HEADER RECORD*******LIBRARY HEADER RECORD!!!!!!!000000000000000000000000000000 SAS SAS SASLIB 6.06 MAC1. 28DEC23:07:50:1828DEC23:07:50:18 HEADER RECORD*******MEMBER HEADER RECORD!!!!!!!000000000000000001600000000140 HEADER RECORD*******DSCRPTR HEADER RECORD!!!!!!!000000000000000000000000000000 SAS _1257722SASDATA 6.06 28DEC23:07:50:1828DEC23:07:50:18 ADAE HEADER RECORD*******NAMESTR HEADER RECORD!!!!!!!000000016900000000000000000000 SUBJID Subject Identifier for the Study SITEID Study Site Identifier ARM Description of Planned Arm  ARMCD Planned Arm Code 'ACTARM Description of Actual Arm 0 ACTARMCDActual Arm Code KAGE Age BEST  TAGEU Age Units \ AGEGR1 Pooled Age Group 1 a AGEGR1N Pooled Age Group 1 (N) BEST  l AGEGR2 Pooled Age Group 2 t AGEGR2N Pooled Age Group 2 (N) BEST  } AGEGR3 Pooled Age Group 3 AGEGR3N Pooled Age Group 3 (N) BEST   AGEGR4 Pooled Age Group 4 AGEGR4N Pooled Age Group 4 (N) BEST  )RACE Race RACEN Race (N) BEST  SEX Sex SEXN Sex (N) BEST  ETHNIC Ethnicity ETHNICN Ethnicity (N) BEST  COUNTRY Country )ARACE Analysis Race ARACEN Analysis Race (N) BEST  %TRTSDT Date of First Exposure to Treatment DATE  -TRTSTM Time of First Exposure to Treatment TIME  5TRTSDTM Datetime of First Exposure to Treatment DATETIME =TRTEDT Date of Last Exposure to Treatment DATE  ETRTETM Time of Last Exposure to Treatment TIME  MTRTEDTM Datetime of Last Exposure to Treatment DATETIME U TRT01A Actual Treatment for Period 01 ]!TRT01AN Actual Treatment for Period 01 (N) BEST  x"TRT01P Planned Treatment for Period 01 #TRT01PN Planned Treatment for Period 01 (N) BEST  $VAX101DTVaccination Date 01 DATE  %VAX101TMVaccination Time 01 TIME  &VAX102DTVaccination Date 02 DATE  'VAX102TMVaccination Time 02 TIME  (SAFFL Safety Population Flag )COHORT Cohort Group *COHORTN Cohort Group (N) BEST  +DOSALVL Actual Dosing Level ,DOSALVLNActual Dosing Level (N) BEST  -DOSPLVL Planned Dosing Level .DOSPLVLNPlanned Dosing Level (N) BEST  $/VAX101 Vaccination 01 $0VAX102 Vaccination 02 1V01DT Date of Unblinding or Visit at 1MPD2 DATE  '2V02DT Date of Unblinding or Visit at 6MPD2 DATE  /3RANDFL Randomized Population Flag 74PHASE Study Phase 85PHASEN Study Phase (N) BEST  ?6DS30KFL Phase 3 30k Subjects Flag G7COVBLST Baseline SARS-CoV-2 Status H8UNBLNDDTTreatment Unblinded Date DATE  K$9VAX10U Vaccination Unplanned S$:VAX201 Vaccination 03 w$;VAX202 Vaccination 04 VAX202DTVaccination Date 04 DATE  ?VAX201TMVaccination Time 03 TIME  @VAX202TMVaccination Time 04 TIME  AV03DT Date of Visit at 1M after Vax3/4 DATE  BV04DT Date of Visit at 6M after Vax3/4 DATE  CTRT02A Actual Treatment for Period 02 DTRT02AN Actual Treatment for Period 02 (N) BEST  ETRT02P Planned Treatment for Period 02 FTRT02PN Planned Treatment for Period 02 (N) BEST  5GHIVFL HIV Positive Subjects Flag =HDS3KFL FU to 6MPD2 >IEOTXDCDTEnd Of Open Label Treatment D/C Date DATE  ?JBDCSRDT Double Blinded Follow-up Censor Date DATE  GKX1CSRDT Crossover Dose1 Censor Date DATE  OLFUP1UNB PD1 FU Time in Days: to Unblinding BEST  WMFPX1CUT Post Xover D1 FUTM in Days: to Cutoff BEST  _NFUNBCUT Unblinding FUTM in Days: to Cutoff BEST  gOFUP1CUT PD1 FU Time in Days: to Cutoff BEST  oPAGETR01 Age at Vaccination 01 BEST  wQTR01SDTMDatetime of First Exposure in Period 01 DATETIME RTR01EDTMDatetime of Last Exposure in Period 01 DATETIME STR02SDTMDatetime of First Exposure in Period 02 DATETIME TTR02EDTMDatetime of Last Exposure in Period 02 DATETIME UVAX20U Vaccination Unplanned in Period 02 VVAX20UDTVaccination Date Unplanned in Period 02 DATE  WV02OBDT Date of Dose 3 or Visit at 6MPD2 DATE  XRACEGR1 Pooled Race Group 1 YRACEGR1NPooled Race Group 1 (N) BEST  ZSTUDYID Study Identifier [USUBJID Unique Subject Identifier \AESEQ Sequence Number BEST  ]AECAT Category for Adverse Event ^AESPID Sponsor-Defined Identifier d_AETERM Reported Term for the Adverse Event  (`AEDECOD Dictionary-Derived Term maAEBDSYCDBody System or Organ Class Code BEST  CbAEBODSYSBody System or Organ Class >cAELLT Lowest Level Term dAELLTCD Lowest Level Term Code BEST  eAEPTCD Preferred Term Code BEST  &CfAEHLT High Level Term .gAEHLTCD High Level Term Code BEST  q@hAEHLGT High Level Group Term yiAEHLGTCDHigh Level Group Term Code BEST  CjAESOC Primary System Organ Class kAESOCCD Primary System Organ Class Code BEST  lAESTDTC Start Date/Time of Adverse Event  mAESTDY Study Day of Start of Adverse Event BEST  nAEENDTC End Date/Time of Adverse Event $oAEENDY Study Day of End of Adverse Event BEST  4pAEENRTPTEnd Relative to Reference Time Point <qAEENTPT End Reference Time Point CrAETOXGR Standard Toxicity Grade Y sDICTVER Dictionary Name and Version ZtADESFL Discontinued due to AE fuASTDT Analysis Start Date DATE  gvASTDTF Analysis Start Date Imputation Flag owASTDY Analysis Start Relative Day BEST  pxASTTM Analysis Start Time TIME  xyASTDTM Analysis Start Date/Time DATETIME zAENDT Analysis End Date DATE  {AENDY Analysis End Relative Day BEST  |AENTM Analysis End Time TIME  }AENDTM Analysis End Date/Time DATETIME ~ADURN Analysis Duration (N) BEST  ADURU Analysis Duration Units AESER Serious Event AESCONG Congenital Anomaly or Birth Defect AESDISABPersist or Signif Disability/Incapacity AESDTH Results in Death AESHOSP Requires or Prolongs Hospitalization AESLIFE Is Life Threatening AESMIE Other Medically Important Serious Event AEMERES Is AE a Result of a Medication Error  AEREL Causality AERELNSTRelationship to Non-Study Treatment SAERELTXTEvent Due to Other Specify AEACN Action Taken with Study Treatment 8AECMGIV Concomitant Medication Given HAENDGIV Was a Non-Drug Treatment given I AEOUT Outcome of Adverse Event JAESUBJDCDiscontinued because of this AE j AEREFID Reference ID kAERELN Causality (N) BEST  w AREL Analysis Causality ARELN Analysis Causality (N) BEST  AETOXGRNStandard Toxicity Grade (N) BEST  ATOXGR Analysis Toxicity Grade ATOXGRN Analysis Toxicity Grade (N) BEST  AEMEFL Medication Error Associated With AE AETPDOS Time Post Dose BEST  AEIMMFL Vaccine Studies AE Immediate flag APERIOD Period BEST   APERIODCPeriod (C) APERSDT Period Start Date DATE  APERSTM Period Start Time TIME  APERSDTMPeriod Start Date/Time DATETIME APEREDT Period End Date DATE  APERETM Period End Time TIME  APEREDTMPeriod End Date/Time DATETIME )VPHASE Vaccine Phase VPHASEN Vaccine Phase(N) BEST  INWDFL Within Reporting Window Flag %PREFL Pre-treatment Flag &VAXNO AE Occured after Which Vaccination BEST  'LSTCGDTCDate/Time of Last change /DATCHGFLNew AE Reported post EUA snapshot Flag BIDATACHGCAE data change post EUA snapshot C HEADER RECORD*******OBS HEADER RECORD!!!!!!!000000000000000000000000000000 100513171005BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHr^DVDHr|xBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADVDDVDY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DVDWYPhase 3A@NNEGDW ....... . .NY.DWDWBBqCAHr^Hr|x.. .DWWHITE AC4591001C4591001 1005 10051317AADVERSE EVENT 1 CHILLS Chills FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills FFFeelings and sensations NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2020-10-21T00:15A 2020-10-22T07:00A0 2MedDRA v24.0NDV A C8@Hr_uDVA0DbHra%A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C7 APeriod 01DVDHr^DXDDHt^%Vaccination 1 AY A2020-11-12T21:04:31 100513281005BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHr^DVDHr{BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADVDDVDY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DVDWYPhase 3A@NNEGDW ....... . .NY.DWDWBBqCAHr^Hr{.. .DWWHITE AC4591001C4591001 1005 10051328AADVERSE EVENT 2 NAUSEA Nausea FܛGASTROINTESTINAL DISORDERS Nausea F F Nausea and vomiting symptoms FGastrointestinal signs and symptoms FGastrointestinal disorders Fܛ2020-11-12 B2020-11-13T06:00B 2MedDRA v24.0NDV A ..DVA0DTHr~A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . APeriod 01DVDHr^DXCDHt\ Vaccination 2 A Y A 2021-02-25T20:35:11 100513391005Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDLHr`DWDLHsLPlacebo APlacebo ADVDLDVDY . . .Placebo Placebo DVDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDLDWDXeBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBmBqCAHr`Hr{Hsr|pHsL .DWWHITE AC4591001C4591001 1005 10051339AADVERSE EVENT 1 anxiety Anxiety F'PSYCHIATRIC DISORDERS Anxiety FFAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'2021-04-21 B .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDWw B....... N NNOT RELATEDOTHER unknown NOT APPLICABLE YNNOT RECOVERED/NOT RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVDLHr`DWDHsr|oFollow Up 1 A0Y A 2021-05-18T18:05:13Y 100513391005Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDLHr`DWDLHsLPlacebo APlacebo ADVDLDVDY . . .Placebo Placebo DVDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDLDWDXeBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBmBqCAHr`Hr{Hsr|pHsL .DWWHITE AC4591001C4591001 1005 10051339A ADVERSE EVENT 2 generalized myalgia Myalgia FkMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Myalgia F{F{Muscle pains F#Muscle disorders FMusculoskeletal and connective tissue disorders Fk2021-05-19 B2021-05-23 B 1MedDRA v24.0NDW A0..DWAp..APDAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDHsr|pDYDLHuqLVaccination 3 APY A02021-06-16T20:56:19Y 100514171005Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHrDWD HsFPlacebo APlacebo ADVDDWDY . . .Placebo Placebo DW1DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDD DX DXBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBB-B1CPAHrHrŅHsƶxHsF .DWWHITE AC4591001C4591001 1005 10051417AADVERSE EVENT 1 fever Pyrexia FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F.F)Febrile disorders FBody temperature conditions FGeneral disorders and administration site conditions F2021-08-13T19:00B2021-08-14T12:30B 2MedDRA v24.0NDW AEHs渰DWA DHsA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A Cp A Period 02DWDHsƶxDYVD Huz Vaccination 4 A`Y A@2021-09-09T23:28:49Y 100514201005BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDިHr$(DW DHrBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADVDިDW DY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW(DWYPhase 3A@NNEGDW ....... . .NY.DWDWBBlCPAHr$(Hr.. .DWWHITE AC4591001C4591001 1005 10051420AADVERSE EVENT 2 Anxiety Anxiety F'PSYCHIATRIC DISORDERS Anxiety FFAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'2021-05-03 B .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDW Bx....... N NNOT RELATEDOTHER unknown NOT APPLICABLE YNNOT RECOVERED/NOT RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVDިHr$(DXyDHt1LFollow Up 1 A0Y A 2021-05-11T13:19:42Y 100514201005BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDިHr$(DW DHrBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADVDިDW DY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW(DWYPhase 3A@NNEGDW ....... . .NY.DWDWBBlCPAHr$(Hr.. .DWWHITE AC4591001C4591001 1005 10051420A ADVERSE EVENT 1 Depression Depression F'PSYCHIATRIC DISORDERS Depression FFDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'2021-05-03 B .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDW Bx....... N NNOT RELATEDOTHER unknown NOT APPLICABLE YNNOT RECOVERED/NOT RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVDިHr$(DXyDHt1LFollow Up 1 A0Y A 2021-05-11T13:19:32Y 100514241005BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHroDWDDHrDBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADVDDWDDY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW3DWYPhase 3A@NNEGDW ....... . .NY.DWDWBB^C0AHroHrD.. .DWWHITE AC4591001C4591001 1005 10051424AADVERSE EVENT 4 FATIGUE Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-01-08T21:00B2021-01-11 B 2MedDRA v24.0NDW AEuHrȿPDWA@..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C, APeriod 01DVDHroDX}DDHtJVaccination 2 A Y A 2021-01-27T04:17:59 100514241005BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHroDWDDHrDBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADVDDWDDY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW3DWYPhase 3A@NNEGDW ....... . .NY.DWDWBB^C0AHroHrD.. .DWWHITE AC4591001C4591001 1005 10051424A ADVERSE EVENT 1 HEADACHE Headache FNERVOUS SYSTEM DISORDERS Headache FFHeadaches NEC FHeadaches FNervous system disorders F2021-01-08T21:00B2021-01-11 B 2MedDRA v24.0NDW AEuHrȿPDWA@..A@DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C, APeriod 01DVDHroDX}DDHtJVaccination 2 A Y A 2021-01-27T04:17:43 100514241005BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHroDWDDHrDBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADVDDWDDY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW3DWYPhase 3A@NNEGDW ....... . .NY.DWDWBB^C0AHroHrD.. .DWWHITE AC4591001C4591001 1005 10051424A0ADVERSE EVENT 5 INJECTION SITE PAIN Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-01-08T21:00B2021-01-11 B 2MedDRA v24.0NDW AEuHrȿPDWA@..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C, APeriod 01DVDHroDX}DDHtJVaccination 2 A Y A 2021-01-27T14:02:31 100514241005BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHroDWDDHrDBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADVDDWDDY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW3DWYPhase 3A@NNEGDW ....... . .NY.DWDWBB^C0AHroHrD.. .DWWHITE AC4591001C4591001 1005 10051424A@ADVERSE EVENT 3 GENERALIZED MYALGIA Myalgia FkMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Myalgia F{F{Muscle pains F#Muscle disorders FMusculoskeletal and connective tissue disorders Fk2021-01-08T21:00B2021-01-11 B 2MedDRA v24.0NDW AEuHrȿPDWA@..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C, APeriod 01DVDHroDX}DDHtJVaccination 2 A Y A 2021-01-27T04:17:54 100514241005BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHroDWDDHrDBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADVDDWDDY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW3DWYPhase 3A@NNEGDW ....... . .NY.DWDWBB^C0AHroHrD.. .DWWHITE AC4591001C4591001 1005 10051424APADVERSE EVENT 2 NAUSEA Nausea FܛGASTROINTESTINAL DISORDERS Nausea F F Nausea and vomiting symptoms FGastrointestinal signs and symptoms FGastrointestinal disorders Fܛ2021-01-08T21:00B2021-01-11 B 1MedDRA v24.0NDW AEuHrȿPDWA@..A@DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C, APeriod 01DVDHroDX}DDHtJVaccination 2 A Y A 2021-01-27T04:17:48 100514271005Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDDHrzDDWDHsPlacebo APlacebo ADVDDDWDY . . .Placebo Placebo DW/DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD@DDWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBmBqCAHrzDHr%PHsrYHs .DWWHITE AC4591001C4591001 1005 10051427AADVERSE EVENT 1 chills Chills FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills FFFeelings and sensations NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2021-06-07T17:00B2021-06-09 B 2MedDRA v24.0NDW ADHsHDWA0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C A Period 02DWD@HsrYDYDHuo9xVaccination 4 A`Y A@2021-07-12T13:00:57Y 100514271005Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDDHrzDDWDHsPlacebo APlacebo ADVDDDWDY . . .Placebo Placebo DW/DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD@DDWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBmBqCAHrzDHr%PHsrYHs .DWWHITE AC4591001C4591001 1005 10051427A ADVERSE EVENT 2 generalized myalgia Myalgia FkMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Myalgia F{F{Muscle pains F#Muscle disorders FMusculoskeletal and connective tissue disorders Fk2021-06-07T17:00B2021-06-09 B 2MedDRA v24.0NDW ADHsHDWA0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C A Period 02DWD@HsrYDYDHuo9xVaccination 4 A`Y A@2021-07-12T13:01:43Y 100514371005Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDpHrDWDHs!Placebo APlacebo ADVDpDWDY . . .Placebo Placebo DW6DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD@DDWDXmBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBcBlBAHrHrͨHsjHs! .DWWHITE AC4591001C4591001 1005 10051437AADVERSE EVENT 2 Fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-06-17T17:00B2021-06-26T08:00B 2MedDRA v24.0NDW ADHswDWADpHs;ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C A Period 02DWD@HsjDYDHu|U|Vaccination 4 A`Y A@2021-06-28T17:28:28Y 100514371005Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDpHrDWDHs!Placebo APlacebo ADVDpDWDY . . .Placebo Placebo DW6DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD@DDWDXmBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBcBlBAHrHrͨHsjHs! .DWWHITE AC4591001C4591001 1005 10051437A ADVERSE EVENT 1 Generalized myalgia Myalgia FkMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Myalgia F{F{Muscle pains F#Muscle disorders FMusculoskeletal and connective tissue disorders Fk2021-06-17T17:00B2021-06-26T08:00B 2MedDRA v24.0NDW ADHswDWADpHs;ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C A Period 02DWD@HsjDYDHu|U|Vaccination 4 A`Y A@2021-06-28T17:28:17Y 100514501005Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DWDшHr^DWDHsmxPlacebo APlacebo ADWDшDW(DPY . . .Placebo Placebo DWDDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD<DDWDXjBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBfBlBAHr^HrPHs{<Hsmx .DWALL OTHERS A0C4591001C4591001 1005 10051450AADVERSE EVENT 1 Broken left thumb Hand fracture FINJURY, POISONING AND PROCEDURAL COMPLICATIONS Fractured thumb F!F*Limb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications F2021-06-10 B2021-07-16 B 2MedDRA v24.0NDW B..DWB6..B%DAYSN NNOT RELATEDOTHER outdoor activities NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . A Period 02DWD<Hs{<DYDHuxVaccination 3 APY A02021-08-06T13:01:14Y 100611831006Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAMULTIPLE A`MAHISPANIC OR LATINO AUSAMULTIRACIAL A`DVD0HrDWDHs,Placebo APlacebo ADVD0DWDY . . .Placebo Placebo DW0DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDXdBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBjBlCPAHrHr̐Hsv/Hs, .DWALL OTHERS A0C4591001C4591001 1006 10061183AADVERSE EVENT 1 Broken thumb- left Hand fracture FINJURY, POISONING AND PROCEDURAL COMPLICATIONS Fractured thumb F!F*Limb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications F2021-05-12 B2021-06-16 B 2MedDRA v24.0NDW B~..DWB..B$DAYSN NNOT RELATEDOTHER Sports Injury NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVD0HrDWDHsv/Follow Up 1 A0Y A 2021-07-12T19:57:29Y 100611831006Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAMULTIPLE A`MAHISPANIC OR LATINO AUSAMULTIRACIAL A`DVD0HrDWDHs,Placebo APlacebo ADVD0DWDY . . .Placebo Placebo DW0DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDXdBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBjBlCPAHrHr̐Hsv/Hs, .DWALL OTHERS A0C4591001C4591001 1006 10061183A ADVERSE EVENT 2 Injection Site Tenderness Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site tenderness FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-05-20T12:00B2021-05-22 B 1MedDRA v24.0NDW ADHsvFDWA0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Bb A Period 02DWDHsv/DYDHup`Vaccination 3 APY A02021-06-08T19:08:47Y 100611961006Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADVD Hr͠DWDtHsSPlacebo APlacebo ADVD DVDY . . .Placebo Placebo DWDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDtDWDXdBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBkBlC0AHr͠HrԼHsuPHsS .DWWHITE AC4591001C4591001 1006 10061196AADVERSE EVENT 1 Injection site tenderness Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site tenderness FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-05-19T23:00B2021-05-26 B 1MedDRA v24.0NDW AE7HsuDWA..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C! A Period 02DWDHsuPDYDtHuptVaccination 3 APY A02021-06-09T00:01:47Y 100612031006BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDXHrXDVD8Hr׸BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADVDXDVD8Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWDWYPhase 3A@NNEGDW ....... . .NY.DWDWBBdC AHrXHr׸.. .DWWHITE AC4591001C4591001 1006 10061203AADVERSE EVENT 2 Fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2020-12-04 A 2020-12-04 A 1MedDRA v24.0NDV A ..DVA ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . APeriod 01DVDXHrXDXlD8Ht 8Vaccination 1 AY A2021-02-05T02:15:18 100612031006BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDXHrXDVD8Hr׸BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADVDXDVD8Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWDWYPhase 3A@NNEGDW ....... . .NY.DWDWBBdC AHrXHr׸.. .DWWHITE AC4591001C4591001 1006 10061203A ADVERSE EVENT 5 Fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2020-12-22T19:00B2020-12-24 B 1MedDRA v24.0NDV AEHr9DWA0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C APeriod 01DVDXHrXDXlD8Ht 8Vaccination 2 A Y A 2021-02-06T00:30:16 100612031006BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDXHrXDVD8Hr׸BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADVDXDVD8Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWDWYPhase 3A@NNEGDW ....... . .NY.DWDWBBdC AHrXHr׸.. .DWWHITE AC4591001C4591001 1006 10061203A0ADVERSE EVENT 3 Headache Headache FNERVOUS SYSTEM DISORDERS Headache FFHeadaches NEC FHeadaches FNervous system disorders F2020-12-04 A 2020-12-05 A0 1MedDRA v24.0NDV A ..DVA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . APeriod 01DVDXHrXDXlD8Ht 8Vaccination 1 AY A2021-02-05T02:15:24 100612031006BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDXHrXDVD8Hr׸BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADVDXDVD8Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWDWYPhase 3A@NNEGDW ....... . .NY.DWDWBBdC AHrXHr׸.. .DWWHITE AC4591001C4591001 1006 10061203A@ADVERSE EVENT 6 Headache Headache FNERVOUS SYSTEM DISORDERS Headache FFHeadaches NEC FHeadaches FNervous system disorders F2020-12-22T19:00B2020-12-24 B 2MedDRA v24.0NDV AEHr9DWA0..A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C APeriod 01DVDXHrXDXlD8Ht 8Vaccination 2 A Y A 2021-02-06T00:30:22 100612031006BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDXHrXDVD8Hr׸BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADVDXDVD8Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWDWYPhase 3A@NNEGDW ....... . .NY.DWDWBBdC AHrXHr׸.. .DWWHITE AC4591001C4591001 1006 10061203A`ADVERSE EVENT 4 Injection site pain Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2020-12-04 A 2020-12-08 A` 1MedDRA v24.0NDV A ..DVA`..APDAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . APeriod 01DVDXHrXDXlD8Ht 8Vaccination 1 AY A2021-02-11T23:57:32 100612031006BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDXHrXDVD8Hr׸BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADVDXDVD8Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWDWYPhase 3A@NNEGDW ....... . .NY.DWDWBBdC AHrXHr׸.. .DWWHITE AC4591001C4591001 1006 10061203APADVERSE EVENT 7 Injection Site Pain Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2020-12-22T19:00B2020-12-24 B 2MedDRA v24.0NDV AEHr9DWA0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C APeriod 01DVDXHrXDXlD8Ht 8Vaccination 2 A Y A 2021-02-06T00:30:28 100612031006BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDXHrXDVD8Hr׸BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADVDXDVD8Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWDWYPhase 3A@NNEGDW ....... . .NY.DWDWBBdC AHrXHr׸.. .DWWHITE AC4591001C4591001 1006 10061203ApADVERSE EVENT 1 Nausea Nausea FܛGASTROINTESTINAL DISORDERS Nausea F F Nausea and vomiting symptoms FGastrointestinal signs and symptoms FGastrointestinal disorders Fܛ2020-12-04T16:38A 2020-12-04T16:38A 1MedDRA v24.0NDV A DHr]hDVA D#Hr]ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CW APeriod 01DVDXHrXDXlD8Ht 8Vaccination 1 AY A2021-02-05T02:15:13 100612091006BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHr\DWDHrBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADVDDWDY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW"DWYPhase 3A@NPOSDW ....... . .NY.DWDWBBlCAHr\Hr.. .DWWHITE AC4591001C4591001 1006 10061209AADVERSE EVENT 2 Syncope Vasovagal response Syncope FNERVOUS SYSTEM DISORDERS Syncope vasovagal F=F=Disturbances in consciousness NEC FENeurological disorders NEC FNervous system disorders F2021-03-12 Bc2021-03-12 Bc 1MedDRA v24.0NDWO BP..DWOBP..ADAYSN NNOT RELATEDOTHER blood draw NOT APPLICABLE NYRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVDHr\DXmDHtRhFollow Up 1 A0Y A 2021-03-12T20:09:45 100612231006Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHr*DWDDHsGPlacebo APlacebo ADVDDWDY . . .Placebo Placebo DW)DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD{ DDDWDXdBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBmBpCAHr*Hr|Hsr$HsG .DWWHITE AC4591001C4591001 1006 10061223AADVERSE EVENT 1 Injection Site Pain Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-05-18T08:00B2021-05-21 B 1MedDRA v24.0NDW A DpHsskDWAP..A@DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CW0 A Period 02DWD{ Hsr$DYDDHup{DVaccination 3 APY A02021-06-08T21:14:47Y 100612261006Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHrODWDHs@Placebo APlacebo ADVDDWDY . . .Placebo Placebo DW!DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD$DDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBqCAHrOHr \HsnT$Hs@ .DWWHITE AC4591001C4591001 1006 10061226AADVERSE EVENT 1 Attention Deficit Hyperactivity Disorder Attention deficit hyperactivity disorderF'PSYCHIATRIC DISORDERS Attention deficit hyperactivity disorder F&F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'2021-03-24 Bl .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDW[ BW....... N NNOT RELATEDOTHER established diagnosis NOT APPLICABLE YNNOT RECOVERED/NOT RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVDHrODWD#HsnT#Follow Up 1 A0Y A 2021-06-02T23:29:43Y 100612281006Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHrS@DWD4Hs/Placebo APlacebo ADVDDWDHY . . .Placebo Placebo DW$DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD$D4DWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBqCAHrS@Hr/HHsnT$Hs/ .DWWHITE AC4591001C4591001 1006 10061228AADVERSE EVENT 1 Attention Deficit Hyperactivity Disorder Attention deficit hyperactivity disorderF'PSYCHIATRIC DISORDERS Attention deficit hyperactivity disorder F&F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'2021-03-24 Bk .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDW[ BV....... N NNOT RELATEDOTHER Established diagnosis NOT APPLICABLE YNNOT RECOVERED/NOT RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVDHrS@DWD#HsnT#Follow Up 1 A0Y A 2021-05-14T22:46:43Y 100612451006Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDTHrDWDhHshPlacebo APlacebo ADVDTDWD\Y . . .Placebo Placebo DW"DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDhDWDXeBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBlBmCAHrHr \HssHsh .DWWHITE AC4591001C4591001 1006 10061245AADVERSE EVENT 1 Hives face Urticaria F5SKIN AND SUBCUTANEOUS TISSUE DISORDERS Hives FeFMUrticarias FMAngioedema and urticaria FSkin and subcutaneous tissue disorders F52020-12-12 A02020-12-31 B 1MedDRA v24.0NDV A0..DWB..BDAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . APeriod 01DVDTHrDWDHssVaccination 1 AY A2021-01-26T23:14:59 100612451006Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDTHrDWDhHshPlacebo APlacebo ADVDTDWD\Y . . .Placebo Placebo DW"DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDhDWDXeBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBlBmCAHrHr \HssHsh .DWWHITE AC4591001C4591001 1006 10061245A ADVERSE EVENT 2 Hives trunk Urticaria F5SKIN AND SUBCUTANEOUS TISSUE DISORDERS Hives FeFMUrticarias FMAngioedema and urticaria FSkin and subcutaneous tissue disorders F52020-12-12 A02020-12-15 A` 1MedDRA v24.0NDV A0..DVA`..A@DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . APeriod 01DVDTHrDWDHssVaccination 1 AY A2020-12-30T15:20:57 100612531006Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDdHrvdDWDHsCPPlacebo APlacebo ADVDdDWD Y . . .Placebo Placebo DW(DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD~DDWDXdBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBmBpCAHrvdHr]Hsr'HsCP .DWWHITE AC4591001C4591001 1006 10061253AADVERSE EVENT 1 Fractured Nasal Septum Facial bones fracture FINJURY, POISONING AND PROCEDURAL COMPLICATIONS Fractured nose FF*Skull fractures, facial bone fractures and dislocations F6Bone and joint injuries FInjury, poisoning and procedural complications F2021-06-02 B2021-06-06 B 1MedDRA v24.0NDW B..DWB..APDAYSN NNOT RELATEDOTHER basketball injury NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . A Period 02DWD~Hsr'DYDHupvVaccination 3 APY A02021-06-08T21:14:58Y 100612581006BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsANATIVE HAWAIIAN OR OTHER PACIFIC ISLANDERAPMANOT HISPANIC OR LATINOA USANATIVE HAWAIIAN OR OTHER PACIFIC ISLANDERAPDVDHr$DW D}Hr!\BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADVDDW D}Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW/DWYPhase 3A@NNEGDW ....... . .NY.DWDWBBlCpAHr$Hr!\.. .DWALL OTHERS A0C4591001C4591001 1006 10061258AADVERSE EVENT 1 ORAL CANKERS Aphthous ulcer FܛGASTROINTESTINAL DISORDERS Canker sores oral F~FStomatitis and ulceration F;Oral soft tissue conditions FGastrointestinal disorders Fܛ2021-06-27 B2021-07-05 B 2MedDRA v24.0NDW B..DWB..ADAYSN NNOT RELATEDOTHER VIRAL NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVDHr$DXzD}HtTAfter unblinding and before Vaccination 3A@ A 2021-07-12T17:41:35Y 100612661006Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAMULTIPLE A`FA NOT HISPANIC OR LATINOA USAMULTIRACIAL A`DVD4Hr4DWTDtHs!tPlacebo APlacebo ADVD4DWDdY . . .Placebo Placebo DW1DW=YPhase 3A@NNEGDW> BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW?DWTDDtDWpDXBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DW=DWBFBBC`AHr4HrŐdHs-hHs!t .DW>ALL OTHERS A0C4591001C4591001 1006 10061266AADVERSE EVENT 1 CHILLS Chills FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills FFFeelings and sensations NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2021-02-24T22:00BH2021-02-26T11:00BJ 2MedDRA v24.0NDW? AEVHsDWAA0DHskA0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C( A Period 02DW?DHs-hDXDtHu Vaccination 3 APY A02021-03-17T18:54:00 100612721006BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsABLACK OR AFRICAN AMERICAN A FA NOT HISPANIC OR LATINOA USABLACK OR AFRICAN AMERICAN A DVDdHrDWDHsrBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADVDd..Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDWYPhase 3A@NNEGDWBNT162b2 (30 (*ESC*){unicode 03BC}g) DW...... . .NN.DWDWBBpCPAHrHsr.. .DXNBLACK OR AFRICAN AMERICANA C4591001C4591001 1006 10061272A ADVERSE EVENT 3 Contusion left elbow Contusion FINJURY, POISONING AND PROCEDURAL COMPLICATIONS Contusion of elbow FF\Skin injuries NEC FInjuries NEC FInjury, poisoning and procedural complications F2021-02-05 B42021-03-05 BP 1MedDRA v24.0NDW, B4..DWHBP..BDAYSN NNOT RELATEDOTHER Fall on ice NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVDdHrDXDHuSǜVaccination 1 AY A2021-06-30T20:23:29 AE outcome changed from EUA to sBLA 100612721006BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsABLACK OR AFRICAN AMERICAN A FA NOT HISPANIC OR LATINOA USABLACK OR AFRICAN AMERICAN A DVDdHrDWDHsrBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADVDd..Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDWYPhase 3A@NNEGDWBNT162b2 (30 (*ESC*){unicode 03BC}g) DW...... . .NN.DWDWBBpCPAHrHsr.. .DXNBLACK OR AFRICAN AMERICANA C4591001C4591001 1006 10061272A@ADVERSE EVENT 5 Fall Fall FINJURY, POISONING AND PROCEDURAL COMPLICATIONS Fall FխFխNon-site specific injuries NEC F Injuries NEC FInjury, poisoning and procedural complications F2021-02-05 B42021-02-05 B4 1MedDRA v24.0NDW, B4..DW,B4..ADAYSN NNOT RELATEDOTHER Icy conditions NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVDdHrDXDHuSǜVaccination 1 AY A2021-07-08T16:02:43Y 100612721006BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsABLACK OR AFRICAN AMERICAN A FA NOT HISPANIC OR LATINOA USABLACK OR AFRICAN AMERICAN A DVDdHrDWDHsrBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADVDd..Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDWYPhase 3A@NNEGDWBNT162b2 (30 (*ESC*){unicode 03BC}g) DW...... . .NN.DWDWBBpCPAHrHsr.. .DXNBLACK OR AFRICAN AMERICANA C4591001C4591001 1006 10061272APADVERSE EVENT 4 Injection site soreness Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-05-17T20:00B2021-05-20 B 1MedDRA v24.0NDW AEHsrDWA@..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A B APeriod 01DVDdHrDXDHuSǜAfter unblinding and before Vaccination 3A@ A 2021-06-21T20:20:50Y 100612741006BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDPHr?DWDHr1BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADVDPDWDY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW,DWYPhase 3A@NNEGDW ....... . .NY.DWDWBBpCPAHr?Hr1.. .DWWHITE AC4591001C4591001 1006 10061274AADVERSE EVENT 1 MIGRAINE HEADACHES Migraine FNERVOUS SYSTEM DISORDERS Migraine headache FRFOMigraine headaches FSHeadaches FNervous system disorders F2021-04 . .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDWcDBT....... N NNOT RELATEDOTHER HORMONAL CHANGES NOT APPLICABLE YNNOT RECOVERED/NOT RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVDPHr?DX}DHte@Follow Up 1 A0Y A 2021-08-03T07:25:35Y 100612791006Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDTHrTDWDHsJPlacebo APlacebo ADVDTDW DtY . . .Placebo Placebo DW)DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDHDDWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBmBpC@AHrTHrėHsrBHsJ .DWWHITE AC4591001C4591001 1006 10061279AADVERSE EVENT 1 Worsening of Anxiety Anxiety F'PSYCHIATRIC DISORDERS Anxiety aggravated FSSFAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'2021-03 . .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDWDDB8....... N NNOT RELATEDOTHER Outgrew anxiety med dose NOT APPLICABLE YNNOT RECOVERED/NOT RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVDTHrTDWDGHsrBFollow Up 1 A0Y A 2021-06-04T18:46:43Y 100612791006Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDTHrTDWDHsJPlacebo APlacebo ADVDTDW DtY . . .Placebo Placebo DW)DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDHDDWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBmBpC@AHrTHrėHsrBHsJ .DWWHITE AC4591001C4591001 1006 10061279A ADVERSE EVENT 2 Left Sprained Ankle Ligament sprain FINJURY, POISONING AND PROCEDURAL COMPLICATIONS Sprained ankle F9FMuscle, tendon and ligament injuries FInjuries NEC FInjury, poisoning and procedural complications F2021-03-26 Bd .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDW] BQ....... N NNOT RELATEDOTHER Acute Physical Trauma NOT APPLICABLE YYNOT RECOVERED/NOT RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVDTHrTDWDGHsrBFollow Up 1 A0Y A 2021-06-04T18:48:34Y 100612791006Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDTHrTDWDHsJPlacebo APlacebo ADVDTDW DtY . . .Placebo Placebo DW)DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDHDDWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBmBpC@AHrTHrėHsrBHsJ .DWWHITE AC4591001C4591001 1006 10061279A0ADVERSE EVENT 3 Left Foot Plantar Wart Skin papilloma F0NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)Plantar warts FF6KSkin neoplasms benign F6BCutaneous neoplasms benign F6CNeoplasms benign, malignant and unspecified (incl cysts and polyps)F02021-06-09 B2021-06-17 B 2MedDRA v24.0NDW A0..DWA..ADAYSN NNOT RELATEDOTHER viral infection NOT APPLICABLE NYRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . A Period 02DWDHHsrBDYDHuo~`Vaccination 4 A`Y A@2021-07-12T18:46:02Y 100612851006Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHrDWDôHs4Placebo APlacebo ADVDDWDpY . . .Placebo Placebo DW7DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDpDôDWDXrBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBB\B]CAHrHrpHspHs4 .DWWHITE AC4591001C4591001 1006 10061285AADVERSE EVENT 1 dysuria Dysuria F,WRENAL AND URINARY DISORDERS Dysuria F&F&Bladder and urethral symptoms FUrinary tract signs and symptoms FL~Renal and urinary disorders F,W2021-05-31 B2021-07-20 B 1MedDRA v24.0NDW B..DWB..B3DAYSN NNOT RELATEDOTHER mechanical irritation, concentrated urine NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVDHrDWDoHsoFollow Up 1 A0Y A 2021-08-04T20:50:06Y 100612851006Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHrDWDôHs4Placebo APlacebo ADVDDWDpY . . .Placebo Placebo DW7DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDpDôDWDXrBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBB\B]CAHrHrpHspHs4 .DWWHITE AC4591001C4591001 1006 10061285A ADVERSE EVENT 2 Injection site pain Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-06-04 B2021-06-05 B 2MedDRA v24.0NDW A ..DWA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWDpHspDY"DôHuVaccination 3 APY A02021-06-23T00:00:52Y 100612861006BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHrDWDHrytBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADVDDWDY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW0DWYPhase 3A@NNEGDW ....... . .NY.DWDWBBlCAHrHryt.. .DWWHITE AC4591001C4591001 1006 10061286AADVERSE EVENT 2 CONTUSION RIGHT CALCANEUS Bone contusion FINJURY, POISONING AND PROCEDURAL COMPLICATIONS Bone contusion FKFKNon-site specific injuries NEC F Injuries NEC FInjury, poisoning and procedural complications F2021-03-08 BN .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDWK B9....... N NNOT RELATEDOTHER SKIING INJURY NOT APPLICABLE NYNOT RECOVERED/NOT RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVDHrDXDHtFollow Up 1 A0Y A 2021-04-09T16:43:00Y 100612861006BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHrDWDHrytBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADVDDWDY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW0DWYPhase 3A@NNEGDW ....... . .NY.DWDWBBlCAHrHryt.. .DWWHITE AC4591001C4591001 1006 10061286A ADVERSE EVENT 1 FATIGUE Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-01-16 B2021-01-19 B 2MedDRA v24.0NDW A`..DWA..