091221100912211009ABILATERAL ANKLE PAIN Arthralgia F'Musculoskeletal and connective tissue disorders FkPain ankle FJoint related signs and symptoms F:Joint disorders F-Musculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1022 N DV 2.8 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDhHr]DVDHrvxBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDhHr]DVDHrvx......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1009 10091221100912211009A BILATERAL HIP PAIN Arthralgia F'Musculoskeletal and connective tissue disorders FkPain in hip FJoint related signs and symptoms F:Joint disorders F-Musculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2018M-1022 N DV 2.8 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDhHr]DVDHrvxBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDhHr]DVDHrvx......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1009 10091221100912211009A0BILATERAL KNEE PAIN Arthralgia F'Musculoskeletal and connective tissue disorders FkKnee pain F5Joint related signs and symptoms F:Joint disorders F-Musculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1022 N DV 2.8 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDhHr]DVDHrvxBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDhHr]DVDHrvx......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1009 10091221100912211009A@TONSILLITIS Tonsillitis FBhInfections and infestations FTonsillitis FBhUpper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2017-08-102019-04 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 10Aug2017 -1166 30Apr2019D-538 N DV 3.2 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDhHr]DVDHrvxBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDhHr]DVDHrvx......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1009 10091223100912231009ABenign Rolandic Epilepsy Benign rolandic epilepsy FNervous system disorders FBenign rolandic epilepsy FSeizures and seizure disorders NEC F2hSeizures (incl subtypes) F2gNervous system disorders FGENERAL MEDICAL HISTORY2014 2016 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2014M-2483 31Dec2016M-1388 N DV 6.8 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDtHr]DVDtHrzBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDtHr]DVDtHrz......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091226100912261009ADepression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019D-658 N DV 1.8 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr^DWDHs;Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr^DVDHry8DWDPHsvMPDWDHs;Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091227100912271009A Seasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-3945 N DV 10.8 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD|Hr_ |DVDHrz@BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD|Hr_ |DVDHrz@......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DW=DV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091227100912271009APenicillin Allergy (hives) Urticaria FMSkin and subcutaneous tissue disorders F5Urticaria drug-induced FcUrticarias FMAngioedema and urticaria FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1023 N DV 2.8 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD|Hr_ |DVDHrz@BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD|Hr_ |DVDHrz@......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DW=DV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091229100912291009A0SEASONAL ALLERGIES Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2013M-2849 N DV 7.8 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr_DWD0Hs}0Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr_DWUD Hs#DWDXHswDWD0Hs}0Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DV.DWUDWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091229100912291009A RECURRENT EAR INFECTIONS Ear infection F;Infections and infestations FEar infection F;Ear infections F=Infections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2016M-1754 N DV 4.8 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr_DWD0Hs}0Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr_DWUD Hs#DWDXHswDWD0Hs}0Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DV.DWUDWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091229100912291009AEXERCISE INDUCED ASTHMA Asthma exercise induced FeRespiratory, thoracic and mediastinal disorders F-Exercise induced asthma FӡBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2020-08-19 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 19Aug2020 -62 YChronic pulmonary disease DV 0.17 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr_DWD0Hs}0Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr_DWUD Hs#DWDXHswDWD0Hs}0Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DV.DWUDWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091233100912331009Aattention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1389 N DV 3.81 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDhHr`DWDXHsXPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDhHr`DVD Hr}eDWDxHsDWDXHsXPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1009 10091234100912341009ASeasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1389 N DV 3.81 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD@Hr`?DVDHr{BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD@Hr`?DVDHr{......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1009 10091237100912371009APlactose intolerance Lactose intolerance FMetabolism and nutrition disorders FLactose intolerance FSugar intolerance (excl glucose intolerance) FDWyDHsRlPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWdDWy.DWdDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091292100912921009A seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1068 N DV 2.93 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD`HrNDWyDHsRlPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD`HrNDWDHr)DWdDHs7>DWyDHsRlPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWdDWy.DWdDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091293100912931009A eczema Eczema FSkin and subcutaneous tissue disorders F5Eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4721 N DV 12.93 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrn DWDנHs% Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrn DWDXHrEXDWDHsu20DWDנHs% Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091293100912931009Acephalosprin allergy Drug hypersensitivity FImmune system disorders F4Allergic reaction to antibiotics F8Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2011M-3625 N DV 9.93 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrn DWDנHs% Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrn DWDXHrEXDWDHsu20DWDנHs% Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091294100912941009Aacne, generalized Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1436 N DV 3.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr DW~DHsY#Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr DWDHrDWhDHs<DW~DHsY#Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWhDW~.DWdDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091294100912941009A dermatitis, atopic Dermatitis atopic FSkin and subcutaneous tissue disorders F5Atopic dermatitis FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1071 N DV 2.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr DW~DHsY#Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr DWDHrDWhDHs<DW~DHsY#Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWhDW~.DWdDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091294100912941009A0menorrhagia Heavy menstrual bleeding F/Reproductive system and breast disorders F-LMenorrhagia F1Menstruation with increased bleeding FNMenstrual cycle and uterine bleeding disorders FʎReproductive system and breast disorders F-LGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2018M-1071 N DV 2.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr DW~DHsY#Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr DWDHrDWhDHs<DW~DHsY#Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWhDW~.DWdDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091295100912951009Apremenarchal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr6DWDhHr-hBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr6DWDhHr-h......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091297100912971009A0PEANUT ALLERGY Food allergy FزImmune system disorders F4Peanut allergy FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2008M-4724 N DV 12.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrADWD HrɠBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrADWD Hrɠ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091297100912971009A@TREE NUT ALLERGY Food allergy FزImmune system disorders F4Allergy to nuts Fm/Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2008M-4724 N DV 12.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrADWD HrɠBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrADWD Hrɠ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091297100912971009AASTHMA, MILD Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2014M-2532 YChronic pulmonary disease DV 6.93 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrADWD HrɠBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrADWD Hrɠ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091297100912971009A HEADACHES Headache FNervous system disorders FHeadache FHeadaches NEC FHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2014M-2532 N DV 6.93 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrADWD HrɠBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrADWD Hrɠ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091300100913001009Aattention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1802 N DV 4.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrfDWDPHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrfDWDPHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091301100913011009Amigraines Migraine FONervous system disorders FMigraine FOMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.09 01Jan2015M-2167 N DV 5.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDLHrfLDWD(Hs(Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDLHrfLDWD̜HrDWDHskDWD(Hs(Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091301100913011009A ASTHMA, MODERATE Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1802 YChronic pulmonary disease DV 4.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDLHrfLDWD(Hs(Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDLHrfLDWD̜HrDWDHskDWD(Hs(Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091301100913011009APFUR ALLERGY Allergy to animal FNImmune system disorders F4Allergy to animal FNAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2016M-1802 N DV 4.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDLHrfLDWD(Hs(Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDLHrfLDWD̜HrDWDHskDWD(Hs(Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091301100913011009A`ORAL ALLERGY SYNDROME Oral allergy syndrome FImmune system disorders F4Oral allergy syndrome FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2016M-1802 N DV 4.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDLHrfLDWD(Hs(Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDLHrfLDWD̜HrDWDHskDWD(Hs(Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091301100913011009ApPOLLEN ALLERGY Seasonal allergy FUImmune system disorders F4Pollen allergy F#3Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.07 01Jan2016M-1802 N DV 4.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDLHrfLDWD(Hs(Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDLHrfLDWD̜HrDWDHskDWD(Hs(Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091301100913011009ARAW FRUITS AND VEGETABLE ALLERGY Food allergy FزImmune system disorders F4Food allergy FزAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.08 01Jan2016M-1802 N DV 4.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDLHrfLDWD(Hs(Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDLHrfLDWD̜HrDWDHskDWD(Hs(Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091301100913011009AANXIETY Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2017M-1436 N DV 3.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDLHrfLDWD(Hs(Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDLHrfLDWD̜HrDWDHskDWD(Hs(Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091301100913011009A0ATTENTION DEFICIT HYPERACTIVITY DISORDER Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1436 N DV 3.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDLHrfLDWD(Hs(Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDLHrfLDWD̜HrDWDHskDWD(Hs(Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091301100913011009A@DEPRESSION Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2017M-1436 N DV 3.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDLHrfLDWD(Hs(Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDLHrfLDWD̜HrDWDHskDWD(Hs(Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091304100913041009Agrade 3 systolic ejection murmur Cardiac murmur F"Investigations FSystolic ejection murmur F\Cardiac auscultatory investigations FYCardiac and vascular investigations (excl enzyme tests) FInvestigations FGENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2007M-5090 N DV 13.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrtDWDHrXBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrtDWDHrX......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091304100913041009A viral induced asthma, severe Asthma FaRespiratory, thoracic and mediastinal disorders F-Infection induced asthma FcBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-3994 YChronic pulmonary disease DV 10.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrtDWDHrXBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrtDWDHrX......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091305100913051009AAttention Deficit Disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2011M-3629 N DV 9.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD HrDWkDDHs@<Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD HrDWDHrDWVDTHs$TDWkDDHs@<Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWVDWk.DW=DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091305100913051009A Seasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2012M-3264 N DV 8.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD HrDWkDDHs@<Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD HrDWDHrDWVDTHs$TDWkDDHs@<Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWVDWk.DW=DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091307100913071009Aamoxicillin allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4726 N DV 12.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDxHrxDWDHr=HBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDxHrxDWDHr=H......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091307100913071009A eczema to bilateral hands Hand dermatitis F|Skin and subcutaneous tissue disorders F5Hand eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2015M-2169 N DV 5.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDxHrxDWDHr=HBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDxHrxDWDHr=H......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091308100913081009Aamoxicillin allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2010M-3995 N DV 10.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHr= Placebo A .Placebo A .DVDHrDWDHr= ......Placebo Placebo DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091308100913081009A attention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-708 N DV 1.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHr= Placebo A .Placebo A .DVDHrDWDHr= ......Placebo Placebo DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091309100913091009AArachnoid Cyst Arachnoid cyst FUNervous system disorders FArachnoid cyst FUNervous system cysts and polyps FNervous system neoplasms benign FNervous system disorders FGENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2006M-5456 N DV 14.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr<BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr<......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091309100913091009A0Febrile Seizure Febrile convulsion FNervous system disorders FFebrile seizure F"Seizures and seizure disorders NEC F2hSeizures (incl subtypes) F2gNervous system disorders FGENERAL MEDICAL HISTORY2008-07 2008-07 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jul2008D-4544 31Jul2008D-4514 N DV 12.44 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr<BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr<......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091309100913091009A Endoscopic fenestration of arachnoid cyst and drain placement Cerebral cyst excision FbLSurgical and medical procedures F<Cerebral cyst excision FbLSkull and brain therapeutic procedures F6}Nervous system, skull and spine therapeutic procedures FxSurgical and medical procedures F<GENERAL MEDICAL HISTORY2018-10-012018-10-01BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Oct2018 -800 01Oct2018 -800 N DV 2.19 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr<BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr<......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091310100913101009A0migraines Migraine FONervous system disorders FMigraine FOMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2011M-3630 N DV 9.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDhHrhDWDƄHr/BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDhHrhDWDƄHr/......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1009 10091310100913101009A Seasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2012M-3265 N DV 8.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDhHrhDWDƄHr/BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDhHrhDWDƄHr/......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1009 10091310100913101009APostural Orthostatic Tachycardia Syndrome Postural orthostatic tachycardia syndrome FCardiac disorders FPostural orthostatic tachycardia syndrome FRate and rhythm disorders NEC F*Cardiac arrhythmias FCardiac disorders FGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1073 N DV 2.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDhHrhDWDƄHr/BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDhHrhDWDƄHr/......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1009 10091311100913111009ABicuspid Aortic Valve Bicuspid aortic valve FHCongenital, familial and genetic disorders FBicuspid aortic valve FHCardiac valve disorders congenital F>Cardiac and vascular disorders congenital FCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDxHs^Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDwHrDDWDHsr8DWDxHs^Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091311100913111009A Burning during Urination Dysuria F&Renal and urinary disorders F,WBurning micturition FBladder and urethral symptoms FUrinary tract signs and symptoms FL~Renal and urinary disorders F,WGENERAL MEDICAL HISTORY2020-11-202020-11-23BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 20Nov2020 -19 23Nov2020 -16 N DV 0.05 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDxHs^Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDwHrDDWDHsr8DWDxHs^Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091312100913121009AANIMAL FUR INTOLERANCE, RHINITIS Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2011M-3630 N DV 9.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDۜHrDWDXHsXPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDۜHrDWDHrDWDHs3DWDXHsXPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091312100913121009A0SEASONAL ALLERGIES Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2011M-3630 N DV 9.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDۜHrDWDXHsXPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDۜHrDWDHrDWDHs3DWDXHsXPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091312100913121009A ASTHMA, MILD Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2169 YChronic pulmonary disease DV 5.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDۜHrDWDXHsXPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDۜHrDWDHrDWDHs3DWDXHsXPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091314100913141009Aallergy to azithromycin Drug hypersensitivity FImmune system disorders F4Allergic reaction to antibiotics F8Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2007M-5091 N DV 13.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWD,Hs,Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWD<HrDWDHsJ`DWD,Hs,Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1009 10091314100913141009A seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2013M-2899 N DV 7.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWD,Hs,Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWD<HrDWDHsJ`DWD,Hs,Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1009 10091315100913151009A0acne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2020-02 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Feb2020D-312 N DV 0.86 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVEBHr(DWDHr<BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVEBHr(DWDHr<......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1009 10091315100913151009AAMOXICILLIN ALLERGY Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4726 N DV 12.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVEBHr(DWDHr<BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVEBHr(DWDHr<......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1009 10091315100913151009A HEADACHES Headache FNervous system disorders FHeadache FHeadaches NEC FHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2012M-3265 N DV 8.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVEBHr(DWDHr<BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVEBHr(DWDHr<......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1009 10091316100913161009APinsomnia Insomnia F%Psychiatric disorders F'Insomnia F%Disturbances in initiating and maintaining sleep FFSleep disorders and disturbances F6Psychiatric disorders F'GENERAL MEDICAL HISTORY2010-12 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Dec2010D-3661 N DV 10.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVE7@HrtDWjDHs>ҨPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVE7@HrtDWDHrDWTDHs"DWjDHs>ҨPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWTDWj.DW=DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091316100913161009Aamoxicillin allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2006M-5456 N DV 14.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVE7@HrtDWjDHs>ҨPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVE7@HrtDWDHrDWTDHs"DWjDHs>ҨPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWTDWj.DW=DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091316100913161009A anxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2008M-4726 N DV 12.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVE7@HrtDWjDHs>ҨPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVE7@HrtDWDHrDWTDHs"DWjDHs>ҨPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWTDWj.DW=DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091316100913161009A@depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2008M-4726 N DV 12.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVE7@HrtDWjDHs>ҨPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVE7@HrtDWDHrDWTDHs"DWjDHs>ҨPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWTDWj.DW=DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091316100913161009A0attention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2169 N DV 5.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVE7@HrtDWjDHs>ҨPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVE7@HrtDWDHrDWTDHs"DWjDHs>ҨPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWTDWj.DW=DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091318100913181009A premenarchal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDtHrDWD Hr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDtHrDWD Hr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1009 10091318100913181009Aenvironmental allergies Hypersensitivity FImmune system disorders F4Environmental allergy FTAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3266 N DV 8.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDtHrDWD Hr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDtHrDWD Hr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1009 10091319100913191009AALLERGY TO FRUIT Food allergy FزImmune system disorders F4Fruit allergy FvAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2014M-2535 N DV 6.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD4Hr'DWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD4Hr'DWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1009 10091319100913191009A SEASONAL ALLERGIES Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2014M-2535 N DV 6.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD4Hr'DWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD4Hr'DWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1009 10091320100913201009ADepression, major Major depression FxpPsychiatric disorders F'Major depression FxpDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-09 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Sep2020D-100 N DV 0.28 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr)DWDHspPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr)DWDHrHDWD@Hs\@DWDHspPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091320100913201009A suicidal ideations Suicidal ideation FNCardiac auscultatory investigations FYCardiac and vascular investigations (excl enzyme tests) FInvestigations FGENERAL MEDICAL HISTORY2020-12-10 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 10Dec2020 1 N DV 0 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDpHr6DWDĤHr$BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDpHr6DWDĤHr$......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1009 10091323100913231009A penicillin allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2013M-2900 N DV 7.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDDWD8Hs}Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDDWDHrDWDHsDWD8Hs}Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091323100913231009Acephalosporin allergy Drug hypersensitivity FImmune system disorders F4Allergic reaction to antibiotics F8Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2015M-2170 N DV 5.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDDWD8Hs}Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDDWDHrDWDHsDWD8Hs}Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091324100913241009Aseasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2171 N DV 5.95 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDDWD@Hs1@Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDDWD(Hr(DWDHsҚDWD@Hs1@Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091326100913261009AECZEMA Eczema FSkin and subcutaneous tissue disorders F5Eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD8HrH8DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD8HrH8DWDHrHDWD\Hs{DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091326100913261009A0PREMENARCHAL Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD8HrH8DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD8HrH8DWDHrHDWD\Hs{DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091326100913261009A@SEASONAL ALLERGIES Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1440 N DV 3.95 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD8HrH8DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD8HrH8DWDHrHDWD\Hs{DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091326100913261009A GENERALIZED ANXIETY Generalised anxiety disorder FPsychiatric disorders F'Generalised anxiety disorder FAnxiety disorders NEC FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2018M-1075 N DV 2.95 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD8HrH8DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD8HrH8DWDHrHDWD\Hs{DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091328100913281009A Pectus Excavatum Pectus excavatum FCongenital, familial and genetic disorders FPectus excavatum FMusculoskeletal and connective tissue disorders of trunk congenital (excl spine)F`Musculoskeletal and connective tissue disorders congenital FlCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHroDWDPHrZBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHroDWDPHrZ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091328100913281009A0Premenarchal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) D(b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHroDWDPHrZBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHroDWDPHrZ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091328100913281009AAttention Deficit Disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2016M-1806 N DV 4.95 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHroDWDPHrZBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHroDWDPHrZ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091330100913301009A0PREMENARCHAL Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrnDWDxHs+Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrnDWDHrZXDWDHsxDWDxHs+Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091330100913301009A PINEAPPLE INTOLERANCE Food intolerance FMetabolism and nutrition disorders FFood intolerance FFood malabsorption and intolerance syndromes (excl sugar intolerance) FطFood intolerance syndromes FضMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2171 N DV 5.95 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrnDWDxHs+Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrnDWDHrZXDWDHsxDWDxHs+Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091330100913301009A@TOMATO INTOLERANCE Food intolerance FMetabolism and nutrition disorders FFood intolerance FFood malabsorption and intolerance syndromes (excl sugar intolerance) FطFood intolerance syndromes FضMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2015M-2171 N DV 5.95 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrnDWDxHs+Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrnDWDHrZXDWDHsxDWDxHs+Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091330100913301009ALACTOSE INTOLERANCE Lactose intolerance FMetabolism and nutrition disorders FLactose intolerance FSugar intolerance (excl glucose intolerance) FNCardiac auscultatory investigations FYCardiac and vascular investigations (excl enzyme tests) FInvestigations FGENERAL MEDICAL HISTORY2020-12-15 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 15Dec2020 1 N DV 0 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD4Hr4DWDHs|Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD4Hr4DWDHrŒDWDHs-DWDHs|Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091349100913491009ADysmenorrhea Dysmenorrhoea FReproductive system and breast disorders F-LDysmenorrhea FMenstruation and uterine bleeding NEC FGMenstrual cycle and uterine bleeding disorders FʎReproductive system and breast disorders F-LGENERAL MEDICAL HISTORY2019-08 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Aug2019D-502 N DV 1.38 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHsHPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWD`Hr`DWDHssDWDHsHPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091349100913491009A Imperforate Hymen Imperforate hymen FCongenital, familial and genetic disorders FImperforate hymen FFemale reproductive tract disorders congenital F֠Reproductive tract and breast disorders congenital F-PCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY2020-07-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 06Jul2020 -162 N DV 0.45 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHsHPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWD`Hr`DWDHssDWDHsHPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091350100913501009ACat Allergy Allergy to animal FNImmune system disorders F4Allergic to cats FCAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr|DWD$Hsں$Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr|DWDHr0DWDHsTDWD$Hsں$Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091351100913511009APREMENARCHAL Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) 2021-01-31BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6)31Jan2021 47 N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDXHrDWDôHrŸBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDXHrDWDôHrŸ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1009 10091353100913531009APREMENARCHAL Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDDHrDWD8Hr8BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDDHrDWD8Hr8......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.....DV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091354100913541009A PENICILLIN ALLERGY Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2008M-4733 N DV 12.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDlHrDWDTHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDlHrDWDTHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1009 10091354100913541009AATTENTION DEFICIT DISORDER Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1080 N DV 2.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDlHrDWDTHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDlHrDWDTHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1009 10091355100913551009A insomnia Insomnia F%Psychiatric disorders F'Insomnia F%Disturbances in initiating and maintaining sleep FFSleep disorders and disturbances F6Psychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1445 N DV 3.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr0DWDHrxBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr0DWDHrx......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1009 10091355100913551009Aattention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2019D-715 N DV 1.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr0DWDHrxBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr0DWDHrx......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1009 10091355100913551009A0oppositional defiant disorder Oppositional defiant disorder FrPsychiatric disorders F'Oppositional defiant disorder FrAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019D-715 N DV 1.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr0DWDHrxBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr0DWDHrx......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1009 10091356100913561009APREMENARCHAL Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr;\DWDwHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr;\DW DHrGDWD,HsrDWDwHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091357100913571009A0INSOMNIA Insomnia F%Psychiatric disorders F'Insomnia F%Disturbances in initiating and maintaining sleep FFSleep disorders and disturbances F6Psychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2017M-1446 N DV 3.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr-DWgDHs:xPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr-DW DHr3hDWSDdHs DWgDHs:xPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWSDWg.DW=DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091357100913571009A@JOINT PAIN, GENERALIZED Arthralgia F'Musculoskeletal and connective tissue disorders FkGeneralized joint pain FfJoint related signs and symptoms F:Joint disorders F-Musculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1446 N DV 3.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr-DWgDHs:xPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr-DW DHr3hDWSDdHs DWgDHs:xPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWSDWg.DW=DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091357100913571009ABACK PAIN Back pain FMusculoskeletal and connective tissue disorders FkBack pain FMusculoskeletal and connective tissue pain and discomfort FMusculoskeletal and connective tissue disorders NEC FiMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2018M-1081 N DV 2.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr-DWgDHs:xPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr-DW DHr3hDWSDdHs DWgDHs:xPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWSDWg.DW=DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091357100913571009A HEADACHES, RECURRENT Headache FNervous system disorders FHeadache recurrent FHeadaches NEC FHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1081 N DV 2.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr-DWgDHs:xPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr-DW DHr3hDWSDdHs DWgDHs:xPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWSDWg.DW=DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091358100913581009A penicillin allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2007M-5099 N DV 13.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDLHr,LDWDHrvBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDLHr,LDWDHrv......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1009 10091358100913581009AMIGRAINES Migraine FONervous system disorders FMigraine FOMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1081 N DV 2.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDLHr,LDWDHrvBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDLHr,LDWDHrv......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1009 10091359100913591009A0Positional Heart Murmur Cardiac murmur F"Investigations FHeart murmur FCardiac auscultatory investigations FYCardiac and vascular investigations (excl enzyme tests) FInvestigations FGENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHHrNHDWD\Hs\Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHHrNHDWD$Hr$DWDHsrgXDWD\Hs\Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091359100913591009A Arterial Switch Surgery Arterial switch operation FSurgical and medical procedures F<Arterial switch operation FVascular therapeutic procedures NEC FNvVascular therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY(b)(6) (b)(6) BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 (b)(6) (b)(6)(b)(6) (b)(6)N DV (b)(6)YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHHrNHDWD\Hs\Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHHrNHDWD$Hr$DWDHsrgXDWD\Hs\Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091359100913591009A`Transposition of Great Arteries Transposition of the great vessels FDCongenital, familial and genetic disorders FTransposition of great vessels FDGreat vessel disorders congenital FߝCardiac and vascular disorders congenital FCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY(b)(6) (b)(6) BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 (b)(6) (b)(6)(b)(6) (b)(6)N DV (b)(6)YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHHrNHDWD\Hs\Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHHrNHDWD$Hr$DWDHsrgXDWD\Hs\Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091359100913591009AAllergic Rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2012M-3273 N DV 8.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHHrNHDWD\Hs\Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHHrNHDWD$Hr$DWDHsrgXDWD\Hs\Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091359100913591009APSleep Insomnia Insomnia F%Psychiatric disorders F'Insomnia F%Disturbances in initiating and maintaining sleep FFSleep disorders and disturbances F6Psychiatric disorders F'GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2177 N DV 5.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHHrNHDWD\Hs\Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHHrNHDWD$Hr$DWDHsrgXDWD\Hs\Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091359100913591009A@Recurrent Headaches Headache FNervous system disorders FHeadache recurrent FHeadaches NEC FHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2018M-1081 N DV 2.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHHrNHDWD\Hs\Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHHrNHDWD$Hr$DWDHsrgXDWD\Hs\Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091360100913601009A insomnia Insomnia F%Psychiatric disorders F'Insomnia F%Disturbances in initiating and maintaining sleep FFSleep disorders and disturbances F6Psychiatric disorders F'GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4003 N DV 10.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrNDWD̜HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrNDWD̜Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1009 10091360100913601009AT3-L2 fusion Spinal fusion surgery F[Surgical and medical procedures F<Spinal fusion F8Spine and spinal cord therapeutic procedures F8Nervous system, skull and spine therapeutic procedures FxSurgical and medical procedures F<GENERAL MEDICAL HISTORY2019-07 2019-07 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jul2019D-535 31Jul2019D-505 N DV 1.47 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrNDWD̜HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrNDWD̜Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1009 10091360100913601009A0scoliosis Scoliosis F1Musculoskeletal and connective tissue disorders FkScoliosis F1Spine and neck deformities FMusculoskeletal and connective tissue deformities (incl intervertebral disc disorders)FYMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2019-05 2019-07 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01May2019D-596 31Jul2019D-505 N DV 1.63 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrNDWD̜HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrNDWD̜Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1009 10091361100913611009AINSOMNIA Insomnia F%Psychiatric disorders F'Insomnia F%Disturbances in initiating and maintaining sleep FFSleep disorders and disturbances F6Psychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-716 N DV 1.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr^DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr^DW DxHrēDWD HsrDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091362100913621009A0bicuspid aortic valve Bicuspid aortic valve FHCongenital, familial and genetic disorders FBicuspid aortic valve FHCardiac valve disorders congenital F>Cardiac and vascular disorders congenital FCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr|DWD@HriBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr|DWD@Hri......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1009 10091362100913621009A@insomnia Insomnia F%Psychiatric disorders F'Insomnia F%Disturbances in initiating and maintaining sleep FFSleep disorders and disturbances F6Psychiatric disorders F'GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2016M-1812 N DV 4.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr|DWD@HriBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr|DWD@Hri......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1009 10091362100913621009A attention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1446 N DV 3.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr|DWD@HriBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr|DWD@Hri......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1009 10091362100913621009Aanxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2018M-1081 N DV 2.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr|DWD@HriBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr|DWD@Hri......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1009 10091363100913631009A ATTENTION DEFICIT HYPERACTIVITY DISORDER Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1812 N DV 4.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDtHr|tDWDHspPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDtHr|tDVDtHr|tDWDHsDWDHspPlacebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DV..DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091363100913631009A0INSOMNIA Insomnia F%Psychiatric disorders F'Insomnia F%Disturbances in initiating and maintaining sleep FFSleep disorders and disturbances F6Psychiatric disorders F'GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2016M-1812 N DV 4.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDtHr|tDWDHspPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDtHr|tDVDtHr|tDWDHsDWDHspPlacebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DV..DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091363100913631009AACNE Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019M-716 N DV 1.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDtHr|tDWDHspPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDtHr|tDVDtHr|tDWDHsDWDHspPlacebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DV..DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091364100913641009AObesity Obesity F ;Metabolism and nutrition disorders FObesity F ;General nutritional disorders NEC FAppetite and general nutritional disorders FJMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1812 N DV 4.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDנHr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDנHr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1009 10091365100913651009Aanxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2014M-2542 N DV 6.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDLHsvPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDHrDWDĤHs$DWDLHsvPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091366100913661009AATRIAL SEPTAL DEFECT Atrial septal defect FCongenital, familial and genetic disorders FAtrial septal defect FCardiac septal defects congenital F7Cardiac and vascular disorders congenital FCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY(b)(6) 2009-08 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 (b)(6) (b)(6)31Aug2009D-4126 N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD<Hr<DWD|HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD<Hr<DWADHHs DWDHs9DWD|HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DV.DWADWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091366100913661009A ATRIAL SEPTAL DEFECT REPAIR Atrial septal defect repair FSurgical and medical procedures F<Atrial septal defect repair FCongenital cardiovascular anomaly therapeutic procedures F!Cardiac therapeutic procedures F)Surgical and medical procedures F<GENERAL MEDICAL HISTORY2009-08 2009-08 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 01Aug2009D-4156 31Aug2009D-4126 N DV 11.38 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD<Hr<DWD|HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD<Hr<DWADHHs DWDHs9DWD|HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DV.DWADWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091366100913661009A0HAYFEVER Seasonal allergy FUImmune system disorders F4Hay fever FbAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2010M-4003 N DV 10.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD<Hr<DWD|HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD<Hr<DWADHHs DWDHs9DWD|HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DV.DWADWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091366100913661009A@SHELLFISH ALLERGY Food allergy FزImmune system disorders F4Shellfish allergy F4Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2177 N DV 5.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD<Hr<DWD|HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD<Hr<DWADHHs DWDHs9DWD|HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DV.DWADWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091369100913691009A`PREMENARCHAL Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) 2021-03 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6)31Mar2021D104 N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr0DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr0DWDHrDWDHsw{0DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091369100913691009APPERENNIAL ALLERGIES Perennial allergy FImmune system disorders F4Perennial allergy FAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2014M-2543 N DV 6.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr0DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr0DWDHrDWDHsw{0DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091369100913691009A0HEADACHES Headache FNervous system disorders FHeadache FHeadaches NEC FHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2019M-717 N DV 1.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr0DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr0DWDHrDWDHsw{0DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091369100913691009A@LEFT KNEE SPRAIN Ligament sprain FInjury, poisoning and procedural complications FKnee sprain F6Muscle, tendon and ligament injuries FInjuries NEC FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2019 2019-09 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2019M-717 30Sep2019D-445 N DV 1.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr0DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr0DWDHrDWDHsw{0DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091369100913691009A DRY SKIN Dry skin FZSkin and subcutaneous tissue disorders F5Dry skin FZDermal and epidermal conditions NEC FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018-02-18 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 18Feb2018 -1034 N DV 2.83 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr0DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr0DWDHrDWDHsw{0DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091369100913691009AACNE VULGARIS Acne FpSkin and subcutaneous tissue disorders F5Acne vulgaris FAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019-02-19 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 19Feb2019 -668 N DV 1.83 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr0DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr0DWDHrDWDHsw{0DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091370100913701009APREMENARCHAL Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr DWDXHrNXBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr DWDXHrNX......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091371100913711009Aseasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1447 N DV 3.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrtDWDHrABNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrtDWDHrA......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.....DV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091372100913721009AType 1 Diabetes Type 1 diabetes mellitus FMetabolism and nutrition disorders FType 1 diabetes mellitus FDiabetes mellitus (incl subtypes) FǺGlucose metabolism disorders (incl diabetes mellitus) FxMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2019-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jun2019D-566 YDiabetes without chronic complication DV 1.55 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHHrDWD(Hr`(BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHHrDWD(Hr`(......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.....DV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091376100913761009Aattention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2014M-2546 N DV 6.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDݸHrj8BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDݸHrj8......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091376100913761009A insomnia Insomnia F%Psychiatric disorders F'Insomnia F%Disturbances in initiating and maintaining sleep FFSleep disorders and disturbances F6Psychiatric disorders F'GENERAL MEDICAL HISTORY2020 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2020M-355 N DV 0.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDݸHrj8BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDݸHrj8......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091380100913801009Apenicillin allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2007M-5111 N DW 14 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDDHrQDDWDHs3$Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDDHrQDDWDݸHr8DWDTHs+TDWDHs3$Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091381100913811009A@PREMENARCHAL Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD@Hr@DWDxHr֑4BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD@Hr@DWDxHr֑4......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091381100913811009A0PENICILLIN ALLERGY (HIVES) Urticaria FMSkin and subcutaneous tissue disorders F5Urticaria drug-induced FcUrticarias FMAngioedema and urticaria FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2012M-3287 N DW 9 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD@Hr@DWDxHr֑4BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD@Hr@DWDxHr֑4......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091381100913811009AATTENTION DEFICIT HYPERACTIVITY DISORDER Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2016M-1826 N DW 5 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD@Hr@DWDxHr֑4BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD@Hr@DWDxHr֑4......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091381100913811009A MIGRAINES Migraine FONervous system disorders FMigraine FOMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2016M-1826 N DW 5 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD@Hr@DWDxHr֑4BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD@Hr@DWDxHr֑4......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091382100913821009A CELIAC DISEASE Coeliac disease FGastrointestinal disorders FܛCeliac disease F8Malabsorption syndromes FMalabsorption conditions FGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2013M-2925 N DW 8.01 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DHr:DWD8HsLPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DHr:DW!DHr|DWDpHsn5pDWD8HsLPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091382100913821009AANXIETY Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1099 N DW 3.01 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DHr:DWD8HsLPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DHr:DW!DHr|DWDpHsn5pDWD8HsLPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091383100913831009A@NYSTAMUS, BILATERAL Nystagmus F (Nervous system disorders FNystagmus F (Coordination and balance disturbances FNeurological disorders NEC FNervous system disorders FGENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHrctDW!D0Hr޲BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHrctDW!D0Hr޲......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!....DW=DW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091383100913831009A0CODEINE ALLERGY Drug hypersensitivity FImmune system disorders F4Specific allergy (drug) F8OAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2008M-4753 N DW 13.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHrctDW!D0Hr޲BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHrctDW!D0Hr޲......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!....DW=DW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091383100913831009A ASTHMA, MILD Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2009M-4387 YChronic pulmonary disease DW 12.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHrctDW!D0Hr޲BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHrctDW!D0Hr޲......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!....DW=DW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091383100913831009APOBSESSIVE COMPULSIVE DISORDER Obsessive-compulsive disorder F JPsychiatric disorders F'Obsessive-compulsive disorder F JObsessive-compulsive disorders and symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2017M-1465 N DW 4.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHrctDW!D0Hr޲BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHrctDW!D0Hr޲......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!....DW=DW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091383100913831009AACNE Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2018M-1100 N DW 3.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHrctDW!D0Hr޲BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHrctDW!D0Hr޲......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!....DW=DW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091384100913841009Aacne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1100 N DW 3.01 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW D|HrbDWSDHs zPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW D|HrbDW!D@HrޱDW>D,Hs,DWSDHs zPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!.DW>DWS.DW:DW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091386100913861009Apenicillin allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4754 N DW 13.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD Hrŧ DW!D8HrތBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD Hrŧ DW!D8Hrތ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW!....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091386100913861009A scalp psoriasis Psoriasis F'Skin and subcutaneous tissue disorders F5Psoriasis of scalp F'Psoriatic conditions FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2015M-2197 N DW 6.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD Hrŧ DW!D8HrތBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD Hrŧ DW!D8Hrތ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW!....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091386100913861009A0seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2020 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2020M-371 N DW 1.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD Hrŧ DW!D8HrތBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD Hrŧ DW!D8Hrތ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW!....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091387100913871009ARight Wrist Fracture Wrist fracture FR1Injury, poisoning and procedural complications FWrist fracture FR1Limb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2021-01-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2021 -5 N DW 0.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDǰHrżDW$DLHrLBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDǰHrżDW$DLHrL......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091388100913881009APsulfa drug allergy Drug hypersensitivity FImmune system disorders F4Sulfonamide allergy FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018-12 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Dec2018D-767 N DW 2.1 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDHHsHPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDW$DHrDWDHsu|DWDHHsHPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091388100913881009A eczema Eczema FSkin and subcutaneous tissue disorders F5Eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2008M-4754 N DW 13.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDHHsHPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDW$DHrDWDHsu|DWDHHsHPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091388100913881009Aanxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2017M-1466 N DW 4.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDHHsHPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDW$DHrDWDHsu|DWDHHsHPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091388100913881009A@seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1101 N DW 3.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDHHsHPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDW$DHrDWDHsu|DWDHHsHPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091388100913881009A0right fractured radius Radius fracture F**Injury, poisoning and procedural complications FRadius fracture F**Limb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2020-12-26 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 26Dec2020 -11 N DW 0.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDHHsHPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDW$DHrDWDHsu|DWDHHsHPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091391100913911009A0PEANUT ALLERGY-ANAPHYLAXIS Anaphylactic reaction FImmune system disorders F4Anaphylactic reaction to food FlAnaphylactic and anaphylactoid responses F_Allergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2007-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2007D-5120 N DW 14.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrXDW%D(HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrXDW%D(Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091391100913911009A ASTHMA Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2014M-2563 YChronic pulmonary disease DW 7.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrXDW%D(HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrXDW%D(Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091391100913911009AACNE-FACIAL Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2017M-1467 N DW 4.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrXDW%D(HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrXDW%D(Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091392100913921009A0PREMENARCHAL Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDPHrDWDHsd@Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDPHrDW%DHr DWDHsDWDHsd@Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091392100913921009A PEANUT ALLERGY Food allergy FزImmune system disorders F4Peanut allergy FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010-02 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Feb2010D-3993 N DW 10.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDPHrDWDHsd@Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDPHrDW%DHr DWDHsDWDHsd@Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091392100913921009AASTHMA, MODERATE Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2012-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2012D-3294 YChronic pulmonary disease DW 9.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDPHrDWDHsd@Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDPHrDW%DHr DWDHsDWDHsd@Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091396100913961009A Attention Deficit Hyperactivity Disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2013M-2928 N DW 8.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr.DW"DHr4BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr.DW"DHr4......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW"....DWvDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091396100913961009AAcne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1102 N DW 3.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr.DW"DHr4BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr.DW"DHr4......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW"....DWvDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091398100913981009Aexercise-induced asthma Asthma exercise induced FeRespiratory, thoracic and mediastinal disorders F-Exercise induced asthma FӡBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2020-09 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Sep2020D-128 YChronic pulmonary disease DW 0.35 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr?hDW$DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr?hDW$DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$....DW\DW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091398100913981009A right torn meniscus Meniscus injury FInjury, poisoning and procedural complications FMeniscus tear F)Bone and joint injuries NEC FuBone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2020-12-31 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 31Dec2020 -7 N DW 0.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr?hDW$DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr?hDW$DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$....DW\DW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091399100913991009Apremenarchal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr@DWDHsϐPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr@DW%DHrDWDPHsDWDHsϐPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091400100914001009A0Penicillin Allergy (Rash) Drug eruption FSkin and subcutaneous tissue disorders F5Allergic drug rash FDermatitis ascribed to specific agent FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2008M-4756 N DW 13.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD`HrU`DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD`HrU`DW3DHrG@DWDHsDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW3.DW..DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091400100914001009A@Recurrent Otitis Media Otitis media FInfections and infestations FOtitis media FEar infections F=Infections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2008 2017 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2008M-4756 31Dec2017M-1104 N DW 13.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD`HrU`DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD`HrU`DW3DHrG@DWDHsDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW3.DW..DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091400100914001009A Bilateral tympanic Ear Tubes Insertion Ear tube insertion FxSurgical and medical procedures F<Tympanostomy tube insertion Fy*Middle ear therapeutic procedures FDHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2014 2014 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2014M-2564 31Dec2014M-2200 N DW 7.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD`HrU`DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD`HrU`DW3DHrG@DWDHsDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW3.DW..DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091400100914001009AAdenoidectomy Adenoidectomy FNSurgical and medical procedures F<Adenoidectomy FNTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2016 2016 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1834 31Dec2016M-1469 N DW 5.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD`HrU`DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD`HrU`DW3DHrG@DWDHsDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW3.DW..DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091402100914021009Apenicillin allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2199 N DW 6.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD Hrh DW%DHr'TBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD Hrh DW%DHr'T......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091403100914031009A Environmental allergies Hypersensitivity FImmune system disorders F4Environmental allergy FTAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2012M-3295 N DW 9.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD܌HrtDWVD<Hs$<Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD܌HrtDW#DHr'DW?DHsq$DWVD<Hs$<Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DW?DWV.DW=DW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091403100914031009AAcne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1468 N DW 4.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD܌HrtDWVD<Hs$<Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD܌HrtDW#DHr'DW?DHsq$DWVD<Hs$<Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DW?DWV.DW=DW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091403100914031009A0obesity Obesity F ;Metabolism and nutrition disorders FObesity F ;General nutritional disorders NEC FAppetite and general nutritional disorders FJMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2017M-1468 N DW 4.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD܌HrtDWVD<Hs$<Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD܌HrtDW#DHr'DW?DHsq$DWVD<Hs$<Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DW?DWV.DW=DW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091404100914041009A Premenarchal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD|HrȄ|DW%DLHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD|HrȄ|DW%DLHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.....DW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091404100914041009A0Seasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2014M-2564 N DW 7.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD|HrȄ|DW%DLHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD|HrȄ|DW%DLHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.....DW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091404100914041009AAsthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1834 YChronic pulmonary disease DW 5.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD|HrȄ|DW%DLHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD|HrȄ|DW%DLHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.....DW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091405100914051009ASeasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2005 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2005M-5851 N DW 16.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWEHrȘDWD HszPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWEHrȘDW%DHr DWDHsC,DWD HszPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091406100914061009Aacne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1103 N DW 3.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWEHrȘhDWDHszPPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWEHrȘhDW%DPHrDWDdHsdDWDHszPPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091406100914061009A omnicef allergy Drug hypersensitivity FImmune system disorders F4Allergic reaction to antibiotics F8Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1103 N DW 3.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWEHrȘhDWDHszPPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWEHrȘhDW%DPHrDWDdHsdDWDHszPPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091407100914071009A AMOXICILLIN ALLERGY Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2008M-4759 N DW 13.03 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrB$DW(DTHrTBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrB$DW(DTHrT......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091407100914071009AACNE Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-741 N DW 2.03 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrB$DW(DTHrTBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrB$DW(DTHrT......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091407100914071009A0MINOCYCLINE ALLERGY Drug hypersensitivity FImmune system disorders F4Allergic reaction to antibiotics F8Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2019-09 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Sep2019D-498 N DW 1.37 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrB$DW(DTHrTBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrB$DW(DTHrT......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091408100914081009A Premenarchal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr̄xDW)DTHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr̄xDW)DTHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW)....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091408100914081009AAttention Deficit Disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jun2020D-224 N DW 0.62 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr̄xDW)DTHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr̄xDW)DTHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW)....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091409100914091009A spinal kyphosis Kyphosis FUMusculoskeletal and connective tissue disorders FkKyphosis FUSpine and neck deformities FMusculoskeletal and connective tissue deformities (incl intervertebral disc disorders)FYMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr̄DW)DHr\BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr̄DW)DHr\......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW)....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091409100914091009ADepression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2020M-376 N DW 1.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr̄DW)DHr\BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr̄DW)DHr\......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW)....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091410100914101009A Premenarchal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrgDW(DHr&BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrgDW(DHr&......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091410100914101009AAttention Deficit Disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2203 N DW 6.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrgDW(DHr&BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrgDW(DHr&......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091411100914111009AHORIZONTAL MANDIBULAR HYPOPLASIA Microgenia FCongenital, familial and genetic disorders FMandibular hypoplasia FMusculoskeletal and connective tissue disorders of face, neck and jaw congenitalF\Musculoskeletal and connective tissue disorders congenital FlCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY(b)(6) 2021-03-24BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 (b)(6) (b)(6)24Mar2021 72 N DW (b)(6)YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDLHrsLDWDHsGPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDLHrsLDW(DנHrDWDHsv@DWDHsGPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091411100914111009A IMPACTED WISDOM TEETH Tooth impacted FBGastrointestinal disorders FܛImpacted wisdom tooth FDental disorders NEC FBDental and gingival conditions FBrGastrointestinal disorders FܛGENERAL MEDICAL HISTORY(b)(6) 2021-03-24BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 (b)(6) (b)(6)24Mar2021 72 N DW (b)(6)YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDLHrsLDWDHsGPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDLHrsLDW(DנHrDWDHsv@DWDHsGPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091411100914111009A0TREE NUT ALLERGY Food allergy FزImmune system disorders F4Allergy to nuts Fm/Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4029 N DW 11.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDLHrsLDWDHsGPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDLHrsLDW(DנHrDWDHsv@DWDHsGPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091412100914121009A asthma, mild Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2010M-4029 YChronic pulmonary disease DW 11.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDټHrͷDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDټHrͷDW(DLHrLDWD(HsDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091412100914121009APseasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4029 N DW 11.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDټHrͷDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDټHrͷDW(DLHrLDWD(HsDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091412100914121009Aanxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2015M-2203 N DW 6.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDټHrͷDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDټHrͷDW(DLHrLDWD(HsDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091412100914121009A@high functioning autism spectrum disorder Autism spectrum disorder FPsychiatric disorders F'Autism spectrum disorder FPervasive developmental disorders NEC F4Developmental disorders NEC FǒPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2018M-1107 N DW 3.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDټHrͷDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDټHrͷDW(DLHrLDWD(HsDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091412100914121009A0attention deficit disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018-10-30 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 30Oct2018 -805 N DW 2.21 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDټHrͷDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDټHrͷDW(DLHrLDWD(HsDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1009 10091413100914131009A0premenarchal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDިHrͼDW*DHrİBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDިHrͼDW*DHrİ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW*....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091413100914131009A exercise induced asthma Asthma exercise induced FeRespiratory, thoracic and mediastinal disorders F-Exercise induced asthma FӡBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1472 YChronic pulmonary disease DW 4.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDިHrͼDW*DHrİBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDިHrͼDW*DHrİ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW*....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091413100914131009Aacne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2020-05 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01May2020D-256 N DW 0.7 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDިHrͼDW*DHrİBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDިHrͼDW*DHrİ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW*....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091414100914141009AAmoxicillin Allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3299 N DW 9.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDW+DHr<BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDW+DHr<......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW+....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091414100914141009A Cat Allergy Allergy to animal FNImmune system disorders F4Allergic to cats FCAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1472 N DW 4.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDW+DHr<BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDW+DHr<......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW+....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1009 10091414100914141009A0Seasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2017M-1472 N DW 4.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDW+DHr<BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDW+DHr<......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW+....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1013 10131821101318211013A RECURRENT GALLSTONES Cholelithiasis F5Hepatobiliary disorders FGallstones FrCholecystitis and cholelithiasis F(Gallbladder disorders F\Hepatobiliary disorders FGENERAL MEDICAL HISTORY2020-06 2020-06 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jun2020D-182 30Jun2020D-153 N DV 0.5 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD`HrDVD|Hr|BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD`HrDVD|Hr|......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1013 10131821101318211013ACHOLECYSTECTOMY Cholecystectomy F#Surgical and medical procedures F<Cholecystectomy F#Biliary tract and gallbladder therapeutic procedures FHepatobiliary therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2020-09 2020-09 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Sep2020D-90 30Sep2020D-61 N DV 0.25 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD`HrDVD|Hr|BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD`HrDVD|Hr|......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1013 10131823101318231013A SICKLE CELL TRAIT Sickle cell trait F5JCongenital, familial and genetic disorders FSickle cell trait F5JHaemoglobinopathies congenital FWBlood and lymphatic system disorders congenital FRCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVDHr6DWDXHsXPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr6DVD HrDWDHsDWDXHsXPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1013 10131823101318231013AOBESITY Obesity F ;Metabolism and nutrition disorders FObesity F ;General nutritional disorders NEC FAppetite and general nutritional disorders FJMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2013M-2891 N DV 7.92 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVDHr6DWDXHsXPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr6DVD HrDWDHsDWDXHsXPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1013 10131824101318241013A SICKLE CELL ANEMIA Sickle cell anaemia F5ACongenital, familial and genetic disorders FSickle cell anemia FkHaemoglobinopathies congenital FWBlood and lymphatic system disorders congenital FRCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2007M-5083 N DV 13.92 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr7DVDИHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr7DVDИHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1013 10131824101318241013ALEFT PORT-A-CATH INSERTION Central venous catheterisation FgSurgical and medical procedures F<Portacath insertion FVenous therapeutic procedures FNVascular therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1065 N DV 2.92 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr7DVDИHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr7DVDИHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1013 10131826101318261013ASULFA ALLERGY Drug hypersensitivity FImmune system disorders F4Sulfonamide allergy FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1065 N DV 2.92 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrfDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrfDWD4Hri4DWDHsIpDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1013 10131828101318281013AAMOXICILLIN ALLERGY Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2006M-5449 N DV 14.92 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD HrdDWDHHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD HrdDWDHHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1013 10131828101318281013A SEASONAL ALLERGIES Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2008M-4719 N DV 12.92 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD HrdDWDHHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD HrdDWDHHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1013 10131830101318301013ASULFA ALLERGY Drug hypersensitivity FImmune system disorders F4Sulfonamide allergy FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3258 N DV 8.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDxHrfDWDנHrWPlacebo A .Placebo A .DVDxHrfDWDנHrW......Placebo Placebo DVDW.....DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1013 10131839101318391013AATTENTION DEFICIT HYPERACTIVE DISORDER Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit/hyperactivity disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-701 N DV 1.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDTHrDWD HrP Placebo A .Placebo A .DVDTHrDWD HrP ......Placebo Placebo DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1013 10131841101318411013AATTENTION DEFICIT HYPERACTIVE DISORDER Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit/hyperactivity disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2013M-2892 N DV 7.92 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr8DVD4HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr8DVD4Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1013 10131842101318421013AATTENTION DEFICIT HYPERACTIVE DISORDER Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit/hyperactivity disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2011M-3623 N DV 9.92 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVD0HrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD0HrDVDHrLDWDߘHsgDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1013 10131843101318431013AASTHMA Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2016M-1797 YChronic pulmonary disease DV 4.92 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDVD,HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDVD,Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1013 10131843101318431013A0DECREASED APPETITE Decreased appetite FtMetabolism and nutrition disorders FDecreased appetite FtAppetite disorders FNAppetite and general nutritional disorders FJMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2018M-1066 N DV 2.92 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDVD,HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDVD,Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1013 10131843101318431013A@ENVIRONMENTAL ALLERGIES Hypersensitivity FImmune system disorders F4Environmental allergy FTAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1066 N DV 2.92 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDVD,HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDVD,Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1013 10131843101318431013APINSOMNIA Insomnia F%Psychiatric disorders F'Insomnia F%Disturbances in initiating and maintaining sleep FFSleep disorders and disturbances F6Psychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2018M-1066 N DV 2.92 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDVD,HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDVD,Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1013 10131843101318431013A ATTENTION DEFICIT HYPERACTIVE DISORDER Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit/hyperactivity disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016-12-02 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 02Dec2016 -1461 N DV 4 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDVD,HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDVD,Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1013 10131844101318441013AATTENTION DEFICIT HYPERACTIVITY DISORDER Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1797 N DV 4.92 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHs\Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDVDHr`DWDHsDWDHs\Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1013 10131844101318441013A DECREASED APPETITITE Decreased appetite FtMetabolism and nutrition disorders FDecreased appetite FtAppetite disorders FNAppetite and general nutritional disorders FJMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2018M-1066 N DV 2.92 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHs\Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDVDHr`DWDHsDWDHs\Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1013 10131844101318441013A0ENVIRONMENTAL ALLERGIES Hypersensitivity FImmune system disorders F4Environmental allergy FTAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1066 N DV 2.92 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHs\Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDVDHr`DWDHsDWDHs\Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1013 10131845101318451013APENICILLIN ALLERGY Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2163 N DV 5.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDdHrHdBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDdHrHd......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1013 10131846101318461013AENVIRONMENTAL ALLERGIES Hypersensitivity FImmune system disorders F4Environmental allergy FTAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2007M-5085 N DV 13.92 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDVDHrTBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDVDHrT......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.....DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1013 10131850101318501013AATTENTION DEFICIT HYPERACTIVITY DISORDER Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2011M-3624 N DV 9.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHrXBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHrX......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1013 10131850101318501013A NEARSIGHTEDNESS Myopia FkEye disorders FԯNearsighted FxRefractive and accommodative disorders F+Vision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2014M-2528 N DV 6.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHrXBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHrX......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1013 10131852101318521013AMIGRAINE HEADACHES Migraine FONervous system disorders FMigraine headache FRMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2015M-2167 N DV 5.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDhHrhDWDHs\Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDhHrhDWDHrTDWDנHsGDWDHs\Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1013 10131852101318521013A NON MIGRAINE HEADACHES Headache FNervous system disorders FHeadache FHeadaches NEC FHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1802 N DV 4.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDhHrhDWDHs\Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDhHrhDWDHrTDWDנHsGDWDHs\Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1013 10131855101318551013AATTENTION DEFICIT HYPERACTIVITY DISORDER Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2011M-3629 N DV 9.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrZ DWD(HrO(BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrZ DWD(HrO(......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1013 10131855101318551013A DEPRESSION Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019M-707 N DV 1.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrZ DWD(HrO(BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrZ DWD(HrO(......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1013 10131855101318551013A0INSOMNIA Insomnia F%Psychiatric disorders F'Insomnia F%Disturbances in initiating and maintaining sleep FFSleep disorders and disturbances F6Psychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2019M-707 N DV 1.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrZ DWD(HrO(BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrZ DWD(HrO(......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1013 10131858101318581013APRE-MENARCHE Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDנHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDpHr4pDWDިHss٨DWDנHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1013 10131859101318591013AATTENTION DEFICIT DISORDER Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jun2020D-191 N DV 0.53 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD0Hr0DWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD0Hr0DWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1013 10131860101318601013ASEASONAL ALLERGIES Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1438 N DV 3.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDxHrxDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDxHrxDWDHr:DWDHHs~\HDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1013 10131861101318611013AATTENTION DEFICIT HYPERACTIVITY DISORDER Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1805 N DV 4.94 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVDxHrDW D8Hr8Placebo A .Placebo A .DVDxHrDW D8Hr8......Placebo Placebo DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1013 10131867101318671013AASTHMA Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2014M-2542 YChronic pulmonary disease DV 6.96 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVD@HrG@DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD@HrG@DW D HrĂDWDHs;DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1013 10131867101318671013A ENVIRONMENTAL ALLERGY Hypersensitivity FImmune system disorders F4Environmental allergy FTAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2015M-2177 N DV 5.96 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVD@HrG@DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD@HrG@DW D HrĂDWDHs;DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1013 10131867101318671013A0TONSILLECTOMY Tonsillectomy FBfSurgical and medical procedures F<Tonsillectomy FBfTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2016 2016 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2016M-1812 31Dec2016M-1447 N DV 4.96 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVD@HrG@DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD@HrG@DW D HrĂDWDHs;DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1013 10131867101318671013A@TONSILLITIS Tonsillitis FBhInfections and infestations FTonsillitis FBhUpper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2016 2016 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2016M-1812 31Dec2016M-1447 N DV 4.96 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVD@HrG@DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD@HrG@DW D HrĂDWDHs;DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1013 10131868101318681013A SEASONAL ALLERGIES Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1085 N DV 2.97 YEARSAYEARS12-15 YearsAFA MULTIPLE A`MULTIRACIAL A`YYPlacebo PLACEBO Placebo PLACEBO DVDHrxDWDHrͯPlacebo A .Placebo A .DVDHrxDWDHrͯ......Placebo Placebo DVDW.....DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1013 10131868101318681013ASCOLIOSIS Scoliosis F1Musculoskeletal and connective tissue disorders FkScoliosis F1Spine and neck deformities FMusculoskeletal and connective tissue deformities (incl intervertebral disc disorders)FYMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2018-07 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jul2018D-904 N DV 2.48 YEARSAYEARS12-15 YearsAFA MULTIPLE A`MULTIRACIAL A`YYPlacebo PLACEBO Placebo PLACEBO DVDHrxDWDHrͯPlacebo A .Placebo A .DVDHrxDWDHrͯ......Placebo Placebo DVDW.....DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1013 10131869101318691013A SEASONAL ALLERGIES Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHrDPlacebo A .Placebo A .DVDHrDWDHrD......Placebo Placebo DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1013 10131869101318691013AATTENTION DEFICITY HYPERACTIVITY DISRODER Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit-hyperactivity disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016-03 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Mar2016D-1756 N DV 4.81 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHrDPlacebo A .Placebo A .DVDHrDWDHrD......Placebo Placebo DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1013 10131870101318701013AATTENTION DEFICIT HYPERACTIVITY DISORDER Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3277 N DV 8.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHrPlacebo A .Placebo A .DVDHrDWDHr......Placebo Placebo DVDW.....DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1013 10131871101318711013AATTENTION DEFICIT HYPERACTIVE DISORDER Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit/hyperactivity disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2013M-2911 N DV 7.97 YEARSAYEARS12-15 YearsAMAMULTIPLE A`MULTIRACIAL A`YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD`Hr`DWDHrmBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD`Hr`DWDHrm......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1013 10131872101318721013A PEANUT ALLERGY Food allergy FزImmune system disorders F4Peanut allergy FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4007 N DV 10.97 YEARSAYEARS12-15 YearsAMAMULTIPLE A`MULTIRACIAL A`YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHrlTBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHrlT......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1013 10131872101318721013AATTENTION DEFICIT HYPERACTIVE DISORDER Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit/hyperactivity disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1450 N DV 3.97 YEARSAYEARS12-15 YearsAMAMULTIPLE A`MULTIRACIAL A`YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHrlTBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHrlT......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1013 10131873101318731013ANEARSIGHTEDNESS Myopia FkEye disorders FԯNearsighted FxRefractive and accommodative disorders F+Vision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2014M-2547 N DV 6.98 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHHrDWDƄHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHHrDWDƄHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.....DV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1013 10131874101318741013A TYMPANOSTOMY BILATERAL Myringotomy FvSurgical and medical procedures F<Myringotomy FvMiddle ear therapeutic procedures FDHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2009 2009 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2009M-4373 31Dec2009M-4009 N DV 11.98 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DVDHrڈDWDôHs4Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrڈDWDHr`DWDPHsDWDôHs4Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1013 10131874101318741013ANEARSIGHTEDNESS Myopia FkEye disorders FԯNearsighted FxRefractive and accommodative disorders F+Vision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1817 N DV 4.98 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DVDHrڈDWDôHs4Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrڈDWDHr`DWDPHsDWDôHs4Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1013 10131875101318751013A AZITHROMYCIN ALLERGY Drug hypersensitivity FImmune system disorders F4Allergic reaction to antibiotics F8Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2015M-2182 N DV 5.98 YEARSAYEARS12-15 YearsAMAMULTIPLE A`MULTIRACIAL A`YYPlacebo PLACEBO Placebo PLACEBO DVDHr<DWDHs\Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr<DWD HrDWDHs{DWDHs\Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1013 10131875101318751013AANKLE TENDONITIS Tendonitis F?wMusculoskeletal and connective tissue disorders FkTendonitis F?wTendon disorders F?bTendon, ligament and cartilage disorders F?eMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-721 N DV 1.98 YEARSAYEARS12-15 YearsAMAMULTIPLE A`MULTIRACIAL A`YYPlacebo PLACEBO Placebo PLACEBO DVDHr<DWDHs\Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr<DWD HrDWDHs{DWDHs\Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1013 10131876101318761013AATTENTION DEFICIT HYPERACTIVITY DISORDER Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2013M-2912 N DV 7.98 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD8HrDWDHrͤBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD8HrDWDHrͤ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1013 10131877101318771013AATTENTION DEFICIT HYPERACTIVITY DISORDER Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2013-11 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Nov2013D-2609 N DW 7.15 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHHr HDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHHr HDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1013 10131879101318791013AGROWTH HORMONE DEFICIENCY Growth hormone deficiency FrEndocrine disorders FGrowth hormone deficiency FrAnterior pituitary hypofunction F Hypothalamus and pituitary gland disorders FEndocrine disorders FGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-722 N DW 1.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWD܌Hsu) Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDWD8HrqDW~DHsYzDWD܌Hsu) Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DW~DW.DWxDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1013 10131881101318811013AASTHMA Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2007M-5110 YChronic pulmonary disease DW 13.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD<HrDWDXHr>XBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD<HrDWDXHr>X......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1013 10131881101318811013A ATTENTION DEFICIT HYPERACTIVITY DISORDER Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4745 N DW 12.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD<HrDWDXHr>XBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD<HrDWDXHr>X......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1016 10161307101613071016ASeasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016-02-04 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 04Feb2016 -1715 N DV 4.7 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVDHrX5xDWDHs0Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrX5xDVD|HrrxDWDHstDWDHs0Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161307101613071016A depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-06-15 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 15Jun2020 -122 N DV 0.34 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVDHrX5xDWDHs0Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrX5xDVD|HrrxDWDHstDWDHs0Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161308101613081016A eczema Eczema FSkin and subcutaneous tissue disorders F5Eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2013-01-08 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 08Jan2013 -2837 N DV 7.77 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD`HrX6DWDPHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD`HrX6DVDLHrqLDWDHs~DWDPHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161308101613081016A0psoriasis Psoriasis F'Skin and subcutaneous tissue disorders F5Psoriasis F'Psoriatic conditions FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2014-12-16 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 16Dec2014 -2130 N DV 5.83 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD`HrX6DWDPHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD`HrX6DVDLHrqLDWDHs~DWDPHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161308101613081016Aasthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2010-03-30 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 30Mar2010 -3852 YChronic pulmonary disease DV 10.55 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD`HrX6DWDPHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD`HrX6DVDLHrqLDWDHs~DWDPHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161308101613081016A@seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010-03-30 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 30Mar2010 -3852 N DV 10.55 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD`HrX6DWDPHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD`HrX6DVDLHrqLDWDHs~DWDPHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161310101613101016Aseasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016-04-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Apr2016 -1658 N DV 4.54 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDԔHrX]DVD0HrrjBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDԔHrX]DVD0Hrrj......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1016 10161311101613111016AAsthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2012-03-07 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 07Mar2012 -3144 YChronic pulmonary disease DV 8.61 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDpHrXbDVDHrq_BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDpHrXbDVDHrq_......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DW@DV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1016 10161311101613111016A seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015-12-18 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 18Dec2015 -1763 N DV 4.83 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDpHrXbDVDHrq_BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDpHrXbDVDHrq_......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DW@DV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1016 10161314101613141016Aseasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2007-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jun2007D-4886 N DV 13.38 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrYwDVD(Hrs(BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrYwDVD(Hrs(......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.....DV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1016 10161315101613151016Aseasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2014-04 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Apr2014D-2390 N DV 6.55 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD,HrY,DWDިHsڨPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD,HrY,DVDHruTDWD@Hsvl@DWDިHsڨPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161316101613161016Aseasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2007-03-08 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 08Mar2007 -4971 N DV 13.61 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHHrYHDWSD̜Hs Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHHrYHDVDHHrYHDW@DlHslDWSD̜Hs Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DV..DW@DWS.DW>DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161318101613181016Aconstipation Constipation FGastrointestinal disorders FܛConstipation FGastrointestinal atonic and hypomotility disorders NEC F܍Gastrointestinal motility and defaecation conditions FܹGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2009-02 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Feb2009D-4275 N DV 11.71 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrYDWDHs*Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrYDVD HrrDWD8Hs#DWDHs*Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161318101613181016A seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008-03 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Mar2008D-4612 N DV 12.63 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrYDWDHs*Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrYDVD HrrDWD8Hs#DWDHs*Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161319101613191016A seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015-10 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Oct2015D-1842 N DV 5.05 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD\HrY\DWDHsi|Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD\HrY\DVD|HrrDWDHs}$DWDHsi|Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161319101613191016Aasthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2015-10 2017-11 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Oct2015D-1842 30Nov2017D-1051 YChronic pulmonary disease DV 5.05 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD\HrY\DWDHsi|Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD\HrY\DVD|HrrDWDHs}$DWDHsi|Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161319101613191016A0sore throat Oropharyngeal pain F_Respiratory, thoracic and mediastinal disorders F-Sore throat F8Upper respiratory tract signs and symptoms FKiRespiratory tract signs and symptoms F}Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2020-10-122020-10-15BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 12Oct2020 -4 15Oct2020 -1 N DV 0.01 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD\HrY\DWDHsi|Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD\HrY\DVD|HrrDWDHs}$DWDHsi|Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161320101613201016Aattention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2012-02 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Feb2012D-3185 N DV 8.72 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDTHr` DVDHry BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDTHr` DVDHry ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1016 10161322101613221016A@generalized abdominal pain Abdominal pain FGastrointestinal disorders FܛAbdominal pain generalized F|JGastrointestinal and abdominal pains (excl oral and throat) F܆Gastrointestinal signs and symptoms FGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2019-10 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Oct2019D-384 N DV 1.05 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr]u`DVDHryBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr]u`DVDHry......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1016 10161322101613221016APpsoriasis Psoriasis F'Skin and subcutaneous tissue disorders F5Psoriasis F'Psoriatic conditions FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2020-01-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 06Jan2020 -287 N DV 0.79 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr]u`DVDHryBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr]u`DVDHry......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1016 10161322101613221016A febrile seizure Febrile convulsion FNervous system disorders FFebrile seizure F"Seizures and seizure disorders NEC F2hSeizures (incl subtypes) F2gNervous system disorders FGENERAL MEDICAL HISTORY2008-04-082008-04-08BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 08Apr2008 -4577 08Apr2008 -4577 N DV 12.53 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr]u`DVDHryBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr]u`DVDHry......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1016 10161322101613221016A0febrile seizure Febrile convulsion FNervous system disorders FFebrile seizure F"Seizures and seizure disorders NEC F2hSeizures (incl subtypes) F2gNervous system disorders FGENERAL MEDICAL HISTORY2010-08-202010-08-20BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.05 20Aug2010 -3713 20Aug2010 -3713 N DV 10.17 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr]u`DVDHryBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr]u`DVDHry......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1016 10161322101613221016Aattention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2014-06-26 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 26Jun2014 -2307 N DV 6.32 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr]u`DVDHryBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr]u`DVDHry......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1016 10161323101613231016Aattention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2012-09-18 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 18Sep2012 -2953 N DV 8.09 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr]PDVDHry"BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr]PDVDHry"......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1016 10161324101613241016A seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015-05 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01May2015D-1998 N DV 5.47 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVDXHr]DWDHsQPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDXHr]DVDHry#DWDHspDWDHsQPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1016 10161324101613241016Aasthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2015-09 2015 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Sep2015D-1875 31Dec2015M-1754 YChronic pulmonary disease DV 5.14 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVDXHr]DWDHsQPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDXHr]DVDHry#DWDHspDWDHsQPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1016 10161326101613261016Aasthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2007-05-11 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 11May2007 -4911 YChronic pulmonary disease DV 13.45 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDXHr^XDVDHrzg`BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDXHr^XDVDHrzg`......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1016 10161326101613261016A seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009-04-24 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 24Apr2009 -4197 N DV 11.49 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDXHr^XDVDHrzg`BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDXHr^XDVDHrzg`......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1016 10161327101613271016Aasthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2009-04-24 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 24Apr2009 -4197 YChronic pulmonary disease DV 11.49 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDXHr^XDWDHs8Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDXHr^XDVDHrzg$DWDtHsFtDWDHs8Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161327101613271016A seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009-04-24 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 24Apr2009 -4197 N DV 11.49 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDXHr^XDWDHs8Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDXHr^XDVDHrzg$DWDtHsFtDWDHs8Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161329101613291016Aanxiety(per patient) Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019-08 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Aug2019D-446 N DV 1.22 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr^DWD\Hs\Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr^DVDHrz DWDԔHsu!DWD\Hs\Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161329101613291016A asthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2010-12 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Dec2010D-3611 YChronic pulmonary disease DV 9.89 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr^DWD\Hs\Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr^DVDHrz DWDԔHsu!DWD\Hs\Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161329101613291016APconstipation (intermittent) Constipation FGastrointestinal disorders FܛConstipation FGastrointestinal atonic and hypomotility disorders NEC F܍Gastrointestinal motility and defaecation conditions FܹGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2013-02 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Feb2013D-2818 N DV 7.72 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr^DWD\Hs\Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr^DVDHrz DWDԔHsu!DWD\Hs\Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161329101613291016A0attention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018-03 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Mar2018D-964 N DV 2.64 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr^DWD\Hs\Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr^DVDHrz DWDԔHsu!DWD\Hs\Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161329101613291016A`seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2012-05 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01May2012D-3094 N DV 8.47 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr^DWD\Hs\Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr^DVDHrz DWDԔHsu!DWD\Hs\Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161329101613291016A@chronic motor tic disorder Chronic tic disorder FPsychiatric disorders F'Chronic motor tic disorder FTic disorders FAChanges in physical activity FQPsychiatric disorders F'GENERAL MEDICAL HISTORY2015-09 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Sep2015D-1876 N DV 5.14 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr^DWD\Hs\Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr^DVDHrz DWDԔHsu!DWD\Hs\Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161330101613301016Aanxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019-08 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Aug2019D-446 N DV 1.22 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDҴHr^DVDHr|BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDҴHr^DVDHr|......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1016 10161330101613301016A migraines Migraine FONervous system disorders FMigraine FOMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2009-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jun2009D-4159 N DV 11.39 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDҴHr^DVDHr|BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDҴHr^DVDHr|......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1016 10161331101613311016A migraines Migraine FONervous system disorders FMigraine FOMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2016-04 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Apr2016D-1663 N DV 4.56 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDшHr^DWDHs;PPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDшHr^DVD<Hr|<DWDXHs~jXDWDHs;PPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161331101613311016A0seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016-08 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Aug2016D-1541 N DV 4.22 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDшHr^DWDHs;PPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDшHr^DVD<Hr|<DWDXHs~jXDWDHs;PPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161331101613311016Afracture of collar bone Clavicle fracture FInjury, poisoning and procedural complications FFractured collar bone FLimb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2018-08 2018-10 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Aug2018D-811 31Oct2018D-720 N DV 2.22 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDшHr^DWDHs;PPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDшHr^DVD<Hr|<DWDXHs~jXDWDHs;PPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161332101613321016Aattention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2011-04 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Apr2011D-3491 N DV 9.56 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr`>DVDHry!BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr`>DVDHry!......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1016 10161334101613341016Aasthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2009-10-23 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 23Oct2009 -4016 YChronic pulmonary disease DV 11 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDҴHr`D4DWDHslPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDҴHr`D4DVD\Hr|\DWDHs\DWDHslPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1016 10161335101613351016A@seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010-08 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Aug2010D-3734 N DV 10.23 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr`^tDVD0Hr{0BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr`^tDVD0Hr{0......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1016 10161335101613351016A0insomnia Insomnia F%Psychiatric disorders F'Insomnia F%Disturbances in initiating and maintaining sleep FFSleep disorders and disturbances F6Psychiatric disorders F'GENERAL MEDICAL HISTORY2017-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jun2017D-1238 N DV 3.39 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr`^tDVD0Hr{0BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr`^tDVD0Hr{0......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1016 10161335101613351016A attention deficit disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2015-08-282018-09 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 28Aug2015 -1881 30Sep2018D-752 N DV 5.15 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr`^tDVD0Hr{0BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr`^tDVD0Hr{0......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1016 10161335101613351016Aadenoidectomy Adenoidectomy FNSurgical and medical procedures F<Adenoidectomy FNTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2020-05-282020-05-28BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 28May2020 -146 28May2020 -146 N DV 0.4 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr`^tDVD0Hr{0BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr`^tDVD0Hr{0......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1016 10161335101613351016APtonsillectomy Tonsillectomy FBfSurgical and medical procedures F<Tonsillectomy FBfTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2020-05-282020-05-28BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 28May2020 -146 28May2020 -146 N DV 0.4 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr`^tDVD0Hr{0BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr`^tDVD0Hr{0......