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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