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . APeriod 01DVDHrDXDHtVaccination 2 A Y A 2021-02-10T02:18:55 100612901006BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHrDWDHr8BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADVDDWDY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW6DWYPhase 3A@NNEGDW ....... . .NY.DWDWBBiBAHrHr8.. .DWWHITE AC4591001C4591001 1006 10061290AADVERSE EVENT 1 Concussion Concussion FINJURY, POISONING AND PROCEDURAL COMPLICATIONS Concussion FFCerebral injuries NEC FdInjuries NEC FInjury, poisoning and procedural complications F2021-01-12 B2021-02-12 B5 2MedDRA v24.0NDW B..DW3B5..B DAYSN NNOT RELATEDOTHER Fall (cheer) NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVDHrDXDHtOVaccination 1 AY A2021-07-20T22:11:00 AE outcome changed from EUA to sBLA 100612921006Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVD<HrDWDHsAxPlacebo APlacebo ADVD<DWDY . . .Placebo Placebo DW1DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD|DDWDX^BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBqBAHrHr`Hsn8|HsAx .DWWHITE AC4591001C4591001 1006 10061292AADVERSE EVENT 1 Earwax Impaction Left Ear Cerumen impaction F)EAR AND LABYRINTH DISORDERS Cerumen impaction F[!F[!External ear disorders NEC FExternal ear disorders (excl congenital) FEar and labyrinth disorders F)2021-01-24 B"2021-01-28 B& 2MedDRA v24.0NDW A..DW$B..APDAYSN NNOT RELATEDOTHER Wax overproduction and packing NOT APPLICABLE NYRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVD<HrDWD{Hsn8{Vaccination 2 A Y A 2021-02-15T19:55:57 100612921006Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVD<HrDWDHsAxPlacebo APlacebo ADVD<DWDY . . .Placebo Placebo DW1DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD|DDWDX^BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBqBAHrHr`Hsn8|HsAx .DWWHITE AC4591001C4591001 1006 10061292A ADVERSE EVENT 2 Post Surgical pain Spinal hardware removal Procedural pain FINJURY, POISONING AND PROCEDURAL COMPLICATIONS Postoperative pain Fl7FNon-site specific procedural complications F Procedural related injuries and complications NEC FInjury, poisoning and procedural complications F2021-03-30 Bc2021-04-04 Bh 3MedDRA v24.0NDWa BN..DWfBS..A`DAYSN NNOT RELATEDOTHER Surgery NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A0GRADE 3A0 . APeriod 01DVD<HrDWD{Hsn8{Follow Up 1 A0Y A 2021-04-06T22:21:39Y 100714091007BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DVD|Hrad|DWDHsnBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADVD|..Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDWYPhase 3A@NNEGDWBNT162b2 (30 (*ESC*){unicode 03BC}g) DW...... . .NN.DWDWBBmCAHrad|Hsn.. .DXXALL OTHERS A0C4591001C4591001 1007 10071409AADVERSE EVENT 3 fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-05-28 B2021-05-30 B 2MedDRA v24.0NDW A ..DWA@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . APeriod 01DVD|Hrad|DYDHu`After unblinding and before Vaccination 3A@ A 2021-06-01T23:34:29Y 100714091007BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DVD|Hrad|DWDHsnBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADVD|..Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDWYPhase 3A@NNEGDWBNT162b2 (30 (*ESC*){unicode 03BC}g) DW...... . .NN.DWDWBBmCAHrad|Hsn.. .DXXALL OTHERS A0C4591001C4591001 1007 10071409A ADVERSE EVENT 4 headache Headache FNERVOUS SYSTEM DISORDERS Headache FFHeadaches NEC FHeadaches FNervous system disorders F2021-05-28 B2021-05-30 B 1MedDRA v24.0NDW A ..DWA@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . APeriod 01DVD|Hrad|DYDHu`After unblinding and before Vaccination 3A@ A 2021-06-01T23:34:39Y 100714091007BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DVD|Hrad|DWDHsnBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADVD|..Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDWYPhase 3A@NNEGDWBNT162b2 (30 (*ESC*){unicode 03BC}g) DW...... . .NN.DWDWBBmCAHrad|Hsn.. .DXXALL OTHERS A0C4591001C4591001 1007 10071409A0ADVERSE EVENT 2 pain at injection site Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-05-28 B2021-05-31 B 1MedDRA v24.0NDW A ..DWAP..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . APeriod 01DVD|Hrad|DYDHu`After unblinding and before Vaccination 3A@ A 2021-06-01T23:34:18Y 100714091007BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DVD|Hrad|DWDHsnBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADVD|..Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDWYPhase 3A@NNEGDWBNT162b2 (30 (*ESC*){unicode 03BC}g) DW...... . .NN.DWDWBBmCAHrad|Hsn.. .DXXALL OTHERS A0C4591001C4591001 1007 10071409A@ADVERSE EVENT 1 fever Pyrexia FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F.F)Febrile disorders FBody temperature conditions FGeneral disorders and administration site conditions F2021-05-28T23:00B2021-05-30 B 3MedDRA v24.0NDW A E7HsmpDWA@..A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA0GRADE 3A0 C@ APeriod 01DVD|Hrad|DYDHu`After unblinding and before Vaccination 3A@ A 2021-06-01T23:34:07Y 100714141007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHraoDWDHsaHPlacebo APlacebo ADVDDVDY . . .Placebo Placebo DVDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDXjBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBkBrCAHraoHr}+0Hsu|HsaH .DWWHITE AC4591001C4591001 1007 10071414AADVERSE EVENT 1 chills Chills FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills FFFeelings and sensations NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2021-05-20 B2021-05-22 B 2MedDRA v24.0NDW A ..DWA@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWDHsu|DYDHuxVaccination 3 APY A02021-06-14T21:59:32Y 100714141007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHraoDWDHsaHPlacebo APlacebo ADVDDVDY . . .Placebo Placebo DVDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDXjBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBkBrCAHraoHr}+0Hsu|HsaH .DWWHITE AC4591001C4591001 1007 10071414A ADVERSE EVENT 2 Fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-05-20 B2021-05-22 B 3MedDRA v24.0NDW A ..DWA@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA0GRADE 3A0 . A Period 02DWDHsu|DYDHuxVaccination 3 APY A02021-06-14T21:59:43Y 100714761007BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHHr DVDHrBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADVDHDVDY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWDWYPhase 3A@NNEGDW ....... . .NY.DWDWBBrCPAHr Hr.. .DWWHITE AC4591001C4591001 1007 10071476A ADVERSE EVENT 2 lightheadness after vaccination Dizziness FNERVOUS SYSTEM DISORDERS Lightheadedness F,F˅Neurological signs and symptoms NEC FNeurological disorders NEC FNervous system disorders F2020-12-21T11:50B2020-12-21T11:53B 1MedDRA v24.0NDV ADhHrhDVADWHrWADAYSN NNOT RELATEDOTHER Anxiety NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A A0YAPeriod 01DVDHHr DXkDHt4Vaccination 2 A Y A 2020-12-23T03:04:52 100714761007BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHHr DVDHrBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADVDHDVDY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWDWYPhase 3A@NNEGDW ....... . .NY.DWDWBBrCPAHr Hr.. .DWWHITE AC4591001C4591001 1007 10071476AADVERSE EVENT 1 Vasovagal syncope without collapse Syncope FNERVOUS SYSTEM DISORDERS Syncope vasovagal F=F=Disturbances in consciousness NEC FENeurological disorders NEC FNervous system disorders F2020-11-30T16:26A2020-11-30T16:34A 1MedDRA v24.0NDV ADHrDVAD3HrADAYSN NNOT RELATEDOTHER vasovagal event from blood collection NOT APPLICABLE YYRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A 4 APeriod 01DVDHHr DXkDHt4Pre-Vaccination Y.2020-12-21T22:39:51 100714801007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHr!|DWD$HsIPlacebo APlacebo ADVDDVDY . . .Placebo Placebo DWDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDxD$DWDXdBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBmBrCPAHr!|HrHsrlHsI .DWWHITE AC4591001C4591001 1007 10071480AADVERSE EVENT 4 headache Headache FNERVOUS SYSTEM DISORDERS Headache FFHeadaches NEC FHeadaches FNervous system disorders F2021-06-09 B2021-06-10 B 2MedDRA v24.0NDW A ..DWA0..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWDxHsrlDYD$Hup}$Vaccination 4 A`Y A@2021-06-21T20:09:39Y 100714801007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHr!|DWD$HsIPlacebo APlacebo ADVDDVDY . . .Placebo Placebo DWDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDxD$DWDXdBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBmBrCPAHr!|HrHsrlHsI .DWWHITE AC4591001C4591001 1007 10071480A ADVERSE EVENT 8 shingles Herpes zoster FINFECTIONS AND INFESTATIONS Shingles F4FHerpes viral infections FViral infectious disorders FOInfections and infestations F2021-06-18 B2021-06-30 B 2MedDRA v24.0NDW A..DWB..ADAYSN NNOT RELATEDOTHER Varicella-zoster virus NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . A Period 02DWDxHsrlDYD$Hup}$Vaccination 4 A`Y A@2021-07-12T19:31:29Y 100714801007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHr!|DWD$HsIPlacebo APlacebo ADVDDVDY . . .Placebo Placebo DWDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDxD$DWDXdBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBmBrCPAHr!|HrHsrlHsI .DWWHITE AC4591001C4591001 1007 10071480A0ADVERSE EVENT 1 Injection site pain Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-05-17T19:00B2021-05-24T07:00B 1MedDRA v24.0NDW AEHsrDWADbHs{FADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C A Period 02DWDxHsrlDYD$Hup}$Vaccination 3 APY A02021-07-28T11:28:15Y 100714801007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHr!|DWD$HsIPlacebo APlacebo ADVDDVDY . . .Placebo Placebo DWDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDxD$DWDXdBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBmBrCPAHr!|HrHsrlHsI .DWWHITE AC4591001C4591001 1007 10071480A@ADVERSE EVENT 2 Injection site pain Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-06-08T14:30B2021-06-10 B 1MedDRA v24.0NDW ADHsvhDWA0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A B A Period 02DWDxHsrlDYD$Hup}$Vaccination 4 A`Y A@2021-06-21T20:08:54Y 100714801007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHr!|DWD$HsIPlacebo APlacebo ADVDDVDY . . .Placebo Placebo DWDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDxD$DWDXdBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBmBrCPAHr!|HrHsrlHsI .DWWHITE AC4591001C4591001 1007 10071480APADVERSE EVENT 5 neck pain Neck pain FkMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Neck pain F$F$Musculoskeletal and connective tissue pain and discomfort FMusculoskeletal and connective tissue disorders NEC FiMusculoskeletal and connective tissue disorders Fk2021-06-11 B .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDW A@....... N NNOT RELATEDOTHER Shingles related pain NOT APPLICABLE NNNOT RECOVERED/NOT RESOLVED N A0NOT RELATEDA0A GRADE 2A . A Period 02DWDxHsrlDYD$Hup}$Vaccination 4 A`Y A@2021-06-23T10:29:18Y 100714801007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHr!|DWD$HsIPlacebo APlacebo ADVDDVDY . . .Placebo Placebo DWDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDxD$DWDXdBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBmBrCPAHr!|HrHsrlHsI .DWWHITE AC4591001C4591001 1007 10071480A`ADVERSE EVENT 7 Deltoid of left arm pain Pain in extremity FkMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Painful L arm FiFMusculoskeletal and connective tissue pain and discomfort FMusculoskeletal and connective tissue disorders NEC FiMusculoskeletal and connective tissue disorders Fk2021-06-20 B2021-06-23 B 2MedDRA v24.0NDW A..DWB..A@DAYSN NNOT RELATEDOTHER shingles NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . A Period 02DWDxHsrlDYD$Hup}$Vaccination 4 A`Y A@2021-07-07T19:45:58Y 100714801007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHr!|DWD$HsIPlacebo APlacebo ADVDDVDY . . .Placebo Placebo DWDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDxD$DWDXdBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBmBrCPAHr!|HrHsrlHsI .DWWHITE AC4591001C4591001 1007 10071480ApADVERSE EVENT 3 fever Pyrexia FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F.F)Febrile disorders FBody temperature conditions FGeneral disorders and administration site conditions F2021-06-09 B2021-06-10 B 2MedDRA v24.0NDW A ..DWA0..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWDxHsrlDYD$Hup}$Vaccination 4 A`Y A@2021-06-21T20:09:12Y 100714831007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVD`Hr`DWvD$HsN$Placebo APlacebo ADVD`DVD4Y . . .Placebo Placebo DW"DWJYPhase 3A@NNEGDWK BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWaDWvDD$DWDX3BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWJDWBaBBC@AHr`Hr۴Hs3ILHsN$ .DW`WHITE AC4591001C4591001 1007 10071483AADVERSE EVENT 1 Injection site pain Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-03-30T18:00Bx2021-04-03T08:00B| 1MedDRA v24.0NDWa AD Hs3^DWeAPDpHs8;APDAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A B[ A Period 02DWaDHs3ILDXD$Hu0Vaccination 3 APY A02021-04-21T10:56:22Y 100714841007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDpHrpDWD Hs Placebo APlacebo ADVDpDVDY . . .Placebo Placebo DW"DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDD DWDXeBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBkBrC@AHrpHrhHsulHs .DWWHITE AC4591001C4591001 1007 10071484AADVERSE EVENT 4 fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-05-20T06:00B2021-06-22 B 1MedDRA v24.0NDW A DT`Hsu`DWB#..B"DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C;0 A Period 02DWDHsulDYD HurVaccination 3 APY A02021-07-13T19:56:35Y 100714841007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDpHrpDWD Hs Placebo APlacebo ADVDpDVDY . . .Placebo Placebo DW"DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDD DWDXeBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBkBrC@AHrpHrhHsulHs .DWWHITE AC4591001C4591001 1007 10071484A ADVERSE EVENT 3 injection site pain Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-05-20T06:00B2021-05-20T06:00B 1MedDRA v24.0NDW A DT`Hsu`DWA DTHsuADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C;0 A Period 02DWDHsulDYD HurVaccination 3 APY A02021-07-13T19:54:19Y 100714841007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDpHrpDWD Hs Placebo APlacebo ADVDpDVDY . . .Placebo Placebo DW"DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDD DWDXeBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBkBrC@AHrpHrhHsulHs .DWWHITE AC4591001C4591001 1007 10071484A0ADVERSE EVENT 1 generalized muscle aches Myalgia FkMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Generalized muscle aches FiF{Muscle pains F#Muscle disorders FMusculoskeletal and connective tissue disorders Fk2021-05-20T06:00B2021-05-22 B 1MedDRA v24.0NDW A DT`Hsu`DWA@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C;0 A Period 02DWDHsulDYD HurVaccination 3 APY A02021-07-13T19:52:09Y 100714841007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDpHrpDWD Hs Placebo APlacebo ADVDpDVDY . . .Placebo Placebo DW"DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDD DWDXeBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBkBrC@AHrpHrhHsulHs .DWWHITE AC4591001C4591001 1007 10071484A@ADVERSE EVENT 2 subjective fever Pyrexia FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Subjective fever F0F)Febrile disorders FBody temperature conditions FGeneral disorders and administration site conditions F2021-05-20T06:00B2021-05-22 B 1MedDRA v24.0NDW A DT`Hsu`DWA@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C;0 A Period 02DWDHsulDYD HurVaccination 3 APY A02021-07-13T19:53:10Y 100714971007BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DVD8HrĸDVDHHrBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADVD8DVDHY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWDWYPhase 3A@NNEGDW ....... . .NY.DWDWBBrC0AHrĸHr.. .DWALL OTHERS A0C4591001C4591001 1007 10071497AADVERSE EVENT 1 swollen lymph node left axilla Lymphadenopathy FQBLOOD AND LYMPHATIC SYSTEM DISORDERS Swollen lymph nodes FFLymphatic system disorders NEC FSpleen, lymphatic and reticuloendothelial system disorders F9)Blood and lymphatic system disorders FQ2020-12-25 B2021-01-20T09:00B2 1MedDRA v24.0NDW A@..DWBD~HrBDAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . APeriod 01DVD8HrĸDXlDHHtHVaccination 2 A Y A 2021-03-31T15:05:01 AE outcome changed from EUA to sBLA 100714991007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHrDVD(HrPlacebo APlacebo ADVDDVD(Y . . .Placebo Placebo DWDWYPhase 3A@NNEGDW ....... . .NN.DWDWBBrC AHrHr.. .DWWHITE AC4591001C4591001 1007 10071499AADVERSE EVENT 1 left wrist pain Arthralgia FkMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Wrist pain FTF'Joint related signs and symptoms F:Joint disorders F-Musculoskeletal and connective tissue disorders Fk2021-05-01 B2021-05-03 B 1MedDRA v24.0NDW B..DWB..A0DAYSN NNOT RELATEDOTHER Trauma NOT APPLICABLE YYRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVDHrDXlD(Ht9(Follow Up 1 A0Y A 2021-05-26T17:15:04Y 100715001007BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHrDVDHr8BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADVDDVDY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWDW=YPhase 3A@NNEGDW> ....... . .NY.DW=DWBRBC AHrHr8.. .DWWHITE AC4591001C4591001 1007 10071500AADVERSE EVENT 1 Night Terror Sleep terror F'PSYCHIATRIC DISORDERS Night terrors F cF6Parasomnias FSleep disorders and disturbances F6Psychiatric disorders F'2020-12-23 B2020-12-23 B 1MedDRA v24.0NDW A ..DWA ..ADAYSN NNOT RELATEDOTHER stress NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVDHrDXlDHtVaccination 2 A Y A 2021-01-29T15:39:13 100715051007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVD`Hr`DWDˆHs3Placebo APlacebo ADVD`DWDY . . .Placebo Placebo DW(DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDˆDWDXsBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBB]BpCAHr`Hr,Hs_<Hs3 .DWWHITE AC4591001C4591001 1007 10071505AADVERSE EVENT 7 lightheadedness Dizziness FNERVOUS SYSTEM DISORDERS Lightheadedness F,F˅Neurological signs and symptoms NEC FNeurological disorders NEC FNervous system disorders F2021-06-24T17:01B2021-06-25 B 1MedDRA v24.0NDW A DLHsDWA0..A DAYSN NRELATED NOT APPLICABLE NYRECOVERED/RESOLVED N ARELATED AAGRADE 1A Ce A Period 02DWDHs_<DY#DˆHugVaccination 4 A`Y A@2021-07-06T13:25:08Y 100715051007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVD`Hr`DWDˆHs3Placebo APlacebo ADVD`DWDY . . .Placebo Placebo DW(DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDˆDWDXsBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBB]BpCAHr`Hr,Hs_<Hs3 .DWWHITE AC4591001C4591001 1007 10071505A ADVERSE EVENT 2 Fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-06-03 B2021-06-04 B 1MedDRA v24.0NDW A ..DWA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDHs_<DY#DˆHugVaccination 3 APY A02021-07-06T13:24:17Y 100715051007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVD`Hr`DWDˆHs3Placebo APlacebo ADVD`DWDY . . .Placebo Placebo DW(DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDˆDWDXsBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBB]BpCAHr`Hr,Hs_<Hs3 .DWWHITE AC4591001C4591001 1007 10071505A0ADVERSE EVENT 4 headache Headache FNERVOUS SYSTEM DISORDERS Headache FFHeadaches NEC FHeadaches FNervous system disorders F2021-06-24T05:00B2021-06-25 B 2MedDRA v24.0NDW A DFPHsDWA0..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C8 A Period 02DWDHs_<DY#DˆHugVaccination 4 A`Y A@2021-06-29T15:53:45Y 100715051007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVD`Hr`DWDˆHs3Placebo APlacebo ADVD`DWDY . . .Placebo Placebo DW(DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDˆDWDXsBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBB]BpCAHr`Hr,Hs_<Hs3 .DWWHITE AC4591001C4591001 1007 10071505A@ADVERSE EVENT 3 injection site pain Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-06-23T17:00B2021-06-25 B 1MedDRA v24.0NDW ADHs`DWA0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A B A Period 02DWDHs_<DY#DˆHugVaccination 4 A`Y A@2021-06-29T15:53:33Y 100715051007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVD`Hr`DWDˆHs3Placebo APlacebo ADVD`DWDY . . .Placebo Placebo DW(DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDˆDWDXsBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBB]BpCAHr`Hr,Hs_<Hs3 .DWWHITE AC4591001C4591001 1007 10071505APADVERSE EVENT 6 nausea Nausea FܛGASTROINTESTINAL DISORDERS Nausea F F Nausea and vomiting symptoms FGastrointestinal signs and symptoms FGastrointestinal disorders Fܛ2021-06-24T17:00B2021-06-25 B 1MedDRA v24.0NDW A DHsDWA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Ce A Period 02DWDHs_<DY#DˆHugVaccination 4 A`Y A@2021-06-29T15:54:08Y 100715051007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVD`Hr`DWDˆHs3Placebo APlacebo ADVD`DWDY . . .Placebo Placebo DW(DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDˆDWDXsBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBB]BpCAHr`Hr,Hs_<Hs3 .DWWHITE AC4591001C4591001 1007 10071505A`ADVERSE EVENT 1 Right Arm Pain Pain in extremity FkMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Painful R arm FkFMusculoskeletal and connective tissue pain and discomfort FMusculoskeletal and connective tissue disorders NEC FiMusculoskeletal and connective tissue disorders Fk2021-06-03 B2021-06-06 B 1MedDRA v24.0NDW A ..DWAP..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDHs_<DY#DˆHugVaccination 3 APY A02021-06-23T21:38:47Y 100715051007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVD`Hr`DWDˆHs3Placebo APlacebo ADVD`DWDY . . .Placebo Placebo DW(DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDˆDWDXsBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBB]BpCAHr`Hr,Hs_<Hs3 .DWWHITE AC4591001C4591001 1007 10071505ApADVERSE EVENT 5 fever 101 Pyrexia FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F.F)Febrile disorders FBody temperature conditions FGeneral disorders and administration site conditions F2021-06-24T17:00B2021-06-25 B 2MedDRA v24.0NDW A DHsDWA0..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A Ce A Period 02DWDHs_<DY#DˆHugVaccination 4 A`Y A@2021-06-29T15:53:57Y 100715091007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDθHr6DWDHsPlacebo APlacebo ADVDθDWDY . . .Placebo Placebo DW#DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDXeBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBjBrCAHr6HrOTHsv&Hs .DWWHITE AC4591001C4591001 1007 10071509AADVERSE EVENT 1 Right Arm Pain Pain in extremity FkMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Painful R arm FkFMusculoskeletal and connective tissue pain and discomfort FMusculoskeletal and connective tissue disorders NEC FiMusculoskeletal and connective tissue disorders Fk2021-05-21 B2021-05-23 B 1MedDRA v24.0NDW A ..DWA@..A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDHsv&DYDHuqVaccination 3 APY A02021-06-10T11:04:18Y 100715111007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHrTDWDHs7\Placebo APlacebo ADVDDWDY . . .Placebo Placebo DW!DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD DDWDXdBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBlBrCAHrTHrHss Hs7\ .DWWHITE AC4591001C4591001 1007 10071511AADVERSE EVENT 1 Headache Headache FNERVOUS SYSTEM DISORDERS Headache FFHeadaches NEC FHeadaches FNervous system disorders F2021-05-18T21:00B2021-05-19T08:00B 1MedDRA v24.0NDW AEuHst"PDWA DpHst;A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C+@ A Period 02DWD Hss DYDHupjVaccination 3 APY A02021-06-08T17:03:17Y 100715111007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHrTDWDHs7\Placebo APlacebo ADVDDWDY . . .Placebo Placebo DW!DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD DDWDXdBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBlBrCAHrTHrHss Hs7\ .DWWHITE AC4591001C4591001 1007 10071511A ADVERSE EVENT 2 Left arm pain Pain in extremity FkMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Painful L arm FiFMusculoskeletal and connective tissue pain and discomfort FMusculoskeletal and connective tissue disorders NEC FiMusculoskeletal and connective tissue disorders Fk2021-05-19T12:00B2021-05-20T12:00B 1MedDRA v24.0NDW A DHst@DWA0DHsvFA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Cc A Period 02DWD Hss DYDHupjVaccination 3 APY A02021-06-08T17:04:14Y 100715161007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHrB$DWDLHs?Placebo APlacebo ADVDDWDPY . . .Placebo Placebo DW"DWYPhase 3A@NPOSDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDԔDLDWDXdBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBlBrCAHrB$Hr PHssϔHs? .DWWHITE AC4591001C4591001 1007 10071516AADVERSE EVENT 2 Chills Chills FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills FFFeelings and sensations NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2021-05-19T08:30B2021-05-20T02:00B 1MedDRA v24.0NDW A DwHstDWA0D[Hsu[A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CA0 A Period 02DWDԔHssϔDYDLHupsLVaccination 3 APY A02021-06-08T17:09:25Y 100715161007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHrB$DWDLHs?Placebo APlacebo ADVDDWDPY . . .Placebo Placebo DW"DWYPhase 3A@NPOSDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDԔDLDWDXdBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBlBrCAHrB$Hr PHssϔHs? .DWWHITE AC4591001C4591001 1007 10071516A ADVERSE EVENT 1 Fever Pyrexia FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F.F)Febrile disorders FBody temperature conditions FGeneral disorders and administration site conditions F2021-05-19T08:30B2021-05-20T02:00B 1MedDRA v24.0NDW A DwHstDWA0D[Hsu[A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CA0 A Period 02DWDԔHssϔDYDLHupsLVaccination 3 APY A02021-06-08T17:08:59Y 100715191007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHHraDWwDtHsP)Placebo APlacebo ADVDHDWDY . . .Placebo Placebo DW#DW`YPhase 3A@NNEGDWa BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWbDWwDHDtDWDX4BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DW`DWBpBBCAHraHr Hs4LHHsP) .DWaWHITE AC4591001C4591001 1007 10071519AADVERSE EVENT 1 Pain at injection site Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-03-31T19:00Br2021-04-01T19:00Bs 2MedDRA v24.0NDWb AEHs40DWcA EHs6A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C` A Period 02DWbDHHs4LHDXDtHu1]tVaccination 3 APY A02021-04-21T23:28:38Y 100715241007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHrdDWUDHs#rPlacebo APlacebo ADVDDWDY . . .Placebo Placebo DW*DW0YPhase 3A@NNEGDW1 BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW@DWUDLDDWvDXBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DW0DWB@BBCAHrdHr HsLHs#r .DW?WHITE AC4591001C4591001 1007 10071524AADVERSE EVENT 2 thrush Candida infection FINFECTIONS AND INFESTATIONS Thrush FAF:Candida infections F^Fungal infectious disorders FInfections and infestations F2021-02-01 B82021-02-02 B9 2MedDRA v24.0NDW( B#..DW)B$..A DAYSN NNOT RELATEDCONCOMITANT DRUG TREATMENT NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVDHrdDW@DKHsKVaccination 2 A Y A 2021-03-03T20:29:46 100715311007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDhHrhDWD\HsPlacebo APlacebo ADVDhDWDY . . .Placebo Placebo DW#DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDdD\DWDXrBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBeBqCAHrhHrSHs|Hs .DWWHITE AC4591001C4591001 1007 10071531AADVERSE EVENT 1 Headache Headache FNERVOUS SYSTEM DISORDERS Headache FFHeadaches NEC FHeadaches FNervous system disorders F2021-05-26T11:00B2021-05-26T22:00B 2MedDRA v24.0NDW A DHs~!DWA EYHs~ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A CU A Period 02DWDdHs|DY"D\Hu\Vaccination 3 APY A02021-06-23T12:12:06Y 100715311007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDhHrhDWD\HsPlacebo APlacebo ADVDhDWDY . . .Placebo Placebo DW#DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDdD\DWDXrBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBeBqCAHrhHrSHs|Hs .DWWHITE AC4591001C4591001 1007 10071531A ADVERSE EVENT 2 injection site pain Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-06-22T01:30B2021-06-24 B 1MedDRA v24.0NDW BDHs4DWB..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A D A Period 02DWDdHs|DY"D\Hu\Vaccination 3 APY A02021-07-20T14:45:06Y 100715311007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDhHrhDWD\HsPlacebo APlacebo ADVDhDWDY . . .Placebo Placebo DW#DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDdD\DWDXrBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBeBqCAHrhHrSHs|Hs .DWWHITE AC4591001C4591001 1007 10071531A0ADVERSE EVENT 3 muscle aches to legs Myalgia FkMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Myalgia of lower extremities F`F{Muscle pains F#Muscle disorders FMusculoskeletal and connective tissue disorders Fk2021-06-22T19:00B2021-06-24 B 1MedDRA v24.0NDW AEHs*DWA0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C# A Period 02DWDdHs|DY"D\Hu\Vaccination 4 A`Y A@2021-07-20T14:46:04Y 100715331007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDxHrxDWDdHsPlacebo APlacebo ADVDxDWDY . . .Placebo Placebo DW#DWYPhase 3A@NPOSDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDdDWDXlBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBdBrCAHrxHrbPHs~$Hs .DWWHITE AC4591001C4591001 1007 10071533AADVERSE EVENT 1 abdominal muscle pain Myalgia FkMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Muscle pain F"F{Muscle pains F#Muscle disorders FMusculoskeletal and connective tissue disorders Fk2021-01-06 B2021-01-07 B 1MedDRA v24.0NDW A..DWA..A DAYSN NNOT RELATEDOTHER Injury while exercising; no fall NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVDxHrxDWDHs~$Vaccination 2 A Y A 2021-01-19T02:33:05 100715471007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDtHrDWDHs Placebo APlacebo ADVDtDWDY . . .Placebo Placebo DW#DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDĤDDWDXfBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBjBqCAHrHrX<HsvbHs .DWWHITE AC4591001C4591001 1007 10071547AADVERSE EVENT 1 Injection site redness Injection site erythema FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site redness FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-05-21T06:00B2021-05-24T06:00B 1MedDRA v24.0NDW A DT`HswCDWAPDTHs{8A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C< A Period 02DWDĤHsvbDYDHusVaccination 3 APY A02021-06-10T16:58:48Y 100715471007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDtHrDWDHs Placebo APlacebo ADVDtDWDY . . .Placebo Placebo DW#DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDĤDDWDXfBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBjBqCAHrHrX<HsvbHs .DWWHITE AC4591001C4591001 1007 10071547A ADVERSE EVENT 2 Injection site pain Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-05-20T17:00B2021-05-22T20:00B 1MedDRA v24.0NDW ADHsvDWA0EHsyZ{A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A B A Period 02DWDĤHsvbDYDHusVaccination 3 APY A02021-06-10T16:58:59Y 100715591007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHrI`DWDHs-Placebo APlacebo ADVDDW D܌Y . . .Placebo Placebo DW/DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD0DDWDXmBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBcBqCpAHrI`Hr.HsHs- .DWWHITE AC4591001C4591001 1007 10071559AADVERSE EVENT 8 chills Chills FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills FFFeelings and sensations NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2021-06-17T23:00B2021-06-18 B 1MedDRA v24.0NDW AE7HspDWA ..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C* A Period 02DWD0HsDYDHu|apVaccination 4 A`Y A@2021-06-22T13:47:30Y 100715591007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHrI`DWDHs-Placebo APlacebo ADVDDW D܌Y . . .Placebo Placebo DW/DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD0DDWDXmBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBcBqCpAHrI`Hr.HsHs- .DWWHITE AC4591001C4591001 1007 10071559A ADVERSE EVENT 3 dizziness Dizziness FNERVOUS SYSTEM DISORDERS Dizziness F˅F˅Neurological signs and symptoms NEC FNeurological disorders NEC FNervous system disorders F2021-05-28 B2021-05-30 B 1MedDRA v24.0NDW A ..DWA@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWD0HsDYDHu|apVaccination 3 APY A02021-06-10T11:25:09Y 100715591007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHrI`DWDHs-Placebo APlacebo ADVDDW D܌Y . . .Placebo Placebo DW/DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD0DDWDXmBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBcBqCpAHrI`Hr.HsHs- .DWWHITE AC4591001C4591001 1007 10071559A0ADVERSE EVENT 2 fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-05-28 B2021-05-30 B 2MedDRA v24.0NDW A ..DWA@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWD0HsDYDHu|apVaccination 3 APY A02021-06-07T20:55:08Y 100715591007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHrI`DWDHs-Placebo APlacebo ADVDDW D܌Y . . .Placebo Placebo DW/DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD0DDWDXmBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBcBqCpAHrI`Hr.HsHs- .DWWHITE AC4591001C4591001 1007 10071559A@ADVERSE EVENT 1 headache Headache FNERVOUS SYSTEM DISORDERS Headache FFHeadaches NEC FHeadaches FNervous system disorders F2021-05-28 B2021-05-30 B 2MedDRA v24.0NDW A ..DWA@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWD0HsDYDHu|apVaccination 3 APY A02021-06-07T20:54:58Y 100715591007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHrI`DWDHs-Placebo APlacebo ADVDDW D܌Y . . .Placebo Placebo DW/DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD0DDWDXmBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBcBqCpAHrI`Hr.HsHs- .DWWHITE AC4591001C4591001 1007 10071559APADVERSE EVENT 4 headache Headache FNERVOUS SYSTEM DISORDERS Headache FFHeadaches NEC FHeadaches FNervous system disorders F2021-06-05 B2021-06-05 B 2MedDRA v24.0NDW A..DWA..ADAYSN NNOT RELATEDOTHER unknown etiology but headache is more than 7 days post COVID vaccine NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . A Period 02DWD0HsDYDHu|apVaccination 3 APY A02021-06-10T11:26:17Y 100715591007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHrI`DWDHs-Placebo APlacebo ADVDDW D܌Y . . .Placebo Placebo DW/DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD0DDWDXmBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBcBqCpAHrI`Hr.HsHs- .DWWHITE AC4591001C4591001 1007 10071559A`ADVERSE EVENT 6 headache Headache FNERVOUS SYSTEM DISORDERS Headache FFHeadaches NEC FHeadaches FNervous system disorders F2021-06-17T23:00B2021-06-18 B 1MedDRA v24.0NDW AE7HspDWA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C* A Period 02DWD0HsDYDHu|apVaccination 4 A`Y A@2021-06-22T13:47:05Y 100715591007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHrI`DWDHs-Placebo APlacebo ADVDDW D܌Y . . .Placebo Placebo DW/DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD0DDWDXmBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBcBqCpAHrI`Hr.HsHs- .DWWHITE AC4591001C4591001 1007 10071559ApADVERSE EVENT 5 injection site pain Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-06-17T23:00B2021-06-19 B 1MedDRA v24.0NDW AE7HspDWA0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C* A Period 02DWD0HsDYDHu|apVaccination 4 A`Y A@2021-06-22T13:44:12Y 100715591007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHrI`DWDHs-Placebo APlacebo ADVDDW D܌Y . . .Placebo Placebo DW/DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD0DDWDXmBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBcBqCpAHrI`Hr.HsHs- .DWWHITE AC4591001C4591001 1007 10071559AADVERSE EVENT 9 generalized muscle pain Myalgia FkMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Muscle pain F"F{Muscle pains F#Muscle disorders FMusculoskeletal and connective tissue disorders Fk2021-06-17T23:00B2021-06-18 B 2MedDRA v24.0NDW AE7HspDWA ..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C* A Period 02DWD0HsDYDHu|apVaccination 4 A`Y A@2021-06-22T13:47:41Y 100715591007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHrI`DWDHs-Placebo APlacebo ADVDDW D܌Y . . .Placebo Placebo DW/DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD0DDWDXmBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBcBqCpAHrI`Hr.HsHs- .DWWHITE AC4591001C4591001 1007 10071559AADVERSE EVENT 7 fever 101.9 Pyrexia FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F.F)Febrile disorders FBody temperature conditions FGeneral disorders and administration site conditions F2021-06-17T23:00B2021-06-18 B 2MedDRA v24.0NDW AE7HspDWA ..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C* A Period 02DWD0HsDYDHu|apVaccination 4 A`Y A@2021-06-22T13:47:18Y 100715621007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHrDWDHsPlacebo APlacebo ADVDDW D<Y . . .Placebo Placebo DW(DWYPhase 3A@NPOSDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBmBrCpAHrHrB<HsrIHs .DWWHITE AC4591001C4591001 1007 10071562AADVERSE EVENT 1 elevated body temp Body temperature increased FINVESTIGATIONS Body temperature increased FFPhysical examination procedures and organ system status FPhysical examination and organ system status topics FInvestigations F2021-05-18T08:00B2021-05-18 B 2MedDRA v24.0NDW A DpHsskDWA ..ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A CMP A Period 02DWDHsrIDYDHuo;XVaccination 3 APY A02021-05-24T15:48:36Y 100715621007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHrDWDHsPlacebo APlacebo ADVDDW D<Y . . .Placebo Placebo DW(DWYPhase 3A@NPOSDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBmBrCpAHrHrB<HsrIHs .DWWHITE AC4591001C4591001 1007 10071562A ADVERSE EVENT 4 elevated body temp 100.0 Body temperature increased FINVESTIGATIONS Body temperature increased FFPhysical examination procedures and organ system status FPhysical examination and organ system status topics FInvestigations F2021-06-07T23:59B2021-06-08T19:01B 2MedDRA v24.0NDW AE@HsDDWA EpHs'A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C+P A Period 02DWDHsrIDYDHuo;XVaccination 4 A`Y A@2021-06-14T18:40:30Y 100715621007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHrDWDHsPlacebo APlacebo ADVDDW D<Y . . .Placebo Placebo DW(DWYPhase 3A@NPOSDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBmBrCpAHrHrB<HsrIHs .DWWHITE AC4591001C4591001 1007 10071562A@ADVERSE EVENT 5 fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-06-08 B2021-06-08T19:00B 2MedDRA v24.0NDW A ..DWA EHsADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWDHsrIDYDHuo;XVaccination 4 A`Y A@2021-06-14T18:40:49Y 100715621007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHrDWDHsPlacebo APlacebo ADVDDW D<Y . . .Placebo Placebo DW(DWYPhase 3A@NPOSDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBmBrCpAHrHrB<HsrIHs .DWWHITE AC4591001C4591001 1007 10071562A0ADVERSE EVENT 2 fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-05-18T08:00B2021-05-18 B 1MedDRA v24.0NDW A DpHsskDWA ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CMP A Period 02DWDHsrIDYDHuo;XVaccination 3 APY A02021-05-24T14:47:38Y 100715621007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHrDWDHsPlacebo APlacebo ADVDDW D<Y . . .Placebo Placebo DW(DWYPhase 3A@NPOSDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBmBrCpAHrHrB<HsrIHs .DWWHITE AC4591001C4591001 1007 10071562A`ADVERSE EVENT 6 generalized muscle aches Myalgia FkMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Generalized muscle aches FiF{Muscle pains F#Muscle disorders FMusculoskeletal and connective tissue disorders Fk2021-06-08 B2021-06-08 B 1MedDRA v24.0NDW A ..DWA ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDHsrIDYDHuo;XVaccination 4 A`Y A@2021-06-14T18:41:06Y 100715621007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHrDWDHsPlacebo APlacebo ADVDDW D<Y . . .Placebo Placebo DW(DWYPhase 3A@NPOSDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBmBrCpAHrHrB<HsrIHs .DWWHITE AC4591001C4591001 1007 10071562APADVERSE EVENT 3 generalized muscle aches Myalgia FkMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Generalized muscle aches FiF{Muscle pains F#Muscle disorders FMusculoskeletal and connective tissue disorders Fk2021-05-18T08:00B2021-05-18 B 1MedDRA v24.0NDW A DpHsskDWA ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CMP A Period 02DWDHsrIDYDHuo;XVaccination 3 APY A02021-05-25T23:23:05Y 100715631007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHrlDWDHs Placebo APlacebo ADVDDW DY . . .Placebo Placebo DW(DWYPhase 3A@NPOSDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBmBrCpAHrlHr@HsrJHs  .DWWHITE AC4591001C4591001 1007 10071563AADVERSE EVENT 1 lightheadness Dizziness FNERVOUS SYSTEM DISORDERS Lightheadedness F,F˅Neurological signs and symptoms NEC FNeurological disorders NEC FNervous system disorders F2020-12-14T16:22A2020-12-14T18:30A 1MedDRA v24.0NDV AD(HrDVAEF0HrADAYSN NRELATED NOT APPLICABLE NYRECOVERED/RESOLVED N ARELATED AAGRADE 1A AYAPeriod 01DVDHrlDWDHsrJVaccination 1 AY A2021-03-18T16:28:02 100715681007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVD`Hr`DWD\HsPlacebo APlacebo ADVD`DW DY . . .Placebo Placebo DW)DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDD\DWDXrBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBB^BkC`AHr`HrĆ`HsHs .DWWHITE AC4591001C4591001 1007 10071568AADVERSE EVENT 1 injection site soreness Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2020-12-15T10:21A2020-12-15 A 1MedDRA v24.0NDV ADHrDVA..