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1016 10161336101613361016A anxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2012-04 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Apr2012D-3125 N DV 8.56 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDlHr`^DWDXHsΙPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDlHr`^DVDHr{DWDHs1LDWDXHsΙPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161336101613361016A@chronic headaches Headache FNervous system disorders FChronic headaches FhHeadaches NEC FHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2015-04 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Apr2015D-2030 N DV 5.56 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDlHr`^DWDXHsΙPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDlHr`^DVDHr{DWDHs1LDWDXHsΙPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161336101613361016A`unaggressive type conduct disorder Behaviour disorder FPsychiatric disorders F'Conduct disorder F^Abnormal behaviour NEC FPsychiatric and behavioural symptoms NEC F'Psychiatric disorders F'GENERAL MEDICAL HISTORY2007-08-07 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 07Aug2007 -4824 N DV 13.21 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDlHr`^DWDXHsΙPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDlHr`^DVDHr{DWDHs1LDWDXHsΙPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161336101613361016Aaggressive conduct disorder Aggression FPPsychiatric disorders F'Aggression FPBehaviour and socialisation disturbances FPersonality disorders and disturbances in behaviour F&Psychiatric disorders F'GENERAL MEDICAL HISTORY2012-07-23 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 23Jul2012 -3012 N DV 8.25 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDlHr`^DWDXHsΙPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDlHr`^DVDHr{DWDHs1LDWDXHsΙPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161336101613361016A0attention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2014-04-24 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 24Apr2014 -2372 N DV 6.5 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDlHr`^DWDXHsΙPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDlHr`^DVDHr{DWDHs1LDWDXHsΙPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161336101613361016APpost traumatic stress disorder Post-traumatic stress disorder F$\Psychiatric disorders F'Post-traumatic stress disorder F$\Stress disorders F;cAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-07-27 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 27Jul2020 -86 N DV 0.24 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDlHr`^DWDXHsΙPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDlHr`^DVDHr{DWDHs1LDWDXHsΙPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161337101613371016Adepression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-07 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jul2020D-112 N DV 0.31 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDDHr`YDWDHsiUPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDDHr`YDVDHrz0DWuDHsMDWDHsiUPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWuDW.DWYDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161338101613381016A attention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2015-03 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Mar2015D-2062 N DV 5.65 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHraQDVDHrzkBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHraQDVDHrzk......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1016 10161338101613381016Aallergy to omnicef Drug hypersensitivity FImmune system disorders F4Allergic reaction to antibiotics F8Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2013-11-20 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 20Nov2013 -2528 N DV 6.92 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHraQDVDHrzkBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHraQDVDHrzk......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1016 10161339101613391016A`seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016-04 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Apr2016D-1665 N DV 4.56 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD(Hra^(DVD`Hrz_BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD(Hra^(DVD`Hrz_......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1016 10161339101613391016A constipation Constipation FGastrointestinal disorders FܛConstipation FGastrointestinal atonic and hypomotility disorders NEC F܍Gastrointestinal motility and defaecation conditions FܹGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2020-04 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Apr2020D-204 N DV 0.56 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD(Hra^(DVD`Hrz_BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD(Hra^(DVD`Hrz_......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1016 10161339101613391016APleft foot pain Pain in extremity FMusculoskeletal and connective tissue disorders FkFoot pain FMusculoskeletal and connective tissue pain and discomfort FMusculoskeletal and connective tissue disorders NEC FiMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2020-09-012020-09-09BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Sep2020 -51 09Sep2020 -43 N DV 0.14 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD(Hra^(DVD`Hrz_BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD(Hra^(DVD`Hrz_......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1016 10161339101613391016AAttention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016-11-10 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 10Nov2016 -1442 N DV 3.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD(Hra^(DVD`Hrz_BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD(Hra^(DVD`Hrz_......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1016 10161339101613391016A0headaches(intermittent) Headache FNervous system disorders FIntermittent headache F~ Headaches NEC FHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2020-02-11 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 11Feb2020 -254 N DV 0.7 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD(Hra^(DVD`Hrz_BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD(Hra^(DVD`Hrz_......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1016 10161339101613391016A@insomnia Insomnia F%Psychiatric disorders F'Insomnia F%Disturbances in initiating and maintaining sleep FFSleep disorders and disturbances F6Psychiatric disorders F'GENERAL MEDICAL HISTORY2020-02-12 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 12Feb2020 -253 N DV 0.7 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD(Hra^(DVD`Hrz_BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD(Hra^(DVD`Hrz_......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1016 10161340101613401016A attention deficit disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018-04 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Apr2018D-935 N DV 2.56 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDdHra^dDWDHskPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDdHra^dDVD$Hrz_DWDHs~DWDHskPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1016 10161340101613401016Aasthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2010-02 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Feb2010D-3916 YChronic pulmonary disease DV 10.72 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDdHra^dDWDHskPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDdHra^dDVD$Hrz_DWDHs~DWDHskPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1016 10161340101613401016A@insomnia Insomnia F%Psychiatric disorders F'Insomnia F%Disturbances in initiating and maintaining sleep FFSleep disorders and disturbances F6Psychiatric disorders F'GENERAL MEDICAL HISTORY2013-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2013D-2851 N DV 7.81 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDdHra^dDWDHskPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDdHra^dDVD$Hrz_DWDHs~DWDHskPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1016 10161340101613401016A`seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2019-05 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01May2019D-540 N DV 1.48 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDdHra^dDWDHskPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDdHra^dDVD$Hrz_DWDHs~DWDHskPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1016 10161340101613401016APmononucleosis Infectious mononucleosis FInfections and infestations FMononucleosis FEpstein-Barr viral infections FуViral infectious disorders FOInfections and infestations FGENERAL MEDICAL HISTORY2017-09 2017-10 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Sep2017D-1147 31Oct2017D-1087 N DV 3.14 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDdHra^dDWDHskPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDdHra^dDVD$Hrz_DWDHs~DWDHskPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1016 10161340101613401016A0disruptive mood dysregulation disorder Disruptive mood dysregulation disorder FjPsychiatric disorders F'Disruptive mood dysregulation disorder FjAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-09-10 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 10Sep2020 -42 N DV 0.12 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDdHra^dDWDHskPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDdHra^dDVD$Hrz_DWDHs~DWDHskPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1016 10161343101613431016A0organic tics Tic FAPsychiatric disorders F'Tics FATic disorders FAChanges in physical activity FQPsychiatric disorders F'GENERAL MEDICAL HISTORY2017-06-142017-07-05BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 14Jun2017 -1226 05Jul2017 -1205 N DV 3.36 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD$Hra$DVDHr~BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD$Hra$DVDHr~......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1016 10161343101613431016Aattention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2012-01-30 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 30Jan2012 -3188 N DV 8.73 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD$Hra$DVDHr~BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD$Hra$DVDHr~......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1016 10161343101613431016A oppositional defiant disorder Oppositional defiant disorder FrPsychiatric disorders F'Oppositional defiant disorder FrAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017-03-30 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 30Mar2017 -1302 N DV 3.57 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD$Hra$DVDHr~BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD$Hra$DVDHr~......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1016 10161344101613441016A0anxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017-08 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Aug2017D-1178 N DV 3.23 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDPHraPDWDHs>Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDPHraPDVDۜHr{DWDHst0DWDHs>Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161344101613441016Aseasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010-02 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Feb2010D-3916 N DV 10.72 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDPHraPDWDHs>Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDPHraPDVDۜHr{DWDHst0DWDHs>Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161344101613441016Aacne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2017-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.07 01Jun2017D-1239 N DV 3.39 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDPHraPDWDHs>Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDPHraPDVDۜHr{DWDHst0DWDHs>Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161344101613441016A`hypotension Hypotension FVascular disorders FNYHypotension FVascular hypotensive disorders FuDecreased and nonspecific blood pressure disorders and shock F2Vascular disorders FNYGENERAL MEDICAL HISTORY2017-05 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01May2017D-1270 N DV 3.48 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDPHraPDWDHs>Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDPHraPDVDۜHr{DWDHst0DWDHs>Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161344101613441016Apmoderate depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019-05 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01May2019D-540 N DV 1.48 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDPHraPDWDHs>Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDPHraPDVDۜHr{DWDHst0DWDHs>Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161344101613441016APchronic vocal tic disorder Chronic tic disorder FPsychiatric disorders F'Chronic motor or vocal tic disorder FTic disorders FAChanges in physical activity FQPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-05-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.09 01May2020 -174 N DV 0.48 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDPHraPDWDHs>Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDPHraPDVDۜHr{DWDHst0DWDHs>Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161344101613441016A anger disorder Anger FPsychiatric disorders F'Anger FEmotional and mood disturbances NEC F\Mood disorders and disturbances NEC FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018-11 2019-06 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.08 01Nov2018D-721 30Jun2019D-480 N DV 1.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDPHraPDWDHs>Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDPHraPDVDۜHr{DWDHst0DWDHs>Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161344101613441016Aoppositional defiance disorder Oppositional defiant disorder FrPsychiatric disorders F'Oppositional defiant disorder FrAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018-11 2019-06 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.05 01Nov2018D-721 30Jun2019D-480 N DV 1.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDPHraPDWDHs>Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDPHraPDVDۜHr{DWDHst0DWDHs>Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161344101613441016A@attention deficit disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2014-09 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Sep2014D-2243 N DV 6.14 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDPHraPDWDHs>Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDPHraPDVDۜHr{DWDHst0DWDHs>Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161350101613501016A asthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2012-09-062018 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 06Sep2012 -3007 31Dec2018M-700 YChronic pulmonary disease DV 8.24 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr(DVDHr}BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr(DVDHr}......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1016 10161350101613501016Aacne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2020-09-17 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 17Sep2020 -74 N DV 0.21 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr(DVDHr}BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr(DVDHr}......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1016 10161350101613501016A0hearing loss, right ear Deafness unilateral FU,Ear and labyrinth disorders F)Hearing loss unilateral FxuHearing losses FHearing disorders FEar and labyrinth disorders F)GENERAL MEDICAL HISTORY2010-05-24 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 24May2010 -3843 N DV 10.52 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr(DVDHr}BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr(DVDHr}......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1016 10161350101613501016APvaricocele Varicocele FN Reproductive system and breast disorders F-LVaricocele FN Scrotal disorders NEC F1Penile and scrotal disorders (excl infections and inflammations) FʫReproductive system and breast disorders F-LGENERAL MEDICAL HISTORY2020-09-24 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 24Sep2020 -67 N DV 0.19 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr(DVDHr}BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr(DVDHr}......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1016 10161350101613501016A@seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2007-08-31 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 31Aug2007 -4840 N DV 13.25 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr(DVDHr}BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr(DVDHr}......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1016 10161351101613511016Aasthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2012-06 2017-07 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jun2012D-3104 31Jul2017D-1218 YChronic pulmonary disease DV 8.5 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWD HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDVDHriDWDHs"DWD HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161351101613511016A oppositional defiance disorder Oppositional defiant disorder FrPsychiatric disorders F'Oppositional defiant disorder FrAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2009-05 2010-05 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01May2009D-4231 31May2010D-3836 N DV 11.59 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWD HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDVDHriDWDHs"DWD HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161351101613511016A0seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2007-10 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Oct2007D-4809 N DV 13.17 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWD HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDVDHriDWDHs"DWD HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161352101613521016A0seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015-10 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Oct2015D-1887 N DV 5.17 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDlHr DWD Hsv Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDlHr DVD͌HrDWD8Hs8DWD Hsv Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161352101613521016A attention deficit hyperactive disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit/hyperactivity disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2010-10-04 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 04Oct2010 -3710 N DV 10.16 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDlHr DWD Hsv Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDlHr DVD͌HrDWD8Hs8DWD Hsv Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161352101613521016Aasthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2017-04-14 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 14Apr2017 -1326 YChronic pulmonary disease DV 3.63 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDlHr DWD Hsv Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDlHr DVD͌HrDWD8Hs8DWD Hsv Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161353101613531016Aseasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2011-05 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01May2011D-3501 N DV 9.59 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr<DWD,Hs*Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr<DWD Hr DWDHs{DWD,Hs*Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161354101613541016Avesicoureteral reflux Vesicoureteric reflux FORenal and urinary disorders F,WVesicoureteral reflux FOBladder reflux conditions FMBladder and bladder neck disorders (excl calculi) FRenal and urinary disorders F,WGENERAL MEDICAL HISTORY2006-09 2011-01 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Sep2006D-5206 31Jan2011D-3593 N DV 14.26 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr_DWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr_DWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1016 10161356101613561016Aattention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2012-09-18 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 18Sep2012 -2997 N DV 8.21 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD(HrkDVDpHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD(HrkDVDpHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1016 10161356101613561016A impulse disorder Impulse-control disorder FPsychiatric disorders F'Impulse control disorder, unspecified FImpulse control disorders FImpulse control disorders NEC FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016-04-20 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 20Apr2016 -1687 N DV 4.62 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD(HrkDVDpHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD(HrkDVDpHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1016 10161358101613581016Aseasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017-03 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Mar2017D-1373 N DV 3.76 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDVDʀHrPlacebo A .Placebo A .DVDHrDVDʀHr......Placebo Placebo DVDV.....DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161361101613611016A seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-3990 N DV 10.93 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDlHrDWD Hs) Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDlHrDWD Hr DWD\HsrjDWD Hs) Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1016 10161361101613611016Aleg abscess Abscess limb F[Infections and infestations FAbscess leg F[Infections NEC FInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2015-06 2015-06 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jun2015D-2013 30Jun2015D-1984 N DV 5.51 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDlHrDWD Hs) Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDlHrDWD Hr DWD\HsrjDWD Hs) Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1016 10161362101613621016A seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2013-05 2015-10 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01May2013D-2774 31Oct2015D-1861 N DV 7.6 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrOXDWDHrHBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrOXDWDHrH......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1016 10161362101613621016Aasthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2011-08-092016-03 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 09Aug2011 -3405 31Mar2016D-1709 YChronic pulmonary disease DV 9.33 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrOXDWDHrHBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrOXDWDHrH......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1016 10161363101613631016Aseasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009-05 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01May2009D-4239 N DV 11.61 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr$DWDtHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr$DWDtHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1016 10161364101613641016A@seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2005 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2005M-5821 N DV 15.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1016 10161364101613641016A0primary dysmenorrhea Dysmenorrhoea FReproductive system and breast disorders F-LPrimary dysmenorrhea FMenstruation and uterine bleeding NEC FGMenstrual cycle and uterine bleeding disorders FʎReproductive system and breast disorders F-LGENERAL MEDICAL HISTORY2020-08-03 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 03Aug2020 -128 N DV 0.35 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1016 10161364101613641016Aattention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2012-03-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 06Mar2012 -3200 N DV 8.76 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1016 10161364101613641016A bipolar disorder Bipolar disorder FwPsychiatric disorders F'Bipolar disorder FwBipolar disorders FManic and bipolar mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018-07-24 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 24Jul2018 -869 N DV 2.38 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1016 10161365101613651016Aanxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-03 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Mar2020D-284 N DV 0.78 YEARSAYEARS12-15 YearsAFA MULTIPLE A`MULTIRACIAL A`YYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWD(Hr(DWDԔHsr~DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161365101613651016A depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-03 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Mar2020D-284 N DV 0.78 YEARSAYEARS12-15 YearsAFA MULTIPLE A`MULTIRACIAL A`YYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWD(Hr(DWDԔHsr~DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161365101613651016A0eczema Eczema FSkin and subcutaneous tissue disorders F5Eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2009-01-062016-04 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 06Jan2009 -4356 30Apr2016D-1685 N DV 11.93 YEARSAYEARS12-15 YearsAFA MULTIPLE A`MULTIRACIAL A`YYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWD(Hr(DWDԔHsr~DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161366101613661016Aheadaches, frequent Headache FNervous system disorders FFrequent headaches Fc3Headaches NEC FHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2018-12 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Dec2018D-745 N DV 2.04 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDـHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDPHr1DWDHsu3DWDـHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161367101613671016Aattention deficit disorder with hyperactivity Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit/hyperactivity disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2014-12 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Dec2014D-2220 N DW 6.08 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDHs>Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDWDdHrֳDWD`Hs{`DWDHs>Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161367101613671016A dysfunctional uterine bleeding Abnormal uterine bleeding F0Reproductive system and breast disorders F-LDysfunctional uterine bleeding FMenstruation and uterine bleeding NEC FGMenstrual cycle and uterine bleeding disorders FʎReproductive system and breast disorders F-LGENERAL MEDICAL HISTORY2020-07 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jul2020D-181 N DW 0.5 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDHs>Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDWDdHrֳDWD`Hs{`DWDHs>Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161367101613671016A@seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008-11 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Nov2008D-4441 N DW 12.16 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDHs>Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDWDdHrֳDWD`Hs{`DWDHs>Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161367101613671016A0gastroesophageal reflux disease Gastrooesophageal reflux disease F]Gastrointestinal disorders FܛGastroesophageal reflux disease FGastrointestinal atonic and hypomotility disorders NEC F܍Gastrointestinal motility and defaecation conditions FܹGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2008-09 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Sep2008D-4502 N DW 12.33 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDHs>Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDWDdHrֳDWD`Hs{`DWDHs>Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161368101613681016Apremenarche Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDxHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDxHrDWDHrPDWD`Hsu'DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161369101613691016A0premenarche Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD8HrDW#DxHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD8HrDW#DxHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1016 10161369101613691016Aattention deficit disorder with hyperactivity Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit/hyperactivity disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2015-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jun2015D-2039 N DW 5.59 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD8HrDW#DxHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD8HrDW#DxHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1016 10161369101613691016A miliaria rubra Miliaria FkSkin and subcutaneous tissue disorders F5Miliaria rubra FlApocrine and eccrine gland disorders F&Skin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jun2019D-578 N DW 1.59 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD8HrDW#DxHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD8HrDW#DxHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1016 10161369101613691016A@seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2019-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jun2019D-578 N DW 1.59 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD8HrDW#DxHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD8HrDW#DxHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1016 10161372101613721016Aseasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2019-04 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Apr2019D-645 N DW 1.77 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DHrĂdDWDިHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DHrĂdDW#DHrᅀDWD(HsmIDWDިHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161373101613731016Akyphosis Kyphosis FUMusculoskeletal and connective tissue disorders FkKyphosis FUSpine and neck deformities FMusculoskeletal and connective tissue deformities (incl intervertebral disc disorders)FYMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2020-02 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Feb2020D-339 N DW 0.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHrĊDW#DHr1BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHrĊDW#DHr1......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1016 10161373101613731016A lordosis Lordosis FMusculoskeletal and connective tissue disorders FkLordosis FSpine and neck deformities FMusculoskeletal and connective tissue deformities (incl intervertebral disc disorders)FYMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2020-02 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Feb2020D-339 N DW 0.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHrĊDW#DHr1BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHrĊDW#DHr1......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1016 10161373101613731016A@spina bifida occulta Spina bifida occulta F8Congenital, familial and genetic disorders FSpina bifida occulta F8Central nervous system disorders congenital NEC FqNeurological disorders congenital FCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY2020-02 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Feb2020D-339 N DW 0.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHrĊDW#DHr1BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHrĊDW#DHr1......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1016 10161373101613731016A0seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2019-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jun2019D-584 N DW 1.6 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHrĊDW#DHr1BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHrĊDW#DHr1......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1016 10161374101613741016Aseasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2013-04 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Apr2013D-2837 N DW 7.77 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDPHrŤPDW$D<Hr<BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDPHrŤPDW$D<Hr<......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1016 10161375101613751016A seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010-04 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Apr2010D-3933 N DW 10.77 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDW#DߘHrDWDPHsrDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161375101613751016Amigraines Migraine FONervous system disorders FMigraine FOMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2019-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jun2019D-585 N DW 1.6 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDW#DߘHrDWDPHsrDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161376101613761016A right torn labrum repair Chondroplasty F}Surgical and medical procedures F<Cartilage repair FuCartilage therapeutic procedures Fd|Soft tissue therapeutic procedures F7Surgical and medical procedures F<GENERAL MEDICAL HISTORY2020-02 2020-02-14BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Feb2020D-341 14Feb2020 -328 N DW 0.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr0DW"DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr0DW"DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW"....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1016 10161376101613761016Aacne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019-03 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Mar2019D-678 N DW 1.86 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr0DW"DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr0DW"DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW"....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1016 10161377101613771016A0seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016-04 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Apr2016D-1742 N DW 4.77 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrlDW"D0Hr0BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrlDW"D0Hr0......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW"....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1016 10161377101613771016A osgood schlatter's right knee Osteochondrosis FMusculoskeletal and connective tissue disorders FkOsgood-Schlatter's disease FCartilage disorders FTendon, ligament and cartilage disorders F?eMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2016-02 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Feb2016D-1802 N DW 4.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrlDW"D0Hr0BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrlDW"D0Hr0......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW"....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1016 10161377101613771016Aacne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jun2019D-586 N DW 1.61 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrlDW"D0Hr0BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrlDW"D0Hr0......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW"....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1016 10161378101613781016Aattention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018-05 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01May2018D-982 N DW 2.69 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDhHr(DWDHsf\Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDhHr(DW"DDHr;DDWDDHsڸDDWDHsf\Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW".DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161378101613781016A eczema Eczema FSkin and subcutaneous tissue disorders F5Eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2010-03-03 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 03Mar2010 -3963 N DW 10.85 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDhHr(DWDHsf\Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDhHr(DW"DDHr;DDWDDHsڸDDWDHsf\Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW".DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161379101613791016Aseasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2012-04 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Apr2012D-3203 N DW 8.77 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD|Hr2DWDHs(Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD|Hr2DWD|Hr2DWDHsDWDHs(Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW..DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161381101613811016Aseasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2006-04 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Apr2006D-5396 N DW 14.78 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr.DW$DHr╜BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr.DW$DHr╜......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1016 10161382101613821016A seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2014-08 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Aug2014D-2352 N DW 6.44 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDtHr2tDW$D$Hr$BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDtHr2tDW$D$Hr$......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1016 10161382101613821016Aeczema Eczema FSkin and subcutaneous tissue disorders F5Eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2010-11 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Nov2010D-3721 N DW 10.19 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDtHr2tDW$D$Hr$BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDtHr2tDW$D$Hr$......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1016 10161383101613831016A seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2011-04 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Apr2011D-3570 N DW 9.78 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DWDHr1DWDHs Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr1DW$DHrDWDـHsm=DWDHs Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161383101613831016Aeczema Eczema FSkin and subcutaneous tissue disorders F5Eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2010-12 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Dec2010D-3691 N DW 10.11 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DWDHr1DWDHs Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr1DW$DHrDWDـHsm=DWDHs Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161384101613841016Aattention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016-08 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Aug2016D-1621 N DW 4.44 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr8DW#DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr8DW#DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1016 10161384101613841016A nut allergy Food allergy FزImmune system disorders F4Allergy to nuts Fm/Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009-05 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01May2009D-4270 N DW 11.69 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr8DW#DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr8DW#DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1016 10161384101613841016A0seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009-10 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Oct2009D-4117 N DW 11.27 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr8DW#DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr8DW#DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1016 10161385101613851016A eczema Eczema FSkin and subcutaneous tissue disorders F5Eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2006-11-14 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 14Nov2006 -5169 N DW 14.15 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DWDHrjDW%DHr(Placebo A .Placebo A .DWDHrjDW%DHr(......Placebo Placebo DWDW%.....DW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161385101613851016Aattention deficit disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2011-08-15 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 15Aug2011 -3434 N DW 9.4 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DWDHrjDW%DHr(Placebo A .Placebo A .DWDHrjDW%DHr(......Placebo Placebo DWDW%.....DW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161386101613861016Apremenacrche Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrpDWDɐHs9Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrpDW$DHrDWDXHsmUDWDɐHs9Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161386101613861016A reactive airway disease Bronchial hyperreactivity FRespiratory, thoracic and mediastinal disorders F-Reactive airways disease F*Bronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2011-04 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Apr2011D-3570 N DW 9.78 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrpDWDɐHs9Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrpDW$DHrDWDXHsmUDWDɐHs9Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161386101613861016A0seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2011-04 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Apr2011D-3570 N DW 9.78 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrpDWDɐHs9Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrpDW$DHrDWDXHsmUDWDɐHs9Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161387101613871016A0premenarche Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDhHrzhDW#DHryPBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDhHrzhDW#DHryP......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1016 10161387101613871016A@seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009-04 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Apr2009D-4300 N DW 11.78 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDhHrzhDW#DHryPBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDhHrzhDW#DHryP......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1016 10161387101613871016A plantar wart, right foot Skin papilloma F6KNeoplasms benign, malignant and unspecified (incl cysts and polyps)F0Plantar warts FSkin neoplasms benign F6BCutaneous neoplasms benign F6CNeoplasms benign, malignant and unspecified (incl cysts and polyps)F0GENERAL MEDICAL HISTORY2019-05 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01May2019D-618 N DW 1.69 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDhHrzhDW#DHryPBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDhHrzhDW#DHryP......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1016 10161387101613871016Agender identity disorder Gender dysphoria F{Psychiatric disorders F'Gender identity disorder FSexual and gender identity disorders NEC F4Sexual dysfunctions, disturbances and gender identity disorders F4Psychiatric disorders F'GENERAL MEDICAL HISTORY2016-09 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Sep2016D-1590 N DW 4.36 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDhHrzhDW#DHryPBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDhHrzhDW#DHryP......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1016 10161388101613881016A@seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2006-04 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Apr2006D-5399 N DW 14.78 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHHrpDWDHs{qPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHHrpDW)DɐHrWDWDlHsbjDWDHs{qPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW).DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161388101613881016A excessive menstruation Heavy menstrual bleeding F/Reproductive system and breast disorders F-LExcessive menstruation FvMenstruation with increased bleeding FNMenstrual cycle and uterine bleeding disorders FʎReproductive system and breast disorders F-LGENERAL MEDICAL HISTORY2017-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jun2017D-1320 N DW 3.62 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHHrpDWDHs{qPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHHrpDW)DɐHrWDWDlHsbjDWDHs{qPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW).DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161388101613881016Aeczema Eczema FSkin and subcutaneous tissue disorders F5Eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2006-03 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Mar2006D-5430 N DW 14.87 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHHrpDWDHs{qPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHHrpDW)DɐHrWDWDlHsbjDWDHs{qPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW).DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1016 10161388101613881016A0headaches Headache FNervous system disorders FHeadache FHeadaches NEC FHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2012-05 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01May2012D-3177 N DW 8.7 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHHrpDWDHs{qPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHHrpDW)DɐHrWDWDlHsbjDWDHs{qPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW).DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391246103912461039A0myopia Myopia FkEye disorders FԯMyopia FkRefractive and accommodative disorders F+Vision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-3987 N DV 10.92 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD~THrTDWUDHs#*0Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD~THrTDVDHr_DWADmHs0DWUDHs#*0Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWADWU.DW>DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391246103912461039A glasses user Corrective lens user F]*Social circumstances F7Eyeglasses wearer F];Disability issues FuLifestyle issues FSocial circumstances F7GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2011M-3622 N DV 9.92 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD~THrTDWUDHs#*0Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD~THrTDVDHr_DWADmHs0DWUDHs#*0Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWADWU.DW>DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391246103912461039A@seasonal allergic rhinitis Seasonal allergy FUImmune system disorders F4Seasonal allergic rhinitis F1Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2011M-3622 N DV 9.92 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD~THrTDWUDHs#*0Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD~THrTDVDHr_DWADmHs0DWUDHs#*0Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWADWU.DW>DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391246103912461039Aacne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2018M-1065 N DV 2.92 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD~THrTDWUDHs#*0Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD~THrTDVDHr_DWADmHs0DWUDHs#*0Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWADWU.DW>DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391247103912471039A seasonal allergic rhinitis Seasonal allergy FUImmune system disorders F4Seasonal allergic rhinitis F1Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4718 N DV 12.92 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDVDHr_BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDVDHr_......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1039 10391247103912471039Aacne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2020-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2020D-335 N DV 0.92 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDVDHr_BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDVDHr_......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1039 10391250103912501039A benign cyst right foot Cyst FTGeneral disorders and administration site conditions FCyst FTMass conditions NEC FuTissue disorders NEC F;General disorders and administration site conditions FGENERAL MEDICAL HISTORY2015 2015 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2015M-2164 31Dec2015M-1800 N DV 5.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDwHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDwHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391250103912501039A0menarche Menarche FSocial circumstances F7Menarche FAge related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1068 N DV 2.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDwHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDwHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391250103912501039ATIC syndrome Tic FAPsychiatric disorders F'Tic disorder, unspecified FATic disorders FAChanges in physical activity FQPsychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2019M-703 N DV 1.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDwHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDwHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391251103912511039APvegetarian Vegetarian FNSocial circumstances F7Vegetarian FNDietary and nutritional issues FhLifestyle issues FSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DVDsHrDW@DlHsLPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDsHrDW DqHrDW)DwHrDW@DlHsLPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DW)DW@.DW)DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391251103912511039A0menarche Menarche FSocial circumstances F7Menarche FAge related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1802 N DV 4.94 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DVDsHrDW@DlHsLPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDsHrDW DqHrDW)DwHrDW@DlHsLPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DW)DW@.DW)DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391251103912511039Aanxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2017M-1436 N DV 3.93 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DVDsHrDW@DlHsLPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDsHrDW DqHrDW)DwHrDW@DlHsLPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DW)DW@.DW)DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391251103912511039A@menorrhagia Heavy menstrual bleeding F/Reproductive system and breast disorders F-LMenorrhagia F1Menstruation with increased bleeding FNMenstrual cycle and uterine bleeding disorders FʎReproductive system and breast disorders F-LGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1071 N DV 2.93 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DVDsHrDW@DlHsLPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDsHrDW DqHrDW)DwHrDW@DlHsLPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DW)DW@.DW)DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391251103912511039A eczema Eczema FSkin and subcutaneous tissue disorders F5Eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2020-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jun2020D-189 N DV 0.52 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DVDsHrDW@DlHsLPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDsHrDW DqHrDW)DwHrDW@DlHsLPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DW)DW@.DW)DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391252103912521039A contacts user Corrective lens user F]*Social circumstances F7Contact lens wearer F]:Disability issues FuLifestyle issues FSocial circumstances F7GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2008M-4724 N DV 12.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDxHrDWqD<HsH<Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDxHrDWDHr<DW\DHs,DWqD<HsH<Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DW\DWq.DWVDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391252103912521039A0glasses user Corrective lens user F]*Social circumstances F7Eyeglasses wearer F];Disability issues FuLifestyle issues FSocial circumstances F7GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4724 N DV 12.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDxHrDWqD<HsH<Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDxHrDWDHr<DW\DHs,DWqD<HsH<Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DW\DWq.DWVDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391252103912521039A@strabismus- os Strabismus F;/Eye disorders FԯStrabismus F;/Ocular nerve and muscle disorders F Ocular neuromuscular disorders F Eye disorders FԯGENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2008M-4724 N DV 12.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDxHrDWqD<HsH<Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDxHrDWDHr<DW\DHs,DWqD<HsH<Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DW\DWq.DWVDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391252103912521039Aacne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2018M-1071 N DV 2.93 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDxHrDWqD<HsH<Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDxHrDWDHr<DW\DHs,DWqD<HsH<Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DW\DWq.DWVDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391253103912531039Apremenarchal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD$Hr$DWD4HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD$Hr$DWD4Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391255103912551039A penicillin allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2014M-2532 N DV 6.93 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1039 10391255103912551039Aacne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1071 N DV 2.93 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1039 10391255103912551039A0vegan Vegan FNSocial circumstances F7Vegan FNDietary and nutritional issues FhLifestyle issues FSocial circumstances F7GENERAL MEDICAL HISTORY2020-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jun2020D-189 N DV 0.52 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1039 10391256103912561039A vegetarian Vegetarian FNSocial circumstances F7Vegetarian FNDietary and nutritional issues FhLifestyle issues FSocial circumstances F7GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2008M-4724 N DV 12.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD<Hr<DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD<Hr<DWDHr DWDHsm|DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1039 10391256103912561039Aepilepsy Epilepsy F=Nervous system disorders FEpilepsy F=Seizures and seizure disorders NEC F2hSeizures (incl subtypes) F2gNervous system disorders FGENERAL MEDICAL HISTORY2017 2020-09 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1436 30Sep2020D-68 N DV 3.93 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD<Hr<DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD<Hr<DWDHr DWDHsm|DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1039 10391258103912581039APseasonal allergic rhinitis Seasonal allergy FUImmune system disorders F4Seasonal allergic rhinitis F1Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2009M-4358 N DV 11.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD Hr DWD8Hs8Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD Hr DWDHr(DWDHsm$DWD8Hs8Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391258103912581039A adenoidectomy Adenoidectomy FNSurgical and medical procedures F<Adenoidectomy FNTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2013 2013 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.07 01Jan2013M-2897 31Dec2013M-2533 N DV 7.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD Hr DWD8Hs8Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD Hr DWDHr(DWDHsm$DWD8Hs8Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391258103912581039A`sleep apnea Sleep apnoea syndrome F6Respiratory, thoracic and mediastinal disorders F-Sleep apnea F6Breathing abnormalities F>Respiratory disorders NEC F-Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2013 2013 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2013M-2897 31Dec2013M-2533 N DV 7.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD Hr DWD8Hs8Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD Hr DWDHr(DWDHsm$DWD8Hs8Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391258103912581039Aptonsillectomy Tonsillectomy FBfSurgical and medical procedures F<Tonsillectomy FBfTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2013 2013 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2013M-2897 31Dec2013M-2533 N DV 7.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD Hr DWD8Hs8Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD Hr DWDHr(DWDHsm$DWD8Hs8Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391258103912581039A0asthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2016M-1802 YChronic pulmonary disease DV 4.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD Hr DWD8Hs8Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD Hr DWDHr(DWDHsm$DWD8Hs8Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391258103912581039A@menarche Menarche FSocial circumstances F7Menarche FAge related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2017M-1436 N DV 3.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD Hr DWD8Hs8Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD Hr DWDHr(DWDHsm$DWD8Hs8Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391258103912581039Aacne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2018M-1071 N DV 2.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD Hr DWD8Hs8Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD Hr DWDHr(DWDHsm$DWD8Hs8Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391259103912591039APmyringotomy Myringotomy FvSurgical and medical procedures F<Myringotomy FvMiddle ear therapeutic procedures FDHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2008-04 2008-04 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.05 01Apr2008D-4633 30Apr2008D-4604 N DV 12.69 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr'DWDdHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr'DWDHrDWD<Hsnx<DWDdHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391259103912591039A circumcision Circumcision FoSurgical and medical procedures F<Circumcision FoPenile therapeutic procedures FMale genital tract therapeutic procedures F"Surgical and medical procedures F<GENERAL MEDICAL HISTORY2007 2007 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2007M-5089 31Dec2007M-4725 N DV 13.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr'DWDdHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr'DWDHrDWD<Hsnx<DWDdHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391259103912591039Aamblyopia, left eye Amblyopia FEye disorders FԯAmblyopia FAmblyopic vision impairment FVision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2011M-3628 N DV 9.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr'DWDdHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr'DWDHrDWD<Hsnx<DWDdHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391259103912591039A0glasses user Corrective lens user F]*Social circumstances F7Eyeglasses wearer F];Disability issues FuLifestyle issues FSocial circumstances F7GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2011M-3628 N DV 9.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr'DWDdHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr'DWDHrDWD<Hsnx<DWDdHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391259103912591039A@myopia Myopia FkEye disorders FԯMyopia FkRefractive and accommodative disorders F+Vision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2011M-3628 N DV 9.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr'DWDdHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr'DWDHrDWD<Hsnx<DWDdHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391259103912591039A`seasonal allergic rhinitis Seasonal allergy FUImmune system disorders F4Seasonal allergic rhinitis F1Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2012M-3263 N DV 8.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr'DWDdHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr'DWDHrDWD<Hsnx<DWDdHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391260103912601039A attention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2014M-2532 N DV 6.93 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr1DWDXHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr1DWDXHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391260103912601039Aallergic rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2018M-1071 N DV 2.93 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr1DWDXHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr1DWDXHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391260103912601039A0glasses user Corrective lens user F]*Social circumstances F7Eyeglasses wearer F];Disability issues FuLifestyle issues FSocial circumstances F7GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019M-706 N DV 1.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr1DWDXHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr1DWDXHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391260103912601039A@myopia Myopia FkEye disorders FԯMyopia FkRefractive and accommodative disorders F+Vision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-706 N DV 1.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr1DWDXHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr1DWDXHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391262103912621039A0premenarchal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDtHr.tDWDq4Hr4BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDtHr.tDWDq4Hr4......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391262103912621039A@strawberry extract allergy Food allergy FزImmune system disorders F4Fruit allergy FvAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2007M-5090 N DV 13.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDtHr.tDWDq4Hr4BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDtHr.tDWDq4Hr4......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391262103912621039Aglasses user Corrective lens user F]*Social circumstances F7Eyeglasses wearer F];Disability issues FuLifestyle issues FSocial circumstances F7GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2016M-1803 N DV 4.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDtHr.tDWDq4Hr4BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDtHr.tDWDq4Hr4......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391262103912621039A myopia Myopia FkEye disorders FԯMyopia FkRefractive and accommodative disorders F+Vision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2016M-1803 N DV 4.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDtHr.tDWDq4Hr4BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDtHr.tDWDq4Hr4......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391263103912631039Aallergic rhinitis- perrennial Rhinitis perennial F/6Respiratory, thoracic and mediastinal disorders F-Perennial allergic rhinitis FNasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2007M-5090 N DV 13.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDxHr2pDWDpHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDxHr2pDWDpHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391264103912641039A0premenarchal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DVDHraDWDhHs{hPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHraDWDHr DWDhHs{hDWDhHs{hPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DW..DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391264103912641039Aeczema, bilateral arms Eczema FSkin and subcutaneous tissue disorders F5Eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2011M-3629 N DV 9.94 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DVDHraDWDhHs{hPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHraDWDHr DWDhHs{hDWDhHs{hPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DW..DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391264103912641039A eczema, bilateral cheeks Eczema FSkin and subcutaneous tissue disorders F5Eczema facial FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2011M-3629 N DV 9.94 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DVDHraDWDhHs{hPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHraDWDHr DWDhHs{hDWDhHs{hPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DW..DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391265103912651039A@asthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2008M-4725 YChronic pulmonary disease DV 12.94 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrdDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrdDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391265103912651039A`myringotomy Myringotomy FvSurgical and medical procedures F<Myringotomy FvMiddle ear therapeutic procedures FDHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2010 2010 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.08 01Jan2010M-3994 31Dec2010M-3630 N DV 10.94 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrdDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrdDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391265103912651039Aprecurrent ear infections Ear infection F;Infections and infestations FEar infection F;Ear infections F=Infections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2010 2014 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.07 01Jan2010M-3994 31Dec2014M-2169 N DV 10.94 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrdDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrdDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391265103912651039Aactinic keratosis, bilateral arms Actinic keratosis FSkin and subcutaneous tissue disorders F5Actinic keratosis FSkin preneoplastic conditions NEC FcCornification and dystrophic skin disorders FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2011M-3629 N DV 9.94 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrdDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrdDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391265103912651039A actinic keratosis, bilateral legs Actinic keratosis FSkin and subcutaneous tissue disorders F5Actinic keratosis FSkin preneoplastic conditions NEC FcCornification and dystrophic skin disorders FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2011M-3629 N DV 9.94 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrdDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrdDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391265103912651039Aseasonal allergic rhinitis Seasonal allergy FUImmune system disorders F4Seasonal allergic rhinitis F1Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2011M-3629 N DV 9.94 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrdDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrdDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391265103912651039Asingulair allergy Drug hypersensitivity FImmune system disorders F4Specific allergy (drug) F8OAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2011M-3629 N DV 9.94 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrdDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrdDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391265103912651039A0adenoidectomy Adenoidectomy FNSurgical and medical procedures F<Adenoidectomy FNTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2014 2014 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.09 01Jan2014M-2533 31Dec2014M-2169 N DV 6.94 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrdDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrdDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391265103912651039APattention deficit disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2015M-2168 N DV 5.94 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrdDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrdDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391266103912661039Acircumcision Circumcision FoSurgical and medical procedures F<Circumcision FoPenile therapeutic procedures FMale genital tract therapeutic procedures F"Surgical and medical procedures F<GENERAL MEDICAL HISTORY2008 2008 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2008M-4725 31Dec2008M-4360 N DV 12.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrtDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrtDWDXHrXDWDǰHsn|DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391266103912661039A0tympanostomy tube placement Ear tube insertion FxSurgical and medical procedures F<Tympanostomy tube insertion Fy*Middle ear therapeutic procedures FDHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2009 2009 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2009M-4359 31Dec2009M-3995 N DV 11.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrtDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrtDWDXHrXDWDǰHsn|DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391266103912661039A@tympanostomy tube placement Ear tube insertion FxSurgical and medical procedures F<Tympanostomy tube insertion Fy*Middle ear therapeutic procedures FDHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2013 2013 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2013M-2898 31Dec2013M-2534 N DV 7.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrtDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrtDWDXHrXDWDǰHsn|DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391266103912661039A scoliosis Scoliosis F1Musculoskeletal and connective tissue disorders FkScoliosis F1Spine and neck deformities FMusculoskeletal and connective tissue deformities (incl intervertebral disc disorders)FYMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-707 N DV 1.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrtDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrtDWDXHrXDWDǰHsn|DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391267103912671039A0omnicef allergy Drug hypersensitivity FImmune system disorders F4Allergic reaction to antibiotics F8Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-3994 N DV 10.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDxHr|DWD{Hr@BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDxHr|DWD{Hr@......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWRDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391267103912671039Aanxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2013M-2898 N DV 7.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDxHr|DWD{Hr@BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDxHr|DWD{Hr@......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWRDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391267103912671039A@seasonal allergic rhinitis Seasonal allergy FUImmune system disorders F4Seasonal allergic rhinitis F1Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2013M-2898 N DV 7.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDxHr|DWD{Hr@BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDxHr|DWD{Hr@......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWRDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391267103912671039A menarche Menarche FSocial circumstances F7Menarche FAge related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2018M-1072 N DV 2.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDxHr|DWD{Hr@BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDxHr|DWD{Hr@......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWRDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391267103912671039APvegetarian Vegetarian FNSocial circumstances F7Vegetarian FNDietary and nutritional issues FhLifestyle issues FSocial circumstances F7GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2019M-707 N DV 1.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDxHr|DWD{Hr@BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDxHr|DWD{Hr@......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWRDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391268103912681039Amenarche Menarche FSocial circumstances F7Menarche FAge related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1072 N DV 2.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrwXDWDHslPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrwXDWDpHrDWDHslxDWDHslPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391269103912691039A@frequent ear infections Ear infection F;Infections and infestations FEar infection F;Ear infections F=Infections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY(b)(6) 2010 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 (b)(6) (b)(6)31Dec2010M-3630 N DV (b)(6)YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrz(DWDpHrxBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrz(DWDpHrx......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1039 10391269103912691039Aadenoidectomy Adenoidectomy FNSurgical and medical procedures F<Adenoidectomy FNTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2009-04 2009-04 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Apr2009D-4269 30Apr2009D-4240 N DV 11.69 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrz(DWDpHrxBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrz(DWDpHrx......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1039 10391269103912691039A0ear tube placement Ear tube insertion FxSurgical and medical procedures F<Ear tube insertion FxMiddle ear therapeutic procedures FDHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2010 2010 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2010M-3994 31Dec2010M-3630 N DV 10.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrz(DWDpHrxBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrz(DWDpHrx......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1039 10391269103912691039APmyringotomy Myringotomy FvSurgical and medical procedures F<Myringotomy FvMiddle ear therapeutic procedures FDHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2010 2010 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2010M-3994 31Dec2010M-3630 N DV 10.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrz(DWDpHrxBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrz(DWDpHrx......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1039 10391269103912691039A allergic rhinitis - seasonal Seasonal allergy FUImmune system disorders F4Seasonal allergic rhinitis F1Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2013M-2898 N DV 7.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrz(DWDpHrxBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrz(DWDpHrx......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1039 10391270103912701039A`menarche Menarche FSocial circumstances F7Menarche FAge related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY2020-04 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Apr2020D-252 N DV 0.69 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWD{HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDdHrDWD{ HslތDWD{HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391270103912701039A@ear infection Ear infection F;Infections and infestations FEar infection F;Ear infections F=Infections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2008 2011 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.07 01Jan2008M-4726 31Dec2011M-3266 N DV 12.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWD{HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDdHrDWD{ HslތDWD{HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391270103912701039Appenicillin allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2009M-4360 N DV 11.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWD{HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDdHrDWD{ HslތDWD{HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391270103912701039A astigmatism Astigmatism FqEye disorders FԯAstigmatism FqRefractive and accommodative disorders F+Vision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2010M-3995 N DV 10.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWD{HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDdHrDWD{ HslތDWD{HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391270103912701039APglasses user Corrective lens user F]*Social circumstances F7Eyeglasses wearer F];Disability issues FuLifestyle issues FSocial circumstances F7GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2010M-3995 N DV 10.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWD{HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDdHrDWD{ HslތDWD{HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391270103912701039Atympanostomy Myringotomy FvSurgical and medical procedures F<Myringotomy FvMiddle ear therapeutic procedures FDHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2011 2011 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.08 01Jan2011M-3630 31Dec2011M-3266 N DV 9.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWD{HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDdHrDWD{ HslތDWD{HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391270103912701039Aanxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2016M-1804 N DV 4.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWD{HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDdHrDWD{ HslތDWD{HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391270103912701039A0attention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2016M-1804 N DV 4.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWD{HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDdHrDWD{ HslތDWD{HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391271103912711039Aeczema Eczema FSkin and subcutaneous tissue disorders F5Eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2018M-1073 N DV 2.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDHrјDWDTHslDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391271103912711039A0seasonal allergic rhinitis Seasonal allergy FUImmune system disorders F4Seasonal allergic rhinitis F1Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1073 N DV 2.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDHrјDWDTHslDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391271103912711039A menarche Menarche FSocial circumstances F7Menarche FAge related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY2020-03 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Mar2020D-283 N DV 0.78 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDHrјDWDTHslDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391272103912721039A peanut allergy Food allergy FزImmune system disorders F4Peanut allergy FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-3995 N DV 10.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1039 10391272103912721039A@tympanostomy Myringotomy FvSurgical and medical procedures F<Myringotomy FvMiddle ear therapeutic procedures FDHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2010 2010 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2010M-3995 31Dec2010M-3631 N DV 10.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1039 10391272103912721039Aeczema Eczema FSkin and subcutaneous tissue disorders F5Eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2011M-3630 N DV 9.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1039 10391272103912721039A0seasonal allergic rhinitis Seasonal allergy FUImmune system disorders F4Seasonal allergic rhinitis F1Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019M-708 N DV 1.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1039 10391273103912731039A0menarche Menarche FSocial circumstances F7Menarche FAge related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY2020-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2020D-343 N DV 0.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDhHrhDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDhHrhDWDHr\DWDHslDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391273103912731039A attention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-11 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Nov2020D-38 N DV 0.11 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDhHrhDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDhHrhDWDHr\DWDHslDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391273103912731039ADepression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-10 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Oct2020D-69 N DV 0.19 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDhHrhDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDhHrhDWDHr\DWDHslDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391274103912741039A seasonal allergic rhinitis Seasonal allergy FUImmune system disorders F4Seasonal allergic rhinitis F1Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2007M-5098 N DV 13.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD{HrDWDqHshPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD{HrDW DpDHrDDWDtHsnOtDWDqHshPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391274103912741039Apineapple allergy Food allergy FزImmune system disorders F4Fruit allergy FvAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2013M-2906 N DV 7.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD{HrDWDqHshPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD{HrDW DpDHrDDWDtHsnOtDWDqHshPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391276103912761039A Seasonal allergic rhinitis Seasonal allergy FUImmune system disorders F4Seasonal allergic rhinitis F1Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2009M-4367 N DV 11.96 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrTDW DHr/0BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrTDW DHr/0......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1039 10391276103912761039AIdiopathic Urticaria - neck and face Idiopathic urticaria FSkin and subcutaneous tissue disorders F5Idiopathic urticaria FUrticarias FMAngioedema and urticaria FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2018M-1080 N DV 2.96 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrTDW DHr/0BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrTDW DHr/0......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1039 10391276103912761039A0acne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019M-715 N DV 1.96 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrTDW DHr/0BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrTDW DHr/0......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1039 10391277103912771039A vegetarian Vegetarian FNSocial circumstances F7Vegetarian FNDietary and nutritional issues FhLifestyle issues FSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVDHrݜDWDHsHPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrݜDWD\HrŘ\DWDHsl<DWDHsHPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391277103912771039Amenarche Menarche FSocial circumstances F7Menarche FAge related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-715 N DV 1.96 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVDHrݜDWDHsHPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrݜDWD\HrŘ\DWDHsl<DWDHsHPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391278103912781039A chronic strepthroat Pharyngitis streptococcal FInfections and infestations FStreptococcal sore throat F;JStreptococcal infections F;DBacterial infectious disorders F2Infections and infestations FGENERAL MEDICAL HISTORY2010 2012 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2010M-4002 31Dec2012M-2907 N DV 10.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHHrDW DHr-PBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHHrDW DHr-P......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391278103912781039Aallergic rhinitis - seasonal Seasonal allergy FUImmune system disorders F4Seasonal allergic rhinitis F1Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2011M-3637 N DV 9.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHHrDW DHr-PBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHHrDW DHr-P......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391278103912781039A0tonsillectomy Tonsillectomy FBfSurgical and medical procedures F<Tonsillectomy FBfTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2012 2012 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2012M-3272 31Dec2012M-2907 N DV 8.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHHrDW DHr-PBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHHrDW DHr-P......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391279103912791039Amenarche Menarche FSocial circumstances F7Menarche FAge related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY2019-02 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Feb2019D-684 N DV 1.88 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDPHrDWD<Hs<Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDPHrDWDHrŶDWDpHsrGDWD<Hs<Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391280103912801039Avirectomy, left eye Vitrectomy FPSurgical and medical procedures F<Vitrectomy FPEye therapeutic procedures NEC FEye therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2012 2012 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01201Jan2012M-3273 31Dec2012M-2908 N DV 8.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDdHs,Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDlHrDWD{Hsn0DWDdHs,Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391280103912801039A@cataract surgery Cataract operation FSurgical and medical procedures F<Cataract operation FLens therapeutic procedures FEye therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2013 2013 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01101Jan2013M-2907 31Dec2013M-2543 N DV 7.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDdHs,Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDlHrDWD{Hsn0DWDdHs,Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391280103912801039Aanxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2014M-2542 N DV 6.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDdHs,Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDlHrDWD{Hsn0DWDdHs,Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391280103912801039A attention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.07 01Jan2014M-2542 N DV 6.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDdHs,Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDlHrDWD{Hsn0DWDdHs,Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391280103912801039A0blindness, left eye Blindness unilateral FEye disorders FԯBlind left eye FVisual impairment and blindness (excl colour blindness) FVision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.09 01Jan2014M-2542 N DV 6.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDdHs,Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDlHrDWD{Hsn0DWDdHs,Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391280103912801039APdepression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2014M-2542 N DV 6.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDdHs,Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDlHrDWD{Hsn0DWDdHs,Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391280103912801039Avirectomy, left eye Vitrectomy FPSurgical and medical procedures F<Vitrectomy FPEye therapeutic procedures NEC FEye therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2014 2014 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01301Jan2014M-2542 31Dec2014M-2178 N DV 6.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDdHs,Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDlHrDWD{Hsn0DWDdHs,Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391280103912801039Apinsomnia Insomnia F%Psychiatric disorders F'Insomnia F%Disturbances in initiating and maintaining sleep FFSleep disorders and disturbances F6Psychiatric disorders F'GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2016M-1812 N DV 4.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDdHs,Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDlHrDWD{Hsn0DWDdHs,Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391280103912801039Apost traumatic stress disorder Post-traumatic stress disorder F$\Psychiatric disorders F'Post-traumatic stress disorder F$\Stress disorders F;cAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.08 01Jan2016M-1812 N DV 4.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDdHs,Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDlHrDWD{Hsn0DWDdHs,Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391280103912801039Amenarche Menarche FSocial circumstances F7Menarche FAge related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY2017-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017D-1446 N DV 3.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDdHs,Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDlHrDWD{Hsn0DWDdHs,Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391280103912801039A`headaches Headache FNervous system disorders FHeadache FHeadaches NEC FHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019M-716 N DV 1.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDdHs,Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDlHrDWD{Hsn0DWDdHs,Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391280103912801039Avitamin d deficiency Vitamin D deficiency FPMetabolism and nutrition disorders FVitamin D deficiency FPFat soluble vitamin deficiencies and disorders FVitamin related disorders FPMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01001Jan2019M-716 N DV 1.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDdHs,Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDlHrDWD{Hsn0DWDdHs,Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391280103912801039Apersistent rash, scalp Rash F*TSkin and subcutaneous tissue disorders F5Scalp rash FWRashes, eruptions and exanthems NEC FcEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2020-03 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Mar2020D-291 N DV 0.8 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDdHs,Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDlHrDWD{Hsn0DWDdHs,Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391281103912811039A rosacea Rosacea F/Skin and subcutaneous tissue disorders F5Rosacea F/Rosaceas F/Skin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1446 N DV 3.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDxHrZxDW DHrohBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDxHrZxDW DHroh......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DW0DV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1039 10391281103912811039AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-11 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Nov2020D-46 N DV 0.13 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDxHrZxDW DHrohBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDxHrZxDW DHroh......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DW0DV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1039 10391282103912821039Aallergies to cashews Food allergy FزImmune system disorders F4Allergy to nuts Fm/Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3274 N DV 8.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDzHrcPDWDHrTBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDzHrcPDWDHrT......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1039 10391283103912831039A allergy to apples and cherries Food allergy FزImmune system disorders F4Fruit allergy FvAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2005 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2005M-5830 N DV 15.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrk DWD4Hs4Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrk DWDlHrƳDWDsHsl֔DWD4Hs4Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391283103912831039Appenicillin allergy - rash and hives Drug eruption FSkin and subcutaneous tissue disorders F5Allergic drug rash FDermatitis ascribed to specific agent FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2005 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2005M-5830 N DV 15.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrk DWD4Hs4Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrk DWDlHrƳDWDsHsl֔DWD4Hs4Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391283103912831039APdacryocysterhinostomy Dacryocystorhinostomy FSurgical and medical procedures F<Dacryocystorhinostomy FLacrimal apparatus therapeutic procedures FEye therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2007 2007 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.07 01Jan2007M-5100 31Dec2007M-4736 N DV 13.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrk DWD4Hs4Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrk DWDlHrƳDWDsHsl֔DWD4Hs4Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391283103912831039Aseasonal allergic rhinitis Seasonal allergy FUImmune system disorders F4Seasonal allergic rhinitis F1Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1447 N DV 3.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrk DWD4Hs4Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrk DWDlHrƳDWDsHsl֔DWD4Hs4Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391283103912831039Aacne- on face Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2018M-1082 N DV 2.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrk DWD4Hs4Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrk DWDlHrƳDWDsHsl֔DWD4Hs4Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391283103912831039A0asthma exercise induced Asthma exercise induced FeRespiratory, thoracic and mediastinal disorders F-Asthma exercise induced FeBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.08 01Jan2018M-1082 YChronic pulmonary disease DV 2.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrk DWD4Hs4Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrk DWDlHrƳDWDsHsl֔DWD4Hs4Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391283103912831039A@asthma- mild persistent (seasonal) Asthma FaRespiratory, thoracic and mediastinal disorders F-Seasonal asthma FBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2018M-1082 YChronic pulmonary disease DV 2.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrk DWD4Hs4Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrk DWDlHrƳDWDsHsl֔DWD4Hs4Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391283103912831039A`myopia Myopia FkEye disorders FԯMyopia FkRefractive and accommodative disorders F+Vision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-717 N DV 1.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrk DWD4Hs4Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrk DWDlHrƳDWDsHsl֔DWD4Hs4Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391284103912841039Aseasonal allergic rhinitis Seasonal allergy FUImmune system disorders F4Seasonal allergic rhinitis F1Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3274 N DV 8.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrmdDWDn(HrƴBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrmdDWDn(Hrƴ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1039 10391284103912841039A0asthma - mild persistent and exercised induced Asthma exercise induced FeRespiratory, thoracic and mediastinal disorders F-Asthma exercise induced FeBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2013M-2908 YChronic pulmonary disease DV 7.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrmdDWDn(HrƴBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrmdDWDn(Hrƴ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1039 10391284103912841039A@eczema - right hand Hand dermatitis F|Skin and subcutaneous tissue disorders F5Hand eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2013M-2908 N DV 7.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrmdDWDn(HrƴBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrmdDWDn(Hrƴ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1039 10391284103912841039APeczema, chest Eczema FSkin and subcutaneous tissue disorders F5Eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.09 01Jan2013M-2908 N DV 7.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrmdDWDn(HrƴBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrmdDWDn(Hrƴ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1039 10391284103912841039Apmigraines Migraine FONervous system disorders FMigraine FOMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2013M-2908 N DV 7.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrmdDWDn(HrƴBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrmdDWDn(Hrƴ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1039 10391284103912841039Aacne, chest Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.08 01Jan2018M-1082 N DV 2.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrmdDWDn(HrƴBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrmdDWDn(Hrƴ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1039 10391284103912841039A acne, face Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2018M-1082 N DV 2.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrmdDWDn(HrƴBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrmdDWDn(Hrƴ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1039 10391284103912841039A`epididymal cyst - both testicles (benign) Epididymal cyst FReproductive system and breast disorders F-LEpididymal cyst FTesticular and epididymal neoplasms F4Testicular and epididymal disorders FʲReproductive system and breast disorders F-LGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.07 01Jan2018M-1082 N DV 2.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrmdDWDn(HrƴBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrmdDWDn(Hrƴ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1039 10391284103912841039Arecurrent heartburn Dyspepsia FGastrointestinal disorders FܛHeartburn FDyspeptic signs and symptoms FGastrointestinal signs and symptoms FGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2019M-717 N DV 1.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrmdDWDn(HrƴBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrmdDWDn(Hrƴ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1039 10391285103912851039A premenarche Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDdHrtDWDt@HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDdHrtDWD|tHrtDWDxHsn-DWDt@HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391285103912851039Aamoxicillin allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4004 N DV 10.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDdHrtDWDt@HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDdHrtDWD|tHrtDWDxHsn-DWDt@HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391285103912851039A0vegetarian Vegetarian FNSocial circumstances F7Vegetarian FNDietary and nutritional issues FhLifestyle issues FSocial circumstances F7GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2019M-717 N DV 1.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDdHrtDWDt@HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDdHrtDWD|tHrtDWDxHsn-DWDt@HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391286103912861039Apremenarche Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD4HrwDWD|8Hr8BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD4HrwDWD|8Hr8......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1039 10391287103912871039Aallergic rhinitis - seasonal Seasonal allergy FUImmune system disorders F4Seasonal allergic rhinitis F1Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2009M-4369 N DV 11.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHHrDWD{HHrHDWDHsmDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391287103912871039A0asthma - mild persistent Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2011M-3639 YChronic pulmonary disease DV 9.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHHrDWD{HHrHDWDHsmDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391287103912871039A`umbilical hernia Umbilical hernia FHGastrointestinal disorders FܛUmbilical hernia FHUmbilical hernias FHAbdominal hernias and other abdominal wall conditions FGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2013M-2908 N DV 7.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHHrDWD{HHrHDWDHsmDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391287103912871039APeczema Eczema FSkin and subcutaneous tissue disorders F5Eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2016M-1813 N DV 4.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHHrDWD{HHrHDWDHsmDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391287103912871039A anxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2017M-1447 N DV 3.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHHrDWD{HHrHDWDHsmDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391287103912871039A@dysmenorrhea Dysmenorrhoea FReproductive system and breast disorders F-LDysmenorrhea FMenstruation and uterine bleeding NEC FGMenstrual cycle and uterine bleeding disorders FʎReproductive system and breast disorders F-LGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2018M-1082 N DV 2.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHHrDWD{HHrHDWDHsmDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391289103912891039Apremenarchal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWD\HrJ\BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWD\HrJ\......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391289103912891039A@seasonal allergic rhinitis Seasonal allergy FUImmune system disorders F4Seasonal allergic rhinitis F1Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4004 N DV 10.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWD\HrJ\BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWD\HrJ\......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391289103912891039A recurrent heartburn Dyspepsia FGastrointestinal disorders FܛHeartburn FDyspeptic signs and symptoms FGastrointestinal signs and symptoms FGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019M-717 N DV 1.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWD\HrJ\BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWD\HrJ\......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391289103912891039A0right knee pain Arthralgia F'Musculoskeletal and connective tissue disorders FkKnee pain F5Joint related signs and symptoms F:Joint disorders F-Musculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2020 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2020M-352 N DV 0.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWD\HrJ\BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWD\HrJ\......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391290103912901039Aglasses user Corrective lens user F]*Social circumstances F7Eyeglasses wearer F];Disability issues FuLifestyle issues FSocial circumstances F7GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019M-717 N DV 1.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDXHrDWDHr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDXHrDWDHr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391290103912901039A0myopia Myopia FkEye disorders FԯMyopia FkRefractive and accommodative disorders F+Vision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-717 N DV 1.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDXHrDWDHr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDXHrDWDHr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391290103912901039A menarche Menarche FSocial circumstances F7Menarche FAge related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY2020-06-30 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 30Jun2020 -171 N DV 0.47 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDXHrDWDHr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDXHrDWDHr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391291103912911039APvegetarian Vegetarian FNSocial circumstances F7Vegetarian FNDietary and nutritional issues FhLifestyle issues FSocial circumstances F7GENERAL MEDICAL HISTORY2004 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2004M-6196 N DV 16.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrPDWrDy,HsID,Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrPDWDHr/DW]DHs-@DWrDy,HsID,Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DW]DWr.DWUDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391291103912911039Aacne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2018M-1082 N DV 2.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrPDWrDy,HsID,Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrPDWDHr/DW]DHs-@DWrDy,HsID,Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DW]DWr.DWUDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391291103912911039A glasses user Corrective lens user F]*Social circumstances F7Eyeglasses wearer F];Disability issues FuLifestyle issues FSocial circumstances F7GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019M-717 N DV 1.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrPDWrDy,HsID,Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrPDWDHr/DW]DHs-@DWrDy,HsID,Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DW]DWr.DWUDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391291103912911039A0hyperopia Hypermetropia FCEye disorders FԯHyperopia FRRefractive and accommodative disorders F+Vision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-717 N DV 1.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrPDWrDy,HsID,Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrPDWDHr/DW]DHs-@DWrDy,HsID,Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DW]DWr.DWUDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391291103912911039A@transgender hormonal therapy, female to male Transgender hormonal therapy FXSurgical and medical procedures F<Transgender hormonal therapy FXHormonal therapeutic procedures NEC FEndocrine gland therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2019M-717 N DV 1.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrPDWrDy,HsID,Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrPDWDHr/DW]DHs-@DWrDy,HsID,Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DW]DWr.DWUDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391292103912921039A seasonal allergic rhinitis Seasonal allergy FUImmune system disorders F4Seasonal allergic rhinitis F1Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1082 N DV 2.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr(DWDvHsTPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr(DWDPHrGPDWD{ Hsn0 DWDvHsTPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391292103912921039Amenarche Menarche FSocial circumstances F7Menarche FAge related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY2018-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jun2018D-931 N DV 2.55 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr(DWDvHsTPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr(DWDPHrGPDWD{ Hsn0 DWDvHsTPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391293103912931039Aallergic rhinitis - seasonal Seasonal allergy FUImmune system disorders F4Seasonal allergic rhinitis F1Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2013M-2911 N DV 7.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD|Hr|DWDHr< BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD|Hr|DWDHr< ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391294103912941039Aacne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2020-08 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Aug2020D-142 N DV 0.39 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDmHrΝ0DWDvHsn+DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391295103912951039Atonsillectomy Tonsillectomy FBfSurgical and medical procedures F<Tonsillectomy FBfTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2013 2013 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.08 01Jan2013M-2919 31Dec2013M-2555 N DW 7.99 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDxHrDWDHrPBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDxHrDWDHrP......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391295103912951039A@menarche Menarche FSocial circumstances F7Menarche FAge related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2017M-1458 N DW 3.99 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDxHrDWDHrPBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDxHrDWDHrP......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391295103912951039A anxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2018M-1093 N DW 3 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDxHrDWDHrPBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDxHrDWDHrP......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391295103912951039A0depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2018M-1093 N DW 3 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDxHrDWDHrPBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDxHrDWDHrP......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391295103912951039A`seasonal allergic rhinitis Seasonal allergy FUImmune system disorders F4Seasonal allergic rhinitis F1Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2018M-1093 N DW 3 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDxHrDWDHrPBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDxHrDWDHrP......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391295103912951039Apseptra allergy Drug hypersensitivity FImmune system disorders F4Allergic reaction to antibiotics F8Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1093 N DW 3 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDxHrDWDHrPBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDxHrDWDHrP......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391295103912951039A4 wisdom teeth extraction Wisdom teeth removal FQSurgical and medical procedures F<Wisdom teeth removal FQDental and gingival therapeutic procedures FƝHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2020-07 2020-07 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jul2020D-181 31Jul2020D-151 N DW 0.5 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDxHrDWDHrPBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDxHrDWDHrP......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391295103912951039APpartial avulsion fracture, left arm Upper limb fracture FRInjury, poisoning and procedural complications FArm fracture FVgLimb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2020-11 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.07 01Nov2020D-58 N DW 0.16 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDxHrDWDHrPBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDxHrDWDHrP......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391296103912961039Aattention deficit disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1458 N DW 3.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDPHrPDWDHs@Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDPHrPDWDr$Hr֊DWDHsnADWDHs@Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391296103912961039A dyslexia Dyslexia FNervous system disorders FDyslexia FCortical dysfunction NEC F Neurological disorders NEC FNervous system disorders FGENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1458 N DW 3.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDPHrPDWDHs@Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDPHrPDWDr$Hr֊DWDHsnADWDHs@Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391298103912981039A seasonal allergic rhinitis Seasonal allergy FUImmune system disorders F4Seasonal allergic rhinitis F1Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2189 N DW 6 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHHrHDWDHr֡`BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHHrHDWDHr֡`......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391298103912981039Ainsomnia Insomnia F%Psychiatric disorders F'Insomnia F%Disturbances in initiating and maintaining sleep FFSleep disorders and disturbances F6Psychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1458 N DW 3.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHHrHDWDHr֡`BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHHrHDWDHr֡`......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391299103912991039A0seasonal allergic rhinitis Seasonal allergy FUImmune system disorders F4Seasonal allergic rhinitis F1Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4015 N DW 11 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDpHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDWDqpHr։DWDHsn@DWDpHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391299103912991039A exercise induced asthma Asthma exercise induced FeRespiratory, thoracic and mediastinal disorders F-Exercise induced asthma FӡBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2016M-1824 YChronic pulmonary disease DW 5 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDpHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDWDqpHr։DWDHsn@DWDpHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391299103912991039Aattention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2018M-1093 N DW 3 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDpHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDWDqpHr։DWDHsn@DWDpHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391300103913001039Aallergic rhinitis- seasonal Seasonal allergy FUImmune system disorders F4Seasonal allergic rhinitis F1Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1458 N DW 3.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD(Hr(DWDsPHr.BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD(Hr(DWDsPHr.......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391301103913011039Aallergic mild intermittent asthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Allergic asthma F)Bronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2016M-1824 YChronic pulmonary disease DW 5 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDtHrtDWDHs"Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDtHrtDWDsHr/ DWDtHsm DWDHs"Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391301103913011039A allergic rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2016M-1824 N DW 5 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDtHrtDWDHs"Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDtHrtDWDsHr/ DWDtHsm DWDHs"Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391301103913011039A0sulfa allergy Drug hypersensitivity FImmune system disorders F4Sulfonamide allergy FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1824 N DW 5 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDtHrtDWDHs"Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDtHrtDWDsHr/ DWDtHsm DWDHs"Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391302103913021039Aallergic rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2189 N DW 6 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD0Hr0DWD\Hry\BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD0Hr0DWD\Hry\......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391302103913021039A anxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2016M-1824 N DW 5 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD0Hr0DWD\Hry\BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD0Hr0DWD\Hry\......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391302103913021039A0depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2016M-1824 N DW 5 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD0Hr0DWD\Hry\BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD0Hr0DWD\Hry\......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391303103913031039A0right hip dysplasia Developmental hip dysplasia FCongenital, familial and genetic disorders FHip dysplasia FGMusculoskeletal and connective tissue disorders of limbs congenital F]Musculoskeletal and connective tissue disorders congenital FlCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY2008-04 2008-04 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 01Apr2008D-4655 30Apr2008D-4626 N DW 12.75 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr(DWDr`HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr(DWDkHr'DWDlHsmDWDr`HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391303103913031039Aglasses user Corrective lens user F]*Social circumstances F7Eyeglasses wearer F];Disability issues FuLifestyle issues FSocial circumstances F7GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1458 N DW 3.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr(DWDr`HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr(DWDkHr'DWDlHsmDWDr`HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391303103913031039A myopia Myopia FkEye disorders FԯMyopia FkRefractive and accommodative disorders F+Vision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1458 N DW 3.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr(DWDr`HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr(DWDkHr'DWDlHsmDWDr`HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391303103913031039A@seasonal allergic rhinitis Seasonal allergy FUImmune system disorders F4Seasonal allergic rhinitis F1Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2017M-1458 N DW 3.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr(DWDr`HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr(DWDkHr'DWDlHsmDWDr`HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391304103913041039A`seasonal allergic rhinitis Seasonal allergy FUImmune system disorders F4Seasonal allergic rhinitis F1Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1458 N DW 3.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr+DWDHHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr+DWDHHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391304103913041039APmild depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 2017 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2017M-1458 31Dec2017M-1094 N DW 3.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr+DWDHHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr+DWDHHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391304103913041039Aasthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1093 YChronic pulmonary disease DW 3 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr+DWDHHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr+DWDHHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391304103913041039A0exercise induced general body ache Pain FGeneral disorders and administration site conditions FGeneral body pain FUPain and discomfort NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions FGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2018M-1093 N DW 3 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr+DWDHHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr+DWDHHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391304103913041039A dehydration Dehydration FMetabolism and nutrition disorders FDehydration FTotal fluid volume decreased FBElectrolyte and fluid balance conditions FMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2020-06 2020-06 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.06 01Jun2020D-211 30Jun2020D-182 N DW 0.58 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr+DWDHHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr+DWDHHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391304103913041039A@hematuria Haematuria F3Renal and urinary disorders F,WHematuria FzUrinary abnormalities FDUrinary tract signs and symptoms FL~Renal and urinary disorders F,WGENERAL MEDICAL HISTORY2020-06 2020-06 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.05 01Jun2020D-211 30Jun2020D-182 N DW 0.58 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr+DWDHHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr+DWDHHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391306103913061039A0penicillin allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrŲDW!DsHruHBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrŲDW!DsHruH......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW!....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391306103913061039A attention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1466 N DW 4.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrŲDW!DsHruHBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrŲDW!DsHruH......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW!....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391306103913061039Aappendectomy Appendicectomy FBSurgical and medical procedures F<Appendectomy F@Large intestine therapeutic procedures F{Gastrointestinal therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2018 2018 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2018M-1101 31Dec2018M-737 N DW 3.