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A APYAPeriod 01DVD`Hr`DWDHsVaccination 1 AY A2021-01-06T02:26:33 100715681007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVD`Hr`DWD\HsPlacebo APlacebo ADVD`DW DY . . .Placebo Placebo DW)DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDD\DWDXrBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBB^BkC`AHr`HrĆ`HsHs .DWWHITE AC4591001C4591001 1007 10071568A ADVERSE EVENT 2 maculopapular rash Rash maculo-papular F5SKIN AND SUBCUTANEOUS TISSUE DISORDERS Maculopapular rash FF*lRashes, eruptions and exanthems NEC FcEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F52021-01-05T16:38B2021-02-02 B2 1MedDRA v24.0NDW ADHrčhDW)B..BDAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A BYAPeriod 01DVD`Hr`DWDHsVaccination 2 A Y A 2021-02-02T14:39:04 100715751007BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDՄHrDWDHrBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADVDՄDWDY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW*DW=YPhase 3A@NNEGDW> ....... . .NY.DW=DWBEBCPAHrHr.. .DWWHITE AC4591001C4591001 1007 10071575AADVERSE EVENT 1 Contusion of Left Arm Contusion FINJURY, POISONING AND PROCEDURAL COMPLICATIONS Contusion of upper limb FF\Skin injuries NEC FInjuries NEC FInjury, poisoning and procedural complications F2021-01-03 B2021-01-13 B 2MedDRA v24.0NDW B..DWB..ADAYSN NNOT RELATEDOTHER soccer injury NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVDՄHrDX{DHtVaccination 1 AY A2021-07-13T19:33:43 AEDECOD, AE outcome changed from EUA to sBLA 100715811007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDlHrulDWDHs3Placebo APlacebo ADVDlDWDlY . . .Placebo Placebo DW+DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDdDDWDXjBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBfBrC@AHrulHr$Hs{dHs3 .DWWHITE AC4591001C4591001 1007 10071581A ADVERSE EVENT 3 fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-06-15 B2021-06-16 B 2MedDRA v24.0NDW A ..DWA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWDdHs{dDYDHuxgVaccination 4 A`Y A@2021-06-17T14:18:04Y 100715811007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDlHrulDWDHs3Placebo APlacebo ADVDlDWDlY . . .Placebo Placebo DW+DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDdDDWDXjBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBfBrC@AHrulHr$Hs{dHs3 .DWWHITE AC4591001C4591001 1007 10071581A0ADVERSE EVENT 2 injection site pain Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-06-15 B2021-06-16 B 1MedDRA v24.0NDW A ..DWA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDdHs{dDYDHuxgVaccination 4 A`Y A@2021-06-17T14:17:27Y 100715811007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDlHrulDWDHs3Placebo APlacebo ADVDlDWDlY . . .Placebo Placebo DW+DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDdDDWDXjBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBfBrC@AHrulHr$Hs{dHs3 .DWWHITE AC4591001C4591001 1007 10071581A@ADVERSE EVENT 4 generalized muscle aches Myalgia FkMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Generalized muscle aches FiF{Muscle pains F#Muscle disorders FMusculoskeletal and connective tissue disorders Fk2021-06-15 B2021-06-16 B 2MedDRA v24.0NDW A ..DWA0..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWDdHs{dDYDHuxgVaccination 4 A`Y A@2021-06-17T15:15:48Y 100715831007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHrDWDxHsxPlacebo APlacebo ADVDDWDLY . . .Placebo Placebo DW+DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD(DxDWDXeBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBlBrC@AHrHr&Hss(Hsx .DWWHITE AC4591001C4591001 1007 10071583AADVERSE EVENT 2 headache Headache FNERVOUS SYSTEM DISORDERS Headache FFHeadaches NEC FHeadaches FNervous system disorders F2021-06-10 B2021-06-10 B 1MedDRA v24.0NDW A ..DWA ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWD(Hss(DYDxHuqVaccination 4 A`Y A@2021-06-14T16:47:18Y 100715831007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHrDWDxHsxPlacebo APlacebo ADVDDWDLY . . .Placebo Placebo DW+DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD(DxDWDXeBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBlBrC@AHrHr&Hss(Hsx .DWWHITE AC4591001C4591001 1007 10071583A ADVERSE EVENT 1 injection site pain Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-06-09T21:00B2021-06-11 B 2MedDRA v24.0NDW AEuHs#PDWA0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C A Period 02DWD(Hss(DYDxHuqVaccination 4 A`Y A@2021-06-14T16:47:07Y 100715841007BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADVDHr}DWDHr*PBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADVDDWDY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW+DWYPhase 3A@NNEGDW ....... . .NY.DWDWBBpC@AHr}Hr*P.. .DWWHITE AC4591001C4591001 1007 10071584AADVERSE EVENT 1 Soreness at injection site Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-01-07T16:37B2021-01-10T07:00B 1MedDRA v24.0NDW ADHr0,DWA@DbHrʝA@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A BYAPeriod 01DVDHr}DX|DHt]Vaccination 2 A Y A 2021-02-04T20:54:22 100715851007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDTHr~TDWDHslPlacebo APlacebo ADVDTDWDY . . .Placebo Placebo DW+DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDXdBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBmBrC@AHr~THr'Hsr@Hsl .DWWHITE AC4591001C4591001 1007 10071585AADVERSE EVENT 2 hives; trunk, abdomen, back Urticaria F5SKIN AND SUBCUTANEOUS TISSUE DISORDERS Hives FeFMUrticarias FMAngioedema and urticaria FSkin and subcutaneous tissue disorders F52021-01-16 B2021-02-02 B0 2MedDRA v24.0NDW A..DW)B..BDAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . APeriod 01DVDTHr~TDWDտHsr?Vaccination 2 A Y A 2021-04-01T15:23:14 AE outcome changed from EUA to sBLA 100715861007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHrDWD HsPlacebo APlacebo ADVDDWD0Y . . .Placebo Placebo DW+DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDD DWDXrBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBB^BrC@AHrHr$HsHs .DWWHITE AC4591001C4591001 1007 10071586AADVERSE EVENT 1 Injection site pain Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-06-02T11:00B2021-06-04T11:00B 1MedDRA v24.0NDW A DHs\0DWA@DHskA0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C]` A Period 02DWDHsDY"D Hu Vaccination 3 APY A02021-06-22T17:05:53Y 100715931007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDHr͜DWDHr͜Placebo APlacebo ADWD..Y . . .Placebo DW2DW2YPhase 3A@NNEGDW3 ....... . .NN.DW2DW3B.AB/AHr͜Hr͜.. .DWWHITE AC4591001C4591001 1007 10071593AADVERSE EVENT 1 left Ankle sprain Ligament sprain FINJURY, POISONING AND PROCEDURAL COMPLICATIONS Ankle sprain FuFMuscle, tendon and ligament injuries FInjuries NEC FInjury, poisoning and procedural complications F2020-12-30T17:00A02021-01-15 B 2MedDRA v24.0NDW A0DHrDWB..BDAYSN NNOT RELATEDOTHER injury NOT APPLICABLE NYRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A C0 APeriod 01DWDHr͜DXrDHtVaccination 1 AY A2021-02-15T02:09:46 100715951007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDИHrDWDHs|Placebo APlacebo ADWDИDWDY . . .Placebo Placebo DW8DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD$DDWDXfBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBlBrBAHrHrֱPHss$Hs| .DWWHITE AC4591001C4591001 1007 10071595AADVERSE EVENT 1 Vaso-vagal response Presyncope FNERVOUS SYSTEM DISORDERS Vasovagal reaction FNF%Neurological signs and symptoms NEC FNeurological disorders NEC FNervous system disorders F2021-03-30T13:15B]2021-03-30T13:25B] 1MedDRA v24.0NDWa BGDTHs3DWaBGDHs3gADAYSN NNOT RELATEDOTHER Phlebotomy NOT APPLICABLE NYRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A E APeriod 01DWDИHrDWD#Hss#Follow Up 1 A0Y A 2021-03-30T21:09:16Y 100715961007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDHrDWDHs5tPlacebo APlacebo ADWDDWDpY . . .Placebo Placebo DW8DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDXjBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBfBrBAHrHrDpHs{Hs5t .DWWHITE AC4591001C4591001 1007 10071596AADVERSE EVENT 2 fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-05-24T20:30B2021-05-28 B 2MedDRA v24.0NDW AEHs|HDWAP..APDAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C0 A Period 02DWDHs{DYDHuxhVaccination 3 APY A02021-06-21T11:17:50Y 100715961007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDHrDWDHs5tPlacebo APlacebo ADWDDWDpY . . .Placebo Placebo DW8DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDXjBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBfBrBAHrHrDpHs{Hs5t .DWWHITE AC4591001C4591001 1007 10071596A ADVERSE EVENT 1 headache Headache FNERVOUS SYSTEM DISORDERS Headache FFHeadaches NEC FHeadaches FNervous system disorders F2021-05-24T20:30B2021-05-28 B 2MedDRA v24.0NDW AEHs|HDWAP..APDAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C0 A Period 02DWDHs{DYDHuxhVaccination 3 APY A02021-06-21T11:17:24Y 100715961007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDHrDWDHs5tPlacebo APlacebo ADWDDWDpY . . .Placebo Placebo DW8DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDXjBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBfBrBAHrHrDpHs{Hs5t .DWWHITE AC4591001C4591001 1007 10071596A0ADVERSE EVENT 4 muscle aches Myalgia FkMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Muscle ache FF{Muscle pains F#Muscle disorders FMusculoskeletal and connective tissue disorders Fk2021-05-25 B2021-05-28 B 2MedDRA v24.0NDW A ..DWAP..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWDHs{DYDHuxhVaccination 3 APY A02021-06-21T11:18:33Y 100715961007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDHrDWDHs5tPlacebo APlacebo ADWDDWDpY . . .Placebo Placebo DW8DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDXjBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBfBrBAHrHrDpHs{Hs5t .DWWHITE AC4591001C4591001 1007 10071596A@ADVERSE EVENT 3 fever Pyrexia FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F.F)Febrile disorders FBody temperature conditions FGeneral disorders and administration site conditions F2021-05-25 B2021-05-28 B 1MedDRA v24.0NDW A ..DWAP..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDHs{DYDHuxhVaccination 3 APY A02021-06-21T11:18:12Y 100716131007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWD HrM DWDHslPlacebo APlacebo ADWD DWDϨY . . .Placebo Placebo DW8DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDXkBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBeBrBAHrM Hr(Hs|4Hsl .DWWHITE AC4591001C4591001 1007 10071613AADVERSE EVENT 1 Pain at injection site Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2020-12-29T17:00A2020-12-29 A 1MedDRA v24.0NDW ADHrXDWA..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A B/ APeriod 01DWD HrM DWDHs|3Vaccination 1 AY A2021-01-29T14:26:27 100716141007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWD`HrS`DWDHs|Placebo APlacebo ADWD`DWDY . . .Placebo Placebo DW>DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD,DDWDXxBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBjBrBAHrS`HrHsvq,Hs| .DWWHITE AC4591001C4591001 1007 10071614AADVERSE EVENT 5 chills Chills FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills FFFeelings and sensations NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2021-06-29 B2021-06-29 B 1MedDRA v24.0NDW A ..DWA ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWD,Hsvq,DY(DHuVaccination 4 A`Y A@2021-07-13T21:38:29Y 100716141007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWD`HrS`DWDHs|Placebo APlacebo ADWD`DWDY . . .Placebo Placebo DW>DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD,DDWDXxBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBjBrBAHrS`HrHsvq,Hs| .DWWHITE AC4591001C4591001 1007 10071614A ADVERSE EVENT 3 fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-06-29T06:30B2021-07-01 B 1MedDRA v24.0NDW A D[hHshDWA@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C=P A Period 02DWD,Hsvq,DY(DHuVaccination 4 A`Y A@2021-07-13T21:38:04Y 100716141007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWD`HrS`DWDHs|Placebo APlacebo ADWD`DWDY . . .Placebo Placebo DW>DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD,DDWDXxBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBjBrBAHrS`HrHsvq,Hs| .DWWHITE AC4591001C4591001 1007 10071614A0ADVERSE EVENT 4 headache Headache FNERVOUS SYSTEM DISORDERS Headache FFHeadaches NEC FHeadaches FNervous system disorders F2021-06-29T06:30B2021-06-29T14:40B 1MedDRA v24.0NDW A D[hHshDWA D{Hs({ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C=P A Period 02DWD,Hsvq,DY(DHuVaccination 4 A`Y A@2021-07-13T21:38:16Y 100716141007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWD`HrS`DWDHs|Placebo APlacebo ADWD`DWDY . . .Placebo Placebo DW>DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD,DDWDXxBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBjBrBAHrS`HrHsvq,Hs| .DWWHITE AC4591001C4591001 1007 10071614A@ADVERSE EVENT 1 injection site soreness Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-06-28T18:00B2021-07-01 B 1MedDRA v24.0NDW AD HsDWA@..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A B A Period 02DWD,Hsvq,DY(DHuVaccination 4 A`Y A@2021-07-13T21:37:41Y 100716141007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWD`HrS`DWDHs|Placebo APlacebo ADWD`DWDY . . .Placebo Placebo DW>DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD,DDWDXxBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBjBrBAHrS`HrHsvq,Hs| .DWWHITE AC4591001C4591001 1007 10071614APADVERSE EVENT 2 fever 101.9 Pyrexia FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F.F)Febrile disorders FBody temperature conditions FGeneral disorders and administration site conditions F2021-06-29T06:30B2021-07-01 B 2MedDRA v24.0NDW A D[hHshDWA@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C=P A Period 02DWD,Hsvq,DY(DHuVaccination 4 A`Y A@2021-07-13T21:37:53Y 100716151007BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDHrLDWDHrxBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADWDDWDY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW>DWYPhase 3A@NNEGDW ....... . .NY.DWDWBBrBAHrLHrx.. .DWWHITE AC4591001C4591001 1007 10071615AADVERSE EVENT 1 left axillary lymph node swelling Lymphadenopathy FQBLOOD AND LYMPHATIC SYSTEM DISORDERS Axillary lymph nodes enlarged FFLymphatic system disorders NEC FSpleen, lymphatic and reticuloendothelial system disorders F9)Blood and lymphatic system disorders FQ2021-01-20 B2021-01-23 B 1MedDRA v24.0NDW A ..DWAP..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . APeriod 01DWDHrLDXDHt4Vaccination 2 A Y A 2021-03-10T21:43:35 100716171007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDXHr[XDWDHsi^Placebo APlacebo ADWDXDWDhY . . .Placebo Placebo DW8DWiYPhase 3A@NNEGDWj BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWuDWDhDDWDXGBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWiDWBdBBBAHr[XHrLhHsMGHsi^ .DWtWHITE AC4591001C4591001 1007 10071617AADVERSE EVENT 1 worsening of Anxiety Anxiety F'PSYCHIATRIC DISORDERS Anxiety aggravated FSSFAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'2021-02-15 B1 .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDW6 B....... N NNOT RELATEDOTHER psychosocial stress NOT APPLICABLE YNNOT RECOVERED/NOT RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DWDXHr[XDWuDgHsMGVaccination 2 A Y A 2021-05-13T17:32:16Y 100716171007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDXHr[XDWDHsi^Placebo APlacebo ADWDXDWDhY . . .Placebo Placebo DW8DWiYPhase 3A@NNEGDWj BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWuDWDhDDWDXGBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWiDWBdBBBAHr[XHrLhHsMGHsi^ .DWtWHITE AC4591001C4591001 1007 10071617A ADVERSE EVENT 2 worsening of Obsessive Compulsive Disorder Obsessive-compulsive disorder F'PSYCHIATRIC DISORDERS Obsessive-compulsive disorder F JF JObsessive-compulsive disorders and symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'2021-02-15 B1 .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDW6 B....... N NNOT RELATEDOTHER psychosocial stress NOT APPLICABLE YNNOT RECOVERED/NOT RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DWDXHr[XDWuDgHsMGVaccination 2 A Y A 2021-05-13T17:33:03Y 100716181007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDHr[DWD0Hr֜Placebo APlacebo ADWDDWD0Y . . .Placebo Placebo DW?DWYPhase 3A@NNEGDW ....... . .NN.DWDWBBrBAHr[Hr֜.. .DWWHITE AC4591001C4591001 1007 10071618AADVERSE EVENT 1 Pain at injection nsite Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2020-12-29T17:14A2020-12-30 A 1MedDRA v24.0NDW ADXHr[XDWA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A AYAPeriod 01DWDHr[DXD0Ht0Vaccination 1 AY A2021-01-29T14:26:09 100716201007BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADWDHrM8DWDHrRBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADWDDWDY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW9DWYPhase 3A@NNEGDW ....... . .NY.DWDWBBmBAHrM8HrR.. .DWWHITE AC4591001C4591001 1007 10071620AADVERSE EVENT 2 Abdominal pain Abdominal pain FܛGASTROINTESTINAL DISORDERS Abdominal pain FFGastrointestinal and abdominal pains (excl oral and throat) F܆Gastrointestinal signs and symptoms FGastrointestinal disorders Fܛ2021-01-21 B2021-02-09 B* 2MedDRA v24.0NDW A ..DW0B..BDAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . APeriod 01DWDHrM8DXDHtVaccination 2 A Y A 2021-02-15T02:05:35 100716201007BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADWDHrM8DWDHrRBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADWDDWDY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW9DWYPhase 3A@NNEGDW ....... . .NY.DWDWBBmBAHrM8HrR.. .DWWHITE AC4591001C4591001 1007 10071620A0ADVERSE EVENT 9 worsening anxiety Anxiety F'PSYCHIATRIC DISORDERS Anxiety aggravated FSSFAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'2021-01-30 B .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDW& A....... N NNOT RELATEDOTHER pain NOT APPLICABLE YYNOT RECOVERED/NOT RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DWDHrM8DXDHtVaccination 2 A Y A 2021-04-06T11:12:33Y 100716201007BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADWDHrM8DWDHrRBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADWDDWDY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW9DWYPhase 3A@NNEGDW ....... . .NY.DWDWBBmBAHrM8HrR.. .DWWHITE AC4591001C4591001 1007 10071620APADVERSE EVENT 11constipation Constipation FܛGASTROINTESTINAL DISORDERS Constipation FFGastrointestinal atonic and hypomotility disorders NEC F܍Gastrointestinal motility and defaecation conditions FܹGastrointestinal disorders Fܛ2021-03-13 BJ .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDWP B5....... N NNOT RELATEDOTHER no organic cause identified NOT APPLICABLE YNRECOVERING/RESOLVING N A0NOT RELATEDA0A GRADE 2A . APeriod 01DWDHrM8DXDHtFollow Up 1 A0Y A 2021-06-14T15:08:12Y 100716201007BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADWDHrM8DWDHrRBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADWDDWDY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW9DWYPhase 3A@NNEGDW ....... . .NY.DWDWBBmBAHrM8HrR.. .DWWHITE AC4591001C4591001 1007 10071620ApADVERSE EVENT 6 contact dermatitis bilateral arms Dermatitis contact F5SKIN AND SUBCUTANEOUS TISSUE DISORDERS Contact dermatitis FFDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F52021-02-12 B-2021-04 . 1MedDRA v24.0NDW3 B....... N NNOT RELATEDOTHER suspected reaction to tape NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DWDHrM8DXDHtVaccination 2 A Y A 2021-06-08T19:34:46 AE outcome changed from EUA to sBLA 100716201007BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADWDHrM8DWDHrRBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADWDDWDY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW9DWYPhase 3A@NNEGDW ....... . .NY.DWDWBBmBAHrM8HrR.. .DWWHITE AC4591001C4591001 1007 10071620AADVERSE EVENT 4 Gastritis Gastritis FܛGASTROINTESTINAL DISORDERS Gastritis F=F=Gastritis (excl infective) F>Gastrointestinal inflammatory conditions FܱGastrointestinal disorders Fܛ2021-01-30 B 2021-04 . 2MedDRA v24.0NDW& A....... N NNOT RELATEDCONCOMITANT DRUG TREATMENT NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DWDHrM8DXDHtVaccination 2 A Y A 2021-06-08T19:33:07 AE outcome changed from EUA to sBLA 100716201007BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADWDHrM8DWDHrRBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADWDDWDY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW9DWYPhase 3A@NNEGDW ....... . .NY.DWDWBBmBAHrM8HrR.. .DWWHITE AC4591001C4591001 1007 10071620AADVERSE EVENT 1 Vulvar boil Vulval abscess FINFECTIONS AND INFESTATIONS Vulval boil FPFPFemale reproductive tract infections F-:Infections - pathogen unspecified FInfections and infestations F2021-01-24 B2021-01-26 B 1MedDRA v24.0NDW AP..DW"Ap..A0DAYSN NNOT RELATEDOTHER Presumed staph infection NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DWDHrM8DXDHtVaccination 2 A Y A 2021-02-09T17:31:51 100716231007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDtHrTDWDHslPlacebo APlacebo ADWDtDWDTY . . .Placebo Placebo DW?DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDXrBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBB^BrBAHrTHr٢HsLHsl .DWWHITE AC4591001C4591001 1007 10071623AADVERSE EVENT 3 Fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-06-01T16:30B2021-06-02T08:30B 1MedDRA v24.0NDW ADHsXDWA DwHs9CA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A B0 A Period 02DWDHsLDY"DHuVaccination 3 APY A02021-06-22T21:47:21Y 100716231007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDtHrTDWDHslPlacebo APlacebo ADWDtDWDTY . . .Placebo Placebo DW?DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDXrBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBB^BrBAHrTHr٢HsLHsl .DWWHITE AC4591001C4591001 1007 10071623A ADVERSE EVENT 4 Injection site pain Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-06-01T17:00B2021-06-03T08:30B 1MedDRA v24.0NDW ADHs_DWA0DwHsA0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A BN A Period 02DWDHsLDY"DHuVaccination 3 APY A02021-06-22T21:47:32Y 100716231007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDtHrTDWDHslPlacebo APlacebo ADWDtDWDTY . . .Placebo Placebo DW?DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDXrBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBB^BrBAHrTHr٢HsLHsl .DWWHITE AC4591001C4591001 1007 10071623A0ADVERSE EVENT 2 right wrist tendonitis Tendonitis FkMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Tendonitis F?wF?wTendon disorders F?bTendon, ligament and cartilage disorders F?eMusculoskeletal and connective tissue disorders Fk2021-02-15 B02021-08-09 B 2MedDRA v24.0NDW6 B..DWB..BDAYSN NNOT RELATEDOTHER potential lacrosse injury NOT APPLICABLE YNRECOVERED/RESOLVED WITH SEQUELAEN A0NOT RELATEDA0A GRADE 2A . APeriod 01DWDtHrTDWDHsLVaccination 2 A Y A 2021-08-18T17:01:35Y 100716231007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDtHrTDWDHslPlacebo APlacebo ADWDtDWDTY . . .Placebo Placebo DW?DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDXrBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBB^BrBAHrTHr٢HsLHsl .DWWHITE AC4591001C4591001 1007 10071623A@ADVERSE EVENT 1 teeth pain Toothache FܛGASTROINTESTINAL DISORDERS Tooth pain FFBDental pain and sensation disorders FBDental and gingival conditions FBrGastrointestinal disorders Fܛ2021-01-27T12:00B2021-01-28T06:45B 2MedDRA v24.0NDW# ApDHrM@DW$AD_'HrU'A DAYSN NNOT RELATEDCONCOMITANT NON-DRUG TREATMENT NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A D APeriod 01DWDtHrTDWDHsLVaccination 2 A Y A 2021-02-27T15:46:29 100716241007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDHre DWD4Hs$4Placebo APlacebo ADWDDW"DdY . . .Placebo Placebo DW>DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDD4DWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBkBqBAHre HrdHsuXHs$4 .DWWHITE AC4591001C4591001 1007 10071624AADVERSE EVENT 1 left Arm Pain Pain in extremity FkMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Painful L arm FiFMusculoskeletal and connective tissue pain and discomfort FMusculoskeletal and connective tissue disorders NEC FiMusculoskeletal and connective tissue disorders Fk2021-05-20T07:00B2021-05-21T13:00B 1MedDRA v24.0NDW A DbpHsvpDWA0D HswA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C= A Period 02DWDHsuXDYD4HuoWVaccination 3 APY A02021-06-08T14:53:53Y 100716251007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDHrg<DWDHs"Placebo APlacebo ADWDDW"DtY . . .Placebo Placebo DW>DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD$DDWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBkBqBAHrg<HrtHsuHs" .DWWHITE AC4591001C4591001 1007 10071625AADVERSE EVENT 2 Injection Site Arm Pain Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-05-20T07:00B2021-05-21T13:00B 1MedDRA v24.0NDW A DbpHsvpDWA0D HswA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C= A Period 02DWD$HsuDYDHuoVLVaccination 3 APY A02021-06-08T15:15:27Y 100716251007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDHrg<DWDHs"Placebo APlacebo ADWDDW"DtY . . .Placebo Placebo DW>DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD$DDWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBkBqBAHrg<HrtHsuHs" .DWWHITE AC4591001C4591001 1007 10071625A ADVERSE EVENT 1 fever Pyrexia FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F.F)Febrile disorders FBody temperature conditions FGeneral disorders and administration site conditions F2021-05-20T07:00B2021-05-20T08:00B 1MedDRA v24.0NDW A DbpHsvpDWA DpHsvADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C= A Period 02DWD$HsuDYDHuoVLVaccination 3 APY A02021-06-08T15:15:02Y 100716321007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADWDHr DWDHs9Placebo APlacebo ADWDDWDlY . . .Placebo Placebo DW?DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDPDDWDXdBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBlBrBAHr Hr]HssPHs9 .DWWHITE AC4591001C4591001 1007 10071632AADVERSE EVENT 6 Headache Headache FNERVOUS SYSTEM DISORDERS Headache FFHeadaches NEC FHeadaches FNervous system disorders F2021-05-19 B2021-05-19 B 1MedDRA v24.0NDW A ..DWA ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDPHssPDYDHuplVaccination 3 APY A02021-06-08T18:23:53Y 100716321007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADWDHr DWDHs9Placebo APlacebo ADWDDWDlY . . .Placebo Placebo DW?DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDPDDWDXdBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBlBrBAHr Hr]HssPHs9 .DWWHITE AC4591001C4591001 1007 10071632AADVERSE EVENT 1 headache Headache FNERVOUS SYSTEM DISORDERS Headache FFHeadaches NEC FHeadaches FNervous system disorders F2020-12-30T16:55A2020-12-30T16:56A 1MedDRA v24.0NDW ADHrdDWAD[HrADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A AYAPeriod 01DWDHr DWDOHssOVaccination 1 AY A2021-01-05T22:27:08 100716321007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADWDHr DWDHs9Placebo APlacebo ADWDDWDlY . . .Placebo Placebo DW?DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDPDDWDXdBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBlBrBAHr Hr]HssPHs9 .DWWHITE AC4591001C4591001 1007 10071632AADVERSE EVENT 2 tenderness at injection site Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site tenderness FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2020-12-30T16:47A2020-12-31 A 1MedDRA v24.0NDW ADHrDWA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A A YAPeriod 01DWDHr DWDOHssOVaccination 1 AY A2021-01-27T11:40:32 100716321007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADWDHr DWDHs9Placebo APlacebo ADWDDWDlY . . .Placebo Placebo DW?DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDPDDWDXdBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBlBrBAHr Hr]HssPHs9 .DWWHITE AC4591001C4591001 1007 10071632A0ADVERSE EVENT 10nausea Nausea FܛGASTROINTESTINAL DISORDERS Nausea F F Nausea and vomiting symptoms FGastrointestinal signs and symptoms FGastrointestinal disorders Fܛ2021-06-09 B2021-06-09 B 1MedDRA v24.0NDW A ..DWA ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDPHssPDYDHuplVaccination 4 A`Y A@2021-06-14T16:47:41Y 100716321007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADWDHr DWDHs9Placebo APlacebo ADWDDWDlY . . .Placebo Placebo DW?DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDPDDWDXdBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBlBrBAHr Hr]HssPHs9 .DWWHITE AC4591001C4591001 1007 10071632A ADVERSE EVENT 8 Nausea Nausea FܛGASTROINTESTINAL DISORDERS Nausea F F Nausea and vomiting symptoms FGastrointestinal signs and symptoms FGastrointestinal disorders Fܛ2021-05-19 B2021-05-19 B 1MedDRA v24.0NDW A ..DWA ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDPHssPDYDHuplVaccination 3 APY A02021-06-08T18:24:28Y 100716321007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADWDHr DWDHs9Placebo APlacebo ADWDDWDlY . . .Placebo Placebo DW?DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDPDDWDXdBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBlBrBAHr Hr]HssPHs9 .DWWHITE AC4591001C4591001 1007 10071632A@ADVERSE EVENT 7 Body ache Pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Ache F(FPain and discomfort NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2021-05-19 B2021-05-19 B 1MedDRA v24.0NDW A ..DWA ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDPHssPDYDHuplVaccination 3 APY A02021-06-08T18:24:09Y 100716321007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADWDHr DWDHs9Placebo APlacebo ADWDDWDlY . . .Placebo Placebo DW?DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDPDDWDXdBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBlBrBAHr Hr]HssPHs9 .DWWHITE AC4591001C4591001 1007 10071632APADVERSE EVENT 9 generalized body aches Pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalised aching FFPain and discomfort NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2021-06-09 B2021-06-09 B 2MedDRA v24.0NDW A ..DWA ..ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWDPHssPDYDHuplVaccination 4 A`Y A@2021-06-14T16:47:30Y 100716321007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADWDHr DWDHs9Placebo APlacebo ADWDDWDlY . . .Placebo Placebo DW?DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDPDDWDXdBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBlBrBAHr Hr]HssPHs9 .DWWHITE AC4591001C4591001 1007 10071632A`ADVERSE EVENT 5 Arm pain Pain in extremity FkMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Pain in arm F FMusculoskeletal and connective tissue pain and discomfort FMusculoskeletal and connective tissue disorders NEC FiMusculoskeletal and connective tissue disorders Fk2021-05-19 B2021-05-22 B 1MedDRA v24.0NDW A ..DWAP..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDPHssPDYDHuplVaccination 3 APY A02021-06-08T18:23:09Y 100716321007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADWDHr DWDHs9Placebo APlacebo ADWDDWDlY . . .Placebo Placebo DW?DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDPDDWDXdBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBlBrBAHr Hr]HssPHs9 .DWWHITE AC4591001C4591001 1007 10071632ApADVERSE EVENT 4 rash to chest and back Rash F5SKIN AND SUBCUTANEOUS TISSUE DISORDERS Rash trunk F`F*TRashes, eruptions and exanthems NEC FcEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F52021-01-22T13:00B2021-01-26 B 2MedDRA v24.0NDW A DHrDW"A`..APDAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C_p APeriod 01DWDHr DWDOHssOVaccination 2 A Y A 2021-02-24T22:37:31 100716321007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADWDHr DWDHs9Placebo APlacebo ADWDDWDlY . . .Placebo Placebo DW?DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDPDDWDXdBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBlBrBAHr Hr]HssPHs9 .DWWHITE AC4591001C4591001 1007 10071632AADVERSE EVENT 3 pain at blood draw site Vessel puncture site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Venipuncture site pain FU7FAdministration site reactions NEC FuAdministration site reactions FGeneral disorders and administration site conditions F2020-12-30T16:47A2020-12-31 A 1MedDRA v24.0NDW ADHrDWA ..A DAYSN NNOT RELATEDOTHER venipuncture NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A A YAPeriod 01DWDHr DWDOHssOVaccination 1 AY A2021-01-27T11:39:46 100716341007BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADW DHrDW!DHrޜlBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADW DDW!DY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW=DWYPhase 3A@NNEGDW ....... . .NY.DWDWBBrBAHrHrޜl.. .DWWHITE AC4591001C4591001 1007 10071634AADVERSE EVENT 2 vasovagal response Presyncope FNERVOUS SYSTEM DISORDERS Vasovagal reaction FNF%Neurological signs and symptoms NEC FNeurological disorders NEC FNervous system disorders F2021-02-22T15:39B22021-02-22 B2 1MedDRA v24.0NDW= BDHsǔDW=B..ADAYSN NNOT RELATEDOTHER Most likely due to anxiety/fear of receiving an injection NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A D APeriod 01DW DHrDXDHtVaccination 2 A Y A 2021-03-10T13:14:53 100716341007BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADW DHrDW!DHrޜlBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADW DDW!DY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW=DWYPhase 3A@NNEGDW ....... . .NY.DWDWBBrBAHrHrޜl.. .DWWHITE AC4591001C4591001 1007 10071634A ADVERSE EVENT 1 Rhinorrhea Rhinorrhoea F-RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS Rhinorrhea F/<F/=Upper respiratory tract signs and symptoms FKiRespiratory tract signs and symptoms F}Respiratory, thoracic and mediastinal disorders F-2021-02-18 B. .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDW9 B....... N NNOT RELATEDOTHER viral infection NOT APPLICABLE NNRECOVERING/RESOLVING N A0NOT RELATEDA0AGRADE 1A . APeriod 01DW DHrDXDHtVaccination 2 A Y A 2021-02-27T15:50:57 100716401007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADW DHrDWDhHsPlacebo APlacebo ADW DDW!DY . . .Placebo Placebo DWEDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDhDWDXrBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBB\BqBAHrHr@HsHs .DWWHITE AC4591001C4591001 1007 10071640AADVERSE EVENT 4 Chills Chills FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills FFFeelings and sensations NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2021-06-22T21:00B2021-06-23T20:00B 1MedDRA v24.0NDW AEuHsFDWA EHs{A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C` A Period 02DWDHsDY"DhHuhVaccination 4 A`Y A@2021-06-29T14:40:41Y 100716401007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADW DHrDWDhHsPlacebo APlacebo ADW DDW!DY . . .Placebo Placebo DWEDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDhDWDXrBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBB\BqBAHrHr@HsHs .DWWHITE AC4591001C4591001 1007 10071640A ADVERSE EVENT 3 headache Headache FNERVOUS SYSTEM DISORDERS Headache FFHeadaches NEC FHeadaches FNervous system disorders F2021-06-22T21:00B2021-06-23T20:00B 2MedDRA v24.0NDW AEuHsFDWA EHs{A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C` A Period 02DWDHsDY"DhHuhVaccination 4 A`Y A@2021-06-29T14:40:30Y 100716401007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADW DHrDWDhHsPlacebo APlacebo ADW DDW!DY . . .Placebo Placebo DWEDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDhDWDXrBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBB\BqBAHrHr@HsHs .DWWHITE AC4591001C4591001 1007 10071640A0ADVERSE EVENT 1 Injection site pain Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-06-03T19:00B2021-06-04T19:00B 1MedDRA v24.0NDW AEHs0DWA EHsoA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C@ A Period 02DWDHsDY"DhHuhVaccination 3 APY A02021-06-22T21:47:43Y 100716401007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADW DHrDWDhHsPlacebo APlacebo ADW DDW!DY . . .Placebo Placebo DWEDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDhDWDXrBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBB\BqBAHrHr@HsHs .DWWHITE AC4591001C4591001 1007 10071640A@ADVERSE EVENT 2 fever Pyrexia FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F.F)Febrile disorders FBody temperature conditions FGeneral disorders and administration site conditions F2021-06-22T21:00B2021-06-23T20:00B 1MedDRA v24.0NDW AEuHsFDWA EHs{A DAYSN NRELATED NOT APPLICABLE YYRECOVERED/RESOLVED N ARELATED AAGRADE 1A C` A Period 02DWDHsDY"DhHuhVaccination 4 A`Y A@2021-06-29T14:40:18Y 100716421007BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADW D,Hr%,DWDθHs8BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADW D,..Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDWYPhase 3A@NNEGDWBNT162b2 (30 (*ESC*){unicode 03BC}g) DW...... . .NN.DWDWBBqBAHr%,Hs8.. .DXXWHITE AC4591001C4591001 1007 10071642AADVERSE EVENT 4 dizziness Dizziness FNERVOUS SYSTEM DISORDERS Dizziness F˅F˅Neurological signs and symptoms NEC FNeurological disorders NEC FNervous system disorders F2021-05-28 B2021-05-29 B 1MedDRA v24.0NDW A ..DWA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . APeriod 01DW D,Hr%,DYDθHu`ڸAfter unblinding and before Vaccination 3A@ A 2021-06-07T14:29:53Y 100716421007BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADW D,Hr%,DWDθHs8BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADW D,..Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDWYPhase 3A@NNEGDWBNT162b2 (30 (*ESC*){unicode 03BC}g) DW...... . .NN.DWDWBBqBAHr%,Hs8.. .DXXWHITE AC4591001C4591001 1007 10071642A ADVERSE EVENT 3 fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-05-28 B2021-05-29 B 2MedDRA v24.0NDW A ..DWA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . APeriod 01DW D,Hr%,DYDθHu`ڸAfter unblinding and before Vaccination 3A@ A 2021-06-07T14:29:25Y 100716421007BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADW D,Hr%,DWDθHs8BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADW D,..Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDWYPhase 3A@NNEGDWBNT162b2 (30 (*ESC*){unicode 03BC}g) DW...... . .NN.DWDWBBqBAHr%,Hs8.. .DXXWHITE AC4591001C4591001 1007 10071642A0ADVERSE EVENT 5 headache Headache FNERVOUS SYSTEM DISORDERS Headache FFHeadaches NEC FHeadaches FNervous system disorders F2021-05-28 B2021-05-29 B 1MedDRA v24.0NDW A ..DWA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . APeriod 01DW D,Hr%,DYDθHu`ڸAfter unblinding and before Vaccination 3A@ A 2021-06-07T14:30:18Y 100716421007BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADW D,Hr%,DWDθHs8BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADW D,..Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDWYPhase 3A@NNEGDWBNT162b2 (30 (*ESC*){unicode 03BC}g) DW...... . .NN.DWDWBBqBAHr%,Hs8.. .DXXWHITE AC4591001C4591001 1007 10071642A@ADVERSE EVENT 2 body aches Pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalized aching F\FPain and discomfort NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2021-05-28 B2021-05-29 B 2MedDRA v24.0NDW A ..DWA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . APeriod 01DW D,Hr%,DYDθHu`ڸAfter unblinding and before Vaccination 3A@ A 2021-06-07T14:29:00Y 100716421007BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADW D,Hr%,DWDθHs8BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADW D,..Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDWYPhase 3A@NNEGDWBNT162b2 (30 (*ESC*){unicode 03BC}g) DW...... . .NN.DWDWBBqBAHr%,Hs8.. .DXXWHITE AC4591001C4591001 1007 10071642APADVERSE EVENT 1 fever 103.5 Pyrexia FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F.F)Febrile disorders FBody temperature conditions FGeneral disorders and administration site conditions F2021-05-28 B2021-05-29 B 3MedDRA v24.0NDW A ..DWA0..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA0GRADE 3A0 . APeriod 01DW D,Hr%,DYDθHu`ڸAfter unblinding and before Vaccination 3A@ A 2021-06-07T14:28:37Y 100716481007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DW DHr(dDWDHsji@Placebo APlacebo ADW DDW"DY . . .Placebo Placebo DW>DWtYPhase 3A@NNEGDWu BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWvDWDDDWDXHBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWtDWBhBBBAHr(dHrHsN¨Hsji@ .DWuALL OTHERS A0C4591001C4591001 1007 10071648AADVERSE EVENT 1 Injection site pain Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-01-26T09:06B2021-01-27T07:00B 1MedDRA v24.0NDW" ADHrDW#A DbHr+A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A YAPeriod 01DW DHr(dDWvDHsN§Vaccination 2 A Y A 2021-03-01T15:45:10 100716501007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADW DHr@LDWDHsPlacebo APlacebo ADW DDW"DY . . .Placebo Placebo DW@DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDpDDWDXkBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBeBrBAHr@LHrHs}Hs .DWWHITE AC4591001C4591001 1007 10071650AADVERSE EVENT 3 elevated body temperature unknown temp Body temperature increased FINVESTIGATIONS Body temperature increased FFPhysical examination procedures and organ system status FPhysical examination and organ system status topics FInvestigations F2021-06-16T08:30B2021-06-16T10:00B 1MedDRA v24.0NDW A DwHsDWA DHs[ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CC0 A Period 02DWDpHs}DYDHuyVaccination 4 A`Y A@2021-06-21T15:34:11Y 100716501007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADW DHr@LDWDHsPlacebo APlacebo ADW DDW"DY . . .Placebo Placebo DW@DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDpDDWDXkBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBeBrBAHr@LHrHs}Hs .DWWHITE AC4591001C4591001 1007 10071650A ADVERSE EVENT 2 chest tightness Chest discomfort FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chest tightness FFPain and discomfort NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2021-06-16T08:30B2021-06-16T10:00B 1MedDRA v24.0NDW A DwHsDWA DHs[ADAYSN NNOT RELATEDOTHER Anxiety NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A CC0 A Period 02DWDpHs}DYDHuyVaccination 4 A`Y A@2021-06-21T15:33:49Y 100716501007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADW DHr@LDWDHsPlacebo APlacebo ADW DDW"DY . . .Placebo Placebo DW@DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDpDDWDXkBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBeBrBAHr@LHrHs}Hs .DWWHITE AC4591001C4591001 1007 10071650A0ADVERSE EVENT 4 chills Chills FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills FFFeelings and sensations NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2021-06-16T08:30B2021-06-16T10:00B 1MedDRA v24.0NDW A DwHsDWA DHs[ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CC0 A Period 02DWDpHs}DYDHuyVaccination 4 A`Y A@2021-06-21T15:34:47Y 100716501007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADW DHr@LDWDHsPlacebo APlacebo ADW DDW"DY . . .Placebo Placebo DW@DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDpDDWDXkBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBeBrBAHr@LHrHs}Hs .DWWHITE AC4591001C4591001 1007 10071650A@ADVERSE EVENT 7 fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-06-16T08:30B2021-06-16T10:00B 1MedDRA v24.0NDW A DwHsDWA DHs[ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CC0 A Period 02DWDpHs}DYDHuyVaccination 4 A`Y A@2021-06-21T15:36:42Y 100716501007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADW DHr@LDWDHsPlacebo APlacebo ADW DDW"DY . . .Placebo Placebo DW@DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDpDDWDXkBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBeBrBAHr@LHrHs}Hs .DWWHITE AC4591001C4591001 1007 10071650APADVERSE EVENT 1 Headache Headache FNERVOUS SYSTEM DISORDERS Headache FFHeadaches NEC FHeadaches FNervous system disorders F2021-06-15T23:59B2021-06-16T10:00B 2MedDRA v24.0NDW AE@Hs6DDWA DHs[A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C#@ A Period 02DWDpHs}DYDHuyVaccination 4 A`Y A@2021-06-21T14:24:25Y 100716501007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADW DHr@LDWDHsPlacebo APlacebo ADW DDW"DY . . .Placebo Placebo DW@DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDpDDWDXkBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBeBrBAHr@LHrHs}Hs .DWWHITE AC4591001C4591001 1007 10071650A`ADVERSE EVENT 6 injection site pain Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-06-16T08:30B2021-06-16T10:00B 1MedDRA v24.0NDW A DwHsDWA DHs[ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CC0 A Period 02DWDpHs}DYDHuyVaccination 4 A`Y A@2021-06-21T15:36:02Y 100716501007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADW DHr@LDWDHsPlacebo APlacebo ADW DDW"DY . . .Placebo Placebo DW@DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDpDDWDXkBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBeBrBAHr@LHrHs}Hs .DWWHITE AC4591001C4591001 1007 10071650ApADVERSE EVENT 5 generalized muscle aches Myalgia FkMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Generalized muscle aches FiF{Muscle pains F#Muscle disorders FMusculoskeletal and connective tissue disorders Fk2021-06-16T08:30B2021-06-16T10:00B 2MedDRA v24.0NDW A DwHsDWA DHs[ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A CC0 A Period 02DWDpHs}DYDHuyVaccination 4 A`Y A@2021-06-21T15:35:19Y 100716511007BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADW DHr=DW"DHrBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADW DDW"DY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW>DWYPhase 3A@NNEGDW ....... . .NY.DWDWBBrBAHr=Hr.. .DWWHITE AC4591001C4591001 1007 10071651AADVERSE EVENT 1 Left deep cervical chain lymph node swelling Lymphadenopathy FQBLOOD AND LYMPHATIC SYSTEM DISORDERS Lymph nodes cervical swollen FFLymphatic system disorders NEC FSpleen, lymphatic and reticuloendothelial system disorders F9)Blood and lymphatic system disorders FQ2021-01-12T12:30A2021-02-09 B$ 1MedDRA v24.0NDW ADHr͍DW0B$..BDAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A D' APeriod 01DW DHr=DXDHt`Vaccination 1 AY A2021-02-25T17:23:14 100716511007BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADW DHr=DW"DHrBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADW DDW"DY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW>DWYPhase 3A@NNEGDW ....... . .NY.DWDWBBrBAHr=Hr.. .DWWHITE AC4591001C4591001 1007 10071651A ADVERSE EVENT 2 left Cervical lymphadenopathy Lymphadenopathy FQBLOOD AND LYMPHATIC SYSTEM DISORDERS Lymphadenopathy cervical FFLymphatic system disorders NEC FSpleen, lymphatic and reticuloendothelial system disorders F9)Blood and lymphatic system disorders FQ2021-02-23T07:30B22021-03-09 B@ 1MedDRA v24.0NDW> BDixHsxDWLB+..ADAYSN NNOT RELATEDOTHER Local adenopathy. Do not think related to study agent NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A D APeriod 01DW DHr=DXDHt`Vaccination 2 A Y A 2021-07-14T13:17:55 AE outcome changed from EUA to sBLA 100716521007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADW DHrB,DWDHslPlacebo APlacebo ADW DDW"D\Y . . .Placebo Placebo DW>DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDXqBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBeBrBAHrB,Hr\Hs|HHsl .DWWHITE AC4591001C4591001 1007 10071652AADVERSE EVENT 1 Erythema at injection site Injection site erythema FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site erythema FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-06-21T11:47B2021-06-22 B 1MedDRA v24.0NDW ADHssDWA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A BYA Period 02DWDHs|HDY!DHu,Vaccination 4 A`Y A@2021-07-14T13:16:11Y 100716581007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDHrDWDHs-Placebo APlacebo ADWDDW#DY . . .Placebo Placebo DW?DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWB~BmBrBAHrHr9HsrlHs- .DWWHITE AC4591001C4591001 1007 10071658AADVERSE EVENT 6 headache Headache FNERVOUS SYSTEM DISORDERS Headache FFHeadaches NEC FHeadaches FNervous system disorders F2021-06-08 B2021-06-10 B 2MedDRA v24.0NDW A ..DWA@..A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWDHsrlDYDHuoaPVaccination 4 A`Y A@2021-06-14T15:20:32Y 100716581007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDHrDWDHs-Placebo APlacebo ADWDDW#DY . . .Placebo Placebo DW?DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWB~BmBrBAHrHr9HsrlHs- .DWWHITE AC4591001C4591001 1007 10071658A ADVERSE EVENT 7 injection site pain Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-06-07T19:00B2021-06-10 B 1MedDRA v24.0NDW AEHsd0DWA@..A@DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A B A Period 02DWDHsrlDYDHuoaPVaccination 4 A`Y A@2021-06-14T15:21:45Y 100716581007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDHrDWDHs-Placebo APlacebo ADWDDW#DY . . .Placebo Placebo DW?DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWB~BmBrBAHrHr9HsrlHs- .DWWHITE AC4591001C4591001 1007 10071658A0ADVERSE EVENT 5 malaise Malaise FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Malaise F F Asthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-06-07T19:00B2021-06-10 B 3MedDRA v24.0NDW AEHsd0DWA@..A@DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA0GRADE 3A0 B A Period 02DWDHsrlDYDHuoaPVaccination 4 A`Y A@2021-06-14T15:19:44Y 100716581007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDHrDWDHs-Placebo APlacebo ADWDDW#DY . . .Placebo Placebo DW?DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWB~BmBrBAHrHr9HsrlHs- .DWWHITE AC4591001C4591001 1007 10071658A@ADVERSE EVENT 2 anterior chest wall pain Musculoskeletal chest pain FkMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Chest wall pain FF]Musculoskeletal and connective tissue pain and discomfort FMusculoskeletal and connective tissue disorders NEC FiMusculoskeletal and connective tissue disorders Fk2021-06-08T12:00B2021-06-08T20:00B 3MedDRA v24.0NDW A DHsS@DWA EHsADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA0GRADE 3A0 CN@ A Period 02DWDHsrlDYDHuoaPVaccination 4 A`Y A@2021-06-21T17:19:43Y 100716581007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDHrDWDHs-Placebo APlacebo ADWDDW#DY . . .Placebo Placebo DW?DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWB~BmBrBAHrHr9HsrlHs- .DWWHITE AC4591001C4591001 1007 10071658APADVERSE EVENT 4 generalized myalgia Myalgia FkMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Myalgia F{F{Muscle pains F#Muscle disorders FMusculoskeletal and connective tissue disorders Fk2021-06-07T19:00B2021-06-10 B 3MedDRA v24.0NDW AEHsd0DWA@..A@DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA0GRADE 3A0 B A Period 02DWDHsrlDYDHuoaPVaccination 4 A`Y A@2021-06-14T15:19:01Y 100716581007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDHrDWDHs-Placebo APlacebo ADWDDW#DY . . .Placebo Placebo DW?DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWB~BmBrBAHrHr9HsrlHs- .DWWHITE AC4591001C4591001 1007 10071658A`ADVERSE EVENT 3 fever Pyrexia FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F.F)Febrile disorders FBody temperature conditions FGeneral disorders and administration site conditions F2021-06-07T19:00B2021-06-09 B 1MedDRA v24.0NDW AEHsd0DWA0..A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A B A Period 02DWDHsrlDYDHuoaPVaccination 4 A`Y A@2021-06-14T13:51:22Y 100716601007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDlHrlDWD$HsPlacebo APlacebo ADWDlDW#D\Y . . .Placebo Placebo DW?DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDD$DWDXtBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBB]BlBAHrlHrHsq Hs .DWWHITE AC4591001C4591001 1007 10071660AADVERSE EVENT 2 chills Chills FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills FFFeelings and sensations NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2021-06-03 B2021-06-04 B 1MedDRA v24.0NDW A ..DWA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDHsq DY$D$Hu$Vaccination 3 APY A02021-07-20T14:49:40Y 100716601007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDlHrlDWD$HsPlacebo APlacebo ADWDlDW#D\Y . . .Placebo Placebo DW?DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDD$DWDXtBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBB]BlBAHrlHrHsq Hs .DWWHITE AC4591001C4591001 1007 10071660A ADVERSE EVENT 5 fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-06-25 B2021-06-26 B 2MedDRA v24.0NDW A ..DWA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWDHsq DY$D$Hu$Vaccination 4 A`Y A@2021-07-20T14:53:10Y 100716601007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDlHrlDWD$HsPlacebo APlacebo ADWDlDW#D\Y . . .Placebo Placebo DW?DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDD$DWDXtBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBB]BlBAHrlHrHsq Hs .DWWHITE AC4591001C4591001 1007 10071660A0ADVERSE EVENT 1 injection site pain Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-06-02T14:30B2021-06-04 B 2MedDRA v24.0NDW ADHshDWA0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A By A Period 02DWDHsq DY$D$Hu$Vaccination 3 APY A02021-07-20T14:48:25Y 100716601007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDlHrlDWD$HsPlacebo APlacebo ADWDlDW#D\Y . . .Placebo Placebo DW?DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDD$DWDXtBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBB]BlBAHrlHrHsq Hs .DWWHITE AC4591001C4591001 1007 10071660APADVERSE EVENT 4 injection site pain Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-06-24T15:00B2021-06-25 B 1MedDRA v24.0NDW ADHspDWA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A BYA Period 02DWDHsq DY$D$Hu$Vaccination 4 A`Y A@2021-07-20T14:52:11Y 100716601007Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDlHrlDWD$HsPlacebo APlacebo ADWDlDW#D\Y . . .Placebo Placebo DW?DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDD$DWDXtBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBB]BlBAHrlHrHsq Hs .DWWHITE AC4591001C4591001 1007 10071660A@ADVERSE EVENT 3 fever 101.4 Pyrexia FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F.F)Febrile disorders FBody temperature conditions FGeneral disorders and administration site conditions F2021-06-03T08:00B2021-06-04 B 2MedDRA v24.0NDW A DpHsDWA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A CI0 A Period 02DWDHsq DY$D$Hu$Vaccination 3 APY A02021-07-20T14:50:47Y 100817611008Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHr:DW}DHsXPlacebo APlacebo ADVDDWDY . . .Placebo Placebo DW%DWfYPhase 3A@NNEGDWg BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWgDW}DDDWDX:BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWfDWBwBBCAHr:HrtHs;"HsX .DWfWHITE AC4591001C4591001 1008 10081761AADVERSE EVENT 1 Fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-04-05T20:00Bx2021-04-06 By 1MedDRA v24.0NDWg AEHs;cDWhA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C` A Period 02DWgDHs;"DXDHu9QVaccination 3 APY A02021-04-27T23:11:55Y 100817811008Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDhHr/DWDHsPlacebo APlacebo ADVDhDWD8Y . . .Placebo Placebo DW)DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDXeBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBjBrCAHr/Hr8Hsv/Hs .DWWHITE AC4591001C4591001 1008 10081781AADVERSE EVENT 1 injection site pain Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-06-10 B2021-06-12 B 1MedDRA v24.0NDW A ..DWA@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDHsv/DYDHuqVaccination 4 A`Y A@2021-07-07T15:53:35Y 100817811008Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDhHr/DWDHsPlacebo APlacebo ADVDhDWD8Y . . .Placebo Placebo DW)DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDXeBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBjBrCAHr/Hr8Hsv/Hs .DWWHITE AC4591001C4591001 1008 10081781A ADVERSE EVENT 2 injection site fatigue Injection site reaction FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site reaction FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-06-10 B2021-06-12 B 1MedDRA v24.0NDW A ..DWA@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDHsv/DYDHuqVaccination 4 A`Y A@2021-07-07T15:54:37Y 100817881008Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHr3DWDLHsLPlacebo APlacebo ADVDDW D Y . . .Placebo Placebo DW(DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDTDLDWDX_BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBqBqCpAHr3Hr HslHsL .DWWHITE AC4591001C4591001 1008 10081788AADVERSE EVENT 1 injection site pain Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-05-13T19:00B2021-05-14 B 1MedDRA v24.0NDW AEHsmnDWA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C A Period 02DWDTHslDYDLHujVaccination 3 APY A02021-06-04T00:10:42Y 100818011008Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVD(Hr2(DWDlHslPlacebo APlacebo ADVD(DWDY . . .Placebo Placebo DW,DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDlDWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBmBrC@AHr2(HrHsrn`Hsl .DWWHITE AC4591001C4591001 1008 10081801AADVERSE EVENT 1 Fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-06-08 B2021-06-09 B 1MedDRA v24.0NDW A ..DWA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDHsrn`DYDlHuoLVaccination 4 A`Y A@2021-07-06T21:29:21Y 100818081008Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DVDHr~DWDHsPlacebo APlacebo ADVDDWDY . . .Placebo Placebo DW3DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBmBrC0AHr~Hr>Hsr3Hs .DWALL OTHERS A0C4591001C4591001 1008 10081808AADVERSE EVENT 1 Fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-05-18 B2021-05-19 B 1MedDRA v24.0NDW A ..DWA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDHsr3DYDHuoPVaccination 3 APY A02021-07-06T21:29:32Y 100818081008Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DVDHr~DWDHsPlacebo APlacebo ADVDDWDY . . .Placebo Placebo DW3DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBmBrC0AHr~Hr>Hsr3Hs .DWALL OTHERS A0C4591001C4591001 1008 10081808A ADVERSE EVENT 2 Fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-06-08 B2021-06-09 B 1MedDRA v24.0NDW A ..DWA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDHsr3DYDHuoPVaccination 4 A`Y A@2021-07-06T21:29:44Y 100818121008Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDɐHrDWDHs$Placebo APlacebo ADVDɐDWDY . . .Placebo Placebo DW1DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDtDDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBqBrC0AHrHrfHsmHHs$ .DWWHITE AC4591001C4591001 1008 10081812AADVERSE EVENT 1 headache Headache FNERVOUS SYSTEM DISORDERS Headache FFHeadaches NEC FHeadaches FNervous system disorders F2021-05-14 B2021-05-15 B 2MedDRA v24.0NDW A ..DWA0..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWDtHsmHDYDHuk Vaccination 3 APY A02021-06-04T16:56:23Y 100818371008Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDPHr DWDHsPlacebo APlacebo ADVDPDWDDY . . .Placebo Placebo DW3DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDXeBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBkBrBAHr HrͷDHsuPHs .DWWHITE AC4591001C4591001 1008 10081837AADVERSE EVENT 1 Fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-05-20 B2021-05-21 B 2MedDRA v24.0NDW A ..DWA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWDHsuPDYDHuqTVaccination 3 APY A02021-06-09T22:45:37Y 100818371008Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDPHr DWDHsPlacebo APlacebo ADVDPDWDDY . . .Placebo Placebo DW3DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDXeBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBkBrBAHr HrͷDHsuPHs .DWWHITE AC4591001C4591001 1008 10081837A ADVERSE EVENT 2 headache Headache FNERVOUS SYSTEM DISORDERS Headache FFHeadaches NEC FHeadaches FNervous system disorders F2021-05-20 B2021-05-21 B 2MedDRA v24.0NDW A ..DWA0..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWDHsuPDYDHuqTVaccination 3 APY A02021-06-09T22:45:48Y 100818371008Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDPHr DWDHsPlacebo APlacebo ADVDPDWDDY . . .Placebo Placebo DW3DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDXeBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBkBrBAHr HrͷDHsuPHs .DWWHITE AC4591001C4591001 1008 10081837A0ADVERSE EVENT 3 body aches Pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalized aching F\FPain and discomfort NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2021-05-20 B2021-05-21 B 2MedDRA v24.0NDW A ..DWA0..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWDHsuPDYDHuqTVaccination 3 APY A02021-06-09T22:45:59Y 100818441008Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDHrDWD(Hs(Placebo APlacebo ADWDDWDY . . .Placebo Placebo DW1DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDD(DWDXeBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBkBrBAHrHr`HstHs( .DWWHITE AC4591001C4591001 1008 10081844AADVERSE EVENT 1 headache Headache FNERVOUS SYSTEM DISORDERS Headache FFHeadaches NEC FHeadaches FNervous system disorders F2021-05-20 B2021-05-20 B 1MedDRA v24.0NDW A ..DWA ..ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDDHstDYD(HurVaccination 3 APY A02021-06-10T02:01:52Y 100818441008Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDHrDWD(Hs(Placebo APlacebo ADWDDWDY . . .Placebo Placebo DW1DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDD(DWDXeBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBkBrBAHrHr`HstHs( .DWWHITE AC4591001C4591001 1008 10081844A ADVERSE EVENT 2 nausea Nausea FܛGASTROINTESTINAL DISORDERS Nausea F F Nausea and vomiting symptoms FGastrointestinal signs and symptoms FGastrointestinal disorders Fܛ2021-05-19T14:00B2021-05-20 B 1MedDRA v24.0NDW ADHsu`DWA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A B A Period 02DWDDHstDYD(HurVaccination 3 APY A02021-06-10T02:02:03Y 100818441008Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDHrDWD(Hs(Placebo APlacebo ADWDDWDY . . .Placebo Placebo DW1DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDD(DWDXeBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBkBrBAHrHr`HstHs( .DWWHITE AC4591001C4591001 1008 10081844A0ADVERSE EVENT 3 body aches Pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalized aching F\FPain and discomfort NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2021-05-20 B2021-05-20 B 1MedDRA v24.0NDW A ..DWA ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDDHstDYD(HurVaccination 3 APY A02021-06-10T02:02:16Y 100818631008Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DWDPHr PDWDXHsXPlacebo APlacebo ADWDPDWDY . . .Placebo Placebo DW7DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDXDWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBmBrBAHr PHrdHsr3PHsX .DWALL OTHERS A0C4591001C4591001 1008 10081863AADVERSE EVENT 1 Headache Headache FNERVOUS SYSTEM DISORDERS Headache FFHeadaches NEC FHeadaches FNervous system disorders F2021-06-08 B2021-06-09 B 1MedDRA v24.0NDW A ..DWA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDHsr3PDYDXHuoVaccination 4 A`Y A@2021-07-06T21:30:40Y 100818631008Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DWDPHr PDWDXHsXPlacebo APlacebo ADWDPDWDY . . .Placebo Placebo DW7DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDXDWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBmBrBAHr PHrdHsr3PHsX .DWALL OTHERS A0C4591001C4591001 1008 10081863A ADVERSE EVENT 2 Body Aches Pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalized aching F\FPain and discomfort NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2021-06-08 B2021-06-09 B 1MedDRA v24.0NDW A ..DWA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDHsr3PDYDXHuoVaccination 4 A`Y A@2021-07-06T21:30:51Y 100818771008Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDPHrDWD$Hs$Placebo APlacebo ADWDPDWDY . . .Placebo Placebo DW?DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDôD$DWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBmBrBAHrHr6Hsrm4Hs$ .DWWHITE AC4591001C4591001 1008 10081877AADVERSE EVENT 1 fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-05-17T18:30B2021-05-19 B 2MedDRA v24.0NDW AEBHsrDWA0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C0 A Period 02DWDôHsrm4DYD$HuoIVaccination 3 APY A02021-06-08T00:02:51Y 100818771008Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDPHrDWD$Hs$Placebo APlacebo ADWDPDWDY . . .Placebo Placebo DW?DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDôD$DWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBmBrBAHrHr6Hsrm4Hs$ .DWWHITE AC4591001C4591001 1008 10081877A ADVERSE EVENT 2 body aches Pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalized aching F\FPain and discomfort NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2021-05-18 B2021-05-19 B 2MedDRA v24.0NDW A ..DWA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWDôHsrm4DYD$HuoIVaccination 3 APY A02021-06-08T00:03:02Y 100818871008Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADW DHrDWD4Hs4Placebo APlacebo ADW DDW!D\Y . . .Placebo Placebo DW=DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDD4DWDX_BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBqBrBAHrHrHsmKHs4 .DWWHITE AC4591001C4591001 1008 10081887AADVERSE EVENT 3 chills Chills FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills FFFeelings and sensations NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2021-05-14 B2021-05-17 B 1MedDRA v24.0NDW A ..DWAP..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDHsmKDYD4HuiƴVaccination 3 APY A02021-06-04T00:11:16Y 100818871008Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADW DHrDWD4Hs4Placebo APlacebo ADW DDW!D\Y . . .Placebo Placebo DW=DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDD4DWDX_BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBqBrBAHrHrHsmKHs4 .DWWHITE AC4591001C4591001 1008 10081887A ADVERSE EVENT 2 headache Headache FNERVOUS SYSTEM DISORDERS Headache FFHeadaches NEC FHeadaches FNervous system disorders F2021-05-14 B2021-05-17 B 2MedDRA v24.0NDW A ..DWAP..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWDHsmKDYD4HuiƴVaccination 3 APY A02021-06-03T17:25:04Y 100818871008Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADW DHrDWD4Hs4Placebo APlacebo ADW DDW!D\Y . . .Placebo Placebo DW=DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDD4DWDX_BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBqBrBAHrHrHsmKHs4 .DWWHITE AC4591001C4591001 1008 10081887A0ADVERSE EVENT 1 sweating Hyperhidrosis F5SKIN AND SUBCUTANEOUS TISSUE DISORDERS Sweating F=%F"Apocrine and eccrine gland disorders F&Skin appendage conditions F5Skin and subcutaneous tissue disorders F52021-05-14 B2021-05-17 B 1MedDRA v24.0NDW A ..DWAP..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDHsmKDYD4HuiƴVaccination 3 APY A02021-06-04T02:24:39Y 100818921008Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAAMERICAN INDIAN OR ALASKA NATIVE A0MAHISPANIC OR LATINO AUSAAMERICAN INDIAN OR ALASKA NATIVE A0DW D`Hr`DWD|8Hsa8Placebo APlacebo ADW D`DW!DИY . . .Placebo Placebo DW=DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD~D|8DWDXkBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBeBrBAHr`HrHs|Hsa8 .DWALL OTHERS A0C4591001C4591001 1008 10081892AADVERSE EVENT 1 injection site pain Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-05-25T10:00B2021-05-29 B 1MedDRA v24.0NDW ADHs| DWAP..APDAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A B< A Period 02DWD~Hs|DYD|8HuyVaccination 3 APY A02021-06-04T00:11:29Y 100819131008Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDנHr̠DWD|Hs|Placebo APlacebo ADWDנDW$D@Y . . .Placebo Placebo DWADWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDD|DWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWB~BmBrBAHr̠Hr@Hsr4Hs| .DWWHITE AC4591001C4591001 1008 10081913AADVERSE EVENT 1 injection site pain Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-05-16T16:00B2021-05-19 B 1MedDRA v24.0NDW BmDHsq9DWBp..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A E% APeriod 01DWDנHr̠DWDHsr4After unblinding and before Vaccination 3A@ A 2021-06-08T00:03:13Y 100819281008BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDTHrpTDW%DHrxBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADWDTDW%DY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWADWYPhase 3A@NNEGDW ....... . .NY.DWDWB|BrBAHrpTHrx.. .DWWHITE AC4591001C4591001 1008 10081928AADVERSE EVENT 1 urticaria multiple sites Urticaria F5SKIN AND SUBCUTANEOUS TISSUE DISORDERS Urticaria FMFMUrticarias FMAngioedema and urticaria FSkin and subcutaneous tissue disorders F52021-01-10 A02021-01-22 A 1MedDRA v24.0NDW A0..DWA..ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . APeriod 01DWDTHrpTDXDHtEVaccination 1 AY A2021-01-29T21:14:23 100819311008Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DWDHr$`DWDHsPlacebo APlacebo ADWDDW(DY . . .Placebo Placebo DWDDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDXeBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWByBkBrBAHr$`Hr罜HstHs .DWALL OTHERS A0C4591001C4591001 1008 10081931AADVERSE EVENT 1 Cellulitis left leg Cellulitis FINFECTIONS AND INFESTATIONS Cellulitis of leg FhFJBacterial infections NEC FOBacterial infectious disorders F2Infections and infestations F2021-03-15 B@2021-03-19 BD 1MedDRA v24.0NDWR B+..DWVB/..APDAYSN NNOT RELATEDOTHER Unknown NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DWDHr$`DWDHstFollow Up 1 A0Y A 2021-03-19T21:23:05Y 100819331008Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDLHrNDWDƄHsPlacebo APlacebo ADWDLDW)DY . . .Placebo Placebo DWEDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD`DƄDWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWByBmBrBAHrNHrVHsruHs .DWWHITE AC4591001C4591001 1008 10081933AADVERSE EVENT 1 injection site pain Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-06-08 B2021-06-09 B 1MedDRA v24.0NDW A ..DWA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWD`HsruDYDƄHuoSVaccination 4 A`Y A@2021-07-06T21:31:58Y 100912201009Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVD<Hr]DVDHrvxPlacebo APlacebo ADVD<DVDY . . .Placebo Placebo DVDWYPhase 3A@NNEGDW ....... . .NN.DWDWBBqCAHr]Hrvx.. .DWWHITE AC4591001C4591001 1009 10091220AADVERSE EVENT 1 POST SURGICAL PAIN, ORAL Procedural pain FINJURY, POISONING AND PROCEDURAL COMPLICATIONS Postoperative pain Fl7FNon-site specific procedural complications F Procedural related injuries and complications NEC FInjury, poisoning and procedural complications F2020-11-20 B!2020-11-30 B+ 2MedDRA v24.0NDV A..DVB..ADAYSN NNOT RELATEDOTHER PHYSIOLOGIC due to wisdom teeth removal NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVD<Hr]DX?DHtWVaccination 2 A Y A 2020-12-24T19:21:42 100912211009BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDhHr]DVDHrvxBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADVDhDVDY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DVDWYPhase 3A@NNEGDW ....... . .NY.DWDWBBqCAHr]Hrvx.. .DWWHITE AC4591001C4591001 1009 10091221AADVERSE EVENT 1 worsening right ankle pain Arthralgia FkMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Pain ankle FF'Joint related signs and symptoms F:Joint disorders F-Musculoskeletal and connective tissue disorders Fk2020-10-19T17:00A2020-10-19 A 3MedDRA v24.0NDV ADHr]DVA..ADAYSN NNOT RELATEDOTHER dance injury NOT APPLICABLE NYRECOVERED/RESOLVED N A0NOT RELATEDA0A0GRADE 3A0 B APeriod 01DVDhHr]DX?DHtWVaccination 1 AY A2020-11-25T18:24:30 100912291009Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHr_DWD0Hs}0Placebo APlacebo ADVD..Y . . .Placebo DWxDWYPhase 3A@NNEGDWPlacebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWUDWDWDXD0DWDXgBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBiBpCAHr_Hs#HswHs}0 .DWWHITE AC4591001C4591001 1009 10091229AADVERSE EVENT 1 Body Aches following vaccination Pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalized aching F\FPain and discomfort NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2021-05-22 B2021-05-23 B 2MedDRA v24.0NDW A ..DWA0..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWDXHswDYD0HutVaccination 3 APY A02021-06-12T14:30:10Y 100912311009BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DVEHr_ DVDHry^BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADVEDVDY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DVDWYPhase 3A@NNEGDW ....... . .NY.DWDWBBkCAHr_ Hry^.. .DWALL OTHERS A0C4591001C4591001 1009 10091231AADVERSE EVENT 1 left swollen axillary lymph node Lymphadenopathy FQBLOOD AND LYMPHATIC SYSTEM DISORDERS Axillary lymph nodes enlarged FFLymphatic system disorders NEC FSpleen, lymphatic and reticuloendothelial system disorders F9)Blood and lymphatic system disorders FQ2020-11-10 B2020-11-10 B 1MedDRA v24.0NDV A ..DVA ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . APeriod 01DVEHr_ DXADHtZVaccination 2 A Y A 2020-12-15T20:40:58 100912671009Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHr9DWDHsPlacebo APlacebo ADVDDVD Y . . .Placebo Placebo DWDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD(DDWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBmBpC@AHr9HrHsrHs .DWWHITE AC4591001C4591001 1009 10091267AADVERSE EVENT 1 RUNNY NOSE Rhinorrhoea F-RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS Runny nose F0F/=Upper respiratory tract signs and symptoms FKiRespiratory tract signs and symptoms F}Respiratory, thoracic and mediastinal disorders F-2020-12-27 B2021-01-01 B 1MedDRA v24.0NDW A`..DW A..A`DAYSN NNOT RELATEDOTHER RHINORHEA FROM URI-VIRAL NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVDHr9DWD'HsrVaccination 2 A Y A 2021-01-22T04:19:01 100912941009Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADVDHr DW~DHsY#Placebo APlacebo ADVDDWDY . . .Placebo Placebo DW!DWcYPhase 3A@NNEGDWd BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWhDW~DDDWDX;BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWcDWBtBBCAHr HrHs<HsY# .DWgWHITE AC4591001C4591001 1009 10091294AADVERSE EVENT 1 bilateral shoulder pain Arthralgia FkMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Shoulder pain F5)F'Joint related signs and symptoms F:Joint disorders F-Musculoskeletal and connective tissue disorders Fk2020-12-22 B2020-12-24 B 1MedDRA v24.0NDV B..DWB..A0DAYSN NNOT RELATEDOTHER lifting heavy object NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVDHr DWhDHs<Vaccination 1 AY A2020-12-28T22:18:38 100912941009Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADVDHr DW~DHsY#Placebo APlacebo ADVDDWDY . . .Placebo Placebo DW!DWcYPhase 3A@NNEGDWd BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWhDW~DDDWDX;BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWcDWBtBBCAHr HrHs<HsY# .DWgWHITE AC4591001C4591001 1009 10091294A ADVERSE EVENT 2 body aches Pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalized aching F\FPain and discomfort NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2021-04-06T18:00By2021-04-07 Bz 1MedDRA v24.0NDWh AD Hs< DWiA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C ` A Period 02DWhDHs<DXDHu:WDVaccination 3 APY A02021-04-16T16:40:05Y 100913011009Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDLHrfLDWD(Hs(Placebo APlacebo ADVDLDWD̜Y . . .Placebo Placebo DW$DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDD(DWDXqBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBB^B~CAHrfLHrHskHs( .DWWHITE AC4591001C4591001 1009 10091301AADVERSE EVENT 1 spider bite Arthropod bite FINJURY, POISONING AND PROCEDURAL COMPLICATIONS Spider bite F8FNon-site specific injuries NEC F Injuries NEC FInjury, poisoning and procedural complications F2021-07-22 B2021-08-05 B 2MedDRA v24.0NDW B ..DWB...ADAYSN NNOT RELATEDOTHER insect bite NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . A Period 02DWDHskDY!D(HuVaccination 4 A`Y A@2021-09-10T21:03:38Y 100913051009Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVD HrDWkDDHs@<Placebo APlacebo ADVD DWDY . . .Placebo Placebo DW#DW<YPhase 3A@NNEGDW= BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWVDWkDTDDDWDX(BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DW<DWBLBBCAHrHrHs$THs@< .DWUWHITE AC4591001C4591001 1009 10091305AADVERSE EVENT 1 Right Axillary Adenitis Lymphadenitis FQBLOOD AND LYMPHATIC SYSTEM DISORDERS Axillary adenitis FZFLymphatic system disorders NEC FSpleen, lymphatic and reticuloendothelial system disorders F9)Blood and lymphatic system disorders FQ2021-03-24 Bk2021-04-16 B 2MedDRA v24.0NDW[ A`..DWrB..BDAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWVDTHs$TDXDDHu!pDVaccination 3 APY A02021-07-12T16:54:19Y 100913191009BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVD4Hr'DWDHrBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADVD4DWDY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW)DWYPhase 3A@NNEGDW ....... . .NY.DWDWBBmCAHr'Hr.. .DWWHITE AC4591001C4591001 1009 10091319AADVERSE EVENT 1 headache Headache FNERVOUS SYSTEM DISORDERS Headache FFHeadaches NEC FHeadaches FNervous system disorders F2021-01-22 B,2021-01-22 B, 2MedDRA v24.0NDW B..DWB..ADAYSN NNOT RELATEDOTHER unknown NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVD4Hr'DXsDHtVaccination 2 A Y A 2021-01-27T21:45:18 100913231009Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHrDDWD8Hs}Placebo APlacebo ADVDDWDY . . .Placebo Placebo DW$DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDD8DWDXBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBB;B?CAHrDHrHsHs} .DWWHITE AC4591001C4591001 1009 10091323AADVERSE EVENT 1 fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-01-08 B2021-01-08 B 1MedDRA v24.0NDW A..DWA..ADAYSN NNOT RELATEDOTHER prolonged fasting NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVDHrDDWDHsVaccination 2 A Y A 2021-01-13T05:29:45 100913231009Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHrDDWD8Hs}Placebo APlacebo ADVDDWDY . . .Placebo Placebo DW$DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDD8DWDXBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBB;B?CAHrDHrHsHs} .DWWHITE AC4591001C4591001 1009 10091323A ADVERSE EVENT 2 nausea Nausea FܛGASTROINTESTINAL DISORDERS Nausea F F Nausea and vomiting symptoms FGastrointestinal signs and symptoms FGastrointestinal disorders Fܛ2021-01-08 B2021-01-08 B 1MedDRA v24.0NDW A..DWA..ADAYSN NNOT RELATEDOTHER prolonged fasting NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVDHrDDWDHsVaccination 2 A Y A 2021-01-13T05:29:51 100913261009Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVD8HrH8DWDHsPlacebo APlacebo ADVD8DWDY . . .Placebo Placebo DW%DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD\DDWDXuBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBcBiCAHrH8HrHHs{Hs .DWWHITE AC4591001C4591001 1009 10091326AADVERSE EVENT 2 headache Headache FNERVOUS SYSTEM DISORDERS Headache FFHeadaches NEC FHeadaches FNervous system disorders F2021-06-26 B2021-06-26 B 1MedDRA v24.0NDW A ..DWA ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWD\Hs{DY%DHu(DVaccination 4 A`Y A@2021-07-01T02:22:59Y 100913261009Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVD8HrH8DWDHsPlacebo APlacebo ADVD8DWDY . . .Placebo Placebo DW%DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD\DDWDXuBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBcBiCAHrH8HrHHs{Hs .DWWHITE AC4591001C4591001 1009 10091326A ADVERSE EVENT 1 Sore (pain) left deltoid- at injection site Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-06-26 B2021-06-26 B 1MedDRA v24.0NDW A ..DWA ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWD\Hs{DY%DHu(DVaccination 4 A`Y A@2021-07-01T14:59:50Y 100913341009Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVEɀHrDWD\HsPlacebo APlacebo ADVEɀDWD<Y . . .Placebo Placebo DW%DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD,D\DWDXdBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBkBkCAHrHr<Hsu=Hs .DWWHITE AC4591001C4591001 1009 10091334AADVERSE EVENT 1 runny nose Rhinorrhoea F-RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS Runny nose F0F/=Upper respiratory tract signs and symptoms FKiRespiratory tract signs and symptoms F}Respiratory, thoracic and mediastinal disorders F-2021-01-11 B 2021-01-11 B 1MedDRA v24.0NDW A..DWA..ADAYSN NNOT RELATEDOTHER cooking fumes from hot peppers NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVEɀHrDWD+Hsu=Vaccination 2 A Y A 2021-01-18T20:41:00 100913381009Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVD,HrfDWD$HsI$Placebo APlacebo ADVD,..Y . . .Placebo DW6DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDD$DX DXBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBB-BICpAHrfHrfHsƦHsI$ .DWWHITE AC4591001C4591001 1009 10091338AADVERSE EVENT 4 Mouth Ulcer Mouth ulceration FܛGASTROINTESTINAL DISORDERS Mouth ulcer FFStomatitis and ulceration F;Oral soft tissue conditions FGastrointestinal disorders Fܛ2021-06-16 B2021-06-21 B 2MedDRA v24.0NDW B..DWB..A`DAYSN NNOT RELATEDOTHER Unknown NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVD,HrfDWDHsƦFollow Up 1 A0Y A2021-07-01T17:27:43Y 100913381009Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVD,HrfDWD$HsI$Placebo APlacebo ADVD,..Y . . .Placebo DW6DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDD$DX DXBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBB-BICpAHrfHrfHsƦHsI$ .DWWHITE AC4591001C4591001 1009 10091338A ADVERSE EVENT 3 Wisdom Teeth Removal Wisdom teeth removal F<SURGICAL AND MEDICAL PROCEDURES Wisdom teeth removal FQFQDental and gingival therapeutic procedures FƝHead and neck therapeutic procedures FvSurgical and medical procedures F<2021-06-08 B2021-06-08 B 2MedDRA v24.0NDW B..DWB..ADAYSN NNOT RELATEDOTHER Surgery NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVD,HrfDWDHsƦFollow Up 1 A0Y A2021-07-01T15:56:56Y 100913411009Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVE7@HrDWD~HsPlacebo APlacebo ADVE7@DW DXY . . .Placebo Placebo DW,DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDD~DWDXBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBB?BACpAHrHrDXHs Hs .DWWHITE AC4591001C4591001 1009 10091341AADVERSE EVENT 1 body aches Pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalized aching F\FPain and discomfort NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2021-07-03 B2021-07-03 B 1MedDRA v24.0NDW A ..DWA ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDHs DY?D~Hu Vaccination 3 APY A02021-07-08T20:03:01Y 100913421009BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVE/Hr|DW DHrCBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADVE/DW DY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW,DWYPhase 3A@NNEGDW ....... . .NY.DWDWBBACpAHr|HrC.. .DWWHITE AC4591001C4591001 1009 10091342AADVERSE EVENT 1 swollen cervical lymph nodes bilateral Lymphadenopathy FQBLOOD AND LYMPHATIC SYSTEM DISORDERS Lymph nodes cervical swollen FFLymphatic system disorders NEC FSpleen, lymphatic and reticuloendothelial system disorders F9)Blood and lymphatic system disorders FQ2021-01-31 B12021-02-02 B3 1MedDRA v24.0NDW' B..DW)B..A0DAYSN NNOT RELATEDOTHER unknown NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVE/Hr|DXyDHtw$Vaccination 2 A Y A 2021-02-21T09:53:54 100913571009Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHr-DWgDHs:xPlacebo APlacebo ADVDDW DY . . .Placebo Placebo DW)DW<YPhase 3A@NNEGDW= BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWSDWgDdDDWDX$BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DW<DWBCBBC@AHr-Hr3hHs Hs:x .DWRWHITE AC4591001C4591001 1009 10091357AADVERSE EVENT 4 headache Headache FNERVOUS SYSTEM DISORDERS Headache FFHeadaches NEC FHeadaches FNervous system disorders F2021-04-06T03:00Bo2021-04-07 Bp 1MedDRA v24.0NDWh A D*0Hs;0DWiA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C? A Period 02DWSDdHs DXDHu Vaccination 4 A`Y A@2021-04-16T16:40:37Y 100913571009Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHr-DWgDHs:xPlacebo APlacebo ADVDDW DY . . .Placebo Placebo DW)DW<YPhase 3A@NNEGDW= BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWSDWgDdDDWDX$BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DW<DWBCBBC@AHr-Hr3hHs Hs:x .DWRWHITE AC4591001C4591001 1009 10091357A ADVERSE EVENT 5 body aches Pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalized aching F\FPain and discomfort NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2021-04-06T03:00Bo2021-04-07 Bp 1MedDRA v24.0NDWh A D*0Hs;0DWiA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C? A Period 02DWSDdHs DXDHu Vaccination 4 A`Y A@2021-04-16T16:40:48Y 100913571009Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHr-DWgDHs:xPlacebo APlacebo ADVDDW DY . . .Placebo Placebo DW)DW<YPhase 3A@NNEGDW= BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWSDWgDdDDWDX$BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DW<DWBCBBC@AHr-Hr3hHs Hs:x .DWRWHITE AC4591001C4591001 1009 10091357A0ADVERSE EVENT 1 congenital vertebral pedicle hypoplasia Spine malformation FCONGENITAL, FAMILIAL AND GENETIC DISORDERS Congenital anomalies of spine FF9 Musculoskeletal and connective tissue disorders of spine congenitalF_Musculoskeletal and connective tissue disorders congenital FlCongenital, familial and genetic disorders F2021-02-12 B: .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDW3 B'....... N NNOT RELATEDOTHER congenital NOT APPLICABLE NNNOT RECOVERED/NOT RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVDHr-DWSDcHs Follow Up 1 A0Y A 2021-06-18T23:14:04Y 100913611009Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHr^DWDHsPlacebo APlacebo ADVDDW DxY . . .Placebo Placebo DW)DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD DDWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBmBqC@AHr^HrēHsrHs .DWWHITE AC4591001C4591001 1009 10091361AADVERSE EVENT 1 sprained right thumb Ligament sprain FINJURY, POISONING AND PROCEDURAL COMPLICATIONS Thumb sprain FA FMuscle, tendon and ligament injuries FInjuries NEC FInjury, poisoning and procedural complications F2021-01-02T18:30B2021-01-31 B. 2MedDRA v24.0NDW BEBHr(DW'B...BDAYSN NNOT RELATEDOTHER thumb sprain from volleyball NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A D[ APeriod 01DVDHr^DWD HsrVaccination 1 AY A2021-02-03T17:08:33 100913631009Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDtHr|tDWDHspPlacebo APlacebo ADVDt..Y . . .Placebo DW0DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDXDXBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBB#B-C@AHr|tHr|tHsHsp .DWWHITE AC4591001C4591001 1009 10091363AADVERSE EVENT 1 Vasovagal Reaction Presyncope FNERVOUS SYSTEM DISORDERS Vasovagal reaction FNF%Neurological signs and symptoms NEC FNeurological disorders NEC FNervous system disorders F2021-02-09T09:04B72021-02-09T09:30B7 1MedDRA v24.0NDW0 B7DHrGDW0B7DHrMADAYSN NNOT RELATEDOTHER Secondary to veinipuncture NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A E APeriod 01DVDtHr|tDWDHsVaccination 1 AY A2021-02-12T23:06:36 100913651009Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHrDWDLHsvPlacebo APlacebo ADVDDWDY . . .Placebo Placebo DW7DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDĤDLDXDXBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBB-BfC@AHrHrHs$Hsv .DWWHITE AC4591001C4591001 1009 10091365AADVERSE EVENT 1 right arm fracture Upper limb fracture FINJURY, POISONING AND PROCEDURAL COMPLICATIONS Arm fracture FVgFRLimb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications F2021-03-19 B] .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDWV B<....... N NNOT RELATEDOTHER accidental injury NOT APPLICABLE YNRECOVERING/RESOLVING N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVDHrDWDģHs#Follow Up 1 A0Y A 2021-03-29T15:53:38Y 100913661009Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVD<Hr<DWD|HsPlacebo APlacebo ADVD<..Y . . .Placebo DWdDWYPhase 3A@NNEGDWPlacebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWADWDWDD|DXDXBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBBC@AHr<Hs Hs9Hs .DWWHITE AC4591001C4591001 1009 10091366AADVERSE EVENT 1 Mild Injection Site Pain Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-02-26T20:00BH2021-02-27 BI 1MedDRA v24.0NDWA AEHs JDWBA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A B APeriod 01DVD<Hr<DWDHs9Vaccination 2 A Y A 2021-06-09T18:40:17 AE onset date changed from EUA to sBLA 100913701009BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADVDHr DWDXHrNXBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADVDDWDXY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW,DWYPhase 3A@NNEGDW ....... . .NY.DWDWBB?C0AHr HrNX.. .DWWHITE AC4591001C4591001 1009 10091370AADVERSE EVENT 1 headache Headache FNERVOUS SYSTEM DISORDERS Headache FFHeadaches NEC FHeadaches FNervous system disorders F2021-01-06 B2021-01-06 B 3MedDRA v24.0NDW B..DWB..ADAYSN NNOT RELATEDOTHER braces tightening NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A0GRADE 3A0 . APeriod 01DVDHr DX}DXHtVaccination 1 AY A2021-01-10T22:00:09 100913791009Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDTHrDWDlHslPlacebo APlacebo ADVDTDWDzY . . .Placebo Placebo DW6DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDlDWDXeBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBkBlBAHrHrHst,Hsl .DWWHITE AC4591001C4591001 1009 10091379AADVERSE EVENT 1 BRUISED KNEE, LEFT Contusion FINJURY, POISONING AND PROCEDURAL COMPLICATIONS Contusion of knee FF\Skin injuries NEC FInjuries NEC FInjury, poisoning and procedural complications F2021-03-22 B[2021-04-09 Bm 2MedDRA v24.0NDWY BD..DWkBV..BDAYSN NNOT RELATEDOTHER FALL INJURY NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVDTHrDWDHst+Follow Up 1 A0Y A 2021-07-09T21:02:10Y 100913791009Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDTHrDWDlHslPlacebo APlacebo ADVDTDWDzY . . .Placebo Placebo DW6DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDlDWDXeBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBkBlBAHrHrHst,Hsl .DWWHITE AC4591001C4591001 1009 10091379A ADVERSE EVENT 2 GROUND LEVEL FALL Fall FINJURY, POISONING AND PROCEDURAL COMPLICATIONS Fall FխFխNon-site specific injuries NEC F Injuries NEC FInjury, poisoning and procedural complications F2021-02-26 BC2021-02-26 BC 2MedDRA v24.0NDWA B,..DWAB,..ADAYSN NNOT RELATEDOTHER TRIP OVER SCOOTER NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVDTHrDWDHst+Follow Up 1 A0Y A 2021-03-22T21:44:46 100913791009Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDTHrDWDlHslPlacebo APlacebo ADVDTDWDzY . . .Placebo Placebo DW6DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDlDWDXeBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBkBlBAHrHrHst,Hsl .DWWHITE AC4591001C4591001 1009 10091379A0ADVERSE EVENT 3 bilateral great toe ingrown toenail Ingrowing nail F5SKIN AND SUBCUTANEOUS TISSUE DISORDERS Ingrown toe nail FF}Nail and nail bed conditions (excl infections and infestations) FSkin appendage conditions F5Skin and subcutaneous tissue disorders F52021-06-03 B .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDW B....... N NNOT RELATEDOTHER physiologic NOT APPLICABLE YNNOT RECOVERED/NOT RESOLVED N A0NOT RELATEDA0AGRADE 1A . A Period 02DWDHst,DYDlHuqVaccination 3 APY A02021-06-15T18:40:08Y 100913801009Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDDHrQDDWDHs3$Placebo APlacebo ADWDDDWDݸY . . .Placebo Placebo DW=DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDTDDWDXBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBHBdBAHrQDHr8Hs+THs3$ .DWWHITE AC4591001C4591001 1009 10091380AADVERSE EVENT 1 Right Clavicle Fracture Clavicle fracture FINJURY, POISONING AND PROCEDURAL COMPLICATIONS Clavicle fracture FFLimb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications F2021-01-18T20:30B2021-02-22 B8 2MedDRA v24.0NDW BEHrHDW=B8..B$DAYSN NNOT RELATEDOTHER Snowboarding Accident NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A Dqo APeriod 01DWDDHrQDDWDSHs+SVaccination 1 AY A2021-07-09T20:56:58 AE outcome changed from EUA to sBLA 100913801009Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDDHrQDDWDHs3$Placebo APlacebo ADWDDDWDݸY . . .Placebo Placebo DW=DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDTDDWDXBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBHBdBAHrQDHr8Hs+THs3$ .DWWHITE AC4591001C4591001 1009 10091380A ADVERSE EVENT 2 pain after wisdom teeth removal Procedural pain FINJURY, POISONING AND PROCEDURAL COMPLICATIONS Post procedural pain FXFNon-site specific procedural complications F Procedural related injuries and complications NEC FInjury, poisoning and procedural complications F2021-02-11 B-2021-02-15 B1 1MedDRA v24.0NDW2 B..DW6B..APDAYSN NNOT RELATEDOTHER wisdom teeth removal NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DWDDHrQDDWDSHs+SVaccination 2 A Y A 2021-02-24T09:04:45 100913821009Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADW DHr:DWD8HsLPlacebo APlacebo ADW DDW!DY . . .Placebo Placebo DW@DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDpD8DWDX^BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBqBAHr:Hr|Hsn5pHsL .DWWHITE AC4591001C4591001 1009 10091382AADVERSE EVENT 1 RIGHT KNEE PAIN Arthralgia FkMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Knee pain F5F'Joint related signs and symptoms F:Joint disorders F-Musculoskeletal and connective tissue disorders Fk2021-01-10 Ap2021-01-25 B 2MedDRA v24.0NDW Ap..DW!B..BDAYSN NNOT RELATEDOTHER DANCING OVERUSE NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DW DHr:DWDoHsn5oVaccination 1 AY A2021-03-08T22:08:58 100913821009Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADW DHr:DWD8HsLPlacebo APlacebo ADW DDW!DY . . .Placebo Placebo DW@DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDpD8DWDX^BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBqBAHr:Hr|Hsn5pHsL .DWWHITE AC4591001C4591001 1009 10091382A ADVERSE EVENT 2 chills Chills FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills FFFeelings and sensations NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2021-06-03 B2021-06-03 B 1MedDRA v24.0NDW A ..DWA ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDpHsn5pDYD8Huh8Vaccination 4 A`Y A@2021-06-15T18:42:14Y 100913821009Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADW DHr:DWD8HsLPlacebo APlacebo ADW DDW!DY . . .Placebo Placebo DW@DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDpD8DWDX^BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBqBAHr:Hr|Hsn5pHsL .DWWHITE AC4591001C4591001 1009 10091382A0ADVERSE EVENT 5 dizziness Dizziness FNERVOUS SYSTEM DISORDERS Dizziness F˅F˅Neurological signs and symptoms NEC FNeurological disorders NEC FNervous system disorders F2021-05-15 B2021-05-16 B 1MedDRA v24.0NDW A ..DWA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDpHsn5pDYD8Huh8Vaccination 3 APY A02021-07-13T23:16:01Y 100913821009Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADW DHr:DWD8HsLPlacebo APlacebo ADW DDW!DY . . .Placebo Placebo DW@DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDpD8DWDX^BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBqBAHr:Hr|Hsn5pHsL .DWWHITE AC4591001C4591001 1009 10091382A@ADVERSE EVENT 3 generalized muscle pain Myalgia FkMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Muscle pain F"F{Muscle pains F#Muscle disorders FMusculoskeletal and connective tissue disorders Fk2021-05-15 B2021-05-20 B 1MedDRA v24.0NDW A ..DWAp..A`DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDpHsn5pDYD8Huh8Vaccination 3 APY A02021-07-13T23:15:38Y 100913821009Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADW DHr:DWD8HsLPlacebo APlacebo ADW DDW!DY . . .Placebo Placebo DW@DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDpD8DWDX^BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBqBAHr:Hr|Hsn5pHsL .DWWHITE AC4591001C4591001 1009 10091382APADVERSE EVENT 7 nausea Nausea FܛGASTROINTESTINAL DISORDERS Nausea F F Nausea and vomiting symptoms FGastrointestinal signs and symptoms FGastrointestinal disorders Fܛ2021-05-15 B2021-05-17 B 1MedDRA v24.0NDW A ..DWA@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDpHsn5pDYD8Huh8Vaccination 3 APY A02021-07-13T23:16:24Y 100913821009Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADW DHr:DWD8HsLPlacebo APlacebo ADW DDW!DY . . .Placebo Placebo DW@DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDpD8DWDX^BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBqBAHr:Hr|Hsn5pHsL .DWWHITE AC4591001C4591001 1009 10091382A`ADVERSE EVENT 6 rhinorrhea Rhinorrhoea F-RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS Rhinorrhea F/<F/=Upper respiratory tract signs and symptoms FKiRespiratory tract signs and symptoms F}Respiratory, thoracic and mediastinal disorders F-2021-05-15 B2021-05-17 B 1MedDRA v24.0NDW A ..DWA@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDpHsn5pDYD8Huh8Vaccination 3 APY A02021-07-13T23:16:13Y 100913991009Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDHr@DWDHsϐPlacebo APlacebo ADWDDW%DY . . .Placebo Placebo DWADWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDPDDXDXBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBB#B$BAHr@HrHsHsϐ .DWWHITE AC4591001C4591001 1009 10091399AADVERSE EVENT 1 Left Fifth Metatarsal Fracture Foot fracture FINJURY, POISONING AND PROCEDURAL COMPLICATIONS Fractured metatarsal FFLimb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications F2021-02-23 B/2021-05-15 B 2MedDRA v24.0NDW> B..DWBk..BRDAYSN NNOT RELATEDOTHER Injury NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DWDHr@DWDOHsVaccination 2 A Y A 2021-07-09T20:10:07 AE outcome changed from EUA to sBLA 100914001009Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWD`HrU`DWDHsPlacebo APlacebo ADWD`DW3DY . . .Placebo Placebo DWODWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW.D.DX4DXBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBA@BBAHrU`HrG@HsHs .DWWHITE AC4591001C4591001 1009 10091400AADVERSE EVENT 1 Eczema generalized Eczema F5SKIN AND SUBCUTANEOUS TISSUE DISORDERS Eczema FFDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F52021-04-02 BU2021-04-04 BW 2MedDRA v24.0NDWd B2..DWfB4..A0DAYSN NNOT RELATEDOTHER Unknown NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DWD`HrU`DWDHsFollow Up 1 A0Y A 2021-04-23T19:21:58Y 100914001009Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWD`HrU`DWDHsPlacebo APlacebo ADWD`DW3DY . . .Placebo Placebo DWODWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW.D.DX4DXBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBA@BBAHrU`HrG@HsHs .DWWHITE AC4591001C4591001 1009 10091400A ADVERSE EVENT 2 Urticaria generalized Urticaria F5SKIN AND SUBCUTANEOUS TISSUE DISORDERS Urticaria generalised FcFMUrticarias FMAngioedema and urticaria FSkin and subcutaneous tissue disorders F52021-04-07 BZ2021-04-14 Ba 3MedDRA v24.0NDWi B7..DWpB>..ADAYSN NNOT RELATEDOTHER Unknown NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A0GRADE 3A0 . APeriod 01DWD`HrU`DWDHsFollow Up 1 A0Y A 2021-04-23T19:22:09Y 100914011009Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDИHrhDWD(Hs¨Placebo APlacebo ADWDИDW%D Y . . .Placebo Placebo DWADWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD8D(DXDXBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBB B&BAHrhHr&Hs8Hs¨ .DWWHITE AC4591001C4591001 1009 10091401AADVERSE EVENT 1 motion sickness Motion sickness F)EAR AND LABYRINTH DISORDERS Motion sickness FFInner ear signs and symptoms FInner ear and VIIIth cranial nerve disorders FEar and labyrinth disorders F)2021-08-08 B2021-08-08 B 1MedDRA v24.0NDW Ap..DWAp..ADAYSN NNOT RELATEDOTHER unknown NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . A Period 02DWD8Hs8DY`D(Hu(Vaccination 3 APY A02021-08-23T18:40:28Y 100914031009Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWD܌HrtDWVD<Hs$<Placebo APlacebo ADWD܌DW#DY . . .Placebo Placebo DW<DW<YPhase 3A@NNEGDW= BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW?DWVDD<DWuDXBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DW<DWB-BBBAHrtHr'Hsq$Hs$< .DW>WHITE AC4591001C4591001 1009 10091403AADVERSE EVENT 1 runny nose Rhinorrhoea F-RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS Runny nose F0F/=Upper respiratory tract signs and symptoms FKiRespiratory tract signs and symptoms F}Respiratory, thoracic and mediastinal disorders F-2021-01-10 A02021-01-13 A` 1MedDRA v24.0NDW A0..DWA`..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . APeriod 01DWD܌HrtDW?DHsq#Vaccination 1 AY A2021-02-02T00:45:55 100914051009Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWEHrȘDWD HszPlacebo APlacebo ADWEDW%DY . . .Placebo Placebo DWADWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDD DXDXBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBB%B&BAHrȘHr HsC,Hsz .DWWHITE AC4591001C4591001 1009 10091405AADVERSE EVENT 2 fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-08-20 B2021-08-21 B 2MedDRA v24.0NDW A ..DWA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWDHsC,DY\D HuϮ Vaccination 4 A`Y A@2021-08-23T21:20:58Y 100914051009Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWEHrȘDWD HszPlacebo APlacebo ADWEDW%DY . . .Placebo Placebo DWADWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDD DXDXBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBB%B&BAHrȘHr HsC,Hsz .DWWHITE AC4591001C4591001 1009 10091405A ADVERSE EVENT 3 headache Headache FNERVOUS SYSTEM DISORDERS Headache FFHeadaches NEC FHeadaches FNervous system disorders F2021-08-20 B2021-08-21 B 1MedDRA v24.0NDW A ..DWA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDHsC,DY\D HuϮ Vaccination 4 A`Y A@2021-08-23T21:21:10Y 100914051009Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWEHrȘDWD HszPlacebo APlacebo ADWEDW%DY . . .Placebo Placebo DWADWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDD DXDXBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBB%B&BAHrȘHr HsC,Hsz .DWWHITE AC4591001C4591001 1009 10091405A0ADVERSE EVENT 4 left axillary adenopathy Lymphadenopathy FQBLOOD AND LYMPHATIC SYSTEM DISORDERS Axillary adenopathy FFLymphatic system disorders NEC FSpleen, lymphatic and reticuloendothelial system disorders F9)Blood and lymphatic system disorders FQ2021-08-20 B .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDW A ....... N NRELATED NOT APPLICABLE NNNOT RECOVERED/NOT RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDHsC,DY\D HuϮ Vaccination 4 A`Y A@2021-08-23T21:21:23Y 100914051009Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWEHrȘDWD HszPlacebo APlacebo ADWEDW%DY . . .Placebo Placebo DWADWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDD DXDXBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBB%B&BAHrȘHr HsC,Hsz .DWWHITE AC4591001C4591001 1009 10091405A@ADVERSE EVENT 1 fever Pyrexia FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F.F)Febrile disorders FBody temperature conditions FGeneral disorders and administration site conditions F2021-08-20 B2021-08-20 B 1MedDRA v24.0NDW A ..DWA ..ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDHsC,DY\D HuϮ Vaccination 4 A`Y A@2021-08-23T21:20:46Y 100914061009Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWEHrȘhDWDHszPPlacebo APlacebo ADWEDW%DPY . . .Placebo Placebo DWADWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDdDDXDXBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBB&B&BAHrȘhHrHsdHszP .DWWHITE AC4591001C4591001 1009 10091406AADVERSE EVENT 2 fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-08-20 B2021-08-21 B 2MedDRA v24.0NDW A ..DWA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWDdHsdDY\DHuϭVaccination 4 A`Y A@2021-08-23T21:20:22Y 100914061009Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWEHrȘhDWDHszPPlacebo APlacebo ADWEDW%DPY . . .Placebo Placebo DWADWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDdDDXDXBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBB&B&BAHrȘhHrHsdHszP .DWWHITE AC4591001C4591001 1009 10091406A ADVERSE EVENT 3 headache Headache FNERVOUS SYSTEM DISORDERS Headache FFHeadaches NEC FHeadaches FNervous system disorders F2021-08-20 B2021-08-21 B 1MedDRA v24.0NDW A ..DWA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDdHsdDY\DHuϭVaccination 4 A`Y A@2021-08-24T15:12:40Y 100914061009Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWEHrȘhDWDHszPPlacebo APlacebo ADWEDW%DPY . . .Placebo Placebo DWADWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDdDDXDXBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBB&B&BAHrȘhHrHsdHszP .DWWHITE AC4591001C4591001 1009 10091406A0ADVERSE EVENT 1 Swilling in bilateral knees Joint swelling FkMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Swelling of knees F=IF@Joint related signs and symptoms F:Joint disorders F-Musculoskeletal and connective tissue disorders Fk2021-01-25 B2021-03-01 B5 1MedDRA v24.0NDW! B..DWDB5..B$DAYSN NNOT RELATEDOTHER activity related, exercise NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DWEHrȘhDWDcHscVaccination 1 AY A2021-07-09T20:45:30 AE outcome changed from EUA to sBLA 100914061009Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWEHrȘhDWDHszPPlacebo APlacebo ADWEDW%DPY . . .Placebo Placebo DWADWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDdDDXDXBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBB&B&BAHrȘhHrHsdHszP .DWWHITE AC4591001C4591001 1009 10091406A@ADVERSE EVENT 4 fever Pyrexia FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F.F)Febrile disorders FBody temperature conditions FGeneral disorders and administration site conditions F2021-08-20 B2021-08-21 B 1MedDRA v24.0NDW A ..DWA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDdHsdDY\DHuϭVaccination 4 A`Y A@2021-08-23T21:20:34Y 100914091009BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDHr̄DW)DHr\BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADWDDW)DY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWHDWYPhase 3A@NNEGDW ....... . .NY.DWDWBBBAHr̄Hr\.. .DWWHITE AC4591001C4591001 1009 10091409AADVERSE EVENT 1 Post Surgical Pain Procedural pain FINJURY, POISONING AND PROCEDURAL COMPLICATIONS Postoperative pain Fl7FNon-site specific procedural complications F Procedural related injuries and complications NEC FInjury, poisoning and procedural complications F2021-07-22 B .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDW B....... N NNOT RELATEDOTHER Developmental-Spinal Fusion Surgery NOT APPLICABLE YNNOT RECOVERED/NOT RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DWDHr̄DXDHtʶFollow Up 1 A0Y A 2021-08-09T15:38:52Y 100914101009BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDHrgDW(DHr&BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADWDDW(DY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWDDWYPhase 3A@NNEGDW ....... . .NY.DWDWByBqBAHrgHr&.. .DWWHITE AC4591001C4591001 1009 10091410AADVERSE EVENT 1 FATIGUE Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-02-01T20:00B2021-02-03 B 2MedDRA v24.0NDW( AEHrU@DW*A0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A B APeriod 01DWDHrgDXDHtZXVaccination 2 A Y A 2021-03-04T18:07:07 100914101009BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDHrgDW(DHr&BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADWDDW(DY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWDDWYPhase 3A@NNEGDW ....... . .NY.DWDWByBqBAHrgHr&.. .DWWHITE AC4591001C4591001 1009 10091410A ADVERSE EVENT 2 INJECTION SITE PAIN Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-02-01T20:00B2021-02-03 B 2MedDRA v24.0NDW( AEHrU@DW*A0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A B APeriod 01DWDHrgDXDHtZXVaccination 2 A Y A 2021-03-04T18:07:31 100914131009BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDިHrͼDW*DHrİBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADWDިDW*DY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWHDWYPhase 3A@NNEGDW ....... . .NY.DWDWB}BmBAHrͼHrİ.. .DWWHITE AC4591001C4591001 1009 10091413A ADVERSE EVENT 3 bilateral rib pain Musculoskeletal chest pain FkMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Rib pain FTF]Musculoskeletal and connective tissue pain and discomfort FMusculoskeletal and connective tissue disorders NEC FiMusculoskeletal and connective tissue disorders Fk2021-02-05T05:00B2021-02-05T06:30B 2MedDRA v24.0NDW, A0DFPHrPDW,A0D[HrݣADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C APeriod 01DWDިHrͼDXDHt0Vaccination 2 A Y A 2021-05-05T18:00:10Y 100914131009BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDިHrͼDW*DHrİBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADWDިDW*DY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWHDWYPhase 3A@NNEGDW ....... . .NY.DWDWB}BmBAHrͼHrİ.. .DWWHITE AC4591001C4591001 1009 10091413A0ADVERSE EVENT 2 Post Surgical Right Leg Pain Procedural pain FINJURY, POISONING AND PROCEDURAL COMPLICATIONS Postoperative pain Fl7FNon-site specific procedural complications F Procedural related injuries and complications NEC FInjury, poisoning and procedural complications F2021-03-16 B@2021-03-30 BN 2MedDRA v24.0NDWS B*..DWaB8..ADAYSN NNOT RELATEDOTHER Post Surgical pain NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DWDިHrͼDXDHt0Follow Up 1 A0Y A 2021-07-09T19:57:59Y 101318241013BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsABLACK OR AFRICAN AMERICAN A FA NOT HISPANIC OR LATINOA USABLACK OR AFRICAN AMERICAN A DVDHr7DVDИHrBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADVDDVDИY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWDWYPhase 3A@NNEGDW ....... . .NY.DWDWBBkC@AHr7Hr.. .DWBLACK OR AFRICAN AMERICANA C4591001C4591001 1013 10131824AADVERSE EVENT 1 SWELLING LEFT ARM Peripheral swelling FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Swelling arm F=8FUGeneral signs and symptoms NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2020-12-05 AP2020-12-06 A` 1MedDRA v24.0NDV AP..DVA`..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . APeriod 01DVDHr7DXlDИHt2Vaccination 1 AY A2020-12-22T23:55:37 101318391013Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDTHrDWD HrP Placebo APlacebo ADVDTDWD Y . . .Placebo Placebo DWDWYPhase 3A@NNEGDW ....... . .NN.DWDWBB@C0AHrHrP .. .DWWHITE AC4591001C4591001 1013 10131839AADVERSE EVENT 1 SPORTS RELATED CONCUSSION Concussion FINJURY, POISONING AND PROCEDURAL COMPLICATIONS Concussion FFCerebral injuries NEC FdInjuries NEC FInjury, poisoning and procedural complications F2021-03-01 BZ .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDWD BE....... N NNOT RELATEDOTHER INJURY NOT APPLICABLE NNRECOVERING/RESOLVING N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVDTHrDXmD HtFollow Up 1 A0Y A 2021-03-31T18:21:42 Minor AE term changed from EUA to sBLA 101613161016Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHHrYHDWSD̜Hs Placebo APlacebo ADVDH..Y . . .Placebo DVDW=YPhase 3A@NNEGDW> BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW@DWSDlD̜DWoDXBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DW=DWBBBC AHrYHHrYHHslHs  .DW?WHITE AC4591001C4591001 1016 10161316AADVERSE EVENT 2 chills Chills FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills FFFeelings and sensations NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2021-02-26 B2021-02-26 B 2MedDRA v24.0NDWA A ..DWAA ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DW@DlHslDXD̜HuVaccination 3 APY A02021-03-02T22:52:38 101613161016Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHHrYHDWSD̜Hs Placebo APlacebo ADVDH..Y . . .Placebo DVDW=YPhase 3A@NNEGDW> BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW@DWSDlD̜DWoDXBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DW=DWBBBC AHrYHHrYHHslHs  .DW?WHITE AC4591001C4591001 1016 10161316A ADVERSE EVENT 1 muscle pain Myalgia FkMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Muscle pain F"F{Muscle pains F#Muscle disorders FMusculoskeletal and connective tissue disorders Fk2021-02-26 B2021-02-26 B 2MedDRA v24.0NDWA A ..DWAA ..ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DW@DlHslDXD̜HuVaccination 3 APY A02021-03-02T22:52:29 101613271016Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDXHr^XDWDHs8Placebo APlacebo ADVDXDVDY . . .Placebo Placebo DVDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDtDDWDXrBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBB^BqCAHr^XHrzg$HsFtHs8 .DWWHITE AC4591001C4591001 1016 10161327A ADVERSE EVENT 2 syncope Syncope FNERVOUS SYSTEM DISORDERS Syncope F=F=Disturbances in consciousness NEC FENeurological disorders NEC FNervous system disorders F2021-04-09 B2021-04-09 B 2MedDRA v24.0NDWk B..DWkB..ADAYSN NNOT RELATEDOTHER unknown-possible dehydration NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVDXHr^XDWDsHsFsFollow Up 1 A0Y A 2021-08-26T21:00:15Y 101613291016Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHr^DWD\Hs\Placebo APlacebo ADVDDVDY . . .Placebo Placebo DVDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDԔD\DWDXeBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBkBmCAHr^Hrz Hsu!Hs\ .DWWHITE AC4591001C4591001 1016 10161329AADVERSE EVENT 2 cellulitis of left foot Cellulitis FINFECTIONS AND INFESTATIONS Cellulitis of foot FgFJBacterial infections NEC FOBacterial infectious disorders F2Infections and infestations F2021-07-06 C@2021-07-16 C 1MedDRA v24.0NDW B..DWB&..ADAYSN NNOT RELATEDOTHER bacterial infection secondary to puncture wound NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . A Period 02DWDԔHsu!DYD\HurVaccination 4 A`Y A@2021-09-13T16:25:27Y 101613291016Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHr^DWD\Hs\Placebo APlacebo ADVDDVDY . . .Placebo Placebo DVDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDԔD\DWDXeBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBkBmCAHr^Hrz Hsu!Hs\ .DWWHITE AC4591001C4591001 1016 10161329A ADVERSE EVENT 1 left foot puncture would Wound FINJURY, POISONING AND PROCEDURAL COMPLICATIONS Puncture wound FUFcLNon-site specific injuries NEC F Injuries NEC FInjury, poisoning and procedural complications F2021-07-04 C 2021-07-24 C` 1MedDRA v24.0NDW B..DWB...BDAYSN NNOT RELATEDOTHER accidental trauma NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . A Period 02DWDԔHsu!DYD\HurVaccination 4 A`Y A@2021-09-13T16:24:40Y 101613441016Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDPHraPDWDHs>Placebo APlacebo ADVDPDVDۜY . . .Placebo Placebo DVDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBkBmCAHraPHr{Hst0Hs> .DWWHITE AC4591001C4591001 1016 10161344AADVERSE EVENT 2 infectious mononuclesosis Infectious mononucleosis FINFECTIONS AND INFESTATIONS Infectious mononucleosis FFEpstein-Barr viral infections FуViral infectious disorders FOInfections and infestations F2020-11-25 B#2021-01-06 BM 1MedDRA v24.0NDV A..DWB9..B+DAYSN NNOT RELATEDOTHER mono infection NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVDPHraPDWDHst/Vaccination 2 A Y A 2021-03-05T20:11:26 101613441016Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDPHraPDWDHs>Placebo APlacebo ADVDPDVDۜY . . .Placebo Placebo DVDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBkBmCAHraPHr{Hst0Hs> .DWWHITE AC4591001C4591001 1016 10161344A ADVERSE EVENT 1 enlarged lymph nodes, right anterior cervical nodes Lymphadenopathy FQBLOOD AND LYMPHATIC SYSTEM DISORDERS Lymph nodes cervical swollen FFLymphatic system disorders NEC FSpleen, lymphatic and reticuloendothelial system disorders F9)Blood and lymphatic system disorders FQ2020-11-25 B#2021-01-06 BM 1MedDRA v24.0NDV A..DWB9..B+DAYSN NNOT RELATEDOTHER mono NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVDPHraPDWDHst/Vaccination 2 A Y A 2021-03-05T20:10:44 101613531016Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHr<DWD,Hs*Placebo APlacebo ADVDDWD Y . . .Placebo Placebo DWDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDD,DWDXjBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBfBpCPAHr<Hr Hs{Hs* .DWWHITE AC4591001C4591001 1016 10161353A ADVERSE EVENT 4 chills Chills FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills FFFeelings and sensations NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2021-06-14 B2021-06-15 B 2MedDRA v24.0NDW A..DWA ..