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrŲDW!DsHruHBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrŲDW!DsHruH......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW!....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391307103913071039A seasonal allergic rhinitis Seasonal allergy FUImmune system disorders F4Seasonal allergic rhinitis F1Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2005 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2005M-5849 N DW 16.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrŻDWDHs4Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrŻDW#DHrY4DWD0Hsnu0DWDHs4Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391307103913071039Amenarche Menarche FSocial circumstances F7Menarche FAge related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY2019-09 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Sep2019D-493 N DW 1.35 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrŻDWDHs4Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrŻDW#DHrY4DWD0Hsnu0DWDHs4Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391308103913081039APREMENARCHE Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrŻDW#DHrYpBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrŻDW#DHrYp......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391308103913081039A allergic rhinitis- seasonal Seasonal allergy FUImmune system disorders F4Seasonal allergic rhinitis F1Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2007M-5119 N DW 14.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrŻDW#DHrYpBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrŻDW#DHrYp......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391308103913081039A@pectus excavatum Pectus excavatum FCongenital, familial and genetic disorders FPectus excavatum FMusculoskeletal and connective tissue disorders of trunk congenital (excl spine)F`Musculoskeletal and connective tissue disorders congenital FlCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2008M-4754 N DW 13.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrŻDW#DHrYpBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrŻDW#DHrYp......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391308103913081039APtonsillectomy Tonsillectomy FBfSurgical and medical procedures F<Tonsillectomy FBfTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2013 2013 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2013M-2927 31Dec2013M-2563 N DW 8.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrŻDW#DHrYpBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrŻDW#DHrYp......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391308103913081039A0epistaxis Epistaxis FrRespiratory, thoracic and mediastinal disorders F-Epistaxis FrNasal disorders NEC FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2015M-2197 N DW 6.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrŻDW#DHrYpBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrŻDW#DHrYp......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391309103913091039Aallergic rhinitis- seasonal Seasonal allergy FUImmune system disorders F4Seasonal allergic rhinitis F1Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2011M-3659 N DW 10.02 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DWDrHrƹXDWDHsc0Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDrHrƹXDW#D8HrkDWDHsr.dDWDHsc0Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391309103913091039A eyeglasses wearer Corrective lens user F]*Social circumstances F7Eyeglasses wearer F];Disability issues FuLifestyle issues FSocial circumstances F7GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2016M-1833 N DW 5.02 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DWDrHrƹXDWDHsc0Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDrHrƹXDW#D8HrkDWDHsr.dDWDHsc0Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391309103913091039A0myopia Myopia FkEye disorders FԯMyopia FkRefractive and accommodative disorders F+Vision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1833 N DW 5.02 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DWDrHrƹXDWDHsc0Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDrHrƹXDW#D8HrkDWDHsr.dDWDHsc0Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391310103913101039Aseasonal allergic rhinitis Seasonal allergy FUImmune system disorders F4Seasonal allergic rhinitis F1Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD{ HrDWDXHsXPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD{ HrDW"D|8Hr8DWDĤHsnyDWDXHsXPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW".DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391314103913141039AFibroadenoma of right breast Fibroadenoma of breast FeNeoplasms benign, malignant and unspecified (incl cysts and polyps)F0Fibroadenoma of breast FeBreast and nipple neoplasms benign FBreast neoplasms benign (incl nipple) FNeoplasms benign, malignant and unspecified (incl cysts and polyps)F0GENERAL MEDICAL HISTORY2020-02 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Feb2020D-341 N DW 0.94 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DWD HrDWDqHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD HrDW$DLHrLDWDpHsrDWDqHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391314103913141039A0attention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2015M-2198 N DW 6.02 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DWD HrDWDqHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD HrDW$DLHrLDWDpHsrDWDqHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391314103913141039A anxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2018M-1102 N DW 3.02 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DWD HrDWDqHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD HrDW$DLHrLDWDpHsrDWDqHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391314103913141039A@heavy periods Heavy menstrual bleeding F/Reproductive system and breast disorders F-LHeavy periods F Menstruation with increased bleeding FNMenstrual cycle and uterine bleeding disorders FʎReproductive system and breast disorders F-LGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1102 N DW 3.02 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DWD HrDWDqHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD HrDW$DLHrLDWDpHsrDWDqHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391314103913141039APmenarche Menarche FSocial circumstances F7Menarche FAge related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1102 N DW 3.02 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DWD HrDWDqHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD HrDW$DLHrLDWDpHsrDWDqHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391314103913141039A`painful periods Dysmenorrhoea FReproductive system and breast disorders F-LPainful periods FjMenstruation and uterine bleeding NEC FGMenstrual cycle and uterine bleeding disorders FʎReproductive system and breast disorders F-LGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2018M-1102 N DW 3.02 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DWD HrDWDqHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD HrDW$DLHrLDWDpHsrDWDqHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391315103913151039Aseasonal allergic rhinitis Seasonal allergy FUImmune system disorders F4Seasonal allergic rhinitis F1Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4755 N DW 13.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDôHr 4DW#DhHrhBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDôHr 4DW#DhHrh......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391316103913161039A premenarchal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD,Hr DW#D,HrhBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD,Hr DW#D,Hrh......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391316103913161039Aallergic rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1102 N DW 3.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD,Hr DW#D,HrhBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD,Hr DW#D,Hrh......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391317103913171039A0recurrent diarrhea Diarrhoea F?Gastrointestinal disorders FܛDiarrhea F7Diarrhoea (excl infective) F@Gastrointestinal motility and defaecation conditions FܹGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2011M-3659 N DW 10.02 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DWDĤHr $DWDrHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDĤHr $DW$DPHrPDWDHsnDWDrHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391317103913171039Aastigmatism Astigmatism FqEye disorders FԯAstigmatism FqRefractive and accommodative disorders F+Vision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2013M-2928 N DW 8.02 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DWDĤHr $DWDrHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDĤHr $DW$DPHrPDWDHsnDWDrHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391317103913171039A eyeglasses wearer Corrective lens user F]*Social circumstances F7Eyeglasses wearer F];Disability issues FuLifestyle issues FSocial circumstances F7GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2013M-2928 N DW 8.02 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DWDĤHr $DWDrHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDĤHr $DW$DPHrPDWDHsnDWDrHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391318103913181039A adenoidectomy Adenoidectomy FNSurgical and medical procedures F<Adenoidectomy FNTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2012 2012 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.08 01Jan2012M-3294 31Dec2012M-2929 N DW 9.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDԔHrDW%DhHr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDԔHrDW%DhHr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391318103913181039Atonsillectomy Tonsillectomy FBfSurgical and medical procedures F<Tonsillectomy FBfTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2012 2012 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.07 01Jan2012M-3294 31Dec2012M-2929 N DW 9.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDԔHrDW%DhHr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDԔHrDW%DhHr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391318103913181039Apmenarche Menarche FSocial circumstances F7Menarche FAge related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2016M-1833 N DW 5.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDԔHrDW%DhHr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDԔHrDW%DhHr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391318103913181039A0anxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2017M-1467 N DW 4.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDԔHrDW%DhHr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDԔHrDW%DhHr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391318103913181039A@depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2017M-1467 N DW 4.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDԔHrDW%DhHr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDԔHrDW%DhHr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391318103913181039A`insomnia Insomnia F%Psychiatric disorders F'Insomnia F%Disturbances in initiating and maintaining sleep FFSleep disorders and disturbances F6Psychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2017M-1467 N DW 4.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDԔHrDW%DhHr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDԔHrDW%DhHr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391318103913181039APgeneral idiopathic urticaria Idiopathic urticaria FSkin and subcutaneous tissue disorders F5Idiopathic urticaria FUrticarias FMAngioedema and urticaria FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2018M-1102 N DW 3.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDԔHrDW%DhHr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDԔHrDW%DhHr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391318103913181039AGERD Gastrooesophageal reflux disease F]Gastrointestinal disorders FܛGERD FݛGastrointestinal atonic and hypomotility disorders NEC F܍Gastrointestinal motility and defaecation conditions FܹGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2018 2018 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1102 31Dec2018M-738 N DW 3.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDԔHrDW%DhHr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDԔHrDW%DhHr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391319103913191039Aseasonal allergic rhinitis Seasonal allergy FUImmune system disorders F4Seasonal allergic rhinitis F1Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3295 N DW 9.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDu0Hr 0DWDHsePlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDu0Hr 0DW%DHrDWDHsvcDWDHsePlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391319103913191039A vegetarian Vegetarian FNSocial circumstances F7Vegetarian FNDietary and nutritional issues FhLifestyle issues FSocial circumstances F7GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1103 N DW 3.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDu0Hr 0DWDHsePlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDu0Hr 0DW%DHrDWDHsvcDWDHsePlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391320103913201039A seasonal allergic rhinitis Seasonal allergy FUImmune system disorders F4Seasonal allergic rhinitis F1Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3295 N DW 9.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr)DW%DHrلPlacebo A .Placebo A .DWDHr)DW%DHrل......Placebo Placebo DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391320103913201039Amenarche Menarche FSocial circumstances F7Menarche FAge related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY2020-09 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Sep2020D-129 N DW 0.36 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr)DW%DHrلPlacebo A .Placebo A .DWDHr)DW%DHrل......Placebo Placebo DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391321103913211039Amenarche Menarche FSocial circumstances F7Menarche FAge related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY2020-09 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Sep2020D-129 N DW 0.36 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr$DWDˆHsmPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr$DW%Dm8Hr㴸DWDpHsrDWDˆHsmPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391322103913221039APpenicillin allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrNDW%DHrtBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrNDW%DHrt......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391322103913221039A@myopia Myopia FkEye disorders FԯMyopia FkRefractive and accommodative disorders F+Vision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2016M-1834 N DW 5.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrNDW%DHrtBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrNDW%DHrt......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391322103913221039A menarche Menarche FSocial circumstances F7Menarche FAge related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2017M-1468 N DW 4.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrNDW%DHrtBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrNDW%DHrt......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391322103913221039A0menorrhagia Heavy menstrual bleeding F/Reproductive system and breast disorders F-LMenorrhagia F1Menstruation with increased bleeding FNMenstrual cycle and uterine bleeding disorders FʎReproductive system and breast disorders F-LGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2018M-1103 N DW 3.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrNDW%DHrtBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrNDW%DHrt......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391322103913221039Aanxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-03 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Mar2020D-313 N DW 0.86 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrNDW%DHrtBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrNDW%DHrt......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391323103913231039Ahernia -abdominal Abdominal hernia FGastrointestinal disorders FܛAbdominal hernia FAbdominal hernias NEC FAbdominal hernias and other abdominal wall conditions FGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4756 N DW 13.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrRDW%DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrRDW%DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391323103913231039A sulfur allergy Drug hypersensitivity FImmune system disorders F4Drug allergy FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2015M-2199 N DW 6.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrRDW%DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrRDW%DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391324103913241039Aglasses user Corrective lens user F]*Social circumstances F7Eyeglasses wearer F];Disability issues FuLifestyle issues FSocial circumstances F7GENERAL MEDICAL HISTORY2020-10 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Oct2020D-99 N DW 0.27 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrtDW%D`HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrtDW%D`Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391324103913241039A menarche Menarche FSocial circumstances F7Menarche FAge related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY2020-09-02 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 02Sep2020 -128 N DW 0.35 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrtDW%D`HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrtDW%D`Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391325103913251039Aglasses wearer Corrective lens user F]*Social circumstances F7Eyeglasses wearer F];Disability issues FuLifestyle issues FSocial circumstances F7GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2013M-2932 N DW 8.03 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DWDHrA4DWDxxHsxPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrA4DW(Dv\Hr\DWDHslDWDxxHsxPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391325103913251039A menarche Menarche FSocial circumstances F7Menarche FAge related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY2020-09 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Sep2020D-132 N DW 0.36 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DWDHrA4DWDxxHsxPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrA4DW(Dv\Hr\DWDHslDWDxxHsxPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391326103913261039A0asthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2006 2018 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2006M-5489 31Dec2018M-742 YChronic pulmonary disease DW 15.03 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDxHr@DW(DwHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDxHr@DW(DwHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(....DWjDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391326103913261039APglasses user Corrective lens user F]*Social circumstances F7Eyeglasses wearer F];Disability issues FuLifestyle issues FSocial circumstances F7GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3298 N DW 9.03 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDxHr@DW(DwHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDxHr@DW(DwHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(....DWjDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391326103913261039A`seasonal allergic rhinitis Seasonal allergy FUImmune system disorders F4Seasonal allergic rhinitis F1Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2016M-1837 N DW 5.03 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDxHr@DW(DwHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDxHr@DW(DwHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(....DWjDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391326103913261039ADepression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2018M-1106 N DW 3.03 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDxHr@DW(DwHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDxHr@DW(DwHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(....DWjDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391326103913261039A anxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2018M-1106 N DW 3.03 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDxHr@DW(DwHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDxHr@DW(DwHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(....DWjDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391326103913261039A@attention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2018M-1106 N DW 3.03 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDxHr@DW(DwHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDxHr@DW(DwHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(....DWjDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391327103913271039A0myopia Myopia FkEye disorders FԯMyopia FkRefractive and accommodative disorders F+Vision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1106 N DW 3.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrE0DW(DzHrPlacebo A .Placebo A .DWDHrE0DW(DzHr......Placebo Placebo DWDW(....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391327103913271039Aanxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-11 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Nov2020D-71 N DW 0.2 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrE0DW(DzHrPlacebo A .Placebo A .DWDHrE0DW(DzHr......Placebo Placebo DWDW(....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391327103913271039A depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-11 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Nov2020D-71 N DW 0.2 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrE0DW(DzHrPlacebo A .Placebo A .DWDHrE0DW(DzHr......Placebo Placebo DWDW(....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391327103913271039A@toe reconstruction surgery, left foot Limb reconstructive surgery FSurgical and medical procedures F<Limb reconstructive surgery FLimb therapeutic procedures F6Bone and joint therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2020-07-312020-07-31BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 31Jul2020 -164 31Jul2020 -164 N DW 0.45 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrE0DW(DzHrPlacebo A .Placebo A .DWDHrE0DW(DzHr......Placebo Placebo DWDW(....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391328103913281039Aallergic rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1837 N DW 5.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDTHrFDWDHs|Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDTHrFDW)DkHrPDWDPHsndPDWDHs|Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW).DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391328103913281039A0menarche Menarche FSocial circumstances F7Menarche FAge related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1471 N DW 4.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDTHrFDWDHs|Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDTHrFDW)DkHrPDWDPHsndPDWDHs|Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW).DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391328103913281039A depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2018M-1106 N DW 3.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDTHrFDWDHs|Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDTHrFDW)DkHrPDWDPHsndPDWDHs|Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW).DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391329103913291039A tonsillectomy Tonsillectomy FBfSurgical and medical procedures F<Tonsillectomy FBfTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2011 2011 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2011M-3663 31Dec2011M-3299 N DW 10.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDXHr`DWDHs Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDXHr`DW(DyHr絤DWDXHsvcXDWDHs Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391329103913291039Aseasonal allergic rhinitis Seasonal allergy FUImmune system disorders F4Seasonal allergic rhinitis F1Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1837 N DW 5.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDXHr`DWDHs Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDXHr`DW(DyHr絤DWDXHsvcXDWDHs Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391330103913301039A@glasses user Corrective lens user F]*Social circumstances F7Eyeglasses wearer F];Disability issues FuLifestyle issues FSocial circumstances F7GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2011M-3663 N DW 10.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDҴHr_4DW)DHrLHBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDҴHr_4DW)DHrLH......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW)....DWqDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391330103913301039APpresbyopia Presbyopia F%Eye disorders FԯPresbyopia F%Refractive and accommodative disorders F+Vision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2011M-3663 N DW 10.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDҴHr_4DW)DHrLHBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDҴHr_4DW)DHrLH......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW)....DWqDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391330103913301039Aanxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2016M-1837 N DW 5.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDҴHr_4DW)DHrLHBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDҴHr_4DW)DHrLH......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW)....DWqDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391330103913301039A0depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2016M-1837 N DW 5.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDҴHr_4DW)DHrLHBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDҴHr_4DW)DHrLH......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW)....DWqDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391330103913301039A attention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2018M-1106 N DW 3.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDҴHr_4DW)DHrLHBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDҴHr_4DW)DHrLH......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW)....DWqDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391330103913301039A`wisdom teeth extraction Wisdom teeth removal FQSurgical and medical procedures F<Wisdom teeth removal FQDental and gingival therapeutic procedures FƝHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2019 2019 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-741 31Dec2019M-377 N DW 2.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDҴHr_4DW)DHrLHBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDҴHr_4DW)DHrLH......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW)....DWqDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391331103913311039Aamoxicillin allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2009M-4394 N DW 12.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDr`HrP`DW(Dx<Hr<BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDr`HrP`DW(Dx<Hr<......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391331103913311039A seasonal allergic rhinitis Seasonal allergy FUImmune system disorders F4Seasonal allergic rhinitis F1Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2016M-1838 N DW 5.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDr`HrP`DW(Dx<Hr<BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDr`HrP`DW(Dx<Hr<......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391332103913321039AMajor Depression Major depression FxpPsychiatric disorders F'Major depression FxpDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2018M-1107 N DW 3.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD|HrZDW)DpHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD|HrZDW)DpHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW)....DWrDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391332103913321039A0anxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2018M-1107 N DW 3.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD|HrZDW)DpHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD|HrZDW)DpHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW)....DWrDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391332103913321039APmenarche Menarche FSocial circumstances F7Menarche FAge related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2018M-1107 N DW 3.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD|HrZDW)DpHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD|HrZDW)DpHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW)....DWrDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391332103913321039A`menorrhagia Heavy menstrual bleeding F/Reproductive system and breast disorders F-LMenorrhagia F1Menstruation with increased bleeding FNMenstrual cycle and uterine bleeding disorders FʎReproductive system and breast disorders F-LGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1107 N DW 3.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD|HrZDW)DpHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD|HrZDW)DpHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW)....DWrDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391332103913321039A PTSD Post-traumatic stress disorder F$\Psychiatric disorders F'Post-traumatic stress disorder F$\Stress disorders F;cAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-11 2020-11 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.07 01Nov2020D-72 30Nov2020D-43 N DW 0.2 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD|HrZDW)DpHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD|HrZDW)DpHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW)....DWrDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391332103913321039A@depression hospitalization Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-11 2020-11 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.06 01Nov2020D-72 30Nov2020D-43 N DW 0.2 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD|HrZDW)DpHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD|HrZDW)DpHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW)....DWrDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391332103913321039Apmigraines Migraine FONervous system disorders FMigraine FOMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2020-09 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Sep2020D-133 N DW 0.37 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD|HrZDW)DpHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD|HrZDW)DpHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW)....DWrDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391333103913331039Aactinic keratosis Actinic keratosis FSkin and subcutaneous tissue disorders F5Actinic keratosis FSkin preneoplastic conditions NEC FcCornification and dystrophic skin disorders FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019 2020 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-742 31Dec2020M-12 N DW 2.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHreDWDtHsftPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHreDW)Du0HrDWDHHswDWDtHsftPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW).DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391334103913341039Agrowth hormone deficiency Growth hormone deficiency FrEndocrine disorders FGrowth hormone deficiency FrAnterior pituitary hypofunction F Hypothalamus and pituitary gland disorders FEndocrine disorders FGENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4029 N DW 11.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHreDWD8Hsf8Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHreDW)DtHrtDWDƄHswDWD8Hsf8Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW).DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391334103913341039A lipoma removal - right axilla Lipoma excision FSurgical and medical procedures F<Lipoma excision FSoft tissue therapeutic procedures NEC Fe Soft tissue therapeutic procedures F7Surgical and medical procedures F<GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2012M-3299 N DW 9.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHreDWD8Hsf8Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHreDW)DtHrtDWDƄHswDWD8Hsf8Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW).DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391336103913361039Aasthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2014M-2568 YChronic pulmonary disease DW 7.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr̀DW)D|tHr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr̀DW)D|tHr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW)....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391336103913361039A@seasonal allergic rhinitis Seasonal allergy FUImmune system disorders F4Seasonal allergic rhinitis F1Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2015M-2203 N DW 6.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr̀DW)D|tHr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr̀DW)D|tHr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW)....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391336103913361039A ibuprofen allergy Drug hypersensitivity FImmune system disorders F4Allergic reaction to analgesics FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1107 N DW 3.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr̀DW)D|tHr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr̀DW)D|tHr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW)....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391336103913361039A0naproxen allergy Drug hypersensitivity FImmune system disorders F4Allergic reaction to analgesics FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1107 N DW 3.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr̀DW)D|tHr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr̀DW)D|tHr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW)....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391337103913371039A0penicillin allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2007M-5125 N DW 14.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr͈DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr͈DW*DndHrMdDWDHsnUDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW*.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391337103913371039A@recurrent diarrhea Diarrhoea F?Gastrointestinal disorders FܛDiarrhea F7Diarrhoea (excl infective) F@Gastrointestinal motility and defaecation conditions FܹGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2010M-4029 N DW 11.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr͈DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr͈DW*DndHrMdDWDHsnUDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW*.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391337103913371039APtonsillectomy Tonsillectomy FBfSurgical and medical procedures F<Tonsillectomy FBfTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2011 2011 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2011M-3664 31Dec2011M-3300 N DW 10.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr͈DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr͈DW*DndHrMdDWDHsnUDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW*.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391337103913371039A eczema, bilateral arms Eczema FSkin and subcutaneous tissue disorders F5Eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2012 2012 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2012M-3299 31Dec2012M-2934 N DW 9.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr͈DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr͈DW*DndHrMdDWDHsnUDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW*.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391337103913371039Aacne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1107 N DW 3.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr͈DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr͈DW*DndHrMdDWDHsnUDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW*.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1039 10391338103913381039A0menarche Menarche FSocial circumstances F7Menarche FAge related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY2016-12 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Dec2016D-1503 N DW 4.12 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDИHrͮDW*DwHrVBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDИHrͮDW*DwHrV......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW*....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391338103913381039ADepression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2018M-1107 N DW 3.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDИHrͮDW*DwHrVBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDИHrͮDW*DwHrV......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW*....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391338103913381039A acne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1107 N DW 3.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDИHrͮDW*DwHrVBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDИHrͮDW*DwHrV......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW*....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391338103913381039A@vegetarian Vegetarian FNSocial circumstances F7Vegetarian FNDietary and nutritional issues FhLifestyle issues FSocial circumstances F7GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2018M-1107 N DW 3.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDИHrͮDW*DwHrVBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDИHrͮDW*DwHrV......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW*....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1039 10391339103913391039Apremenarche Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrͯDWDrHs˜Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrͯDW*DxHrWDWD~HssyDWDrHs˜Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW*.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441256104412561044AAllergic Rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2009M-4352 N DV 11.92 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr!DWD,Hs,Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr!DVDHrDWD4HsreDWD,Hs,Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441260104412601044A Vitamin C Supplements EXCIPIENT Allergy Drug hypersensitivity FImmune system disorders F4Drug allergy FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2020-02 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Feb2020D-304 N DV 0.84 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD$Hrx$DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD$Hrx$DVDHrDWDHsnDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1044 10441260104412601044ACefdinir Allergy Drug hypersensitivity FImmune system disorders F4Allergic reaction to antibiotics F8Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4718 N DV 12.92 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD$Hrx$DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD$Hrx$DVDHrDWDHsnDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1044 10441263104412631044AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019-11 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Nov2019D-402 N DV 1.1 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr;DWDHHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr;DWDHHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1044 10441266104412661044AAllergic Rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2008M-4725 N DV 12.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr\(DWDDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr\(DWDDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.....DV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441266104412661044A0Migraine Headaches Migraine FONervous system disorders FMigraine headache FRMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2010M-3994 N DV 10.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr\(DWDDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr\(DWDDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.....DV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441266104412661044A Menstrual Cramps Dysmenorrhoea FReproductive system and breast disorders F-LMenstrual cramps F<Menstruation and uterine bleeding NEC FGMenstrual cycle and uterine bleeding disorders FʎReproductive system and breast disorders F-LGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1072 N DV 2.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr\(DWDDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr\(DWDDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.....DV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441266104412661044A@acne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2019M-707 N DV 1.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr\(DWDDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr\(DWDDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.....DV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441267104412671044AEczema Eczema FSkin and subcutaneous tissue disorders F5Eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2009M-4359 N DV 11.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrc0DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrc0DWDHrXDWDHstHDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441268104412681044AHearing Loss (Bilateral) Deafness bilateral FcEar and labyrinth disorders F)Hearing loss bilateral FxtHearing losses FHearing disorders FEar and labyrinth disorders F)GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-3994 N DV 10.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrnpDWDިHr(BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrnpDWDިHr(......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.....DV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1044 10441273104412731044Agerd Gastrooesophageal reflux disease F]Gastrointestinal disorders FܛGERD FݛGastrointestinal atonic and hypomotility disorders NEC F܍Gastrointestinal motility and defaecation conditions FܹGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4725 N DV 12.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVE@Hr4DWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVE@Hr4DWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441273104412731044A premenarchal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY2020-11 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Nov2020D-37 N DV 0.1 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVE@Hr4DWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVE@Hr4DWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441274104412741044AAllergic Rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2009M-4359 N DV 11.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVEHrDWODHstPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVEHrDWDHrPDW8DDHrDDWODHstPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DW8DWO.DW0DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441276104412761044Aadd Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2013M-2899 N DV 7.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDdHrdDWD`Hr`BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDdHrdDWD`Hr`......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1044 10441279104412791044AAllergic Rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3265 N DV 8.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DW1DV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441279104412791044A acne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2016M-1804 N DV 4.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DW1DV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441280104412801044AAllergic Rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2008M-4726 N DV 12.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDW8DHr!Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDHrDW$D4Hr4DW8DHr!Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DW$DW8.DW"DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441280104412801044A Type 1 diabetes Type 1 diabetes mellitus FMetabolism and nutrition disorders FType 1 diabetes mellitus FDiabetes mellitus (incl subtypes) FǺGlucose metabolism disorders (incl diabetes mellitus) FxMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2010-07 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jul2010D-3814 YDiabetes without chronic complication DV 10.44 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDW8DHr!Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDHrDW$D4Hr4DW8DHr!Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DW$DW8.DW"DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441281104412811044Aacne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2020-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jun2020D-191 N DV 0.53 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVE`HrDWDpHrpBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVE`HrDWDpHrp......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441282104412821044A Amoxicillin intolerance Drug intolerance FGeneral disorders and administration site conditions FDrug intolerance FTherapeutic and nontherapeutic responses F@Therapeutic and nontherapeutic effects (excl toxicity) FCGeneral disorders and administration site conditions FGENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2006M-5456 N DV 14.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVEF@HrdDW[DHs+9dPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVEF@HrdDWDϨHr(DWFDHsfDW[DHs+9dPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWFDW[.DW=DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441282104412821044AAllergic Rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4726 N DV 12.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVEF@HrdDW[DHs+9dPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVEF@HrdDWDϨHr(DWFDHsfDW[DHs+9dPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWFDW[.DW=DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441282104412821044A0Exercise Induced Asthma Asthma exercise induced FeRespiratory, thoracic and mediastinal disorders F-Exercise induced asthma FӡBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1073 YChronic pulmonary disease DV 2.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVEF@HrdDW[DHs+9dPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVEF@HrdDWDϨHr(DWFDHsfDW[DHs+9dPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWFDW[.DW=DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441284104412841044A Allergic Rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2005 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2005M-5822 N DV 15.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr3lDWDLHsLPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr3lDWDHr4DWDHsm:lDWDLHsLPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441284104412841044AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2170 N DV 5.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr3lDWDLHsLPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr3lDWDHr4DWDHsm:lDWDLHsLPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441284104412841044A0acne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2015M-2170 N DV 5.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr3lDWDLHsLPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr3lDWDHr4DWDHsm:lDWDLHsLPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441285104412851044Aanxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019-08 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Aug2019D-497 N DV 1.36 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHHr@DWD|HrLBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHHr@DWD|HrL......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.....DV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1044 10441286104412861044Airregular periods Menstruation irregular FKReproductive system and breast disorders F-LIrregular periods FQMenstruation and uterine bleeding NEC FGMenstrual cycle and uterine bleeding disorders FʎReproductive system and breast disorders F-LGENERAL MEDICAL HISTORY2018-03 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Mar2018D-1016 N DV 2.78 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrHDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrHDWD(HrDWD,HsrODWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441288104412881044APremenarche Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY2020-11 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Nov2020D-45 N DV 0.13 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD|HrDWDHrŸBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD|HrDWDHrŸ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441289104412891006APremenarche Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr hDWDHr^Placebo A .Placebo A .DVDHr hDWDHr^......Placebo Placebo DVDW.....DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441289104412891006A asthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2009M-4367 YChronic pulmonary disease DV 11.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr hDWDHr^Placebo A .Placebo A .DVDHr hDWDHr^......Placebo Placebo DVDW.....DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441289104412891006A0feline allergy Allergy to animal FNImmune system disorders F4Allergic to cats FCAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2009M-4367 N DV 11.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr hDWDHr^Placebo A .Placebo A .DVDHr hDWDHr^......Placebo Placebo DVDW.....DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441289104412891006A@nut allergy Food allergy FزImmune system disorders F4Allergy to nuts Fm/Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2009M-4367 N DV 11.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr hDWDHr^Placebo A .Placebo A .DVDHr hDWDHr^......Placebo Placebo DVDW.....DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441290104412901044A Insomnia Insomnia F%Psychiatric disorders F'Insomnia F%Disturbances in initiating and maintaining sleep FFSleep disorders and disturbances F6Psychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1103 N DW 3.02 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrZDW%DHr pBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrZDW%DHr p......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441290104412901044AAllergic Rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2019M-738 N DW 2.02 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrZDW%DHr pBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrZDW%DHr p......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441290104412901044A0Premenarche Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY2020-11 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Nov2020D-68 N DW 0.19 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrZDW%DHr pBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrZDW%DHr p......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441292104412921044Aadhd Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3273 N DV 8.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHreDWcDHs5Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHreDW D,HrIDWMDHHsDWcDHs5Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWMDWc.DWKDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441293104412931044Asulfa allergy Drug hypersensitivity FImmune system disorders F4Sulfonamide allergy FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2177 N DV 5.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVE7@HrtDWDHsnPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVE7@HrtDW DHrēDWDHsnDWDHsnPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DW..DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441294104412941044Asulfa allergy Drug hypersensitivity FImmune system disorders F4Sulfonamide allergy FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2177 N DV 5.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVE;HrDWDTHsnTPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVE;HrDW DHrēDDWDTHsnTDWDTHsnTPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DW..DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441295104412951044Apenicillin allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2009M-4369 N DV 11.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrq`DWDHr'BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrq`DWDHr'......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1044 10441295104412951044A sulfa allergy Drug hypersensitivity FImmune system disorders F4Sulfonamide allergy FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2178 N DV 5.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrq`DWDHr'BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrq`DWDHr'......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1044 10441296104412961044AFracture of Right Radius Radius fracture F**Injury, poisoning and procedural complications FRadius fracture F**Limb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2020-09 2020-09-18BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Sep2020D-112 18Sep2020 -95 N DV 0.31 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD HrDWDXHr$BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD HrDWDXHr$......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441297104412971044Aseasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3279 N DW 8.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDWDHrLBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDWDHrL......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441298104412981044A seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1087 N DW 2.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr'DWDHsTPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr'DWDHrDDWDHsDWDHsTPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441298104412981044APREMENARCHE Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY2020-11 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Nov2020D-52 N DW 0.15 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr'DWDHsTPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr'DWDHrDDWDHsDWDHsTPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441299104412991044A Cefdinir Allergy Drug hypersensitivity FImmune system disorders F4Allergic reaction to antibiotics F8Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2006M-5475 N DW 14.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr DWD<Hs6Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr DWDHrXDWDPHslDWD<Hs6Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441299104412991044A0Penicillin Allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2006M-5475 N DW 14.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr DWD<Hs6Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr DWDHrXDWDPHslDWD<Hs6Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441299104412991044AAllergic Rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2010M-4014 N DW 10.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr DWD<Hs6Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr DWDHrXDWDPHslDWD<Hs6Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441300104413001044A Cefdinir Allergy Drug hypersensitivity FImmune system disorders F4Allergic reaction to antibiotics F8Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2005 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2005M-5840 N DW 15.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDPHrDWDHrtBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDPHrDWDHrt......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441300104413001044A@Sulfa Allergy Drug hypersensitivity FImmune system disorders F4Sulfonamide allergy FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2005 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2005M-5840 N DW 15.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDPHrDWDHrtBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDPHrDWDHrt......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441300104413001044AAllergic Rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2007M-5110 N DW 13.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDPHrDWDHrtBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDPHrDWDHrt......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441300104413001044A0Claritin Allergy Drug hypersensitivity FImmune system disorders F4Specific allergy (drug) F8OAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2010M-4014 N DW 10.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDPHrDWDHrtBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDPHrDWDHrt......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441302104413021044Aacne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-728 N DW 2 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrVDWD@Hs@Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrVDWD8Hr DWDhHsrDWD@Hs@Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441303104413031044Aacne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-728 N DW 2 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD\HrW\DWDHslPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD\HrW\DWDHr |DWvDHsNDWDHslPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWvDW.DWrDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441304104413041044Aaugmentin allergy Drug hypersensitivity FImmune system disorders F4Allergic reaction to antibiotics F8Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018-08 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Aug2018D-881 N DW 2.41 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrdDWDHr`BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrdDWDHr`......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441306104413061044AAllergic Rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1459 N DW 4 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrc@DWDPHrXPBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrc@DWDPHrXP......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441308104413081044AAllergic Rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2014M-2555 N DW 7 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD`HrhDWDxHsxPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD`HrhDWDڬHrDDWDHsrp|DWDxHsxPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441308104413081044A adhd Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1825 N DW 5 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD`HrhDWDxHsxPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD`HrhDWDڬHrDDWDHsrp|DWDxHsxPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441309104413091044AAllergic Rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2190 N DW 6 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrt\DWDLHrՉLBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrt\DWDLHrՉL......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.....DW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441310104413101044AAllergic Rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2020-07 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jul2020D-182 N DW 0.5 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD@HrDWDHrՐBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD@HrDWDHrՐ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.....DW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441311104413111044AMenstrual Cramps Dysmenorrhoea FReproductive system and breast disorders F-LMenstrual cramps F<Menstruation and uterine bleeding NEC FGMenstrual cycle and uterine bleeding disorders FʎReproductive system and breast disorders F-LGENERAL MEDICAL HISTORY2020 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2020M-369 N DW 1.01 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW D,Hr,DW!DHrޓBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW D,Hr,DW!DHrޓ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!.....DW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441312104413121044AAsthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4752 YChronic pulmonary disease DW 13.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DHrDWDHsbHPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DHrDW"DHrDWD Hsnv DWDHsbHPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW".DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441313104413131044Aacne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2009M-4386 N DW 12.01 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DHrDW!D<HrޗDWDHsΦDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441316104413161044AAmoxicillin Clavulanic acid Allergy Drug hypersensitivity FImmune system disorders F4Allergy to antibiotic FxAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2007M-5117 N DW 14.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHr-DW!DHr޶pBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHr-DW!DHr޶p......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441317104413171044ASeasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1099 N DW 3.01 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DHr4DWD8Hs8Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DHr4DW#DpHr~DWD4HsuDWD8Hs8Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441319104413191044ACephalosporin Allergy Drug hypersensitivity FImmune system disorders F4Allergic reaction to antibiotics F8Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2009M-4387 N DW 12.01 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHr;DW!D\HrޕBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHr;DW!D\Hrޕ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441319104413191044A penicillin allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2009M-4387 N DW 12.01 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHr;DW!D\HrޕBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHr;DW!D\Hrޕ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441321104413211044A ASD Repaired Atrial septal defect repair FSurgical and medical procedures F<Atrial septal defect repair FCongenital cardiovascular anomaly therapeutic procedures F!Cardiac therapeutic procedures F)Surgical and medical procedures F<GENERAL MEDICAL HISTORY2007 2007-09 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2007M-5118 30Sep2007D-4846 N DW 14.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW D|HrbDW"DƄHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW D|HrbDW"DƄHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW"....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441321104413211044A0ATRIAL SEPTAL DEFECT Atrial septal defect FCongenital, familial and genetic disorders FAtrial septal defect FCardiac septal defects congenital F7Cardiac and vascular disorders congenital FCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY2007 2007-09 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2007M-5118 30Sep2007D-4846 N DW 14.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW D|HrbDW"DƄHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW D|HrbDW"DƄHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW"....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441321104413211044AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2015M-2196 N DW 6.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW D|HrbDW"DƄHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW D|HrbDW"DƄHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW"....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441322104413221044A Seasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1465 N DW 4.01 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW D4Hr}DW#D$HrᎤBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW D4Hr}DW#D$HrᎤ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW#....DWNDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441322104413221044AACNE Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2020-09 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Sep2020D-126 N DW 0.35 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW D4Hr}DW#D$HrᎤBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW D4Hr}DW#D$HrᎤ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW#....DWNDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441324104413241044AAsthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2007M-5118 YChronic pulmonary disease DW 14.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW Ed@HrĩDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW Ed@HrĩDW!DHrޡDWDHHsnHDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441326104413261044Apremenarchal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrňDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrňDW!D<Hr޵DWDdHsuDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW!.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441327104413271044AAllergic Rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019M-736 N DW 2.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD Hrʼn DWDXHsXPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD Hrʼn DW!DxHr޵DWD(HsuDWDXHsXPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW!.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441327104413271044A acne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-736 N DW 2.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD Hrʼn DWDXHsXPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD Hrʼn DW!DxHr޵DWD(HsuDWDXHsXPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW!.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441327104413271044A0irregular periods Menstruation irregular FKReproductive system and breast disorders F-LIrregular periods FQMenstruation and uterine bleeding NEC FGMenstrual cycle and uterine bleeding disorders FʎReproductive system and breast disorders F-LGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2019M-736 N DW 2.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD Hrʼn DWDXHsXPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD Hrʼn DW!DxHr޵DWD(HsuDWDXHsXPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW!.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441330104413301044AAttention Deficit Hyperactive Disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit/hyperactivity disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-11 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Nov2020D-66 N DW 0.18 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDDHrDDWDHsvhPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDDHrDDW#DшHrvDWDHsuDWDHsvhPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441331104413311044AAttention Deficit Hyperactive Disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit/hyperactivity disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1832 N DW 5.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDW#DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDW#DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441332104413321044AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2014M-2562 N DW 7.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD$Hr$DWDHHsHPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD$Hr$DW#DHrXDWDɐHsn~DWDHHsHPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441333104413331044ASeasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4023 N DW 11.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWEHr`DW#DHrqBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWEHr`DW#DHrq......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441334104413341044Apremenarchal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD@HrDW"DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD@HrDW"DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW"....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441335104413351044A0anxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2017M-1467 N DW 4.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDټHr <DWD(Hs?(Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDټHr <DW%DנHr DWDHssDWD(Hs?(Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441335104413351044A@depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2017M-1467 N DW 4.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDټHr <DWD(Hs?(Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDټHr <DW%DנHr DWDHssDWD(Hs?(Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441335104413351044A acne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019M-737 N DW 2.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDټHr <DWD(Hs?(Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDټHr <DW%DנHr DWDHssDWD(Hs?(Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441335104413351044APdry skin Dry skin FZSkin and subcutaneous tissue disorders F5Dry skin FZDermal and epidermal conditions NEC FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2020 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2020M-372 N DW 1.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDټHr <DWD(Hs?(Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDټHr <DW%DנHr DWDHssDWD(Hs?(Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441335104413351044AKnee-osteochondral defect (left) Osteochondrosis FMusculoskeletal and connective tissue disorders FkOsteochondral defects F)Cartilage disorders FTendon, ligament and cartilage disorders F?eMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2019-10 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Oct2019D-464 N DW 1.27 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDټHr <DWD(Hs?(Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDټHr <DW%DנHr DWDHssDWD(Hs?(Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441338104413381044AAllergic Rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2018-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018D-1103 N DW 3.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD$Hr($DW%D0HrPlacebo A .Placebo A .DWD$Hr($DW%D0Hr......Placebo Placebo DWDW%.....DW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441341104413411044AAttention Deficit Hyperactive Disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit/hyperactivity disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018-10 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Oct2018D-830 N DW 2.28 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrzDWDhHshPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrzDW%DHr'TDWDHsmAtDWDhHshPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441343104413431044AThygeson Keratitis Punctate keratitis F)Eye disorders FԯSuperficial punctate keratitis FhCorneal infections, oedemas and inflammations FOcular infections, irritations and inflammations FEye disorders FԯGENERAL MEDICAL HISTORY2013-08-15 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 15Aug2013 -2704 N DW 7.41 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD@Hr{DW%DHr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD@Hr{DW%DHr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441345104413451044APREMENARCHE Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrɌdDWD0Hs0Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrɌdDW$D0Hr0DWDHsrC|DWD0Hs0Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441345104413451044A Seasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1835 N DW 5.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrɌdDWD0Hs0Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrɌdDW$D0Hr0DWDHsrC|DWD0Hs0Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441345104413451044A0food nut allergy Food allergy FزImmune system disorders F4Allergy to nuts Fm/Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1469 N DW 4.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrɌdDWD0Hs0Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrɌdDW$D0Hr0DWDHsrC|DWD0Hs0Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441347104413471044Aacne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019D-739 N DW 2.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrɍDW%DHr@Placebo A .Placebo A .DWDHrɍDW%DHr@......Placebo Placebo DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441347104413471044A depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jun2020D-222 N DW 0.61 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrɍDW%DHr@Placebo A .Placebo A .DWDHrɍDW%DHr@......Placebo Placebo DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441348104413481044AAllergic Rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3296 N DW 9.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrɖDWDLHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrɖDW$DHrDWDPHsrDWDLHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441349104413491044AAllergic Rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2009-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2009D-4391 N DW 12.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD4HrɖDW%DHr8BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD4HrɖDW%DHr8......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441350104413501044A Von Willebrands Disease Von Willebrand's disease FPCongenital, familial and genetic disorders FVon Willebrand's disease FPCoagulation disorders congenital FBlood and lymphatic system disorders congenital FRCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY2019-02 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Feb2019D-708 N DW 1.94 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrɝDW%DHrtBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrɝDW%DHrt......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWuDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441350104413501044ASeasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2005 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2005M-5852 N DW 16.02 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrɝDW%DHrtBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrɝDW%DHrt......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWuDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441350104413501044A0acne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4757 N DW 13.03 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrɝDW%DHrtBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrɝDW%DHrt......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWuDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441352104413521044AMenstrual Pain Dysmenorrhoea FReproductive system and breast disorders F-LPain menstrual F7Menstruation and uterine bleeding NEC FGMenstrual cycle and uterine bleeding disorders FʎReproductive system and breast disorders F-LGENERAL MEDICAL HISTORY2017-04 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Apr2017D-1380 N DW 3.78 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD`Hr`DW%DHrPBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD`Hr`DW%DHrP......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441353104413531044AAllergic Rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2014M-2566 N DW 7.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDW(DڬHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDW(DڬHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441354104413541044APPREMENARCHE Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDlHrlDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDlHrlDW%D HrDWDHstDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441354104413541044A Asthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2009M-4392 YChronic pulmonary disease DW 12.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDlHrlDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDlHrlDW%D HrDWDHstDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441354104413541044A`Seasonal Allergic Rhinitis Seasonal allergy FUImmune system disorders F4Seasonal allergic rhinitis F1Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2011M-3662 N DW 10.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDlHrlDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDlHrlDW%D HrDWDHstDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441354104413541044A0Insomnia Insomnia F%Psychiatric disorders F'Insomnia F%Disturbances in initiating and maintaining sleep FFSleep disorders and disturbances F6Psychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2019M-740 N DW 2.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDlHrlDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDlHrlDW%D HrDWDHstDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441354104413541044A@Migraine Headaches Migraine FONervous system disorders FMigraine headache FRMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2019M-740 N DW 2.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDlHrlDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDlHrlDW%D HrDWDHstDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441354104413541044AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-07 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jul2020D-193 N DW 0.53 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDlHrlDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDlHrlDW%D HrDWDHstDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441355104413551044AAllergic Rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2012-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2012D-3297 N DW 9.03 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrݨDW%DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrݨDW%DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441355104413551044A Asthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2012-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012D-3297 YChronic pulmonary disease DW 9.03 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrݨDW%DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrݨDW%DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441355104413551044A0Insomnia Insomnia F%Psychiatric disorders F'Insomnia F%Disturbances in initiating and maintaining sleep FFSleep disorders and disturbances F6Psychiatric disorders F'GENERAL MEDICAL HISTORY2019-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2019D-740 N DW 2.03 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrݨDW%DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrݨDW%DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441356104413561044A Rash on face Rash F*TSkin and subcutaneous tissue disorders F5Rash on face F*qRashes, eruptions and exanthems NEC FcEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2020-12-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Dec2020 -40 N DW 0.11 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrޘDW)DHrlPlacebo A .Placebo A .DWDHrޘDW)DHrl......Placebo Placebo DWDW).....DW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441356104413561044AAsthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2010M-4027 YChronic pulmonary disease DW 11.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrޘDW)DHrlPlacebo A .Placebo A .DWDHrޘDW)DHrl......Placebo Placebo DWDW).....DW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441357104413571044A Eczema Eczema FSkin and subcutaneous tissue disorders F5Eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2008M-4758 N DW 13.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDdHs?dPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDW%DdHrDWDHssDWDdHs?dPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441357104413571044A@Ostochondral Defect Right Knee (Pain) Osteochondrosis FMusculoskeletal and connective tissue disorders FkOsteochondral defects F)Cartilage disorders FTendon, ligament and cartilage disorders F?eMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2020 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2020M-375 N DW 1.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDdHs?dPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDW%DdHrDWDHssDWDdHs?dPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441357104413571044ADepression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019-03 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Mar2019D-681 N DW 1.87 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDdHs?dPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDW%DdHrDWDHssDWDdHs?dPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441357104413571044A0Obsessive-compulsive disorder Obsessive-compulsive disorder F JPsychiatric disorders F'Obsessive-compulsive disorder F JObsessive-compulsive disorders and symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019-03 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Mar2019D-681 N DW 1.87 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDdHs?dPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDW%DdHrDWDHssDWDdHs?dPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441358104413581044AAllergic Rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2020-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2020D-375 N DW 1.03 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDW(DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDW(DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441361104413611044A0TOPICAL ADHESIVE ALLERGY Dermatitis contact FSkin and subcutaneous tissue disorders F5Topical adhesive allergy FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2007M-5124 N DW 14.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr?TDW*DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr?TDW*DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW*....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441361104413611044AAllergic Rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4759 N DW 13.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr?TDW*DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr?TDW*DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW*....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441361104413611044A Asthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2014M-2567 YChronic pulmonary disease DW 7.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr?TDW*DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr?TDW*DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW*....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441362104413621044A Augmentin Drug Allergy Drug hypersensitivity FImmune system disorders F4Allergic reaction to antibiotics F8Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2012M-3298 N DW 9.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrODDWDHs5Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrODDW*DXHrwXDWDHsmKDWDHs5Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW*.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441362104413621044A@Omnicef Drug Allergy Drug hypersensitivity FImmune system disorders F4Allergy to antibiotic FxAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2012M-3298 N DW 9.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrODDWDHs5Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrODDW*DXHrwXDWDHsmKDWDHs5Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW*.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441362104413621044A0Juvenile rheumatoid arthritis Juvenile idiopathic arthritis F}Musculoskeletal and connective tissue disorders FkJuvenile rheumatoid arthritis FcRheumatoid arthropathies F/&Joint disorders F-Musculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2012-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012D-3298 YRheumatic disease DW 9.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrODDWDHs5Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrODDW*DXHrwXDWDHsmKDWDHs5Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW*.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441362104413621044AAllergic Rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1471 N DW 4.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrODDWDHs5Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrODDW*DXHrwXDWDHsmKDWDHs5Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW*.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441362104413621044APacne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2018M-1106 N DW 3.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrODDWDHs5Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrODDW*DXHrwXDWDHsmKDWDHs5Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW*.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441366104413661044A0Penicillin Allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2015M-2202 N DW 6.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDPHrhDW)DנHre BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDPHrhDW)DנHre ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW)....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441366104413661044AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-741 N DW 2.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDPHrhDW)DנHre BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDPHrhDW)DנHre ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW)....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441366104413661044A Left tibia stress fracture Stress fracture F;dInjury, poisoning and procedural complications FStress fracture F;dFractures and dislocations NEC FBone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2020-12-21 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 21Dec2020 -21 N DW 0.06 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDPHrhDW)DנHre BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDPHrhDW)DנHre ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW)....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441367104413671044A Amoxicillin Allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2008M-4759 N DW 13.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD HrzDW*DHrꇄBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD HrzDW*DHrꇄ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW*....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441367104413671044AAllergic Rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2014M-2567 N DW 7.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD HrzDW*DHrꇄBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD HrzDW*DHrꇄ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW*....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441368104413681044AOcular Migraines Ophthalmic migraine FNervous system disorders FOphthalmic migraine FMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2014M-2567 N DW 7.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr̂ DWaDTHs39Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr̂ DW*DôHrꢴDWLD`Hs`DWaDTHs39Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW*.DWLDWa.DWKDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441371104413711044AAllergic Rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2012M-3298 N DW 9.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWEkHr̓<DW)DHrT@Placebo A .Placebo A .DWEkHr̓<DW)DHrT@......Placebo Placebo DWDW).....DW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441371104413711044A Irregular Menses Menstruation irregular FKReproductive system and breast disorders F-LMenses irregular F5Menstruation and uterine bleeding NEC FGMenstrual cycle and uterine bleeding disorders FʎReproductive system and breast disorders F-LGENERAL MEDICAL HISTORY2019-11-17 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 17Nov2019 -421 N DW 1.16 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWEkHr̓<DW)DHrT@Placebo A .Placebo A .DWEkHr̓<DW)DHrT@......Placebo Placebo DWDW).....DW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441372104413721044A Allergic Rhinits Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2012M-3298 N DW 9.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWEhHr̓DW)DƄHrTBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWEhHr̓DW)DƄHrT......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW)....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441372104413721044AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2013-10 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Oct2013D-2659 N DW 7.28 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWEhHr̓DW)DƄHrTBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWEhHr̓DW)DƄHrT......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW)....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441373104413731044A GERD Gastrooesophageal reflux disease F]Gastrointestinal disorders FܛGERD FݛGastrointestinal atonic and hypomotility disorders NEC F܍Gastrointestinal motility and defaecation conditions FܹGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2006M-5490 N DW 15.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD\Hrr\DWD<Hs1Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD\Hrr\DW+DHrDWDHsr@4DWD<Hs1Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW+.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441373104413731044AAllergic Rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2011M-3664 N DW 10.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD\Hrr\DWD<Hs1Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD\Hrr\DW+DHrDWDHsr@4DWD<Hs1Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW+.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441373104413731044A@anxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1107 N DW 3.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD\Hrr\DWD<Hs1Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD\Hrr\DW+DHrDWDHsr@4DWD<Hs1Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW+.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441373104413731044A0Obsessive-compulsive disorder Obsessive-compulsive disorder F JPsychiatric disorders F'Obsessive-compulsive disorder F JObsessive-compulsive disorders and symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2020M-377 N DW 1.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD\Hrr\DWD<Hs1Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD\Hrr\DW+DHrDWDHsr@4DWD<Hs1Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW+.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441375104413751044AAllergic Rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2011M-3664 N DW 10.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr͐DW)DHr/8BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr͐DW)DHr/8......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW)....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441376104413761044AAsthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2007M-5125 YChronic pulmonary disease DW 14.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr͐DW)D|Hr.BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr͐DW)D|Hr.......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW)....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441376104413761044A Environmental allergies Hypersensitivity FImmune system disorders F4Environmental allergy FTAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2009M-4394 N DW 12.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr͐DW)D|Hr.BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr͐DW)D|Hr.......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW)....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441376104413761044A0peanut allergy Food allergy FزImmune system disorders F4Peanut allergy FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2009M-4394 N DW 12.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr͐DW)D|Hr.BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr͐DW)D|Hr.......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW)....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441377104413771044A0PREMENARCHE Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW(DHrDW=DPHsBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW(DHrDW=DPHs......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW(DW=....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441377104413771044A@Penicillin Allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2012M-3319 N DW 9.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW(DHrDW=DPHsBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW(DHrDW=DPHs......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW(DW=....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441377104413771044A`vasomotor rhinitis Vasomotor rhinitis FNRespiratory, thoracic and mediastinal disorders F-Vasomotor rhinitis FNNasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2015M-2223 N DW 6.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW(DHrDW=DPHsBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW(DHrDW=DPHs......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW(DW=....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441377104413771044ADIZZINES Dizziness F˅Nervous system disorders FDizziness F˅Neurological signs and symptoms NEC FNeurological disorders NEC FNervous system disorders FGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-762 N DW 2.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW(DHrDW=DPHsBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW(DHrDW=DPHs......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW(DW=....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441377104413771044A Fracture, Right Foot Foot fracture FInjury, poisoning and procedural complications FFoot fracture FLimb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2021-01-08 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 08Jan2021 -24 N DW 0.01 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW(DHrDW=DPHsBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW(DHrDW=DPHs......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW(DW=....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441377104413771044APsore throat Oropharyngeal pain F_Respiratory, thoracic and mediastinal disorders F-Sore throat F8Upper respiratory tract signs and symptoms FKiRespiratory tract signs and symptoms F}Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2021-01-122021-01-22BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.06 12Jan2021 -20 22Jan2021 -10 N DW 0 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW(DHrDW=DPHsBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW(DHrDW=DPHs......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW(DW=....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441378104413781044AAllergic Rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2014M-2568 N DW 7.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD$Hrͪ$DW+DLHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD$Hrͪ$DW+DLHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW+....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441378104413781044A Anxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019-03-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Mar2019 -683 N DW 1.87 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD$Hrͪ$DW+DLHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD$Hrͪ$DW+DLHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW+....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441379104413791044AAllergic Rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2009M-4394 N DW 12.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD`Hrͪ`DW+DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD`Hrͪ`DW+DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW+....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441380104413801044ASeasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2011M-3664 N DW 10.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr„DWD0Hs0Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr„DW*DHrʌDWDHsm'pDWD0Hs0Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW*.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441381104413811044A Hydrocodone Allergy Drug hypersensitivity FImmune system disorders F4Specific allergy (drug) F8OAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2203 N DW 6.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrðDWDшHspPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrðDW(DxHrxDWDHsr,DWDшHspPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441381104413811044AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1472 N DW 4.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrðDWDшHspPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrðDW(DxHrxDWDHsr,DWDшHspPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441382104413821044AAllergic Rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2011M-3664 N DW 10.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDۜHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDW*D8Hr8DWDHsmMhDWDۜHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW*.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441383104413831044ABroken right sesamoid bone Limb fracture FInjury, poisoning and procedural complications FLimb fracture FLimb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2020-09-30 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 30Sep2020 -104 N DW 0.29 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrלDW*DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrלDW*DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW*....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1044 10441384104413841044A Allergy Cefzil Drug hypersensitivity FImmune system disorders F4Allergy to antibiotic FxAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2007M-5125 N DW 14.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWD܌Hs Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDW+DlHrDWDHsvvDWD܌Hs Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW+.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441384104413841044A0Food Allergy: Casin Milk allergy FqImmune system disorders F4Milk protein allergy FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2009M-4394 N DW 12.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWD܌Hs Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDW+DlHrDWDHsvvDWD܌Hs Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW+.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441384104413841044AAllergic Rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2014M-2568 N DW 7.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWD܌Hs Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDW+DlHrDWDHsvvDWD܌Hs Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW+.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1044 10441384104413841044A@Hashomoto's Thyroiditis Autoimmune thyroiditis FVEndocrine disorders FHashimoto's thyroiditis F_Acute and chronic thyroiditis FAThyroid gland disorders FA[Endocrine disorders FGENERAL MEDICAL HISTORY2018-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jun2018D-956 N DW 2.62 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWD܌Hs Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDW+DlHrDWDHsvvDWD܌Hs Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW+.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571377105713771057A0Environmental Allergies Hypersensitivity FImmune system disorders F4Environmental allergy FTAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4724 N DV 12.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr9DWDHrxPlacebo A .Placebo A .DVDHr9DWDHrx......Placebo Placebo DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571377105713771057AAdenoidectomy Adenoidectomy FNSurgical and medical procedures F<Adenoidectomy FNTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2010 2010 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2010M-3993 31Dec2010M-3629 N DV 10.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr9DWDHrxPlacebo A .Placebo A .DVDHr9DWDHrx......Placebo Placebo DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571377105713771057A Adenoiditis Adenoiditis F^Infections and infestations FAdenoiditis F^Upper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2010 2010 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2010M-3993 31Dec2010M-3629 N DV 10.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr9DWDHrxPlacebo A .Placebo A .DVDHr9DWDHrx......Placebo Placebo DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571378105713781057APPREMENARCHAL Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.08 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD(Hr?(DWDHr,BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD(Hr?(DWDHr,......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1057 10571378105713781057A`Seasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2009M-4358 N DV 11.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD(Hr?(DWDHr,BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD(Hr?(DWDHr,......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1057 10571378105713781057AAdenoidectomy Adenoidectomy FNSurgical and medical procedures F<Adenoidectomy FNTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2009 2009 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2009M-4358 31Dec2009M-3994 N DV 11.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD(Hr?(DWDHr,BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD(Hr?(DWDHr,......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1057 10571378105713781057A Adenoiditis Adenoiditis F^Infections and infestations FAdenoiditis F^Upper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2009 2009 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2009M-4358 31Dec2009M-3994 N DV 11.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD(Hr?(DWDHr,BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD(Hr?(DWDHr,......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1057 10571378105713781057ApTonsillectomy Tonsillectomy FBfSurgical and medical procedures F<Tonsillectomy FBfTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2011 2011 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2011M-3628 31Dec2011M-3264 N DV 9.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD(Hr?(DWDHr,BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD(Hr?(DWDHr,......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1057 10571378105713781057ATonsillitis Tonsillitis FBhInfections and infestations FTonsillitis FBhUpper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2011 2011 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2011M-3628 31Dec2011M-3264 N DV 9.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD(Hr?(DWDHr,BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD(Hr?(DWDHr,......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1057 10571378105713781057A0Generalized Anxiety Disorder Generalised anxiety disorder FPsychiatric disorders F'Generalized anxiety disorder F9Anxiety disorders NEC FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2016M-1802 N DV 4.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD(Hr?(DWDHr,BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD(Hr?(DWDHr,......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1057 10571378105713781057A@Obesity Obesity F ;Metabolism and nutrition disorders FObesity F ;General nutritional disorders NEC FAppetite and general nutritional disorders FJMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.07 01Jan2019M-706 N DV 1.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD(Hr?(DWDHr,BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD(Hr?(DWDHr,......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1057 10571379105713791057AHYPERHYDROSIS Hyperhidrosis F"Skin and subcutaneous tissue disorders F5Hyperhidrosis F"Apocrine and eccrine gland disorders F&Skin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2014M-2532 N DV 6.93 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DVDHrPDWDHsdPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrPDWDHrDDWD8HsmHDWDHsdPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571380105713801057AATTENTION DEFICIT HYPERACTIVITY DISORDER STABLE Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2013-12 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Dec2013D-2564 N DV 7.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDDW D~HrАBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDDW D~HrА......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571380105713801057A SEASONAL ALLERGIES Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2015M-2168 N DV 5.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDDW D~HrАBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDDW D~HrА......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571382105713821057A ATOPIC DERMATITIS Dermatitis atopic FSkin and subcutaneous tissue disorders F5Atopic dermatitis FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2007M-5090 N DV 13.94 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDW DHr6tBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDW DHr6t......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571382105713821057AASTHMA Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2009 2012 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2009M-4359 31Dec2012M-2899 YChronic pulmonary disease DV 11.94 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDW DHr6tBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDW DHr6t......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571382105713821057A0PENICILLIN ALLERGY Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2013M-2898 N DV 7.94 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDW DHr6tBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDW DHr6t......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571383105713831057A0SEASONAL ALLERGIES Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2013M-2898 N DV 7.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDߘHrDWDHsGPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDߘHrDWDHr`DWDHsrDWDHsGPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571383105713831057AGENERALIZED ANXIETY DISORDER STABLE Generalised anxiety disorder FPsychiatric disorders F'Generalized anxiety disorder F9Anxiety disorders NEC FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1072 N DV 2.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDߘHrDWDHsGPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDߘHrDWDHr`DWDHsrDWDHsGPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571383105713831057A INSOMNIA Insomnia F%Psychiatric disorders F'Insomnia F%Disturbances in initiating and maintaining sleep FFSleep disorders and disturbances F6Psychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2018M-1072 N DV 2.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDߘHrDWDHsGPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDߘHrDWDHr`DWDHsrDWDHsGPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571385105713851057AATTENTION DEFICIT HYPERACTIVITY DISORDER STABLE Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2168 N DV 5.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr DWDHrtBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr DWDHrt......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DW3DV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571385105713851057A MAJOR DEPRESSIVE DISORDER Major depression FxpPsychiatric disorders F'Major depressive disorder FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016 2017 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2016M-1803 31Dec2017M-1073 N DV 4.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr DWDHrtBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr DWDHrt......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DW3DV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571386105713861057AOBESITY Obesity F ;Metabolism and nutrition disorders FObesity F ;General nutritional disorders NEC FAppetite and general nutritional disorders FJMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2168 N DV 5.94 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVDPHrDWDߘHrHPlacebo A .Placebo A .DVDPHrDWDߘHrH......Placebo Placebo DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571388105713881057ACAT ALLERGY Allergy to animal FNImmune system disorders F4Allergic to cats FCAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1804 N DV 4.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr|BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr|......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571389105713891057ACAT ALLERGY Allergy to animal FNImmune system disorders F4Allergic to cats FCAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1804 N DV 4.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD4Hr4DW DHr<Placebo A .Placebo A .DVD4Hr4DW DHr<......Placebo Placebo DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571390105713901057A0SEASONAL ALLERGIES Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2007M-5091 N DV 13.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDlHrlDWDИHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDlHrlDWDИHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571390105713901057A MAJOR DEPRESSIVE DISORDER STABLE Major depression FxpPsychiatric disorders F'Major depressive disorder FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1804 N DV 4.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDlHrlDWDИHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDlHrlDWDИHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571390105713901057AACNE VULGARIS Acne FpSkin and subcutaneous tissue disorders F5Acne vulgaris FAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2017M-1438 N DV 3.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDlHrlDWDИHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDlHrlDWDИHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571391105713911057ASEASONAL ALLERGIES Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2007M-5091 N DV 13.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDИHrۘDWTD@Hs"@Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDИHrۘDWDLHrDW?DHsgDWTD@Hs"@Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DW?DWT.DW:DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571393105713931057AMAJOR DEPRESSIVE DISORDER STABLE Major depression FxpPsychiatric disorders F'Major depressive disorder FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jun2018D-922 N DV 2.53 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHHrHDWDXHsXPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHHrHDWDHr|DWDڬHs,DWDXHsXPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571394105713941057A ADENOIDITIS Adenoiditis F^Infections and infestations FAdenoiditis F^Upper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2011-01 2011-03 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2011D-3630 31Mar2011D-3541 N DV 9.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDDHrDDWD\HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDDHrDDWDXHr.XDWDݸHsr8DWD\HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571394105713941057A0HYPERMOBILITY SYNDROME Hypermobility syndrome FEMusculoskeletal and connective tissue disorders FkHypermobility syndrome FEJoint related disorders NEC FJoint disorders F-Musculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2020-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jun2020D-191 N DV 0.53 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDDHrDDWD\HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDDHrDDWDXHr.XDWDݸHsr8DWD\HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571394105713941057AADENOIDECTOMY Adenoidectomy FNSurgical and medical procedures F<Adenoidectomy FNTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2011-03 2011-03 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Mar2011D-3571 31Mar2011D-3541 N DV 9.78 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDDHrDDWD\HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDDHrDDWDXHr.XDWDݸHsr8DWD\HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571395105713951057AHAZELNUT ALLERGY Food allergy FزImmune system disorders F4Allergy to nuts Fm/Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2009M-4360 N DV 11.94 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD$Hr$DWDHreBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD$Hr$DWDHre......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1057 10571395105713951057A POLLEN ALLERGIES Seasonal allergy FUImmune system disorders F4Pollen allergy F#3Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2009M-4360 N DV 11.94 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD$Hr$DWDHreBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD$Hr$DWDHre......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1057 10571395105713951057A0SEASONAL ALLERGIES Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2013M-2899 N DV 7.94 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD$Hr$DWDHreBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD$Hr$DWDHre......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1057 10571396105713961057A Seasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-3996 N DV 10.94 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDθHr+8DWD Hr݌BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDθHr+8DWD Hr݌......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1057 10571396105713961057AExercised Induced Asthma Asthma exercise induced FeRespiratory, thoracic and mediastinal disorders F-Exercise induced asthma FӡBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2015M-2170 YChronic pulmonary disease DV 5.94 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDθHr+8DWD Hr݌BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDθHr+8DWD Hr݌......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1057 10571397105713971057ASeasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2009M-4361 N DV 11.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDXHr?DWDۜHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDXHr?DWDۜHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571398105713981057AConstipation Constipation FGastrointestinal disorders FܛConstipation FGastrointestinal atonic and hypomotility disorders NEC F܍Gastrointestinal motility and defaecation conditions FܹGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2007-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2007D-5092 N DV 13.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrA|DWDhHshPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrA|DWDHr{(DWD\HsrjDWDhHshPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571399105713991057AAdenoidectomy Adenoidectomy FNSurgical and medical procedures F<Adenoidectomy FNTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2013 2013 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2013M-2900 31Dec2013M-2536 N DV 7.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD4HrEDWDHHr>HBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD4HrEDWDHHr>H......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1057 10571399105713991057A Adenoiditis Adenoiditis F^Infections and infestations FAdenoiditis F^Upper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2013 2013 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2013M-2900 31Dec2013M-2536 N DV 7.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD4HrEDWDHHr>HBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD4HrEDWDHHr>H......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1057 10571399105713991057A0Bipolar Disorder Bipolar disorder FwPsychiatric disorders F'Bipolar disorder FwBipolar disorders FManic and bipolar mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019-06-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jun2019 -558 N DV 1.53 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD4HrEDWDHHr>HBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD4HrEDWDHHr>H......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1057 10571399105713991057A@Obsessive Compulsive Disorder Obsessive-compulsive disorder F JPsychiatric disorders F'Obsessive-compulsive disorder F JObsessive-compulsive disorders and symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019-06-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jun2019 -558 N DV 1.53 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD4HrEDWDHHr>HBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD4HrEDWDHHr>H......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1057 10571400105714001057AAttention Deficit Hyperactivity Disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2171 N DV 5.95 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVDHrGDWDHs/Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrGDWD{HHr5DWDHsrn`DWDHs/Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1057 10571401105714011057A Surgical Correction of Knock Knee Syndrome Right Leg Knee operation FX Surgical and medical procedures F<Knee operation FX Joint therapeutic procedures F5Bone and joint therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2018-12 2018-12 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Dec2018D-741 31Dec2018D-711 N DV 2.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrZDWDhHr~BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrZDWDhHr~......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571401105714011057AKnock Knee Syndrome Right Leg Knee deformity FMusculoskeletal and connective tissue disorders FkKnock-knee F8Extremity deformities FMusculoskeletal and connective tissue deformities (incl intervertebral disc disorders)FYMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2016 2018-12 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1806 31Dec2018D-711 N DV 4.95 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrZDWDhHr~BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrZDWDhHr~......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571402105714021057AOBESITY Obesity F ;Metabolism and nutrition disorders FObesity F ;General nutritional disorders NEC FAppetite and general nutritional disorders FJMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2013M-2904 N DV 7.95 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrPDW[DLHs+XPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrPDWD Hr DWFDdHsdDW[DLHs+XPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWFDW[.DW6DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571404105714041057A ATOPIC DERMATITIS Dermatitis atopic FSkin and subcutaneous tissue disorders F5Atopic dermatitis FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2008M-4733 N DV 12.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrXDWDHs&Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrXDW DHr'DWDԔHsDWDHs&Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571404105714041057AASTHMA Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2010M-4002 YChronic pulmonary disease DV 10.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrXDWDHs&Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrXDW DHr'DWDԔHsDWDHs&Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571404105714041057APSEASONAL ALLERGIES Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2010M-4002 N DV 10.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrXDWDHs&Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrXDW DHr'DWDԔHsDWDHs&Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571404105714041057A0GENERALIZED ANXIETY DISORDER STABLE Generalised anxiety disorder FPsychiatric disorders F'Generalized anxiety disorder F9Anxiety disorders NEC FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019M-715 N DV 1.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrXDWDHs&Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrXDW DHr'DWDԔHsDWDHs&Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571404105714041057A@MAJOR DEPRESSIVE DISORDER STABLE Major depression FxpPsychiatric disorders F'Major depressive disorder FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-715 N DV 1.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrXDWDHs&Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrXDW DHr'DWDԔHsDWDHs&Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571405105714051057AATTENTION DEFICIT HYPERACTIVITY DISORDER STABLE Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2013-08 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Aug2013D-2694 N DV 7.38 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD4Hr.DW DxHrĄBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD4Hr.DW DxHrĄ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571406105714061057AATTENTION DEFICIT HYPERACTIVITY DISORDER STABLE Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3272 N DV 8.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD`Hr/DWD<Hs<Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD`Hr/DW DHrĆ$DWD,HsrDWD<Hs<Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571408105714081057A0MOLD ALLERGY Mycotic allergy FdImmune system disorders F4Allergy to molds Fm.Allergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2010M-4003 N DV 10.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrdDWDHshPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrdDW DߘHrăDWD@Hs}DWDHshPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571408105714081057A@SEASONAL ALLERGIES Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2010M-4003 N DV 10.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrdDWDHshPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrdDW DߘHrăDWD@Hs}DWDHshPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571408105714081057AADENOIDECTOMY Adenoidectomy FNSurgical and medical procedures F<Adenoidectomy FNTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2012 2012 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2012M-3273 31Dec2012M-2908 N DV 8.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrdDWDHshPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrdDW DߘHrăDWD@Hs}DWDHshPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571408105714081057A ADENOIDITIS Adenoiditis F^Infections and infestations FAdenoiditis F^Upper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2012 2012 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3273 31Dec2012M-2908 N DV 8.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrdDWDHshPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrdDW DߘHrăDWD@Hs}DWDHshPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571411105714111057ASEASONAL ALLERGIES Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1446 N DV 3.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571413105714131057ATONSILLECTOMY Tonsillectomy FBfSurgical and medical procedures F<Tonsillectomy FBfTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2014 2014 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2014M 31Dec2014M N DV 6.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYNBNT162b2 Phase 2/3 (30 mcg)B2_P23_30Not Treated NOTTRT ...... . .BNT162b2 Phase 2/3 (30 mcg)A ............. .......DV . . .NPhase 3A@12-15 YearsAN NAYEARSC4591001C4591001 1057 10571413105714131057A TONSILLITIS Tonsillitis FBhInfections and infestations FTonsillitis FBhUpper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2014 2014 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2014M 31Dec2014M N DV 6.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYNBNT162b2 Phase 2/3 (30 mcg)B2_P23_30Not Treated NOTTRT ...... . .BNT162b2 Phase 2/3 (30 mcg)A ............. .......DV . . .NPhase 3A@12-15 YearsAN NAYEARSC4591001C4591001 1057 10571414105714141057ALATEX ALLERGY Rubber sensitivity F/Immune system disorders F4Latex allergy FrAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1085 N DV 2.97 YEARSAYEARS12-15 YearsAFA MULTIPLE A`MULTIRACIAL A`YYPlacebo PLACEBO Placebo PLACEBO DVDנHrDWDPHrͺPPlacebo A .Placebo A .DVDנHrDWDPHrͺP......Placebo Placebo DVDW.....DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571415105714151057AATTENTION DEFICIT HYPERACTIVITY DISORDER STABLE Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2009M-4372 N DV 11.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWD Hs1 Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDPHr]PDWDXHsXDWD Hs1 Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571417105714171057A ATTENTION DEFICIT HYPERACTIVITY DISORDER STABLE Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2014M-2546 N DV 6.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWD@HsaPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWD|HriDWDlHsrxDWD@HsaPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571417105714171057AACNE VULARIS Acne FpSkin and subcutaneous tissue disorders F5Acne vulgaris FAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019M-720 N DV 1.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWD@HsaPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWD|HriDWDlHsrxDWD@HsaPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571418105714181057A0OBESITY Obesity F ;Metabolism and nutrition disorders FObesity F ;General nutritional disorders NEC FAppetite and general nutritional disorders FJMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2015-04 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Apr2015D-2092 N DV 5.73 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDDHrDWDHrWxBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDDHrDWDHrWx......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571418105714181057A MENORRHAGIA Heavy menstrual bleeding F/Reproductive system and breast disorders F-LMenorrhagia F1Menstruation with increased bleeding FNMenstrual cycle and uterine bleeding disorders FʎReproductive system and breast disorders F-LGENERAL MEDICAL HISTORY2019-12 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Dec2019D-387 N DV 1.06 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDDHrDWDHrWxBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDDHrDWDHrWx......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571418105714181057AATTENTION DEFICIT HYPERACTIVITY DISORDER STABLE Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018-03-27 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 27Mar2018 -1001 N DV 2.74 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDDHrDWDHrWxBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDDHrDWDHrWx......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571419105714191057A@CLINDAMYCIN ALLERGY Drug hypersensitivity FImmune system disorders F4Allergic reaction to antibiotics F8Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2011-04 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Apr2011D-3553 N DV 9.73 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD$Hr DWDHr3BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD$Hr DWDHr3......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571419105714191057AADENOIDECTOMY Adenoidectomy FNSurgical and medical procedures F<Adenoidectomy FNTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2010-01 2010-01 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2010D-4008 31Jan2010D-3978 N DV 10.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD$Hr DWDHr3BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD$Hr DWDHr3......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571419105714191057A ADENOIDITIS Adenoiditis F^Infections and infestations FAdenoiditis F^Upper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2010-01 2010-01 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2010D-4008 31Jan2010D-3978 N DV 10.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD$Hr DWDHr3BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD$Hr DWDHr3......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571419105714191057A0AUTISM SPECTRUM DISORDER STABLE Autism spectrum disorder FPsychiatric disorders F'Autism spectrum disorder FPervasive developmental disorders NEC F4Developmental disorders NEC FǒPsychiatric disorders F'GENERAL MEDICAL HISTORY2010-03 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Mar2010D-3949 N DV 10.81 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD$Hr DWDHr3BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD$Hr DWDHr3......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571420105714201057AATTENTION DEFICIT HYPERACTIVITY DISORDER Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2013 2014 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2013M-2913 31Dec2014M-2184 N DW 7.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDHr24Placebo A .Placebo A .DWDHrDWDHr24......Placebo Placebo DWDW.....DW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571421105714211057AATTENTION DEFICIT HYPERACTIVITY DISORDER Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017-04 2019-03 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Apr2017D-1362 31Mar2019D-633 N DW 3.73 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DWDPHrMPDWD|HriPlacebo A .Placebo A .DWDPHrMPDWD|Hri......Placebo Placebo DWDW.....DW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571421105714211057A@SEASONAL ALLERGIES Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2007M-5105 N DW 13.98 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DWDPHrMPDWD|HriPlacebo A .Placebo A .DWDPHrMPDWD|Hri......Placebo Placebo DWDW.....DW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571421105714211057A ECZEMA Eczema FSkin and subcutaneous tissue disorders F5Eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4009 N DW 10.98 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DWDPHrMPDWD|HriPlacebo A .Placebo A .DWDPHrMPDWD|Hri......Placebo Placebo DWDW.....DW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571421105714211057A0OBESITY Obesity F ;Metabolism and nutrition disorders FObesity F ;General nutritional disorders NEC FAppetite and general nutritional disorders FJMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2014M-2548 N DW 6.98 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DWDPHrMPDWD|HriPlacebo A .Placebo A .DWDPHrMPDWD|Hri......Placebo Placebo DWDW.....DW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571422105714221057AASTHMA Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2010M-4009 YChronic pulmonary disease DW 10.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDިHr^DWD HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDިHr^DWD Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571422105714221057A OBESITY Obesity F ;Metabolism and nutrition disorders FObesity F ;General nutritional disorders NEC FAppetite and general nutritional disorders FJMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4009 N DW 10.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDިHr^DWD HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDިHr^DWD Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571423105714231057A0ASTHMA Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 (b)(6) (b)(6) YChronic pulmonary disease DW (b)(6)YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr[DWDDHr`BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr[DWDDHr`......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571423105714231057A@SEASONAL ALLERGIES Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr[DWDDHr`BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr[DWDDHr`......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571423105714231057AADENOIDECTOMY Adenoidectomy FNSurgical and medical procedures F<Adenoidectomy FNTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2011 2011 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2011M-3645 31Dec2011M-3281 N DW 9.98 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr[DWDDHr`BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr[DWDDHr`......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571423105714231057A ADENOIDITIS Adenoiditis F^Infections and infestations FAdenoiditis F^Upper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2011 2011 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2011M-3645 31Dec2011M-3281 N DW 9.98 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr[DWDDHr`BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr[DWDDHr`......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571423105714231057APTONSILLECTOMY Tonsillectomy FBfSurgical and medical procedures F<Tonsillectomy FBfTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2011 2011 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2011M-3645 31Dec2011M-3281 N DW 9.98 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr[DWDDHr`BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr[DWDDHr`......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571423105714231057A`TONSILLITIS Tonsillitis FBhInfections and infestations FTonsillitis FBhUpper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2011 2011 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2011M-3645 31Dec2011M-3281 N DW 9.98 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr[DWDDHr`BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr[DWDDHr`......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571424105714241057AASTHMA Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 (b)(6) (b)(6) YChronic pulmonary disease DW (b)(6)YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DWDhHrYDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDhHrYDWDpHraDWDHsrTDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571424105714241057A0SEASONAL ALLERGIES Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DWDhHrYDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDhHrYDWDpHraDWDHsrTDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571424105714241057A OBESITY Obesity F ;Metabolism and nutrition disorders FObesity F ;General nutritional disorders NEC FAppetite and general nutritional disorders FJMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2184 N DW 5.98 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DWDhHrYDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDhHrYDWDpHraDWDHsrTDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571425105714251057APREMENARCHAL Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrnDWDHrͣPlacebo A .Placebo A .DWDHrnDWDHrͣ......Placebo Placebo DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571426105714261057APREMENARCHAL Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY2008-11-07 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 07Nov2008 -4430 N DW 12.13 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrphDWDHr٢ BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrphDWDHr٢ ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571427105714271057APREMENARCHAL Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDPHrqDWDHr٠|BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDPHrqDWDHr٠|......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571428105714281057AHEREDITARY SPHEROUTOSIS Hereditary spherocytosis F@Congenital, familial and genetic disorders FHereditary spherocytosis F@Haematological disorders congenital NEC F Blood and lymphatic system disorders congenital FRCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4010 N DW 10.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHruDWDHr٢ Placebo A .Placebo A .DWDHruDWDHr٢ ......Placebo Placebo DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571431105714311057ATONSILLECTOMY Tonsillectomy FBfSurgical and medical procedures F<Tonsillectomy FBfTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2014 2014 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2014M-2555 31Dec2014M-2191 N DW 7 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDʼHr<DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDʼHr<DWDôHrՊDWDHsDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571431105714311057A TONSILLITIS Tonsillitis FBhInfections and infestations FTonsillitis FBhUpper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2014 2014 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2014M-2555 31Dec2014M-2191 N DW 7 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDʼHr<DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDʼHr<DWDôHrՊDWDHsDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571432105714321057A PREMENARCHAL Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWD0HsN0Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDWDxHrըxDWDHsm7DWD0HsN0Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571432105714321057AOPTIC NERVE ATROPHY Optic atrophy F>Eye disorders FԯAtrophy optic nerve FOptic disc abnormalities NEC FAOcular structural change, deposit and degeneration NEC F;Eye disorders FԯGENERAL MEDICAL HISTORY2019-11 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Nov2019D-425 N DW 1.17 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWD0HsN0Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDWDxHrըxDWDHsm7DWD0HsN0Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571433105714331057AATTENTION DEFICIT HYPERACTIVITY DISORDER STABLE Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2014-10-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Oct2014 -2282 N DW 6.25 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDWD{ Hrڈ BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDWD{ Hrڈ ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571433105714331057A SCOLIOSIS Scoliosis F1Musculoskeletal and connective tissue disorders FkScoliosis F1Spine and neck deformities FMusculoskeletal and connective tissue deformities (incl intervertebral disc disorders)FYMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2015-10-15 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 15Oct2015 -1903 N DW 5.21 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDWD{ Hrڈ BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDWD{ Hrڈ ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571433105714331057A0SCOLIOSIS CORRECTION SURGERY Scoliosis surgery F1Surgical and medical procedures F<Scoliosis surgery F1Spine and spinal cord therapeutic procedures F8Nervous system, skull and spine therapeutic procedures FxSurgical and medical procedures F<GENERAL MEDICAL HISTORY2020-10-152020-10-15BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 15Oct2020 -76 15Oct2020 -76 N DW 0.21 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDWD{ Hrڈ BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDWD{ Hrڈ ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571434105714341057AOBESITY Obesity F ;Metabolism and nutrition disorders FObesity F ;General nutritional disorders NEC FAppetite and general nutritional disorders FJMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4017 N DW 11 YEARSAYEARS12-15 YearsAMAMULTIPLE A`MULTIRACIAL A`YYPlacebo PLACEBO Placebo PLACEBO DWD4Hr4DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD4Hr4DWD`HrٖDWDHsDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571435105714351057A0OBESITY Obesity F ;Metabolism and nutrition disorders FObesity F ;General nutritional disorders NEC FAppetite and general nutritional disorders FJMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2010M-4021 N DW 11.01 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHrDW!DHrމpBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHrDW!DHrމp......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571435105714351057AASTHMA Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2195 YChronic pulmonary disease DW 6.01 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHrDW!DHrމpBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHrDW!DHrމp......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571435105714351057A ATTENTION DEFICIT HYPERACTIVITY DISORDER STABLE Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2015M-2195 N DW 6.01 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHrDW!DHrމpBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHrDW!DHrމp......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571436105714361057AASTHMA Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2007M-5117 YChronic pulmonary disease DW 14.01 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DW DHrDWDlHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DHrDW!DHrދPDWD@Hs>DWDlHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571437105714371057AADENOIDECTOMY Adenoidectomy FNSurgical and medical procedures F<Adenoidectomy FNTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2008 2008 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2008M-4752 31Dec2008M-4387 N DW 13.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DHr6DWDHHsRHPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DHr6DW!D|HrDWDӤHs$DWDHHsRHPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571437105714371057A ADENOIDITIS Adenoiditis F^Infections and infestations FAdenoiditis F^Upper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2008 2008 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2008M-4752 31Dec2008M-4387 N DW 13.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DHr6DWDHHsRHPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DHr6DW!D|HrDWDӤHs$DWDHHsRHPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571437105714371057A`TONSILLECTOMY Tonsillectomy FBfSurgical and medical procedures F<Tonsillectomy FBfTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2008 2008 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2008M-4752 31Dec2008M-4387 N DW 13.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DHr6DWDHHsRHPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DHr6DW!D|HrDWDӤHs$DWDHHsRHPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571437105714371057ApTONSILLITIS Tonsillitis FBhInfections and infestations FTonsillitis FBhUpper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2008 2008 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.07 01Jan2008M-4752 31Dec2008M-4387 N DW 13.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DHr6DWDHHsRHPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DHr6DW!D|HrDWDӤHs$DWDHHsRHPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571437105714371057A@AUTISM STABLE Autism spectrum disorder FPsychiatric disorders F'Autism F]Pervasive developmental disorders NEC F4Developmental disorders NEC FǒPsychiatric disorders F'GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2011M-3656 N DW 10.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DHr6DWDHHsRHPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DHr6DW!D|HrDWDӤHs$DWDHHsRHPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571437105714371057A0ATTENTION DEFICIT HYPERACTIVITY DISORDER STABLE Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2014M-2560 N DW 7.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DHr6DWDHHsRHPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DHr6DW!D|HrDWDӤHs$DWDHHsRHPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571437105714371057APGENERALIZED ANXIETY DISORDER STABLE Generalised anxiety disorder FPsychiatric disorders F'Generalized anxiety disorder F9Anxiety disorders NEC FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2018M-1099 N DW 3.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DHr6DWDHHsRHPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DHr6DW!D|HrDWDӤHs$DWDHHsRHPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571438105714381057ASEASONAL ALLERGIES Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1099 N DW 3.01 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHr9DW!D܌Hr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHr9DW!D܌Hr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571439105714391057AMETRORRHAGIA Intermenstrual bleeding FReproductive system and breast disorders F-LMetrorrhagia FMenstruation and uterine bleeding NEC FGMenstrual cycle and uterine bleeding disorders FʎReproductive system and breast disorders F-LGENERAL MEDICAL HISTORY2020 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2020M-371 N DW 1.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDdHrŽdDWDϨHs(Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDdHrŽdDW!DHr`DWDxHsuDWDϨHs(Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW!.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571440105714401057APENICILLIN ALLERGY Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4754 N DW 13.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDhHrhDW#D̜HrqBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDhHrhDW#D̜Hrq......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571441105714411057AGENERALIZED ANXIETY DISORDER STABLE Generalised anxiety disorder FPsychiatric disorders F'Generalized anxiety disorder F9Anxiety disorders NEC FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-03 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Mar2020D-311 N DW 0.85 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDW#DHr~xDWDhHsu.DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571442105714421057AATTENTION DEFICIT HYPERACTIVITY DISORDER STABLE Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2013M-2928 N DW 8.02 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDHs:Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDW%DHrDWDHsDWDHs:Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571442105714421057A UMBILICAL HERNIA Umbilical hernia FHGastrointestinal disorders FܛUmbilical hernia FHUmbilical hernias FHAbdominal hernias and other abdominal wall conditions FGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2014 2014 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2014M-2563 31Dec2014M-2199 N DW 7.02 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDHs:Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDW%DHrDWDHsDWDHs:Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571442105714421057A0UMBILICAL HERNIA REPAIR Umbilical hernia repair FHSurgical and medical procedures F<Umbilical hernia repair FHHernia repairs F[Gastrointestinal therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2014 2014 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2014M-2563 31Dec2014M-2199 N DW 7.02 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDHs:Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDW%DHrDWDHsDWDHs:Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571443105714431057ASEASONAL ALLERGIES Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018D-1103 N DW 3.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr7DW$DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr7DW$DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571446105714461057ASEASONAL ALLERGIES Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2015M-2202 N DW 6.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrVDW(DLHrLPlacebo A .Placebo A .DWDHrVDW(DLHrL......Placebo Placebo DWDW(.....DW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571446105714461057A TYPE I DIABETES MELLITUS Type 1 diabetes mellitus FMetabolism and nutrition disorders FType I diabetes mellitus FG,Diabetes mellitus (incl subtypes) FǺGlucose metabolism disorders (incl diabetes mellitus) FxMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2202 YDiabetes without chronic complication DW 6.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrVDW(DLHrLPlacebo A .Placebo A .DWDHrVDW(DLHrL......Placebo Placebo DWDW(.....DW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571447105714471057ASEASONAL ALLERGIES Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2202 N DW 6.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHruxDWD}Hs֠Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHruxDW(DlHrlDWDިHss٨DWD}Hs֠Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571448105714481057A0BILATERAL EYE SURGERY Eye operation FSurgical and medical procedures F<Eye operation FEye therapeutic procedures NEC FEye therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2008 2008 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2008M-4759 31Dec2008M-4394 N DW 13.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrwDW(DިHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrwDW(DިHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571448105714481057ApESOTROPIA Strabismus F;/Eye disorders FԯEsotropia FOcular nerve and muscle disorders F Ocular neuromuscular disorders F Eye disorders FԯGENERAL MEDICAL HISTORY2008 2018 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2008M-4759 31Dec2018M-742 N DW 13.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrwDW(DިHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrwDW(DިHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571448105714481057A@BILATERAL EYE SURGERY Eye operation FSurgical and medical procedures F<Eye operation FEye therapeutic procedures NEC FEye therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2010 2010 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.07 01Jan2010M-4028 31Dec2010M-3664 N DW 11.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrwDW(DިHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrwDW(DިHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571448105714481057AGENERALIZED ANXIETY DISORDER STABLE Generalised anxiety disorder FPsychiatric disorders F'Generalized anxiety disorder F9Anxiety disorders NEC FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01001Jan2015M-2202 N DW 6.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrwDW(DިHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrwDW(DިHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571448105714481057APBILATERAL EYE SURGERY Eye operation FSurgical and medical procedures F<Eye operation FEye therapeutic procedures NEC FEye therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2015 2015 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.08 01Jan2015M-2202 31Dec2015M-1838 N DW 6.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrwDW(DިHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrwDW(DިHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571448105714481057AADENOIDECTOMY Adenoidectomy FNSurgical and medical procedures F<Adenoidectomy FNTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2016 2016 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2016M-1837 31Dec2016M-1472 N DW 5.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrwDW(DިHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrwDW(DިHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571448105714481057A ADENOIDITIS Adenoiditis F^Infections and infestations FAdenoiditis F^Upper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2016 2016 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2016M-1837 31Dec2016M-1472 N DW 5.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrwDW(DިHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrwDW(DިHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571448105714481057ATONSILLECTOMY Tonsillectomy FBfSurgical and medical procedures F<Tonsillectomy FBfTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2016 2016 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2016M-1837 31Dec2016M-1472 N DW 5.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrwDW(DިHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrwDW(DިHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571448105714481057ATONSILLITIS Tonsillitis FBhInfections and infestations FTonsillitis FBhUpper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2016 2016 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1837 31Dec2016M-1472 N DW 5.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrwDW(DިHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrwDW(DިHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571448105714481057A`BILATERAL EYE SURGERY Eye operation FSurgical and medical procedures F<Eye operation FEye therapeutic procedures NEC FEye therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2018 2018 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.09 01Jan2018M-1106 31Dec2018M-742 N DW 3.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrwDW(DިHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrwDW(DިHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1057 10571449105714491057AATTENTION DEFICIT HYPERACTIVITY DISORDER Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019-10 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Oct2019D-469 N DW 1.29 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr{DWD0HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr{DW)D@Hr[DWDߘHsv}DWD0HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW).DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571450105714501057A FRACTURE OF THE RIGHT FOOT Foot fracture FInjury, poisoning and procedural complications FFoot fracture FLimb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2007 2007 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2007M-5125 31Dec2007M-4761 N DW 14.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD`Hr}`DW)DĤHrR$Placebo A .Placebo A .DWD`Hr}`DW)DĤHrR$......Placebo Placebo DWDW)....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571450105714501057AASTHMA Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1107 YChronic pulmonary disease DW 3.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD`Hr}`DW)DĤHrR$Placebo A .Placebo A .DWD`Hr}`DW)DĤHrR$......Placebo Placebo DWDW)....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1057 10571451105714511057ARECURRENT VAGINAL YEAST INFECTIONS Vulvovaginal mycotic infection FInfections and infestations FVaginal yeast infection FMFungal infections NEC FFungal infectious disorders FInfections and infestations FGENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3299 N DW 9.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD4Hrͩ4DW)DƄHrTBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD4Hrͩ4DW)DƄHrT......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW)....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1066 10661394106613941066A throat abscess Pharyngeal abscess FEInfections and infestations FPharyngeal abscess FEUpper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2008 2008 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2008M-4726 31Dec2008M-4361 N DV 12.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD4Hr4DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD4Hr4DWDHr]dDWDv\Hssq\DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1066 10661394106613941066A0throat abscess removal Abscess drainage FSurgical and medical procedures F<Abscess drainage FTherapeutic procedures NEC FTherapeutic procedures and supportive care NEC F@Surgical and medical procedures F<GENERAL MEDICAL HISTORY2008 2008 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2008M-4726 31Dec2008M-4361 N DV 12.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD4Hr4DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD4Hr4DWDHr]dDWDv\Hssq\DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1066 10661394106613941066Aseasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-3995 N DV 10.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD4Hr4DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD4Hr4DWDHr]dDWDv\Hssq\DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1066 10661395106613951066AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019M-700 N DV 1.92 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrLDVD Hr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrLDVD Hr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1066 10661395106613951066A Autism Autism spectrum disorder FPsychiatric disorders F'Autism F]Pervasive developmental disorders NEC F4Developmental disorders NEC FǒPsychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-700 N DV 1.92 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrLDVD Hr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrLDVD Hr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1066 10661395106613951066A0intellectual delay disorder Mental impairment FnNervous system disorders FMental impairment FnMental impairment (excl dementia and memory loss) FoMental impairment disorders FuNervous system disorders FGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2019M-700 N DV 1.92 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrLDVD Hr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrLDVD Hr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1066 10661397106613971066A anxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018-12 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Dec2018D-731 N DV 2 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDdHrtdDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDdHrtdDVD<HrDWD{HstDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1066 10661397106613971066A@insomnia Insomnia F%Psychiatric disorders F'Insomnia F%Disturbances in initiating and maintaining sleep FFSleep disorders and disturbances F6Psychiatric disorders F'GENERAL MEDICAL HISTORY2018-12 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Dec2018D-731 N DV 2 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDdHrtdDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDdHrtdDVD<HrDWD{HstDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1066 10661397106613971066Aacne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019-12 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Dec2019D-366 N DV 1 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDdHrtdDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDdHrtdDVD<HrDWD{HstDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1066 10661397106613971066A0headaches Headache FNervous system disorders FHeadache FHeadaches NEC FHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2018-11 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Nov2018D-761 N DV 2.09 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDdHrtdDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDdHrtdDVD<HrDWD{HstDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1066 10661401106614011066Aattention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1431 N DV 3.92 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrpDWDxxHsxPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrpDVDθHrDWD|Hsu)DWDxxHsxPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1066 10661401106614011066A environmental allergies Hypersensitivity FImmune system disorders F4Environmental allergy FTAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1431 N DV 3.92 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrpDWDxxHsxPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrpDVDθHrDWD|Hsu)DWDxxHsxPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1066 10661402106614021066A eating disorder-stable Eating disorder FnPsychiatric disorders F'Eating disorder FnEating disorders NEC FtEating disorders and disturbances FsPsychiatric disorders F'GENERAL MEDICAL HISTORY2019-02 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Feb2019D-670 N DV 1.84 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDިHr(DVDިHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDިHr(DVDިHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1066 10661402106614021066Aanxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1066 N DV 2.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDިHr(DVDިHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDިHr(DVDިHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1066 10661404106614041066A@premenarchal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDxHrxBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDxHrx......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1066 10661404106614041066AEczema Eczema FSkin and subcutaneous tissue disorders F5Eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-3989 N DV 10.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDxHrxBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDxHrx......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1066 10661404106614041066A adnoidectomy Adenoidectomy FNSurgical and medical procedures F<Adenoidectomy FNTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2010 2010 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2010M-3989 31Dec2010M-3625 N DV 10.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDxHrxBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDxHrx......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1066 10661404106614041066APrecurrent tonsillitis Tonsillitis FBhInfections and infestations FTonsillitis recurrent FBlUpper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2010 2010 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2010M-3989 31Dec2010M-3625 N DV 10.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDxHrxBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDxHrx......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1066 10661404106614041066A`tonsillectomy Tonsillectomy FBfSurgical and medical procedures F<Tonsillectomy FBfTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2010 2010 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2010M-3989 31Dec2010M-3625 N DV 10.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDxHrxBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDxHrx......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1066 10661404106614041066A0enlarged turbinates Nasal turbinate hypertrophy FRespiratory, thoracic and mediastinal disorders F-Nasal turbinate hypertrophy FNasal disorders NEC FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2012 2012 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2012M-3259 31Dec2012M-2894 N DV 8.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDxHrxBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDxHrx......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1066 10661404106614041066Apturbinoplasty Turbinoplasty F2Surgical and medical procedures F<Turbinoplasty F2Nasal therapeutic procedures FHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2012 2012 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.07 01Jan2012M-3259 31Dec2012M-2894 N DV 8.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDxHrxBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDxHrx......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1066 10661405106614051066AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2013M-2893 N DV 7.92 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD8Hr8DWD͌Hs&Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD8Hr8DVDHrDWD(Hss(DWD͌Hs&Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1066 10661405106614051066A0Sleep Disorder Sleep disorder F6Psychiatric disorders F'Sleep disorder F6Sleep disorders NEC F6Sleep disorders and disturbances F6Psychiatric disorders F'GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2013M-2893 N DV 7.92 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD8Hr8DWD͌Hs&Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD8Hr8DVDHrDWD(Hss(DWD͌Hs&Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1066 10661405106614051066A Depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1067 N DV 2.92 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD8Hr8DWD͌Hs&Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD8Hr8DVDHrDWD(Hss(DWD͌Hs&Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1066 10661407106614071066Acold sores Oral herpes FInfections and infestations FCold sores F Herpes viral infections FViral infectious disorders FOInfections and infestations FGENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1433 N DV 3.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDXHr DVDHrhBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDXHr DVDHrh......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1066 10661408106614081066A Keflex allergy Drug hypersensitivity FImmune system disorders F4Allergic reaction to antibiotics F8Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2005 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2005M-5820 N DV 15.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr<DWDˆHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr<DWDˆHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DW2DV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1066 10661408106614081066AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1803 N DV 4.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr<DWDˆHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr<DWDˆHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DW2DV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1066 10661408106614081066A0Left big toe ingrown nail Ingrowing nail F}Skin and subcutaneous tissue disorders F5Ingrown toe nail FNail and nail bed conditions (excl infections and infestations) FSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019 2019 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2019M-707 31Dec2019M-343 N DV 1.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr<DWDˆHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr<DWDˆHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DW2DV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1066 10661408106614081066A@left big toe nail removal Nail operation FSurgical and medical procedures F<Toe nail removal FBNail therapeutic procedures FSkin and subcutaneous tissue therapeutic procedures F5Surgical and medical procedures F<GENERAL MEDICAL HISTORY2019 2019 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2019M-707 31Dec2019M-343 N DV 1.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr<DWDˆHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr<DWDˆHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DW2DV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1066 10661408106614081066APright big toe ingrown toenail Ingrowing nail F}Skin and subcutaneous tissue disorders F5Ingrown toe nail FNail and nail bed conditions (excl infections and infestations) FSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019 2019 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019M-707 31Dec2019M-343 N DV 1.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr<DWDˆHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr<DWDˆHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DW2DV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1066 10661408106614081066A`right toe nail removal Nail operation FSurgical and medical procedures F<Toe nail removal FBNail therapeutic procedures FSkin and subcutaneous tissue therapeutic procedures F5Surgical and medical procedures F<GENERAL MEDICAL HISTORY2019 2019 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2019M-707 31Dec2019M-343 N DV 1.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr<DWDˆHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr<DWDˆHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DW2DV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1066 10661409106614091066ASeasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2013M-2898 N DV 7.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD4HrDWDHrDBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD4HrDWDHrD......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1066 10661410106614101066ATonsillectomy Tonsillectomy FBfSurgical and medical procedures F<Tonsillectomy FBfTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2014 2014 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2014M-2534 31Dec2014M-2170 N DV 6.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDˆHr͈DWDHsX,Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDˆHr͈DWDHrCDWDHssDWDHsX,Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1066 10661410106614101066A reoccurring strep throat Pharyngitis streptococcal FInfections and infestations FStreptococcal sore throat F;JStreptococcal infections F;DBacterial infectious disorders F2Infections and infestations FGENERAL MEDICAL HISTORY2014 2014 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2014M-2534 31Dec2014M-2170 N DV 6.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDˆHr͈DWDHsX,Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDˆHr͈DWDHrCDWDHssDWDHsX,Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1066 10661411106614111066AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1438 N DV 3.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDlHr)lBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDlHr)l......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DW2DV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1066 10661412106614121066AHeadaches Headache FNervous system disorders FHeadache FHeadaches NEC FHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2014M-2534 N DV 6.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDtHstPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWD0Hr)0DWDn(Hssi(DWDtHstPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1066 10661412106614121066A Migraines Migraine FONervous system disorders FMigraine FOMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2014M-2534 N DV 6.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDtHstPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWD0Hr)0DWDn(Hssi(DWDtHstPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1066 10661412106614121066APstable exercise induced asthma Asthma exercise induced FeRespiratory, thoracic and mediastinal disorders F-Exercise induced asthma FӡBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2014M-2534 YChronic pulmonary disease DV 6.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDtHstPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWD0Hr)0DWDn(Hssi(DWDtHstPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1066 10661412106614121066A0Recurring strep throat Pharyngitis streptococcal FInfections and infestations FStreptococcal sore throat F;JStreptococcal infections F;DBacterial infectious disorders F2Infections and infestations FGENERAL MEDICAL HISTORY2014 2014 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2014M-2534 31Dec2014M-2170 N DV 6.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDtHstPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWD0Hr)0DWDn(Hssi(DWDtHstPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1066 10661412106614121066A@Tonsillectomy Tonsillectomy FBfSurgical and medical procedures F<Tonsillectomy FBfTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2014 2014 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2014M-2534 31Dec2014M-2170 N DV 6.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDtHstPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWD0Hr)0DWDn(Hssi(DWDtHstPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1066 10661414106614141066A autism disorder Autism spectrum disorder FPsychiatric disorders F'Autism F]Pervasive developmental disorders NEC F4Developmental disorders NEC FǒPsychiatric disorders F'GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2007M-5096 N DV 13.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDިHr(DW DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDިHr(DW DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1066 10661414106614141066Aacne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-713 N DV 1.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDިHr(DW DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDިHr(DW DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1066 10661415106614151066APpremature birth at 28 weeks Premature baby F%nPregnancy, puerperium and perinatal conditions F%iPremature birth F%rGestational age and weight conditions FݠNeonatal and perinatal conditions FxPregnancy, puerperium and perinatal conditions F%iGENERAL MEDICAL HISTORY(b)(6) (b)(6) BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 (b)(6) (b)(6)(b)(6) (b)(6)N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrHDWDHsΈPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrHDW DtHrtDWDPHsPDWDHsΈPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1066 10661415106614151066A headaches Headache FNervous system disorders FHeadache FHeadaches NEC FHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1443 N DV 3.95 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrHDWDHsΈPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrHDW DtHrtDWDPHsPDWDHsΈPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1066 10661415106614151066A0obesity Obesity F ;Metabolism and nutrition disorders FObesity F ;General nutritional disorders NEC FAppetite and general nutritional disorders FJMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2017M-1443 N DV 3.95 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrHDWDHsΈPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrHDW DtHrtDWDPHsPDWDHsΈPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1066 10661415106614151066A@polycystic ovarian syndrome Polycystic ovaries F#QReproductive system and breast disorders F-LPolycystic ovarian syndrome F Ovarian and fallopian tube cysts and neoplasms FOvarian and fallopian tube disorders FReproductive system and breast disorders F-LGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2019M-713 N DV 1.95 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrHDWDHsΈPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrHDW DtHrtDWDPHsPDWDHsΈPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1066 10661415106614151066Adepression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017-10 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Oct2017D-1170 N DV 3.21 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrHDWDHsΈPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrHDW DtHrtDWDPHsPDWDHsΈPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1066 10661416106614161066A broken right tibia Tibia fracture FAInjury, poisoning and procedural complications FTibia fracture FALimb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2010 2010 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4001 31Dec2010M-3637 N DV 10.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHs8Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDW DHr}xDWDDHs}DWDHs8Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1066 10661416106614161066Aallergic rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2017 2019 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1444 31Dec2019M-350 N DV 3.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHs8Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDW DHr}xDWDDHs}DWDHs8Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1066 10661417106614171066Aenvironmental allergies Hypersensitivity FImmune system disorders F4Environmental allergy FTAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4002 N DV 10.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDDWDנHr̠BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDDWDנHr̠......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1066 10661418106614181066AAcne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1080 N DV 2.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrlDWD\Hs \Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrlDW DנHr{ DWDɐHsvgDWD\Hs \Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1066 10661419106614191066Aconcussion Concussion FInjury, poisoning and procedural complications FConcussion FCerebral injuries NEC FdInjuries NEC FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2019-08 2019-09 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Aug2019D-503 30Sep2019D-443 N DV 1.38 YEARSAYEARS12-15 YearsAFA MULTIPLE A`MULTIRACIAL A`YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr&DWDˆHrŷBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr&DWDˆHrŷ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1066 10661419106614191066A seasonal allergic rhinitis Seasonal allergy FUImmune system disorders F4Seasonal allergic rhinitis F1Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1080 N DV 2.96 YEARSAYEARS12-15 YearsAFA MULTIPLE A`MULTIRACIAL A`YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr&DWDˆHrŷBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr&DWDˆHrŷ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1066 10661419106614191066A0vocal chord dysfunction Vocal cord disorder F Respiratory, thoracic and mediastinal disorders F-Vocal cord disorder NOS FPLaryngeal and adjacent sites disorders NEC (excl infections and neoplasms) FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1080 N DV 2.96 YEARSAYEARS12-15 YearsAFA MULTIPLE A`MULTIRACIAL A`YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr&DWDˆHrŷBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr&DWDˆHrŷ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1066 10661420106614201066A0Penicillin allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2006M-5464 N DV 14.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDـHrpDW DHrĄBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDـHrpDW DHrĄ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWKDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1066 10661420106614201066AAppendectomy Appendicectomy FBSurgical and medical procedures F<Appendectomy F@Large intestine therapeutic procedures F{Gastrointestinal therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2020-03 2020-03 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Mar2020D-291 31Mar2020D-261 N DV 0.8 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDـHrpDW DHrĄBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDـHrpDW DHrĄ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWKDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1066 10661420106614201066A Appendicitis Appendicitis FCInfections and infestations FAppendicitis FCAbdominal and gastrointestinal infections FܯInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2020-03 2020-03 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Mar2020D-291 31Mar2020D-261 N DV 0.8 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDـHrpDW DHrĄBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDـHrpDW DHrĄ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWKDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1066 10661421106614211066A@reactive attachment disorder Reactive attachment disorder of infancy or early childhood F*Psychiatric disorders F'Reactive attachment disorder of infancy or early childhood F*Infancy, childhood and adolescence psychiatric disorders NEC F'Psychiatric disorders NEC F'Psychiatric disorders F'GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2008M-4739 N DV 12.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrTDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrTDWDHrνDWDHst@DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1066 10661421106614211066A0enuresis disorder Enuresis FPsychiatric disorders F'Enuresis FPsychiatric elimination disorders F'Psychiatric disorders NEC F'Psychiatric disorders F'GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2010M-4008 N DV 10.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrTDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrTDWDHrνDWDHst@DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1066 10661421106614211066Aanxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2013M-2912 N DV 7.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrTDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrTDWDHrνDWDHst@DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1066 10661421106614211066A attention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2013M-2912 N DV 7.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrTDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrTDWDHrνDWDHst@DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1066 10661422106614221066A autism Autism spectrum disorder FPsychiatric disorders F'Autism F]Pervasive developmental disorders NEC F4Developmental disorders NEC FǒPsychiatric disorders F'GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2011M-3643 N DV 9.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDLHrDWDTHrμBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDLHrDWDTHrμ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1066 10661422106614221066Aattention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2014M-2547 N DV 6.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDLHrDWDTHrμBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDLHrDWDTHrμ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1066 10661423106614231066Aseasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1825 N DW 5 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDu0Hr/DWDHsBPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDu0Hr/DW"D{HHrHDWDHsu!PDWDHsBPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW".DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1066 10661424106614241066A chronic tonsilitis Chronic tonsillitis F@Infections and infestations FChronic tonsillitis F@Upper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY(b)(6) 2006-07 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 (b)(6) D(b)(6)31Jul2006D-5266 N DW (b)(6)YEARSAYEARS12-15 YearsAMANATIVE HAWAIIAN OR OTHER PACIFIC ISLANDERAPNATIVE HAWAIIAN OR OTHER PACIFIC ISLANDERAPYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrKXDWD Hr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrKXDWD Hr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1066 10661424106614241066Aamoxicillin allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.07 01Jan2008M-4747 N DW 13 YEARSAYEARS12-15 YearsAMANATIVE HAWAIIAN OR OTHER PACIFIC ISLANDERAPNATIVE HAWAIIAN OR OTHER PACIFIC ISLANDERAPYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrKXDWD Hr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrKXDWD Hr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1066 10661424106614241066A@endoscopy Endoscopy FUInvestigations FEndoscopy FUImaging procedures NEC FInvestigations, imaging and histopathology procedures NEC FInvestigations FGENERAL MEDICAL HISTORY2008 2008 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2008M-4747 31Dec2008M-4382 N DW 13 YEARSAYEARS12-15 YearsAMANATIVE HAWAIIAN OR OTHER PACIFIC ISLANDERAPNATIVE HAWAIIAN OR OTHER PACIFIC ISLANDERAPYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrKXDWD Hr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrKXDWD Hr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1066 10661424106614241066APenvironmental allergies Hypersensitivity FImmune system disorders F4Environmental allergy FTAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 2018 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4747 31Dec2018M-730 N DW 13 YEARSAYEARS12-15 YearsAMANATIVE HAWAIIAN OR OTHER PACIFIC ISLANDERAPNATIVE HAWAIIAN OR OTHER PACIFIC ISLANDERAPYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrKXDWD Hr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrKXDWD Hr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1066 10661424106614241066A`eosinophilic esophagitis Eosinophilic oesophagitis FTGastrointestinal disorders FܛEosinophilic esophagitis F\Oesophagitis (excl infective) Ff3Gastrointestinal inflammatory conditions FܱGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2008 2018 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2008M-4747 31Dec2018M-730 N DW 13 YEARSAYEARS12-15 YearsAMANATIVE HAWAIIAN OR OTHER PACIFIC ISLANDERAPNATIVE HAWAIIAN OR OTHER PACIFIC ISLANDERAPYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrKXDWD Hr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrKXDWD Hr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1066 10661424106614241066A0cyclical vomiting Cyclic vomiting syndrome FYGastrointestinal disorders FܛCyclic vomiting syndrome FYNausea and vomiting symptoms FGastrointestinal signs and symptoms FGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2010 2018 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2010M-4016 31Dec2018M-730 N DW 11 YEARSAYEARS12-15 YearsAMANATIVE HAWAIIAN OR OTHER PACIFIC ISLANDERAPNATIVE HAWAIIAN OR OTHER PACIFIC ISLANDERAPYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrKXDWD Hr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrKXDWD Hr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1066 10661424106614241066Aptonsillectomy Tonsillectomy FBfSurgical and medical procedures F<Tonsillectomy FBfTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2006-07 2006 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.05 01Jul2006D-5296 31Dec2006M-5113 N DW 14.5 YEARSAYEARS12-15 YearsAMANATIVE HAWAIIAN OR OTHER PACIFIC ISLANDERAPNATIVE HAWAIIAN OR OTHER PACIFIC ISLANDERAPYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrKXDWD Hr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrKXDWD Hr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1066 10661425106614251066AAcne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1100 N DW 3.01 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW D<HrĄDWDHs?TPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW D<HrĄDW"DHr"DWDxHsvDWDHs?TPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW".DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1066 10661425106614251066A Rosacea Rosacea F/Skin and subcutaneous tissue disorders F5Rosacea F/Rosaceas F/Skin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1100 N DW 3.01 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW D<HrĄDWDHs?TPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW D<HrĄDW"DHr"DWDxHsvDWDHs?TPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW".DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1066 10661426106614261066A hypospadias Hypospadias FCongenital, familial and genetic disorders FHypospadias FMale reproductive tract disorders congenital F-Reproductive tract and breast disorders congenital F-PCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY(b)(6) 2006-04 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6)30Apr2006D-5365 N DW (b)(6)YEARSAYEARS12-15 YearsAMAMULTIPLE A`MULTIRACIAL A`YYPlacebo PLACEBO Placebo PLACEBO DWDHrŐDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrŐDW$D|Hr|DWDXHstDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1066 10661426106614261066A0hypospadias repair Urethral repair FKSurgical and medical procedures F<Hypospadias repair FUrethral therapeutic procedures FKRenal and urinary tract therapeutic procedures F,]Surgical and medical procedures F<GENERAL MEDICAL HISTORY2006-04 2006-04 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Apr2006D-5394 30Apr2006D-5365 N DW 14.77 YEARSAYEARS12-15 YearsAMAMULTIPLE A`MULTIRACIAL A`YYPlacebo PLACEBO Placebo PLACEBO DWDHrŐDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrŐDW$D|Hr|DWDXHstDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1066 10661426106614261066Aenvironmental allergies Hypersensitivity FImmune system disorders F4Environmental allergy FTAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1466 N DW 4.02 YEARSAYEARS12-15 YearsAMAMULTIPLE A`MULTIRACIAL A`YYPlacebo PLACEBO Placebo PLACEBO DWDHrŐDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrŐDW$D|Hr|DWDXHstDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1066 10661428106614281066A penicillin allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2013M-2927 N DW 8.02 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DWDHrūDWgDdHs;Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrūDW"DԔHr'DWRD$Hsv$DWgDdHs;Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW".DWRDWg.DW2DW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1066 10661428106614281066Aasthma-stable Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2020-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jun2020D-219 YChronic pulmonary disease DW 0.6 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DWDHrūDWgDdHs;Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrūDW"DԔHr'DWRD$Hsv$DWgDdHs;Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW".DWRDWg.DW2DW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1066 10661430106614301066Aacne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1102 N DW 3.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDpHrƷDW"Dg Hrߺ BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDpHrƷDW"Dg Hrߺ ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW"....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1066 10661431106614311066A0headaches Headache FNervous system disorders FHeadache FHeadaches NEC FHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2005 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2005M-5850 N DW 16.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrlDW#DoHrLBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrlDW#DoHrL......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1066 10661431106614311066AAcne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1467 N DW 4.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrlDW#DoHrLBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrlDW#DoHrL......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1066 10661431106614311066A Anxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019M-737 N DW 2.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrlDW#DoHrLBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrlDW#DoHrL......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1066 10661432106614321066A0pre-menarche Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDpHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDpHrDW"D$Hr$DWD,Hss,DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW".DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1066 10661432106614321066A@recurrent tonsillitis Tonsillitis FBhInfections and infestations FTonsillitis recurrent FBlUpper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2009 2011 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2009M-4389 31Dec2011M-3295 N DW 12.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDpHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDpHrDW"D$Hr$DWD,Hss,DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW".DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1066 10661432106614321066APtonsillectomy Tonsillectomy FBfSurgical and medical procedures F<Tonsillectomy FBfTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2011 2011 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2011M-3659 31Dec2011M-3295 N DW 10.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDpHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDpHrDW"D$Hr$DWD,Hss,DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW".DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1066 10661432106614321066Aappendectomy Appendicectomy FBSurgical and medical procedures F<Appendectomy F@Large intestine therapeutic procedures F{Gastrointestinal therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2018-05 2018-05 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.05 01May2018D-982 31May2018D-952 N DW 2.69 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDpHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDpHrDW"D$Hr$DWD,Hss,DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW".DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1066 10661432106614321066A appendicitis Appendicitis FCInfections and infestations FAppendicitis FCAbdominal and gastrointestinal infections FܯInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2018-05 2018-05 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01May2018D-982 31May2018D-952 N DW 2.69 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDpHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDpHrDW"D$Hr$DWD,Hss,DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW".DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1066 10661433106614331066Apenicllin allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4024 N DW 11.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr'DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr'DW"DXHr'XDWDHst՜DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW".DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1066 10661434106614341066Aattention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2015-01-12 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 12Jan2015 -2192 N DW 6 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr͌DW)DHr. BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr͌DW)DHr. ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW)....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1066 10661434106614341066A insomnia Insomnia F%Psychiatric disorders F'Insomnia F%Disturbances in initiating and maintaining sleep FFSleep disorders and disturbances F6Psychiatric disorders F'GENERAL MEDICAL HISTORY2019-01-12 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 12Jan2019 -731 N DW 2 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr͌DW)DHr. BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr͌DW)DHr. ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW)....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1066 10661435106614351066A`neurodevelopment disorder Neurodevelopmental disorder FPsychiatric disorders F'Neurodevelopmental disorder FPervasive developmental disorders NEC F4Developmental disorders NEC FǒPsychiatric disorders F'GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD`Hr͌`DW)DHr.HBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD`Hr͌`DW)DHr.H......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW)....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1066 10661435106614351066A@bilateral club foot Talipes F>Congenital, familial and genetic disorders FClubfoot F^Musculoskeletal and connective tissue disorders of limbs congenital F]Musculoskeletal and connective tissue disorders congenital FlCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY(b)(6) (b)(6) BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.06 (b)(6) (b)(6)(b)(6) D(b)(6)N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD`Hr͌`DW)DHr.HBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD`Hr͌`DW)DHr.H......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW)....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1066 10661435106614351066Aanxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1472 N DW 4.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD`Hr͌`DW)DHr.HBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD`Hr͌`DW)DHr.H......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW)....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1066 10661435106614351066A attention deficit hyperactivity disroder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1472 N DW 4.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD`Hr͌`DW)DHr.HBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD`Hr͌`DW)DHr.H......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW)....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1066 10661435106614351066A0auditory hallucinations Hallucination, auditory FPsychiatric disorders F'Auditory hallucinations FIHallucinations (excl sleep-related) FפDisturbances in thinking and perception FGPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2017M-1472 N DW 4.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD`Hr͌`DW)DHr.HBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD`Hr͌`DW)DHr.H......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW)....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1066 10661435106614351066APborderline intellectual functioning Mental impairment FnNervous system disorders FMental function decreased FlMental impairment (excl dementia and memory loss) FoMental impairment disorders FuNervous system disorders FGENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2017M-1472 N DW 4.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD`Hr͌`DW)DHr.HBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD`Hr͌`DW)DHr.H......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW)....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1077 10771274107712741077ARIGHT RADIAL FRACTURE Radius fracture F**Injury, poisoning and procedural complications FRadius fracture F**Limb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2011 2011 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2011M-3624 31Dec2011M-3260 N DV 9.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDhHrhDVD$HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDhHrhDVD$Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1077 10771274107712741077A SEASONAL ALLERGIES Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2163 N DV 5.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDhHrhDVD$HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDhHrhDVD$Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1077 10771277107712771077AGOLDENHAR SYNDROME Oculoauriculovertebral dysplasia Fa^Congenital, familial and genetic disorders FGoldenhar's syndrome F[-Musculoskeletal and connective tissue disorders of skull congenital F^Musculoskeletal and connective tissue disorders congenital FlCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDHrDWDHs{DWDDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1077 10771277107712771077A HEARING LOSS RIGHT EAR Deafness unilateral FU,Ear and labyrinth disorders F)Hearing loss unilateral FxuHearing losses FHearing disorders FEar and labyrinth disorders F)GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDHrDWDHs{DWDDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1077 10771277107712771077APTHREE HEMI-VERTEBRAE Hemivertebra FCongenital, familial and genetic disorders FHemivertebra FMusculoskeletal and connective tissue disorders of spine congenital F_Musculoskeletal and connective tissue disorders congenital FlCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDHrDWDHs{DWDDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1077 10771277107712771077A0LIPOMA RIGHT EYE Lipoma FNeoplasms benign, malignant and unspecified (incl cysts and polyps)F0Lipoma FSoft tissue neoplasms benign NEC F7Soft tissue neoplasms benign F7Neoplasms benign, malignant and unspecified (incl cysts and polyps)F0GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2013M-2894 N DV 7.93 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDHrDWDHs{DWDDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1077 10771277107712771077A@TEMPOROMANDIBULAR JOINT GRAFT, RIGHT Temporomandibular joint surgery FZKSurgical and medical procedures F<Temporomandibular joint surgery FZKJoint therapeutic procedures F5Bone and joint therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2014 2014 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2014M-2529 31Dec2014M-2165 N DV 6.93 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDHrDWDHs{DWDDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1077 10771279107712791077AAMOXICILLIN ALLERGY Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1443 N DV 3.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr$DW DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr$DW DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1077 10771280107712801077AASTHMA Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1078 YChronic pulmonary disease DV 2.95 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr#hDWDtHssPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr#hDW DHrԌDWDXHsXDWDtHssPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1077 10771280107712801077A0HEADACHES Headache FNervous system disorders FHeadache FHeadaches NEC FHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2018M-1078 N DV 2.95 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr#hDWDtHssPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr#hDW DHrԌDWDXHsXDWDtHssPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1077 10771280107712801077A@LATEX ALLERGY Rubber sensitivity F/Immune system disorders F4Latex allergy FrAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1078 N DV 2.95 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr#hDWDtHssPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr#hDW DHrԌDWDXHsXDWDtHssPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1077 10771280107712801077A DEPRESSION Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2019M-713 N DV 1.95 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr#hDWDtHssPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr#hDW DHrԌDWDXHsXDWDtHssPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1077 10771281107712811077AANXIETY Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-713 N DV 1.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDtHr-DW DԔHr&BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDtHr-DW DԔHr&......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1077 10771282107712821077ASEASONAL ALLERGIES Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1443 N DV 3.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrpDW DHrČ<Placebo A .Placebo A .DVDHrpDW DHrČ<......Placebo Placebo DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1077 10771283107712831077AADENOIDECTOMY Adenoidectomy FNSurgical and medical procedures F<Adenoidectomy FNTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2009 2009 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2009M-4366 31Dec2009M-4002 N DV 11.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrvDWDuHs dPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrvDWDrHrgDWDvHsr TDWDuHs dPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1077 10771283107712831077A RECURRENT SINUS INFECTIONS Sinusitis F5Infections and infestations FSinus infection F5Upper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2009 2009 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2009M-4366 31Dec2009M-4002 N DV 11.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrvDWDuHs dPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrvDWDrHrgDWDvHsr TDWDuHs dPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1077 10771286107712861077APRIGHT EYE STRABISMUS SURGERY Strabismus correction FSurgical and medical procedures F<Strabismus correction FOrbit and globe therapeutic procedures FEye therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2009 2009 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2009M-4366 31Dec2009M-4002 N DV 11.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDŔHrDW D4Hr4BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDŔHrDW D4Hr4......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1077 10771286107712861077ApSEASONAL ALLERGIES Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2011M-3636 N DV 9.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDŔHrDW D4Hr4BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDŔHrDW D4Hr4......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1077 10771286107712861077A`RIGHT EYE STRABISMUS SURGERY Strabismus correction FSurgical and medical procedures F<Strabismus correction FOrbit and globe therapeutic procedures FEye therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2013 2013 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.07 01Jan2013M-2905 31Dec2013M-2541 N DV 7.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDŔHrDW D4Hr4BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDŔHrDW D4Hr4......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1077 10771286107712861077A@RED 40 DYE ALLERGY Reaction to colouring F*Immune system disorders F4Reaction to food coloring F*Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2014M-2540 N DV 6.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDŔHrDW D4Hr4BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDŔHrDW D4Hr4......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1077 10771286107712861077AATTENTION DEFICIT DISORDER Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2017M-1444 N DV 3.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDŔHrDW D4Hr4BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDŔHrDW D4Hr4......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1077 10771286107712861077A0RECURRENT TONSILLITIS Tonsillitis FBhInfections and infestations FTonsillitis recurrent FBlUpper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2017 2017 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.08 01Jan2017M-1444 31Dec2017M-1080 N DV 3.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDŔHrDW D4Hr4BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDŔHrDW D4Hr4......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1077 10771286107712861077A PARTIAL ADENOIDECTOMY Adenoidectomy FNSurgical and medical procedures F<Adenoidectomy FNTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2018-01 2018-01 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2018D-1079 31Jan2018D-1049 N DV 2.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDŔHrDW D4Hr4BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDŔHrDW D4Hr4......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1077 10771286107712861077ATONSILLECTOMY Tonsillectomy FBfSurgical and medical procedures F<Tonsillectomy FBfTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2018-01 2018-01 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2018D-1079 31Jan2018D-1049 N DV 2.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDŔHrDW D4Hr4BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDŔHrDW D4Hr4......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1077 10771286107712861077AUNDERLYING EPILEPSY Epilepsy F=Nervous system disorders FEpilepsy F=Seizures and seizure disorders NEC F2hSeizures (incl subtypes) F2gNervous system disorders FGENERAL MEDICAL HISTORY2019-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.09 01Jan2019D-714 N DV 1.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDŔHrDW D4Hr4BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDŔHrDW D4Hr4......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1077 10771287107712871077A0POLLEN ALLERGY Seasonal allergy FUImmune system disorders F4Pollen allergy F#3Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2010M-4001 N DV 10.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDʼHrDWDHrŠBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDʼHrDWDHrŠ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1077 10771287107712871077AAPPENDECTOMY Appendicectomy FBSurgical and medical procedures F<Appendectomy F@Large intestine therapeutic procedures F{Gastrointestinal therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2012 2012 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2012M-3271 31Dec2012M-2906 N DV 8.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDʼHrDWDHrŠBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDʼHrDWDHrŠ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1077 10771287107712871077A APPENDICITIS Appendicitis FCInfections and infestations FAppendicitis FCAbdominal and gastrointestinal infections FܯInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2012 2012 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3271 31Dec2012M-2906 N DV 8.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDʼHrDWDHrŠBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDʼHrDWDHrŠ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1077 10771288107712881077AATTENTION DEFICIT DISORDER Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-10-30 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 30Oct2020 -47 N DV 0.13 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrxDWDHrŌBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrxDWDHrŌ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1077 10771290107712901077ADEPRESSION Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1082 N DV 2.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDXHrDWDHrePlacebo A .Placebo A .DVDXHrDWDHre......Placebo Placebo DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1077 10771290107712901077A SEVERE NODULAR ACNE Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019M-717 N DV 1.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDXHrDWDHrePlacebo A .Placebo A .DVDXHrDWDHre......Placebo Placebo DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1077 10771293107712931077A ATTENTION DEFICIT HYPERACTIVITY DISORDER Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2014M N DV 6.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYNPlacebo PLACEBO Not Treated NOTTRT ...... . .Placebo A ............. .......DV . . .NPhase 3A@12-15 YearsAN NAYEARSC4591001C4591001 1077 10771293107712931077AANXIETY Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M N DV 2.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYNPlacebo PLACEBO Not Treated NOTTRT ...... . .Placebo A ............. .......DV . . .NPhase 3A@12-15 YearsAN NAYEARSC4591001C4591001 1077 10771294107712941077AANXIETY Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2014M-2553 N DW 6.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrՔDWD8HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrՔDWDHr%DWD Hs{ DWD8HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1077 10771295107712951077AENVIRONMENTAL ALLERGIES Hypersensitivity FImmune system disorders F4Environmental allergy FTAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3284 N DW 8.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDƄHrDWTDˆHs"Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDƄHrDWDXHr/XDW@DHsDWTDˆHs"Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DW@DWT.DW=DW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1077 10771296107712961077AASTHMA Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2007-07 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jul2007D-4930 YChronic pulmonary disease DW 13.5 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1077 10771300107713001077AANXIETY Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-05 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01May2020D-251 N DW 0.69 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr0hDW#DHr@BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr0hDW#DHr@......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841541108415411084A chronic ear infection Ear infection F;Infections and infestations FEar infection F;Ear infections F=Infections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2009 2010 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2009M-4362 31Dec2010M-3633 N DV 11.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr;DWD|HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr;DWD|Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841541108415411084A0chronic throat infection Pharyngitis FInfections and infestations FChronic pharyngitis FUpper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2009 2010 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2009M-4362 31Dec2010M-3633 N DV 11.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr;DWD|HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr;DWD|Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841541108415411084Aattention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2011 2019 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2011M-3632 31Dec2019M-346 N DV 9.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr;DWD|HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr;DWD|Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841541108415411084A@seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1075 N DV 2.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr;DWD|HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr;DWD|Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841542108415421084A seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2006M-5458 N DV 14.95 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DVDHrWDWDHrxPlacebo A .Placebo A .DVDHrWDWDHrx......Placebo Placebo DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841542108415421084Airregular menses Menstruation irregular FKReproductive system and breast disorders F-LMenses irregular F5Menstruation and uterine bleeding NEC FGMenstrual cycle and uterine bleeding disorders FʎReproductive system and breast disorders F-LGENERAL MEDICAL HISTORY2019-09 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Sep2019D-467 N DV 1.28 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DVDHrWDWDHrxPlacebo A .Placebo A .DVDHrWDWDHrx......Placebo Placebo DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841543108415431084A Hairline fracture in right tibia Tibia fracture FAInjury, poisoning and procedural complications FTibia fracture FALimb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2009 2009 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2009M-4369 31Dec2009M-4005 N DV 11.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDDHrDWD`Hs4`Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDDHrDWDLHrxLDWDHsr|DWD`Hs4`Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841543108415431084A@seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2013M-2908 N DV 7.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDDHrDWD`Hs4`Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDDHrDWDLHrxLDWDHsr|DWD`Hs4`Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841543108415431084ABroken hallux toe in left foot Foot fracture FInjury, poisoning and procedural complications FFractured toe F"Limb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2017 2017 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2017M-1447 31Dec2017M-1083 N DV 3.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDDHrDWD`Hs4`Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDDHrDWDLHrxLDWDHsr|DWD`Hs4`Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841543108415431084A0decreased visual acuity Visual acuity reduced FP+Eye disorders FԯVisual acuity decreased FV%Visual impairment and blindness (excl colour blindness) FVision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1082 N DV 2.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDDHrDWD`Hs4`Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDDHrDWDLHrxLDWDHsr|DWD`Hs4`Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841544108415441084A allergic rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4004 N DV 10.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841544108415441084AAttention-deficit/hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit-hyperactivity disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1447 N DV 3.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841545108415451084AChronic ear infection Ear infection F;Infections and infestations FEar infection F;Ear infections F=Infections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2016 2019-01 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2016M-1813 31Jan2019D-687 N DV 4.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrlDWDHs{Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrlDWDHrݼDWDHssDWDHs{Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841545108415451084A0seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018D-1082 N DV 2.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrlDWDHs{Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrlDWDHrݼDWDHssDWDHs{Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841545108415451084A myringotomy Myringotomy FvSurgical and medical procedures F<Myringotomy FvMiddle ear therapeutic procedures FDHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2019-01 2019-01 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2019D-717 31Jan2019D-687 N DV 1.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrlDWDHs{Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrlDWDHrݼDWDHssDWDHs{Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841546108415461084Aseasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018D-1082 N DV 2.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrޘDWDpHrpBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrޘDWDpHrp......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1084 10841547108415471084A0myringotomy Myringotomy FvSurgical and medical procedures F<Myringotomy FvMiddle ear therapeutic procedures FDHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2006 2006 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2006M-5468 31Dec2006M-5104 N DV 14.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHriDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHriDWDHr`DWD4HswoDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841547108415471084A asthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2010M-4007 YChronic pulmonary disease DV 10.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHriDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHriDWDHr`DWD4HswoDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841547108415471084A@seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1816 N DV 4.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHriDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHriDWDHr`DWD4HswoDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841547108415471084Aanxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-09 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Sep2020D-111 N DV 0.31 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHriDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHriDWDHr`DWD4HswoDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841548108415481084A Seasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4007 N DV 10.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDPHrPDWDHrTBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDPHrPDWDHrT......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841548108415481084ADECREASED VISUAL ACUITY Visual acuity reduced FP+Eye disorders FԯVisual acuity decreased FV%Visual impairment and blindness (excl colour blindness) FVision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2014M-2546 N DV 6.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDPHrPDWDHrTBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDPHrPDWDHrT......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841549108415491084Aseasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2007M-5103 N DV 13.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr!BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr!......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841549108415491084Apmyringotomy Myringotomy FvSurgical and medical procedures F<Myringotomy FvMiddle ear therapeutic procedures FDHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2008 2008 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2008M-4738 31Dec2008M-4373 N DV 12.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr!BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr!......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841549108415491084Asleep apnea Sleep apnoea syndrome F6Respiratory, thoracic and mediastinal disorders F-Sleep apnea F6Breathing abnormalities F>Respiratory disorders NEC F-Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2009 2010 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2009M-4372 31Dec2010M-3643 N DV 11.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr!BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr!......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841549108415491084A@adenoidectomy Adenoidectomy FNSurgical and medical procedures F<Adenoidectomy FNTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2010 2010 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2010M-4007 31Dec2010M-3643 N DV 10.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr!BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr!......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841549108415491084A`myringotomy Myringotomy FvSurgical and medical procedures F<Myringotomy FvMiddle ear therapeutic procedures FDHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2010 2010 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01001Jan2010M-4007 31Dec2010M-3643 N DV 10.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr!BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr!......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841549108415491084Atonsillectomy Tonsillectomy FBfSurgical and medical procedures F<Tonsillectomy FBfTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2010 2010 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2010M-4007 31Dec2010M-3643 N DV 10.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr!BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr!......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841549108415491084AFracture left wrist Wrist fracture FR1Injury, poisoning and procedural complications FWrist fracture FR1Limb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2012 2012 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.07 01Jan2012M-3277 31Dec2012M-2912 N DV 8.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr!BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr!......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841549108415491084A0Gastroesophageal reflux Gastrooesophageal reflux disease F]Gastrointestinal disorders FܛGastroesophageal reflux F܄Gastrointestinal atonic and hypomotility disorders NEC F܍Gastrointestinal motility and defaecation conditions FܹGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1450 N DV 3.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr!BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr!......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841549108415491084APleft pinky fracture Hand fracture F*Injury, poisoning and procedural complications FFractured finger FLimb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2018 2018 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.09 01Jan2018M-1085 31Dec2018M-721 N DV 2.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr!BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr!......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841549108415491084A Fracture right wrist Wrist fracture FR1Injury, poisoning and procedural complications FFractured wrist F'Limb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2019-07 2020 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.08 01Jul2019D-539 31Dec2020M11 N DV 1.48 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr!BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr!......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841550108415501084A Scoliosis Scoliosis F1Musculoskeletal and connective tissue disorders FkScoliosis F1Spine and neck deformities FMusculoskeletal and connective tissue deformities (incl intervertebral disc disorders)FYMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2009M-4372 N DV 11.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD|Hr|DWDHs,Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD|Hr|DWD܌Hr DWDĤHsDWDHs,Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841550108415501084ABenign Fibroma Fibroma FuNeoplasms benign, malignant and unspecified (incl cysts and polyps)F0Fibroma FuNeoplasms benign site unspecified NEC F2Miscellaneous and site unspecified neoplasms benign FNeoplasms benign, malignant and unspecified (incl cysts and polyps)F0GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2013M-2911 N DV 7.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD|Hr|DWDHs,Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD|Hr|DWD܌Hr DWDĤHsDWDHs,Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841550108415501084A@multicystic dysplastic kidney Renal dysplasia F,Congenital, familial and genetic disorders FMulticystic dysplastic kidney F(Renal disorders congenital F,Renal and urinary tract disorders congenital F,XCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2013M-2911 N DV 7.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD|Hr|DWDHs,Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD|Hr|DWD܌Hr DWDĤHsDWDHs,Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841550108415501084A0Seasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2181 N DV 5.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD|Hr|DWDHs,Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD|Hr|DWD܌Hr DWDĤHsDWDHs,Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841551108415511084A0inguinal hernia Inguinal hernia FGastrointestinal disorders FܛInguinal hernia FInguinal hernias FAbdominal hernias and other abdominal wall conditions FGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2009 2009 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.07 01Jan2009M-4372 31Dec2009M-4008 N DV 11.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr XBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr X......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.....DV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841551108415511084A@inguinal hernia repair Inguinal hernia repair FSurgical and medical procedures F<Inguinal hernia repair FHernia repairs F[Gastrointestinal therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2009 2009 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2009M-4372 31Dec2009M-4008 N DV 11.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr XBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr X......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.....DV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841551108415511084A`umbilical hernia Umbilical hernia FHGastrointestinal disorders FܛUmbilical hernia FHUmbilical hernias FHAbdominal hernias and other abdominal wall conditions FGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2009 2009 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2009M-4372 31Dec2009M-4008 N DV 11.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr XBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr X......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.....DV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841551108415511084Apumbilical hernia repair Umbilical hernia repair FHSurgical and medical procedures F<Umbilical hernia repair FHHernia repairs F[Gastrointestinal therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2009 2009 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2009M-4372 31Dec2009M-4008 N DV 11.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr XBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr X......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.....DV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841551108415511084Aadenoidectomy Adenoidectomy FNSurgical and medical procedures F<Adenoidectomy FNTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2010 2010 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4007 31Dec2010M-3643 N DV 10.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr XBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr X......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.....DV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841551108415511084A chronic ear infection Ear infection F;Infections and infestations FEar infection F;Ear infections F=Infections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2010 2010 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2010M-4007 31Dec2010M-3643 N DV 10.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr XBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr X......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.....DV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841551108415511084APmyringotomy Myringotomy FvSurgical and medical procedures F<Myringotomy FvMiddle ear therapeutic procedures FDHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2010 2010 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2010M-4007 31Dec2010M-3643 N DV 10.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr XBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr X......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.....DV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841552108415521084ALeft Buckle Fracture Torus fracture FInjury, poisoning and procedural complications FBuckle fracture FLimb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2015M-2181 N DV 5.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDLHrLDWDHsZPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDLHrLDWD HrpDWDHs{DWDHsZPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841552108415521084A tinnitus Tinnitus FAEar and labyrinth disorders F)Tinnitus FAInner ear signs and symptoms FInner ear and VIIIth cranial nerve disorders FEar and labyrinth disorders F)GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-720 N DV 1.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDLHrLDWDHsZPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDLHrLDWD HrpDWDHs{DWDHsZPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841553108415531084Arecurrent headaches Headache FNervous system disorders FHeadache recurrent FHeadaches NEC FHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2009M-4372 N DV 11.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD Hr DWDHr(BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD Hr DWDHr(......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841553108415531084A seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-720 N DV 1.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD Hr DWDHr(BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD Hr DWDHr(......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841555108415551084A drug allergy to penicillin Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4007 N DV 10.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWD0Hs{0Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDHrb|DWDHsDWD0Hs{0Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841555108415551084Aacne vulgaris Acne FpSkin and subcutaneous tissue disorders F5Acne vulgaris FAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2020-07 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jul2020D-173 N DV 0.48 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWD0Hs{0Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDHrb|DWDHsDWD0Hs{0Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841556108415561084A0kidney infection - side cannot be remembered. Kidney infection FInfections and infestations FKidney infection FUrinary tract infections FLqInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2010 2010 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2010M-4014 31Dec2010M-3650 N DW 10.99 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDWD`HrH`BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDWD`HrH`......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841556108415561084A decreased visual acuity Visual acuity reduced FP+Eye disorders FԯVisual acuity decreased FV%Visual impairment and blindness (excl colour blindness) FVision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2018M-1092 N DW 2.99 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDWD`HrH`BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDWD`HrH`......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841556108415561084Aacne vulgaris Acne FpSkin and subcutaneous tissue disorders F5Acne vulgaris FAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2019M-727 N DW 1.99 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDWD`HrH`BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDWD`HrH`......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841556108415561084A@seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-727 N DW 1.99 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDWD`HrH`BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDWD`HrH`......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841557108415571084Acat allergy Allergy to animal FNImmune system disorders F4Allergic to cats FCAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2014M-2553 N DW 6.99 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrdDWD|HrJ|Placebo A .Placebo A .DWDHrdDWD|HrJ|......Placebo Placebo DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841558108415581084ADiarrhea Diarrhoea F?Gastrointestinal disorders FܛDiarrhea F7Diarrhoea (excl infective) F@Gastrointestinal motility and defaecation conditions FܹGastrointestinal disorders FܛGENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrјDWD4HrV4BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrјDWD4HrV4......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841558108415581084A`seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2007M-5110 N DW 13.99 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrјDWD4HrV4BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrјDWD4HrV4......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841558108415581084APjoint pain in knees, elbows, ankles and wrists Arthralgia F'Musculoskeletal and connective tissue disorders FkArthralgia multiple F*Joint related signs and symptoms F:Joint disorders F-Musculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2009M-4379 N DW 11.99 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrјDWD4HrV4BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrјDWD4HrV4......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841558108415581084A0decreased visual acuity Visual acuity reduced FP+Eye disorders FԯVisual acuity decreased FV%Visual impairment and blindness (excl colour blindness) FVision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1823 N DW 4.99 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrјDWD4HrV4BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrјDWD4HrV4......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841558108415581084A asthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1457 YChronic pulmonary disease DW 3.99 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrјDWD4HrV4BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrјDWD4HrV4......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841558108415581084A@depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2020D-362 N DW 0.99 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrјDWD4HrV4BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrјDWD4HrV4......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841559108415591084A@bug bite allergy Allergy to arthropod bite Fz-Immune system disorders F4Allergy to arthropod bite Fz-Allergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2007M-5110 N DW 13.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrdDWDHrTBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrdDWDHrT......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841559108415591084A`seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2007M-5110 N DW 13.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrdDWDHrTBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrdDWDHrT......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841559108415591084A Respiratory syncytial virus Respiratory syncytial virus infection F#Infections and infestations FRespiratory syncytial virus infection NOS FbhRespiratory syncytial viral infections F-Viral infectious disorders FOInfections and infestations FGENERAL MEDICAL HISTORY2007 2007 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2007M-5110 31Dec2007M-4746 N DW 13.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrdDWDHrTBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrdDWDHrT......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841559108415591084A0asthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2008M-4745 YChronic pulmonary disease DW 12.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrdDWDHrTBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrdDWDHrT......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841559108415591084APdecreased visual acuity Visual acuity reduced FP+Eye disorders FԯVisual acuity decreased FV%Visual impairment and blindness (excl colour blindness) FVision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2016M-1823 N DW 4.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrdDWDHrTBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrdDWDHrT......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841559108415591084AJoint pain caused by growth spurts Growing pains F߹Musculoskeletal and connective tissue disorders FkGrowing pains F߹Musculoskeletal and connective tissue pain and discomfort FMusculoskeletal and connective tissue disorders NEC FiMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2017M-1457 N DW 3.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrdDWDHrTBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrdDWDHrT......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841560108415601084A anxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-08 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Aug2020D-149 N DW 0.41 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDxHrDWDHsnPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDxHrDWDHrDWDИHsDWDHsnPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841560108415601084A@chronic ear infection Ear infection F;Infections and infestations FEar infection F;Ear infections F=Infections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2005 2008 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.07 01Jan2005M-5840 31Dec2008M-4380 N DW 15.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDxHrDWDHsnPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDxHrDWDHrDWDИHsDWDHsnPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841560108415601084Aseasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2006M-5475 N DW 14.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDxHrDWDHsnPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDxHrDWDHrDWDИHsDWDHsnPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841560108415601084Apmyringotomy Myringotomy FvSurgical and medical procedures F<Myringotomy FvMiddle ear therapeutic procedures FDHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2008 2008 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2008M-4745 31Dec2008M-4380 N DW 12.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDxHrDWDHsnPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDxHrDWDHrDWDИHsDWDHsnPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841560108415601084AMolluscum contagiosum Molluscum contagiosum FInfections and infestations FMolluscum contagiosum FMolluscum contagiosum viral infections F Viral infectious disorders FOInfections and infestations FGENERAL MEDICAL HISTORY2008 2009 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01101Jan2008M-4745 31Dec2009M-4015 N DW 12.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDxHrDWDHsnPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDxHrDWDHrDWDИHsDWDHsnPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841560108415601084Atonsillectomy Tonsillectomy FBfSurgical and medical procedures F<Tonsillectomy FBfTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2010 2010 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2010M-4014 31Dec2010M-3650 N DW 10.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDxHrDWDHsnPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDxHrDWDHrDWDИHsDWDHsnPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841560108415601084Atonsillitis Tonsillitis FBhInfections and infestations FTonsillitis FBhUpper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2010 2010 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2010M-4014 31Dec2010M-3650 N DW 10.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDxHrDWDHsnPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDxHrDWDHrDWDИHsDWDHsnPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841560108415601084APdecreased visual acuity Visual acuity reduced FP+Eye disorders FԯVisual acuity decreased FV%Visual impairment and blindness (excl colour blindness) FVision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.08 01Jan2013M-2918 N DW 7.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDxHrDWDHsnPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDxHrDWDHrDWDИHsDWDHsnPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841560108415601084Awarts Skin papilloma F6KNeoplasms benign, malignant and unspecified (incl cysts and polyps)F0Warts FQTSkin neoplasms benign F6BCutaneous neoplasms benign F6CNeoplasms benign, malignant and unspecified (incl cysts and polyps)F0GENERAL MEDICAL HISTORY2014 2014 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01001Jan2014M-2553 31Dec2014M-2189 N DW 6.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDxHrDWDHsnPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDxHrDWDHrDWDИHsDWDHsnPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841560108415601084A0attention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2015M-2188 N DW 5.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDxHrDWDHsnPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDxHrDWDHrDWDИHsDWDHsnPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841560108415601084A`left wrist buckle fracture Torus fracture FInjury, poisoning and procedural complications FBuckle fracture FLimb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2016 2016 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.09 01Jan2016M-1823 31Dec2016M-1458 N DW 4.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDxHrDWDHsnPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDxHrDWDHrDWDИHsDWDHsnPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841561108415611084A0seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2009M-4379 N DW 11.99 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrڀDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrڀDWDHr[DWD(HsrDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841561108415611084Adecreased visual acuity Visual acuity reduced FP+Eye disorders FԯVisual acuity decreased FV%Visual impairment and blindness (excl colour blindness) FVision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2013M-2918 N DW 7.99 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrڀDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrڀDWDHr[DWD(HsrDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841561108415611084A generalized pain Pain FGeneral disorders and administration site conditions FGeneral body pain FUPain and discomfort NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions FGENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2015M-2188 N DW 5.99 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrڀDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrڀDWDHr[DWD(HsrDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841562108415621084Ageneralized pain Pain FGeneral disorders and administration site conditions FGeneral body pain FUPain and discomfort NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions FGENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4745 N DW 12.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDWDXHr_XBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDWDXHr_X......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.....DW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841563108415631084A0drug allergy to Amoxicillin Drug hypersensitivity FImmune system disorders F4Allergic reaction to antibiotics F8Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2009M-4381 N DW 12 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrVDWDHrgBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrVDWDHrg......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841563108415631084A@generalized pain Pain FGeneral disorders and administration site conditions FGeneral body pain FUPain and discomfort NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions FGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2018M-1094 N DW 3 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrVDWDHrgBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrVDWDHrg......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841563108415631084APseasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1094 N DW 3 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrVDWDHrgBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrVDWDHrg......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841563108415631084Aattention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2019M-729 N DW 2 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrVDWDHrgBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrVDWDHrg......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841563108415631084A decreased hearing in left ear Hypoacusis FUaEar and labyrinth disorders F)Hearing decreased FHearing losses FHearing disorders FEar and labyrinth disorders F)GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2019M-729 N DW 2 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrVDWDHrgBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrVDWDHrg......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841564108415641084A0heart murmur Cardiac murmur F"Investigations FHeart murmur FCardiac auscultatory investigations FYCardiac and vascular investigations (excl enzyme tests) FInvestigations FGENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2008M-4747 N DW 13 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrWLDWD͌HslPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrWLDWDTHrcTDWD<HswDWD͌HslPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841564108415641084APsickle cell carrier Sickle cell trait F5JCongenital, familial and genetic disorders FSickle cell trait F5JHaemoglobinopathies congenital FWBlood and lymphatic system disorders congenital FRCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2008M-4747 N DW 13 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrWLDWD͌HslPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrWLDWDTHrcTDWD<HswDWD͌HslPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841564108415641084Aattention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2018M-1094 N DW 3 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrWLDWD͌HslPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrWLDWDTHrcTDWD<HswDWD͌HslPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841564108415641084A generalized pain Pain FGeneral disorders and administration site conditions FGeneral body pain FUPain and discomfort NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions FGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2018M-1094 N DW 3 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrWLDWD͌HslPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrWLDWDTHrcTDWD<HswDWD͌HslPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841564108415641084A@seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1094 N DW 3 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrWLDWD͌HslPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrWLDWDTHrcTDWD<HswDWD͌HslPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841565108415651084A seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1459 N DW 4 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDTHreDWD@Hsm@Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDTHreDWDHrPDWDHswp,DWD@Hsm@Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841565108415651084Aattention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-09-10 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 10Sep2020 -111 N DW 0.31 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDTHreDWD@Hsm@Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDTHreDWDHrPDWDHswp,DWD@Hsm@Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841566108415661084A0right arm fracture Upper limb fracture FRInjury, poisoning and procedural complications FArm fracture FVgLimb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2009 2009 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2009M-4381 31Dec2009M-4017 N DW 12 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDlHrzDWDxHr]xBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDlHrzDWDxHr]x......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841566108415661084A generalized pain Pain FGeneral disorders and administration site conditions FGeneral body pain FUPain and discomfort NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions FGENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2010M-4016 N DW 11 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDlHrzDWDxHr]xBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDlHrzDWDxHr]x......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841566108415661084A@right thumb fracture Hand fracture F*Injury, poisoning and procedural complications FFractured thumb F!Limb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2012 2012 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2012M-3286 31Dec2012M-2921 N DW 9 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDlHrzDWDxHr]xBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDlHrzDWDxHr]x......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841566108415661084Adecreased visual acuity Visual acuity reduced FP+Eye disorders FԯVisual acuity decreased FV%Visual impairment and blindness (excl colour blindness) FVision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2015M-2190 N DW 6 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDlHrzDWDxHr]xBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDlHrzDWDxHr]x......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841566108415661084APseasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1825 N DW 5 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDlHrzDWDxHr]xBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDlHrzDWDxHr]x......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841567108415671084A seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2014M-2555 N DW 7 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDTHrDWD`Hrբ`BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDTHrDWD`Hrբ`......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841567108415671084Aacne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019D-729 N DW 2 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDTHrDWD`Hrբ`BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDTHrDWD`Hrբ`......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841568108415681084A@seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4016 N DW 11 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr\DWDHHr`HPlacebo A .Placebo A .DWDHr\DWDHHr`H......Placebo Placebo DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841568108415681084A0decreased visual acuity Visual acuity reduced FP+Eye disorders FԯVisual acuity decreased FV%Visual impairment and blindness (excl colour blindness) FVision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2013M-2920 N DW 8 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr\DWDHHr`HPlacebo A .Placebo A .DWDHr\DWDHHr`H......Placebo Placebo DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841568108415681084APtibial stress fracture Stress fracture F;dInjury, poisoning and procedural complications FStress fracture F;dFractures and dislocations NEC FBone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2016 2016 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2016M-1825 31Dec2016M-1460 N DW 5 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr\DWDHHr`HPlacebo A .Placebo A .DWDHr\DWDHHr`H......Placebo Placebo DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841568108415681084Aacne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2020-07 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jul2020D-182 N DW 0.5 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr\DWDHHr`HPlacebo A .Placebo A .DWDHr\DWDHHr`H......Placebo Placebo DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841568108415681084A attention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019-03 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Mar2019D-670 N DW 1.84 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr\DWDHHr`HPlacebo A .Placebo A .DWDHr\DWDHHr`H......Placebo Placebo DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841569108415691084A decreased visual acuity Visual acuity reduced FP+Eye disorders FԯVisual acuity decreased FV%Visual impairment and blindness (excl colour blindness) FVision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1094 N DW 3 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr<DWDHs:Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr<DWD`Hr`DWDHswXDWDHs:Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841569108415691084Aattention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jun2020D-212 N DW 0.58 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr<DWDHs:Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr<DWD`Hr`DWDHswXDWDHs:Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841570108415701084Aasthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2013M-2920 YChronic pulmonary disease DW 8 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDpHrDWDTHs;TPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDpHrDWDHrDWDPHswDWDTHs;TPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841570108415701084APleft wrist fracture Wrist fracture FR1Injury, poisoning and procedural complications FWrist fracture FR1Limb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2015M-2190 N DW 6 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDpHrDWDTHs;TPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDpHrDWDHrDWDPHswDWDTHs;TPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841570108415701084A0environmental allergies - grass, trees Hypersensitivity FImmune system disorders F4Environmental allergy FTAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2016M-1825 N DW 5 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDpHrDWDTHs;TPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDpHrDWDHrDWDPHswDWDTHs;TPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841570108415701084A drug allergy to neosporin Drug hypersensitivity FImmune system disorders F4Allergic reaction to antibiotics F8Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1094 N DW 3 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDpHrDWDTHs;TPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDpHrDWDHrDWDPHswDWDTHs;TPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841570108415701084A@generalized pain Pain FGeneral disorders and administration site conditions FGeneral body pain FUPain and discomfort NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions FGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2018M-1094 N DW 3 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDpHrDWDTHs;TPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDpHrDWDHrDWDPHswDWDTHs;TPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841571108415711084Apremenstrual dysphoria Premenstrual dysphoric disorder F_Reproductive system and breast disorders F-LPremenstrual dysphoric disorder F_Menstruation and uterine bleeding NEC FGMenstrual cycle and uterine bleeding disorders FʎReproductive system and breast disorders F-LGENERAL MEDICAL HISTORY2017-12 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.09 01Dec2017D-1125 N DW 3.08 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDWDՄHr?DWD@HswDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841571108415711084APdecreased visual acuity Visual acuity reduced FP+Eye disorders FԯVisual acuity decreased FV%Visual impairment and blindness (excl colour blindness) FVision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2011M-3651 N DW 10 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDWDՄHr?DWD@HswDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841571108415711084A acne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.08 01Jan2014M-2555 N DW 7 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDWDՄHr?DWD@HswDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841571108415711084Aseasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2014M-2555 N DW 7 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDWDՄHr?DWD@HswDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841571108415711084A0anxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2016M-1825 N DW 5 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDWDՄHr?DWD@HswDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841571108415711084A`depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2016M-1825 N DW 5 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDWDՄHr?DWD@HswDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841571108415711084AGERD Gastrooesophageal reflux disease F]Gastrointestinal disorders FܛGERD FݛGastrointestinal atonic and hypomotility disorders NEC F܍Gastrointestinal motility and defaecation conditions FܹGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2019M-729 N DW 2 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDWDՄHr?DWD@HswDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841571108415711084Apiron deficiency Iron deficiency F:Metabolism and nutrition disorders FIron deficiency F:Iron deficiencies F;Iron and trace metal metabolism disorders F.Metabolism and nutrition disorders FGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2019M-729 N DW 2 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDWDՄHr?DWD@HswDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841571108415711084A@autism spectrum Autism spectrum disorder FPsychiatric disorders F'Autism spectrum disorder FPervasive developmental disorders NEC F4Developmental disorders NEC FǒPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-05 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.07 01May2020D-243 N DW 0.67 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDWDՄHr?DWD@HswDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841572108415721084A@seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4752 N DW 13.01 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DpHrpDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DpHrpDW!DHr DWDHs DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841572108415721084A adenoidectomy Adenoidectomy FNSurgical and medical procedures F<Adenoidectomy FNTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2009 2009 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2009M-4386 31Dec2009M-4022 N DW 12.01 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DpHrpDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DpHrpDW!DHr DWDHs DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841572108415721084APtonsillectomy Tonsillectomy FBfSurgical and medical procedures F<Tonsillectomy FBfTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2009 2009 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2009M-4386 31Dec2009M-4022 N DW 12.01 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DpHrpDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DpHrpDW!DHr DWDHs DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841572108415721084A`tonsillitis Tonsillitis FBhInfections and infestations FTonsillitis FBhUpper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2009 2009 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2009M-4386 31Dec2009M-4022 N DW 12.01 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DpHrpDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DpHrpDW!DHr DWDHs DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841572108415721084A0depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-11-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Nov2020 -64 N DW 0.18 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DpHrpDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DpHrpDW!DHr DWDHs DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841572108415721084AEczema Eczema FSkin and subcutaneous tissue disorders F5Eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2020-10 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Oct2020D-95 N DW 0.26 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DpHrpDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DpHrpDW!DHr DWDHs DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841573108415731084Ahemangioma Haemangioma FNeoplasms benign, malignant and unspecified (incl cysts and polyps)F0Hemangioma F:Cardiovascular neoplasms benign FhMiscellaneous and site unspecified neoplasms benign FNeoplasms benign, malignant and unspecified (incl cysts and polyps)F0GENERAL MEDICAL HISTORY(b)(6) 2011 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6)31Dec2011M-3292 N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHr:DW#DHrHBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHr:DW#DHrH......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841574108415741084A`viral infection Viral infection FOInfections and infestations FViral infection FOViral infections NEC FOViral infectious disorders FOInfections and infestations FGENERAL MEDICAL HISTORY2009 2009 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2009M-4386 31Dec2009M-4022 N DW 12.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHr;DW#D4Hr~BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHr;DW#D4Hr~......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841574108415741084A@otitis media Otitis media FInfections and infestations FOtitis media FEar infections F=Infections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2010M-4021 N DW 11.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHr;DW#D4Hr~BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHr;DW#D4Hr~......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841574108415741084APr tarsal break Foot fracture FInjury, poisoning and procedural complications FFoot fracture FLimb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2014M-2560 N DW 7.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHr;DW#D4Hr~BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHr;DW#D4Hr~......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841574108415741084A gi viral infection Gastrointestinal viral infection F9Infections and infestations FGastrointestinal viral infection F9Viral infections NEC FOViral infectious disorders FOInfections and infestations FGENERAL MEDICAL HISTORY2015 2015 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2015M-2195 31Dec2015M-1831 N DW 6.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHr;DW#D4Hr~BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHr;DW#D4Hr~......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841574108415741084Adecreased visual acuity Visual acuity reduced FP+Eye disorders FԯVisual acuity decreased FV%Visual impairment and blindness (excl colour blindness) FVision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2017M-1464 N DW 4.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHr;DW#D4Hr~BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHr;DW#D4Hr~......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841574108415741084A0hyperkeratosis pilaris Hyperkeratosis F)Skin and subcutaneous tissue disorders F5Hyperkeratosis F)Hyperkeratoses F(Cornification and dystrophic skin disorders FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2017M-1464 N DW 4.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHr;DW#D4Hr~BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHr;DW#D4Hr~......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841576108415761084AAsthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2006M-5484 YChronic pulmonary disease DW 15.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD(HrŁ(DW!DHrނ,BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD(HrŁ(DW!DHrނ,......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW!....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841576108415761084A Decreased visual acuity Visual acuity reduced FP+Eye disorders FԯVisual acuity decreased FV%Visual impairment and blindness (excl colour blindness) FVision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2016-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jun2016D-1680 N DW 4.6 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD(HrŁ(DW!DHrނ,BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD(HrŁ(DW!DHrނ,......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW!....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841577108415771084APSeasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4023 N DW 11.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrũDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrũDW#DߘHrDWD8Hsv8DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841577108415771084A Decreased visual Acuity Visual acuity reduced FP+Eye disorders FԯVisual acuity decreased FV%Visual impairment and blindness (excl colour blindness) FVision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2012M-3293 N DW 9.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrũDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrũDW#DߘHrDWD8Hsv8DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841577108415771084A0Left elbow fracture Upper limb fracture FRInjury, poisoning and procedural complications FElbow fracture FΈLimb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2013M-2927 N DW 8.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrũDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrũDW#DߘHrDWD8Hsv8DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841577108415771084A@Open reduction and internal fixation surgery in left elbow Open reduction of fracture FZSurgical and medical procedures F<Open reduction of fracture with internal fixation F[Fracture treatments (excl skull and spine) FDBone and joint therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2013 2013 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2013M-2927 31Dec2013M-2563 N DW 8.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrũDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrũDW#DߘHrDWD8Hsv8DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841577108415771084AAttention deficit hyper-activity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2017M-1466 N DW 4.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrũDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrũDW#DߘHrDWD8Hsv8DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841577108415771084A`anxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2019M-736 N DW 2.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrũDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrũDW#DߘHrDWD8Hsv8DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841578108415781084Aattention deficit hyper-activity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1466 N DW 4.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD,HrŪ,DW#DHr`BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD,HrŪ,DW#DHr`......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841581108415811084Abilateral Muscle pain in legs Myalgia F{Musculoskeletal and connective tissue disorders FkMyalgia of lower extremities F`Muscle pains F#Muscle disorders FMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-736 N DW 2.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDPHrPDWDHs9Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDPHrPDW#DHrxDWDHsrT\DWDHs9Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841582108415821084AEnvironmental Allergies Hypersensitivity FImmune system disorders F4Environmental allergy FTAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-736 N DW 2.02 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDߘHrԘDW#D(HrᙨBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDߘHrԘDW#D(Hrᙨ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841583108415831084A tonsillectomy Tonsillectomy FBfSurgical and medical procedures F<Tonsillectomy FBfTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2010 2010 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4025 31Dec2010M-3661 N DW 11.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr/DW#DHrHBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr/DW#DHrH......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841583108415831084Aattention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2014M-2564 N DW 7.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr/DW#DHrHBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr/DW#DHrH......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841584108415841084A@nosebleeds - caused by dry air Epistaxis FrRespiratory, thoracic and mediastinal disorders F-Nose bleeds F Nasal disorders NEC FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2010M-4025 N DW 11.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD`Hr7`DW%DɐHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD`Hr7`DW%DɐHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841584108415841084A dyslexia Dyslexia FNervous system disorders FDyslexia FCortical dysfunction NEC F Neurological disorders NEC FNervous system disorders FGENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2012M-3295 N DW 9.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD`Hr7`DW%DɐHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD`Hr7`DW%DɐHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841584108415841084APseasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2013M-2929 N DW 8.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD`Hr7`DW%DɐHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD`Hr7`DW%DɐHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841584108415841084A0fractured right thumb Hand fracture F*Injury, poisoning and procedural complications FFractured thumb F!Limb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2018M-1103 N DW 3.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD`Hr7`DW%DɐHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD`Hr7`DW%DɐHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841584108415841084Aacne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2019M-738 N DW 2.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD`Hr7`DW%DɐHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD`Hr7`DW%DɐHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841586108415861084A@decreased visual acuity Visual acuity reduced FP+Eye disorders FԯVisual acuity decreased FV%Visual impairment and blindness (excl colour blindness) FVision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2012M-3295 N DW 9.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDDWD4Hs4Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDDW%D$HrDWDHsvnDWD4Hs4Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841586108415861084AChalazion on left eye lid Chalazion FDEye disorders FԯChalazion FDLid, lash and lacrimal infections, irritations and inflammations FOcular infections, irritations and inflammations FEye disorders FԯGENERAL MEDICAL HISTORY2014 2014 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2014M-2564 31Dec2014M-2200 N DW 7.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDDWD4Hs4Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDDW%D$HrDWDHsvnDWD4Hs4Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841586108415861084A Left eye surgery Eye operation FSurgical and medical procedures F<Eye operation NOS FEye therapeutic procedures NEC FEye therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2014 2014 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2014M-2564 31Dec2014M-2200 N DW 7.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDDWD4Hs4Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDDW%D$HrDWDHsvnDWD4Hs4Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841586108415861084A0Seasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-738 N DW 2.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDDWD4Hs4Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDDW%D$HrDWDHsvnDWD4Hs4Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841587108415871084Adecreased visual acuity Visual acuity reduced FP+Eye disorders FԯVisual acuity decreased FV%Visual impairment and blindness (excl colour blindness) FVision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3295 N DW 9.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD HrO DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD HrO DW%D0Hr˰DWDϨHsvmDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841587108415871084A recurrent headaches Headache FNervous system disorders FHeadache recurrent FHeadaches NEC FHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2012M-3295 N DW 9.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD HrO DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD HrO DW%D0Hr˰DWDϨHsvmDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841588108415881084A`seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2012M-3295 N DW 9.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrXDWDHs5Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrXDW#D,HrwDWD$Hsw٤DWDHs5Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841588108415881084APTonsillectomy Tonsillectomy FBfSurgical and medical procedures F<Tonsillectomy FBfTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2013 2013 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2013M-2929 31Dec2013M-2565 N DW 8.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrXDWDHs5Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrXDW#D,HrwDWD$Hsw٤DWDHs5Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841588108415881084A Asthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2018M-1103 YChronic pulmonary disease DW 3.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrXDWDHs5Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrXDW#D,HrwDWD$Hsw٤DWDHs5Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841588108415881084A0Obestiy Obesity F ;Metabolism and nutrition disorders FObesity F ;General nutritional disorders NEC FAppetite and general nutritional disorders FJMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2018M-1103 N DW 3.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrXDWDHs5Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrXDW#D,HrwDWD$Hsw٤DWDHs5Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841588108415881084AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2019M-738 N DW 2.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrXDWDHs5Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrXDW#D,HrwDWD$Hsw٤DWDHs5Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841588108415881084A@Tinitis Tinnitus FAEar and labyrinth disorders F)Tinnitus FAInner ear signs and symptoms FInner ear and VIIIth cranial nerve disorders FEar and labyrinth disorders F)GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019M-738 N DW 2.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrXDWDHs5Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrXDW#D,HrwDWD$Hsw٤DWDHs5Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841590108415901084A chronic ear infection Ear infection F;Infections and infestations FEar infection F;Ear infections F=Infections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2006 2006 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2006M-5486 31Dec2006M-5122 N DW 15.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDҴHrjDWDtHstPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDҴHrjDW%D$HrפDWDHsrdDWDtHstPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841590108415901084A`seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2009M-4390 N DW 12.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDҴHrjDWDtHstPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDҴHrjDW%D$HrפDWDHsrdDWDtHstPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841590108415901084Abilateral leg pain Pain in extremity FMusculoskeletal and connective tissue disorders FkPain legs F3Musculoskeletal and connective tissue pain and discomfort FMusculoskeletal and connective tissue disorders NEC FiMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2010M-4025 N DW 11.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDҴHrjDWDtHstPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDҴHrjDW%D$HrפDWDHsrdDWDtHstPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841590108415901084A0decreased visual acuity Visual acuity reduced FP+Eye disorders FԯVisual acuity decreased FV%Visual impairment and blindness (excl colour blindness) FVision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2013M-2929 N DW 8.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDҴHrjDWDtHstPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDҴHrjDW%D$HrפDWDHsrdDWDtHstPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841590108415901084A@dysphagia Dysphagia FGastrointestinal disorders FܛDysphagia FGastrointestinal signs and symptoms NEC FGastrointestinal signs and symptoms FGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2017M-1468 N DW 4.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDҴHrjDWDtHstPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDҴHrjDW%D$HrפDWDHsrdDWDtHstPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841590108415901084APleft knee fracture Lower limb fracture FInjury, poisoning and procedural complications FKnee fracture FhLimb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2018 2018 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2018M-1103 31Dec2018M-739 N DW 3.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDҴHrjDWDtHstPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDҴHrjDW%D$HrפDWDHsrdDWDtHstPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841591108415911084APre-menarche Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrjDW%DHr\BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrjDW%DHr\......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841591108415911084A0kidney stones - calcium deposits of unknown cause Nephrolithiasis F\Renal and urinary disorders F,WKidney stones F Renal lithiasis F,Urolithiases FLRenal and urinary disorders F,WGENERAL MEDICAL HISTORY2020-04 2020-04 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.05 01Apr2020D-282 30Apr2020D-253 N DW 0.77 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrjDW%DHr\BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrjDW%DHr\......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841591108415911084A`seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4756 N DW 13.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrjDW%DHr\BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrjDW%DHr\......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841591108415911084A chronic ear infection Ear infection F;Infections and infestations FEar infection F;Ear infections F=Infections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2009 2009 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2009M-4390 31Dec2009M-4026 N DW 12.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrjDW%DHr\BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrjDW%DHr\......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841591108415911084A@myringotomy Myringotomy FvSurgical and medical procedures F<Myringotomy FvMiddle ear therapeutic procedures FDHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2009 2009 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2009M-4390 31Dec2009M-4026 N DW 12.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrjDW%DHr\BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrjDW%DHr\......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841591108415911084APrecurrent headaches Headache FNervous system disorders FHeadache recurrent FHeadaches NEC FHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2019M-738 N DW 2.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrjDW%DHr\BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrjDW%DHr\......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841592108415921084A0Tonsillitis Tonsillitis FBhInfections and infestations FTonsillitis FBhUpper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2012 2012 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2012M-3295 31Dec2012M-2930 N DW 9.02 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDˬHrcDW#DHrBxBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDˬHrcDW#DHrBx......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841592108415921084A@adenoidectomy Adenoidectomy FNSurgical and medical procedures F<Adenoidectomy FNTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2012 2012 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2012M-3295 31Dec2012M-2930 N DW 9.02 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDˬHrcDW#DHrBxBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDˬHrcDW#DHrBx......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841592108415921084APadenoiditis Adenoiditis F^Infections and infestations FAdenoiditis F^Upper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2012 2012 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2012M-3295 31Dec2012M-2930 N DW 9.02 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDˬHrcDW#DHrBxBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDˬHrcDW#DHrBx......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841592108415921084Aptonsillectomy Tonsillectomy FBfSurgical and medical procedures F<Tonsillectomy FBfTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2012 2012 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3295 31Dec2012M-2930 N DW 9.02 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDˬHrcDW#DHrBxBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDˬHrcDW#DHrBx......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841592108415921084A Eczema Eczema FSkin and subcutaneous tissue disorders F5Eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.07 01Jan2015M-2199 N DW 6.02 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDˬHrcDW#DHrBxBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDˬHrcDW#DHrBx......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841592108415921084ADecreased visual acuity Visual acuity reduced FP+Eye disorders FԯVisual acuity decreased FV%Visual impairment and blindness (excl colour blindness) FVision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2016M-1834 N DW 5.02 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDˬHrcDW#DHrBxBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDˬHrcDW#DHrBx......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841592108415921084A`non-migraine headaches Headache FNervous system disorders FHeadache FHeadaches NEC FHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2018M-1103 N DW 3.02 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDˬHrcDW#DHrBxBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDˬHrcDW#DHrBx......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841593108415931084A seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2199 N DW 6.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDټHrqDW%D,HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDټHrqDW%D,Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841593108415931084Aanxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2016M-1834 N DW 5.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDټHrqDW%D,HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDټHrqDW%D,Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841594108415941084AAmoxicillin allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3295 N DW 9.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr}DW%DtHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr}DW%DtHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1084 10841595108415951084Aseasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4025 N DW 11.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDHs*Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDW#D|HrDWDHsrDWDHs*Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841595108415951084A tonsillitis Tonsillitis FBhInfections and infestations FTonsillitis FBhUpper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2012 2012 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2012M-3295 31Dec2012M-2930 N DW 9.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDHs*Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDW#D|HrDWDHsrDWDHs*Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841596108415961084A@seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2006M-5486 N DW 15.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD4Hrȁ4DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD4Hrȁ4DW%D|HrDWDHsrVxDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841596108415961084A0recurrent headaches Headache FNervous system disorders FHeadache recurrent FHeadaches NEC FHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2012M-3295 N DW 9.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD4Hrȁ4DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD4Hrȁ4DW%D|HrDWDHsrVxDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841596108415961084A decreased visual acuity Visual acuity reduced FP+Eye disorders FԯVisual acuity decreased FV%Visual impairment and blindness (excl colour blindness) FVision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2013M-2929 N DW 8.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD4Hrȁ4DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD4Hrȁ4DW%D|HrDWDHsrVxDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841596108415961084Aasthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2018M-1103 YChronic pulmonary disease DW 3.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD4Hrȁ4DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD4Hrȁ4DW%D|HrDWDHsrVxDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841597108415971084A decreased visual acuity Visual acuity reduced FP+Eye disorders FԯVisual acuity decreased FV%Visual impairment and blindness (excl colour blindness) FVision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2011M-3660 N DW 10.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrȂDWD`Hs`Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrȂDW#DHrDWDHseC\DWD`Hs`Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DWDW.DWwDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841597108415971084APseasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3295 N DW 9.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrȂDWD`Hs`Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrȂDW#DHrDWDHseC\DWD`Hs`Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DWDW.DWwDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841597108415971084A0left arm fracture Upper limb fracture FRInjury, poisoning and procedural complications FArm fracture FVgLimb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2016 2016 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2016M-1834 31Dec2016M-1469 N DW 5.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrȂDWD`Hs`Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrȂDW#DHrDWDHseC\DWD`Hs`Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DWDW.DWwDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841597108415971084Aasthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2016 2018 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2016M-1834 31Dec2018M-739 YChronic pulmonary disease DW 5.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrȂDWD`Hs`Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrȂDW#DHrDWDHseC\DWD`Hs`Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DWDW.DWwDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1084 10841597108415971084A@recurrent headaches Headache FNervous system disorders FHeadache recurrent FHeadaches NEC FHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1103 N DW 3.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrȂDWD`Hs`Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrȂDW#DHrDWDHseC\DWD`Hs`Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DWDW.DWwDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911394109113941091Aoccasional headaches Headache FNervous system disorders FIntermittent headache F~ Headaches NEC FHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2162 N DV 5.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDVDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDVDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DW;DV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1091 10911395109113951091AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2006M-5449 N DV 14.92 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD$HrDVDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD$HrDVDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1091 10911396109113961091A Anxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2007M-5084 N DV 13.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHHrDWD(Hs (Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHHrDVD4Hr4DWDHskDWD(Hs (Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911396109113961091AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2012M-3258 N DV 8.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHHrDWD(Hs (Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHHrDVD4Hr4DWDHskDWD(Hs (Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911399109113991091A asthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4721 YChronic pulmonary disease DV 12.93 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr DWDHr.BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr DWDHr.......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1091 10911399109113991091Aacne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1068 N DV 2.93 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr DWDHr.BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr DWDHr.......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1091 10911400109114001091A0Seasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2008M-4721 N DV 12.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrHDWDDHsmPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrHDWDPHrEPDWD<HsB<DWDDHsmPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1091 10911400109114001091AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1433 N DV 3.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrHDWDDHsmPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrHDWDPHrEPDWD<HsB<DWDDHsmPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1091 10911400109114001091A Menstrual Cramps Dysmenorrhoea FReproductive system and breast disorders F-LMenstrual cramps F<Menstruation and uterine bleeding NEC FGMenstrual cycle and uterine bleeding disorders FʎReproductive system and breast disorders F-LGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2018M-1068 N DV 2.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrHDWDDHsmPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrHDWDPHrEPDWD<HsB<DWDDHsmPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1091 10911402109114021091Apremenarche Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911403109114031091AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2011M-3628 N DV 9.94 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr DWD4Hr4BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr DWD4Hr4......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911403109114031091A Anxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2017M-1436 N DV 3.93 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr DWD4Hr4BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr DWD4Hr4......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911403109114031091A0Depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1436 N DV 3.93 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr DWD4Hr4BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr DWD4Hr4......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911403109114031091A@Vitamin D Deficiency Vitamin D deficiency FPMetabolism and nutrition disorders FVitamin D deficiency FPFat soluble vitamin deficiencies and disorders FVitamin related disorders FPMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2019M-706 N DV 1.94 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr DWD4Hr4BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr DWD4Hr4......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911404109114041091AAsthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2015M-2167 YChronic pulmonary disease DV 5.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr'DWDHrPlacebo A .Placebo A .DVDHr'DWDHr......Placebo Placebo DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911404109114041091A0Trouble Sleeping Insomnia F%Psychiatric disorders F'Difficulty sleeping FȄDisturbances in initiating and maintaining sleep FFSleep disorders and disturbances F6Psychiatric disorders F'GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2015M-2167 N DV 5.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr'DWDHrPlacebo A .Placebo A .DVDHr'DWDHr......Placebo Placebo DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911404109114041091A Seasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1436 N DV 3.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr'DWDHrPlacebo A .Placebo A .DVDHr'DWDHr......Placebo Placebo DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911406109114061091A0Surgery: Testicular Torsion Testes exploration F?Surgical and medical procedures F<Torsion of testes reduction FBTesticular and scrotal therapeutic procedures F?Male genital tract therapeutic procedures F"Surgical and medical procedures F<GENERAL MEDICAL HISTORY2019-12 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Dec2019D-372 N DV 1.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrQDWDlHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrQDWDlHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911406109114061091A Allergic to Animal Dander Allergy to animal FNImmune system disorders F4Allergy to animal dander FOAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2006M-5454 N DV 14.93 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrQDWDlHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrQDWDlHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911406109114061091AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2016M-1802 N DV 4.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrQDWDlHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrQDWDlHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911407109114071091A0L Broken Hand Hand fracture F*Injury, poisoning and procedural complications FBroken hand FrLimb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2020-08 2020-10 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.05 01Aug2020D-129 31Oct2020D-38 N DV 0.36 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD\HrDWDHs2Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD\HrDWDLHrDWDHsHDWDHs2Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1091 10911407109114071091AAsthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2009M-4359 YChronic pulmonary disease DV 11.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD\HrDWDHs2Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD\HrDWDLHrDWDHsHDWDHs2Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1091 10911407109114071091A@Myalgia Myalgia F{Musculoskeletal and connective tissue disorders FkMyalgia F{Muscle pains F#Muscle disorders FMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2012M-3264 N DV 8.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD\HrDWDHs2Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD\HrDWDLHrDWDHsHDWDHs2Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1091 10911407109114071091APSeasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2012M-3264 N DV 8.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD\HrDWDHs2Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD\HrDWDLHrDWDHsHDWDHs2Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1091 10911407109114071091A L Broken Elbow Upper limb fracture FRInjury, poisoning and procedural complications FBroken elbow FoLimb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2015 2015 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2015M-2168 31Dec2015M-1804 N DV 5.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD\HrDWDHs2Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD\HrDWDLHrDWDHsHDWDHs2Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1091 10911408109114081091A Seasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2015M-2168 N DV 5.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrTDWDhHr~BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrTDWDhHr~......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWbDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911408109114081091AAcne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1072 N DV 2.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrTDWDhHr~BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrTDWDhHr~......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWbDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911409109114091091AAttention Deficit Hyperactivity Disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2013M-2899 N DV 7.94 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHrPlacebo A .Placebo A .DVDHrDWDHr......Placebo Placebo DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911410109114101091ApPremenarchal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.08 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDXHrXDWD|HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDXHrXDWD|Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911410109114101091AScarlet Fever Scarlet fever F1#Infections and infestations FScarlet fever F1#Streptococcal infections F;DBacterial infectious disorders F2Infections and infestations FGENERAL MEDICAL HISTORY2010 2010 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2010M-3995 31Dec2010M-3631 N DV 10.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDXHrXDWD|HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDXHrXDWD|Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911410109114101091AAllergic to Acetaminophen Drug hypersensitivity FImmune system disorders F4Drug allergy FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.07 01Jan2017M-1438 N DV 3.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDXHrXDWD|HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDXHrXDWD|Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911410109114101091A Allergic to Benadryl Drug hypersensitivity FImmune system disorders F4Specific allergy (drug) F8OAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2017M-1438 N DV 3.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDXHrXDWD|HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDXHrXDWD|Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911410109114101091A0Allergic to Ibuprofen Drug hypersensitivity FImmune system disorders F4Allergic reaction to analgesics FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2017M-1438 N DV 3.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDXHrXDWD|HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDXHrXDWD|Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911410109114101091A`Lyme disease Lyme disease FInfections and infestations FLyme disease FBorrelial infections FBacterial infectious disorders F2Infections and infestations FGENERAL MEDICAL HISTORY2017 2017 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1438 31Dec2017M-1074 N DV 3.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDXHrXDWD|HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDXHrXDWD|Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911410109114101091A@L Ankle Fracture Ankle fracture FpInjury, poisoning and procedural complications FAnkle fracture FpLimb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2020-11-05 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 05Nov2020 -34 N DV 0.1 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDXHrXDWD|HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDXHrXDWD|Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911410109114101091APL Ankle Pain Arthralgia F'Musculoskeletal and connective tissue disorders FkPain in ankle F Joint related signs and symptoms F:Joint disorders F-Musculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2020-11-05 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 05Nov2020 -34 N DV 0.1 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDXHrXDWD|HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDXHrXDWD|Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911411109114111091AAllergic to Amoxicillin Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2010M-3995 N DV 10.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHHrHDWDHsa,Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHHrHDWDHr8DWDHs DWDHsa,Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911411109114111091A Scarlet Fever Scarlet fever F1#Infections and infestations FScarlet fever F1#Streptococcal infections F;DBacterial infectious disorders F2Infections and infestations FGENERAL MEDICAL HISTORY2010 2010 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-3995 31Dec2010M-3631 N DV 10.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHHrHDWDHsa,Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHHrHDWDHr8DWDHs DWDHsa,Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911412109114121091A Adenoidectomy Adenoidectomy FNSurgical and medical procedures F<Adenoidectomy FNTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2007 2007 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2007M-5091 31Dec2007M-4727 N DV 13.94 YEARSAYEARS12-15 YearsAFA MULTIPLE A`MULTIRACIAL A`YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHrtBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHrt......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911412109114121091A0Enlarged Adenoids Adenoidal hypertrophy FMRespiratory, thoracic and mediastinal disorders F-Adenoidal hypertrophy FMPharyngeal disorders (excl infections and neoplasms) FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2007 2007 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2007M-5091 31Dec2007M-4727 N DV 13.94 YEARSAYEARS12-15 YearsAFA MULTIPLE A`MULTIRACIAL A`YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHrtBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHrt......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911412109114121091A@Enlarged Tonsils Tonsillar hypertrophy FBcRespiratory, thoracic and mediastinal disorders F-Enlarged tonsils FPharyngeal disorders (excl infections and neoplasms) FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2007 2007 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2007M-5091 31Dec2007M-4727 N DV 13.94 YEARSAYEARS12-15 YearsAFA MULTIPLE A`MULTIRACIAL A`YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHrtBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHrt......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911412109114121091APTonsillectomy Tonsillectomy FBfSurgical and medical procedures F<Tonsillectomy FBfTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2007 2007 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2007M-5091 31Dec2007M-4727 N DV 13.94 YEARSAYEARS12-15 YearsAFA MULTIPLE A`MULTIRACIAL A`YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHrtBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHrt......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911412109114121091AAcne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-708 N DV 1.94 YEARSAYEARS12-15 YearsAFA MULTIPLE A`MULTIRACIAL A`YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHrtBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHrt......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911413109114131091AAllergy: Penicillin Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4726 N DV 12.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD Hr DWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD Hr DWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1091 10911413109114131091A Asthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2008M-4726 YChronic pulmonary disease DV 12.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD Hr DWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD Hr DWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1091 10911413109114131091A0Environmental Allergies Hypersensitivity FImmune system disorders F4Environmental allergy FTAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2008M-4726 N DV 12.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD Hr DWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD Hr DWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1091 10911413109114131091A@Occasional Headaches Headache FNervous system disorders FIntermittent headache F~ Headaches NEC FHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2010M-3995 N DV 10.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD Hr DWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD Hr DWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1091 10911414109114141091AAsthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2006M-5456 YChronic pulmonary disease DV 14.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHs}*lBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHs}*l......BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) DV.DW...DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911414109114141091A0Occasional Headaches Headache FNervous system disorders FIntermittent headache F~ Headaches NEC FHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2006M-5456 N DV 14.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHs}*lBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHs}*l......BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) DV.DW...DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911414109114141091A@Temporary Immune thrombocytopenic purpura Immune thrombocytopenia FBlood and lymphatic system disorders FQImmune thrombocytopenic purpura F+Thrombocytopenias F@Platelet disorders F!NBlood and lymphatic system disorders FQGENERAL MEDICAL HISTORY2008 2008 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2008M-4726 31Dec2008M-4361 N DV 12.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHs}*lBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHs}*l......BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) DV.DW...DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911414109114141091A Environmental Allergies Hypersensitivity FImmune system disorders F4Environmental allergy FTAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2009M-4360 N DV 11.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHs}*lBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHs}*l......BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) DV.DW...DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911415109114151091AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-709 N DV 1.94 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DVDdHrDWDPHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDdHrDWD@HrF@DWDHsVDWDPHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911417109114171091Atree nut allergy Food allergy FزImmune system disorders F4Allergy to nuts Fm/Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2007M-5092 N DV 13.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD<HrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD<HrDWD<HrDWDzHssuDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911418109114181091Aasthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4727 YChronic pulmonary disease DV 12.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr DWD|HrjDWDDHsrDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911418109114181091A seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2012M-3266 N DV 8.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr DWD|HrjDWDDHsrDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911422109114221091A0tonsillectomy Tonsillectomy FBfSurgical and medical procedures F<Tonsillectomy FBfTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2016 2016 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2016M-1809 31Dec2016M-1444 N DV 4.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr6dDWDyhHrnhBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr6dDWDyhHrnh......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911422109114221091Aauricular dermatitis Dermatitis FSkin and subcutaneous tissue disorders F5Dermatitis FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2019M-713 N DV 1.95 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr6dDWDyhHrnhBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr6dDWDyhHrnh......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911422109114221091A mastoidectomy Mastoidectomy FSurgical and medical procedures F<Mastoidectomy FMastoid therapeutic procedures FHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2019-11 2019-11 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Nov2019D-409 30Nov2019D-380 N DV 1.12 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr6dDWDyhHrnhBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr6dDWDyhHrnh......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911423109114231091Aseasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1443 N DV 3.95 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVD Hr6DWDHs7Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD Hr6DWD|HrŇ|DWDϨHs{(DWDHs7Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911424109114241091A tonsillectomy Tonsillectomy FBfSurgical and medical procedures F<Tonsillectomy FBfTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2011 2011 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2011M-3636 31Dec2011M-3272 N DV 9.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD|Hr|DWDt|Hs|Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD|Hr|DW DHrDWDzHstƜDWDt|Hs|Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1091 10911424109114241091Amyringotomy Myringotomy FvSurgical and medical procedures F<Myringotomy FvMiddle ear therapeutic procedures FDHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2012 2012 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2012M-3271 31Dec2012M-2906 N DV 8.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD|Hr|DWDt|Hs|Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD|Hr|DW DHrDWDzHstƜDWDt|Hs|Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1091 10911425109114251091AAmoxicillin drug allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2010M-4001 N DV 10.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHs1<Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDW DHrODWDHs{DWDHs1<Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911425109114251091A Exercise induced asthma Asthma exercise induced FeRespiratory, thoracic and mediastinal disorders F-Exercise induced asthma FӡBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2019-10 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Oct2019D-441 YChronic pulmonary disease DV 1.21 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHs1<Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDW DHrODWDHs{DWDHs1<Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911427109114271091Aheadaches Headache FNervous system disorders FHeadache FHeadaches NEC FHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2012M-3272 N DV 8.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHrśPlacebo A .Placebo A .DVDHrDWDHrś......Placebo Placebo DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911427109114271091A seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3272 N DV 8.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHrśPlacebo A .Placebo A .DVDHrDWDHrś......Placebo Placebo DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911428109114281091ADysmenorrhea Dysmenorrhoea FReproductive system and breast disorders F-LDysmenorrhea FMenstruation and uterine bleeding NEC FGMenstrual cycle and uterine bleeding disorders FʎReproductive system and breast disorders F-LGENERAL MEDICAL HISTORY2020-08 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Aug2020D-137 N DV 0.38 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD|HrDWD,Hrś,BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD|HrDWD,Hrś,......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911428109114281091A0headaches Headache FNervous system disorders FHeadache FHeadaches NEC FHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019M-715 N DV 1.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD|HrDWD,Hrś,BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD|HrDWD,Hrś,......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911428109114281091A@insomnia Insomnia F%Psychiatric disorders F'Insomnia F%Disturbances in initiating and maintaining sleep FFSleep disorders and disturbances F6Psychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2019M-715 N DV 1.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD|HrDWD,Hrś,BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD|HrDWD,Hrś,......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911428109114281091A celiac disease Coeliac disease FGastrointestinal disorders FܛCeliac disease F8Malabsorption syndromes FMalabsorption conditions FGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2020-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jun2020D-198 N DV 0.54 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD|HrDWD,Hrś,BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD|HrDWD,Hrś,......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911429109114291091Aacne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jun2019D-564 N DV 1.55 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDW}DDHsX3Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDsHrhDWcDHs5DW}DDHsX3Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWcDW}.DWbDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911430109114301091A seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2020-04 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Apr2020D-259 N DV 0.71 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr&DDWD\Hs\Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr&DDW DHrDWD Hsv DWD\Hs\Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911430109114301091AAttention Deficit Hyperactivity Disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1811 N DV 4.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr&DDWD\Hs\Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr&DDW DHrDWD Hsv DWD\Hs\Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911431109114311091Ahayfever Seasonal allergy FUImmune system disorders F4Hay fever FbAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2011M-3638 N DV 9.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDlHr*lDWDqpHrOpBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDlHr*lDWDqpHrOp......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911432109114321091Apremenarcheal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr)DWDHrżBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr)DWDHrż......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911432109114321091A sinusitis Sinusitis F5Infections and infestations FSinusitis F5Upper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2177 N DV 5.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr)DWDHrżBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr)DWDHrż......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911433109114331091A asthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2006M-5464 YChronic pulmonary disease DV 14.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrpDWDHr/<Placebo A .Placebo A .DVDHrpDWDHr/<......Placebo Placebo DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911433109114331091Aallergic rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2008M-4734 N DV 12.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrpDWDHr/<Placebo A .Placebo A .DVDHrpDWDHr/<......Placebo Placebo DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911434109114341091A seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017D-1446 N DV 3.96 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVDـHrpDWD`HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDـHrpDWDHrDWD8Hsv88DWD`HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911434109114341091Aadhd Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2008-07 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jul2008D-4552 N DV 12.47 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVDـHrpDWD`HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDـHrpDWDHrDWD8Hsv88DWD`HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911435109114351091Atonsillectomy Tonsillectomy FBfSurgical and medical procedures F<Tonsillectomy FBfTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2018 2018 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1081 31Dec2018M-717 N DV 2.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr1BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr1......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1091 10911436109114361091A0tonsillectomy Tonsillectomy FBfSurgical and medical procedures F<Tonsillectomy FBfTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2012 2012 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2012M-3273 31Dec2012M-2908 N DV 8.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDlHrlDWD,Hr},BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDlHrlDWD,Hr},......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1091 10911436109114361091Aadhd Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2013M-2907 N DV 7.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDlHrlDWD,Hr},BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDlHrlDWD,Hr},......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1091 10911436109114361091A runners heart murmur Cardiac murmur F"Investigations FHeart murmur FCardiac auscultatory investigations FYCardiac and vascular investigations (excl enzyme tests) FInvestigations FGENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1446 N DV 3.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDlHrlDWD,Hr},BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDlHrlDWD,Hr},......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1091 10911436109114361091A@wrist fracture Wrist fracture FR1Injury, poisoning and procedural complications FWrist fracture FR1Limb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2020-07 2020-07 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 01Jul2020D-169 31Jul2020D-139 N DV 0.47 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDlHrlDWD,Hr},BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDlHrlDWD,Hr},......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1091 10911437109114371091A broken left arm Upper limb fracture FRInjury, poisoning and procedural complications FArm fracture FVgLimb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2015 2015 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2177 31Dec2015M-1813 N DV 5.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDhHr}hDWD(Hs~m(DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911437109114371091ASeasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1081 N DV 2.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDhHr}hDWD(Hs~m(DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911438109114381091A left wrist fracture Wrist fracture FR1Injury, poisoning and procedural complications FWrist fracture FR1Limb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2014 2014 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2014M-2543 31Dec2014M-2179 N DV 6.97 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDxHr~DWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDxHr~DWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911438109114381091Aleft ankle fracture Ankle fracture FpInjury, poisoning and procedural complications FAnkle fracture FpLimb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2018 2018 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1082 31Dec2018M-718 N DV 2.97 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDxHr~DWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDxHr~DWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911439109114391091ASeasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1082 N DV 2.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrpDWD̜Hs=Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrpDWD0Hr0DWDȠHs DWD̜Hs=Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911440109114401091A0premenarche Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr\DWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr\DWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1091 10911440109114401091A attention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1447 N DV 3.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr\DWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr\DWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1091 10911440109114401091A@seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-717 N DV 1.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr\DWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr\DWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1091 10911440109114401091AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-09 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Sep2020D-108 N DV 0.3 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr\DWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr\DWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1091 10911441109114411091Apremenarcheal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWD{Hs&Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWD<Hr<DWDHssDWD{Hs&Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911442109114421091A Left Humeral Fracture Humerus fracture FnInjury, poisoning and procedural complications FHumerus fracture FnLimb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2011 2011 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2011M-3639 31Dec2011M-3275 N DV 9.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWD{Hs&|Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDHrDWDHssDWD{Hs&|Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911442109114421091A0Left Humeral Fracture Repair Fracture treatment FSurgical and medical procedures F<Fracture repair F Fracture treatments (excl skull and spine) FDBone and joint therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2011 2011 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2011M-3639 31Dec2011M-3275 N DV 9.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWD{Hs&|Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDHrDWDHssDWD{Hs&|Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911442109114421091A@asthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2014M-2543 YChronic pulmonary disease DV 6.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWD{Hs&|Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDHrDWDHssDWD{Hs&|Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911442109114421091AAlmond Allergy Food allergy FزImmune system disorders F4Allergy to nuts Fm/Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1813 N DV 4.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWD{Hs&|Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDHrDWDHssDWD{Hs&|Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911443109114431091Ahydrocele repair Hydrocele operation FSurgical and medical procedures F<Hydrocele repair FTesticular and scrotal therapeutic procedures F?Male genital tract therapeutic procedures F"Surgical and medical procedures F<GENERAL MEDICAL HISTORY2010 2010 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4007 31Dec2010M-3643 N DV 10.97 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD8Hr8DWDHrR<BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD8Hr8DWDHrR<......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911444109114441091A@seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2006M-5468 N DV 14.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDPHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDPHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911444109114441091Adifficulty sleeping Insomnia F%Psychiatric disorders F'Difficulty sleeping FȄDisturbances in initiating and maintaining sleep FFSleep disorders and disturbances F6Psychiatric disorders F'GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2181 N DV 5.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDPHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDPHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911444109114441091A histoplasmosis Histoplasmosis F-Infections and infestations FHistoplasmosis F-Histoplasma infections F,Fungal infectious disorders FInfections and infestations FGENERAL MEDICAL HISTORY2015 2015 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2015M-2181 31Dec2015M-1817 N DV 5.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDPHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDPHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911444109114441091A0palmar hyperhidrosis Hyperhidrosis F"Skin and subcutaneous tissue disorders F5Hyperhidrosis F"Apocrine and eccrine gland disorders F&Skin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2020-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2020D-355 N DV 0.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDPHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDPHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911446109114461091A@myringotomy Myringotomy FvSurgical and medical procedures F<Myringotomy FvMiddle ear therapeutic procedures FDHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2009 2009 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2009M-4373 31Dec2009M-4009 N DV 11.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDxHrDWDxHrΨpBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDxHrDWDxHrΨp......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911446109114461091Aadenoidectomy Adenoidectomy FNSurgical and medical procedures F<Adenoidectomy FNTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2011 2011 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2011M-3643 31Dec2011M-3279 N DV 9.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDxHrDWDxHrΨpBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDxHrDWDxHrΨp......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911446109114461091A0myringotomy Myringotomy FvSurgical and medical procedures F<Myringotomy FvMiddle ear therapeutic procedures FDHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2011 2011 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2011M-3643 31Dec2011M-3279 N DV 9.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDxHrDWDxHrΨpBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDxHrDWDxHrΨp......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911446109114461091A`tympanoplasty Tympanoplasty FG!Surgical and medical procedures F<Tympanoplasty FG!Middle ear therapeutic procedures FDHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2013 2013 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2013M-2912 31Dec2013M-2548 N DV 7.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDxHrDWDxHrΨpBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDxHrDWDxHrΨp......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911446109114461091APoccasional headaches Headache FNervous system disorders FIntermittent headache F~ Headaches NEC FHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.07 01Jan2015M-2182 N DV 5.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDxHrDWDxHrΨpBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDxHrDWDxHrΨp......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911446109114461091Aptympanoplasty Tympanoplasty FG!Surgical and medical procedures F<Tympanoplasty FG!Middle ear therapeutic procedures FDHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2015 2015 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2015M-2182 31Dec2015M-1818 N DV 5.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDxHrDWDxHrΨpBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDxHrDWDxHrΨp......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911446109114461091A migraines Migraine FONervous system disorders FMigraine FOMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1451 N DV 3.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDxHrDWDxHrΨpBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDxHrDWDxHrΨp......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911448109114481091A0penicillin allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2008M-4739 N DV 12.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDxHrDWDsHšPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDxHrDWDPHr0PDWDwLHssrLDWDsHšPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911448109114481091A peanut allergy Food allergy FزImmune system disorders F4Peanut allergy FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2011M-3643 N DV 9.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDxHrDWDsHšPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDxHrDWDPHr0PDWDwLHssrLDWDsHšPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911448109114481091Aeye surgery Eye operation FSurgical and medical procedures F<Eye operation NOS FEye therapeutic procedures NEC FEye therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2015 2015 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2015M-2182 31Dec2015M-1818 N DV 5.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDxHrDWDsHšPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDxHrDWDPHr0PDWDwLHssrLDWDsHšPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911449109114491091Aattention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1451 N DV 3.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD|HrDWDtHrSPlacebo A .Placebo A .DVD|HrDWDtHrS......Placebo Placebo DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911451109114511091A attention deficit disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018-12 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Dec2018D N DV 2.06 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYNBNT162b2 Phase 2/3 (30 mcg)B2_P23_30Not Treated NOTTRT ...... . .BNT162b2 Phase 2/3 (30 mcg)A ............. .......DV . . .NPhase 3A@12-15 YearsAN NAYEARSC4591001C4591001 1091 10911451109114511091Aamoxicillin allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2012M N DV 8.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYNBNT162b2 Phase 2/3 (30 mcg)B2_P23_30Not Treated NOTTRT ...... . .BNT162b2 Phase 2/3 (30 mcg)A ............. .......DV . . .NPhase 3A@12-15 YearsAN NAYEARSC4591001C4591001 1091 10911452109114521091Aappendectomy Appendicectomy FBSurgical and medical procedures F<Appendectomy F@Large intestine therapeutic procedures F{Gastrointestinal therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2019-05 2019-05 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01May2019D-601 31May2019D-571 N DV 1.65 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWD$HsAPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDyhHrΨDWDlHsvlDWD$HsAPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911452109114521091A appendicitis Appendicitis FCInfections and infestations FAppendicitis FCAbdominal and gastrointestinal infections FܯInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2019-05 2019-05 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01May2019D-601 31May2019D-571 N DV 1.65 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWD$HsAPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDyhHrΨDWDlHsvlDWD$HsAPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911453109114531091Aallergy - omnicef Drug hypersensitivity FImmune system disorders F4Drug allergy FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2008M-4739 N DV 12.98 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD HrDWDHrnBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD HrDWDHrn......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DW=DV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911453109114531091A0patella repair right leg Knee operation FX Surgical and medical procedures F<Knee operation FX Joint therapeutic procedures F5Bone and joint therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2008 2008 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4739 31Dec2008M-4374 N DV 12.98 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD HrDWDHrnBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD HrDWDHrn......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DW=DV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911453109114531091A@seasonal allergy Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2009M-4373 N DV 11.98 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD HrDWDHrnBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD HrDWDHrn......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DW=DV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911453109114531091A lactose intolerant Lactose intolerance FMetabolism and nutrition disorders FLactose intolerant FSugar intolerance (excl glucose intolerance) FSurgical and medical procedures F<Anorectal operation F\>Anorectal therapeutic procedures FGastrointestinal therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 (b)(6) D(b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD0HrV0DWDHrՔPlacebo A .Placebo A .DWD0HrV0DWDHrՔ......Placebo Placebo DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911456109114561091A0anorectal malformation Anorectal malformation FCongenital, familial and genetic disorders FAnorectal malformation FAnorectal disorders congenital FGastrointestinal tract disorders congenital FCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY(b)(6) (b)(6) BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.010(b)(6) D(b)(6)(b)(6) D(b)(6)N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD0HrV0DWDHrՔPlacebo A .Placebo A .DWD0HrV0DWDHrՔ......Placebo Placebo DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911456109114561091A allergic rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.09 01Jan2017M-1458 N DW 3.99 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD0HrV0DWDHrՔPlacebo A .Placebo A .DWD0HrV0DWDHrՔ......Placebo Placebo DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911456109114561091Apgeneralized anxiety disorder Generalised anxiety disorder FPsychiatric disorders F'Generalized anxiety disorder F9Anxiety disorders NEC FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2018M-1093 N DW 3 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD0HrV0DWDHrՔPlacebo A .Placebo A .DWD0HrV0DWDHrՔ......Placebo Placebo DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911456109114561091ATonsilloadenoidectomy Adenotonsillectomy FhSurgical and medical procedures F<Adenotonsillectomy FhTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2018-11 2018-11 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.07 01Nov2018D-789 30Nov2018D-760 N DW 2.16 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD0HrV0DWDHrՔPlacebo A .Placebo A .DWD0HrV0DWDHrՔ......Placebo Placebo DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911456109114561091Asensory processing difficulty Sensory processing disorder FLNervous system disorders FSensory processing disorder FLCortical dysfunction NEC F Neurological disorders NEC FNervous system disorders FGENERAL MEDICAL HISTORY2018-12-12 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 12Dec2018 -748 N DW 2.05 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD0HrV0DWDHrՔPlacebo A .Placebo A .DWD0HrV0DWDHrՔ......Placebo Placebo DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911456109114561091Avertebral body tethering Scoliosis surgery F1Surgical and medical procedures F<Scoliosis surgery F1Spine and spinal cord therapeutic procedures F8Nervous system, skull and spine therapeutic procedures FxSurgical and medical procedures F<GENERAL MEDICAL HISTORY2020-10-202020-10-20BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.08 20Oct2020 -70 20Oct2020 -70 N DW 0.19 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD0HrV0DWDHrՔPlacebo A .Placebo A .DWD0HrV0DWDHrՔ......Placebo Placebo DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911456109114561091A`depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018-12-21 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 21Dec2018 -739 N DW 2.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD0HrV0DWDHrՔPlacebo A .Placebo A .DWD0HrV0DWDHrՔ......Placebo Placebo DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911456109114561091Aidiopathic Scoliosis Scoliosis F1Musculoskeletal and connective tissue disorders FkScoliosis F1Spine and neck deformities FMusculoskeletal and connective tissue deformities (incl intervertebral disc disorders)FYMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2018-12-21 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 21Dec2018 -739 N DW 2.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD0HrV0DWDHrՔPlacebo A .Placebo A .DWD0HrV0DWDHrՔ......Placebo Placebo DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911456109114561091APattention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-07-30 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 30Jul2020 -152 N DW 0.42 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD0HrV0DWDHrՔPlacebo A .Placebo A .DWD0HrV0DWDHrՔ......Placebo Placebo DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1091 10911457109114571091A autism spectrum disorder Autism spectrum disorder FPsychiatric disorders F'Autism spectrum disorder FPervasive developmental disorders NEC F4Developmental disorders NEC FǒPsychiatric disorders F'GENERAL MEDICAL HISTORY2019-04-02 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.09 02Apr2019 -637 N DW 1.75 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDlHrVlDWD͌HrՔBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDlHrVlDWD͌HrՔ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911457109114571091A@congenital nystagmus Congenital nystagmus FCongenital, familial and genetic disorders FCongenital nystagmus FNeurological disorders congenital NEC FNeurological disorders congenital FCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY2019-03-04 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.07 04Mar2019 -666 N DW 1.83 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDlHrVlDWD͌HrՔBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDlHrVlDWD͌HrՔ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911457109114571091Astrabismic amblyopia of right eye Amblyopia strabismic FEye disorders FԯStrabismic amblyopia F;.Amblyopic vision impairment FVision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2019-03-04 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.08 04Mar2019 -666 N DW 1.83 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDlHrVlDWD͌HrՔBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDlHrVlDWD͌HrՔ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911457109114571091Apain amplification syndrome Pain FGeneral disorders and administration site conditions FPain FPain and discomfort NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions FGENERAL MEDICAL HISTORY2018-12-11 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 11Dec2018 -749 N DW 2.05 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDlHrVlDWD͌HrՔBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDlHrVlDWD͌HrՔ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1091 10911457109114571091Asuicidal ideation Suicidal ideation FPlacebo A .Placebo A .DVDHr-DWD0Hr>......Placebo Placebo DVDW.....DV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1123 11231449112314491123A Shellfish allergy Food allergy FزImmune system disorders F4Shellfish allergy F4Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2020-07 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jul2020D-163 N DV 0.45 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr=DWDdHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr=DWDdHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231449112314491123AAcne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2020-10 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Oct2020D-71 N DV 0.2 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr=DWDdHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr=DWDdHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231450112314501123AAttention deficit disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-710 N DV 1.95 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVDHrDDWD|HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDDWDĤHr$DWD|Hs~d|DWD|HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231451112314511123A0Left eye alignment surgery Strabismus correction FSurgical and medical procedures F<Strabismus correction FOrbit and globe therapeutic procedures FEye therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2020-12-012020-12-01BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Dec2020 -14 01Dec2020 -14 N DV 0.04 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr}DW DHr6BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr}DW DHr6......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231451112314511123AAmoxicillin allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4732 N DV 12.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr}DW DHr6BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr}DW DHr6......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231451112314511123A Left esotropia Strabismus F;/Eye disorders FԯMonocular esotropia F\Ocular nerve and muscle disorders F Ocular neuromuscular disorders F Eye disorders FԯGENERAL MEDICAL HISTORY2009-01 2009-01 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2009D-4366 31Jan2009D-4336 N DV 11.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr}DW DHr6BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr}DW DHr6......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231452112314521123A Von Willebrand Disease Von Willebrand's disease FPCongenital, familial and genetic disorders FVon Willebrand's disease FPCoagulation disorders congenital FBlood and lymphatic system disorders congenital FRCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4001 N DV 10.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDxHrxDWDHs~MPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDxHrxDW DHrոDWD\HseDWDHs~MPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231452112314521123AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2011M-3636 N DV 9.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDxHrxDWDHs~MPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDxHrxDW DHrոDWD\HseDWDHs~MPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231453112314531123A Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1079 N DV 2.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231453112314531123ALeft elbow fracture Upper limb fracture FRInjury, poisoning and procedural complications FElbow fracture FΈLimb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2019 2019 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019M-714 31Dec2019M-350 N DV 1.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231454112314541123AFacial/back acne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1444 N DV 3.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDtHrtDWRD Hsk Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDtHrtDWDؐHrDW;D@HsDWRD Hsk Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DW;DWR.DW6DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231455112314551123AFacial acne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1079 N DV 2.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD,Hr,DW DHr>BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD,Hr,DW DHr>......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1123 11231455112314551123A keratosis pilaris bilateral arms Keratosis pilaris FwSkin and subcutaneous tissue disorders F5Keratosis pilaris FwHyperkeratoses F(Cornification and dystrophic skin disorders FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1079 N DV 2.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD,Hr,DW DHr>BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD,Hr,DW DHr>......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1123 11231456112314561123APediatric autoimmune neuropsychiatric disorders associated with streptococcal infectionsPaediatric autoimmune neuropsychiatric disorders associated with streptococcal infectionFSPsychiatric disorders F'Pediatric autoimmune neuropsychiatric disorders associated with streptococcal infectionFObsessive-compulsive disorders and symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2176 N DV 5.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr|DWDHs)Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr|DW DHrDWDHssDWDHs)Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231457112314571123AAcne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019-12 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Dec2019D-381 N DV 1.05 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr`DWD HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr`DW DHrDWD,HsnL,DWD HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231458112314581123AAttention deficit disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1445 N DV 3.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD|HrDW D<Hr3<BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD|HrDW D<Hr3<......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1123 11231458112314581123A Intermittent headaches Headache FNervous system disorders FIntermittent headache F~ Headaches NEC FHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1080 N DV 2.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD|HrDW D<Hr3<BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD|HrDW D<Hr3<......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1123 11231459112314591123AIntermittent headaches Headache FNervous system disorders FIntermittent headache F~ Headaches NEC FHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2176 N DV 5.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr"DW D,Hr%,BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr"DW D,Hr%,......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DW6DV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1123 11231460112314601123AAcne- facial Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2020-08 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Aug2020D-138 N DV 0.38 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD\HrI\DWMD܌Hs Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD\HrI\DWDHraDW8DLHrCLDWMD܌Hs Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DW8DWM.DW6DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231460112314601123A Ankle pain Arthralgia F'Musculoskeletal and connective tissue disorders FkPain ankle FJoint related signs and symptoms F:Joint disorders F-Musculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2020-03 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Mar2020D-291 N DV 0.8 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD\HrI\DWMD܌Hs Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD\HrI\DWDHraDW8DLHrCLDWMD܌Hs Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DW8DWM.DW6DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231461112314611123ABilateral knee pain Arthralgia F'Musculoskeletal and connective tissue disorders FkKnee pain F5Joint related signs and symptoms F:Joint disorders F-Musculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2020-05-15 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 15May2020 -216 N DV 0.59 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrMDW DHr)TBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrMDW DHr)T......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DW9DV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231461112314611123A Left tibia fracture Tibia fracture FAInjury, poisoning and procedural complications FTibia fracture FALimb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2020-05-152020-05-15BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 15May2020 -216 15May2020 -216 N DV 0.59 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrMDW DHr)TBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrMDW DHr)T......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DW9DV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231461112314611123A0Open reduction internal fixation left tibia (ORIF) Open reduction of fracture FZSurgical and medical procedures F<Open reduction of fracture with internal fixation F[Fracture treatments (excl skull and spine) FDBone and joint therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2020-05-152020-05-15BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 15May2020 -216 15May2020 -216 N DV 0.59 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrMDW DHr)TBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrMDW DHr)T......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DW9DV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231465112314651123AFacial acne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2020-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jun2020D-200 N DV 0.55 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrHDWD Hs Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrHDWD Hrh DWD8HswDWD Hs Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231467112314671123AMild asthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2009M-4372 YChronic pulmonary disease DV 11.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr_DWDHsBhPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr_DWDHrDWDtHsnOtDWDHsBhPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231467112314671123A Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2016M-1816 N DV 4.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr_DWDHsBhPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr_DWDHrDWDtHsnOtDWDHsBhPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231468112314681123A Ankyloglossia CONGENITAL Ankyloglossia congenital FVCongenital, familial and genetic disorders FAnkyloglossia congenital FVTongue disorders congenital FB1Gastrointestinal tract disorders congenital FCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY2005 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2005M-5833 N DV 15.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD|Hr`|DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD|Hr`|DWDxxHrDWDHsDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231468112314681123A0Asthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2007M-5103 YChronic pulmonary disease DV 13.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD|Hr`|DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD|Hr`|DWDxxHrDWDHsDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231468112314681123APSeasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2007M-5103 N DV 13.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD|Hr`|DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD|Hr`|DWDxxHrDWDHsDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231468112314681123AAcne vulgaris (facial) Acne FpSkin and subcutaneous tissue disorders F5Acne vulgaris FAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2017M-1450 N DV 3.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD|Hr`|DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD|Hr`|DWDxxHrDWDHsDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231468112314681123A@Depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2019M-720 N DV 1.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD|Hr`|DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD|Hr`|DWDxxHrDWDHsDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231469112314691123ASeborrhea (scalp) Seborrhoea F1Skin and subcutaneous tissue disorders F5Seborrhea capitis F1Sebaceous gland disorders F1Skin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2181 N DV 5.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD|Hr~|DWD|Hrp|BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD|Hr~|DWD|Hrp|......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231470112314701123ASeasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4007 N DV 10.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHs~Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWD HrDWDHHs~MHDWDHs~Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231472112314721123AAcne vulgaris Acne FpSkin and subcutaneous tissue disorders F5Acne vulgaris FAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-720 N DV 1.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD<Hr<DWD Hrc BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD<Hr<DWD Hrc ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231473112314731123ASeasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2181 N DV 5.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD,Hr,DWD(HsTPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD,Hr,DWDLHrͯLDWD\Hss\DWD(HsTPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231474112314741123AAcne vulgaris (facial) Acne FpSkin and subcutaneous tissue disorders F5Acne vulgaris FAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-720 N DV 1.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDӤHrDWD}(Hr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDӤHrDWD}(Hr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231475112314751123AAcne (facial) Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2020-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jun2020D-203 N DV 0.56 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD,Hr,DWD|Hr 0BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD,Hr,DWD|Hr 0......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231477112314771123ASeasonal allergy Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4007 N DV 10.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrżDWD(Hr'BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrżDWD(Hr'......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231478112314781123AAcne vulgaris (facial) Acne FpSkin and subcutaneous tissue disorders F5Acne vulgaris FAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-720 N DV 1.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD4Hr4DWDHr'lPlacebo A .Placebo A .DVD4Hr4DWDHr'l......Placebo Placebo DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231479112314791123A0Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDlHr[Placebo A .Placebo A .DVDHrDWDlHr[......Placebo Placebo DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231479112314791123ACervical lymph node dissection Lymphadenectomy FUSurgical and medical procedures F<Excision of cervical lymph node FLymphoid tissue therapeutic procedures F\Haematological and lymphoid tissue therapeutic procedures F]Surgical and medical procedures F<GENERAL MEDICAL HISTORY2019-05 2019-05 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01May2019D-600 31May2019D-570 N DV 1.65 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDlHr[Placebo A .Placebo A .DVDHrDWDlHr[......Placebo Placebo DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231479112314791123A Cervical lymphadenopathy Lymphadenopathy FBlood and lymphatic system disorders FQLymphadenopathy cervical FLymphatic system disorders NEC FSpleen, lymphatic and reticuloendothelial system disorders F9)Blood and lymphatic system disorders FQGENERAL MEDICAL HISTORY2019-05 2019-05 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01May2019D-600 31May2019D-570 N DV 1.65 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDlHr[Placebo A .Placebo A .DVDHrDWDlHr[......Placebo Placebo DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231482112314821123A Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1817 N DV 4.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD@HrDWD8HrbBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD@HrDWD8Hrb......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231482112314821123AIrritable contact dermatitis Dermatitis contact FSkin and subcutaneous tissue disorders F5Contact dermatitis FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2020-12-20 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 20Dec2020 -2 N DV 0.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD@HrDWD8HrbBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD@HrDWD8Hrb......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231483112314831123A@Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010-08 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Aug2010D-3796 N DV 10.4 YEARSAYEARS12-15 YearsAFA MULTIPLE A`MULTIRACIAL A`YYPlacebo PLACEBO Placebo PLACEBO DVD8HrDWD,HrPlacebo A .Placebo A .DVD8HrDWD,Hr......Placebo Placebo DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231483112314831123A Attention Deficit Disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2013-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2013D-2912 N DV 7.98 YEARSAYEARS12-15 YearsAFA MULTIPLE A`MULTIRACIAL A`YYPlacebo PLACEBO Placebo PLACEBO DVD8HrDWD,HrPlacebo A .Placebo A .DVD8HrDWD,Hr......Placebo Placebo DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231483112314831123AAcne vulgaris (facial) Acne FpSkin and subcutaneous tissue disorders F5Acne vulgaris FAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2019M-721 N DV 1.98 YEARSAYEARS12-15 YearsAFA MULTIPLE A`MULTIRACIAL A`YYPlacebo PLACEBO Placebo PLACEBO DVD8HrDWD,HrPlacebo A .Placebo A .DVD8HrDWD,Hr......Placebo Placebo DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231483112314831123A0Depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019-09 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Sep2019D-478 N DV 1.31 YEARSAYEARS12-15 YearsAFA MULTIPLE A`MULTIRACIAL A`YYPlacebo PLACEBO Placebo PLACEBO DVD8HrDWD,HrPlacebo A .Placebo A .DVD8HrDWD,Hr......Placebo Placebo DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231485112314851123A Penicillin allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4739 N DV 12.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD$HrͤDWDdHsHdPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD$HrͤDWD0Hrb0DWDHsL|DWDdHsHdPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231485112314851123AAsthma (mild, intermittent) Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2015M-2182 YChronic pulmonary disease DV 5.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD$HrͤDWDdHsHdPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD$HrͤDWD0Hrb0DWDHsL|DWDdHsHdPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231486112314861123ASeasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2006M-5469 N DV 14.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDDWD HrRBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDDWD HrR......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231488112314881123A Sleep apnea Sleep apnoea syndrome F6Respiratory, thoracic and mediastinal disorders F-Sleep apnea F6Breathing abnormalities F>Respiratory disorders NEC F-Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2011 2012 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2011M-3643 31Dec2012M-2913 N DV 9.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD HrDWDHrdBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD HrDWDHrd......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231488112314881123A0Tonsils shaved (adenoidectomy) Adenoidectomy FNSurgical and medical procedures F<Adenoidectomy FNTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2012 2012 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2012M-3278 31Dec2012M-2913 N DV 8.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD HrDWDHrdBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD HrDWDHrd......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231488112314881123AChronic ear infection Ear infection F;Infections and infestations FEar infection F;Ear infections F=Infections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2013 2014 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2013M-2912 31Dec2014M-2183 N DV 7.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD HrDWDHrdBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD HrDWDHrd......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231488112314881123A@Tympanostomy Myringotomy FvSurgical and medical procedures F<Myringotomy FvMiddle ear therapeutic procedures FDHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2014 2015 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2014M-2547 31Dec2015M-1818 N DV 6.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD HrDWDHrdBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD HrDWDHrd......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231489112314891123A Seasonal allergy Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr8BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr8......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231489112314891123ACephalosporin allergy Drug hypersensitivity FImmune system disorders F4Allergic reaction to antibiotics F8Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4739 N DV 12.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr8BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr8......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231491112314911123AAttention deficit hyperactive disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit/hyperactivity disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1451 N DV 3.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDxHrDWDxHr1Placebo A .Placebo A .DVDxHrDWDxHr1......Placebo Placebo DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231493112314931123AAbdominal migraines Abdominal migraine FXGastrointestinal disorders FܛAbdominal migraine FXGastrointestinal and abdominal pains (excl oral and throat) F܆Gastrointestinal signs and symptoms FGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2183 N DW 5.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDWDDHrќBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDWDDHrќ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231493112314931123A0Obesity Obesity F ;Metabolism and nutrition disorders FObesity F ;General nutritional disorders NEC FAppetite and general nutritional disorders FJMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2018M-1087 N DW 2.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDWDDHrќBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDWDDHrќ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231493112314931123A Left finger amputations Finger amputation FצSurgical and medical procedures F<Finger amputation FצLimb therapeutic procedures F6Bone and joint therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2020-07 2020-07 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jul2020D-175 31Jul2020D-145 N DW 0.48 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDWDDHrќBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDWDDHrќ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231494112314941123AAsthma (mild, intermittent) Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2020-01-29 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 29Jan2020 -329 YChronic pulmonary disease DW 0.9 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD@Hr!@DWD`Hr\`BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD@Hr!@DWD`Hr\`......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231495112314951123AFacial acne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-722 N DW 1.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr)DWD͌Hr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr)DWD͌Hr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231497112314971123A Attention deficit hyperactive disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit/hyperactivity disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3279 N DW 8.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD,Hr5,DWDtHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD,Hr5,DWD0Hr0DWDHsDWDtHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231497112314971123AAcne vulgaris - facial Acne FpSkin and subcutaneous tissue disorders F5Acne vulgaris FAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019M-722 N DW 1.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD,Hr5,DWDtHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD,Hr5,DWD0Hr0DWDHsDWDtHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231500112315001123A Asthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3284 YChronic pulmonary disease DW 8.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDDWDHrSBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDDWDHrS......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231500112315001123A0Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2012 2020-01 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2012M-3284 31Jan2020D-332 N DW 8.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDDWDHrSBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDDWDHrS......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231500112315001123AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-07 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jul2020D-180 N DW 0.5 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDDWDHrSBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDDWDHrS......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231501112315011123AAttention deficit hyperactive disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit/hyperactivity disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1092 N DW 2.99 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDŽDWDHs_Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDŽDW9DHr~DWD@HswDWDHs_Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW9.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231502112315021123AAcne vulgaris - facial Acne FpSkin and subcutaneous tissue disorders F5Acne vulgaris FAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1092 N DW 2.99 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD|HrDWD(HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD|HrDWD(Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231503112315031123ASeasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4014 N DW 10.99 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDpHrDWDƄHs„Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDpHrDWDHrKDWD8HswDWDƄHs„Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231506112315061123A@Intermittent headaches Headache FNervous system disorders FIntermittent headache F~ Headaches NEC FHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2018-08 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Aug2018D-880 N DW 2.41 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD<HrDWD`Hrf`BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD<HrDWD`Hrf`......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231506112315061123A0Eczema Eczema FSkin and subcutaneous tissue disorders F5Eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2009M-4379 N DW 11.99 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD<HrDWD`Hrf`BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD<HrDWD`Hrf`......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231506112315061123A`insomnia Insomnia F%Psychiatric disorders F'Insomnia F%Disturbances in initiating and maintaining sleep FFSleep disorders and disturbances F6Psychiatric disorders F'GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2015M-2188 N DW 5.99 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD<HrDWD`Hrf`BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD<HrDWD`Hrf`......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231506112315061123A Attention deficit hyperactive disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit/hyperactivity disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016-07 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jul2016D-1641 N DW 4.5 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD<HrDWD`Hrf`BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD<HrDWD`Hrf`......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231506112315061123AAcne vulgaris - facial Acne FpSkin and subcutaneous tissue disorders F5Acne vulgaris FAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jun2018D-941 N DW 2.58 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD<HrDWD`Hrf`BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD<HrDWD`Hrf`......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231506112315061123APSeasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015-03 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Mar2015D-2129 N DW 5.83 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD<HrDWD`Hrf`BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD<HrDWD`Hrf`......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231507112315071123APSeasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2008M-4745 N DW 12.99 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD0HrDWDhHrmhBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD0HrDWDhHrmh......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231507112315071123A Attention deficit hyperactive disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit/hyperactivity disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2013M-2918 N DW 7.99 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD0HrDWDhHrmhBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD0HrDWDhHrmh......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231507112315071123A@Migraines Migraine FONervous system disorders FMigraine FOMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2015M-2188 N DW 5.99 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD0HrDWDhHrmhBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD0HrDWDhHrmh......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231507112315071123AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018-10 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Oct2018D-819 N DW 2.25 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD0HrDWDhHrmhBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD0HrDWDhHrmh......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231507112315071123A0Depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018-10 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Oct2018D-819 N DW 2.25 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD0HrDWDhHrmhBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD0HrDWDhHrmh......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231508112315081123AEczema Eczema FSkin and subcutaneous tissue disorders F5Eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2013M-2918 N DW 7.99 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDlHrDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDlHrDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231508112315081123A0Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2013M-2918 N DW 7.99 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDlHrDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDlHrDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231508112315081123A Environmental allergies Hypersensitivity FImmune system disorders F4Environmental allergy FTAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2017M-1457 N DW 3.99 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDlHrDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDlHrDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231509112315091123AAcne vulgaris - facial Acne FpSkin and subcutaneous tissue disorders F5Acne vulgaris FAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-728 N DW 2 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDHsZPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDWDʀHrنDWDHs~kDWDHsZPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231510112315101123AAttention deficit hyperactive disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit/hyperactivity disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1824 N DW 5 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDWDՄHrDWDTHs} DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231511112315111123AAttention deficit hyperactive disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit/hyperactivity disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2013M-2920 N DW 8 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD`HrJDWDHrXBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD`HrJDWDHrX......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.....DW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231512112315121123APenicillin allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2009M-4381 N DW 12 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrKDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrKDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.....DW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231513112315131123ASkin abscess incision and drainage (furuncles) Abscess drainage FSurgical and medical procedures F<Skin abscess drainage FTherapeutic procedures NEC FTherapeutic procedures and supportive care NEC F@Surgical and medical procedures F<GENERAL MEDICAL HISTORY(b)(6) 2009-01 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) D(b)(6)31Jan2009D-4351 N DW (b)(6)YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrPDWDHs:<Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrPDWDǰHr1DWD8Hs98DWDHs:<Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231514112315141123ANevus flammeus Naevus flammeus FCongenital, familial and genetic disorders FNevus flammeus FSkin and subcutaneous tissue disorders congenital NEC F6Skin and subcutaneous tissue disorders congenital F5Congenital, familial and genetic disorders FGENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD8HrDWDHHs~HPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD8HrDWD HrՍ DWDHs|ՔDWDHHs~HPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231514112315141123A Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4016 N DW 11 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD8HrDWDHHs~HPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD8HrDWD HrՍ DWDHs|ՔDWDHHs~HPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231515112315151123ATonsillar hypertrophy Tonsillar hypertrophy FBcRespiratory, thoracic and mediastinal disorders F-Tonsillar hypertrophy FBcPharyngeal disorders (excl infections and neoplasms) FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4747 N DW 13 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD\HrDWDŔHrՌPlacebo A .Placebo A .DWD\HrDWDŔHrՌ......Placebo Placebo DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231515112315151123A bilateral Cervical lymphadenopathy Lymphadenopathy FBlood and lymphatic system disorders FQLymphadenopathy cervical FLymphatic system disorders NEC FSpleen, lymphatic and reticuloendothelial system disorders F9)Blood and lymphatic system disorders FQGENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2008M-4747 N DW 13 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD\HrDWDŔHrՌPlacebo A .Placebo A .DWD\HrDWDŔHrՌ......Placebo Placebo DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231516112315161123AAsthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2011-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2011D-3651 YChronic pulmonary disease DW 10 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD8HrDWD,HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD8HrDWDHr:DWDHsDWD,HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231516112315161123A0Peanut allergy Food allergy FزImmune system disorders F4Peanut allergy FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008-07 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jul2008D-4565 N DW 12.5 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD8HrDWD,HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD8HrDWDHr:DWDHsDWD,HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231516112315161123A@Tree nut allergy Food allergy FزImmune system disorders F4Allergy to nuts Fm/Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008-07 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jul2008D-4565 N DW 12.5 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD8HrDWD,HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD8HrDWDHr:DWDHsDWD,HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231516112315161123A Contact dermatitis - irritable Dermatitis contact FSkin and subcutaneous tissue disorders F5Dermatitis irritant contact Fs\Dermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2020-12-16 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 16Dec2020 -14 N DW 0.04 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD8HrDWD,HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD8HrDWDHr:DWDHsDWD,HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231517112315171123APenicillin allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2190 N DW 6 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD$HrDWDxHr{xBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD$HrDWDxHr{x......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231518112315181123AEczema Eczema FSkin and subcutaneous tissue disorders F5Eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2007-03 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Mar2007D-5053 N DW 13.84 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr|DWDHr;BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr|DWDHr;......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231518112315181123A Fractured distal radius left Radius fracture F**Injury, poisoning and procedural complications FRadius fracture F**Limb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2017-10 2017-10 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Oct2017D-1186 31Oct2017D-1156 N DW 3.25 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr|DWDHr;BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr|DWDHr;......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231518112315181123A0Radial fracture fixation left Fracture treatment FSurgical and medical procedures F<Fracture treatment FFracture treatments (excl skull and spine) FDBone and joint therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2017-10 2017-10 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Oct2017D-1186 31Oct2017D-1156 N DW 3.25 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr|DWDHr;BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr|DWDHr;......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231519112315191123A Attention deficit disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019-12 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Dec2019D-395 N DW 1.08 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD\HrDWD4Hr4BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD\HrDWD4Hr4......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231519112315191123AAcetaminophen allergy Drug hypersensitivity FImmune system disorders F4Allergic reaction to analgesics FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2010M-4016 N DW 11 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD\HrDWD4Hr4BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD\HrDWD4Hr4......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231519112315191123A0Erythromycin allergy Drug hypersensitivity FImmune system disorders F4Allergic reaction to antibiotics F8Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2010M-4016 N DW 11 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD\HrDWD4Hr4BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD\HrDWD4Hr4......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231520112315201123A Chronic constipation Constipation FGastrointestinal disorders FܛConstipation chronic FGastrointestinal atonic and hypomotility disorders NEC F܍Gastrointestinal motility and defaecation conditions FܹGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3286 N DW 9 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDXHrDWDXHs(XPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDXHrDWDLHrzLDWDLHswDWDXHs(XPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231520112315201123AAcne vulgaris -facial Acne FpSkin and subcutaneous tissue disorders F5Acne vulgaris FAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019M-729 N DW 2 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDXHrDWDXHs(XPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDXHrDWDLHrzLDWDLHswDWDXHs(XPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231521112315211123A@premenarche Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDXHrDWDHrzBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDXHrDWDHrz......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231521112315211123A0Penicillin allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2009M-4381 N DW 12 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDXHrDWDHrzBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDXHrDWDHrz......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231521112315211123A Chronic constipation Constipation FGastrointestinal disorders FܛConstipation chronic FGastrointestinal atonic and hypomotility disorders NEC F܍Gastrointestinal motility and defaecation conditions FܹGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3286 N DW 9 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDXHrDWDHrzBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDXHrDWDHrz......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231521112315211123AAcne vulgaris - facial Acne FpSkin and subcutaneous tissue disorders F5Acne vulgaris FAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2019M-729 N DW 2 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDXHrDWDHrzBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDXHrDWDHrz......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231522112315221123AEosinophilic esophagitis Eosinophilic oesophagitis FTGastrointestinal disorders FܛEosinophilic esophagitis F\Oesophagitis (excl infective) Ff3Gastrointestinal inflammatory conditions FܱGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1831 N DW 5.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DĤHrh$DWDHsj8Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DĤHrh$DW"DHr/DWDHssDWDHsj8Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW".DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231522112315221123A Hazelnut allergy Food allergy FزImmune system disorders F4Allergy to nuts Fm/Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2016M-1831 N DW 5.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DĤHrh$DWDHsj8Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DĤHrh$DW"DHr/DWDHssDWDHsj8Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW".DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231522112315221123A0Peanut allergy Food allergy FزImmune system disorders F4Peanut allergy FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2016M-1831 N DW 5.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DĤHrh$DWDHsj8Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DĤHrh$DW"DHr/DWDHssDWDHsj8Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW".DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231522112315221123A@Sesame seed allergy Food allergy FزImmune system disorders F4Food allergy FزAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2016M-1831 N DW 5.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DĤHrh$DWDHsj8Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DĤHrh$DW"DHr/DWDHssDWDHsj8Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW".DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231522112315221123APUpper endoscopy Endoscopy upper gastrointestinal tract FcInvestigations FEndoscopy upper gastrointestinal tract FcGastrointestinal and abdominal imaging procedures FܫGastrointestinal investigations FܳInvestigations FGENERAL MEDICAL HISTORY2018 2018 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2018M-1100 31Dec2018M-736 N DW 3.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DĤHrh$DWDHsj8Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DĤHrh$DW"DHr/DWDHssDWDHsj8Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW".DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231523112315231123AHivschsprung's disease Congenital megacolon FCongenital, familial and genetic disorders FHirschsprung's disease F Intestinal disorders congenital FGastrointestinal tract disorders congenital FCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY(b)(6) (b)(6) BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6)(b)(6) (b)(6)N DW (b)(6)YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DĤHrh$DWDHsjtPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DĤHrh$DW"DPHr/PDWDHssDWDHsjtPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW".DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231523112315231123A Hivschsprung's surgical repair Colon operation FSurgical and medical procedures F<Colon operation FLarge intestine therapeutic procedures F{Gastrointestinal therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY(b)(6) (b)(6) BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 (b)(6) (b)(6)(b)(6) (b)(6)N DW (b)(6)YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DĤHrh$DWDHsjtPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DĤHrh$DW"DPHr/PDWDHssDWDHsjtPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW".DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231524112315241123A0Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2010M-4022 N DW 11.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW D@HrĀDW$DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW D@HrĀDW$DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW$....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231524112315241123AAppendectomy Appendicectomy FBSurgical and medical procedures F<Appendectomy F@Large intestine therapeutic procedures F{Gastrointestinal therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2018-03 2018-03 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Mar2018D-1041 31Mar2018D-1011 N DW 2.85 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW D@HrĀDW$DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW D@HrĀDW$DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW$....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231524112315241123A Appendicitis Appendicitis FCInfections and infestations FAppendicitis FCAbdominal and gastrointestinal infections FܯInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2018-03 2018-03 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Mar2018D-1041 31Mar2018D-1011 N DW 2.85 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW D@HrĀDW$DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW D@HrĀDW$DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW$....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231525112315251123AScoliosis Scoliosis F1Musculoskeletal and connective tissue disorders FkScoliosis F1Spine and neck deformities FMusculoskeletal and connective tissue deformities (incl intervertebral disc disorders)FYMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1467 N DW 4.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr/xDW%D4Hr!BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr/xDW%D4Hr!......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1123 11231526112315261123APsoriasis Psoriasis F'Skin and subcutaneous tissue disorders F5Psoriasis F'Psoriatic conditions FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2020-02 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Feb2020D-342 N DW 0.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDLHrLDWD Hs}Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDLHrLDW%DHrXDWD Hs}DWD Hs}Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DW..DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1123 11231526112315261123A Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2010M-4025 N DW 11.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDLHrLDWD Hs}Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDLHrLDW%DHrXDWD Hs}DWD Hs}Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DW..DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1124 11241236112412361124AAllergy to bees Allergy to arthropod sting Fz,Immune system disorders F4Bee sting hypersensitivity FAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2020-09 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Sep2020D-104 N DV 0.29 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DVDHrA,DW DXHrXPlacebo A .Placebo A .DVDHrA,DW DXHrX......Placebo Placebo DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1124 11241239112412391124Aeczema bilateral hands Hand dermatitis F|Skin and subcutaneous tissue disorders F5Hand eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2008M-4731 N DV 12.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrz\DWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrz\DWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1124 11241239112412391124A seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2009M-4365 N DV 11.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrz\DWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrz\DWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1124 11241240112412401124AAcne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018 2020-01 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1078 31Jan2020D-318 N DV 2.95 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHsޤPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDW DшHr#DWDxHsrDWDHsޤPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1124 11241241112412411124AAsthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4000 YChronic pulmonary disease DV 10.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDLHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDLHrDW DHr#DWDHsrDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1124 11241242112412421124A right scrotum cyst removal Scrotal cystectomy FiSurgical and medical procedures F<Scrotal cystectomy FiTesticular and scrotal therapeutic procedures F?Male genital tract therapeutic procedures F"Surgical and medical procedures F<GENERAL MEDICAL HISTORY2009 2009 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2009M-4365 31Dec2009M-4001 N DV 11.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDDW D\HrsPlacebo A .Placebo A .DVDHrDDW D\Hrs......Placebo Placebo DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1124 11241242112412421124Aleft scrotum cyst removal Scrotal cystectomy FiSurgical and medical procedures F<Scrotal cystectomy FiTesticular and scrotal therapeutic procedures F?Male genital tract therapeutic procedures F"Surgical and medical procedures F<GENERAL MEDICAL HISTORY2013 2013 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2013M-2904 31Dec2013M-2540 N DV 7.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDDW D\HrsPlacebo A .Placebo A .DVDHrDDW D\Hrs......Placebo Placebo DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1124 11241243112412431124A High Functioning Autism Autism spectrum disorder FPsychiatric disorders F'Autism F]Pervasive developmental disorders NEC F4Developmental disorders NEC FǒPsychiatric disorders F'GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4001 N DV 10.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDW D$HrčBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDW D$Hrč......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1124 11241243112412431124AAttention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2013M-2905 N DV 7.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDW D$HrčBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDW D$Hrč......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1124 11241244112412441124A@constipation Constipation FGastrointestinal disorders FܛConstipation FGastrointestinal atonic and hypomotility disorders NEC F܍Gastrointestinal motility and defaecation conditions FܹGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2016M-1810 N DV 4.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDˬHrDW DHrh`BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDˬHrDW DHrh`......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1124 11241244112412441124AAttention deficit disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1444 N DV 3.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDˬHrDW DHrh`BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDˬHrDW DHrh`......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1124 11241244112412441124A0anxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2018M-1079 N DV 2.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDˬHrDW DHrh`BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDˬHrDW DHrh`......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1124 11241244112412441124A MIGRAINE HEADACHES Migraine FONervous system disorders FMigraine headache FRMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-714 N DV 1.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDˬHrDW DHrh`BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDˬHrDW DHrh`......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1124 11241245112412451124AAttention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2175 N DV 5.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1124 11241245112412451124A spinal scoliosis Scoliosis F1Musculoskeletal and connective tissue disorders FkScoliosis F1Spine and neck deformities FMusculoskeletal and connective tissue deformities (incl intervertebral disc disorders)FYMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019M-714 N DV 1.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1124 11241246112412461124AAttention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2175 N DV 5.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDhHrhDWD0Hr0BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDhHrhDWD0Hr0......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1124 11241248112412481124Aallergy to penicillin Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2008M-4733 N DV 12.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrۀDWD܌Hs،Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrۀDWDHr~DWDۜHsrDWD܌Hs،Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1124 11241248112412481124A allergy to polytrim eye drops Drug hypersensitivity FImmune system disorders F4Allergy to antibiotic FxAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2010M-4002 N DV 10.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrۀDWD܌Hs،Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrۀDWDHr~DWDۜHsrDWD܌Hs،Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1124 11241248112412481124A0anxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2015M-2176 N DV 5.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrۀDWD܌Hs،Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrۀDWDHr~DWDۜHsrDWD܌Hs،Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1124 11241248112412481124A@right broken arm Upper limb fracture FRInjury, poisoning and procedural complications FArm fracture FVgLimb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2020-11-182020-11-18BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 18Nov2020 -28 18Nov2020 -28 N DV 0.08 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrۀDWD܌Hs،Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrۀDWDHr~DWDۜHsrDWD܌Hs،Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1124 11241249112412491124APremature Birth Premature baby F%nPregnancy, puerperium and perinatal conditions F%iPremature birth F%rGestational age and weight conditions FݠNeonatal and perinatal conditions FxPregnancy, puerperium and perinatal conditions F%iGENERAL MEDICAL HISTORY(b)(6) 2006 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6)31Dec2006M-5099 N DV (b)(6)YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDʀHrDW DHr4BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDʀHrDW DHr4......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1124 11241250112412501124AAsthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2014M-2542 YChronic pulmonary disease DV 6.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr{DWD8Hs>8Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr{DWD4Hr/DWDXHsrDWD8Hs>8Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1124 11241250112412501124A Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2177 N DV 5.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr{DWD8Hs>8Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr{DWD4Hr/DWDXHsrDWD8Hs>8Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1124 11241253112412531124AAllergy to Amoxicillin Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2012M-3274 N DV 8.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr?BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr?......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1124 11241253112412531124A Attention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1082 N DV 2.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr?BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr?......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1124 11241253112412531124A0Migraine headaches Migraine FONervous system disorders FMigraine headache FRMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019M-717 N DV 1.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr?BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr?......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1124 11241254112412541124A0Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4735 N DV 12.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDLHrDWDHr>BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDLHrDWDHr>......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1124 11241254112412541124A Pneumonia Pneumonia F!Infections and infestations FPneumonia F!Lower respiratory tract and lung infections FInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2010 2010 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2010M-4004 31Dec2010M-3640 N DV 10.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDLHrDWDHr>BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDLHrDWDHr>......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1124 11241254112412541124AAttention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2017M-1447 N DV 3.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDLHrDWDHr>BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDLHrDWDHr>......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1124 11241254112412541124A@Tourette's Syndrome Tourette's disorder FBCongenital, familial and genetic disorders FTourette's syndrome FBNeurological disorders congenital NEC FNeurological disorders congenital FCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY2020-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2020D-352 N DV 0.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDLHrDWDHr>BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDLHrDWDHr>......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1124 11241255112412551124A@umbilical hernia Umbilical hernia FHGastrointestinal disorders FܛUmbilical hernia FHUmbilical hernias FHAbdominal hernias and other abdominal wall conditions FGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2007 2009 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2007M-5100 31Dec2009M-4005 N DV 13.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD0HrհDWDDHsDPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD0HrհDWD$Hr$DWD0Hsu*DWDDHsDPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1124 11241255112412551124APumbilical hernia surgery Umbilical hernia repair FHSurgical and medical procedures F<Umbilical hernia repair FHHernia repairs F[Gastrointestinal therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2009 2009 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2009M-4369 31Dec2009M-4005 N DV 11.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD0HrհDWDDHsDPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD0HrհDWD$Hr$DWD0Hsu*DWDDHsDPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1124 11241255112412551124A Adenoidectomy Adenoidectomy FNSurgical and medical procedures F<Adenoidectomy FNTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2014 2014 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2014M-2543 31Dec2014M-2179 N DV 6.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD0HrհDWDDHsDPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD0HrհDWD$Hr$DWD0Hsu*DWDDHsDPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1124 11241255112412551124A0Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1447 N DV 3.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD0HrհDWDDHsDPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD0HrհDWD$Hr$DWD0Hsu*DWDDHsDPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1124 11241255112412551124AAcne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2018M-1082 N DV 2.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD0HrհDWDDHsDPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD0HrհDWD$Hr$DWD0Hsu*DWDDHsDPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1124 11241257112412571124AAllergy to Penicillin Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2009M-4373 N DV 11.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr`DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr`DWDHrͷDWDxHsrDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1124 11241257112412571124A Seasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2020-05 2020-08 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01May2020D-235 31Aug2020D-113 N DV 0.65 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr`DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr`DWDHrͷDWDxHsrDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1124 11241259112412591124AAllergy to Sulfa Drug hypersensitivity FImmune system disorders F4Sulfonamide allergy FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2010M-4009 N DW 10.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr&DWDXHrdXBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr&DWDXHrdX......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1124 11241259112412591124A Pneumonia Pneumonia F!Infections and infestations FPneumonia F!Lower respiratory tract and lung infections FInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2019 2019 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-722 31Dec2019M-358 N DW 1.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr&DWDXHrdXBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr&DWDXHrdX......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1124 11241260112412601124AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2183 N DW 5.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr(DWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr(DWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1124 11241260112412601124A Depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2015 2019 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2015M-2183 31Dec2019M-358 N DW 5.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr(DWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr(DWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1124 11241261112412611124AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1087 N DW 2.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr2DWDߘHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr2DWDߘHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1124 11241261112412611124A Seasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010-09 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Sep2010D-3766 N DW 10.31 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr2DWDߘHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr2DWDߘHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1124 11241262112412621124A`Eczema Eczema FSkin and subcutaneous tissue disorders F5Eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2005 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2005M-5835 N DW 15.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDθHrNDWD`HrvBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDθHrNDWD`Hrv......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1124 11241262112412621124A Anxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2010M-4009 N DW 10.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDθHrNDWD`HrvBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDθHrNDWD`Hrv......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1124 11241262112412621124A@Attention deficit disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2010M-4009 N DW 10.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDθHrNDWD`HrvBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDθHrNDWD`Hrv......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1124 11241262112412621124A0Asthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2014M-2548 YChronic pulmonary disease DW 6.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDθHrNDWD`HrvBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDθHrNDWD`Hrv......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1124 11241262112412621124APDermatitis Dermatitis FSkin and subcutaneous tissue disorders F5Dermatitis FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2017M-1452 N DW 3.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDθHrNDWD`HrvBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDθHrNDWD`Hrv......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1124 11241262112412621124AAcne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2019M-722 N DW 1.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDθHrNDWD`HrvBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDθHrNDWD`Hrv......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1124 11241268112412681124A Attention deficit disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-04 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Apr2020D-278 N DW 0.76 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DHrDWDټHs<Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DHrDW#DHrbDWDHssDWDټHs<Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1124 11241268112412681124A0Depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2019M-734 N DW 2.01 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DHrDWDټHs<Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DHrDW#DHrbDWDHssDWDټHs<Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1124 11241268112412681124AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2020M-369 N DW 1.01 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DHrDWDټHs<Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DHrDW#DHrbDWDHssDWDټHs<Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1124 11241269112412691124A Attention deficit disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3291 N DW 9.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHr9DW!DdHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHr9DW!DdHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!....DW>DW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1124 11241269112412691124AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2013M-2925 N DW 8.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHr9DW!DdHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHr9DW!DdHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!....DW>DW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1124 11241269112412691124A0Depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2013M-2925 N DW 8.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHr9DW!DdHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHr9DW!DdHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!....DW>DW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1124 11241269112412691124A@Insomnia Insomnia F%Psychiatric disorders F'Insomnia F%Disturbances in initiating and maintaining sleep FFSleep disorders and disturbances F6Psychiatric disorders F'GENERAL MEDICAL HISTORY2020-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jun2020D-217 N DW 0.6 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHr9DW!DdHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHr9DW!DdHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!....DW>DW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1124 11241270112412701124AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4022 N DW 11.01 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DHrą4DWSDנHs Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DHrą4DW"DHr$DW>DݸHsDWSDנHs Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW".DW>DWS.DW>DW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1124 11241271112412711124AAsthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2010M-4022 YChronic pulmonary disease DW 11.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DlHrĐDW"DdHr9dBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DlHrĐDW"DdHr9d......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW"....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1124 11241271112412711124A Seasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4022 N DW 11.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DlHrĐDW"DdHr9dBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DlHrĐDW"DdHr9d......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW"....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1124 11241272112412721124AAllergy to Amoxicillin Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2009M-4387 N DW 12.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DhHrĔDWDxHsxPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DhHrĔDW#D0HrdDWDHssDWDxHsxPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1124 11241272112412721124A Anxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2010M-4022 N DW 11.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DhHrĔDWDxHsxPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DhHrĔDW#D0HrdDWDHssDWDxHsxPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1124 11241272112412721124A0eczema Eczema FSkin and subcutaneous tissue disorders F5Eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2012M-3292 N DW 9.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DhHrĔDWDxHsxPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DhHrĔDW#D0HrdDWDHssDWDxHsxPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1124 11241273112412731124AAllergy to Penicillin Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2197 N DW 6.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDW#DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDW#DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1125 11251241112512411125AAcne on face Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1071 N DV 2.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWD\Hr?BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWD\Hr?......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1125 11251244112512441125AChronic otitis media Otitis media chronic FInfections and infestations FOtitis media chronic FEar infections F=Infections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2007 2007 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2007M-5090 31Dec2007M-4726 N DV 13.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVEF@HrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVEF@HrDWDHr\8DWDHs%DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1125 11251244112512441125A Maxillary balloon surgery Sinuplasty FSurgical and medical procedures F<Balloon sinuplasty F"Paranasal therapeutic procedures FHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2007 2007 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2007M-5090 31Dec2007M-4726 N DV 13.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVEF@HrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVEF@HrDWDHr\8DWDHs%DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1125 11251244112512441125A0Tonsillectomy Tonsillectomy FBfSurgical and medical procedures F<Tonsillectomy FBfTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2012 2012 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2012M-3264 31Dec2012M-2899 N DV 8.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVEF@HrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVEF@HrDWDHr\8DWDHs%DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1125 11251244112512441125A@Tonsillitis Tonsillitis FBhInfections and infestations FTonsillitis FBhUpper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2012 2012 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3264 31Dec2012M-2899 N DV 8.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVEF@HrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVEF@HrDWDHr\8DWDHs%DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1125 11251246112512461125ABilateral ear tympanostomy tubes insertion Ear tube insertion FxSurgical and medical procedures F<Tympanostomy tube insertion Fy*Middle ear therapeutic procedures FDHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2009 2010 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2009M-4361 31Dec2010M-3632 N DV 11.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrxDWDLHrmBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrxDWDLHrm......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1125 11251246112512461125A Chronic otitis media Otitis media chronic FInfections and infestations FOtitis media chronic FEar infections F=Infections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2009 2010 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2009M-4361 31Dec2010M-3632 N DV 11.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrxDWDLHrmBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrxDWDLHrm......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1125 11251249112512491125AOccasional Migraines Migraine FONervous system disorders FMigraine FOMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1806 N DV 4.95 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHs|Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDHrxDWDHsrXDWDHs|Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1125 11251250112512501125ASeasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1078 N DV 2.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrK|DWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrK|DWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1125 11251252112512521125ABilateral tympanostomy tubes insertion Ear tube insertion FxSurgical and medical procedures F<Tympanostomy tube insertion Fy*Middle ear therapeutic procedures FDHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2016 2016 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1811 31Dec2016M-1446 N DV 4.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDϨHr(DWDyHrΩ`BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDϨHr(DWDyHrΩ`......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1125 11251254112512541125AAmoxicillin allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008-12 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Dec2008D-4410 N DW 12.08 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDXHrDWDHsLPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDXHrDWDHrDWDXHssXDWDHsLPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1125 11251255112512551125AAllergy to cottonwood trees Allergy to plants FmImmune system disorders F4Allergy to plants FmAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1101 N DW 3.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDW#D|HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDW#D|Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.....DW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1126 11261235112612351126A Exercised Induced Asthma, Stable Asthma exercise induced FeRespiratory, thoracic and mediastinal disorders F-Exercise induced asthma FӡBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2018-12-10 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 10Dec2018 -722 YChronic pulmonary disease DV 1.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD܌Hr[DWDLHsNPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD܌Hr[DWDHHr HDWDHssDWDLHsNPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1126 11261235112612351126ADermatitis Dermatitis FSkin and subcutaneous tissue disorders F5Dermatitis FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2015-08-14 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 14Aug2015 -1936 N DV 5.3 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD܌Hr[DWDLHsNPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD܌Hr[DWDHHr HDWDHssDWDLHsNPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1126 11261239112612391126A Attention Deficit Hyperactivity Disorder, Combined Presentation Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD, combined type FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2015-07-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jul2015 -1981 N DV 5.43 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr] DWD(Hs(Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr] DVD{HrXDWDHsrS0DWD(Hs(Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1126 11261239112612391126AAllergy to Bee Venom Allergy to arthropod sting Fz,Immune system disorders F4Allergy to arthropod sting Fz,Allergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016-05-03 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 03May2016 -1674 N DV 4.59 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr] DWD(Hs(Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr] DVD{HrXDWDHsrS0DWD(Hs(Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1126 11261239112612391126A0Mild Asthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2012-04-252019-05-17BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 25Apr2012 -3143 17May2019 -565 YChronic pulmonary disease DV 8.61 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr] DWD(Hs(Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr] DVD{HrXDWDHsrS0DWD(Hs(Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1126 11261240112612401126AAcne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2020-12-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Dec2020 -1 N DV 0.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr]\DWDHs@Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr]\DVD{HHrXHDWDhHswDWDHs@Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1126 11261240112612401126A Attention Deficit Hyperactivity Disorder, Inattentive Presentation Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2014-04-11 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 11Apr2014 -2427 N DV 6.65 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr]\DWDHs@Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr]\DVD{HHrXHDWDhHswDWDHs@Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1126 11261240112612401126A0Autism Spectrum Disorder Autism spectrum disorder FPsychiatric disorders F'Autism spectrum disorder FPervasive developmental disorders NEC F4Developmental disorders NEC FǒPsychiatric disorders F'GENERAL MEDICAL HISTORY2008-02-27 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 27Feb2008 -4662 N DV 12.77 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr]\DWDHs@Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr]\DVD{HHrXHDWDhHswDWDHs@Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1126 11261240112612401126A@Bilateral Foot Pain, Shallow Arches with Ankle Pronation. Foot deformity FgMusculoskeletal and connective tissue disorders FkFlat feet FExtremity deformities FMusculoskeletal and connective tissue deformities (incl intervertebral disc disorders)FYMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2020-07-27 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 27Jul2020 -128 N DV 0.35 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr]\DWDHs@Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr]\DVD{HHrXHDWDhHswDWDHs@Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1126 11261241112612411126AHeadache Headache FNervous system disorders FHeadache FHeadaches NEC FHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2018-10-09 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 09Oct2018 -785 N DV 2.15 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrpDVDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrpDVDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1126 11261243112612431126A Enuresis Enuresis FPsychiatric disorders F'Enuresis FPsychiatric elimination disorders F'Psychiatric disorders NEC F'Psychiatric disorders F'GENERAL MEDICAL HISTORY2016-10-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Oct2016 -1523 N DV 4.17 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDlHrDVDHrdBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDlHrDVDHrd......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1126 11261243112612431126AConstipation Constipation FGastrointestinal disorders FܛConstipation FGastrointestinal atonic and hypomotility disorders NEC F܍Gastrointestinal motility and defaecation conditions FܹGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2016-10-21 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 21Oct2016 -1503 N DV 4.12 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDlHrDVDHrdBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDlHrDVDHrd......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1126 11261246112612461126A Vocal Cord Nodule Vocal cord thickening FPRespiratory, thoracic and mediastinal disorders F-Vocal cord nodule F-Laryngeal and adjacent sites disorders NEC (excl infections and neoplasms) FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2010-07-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 06Jul2010 -3802 N DV 10.41 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDdHrDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDdHrDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1126 11261246112612461126AUtacaria Urticaria FMSkin and subcutaneous tissue disorders F5Urticaria FMUrticarias FMAngioedema and urticaria FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2009-05-27 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 27May2009 -4207 N DV 11.52 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDdHrDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDdHrDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1126 11261253112612531126A@Oral Allergy Syndrome Oral allergy syndrome FImmune system disorders F4Oral allergy syndrome FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2019-04-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Apr2019 -612 N DV 1.68 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHs3$Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWD Hr# DWDTHsr6DWDHs3$Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1126 11261253112612531126A Elevated Blood Pressure Reading without Hypertension Diagnosis Blood pressure increased FInvestigations FElevated blood pressure reading without diagnosis of hypertension F Vascular tests NEC (incl blood pressure) FNCardiac and vascular investigations (excl enzyme tests) FInvestigations FGENERAL MEDICAL HISTORY2020-11-12 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 12Nov2020 -21 N DV 0.06 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHs3$Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWD Hr# DWDTHsr6DWDHs3$Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1126 11261253112612531126APSeasonal Allergic Rhinitis Seasonal allergy FUImmune system disorders F4Seasonal allergic rhinitis F1Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2013-05-17 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 17May2013 -2757 N DV 7.55 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHs3$Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWD Hr# DWDTHsr6DWDHs3$Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1126 11261253112612531126A0IGA Deficiency Selective IgA immunodeficiency F2kImmune system disorders F4IgA deficiency FPrimary immunodeficiency syndromes F%Immunodeficiency syndromes FTImmune system disorders F4GENERAL MEDICAL HISTORY2012-09-202016-06-09BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 20Sep2012 -2996 09Jun2016 -1638 N DV 8.21 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHs3$Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWD Hr# DWDTHsr6DWDHs3$Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1126 11261253112612531126AAllergy to Mango Food allergy FزImmune system disorders F4Fruit allergy FvAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2020-01-23 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 23Jan2020 -315 N DV 0.87 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHs3$Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWD Hr# DWDTHsr6DWDHs3$Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1126 11261254112612541126AAllergy to Peanuts Food allergy FزImmune system disorders F4Peanut allergy FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2014-09-12 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 12Sep2014 -2274 N DV 6.23 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDdHs Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDW"D͌Hr DWDθHs8DWDdHs Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW".DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1126 11261254112612541126A Left recession of chamber angle Recession of chamber angle of eye F*Eye disorders FԯRecession of chamber angle of eye F*Anterior chamber structural change, deposit and degeneration FAnterior eye structural change, deposit and degeneration FEye disorders FԯGENERAL MEDICAL HISTORY2018-12-28 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 28Dec2018 -706 N DV 1.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDdHs Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDW"D͌Hr DWDθHs8DWDdHs Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW".DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1126 11261255112612551126AAcne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019-04-24 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 24Apr2019 -589 N DV 1.62 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDݸHrDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDݸHrDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1126 11261258112612581126AAcne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019-06-04 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 04Jun2019 -548 N DV 1.5 YEARSAYEARS12-15 YearsAFA MULTIPLE A`MULTIRACIAL A`YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDVDHrpBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDVDHrp......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1126 11261263112612631126AAppendicitis Appendicitis FCInfections and infestations FAppendicitis FCAbdominal and gastrointestinal infections FܯInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2016-10-262016-10-26BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 26Oct2016 -1500 26Oct2016 -1500 N DV 4.11 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr`tDWDHr\BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr`tDWDHr\......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1126 11261263112612631126A Laparoscopic Appendectomy Appendicectomy FBSurgical and medical procedures F<Appendectomy F@Large intestine therapeutic procedures F{Gastrointestinal therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2016-10-262016-10-26BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 26Oct2016 -1500 26Oct2016 -1500 N DV 4.11 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr`tDWDHr\BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr`tDWDHr\......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1126 11261264112612641126A Premenarchal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrnDWDHrJBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrnDWDHrJ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1126 11261264112612641126AAllergy to Amoxicillin Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010-03-29 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 29Mar2010 -3903 N DV 10.69 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrnDWDHrJBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrnDWDHrJ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1126 11261265112612651126A0Attention Deficit Hyperactivity Disorder, Predominantly Inatentive Presentation Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD, predominantly inattentive type FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016-03 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Mar2016D-1749 N DV 4.79 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD<HrDWD(Hs=Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD<HrDW DHrDWDHsuDWD(Hs=Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1126 11261265112612651126AAllergic Rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2017-10-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 06Oct2017 -1165 N DV 3.19 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD<HrDWD(Hs=Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD<HrDW DHrDWDHsuDWD(Hs=Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1126 11261265112612651126A Allergy to Bee Venom Allergy to arthropod sting Fz,Immune system disorders F4Allergy to arthropod sting Fz,Allergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017-08-28 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 28Aug2017 -1204 N DV 3.3 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD<HrDWD(Hs=Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD<HrDW DHrDWDHsuDWD(Hs=Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1126 11261268112612681126A@Premenarchal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.07 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr?DW D,HrąBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr?DW D,Hrą......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1126 11261268112612681126AAllergy to Bee Venom Allergy to arthropod sting Fz,Immune system disorders F4Allergy to arthropod sting Fz,Allergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010-10-07 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 07Oct2010 -3721 N DV 10.19 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr?DW D,HrąBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr?DW D,Hrą......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1126 11261268112612681126A`Urticaria, No Known Triggers Urticaria FMSkin and subcutaneous tissue disorders F5Urticaria FMUrticarias FMAngioedema and urticaria FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2010-10-07 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 07Oct2010 -3721 N DV 10.19 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr?DW D,HrąBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr?DW D,Hrą......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1126 11261268112612681126ApVerruca Vulgaris Skin papilloma F6KNeoplasms benign, malignant and unspecified (incl cysts and polyps)F0Verruca vulgaris FOZSkin neoplasms benign F6BCutaneous neoplasms benign F6CNeoplasms benign, malignant and unspecified (incl cysts and polyps)F0GENERAL MEDICAL HISTORY2017-11-09 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 09Nov2017 -1131 N DV 3.1 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr?DW D,HrąBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr?DW D,Hrą......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1126 11261268112612681126APRight Hip Flexor Strain Muscle strain FYInjury, poisoning and procedural complications FMuscle strain FYMuscle, tendon and ligament injuries FInjuries NEC FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2020-11-12 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 12Nov2020 -32 N DV 0.09 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr?DW D,HrąBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr?DW D,Hrą......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1126 11261268112612681126A Juvenile Osteochondrosis of Right Tarsal Osteochondrosis FMusculoskeletal and connective tissue disorders FkJuvenile osteochondrosis F[Cartilage disorders FTendon, ligament and cartilage disorders F?eMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2020-06-25 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 25Jun2020 -172 N DV 0.47 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr?DW D,HrąBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr?DW D,Hrą......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1126 11261268112612681126A0Left Proximal Radius Fracture Radius fracture F**Injury, poisoning and procedural complications FRadius fracture F**Limb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2012-07-272012-08-22BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 27Jul2012 -3062 22Aug2012 -3036 N DV 8.39 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr?DW D,HrąBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr?DW D,Hrą......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1126 11261269112612691126ARight Lesser Toe Proximal Phalanx Fracture Foot fracture FInjury, poisoning and procedural complications FFractured toe F"Limb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2020-12-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01201Dec2020 -13 N DV 0.04 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrZ@DWDLHrřLBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrZ@DWDLHrřL......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1126 11261269112612691126ApGeneralized Anxiety Disorder Generalised anxiety disorder FPsychiatric disorders F'Generalized anxiety disorder F9Anxiety disorders NEC FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-06-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jun2020 -196 N DV 0.54 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrZ@DWDLHrřLBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrZ@DWDLHrřL......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1126 11261269112612691126AMajor Depressive Disorder, Single Episode Major depression FxpPsychiatric disorders F'Major depressive disorder, single episode FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-06-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jun2020 -196 N DV 0.54 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrZ@DWDLHrřLBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrZ@DWDLHrřL......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1126 11261269112612691126A`Excision of Sesamoid Bone, Left Ostectomy FfSurgical and medical procedures F<Ostectomy FfBone therapeutic procedures NEC FBone and joint therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2019-10-032019-10-03BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01103Oct2019 -438 03Oct2019 -438 N DV 1.2 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrZ@DWDLHrřLBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrZ@DWDLHrřL......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1126 11261269112612691126ALeft Sesamoid Foot Fracture Foot fracture FInjury, poisoning and procedural complications FFoot fracture FLimb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2019-03-062019-10-03BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.08 06Mar2019 -649 03Oct2019 -438 N DV 1.78 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrZ@DWDLHrřLBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrZ@DWDLHrřL......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1126 11261269112612691126AUrticaria, Triggered by Eggs and Seasame Urticaria FMSkin and subcutaneous tissue disorders F5Allergic urticaria FFUrticarias FMAngioedema and urticaria FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2006-07-13 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 13Jul2006 -5268 N DV 14.43 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrZ@DWDLHrřLBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrZ@DWDLHrřL......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1126 11261269112612691126A Acquired Left Hallux Valgus Foot deformity FgMusculoskeletal and connective tissue disorders FkHallux valgus (acquired) FExtremity deformities FMusculoskeletal and connective tissue deformities (incl intervertebral disc disorders)FYMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2016-11-15 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.07 15Nov2016 -1490 N DV 4.08 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrZ@DWDLHrřLBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrZ@DWDLHrřL......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1126 11261269112612691126ASesamoiditis Tendonitis F?wMusculoskeletal and connective tissue disorders FkSesamoiditis FTendon disorders F?bTendon, ligament and cartilage disorders F?eMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2019-09-192019-10-03BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.09 19Sep2019 -452 03Oct2019 -438 N DV 1.24 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrZ@DWDLHrřLBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrZ@DWDLHrřL......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1126 11261269112612691126A0Allergic Rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2008-08-20 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 20Aug2008 -4499 N DV 12.32 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrZ@DWDLHrřLBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrZ@DWDLHrřL......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1126 11261269112612691126APAllergy to Sesame Oil Food allergy FزImmune system disorders F4Oil allergy F<Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018-11-20 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01320Nov2018 -755 N DV 2.07 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrZ@DWDLHrřLBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrZ@DWDLHrřL......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1126 11261269112612691126A@Allergy to Estrogens, Synthetic A Drug hypersensitivity FImmune system disorders F4Drug allergy FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2019-11-25 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01425Nov2019 -385 N DV 1.06 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrZ@DWDLHrřLBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrZ@DWDLHrřL......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1126 11261269112612691126AMigraine with Aura Migraine with aura FWNervous system disorders FMigraine with aura FWMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2019-11-25 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 25Nov2019 -385 N DV 1.06 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrZ@DWDLHrřLBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrZ@DWDLHrřL......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1126 11261269112612691126AAbnormal Uterine Bleeding Abnormal uterine bleeding F0Reproductive system and breast disorders F-LAbnormal uterine bleeding F0Menstruation and uterine bleeding NEC FGMenstrual cycle and uterine bleeding disorders FʎReproductive system and breast disorders F-LGENERAL MEDICAL HISTORY2019-11-252019-11-25BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01025Nov2019 -385 25Nov2019 -385 N DV 1.06 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrZ@DWDLHrřLBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrZ@DWDLHrřL......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1126 11261269112612691126AModerate Persistant Asthma, Stable Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2008-09-29 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 29Sep2008 -4459 YChronic pulmonary disease DV 12.21 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrZ@DWDLHrřLBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrZ@DWDLHrřL......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1126 11261271112612711126AIntermittent Asthma, stable Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2009-07-02 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 02Jul2009 -4183 YChronic pulmonary disease DV 11.46 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr@DWDdHrŽdBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr@DWDdHrŽd......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1126 11261275112612751126AAllergy to Latex Rubber sensitivity F/Immune system disorders F4Latex allergy FrAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010-01-15 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 15Jan2010 -3987 N DV 10.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWFD4Hs4Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDHrDW/DHrWDWFD4Hs4Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DW/DWF.DW+DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1126 11261277112612771126AAllergic Rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2010-04-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 06Apr2010 -3906 N DV 10.7 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDW D͌Hrq BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDW D͌Hrq ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1126 11261278112612781126AAllergy to Erythromycin Base Drug hypersensitivity FImmune system disorders F4Allergy to antibiotic FxAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2007-01-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2007 -5097 N DV 13.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD|Hr|DW DHrqBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD|Hr|DW DHrq......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1126 11261278112612781126A Allergy to Sulfa Antibiotics Drug hypersensitivity FImmune system disorders F4Sulfonamide allergy FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2007-01-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2007 -5097 N DV 13.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD|Hr|DW DHrqBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD|Hr|DW DHrq......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1126 11261278112612781126A0Right little finger middle phalanx fracture Hand fracture F*Injury, poisoning and procedural complications FFractured finger FLimb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2020-09-092020-09-09BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 09Sep2020 -97 09Sep2020 -97 N DV 0.27 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD|Hr|DW DHrqBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD|Hr|DW DHrq......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1126 11261279112612791126A Left Calcaneal Apophysitis Osteitis F-Musculoskeletal and connective tissue disorders FkApophysitis FBone disorders NEC FBone disorders (excl congenital and fractures) FMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2018-08-15 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 15Aug2018 -854 N DV 2.34 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDtHrDWDHsVPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDtHrDWDـHr DWDǰHsveDWDHsVPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1126 11261279112612791126A0Right Calcaneal Apophysitis Osteitis F-Musculoskeletal and connective tissue disorders FkApophysitis FBone disorders NEC FBone disorders (excl congenital and fractures) FMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2018-08-15 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 15Aug2018 -854 N DV 2.34 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDtHrDWDHsVPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDtHrDWDـHr DWDǰHsveDWDHsVPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1126 11261279112612791126A@Tendinitis of Bilateral Achilles Tendon Tendonitis F?wMusculoskeletal and connective tissue disorders FkAchilles tendinitis F1Tendon disorders F?bTendon, ligament and cartilage disorders F?eMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2018-08-15 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 15Aug2018 -854 N DV 2.34 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDtHrDWDHsVPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDtHrDWDـHr DWDǰHsveDWDHsVPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1126 11261279112612791126AIntermittent Asthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2008-01-162015-04-09BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 16Jan2008 -4718 09Apr2015 -2078 YChronic pulmonary disease DV 12.92 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDtHrDWDHsVPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDtHrDWDـHr DWDǰHsveDWDHsVPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1126 11261282112612821126A Appendectomy Laparoscopic Appendicectomy FBSurgical and medical procedures F<Appendectomy F@Large intestine therapeutic procedures F{Gastrointestinal therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2019-07-162019-07-16BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 16Jul2019 -519 16Jul2019 -519 N DV 1.42 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDPHrŕPBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDPHrŕP......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1126 11261282112612821126A0Appendicitis Appendicitis FCInfections and infestations FAppendicitis FCAbdominal and gastrointestinal infections FܯInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2019-07-162019-07-16BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 16Jul2019 -519 16Jul2019 -519 N DV 1.42 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDPHrŕPBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDPHrŕP......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1126 11261282112612821126AAbnormal Uterine Bleeding Due to Ovulatory Dysfunction Ovulation disorder F"Reproductive system and breast disorders F-LOvulation disorder F"Ovarian and fallopian tube disorders NEC FʞOvarian and fallopian tube disorders FReproductive system and breast disorders F-LGENERAL MEDICAL HISTORY2020-10-27 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 27Oct2020 -50 N DV 0.14 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDPHrŕPBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDPHrŕP......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1126 11261284112612841126AAsthma, Stable Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2011M-3637 YChronic pulmonary disease DV 9.96 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DVDHr`DWDHs.Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr`DWDHrDWDHsrXDWDHs.Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1126 11261284112612841126A Chronic Tonsillitis Chronic tonsillitis F@Infections and infestations FChronic tonsillitis F@Upper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2011-04-042012-06-20BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 04Apr2011 -3544 20Jun2012 -3101 N DV 9.71 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DVDHr`DWDHs.Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr`DWDHrDWDHsrXDWDHs.Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1126 11261284112612841126A0Spider Nevus of Skin Spider naevus F8Skin and subcutaneous tissue disorders F5Spider nevus F8Telangiectasia and related conditions F?6Skin vascular abnormalities FNCSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2013-06-172018-06-21BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 17Jun2013 -2739 21Jun2018 -909 N DV 7.5 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DVDHr`DWDHs.Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr`DWDHrDWDHsrXDWDHs.Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1126 11261284112612841126A@Tonsillectomy and Adenoidectomy Adenotonsillectomy FhSurgical and medical procedures F<Tonsillectomy & Adenoidectomy FBgTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2012-06-202012-06-20BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 20Jun2012 -3101 20Jun2012 -3101 N DV 8.49 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DVDHr`DWDHs.Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr`DWDHrDWDHsrXDWDHs.Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1126 11261290112612901126A@Psoriasis Psoriasis F'Skin and subcutaneous tissue disorders F5Psoriasis F'Psoriatic conditions FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019-12-10 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 10Dec2019 -373 N DV 1.02 YEARSAYEARS12-15 YearsAMANOT REPORTED ApNOT REPORTED ApYYPlacebo PLACEBO Placebo PLACEBO DVDHrzDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrzDW DϨHrs(DWDHssDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1126 11261290112612901126A0Pityriasis Rosea Pityriasis rosea FSkin and subcutaneous tissue disorders F5Pityriasis rosea FPapulosquamous conditions FJEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2020-12-14 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 14Dec2020 -3 N DV 0.01 YEARSAYEARS12-15 YearsAMANOT REPORTED ApNOT REPORTED ApYYPlacebo PLACEBO Placebo PLACEBO DVDHrzDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrzDW DϨHrs(DWDHssDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1126 11261290112612901126AAutism spectrum disorder Autism spectrum disorder FPsychiatric disorders F'Autism spectrum disorder FPervasive developmental disorders NEC F4Developmental disorders NEC FǒPsychiatric disorders F'GENERAL MEDICAL HISTORY2014-07-24 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 24Jul2014 -2338 N DV 6.4 YEARSAYEARS12-15 YearsAMANOT REPORTED ApNOT REPORTED ApYYPlacebo PLACEBO Placebo PLACEBO DVDHrzDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrzDW DϨHrs(DWDHssDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1126 11261290112612901126A Phimosis Phimosis FCongenital, familial and genetic disorders FPhimosis FMale reproductive tract disorders congenital F-Reproductive tract and breast disorders congenital F-PCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY2013-06-26 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 26Jun2013 -2731 N DV 7.48 YEARSAYEARS12-15 YearsAMANOT REPORTED ApNOT REPORTED ApYYPlacebo PLACEBO Placebo PLACEBO DVDHrzDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrzDW DϨHrs(DWDHssDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1126 11261292112612921126AMild obstructive sleep apnea Sleep apnoea syndrome F6Respiratory, thoracic and mediastinal disorders F-Obstructive sleep apnea syndrome FoBreathing abnormalities F>Respiratory disorders NEC F-Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2016-02-012019-07-15BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Feb2016 -1781 15Jul2019 -521 N DV 4.88 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDHr+|DWD$HsrfDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1126 11261293112612931126A Beta Thalassemia Trait Thalassaemia beta F?Congenital, familial and genetic disorders FBeta-thalassemia trait FHaemoglobinopathies congenital FWBlood and lymphatic system disorders congenital FRCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY2007-08-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 06Aug2007 -4883 N DV 13.37 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDpHrhDWDHrȈBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDpHrhDWDHrȈ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1126 11261293112612931126AAllergy to Amoxicillin Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010-09-23 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 23Sep2010 -3739 N DV 10.24 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDpHrhDWDHrȈBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDpHrhDWDHrȈ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1126 11261293112612931126A0Intermittent Asthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2008-09-25 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 25Sep2008 -4467 YChronic pulmonary disease DV 12.23 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDpHrhDWDHrȈBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDpHrhDWDHrȈ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1126 11261294112612941126AAllergy to Keflex Drug hypersensitivity FImmune system disorders F4Allergic reaction to antibiotics F8Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009-01-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2009 -4369 N DV 11.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWD|Hs|Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDHrTDWDHsoLDWD|Hs|Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1126 11261295112612951126AIntermittent Asthma, stable Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2019-03-15 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 15Mar2019 -644 YChronic pulmonary disease DV 1.77 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD\HrDWD$Hrs$BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD\HrDWD$Hrs$......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1126 11261297112612971126Avitiligo Vitiligo FPSkin and subcutaneous tissue disorders F5Vitiligo FPHypopigmentation disorders FPigmentation disorders FOSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019-07-30 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 30Jul2019 -507 N DV 1.39 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrhDWDߘHsۘPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrhDWD Hrw DWDpHsu5DWDߘHsۘPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1126 11261298112612981126APUndescended testicles Cryptorchism FjCongenital, familial and genetic disorders FTesticle undescended F?Male reproductive tract disorders congenital F-Reproductive tract and breast disorders congenital F-PCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY(b)(6) 2017-12-01BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 (b)(6) (b)(6)01Dec2017 -1113 N DV (b)(6)YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr@DWDHr38BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr@DWDHr38......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1126 11261298112612981126A0Orchidopexy Orchidopexy FSurgical and medical procedures F<Orchidopexy FTesticular and scrotal therapeutic procedures F?Male genital tract therapeutic procedures F"Surgical and medical procedures F<GENERAL MEDICAL HISTORY2017-12-012017-12-01BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Dec2017 -1113 01Dec2017 -1113 N DV 3.05 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr@DWDHr38BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr@DWDHr38......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1126 11261298112612981126A Circumcision Circumcision FoSurgical and medical procedures F<Circumcision FoPenile therapeutic procedures FMale genital tract therapeutic procedures F"Surgical and medical procedures F<GENERAL MEDICAL HISTORY2019-08-082019-08-08BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 08Aug2019 -498 08Aug2019 -498 N DV 1.37 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr@DWDHr38BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr@DWDHr38......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1126 11261298112612981126A@Phimosis Phimosis FCongenital, familial and genetic disorders FPhimosis FMale reproductive tract disorders congenital F-Reproductive tract and breast disorders congenital F-PCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY2019-07-192019-08-08BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 19Jul2019 -518 08Aug2019 -498 N DV 1.42 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr@DWDHr38BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr@DWDHr38......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1126 11261298112612981126AAllergy to Penicillin Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2020-05-30 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 30May2020 -202 N DV 0.56 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr@DWDHr38BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr@DWDHr38......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1126 11261301112613011126AHeadaches Headache FNervous system disorders FHeadache FHeadaches NEC FHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2182 N DV 5.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrXDWD0Hr_0BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrXDWD0Hr_0......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1126 11261302112613021126AAttention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2014-11-12 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 12Nov2014 -2233 N DW 6.12 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr@DWDŔHsdPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr@DWDHrىDWDHswDWDŔHsdPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1126 11261302112613021126A Idiopathic scoliosis Scoliosis F1Musculoskeletal and connective tissue disorders FkScoliosis F1Spine and neck deformities FMusculoskeletal and connective tissue deformities (incl intervertebral disc disorders)FYMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2020-02-23 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 23Feb2020 -304 N DW 0.84 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr@DWDŔHsdPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr@DWDHrىDWDHswDWDŔHsdPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1126 11261303112613031126A0Hyperglyceridemia Hypertriglyceridaemia FMetabolism and nutrition disorders FHyperglyceridemia Fk Elevated triglycerides FLipid metabolism disorders FʅMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2020-08-05 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 05Aug2020 -146 N DW 0.4 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDWDXHrժXBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDWDXHrժX......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1126 11261303112613031126A@Prediabetes Glucose tolerance impaired F}Metabolism and nutrition disorders FPrediabetes FHyperglycaemic conditions NEC FGlucose metabolism disorders (incl diabetes mellitus) FxMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2020-08-05 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 05Aug2020 -146 N DW 0.4 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDWDXHrժXBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDWDXHrժX......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1126 11261303112613031126AAllergy to Penicillins class Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009-01-05 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 05Jan2009 -4376 N DW 11.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDWDXHrժXBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDWDXHrժX......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1126 11261303112613031126A Allergy to Sulfa class Drug hypersensitivity FImmune system disorders F4Sulfonamide allergy FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009-01-05 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 05Jan2009 -4376 N DW 11.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDWDXHrժXBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDWDXHrժX......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1126 11261304112613041126AAllergy to Cats Allergy to animal FNImmune system disorders F4Allergic to cats FCAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010-01-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2010 -4015 N DW 11 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDWDHrժBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDWDHrժ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1126 11261304112613041126A@Intermittent Migraine headaches Migraine FONervous system disorders FMigraine headache FRMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2012-09-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 06Sep2012 -3036 N DW 8.31 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDWDHrժBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDWDHrժ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1126 11261304112613041126APModerate persistent asthma - stable Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2008-12-16 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 16Dec2008 -4396 YChronic pulmonary disease DW 12.04 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDWDHrժBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDWDHrժ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1126 11261304112613041126A0Bilateral eustachian tube dysfunction Eustachian tube dysfunction F7Ear and labyrinth disorders F)Eustachian tube dysfunction F7Eustachian tube disorders F6Middle ear disorders (excl congenital) F@Ear and labyrinth disorders F)GENERAL MEDICAL HISTORY2018-01-162018-02-20BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 16Jan2018 -1078 20Feb2018 -1043 N DW 2.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDWDHrժBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDWDHrժ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1126 11261304112613041126A Bilateral Myringotomy with insertion of tubes Ear tube insertion FxSurgical and medical procedures F<Tympanostomy tube insertion Fy*Middle ear therapeutic procedures FDHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2018-02-202018-02-20BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 20Feb2018 -1043 20Feb2018 -1043 N DW 2.86 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDWDHrժBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDWDHrժ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1126 11261307112613071126ABilateral Eustachian tube dysfunction Eustachian tube dysfunction F7Ear and labyrinth disorders F)Eustachian tube dysfunction F7Eustachian tube disorders F6Middle ear disorders (excl congenital) F@Ear and labyrinth disorders F)GENERAL MEDICAL HISTORY2020-11-022020-12-15BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 02Nov2020 -63 15Dec2020 -20 N DW 0.18 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHr9DW!DHHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHr9DW!DHHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1126 11261307112613071126A Intermittent Migraine headaches Migraine FONervous system disorders FMigraine headache FRMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2020-09-23 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 23Sep2020 -103 N DW 0.28 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHr9DW!DHHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHr9DW!DHHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1126 11261310112613101126ARed Green Color blindness Colour blindness FCongenital, familial and genetic disorders FRed-green colour blindness FOcular disorders congenital NEC FEye disorders congenital F԰Congenital, familial and genetic disorders FGENERAL MEDICAL HISTORY2013-09-09 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 09Sep2013 -2675 N DW 7.33 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHr5DW"DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHr5DW"DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW"....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1126 11261312112613121126A Allergy to Lavender Oil Drug hypersensitivity FImmune system disorders F4Specific allergy (drug) F8OAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017-05-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01May2017 -1345 N DW 3.69 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DHrĀDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DHrĀDW!DXHrDWDxHssxDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1126 11261312112613121126A0Urinary Tract Infection Urinary tract infection FLkInfections and infestations FUrinary tract infection FLkUrinary tract infections FLqInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2021-01-03 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 03Jan2021 -2 N DW 0.01 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DHrĀDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DHrĀDW!DXHrDWDxHssxDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1126 11261312112613121126AAllergic Rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2015-06-23 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 23Jun2015 -2023 N DW 5.54 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DHrĀDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DHrĀDW!DXHrDWDxHssxDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1126 11261313112613131126A Allergy to Nuts Food allergy FزImmune system disorders F4Allergy to nuts Fm/Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2019-06-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jun2019 -585 N DW 1.6 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD$Hr$DW$DdHrdBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD$Hr$DW$DdHrd......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1126 11261313112613131126AAllergic rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2014-12-02 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 02Dec2014 -2227 N DW 6.1 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD$Hr$DW$DdHrdBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD$Hr$DW$DdHrd......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1126 11261313112613131126A0Localized swelling on Left foot Peripheral swelling FUGeneral disorders and administration site conditions FSwelling of feet F=EGeneral signs and symptoms NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions FGENERAL MEDICAL HISTORY2020-12-072020-12-31BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 07Dec2020 -30 31Dec2020 -6 N DW 0.08 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD$Hr$DW$DdHrdBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD$Hr$DW$DdHrd......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1126 11261314112613141126A Intermittent Asthma, Controlled Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2012-11-20 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 20Nov2012 -2969 YChronic pulmonary disease DW 8.13 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDɐHržDWDXHsAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018-04-10 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 10Apr2018 -1004 N DW 2.75 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrȍDWDǰHsr0Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrȍDW%DHr+PDWDHHssHDWDǰHsr0Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1131 11311275113112751131A`latex allergy Rubber sensitivity F/Immune system disorders F4Latex allergy FrAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.07 01Jan2006M-5451 N DV 14.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr,DWDHr-BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr,DWDHr-......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1131 11311275113112751131Apmigraine headaches Migraine FONervous system disorders FMigraine headache FRMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2009M-4355 N DV 11.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr,DWDHr-BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr,DWDHr-......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1131 11311275113112751131Aallergic rhinitis, seasonal Seasonal allergy FUImmune system disorders F4Seasonal allergic rhinitis F1Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2010M-3990 N DV 10.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr,DWDHr-BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr,DWDHr-......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1131 11311275113112751131A contact lens wearer Corrective lens user F]*Social circumstances F7Contact lens wearer F]:Disability issues FuLifestyle issues FSocial circumstances F7GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2015M-2164 N DV 5.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr,DWDHr-BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr,DWDHr-......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1131 11311275113112751131A0eczema Eczema FSkin and subcutaneous tissue disorders F5Eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2015M-2164 N DV 5.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr,DWDHr-BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr,DWDHr-......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1131 11311275113112751131A@eye glass wearer Corrective lens user F]*Social circumstances F7Eyeglasses wearer F];Disability issues FuLifestyle issues FSocial circumstances F7GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2015M-2164 N DV 5.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr,DWDHr-BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr,DWDHr-......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1131 11311275113112751131Amyopia Myopia FkEye disorders FԯMyopia FkRefractive and accommodative disorders F+Vision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2164 N DV 5.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr,DWDHr-BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr,DWDHr-......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1131 11311275113112751131APlactose intolerance Lactose intolerance FMetabolism and nutrition disorders FLactose intolerance FSugar intolerance (excl glucose intolerance) FDWDDHr,DBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD4Hr>DWDDHr,D......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1139 11391152113911521139AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2012-06-30 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 30Jun2012 -3079 N DV 8.43 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrhlDWD\Hs\Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrhlDWDHrxDWDHsm$(DWD\Hs\Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1139 11391152113911521139A0Left wrist fracture Wrist fracture FR1Injury, poisoning and procedural complications FWrist fracture FR1Limb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2015-06-302015-06-30BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 30Jun2015 -1984 30Jun2015 -1984 N DV 5.43 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrhlDWD\Hs\Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrhlDWDHrxDWDHsm$(DWD\Hs\Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1139 11391152113911521139A Bilateral myopia Myopia FkEye disorders FԯMyopia FkRefractive and accommodative disorders F+Vision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2016-06-30 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 30Jun2016 -1618 N DV 4.43 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrhlDWD\Hs\Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrhlDWDHrxDWDHsm$(DWD\Hs\Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1139 11391154113911541139ACeliac Disease Coeliac disease FGastrointestinal disorders FܛCeliac disease F8Malabsorption syndromes FMalabsorption conditions FGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2012-06-30 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 30Jun2012 -3079 N DV 8.43 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrjDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrjDWDHrTDWDHsm|DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1139 11391157113911571139AFood Allergies to bananas, apple, hazelnut, peas and carrots Food allergy FزImmune system disorders F4Food allergy FزAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009-01-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2009 -4359 N DV 11.94 YEARSAYEARS12-15 YearsAMAMULTIPLE A`MULTIRACIAL A`YYPlacebo PLACEBO Placebo PLACEBO DVDHrZ DWhDTHsAnaemia deficiencies FzAnaemias nonhaemolytic and marrow depression FBlood and lymphatic system disorders FQGENERAL MEDICAL HISTORY2020-05-27 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 27May2020 -199 N DV 0.55 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrpDWD Hs Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrpDW DHr;DWDPHsnPDWD Hs Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1147 11471282114712821147ACataract - Right Eye Cataract FEye disorders FԯCataract (right) FCataract conditions FAnterior eye structural change, deposit and degeneration FEye disorders FԯGENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2006M-5459 N DV 14.95 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDW DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDW DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1147 11471282114712821147A0Seasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2011M-3633 N DV 9.95 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDW DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDW DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1147 11471282114712821147A Childhood Depression Childhood depression FPsychiatric disorders F'Childhood depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1076 N DV 2.95 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDW DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDW DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1147 11471283114712831147AClindamycin Allergy Drug hypersensitivity FImmune system disorders F4Allergic reaction to antibiotics F8Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2020-11-26 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 26Nov2020 -16 N DV 0.05 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrTDW DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrTDW DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1147 11471284114712841147AAllergic Reaction to Adhesive Dermatitis contact FSkin and subcutaneous tissue disorders F5Dermatitis contact FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2005 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2005M-5824 N DV 15.95 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDW DɐHrPlacebo A .Placebo A .DVDHrDW DɐHr......Placebo Placebo DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1147 11471284114712841147A Generalized Anxiety Disorder Generalised anxiety disorder FPsychiatric disorders F'Generalized anxiety disorder F9Anxiety disorders NEC FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1076 N DV 2.95 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDW DɐHrPlacebo A .Placebo A .DVDHrDW DɐHr......Placebo Placebo DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1147 11471285114712851147A Penicillin Allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2019-04 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Apr2019D-621 N DV 1.7 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrXDWDHspPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrXDW DHrDWDHsm(`DWDHspPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1147 11471285114712851147AAttention Deficit Hyperactivity Disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1076 N DV 2.95 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrXDWDHspPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrXDW DHrDWDHsm(`DWDHspPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1147 11471286114712861147AMigraines Migraine FONervous system disorders FMigraine FOMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2018-04 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Apr2018D-986 N DV 2.7 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDɐHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDɐHrDW D$Hr$DWDHsnDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1147 11471286114712861147A Seasonal Rhinitis Seasonal allergy FUImmune system disorders F4Seasonal rhinitis F1Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2007M-5094 N DV 13.95 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDɐHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDɐHrDW D$Hr$DWDHsnDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1147 11471288114712881147A@Seasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2006M-5459 N DV 14.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDXHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDXHrDW DHrDWD8Hsm*DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1147 11471288114712881147AAttention Deficit Hyperactivity Disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2013M-2902 N DV 7.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDXHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDXHrDW DHrDWD8Hsm*DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1147 11471288114712881147A Dysgraphia Dysgraphia FzONervous system disorders FDysgraphia FzOCortical dysfunction NEC F Neurological disorders NEC FNervous system disorders FGENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2013M-2902 N DV 7.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDXHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDXHrDW DHrDWD8Hsm*DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1147 11471288114712881147APWritten Expression Disorder Dysgraphia FzONervous system disorders FDisorder of written expression F@Cortical dysfunction NEC F Neurological disorders NEC FNervous system disorders FGENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2013M-2902 N DV 7.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDXHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDXHrDW DHrDWD8Hsm*DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1147 11471288114712881147A0Pseudotumor cerebri Idiopathic intracranial hypertension FʸNervous system disorders FPseudotumor cerebri F'Increased intracranial pressure disorders F@Increased intracranial pressure and hydrocephalus F"Nervous system disorders FGENERAL MEDICAL HISTORY2020-03 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Mar2020D-286 N DV 0.79 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDXHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDXHrDW DHrDWD8Hsm*DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1147 11471289114712891147A Penicillin Allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2014M-2544 N DV 6.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDXHrɮBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDXHrɮ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1147 11471289114712891147AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016-05 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01May2016D-1693 N DV 4.64 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDXHrɮBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDXHrɮ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1147 11471290114712901147APAsthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2013M-2909 YChronic pulmonary disease DV 7.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrٜDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrٜDWDHrl DWDHsm1HDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1147 11471290114712901147AAcne Vulgaris Acne FpSkin and subcutaneous tissue disorders F5Acne vulgaris FAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1448 N DV 3.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrٜDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrٜDWDHrl DWDHsm1HDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1147 11471290114712901147A Allergy to Cats Allergy to animal FNImmune system disorders F4Allergic to cats FCAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2020 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2020M-353 N DV 0.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrٜDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrٜDWDHrl DWDHsm1HDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1147 11471290114712901147A0Allergy to Dogs Allergy to animal FNImmune system disorders F4Allergic to dogs FDAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2020 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2020M-353 N DV 0.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrٜDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrٜDWDHrl DWDHsm1HDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1147 11471290114712901147A@Allergy to cockroaches Cockroach allergy FwImmune system disorders F4Cockroach allergy FwAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2020 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2020M-353 N DV 0.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrٜDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrٜDWDHrl DWDHsm1HDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1147 11471290114712901147A`Migraines Migraine FONervous system disorders FMigraine FOMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2020-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2020D-353 N DV 0.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrٜDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrٜDWDHrl DWDHsm1HDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1147 11471294114712941147AADD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018-10 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Oct2018D-810 N DV 2.22 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHrjhBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHrjh......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1147 11471296114712961147AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2020M-353 N DV 0.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHrɒ|BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHrɒ|......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1147 11471301114713011147AAllergy to Tamiflu Drug hypersensitivity FImmune system disorders F4Specific allergy (drug) F8OAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2015M-2179 N DV 5.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWD$HrɦBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWD$Hrɦ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1147 11471301114713011147A Migraines Migraine FONervous system disorders FMigraine FOMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1448 N DV 3.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWD$HrɦBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWD$Hrɦ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1147 11471302114713021147AAllergy to cat dander Allergy to animal FNImmune system disorders F4Allergy to animal dander FOAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2005 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2005M-5831 N DV 15.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWD`HryBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWD`Hry......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1147 11471302114713021147A Atopic dermatitis Dermatitis atopic FSkin and subcutaneous tissue disorders F5Atopic dermatitis FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2005 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2005M-5831 N DV 15.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWD`HryBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWD`Hry......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1147 11471302114713021147A@seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2006M-5466 N DV 14.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWD`HryBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWD`Hry......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1147 11471302114713021147A0Menstrual cramps Dysmenorrhoea FReproductive system and breast disorders F-LMenstrual cramps F<Menstruation and uterine bleeding NEC FGMenstrual cycle and uterine bleeding disorders FʎReproductive system and breast disorders F-LGENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1448 N DV 3.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWD`HryBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWD`Hry......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1147 11471303114713031147AAcne Vulgaris Acne FpSkin and subcutaneous tissue disorders F5Acne vulgaris FAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019-10 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Oct2019D-447 N DV 1.23 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHHrgHDWD0HrmPlacebo A .Placebo A .DVDHHrgHDWD0Hrm......Placebo Placebo DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1147 11471308114713081147AEhlers-Danlos Syndrome Ehlers-Danlos syndrome FlCongenital, familial and genetic disorders FEhlers-Danlos syndrome FlConnective tissue disorders congenital FMusculoskeletal and connective tissue disorders congenital FlCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-720 N DV 1.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHs2Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDHrɡ@DWDנHsnDWDHs2Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1147 11471310114713101147A`seasonal allergy Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1450 N DV 3.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHrɲ\BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHrɲ\......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1147 11471310114713101147Aalcohol allergy Allergy to chemicals F:Immune system disorders F4Alcohol allergy FӎAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2019M-720 N DV 1.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHrɲ\BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHrɲ\......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1147 11471310114713101147A bleach allergy Allergy to chemicals F:Immune system disorders F4Bleaches & cleansers sensitivity FlAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2019M-720 N DV 1.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHrɲ\BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHrɲ\......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1147 11471310114713101147A0hand sanitizer allergy Allergy to chemicals F:Immune system disorders F4Allergy to chemicals F:Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2019M-720 N DV 1.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHrɲ\BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHrɲ\......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1147 11471310114713101147A@latex allergy Rubber sensitivity F/Immune system disorders F4Latex allergy FrAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019M-720 N DV 1.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHrɲ\BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHrɲ\......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1147 11471310114713101147APperfume allergy Perfume sensitivity FImmune system disorders F4Perfume sensitivity FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2019M-720 N DV 1.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHrɲ\BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHrɲ\......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1147 11471311114713111147Aallergies to cats Allergy to animal FNImmune system disorders F4Allergic to cats FCAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2181 N DV 5.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDˆHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDˆHrDWDHrɰ@DWD͌Hsm1 DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1147 11471317114713171013Aattention deficient hyperactive disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit-hyperactivity disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2011M-3656 N DW 10.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHrDWDHrTBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHrDWDHrT......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1147 11471319114713191147AAttention deficient disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2014M-2561 N DW 7.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHr0DW$DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHr0DW$DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW$....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1147 11471320114713201147AAllergy to latex Rubber sensitivity F/Immune system disorders F4Latex allergy FrAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2005 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2005M-5848 N DW 16.01 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHr? DW#DHr2LBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHr? DW#DHr2L......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1147 11471320114713201147A allergy to sulfa Drug hypersensitivity FImmune system disorders F4Sulfonamide allergy FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2005 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2005M-5848 N DW 16.01 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHr? DW#DHr2LBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHr? DW#DHr2L......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1147 11471321114713211147AObesity Obesity F ;Metabolism and nutrition disorders FObesity F ;General nutritional disorders NEC FAppetite and general nutritional disorders FJMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2015-05-12 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 12May2015 -2065 N DW 5.66 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DW DHrohDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DHrohDW$DHrDWDHHssHDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW$.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1147 11471322114713221147AAsthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2011M-3657 YChronic pulmonary disease DW 10.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DHrtTDW#DHr'Placebo A .Placebo A .DW DHrtTDW#DHr'......Placebo Placebo DW DW#....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1147 11471322114713221147A Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2011M-3657 N DW 10.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DHrtTDW#DHr'Placebo A .Placebo A .DW DHrtTDW#DHr'......Placebo Placebo DW DW#....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1147 11471323114713231147A`Attention deficit hyperactive disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit/hyperactivity disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2009M-4387 N DW 12.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DdHrĉDW#DHr4Placebo A .Placebo A .DW DdHrĉDW#DHr4......Placebo Placebo DW DW#....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1147 11471323114713231147ApDisruptive mood disorder Disruptive mood dysregulation disorder FjPsychiatric disorders F'Disruptive mood dysregulation disorder FjAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2012M-3292 N DW 9.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DdHrĉDW#DHr4Placebo A .Placebo A .DW DdHrĉDW#DHr4......Placebo Placebo DW DW#....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1147 11471323114713231147A Allergy to adhesives Dermatitis contact FSkin and subcutaneous tissue disorders F5Dermatitis contact FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.07 01Jan2013M-2926 N DW 8.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DdHrĉDW#DHr4Placebo A .Placebo A .DW DdHrĉDW#DHr4......Placebo Placebo DW DW#....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1147 11471323114713231147A0Allergy to latex Rubber sensitivity F/Immune system disorders F4Latex allergy FrAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2013M-2926 N DW 8.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DdHrĉDW#DHr4Placebo A .Placebo A .DW DdHrĉDW#DHr4......Placebo Placebo DW DW#....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1147 11471323114713231147A@Allergy to paroxetine Drug hypersensitivity FImmune system disorders F4Drug allergy FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.08 01Jan2013M-2926 N DW 8.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DdHrĉDW#DHr4Placebo A .Placebo A .DW DdHrĉDW#DHr4......Placebo Placebo DW DW#....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1147 11471323114713231147APAllergy to sertraline Drug hypersensitivity FImmune system disorders F4Specific allergy (drug) F8OAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2013M-2926 N DW 8.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DdHrĉDW#DHr4Placebo A .Placebo A .DW DdHrĉDW#DHr4......Placebo Placebo DW DW#....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1147 11471323114713231147ARight hip hardware placement Hip surgery F]Surgical and medical procedures F<Hip surgery F]Joint therapeutic procedures F5Bone and joint therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2017-01 2017-01 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.09 01Jan2017D-1465 31Jan2017D-1435 N DW 4.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DdHrĉDW#DHr4Placebo A .Placebo A .DW DdHrĉDW#DHr4......Placebo Placebo DW DW#....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1147 11471323114713231147AAcne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2018M-1100 N DW 3.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DdHrĉDW#DHr4Placebo A .Placebo A .DW DdHrĉDW#DHr4......Placebo Placebo DW DW#....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1147 11471323114713231147AMultiple epiphyseal dysplasia Multiple epiphyseal dysplasia FCongenital, familial and genetic disorders FMultiple epiphyseal dysplasia FMusculoskeletal disorders congenital NEC F Musculoskeletal and connective tissue disorders congenital FlCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY2016-04-04 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 04Apr2016 -1737 N DW 4.76 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DdHrĉDW#DHr4Placebo A .Placebo A .DW DdHrĉDW#DHr4......Placebo Placebo DW DW#....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1147 11471325114713251147AAllergies to dust Mite allergy FjImmune system disorders F4House dust allergy FwAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2011M-3657 N DW 10.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHrĉ0DW#DHrdBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHrĉ0DW#DHrd......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW#....DWxDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1147 11471325114713251147A allergy to cats Allergy to animal FNImmune system disorders F4Allergic to cats FCAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2011M-3657 N DW 10.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHrĉ0DW#DHrdBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHrĉ0DW#DHrd......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW#....DWxDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1147 11471325114713251147A0allergy to cockroach Cockroach allergy FwImmune system disorders F4Cockroach allergy FwAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2011M-3657 N DW 10.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHrĉ0DW#DHrdBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHrĉ0DW#DHrd......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW#....DWxDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1147 11471328114713281147APchronic otitis media Otitis media chronic FInfections and infestations FOtitis media chronic FEar infections F=Infections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2006M-5483 N DW 15.01 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DHrĒDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DHrĒDW$DHHrHDWDHsDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW$.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1147 11471328114713281147AAdenoidectomy Adenoidectomy FNSurgical and medical procedures F<Adenoidectomy FNTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2006 2006 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2006M-5483 31Dec2006M-5119 N DW 15.01 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DHrĒDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DHrĒDW$DHHrHDWDHsDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW$.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1147 11471328114713281147Apumbilical hernia repair Umbilical hernia repair FHSurgical and medical procedures F<Umbilical hernia repair FHHernia repairs F[Gastrointestinal therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2006 2006 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2006M-5483 31Dec2006M-5119 N DW 15.01 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DHrĒDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DHrĒDW$DHHrHDWDHsDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW$.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1147 11471328114713281147A Seasonal allergy Rhinitis Seasonal allergy FUImmune system disorders F4Seasonal allergic rhinitis F1Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.07 01Jan2008M-4753 N DW 13.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DHrĒDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DHrĒDW$DHHrHDWDHsDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW$.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1147 11471328114713281147A@attention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4022 N DW 11.01 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DHrĒDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DHrĒDW$DHHrHDWDHsDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW$.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1147 11471328114713281147A`exercise induced Bronchospasm Bronchospasm FRespiratory, thoracic and mediastinal disorders F-Exercise-induced bronchospasm FӧBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2010M-4022 YChronic pulmonary disease DW 11.01 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DHrĒDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DHrĒDW$DHHrHDWDHsDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW$.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1147 11471328114713281147A0atopic dermatitis Dermatitis atopic FSkin and subcutaneous tissue disorders F5Atopic dermatitis FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2016M-1831 N DW 5.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DHrĒDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DHrĒDW$DHHrHDWDHsDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW$.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1147 11471329114713291147AAllergies Multiple allergies FImmune system disorders F4Multiple allergies FAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015 2020 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2015M-2196 31Dec2020M-5 N DW 6.02 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DW DpHrěDWD HsV Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DpHrěDW#DXHrZDWDHswTDWD HsV Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1147 11471329114713291147A tooth extraction Tooth extraction F4Surgical and medical procedures F<Tooth extraction F4Dental and gingival therapeutic procedures FƝHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2020-09-032020-09-03BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 03Sep2020 -124 03Sep2020 -124 N DW 0.34 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DW DpHrěDWD HsV Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DpHrěDW#DXHrZDWDHswTDWD HsV Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1147 11471331114713311147A0seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2009M-4387 N DW 12.01 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHrğtDW$DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHrğtDW$DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW$....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1147 11471331114713311147AAsthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2196 YChronic pulmonary disease DW 6.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHrğtDW$DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHrğtDW$DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW$....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1147 11471331114713311147A Reactive airway disorder Bronchial hyperreactivity FRespiratory, thoracic and mediastinal disorders F-Reactive airways disease F*Bronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2015M-2196 N DW 6.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHrğtDW$DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHrğtDW$DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW$....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1147 11471333114713331147A Asthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2007M-5119 YChronic pulmonary disease DW 14.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrŔDW*D$Hr$BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrŔDW*D$Hr$......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW*....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1147 11471333114713331147AAdenoidectomy Adenoidectomy FNSurgical and medical procedures F<Adenoidectomy FNTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2019-11-142019-11-14BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 14Nov2019 -419 14Nov2019 -419 N DW 1.15 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrŔDW*D$Hr$BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrŔDW*D$Hr$......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW*....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1147 11471333114713331147A0tonsillectomy Tonsillectomy FBfSurgical and medical procedures F<Tonsillectomy FBfTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2019-11-142019-11-14BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 14Nov2019 -419 14Nov2019 -419 N DW 1.15 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrŔDW*D$Hr$BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrŔDW*D$Hr$......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW*....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1147 11471334114713341147APremenarche Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrŖDW#D~Hr#BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrŖDW#D~Hr#......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1147 11471337114713371147A allergies to amoxicillin Drug hypersensitivity FImmune system disorders F4Allergic reaction to antibiotics F8Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2014M-2562 N DW 7.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrŮDW#D|HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrŮDW#D|Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1147 11471337114713371147A0seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2014M-2562 N DW 7.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrŮDW#D|HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrŮDW#D|Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1147 11471337114713371147Aacne vulgaris Acne FpSkin and subcutaneous tissue disorders F5Acne vulgaris FAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2020-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2020D-371 N DW 1.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrŮDW#D|HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrŮDW#D|Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1147 11471338114713381147Aattention deficient hyperactive disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit-hyperactivity disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1101 N DW 3.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD`Hr`DW#DHr&BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD`Hr`DW#DHr&......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1147 11471339114713391147A Premenarchal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD@Hr@DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD@Hr@DW$DlHrlDWD Hs\DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1147 11471339114713391147A0asthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2007M-5119 YChronic pulmonary disease DW 14.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD@Hr@DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD@Hr@DW$DlHrlDWD Hs\DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1147 11471339114713391147A@seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2007M-5119 N DW 14.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD@Hr@DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD@Hr@DW$DlHrlDWD Hs\DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1147 11471339114713391147AAdenoidectomy Adenoidectomy FNSurgical and medical procedures F<Adenoidectomy FNTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2009 2009 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2009M-4388 31Dec2009M-4024 N DW 12.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD@Hr@DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD@Hr@DW$DlHrlDWD Hs\DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1147 11471339114713391147APtonsillectomy Tonsillectomy FBfSurgical and medical procedures F<Tonsillectomy FBfTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2009 2009 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2009M-4388 31Dec2009M-4024 N DW 12.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD@Hr@DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD@Hr@DW$DlHrlDWD Hs\DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1147 11471340114713401147Aattention deficient hyperactive disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit-hyperactivity disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2013M-2927 N DW 8.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrڰDW#D̜HrqBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrڰDW#D̜Hrq......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1147 11471341114713411147Aallergy to amoxicillin Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4754 N DW 13.02 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DWDHrDWD|Hs|Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDW#DHrgDDWDHs|`DWD|Hs|Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1147 11471341114713411147A appendectomy Appendicectomy FBSurgical and medical procedures F<Appendectomy F@Large intestine therapeutic procedures F{Gastrointestinal therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2015 2015 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2015M-2197 31Dec2015M-1833 N DW 6.02 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DWDHrDWD|Hs|Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDW#DHrgDDWDHs|`DWD|Hs|Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1147 11471344114713441147A Premenarchal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDW3DHrdBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDW3DHrd......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW3....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1147 11471344114713441147AEnvironmental allergy to grass Seasonal allergy FUImmune system disorders F4Grass allergy FAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2014M-2562 N DW 7.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDW3DHrdBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDW3DHrd......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW3....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1147 11471344114713441147A0allergy to fish Food allergy FزImmune system disorders F4Fish allergy FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2014M-2562 N DW 7.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDW3DHrdBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDW3DHrd......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW3....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1147 11471344114713441147A@environmental allergy to mud Hypersensitivity FImmune system disorders F4Environmental allergy FTAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2014M-2562 N DW 7.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDW3DHrdBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDW3DHrd......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW3....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1147 11471344114713441147APenvironmental allergy to trees Allergy to plants FmImmune system disorders F4Allergy to plants FmAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2014M-2562 N DW 7.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDW3DHrdBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDW3DHrd......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW3....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1147 11471344114713441147A`sesame allergy Food allergy FزImmune system disorders F4Food allergy FزAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2016M-1832 N DW 5.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDW3DHrdBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDW3DHrd......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW3....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1147 11471347114713471147Alatex allergy Rubber sensitivity F/Immune system disorders F4Latex allergy FrAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4023 N DW 11.02 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWEHr,DW$DHrڄBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWEHr,DW$DHrڄ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501118115011181150ASeasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1383 N DV 3.79 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDPHrX DVDHrqBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDPHrX DVDHrq......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1150 11501118115011181150A Tinea Unguium (Right foot) Dermatophytosis of nail F_Infections and infestations FTinea unguium FATinea infections FAFungal infectious disorders FInfections and infestations FGENERAL MEDICAL HISTORY2019-07-31 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 31Jul2019 -442 N DV 1.21 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDPHrX DVDHrqBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDPHrX DVDHrq......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1150 11501119115011191150ARhinitis Due to Pollen Seasonal allergy FUImmune system disorders F4Allergic rhinitis due to pollen F>Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2007M-5036 N DV 13.79 YEARSAYEARS12-15 YearsAMAMULTIPLE A`MULTIRACIAL A`YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrX-DDVDǰHrsBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrX-DDVDǰHrs......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1150 11501119115011191150ApReactive Airway Disease Bronchial hyperreactivity FRespiratory, thoracic and mediastinal disorders F-Reactive airways disease F*Bronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2007 2017 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2007M-5036 31Dec2017M-1019 N DV 13.79 YEARSAYEARS12-15 YearsAMAMULTIPLE A`MULTIRACIAL A`YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrX-DDVDǰHrsBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrX-DDVDǰHrs......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1150 11501119115011191150ASnoring Snoring F7Respiratory, thoracic and mediastinal disorders F-Snoring F7Upper respiratory tract signs and symptoms FKiRespiratory tract signs and symptoms F}Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2008 2018 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2008M-4671 31Dec2018M-654 N DV 12.79 YEARSAYEARS12-15 YearsAMAMULTIPLE A`MULTIRACIAL A`YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrX-DDVDǰHrsBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrX-DDVDǰHrs......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1150 11501119115011191150A0Asthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2009 2017 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2009M-4305 31Dec2017M-1019 YChronic pulmonary disease DV 11.79 YEARSAYEARS12-15 YearsAMAMULTIPLE A`MULTIRACIAL A`YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrX-DDVDǰHrsBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrX-DDVDǰHrs......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1150 11501119115011191150A`Milk Allergy Milk allergy FqImmune system disorders F4Milk allergy FqAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2012M-3210 N DV 8.79 YEARSAYEARS12-15 YearsAMAMULTIPLE A`MULTIRACIAL A`YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrX-DDVDǰHrsBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrX-DDVDǰHrs......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1150 11501119115011191150A@Ceftriaxone Allergy Drug hypersensitivity FImmune system disorders F4Allergic reaction to antibiotics F8Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.09 01Jan2018M-1018 N DV 2.79 YEARSAYEARS12-15 YearsAMAMULTIPLE A`MULTIRACIAL A`YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrX-DDVDǰHrsBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrX-DDVDǰHrs......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1150 11501119115011191150AAcne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2020 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.08 01Jan2020M-288 N DV 0.79 YEARSAYEARS12-15 YearsAMAMULTIPLE A`MULTIRACIAL A`YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrX-DDVDǰHrsBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrX-DDVDǰHrs......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1150 11501119115011191150APIdiopathic Scoliosis Scoliosis F1Musculoskeletal and connective tissue disorders FkScoliosis F1Spine and neck deformities FMusculoskeletal and connective tissue deformities (incl intervertebral disc disorders)FYMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2018-10 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Oct2018D-745 N DV 2.04 YEARSAYEARS12-15 YearsAMAMULTIPLE A`MULTIRACIAL A`YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrX-DDVDǰHrsBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrX-DDVDǰHrs......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1150 11501119115011191150A Acute Appendicitis Appendicitis FCInfections and infestations FAcute appendicitis F%Abdominal and gastrointestinal infections FܯInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2018-10 2018-11 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.07 01Oct2018D-745 30Nov2018D-685 N DV 2.04 YEARSAYEARS12-15 YearsAMAMULTIPLE A`MULTIRACIAL A`YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrX-DDVDǰHrsBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrX-DDVDǰHrs......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1150 11501120115011201150A Egg Allergy Food allergy FزImmune system disorders F4Egg allergy FkAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2006M-5401 N DV 14.79 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDpHrXDDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDpHrXDDVDHru7,DWDިHsv|DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501120115011201150A0Hx of Hematuria Haematuria F3Renal and urinary disorders F,WHematuria FzUrinary abnormalities FDUrinary tract signs and symptoms FL~Renal and urinary disorders F,WGENERAL MEDICAL HISTORY2018 2019 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1018 31Dec2019M-289 N DV 2.79 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDpHrXDDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDpHrXDDVDHru7,DWDިHsv|DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501120115011201150AAnisorcoria Pupils unequal F)"Eye disorders FԯAnisocoria FgPupil disorders F) Ocular neuromuscular disorders F Eye disorders FԯGENERAL MEDICAL HISTORY2019-11-122020 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 12Nov2019 -338 31Dec2020M78 N DV 0.93 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDpHrXDDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDpHrXDDVDHru7,DWDިHsv|DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501121115011211150AEating Disorder Eating disorder FnPsychiatric disorders F'Eating disorder FnEating disorders NEC FtEating disorders and disturbances FsPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-04 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Apr2020D-197 N DV 0.54 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD4HrXqDWDXHs?Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD4HrXqDVDHrq,DWDHsv6DWDXHs?Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501121115011211150A Generalized Anxiety Generalised anxiety disorder FPsychiatric disorders F'Generalised anxiety disorder FAnxiety disorders NEC FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-04 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Apr2020D-197 N DV 0.54 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD4HrXqDWDXHs?Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD4HrXqDVDHrq,DWDHsv6DWDXHs?Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501121115011211150A@Plantar Wart Skin papilloma F6KNeoplasms benign, malignant and unspecified (incl cysts and polyps)F0Plantar warts FSkin neoplasms benign F6BCutaneous neoplasms benign F6CNeoplasms benign, malignant and unspecified (incl cysts and polyps)F0GENERAL MEDICAL HISTORY2017-08 2017 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Aug2017D-1171 31Dec2017M-1019 N DV 3.21 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD4HrXqDWDXHs?Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD4HrXqDVDHrq,DWDHsv6DWDXHs?Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501121115011211150A0Overweight Overweight FMetabolism and nutrition disorders FOverweight FGeneral nutritional disorders NEC FAppetite and general nutritional disorders FJMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2017-08 2018 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Aug2017D-1171 31Dec2018M-654 N DV 3.21 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD4HrXqDWDXHs?Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD4HrXqDVDHrq,DWDHsv6DWDXHs?Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501123115011231150A0Plantar fascial fibromatosis Plantar fascial fibromatosis FMusculoskeletal and connective tissue disorders FkPlantar fascial fibromatosis FMusculoskeletal and connective tissue infections and inflammations NEC FdMusculoskeletal and connective tissue disorders NEC FiMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2020-08 2020-09 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Aug2020D-76 30Sep2020D-16 N DV 0.21 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD HrY DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD HrY DVDHrt DWDPHsmNDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501123115011231150AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2017M-1384 N DV 3.79 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD HrY DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD HrY DVDHrt DWDPHsmNDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501123115011231150A Overweight Overweight FMetabolism and nutrition disorders FOverweight FGeneral nutritional disorders NEC FAppetite and general nutritional disorders FJMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019M-654 N DV 1.79 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD HrY DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD HrY DVDHrt DWDPHsmNDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501124115011241150AAnxiety Disorder Anxiety disorder FwPsychiatric disorders F'Anxiety disorder FwAnxiety disorders NEC FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1022 N DV 2.8 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr]UDDVDHrzBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr]UDDVDHrz......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501124115011241150A Major Depressive Disorder Major depression FxpPsychiatric disorders F'Major depressive disorder FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1022 N DV 2.8 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr]UDDVDHrzBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr]UDDVDHrz......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501125115011251150A Seasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2007M-5040 N DV 13.8 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVDHr]qdDWDHs$Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr]qdDVDHrygDWD@Hss@DWDHs$Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501125115011251150A0Tree nut Allergy Food allergy FزImmune system disorders F4Allergy to nuts Fm/Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2007M-5040 N DV 13.8 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVDHr]qdDWDHs$Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr]qdDVDHrygDWD@Hss@DWDHs$Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501125115011251150APeanut Allergy Food allergy FزImmune system disorders F4Peanut allergy FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1387 N DV 3.8 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVDHr]qdDWDHs$Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr]qdDVDHrygDWD@Hss@DWDHs$Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501126115011261150A PREMENARCHAL Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2008M-4675 N DV 12.8 YEARSAYEARS12-15 YearsAFA MULTIPLE A`MULTIRACIAL A`YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD$Hr]|DVDHrymBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD$Hr]|DVDHrym......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501126115011261150AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018-10 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Oct2018D-749 N DV 2.05 YEARSAYEARS12-15 YearsAFA MULTIPLE A`MULTIRACIAL A`YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD$Hr]|DVDHrymBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD$Hr]|DVDHrym......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501127115011271150AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1387 N DV 3.8 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD,Hr]DVDHr| BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD,Hr]DVDHr| ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1150 11501127115011271150A Anxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1387 N DV 3.8 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD,Hr]DVDHr| BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD,Hr]DVDHr| ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1150 11501127115011271150A0Depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2017M-1387 N DV 3.8 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD,Hr]DVDHr| BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD,Hr]DVDHr| ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1150 11501128115011281150ACat Allergy Allergy to animal FNImmune system disorders F4Allergic to cats FCAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2007M-5040 N DV 13.8 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr]DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr]DVDHrz|DWDHsr+XDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501128115011281150A Dog Allergy Allergy to animal FNImmune system disorders F4Allergic to dogs FDAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2007M-5040 N DV 13.8 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr]DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr]DVDHrz|DWDHsr+XDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501129115011291150AAnxiety Disorder Anxiety disorder FwPsychiatric disorders F'Anxiety disorder FwAnxiety disorders NEC FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-02 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Feb2020D-262 N DV 0.72 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD{Hr^DWDpHsYpPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD{Hr^DVDt|HrzCDWD(HslDWDpHsYpPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1150 11501129115011291150A@PREMENARCHAL Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2008M-4676 N DV 12.8 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD{Hr^DWDpHsYpPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD{Hr^DVDt|HrzCDWD(HslDWDpHsYpPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1150 11501129115011291150A Esophageal Reflux Gastrooesophageal reflux disease F]Gastrointestinal disorders FܛEsophageal reflux FҝGastrointestinal atonic and hypomotility disorders NEC F܍Gastrointestinal motility and defaecation conditions FܹGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2017 2018 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1388 31Dec2018M-659 N DV 3.8 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD{Hr^DWDpHsYpPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD{Hr^DVDt|HrzCDWD(HslDWDpHsYpPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1150 11501129115011291150APPlantar Wart Skin papilloma F6KNeoplasms benign, malignant and unspecified (incl cysts and polyps)F0Plantar warts FSkin neoplasms benign F6BCutaneous neoplasms benign F6CNeoplasms benign, malignant and unspecified (incl cysts and polyps)F0GENERAL MEDICAL HISTORY2017 2018 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2017M-1388 31Dec2018M-659 N DV 3.8 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD{Hr^DWDpHsYpPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD{Hr^DVDt|HrzCDWD(HslDWDpHsYpPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1150 11501129115011291150A`Slow Transit Constipation Constipation FGastrointestinal disorders FܛSlow transit constipation FGastrointestinal atonic and hypomotility disorders NEC F܍Gastrointestinal motility and defaecation conditions FܹGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2017 2019 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1388 31Dec2019M-294 N DV 3.8 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD{Hr^DWDpHsYpPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD{Hr^DVDt|HrzCDWD(HslDWDpHsYpPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1150 11501129115011291150A0Irritable Bowel Syndrome Irritable bowel syndrome F[Gastrointestinal disorders FܛIrritable bowel syndrome F[Gastrointestinal spastic and hypermotility disorders FGastrointestinal motility and defaecation conditions FܹGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2018 2019 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2018M-1023 31Dec2019M-294 N DV 2.8 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD{Hr^DWDpHsYpPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD{Hr^DVDt|HrzCDWD(HslDWDpHsYpPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1150 11501130115011301150AAllergic Rhinitis Due To Pollen Seasonal allergy FUImmune system disorders F4Allergic rhinitis due to pollen F>Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2016M-1754 N DV 4.8 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr_DVDHHryHBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr_DVDHHryH......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1150 11501130115011301150A Atopic Dermatitis Dermatitis atopic FSkin and subcutaneous tissue disorders F5Atopic dermatitis FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1754 N DV 4.8 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr_DVDHHryHBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr_DVDHHryH......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1150 11501130115011301150A0Frequent recurrent Non- Bullous Impetigo Impetigo FInfections and infestations FImpetigo FSkin structures and soft tissue infections F5Infections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2016M-1754 N DV 4.8 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr_DVDHHryHBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr_DVDHHryH......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1150 11501130115011301150A@anisometropia Anisometropia FiEye disorders FԯAnisometropia FiRefractive and accommodative disorders F+Vision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2020 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2020M-293 N DV 0.8 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr_DVDHHryHBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr_DVDHHryH......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1150 11501131115011311150A0Asthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2010M-3945 YChronic pulmonary disease DV 10.8 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr_DWRDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr_DVD Hry DW>DPHsPDWRDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DW>DWR.DW7DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501131115011311150A@Opposition Defiant Disorder Oppositional defiant disorder FrPsychiatric disorders F'Oppositional defiant disorder FrAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2014M-2484 N DV 6.8 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr_DWRDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr_DVD Hry DW>DPHsPDWRDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DW>DWR.DW7DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501131115011311150AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016 2019 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1754 31Dec2019M-294 N DV 4.8 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr_DWRDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr_DVD Hry DW>DPHsPDWRDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DW>DWR.DW7DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501131115011311150APOther Developmental Disorders of Scholastic Skills Developmental delay FǏGeneral disorders and administration site conditions FDevelopmental disturbance FǓGeneral signs and symptoms NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions FGENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2017M-1388 N DV 3.8 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr_DWRDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr_DVD Hry DW>DPHsPDWRDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DW>DWR.DW7DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501131115011311150A`Pneumonia Pneumonia F!Infections and infestations FPneumonia F!Lower respiratory tract and lung infections FInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2019 2019 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2019M-658 31Dec2019M-294 N DV 1.8 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr_DWRDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr_DVD Hry DW>DPHsPDWRDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DW>DWR.DW7DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501131115011311150A Anxiety Disorder Anxiety disorder FwPsychiatric disorders F'Anxiety disorder FwAnxiety disorders NEC FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019 2020 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2019M-658 31Dec2020M73 N DV 1.8 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr_DWRDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr_DVD Hry DW>DPHsPDWRDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DW>DWR.DW7DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501132115011321150A Eustachian Tube Disorder Eustachian tube disorder FEar and labyrinth disorders F)Eustachian tube disorder FEustachian tube disorders F6Middle ear disorders (excl congenital) F@Ear and labyrinth disorders F)GENERAL MEDICAL HISTORY2016 2017 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1754 31Dec2017M-1024 N DV 4.8 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr_DVD Hry BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr_DVD Hry ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1150 11501132115011321150A0Overweight Overweight FMetabolism and nutrition disorders FOverweight FGeneral nutritional disorders NEC FAppetite and general nutritional disorders FJMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2016 2017 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2016M-1754 31Dec2017M-1024 N DV 4.8 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr_DVD Hry BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr_DVD Hry ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1150 11501132115011321150AAttention and concentration deficit Disturbance in attention F8Nervous system disorders FAttention concentration difficulty FMental impairment (excl dementia and memory loss) FoMental impairment disorders FuNervous system disorders FGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2019M-658 N DV 1.8 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr_DVD Hry BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr_DVD Hry ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1150 11501133115011331150ASeasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1024 N DV 2.81 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr_pDVDHrzdBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr_pDVDHrzd......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DW2DV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1150 11501134115011341150ACephalosporin Allergy Drug hypersensitivity FImmune system disorders F4Allergic reaction to antibiotics F8Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2009M-4311 N DV 11.81 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD0Hr`"DWDHs:Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD0Hr`"DVDdHrzyDWDHsrvXDWDHs:Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501134115011341150A Depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1755 N DV 4.81 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD0Hr`"DWDHs:Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD0Hr`"DVDdHrzyDWDHsrvXDWDHs:Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501134115011341150A0Sleeping Problems Sleep disorder F6Psychiatric disorders F'Sleep problem F6Sleep disorders NEC F6Sleep disorders and disturbances F6Psychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1389 N DV 3.81 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD0Hr`"DWDHs:Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD0Hr`"DVDdHrzyDWDHsrvXDWDHs:Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501135115011351150ASeasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2015M-2120 N DV 5.81 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr`%DDVDHr~pBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr`%DDVDHr~p......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501135115011351150A Short Stature Short stature F5Musculoskeletal and connective tissue disorders FkShort stature F5Musculoskeletal and connective tissue conditions NEC FMusculoskeletal and connective tissue disorders NEC FiMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2020 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2020M-294 N DV 0.81 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr`%DDVDHr~pBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr`%DDVDHr~p......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501136115011361150AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1389 N DV 3.81 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHHr`UDWD,HsPPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHHr`UDVDDHrzDWDHsrXDWD,HsPPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501136115011361150A`Rhinitis due to pollen Seasonal allergy FUImmune system disorders F4Allergic rhinitis due to pollen F>Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1389 N DV 3.81 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHHr`UDWD,HsPPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHHr`UDVDDHrzDWDHsrXDWD,HsPPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501136115011361150APPlantar Wart Skin papilloma F6KNeoplasms benign, malignant and unspecified (incl cysts and polyps)F0Plantar warts FSkin neoplasms benign F6BCutaneous neoplasms benign F6CNeoplasms benign, malignant and unspecified (incl cysts and polyps)F0GENERAL MEDICAL HISTORY2017 2018 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2017M-1389 31Dec2018M-660 N DV 3.81 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHHr`UDWD,HsPPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHHr`UDVDDHrzDWDHsrXDWD,HsPPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501136115011361150A Constipation Constipation FGastrointestinal disorders FܛConstipation FGastrointestinal atonic and hypomotility disorders NEC F܍Gastrointestinal motility and defaecation conditions FܹGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2019M-659 N DV 1.81 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHHr`UDWD,HsPPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHHr`UDVDDHrzDWDHsrXDWD,HsPPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501136115011361150A0Gastroesophageal Reflux Gastrooesophageal reflux disease F]Gastrointestinal disorders FܛGastroesophageal reflux F܄Gastrointestinal atonic and hypomotility disorders NEC F܍Gastrointestinal motility and defaecation conditions FܹGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2020 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2020M-294 N DV 0.81 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHHr`UDWD,HsPPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHHr`UDVDDHrzDWDHsrXDWD,HsPPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501136115011361150A@Generalized abdominal pain Abdominal pain FGastrointestinal disorders FܛAbdominal pain generalized F|JGastrointestinal and abdominal pains (excl oral and throat) F܆Gastrointestinal signs and symptoms FGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2020 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2020M-294 N DV 0.81 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHHr`UDWD,HsPPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHHr`UDVDDHrzDWDHsrXDWD,HsPPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501166115011661150A@Penicillin Allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2006M-5447 N DV 14.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr DWDHs*xPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr DVD@HrDWDHsv DWDHs*xPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501166115011661150A Atopic Dermatitis Dermatitis atopic FSkin and subcutaneous tissue disorders F5Atopic dermatitis FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2014M-2525 N DV 6.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr DWDHs*xPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr DVD@HrDWDHsv DWDHs*xPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501166115011661150AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019M-699 N DV 1.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr DWDHs*xPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr DVD@HrDWDHsv DWDHs*xPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501166115011661150A0Eating Disorder Eating disorder FnPsychiatric disorders F'Eating disorder FnEating disorders NEC FtEating disorders and disturbances FsPsychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2019M-699 N DV 1.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr DWDHs*xPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr DVD@HrDWDHsv DWDHs*xPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501168115011681150AIntestinal Malabsorption Malabsorption FGastrointestinal disorders FܛIntestinal malabsorption FMalabsorption syndromes FMalabsorption conditions FGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1066 N DV 2.92 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD8HrDWDHr&BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD8HrDWDHr&......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501168115011681150A Seasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1066 N DV 2.92 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD8HrDWDHr&BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD8HrDWDHr&......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501171115011711150Aacne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019-02 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Feb2019D-671 N DV 1.84 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDXHriBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDXHri......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501176115011761150A0seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2164 N DV 5.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr |DWD<HsOPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr |DWDˆHrBDWDHssDWD<HsOPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501176115011761150A acne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2019M-703 N DV 1.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr |DWD<HsOPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr |DWDˆHrBDWDHssDWD<HsOPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501176115011761150AScoliosis Scoliosis F1Musculoskeletal and connective tissue disorders FkScoliosis F1Spine and neck deformities FMusculoskeletal and connective tissue deformities (incl intervertebral disc disorders)FYMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2018-04-182018-05 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 18Apr2018 -961 31May2018D-918 N DV 2.63 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr |DWD<HsOPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr |DWDˆHrBDWDHssDWD<HsOPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501178115011781150AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2014M-2532 N DV 6.93 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD\Hr\DWDdHr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD\Hr\DWDdHr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501178115011781150A Acne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019M-706 N DV 1.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD\Hr\DWDdHr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD\Hr\DWDdHr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501179115011791150APFructose Intolerance Fructose intolerance F(Metabolism and nutrition disorders FFructose intolerance F(Sugar intolerance (excl glucose intolerance) FRespiratory disorders NEC F-Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2016 2017 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2016M-1805 31Dec2017M-1075 N DV 4.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr$DWDߘHsۘPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr$DWDXHrXDWDHsrDWDߘHsۘPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501192115011921150AAsthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2020 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2020M-344 YChronic pulmonary disease DV 0.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr$DWDߘHsۘPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr$DWDXHrXDWDHsrDWDߘHsۘPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501192115011921150ATic Disorder Tic FAPsychiatric disorders F'Tic FATic disorders FAChanges in physical activity FQPsychiatric disorders F'GENERAL MEDICAL HISTORY2020 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2020M-344 N DV 0.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr$DWDߘHsۘPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr$DWDXHrXDWDHsrDWDߘHsۘPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501193115011931150ASeasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1805 N DV 4.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDhHr/DWDv\Hs\Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDhHr/DWD|Hr|DWDHsmhDWDv\Hs\Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501193115011931150A Sesame Seed Allergy Food allergy FزImmune system disorders F4Food allergy FزAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2016M-1805 N DV 4.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDhHr/DWDv\Hs\Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDhHr/DWD|Hr|DWDHsmhDWDv\Hs\Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501193115011931150A0Sun butter Allergy- Food Allergy Food allergy FزImmune system disorders F4Food allergy FزAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2016M-1805 N DV 4.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDhHr/DWDv\Hs\Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDhHr/DWD|Hr|DWDHsmhDWDv\Hs\Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501195115011951150ASeasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3267 N DV 8.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD,Hr6,DWDHsPPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD,Hr6,DWD\Hr\DWD(HsrDWDHsPPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501196115011961150A Periodic Fever Syndrome Pyrexia F)General disorders and administration site conditions FPeriodic fever FeFebrile disorders FBody temperature conditions FGeneral disorders and administration site conditions FGENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2008M-4728 N DV 12.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr6DWD4HsQ4Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr6DWD Hr DWDHsrlDWD4HsQ4Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501196115011961150A0Seasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3267 N DV 8.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr6DWD4HsQ4Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr6DWD Hr DWDHsrlDWD4HsQ4Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501196115011961150AChronic Sinusitis Chronic sinusitis F1Infections and infestations FChronic sinusitis F1Upper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2017M-1440 N DV 3.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr6DWD4HsQ4Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr6DWD Hr DWDHsrlDWD4HsQ4Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501197115011971150A Penicillin Allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2005 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2005M-5823 N DV 15.95 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDtHrftDWDhHr~BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDtHrftDWDhHr~......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1150 11501197115011971150AAcne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1440 N DV 3.95 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDtHrftDWDhHr~BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDtHrftDWDhHr~......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1150 11501198115011981150A0Headaches Headache FNervous system disorders FHeadache FHeadaches NEC FHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2016M-1806 N DV 4.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrfDWDHr$BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrfDWDHr$......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501198115011981150A@Short Stature Short stature F5Musculoskeletal and connective tissue disorders FkShort stature F5Musculoskeletal and connective tissue conditions NEC FMusculoskeletal and connective tissue disorders NEC FiMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2016M-1806 N DV 4.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrfDWDHr$BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrfDWDHr$......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501198115011981150AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1075 N DV 2.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrfDWDHr$BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrfDWDHr$......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501198115011981150A Dysthymic Disorder Persistent depressive disorder FlPsychiatric disorders F'Dysthymic disorder FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2018M-1075 N DV 2.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrfDWDHr$BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrfDWDHr$......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501199115011991150A seasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2014M-2536 N DV 6.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDټHrDWDHr=HPlacebo A .Placebo A .DVDټHrDWDHr=H......Placebo Placebo DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501199115011991150AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2016M-1806 N DV 4.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDټHrDWDHr=HPlacebo A .Placebo A .DVDټHrDWDHr=H......Placebo Placebo DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501202115012021150A@Psoriasis on elbows Psoriasis F'Skin and subcutaneous tissue disorders F5Non-scalp psoriasis FhPsoriatic conditions FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1809 N DV 4.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD~THr DW DHrġTBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD~THr DW DHrġT......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501202115012021150ADairy Sensitivity Dairy intolerance FMetabolism and nutrition disorders FDairy intolerance FFood malabsorption and intolerance syndromes (excl sugar intolerance) FطFood intolerance syndromes FضMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2020-03 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Mar2020D-288 N DV 0.79 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD~THr DW DHrġTBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD~THr DW DHrġT......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501202115012021150A Idiopathic Scoliosis Scoliosis F1Musculoskeletal and connective tissue disorders FkScoliosis F1Spine and neck deformities FMusculoskeletal and connective tissue deformities (incl intervertebral disc disorders)FYMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2020-03 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Mar2020D-288 N DV 0.79 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD~THr DW DHrġTBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD~THr DW DHrġT......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501202115012021150A0Peanut Sensitivity Food allergy FزImmune system disorders F4Peanut allergy FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2020-03 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Mar2020D-288 N DV 0.79 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD~THr DW DHrġTBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD~THr DW DHrġT......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501202115012021150APWheat Sensitivity Food allergy FزImmune system disorders F4Allergy to grains Fm-Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2020-03 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Mar2020D-288 N DV 0.79 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD~THr DW DHrġTBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD~THr DW DHrġT......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501203115012031150AAmoxicillin allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2008M-4731 N DV 12.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr(DW D|HrΰBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr(DW D|Hrΰ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501203115012031150A Asthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2012 2013 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3270 31Dec2013M-2540 YChronic pulmonary disease DV 8.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr(DW D|HrΰBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr(DW D|Hrΰ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501203115012031150A@Hearing Loss Deafness FEar and labyrinth disorders F)Hearing loss FHearing losses FHearing disorders FEar and labyrinth disorders F)GENERAL MEDICAL HISTORY2012 2013 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2012M-3270 31Dec2013M-2540 N DV 8.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr(DW D|HrΰBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr(DW D|Hrΰ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501203115012031150A0Epistaxis Epistaxis FrRespiratory, thoracic and mediastinal disorders F-Epistaxis FrNasal disorders NEC FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2019 2019 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2019M-713 31Dec2019M-349 N DV 1.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr(DW D|HrΰBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr(DW D|Hrΰ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501204115012041150A Obesity Obesity F ;Metabolism and nutrition disorders FObesity F ;General nutritional disorders NEC FAppetite and general nutritional disorders FJMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2014 2020 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2014M-2539 31Dec2020M18 N DV 6.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr(DWDrHs˜Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr(DW D|tHrtDWDHsr:XDWDrHs˜Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501204115012041150A0Precocious Puberty Precocious puberty FydEndocrine disorders FPrecocious puberty FydEndocrine abnormalities of puberty FEndocrine disorders of gonadal function FEndocrine disorders FGENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2174 N DV 5.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr(DWDrHs˜Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr(DW D|tHrtDWDHsr:XDWDrHs˜Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501204115012041150AAllergic Rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2017M-1443 N DV 3.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr(DWDrHs˜Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr(DW D|tHrtDWDHsr:XDWDrHs˜Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501204115012041150A@Social Phobia Social anxiety disorder F7Psychiatric disorders F'Social phobia F7Fear symptoms and phobic disorders (incl social phobia) FKAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2019M-713 N DV 1.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr(DWDrHs˜Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr(DW D|tHrtDWDHsr:XDWDrHs˜Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501205115012051150AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2011M-3635 N DV 9.95 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrBDW DHrIBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrBDW DHrI......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501206115012061150AScoliosis Scoliosis F1Musculoskeletal and connective tissue disorders FkScoliosis F1Spine and neck deformities FMusculoskeletal and connective tissue deformities (incl intervertebral disc disorders)FYMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2016-09-132017-09 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 13Sep2016 -1553 30Sep2017D-1171 N DV 4.25 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr8DWD`Hs}Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr8DWDxHrxDWDHs} XDWD`Hs}Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501208115012081150APremenarchal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4731 N DV 12.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDXHrDW DHrOBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDXHrDW DHrO......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1150 11501209115012091150AAsthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4001 YChronic pulmonary disease DV 10.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDW DXHrXBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDW DXHrX......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501209115012091150A Cat Allergy Allergy to animal FNImmune system disorders F4Allergic to cats FCAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2010M-4001 N DV 10.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDW DXHrXBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDW DXHrX......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501209115012091150A0Fluency Disorder-Speech Disorder Speech disorder F8zNervous system disorders FSpeech disorder F8zSpeech and language abnormalities F8tNeurological disorders NEC FNervous system disorders FGENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2013M-2905 N DV 7.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDW DXHrXBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDW DXHrX......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501209115012091150A@Traumatic injury to Right Facial Nerve VIIth nerve injury FOInjury, poisoning and procedural complications FInjury to facial nerve F.Cranial nerve injuries FInjuries NEC FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1444 N DV 3.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDW DXHrXBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDW DXHrX......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501210115012101150A Seasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1079 N DV 2.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHHrHDWDڬHsn,Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHHrHDWDHrDWDHs{DWDڬHsn,Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1150 11501210115012101150APremenarchal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY2020-11 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Nov2020D-44 N DV 0.12 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHHrHDWDڬHsn,Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHHrHDWDHrDWDHs{DWDڬHsn,Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1150 11501211115012111150A Mango Allergy Food allergy FزImmune system disorders F4Fruit allergy FvAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2009M-4366 N DV 11.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDhHrhDWDxHrƾBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDhHrhDWDxHrƾ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DW2DV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1150 11501211115012111150A0Penicillin Allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2009M-4366 N DV 11.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDhHrhDWDxHrƾBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDhHrhDWDxHrƾ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DW2DV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1150 11501211115012111150A@Seasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2009M-4366 N DV 11.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDhHrhDWDxHrƾBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDhHrhDWDxHrƾ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DW2DV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1150 11501211115012111150ACherry Allergy Food allergy FزImmune system disorders F4Fruit allergy FvAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 2016 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2009M-4366 31Dec2016M-1445 N DV 11.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDhHrhDWDxHrƾBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDhHrhDWDxHrƾ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DW2DV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1150 11501212115012121150AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2175 N DV 5.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD,Hr,DWD,HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD,Hr,DWDwHrƾDDWDlHsm#DWD,HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501212115012121150A Dyslexia Dyslexia FNervous system disorders FDyslexia FCortical dysfunction NEC F Neurological disorders NEC FNervous system disorders FGENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2015M-2175 N DV 5.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD,Hr,DWD,HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD,Hr,DWDwHrƾDDWDlHsm#DWD,HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501212115012121150A0Premenarchal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY2020-11 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Nov2020D-44 N DV 0.12 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD,Hr,DWD,HsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD,Hr,DWDwHrƾDDWDlHsm#DWD,HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501213115012131150A Atopic Dermatitis Dermatitis atopic FSkin and subcutaneous tissue disorders F5Atopic dermatitis FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4732 N DV 12.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDW DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDW DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501213115012131150APSeasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2015M-2175 N DV 5.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDW DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDW DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501213115012131150A0Gastroesophageal Reflux Disease Gastrooesophageal reflux disease F]Gastrointestinal disorders FܛGastroesophageal reflux disease FGastrointestinal atonic and hypomotility disorders NEC F܍Gastrointestinal motility and defaecation conditions FܹGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2017 2018 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1444 31Dec2018M-715 N DV 3.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDW DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDW DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501213115012131150AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2020D-349 N DV 0.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDW DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDW DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501213115012131150A@Herpes Simplex NOS Herpes simplex FlInfections and infestations FHerpes simplex NOS FuHerpes viral infections FViral infectious disorders FOInfections and infestations FGENERAL MEDICAL HISTORY2015-05 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01May2015D-2055 N DV 5.63 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDW DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDW DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501214115012141150APeanut Allergy Food allergy FزImmune system disorders F4Peanut allergy FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4732 N DV 12.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHsGXPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWD`Hr0DWD Hss DWDHsGXPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501214115012141150A Treenut Allergy Food allergy FزImmune system disorders F4Allergy to nuts Fm/Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2008M-4732 N DV 12.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHsGXPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWD`Hr0DWD Hss DWDHsGXPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501215115012151150AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-10-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Oct2020 -75 N DV 0.21 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDxHrxDWDHsGPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDxHrxDWD$Hr0DWD\Hss\DWDHsGPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501216115012161150A`Vitamin D Deficiency Vitamin D deficiency FPMetabolism and nutrition disorders FVitamin D deficiency FPFat soluble vitamin deficiencies and disorders FVitamin related disorders FPMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2018-02 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Feb2018D-1049 N DV 2.87 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDDWD`Hr`BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDDWD`Hr`......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1150 11501216115012161150APUnspecified blepharitis of left lower eyelid Blepharitis FEye disorders FԯBlepharitis FLid, lash and lacrimal infections, irritations and inflammations FOcular infections, irritations and inflammations FEye disorders FԯGENERAL MEDICAL HISTORY2018-02 2018-03 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Feb2018D-1049 31Mar2018D-991 N DV 2.87 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDDWD`Hr`BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDDWD`Hr`......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1150 11501216115012161150A0Hyperlipidemia Hyperlipidaemia FMetabolism and nutrition disorders FHyperlipidemia F;Hyperlipidaemias NEC F:Lipid metabolism disorders FʅMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2018-02 2019 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Feb2018D-1049 31Dec2019M-351 N DV 2.87 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDDWD`Hr`BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDDWD`Hr`......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1150 11501216115012161150AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2018M-1080 N DV 2.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDDWD`Hr`BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDDWD`Hr`......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1150 11501216115012161150A@Premenarchal Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY2020-11 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Nov2020D-45 N DV 0.13 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDDWD`Hr`BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDDWD`Hr`......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1150 11501216115012161150A Fracture of right ankle Ankle fracture FpInjury, poisoning and procedural complications FAnkle fracture FpLimb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2020-12-03 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 03Dec2020 -13 N DV 0.04 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDDWD`Hr`BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDDWD`Hr`......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1150 11501218115012181150A Eczema Eczema FSkin and subcutaneous tissue disorders F5Eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2005 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2005M-5829 N DV 15.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHs3$Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDHrDWD\HsrjDWDHs3$Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501218115012181150AAsthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-716 YChronic pulmonary disease DV 1.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHs3$Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDHrDWD\HsrjDWDHs3$Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501219115012191150AAllergic Rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2008M-4734 N DV 12.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr!DW DHrfBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr!DW DHrf......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501219115012191150A@Slow Transit Constipation Constipation FGastrointestinal disorders FܛSlow transit constipation FGastrointestinal atonic and hypomotility disorders NEC F܍Gastrointestinal motility and defaecation conditions FܹGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2015 2018 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2177 31Dec2018M-717 N DV 5.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr!DW DHrfBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr!DW DHrf......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501219115012191150A Attention and concentration deficit Disturbance in attention F8Nervous system disorders FAttention concentration difficulty FMental impairment (excl dementia and memory loss) FoMental impairment disorders FuNervous system disorders FGENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2016M-1812 N DV 4.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr!DW DHrfBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr!DW DHrf......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501219115012191150A0Recurrent Vessicles - right foot Blister FSkin and subcutaneous tissue disorders F5Vesicles FOBullous conditions FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2019M-716 N DV 1.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr!DW DHrfBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr!DW DHrf......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501220115012201150ASeasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3273 N DV 8.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr?DWDdHsdPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr?DWD,Hrś,DWDިHss٨DWDdHsdPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501221115012211150AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1081 N DV 2.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrSDWD4HrT4BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrSDWD4HrT4......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWMDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1150 11501221115012211150A Asthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1081 YChronic pulmonary disease DV 2.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrSDWD4HrT4BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrSDWD4HrT4......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWMDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1150 11501222115012221150A Overweight Overweight FMetabolism and nutrition disorders FOverweight FGeneral nutritional disorders NEC FAppetite and general nutritional disorders FJMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2015 2019 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2177 31Dec2019M-352 N DV 5.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD4Hrb4DWDHs Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD4Hrb4DWD@Hr@DWDHsm#tDWDHs Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501222115012221150AAcne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1081 N DV 2.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD4Hrb4DWDHs Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD4Hrb4DWD@Hr@DWDHsm#tDWDHs Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501224115012241150AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2019M-716 N DV 1.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWD|Hs6|Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWD|Hru|DWD|8Hssw8DWD|Hs6|Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501224115012241150A0Reading Disorder Reading disorder F*Psychiatric disorders F'Reading disorder F*Learning disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019M-716 N DV 1.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWD|Hs6|Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWD|Hru|DWD|8Hssw8DWD|Hs6|Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501224115012241150A Constipation Constipation FGastrointestinal disorders FܛConstipation FGastrointestinal atonic and hypomotility disorders NEC F܍Gastrointestinal motility and defaecation conditions FܹGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2019 2020-06 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-716 30Jun2020D-170 N DV 1.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWD|Hs6|Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWD|Hru|DWD|8Hssw8DWD|Hs6|Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501225115012251150A0PCOS Polycystic ovaries F#QReproductive system and breast disorders F-LPolycystic ovarian syndrome F Ovarian and fallopian tube cysts and neoplasms FOvarian and fallopian tube disorders FReproductive system and breast disorders F-LGENERAL MEDICAL HISTORY2020-08 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Aug2020D-138 N DV 0.38 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDPHrȃPBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDPHrȃP......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWMDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501225115012251150A Hyperlipidemia Hyperlipidaemia FMetabolism and nutrition disorders FHyperlipidemia F;Hyperlipidaemias NEC F:Lipid metabolism disorders FʅMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2016M-1812 N DV 4.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDPHrȃPBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDPHrȃP......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWMDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501225115012251150ACardiac Murmur Cardiac murmur F"Investigations FCardiac murmur F"Cardiac auscultatory investigations FYCardiac and vascular investigations (excl enzyme tests) FInvestigations FGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1081 N DV 2.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDPHrȃPBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDPHrȃP......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWMDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501226115012261150AApraxia Apraxia FvNervous system disorders FApraxia FvCortical dysfunction NEC F Neurological disorders NEC FNervous system disorders FGENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHHrHDWD,Hrȉ,BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHHrHDWD,Hrȉ,......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DW0DV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1150 11501226115012261150A Phonological Disorder - speech disorder Speech sound disorder FkPsychiatric disorders F'Phonological disorder FCommunications disorders FCommunication disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2009M-4368 N DV 11.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHHrHDWD,Hrȉ,BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHHrHDWD,Hrȉ,......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DW0DV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1150 11501227115012271150AScoliosis Scoliosis F1Musculoskeletal and connective tissue disorders FkScoliosis F1Spine and neck deformities FMusculoskeletal and connective tissue deformities (incl intervertebral disc disorders)FYMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2178 N DV 5.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDҴHr4DWDtHrŭtBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDҴHr4DWDtHrŭt......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1150 11501228115012281150AAllergic Rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1082 N DV 2.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD HrǠDWD\Hs\Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD HrǠDWDHrDWDHsiDWD\Hs\Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501228115012281150A Cat Allergy Allergy to animal FNImmune system disorders F4Allergic to cats FCAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1082 N DV 2.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD HrǠDWD\Hs\Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD HrǠDWDHrDWDHsiDWD\Hs\Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501228115012281150A0Right Wrist Pain Arthralgia F'Musculoskeletal and connective tissue disorders FkWrist pain FTJoint related signs and symptoms F:Joint disorders F-Musculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2019M-717 N DV 1.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD HrǠDWD\Hs\Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD HrǠDWDHrDWDHsiDWD\Hs\Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501229115012291150AAllergic Rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2016M-1815 N DV 4.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHsPPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDDHr{DDWDƄHsn{DWDHsPPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501229115012291150A0Asthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1815 YChronic pulmonary disease DV 4.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHsPPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDDHr{DDWDƄHsn{DWDHsPPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501229115012291150A Anxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2017M-1449 N DV 3.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHsPPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDDHr{DDWDƄHsn{DWDHsPPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501229115012291150A@Constipation Constipation FGastrointestinal disorders FܛConstipation FGastrointestinal atonic and hypomotility disorders NEC F܍Gastrointestinal motility and defaecation conditions FܹGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2017M-1449 N DV 3.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHsPPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDDHr{DDWDƄHsn{DWDHsPPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501230115012301150AEar tube insertion Ear tube insertion FxSurgical and medical procedures F<Ear tube insertion FxMiddle ear therapeutic procedures FDHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2009M-4371 N DV 11.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr+DWD\Hr̉BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr+DWD\Hr̉......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501232115012321150APenicillin Allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2006M-5468 N DV 14.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDPHr_PDWD$Hs$Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDPHr_PDWDwLHrDWDHssDWD$Hs$Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501232115012321150A Seasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2010M-4007 N DV 10.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDPHr_PDWD$Hs$Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDPHr_PDWDwLHrDWDHssDWD$Hs$Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501233115012331150ASeasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1450 N DV 3.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr_DWDwHrDBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr_DWDwHrD......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501234115012341150A Asthma (reactive airway disorder) Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2008M-4738 YChronic pulmonary disease DV 12.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD`Hr|`DWD HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD`Hr|`DWD Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501234115012341150A@Tree Nuts Allergy Food allergy FزImmune system disorders F4Allergy to nuts Fm/Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4738 N DV 12.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD`Hr|`DWD HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD`Hr|`DWD Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501234115012341150A0Seasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2010M-4007 N DV 10.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD`Hr|`DWD HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD`Hr|`DWD Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501234115012341150AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-09 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Sep2020D-111 N DV 0.31 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD`Hr|`DWD HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD`Hr|`DWD Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501235115012351150A@Tree nut Allergy Food allergy FزImmune system disorders F4Allergy to nuts Fm/Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2005 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2005M-5833 N DV 15.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD0Hr0DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD0Hr0DWDHrxDWD Hss DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501235115012351150A Coconut oil allergy Food allergy FزImmune system disorders F4Oil allergy F<Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2015M-2181 N DV 5.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD0Hr0DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD0Hr0DWDHrxDWD Hss DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501235115012351150A0Seasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2018M-1085 N DV 2.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD0Hr0DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD0Hr0DWDHrxDWD Hss DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501235115012351150AAsthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019M-720 YChronic pulmonary disease DV 1.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD0Hr0DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD0Hr0DWDHrxDWD Hss DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501237115012371150AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2012M-3277 N DV 8.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDxHrDWDHsu$DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501237115012371150A0Anxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3277 N DV 8.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDxHrDWDHsu$DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501237115012371150A@Dyslexia Dyslexia FNervous system disorders FDyslexia FCortical dysfunction NEC F Neurological disorders NEC FNervous system disorders FGENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2012M-3277 N DV 8.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDxHrDWDHsu$DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501237115012371150A Acne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2017M-1450 N DV 3.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWDxHrDWDHsu$DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501238115012381150AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-08 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01001Aug2020D-143 N DV 0.39 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD,HrDWDHrdBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD,HrDWDHrd......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501238115012381150A0Anxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-08 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.09 01Aug2020D-143 N DV 0.39 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD,HrDWDHrdBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD,HrDWDHrd......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501238115012381150APremenarche status - no period yet Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4739 N DV 12.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD,HrDWDHrdBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD,HrDWDHrd......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501238115012381150A Amoxicillin Allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2009M-4373 N DV 11.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD,HrDWDHrdBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD,HrDWDHrd......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501238115012381150A@Cefdinir Allergy Drug hypersensitivity FImmune system disorders F4Allergic reaction to antibiotics F8Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2009M-4373 N DV 11.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD,HrDWDHrdBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD,HrDWDHrd......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501238115012381150APErythromycin Allergy Drug hypersensitivity FImmune system disorders F4Allergic reaction to antibiotics F8Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2009M-4373 N DV 11.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD,HrDWDHrdBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD,HrDWDHrd......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501238115012381150A`Legume Allergy Food allergy FزImmune system disorders F4Allergy to legumes Fm6Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.07 01Jan2009M-4373 N DV 11.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD,HrDWDHrdBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD,HrDWDHrd......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501238115012381150ApPeanut Allergy Food allergy FزImmune system disorders F4Peanut allergy FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2009M-4373 N DV 11.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD,HrDWDHrdBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD,HrDWDHrd......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501238115012381150ASoy Allergy Food allergy FزImmune system disorders F4Soy allergy FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.08 01Jan2009M-4373 N DV 11.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD,HrDWDHrdBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD,HrDWDHrd......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501238115012381150ATree nut Allergy Food allergy FزImmune system disorders F4Allergy to nuts Fm/Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2009M-4373 N DV 11.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD,HrDWDHrdBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD,HrDWDHrd......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501239115012391150AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-11 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Nov2020D-51 N DV 0.14 YEARSAYEARS12-15 YearsAFA MULTIPLE A`MULTIRACIAL A`YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD\Hr DWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD\Hr DWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501240115012401150AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1086 N DV 2.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWD|Hrm|DWDˆHsnwDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501240115012401150A Acne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1086 N DV 2.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDWD|Hrm|DWDˆHsnwDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501241115012411150A Seasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2014M-2547 N DV 6.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVEHr;DWDHrmBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVEHr;DWDHrm......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501241115012411150ADepression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-03 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Mar2020D-296 N DV 0.81 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVEHr;DWDHrmBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVEHr;DWDHrm......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501242115012421150AFactor V Leiden (Heterozygous) Factor V Leiden mutation Fz'Congenital, familial and genetic disorders FFactor V Leiden heterozygote F;Coagulation disorders congenital FBlood and lymphatic system disorders congenital FRCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019M-722 N DW 1.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr,DWgDHs:Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr,DWDHrl|DWMDHsфDWgDHs:Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWMDWg.DWEDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501242115012421150A Short Achilles Tendon (both feet) Tendon disorder F?gMusculoskeletal and connective tissue disorders FkTendon disorder F?gTendon disorders F?bTendon, ligament and cartilage disorders F?eMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2019-07 2020-01 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jul2019D-541 31Jan2020D-327 N DW 1.48 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr,DWgDHs:Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr,DWDHrl|DWMDHsфDWgDHs:Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWMDWg.DWEDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501243115012431150A0Asthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2020-08 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Aug2020D-144 YChronic pulmonary disease DW 0.4 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD@HrN@DWDxHsxPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD@HrN@DWDpHruDWDxHsn-DWDxHsxPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501243115012431150A@Premenarchal - no period yet Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2008M-4740 N DW 12.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD@HrN@DWDxHsxPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD@HrN@DWDpHruDWDxHsn-DWDxHsxPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501243115012431150AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1452 N DW 3.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD@HrN@DWDxHsxPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD@HrN@DWDpHruDWDxHsn-DWDxHsxPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501243115012431150A Anxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1452 N DW 3.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD@HrN@DWDxHsxPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD@HrN@DWDpHruDWDxHsn-DWDxHsxPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501243115012431150APSeasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2017M-1452 N DW 3.98 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD@HrN@DWDxHsxPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD@HrN@DWDpHruDWDxHsn-DWDxHsxPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501244115012441150A0Bactrim Allergy Drug hypersensitivity FImmune system disorders F4Allergic reaction to antibiotics F8Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2016M-1823 N DW 4.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWKDDHs*Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDWDTHrQTDW8DިHr2DWKDDHs*Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DW8DWK.DW0DW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501244115012441150A@Citrus Allergy Food allergy FزImmune system disorders F4Fruit allergy FvAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2018M-1092 N DW 2.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWKDDHs*Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDWDTHrQTDW8DިHr2DWKDDHs*Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DW8DWK.DW0DW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501244115012441150A`Vitamin D Deficiency Vitamin D deficiency FPMetabolism and nutrition disorders FVitamin D deficiency FPFat soluble vitamin deficiencies and disorders FVitamin related disorders FPMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1092 N DW 2.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWKDDHs*Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDWDTHrQTDW8DިHr2DWKDDHs*Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DW8DWK.DW0DW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501244115012441150A Anxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2019M-727 N DW 1.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWKDDHs*Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDWDTHrQTDW8DިHr2DWKDDHs*Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DW8DWK.DW0DW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501244115012441150APPrecocious Puberty Precocious puberty FydEndocrine disorders FPrecocious puberty FydEndocrine abnormalities of puberty FEndocrine disorders of gonadal function FEndocrine disorders FGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2019M-727 N DW 1.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWKDDHs*Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDWDTHrQTDW8DިHr2DWKDDHs*Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DW8DWK.DW0DW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501244115012441150AAdhesive Middle Ear Disease Middle ear adhesions F>Ear and labyrinth disorders F)Adhesive middle ear disease FMiddle ear disorders NEC FMiddle ear disorders (excl congenital) F@Ear and labyrinth disorders F)GENERAL MEDICAL HISTORY2020-03 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Mar2020D-302 N DW 0.83 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrDWKDDHs*Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDWDTHrQTDW8DިHr2DWKDDHs*Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DW8DWK.DW0DW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501246115012461150APPlantar Wart Skin papilloma F6KNeoplasms benign, malignant and unspecified (incl cysts and polyps)F0Plantar warts FSkin neoplasms benign F6BCutaneous neoplasms benign F6CNeoplasms benign, malignant and unspecified (incl cysts and polyps)F0GENERAL MEDICAL HISTORY2005 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.07 01Jan2005M-5840 N DW 15.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrhDW%DhHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrhDW%DhHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501246115012461150ApWheezing Wheezing FQRespiratory, thoracic and mediastinal disorders F-Wheezing FQBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2005 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.08 01Jan2005M-5840 N DW 15.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrhDW%DhHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrhDW%DhHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501246115012461150A Atopic Dermatitis Dermatitis atopic FSkin and subcutaneous tissue disorders F5Atopic dermatitis FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2017M-1457 N DW 3.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrhDW%DhHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrhDW%DhHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501246115012461150A@Eczema Eczema FSkin and subcutaneous tissue disorders F5Eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2017M-1457 N DW 3.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrhDW%DhHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrhDW%DhHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501246115012461150Aconstipation Constipation FGastrointestinal disorders FܛConstipation FGastrointestinal atonic and hypomotility disorders NEC F܍Gastrointestinal motility and defaecation conditions FܹGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2017M-1457 N DW 3.99 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrhDW%DhHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrhDW%DhHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501246115012461150AAnxiety Disorder Anxiety disorder FwPsychiatric disorders F'Anxiety disorder FwAnxiety disorders NEC FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-11 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Nov2020D-57 N DW 0.16 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrhDW%DhHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrhDW%DhHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501246115012461150A0Attention and concentration deficit Disturbance in attention F8Nervous system disorders FAttention concentration difficulty FMental impairment (excl dementia and memory loss) FoMental impairment disorders FuNervous system disorders FGENERAL MEDICAL HISTORY2020-11 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Nov2020D-57 N DW 0.16 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrhDW%DhHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrhDW%DhHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501246115012461150A`Short Stature Short stature F5Musculoskeletal and connective tissue disorders FkShort stature F5Musculoskeletal and connective tissue conditions NEC FMusculoskeletal and connective tissue disorders NEC FiMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2020-11 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Nov2020D-57 N DW 0.16 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrhDW%DhHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrhDW%DhHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501247115012471150ADepression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-12-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Dec2020 -28 N DW 0.08 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDWDHrּBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDWDHrּ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501247115012471150A Nose Bleeds Epistaxis FrRespiratory, thoracic and mediastinal disorders F-Nose bleeds F Nasal disorders NEC FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1093 N DW 3 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDWDHrּBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDWDHrּ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501248115012481150A0Rhinitis due to pollen Seasonal allergy FUImmune system disorders F4Allergic rhinitis due to pollen F>Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2014M-2554 N DW 7 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD@Hr @DWD|Hs|Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD@Hr @DWDHrHDWDHsu1@DWD|Hs|Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501248115012481150AOverweight Overweight FMetabolism and nutrition disorders FOverweight FGeneral nutritional disorders NEC FAppetite and general nutritional disorders FJMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2014 2017 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2014M-2554 31Dec2017M-1094 N DW 7 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD@Hr @DWD|Hs|Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD@Hr @DWDHrHDWDHsu1@DWD|Hs|Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501248115012481150A Pineapple food allergy Food allergy FزImmune system disorders F4Fruit allergy FvAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2020-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jun2020D-211 N DW 0.58 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD@Hr @DWD|Hs|Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD@Hr @DWDHrHDWDHsu1@DWD|Hs|Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501249115012491150AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4015 N DW 11 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD8Hr08DWD4HsMPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD8Hr08DWDHrXDWDHsnDWD4HsMPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501250115012501150ADepression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2020D-363 N DW 1 YEARSAYEARS12-15 YearsAFA NOT REPORTED ApNOT REPORTED ApYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr/DWD`HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr/DWD`Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501251115012511150A@Psoriasis Psoriasis F'Skin and subcutaneous tissue disorders F5Psoriasis F'Psoriatic conditions FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2015M-2189 N DW 6 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDְHr?DWDHsCPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDְHr?DWDTHrcTDWDHsn;DWDHsCPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501251115012511150APTic Disorder Tic FAPsychiatric disorders F'Tic FATic disorders FAChanges in physical activity FQPsychiatric disorders F'GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2015M-2189 N DW 6 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDְHr?DWDHsCPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDְHr?DWDTHrcTDWDHsn;DWDHsCPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501251115012511150A Benign and innocent cardiac murmur Cardiac murmur F"Investigations FCardiac murmur F"Cardiac auscultatory investigations FYCardiac and vascular investigations (excl enzyme tests) FInvestigations FGENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2016M-1824 N DW 5 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDְHr?DWDHsCPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDְHr?DWDTHrcTDWDHsn;DWDHsCPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501251115012511150A0Lactose intolerance Lactose intolerance FMetabolism and nutrition disorders FLactose intolerance FSugar intolerance (excl glucose intolerance) FNCardiac auscultatory investigations FYCardiac and vascular investigations (excl enzyme tests) FInvestigations FGENERAL MEDICAL HISTORY2017-12 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Dec2017D-1131 N DW 3.1 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHrĆDW"DHr<BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHrĆDW"DHr<......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW"....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501276115012761150AHeadaches Headache FNervous system disorders FHeadache FHeadaches NEC FHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2017-10 2019 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Oct2017D-1192 31Dec2019M-371 N DW 3.27 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW DHrĆDW"DHr<BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW DHrĆDW"DHr<......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW"....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501277115012771150AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2014M-2561 N DW 7.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DlHrĐDWD$Hs:Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DlHrĐDW#D\HrDWDzXHstDWD$Hs:Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501277115012771150A Acne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1100 N DW 3.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DlHrĐDWD$Hs:Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DlHrĐDW#D\HrDWDzXHstDWD$Hs:Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501278115012781150A`Obesity Obesity F ;Metabolism and nutrition disorders FObesity F ;General nutritional disorders NEC FAppetite and general nutritional disorders FJMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2014M-2561 N DW 7.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW D|HrĞDWD8Hs8Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW D|HrĞDW"DHrEDWDHs~uDWD8Hs8Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW".DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501278115012781150AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2016M-1831 N DW 5.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW D|HrĞDWD8Hs8Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW D|HrĞDW"DHrEDWDHs~uDWD8Hs8Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW".DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501278115012781150A Atopic Dermatitis Dermatitis atopic FSkin and subcutaneous tissue disorders F5Atopic dermatitis FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1831 N DW 5.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW D|HrĞDWD8Hs8Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW D|HrĞDW"DHrEDWDHs~uDWD8Hs8Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW".DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501278115012781150APEczema Eczema FSkin and subcutaneous tissue disorders F5Eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2016M-1831 N DW 5.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW D|HrĞDWD8Hs8Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW D|HrĞDW"DHrEDWDHs~uDWD8Hs8Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW".DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501278115012781150A0Auditory Disturbance Hypoacusis FUaEar and labyrinth disorders F)Hearing impaired FHearing losses FHearing disorders FEar and labyrinth disorders F)GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2019M-735 N DW 2.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW D|HrĞDWD8Hs8Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW D|HrĞDW"DHrEDWDHs~uDWD8Hs8Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW".DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501278115012781150A@Developmental disorder of scholastic skills Developmental delay FǏGeneral disorders and administration site conditions FDevelopmental disturbance FǓGeneral signs and symptoms NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions FGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019M-735 N DW 2.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW D|HrĞDWD8Hs8Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW D|HrĞDW"DHrEDWDHs~uDWD8Hs8Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW".DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501278115012781150ApSensory Disturbance Sensory disturbance F2Nervous system disorders FSensory disturbance F2Sensory abnormalities NEC F2Neurological disorders NEC FNervous system disorders FGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.07 01Jan2019M-735 N DW 2.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW D|HrĞDWD8Hs8Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW D|HrĞDW"DHrEDWDHs~uDWD8Hs8Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW".DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501279115012791150A0Asthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2011M-3658 YChronic pulmonary disease DW 10.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrtDW!D\HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrtDW!D\Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW!....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501279115012791150APGeneralized Anxiety Disorder Generalised anxiety disorder FPsychiatric disorders F'Generalized anxiety disorder F9Anxiety disorders NEC FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2013M-2927 N DW 8.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrtDW!D\HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrtDW!D\Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW!....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501279115012791150AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2015M-2197 N DW 6.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrtDW!D\HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrtDW!D\Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW!....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501279115012791150A Asperger's Syndrome Autism spectrum disorder FPsychiatric disorders F'Asperger's syndrome FPervasive developmental disorders NEC F4Developmental disorders NEC FǒPsychiatric disorders F'GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2016M-1832 N DW 5.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrtDW!D\HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrtDW!D\Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW!....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501279115012791150A@Atopic Dermatitis Dermatitis atopic FSkin and subcutaneous tissue disorders F5Atopic dermatitis FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2016M-1832 N DW 5.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrtDW!D\HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrtDW!D\Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW!....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501279115012791150A`Plantar Wart Skin papilloma F6KNeoplasms benign, malignant and unspecified (incl cysts and polyps)F0Plantar warts FSkin neoplasms benign F6BCutaneous neoplasms benign F6CNeoplasms benign, malignant and unspecified (incl cysts and polyps)F0GENERAL MEDICAL HISTORY2016 2017 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2016M-1832 31Dec2017M-1102 N DW 5.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrtDW!D\HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrtDW!D\Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW!....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501281115012811150AAcne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-736 N DW 2.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDpHrűpDW#D0HrႰBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDpHrűpDW#D0HrႰ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501281115012811150A Anxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2020M-371 N DW 1.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDpHrűpDW#D0HrႰBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDpHrűpDW#D0HrႰ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501281115012811150A0Depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2020M-371 N DW 1.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDpHrűpDW#D0HrႰBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDpHrűpDW#D0HrႰ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501281115012811150A@Vitamin D Deficiency Vitamin D deficiency FPMetabolism and nutrition disorders FVitamin D deficiency FPFat soluble vitamin deficiencies and disorders FVitamin related disorders FPMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2020 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2020M-371 N DW 1.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDpHrűpDW#D0HrႰBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDpHrűpDW#D0HrႰ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501282115012821150AAcne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2020-09 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Sep2020D-127 N DW 0.35 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDPHrPDWDzHsvPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDPHrPDW$DHrDWDHsrNDDWDzHsvPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501283115012831150ACodeine Allergy Drug hypersensitivity FImmune system disorders F4Specific allergy (drug) F8OAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2009M-4388 N DW 12.02 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDtHstPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDW%DHr*`DWDHsm?DWDtHstPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501283115012831150A Reactive Airway Disease Bronchial hyperreactivity FRespiratory, thoracic and mediastinal disorders F-Reactive airways disease F*Bronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2010M-4023 N DW 11.02 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DWDHrDWDtHstPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrDW%DHr*`DWDHsm?DWDtHstPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501284115012841150AAllergic Rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1102 N DW 3.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrxDWD|Hs|Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrxDW#D{ HrDWDHsr9hDWD|Hs|Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501284115012841150A Dysmenorrhea Dysmenorrhoea FReproductive system and breast disorders F-LDysmenorrhea FMenstruation and uterine bleeding NEC FGMenstrual cycle and uterine bleeding disorders FʎReproductive system and breast disorders F-LGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2019M-737 N DW 2.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrxDWD|Hs|Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrxDW#D{ HrDWDHsr9hDWD|Hs|Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501284115012841150A0Migraines Migraine FONervous system disorders FMigraine FOMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019M-737 N DW 2.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrxDWD|Hs|Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrxDW#D{ HrDWDHsr9hDWD|Hs|Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501285115012851150A@intrinsic eczema Eczema FSkin and subcutaneous tissue disorders F5Eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2006M-5485 N DW 15.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDdHrDW#DlHrUBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDdHrDW#DlHrU......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501285115012851150AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2010M-4024 N DW 11.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDdHrDW#DlHrUBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDdHrDW#DlHrU......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501285115012851150A Anxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2010M-4024 N DW 11.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDdHrDW#DlHrUBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDdHrDW#DlHrU......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501285115012851150A0Seasonal Allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3294 N DW 9.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDdHrDW#DlHrUBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDdHrDW#DlHrU......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501286115012861150A0Seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3294 N DW 9.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr\DW#DHrV(BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr\DW#DHrV(......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501286115012861150AAlopecia Alopecia F`Skin and subcutaneous tissue disorders F5Alopecia F`Alopecias FiSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2013M-2928 N DW 8.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr\DW#DHrV(BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr\DW#DHrV(......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501286115012861150A Anxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2018M-1102 N DW 3.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr\DW#DHrV(BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr\DW#DHrV(......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501287115012871150AIdiopathic Scoliosis Scoliosis F1Musculoskeletal and connective tissue disorders FkScoliosis F1Spine and neck deformities FMusculoskeletal and connective tissue deformities (incl intervertebral disc disorders)FYMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2016-02 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Feb2016D-1802 N DW 4.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDxHrDW$D4Hr4BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDxHrDW$D4Hr4......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501288115012881150Aseasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3295 N DW 9.02 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDW$DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDW$DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501289115012891150AEczema Eczema FSkin and subcutaneous tissue disorders F5Eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2007M-5121 N DW 14.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr^DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr^DW%DlHrDWDXHsnXDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501289115012891150A Penicillin Allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2007M-5121 N DW 14.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr^DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr^DW%DlHrDWDXHsnXDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501289115012891150A0sulfa drug allergy Drug hypersensitivity FImmune system disorders F4Sulfonamide allergy FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2007M-5121 N DW 14.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr^DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr^DW%DlHrDWDXHsnXDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501290115012901150AMigraines Migraine FONervous system disorders FMigraine FOMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-741 N DW 2.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD0HrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD0HrDW(DHr'DWDHsm[<DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501291115012911150A Quaternium Allergy Drug hypersensitivity FImmune system disorders F4Drug allergy FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1106 N DW 3.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr/(DWDHsiHPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr/(DW*D$Hr$DWDHsuGHDWDHsiHPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW*.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501291115012911150AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-741 N DW 2.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr/(DWDHsiHPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr/(DW*D$Hr$DWDHsuGHDWDHsiHPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW*.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501292115012921150AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1106 N DW 3.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD Hr/DW*DۜHr꺜BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD Hr/DW*DۜHr꺜......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW*....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501292115012921150A Quanternium Allergy Drug hypersensitivity FImmune system disorders F4Allergy to topical drugs F]Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1106 N DW 3.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD Hr/DW*DۜHr꺜BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD Hr/DW*DۜHr꺜......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW*....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501293115012931150Alymes disease Lyme disease FInfections and infestations FLyme's disease FBorrelial infections FBacterial infectious disorders F2Infections and infestations FGENERAL MEDICAL HISTORY2008 2009 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4759 31Dec2009M-4029 N DW 13.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr4PDW3DHrtBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr4PDW3DHrt......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW3....DWDDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501294115012941150A@Oral Allergy Syndrome Oral allergy syndrome FImmune system disorders F4Oral allergy syndrome FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4028 N DW 11.03 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DWDHrRPDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrRPDW(D Hr/ DWDHs`DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501294115012941150AAsthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2015M-2202 YChronic pulmonary disease DW 6.03 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DWDHrRPDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrRPDW(D Hr/ DWDHs`DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501294115012941150A Atopic Dermatitis Dermatitis atopic FSkin and subcutaneous tissue disorders F5Atopic dermatitis FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2015M-2202 N DW 6.03 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DWDHrRPDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrRPDW(D Hr/ DWDHs`DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501294115012941150APVitamin D deficiency Vitamin D deficiency FPMetabolism and nutrition disorders FVitamin D deficiency FPFat soluble vitamin deficiencies and disorders FVitamin related disorders FPMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2020 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2020M-376 N DW 1.03 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DWDHrRPDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrRPDW(D Hr/ DWDHs`DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501294115012941150A0Major Depressive Disorder Major depression FxpPsychiatric disorders F'Major depressive disorder FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020 2021-01-01BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2020M-376 01Jan2021 -10 N DW 1.03 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DWDHrRPDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrRPDW(D Hr/ DWDHs`DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501297115012971150A Minor Beta-Thalassemia Thalassaemia beta F?Congenital, familial and genetic disorders FThalassemia beta FlHaemoglobinopathies congenital FWBlood and lymphatic system disorders congenital FRCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4759 N DW 13.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDtHr̀DW)DHHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDtHr̀DW)DHHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW)....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501297115012971150ACat allergy Allergy to animal FNImmune system disorders F4Allergic to cats FCAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2020 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2020M-376 N DW 1.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDtHr̀DW)DHHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDtHr̀DW)DHHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW)....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501298115012981150A nut allergy Food allergy FزImmune system disorders F4Allergy to nuts Fm/Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4029 N DW 11.03 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DWD4Hr|4DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD4Hr|4DW(DHrDWD|HsmODWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501298115012981150ASesame allergy Food allergy FزImmune system disorders F4Food allergy FزAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2014M-2568 N DW 7.03 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DWD4Hr|4DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD4Hr|4DW(DHrDWD|HsmODWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1150 11501299115012991150Apenicillin allergy Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4029 N DW 11.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrͨDW(DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrͨDW(DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501299115012991150A seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2014M-2568 N DW 7.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrͨDW(DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrͨDW(DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501301115013011150A0Premenstral (no period yet) Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) 2021-01-29BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 (b)(6) (b)(6)29Jan2021 18 N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD`Hr`DW*DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD`Hr`DW*DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW*....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501301115013011150AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-08 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Aug2020D-164 N DW 0.45 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD`Hr`DW*DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD`Hr`DW*DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW*....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1150 11501301115013011150A Nevus, non-neoplastic on back Melanocytic naevus FNeoplasms benign, malignant and unspecified (incl cysts and polyps)F0Nevus F HSkin neoplasms benign F6BCutaneous neoplasms benign F6CNeoplasms benign, malignant and unspecified (incl cysts and polyps)F0GENERAL MEDICAL HISTORY2020-08 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Aug2020D-164 N DW 0.45 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD`Hr`DW*DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD`Hr`DW*DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW*....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1152 11521605115216051152A@seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2005 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2005M-5814 N DV 15.92 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr$DVDLHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr$DVDLHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWTDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1152 11521605115216051152Aasthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2006M-5449 YChronic pulmonary disease DV 14.92 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr$DVDLHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr$DVDLHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWTDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1152 11521605115216051152A0nearsightedness Myopia FkEye disorders FԯNearsighted FxRefractive and accommodative disorders F+Vision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2014M-2527 N DV 6.92 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr$DVDLHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr$DVDLHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWTDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1152 11521605115216051152A migraine headaches Migraine FONervous system disorders FMigraine headache FRMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2162 N DV 5.92 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr$DVDLHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr$DVDLHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWTDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1152 11521612115216121152Adeviated septum Nasal septum deviation FRespiratory, thoracic and mediastinal disorders F-Nasal septum deviation FNasal disorders NEC FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2008M-4720 N DV 12.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD0Hr0DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD0Hr0DVDHHrDWDHHsFHDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1152 11521612115216121152A nearsightedness Myopia FkEye disorders FԯNearsighted FxRefractive and accommodative disorders F+Vision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1432 N DV 3.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD0Hr0DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD0Hr0DVDHHrDWDHHsFHDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1152 11521614115216141152Aasthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2006M-5450 YChronic pulmonary disease DV 14.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD|Hr|DVDHrʘBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD|Hr|DVDHrʘ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1152 11521614115216141152A seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2006M-5450 N DV 14.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD|Hr|DVDHrʘBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD|Hr|DVDHrʘ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1152 11521617115216171152A asthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2011 2012 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2011M-3624 31Dec2012M-2894 YChronic pulmonary disease DV 9.92 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1152 11521617115216171152Aallergy to cats Allergy to animal FNImmune system disorders F4Allergic to cats FCAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2018M-1067 N DV 2.92 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1152 11521617115216171152A@ear infection Ear infection F;Infections and infestations FEar infection F;Ear infections F=Infections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2018 2018 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2018M-1067 31Dec2018M-703 N DV 2.92 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1152 11521617115216171152A0conjunctivitis Conjunctivitis FuInfections and infestations FConjunctivitis FuEye and eyelid infections FԥInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2019 2019 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019M-702 31Dec2019M-338 N DV 1.92 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1152 11521625115216251152A asthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2008 2018 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4721 31Dec2018M-704 YChronic pulmonary disease DV 12.93 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr+BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr+......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1152 11521625115216251152Aallergy to Keflex Drug hypersensitivity FImmune system disorders F4Allergic reaction to antibiotics F8Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2014M-2529 N DV 6.93 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr+BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr+......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1152 11521625115216251152A@osteomyelitis Osteomyelitis FInfections and infestations FOsteomyelitis FBone and joint infections FInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2014 2014 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2014M-2529 31Dec2014M-2165 N DV 6.93 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr+BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr+......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1152 11521625115216251152A0croup Croup infectious FInfections and infestations FCroup FUpper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2016 2016 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2016M-1799 31Dec2016M-1434 N DV 4.93 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDHr+BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDHr+......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1152 11521628115216281152A0seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2006 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2006M-5451 N DV 14.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr 4DWD\Hr2\BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr 4DWD\Hr2\......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1152 11521628115216281152Aanxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1068 N DV 2.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr 4DWD\Hr2\BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr 4DWD\Hr2\......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1152 11521628115216281152A depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2018M-1068 N DV 2.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr 4DWD\Hr2\BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr 4DWD\Hr2\......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1152 11521629115216291152A asthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2164 YChronic pulmonary disease DV 5.93 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr |DW!DLHrއPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr |DWDHr_DW DHr'tDW!DLHrއPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DW DW!.DW DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1152 11521629115216291152Aacne Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019M-703 N DV 1.93 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr |DW!DLHrއPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr |DWDHr_DW DHr'tDW!DLHrއPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DW DW!.DW DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1152 11521633115216331152Aasthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2009M-4358 YChronic pulmonary disease DV 11.93 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDxHrxDWDְHs^Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDxHrxDWDθHr8DWDLHs}DWDְHs^Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1152 11521633115216331152A seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2016M-1802 N DV 4.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDxHrxDWDְHs^Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDxHrxDWDθHr8DWDLHs}DWDְHs^Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1152 11521635115216351152A0seasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2009M-4358 N DV 11.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDXHrXDWD$HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDXHrXDWD$Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1152 11521635115216351152A pneumonia Pneumonia F!Infections and infestations FPneumonia F!Lower respiratory tract and lung infections FInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2013 2013 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2013M-2897 31Dec2013M-2533 N DV 7.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDXHrXDWD$HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDXHrXDWD$Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1152 11521635115216351152Aanxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2015M-2167 N DV 5.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDXHrXDWD$HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDXHrXDWD$Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1152 11521637115216371152A birthmark forehead Birth mark FCongenital, familial and genetic disorders FBirth mark FSkin and subcutaneous tissue disorders congenital NEC F6Skin and subcutaneous tissue disorders congenital F5Congenital, familial and genetic disorders FGENERAL MEDICAL HISTORY(b)(6) (b)(6) BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 (b)(6) (b)(6)(b)(6) D(b)(6)N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD(Hr!(DWDְHsҰPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD(Hr!(DWDLHrDWD HsvF DWDְHsҰPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1152 11521637115216371152Aanxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-03 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Mar2020D-281 N DV 0.77 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD(Hr!(DWDְHsҰPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD(Hr!(DWDLHrDWD HsvF DWDְHsҰPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1152 11521639115216391152A@rotavirus infection Rotavirus infection FInfections and infestations FRotavirus infection FRotaviral infections F/Viral infectious disorders FOInfections and infestations FGENERAL MEDICAL HISTORY2009 2009 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2009M-4358 31Dec2009M-3994 N DV 11.93 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDXHrAnaemia deficiencies FzAnaemias nonhaemolytic and marrow depression FBlood and lymphatic system disorders FQGENERAL MEDICAL HISTORY2019-05-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01May2019 -533 N DV 1.46 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVDHrXNPDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrXNPDVD`HrqC`DWD\Hs|DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1156 11561245115612451156AASTHMA Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2015-12-02 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 02Dec2015 -1779 YChronic pulmonary disease DV 4.87 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDƄHrXODVDHrqDBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDƄHrXODVDHrqD......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1156 11561245115612451156A CHRONIC RHINITIS Rhinitis F/+Infections and infestations FChronic rhinitis F)Upper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2019-11-04 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 04Nov2019 -346 N DV 0.95 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDƄHrXODVDHrqDBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDƄHrXODVDHrqD......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1156 11561246115612461156AACNE VULGARIS Acne FpSkin and subcutaneous tissue disorders F5Acne vulgaris FAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019M-660 N DV 1.81 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVDHraDWDPHsPPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHraDVD8HrziDWDHsw4DWDPHsPPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1156 11561246115612461156A ASTHMA Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2017-08-11 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 11Aug2017 -1168 YChronic pulmonary disease DV 3.2 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVDHraDWDPHsPPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHraDVD8HrziDWDHsw4DWDPHsPPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1156 11561247115612471156A hazelnut allergy Food allergy FزImmune system disorders F4Allergy to nuts Fm/Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2011M-3576 N DV 9.79 YEARSAYEARS12-15 YearsAMANOT REPORTED ApNOT REPORTED ApYYPlacebo PLACEBO Placebo PLACEBO DVDlHrYmlDWD Hs Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDlHrYmlDVDHrr<DWDHsDWD Hs Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1156 11561247115612471156Aasthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2115 YChronic pulmonary disease DV 5.79 YEARSAYEARS12-15 YearsAMANOT REPORTED ApNOT REPORTED ApYYPlacebo PLACEBO Placebo PLACEBO DVDlHrYmlDWD Hs Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDlHrYmlDVDHrr<DWDHsDWD Hs Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1156 11561249115612491156Aasthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2009M-4306 YChronic pulmonary disease DV 11.79 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrYDVDtHrrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrYDVDtHrr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1156 11561249115612491156A attention deficit hyperactive disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit/hyperactivity disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2012M-3211 N DV 8.79 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrYDVDtHrrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrYDVDtHrr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1156 11561253115612531156A DYSLIPIDEMIA Dyslipidaemia Fy|Metabolism and nutrition disorders FDyslipidemia Fy~Lipid metabolism and deposit disorders NEC FLipid metabolism disorders FʅMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2020-06-05 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 05Jun2020 -136 N DV 0.38 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVDTHr]yDWDLHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDTHr]yDVDHr{ƴDWDHs:DWDLHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1156 11561253115612531156AALLERGIC RHINITIS Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2020-02-26 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 26Feb2020 -236 N DV 0.65 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVDTHr]yDWDLHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDTHr]yDVDHr{ƴDWDHs:DWDLHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1156 11561254115612541156A attention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2011M-3579 N DV 9.8 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVDHr]4DWDHsGPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr]4DVD,Hr{,DWD8HsDWDHsGPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1156 11561254115612541156Aasthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3214 YChronic pulmonary disease DV 8.8 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVDHr]4DWDHsGPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr]4DVD,Hr{,DWD8HsDWDHsGPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1156 11561255115612551156AASTHMA Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2013M-2849 YChronic pulmonary disease DV 7.8 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVDHr^DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr^DVD HrzhDWDHHsrQDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1156 11561257115612571156ACONDUCT DISORDER Behaviour disorder FPsychiatric disorders F'Conduct disorder F^Abnormal behaviour NEC FPsychiatric and behavioural symptoms NEC F'Psychiatric disorders F'GENERAL MEDICAL HISTORY2017-04-27 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 27Apr2017 -1272 N DV 3.49 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr^DVD0Hr}ABNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr^DVD0Hr}A......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1156 11561260115612601156Adysmenorrhea Dysmenorrhoea FReproductive system and breast disorders F-LDysmenorrhea FMenstruation and uterine bleeding NEC FGMenstrual cycle and uterine bleeding disorders FʎReproductive system and breast disorders F-LGENERAL MEDICAL HISTORY2019-01-24 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 24Jan2019 -636 N DV 1.74 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDxHr`DWqDHsHxPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDxHr`DVD`Hr}DW[DHs+<DWqDHsHxPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DW[DWq.DW=DV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1156 11561262115612621156Aasthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2010-04-05 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 05Apr2010 -3852 YChronic pulmonary disease DV 10.55 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDĤHr`6$DVDHr{BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDĤHr`6$DVDHr{......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1156 11561263115612631156A intermittent epistaxis Epistaxis FrRespiratory, thoracic and mediastinal disorders F-Epistaxis FrNasal disorders NEC FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-659 N DV 1.81 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr`HlDWD|Hs4Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr`HlDVDHrzhDWDlHs|DWD|Hs4Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1156 11561263115612631156Ahyperglyceridemia Hypertriglyceridaemia FMetabolism and nutrition disorders FHyperglyceridemia Fk Elevated triglycerides FLipid metabolism disorders FʅMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2018-11-14 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 14Nov2018 -707 N DV 1.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr`HlDWD|Hs4Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr`HlDVDHrzhDWDlHs|DWD|Hs4Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1156 11561264115612641156A DERMATITIS Dermatitis FSkin and subcutaneous tissue disorders F5Dermatitis FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1390 N DV 3.81 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHraiDVDHrzBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHraiDVDHrz......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1156 11561264115612641156ACONDUCT DISORDER Behaviour disorder FPsychiatric disorders F'Conduct disorder F^Abnormal behaviour NEC FPsychiatric and behavioural symptoms NEC F'Psychiatric disorders F'GENERAL MEDICAL HISTORY2017-10-02 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 02Oct2017 -1116 N DV 3.06 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHraiDVDHrzBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHraiDVDHrz......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1156 11561265115612651156AALLERGIC RHINITIS Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2020-08 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Aug2020D-82 N DV 0.23 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVD|Hra|DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD|Hra|DVDHrzk\DWDHswDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1156 11561304115613041156A@OBESITY Obesity F ;Metabolism and nutrition disorders FObesity F ;General nutritional disorders NEC FAppetite and general nutritional disorders FJMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2008M-4717 N DV 12.92 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDҴHr4DVD(Hrx(BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDҴHr4DVD(Hrx(......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1156 11561304115613041156A ATTENTION DEFICIT DISORDER Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2012M-3256 N DV 8.92 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDҴHr4DVD(Hrx(BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDҴHr4DVD(Hrx(......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1156 11561304115613041156AATOPIC DERMATITIS Dermatitis atopic FSkin and subcutaneous tissue disorders F5Atopic dermatitis FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2020-03-03 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 03Mar2020 -272 N DV 0.75 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDҴHr4DVD(Hrx(BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDҴHr4DVD(Hrx(......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1156 11561304115613041156A0DYSLIPIDEMIA Dyslipidaemia Fy|Metabolism and nutrition disorders FDyslipidemia Fy~Lipid metabolism and deposit disorders NEC FLipid metabolism disorders FʅMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2020-10-26 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 26Oct2020 -35 N DV 0.1 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDҴHr4DVD(Hrx(BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDҴHr4DVD(Hrx(......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1156 11561308115613081156AASTHMA Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3257 YChronic pulmonary disease DV 8.92 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr0DVD Hrv BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr0DVD Hrv ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1156 11561311115613111156A ASTHMA Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2008M-4719 YChronic pulmonary disease DV 12.92 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVDlHrcDW D,HrgPlacebo A .Placebo A .DVDlHrcDW D,Hrg......Placebo Placebo DVDW ....DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1156 11561311115613111156A0ATOPIC DERMATITIS Dermatitis atopic FSkin and subcutaneous tissue disorders F5Atopic dermatitis FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2010M-3988 N DV 10.92 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVDlHrcDW D,HrgPlacebo A .Placebo A .DVDlHrcDW D,Hrg......Placebo Placebo DVDW ....DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1156 11561311115613111156A@CHRONIC TONSILLITIS Chronic tonsillitis F@Infections and infestations FChronic tonsillitis F@Upper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2010 2013 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.06 01Jan2010M-3988 31Dec2013M-2528 N DV 10.92 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVDlHrcDW D,HrgPlacebo A .Placebo A .DVDlHrcDW D,Hrg......Placebo Placebo DVDW ....DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1156 11561311115613111156ApTONSILLECTOMY Tonsillectomy FBfSurgical and medical procedures F<Tonsillectomy FBfTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2013 2013 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.07 01Jan2013M-2892 31Dec2013M-2528 N DV 7.92 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVDlHrcDW D,HrgPlacebo A .Placebo A .DVDlHrcDW D,Hrg......Placebo Placebo DVDW ....DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1156 11561311115613111156A`OBESITY Obesity F ;Metabolism and nutrition disorders FObesity F ;General nutritional disorders NEC FAppetite and general nutritional disorders FJMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2014M-2527 N DV 6.92 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVDlHrcDW D,HrgPlacebo A .Placebo A .DVDlHrcDW D,Hrg......Placebo Placebo DVDW ....DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1156 11561311115613111156APDYSLIPIDEMIA Dyslipidaemia Fy|Metabolism and nutrition disorders FDyslipidemia Fy~Lipid metabolism and deposit disorders NEC FLipid metabolism disorders FʅMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2020-10-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Oct2020 -62 N DV 0.17 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVDlHrcDW D,HrgPlacebo A .Placebo A .DVDlHrcDW D,Hrg......Placebo Placebo DVDW ....DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1156 11561311115613111156AALLERGIC RHINITIS Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2019-06-10 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 10Jun2019 -541 N DV 1.48 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVDlHrcDW D,HrgPlacebo A .Placebo A .DVDlHrcDW D,Hrg......Placebo Placebo DVDW ....DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1156 11561312115613121156AATTENTION DEFICIT HYPERACTIVITY DISORDER Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2014M-2527 N DV 6.92 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVD HrsDWD|Hs5Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD HrsDVDHrDWDtHstDWD|Hs5Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1156 11561313115613131156AHYPERLIPIDEMIA Hyperlipidaemia FMetabolism and nutrition disorders FHyperlipidemia F;Hyperlipidaemias NEC F:Lipid metabolism disorders FʅMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2019-08-15 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 15Aug2019 -475 N DV 1.3 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrLDVD(Hr(BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrLDVD(Hr(......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1156 11561314115613141156A MENSES IRREGULAR Menstruation irregular FKReproductive system and breast disorders F-LMenses irregular F5Menstruation and uterine bleeding NEC FGMenstrual cycle and uterine bleeding disorders FʎReproductive system and breast disorders F-LGENERAL MEDICAL HISTORY2019-12-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Dec2019 -368 N DV 1.01 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD4Hr4DWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD4Hr4DWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1156 11561314115613141156AASTHMA Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2010-01-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010 -3989 YChronic pulmonary disease DV 10.92 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD4Hr4DWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD4Hr4DWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1156 11561317115613171156AASTHMA Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2008-01-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2008 -4720 YChronic pulmonary disease DV 12.93 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDۜHrDWDlHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDۜHrDWDlHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1156 11561317115613171156A MORBID OBESITY Obesity F ;Metabolism and nutrition disorders FMorbid obesity FGeneral nutritional disorders NEC FAppetite and general nutritional disorders FJMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2019-06-26 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 26Jun2019 -526 N DV 1.44 YEARSAYEARS12-15 YearsAMABLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDۜHrDWDlHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDۜHrDWDlHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1156 11561319115613191156AALLERGIC RHINITIS Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2020-10-30 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 30Oct2020 -35 N DV 0.1 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVDǰHr;0DWDHsb`Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDǰHr;0DWD<Hr4<DWD\Hs\DWDHsb`Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1156 11561322115613221156AASTHMA Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2009M-4358 YChronic pulmonary disease DV 11.93 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVD<Hr+<DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD<Hr+<DWDHrDWDDHssDDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1156 11561322115613221156A INSOMNIA Insomnia F%Psychiatric disorders F'Insomnia F%Disturbances in initiating and maintaining sleep FFSleep disorders and disturbances F6Psychiatric disorders F'GENERAL MEDICAL HISTORY2019-09 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Sep2019D-463 N DV 1.27 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVD<Hr+<DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD<Hr+<DWDHrDWDDHssDDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1156 11561324115613241156AASTHMA Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4724 YChronic pulmonary disease DV 12.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDĤHr,DWDŔHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDĤHr,DWDŔHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1156 11561324115613241156A@PENICILLIN ALLERGY Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2009M-4358 N DV 11.93 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDĤHr,DWDŔHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDĤHr,DWDŔHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1156 11561324115613241156A0CEFALOSPORIN ALLERGY Drug hypersensitivity FImmune system disorders F4Allergic reaction to antibiotics F8Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2010M-3993 N DV 10.93 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDĤHr,DWDŔHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDĤHr,DWDŔHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1156 11561324115613241156A ATTENTION DEFICIT DISORDER Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2016M-1802 N DV 4.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDĤHr,DWDŔHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDĤHr,DWDŔHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1156 11561325115613251156AASTHMA Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-3994 YChronic pulmonary disease DV 10.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrlDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrlDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1156 11561328115613281156A@CHRONIC TONSILLITIS Chronic tonsillitis F@Infections and infestations FChronic tonsillitis F@Upper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2009 2012 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2009M-4365 31Dec2012M-2905 N DV 11.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrGDW DHr5BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrGDW DHr5......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1156 11561328115613281156A ASTHMA Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2009 2013 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.05 01Jan2009M-4365 31Dec2013M-2540 YChronic pulmonary disease DV 11.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrGDW DHr5BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrGDW DHr5......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1156 11561328115613281156A0CHRONIC ADENOIDITIS Adenoiditis F^Infections and infestations FAdenoiditis F^Upper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2010 2012 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2010M-4000 31Dec2012M-2905 N DV 10.95 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrGDW DHr5BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrGDW DHr5......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1156 11561328115613281156AADENOIDECTOMY Adenoidectomy FNSurgical and medical procedures F<Adenoidectomy FNTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2012 2012 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2012M-3270 31Dec2012M-2905 N DV 8.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrGDW DHr5BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrGDW DHr5......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1156 11561328115613281156APTONSILLECTOMY Tonsillectomy FBfSurgical and medical procedures F<Tonsillectomy FBfTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2012 2012 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3270 31Dec2012M-2905 N DV 8.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrGDW DHr5BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrGDW DHr5......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1156 11561334115613341156AACNE Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1447 N DV 3.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrTDWDHr(BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrTDWDHr(......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1156 11561335115613351156APREMENARCHE Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DVDHrzDWDHsbPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrzDWDHrTDWDHs\DWDHsbPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1156 11561337115613371156AMASS IN LEFT BREAST (CYSTIC) Breast cyst FReproductive system and breast disorders F-LBreast cyst FBenign and malignant breast neoplasms FBreast disorders FReproductive system and breast disorders F-LGENERAL MEDICAL HISTORY2019-03-11 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 11Mar2019 -652 N DV 1.79 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr(DWDHrnpBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr(DWDHrnp......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1156 11561337115613371156A SCOLIOSIS Scoliosis F1Musculoskeletal and connective tissue disorders FkScoliosis F1Spine and neck deformities FMusculoskeletal and connective tissue deformities (incl intervertebral disc disorders)FYMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2018-03-14 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 14Mar2018 -1014 N DV 2.78 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr(DWDHrnpBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr(DWDHrnp......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1156 11561338115613381156A HYPOPITUITARISM Hypopituitarism FEndocrine disorders FHypopituitarism FAnterior pituitary hypofunction F Hypothalamus and pituitary gland disorders FEndocrine disorders FGENERAL MEDICAL HISTORY2016-06-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jun2016 -1666 N DW 4.56 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr*DWDHrrlBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr*DWDHrrl......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1156 11561338115613381156AATTENTION DEFICIT HYPERACTIVITY DISORDER Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2015-01-22 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 22Jan2015 -2162 N DW 5.92 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr*DWDHrrlBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr*DWDHrrl......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1156 11561339115613391156A@PREMENARCHAL Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DWD$HrŤDWDHrPlacebo A .Placebo A .DWD$HrŤDWDHr......Placebo Placebo DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1156 11561339115613391156APSICKLE CELL TRAIT Sickle cell trait F5JCongenital, familial and genetic disorders FSickle cell trait F5JHaemoglobinopathies congenital FWBlood and lymphatic system disorders congenital FRCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DWD$HrŤDWDHrPlacebo A .Placebo A .DWD$HrŤDWDHr......Placebo Placebo DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1156 11561339115613391156AAPPENDECTOMY Appendicectomy FBSurgical and medical procedures F<Appendectomy F@Large intestine therapeutic procedures F{Gastrointestinal therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2013 2013 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2013M-2918 31Dec2013M-2554 N DW 7.99 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DWD$HrŤDWDHrPlacebo A .Placebo A .DWD$HrŤDWDHr......Placebo Placebo DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1156 11561339115613391156A APPENDICITIS Appendicitis FCInfections and infestations FAppendicitis FCAbdominal and gastrointestinal infections FܯInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2013 2013 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2013M-2918 31Dec2013M-2554 N DW 7.99 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DWD$HrŤDWDHrPlacebo A .Placebo A .DWD$HrŤDWDHr......Placebo Placebo DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1156 11561339115613391156A0OSGOOD-SCHLATTER DISEASE Osteochondrosis FMusculoskeletal and connective tissue disorders FkOsgood-Schlatter's disease FCartilage disorders FTendon, ligament and cartilage disorders F?eMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2019-05-202020-02 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 20May2019 -588 29Feb2020D-303 N DW 1.61 YEARSAYEARS12-15 YearsAFA BLACK OR AFRICAN AMERICAN A BLACK OR AFRICAN AMERICAN A YYPlacebo PLACEBO Placebo PLACEBO DWD$HrŤDWDHrPlacebo A .Placebo A .DWD$HrŤDWDHr......Placebo Placebo DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1156 11561340115613401156AALLERGIC RHINITIS Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2011M-3649 N DW 9.99 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDWDȠHr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDWDȠHr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1156 11561340115613401156A CHRONIC VENOUS INSUFFICIENCY Peripheral venous disease FVascular disorders FNYChronic venous insufficiency FNon-site specific necrosis and vascular insufficiency NEC F Arteriosclerosis, stenosis, vascular insufficiency and necrosis FVascular disorders FNYGENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1457 N DW 3.99 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrDWDȠHr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrDWDȠHr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1156 11561343115613431156AATTENTION DEFICIT HYPERACTIVITY DISORDER Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3291 N DW 9.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DW DHrDWDHs0Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADW DHrDW!DLHrޖDWDHssDWDHs0Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1156 11561344115613441156A ADENOIDITIS Adenoiditis F^Infections and infestations FAdenoiditis F^Upper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2010-01 2010-03 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010D-4021 31Mar2010D-3932 N DW 11.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW D(Hr8(DW!D HrѠBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW D(Hr8(DW!D HrѠ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1156 11561344115613441156A0SEASONAL ALLERGIC RHINITIS Seasonal allergy FUImmune system disorders F4Seasonal allergic rhinitis F1Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2017M-1464 N DW 4.01 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW D(Hr8(DW!D HrѠBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW D(Hr8(DW!D HrѠ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1156 11561344115613441156AADENOIDECTOMY Adenoidectomy FNSurgical and medical procedures F<Adenoidectomy FNTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2010-03 2010-03 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Mar2010D-3962 31Mar2010D-3932 N DW 10.85 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DW D(Hr8(DW!D HrѠBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DW D(Hr8(DW!D HrѠ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DW DW!....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1156 11561346115613461156APREMENARCHAL Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrřDW$DHr⒐BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrřDW$DHr⒐......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1156 11561351115613511156A PREMENARCHAL Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrېDWDHs4 Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrېDW$DDHrDDWD Hs{ DWDHs4 Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1156 11561351115613511156APENICILLIN MILD ALLERGY Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2011M-3659 N DW 10.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrېDWDHs4 Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrېDW$DDHrDDWD Hs{ DWDHs4 Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1156 11561353115613531156A0PECTUS EXCAVATUM Pectus excavatum FCongenital, familial and genetic disorders FPectus excavatum FMusculoskeletal and connective tissue disorders of trunk congenital (excl spine)F`Musculoskeletal and connective tissue disorders congenital FlCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDߘHr&DWDHHsrPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDߘHr&DW#DHr$DWDHHsrDWDHHsrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DW..DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1156 11561353115613531156A@PREMENARCHE Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDߘHr&DWDHHsrPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDߘHr&DW#DHr$DWDHHsrDWDHHsrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DW..DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1156 11561353115613531156A ADENOIDITIS Adenoiditis F^Infections and infestations FAdenoiditis F^Upper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2011 2012 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2011M-3659 31Dec2012M-2929 N DW 10.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDߘHr&DWDHHsrPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDߘHr&DW#DHr$DWDHHsrDWDHHsrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DW..DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1156 11561353115613531156AADENOIDECTOMY Adenoidectomy FNSurgical and medical procedures F<Adenoidectomy FNTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2012 2012 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3294 31Dec2012M-2929 N DW 9.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDߘHr&DWDHHsrPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDߘHr&DW#DHr$DWDHHsrDWDHHsrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DW..DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1156 11561356115613561156AALLERGY TO PENICILLIN Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2007M-5120 N DW 14.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDhHr(DW%DHr0<BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDhHr(DW%DHr0<......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1156 11561356115613561156A ATTENTION DEFICIT HYPERACTIVITY DISORDER Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019-10 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Oct2019D-464 N DW 1.27 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDhHr(DW%DHr0<BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDhHr(DW%DHr0<......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1156 11561357115613571156APREMENARCHAL Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr6DDWDtHstPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr6DDW#DHr4DWDHsr@DWDtHstPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1156 11561357115613571156A REFRACTIVE AMBLYOPIA (RIGHT EYE) Refractive amblyopia F+Eye disorders FԯRefractive amblyopia F+Amblyopic vision impairment FVision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2014M-2563 N DW 7.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr6DDWDtHstPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr6DDW#DHr4DWDHsr@DWDtHstPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1156 11561359115613591156AASTHMA Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2009 2017 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2009M-4390 31Dec2017M-1104 YChronic pulmonary disease DW 12.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDtHr2tDWDHsndPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDtHr2tDW%DHrdDWDHsndDWDHsndPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DW..DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1156 11561360115613601156A0NONALCOHOLIC STEATOHEPATITIS Non-alcoholic steatohepatitis FfcHepatobiliary disorders FNon-alcoholic steatohepatitis FfcHepatocellular damage and hepatitis NEC FHepatic and hepatobiliary disorders FFHepatobiliary disorders FGENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1468 YMild liver disease DW 4.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrGDW#DHr;pBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrGDW#DHr;p......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1156 11561360115613601156A MORBID OBESITY Obesity F ;Metabolism and nutrition disorders FMorbid obesity FGeneral nutritional disorders NEC FAppetite and general nutritional disorders FJMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2017 2021-01-08BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2017M-1468 08Jan2021 1 N DW 4.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrGDW#DHr;pBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrGDW#DHr;p......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1156 11561360115613601156AHYPERGLYCEMIA Hyperglycaemia FMetabolism and nutrition disorders FHyperglycemia FHyperglycaemic conditions NEC FGlucose metabolism disorders (incl diabetes mellitus) FxMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2018M-1103 N DW 3.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrGDW#DHr;pBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrGDW#DHr;p......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1156 11561363115613631156AASTHMA Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2013M-2929 YChronic pulmonary disease DW 8.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHruDWDְHsﾰPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHruDW%DHrpDWD4HsDWDְHsﾰPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1156 11561367115613671156A0MULTIPLE NEVI Melanocytic naevus FNeoplasms benign, malignant and unspecified (incl cysts and polyps)F0Mole of skin FSkin neoplasms benign F6BCutaneous neoplasms benign F6CNeoplasms benign, malignant and unspecified (incl cysts and polyps)F0GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2009M-4393 N DW 12.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD|HrZDWDĤHs$Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD|HrZDW(DˬHrDWDdHsndDWDĤHs$Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1156 11561367115613671156AALLERGIC RHINITIS Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2015M-2202 N DW 6.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD|HrZDWDĤHs$Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD|HrZDW(DˬHrDWDdHsndDWDĤHs$Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1156 11561367115613671156A CHONDROMALACIA PATELLA, RIGHT KNEE Patellofemoral pain syndrome FVwMusculoskeletal and connective tissue disorders FkChondromalacia of patella FJoint related disorders NEC FJoint disorders F-Musculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2015M-2202 N DW 6.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD|HrZDWDĤHs$Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD|HrZDW(DˬHrDWDdHsndDWDĤHs$Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1156 11561371115613711156ATRIMETHROPIN ALLERGY Drug hypersensitivity FImmune system disorders F4Allergy to antibiotic FxAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2013M-2933 N DW 8.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD<Hr̓<DWgD(Hs:Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD<Hr̓<DW+DHr\DWRDHs4DWgD(Hs:Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW+.DWRDWg.DWHDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1156 11561372115613721156AATTENTION DEFICIT HYPERACTIVITY DISORDER Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2015M-2203 N DW 6.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr͂DW+DdHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr͂DW+DdHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW+....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1156 11561372115613721156A PRECOCIOUS PUBERTY Precocious puberty FydEndocrine disorders FPrecocious puberty FydEndocrine abnormalities of puberty FEndocrine disorders of gonadal function FEndocrine disorders FGENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1472 N DW 4.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr͂DW+DdHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr͂DW+DdHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW+....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1156 11561373115613731156A0RIGHT INGUINAL HERNIA Inguinal hernia FGastrointestinal disorders FܛRight inguinal hernia F/sInguinal hernias FAbdominal hernias and other abdominal wall conditions FGastrointestinal disorders FܛGENERAL MEDICAL HISTORY(b)(6) (b)(6) BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.03 (b)(6) D(b)(6)(b)(6) D(b)(6)N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr͍DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr͍DW(DHrDWDHsnDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1156 11561373115613731156A@RIGHT INGUINAL HERNIA REPAIR Inguinal hernia repair FSurgical and medical procedures F<Inguinal hernia repair FHernia repairs F[Gastrointestinal therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY(b)(6) (b)(6) BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 (b)(6) D(b)(6)(b)(6) D(b)(6)N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr͍DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr͍DW(DHrDWDHsnDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1156 11561373115613731156A MANGO SKIN ALLERGY Dermatitis allergic FSkin and subcutaneous tissue disorders F5Allergic skin reaction FADermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2011M-3664 N DW 10.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr͍DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr͍DW(DHrDWDHsnDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1156 11561373115613731156AATTENTION DEFICIT HYPERACTIVITY DISORDER Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019-03 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Mar2019D-683 N DW 1.87 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr͍DWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr͍DW(DHrDWDHsnDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW(.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1156 11561374115613741156AMILD PENICILLIN ALLERGY Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2008M-4760 N DW 13.03 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDXHrXDW)DlHr>BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDXHrXDW)DlHr>......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW)....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1223 12231267122312671223Aacid reflux Gastrooesophageal reflux disease F]Gastrointestinal disorders FܛAcid reflux (oesophageal) F_Gastrointestinal atonic and hypomotility disorders NEC F܍Gastrointestinal motility and defaecation conditions FܹGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1467 N DW 4.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr)$DW#DHrနBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr)$DW#DHrန......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1223 12231267122312671223A anxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2019M-737 N DW 2.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr)$DW#DHrနBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr)$DW#DHrန......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1223 12231267122312671223A0depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2019M-737 N DW 2.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHr)$DW#DHrနBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHr)$DW#DHrန......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1223 12231268122312681223ACerebral cavernous malformation Cerebral cavernous malformation FCongenital, familial and genetic disorders FCerebral cavernous malformation FVascular anomalies congenital NEC FNGCardiac and vascular disorders congenital FCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1467 N DW 4.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr*DWDlHs Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr*DW#D$HrDWDHsv;DWDlHs Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1223 12231271122312711223Aallergy to cats and dogs Allergy to animal FNImmune system disorders F4Allergy to animals FPAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016 2018 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1834 31Dec2018M-739 N DW 5.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHryDW%DHr8BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHryDW%DHr8......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1223 12231272122312721223Aenvironmental allergies Hypersensitivity FImmune system disorders F4Environmental allergy FTAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2007M-5122 N DW 14.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDlHr|DWDHsژPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDlHr|DW%DHr#DWD8HswDWDHsژPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1223 12231272122312721223A food allergies Food allergy FزImmune system disorders F4Food allergy FزAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2007M-5122 N DW 14.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDlHr|DWDHsژPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDlHr|DW%DHr#DWD8HswDWDHsژPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1223 12231273122312731223Aseasonal allergies Seasonal allergy FUImmune system disorders F4Seasonal allergy FUAtopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2005 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2005M-5852 N DW 16.02 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD|Hr{DWD(Hs٨Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD|Hr{DW%D`Hr"DWDHsw DWD(Hs٨Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1223 12231278122312781223Aanxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019-12 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Dec2019D-405 N DW 1.11 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrɐDW)DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrɐDW)DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW)....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1223 12231278122312781223A depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-739 N DW 2.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrɐDW)DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrɐDW)DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW)....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1223 12231283122312831223A attention deficient disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit disorder FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3296 N DW 9.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrɧDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrɧDW%DӤHr$DWDHsv.DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1223 12231283122312831223Aanxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2014M-2565 N DW 7.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrɧDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrɧDW%DӤHr$DWDHsv.DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW%.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1223 12231284122312841223APremenarche Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrͻDW)DHrdlBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrͻDW)DHrdl......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW)....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1223 12231285122312851223Aepilepsy Epilepsy F=Nervous system disorders FEpilepsy F=Seizures and seizure disorders NEC F2hSeizures (incl subtypes) F2gNervous system disorders FGENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2011M-3664 N DW 10.03 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrͺDW)DHre\BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrͺDW)DHre\......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW)....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1235 12351235123512351235AAttention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Psychiatric disorders F'Attention deficit hyperactivity disorder F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3256 N DV 8.92 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHHrDWD|Hs|Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHHrDVDpHrpDWDHssDWD|Hs|Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1235 12351236123512361235AAnxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2017M-1431 N DV 3.92 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD(HrDWD@Hs'@Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD(HrDVDHr$DWDHsrmpDWD@Hs'@Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1235 12351236123512361235A Depression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2017M-1431 N DV 3.92 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD(HrDWD@Hs'@Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD(HrDVDHr$DWDHsrmpDWD@Hs'@Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1235 12351236123512361235A0Insomnia Insomnia F%Psychiatric disorders F'Insomnia F%Disturbances in initiating and maintaining sleep FFSleep disorders and disturbances F6Psychiatric disorders F'GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2017M-1431 N DV 3.92 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD(HrDWD@Hs'@Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD(HrDVDHr$DWDHsrmpDWD@Hs'@Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1235 12351236123512361235A@Seasonal Allergies Rhinitis Seasonal allergy FUImmune system disorders F4Seasonal allergic rhinitis F1Atopic disorders FdAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1431 N DV 3.92 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD(HrDWD@Hs'@Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD(HrDVDHr$DWDHsrmpDWD@Hs'@Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1235 12351239123512391235AAsthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2016 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2016M-1802 YChronic pulmonary disease DV 4.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD@Hr @DWDDHs#DPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD@Hr @DWDHrDWDDHssDDWDDHs#DPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1235 12351242123512421235A PRE-MENARCHE Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrP4DWDy,HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrP4DWDy,Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1235 12351242123512421235AAdenoidectomy Adenoidectomy FNSurgical and medical procedures F<Adenoidectomy FNTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2011M-3629 N DV 9.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrP4DWDy,HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrP4DWDy,Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1235 12351242123512421235A0Tonsillectomy Tonsillectomy FBfSurgical and medical procedures F<Tonsillectomy FBfTonsillar therapeutic procedures FBeHead and neck therapeutic procedures FvSurgical and medical procedures F<GENERAL MEDICAL HISTORY2011 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2011M-3629 N DV 9.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrP4DWDy,HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrP4DWDy,Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1235 12351242123512421235A@allergic rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2012M-3264 N DV 8.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrP4DWDy,HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrP4DWDy,Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1235 12351244123512441235A Eczema Eczema FSkin and subcutaneous tissue disorders F5Eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2007M-5090 N DV 13.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrnpDWD(HrUPlacebo A .Placebo A .DVDHrnpDWD(HrU......Placebo Placebo DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1235 12351244123512441235AAllergic Rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2019 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2019M-707 N DV 1.94 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrnpDWD(HrUPlacebo A .Placebo A .DVDHrnpDWD(HrU......Placebo Placebo DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1235 12351245123512451235APRE-MENARCHE Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD8HrDWDHrC$BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD8HrDWDHrC$......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1235 12351245123512451235A asthma (mild) Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2015M-2168 YChronic pulmonary disease DV 5.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD8HrDWDHrC$BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD8HrDWDHrC$......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1235 12351245123512451235A0sinusitis Sinusitis F5Infections and infestations FSinusitis F5Upper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2015 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2015M-2168 N DV 5.94 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD8HrDWDHrC$BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD8HrDWDHrC$......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1235 12351246123512461235AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2013 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2013M-2905 N DV 7.96 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr{DW DHHr-BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr{DW DHHr-......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1235 12351247123512471235A History of cleft lip and palate Cleft lip and palate FCongenital, familial and genetic disorders FCleft lip and palate FPalate disorders congenital FzGastrointestinal tract disorders congenital FCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY2005 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2005M-5827 N DV 15.96 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDhHr|hDW DHr.|BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDhHr|hDW DHr.|......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1235 12351247123512471235AADHD Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2014 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2014M-2540 N DV 6.96 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDhHr|hDW DHr.|BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDhHr|hDW DHr.|......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1235 12351249123512491235A Migraines Migraine FONervous system disorders FMigraine FOMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2012M-3271 N DV 8.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHs?TPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDW DHrDWDHsv1DWDHs?TPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1235 12351249123512491235A@chronic migraines Migraine FONervous system disorders FChronic migraine FMigraine headaches FSHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2012 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 01Jan2012M-3271 N DV 8.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHs?TPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDW DHrDWDHsv1DWDHs?TPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1235 12351249123512491235AAllergic rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2017 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1444 N DV 3.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHs?TPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDW DHrDWDHsv1DWDHs?TPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1235 12351249123512491235A0Moderate anxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Jan2018M-1079 N DV 2.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHrDWDHs?TPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHrDW DHrDWDHsv1DWDHs?TPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1235 12351250123512501235AAllergic rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2010M-4001 N DV 10.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDW DHrd(BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDW DHrd(......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1235 12351250123512501235A Headaches Headache FNervous system disorders FHeadache FHeadaches NEC FHeadaches FNervous system disorders FGENERAL MEDICAL HISTORY2010 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2010M-4001 N DV 10.96 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDW DHrd(BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDW DHrd(......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1235 12351250123512501235A0Subungual abscess Nail infection FInfections and infestations FNail infection NOS FVSkin structures and soft tissue infections F5Infections - pathogen unspecified FInfections and infestations FGENERAL MEDICAL HISTORY2020-11 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Nov2020D-44 N DV 0.12 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDW DHrd(BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDW DHrd(......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW ....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1235 12351251123512511235AFire ant allergy Allergy to arthropod bite Fz-Immune system disorders F4Insect bite allergy FfEAllergic conditions NEC FAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2009M-4369 N DV 11.96 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHru DWDx<HsܼPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHru DWDXHr0XDWDHsr+XDWDx<HsܼPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1235 12351252123512521235Aexcema Eczema FSkin and subcutaneous tissue disorders F5Eczema FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2007 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2007M-5103 N DV 13.97 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDɐHrDWDHs7\Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDɐHrDWDְHrʹDWD8HsrCDWDHs7\Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1235 12351253123512531235A Urinary Reflux Urinary tract disorder FLfRenal and urinary disorders F,WUrinary tract disorder FLfGenital and urinary tract disorders NEC FGenitourinary tract disorders NEC F݌Renal and urinary disorders F,WGENERAL MEDICAL HISTORY2008 2008 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.02 01Jan2008M-4756 31Dec2008M-4391 N DW 13.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDިHrvDW$D Hr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDިHrvDW$D Hr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1235 12351253123512531235AConcha Bullosa Nasal turbinate hypertrophy FRespiratory, thoracic and mediastinal disorders F-Concha bullosa FNasal disorders NEC FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2017 2017 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1468 31Dec2017M-1104 N DW 4.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDިHrvDW$D Hr BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDިHrvDW$D Hr ......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1235 12351254123512541235AAcid Reflux Gastrooesophageal reflux disease F]Gastrointestinal disorders FܛAcid reflux (oesophageal) F_Gastrointestinal atonic and hypomotility disorders NEC F܍Gastrointestinal motility and defaecation conditions FܹGastrointestinal disorders FܛGENERAL MEDICAL HISTORY2017 2017 BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Jan2017M-1468 31Dec2017M-1104 N DW 4.02 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD\Hrw\DW$DHr♘BNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD\Hrw\DW$DHr♘......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1270 12701173127011731270A0Dysmenorrhea Dysmenorrhoea FReproductive system and breast disorders F-LDysmenorrhea FMenstruation and uterine bleeding NEC FGMenstrual cycle and uterine bleeding disorders FʎReproductive system and breast disorders F-LGENERAL MEDICAL HISTORY2020-06-02 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 02Jun2020 -181 N DV 0.5 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDhHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDhHrDVDHriDWDHsmlDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1270 12701173127011731270A@Idiopathic scoliosis Scoliosis F1Musculoskeletal and connective tissue disorders FkScoliosis F1Spine and neck deformities FMusculoskeletal and connective tissue deformities (incl intervertebral disc disorders)FYMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2017-11-02 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 02Nov2017 -1124 N DV 3.08 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDhHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDhHrDVDHriDWDHsmlDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1270 12701173127011731270APSyncope with blood draws Syncope F=Nervous system disorders FSyncope F=Disturbances in consciousness NEC FENeurological disorders NEC FNervous system disorders FGENERAL MEDICAL HISTORY2020-01-07 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 07Jan2020 -328 N DV 0.9 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDhHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDhHrDVDHriDWDHsmlDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1270 12701173127011731270AAllergic rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2018-05-07 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 07May2018 -938 N DV 2.57 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDhHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDhHrDVDHriDWDHsmlDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1270 12701173127011731270A Chilblains Chillblains FInjury, poisoning and procedural complications FChilblains FConditions caused by cold FInjuries by physical agents FInjury, poisoning and procedural complications FGENERAL MEDICAL HISTORY2020-03-27 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 27Mar2020 -248 N DV 0.68 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDhHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDhHrDVDHriDWDHsmlDWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1270 12701174127011741270AAtopic dermatitis Dermatitis atopic FSkin and subcutaneous tissue disorders F5Atopic dermatitis FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2009-11-20 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 20Nov2009 -4028 N DV 11.03 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDhHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDhHrDVDHriDWDHsm DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1270 12701174127011741270A Exercise induced asthma Asthma exercise induced FeRespiratory, thoracic and mediastinal disorders F-Exercise induced asthma FӡBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2009-05-21 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 21May2009 -4211 YChronic pulmonary disease DV 11.53 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDhHrDWDHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDhHrDVDHriDWDHsm DWDHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsANYYNAYEARSC4591001C4591001 1270 12701184127011841270A CONJUNCTIVA ANGIOMA UNKNOWN ETIOLOGY Eyelid haemangioma FNeoplasms benign, malignant and unspecified (incl cysts and polyps)F0Eyelid hemangioma FOcular neoplasms benign F Ocular neoplasms F Neoplasms benign, malignant and unspecified (incl cysts and polyps)F0GENERAL MEDICAL HISTORY2019-08-13 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 13Aug2019 -477 N DV 1.31 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrdDWDDHr,DBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrdDWDDHr,D......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1270 12701184127011841270AACNE Acne FpSkin and subcutaneous tissue disorders F5Acne FpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2019-12-13 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 13Dec2019 -355 N DV 0.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrdDWDDHr,DBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrdDWDDHr,D......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1270 12701187127011871270AAllergy to amoxicillin Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2007-05-24 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 24May2007 -4942 N DV 13.53 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDx<Hr<DVD~HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDx<Hr<DVD~Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1270 12701187127011871270A Intermittent low back pain unknown etiology Back pain FMusculoskeletal and connective tissue disorders FkLow back pain FMusculoskeletal and connective tissue pain and discomfort FMusculoskeletal and connective tissue disorders NEC FiMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2019-09-27 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 27Sep2019 -433 N DV 1.19 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDx<Hr<DVD~HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDx<Hr<DVD~Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1270 12701187127011871270A0bilateral calcaneal apophysitis Osteitis F-Musculoskeletal and connective tissue disorders FkApophysitis FBone disorders NEC FBone disorders (excl congenital and fractures) FMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2014-09-30 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 30Sep2014 -2256 N DV 6.18 YEARSAYEARS12-15 YearsAFA ASIAN A@ASIAN A@YYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDx<Hr<DVD~HrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDx<Hr<DVD~Hr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1270 12701188127011881270A INTERMITTENT ASTHMA Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2020-02-04 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 04Feb2020 -303 YChronic pulmonary disease DV 0.83 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DVDxHrDWDHs%HPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDxHrDVD~HrLDWDHssDWDHs%HPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1270 12701188127011881270AAllergy to TREE NUTS Food allergy FزImmune system disorders F4Allergy to nuts Fm/Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2012-11-28 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 28Nov2012 -2927 N DV 8.02 YEARSAYEARS12-15 YearsAMAASIAN A@ASIAN A@YYPlacebo PLACEBO Placebo PLACEBO DVDxHrDWDHs%HPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDxHrDVD~HrLDWDHssDWDHs%HPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1270 12701189127011891270AINTERMITTENT ASTHMA Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2009-03-06 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 06Mar2009 -4290 YChronic pulmonary disease DV 11.75 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDdHrdDVDHrdBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDdHrdDVDHrd......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDV....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1270 12701191127011911270A0psoriasis Psoriasis F'Skin and subcutaneous tissue disorders F5Psoriasis F'Psoriatic conditions FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2016-09-012018-12-01BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.01 01Sep2016 -1554 01Dec2018 -733 N DV 4.26 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD|Hr|DWDHrhBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD|Hr|DWDHrh......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1270 12701191127011911270A Snoring Snoring F7Respiratory, thoracic and mediastinal disorders F-Snoring F7Upper respiratory tract signs and symptoms FKiRespiratory tract signs and symptoms F}Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2011-04-05 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 05Apr2011 -3530 N DV 9.67 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD|Hr|DWDHrhBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD|Hr|DWDHrh......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1270 12701191127011911270AIntermittent exercise induced wheezing Wheezing FQRespiratory, thoracic and mediastinal disorders F-Wheezing FQBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2014-09-16 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 16Sep2014 -2270 N DV 6.22 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVD|Hr|DWDHrhBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVD|Hr|DWDHrh......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1270 12701194127011941270A@sacral dimple Congenital skin dimples FCongenital, familial and genetic disorders FSacral dimple congenital FiSkin and subcutaneous tissue disorders congenital NEC F6Skin and subcutaneous tissue disorders congenital F5Congenital, familial and genetic disorders FGENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 (b)(6) (b)(6) N DV (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD|Hr2DWDHHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD|Hr2DWDHr DWDhHswDWDHHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1270 12701194127011941270A0Pityriasis alba Pityriasis alba FSkin and subcutaneous tissue disorders F5Pityriasis alba FPapulosquamous conditions FJEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2012-08-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 01Aug2012 -3047 N DV 8.34 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD|Hr2DWDHHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD|Hr2DWDHr DWDhHswDWDHHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1270 12701194127011941270AAllergy to amoxicillin Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2008-09-22 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 22Sep2008 -4456 N DV 12.2 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD|Hr2DWDHHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD|Hr2DWDHr DWDhHswDWDHHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1270 12701194127011941270A Allergy to penicillins Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2016-01-31 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 31Jan2016 -1769 N DV 4.85 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVD|Hr2DWDHHsPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVD|Hr2DWDHr DWDhHswDWDHHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1270 12701198127011981270AAllergy to cephalexin Drug hypersensitivity FImmune system disorders F4Allergy to antibiotic FxAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2011-08-03 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 03Aug2011 -3414 N DV 9.35 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDtHrcBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDtHrc......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1270 12701198127011981270A0Allergy to peanuts Food allergy FزImmune system disorders F4Peanut allergy FAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009-03-07 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 07Mar2009 -4293 N DV 11.76 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDtHrcBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDtHrc......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1270 12701198127011981270A Allergy to nuts Food allergy FزImmune system disorders F4Allergy to nuts Fm/Allergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2009-08-11 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 11Aug2009 -4136 N DV 11.33 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrDWDtHrcBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrDWDtHrc......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1270 12701199127011991270A Irregular menses Menstruation irregular FKReproductive system and breast disorders F-LMenses irregular F5Menstruation and uterine bleeding NEC FGMenstrual cycle and uterine bleeding disorders FʎReproductive system and breast disorders F-LGENERAL MEDICAL HISTORY2019-09 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 01Sep2019D-464 N DV 1.27 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDՄHrDWDzXHsXPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDՄHrDWD(Hr@(DWDHsrXDWDzXHsXPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1270 12701199127011991270ABilateral Patellofemoral syndrome Patellofemoral pain syndrome FVwMusculoskeletal and connective tissue disorders FkPatellofemoral pain syndrome FVwJoint related disorders NEC FJoint disorders F-Musculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2020-01-10 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 10Jan2020 -333 N DV 0.91 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDՄHrDWDzXHsXPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDՄHrDWD(Hr@(DWDHsrXDWDzXHsXPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW.DWDW.DWDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1270 12701200127012001270A@POLYDACTYLY OF RIGHT FINGERS Polydactyly F#_Congenital, familial and genetic disorders FPolydactyly of fingers F#`Musculoskeletal and connective tissue disorders of limbs congenital F]Musculoskeletal and connective tissue disorders congenital FlCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY(b)(6) 2008-04-10BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.04 (b)(6) (b)(6)10Apr2008 -4627 N DV (b)(6)YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr@PDWDHrIBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr@PDWDHrI......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1270 12701200127012001270APRIGHT THUMB RECONSTRUCTION Limb operation FSurgical and medical procedures F<Finger operation F^Limb therapeutic procedures F6Bone and joint therapeutic procedures FSurgical and medical procedures F<GENERAL MEDICAL HISTORY2008-04-102008-04-10BEFORE LAST SUBJECT ENCOUNTERMedDRA v24.05 10Apr2008 -4627 10Apr2008 -4627 N DV 12.67 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr@PDWDHrIBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr@PDWDHrI......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1270 12701200127012001270AALLERGIC RHINITIS Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2020-02-13 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 13Feb2020 -301 N DV 0.83 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr@PDWDHrIBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr@PDWDHrI......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1270 12701200127012001270A0Allergy to Keflex (Cephalexin) Drug hypersensitivity FImmune system disorders F4Allergy to antibiotic FxAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2007-11-16 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 16Nov2007 -4773 N DV 13.07 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr@PDWDHrIBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr@PDWDHrI......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1270 12701200127012001270A ATOPIC DERMATITIS TO WHOLE BODY Dermatitis atopic FSkin and subcutaneous tissue disorders F5Atopic dermatitis FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2007-12-20 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 20Dec2007 -4739 N DV 12.98 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHr@PDWDHrIBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHr@PDWDHrI......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsANYYYAYEARSC4591001C4591001 1270 12701201127012011270A@EXERCISE INDUCED ASTHMA Asthma exercise induced FeRespiratory, thoracic and mediastinal disorders F-Exercise induced asthma FӡBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2020-02-13 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 13Feb2020 -302 YChronic pulmonary disease DV 0.83 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr<DWD{HsbS|Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr<DW DHrDWrD|HsI|DWD{HsbS|Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWrDW.DWqDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1270 12701201127012011270A BILATERAL MYOPIA Myopia FkEye disorders FԯMyopia FkRefractive and accommodative disorders F+Vision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2013-06-17 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 17Jun2013 -2734 N DV 7.49 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr<DWD{HsbS|Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr<DW DHrDWrD|HsI|DWD{HsbS|Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWrDW.DWqDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1270 12701201127012011270ABILATERAL ASTIGMATISM Astigmatism FqEye disorders FԯAstigmatism FqRefractive and accommodative disorders F+Vision disorders FPEye disorders FԯGENERAL MEDICAL HISTORY2019-06-19 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 19Jun2019 -541 N DV 1.48 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr<DWD{HsbS|Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr<DW DHrDWrD|HsI|DWD{HsbS|Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWrDW.DWqDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1270 12701201127012011270A0DYSMENORRHEA Dysmenorrhoea FReproductive system and breast disorders F-LDysmenorrhea FMenstruation and uterine bleeding NEC FGMenstrual cycle and uterine bleeding disorders FʎReproductive system and breast disorders F-LGENERAL MEDICAL HISTORY2020-06-29 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 29Jun2020 -165 N DV 0.45 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DVDHr<DWD{HsbS|Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADVDHr<DW DHrDWrD|HsI|DWD{HsbS|Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW .DWrDW.DWqDV . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1270 12701202127012021270A Dermatitis in suprapubic crease Dermatitis FSkin and subcutaneous tissue disorders F5Dermatitis FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F5GENERAL MEDICAL HISTORY2018-08-07 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 07Aug2018 -857 N DV 2.35 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrsDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrsDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1270 12701202127012021270AAllergic rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2018-05-29 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 29May2018 -927 N DV 2.54 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DVDHrsDWDHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DVDHrsDWDHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DVDW....DWDV . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1270 12701202127012021270A0Lactose intolerance Lactose intolerance FMetabolism and nutrition disorders FLactose intolerance FSugar intolerance (excl glucose intolerance) FRespiratory disorders NEC F-Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2019-08-08 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 08Aug2019 -517 N DW 1.42 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD`Hrv`DW$D|HrrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD`Hrv`DW$D|Hrr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1270 12701235127012351270AADHD, PREDOMINANTLY INATTENTIVE PRESENTATION Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD, predominantly inattentive type FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2018-05-18 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 18May2018 -964 N DW 2.64 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWD|HrŇ|DW$D~HrtBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWD|HrŇ|DW$D~Hrt......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1270 12701236127012361270ALEARNING DIFFICULTIES Learning disorder FPsychiatric disorders F'Learning disorder FLearning disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2017-08-08 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 08Aug2017 -1247 N DW 3.42 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWD(Hr(DWDHs#Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWD(Hr(DW!DˬHr,DWDLHssLDWDHs#Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW!.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1270 12701237127012371270A0Asthma Asthma FaRespiratory, thoracic and mediastinal disorders F-Asthma FaBronchospasm and obstruction FBronchial disorders (excl neoplasms) FRespiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2016-02-01 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 01Feb2016 -1802 YChronic pulmonary disease DW 4.94 YEARSAYEARS12-15 YearsAFA AMERICAN INDIAN OR ALASKA NATIVE A0AMERICAN INDIAN OR ALASKA NATIVE A0YYPlacebo PLACEBO Placebo PLACEBO DWDHr$DWDtHstPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr$DWDHr$DWDtHstDWDtHstPlacebo BNT162b2 (30 (*ESC*){unicode 03BC}g) DW..DW..DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1270 12701237127012371270APDepression Depression FPsychiatric disorders F'Depression FDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2014-12-02 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.04 02Dec2014 -2228 N DW 6.1 YEARSAYEARS12-15 YearsAFA AMERICAN INDIAN OR ALASKA NATIVE A0AMERICAN INDIAN OR ALASKA NATIVE A0YYPlacebo PLACEBO Placebo PLACEBO DWDHr$DWDtHstPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr$DWDHr$DWDtHstDWDtHstPlacebo BNT162b2 (30 (*ESC*){unicode 03BC}g) DW..DW..DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1270 12701237127012371270A@Bilateral temporomandibular joint pain Temporomandibular joint syndrome F?TMusculoskeletal and connective tissue disorders FkTemporomandibular joint arthralgia F?OJoint related disorders NEC FJoint disorders F-Musculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2020-11-16 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.07 16Nov2020 -52 N DW 0.15 YEARSAYEARS12-15 YearsAFA AMERICAN INDIAN OR ALASKA NATIVE A0AMERICAN INDIAN OR ALASKA NATIVE A0YYPlacebo PLACEBO Placebo PLACEBO DWDHr$DWDtHstPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr$DWDHr$DWDtHstDWDtHstPlacebo BNT162b2 (30 (*ESC*){unicode 03BC}g) DW..DW..DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1270 12701237127012371270ApRight foot pain Pain in extremity FMusculoskeletal and connective tissue disorders FkFoot pain FMusculoskeletal and connective tissue pain and discomfort FMusculoskeletal and connective tissue disorders NEC FiMusculoskeletal and connective tissue disorders FkGENERAL MEDICAL HISTORY2020-12-18 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.06 18Dec2020 -20 N DW 0.06 YEARSAYEARS12-15 YearsAFA AMERICAN INDIAN OR ALASKA NATIVE A0AMERICAN INDIAN OR ALASKA NATIVE A0YYPlacebo PLACEBO Placebo PLACEBO DWDHr$DWDtHstPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr$DWDHr$DWDtHstDWDtHstPlacebo BNT162b2 (30 (*ESC*){unicode 03BC}g) DW..DW..DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1270 12701237127012371270AVitamin D Deficiency Vitamin D deficiency FPMetabolism and nutrition disorders FVitamin D deficiency FPFat soluble vitamin deficiencies and disorders FVitamin related disorders FPMetabolism and nutrition disorders FGENERAL MEDICAL HISTORY2020-06-22 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 22Jun2020 -199 N DW 0.55 YEARSAYEARS12-15 YearsAFA AMERICAN INDIAN OR ALASKA NATIVE A0AMERICAN INDIAN OR ALASKA NATIVE A0YYPlacebo PLACEBO Placebo PLACEBO DWDHr$DWDtHstPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr$DWDHr$DWDtHstDWDtHstPlacebo BNT162b2 (30 (*ESC*){unicode 03BC}g) DW..DW..DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1270 12701237127012371270A Anxiety Anxiety FPsychiatric disorders F'Anxiety FAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2019-08-23 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 23Aug2019 -503 N DW 1.38 YEARSAYEARS12-15 YearsAFA AMERICAN INDIAN OR ALASKA NATIVE A0AMERICAN INDIAN OR ALASKA NATIVE A0YYPlacebo PLACEBO Placebo PLACEBO DWDHr$DWDtHstPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr$DWDHr$DWDtHstDWDtHstPlacebo BNT162b2 (30 (*ESC*){unicode 03BC}g) DW..DW..DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1270 12701237127012371270AAllergy to Vancomycins Drug hypersensitivity FImmune system disorders F4Allergy to antibiotic FxAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2020-12-30 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.08 30Dec2020 -8 N DW 0.02 YEARSAYEARS12-15 YearsAFA AMERICAN INDIAN OR ALASKA NATIVE A0AMERICAN INDIAN OR ALASKA NATIVE A0YYPlacebo PLACEBO Placebo PLACEBO DWDHr$DWDtHstPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr$DWDHr$DWDtHstDWDtHstPlacebo BNT162b2 (30 (*ESC*){unicode 03BC}g) DW..DW..DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1270 12701237127012371270A`Pectus Carinatum Pectus carinatum FCongenital, familial and genetic disorders FPectus carinatum FMusculoskeletal and connective tissue disorders of trunk congenital (excl spine)F`Musculoskeletal and connective tissue disorders congenital FlCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY2020-12-30 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.05 30Dec2020 -8 N DW 0.02 YEARSAYEARS12-15 YearsAFA AMERICAN INDIAN OR ALASKA NATIVE A0AMERICAN INDIAN OR ALASKA NATIVE A0YYPlacebo PLACEBO Placebo PLACEBO DWDHr$DWDtHstPlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr$DWDHr$DWDtHstDWDtHstPlacebo BNT162b2 (30 (*ESC*){unicode 03BC}g) DW..DW..DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1270 12701238127012381270A0Familial adenomatous polyposis Adenomatous polyposis coli FuCongenital, familial and genetic disorders FFamilial adenomatous polyposis F~?Intestinal disorders congenital FGastrointestinal tract disorders congenital FCongenital, familial and genetic disorders FGENERAL MEDICAL HISTORY2016-11-09 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 09Nov2016 -1520 N DW 4.16 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr0DWDHs.Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr0DW"DӤHr&DWDHssDWDHs.Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW".DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1270 12701238127012381270AAllergy to Amoxicillin Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2020-02-12 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 12Feb2020 -330 N DW 0.91 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr0DWDHs.Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr0DW"DӤHr&DWDHssDWDHs.Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW".DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1270 12701238127012381270A Allergy to Penicillin V Potassium Drug hypersensitivity FImmune system disorders F4Penicillin allergy FtAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F4GENERAL MEDICAL HISTORY2020-02-12 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 12Feb2020 -330 N DW 0.91 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHr0DWDHs.Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHr0DW"DӤHr&DWDHssDWDHs.Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW".DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1270 12701239127012391270A0PREMENARCHEAL Premenarche F_Social circumstances F7Premenarche F_Age related issues FCAge related factors FBSocial circumstances F7GENERAL MEDICAL HISTORY(b)(6) ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.03 (b)(6) (b)(6) N DW (b)(6)YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrpDW$DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrpDW$DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1270 12701239127012391270A Generalized Anxiety Disorder Generalised anxiety disorder FPsychiatric disorders F'Generalized anxiety disorder F9Anxiety disorders NEC FAnxiety disorders and symptoms FPsychiatric disorders F'GENERAL MEDICAL HISTORY2020-08-19 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 19Aug2020 -141 N DW 0.39 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrpDW$DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrpDW$DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1270 12701239127012391270AAlternating Exotropia Strabismus F;/Eye disorders FԯAlternating exotropia FOcular nerve and muscle disorders F Ocular neuromuscular disorders F Eye disorders FԯGENERAL MEDICAL HISTORY2016-01-21 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.02 21Jan2016 -1813 N DW 4.97 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHrpDW$DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHrpDW$DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1270 12701240127012401270AAttention Deficit Disorder, Combined Presentation Attention deficit hyperactivity disorder F&Psychiatric disorders F'ADHD, combined type FAttention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'GENERAL MEDICAL HISTORY2012-05-23 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 23May2012 -3151 N DW 8.63 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYBNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30DWDHHrDW$DHrBNT162b2 Phase 2/3 (30 mcg)A .BNT162b2 Phase 2/3 (30 mcg)A .DWDHHrDW$DHr......BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW$....DWDW . . .NPhase 3A@12-15 YearsAN YYAYEARSC4591001C4591001 1270 12701241127012411270AAllergic Rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2017-08-31 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 31Aug2017 -1225 N DW 3.36 YEARSAYEARS12-15 YearsAMAWHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDިHr%(DWDшHsePlacebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDިHr%(DW#DHrxDWDHstHDWDшHsePlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW#.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1270 12701242127012421270AAllergic Rhinitis Rhinitis allergic F/-Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-GENERAL MEDICAL HISTORY2012-10-26 ONGOINGLAST SUBJECT ENCOUNTERMedDRA v24.01 26Oct2012 -2996 N DW 8.21 YEARSAYEARS12-15 YearsAFA WHITE AWHITE AYYPlacebo PLACEBO Placebo PLACEBO DWDHrNDWDhHs(Placebo ABNT162b2 Phase 2/3 (30 mcg)APlacebo ABNT162b2 Phase 2/3 (30 mcg)ADWDHrNDW*DHrwDWDHsnaDWDhHs(Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDW*.DWDW.DWDW . . .NPhase 3A@12-15 YearsAN YNAYEARSC4591001C4591001 1270 12701242127012421270A Lactose Intolerance Lactose intolerance FMetabolism and nutrition disorders FLactose intolerance FSugar intolerance (excl glucose intolerance) F