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWDHs{DYD,Hux^,Vaccination 4 A`Y A@2021-06-16T19:34:06Y 101613531016Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHr<DWD,Hs*Placebo APlacebo ADVDDWD Y . . .Placebo Placebo DWDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDD,DWDXjBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBfBpCPAHr<Hr Hs{Hs* .DWWHITE AC4591001C4591001 1016 10161353AADVERSE EVENT 3 chills Chills FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills FFFeelings and sensations NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2021-05-25T08:00B2021-05-26T08:00B 2MedDRA v24.0NDW A DpHs|DWA0DpHs}A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C: A Period 02DWDHs{DYD,Hux^,Vaccination 3 APY A02021-05-26T23:42:42Y 101613531016Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHr<DWD,Hs*Placebo APlacebo ADVDDWD Y . . .Placebo Placebo DWDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDD,DWDXjBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBfBpCPAHr<Hr Hs{Hs* .DWWHITE AC4591001C4591001 1016 10161353A0ADVERSE EVENT 2 fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-05-25T08:00B2021-05-26T08:00B 2MedDRA v24.0NDW A DpHs|DWA0DpHs}A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C: A Period 02DWDHs{DYD,Hux^,Vaccination 3 APY A02021-05-26T23:42:32Y 101613531016Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHr<DWD,Hs*Placebo APlacebo ADVDDWD Y . . .Placebo Placebo DWDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDD,DWDXjBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBfBpCPAHr<Hr Hs{Hs* .DWWHITE AC4591001C4591001 1016 10161353A@ADVERSE EVENT 7 headache Headache FNERVOUS SYSTEM DISORDERS Headache FFHeadaches NEC FHeadaches FNervous system disorders F2021-06-14 B2021-06-15 B 1MedDRA v24.0NDW A..DWA ..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDHs{DYD,Hux^,Vaccination 4 A`Y A@2021-06-16T19:34:41Y 101613531016Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHr<DWD,Hs*Placebo APlacebo ADVDDWD Y . . .Placebo Placebo DWDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDD,DWDXjBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBfBpCPAHr<Hr Hs{Hs* .DWWHITE AC4591001C4591001 1016 10161353APADVERSE EVENT 8 injection site pain Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-06-14 B2021-06-17 B 1MedDRA v24.0NDW A..DWA@..A@DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDHs{DYD,Hux^,Vaccination 4 A`Y A@2021-07-12T13:32:56Y 101613531016Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHr<DWD,Hs*Placebo APlacebo ADVDDWD Y . . .Placebo Placebo DWDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDD,DWDXjBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBfBpCPAHr<Hr Hs{Hs* .DWWHITE AC4591001C4591001 1016 10161353A`ADVERSE EVENT 1 left deltoid injection site soreness Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-05-25T08:00B2021-05-26T08:00B 1MedDRA v24.0NDW A DpHs|DWA0DpHs}A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C: A Period 02DWDHs{DYD,Hux^,Vaccination 3 APY A02021-05-26T23:42:22Y 101613531016Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHr<DWD,Hs*Placebo APlacebo ADVDDWD Y . . .Placebo Placebo DWDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDD,DWDXjBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBfBpCPAHr<Hr Hs{Hs* .DWWHITE AC4591001C4591001 1016 10161353ApADVERSE EVENT 6 body aches Pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalized aching F\FPain and discomfort NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2021-06-14 B2021-06-15 B 1MedDRA v24.0NDW A..DWA ..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDHs{DYD,Hux^,Vaccination 4 A`Y A@2021-06-16T19:34:29Y 101613531016Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHr<DWD,Hs*Placebo APlacebo ADVDDWD Y . . .Placebo Placebo DWDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDD,DWDXjBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBfBpCPAHr<Hr Hs{Hs* .DWWHITE AC4591001C4591001 1016 10161353AADVERSE EVENT 5 fever Pyrexia FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F.F)Febrile disorders FBody temperature conditions FGeneral disorders and administration site conditions F2021-06-14 B2021-06-15 B 1MedDRA v24.0NDW A..DWA ..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDHs{DYD,Hux^,Vaccination 4 A`Y A@2021-06-16T19:34:17Y 101613661016Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHrDWDـHsPlacebo APlacebo ADVDDWDPY . . .Placebo Placebo DW8DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDـDWDXBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBkBmC`AHrHr1Hsu3Hs .DWWHITE AC4591001C4591001 1016 10161366AADVERSE EVENT 1 vomiting Vomiting FܛGASTROINTESTINAL DISORDERS Vomiting FPFPNausea and vomiting symptoms FGastrointestinal signs and symptoms FGastrointestinal disorders Fܛ2021-07-08 B2021-07-09 B 1MedDRA v24.0NDW A ..DWA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDHsu3DY1DـHuVaccination 4 A`Y A@2021-08-11T19:08:19Y 101613711016Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADW DHr,DWD(HsyPlacebo APlacebo ADW DDW"DY . . .Placebo Placebo DW>DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD܌D(DWDXjBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBeBmBAHr,Hr0Hs} Hsy .DWWHITE AC4591001C4591001 1016 10161371AADVERSE EVENT 2 fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-06-15 B2021-06-17 B 1MedDRA v24.0NDW A ..DWA@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWD܌Hs} DYD(Hux(Vaccination 4 A`Y A@2021-07-12T13:52:34Y 101613711016Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADW DHr,DWD(HsyPlacebo APlacebo ADW DDW"DY . . .Placebo Placebo DW>DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD܌D(DWDXjBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBeBmBAHr,Hr0Hs} Hsy .DWWHITE AC4591001C4591001 1016 10161371A ADVERSE EVENT 1 fever, low grade Pyrexia FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Slight fever F6F)Febrile disorders FBody temperature conditions FGeneral disorders and administration site conditions F2021-06-15 B2021-06-15 B 1MedDRA v24.0NDW A ..DWA ..ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWD܌Hs} DYD(Hux(Vaccination 4 A`Y A@2021-06-16T16:15:56Y 103912461039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVD~THrTDWUDHs#*0Placebo APlacebo ADVD~TDVDY . . .Placebo Placebo DWDW=YPhase 3A@NNEGDW> BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWADWUDmDDWqDXBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DW=DWBTBBC@AHrTHr_Hs0Hs#*0 .DW@WHITE AC4591001C4591001 1039 10391246AADVERSE EVENT 1 fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-02-27 BY2021-03-01 B[ 2MedDRA v24.0NDWB A ..DWDA@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWADmHs0DXDHu]Vaccination 3 APY A02021-03-02T18:33:55 103912461039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVD~THrTDWUDHs#*0Placebo APlacebo ADVD~TDVDY . . .Placebo Placebo DWDW=YPhase 3A@NNEGDW> BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWADWUDmDDWqDXBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DW=DWBTBBC@AHrTHr_Hs0Hs#*0 .DW@WHITE AC4591001C4591001 1039 10391246A ADVERSE EVENT 6 fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-03-19 Bm2021-03-20 Bn 1MedDRA v24.0NDWV A ..DWWA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWADmHs0DXDHu]Vaccination 4 A`Y A@2021-04-15T21:52:16Y 103912461039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVD~THrTDWUDHs#*0Placebo APlacebo ADVD~TDVDY . . .Placebo Placebo DWDW=YPhase 3A@NNEGDW> BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWADWUDmDDWqDXBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DW=DWBTBBC@AHrTHr_Hs0Hs#*0 .DW@WHITE AC4591001C4591001 1039 10391246A0ADVERSE EVENT 4 headache Headache FNERVOUS SYSTEM DISORDERS Headache FFHeadaches NEC FHeadaches FNervous system disorders F2021-02-27 BY2021-03-01 B[ 1MedDRA v24.0NDWB A ..DWDA@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWADmHs0DXDHu]Vaccination 3 APY A02021-03-02T18:34:19 103912461039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVD~THrTDWUDHs#*0Placebo APlacebo ADVD~TDVDY . . .Placebo Placebo DWDW=YPhase 3A@NNEGDW> BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWADWUDmDDWqDXBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DW=DWBTBBC@AHrTHr_Hs0Hs#*0 .DW@WHITE AC4591001C4591001 1039 10391246A@ADVERSE EVENT 2 generalized achiness Pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalised aching FFPain and discomfort NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2021-02-27 BY2021-03-02 B\ 2MedDRA v24.0NDWB A ..DWEAP..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWADmHs0DXDHu]Vaccination 3 APY A02021-03-02T18:34:03 103912461039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVD~THrTDWUDHs#*0Placebo APlacebo ADVD~TDVDY . . .Placebo Placebo DWDW=YPhase 3A@NNEGDW> BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWADWUDmDDWqDXBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DW=DWBTBBC@AHrTHr_Hs0Hs#*0 .DW@WHITE AC4591001C4591001 1039 10391246APADVERSE EVENT 3 fever Pyrexia FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F.F)Febrile disorders FBody temperature conditions FGeneral disorders and administration site conditions F2021-02-27 BY2021-02-28 BZ 1MedDRA v24.0NDWB A ..DWCA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWADmHs0DXDHu]Vaccination 3 APY A02021-03-02T18:34:11 103912461039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVD~THrTDWUDHs#*0Placebo APlacebo ADVD~TDVDY . . .Placebo Placebo DWDW=YPhase 3A@NNEGDW> BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWADWUDmDDWqDXBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DW=DWBTBBC@AHrTHr_Hs0Hs#*0 .DW@WHITE AC4591001C4591001 1039 10391246A`ADVERSE EVENT 5 fever Pyrexia FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F.F)Febrile disorders FBody temperature conditions FGeneral disorders and administration site conditions F2021-03-19 Bm2021-03-20 Bn 1MedDRA v24.0NDWV A ..DWWA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWADmHs0DXDHu]Vaccination 4 A`Y A@2021-04-15T21:52:07Y 103912501039BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHrDWDwHrBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADVDDWDwY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW#DWYPhase 3A@NNEGDW ....... . .NY.DWDWBBrCAHrHr.. .DWWHITE AC4591001C4591001 1039 10391250AADVERSE EVENT 1 exacerbation of tic disorder Tic F'PSYCHIATRIC DISORDERS Tic disorder, unspecified FAFATic disorders FAChanges in physical activity FQPsychiatric disorders F'2021-01-09 B% .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDW A....... N NNOT RELATEDOTHER stress in life NOT APPLICABLE NNRECOVERING/RESOLVING N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVDHrDXrDwHtVaccination 2 A Y A 2021-01-19T20:43:24 103912511039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DVDsHrDW@DlHsLPlacebo APlacebo ADVDsDW DqY . . .Placebo Placebo DW(DW(YPhase 3A@NNEGDW) BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW)DW@DwDlDW\DWBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DW(DWB9BBCAHrHrHrHsL .DW(ALL OTHERS A0C4591001C4591001 1039 10391251AADVERSE EVENT 2 Fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-02-25T20:00BQ2021-02-27 BS 1MedDRA v24.0NDW@ AEHs@DWBA0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C. A Period 02DW)DwHrDXDlHt@Vaccination 4 A`Y A@2021-03-29T17:41:15Y 103912511039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DVDsHrDW@DlHsLPlacebo APlacebo ADVDsDW DqY . . .Placebo Placebo DW(DW(YPhase 3A@NNEGDW) BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW)DW@DwDlDW\DWBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DW(DWB9BBCAHrHrHrHsL .DW(ALL OTHERS A0C4591001C4591001 1039 10391251A ADVERSE EVENT 1 Headache Headache FNERVOUS SYSTEM DISORDERS Headache FFHeadaches NEC FHeadaches FNervous system disorders F2021-02-25T20:00BQ2021-02-27 BS 1MedDRA v24.0NDW@ AEHs@DWBA0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C. A Period 02DW)DwHrDXDlHt@Vaccination 4 A`Y A@2021-03-29T17:41:05Y 103912581039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVD Hr DWD8Hs8Placebo APlacebo ADVD DWDY . . .Placebo Placebo DW$DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDD8DWDX]BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBqBrCAHr Hr(Hsm$Hs8 .DWWHITE AC4591001C4591001 1039 10391258AADVERSE EVENT 5 Fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-06-02 B2021-06-03 B 1MedDRA v24.0NDW A ..DWA0..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDHsm$DY D8HugLVaccination 4 A`Y A@2021-07-06T21:28:46Y 103912581039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVD Hr DWD8Hs8Placebo APlacebo ADVD DWDY . . .Placebo Placebo DW$DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDD8DWDX]BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBqBrCAHr Hr(Hsm$Hs8 .DWWHITE AC4591001C4591001 1039 10391258A ADVERSE EVENT 4 Headache Headache FNERVOUS SYSTEM DISORDERS Headache FFHeadaches NEC FHeadaches FNervous system disorders F2021-06-01T16:00B2021-06-02T16:00B 1MedDRA v24.0NDW ADHsQDWA D;HsA DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A B A Period 02DWDHsm$DY D8HugLVaccination 4 A`Y A@2021-07-06T21:28:35Y 103912581039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVD Hr DWD8Hs8Placebo APlacebo ADVD DWDY . . .Placebo Placebo DW$DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDD8DWDX]BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBqBrCAHr Hr(Hsm$Hs8 .DWWHITE AC4591001C4591001 1039 10391258A0ADVERSE EVENT 3 Fever Pyrexia FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F.F)Febrile disorders FBody temperature conditions FGeneral disorders and administration site conditions F2021-06-01T16:00B2021-06-02T16:00B 1MedDRA v24.0NDW ADHsQDWA D;HsA DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A B A Period 02DWDHsm$DY D8HugLVaccination 4 A`Y A@2021-07-06T21:28:24Y 103912591039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHr'DWDdHsPlacebo APlacebo ADVDDWDY . . .Placebo Placebo DW!DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD<DdDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBrCAHr'HrHsnx<Hs .DWWHITE AC4591001C4591001 1039 10391259A ADVERSE EVENT 6 fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-06-06 B2021-06-06 B 1MedDRA v24.0NDW A0..DWA0..ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWD<Hsnx<DYDdHukQdVaccination 4 A`Y A@2021-07-02T21:10:13Y 103912591039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHr'DWDdHsPlacebo APlacebo ADVDDWDY . . .Placebo Placebo DW!DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD<DdDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBrCAHr'HrHsnx<Hs .DWWHITE AC4591001C4591001 1039 10391259AADVERSE EVENT 1 fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-05-15T10:00B2021-05-15 B 1MedDRA v24.0NDW A DHso DWA ..ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CKp A Period 02DWD<Hsnx<DYDdHukQdVaccination 3 APY A02021-06-04T21:31:25Y 103912591039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHr'DWDdHsPlacebo APlacebo ADVDDWDY . . .Placebo Placebo DW!DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD<DdDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBrCAHr'HrHsnx<Hs .DWWHITE AC4591001C4591001 1039 10391259A0ADVERSE EVENT 5 headache Headache FNERVOUS SYSTEM DISORDERS Headache FFHeadaches NEC FHeadaches FNervous system disorders F2021-06-06 B2021-06-06 B 1MedDRA v24.0NDW A0..DWA0..ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWD<Hsnx<DYDdHukQdVaccination 4 A`Y A@2021-07-02T21:10:02Y 103912591039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHr'DWDdHsPlacebo APlacebo ADVDDWDY . . .Placebo Placebo DW!DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD<DdDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBrCAHr'HrHsnx<Hs .DWWHITE AC4591001C4591001 1039 10391259A@ADVERSE EVENT 2 injection site pain Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-05-14T20:00B2021-05-21 B 1MedDRA v24.0NDW AEHsn@DWA..ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C A Period 02DWD<Hsnx<DYDdHukQdVaccination 3 APY A02021-06-04T21:31:36Y 103912591039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHr'DWDdHsPlacebo APlacebo ADVDDWDY . . .Placebo Placebo DW!DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD<DdDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBrCAHr'HrHsnx<Hs .DWWHITE AC4591001C4591001 1039 10391259APADVERSE EVENT 3 injection site pain Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-06-04T13:11B2021-06-05 B 1MedDRA v24.0NDW ADdHsDWA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A YA Period 02DWD<Hsnx<DYDdHukQdVaccination 4 A`Y A@2021-06-16T19:45:19Y 103912591039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHr'DWDdHsPlacebo APlacebo ADVDDWDY . . .Placebo Placebo DW!DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD<DdDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBrCAHr'HrHsnx<Hs .DWWHITE AC4591001C4591001 1039 10391259A`ADVERSE EVENT 4 fever Pyrexia FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F.F)Febrile disorders FBody temperature conditions FGeneral disorders and administration site conditions F2021-06-05 B2021-06-07 B 1MedDRA v24.0NDW A ..DWA@..A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWD<Hsnx<DYDdHukQdVaccination 4 A`Y A@2021-07-02T21:09:50Y 103912641039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA HISPANIC OR LATINO AUSAASIAN A@DVDHraDWDhHs{hPlacebo APlacebo ADVDDWDY . . .Placebo Placebo DWDDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW.Dh.DWDXlBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANNDWDWDWBBBBAHraHr Hs{hHs{h .DWALL OTHERS A0C4591001C4591001 1039 10391264AADVERSE EVENT 1 General muscle aches Myalgia FkMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Muscle ache FF{Muscle pains F#Muscle disorders FMusculoskeletal and connective tissue disorders Fk2021-05-25T19:00B2021-05-27 B 1MedDRA v24.0NDW A EHs}@DWA@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Cl A Period 02DWDhHs{hDYDhHu\Vaccination 3 APY A02021-06-09T19:39:48Y 103912661039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHrtDWDHsPlacebo APlacebo ADVDDWDXY . . .Placebo Placebo DW"DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDǰDDWDX_BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBrCAHrtHrXHsn|Hs .DWWHITE AC4591001C4591001 1039 10391266AADVERSE EVENT 3 Fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-06-04T22:00B2021-06-05 B 1MedDRA v24.0NDW A EVHsDWA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Cw A Period 02DWDǰHsn|DYDHuj PVaccination 4 A`Y A@2021-07-08T22:44:14Y 103912661039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHrtDWDHsPlacebo APlacebo ADVDDWDXY . . .Placebo Placebo DW"DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDǰDDWDX_BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBrCAHrtHrXHsn|Hs .DWWHITE AC4591001C4591001 1039 10391266A ADVERSE EVENT 4 Left arm muscle ache Myalgia FkMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Myalgia upper extremities FF{Muscle pains F#Muscle disorders FMusculoskeletal and connective tissue disorders Fk2021-06-04T22:00B2021-06-05 B 1MedDRA v24.0NDW A EVHsDWA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Cw A Period 02DWDǰHsn|DYDHuj PVaccination 4 A`Y A@2021-07-09T07:04:44Y 103912661039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHrtDWDHsPlacebo APlacebo ADVDDWDXY . . .Placebo Placebo DW"DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDǰDDWDX_BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBrCAHrtHrXHsn|Hs .DWWHITE AC4591001C4591001 1039 10391266A0ADVERSE EVENT 2 Body ache Pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Ache F(FPain and discomfort NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2021-06-04 B2021-06-05 B 1MedDRA v24.0NDW A ..DWA0..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDǰHsn|DYDHuj PVaccination 4 A`Y A@2021-06-09T16:50:23Y 103912661039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHrtDWDHsPlacebo APlacebo ADVDDWDXY . . .Placebo Placebo DW"DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDǰDDWDX_BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBrCAHrtHrXHsn|Hs .DWWHITE AC4591001C4591001 1039 10391266A@ADVERSE EVENT 1 Fever - max 100F Pyrexia FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F.F)Febrile disorders FBody temperature conditions FGeneral disorders and administration site conditions F2021-06-04 B2021-06-05 B 1MedDRA v24.0NDW A ..DWA0..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDǰHsn|DYDHuj PVaccination 4 A`Y A@2021-06-09T19:39:59Y 103912681039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHrwXDWDHslPlacebo APlacebo ADVDDWDpY . . .Placebo Placebo DW!DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBqBrCAHrwXHrHslxHsl .DWWHITE AC4591001C4591001 1039 10391268AADVERSE EVENT 1 Fever - up to 102.5 Pyrexia FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F.F)Febrile disorders FBody temperature conditions FGeneral disorders and administration site conditions F2021-05-14T00:00B2021-05-15T10:00B 3MedDRA v24.0NDW A HsmDWA0DHso[A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA0GRADE 3A0 C3 A Period 02DWDHslxDYDHukPVaccination 3 APY A02021-06-16T13:46:55Y 103912701039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHrDWD{HsPlacebo APlacebo ADVDDWDdY . . .Placebo Placebo DW!DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD{ D{DWDX_BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBqBrCAHrHrHslތHs .DWWHITE AC4591001C4591001 1039 10391270AADVERSE EVENT 1 Epistaxis Epistaxis F-RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS Epistaxis FrFrNasal disorders NEC FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-2020-12-23T16:00A2020-12-23T20:00A 1MedDRA v24.0NDW ADHraDWAEHr{ADAYSN NNOT RELATEDOTHER dry mucus membranes NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A DO APeriod 01DVDHrDWD{ HslދVaccination 1 AY A2021-06-08T14:58:12Y 103912701039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHrDWD{HsPlacebo APlacebo ADVDDWDdY . . .Placebo Placebo DW!DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD{ D{DWDX_BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBqBrCAHrHrHslތHs .DWWHITE AC4591001C4591001 1039 10391270A ADVERSE EVENT 2 fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-05-14 B2021-05-16 B 1MedDRA v24.0NDW A ..DWA@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWD{ HslތDYD{HuiVaccination 3 APY A02021-06-08T16:54:54Y 103912701039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHrDWD{HsPlacebo APlacebo ADVDDWDdY . . .Placebo Placebo DW!DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD{ D{DWDX_BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBqBrCAHrHrHslތHs .DWWHITE AC4591001C4591001 1039 10391270A0ADVERSE EVENT 5 fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-06-04 B2021-06-06 B 1MedDRA v24.0NDW A ..DWA@..A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWD{ HslތDYD{HuiVaccination 4 A`Y A@2021-07-01T16:11:39Y 103912701039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHrDWD{HsPlacebo APlacebo ADVDDWDdY . . .Placebo Placebo DW!DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD{ D{DWDX_BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBqBrCAHrHrHslތHs .DWWHITE AC4591001C4591001 1039 10391270A@ADVERSE EVENT 3 Injection site pain Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-05-13T19:00B2021-05-14 B 1MedDRA v24.0NDW AEHsmnDWA ..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C&p A Period 02DWD{ HslތDYD{HuiVaccination 3 APY A02021-06-08T19:10:01Y 103912701039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHrDWD{HsPlacebo APlacebo ADVDDWDdY . . .Placebo Placebo DW!DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD{ D{DWDX_BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBqBrCAHrHrHslތHs .DWWHITE AC4591001C4591001 1039 10391270A`ADVERSE EVENT 6 fever Pyrexia FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F.F)Febrile disorders FBody temperature conditions FGeneral disorders and administration site conditions F2021-06-04 B2021-06-05 B 1MedDRA v24.0NDW A ..DWA0..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWD{ HslތDYD{HuiVaccination 4 A`Y A@2021-07-01T16:11:50Y 103912701039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHrDWD{HsPlacebo APlacebo ADVDDWDdY . . .Placebo Placebo DW!DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD{ D{DWDX_BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBqBrCAHrHrHslތHs .DWWHITE AC4591001C4591001 1039 10391270APADVERSE EVENT 4 Fever Pyrexia FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F.F)Febrile disorders FBody temperature conditions FGeneral disorders and administration site conditions F2021-05-14T14:00B2021-05-14T16:00B 1MedDRA v24.0NDW A DHsnyDWA D;Hsn;ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Cm A Period 02DWD{ HslތDYD{HuiVaccination 3 APY A02021-06-08T19:10:11Y 103912711039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHrDWDHsPlacebo APlacebo ADVDDWDY . . .Placebo Placebo DW!DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDTDDWDX_BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBqBrCAHrHrјHslHs .DWWHITE AC4591001C4591001 1039 10391271AADVERSE EVENT 1 Headache Headache FNERVOUS SYSTEM DISORDERS Headache FFHeadaches NEC FHeadaches FNervous system disorders F2021-05-14T16:00B2021-05-14T21:00B 2MedDRA v24.0NDW A DHsnDWA ExHsn܋ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A ClP A Period 02DWDTHslDYDHuiVaccination 3 APY A02021-06-07T18:38:12Y 103912711039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHrDWDHsPlacebo APlacebo ADVDDWDY . . .Placebo Placebo DW!DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDTDDWDX_BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBqBrCAHrHrјHslHs .DWWHITE AC4591001C4591001 1039 10391271A ADVERSE EVENT 2 headache Headache FNERVOUS SYSTEM DISORDERS Headache FFHeadaches NEC FHeadaches FNervous system disorders F2021-06-04T10:00B2021-06-04T12:00B 2MedDRA v24.0NDW A DHs DWA DHs {ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A CQ A Period 02DWDTHslDYDHuiVaccination 4 A`Y A@2021-07-14T20:18:47Y 103912731039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDhHrhDWDHsPlacebo APlacebo ADVDhDWDY . . .Placebo Placebo DW!DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDX_BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBqBrCAHrhHr\HslHs .DWWHITE AC4591001C4591001 1039 10391273AADVERSE EVENT 1 Fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-05-14T07:00B2021-05-14T17:00B 1MedDRA v24.0NDW A DbpHsnpDWA DKHsnKADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CJ A Period 02DWDHslDYDHuiVaccination 3 APY A02021-06-07T18:38:34Y 103912731039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDhHrhDWDHsPlacebo APlacebo ADVDhDWDY . . .Placebo Placebo DW!DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDX_BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBqBrCAHrhHr\HslHs .DWWHITE AC4591001C4591001 1039 10391273A ADVERSE EVENT 2 Injection site soreness Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-05-14T07:00B2021-05-15 B 1MedDRA v24.0NDW A DbpHsnpDWA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CJ A Period 02DWDHslDYDHuiVaccination 3 APY A02021-06-08T14:35:21Y 103912741039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVD{HrDWDqHshPlacebo APlacebo ADVD{DW DpDY . . .Placebo Placebo DW(DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDtDqDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBqCPAHrHrDHsnOtHsh .DWWHITE AC4591001C4591001 1039 10391274AADVERSE EVENT 2 exacerbation of pineapple food allergy Food allergy F4IMMUNE SYSTEM DISORDERS Fruit allergy FvFزAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,Immune system disorders F42021-07-01 B2021-07-01 B 1MedDRA v24.0NDW B..DWB..ADAYSN NNOT RELATEDOTHER allergies NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . A Period 02DWDtHsnOtDYDqHuk Vaccination 4 A`Y A@2021-07-07T08:14:27Y 103912741039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVD{HrDWDqHshPlacebo APlacebo ADVD{DW DpDY . . .Placebo Placebo DW(DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDtDqDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBqCPAHrHrDHsnOtHsh .DWWHITE AC4591001C4591001 1039 10391274A ADVERSE EVENT 1 post nasal drip Upper-airway cough syndrome F-RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS Postnasal drip F$FUpper respiratory tract signs and symptoms FKiRespiratory tract signs and symptoms F}Respiratory, thoracic and mediastinal disorders F-2021-07-01 B2021-07-06 B 1MedDRA v24.0NDW B..DWB!..A`DAYSN NNOT RELATEDOTHER allergies NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . A Period 02DWDtHsnOtDYDqHuk Vaccination 4 A`Y A@2021-07-06T23:25:56Y 103912791039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDPHrDWD<Hs<Placebo APlacebo ADVDPDWDY . . .Placebo Placebo DW/DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDpD<DWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBmBqCPAHrHrŶHsrGHs< .DWWHITE AC4591001C4591001 1039 10391279AADVERSE EVENT 6 Chills Chills FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills FFFeelings and sensations NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2021-06-07T22:00B2021-06-08T23:59B 1MedDRA v24.0NDW AEVHs`DWA EHsA DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C*p A Period 02DWDpHsrGDYD<Huo"Vaccination 4 A`Y A@2021-07-14T20:19:33Y 103912791039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDPHrDWD<Hs<Placebo APlacebo ADVDPDWDY . . .Placebo Placebo DW/DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDpD<DWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBmBqCPAHrHrŶHsrGHs< .DWWHITE AC4591001C4591001 1039 10391279A0ADVERSE EVENT 2 fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-05-18T10:00B2021-05-19T10:00B 1MedDRA v24.0NDW A DHssDWA0DHst[A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CU@ A Period 02DWDpHsrGDYD<Huo"Vaccination 3 APY A02021-06-07T20:55:40Y 103912791039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDPHrDWD<Hs<Placebo APlacebo ADVDPDWDY . . .Placebo Placebo DW/DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDpD<DWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBmBqCPAHrHrŶHsrGHs< .DWWHITE AC4591001C4591001 1039 10391279A ADVERSE EVENT 4 Fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-06-07T22:00B2021-06-08T23:59B 1MedDRA v24.0NDW AEVHs`DWA EHsA DAYSN NRELATED NOT APPLICABLE YYRECOVERED/RESOLVED N ARELATED AAGRADE 1A C*p A Period 02DWDpHsrGDYD<Huo"Vaccination 4 A`Y A@2021-07-14T20:18:27Y 103912791039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDPHrDWD<Hs<Placebo APlacebo ADVDPDWDY . . .Placebo Placebo DW/DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDpD<DWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBmBqCPAHrHrŶHsrGHs< .DWWHITE AC4591001C4591001 1039 10391279APADVERSE EVENT 1 injection site pain Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-05-17T17:00B2021-05-19 B 1MedDRA v24.0NDW ADHsrDWA0..A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C A Period 02DWDpHsrGDYD<Huo"Vaccination 3 APY A02021-06-07T20:55:29Y 103912791039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDPHrDWD<Hs<Placebo APlacebo ADVDPDWDY . . .Placebo Placebo DW/DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDpD<DWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBmBqCPAHrHrŶHsrGHs< .DWWHITE AC4591001C4591001 1039 10391279A@ADVERSE EVENT 5 Injection site pain Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-06-07T17:00B2021-06-08T23:59B 1MedDRA v24.0NDW ADHsHDWA EHsA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C A Period 02DWDpHsrGDYD<Huo"Vaccination 4 A`Y A@2021-07-06T19:27:14Y 103912791039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDPHrDWD<Hs<Placebo APlacebo ADVDPDWDY . . .Placebo Placebo DW/DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDpD<DWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBmBqCPAHrHrŶHsrGHs< .DWWHITE AC4591001C4591001 1039 10391279A`ADVERSE EVENT 3 Body aches Pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalized aching F\FPain and discomfort NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2021-06-07T22:00B2021-06-08T23:59B 1MedDRA v24.0NDW AEVHs`DWA EHsA DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C*p A Period 02DWDpHsrGDYD<Huo"Vaccination 4 A`Y A@2021-07-06T19:26:51Y 103912801039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHrDWDdHs,Placebo APlacebo ADVDDWDlY . . .Placebo Placebo DW+DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD{DdDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBqC@AHrHrHsn0Hs, .DWWHITE AC4591001C4591001 1039 10391280AADVERSE EVENT 2 Injection site soreness Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-05-15T07:00B2021-05-18T12:00B 1MedDRA v24.0NDW A DbpHsohDWAPDHssA@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CS@ A Period 02DWD{Hsn0DYDdHuk`dVaccination 3 APY A02021-06-07T16:54:55Y 103912801039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHrDWDdHs,Placebo APlacebo ADVDDWDlY . . .Placebo Placebo DW+DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD{DdDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBqC@AHrHrHsn0Hs, .DWWHITE AC4591001C4591001 1039 10391280A ADVERSE EVENT 1 Vasovagal episode Presyncope FNERVOUS SYSTEM DISORDERS Vaso vagal attack FNF%Neurological signs and symptoms NEC FNeurological disorders NEC FNervous system disorders F2021-02-04T09:29B22021-02-04T10:10B2 1MedDRA v24.0NDW+ BD\HrDW+BD3Hr뿳ADAYSN NNOT RELATEDOTHER Blood draw during visit 3 NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A DD APeriod 01DVDHrDWD{Hsn0Vaccination 2 A Y A 2021-06-07T16:54:45Y 103912831039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHrk DWD4Hs4Placebo APlacebo ADVDDWDlY . . .Placebo Placebo DW+DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDsD4DWDX_BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBqBqC0AHrk HrƳHsl֔Hs4 .DWWHITE AC4591001C4591001 1039 10391283AADVERSE EVENT 2 Fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-05-14 B2021-05-16 B 2MedDRA v24.0NDW A ..DWA@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWDsHsl֔DYD4HujVaccination 3 APY A02021-06-07T16:55:17Y 103912831039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHrk DWD4Hs4Placebo APlacebo ADVDDWDlY . . .Placebo Placebo DW+DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDsD4DWDX_BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBqBqC0AHrk HrƳHsl֔Hs4 .DWWHITE AC4591001C4591001 1039 10391283A ADVERSE EVENT 1 Headache Headache FNERVOUS SYSTEM DISORDERS Headache FFHeadaches NEC FHeadaches FNervous system disorders F2021-05-14 B2021-05-16 B 2MedDRA v24.0NDW A ..DWA@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWDsHsl֔DYD4HujVaccination 3 APY A02021-06-07T16:55:06Y 103912831039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHrk DWD4Hs4Placebo APlacebo ADVDDWDlY . . .Placebo Placebo DW+DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDsD4DWDX_BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBqBqC0AHrk HrƳHsl֔Hs4 .DWWHITE AC4591001C4591001 1039 10391283A0ADVERSE EVENT 3 Injection site soreness Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-05-13T15:00B2021-05-15 B 1MedDRA v24.0NDW ADHsm6pDWA0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C A Period 02DWDsHsl֔DYD4HujVaccination 3 APY A02021-06-07T16:55:28Y 103912851039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDdHrtDWDt@HsPlacebo APlacebo ADVDdDWD|tY . . .Placebo Placebo DW,DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDxDt@DWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBrC0AHrtHrtHsn-Hs .DWWHITE AC4591001C4591001 1039 10391285AADVERSE EVENT 7 Generalized Arthralgia Arthralgia FkMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Arthralgia F'F'Joint related signs and symptoms F:Joint disorders F-Musculoskeletal and connective tissue disorders Fk2021-06-04T14:00B2021-06-05 B 1MedDRA v24.0NDW ADHs)`DWA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C A Period 02DWDxHsn-DYDt@Huk @Vaccination 4 A`Y A@2021-07-15T18:13:51Y 103912851039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDdHrtDWDt@HsPlacebo APlacebo ADVDdDWD|tY . . .Placebo Placebo DW,DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDxDt@DWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBrC0AHrtHrtHsn-Hs .DWWHITE AC4591001C4591001 1039 10391285A ADVERSE EVENT 1 fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-05-14T18:00B2021-05-15T18:00B 1MedDRA v24.0NDW AD Hsn DWA D[HspA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C#P A Period 02DWDxHsn-DYDt@Huk @Vaccination 3 APY A02021-06-04T16:55:52Y 103912851039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDdHrtDWDt@HsPlacebo APlacebo ADVDdDWD|tY . . .Placebo Placebo DW,DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDxDt@DWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBrC0AHrtHrtHsn-Hs .DWWHITE AC4591001C4591001 1039 10391285A0ADVERSE EVENT 3 injection site pain Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-05-15T08:00B2021-05-15 B 1MedDRA v24.0NDW A DpHsowDWA ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CW A Period 02DWDxHsn-DYDt@Huk @Vaccination 3 APY A02021-06-04T16:56:13Y 103912851039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDdHrtDWDt@HsPlacebo APlacebo ADVDdDWD|tY . . .Placebo Placebo DW,DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDxDt@DWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBrC0AHrtHrtHsn-Hs .DWWHITE AC4591001C4591001 1039 10391285A@ADVERSE EVENT 6 muscle aches Myalgia FkMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Muscle ache FF{Muscle pains F#Muscle disorders FMusculoskeletal and connective tissue disorders Fk2021-06-04T14:00B2021-06-05 B 1MedDRA v24.0NDW ADHs)`DWA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C A Period 02DWDxHsn-DYDt@Huk @Vaccination 4 A`Y A@2021-07-13T19:02:05Y 103912851039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDdHrtDWDt@HsPlacebo APlacebo ADVDdDWD|tY . . .Placebo Placebo DW,DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDxDt@DWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBrC0AHrtHrtHsn-Hs .DWWHITE AC4591001C4591001 1039 10391285APADVERSE EVENT 2 nausea Nausea FܛGASTROINTESTINAL DISORDERS Nausea F F Nausea and vomiting symptoms FGastrointestinal signs and symptoms FGastrointestinal disorders Fܛ2021-05-14T18:00B2021-05-15T18:00B 1MedDRA v24.0NDW AD Hsn DWA D[HspA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C#P A Period 02DWDxHsn-DYDt@Huk @Vaccination 3 APY A02021-06-04T16:56:02Y 103912851039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDdHrtDWDt@HsPlacebo APlacebo ADVDdDWD|tY . . .Placebo Placebo DW,DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDxDt@DWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBrC0AHrtHrtHsn-Hs .DWWHITE AC4591001C4591001 1039 10391285A`ADVERSE EVENT 5 nausea Nausea FܛGASTROINTESTINAL DISORDERS Nausea F F Nausea and vomiting symptoms FGastrointestinal signs and symptoms FGastrointestinal disorders Fܛ2021-06-04T14:00B2021-06-05 B 1MedDRA v24.0NDW ADHs)`DWA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C A Period 02DWDxHsn-DYDt@Huk @Vaccination 4 A`Y A@2021-07-12T21:49:57Y 103912851039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDdHrtDWDt@HsPlacebo APlacebo ADVDdDWD|tY . . .Placebo Placebo DW,DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDxDt@DWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBrC0AHrtHrtHsn-Hs .DWWHITE AC4591001C4591001 1039 10391285ApADVERSE EVENT 4 fever Pyrexia FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F.F)Febrile disorders FBody temperature conditions FGeneral disorders and administration site conditions F2021-06-04T14:00B2021-06-05 B 1MedDRA v24.0NDW ADHs)`DWA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C A Period 02DWDxHsn-DYDt@Huk @Vaccination 4 A`Y A@2021-07-12T21:49:46Y 103912871039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHHrDWDHsPlacebo APlacebo ADVDHDWD{HY . . .Placebo Placebo DW/DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDX_BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBqBqC0AHrHrHHsmHs .DWWHITE AC4591001C4591001 1039 10391287AADVERSE EVENT 2 fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-05-13T14:00B2021-05-14 B 1MedDRA v24.0NDW ADHsm(`DWA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A B. A Period 02DWDHsmDYDHuiVaccination 3 APY A02021-06-17T19:25:42Y 103912871039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHHrDWDHsPlacebo APlacebo ADVDHDWD{HY . . .Placebo Placebo DW/DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDX_BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBqBqC0AHrHrHHsmHs .DWWHITE AC4591001C4591001 1039 10391287A ADVERSE EVENT 3 fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-06-03T12:40B2021-06-04T14:15B 1MedDRA v24.0NDW AD Hs DWA DȟHs-A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A B A Period 02DWDHsmDYDHuiVaccination 4 A`Y A@2021-07-06T21:29:55Y 103912871039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHHrDWDHsPlacebo APlacebo ADVDHDWD{HY . . .Placebo Placebo DW/DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDX_BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBqBqC0AHrHrHHsmHs .DWWHITE AC4591001C4591001 1039 10391287A0ADVERSE EVENT 5 headache Headache FNERVOUS SYSTEM DISORDERS Headache FFHeadaches NEC FHeadaches FNervous system disorders F2021-06-04T09:45B2021-06-05T15:00B 1MedDRA v24.0NDW A DHsDWA0D+Hs+A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CZ A Period 02DWDHsmDYDHuiVaccination 4 A`Y A@2021-07-06T21:30:18Y 103912871039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHHrDWDHsPlacebo APlacebo ADVDHDWD{HY . . .Placebo Placebo DW/DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDX_BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBqBqC0AHrHrHHsmHs .DWWHITE AC4591001C4591001 1039 10391287A@ADVERSE EVENT 1 injection site pain Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-05-14 B2021-05-15 B 1MedDRA v24.0NDW A ..DWA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDHsmDYDHuiVaccination 3 APY A02021-06-17T19:25:31Y 103912871039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHHrDWDHsPlacebo APlacebo ADVDHDWD{HY . . .Placebo Placebo DW/DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDX_BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBqBqC0AHrHrHHsmHs .DWWHITE AC4591001C4591001 1039 10391287APADVERSE EVENT 4 injection site soreness Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-06-04T07:15B2021-06-04T21:30B 1MedDRA v24.0NDW A DeHstDWA E0HsADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CQP A Period 02DWDHsmDYDHuiVaccination 4 A`Y A@2021-07-06T21:30:06Y 103912901039BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDXHrDWDHr BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADVDXDWDY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW,DWYPhase 3A@NNEGDW ....... . .NY.DWDWBBqC0AHrHr .. .DWWHITE AC4591001C4591001 1039 10391290AADVERSE EVENT 1 Vasovagal episode Presyncope FNERVOUS SYSTEM DISORDERS Vaso vagal attack FNF%Neurological signs and symptoms NEC FNeurological disorders NEC FNervous system disorders F2021-07-13T08:10B2021-07-13T08:50B 2MedDRA v24.0NDW BDrHsADWBD|sHsKsADAYSN NNOT RELATEDOTHER Blood draw at Visit 4 NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A EA^0 APeriod 01DVDXHrDX}DHtT$After unblinding and before Vaccination 3A@ A 2021-07-13T16:26:28Y 103912921039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHr(DWDvHsTPlacebo APlacebo ADVDDWDPY . . .Placebo Placebo DW,DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD{ DvDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBqC0AHr(HrGPHsn0 HsT .DWWHITE AC4591001C4591001 1039 10391292AADVERSE EVENT 2 Fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-05-14T18:00B2021-05-16T08:00B 1MedDRA v24.0NDW AD Hsn DWA0DpHspȻA0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C" A Period 02DWD{ Hsn0 DYDvHukVaccination 3 APY A02021-06-07T16:55:39Y 103912921039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHr(DWDvHsTPlacebo APlacebo ADVDDWDPY . . .Placebo Placebo DW,DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD{ DvDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBqC0AHr(HrGPHsn0 HsT .DWWHITE AC4591001C4591001 1039 10391292A ADVERSE EVENT 3 Fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-06-04T17:00B2021-06-06 B 1MedDRA v24.0NDW ADHsSDWA0..A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C  A Period 02DWD{ Hsn0 DYDvHukVaccination 4 A`Y A@2021-07-06T19:27:38Y 103912921039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHr(DWDvHsTPlacebo APlacebo ADVDDWDPY . . .Placebo Placebo DW,DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD{ DvDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBqC0AHr(HrGPHsn0 HsT .DWWHITE AC4591001C4591001 1039 10391292A@ADVERSE EVENT 1 Injection site soreness Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-05-14T18:00B2021-05-22 B 1MedDRA v24.0NDW AD Hsn DWA..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C" A Period 02DWD{ Hsn0 DYDvHukVaccination 3 APY A02021-06-08T14:27:07Y 103912921039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHr(DWDvHsTPlacebo APlacebo ADVDDWDPY . . .Placebo Placebo DW,DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD{ DvDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBqC0AHr(HrGPHsn0 HsT .DWWHITE AC4591001C4591001 1039 10391292A0ADVERSE EVENT 4 Injection arm soreness Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-06-04T17:00B2021-06-10 B 1MedDRA v24.0NDW ADHsSDWAp..ApDAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C  A Period 02DWD{ Hsn0 DYDvHukVaccination 4 A`Y A@2021-07-06T19:27:54Y 103912921039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHr(DWDvHsTPlacebo APlacebo ADVDDWDPY . . .Placebo Placebo DW,DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD{ DvDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBqC0AHr(HrGPHsn0 HsT .DWWHITE AC4591001C4591001 1039 10391292APADVERSE EVENT 5 Nausea Nausea FܛGASTROINTESTINAL DISORDERS Nausea F F Nausea and vomiting symptoms FGastrointestinal signs and symptoms FGastrointestinal disorders Fܛ2021-06-04T17:00B2021-06-06 B 1MedDRA v24.0NDW ADHsSDWA0..A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C  A Period 02DWD{ Hsn0 DYDvHukVaccination 4 A`Y A@2021-07-06T19:28:05Y 103912941039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DVDHrDWDHsPlacebo APlacebo ADVDDWDmY . . .Placebo Placebo DW1DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDvDDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBqCAHrHrΝ0Hsn+Hs .DWALL OTHERS A0C4591001C4591001 1039 10391294A ADVERSE EVENT 1 Injection site pain Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-05-14T22:00B2021-05-16 B 1MedDRA v24.0NDW AEVHsn`DWA0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C2 A Period 02DWDvHsn+DYDHuk%Vaccination 3 APY A02021-06-07T16:56:33Y 103912941039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DVDHrDWDHsPlacebo APlacebo ADVDDWDmY . . .Placebo Placebo DW1DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDvDDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBqCAHrHrΝ0Hsn+Hs .DWALL OTHERS A0C4591001C4591001 1039 10391294AADVERSE EVENT 2 Injection arm soreness Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-06-04T13:30B2021-06-05T13:30B 1MedDRA v24.0NDW ADHs"XDWA DHstA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A B A Period 02DWDvHsn+DYDHuk%Vaccination 4 A`Y A@2021-07-07T17:33:42Y 103912961039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT REPORTED A0USAWHITE ADWDPHrPDWDHs@Placebo APlacebo ADWDPDWDr$Y . . .Placebo Placebo DW>DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBqBAHrPHr֊HsnAHs@ .DWWHITE AC4591001C4591001 1039 10391296AADVERSE EVENT 2 Left armpit soreness Axillary pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Armpit pain FFTPain and discomfort NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2021-06-04T13:00B2021-06-06T08:00B 1MedDRA v24.0NDW ADHsPDWA0DpHsx;A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A B A Period 02DWDHsnADYDHuk"Vaccination 4 A`Y A@2021-07-14T22:48:40Y 103912961039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT REPORTED A0USAWHITE ADWDPHrPDWDHs@Placebo APlacebo ADWDPDWDr$Y . . .Placebo Placebo DW>DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBqBAHrPHr֊HsnAHs@ .DWWHITE AC4591001C4591001 1039 10391296A ADVERSE EVENT 3 Chills Chills FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills FFFeelings and sensations NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2021-06-04T21:30B2021-06-05T21:30B 1MedDRA v24.0NDW AEHsDWA E0HsA DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C+ A Period 02DWDHsnADYDHuk"Vaccination 4 A`Y A@2021-07-02T16:39:30Y 103912961039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT REPORTED A0USAWHITE ADWDPHrPDWDHs@Placebo APlacebo ADWDPDWDr$Y . . .Placebo Placebo DW>DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBqBAHrPHr֊HsnAHs@ .DWWHITE AC4591001C4591001 1039 10391296A0ADVERSE EVENT 1 Injection site soreness Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-05-14T13:03B2021-05-15T09:00B 1MedDRA v24.0NDW ADHsnlDWA D~HsoKA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A B A Period 02DWDHsnADYDHuk"Vaccination 3 APY A02021-06-07T16:56:54Y 103912961039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT REPORTED A0USAWHITE ADWDPHrPDWDHs@Placebo APlacebo ADWDPDWDr$Y . . .Placebo Placebo DW>DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBqBAHrPHr֊HsnAHs@ .DWWHITE AC4591001C4591001 1039 10391296A@ADVERSE EVENT 4 nausea Nausea FܛGASTROINTESTINAL DISORDERS Nausea F F Nausea and vomiting symptoms FGastrointestinal signs and symptoms FGastrointestinal disorders Fܛ2021-06-04T21:30B2021-06-06T08:00B 1MedDRA v24.0NDW AEHsDWA0DpHsx;A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C+ A Period 02DWDHsnADYDHuk"Vaccination 4 A`Y A@2021-07-02T16:39:41Y 103912961039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT REPORTED A0USAWHITE ADWDPHrPDWDHs@Placebo APlacebo ADWDPDWDr$Y . . .Placebo Placebo DW>DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBqBAHrPHr֊HsnAHs@ .DWWHITE AC4591001C4591001 1039 10391296APADVERSE EVENT 5 Fever 102 Pyrexia FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F.F)Febrile disorders FBody temperature conditions FGeneral disorders and administration site conditions F2021-06-05T08:00B2021-06-05T21:30B 2MedDRA v24.0NDW A DpHs&DWA E0HsADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A CS A Period 02DWDHsnADYDHuk"Vaccination 4 A`Y A@2021-07-14T20:19:53Y 103913011039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADWDtHrtDWDHs"Placebo APlacebo ADWDtDWDsY . . .Placebo Placebo DW=DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDtDDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBqBrBAHrtHr/ Hsm Hs" .DWWHITE AC4591001C4591001 1039 10391301AADVERSE EVENT 7 chills Chills FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills FFFeelings and sensations NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2021-06-05 B2021-06-06 B 1MedDRA v24.0NDW A ..DWA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDtHsm DYDHukUVaccination 4 A`Y A@2021-06-28T19:05:44Y 103913011039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADWDtHrtDWDHs"Placebo APlacebo ADWDtDWDsY . . .Placebo Placebo DW=DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDtDDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBqBrBAHrtHr/ Hsm Hs" .DWWHITE AC4591001C4591001 1039 10391301A0ADVERSE EVENT 10headache Headache FNERVOUS SYSTEM DISORDERS Headache FFHeadaches NEC FHeadaches FNervous system disorders F2021-06-05 B2021-06-06 B 1MedDRA v24.0NDW A ..DWA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDtHsm DYDHukUVaccination 4 A`Y A@2021-07-13T21:37:01Y 103913011039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADWDtHrtDWDHs"Placebo APlacebo ADWDtDWDsY . . .Placebo Placebo DW=DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDtDDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBqBrBAHrtHr/ Hsm Hs" .DWWHITE AC4591001C4591001 1039 10391301A ADVERSE EVENT 4 Headache Headache FNERVOUS SYSTEM DISORDERS Headache FFHeadaches NEC FHeadaches FNervous system disorders F2021-05-14T08:00B2021-05-16 B 1MedDRA v24.0NDW A DpHsn%DWA@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CJ A Period 02DWDtHsm DYDHukUVaccination 3 APY A02021-06-07T16:57:26Y 103913011039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADWDtHrtDWDHs"Placebo APlacebo ADWDtDWDsY . . .Placebo Placebo DW=DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDtDDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBqBrBAHrtHr/ Hsm Hs" .DWWHITE AC4591001C4591001 1039 10391301APADVERSE EVENT 8 injection site soreness Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-06-05 B2021-06-08 B 1MedDRA v24.0NDW A ..DWAP..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDtHsm DYDHukUVaccination 4 A`Y A@2021-06-28T19:05:55Y 103913011039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADWDtHrtDWDHs"Placebo APlacebo ADWDtDWDsY . . .Placebo Placebo DW=DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDtDDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBqBrBAHrtHr/ Hsm Hs" .DWWHITE AC4591001C4591001 1039 10391301A@ADVERSE EVENT 2 Injection site pain Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-05-13T19:00B2021-05-18 B 1MedDRA v24.0NDW AEHsmnDWA`..A`DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C A Period 02DWDtHsm DYDHukUVaccination 3 APY A02021-06-07T16:57:05Y 103913011039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADWDtHrtDWDHs"Placebo APlacebo ADWDtDWDsY . . .Placebo Placebo DW=DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDtDDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBqBrBAHrtHr/ Hsm Hs" .DWWHITE AC4591001C4591001 1039 10391301A`ADVERSE EVENT 3 General muscle aches Myalgia FkMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Muscle ache FF{Muscle pains F#Muscle disorders FMusculoskeletal and connective tissue disorders Fk2021-05-14T08:00B2021-05-16 B 1MedDRA v24.0NDW A DpHsn%DWA@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CJ A Period 02DWDtHsm DYDHukUVaccination 3 APY A02021-06-07T16:57:15Y 103913011039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADWDtHrtDWDHs"Placebo APlacebo ADWDtDWDsY . . .Placebo Placebo DW=DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDtDDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBqBrBAHrtHr/ Hsm Hs" .DWWHITE AC4591001C4591001 1039 10391301ApADVERSE EVENT 5 body aches Pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalized aching F\FPain and discomfort NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2021-06-05 B2021-06-06 B 1MedDRA v24.0NDW A ..DWA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDtHsm DYDHukUVaccination 4 A`Y A@2021-06-28T19:05:21Y 103913011039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADWDtHrtDWDHs"Placebo APlacebo ADWDtDWDsY . . .Placebo Placebo DW=DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDtDDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBqBrBAHrtHr/ Hsm Hs" .DWWHITE AC4591001C4591001 1039 10391301AADVERSE EVENT 1 vasovagal episode Presyncope FNERVOUS SYSTEM DISORDERS Vaso vagal attack FNF%Neurological signs and symptoms NEC FNeurological disorders NEC FNervous system disorders F2021-05-13T11:51B2021-05-13T12:00B 1MedDRA v24.0NDW BqDHsm $DWBqDHsm {ADAYSN NNOT RELATEDOTHER blood draw NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A E'm APeriod 01DWDtHrtDWDsHsm After unblinding and before Vaccination 3A@ A 2021-05-13T18:58:26Y 103913011039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADWDtHrtDWDHs"Placebo APlacebo ADWDtDWDsY . . .Placebo Placebo DW=DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDtDDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBqBrBAHrtHr/ Hsm Hs" .DWWHITE AC4591001C4591001 1039 10391301AADVERSE EVENT 6 fever Pyrexia FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F.F)Febrile disorders FBody temperature conditions FGeneral disorders and administration site conditions F2021-06-05 B2021-06-06 B 1MedDRA v24.0NDW A ..DWA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDtHsm DYDHukUVaccination 4 A`Y A@2021-06-28T19:05:32Y 103913031039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDHr(DWDr`HsPlacebo APlacebo ADWDDWDkY . . .Placebo Placebo DW>DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDlDr`DWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBqBqBAHr(Hr'HsmHs .DWWHITE AC4591001C4591001 1039 10391303AADVERSE EVENT 1 chills Chills FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills FFFeelings and sensations NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2021-06-04T22:00B2021-06-05T08:00B 1MedDRA v24.0NDW AEVHsDWA DpHs&A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C4 A Period 02DWDlHsmDYDr`Huk `Vaccination 4 A`Y A@2021-07-06T17:54:34Y 103913051039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWD$HrŲ$DWDHs\Placebo APlacebo ADWD$DW!DtY . . .Placebo Placebo DW=DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBqBAHrŲ$HruHsnHs\ .DWWHITE AC4591001C4591001 1039 10391305AADVERSE EVENT 1 Fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-05-15T13:00B2021-05-16T12:00B 1MedDRA v24.0NDW A DHsoPDWA0DHsqA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CN A Period 02DWDHsnDYDHukQVaccination 3 APY A02021-06-07T16:57:37Y 103913071039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDHrŻDWDHs4Placebo APlacebo ADWDDW#DY . . .Placebo Placebo DW?DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD0DDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBqBAHrŻHrY4Hsnu0Hs4 .DWWHITE AC4591001C4591001 1039 10391307AADVERSE EVENT 4 Hashimoto's thyroiditis Autoimmune thyroiditis FENDOCRINE DISORDERS Hashimoto's thyroiditis F_FVAcute and chronic thyroiditis FAThyroid gland disorders FA[Endocrine disorders F2021-06-14 B .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDW A....... N NNOT RELATEDOTHER automimmune disorder NOT APPLICABLE NNNOT RECOVERED/NOT RESOLVED N A0NOT RELATEDA0AGRADE 1A . A Period 02DWD0Hsnu0DYDHuk.Vaccination 4 A`Y A@2021-07-06T19:28:18Y 103913071039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDHrŻDWDHs4Placebo APlacebo ADWDDW#DY . . .Placebo Placebo DW?DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD0DDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBqBAHrŻHrY4Hsnu0Hs4 .DWWHITE AC4591001C4591001 1039 10391307A ADVERSE EVENT 7 chills Chills FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills FFFeelings and sensations NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2021-06-04T20:00B2021-06-06T12:00B 2MedDRA v24.0NDW AEHs}DWA0DHs{A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C" A Period 02DWD0Hsnu0DYDHuk.Vaccination 4 A`Y A@2021-07-06T19:28:41Y 103913071039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDHrŻDWDHs4Placebo APlacebo ADWDDW#DY . . .Placebo Placebo DW?DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD0DDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBqBAHrŻHrY4Hsnu0Hs4 .DWWHITE AC4591001C4591001 1039 10391307A0ADVERSE EVENT 9 headache Headache FNERVOUS SYSTEM DISORDERS Headache FFHeadaches NEC FHeadaches FNervous system disorders F2021-06-04T20:00B2021-06-06T12:00B 2MedDRA v24.0NDW AEHs}DWA0DHs{A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C" A Period 02DWD0Hsnu0DYDHuk.Vaccination 4 A`Y A@2021-07-06T19:29:05Y 103913071039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDHrŻDWDHs4Placebo APlacebo ADWDDW#DY . . .Placebo Placebo DW?DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD0DDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBqBAHrŻHrY4Hsnu0Hs4 .DWWHITE AC4591001C4591001 1039 10391307AADVERSE EVENT 11injection site soreness Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-06-04T10:44B2021-06-07T10:00B 2MedDRA v24.0NDW ADHspDWA@DHsA@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A AYA Period 02DWD0Hsnu0DYDHuk.Vaccination 4 A`Y A@2021-07-06T19:29:29Y 103913071039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDHrŻDWDHs4Placebo APlacebo ADWDDW#DY . . .Placebo Placebo DW?DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD0DDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBqBAHrŻHrY4Hsnu0Hs4 .DWWHITE AC4591001C4591001 1039 10391307A@ADVERSE EVENT 5 exacerbation of neck muscle strain Muscle strain FINJURY, POISONING AND PROCEDURAL COMPLICATIONS Muscle strain FYFYMuscle, tendon and ligament injuries FInjuries NEC FInjury, poisoning and procedural complications F2021-05-14T22:30B .ONGOINGLAST SUBJECT ENCOUNTER3MedDRA v24.0NDW AEƀHsnh..... N NNOT RELATEDOTHER prior injury NOT APPLICABLE YNRECOVERING/RESOLVING N A0NOT RELATEDA0A0GRADE 3A0 C! A Period 02DWD0Hsnu0DYDHuk.Vaccination 3 APY A02021-07-06T21:15:44Y 103913071039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDHrŻDWDHs4Placebo APlacebo ADWDDW#DY . . .Placebo Placebo DW?DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD0DDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBqBAHrŻHrY4Hsnu0Hs4 .DWWHITE AC4591001C4591001 1039 10391307APADVERSE EVENT 10muscle aches Myalgia FkMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Muscle ache FF{Muscle pains F#Muscle disorders FMusculoskeletal and connective tissue disorders Fk2021-06-04T20:00B2021-06-06T12:00B 2MedDRA v24.0NDW AEHs}DWA0DHs{A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C" A Period 02DWD0Hsnu0DYDHuk.Vaccination 4 A`Y A@2021-07-06T19:29:17Y 103913071039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDHrŻDWDHs4Placebo APlacebo ADWDDW#DY . . .Placebo Placebo DW?DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD0DDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBqBAHrŻHrY4Hsnu0Hs4 .DWWHITE AC4591001C4591001 1039 10391307A`ADVERSE EVENT 12fever Pyrexia FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F.F)Febrile disorders FBody temperature conditions FGeneral disorders and administration site conditions F2021-06-04T20:00B2021-06-06T12:00B 1MedDRA v24.0NDW AEHs}DWA0DHs{A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C" A Period 02DWD0Hsnu0DYDHuk.Vaccination 4 A`Y A@2021-07-06T19:29:40Y 103913071039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDHrŻDWDHs4Placebo APlacebo ADWDDW#DY . . .Placebo Placebo DW?DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD0DDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBqBAHrŻHrY4Hsnu0Hs4 .DWWHITE AC4591001C4591001 1039 10391307ApADVERSE EVENT 6 thyroid nodule Thyroid mass FENDOCRINE DISORDERS Thyroid nodule FAgF|Thyroid disorders NEC FA@Thyroid gland disorders FA[Endocrine disorders F2021-06-01 B .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDW B....... N NNOT RELATEDOTHER Incidental finding NOT APPLICABLE NNNOT RECOVERED/NOT RESOLVED N A0NOT RELATEDA0AGRADE 1A . A Period 02DWD0Hsnu0DYDHuk.Vaccination 3 APY A02021-07-14T20:31:00Y 103913071039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDHrŻDWDHs4Placebo APlacebo ADWDDW#DY . . .Placebo Placebo DW?DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD0DDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBqBAHrŻHrY4Hsnu0Hs4 .DWWHITE AC4591001C4591001 1039 10391307AADVERSE EVENT 13Vitamin D deficiency Vitamin D deficiency FMETABOLISM AND NUTRITION DISORDERS Vitamin D deficiency FPFPFat soluble vitamin deficiencies and disorders FVitamin related disorders FPMetabolism and nutrition disorders F2021-06-11 B .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDW A....... N NNOT RELATEDOTHER Dietary deficiency NOT APPLICABLE YNRECOVERING/RESOLVING N A0NOT RELATEDA0AGRADE 1A . A Period 02DWD0Hsnu0DYDHuk.Vaccination 4 A`Y A@2021-07-15T17:36:07Y 103913071039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDHrŻDWDHs4Placebo APlacebo ADWDDW#DY . . .Placebo Placebo DW?DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD0DDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBqBAHrŻHrY4Hsnu0Hs4 .DWWHITE AC4591001C4591001 1039 10391307AADVERSE EVENT 8 vomiting Vomiting FܛGASTROINTESTINAL DISORDERS Vomiting FPFPNausea and vomiting symptoms FGastrointestinal signs and symptoms FGastrointestinal disorders Fܛ2021-06-05T03:00B2021-06-06T03:00B 1MedDRA v24.0NDW A D*0Hs0DWA0D*kHs1A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C= A Period 02DWD0Hsnu0DYDHuk.Vaccination 4 A`Y A@2021-07-14T20:31:36Y 103913091039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DWDrHrƹXDWDHsc0Placebo APlacebo ADWDrDW#D8Y . . .Placebo Placebo DW?DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDXdBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWB~BmBqBAHrƹXHrkHsr.dHsc0 .DWALL OTHERS A0C4591001C4591001 1039 10391309A ADVERSE EVENT 3 fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-06-09 B2021-06-12 B 1MedDRA v24.0NDW A ..DWAP..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDHsr.dDYDHupVaccination 4 A`Y A@2021-07-22T17:12:08Y 103913091039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DWDrHrƹXDWDHsc0Placebo APlacebo ADWDrDW#D8Y . . .Placebo Placebo DW?DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDXdBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWB~BmBqBAHrƹXHrkHsr.dHsc0 .DWALL OTHERS A0C4591001C4591001 1039 10391309AADVERSE EVENT 1 fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-05-17T07:30B2021-05-18T12:00B 1MedDRA v24.0NDW BoDixHsrDWBpDHssA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A E& APeriod 01DWDrHrƹXDWDHsr.cAfter unblinding and before Vaccination 3A@ A 2021-06-09T00:04:09Y 103913091039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DWDrHrƹXDWDHsc0Placebo APlacebo ADWDrDW#D8Y . . .Placebo Placebo DW?DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDXdBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWB~BmBqBAHrƹXHrkHsr.dHsc0 .DWALL OTHERS A0C4591001C4591001 1039 10391309A0ADVERSE EVENT 2 injection site pain Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-05-17T07:30B2021-05-18T12:00B 1MedDRA v24.0NDW BoDixHsrDWBpDHssA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A E& APeriod 01DWDrHrƹXDWDHsr.cAfter unblinding and before Vaccination 3A@ A 2021-06-09T00:04:20Y 103913101039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADWD{ HrDWDXHsXPlacebo APlacebo ADWD{ DW"D|8Y . . .Placebo Placebo DW>DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDĤDXDWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWB~BpBqBAHrHr8HsnyHsX .DWWHITE AC4591001C4591001 1039 10391310AADVERSE EVENT 2 fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-05-14T07:00B2021-05-15T07:00B 1MedDRA v24.0NDW BmDbpHsnpDWBnDbHsoi+A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A E% APeriod 01DWD{ HrDWDģHsnyAfter unblinding and before Vaccination 3A@ A 2021-07-07T15:16:47Y 103913101039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADWD{ HrDWDXHsXPlacebo APlacebo ADWD{ DW"D|8Y . . .Placebo Placebo DW>DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDĤDXDWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWB~BpBqBAHrHr8HsnyHsX .DWWHITE AC4591001C4591001 1039 10391310A ADVERSE EVENT 6 fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-06-08T14:00B2021-06-09T08:00B 1MedDRA v24.0NDW A DHso`DWA0DpHslA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Ce A Period 02DWDĤHsnyDYDXHuo$Vaccination 4 A`Y A@2021-07-06T21:31:36Y 103913101039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADWD{ HrDWDXHsXPlacebo APlacebo ADWD{ DW"D|8Y . . .Placebo Placebo DW>DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDĤDXDWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWB~BpBqBAHrHr8HsnyHsX .DWWHITE AC4591001C4591001 1039 10391310A0ADVERSE EVENT 1 headache Headache FNERVOUS SYSTEM DISORDERS Headache FFHeadaches NEC FHeadaches FNervous system disorders F2021-05-14T13:00B2021-05-14T18:00B 1MedDRA v24.0NDW BmDHsnkDWBmD[Hsn[ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A E& APeriod 01DWD{ HrDWDģHsnyAfter unblinding and before Vaccination 3A@ A 2021-06-17T15:12:42Y 103913101039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADWD{ HrDWDXHsXPlacebo APlacebo ADWD{ DW"D|8Y . . .Placebo Placebo DW>DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDĤDXDWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWB~BpBqBAHrHr8HsnyHsX .DWWHITE AC4591001C4591001 1039 10391310A@ADVERSE EVENT 7 headache Headache FNERVOUS SYSTEM DISORDERS Headache FFHeadaches NEC FHeadaches FNervous system disorders F2021-06-08T14:00B2021-06-09T08:00B 1MedDRA v24.0NDW A DHso`DWA0DpHslA DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Ce A Period 02DWDĤHsnyDYDXHuo$Vaccination 4 A`Y A@2021-07-06T21:31:47Y 103913101039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADWD{ HrDWDXHsXPlacebo APlacebo ADWD{ DW"D|8Y . . .Placebo Placebo DW>DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDĤDXDWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWB~BpBqBAHrHr8HsnyHsX .DWWHITE AC4591001C4591001 1039 10391310APADVERSE EVENT 3 bruise at injection site Injection site bruising FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site bruising FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-05-14T18:00B2021-05-18 B 1MedDRA v24.0NDW AD Hsn DWAP..APDAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A B A Period 02DWDĤHsnyDYDXHuo$Vaccination 3 APY A02021-06-11T16:31:05Y 103913101039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADWD{ HrDWDXHsXPlacebo APlacebo ADWD{ DW"D|8Y . . .Placebo Placebo DW>DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDĤDXDWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWB~BpBqBAHrHr8HsnyHsX .DWWHITE AC4591001C4591001 1039 10391310A`ADVERSE EVENT 5 bruising at injection site Injection site bruising FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site bruising FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-06-07T15:00B2021-06-14 B 1MedDRA v24.0NDW ADHs+DWA..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A B A Period 02DWDĤHsnyDYDXHuo$Vaccination 4 A`Y A@2021-07-06T21:31:25Y 103913101039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADWD{ HrDWDXHsXPlacebo APlacebo ADWD{ DW"D|8Y . . .Placebo Placebo DW>DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDĤDXDWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWB~BpBqBAHrHr8HsnyHsX .DWWHITE AC4591001C4591001 1039 10391310ApADVERSE EVENT 4 swelling at injection site Injection site swelling FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Swelling of injection site F=HFg1Injection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-05-18 B2021-05-31 B 1MedDRA v24.0NDW AP..DWB..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDĤHsnyDYDXHuo$Vaccination 3 APY A02021-06-08T16:44:37Y 103913131039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWD|HrDWDHsPlacebo APlacebo ADWD|DW$D\Y . . .Placebo Placebo DWEDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD DDWDX_BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWB~BpBqBAHrHr\Hsng Hs .DWWHITE AC4591001C4591001 1039 10391313AADVERSE EVENT 4 Fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-06-04 B2021-06-05 B 2MedDRA v24.0NDW A ..DWA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWD Hsng DYDHuiTVaccination 4 A`Y A@2021-06-08T16:51:28Y 103913131039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWD|HrDWDHsPlacebo APlacebo ADWD|DW$D\Y . . .Placebo Placebo DWEDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD DDWDX_BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWB~BpBqBAHrHr\Hsng Hs .DWWHITE AC4591001C4591001 1039 10391313A ADVERSE EVENT 3 Injection site soreness Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-06-03T21:00B2021-06-05 B 1MedDRA v24.0NDW AEuHs:PDWA0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C' A Period 02DWD Hsng DYDHuiTVaccination 4 A`Y A@2021-06-08T16:50:54Y 103913131039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWD|HrDWDHsPlacebo APlacebo ADWD|DW$D\Y . . .Placebo Placebo DWEDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD DDWDX_BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWB~BpBqBAHrHr\Hsng Hs .DWWHITE AC4591001C4591001 1039 10391313A0ADVERSE EVENT 1 General Body aches Pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalised aching FFPain and discomfort NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2021-05-15T09:00B2021-05-15T20:00B 2MedDRA v24.0NDW A D~HsoDWA EHspADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A CL@ A Period 02DWD Hsng DYDHuiTVaccination 3 APY A02021-06-07T15:20:21Y 103913131039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWD|HrDWDHsPlacebo APlacebo ADWD|DW$D\Y . . .Placebo Placebo DWEDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD DDWDX_BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWB~BpBqBAHrHr\Hsng Hs .DWWHITE AC4591001C4591001 1039 10391313A@ADVERSE EVENT 2 General Body aches Pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalised aching FFPain and discomfort NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2021-06-03T21:00B2021-06-05 B 2MedDRA v24.0NDW AEuHs:PDWA0..A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C' A Period 02DWD Hsng DYDHuiTVaccination 4 A`Y A@2021-06-08T16:49:57Y 103913141039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DWD HrDWDqHsPlacebo APlacebo ADWD DW$DLY . . .Placebo Placebo DW@DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDpDqDWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWB~BmBqBAHrHrLHsrHs .DWALL OTHERS A0C4591001C4591001 1039 10391314AADVERSE EVENT 1 Exacerbation of fibroadenoma of right breast Fibroadenoma of breast F0NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)Fibroadenoma of breast FeFeBreast and nipple neoplasms benign FBreast neoplasms benign (incl nipple) FNeoplasms benign, malignant and unspecified (incl cysts and polyps)F02021-02-06 B2021-04-06 BZ 1MedDRA v24.0NDW- A..DWhBE..B<DAYSN NNOT RELATEDOTHER female hormonal changes NOT APPLICABLE NYRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DWD HrDWDpHsrVaccination 2 A Y A 2021-06-17T19:16:10 AE outcome, Actions to the AE, AERELTXT changed from EUA to sBLA 103913141039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DWD HrDWDqHsPlacebo APlacebo ADWD DW$DLY . . .Placebo Placebo DW@DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDpDqDWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWB~BmBqBAHrHrLHsrHs .DWALL OTHERS A0C4591001C4591001 1039 10391314A ADVERSE EVENT 2 Injection Site Pain Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-05-17T13:00B2021-05-19 B 1MedDRA v24.0NDW ADHsr`PDWA0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C A Period 02DWDpHsrDYDqHunhVaccination 3 APY A02021-06-09T14:59:03Y 103913151039BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDôHr 4DW#DhHrhBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADWDôDW#DhY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW?DWYPhase 3A@NNEGDW ....... . .NY.DWDWBBpBAHr 4Hrh.. .DWWHITE AC4591001C4591001 1039 10391315AADVERSE EVENT 1 vasovagal episode Presyncope FNERVOUS SYSTEM DISORDERS Vaso vagal attack FNF%Neurological signs and symptoms NEC FNeurological disorders NEC FNervous system disorders F2021-07-22T12:31B2021-07-22T12:45B 2MedDRA v24.0NDW BDHs\DWBDHs`ADAYSN NNOT RELATEDOTHER Blood draw procedure at visit. NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A E=ڐ APeriod 01DWDôHr 4DXDhHtœhAfter unblinding and before Vaccination 3A@ A 2021-07-22T21:46:48Y 103913171039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DWDĤHr $DWDrHsPlacebo APlacebo ADWDĤDW$DPY . . .Placebo Placebo DWADWYPhase 3A@NPOSDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDrDWDX_BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWB~BpBqBAHr $HrPHsnHs .DWALL OTHERS A0C4591001C4591001 1039 10391317AADVERSE EVENT 4 chills Chills FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills FFFeelings and sensations NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2021-05-15T13:00B2021-05-15T15:00B 1MedDRA v24.0NDW A DHsoPDWA D+Hso٫ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CQ A Period 02DWDHsnDYDrHuiVaccination 3 APY A02021-06-18T19:36:41Y 103913171039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DWDĤHr $DWDrHsPlacebo APlacebo ADWDĤDW$DPY . . .Placebo Placebo DWADWYPhase 3A@NPOSDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDrDWDX_BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWB~BpBqBAHr $HrPHsnHs .DWALL OTHERS A0C4591001C4591001 1039 10391317A ADVERSE EVENT 3 fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-05-15T08:00B2021-05-15T15:00B 1MedDRA v24.0NDW A DpHsowDWA D+Hso٫ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C> A Period 02DWDHsnDYDrHuiVaccination 3 APY A02021-06-18T19:36:29Y 103913171039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DWDĤHr $DWDrHsPlacebo APlacebo ADWDĤDW$DPY . . .Placebo Placebo DWADWYPhase 3A@NPOSDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDrDWDX_BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWB~BpBqBAHr $HrPHsnHs .DWALL OTHERS A0C4591001C4591001 1039 10391317A0ADVERSE EVENT 2 pre-syncope Presyncope FNERVOUS SYSTEM DISORDERS Pre-syncope F%F%Neurological signs and symptoms NEC FNeurological disorders NEC FNervous system disorders F2021-01-07T13:35A2021-01-07T13:48A 1MedDRA v24.0NDW ADHrDWADKHrADAYSN NNOT RELATEDOTHER blood draw NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A  APeriod 01DWDĤHr $DWDHsnPre-Vaccination Y.2021-06-18T19:36:17Y 103913171039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DWDĤHr $DWDrHsPlacebo APlacebo ADWDĤDW$DPY . . .Placebo Placebo DWADWYPhase 3A@NPOSDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDrDWDX_BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWB~BpBqBAHr $HrPHsnHs .DWALL OTHERS A0C4591001C4591001 1039 10391317A@ADVERSE EVENT 1 vomiting Vomiting FܛGASTROINTESTINAL DISORDERS Vomiting FPFPNausea and vomiting symptoms FGastrointestinal signs and symptoms FGastrointestinal disorders Fܛ2021-01-07T13:35A2021-01-07T13:48A 1MedDRA v24.0NDW ADHrDWADKHrADAYSN NNOT RELATEDOTHER blood draw NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A  APeriod 01DWDĤHr $DWDHsnPre-Vaccination Y.2021-06-18T19:36:05Y 103913191039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDu0Hr 0DWDHsePlacebo APlacebo ADWDu0DW%DY . . .Placebo Placebo DWEDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDXgBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWB}BjBqBAHr 0HrHsvcHse .DWWHITE AC4591001C4591001 1039 10391319AADVERSE EVENT 2 chills Chills FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills FFFeelings and sensations NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2021-05-21 B2021-05-22 B 2MedDRA v24.0NDW A ..DWA0..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWDHsvcDYDHut@Vaccination 3 APY A02021-06-03T14:15:39Y 103913191039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDu0Hr 0DWDHsePlacebo APlacebo ADWDu0DW%DY . . .Placebo Placebo DWEDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDXgBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWB}BjBqBAHr 0HrHsvcHse .DWWHITE AC4591001C4591001 1039 10391319A ADVERSE EVENT 3 injection site pain Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-05-21 B2021-05-23 B 2MedDRA v24.0NDW A ..DWA@..A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWDHsvcDYDHut@Vaccination 3 APY A02021-06-03T14:16:42Y 103913191039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDu0Hr 0DWDHsePlacebo APlacebo ADWDu0DW%DY . . .Placebo Placebo DWEDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDXgBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWB}BjBqBAHr 0HrHsvcHse .DWWHITE AC4591001C4591001 1039 10391319A0ADVERSE EVENT 1 fever - max temp 102.3 Pyrexia FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F.F)Febrile disorders FBody temperature conditions FGeneral disorders and administration site conditions F2021-05-21 B2021-05-23 B 3MedDRA v24.0NDW A ..DWA@..A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA0GRADE 3A0 . A Period 02DWDHsvcDYDHut@Vaccination 3 APY A02021-06-03T14:14:01Y 103913211039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDHr$DWDˆHsmPlacebo APlacebo ADWDDW%Dm8Y . . .Placebo Placebo DWDDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDpDˆDWDXdBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWB}BmBqBAHr$Hr㴸HsrHsm .DWWHITE AC4591001C4591001 1039 10391321AADVERSE EVENT 1 Chills Chills FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills FFFeelings and sensations NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2021-05-17T20:00B2021-05-18T10:00B 2MedDRA v24.0NDW AEHsrDWA DHssA DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C- A Period 02DWDpHsrDYDˆHupVaccination 3 APY A02021-06-08T21:15:48Y 103913211039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDHr$DWDˆHsmPlacebo APlacebo ADWDDW%Dm8Y . . .Placebo Placebo DWDDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDpDˆDWDXdBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWB}BmBqBAHr$Hr㴸HsrHsm .DWWHITE AC4591001C4591001 1039 10391321A ADVERSE EVENT 2 Injection arm soreness Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-06-08T17:00B2021-06-09T17:00B 1MedDRA v24.0NDW ADHsDWA DKHsKA DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A B A Period 02DWDpHsrDYDˆHupVaccination 4 A`Y A@2021-07-15T21:20:29Y 103913251039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DWDHrA4DWDxxHsxPlacebo APlacebo ADWDDW(Dv\Y . . .Placebo Placebo DWGDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDxxDWDX_BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBzBqBqBAHrA4Hr\HslHsx .DWALL OTHERS A0C4591001C4591001 1039 10391325AADVERSE EVENT 2 Chills Chills FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills FFFeelings and sensations NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2021-05-13T22:00B{2021-05-15 B} 2MedDRA v24.0NDW AEVHsmDWA0..A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C, A Period 02DWDHslDYDxxHuiVaccination 3 APY A02021-06-07T18:38:55Y 103913251039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DWDHrA4DWDxxHsxPlacebo APlacebo ADWDDW(Dv\Y . . .Placebo Placebo DWGDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDxxDWDX_BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBzBqBqBAHrA4Hr\HslHsx .DWALL OTHERS A0C4591001C4591001 1039 10391325A ADVERSE EVENT 5 chills Chills FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills FFFeelings and sensations NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2021-06-03T21:00B2021-06-05 B 1MedDRA v24.0NDW AEuHs:PDWA0..A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C. A Period 02DWDHslDYDxxHuiVaccination 4 A`Y A@2021-06-17T20:13:21Y 103913251039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DWDHrA4DWDxxHsxPlacebo APlacebo ADWDDW(Dv\Y . . .Placebo Placebo DWGDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDxxDWDX_BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBzBqBqBAHrA4Hr\HslHsx .DWALL OTHERS A0C4591001C4591001 1039 10391325APADVERSE EVENT 6 fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-06-04 B2021-06-07 B 2MedDRA v24.0NDW A ..DWAP..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWDHslDYDxxHuiVaccination 4 A`Y A@2021-06-17T20:13:38Y 103913251039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DWDHrA4DWDxxHsxPlacebo APlacebo ADWDDW(Dv\Y . . .Placebo Placebo DWGDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDxxDWDX_BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBzBqBqBAHrA4Hr\HslHsx .DWALL OTHERS A0C4591001C4591001 1039 10391325A0ADVERSE EVENT 3 fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-05-13T22:00B{2021-05-15 B} 2MedDRA v24.0NDW AEVHsmDWA0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C, A Period 02DWDHslDYDxxHuiVaccination 3 APY A02021-06-08T16:44:48Y 103913251039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DWDHrA4DWDxxHsxPlacebo APlacebo ADWDDW(Dv\Y . . .Placebo Placebo DWGDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDxxDWDX_BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBzBqBqBAHrA4Hr\HslHsx .DWALL OTHERS A0C4591001C4591001 1039 10391325A@ADVERSE EVENT 8 fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-06-03T14:00B2021-06-04 B 1MedDRA v24.0NDW ADHsDWA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C` A Period 02DWDHslDYDxxHuiVaccination 4 A`Y A@2021-07-06T17:54:46Y 103913251039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DWDHrA4DWDxxHsxPlacebo APlacebo ADWDDW(Dv\Y . . .Placebo Placebo DWGDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDxxDWDX_BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBzBqBqBAHrA4Hr\HslHsx .DWALL OTHERS A0C4591001C4591001 1039 10391325A`ADVERSE EVENT 7 bruise at injection site Injection site bruising FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site bruising FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-06-04 B2021-06-11 B 1MedDRA v24.0NDW A ..DWA..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDHslDYDxxHuiVaccination 4 A`Y A@2021-06-15T15:25:55Y 103913251039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DWDHrA4DWDxxHsxPlacebo APlacebo ADWDDW(Dv\Y . . .Placebo Placebo DWGDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDxxDWDX_BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBzBqBqBAHrA4Hr\HslHsx .DWALL OTHERS A0C4591001C4591001 1039 10391325ApADVERSE EVENT 4 generalized aches Pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalised aching FFPain and discomfort NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2021-06-04 B2021-06-05 B 1MedDRA v24.0NDW A ..DWA0..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDHslDYDxxHuiVaccination 4 A`Y A@2021-06-17T20:13:02Y 103913251039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DWDHrA4DWDxxHsxPlacebo APlacebo ADWDDW(Dv\Y . . .Placebo Placebo DWGDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDxxDWDX_BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBzBqBqBAHrA4Hr\HslHsx .DWALL OTHERS A0C4591001C4591001 1039 10391325AADVERSE EVENT 1 Fever - up to 103.4 Pyrexia FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F.F)Febrile disorders FBody temperature conditions FGeneral disorders and administration site conditions F2021-05-13T22:00B{2021-05-14T09:00B| 3MedDRA v24.0NDW AEVHsmDWA D~Hsn3A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA0GRADE 3A0 C, A Period 02DWDHslDYDxxHuiVaccination 3 APY A02021-06-07T20:45:26Y 103913271039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADWDHrE0DW(DzHrPlacebo APlacebo ADWDDW(DzY . . .Placebo Placebo DWEDWYPhase 3A@NNEGDW ....... . .NN.DWDWBzBqBAHrE0Hr.. .DWWHITE AC4591001C4591001 1039 10391327AADVERSE EVENT 1 Fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-06-06 B2021-06-08 B 1MedDRA v24.0NDW B~..DWB..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . APeriod 01DWDHrE0DXDzHtPAfter unblinding and before Vaccination 3A@ A 2021-06-23T13:35:18Y 103913281039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDTHrFDWDHs|Placebo APlacebo ADWDTDW)DkY . . .Placebo Placebo DWEDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDPDDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBzBpBqBAHrFHrPHsndPHs| .DWWHITE AC4591001C4591001 1039 10391328A ADVERSE EVENT 2 fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-05-14T16:00B|2021-05-17 B 1MedDRA v24.0NDW ADHsnDWA@..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A B A Period 02DWDPHsndPDYDHukOVaccination 3 APY A02021-06-17T23:59:08Y 103913281039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDTHrFDWDHs|Placebo APlacebo ADWDTDW)DkY . . .Placebo Placebo DWEDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDPDDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBzBpBqBAHrFHrPHsndPHs| .DWWHITE AC4591001C4591001 1039 10391328AADVERSE EVENT 4 Fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-06-04T19:00B2021-06-05T19:00B 1MedDRA v24.0NDW AEHsoDWA EHskA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C0 A Period 02DWDPHsndPDYDHukOVaccination 4 A`Y A@2021-07-15T18:00:56Y 103913281039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDTHrFDWDHs|Placebo APlacebo ADWDTDW)DkY . . .Placebo Placebo DWEDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDPDDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBzBpBqBAHrFHrPHsndPHs| .DWWHITE AC4591001C4591001 1039 10391328A@ADVERSE EVENT 1 Injection site pain Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-05-14T18:00B|2021-05-17 B 1MedDRA v24.0NDW AD Hsn DWA@..A@DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C A Period 02DWDPHsndPDYDHukOVaccination 3 APY A02021-06-17T20:16:38Y 103913281039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDTHrFDWDHs|Placebo APlacebo ADWDTDW)DkY . . .Placebo Placebo DWEDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDPDDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBzBpBqBAHrFHrPHsndPHs| .DWWHITE AC4591001C4591001 1039 10391328A0ADVERSE EVENT 3 Injection arm soreness Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-06-04T19:00B2021-06-05T19:00B 1MedDRA v24.0NDW AEHsoDWA EHskA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C0 A Period 02DWDPHsndPDYDHukOVaccination 4 A`Y A@2021-07-08T22:45:11Y 103913291039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDXHr`DWDHs Placebo APlacebo ADWDXDW(DyY . . .Placebo Placebo DWEDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDXDDWDXfBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBzBjBqBAHr`Hr絤HsvcXHs  .DWWHITE AC4591001C4591001 1039 10391329AADVERSE EVENT 2 fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-06-11 B2021-06-13 B 1MedDRA v24.0NDW A ..DWA@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDXHsvcXDYDHus>Vaccination 4 A`Y A@2021-07-09T20:10:38Y 103913291039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDXHr`DWDHs Placebo APlacebo ADWDXDW(DyY . . .Placebo Placebo DWEDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDXDDWDXfBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBzBjBqBAHr`Hr絤HsvcXHs  .DWWHITE AC4591001C4591001 1039 10391329A0ADVERSE EVENT 3 injection arm soreness Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-06-11 B2021-06-13 B 1MedDRA v24.0NDW A ..DWA@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDXHsvcXDYDHus>Vaccination 4 A`Y A@2021-07-09T20:10:50Y 103913291039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDXHr`DWDHs Placebo APlacebo ADWDXDW(DyY . . .Placebo Placebo DWEDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDXDDWDXfBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBzBjBqBAHr`Hr絤HsvcXHs  .DWWHITE AC4591001C4591001 1039 10391329A ADVERSE EVENT 1 Injection site soreness Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-05-21T07:00B2021-05-23 B 1MedDRA v24.0NDW A DbpHswQDWA@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C? A Period 02DWDXHsvcXDYDHus>Vaccination 3 APY A02021-06-10T21:14:02Y 103913301039BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDҴHr_4DW)DHrLHBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADWDҴDW)DY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWHDWpYPhase 3A@NNEGDWq ....... . .NY.DWpDWB^BBAHr_4HrLH.. .DWWHITE AC4591001C4591001 1039 10391330AADVERSE EVENT 1 stomach pain Abdominal pain upper FܛGASTROINTESTINAL DISORDERS Stomach pain F;FGastrointestinal and abdominal pains (excl oral and throat) F܆Gastrointestinal signs and symptoms FGastrointestinal disorders Fܛ2021-06-25 B2021-06-25 B 1MedDRA v24.0NDW B..DWB..ADAYSN NNOT RELATEDOTHER food NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DWDҴHr_4DXDHtAfter unblinding and before Vaccination 3A@ A 2021-06-30T18:53:58Y 103913301039BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDҴHr_4DW)DHrLHBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADWDҴDW)DY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWHDWpYPhase 3A@NNEGDWq ....... . .NY.DWpDWB^BBAHr_4HrLH.. .DWWHITE AC4591001C4591001 1039 10391330A ADVERSE EVENT 2 nausea Nausea FܛGASTROINTESTINAL DISORDERS Nausea F F Nausea and vomiting symptoms FGastrointestinal signs and symptoms FGastrointestinal disorders Fܛ2021-06-25 B2021-06-25 B 1MedDRA v24.0NDW B..DWB..ADAYSN NNOT RELATEDOTHER food NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DWDҴHr_4DXDHtAfter unblinding and before Vaccination 3A@ A 2021-06-30T18:54:09Y 103913331039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADWDHreDWDtHsftPlacebo APlacebo ADWDDW)Du0Y . . .Placebo Placebo DWEDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDHDtDWDXgBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWByBiBqBAHreHrHswHsft .DWWHITE AC4591001C4591001 1039 10391333AADVERSE EVENT 1 fatigue Fatigue FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-06-12 B2021-06-13 B 1MedDRA v24.0NDW A ..DWA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDHHswDYDtHutVaccination 4 A`Y A@2021-07-09T17:19:01Y 103913371039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADWDHr͈DWDHsPlacebo APlacebo ADWDDW*DndY . . .Placebo Placebo DWLDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWByBpBqBAHr͈HrMdHsnUHs .DWWHITE AC4591001C4591001 1039 10391337AADVERSE EVENT 2 chills Chills FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills FFFeelings and sensations NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2021-05-14T23:30B{2021-05-15T16:00B| 2MedDRA v24.0NDW AEHsnxDWA D;HsoA DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C-@ A Period 02DWDHsnUDYDHuk7Vaccination 3 APY A02021-06-17T23:57:48Y 103913371039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADWDHr͈DWDHsPlacebo APlacebo ADWDDW*DndY . . .Placebo Placebo DWLDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWByBpBqBAHr͈HrMdHsnUHs .DWWHITE AC4591001C4591001 1039 10391337A ADVERSE EVENT 6 Fever Pyrexia FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F.F)Febrile disorders FBody temperature conditions FGeneral disorders and administration site conditions F2021-06-05T08:00B2021-06-06 B 1MedDRA v24.0NDW A DpHs&DWA0..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CMp A Period 02DWDHsnUDYDHuk7Vaccination 4 A`Y A@2021-06-17T20:47:35Y 103913371039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADWDHr͈DWDHsPlacebo APlacebo ADWDDW*DndY . . .Placebo Placebo DWLDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWByBpBqBAHr͈HrMdHsnUHs .DWWHITE AC4591001C4591001 1039 10391337A0ADVERSE EVENT 1 urticaria, both hands Urticaria F5SKIN AND SUBCUTANEOUS TISSUE DISORDERS Urticaria FMFMUrticarias FMAngioedema and urticaria FSkin and subcutaneous tissue disorders F52021-02-04 B2021-02-06 B 1MedDRA v24.0NDW+ A ..DW-A@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . APeriod 01DWDHr͈DWDHsnUVaccination 2 A Y A 2021-02-09T19:32:17 103913371039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADWDHr͈DWDHsPlacebo APlacebo ADWDDW*DndY . . .Placebo Placebo DWLDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWByBpBqBAHr͈HrMdHsnUHs .DWWHITE AC4591001C4591001 1039 10391337A@ADVERSE EVENT 3 vomit Vomiting FܛGASTROINTESTINAL DISORDERS Vomiting FPFPNausea and vomiting symptoms FGastrointestinal signs and symptoms FGastrointestinal disorders Fܛ2021-05-15T07:30B|2021-05-15T07:35B| 1MedDRA v24.0NDW A DixHsooDWA DjHsoq_ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CK@ A Period 02DWDHsnUDYDHuk7Vaccination 3 APY A02021-05-18T19:26:50Y 103913391039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADWDHrͯDWDrHs˜Placebo APlacebo ADWDDW*DxY . . .Placebo Placebo DWGDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD~DrDWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWByBlBqBAHrͯHrWHssyHs˜ .DWWHITE AC4591001C4591001 1039 10391339AADVERSE EVENT 2 Nausea Nausea FܛGASTROINTESTINAL DISORDERS Nausea F F Nausea and vomiting symptoms FGastrointestinal signs and symptoms FGastrointestinal disorders Fܛ2021-01-12T20:00A2021-01-12T20:30A 1MedDRA v24.0NDW AEHr@DWAE0HrADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C@ APeriod 01DWDHrͯDWD~HssyVaccination 1 AY A2021-06-09T00:05:14Y 103913391039Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADWDHrͯDWDrHs˜Placebo APlacebo ADWDDW*DxY . . .Placebo Placebo DWGDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD~DrDWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWByBlBqBAHrͯHrWHssyHs˜ .DWWHITE AC4591001C4591001 1039 10391339A ADVERSE EVENT 1 Vomiting Vomiting FܛGASTROINTESTINAL DISORDERS Vomiting FPFPNausea and vomiting symptoms FGastrointestinal signs and symptoms FGastrointestinal disorders Fܛ2021-01-12T20:00A2021-01-12T20:30A 1MedDRA v24.0NDW AEHr@DWAE0HrADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C@ APeriod 01DWDHrͯDWD~HssyVaccination 1 AY A2021-06-09T02:53:27Y 104412651044Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHr^DWDǰHsðPlacebo APlacebo ADVDDWDpY . . .Placebo Placebo DW"DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDxDǰDWDXeBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBkBqCAHr^HrHsuHsð .DWWHITE AC4591001C4591001 1044 10441265AADVERSE EVENT 3 sinusitis Sinusitis FINFECTIONS AND INFESTATIONS Sinusitis F5F5Upper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations F2021-06-16 B2021-06-27 B 1MedDRA v24.0NDW A..DWB..ADAYSN NNOT RELATEDOTHER unk NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . A Period 02DWDxHsuDYDǰHuq0Vaccination 4 A`Y A@2021-07-12T20:57:12Y 104412661044BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHr\(DWDDHrBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADVDDWDDY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW%DWYPhase 3A@NNEG. ....... . .NY.DW.C..CAHr\(Hr.. .DWWHITE AC4591001C4591001 1044 10441266AADVERSE EVENT 1 Worsening of acne Acne F5SKIN AND SUBCUTANEOUS TISSUE DISORDERS Acne aggravated FrFpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F52021-01-07 B2021-02-01 B8 1MedDRA v24.0NDW A..DW(B$..BDAYSN NNOT RELATEDOTHER unk NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVDHr\(DXrDDHtDVaccination 2 A Y A 2021-04-28T22:58:40Y 104412671044Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHrc0DWDHsPlacebo APlacebo ADVDDWDY . . .Placebo Placebo DW!DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDXeBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBkBoCAHrc0HrXHstHHs .DWWHITE AC4591001C4591001 1044 10441267AADVERSE EVENT 1 Accidental fall Fall FINJURY, POISONING AND PROCEDURAL COMPLICATIONS Fall FխFխNon-site specific injuries NEC F Injuries NEC FInjury, poisoning and procedural complications F2021-04-29 B2021-06-02 B 2MedDRA v24.0NDW B{..DWB..B#DAYSN NNOT RELATEDOTHER unk NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVDHrc0DWDHstGFollow Up 1 A0Y A 2021-07-12T20:59:07Y 104412671044Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHrc0DWDHsPlacebo APlacebo ADVDDWDY . . .Placebo Placebo DW!DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDXeBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBkBoCAHrc0HrXHstHHs .DWWHITE AC4591001C4591001 1044 10441267A ADVERSE EVENT 2 thumb fracture Hand fracture FINJURY, POISONING AND PROCEDURAL COMPLICATIONS Fractured thumb F!F*Limb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications F2021-04-29 B2021-06-02 B 2MedDRA v24.0NDW B{..DWB..B#DAYSN NNOT RELATEDOTHER accidental fall NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVDHrc0DWDHstGFollow Up 1 A0Y A 2021-07-12T20:50:59Y 104412751044Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHrDWDpHspPlacebo APlacebo ADVDDWDpY . . .Placebo Placebo DW%DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDHDpDWDXeBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBmBqCAHrHrpHsr`Hsp .DWWHITE AC4591001C4591001 1044 10441275AADVERSE EVENT 1 myalgia Myalgia FkMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Myalgia F{F{Muscle pains F#Muscle disorders FMusculoskeletal and connective tissue disorders Fk2021-01-04 B2021-01-04 B 1MedDRA v24.0NDW Ap..DW Ap..ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . APeriod 01DVDHrDWDGHsr`Vaccination 2 A Y A 2021-01-29T23:53:45 104412821044Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVEF@HrdDW[DHs+9dPlacebo APlacebo ADVEF@DWDϨY . . .Placebo Placebo DW#DW<YPhase 3A@NNEGDW= BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWFDW[DDDWwDXBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DW<DWBKBBCAHrdHr(HsfHs+9d .DWEWHITE AC4591001C4591001 1044 10441282AADVERSE EVENT 1 injection site pain Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-03-25 Bk2021-03-25 Bk 1MedDRA v24.0NDW\ A ..DW\A ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWFDHsfDXDHu lVaccination 4 A`Y A@2021-04-21T23:28:48Y 104412841044Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHr3lDWDLHsLPlacebo APlacebo ADVDDWDY . . .Placebo Placebo DW"DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDLDWDX_BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBqB{CAHr3lHr4Hsm:lHsL .DWWHITE AC4591001C4591001 1044 10441284AADVERSE EVENT 1 Anxiety Anxiety F'PSYCHIATRIC DISORDERS Anxiety FFAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'2021-04-27 B .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDW} Bx....... N NNOT RELATEDOTHER unk NOT APPLICABLE YNRECOVERING/RESOLVING N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVDHr3lDWDHsm:kFollow Up 1 A0Y A 2021-05-14T21:56:59Y 104412841044Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHr3lDWDLHsLPlacebo APlacebo ADVDDWDY . . .Placebo Placebo DW"DWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDLDWDX_BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBqB{CAHr3lHr4Hsm:lHsL .DWWHITE AC4591001C4591001 1044 10441284A ADVERSE EVENT 2 depression Depression F'PSYCHIATRIC DISORDERS Depression FFDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'2021-02-01 B6 .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDW( B#....... N NNOT RELATEDOTHER med history NOT APPLICABLE YNRECOVERING/RESOLVING N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVDHr3lDWDHsm:kFollow Up 1 A0Y A 2021-05-14T21:56:49Y 104412851044BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVDHHr@DWD|HrLBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADVDHDWD|Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW%DWYPhase 3A@NNEG. ....... . .NY.DW.C..CAHr@HrL.. .DWWHITE AC4591001C4591001 1044 10441285AADVERSE EVENT 1 Wisdom teeth extraction Wisdom teeth removal F<SURGICAL AND MEDICAL PROCEDURES Wisdom teeth removal FQFQDental and gingival therapeutic procedures FƝHead and neck therapeutic procedures FvSurgical and medical procedures F<2021-06-22 B2021-06-22 B 2MedDRA v24.0NDW B..DWB..ADAYSN NNOT RELATEDOTHER unk NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVDHHr@DXtD|Ht|Follow Up 1 A0Y A 2021-07-12T12:06:07Y 104412921044Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVDHreDWcDHs5Placebo APlacebo ADVDDW D,Y . . .Placebo Placebo DW+DWJYPhase 3A@NNEGDWK BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWMDWcDHDDWDX BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWJDWBQBBC@AHreHrIHsHs5 .DWLWHITE AC4591001C4591001 1044 10441292AADVERSE EVENT 1 Edema Toes (Bilateral) Oedema peripheral FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Foot edema FF ,Oedema NEC F !General system disorders NEC FGeneral disorders and administration site conditions F2020-12-17 A2020-12-19 A0 1MedDRA v24.0NDV A..DVA0..A0DAYSN NNOT RELATEDOTHER unk NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVDHreDWMDGHsVaccination 1 AY A2021-01-06T10:52:32 104413001044BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDPHrDWDHrtBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADWDPDWDY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW6DWYPhase 3A@NNEGDW ....... . .NY.DWDWBBqBAHrHrt.. .DWWHITE AC4591001C4591001 1044 10441300AADVERSE EVENT 1 Stomach pain Abdominal pain upper FܛGASTROINTESTINAL DISORDERS Stomach pain F;FGastrointestinal and abdominal pains (excl oral and throat) F܆Gastrointestinal signs and symptoms FGastrointestinal disorders Fܛ2021-08-31 B2021-09-01 B 1MedDRA v24.0NDW B..DWB..A DAYSN NNOT RELATEDOTHER unk NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DWDPHrDXDHt,After unblinding and before Vaccination 3A@ A 2021-09-07T12:48:29Y 104413031044Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWD\HrW\DWDHslPlacebo APlacebo ADWD\DWDY . . .Placebo Placebo DW=DWqYPhase 3A@NNEGDWr BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWvDWDDDWDXJBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWqDWBlBBBAHrW\Hr |HsNHsl .DWuWHITE AC4591001C4591001 1044 10441303AADVERSE EVENT 2 Injection site pain Injection site pain FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2021-04-20 Bq2021-04-23 Bt 1MedDRA v24.0NDWv A..DWyA@..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWvDHsNDXDHuN)Vaccination 3 APY A02021-05-14T20:55:34Y 104413031044Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWD\HrW\DWDHslPlacebo APlacebo ADWD\DWDY . . .Placebo Placebo DW=DWqYPhase 3A@NNEGDWr BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWvDWDDDWDXJBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWqDWBlBBBAHrW\Hr |HsNHsl .DWuWHITE AC4591001C4591001 1044 10441303A ADVERSE EVENT 1 generlized Muscle aches Myalgia FkMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Generalized muscle aches FiF{Muscle pains F#Muscle disorders FMusculoskeletal and connective tissue disorders Fk2021-04-20 Bq2021-04-22 Bs 1MedDRA v24.0NDWv A..DWxA0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWvDHsNDXDHuN)Vaccination 3 APY A02021-05-18T08:15:38Y 104413041044BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDHrdDWDHr`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADWDDWDY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW>DWYPhase 3A@NNEGDW ....... . .NY.DWDWBBlBAHrdHr`.. .DWWHITE AC4591001C4591001 1044 10441304AADVERSE EVENT 1 generalized rash Rash F5SKIN AND SUBCUTANEOUS TISSUE DISORDERS Generalized rash FVF*TRashes, eruptions and exanthems NEC FcEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F52021-02-25 B;2021-02-27 B= 1MedDRA v24.0NDW@ B&..DWBB(..A0DAYSN NNOT RELATEDOTHER unk NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DWDHrdDXDHtFollow Up 1 A0Y A 2021-03-27T00:34:25 AERELTXT, Minor AE term changed from EUA to sBLA 104413091044BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDHrt\DWDLHrՉLBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADWDDWDLY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW6DWYPhase 3A@NNEG. ....... . .NY.DW.B..BAHrt\HrՉL.. .DWWHITE AC4591001C4591001 1044 10441309AADVERSE EVENT 1 Ocular Pain in Right Eye Eye pain FԯEYE DISORDERS Ocular pain F=FOcular disorders NEC F Eye disorders NEC FԭEye disorders Fԯ2021-05-12 B2021-05-14 B 2MedDRA v24.0NDW Bs..DWBu..A0DAYSN NNOT RELATEDOTHER unk NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DWDHrt\DXDLHtFollow Up 1 A0Y A 2021-07-16T20:05:51Y 104413201044Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADW DHrY`DWD,Hs(Placebo APlacebo ADW DDW"DY . . .Placebo Placebo DWEDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDdD,DWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBqBAHrY`HrHsn}dHs( .DWWHITE AC4591001C4591001 1044 10441320AADVERSE EVENT 2 chills Chills FGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills FFFeelings and sensations NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2021-06-04 B2021-06-05 B 1MedDRA v24.0NDW A..DWA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDdHsn}dDYD,Huk\,Vaccination 4 A`Y A@2021-07-03T11:09:09Y 104413201044Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADW DHrY`DWD,Hs(Placebo APlacebo ADW DDW"DY . . .Placebo Placebo DWEDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDdD,DWDX`BNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBpBqBAHrY`HrHsn}dHs( .DWWHITE AC4591001C4591001 1044 10441320A ADVERSE EVENT 1 headache Headache FNERVOUS SYSTEM DISORDERS Headache FFHeadaches NEC FHeadaches FNervous system disorders F2021-06-04 B2021-06-05 B 1MedDRA v24.0NDW A..DWA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDdHsn}dDYD,Huk\,Vaccination 4 A`Y A@2021-07-03T11:08:58Y 104413281044BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDHrśDW"DPHrPBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADWDDW"DPY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW>DWYPhase 3A@NNEGDW ....... . .NY.DWDWBBqBAHrśHrP.. .DWWHITE AC4591001C4591001 1044 10441328AADVERSE EVENT 1 Pilonidal cyst Pilonidal cyst FINFECTIONS AND INFESTATIONS Pilonidal cyst FcFcSkin structures and soft tissue infections F5Infections - pathogen unspecified FInfections and infestations F2021-04-22 Bk .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDWx BW....... N NNOT RELATEDOTHER UNKNOWN ETIOLOGY NOT APPLICABLE NYRECOVERING/RESOLVING N A0NOT RELATEDA0A GRADE 2A . APeriod 01DWDHrśDXDPHtFollow Up 1 A0Y A 2021-04-29T15:50:12Y 104413351044Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADWDټHr <DWD(Hs?(Placebo APlacebo ADWDټDW%DנY . . .Placebo Placebo DWHDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDD(DWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBlBpBAHr <Hr HssHs?( .DWWHITE AC4591001C4591001 1044 10441335AADVERSE EVENT 1 Worsening of acne Acne F5SKIN AND SUBCUTANEOUS TISSUE DISORDERS Acne aggravated FrFpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F52021-02-27 B4 .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDWB B....... N NNOT RELATEDOTHER unk NOT APPLICABLE YNRECOVERING/RESOLVING N A0NOT RELATEDA0AGRADE 1A . APeriod 01DWDټHr <DWDHssVaccination 2 A Y A 2021-03-05T23:58:05 104413371044Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWD$Hr($DWDhHshPlacebo APlacebo ADWD$DW%DY . . .Placebo Placebo DWADWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWD<DhDWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWB~BkBpBAHr($Hr(HstHsh .DWWHITE AC4591001C4591001 1044 10441337AADVERSE EVENT 1 Broken humerus (right arm) Humerus fracture FINJURY, POISONING AND PROCEDURAL COMPLICATIONS Humerus fracture FnFnLimb fractures and dislocations FBone and joint injuries FInjury, poisoning and procedural complications F2021-01-10 A02021-02-12 B$ 2MedDRA v24.0NDW A0..DW3B$..B"DAYSN NNOT RELATEDOTHER accident NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DWD$Hr($DWD;HstVaccination 1 AY A2021-05-19T19:28:20 AE outcome changed from EUA to sBLA 104413381044Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWD$Hr($DW%D0HrPlacebo APlacebo ADWD$DW%D0Y . . .Placebo Placebo DWADWYPhase 3A@NNEG. ....... . .NN.DW.B..BAHr($Hr.. .DWWHITE AC4591001C4591001 1044 10441338AADVERSE EVENT 1 Wart on second toe (left) Skin papilloma F0NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)Wart FQQF6KSkin neoplasms benign F6BCutaneous neoplasms benign F6CNeoplasms benign, malignant and unspecified (incl cysts and polyps)F02021-02-01 B2021-02-07 B 1MedDRA v24.0NDW( A@..DW.A..ApDAYSN NNOT RELATEDOTHER unk NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DWD$Hr($DXD0Ht0Vaccination 2 A Y A 2021-02-26T19:49:21 104413451044Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDHrɌdDWD0Hs0Placebo APlacebo ADWDDW$D0Y . . .Placebo Placebo DWEDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDD0DWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWB|BmBqBAHrɌdHr0HsrC|Hs0 .DWWHITE AC4591001C4591001 1044 10441345AADVERSE EVENT 3 dizziness Dizziness FNERVOUS SYSTEM DISORDERS Dizziness F˅F˅Neurological signs and symptoms NEC FNeurological disorders NEC FNervous system disorders F2021-06-07 B2021-06-07 B 2MedDRA v24.0NDW A..DWA..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWDHsrC|DYD0HuoVaccination 4 A`Y A@2021-06-08T21:16:21Y 104413451044Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDHrɌdDWD0Hs0Placebo APlacebo ADWDDW$D0Y . . .Placebo Placebo DWEDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDD0DWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWB|BmBqBAHrɌdHr0HsrC|Hs0 .DWWHITE AC4591001C4591001 1044 10441345A ADVERSE EVENT 4 generalized myalgia Myalgia FkMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Myalgia F{F{Muscle pains F#Muscle disorders FMusculoskeletal and connective tissue disorders Fk2021-06-07 B .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDW A....... N NRELATED NOT APPLICABLE YNRECOVERING/RESOLVING N ARELATED AA GRADE 2A . A Period 02DWDHsrC|DYD0HuoVaccination 4 A`Y A@2021-06-08T21:16:32Y 104413451044Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDHrɌdDWD0Hs0Placebo APlacebo ADWDDW$D0Y . . .Placebo Placebo DWEDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDD0DWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWB|BmBqBAHrɌdHr0HsrC|Hs0 .DWWHITE AC4591001C4591001 1044 10441345A0ADVERSE EVENT 1 nausea Nausea FܛGASTROINTESTINAL DISORDERS Nausea F F Nausea and vomiting symptoms FGastrointestinal signs and symptoms FGastrointestinal disorders Fܛ2021-06-07 B2021-06-08 B 1MedDRA v24.0NDW A..DWA ..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDHsrC|DYD0HuoVaccination 4 A`Y A@2021-06-08T21:16:00Y 104413451044Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDHrɌdDWD0Hs0Placebo APlacebo ADWDDW$D0Y . . .Placebo Placebo DWEDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDD0DWDXcBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWB|BmBqBAHrɌdHr0HsrC|Hs0 .DWWHITE AC4591001C4591001 1044 10441345A@ADVERSE EVENT 2 vomitting Vomiting FܛGASTROINTESTINAL DISORDERS Vomiting FPFPNausea and vomiting symptoms FGastrointestinal signs and symptoms FGastrointestinal disorders Fܛ2021-06-07 B2021-06-08 B 1MedDRA v24.0NDW A..DWA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDHsrC|DYD0HuoVaccination 4 A`Y A@2021-06-08T21:16:11Y 104413511044Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDHrɼDWD HsPlacebo APlacebo ADWDDW(DY . . .Placebo Placebo DWGDWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDtD DXDXBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWBBB$BAHrɼHrHscHs .DWWHITE AC4591001C4591001 1044 10441351AADVERSE EVENT 1 Left hip flexor strain Muscle strain FINJURY, POISONING AND PROCEDURAL COMPLICATIONS Muscle strain FYFYMuscle, tendon and ligament injuries FInjuries NEC FInjury, poisoning and procedural complications F2021-02-11 B!2021-02-27 B1 2MedDRA v24.0NDW2 A..DWBB..BDAYSN NNOT RELATEDOTHER unk NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DWDHrɼDWDsHscVaccination 2 A Y A 2021-03-04T22:57:53 104413541044Placebo PLACEBO Placebo PLACEBO AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDlHrlDWDHsPlacebo APlacebo ADWDlDW%D Y . . .Placebo Placebo DWADWYPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDDDWDXeBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ANN.DWDWB{BkBqBAHrlHrHstHs .DWWHITE AC4591001C4591001 1044 10441354AADVERSE EVENT 1 Worsening of ADHD Attention deficit hyperactivity disorderF'PSYCHIATRIC DISORDERS ADHD FF&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'2021-04-24 Bi .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDWz BV....... N NNOT RELATEDOTHER med history NOT APPLICABLE YNNOT RECOVERED/NOT RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DWDlHrlDWDHstFollow Up 1 A0Y A 2021-05-14T22:46:32Y 104413611044BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDHr?TDW*DHrBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADWDDW*DY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWLDWYPhase 3A@NNEGDW ....... . .NY.DWDWB{BpBAHr?THr.. .DWWHITE AC4591001C4591001 1044 10441361AADVERSE EVENT 1 Concussion Concussion FINJURY, POISONING AND PROCEDURAL COMPLICATIONS Concussion FFCerebral injuries NEC FdInjuries NEC FInjury, poisoning and procedural complications F2021-01-23 A2021-02-13 B" 1MedDRA v24.0NDW A..DW4B"..BDAYSN NNOT RELATEDOTHER unk NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DWDHr?TDXDHtȜVaccination 1 AY A2021-03-09T19:56:22 104413611044BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDHr?TDW*DHrBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADWDDW*DY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWLDWYPhase 3A@NNEGDW ....... . .NY.DWDWB{BpBAHr?THr.. .DWWHITE AC4591001C4591001 1044 10441361A ADVERSE EVENT 2 allergic contact dermatitis involving all extremities (contact with poison sumac) Dermatitis contact F5SKIN AND SUBCUTANEOUS TISSUE DISORDERS Sumac rash F<|FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F52021-04-24 Bh .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDWz BQ....... N NNOT RELATEDOTHER (contact with poison sumac) NOT APPLICABLE YNRECOVERING/RESOLVING N A0NOT RELATEDA0AGRADE 1A . APeriod 01DWDHr?TDXDHtȜFollow Up 1 A0Y A 2021-05-25T09:46:24Y 104413641044BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDְHrc0DW*DHrBNT162b2 Phase 2/3 (30 mcg)ABNT162b2 Phase 2/3 (30 mcg)ADWDְDW*DY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWGDWYPhase 3A@NNEGDW ....... . .NY.DWDWBBjBAHrc0Hr.. .DWWHITE AC4591001C4591001 1044 10441364AADVERSE EVENT 1 attention deficit hyperactivity disorder Attention deficit hyperactivity disorderF'PSYCHIATRIC DISORDERS Attention deficit hyperactivity disorder F&F&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FPsychiatric disorders F'2021-04-29 Bm2021-07 . 1MedDRA v24.0NDW BV....... N NNOT RELATEDOTHER unk NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DWDְHrc0DXDHthFollow Up 1 A0Y A 2021-09-22T15:38:53Y 104413641044BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE