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 tAGEGR2N Pooled Age Group 2 (N) BEST } AGEGR3 Pooled Age Group 3 …AGEGR3N Pooled Age Group 3 (N) BEST †AGEGR4 Pooled Age Group 4 ŽAGEGR4N Pooled Age Group 4 (N) BEST ™)RACE Race ˇRACEN Race (N) BEST ĘSEX Sex ŇSEXN Sex (N) BEST ÓETHNIC Ethnicity ŰETHNICN Ethnicity (N) BEST ńCOUNTRY Country ů)ARACE Analysis Race üARACEN 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 ›$VAX101DTVaccination Date 01 DATE Ł%VAX101TMVaccination Time 01 TIME «&VAX102DTVaccination Date 02 DATE ł'VAX102TMVaccination Time 02 TIME »(SAFFL Safety Population Flag Ă)COHORT Cohort Group Ä*COHORTN Cohort Group (N) BEST Ĺ+DOSALVL Actual Dosing Level Í,DOSALVLNActual Dosing Level (N) BEST Î-DOSPLVL Planned Dosing Level Ö.DOSPLVLNPlanned Dosing Level (N) BEST ×$/VAX101 Vaccination 01 ß$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 Ď?VAX201TMVaccination Time 03 TIME ×@VAX202TMVaccination Time 04 TIME ßAV03DT Date of Visit at 1M after Vax3/4 DATE çBV04DT Date of Visit at 6M after Vax3/4 DATE ďCTRT02A 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 ŹTTR02EDTMDatetime of Last Exposure in Period 02 DATETIME —UVAX20U Vaccination Unplanned in Period 02 źVVAX20UDTVaccination 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 ÉZSTUDYID Study Identifier Ń[USUBJID Unique Subject Identifier Ů\AESEQ Sequence Number BEST ď]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 ť>cAELLT Lowest Level Term ŕdAELLTCD 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 ąCjAESOC Primary System Organ Class ÁkAESOCCD 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 YsDICTVER 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 µ‚AESDISABPersist or Signif Disability/Incapacity ¶AESDTH Results in Death ·„AESHOSP Requires or Prolongs Hospitalization ¸…AESLIFE Is Life Threatening ą†AESMIE Other Medically Important Serious Event ş‡AEMERES Is AE a Result of a Medication Error »AEREL Causality Ľ‰AERELNSTRelationship to Non-Study Treatment ÇSŠAERELTXTEvent Due to Other Specify ĺ‹AEACN Action Taken with Study Treatment 8ŚAECMGIV Concomitant Medication Given HŤAENDGIV Was a Non-Drug Treatment given I ŽAEOUT Outcome of Adverse Event JŹAESUBJDCDiscontinued because of this AE jAEREFID Reference ID k‘AERELN Causality (N) BEST w’AREL Analysis Causality “ARELN Analysis Causality (N) BEST Š”AETOXGRNStandard Toxicity Grade (N) BEST ’•ATOXGR Analysis Toxicity Grade š–ATOXGRN Analysis Toxicity Grade (N) BEST ˇ—AEMEFL Medication Error Associated With AE ©AETPDOS Time Post Dose BEST Ş™AEIMMFL Vaccine Studies AE Immediate flag ˛šAPERIOD Period BEST ł ›APERIODCPeriod (C) »śAPERSDT Period Start Date DATE ÄťAPERSTM Period Start Time TIME ĚžAPERSDTMPeriod Start Date/Time DATETIME ÔźAPEREDT Period End Date DATE Ü APERETM Period End Time TIME äˇAPEREDTMPeriod End Date/Time DATETIME ě)˘VPHASE Vaccine Phase ôŁVPHASEN Vaccine Phase(N) BEST ¤INWDFL Within Reporting Window Flag %ĄPREFL Pre-treatment Flag &¦VAXNO AE Occured after Which Vaccination BEST '§LSTCGDTCDate/Time of Last change /¨DATCHGFLNew AE Reported post EUA snapshot Flag BI©DATACHGCAE 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_30AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVŔD†ÄHr^¦ÄDV×DřHr|ňxBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVŔD†ÄDV×DřY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DVřDW†YPhase 3A@NNEGDWŤ ....... . .NY.DWŚDWýBÍBqCŕAŔHr^¦ÄHr|ňx.. .DW†WHITE AC4591001C4591001 1005 10051317AADVERSE EVENT 1 CHILLS Chills FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills F·ÓF·ÓFeelings and sensations NEC F™ŁGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2020-10-21T00:15A 2020-10-22T07:00A0 2MedDRA v24.0NDVÁ A C8@Hr_uDVÂA0Db«Hra%«A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C7 APeriod 01DVŔD†ÄHr^¦ÄDXDDřHt^%řVaccination 1 AY A2020-11-12T21:04:31 100513281005BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVŔD°Hr^ĐDVÖD› Hr{Ľ BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVŔD°DVÖD› Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DVôDWŠYPhase 3A@NNEGDWŤ ....... . .NY.DWŚDWýBÍBqCŕAŕHr^ĐHr{Ľ .. .DWŠWHITE AC4591001C4591001 1005 10051328AADVERSE EVENT 2 NAUSEA Nausea FÜ›GASTROINTESTINAL DISORDERS Nausea F™ F™ Nausea and vomiting symptoms F™Gastrointestinal signs and symptoms FÜÜGastrointestinal disorders FÜ›2020-11-12 B2020-11-13T06:00B 2MedDRA v24.0NDV× A ..DVŘA0DT›Hr~›A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . APeriod 01DVŔD°Hr^ĐDXCD› Ht\đ Vaccination 2 A Y A 2021-02-25T20:35:11 100513391005Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVÁD¤LHr`ĚDW¨DLHsLPlacebo APlacebo ADVÁD¤LDVÖDŇY . . .Placebo Placebo DVňDWŠYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¨DŇđDLDWÄDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBĚBmBqCĐAŕHr`ĚHr{óHsr|pHsL .DWŠWHITE AC4591001C4591001 1005 10051339AADVERSE EVENT 1 anxiety Anxiety F™'·PSYCHIATRIC DISORDERS Anxiety Fˇ§Fˇ§Anxiety symptoms FˇµAnxiety disorders and symptoms FˇPsychiatric 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 01DVÁD¤LHr`ĚDW‘DŇďHsr|oFollow Up 1 A0Y A 2021-05-18T18:05:13Y 100513391005Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVÁD¤LHr`ĚDW¨DLHsLPlacebo APlacebo ADVÁD¤LDVÖDŇY . . .Placebo Placebo DVňDWŠYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¨DŇđDLDWÄDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBĚBmBqCĐAŕHr`ĚHr{óHsr|pHsL .DWŠWHITE AC4591001C4591001 1005 10051339A ADVERSE EVENT 2 generalized myalgia Myalgia F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Myalgia F™{F™{Muscle pains F™#Muscle disorders F™Musculoskeletal and connective tissue disorders F™k2021-05-19 BÓ2021-05-23 B× 1MedDRA v24.0NDW“ A0..DW—Ap..APDAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW‘DŇđHsr|pDYDLHuqLĚVaccination 3 APY A02021-06-16T20:56:19Y 100514171005Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVůD®śHr©ôDWéD™HsćFŚPlacebo APlacebo ADVůD®śDWDśY . . .Placebo Placebo DW1DWËYPhase 3A@NNEGDWÍ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŃDWéD¬řD™DXDX¦BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWĚDWýBÔB-B1CPAĐHr©ôHrĹ…śHsĆ¶xHsćFŚ .DWËWHITE AC4591001C4591001 1005 10051417AADVERSE EVENT 1 fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-08-13T19:00Bń2021-08-14T12:30Bň 2MedDRA v24.0NDWé AEłHsć¸°DWęA D°HsçŻA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A Cp A Period 02DWŃD¬řHsĆ¶xDYVD™HuÇzVaccination 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_30AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVůDŢ¨HrŞ$(DWD«ĚHrÂýĚBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVůDŢ¨DWD«ĚY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW(DW‘YPhase 3A@NNEGDW’ ....... . .NY.DW‘DWýB™BlCPAŔHrŞ$(HrÂýĚ.. .DWĐWHITE AC4591001C4591001 1005 10051420AADVERSE EVENT 2 Anxiety Anxiety F™'·PSYCHIATRIC DISORDERS Anxiety Fˇ§Fˇ§Anxiety symptoms FˇµAnxiety disorders and symptoms FˇPsychiatric disorders F™'·2021-05-03 B‹ .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDW Bx....... N NNOT RELATEDOTHER unknown NOT APPLICABLE YNNOT RECOVERED/NOT RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVůDŢ¨HrŞ$(DXyD«ĚHt¤1LFollow 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_30AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVůDŢ¨HrŞ$(DWD«ĚHrÂýĚBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVůDŢ¨DWD«ĚY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW(DW‘YPhase 3A@NNEGDW’ ....... . .NY.DW‘DWýB™BlCPAŔHrŞ$(HrÂýĚ.. .DWĐWHITE AC4591001C4591001 1005 10051420A ADVERSE EVENT 1 Depression Depression F™'·PSYCHIATRIC DISORDERS Depression FĆÚFĆÚDepressive disorders FĆńDepressed mood disorders and disturbances FĆ×Psychiatric 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 01DVůDŢ¨HrŞ$(DXyD«ĚHt¤1LFollow 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_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVűD‡Hr¬o€DWDDHrČDBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVűD‡DWDDY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW3DWźYPhase 3A@NNEGDW ....... . .NY.DWźDWýBĄB^C0AĐHr¬o€HrČD.. .DWÉWHITE AC4591001C4591001 1005 10051424AADVERSE EVENT 4 FATIGUE Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-01-08T21:00B2021-01-11 B 2MedDRA v24.0NDW AEuHrČżPDWA@..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C,Đ APeriod 01DVűD‡Hr¬o€DX}DDHt©JÄVaccination 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_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVűD‡Hr¬o€DWDDHrČDBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVűD‡DWDDY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW3DWźYPhase 3A@NNEGDW ....... . .NY.DWźDWýBĄB^C0AĐHr¬o€HrČD.. .DWÉWHITE AC4591001C4591001 1005 10051424A ADVERSE EVENT 1 HEADACHE Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-01-08T21:00B2021-01-11 B 2MedDRA v24.0NDW AEuHrČżPDWA@..A@DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C,Đ APeriod 01DVűD‡Hr¬o€DX}DDHt©JÄVaccination 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_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVűD‡Hr¬o€DWDDHrČDBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVűD‡DWDDY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW3DWźYPhase 3A@NNEGDW ....... . .NY.DWźDWýBĄB^C0AĐHr¬o€HrČD.. .DWÉWHITE AC4591001C4591001 1005 10051424A0ADVERSE EVENT 5 INJECTION SITE PAIN Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-01-08T21:00B2021-01-11 B 2MedDRA v24.0NDW AEuHrČżPDWA@..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C,Đ APeriod 01DVűD‡Hr¬o€DX}DDHt©JÄVaccination 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_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVűD‡Hr¬o€DWDDHrČDBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVűD‡DWDDY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW3DWźYPhase 3A@NNEGDW ....... . .NY.DWźDWýBĄB^C0AĐHr¬o€HrČD.. .DWÉWHITE AC4591001C4591001 1005 10051424A@ADVERSE EVENT 3 GENERALIZED MYALGIA Myalgia F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Myalgia F™{F™{Muscle pains F™#Muscle disorders F™Musculoskeletal and connective tissue disorders F™k2021-01-08T21:00B2021-01-11 B 2MedDRA v24.0NDW AEuHrČżPDWA@..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C,Đ APeriod 01DVűD‡Hr¬o€DX}DDHt©JÄVaccination 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_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVűD‡Hr¬o€DWDDHrČDBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVűD‡DWDDY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW3DWźYPhase 3A@NNEGDW ....... . .NY.DWźDWýBĄB^C0AĐHr¬o€HrČD.. .DWÉWHITE AC4591001C4591001 1005 10051424APADVERSE EVENT 2 NAUSEA Nausea FÜ›GASTROINTESTINAL DISORDERS Nausea F™ F™ Nausea and vomiting symptoms F™Gastrointestinal signs and symptoms FÜÜGastrointestinal disorders FÜ›2021-01-08T21:00B2021-01-11 B 1MedDRA v24.0NDW AEuHrČżPDWA@..A@DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C,Đ APeriod 01DVűD‡Hr¬o€DX}DDHt©JÄVaccination 2 A Y A 2021-01-27T04:17:48 100514271005Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVţDťDHr°zDDW¦D¬řHsŽřPlacebo APlacebo ADVţDťDDWDĐY . . .Placebo Placebo DW/DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦D°@D¬řDWĹDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBŹBmBqCAŕHr°zDHrĚ%PHsrYŔHsŽř .DWWHITE AC4591001C4591001 1005 10051427AADVERSE EVENT 1 chills Chills FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills F·ÓF·ÓFeelings and sensations NEC F™ŁGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-07T17:00B©2021-06-09 B« 2MedDRA v24.0NDW¦ ADďHsŽHDW¨A0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C A Period 02DW‘D°@HsrYŔDYD¬řHuo9xVaccination 4 A`Y A@2021-07-12T13:00:57Y 100514271005Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVţDťDHr°zDDW¦D¬řHsŽřPlacebo APlacebo ADVţDťDDWDĐY . . .Placebo Placebo DW/DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦D°@D¬řDWĹDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBŹBmBqCAŕHr°zDHrĚ%PHsrYŔHsŽř .DWWHITE AC4591001C4591001 1005 10051427A ADVERSE EVENT 2 generalized myalgia Myalgia F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Myalgia F™{F™{Muscle pains F™#Muscle disorders F™Musculoskeletal and connective tissue disorders F™k2021-06-07T17:00B©2021-06-09 B« 2MedDRA v24.0NDW¦ ADďHsŽHDW¨A0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C A Period 02DW‘D°@HsrYŔDYD¬řHuo9xVaccination 4 A`Y A@2021-07-12T13:01:43Y 100514371005Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADV˙DpHr±ŰđDW°D™üHs›!üPlacebo APlacebo ADV˙DpDWDĘřY . . .Placebo Placebo DW6DW‘YPhase 3A@NNEGDW’ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW›DW°D’@D™üDWĐDXmBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‘DWýB“BcBlB˙AđHr±ŰđHrÍ¨řHsjŔHs›!ü .DWšWHITE AC4591001C4591001 1005 10051437AADVERSE EVENT 2 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-17T17:00B˛2021-06-26T08:00B» 2MedDRA v24.0NDW° ADďHs›wDWąA Dp»Hs¦Ö;A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C° A Period 02DW›D’@HsjŔDYD™üHu|U|Vaccination 4 A`Y A@2021-06-28T17:28:28Y 100514371005Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADV˙DpHr±ŰđDW°D™üHs›!üPlacebo APlacebo ADV˙DpDWDĘřY . . .Placebo Placebo DW6DW‘YPhase 3A@NNEGDW’ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW›DW°D’@D™üDWĐDXmBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‘DWýB“BcBlB˙AđHr±ŰđHrÍ¨řHsjŔHs›!ü .DWšWHITE AC4591001C4591001 1005 10051437A ADVERSE EVENT 1 Generalized myalgia Myalgia F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Myalgia F™{F™{Muscle pains F™#Muscle disorders F™Musculoskeletal and connective tissue disorders F™k2021-06-17T17:00B˛2021-06-26T08:00B» 2MedDRA v24.0NDW° ADďHs›wDWąA Dp»Hs¦Ö;A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C° A Period 02DW›D’@HsjŔDYD™üHu|U|Vaccination 4 A`Y A@2021-06-28T17:28:17Y 100514501005Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DWDŃHrĚ^DWDŮřHs—mxPlacebo APlacebo ADWDŃDW(DÜPY . . .Placebo Placebo DWDDW‘YPhase 3A@NNEGDW’ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDá<DŮřDWĐDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‘DWýBBfBlBëAŕHrĚ^HrčPHs{Ĺ<Hs—mx .DW—ALL OTHERS A0C4591001C4591001 1005 10051450AADVERSE EVENT 1 Broken left thumb Hand fracture FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Fractured thumb FÚ!Fá*Limb fractures and dislocations F™ľîBone and joint injuries F¶Injury, poisoning and procedural complications Fěĺ2021-06-10 B—2021-07-16 B» 2MedDRA v24.0NDW© B..DWÍB6..B%DAYSN NNOT RELATEDOTHER outdoor activities NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . A Period 02DWDá<Hs{Ĺ<DYDŮřHux řVaccination 3 APY A02021-08-06T13:01:14Y 100611831006Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAMULTIPLE A`MAHISPANIC OR LATINO AUSAMULTIRACIAL A`DVéD„0Hr”±°DW§D‚HsŹ,”Placebo APlacebo ADVéD„0DWD†Y . . .Placebo Placebo DW0DW‘YPhase 3A@NNEGDW’ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW”DW§D‘ČD‚DWÉDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‘DWýB©BjBlCPAŕHr”±°HrĆĚHsv/ČHsŹ,” .DW“ALL OTHERS A0C4591001C4591001 1006 10061183AADVERSE EVENT 1 Broken thumb- left Hand fracture FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Fractured thumb FÚ!Fá*Limb fractures and dislocations F™ľîBone and joint injuries F¶Injury, poisoning and procedural complications Fěĺ2021-05-12 B¤2021-06-16 BÇ 2MedDRA v24.0NDWŚ B~..DWŻBˇ..B$DAYSN NNOT RELATEDOTHER Sports Injury NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVéD„0Hr”±°DW”D‘ÇHsv/ÇFollow Up 1 A0Y A 2021-07-12T19:57:29Y 100611831006Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAMULTIPLE A`MAHISPANIC OR LATINO AUSAMULTIRACIAL A`DVéD„0Hr”±°DW§D‚HsŹ,”Placebo APlacebo ADVéD„0DWD†Y . . .Placebo Placebo DW0DW‘YPhase 3A@NNEGDW’ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW”DW§D‘ČD‚DWÉDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‘DWýB©BjBlCPAŕHr”±°HrĆĚHsv/ČHsŹ,” .DW“ALL OTHERS A0C4591001C4591001 1006 10061183A ADVERSE EVENT 2 Injection Site Tenderness Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site tenderness FěÖFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-20T12:00B¬2021-05-22 B® 1MedDRA v24.0NDW” AD¨ŔHsvFŔDW–A0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Bb A Period 02DW”D‘ČHsv/ČDYD‚Hup`Vaccination 3 APY A02021-06-08T19:08:47Y 100611961006Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADVëDý Hr—Í DW§D©tHsŹSôPlacebo APlacebo ADVëDý DVţD÷ĽY . . .Placebo Placebo DWDW‘YPhase 3A@NNEGDW’ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DW§DĹĐD©tDWĂDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‘DWýB§BkBlC0AŔHr—Í Hr°ÔĽHsuPHsŹSô .DW’WHITE AC4591001C4591001 1006 10061196AADVERSE EVENT 1 Injection site tenderness Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site tenderness FěÖFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-19T23:00B©2021-05-26 B° 1MedDRA v24.0NDW“ AE7HsuŹđDWšA€..A€DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C!€ A Period 02DW“DĹĐHsuPDYD©tHup‡tVaccination 3 APY A02021-06-09T00:01:47Y 100612031006BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVěDňXHr™XDV˙D©8Hr±×¸BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVěDňXDV˙D©8Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWDW™YPhase 3A@NNEGDWš ....... . .NY.DW™DWýB®BdC AĐHr™XHr±×¸.. .DW°WHITE AC4591001C4591001 1006 10061203AADVERSE EVENT 2 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2020-12-04 A 2020-12-04 A 1MedDRA v24.0NDVí A ..DVíA ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . APeriod 01DVěDňXHr™XDXlD©8Ht“8Vaccination 1 AY A2021-02-05T02:15:18 100612031006BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVěDňXHr™XDV˙D©8Hr±×¸BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVěDňXDV˙D©8Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWDW™YPhase 3A@NNEGDWš ....... . .NY.DW™DWýB®BdC AĐHr™XHr±×¸.. .DW°WHITE AC4591001C4591001 1006 10061203A ADVERSE EVENT 5 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2020-12-22T19:00B2020-12-24 B 1MedDRA v24.0NDV˙ AEłHr˛9°DWA0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C APeriod 01DVěDňXHr™XDXlD©8Ht“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_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVěDňXHr™XDV˙D©8Hr±×¸BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVěDňXDV˙D©8Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWDW™YPhase 3A@NNEGDWš ....... . .NY.DW™DWýB®BdC AĐHr™XHr±×¸.. .DW°WHITE AC4591001C4591001 1006 10061203A0ADVERSE EVENT 3 Headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2020-12-04 A 2020-12-05 A0 1MedDRA v24.0NDVí A ..DVîA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . APeriod 01DVěDňXHr™XDXlD©8Ht“8Vaccination 1 AY A2021-02-05T02:15:24 100612031006BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVěDňXHr™XDV˙D©8Hr±×¸BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVěDňXDV˙D©8Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWDW™YPhase 3A@NNEGDWš ....... . .NY.DW™DWýB®BdC AĐHr™XHr±×¸.. .DW°WHITE AC4591001C4591001 1006 10061203A@ADVERSE EVENT 6 Headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2020-12-22T19:00B2020-12-24 B 2MedDRA v24.0NDV˙ AEłHr˛9°DWA0..A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C APeriod 01DVěDňXHr™XDXlD©8Ht“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_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVěDňXHr™XDV˙D©8Hr±×¸BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVěDňXDV˙D©8Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWDW™YPhase 3A@NNEGDWš ....... . .NY.DW™DWýB®BdC AĐHr™XHr±×¸.. .DW°WHITE AC4591001C4591001 1006 10061203A`ADVERSE EVENT 4 Injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2020-12-04 A 2020-12-08 A` 1MedDRA v24.0NDVí A ..DVńA`..APDAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . APeriod 01DVěDňXHr™XDXlD©8Ht“8Vaccination 1 AY A2021-02-11T23:57:32 100612031006BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVěDňXHr™XDV˙D©8Hr±×¸BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVěDňXDV˙D©8Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWDW™YPhase 3A@NNEGDWš ....... . .NY.DW™DWýB®BdC AĐHr™XHr±×¸.. .DW°WHITE AC4591001C4591001 1006 10061203APADVERSE EVENT 7 Injection Site Pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2020-12-22T19:00B2020-12-24 B 2MedDRA v24.0NDV˙ AEłHr˛9°DWA0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C APeriod 01DVěDňXHr™XDXlD©8Ht“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_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVěDňXHr™XDV˙D©8Hr±×¸BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVěDňXDV˙D©8Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWDW™YPhase 3A@NNEGDWš ....... . .NY.DW™DWýB®BdC AĐHr™XHr±×¸.. .DW°WHITE AC4591001C4591001 1006 10061203ApADVERSE EVENT 1 Nausea Nausea FÜ›GASTROINTESTINAL DISORDERS Nausea F™ F™ Nausea and vomiting symptoms F™Gastrointestinal signs and symptoms FÜÜGastrointestinal disorders FÜ›2020-12-04T16:38A 2020-12-04T16:38A 1MedDRA v24.0NDVí A DéčHrš]hDVíA Dę#Hrš]ŁADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CWŔ APeriod 01DVěDňXHr™XDXlD©8Ht“8Vaccination 1 AY A2021-02-05T02:15:13 100612091006BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVíDŞÜHrš\DWDžčHrłčBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVíDŞÜDWDžčY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW"DW‘YPhase 3A@NPOSDW’ ....... . .NY.DW‘DWýBĄBlCAĐHrš\Hrłč.. .DWµWHITE AC4591001C4591001 1006 10061209AADVERSE EVENT 2 Syncope Vasovagal response Syncope F™•NERVOUS SYSTEM DISORDERS Syncope vasovagal F™=™F™=”Disturbances in consciousness NEC FËENeurological disorders NEC F™ůNervous system disorders F™•2021-03-12 Bc2021-03-12 Bc 1MedDRA v24.0NDWO BP..DWOBP..ADAYSN NNOT RELATEDOTHER blood draw NOT APPLICABLE NYRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVíDŞÜHrš\DXmDžčHt”RhFollow Up 1 A0Y A 2021-03-12T20:09:45 100612231006Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVđDÂHrž*DW§DťDHsŹGÄPlacebo APlacebo ADVđDÂDWDóüY . . .Placebo Placebo DW)DWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW§D{DťDDWĹDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýBžBmBpCŕAđHrž*HrĽ®|Hsr$ŚHsŹGÄ .DWWHITE AC4591001C4591001 1006 10061223AADVERSE EVENT 1 Injection Site Pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-18T08:00BŁ2021-05-21 B¦ 1MedDRA v24.0NDW’ A Dp€Hssk€DW•AP..A@DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CW0 A Period 02DW‘D{Hsr$ŚDYDťDHup{DVaccination 3 APY A02021-06-08T21:14:47Y 100612261006Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVđDçĚHržOĚDWŁD™ŔHs‰ţ@Placebo APlacebo ADVđDçĚDWDőÜY . . .Placebo Placebo DW!DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁDź$D™ŔDWĹDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBťBpBqCŕAđHržOĚHrş \HsnT$Hs‰ţ@ .DWŤWHITE AC4591001C4591001 1006 10061226AADVERSE EVENT 1 Attention Deficit Hyperactivity Disorder Attention deficit hyperactivity disorderF™'·PSYCHIATRIC DISORDERS Attention deficit hyperactivity disorder F™Ý&F™Ý&Attention deficit and disruptive behaviour disorders FĄCognitive and attention disorders and disturbances FĽńPsychiatric 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 01DVđDçĚHržOĚDWŽDź#HsnT#Follow Up 1 A0Y A 2021-06-02T23:29:43Y 100612281006Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVńD™ŔHrźS@DWŁDË4HsŠ/´Placebo APlacebo ADVńD™ŔDWDĆHY . . .Placebo Placebo DW$DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁDź$DË4DWĹDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBśBpBqCĐAŔHrźS@Hr»/HHsnT$HsŠ/´ .DWŤWHITE AC4591001C4591001 1006 10061228AADVERSE EVENT 1 Attention Deficit Hyperactivity Disorder Attention deficit hyperactivity disorderF™'·PSYCHIATRIC DISORDERS Attention deficit hyperactivity disorder F™Ý&F™Ý&Attention deficit and disruptive behaviour disorders FĄCognitive and attention disorders and disturbances FĽńPsychiatric 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 01DVńD™ŔHrźS@DWŽDź#HsnT#Follow Up 1 A0Y A 2021-05-14T22:46:43Y 100612451006Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVóD«THr˘ÔDW¨DÓhHsĎhPlacebo APlacebo ADVóD«TDWDŁ\Y . . .Placebo Placebo DW"DWYPhase 3A@NNEGDW‘ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW¨Dě¸DÓhDWĹDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWDWýBžBlBmC°AđHr˘ÔHr»\Hssç¸HsĎh .DW‘WHITE AC4591001C4591001 1006 10061245AADVERSE EVENT 1 Hives face Urticaria F™5ŃSKIN AND SUBCUTANEOUS TISSUE DISORDERS Hives FĺeF™MUrticarias F™MAngioedema and urticaria FźúSkin and subcutaneous tissue disorders F™5Ń2020-12-12 A02020-12-31 B 1MedDRA v24.0NDVő A0..DWB..BDAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . APeriod 01DVóD«THr˘ÔDW’Dě·Hssç·Vaccination 1 AY A2021-01-26T23:14:59 100612451006Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVóD«THr˘ÔDW¨DÓhHsĎhPlacebo APlacebo ADVóD«TDWDŁ\Y . . .Placebo Placebo DW"DWYPhase 3A@NNEGDW‘ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW¨Dě¸DÓhDWĹDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWDWýBžBlBmC°AđHr˘ÔHr»\Hssç¸HsĎh .DW‘WHITE AC4591001C4591001 1006 10061245A ADVERSE EVENT 2 Hives trunk Urticaria F™5ŃSKIN AND SUBCUTANEOUS TISSUE DISORDERS Hives FĺeF™MUrticarias F™MAngioedema and urticaria FźúSkin and subcutaneous tissue disorders F™5Ń2020-12-12 A02020-12-15 A` 1MedDRA v24.0NDVő A0..DVřA`..A@DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . APeriod 01DVóD«THr˘ÔDW’Dě·Hssç·Vaccination 1 AY A2020-12-30T15:20:57 100612531006Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVôDČdHrŁvdDW§DĐHsŹCPPlacebo APlacebo ADVôDČdDWDŁ Y . . .Placebo Placebo DW(DWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW§D~DĐDWĹDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýBšBmBpC AŕHrŁvdHrĽ] Hsr'HsŹCP .DWWHITE AC4591001C4591001 1006 10061253AADVERSE EVENT 1 Fractured Nasal Septum Facial bones fracture FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Fractured nose FÚFŐ*Skull fractures, facial bone fractures and dislocations F™6Bone and joint injuries F¶Injury, poisoning and procedural complications Fěĺ2021-06-02 B®2021-06-06 B˛ 1MedDRA v24.0NDWˇ B..DWĄB..APDAYSN NNOT RELATEDOTHER basketball injury NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . A Period 02DW‘D~Hsr'DYDĐHupvĐVaccination 3 APY A02021-06-08T21:14:58Y 100612581006BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsANATIVE HAWAIIAN OR OTHER PACIFIC ISLANDERAPMANOT HISPANIC OR LATINOA USANATIVE HAWAIIAN OR OTHER PACIFIC ISLANDERAPDV÷D‚Hr§$”DW D}ÜHrÄ!\BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DV÷D‚DW D}ÜY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW/DW‘YPhase 3A@NNEGDW’ ....... . .NY.DW‘DWýB›BlCpAŕHr§$”HrÄ!\.. .DWĆALL OTHERS A0C4591001C4591001 1006 10061258AADVERSE EVENT 1 ORAL CANKERS Aphthous ulcer FÜ›GASTROINTESTINAL DISORDERS Canker sores oral F˛~F˘Stomatitis and ulceration F™;Oral soft tissue conditions F™ĄGastrointestinal disorders FÜ›2021-06-27 BÄ2021-07-05 BĚ 2MedDRA v24.0NDWş B®..DWÂB¶..ADAYSN NNOT RELATEDOTHER VIRAL NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DV÷D‚Hr§$”DXzD}ÜHtĄTÜAfter unblinding and before Vaccination 3A@ A 2021-07-12T17:41:35Y 100612661006Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAMULTIPLE A`FA NOT HISPANIC OR LATINOA USAMULTIRACIAL A`DVřDž4Hr¨’4DWTDštHs!ŘtPlacebo APlacebo ADVřDž4DWD›dY . . .Placebo Placebo DW1DW=YPhase 3A@NNEGDW> BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW?DWTDžčDštDWpDXBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW=DWýBFBżBŔC`AđHr¨’4HrĹdHs-hHs!Řt .DW>ALL OTHERS A0C4591001C4591001 1006 10061266AADVERSE EVENT 1 CHILLS Chills FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills F·ÓF·ÓFeelings and sensations NEC F™ŁGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-02-24T22:00BH2021-02-26T11:00BJ 2MedDRA v24.0NDW? AEVHsĂŕDWAA0DšëHsĚkA0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C( A Period 02DW?DžčHs-hDXÁDštHuôVaccination 3 APY A02021-03-17T18:54:00 100612721006BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsABLACK OR AFRICAN AMERICAN A FA NOT HISPANIC OR LATINOA USABLACK OR AFRICAN AMERICAN A DVůDŞdHr©ďäDW‘DęśHsr”BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVůDŞd..Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g) DWŤDWŤYPhase 3A@NNEGDWŽBNT162b2 (30 (*ESC*){unicode 03BC}g) DW‘...... . .NN.DWŤDWýB•BpCPAĐHr©ďäHsr”.. .DXNBLACK OR AFRICAN AMERICANA C4591001C4591001 1006 10061272A ADVERSE EVENT 3 Contusion left elbow Contusion FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Contusion of elbow FŔÜF™\Skin injuries NEC F™łInjuries NEC FěâInjury, poisoning and procedural complications Fěĺ2021-02-05 B42021-03-05 BP 1MedDRA v24.0NDW, B4..DWHBP..BDAYSN NNOT RELATEDOTHER Fall on ice NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVůDŞdHr©ďäDXţDęśHuSÇśVaccination 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_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsABLACK OR AFRICAN AMERICAN A FA NOT HISPANIC OR LATINOA USABLACK OR AFRICAN AMERICAN A DVůDŞdHr©ďäDW‘DęśHsr”BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVůDŞd..Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g) DWŤDWŤYPhase 3A@NNEGDWŽBNT162b2 (30 (*ESC*){unicode 03BC}g) DW‘...... . .NN.DWŤDWýB•BpCPAĐHr©ďäHsr”.. .DXNBLACK OR AFRICAN AMERICANA C4591001C4591001 1006 10061272A@ADVERSE EVENT 5 Fall Fall FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Fall FŐFŐNon-site specific injuries NEC F™ ÇInjuries NEC FěâInjury, poisoning and procedural complications Fěĺ2021-02-05 B42021-02-05 B4 1MedDRA v24.0NDW, B4..DW,B4..ADAYSN NNOT RELATEDOTHER Icy conditions NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVůDŞdHr©ďäDXţDęśHuSÇśVaccination 1 AY A2021-07-08T16:02:43Y 100612721006BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsABLACK OR AFRICAN AMERICAN A FA NOT HISPANIC OR LATINOA USABLACK OR AFRICAN AMERICAN A DVůDŞdHr©ďäDW‘DęśHsr”BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVůDŞd..Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g) DWŤDWŤYPhase 3A@NNEGDWŽBNT162b2 (30 (*ESC*){unicode 03BC}g) DW‘...... . .NN.DWŤDWýB•BpCPAĐHr©ďäHsr”.. .DXNBLACK OR AFRICAN AMERICANA C4591001C4591001 1006 10061272APADVERSE EVENT 4 Injection site soreness Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-17T20:00B™2021-05-20 Bś 1MedDRA v24.0NDW‘ AE”HsrÂŔDW”A@..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A BÇ APeriod 01DVůDŞdHr©ďäDXţDęśHuSÇśAfter 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_30AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVůDúPHrŞ?ĐDWD™ŔHrČ1ŔBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVůDúPDWD™ŔY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW,DWŤYPhase 3A@NNEGDWŽ ....... . .NY.DWŤDWýB•BpCPAŕHrŞ?ĐHrČ1Ŕ.. .DWÄWHITE AC4591001C4591001 1006 10061274AADVERSE EVENT 1 MIGRAINE HEADACHES Migraine F™•NERVOUS SYSTEM DISORDERS Migraine headache F™RF™OMigraine headaches F™SHeadaches FáźNervous system disorders F™•2021-04 . .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDWcDBT....... N NNOT RELATEDOTHER HORMONAL CHANGES NOT APPLICABLE YNNOT RECOVERED/NOT RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVůDúPHrŞ?ĐDX}D™ŔHt©e@Follow Up 1 A0Y A 2021-08-03T07:25:35Y 100612791006Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVúDöTHr«ŤTDW¦DńŕHsŽJŕPlacebo APlacebo ADVúDöTDW DôtY . . .Placebo Placebo DW)DWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦D™HDńŕDWĹDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýB”BmBpC@AĐHr«ŤTHrÄ—ôHsrBČHsŽJŕ .DWWHITE AC4591001C4591001 1006 10061279AADVERSE EVENT 1 Worsening of Anxiety Anxiety F™'·PSYCHIATRIC DISORDERS Anxiety aggravated F™SSFˇ§Anxiety symptoms FˇµAnxiety disorders and symptoms FˇPsychiatric 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 01DVúDöTHr«ŤTDW‘D™GHsrBÇFollow Up 1 A0Y A 2021-06-04T18:46:43Y 100612791006Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVúDöTHr«ŤTDW¦DńŕHsŽJŕPlacebo APlacebo ADVúDöTDW DôtY . . .Placebo Placebo DW)DWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦D™HDńŕDWĹDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýB”BmBpC@AĐHr«ŤTHrÄ—ôHsrBČHsŽJŕ .DWWHITE AC4591001C4591001 1006 10061279A ADVERSE EVENT 2 Left Sprained Ankle Ligament sprain FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Sprained ankle F™9¬FöMuscle, tendon and ligament injuries F™Injuries NEC FěâInjury, poisoning and procedural complications Fěĺ2021-03-26 Bd .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDW] BQ....... N NNOT RELATEDOTHER Acute Physical Trauma NOT APPLICABLE YYNOT RECOVERED/NOT RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVúDöTHr«ŤTDW‘D™GHsrBÇFollow Up 1 A0Y A 2021-06-04T18:48:34Y 100612791006Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVúDöTHr«ŤTDW¦DńŕHsŽJŕPlacebo APlacebo ADVúDöTDW DôtY . . .Placebo Placebo DW)DWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦D™HDńŕDWĹDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýB”BmBpC@AĐHr«ŤTHrÄ—ôHsrBČHsŽJŕ .DWWHITE AC4591001C4591001 1006 10061279A0ADVERSE EVENT 3 Left Foot Plantar Wart Skin papilloma F™0NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)Plantar warts F™ÖF™6KSkin neoplasms benign F™6BCutaneous neoplasms benign F™6CNeoplasms benign, malignant and unspecified (incl cysts and polyps)F™02021-06-09 BŻ2021-06-17 B· 2MedDRA v24.0NDW¨ A0..DW°A°..ADAYSN NNOT RELATEDOTHER viral infection NOT APPLICABLE NYRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . A Period 02DW‘D™HHsrBČDYDńŕHuo~`Vaccination 4 A`Y A@2021-07-12T18:46:02Y 100612851006Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVţD¨„Hr°…„DWµDĂ´Hsˇă4Placebo APlacebo ADVţD¨„DWDépY . . .Placebo Placebo DW7DW YPhase 3A@NNEGDWˇ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW˘DWµDŹpDĂ´DWŘDXrBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW DWýBŁB\B]CAŕHr°…„HrÍÇpHs˘pHsˇă4 .DWˇWHITE AC4591001C4591001 1006 10061285AADVERSE EVENT 1 dysuria Dysuria F™,WRENAL AND URINARY DISORDERS Dysuria FÍ&FÍ&Bladder and urethral symptoms FŞUrinary tract signs and symptoms F™L~Renal and urinary disorders F™,W2021-05-31 B˘2021-07-20 BÔ 1MedDRA v24.0NDWź BŚ..DWŃBľ..B3DAYSN NNOT RELATEDOTHER mechanical irritation, concentrated urine NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVţD¨„Hr°…„DW˘DŹoHs˘oFollow Up 1 A0Y A 2021-08-04T20:50:06Y 100612851006Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVţD¨„Hr°…„DWµDĂ´Hsˇă4Placebo APlacebo ADVţD¨„DWDépY . . .Placebo Placebo DW7DW YPhase 3A@NNEGDWˇ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW˘DWµDŹpDĂ´DWŘDXrBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW DWýBŁB\B]CAŕHr°…„HrÍÇpHs˘pHsˇă4 .DWˇWHITE AC4591001C4591001 1006 10061285A ADVERSE EVENT 2 Injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-04 B¦2021-06-05 B§ 2MedDRA v24.0NDWŁ A ..DW¤A0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DW˘DŹpHs˘pDY"DĂ´Hu´Vaccination 3 APY A02021-06-23T00:00:52Y 100612861006BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVţDĘřHr°§řDWDěôHrĚytBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVţDĘřDWDěôY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW0DW‘YPhase 3A@NNEGDW’ ....... . .NY.DW‘DWýB”BlCAŕHr°§řHrĚyt.. .DWÉWHITE AC4591001C4591001 1006 10061286AADVERSE EVENT 2 CONTUSION RIGHT CALCANEUS Bone contusion FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Bone contusion F™™KF™™KNon-site specific injuries NEC F™ ÇInjuries NEC FěâInjury, poisoning and procedural complications Fěĺ2021-03-08 BN .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDWK B9....... N NNOT RELATEDOTHER SKIING INJURY NOT APPLICABLE NYNOT RECOVERED/NOT RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVţDĘřHr°§řDX€DěôHt¬ôFollow 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_30AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVţDĘřHr°§řDWDěôHrĚytBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVţDĘřDWDěôY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW0DW‘YPhase 3A@NNEGDW’ ....... . .NY.DW‘DWýB”BlCAŕHr°§řHrĚyt.. .DWÉWHITE AC4591001C4591001 1006 10061286A ADVERSE EVENT 1 FATIGUE Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-01-16 B2021-01-19 B 2MedDRA v24.0NDW A`..DWA..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . APeriod 01DVţDĘřHr°§řDX€DěôHt¬ôVaccination 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_30AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADV˙DHr±±„DWDě¸HrĎ8BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DV˙DDWDě¸Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW6DW”YPhase 3A@NNEGDW• ....... . .NY.DW”DWýB–BiB˙AđHr±±„HrĎ8.. .DWŃWHITE AC4591001C4591001 1006 10061290AADVERSE EVENT 1 Concussion Concussion FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Concussion FľŽFľŽCerebral injuries NEC F™dInjuries NEC FěâInjury, poisoning and procedural complications Fěĺ2021-01-12 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 01DV˙DHr±±„DX‚Dě¸Ht°O¸Vaccination 1 AY A2021-07-20T22:11:00 AE outcome changed from EUA to sBLA 100612921006Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADV˙DĂ<Hr±ńĽDWˇDřHs‡AxPlacebo APlacebo ADV˙DĂ<DWD‚ŚY . . .Placebo Placebo DW1DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWˇD|DřDW˝DX^BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBŽBpBqB˙AđHr±ńĽHrÍ`ŚHsn8|Hs‡Ax .DWŤWHITE AC4591001C4591001 1006 10061292AADVERSE EVENT 1 Earwax Impaction Left Ear Cerumen impaction FÍ)EAR AND LABYRINTH DISORDERS Cerumen impaction F™[!F™[!External ear disorders NEC F™External ear disorders (excl congenital) FÓôEar and labyrinth disorders FÍ)2021-01-24 B"2021-01-28 B& 2MedDRA v24.0NDW AĐ..DW$B..APDAYSN NNOT RELATEDOTHER Wax overproduction and packing NOT APPLICABLE NYRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DV˙DĂ<Hr±ńĽDWŽD{Hsn8{Vaccination 2 A Y A 2021-02-15T19:55:57 100612921006Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADV˙DĂ<Hr±ńĽDWˇDřHs‡AxPlacebo APlacebo ADV˙DĂ<DWD‚ŚY . . .Placebo Placebo DW1DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWˇD|DřDW˝DX^BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBŽBpBqB˙AđHr±ńĽHrÍ`ŚHsn8|Hs‡Ax .DWŤWHITE AC4591001C4591001 1006 10061292A ADVERSE EVENT 2 Post Surgical pain Spinal hardware removal Procedural pain FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Postoperative pain F™l7F™“ňNon-site specific procedural complications F™ ÷Procedural related injuries and complications NEC F™§€Injury, poisoning and procedural complications Fěĺ2021-03-30 Bc2021-04-04 Bh 3MedDRA v24.0NDWa BN..DWfBS..A`DAYSN NNOT RELATEDOTHER Surgery NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A0GRADE 3A0 . APeriod 01DV˙DĂ<Hr±ńĽDWŽD{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_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DVÂDˇ|Hrad|DW›D–Hsn€BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVÂDˇ|..Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDWYPhase 3A@NNEGDW‘BNT162b2 (30 (*ESC*){unicode 03BC}g) DW›...... . .NN.DWDWýBĎBmCŔAĐHrad|Hsn€.. .DXXALL OTHERS A0C4591001C4591001 1007 10071409AADVERSE EVENT 3 fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-28 BŰ2021-05-30 BÝ 2MedDRA v24.0NDWś A ..DWžA@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . APeriod 01DVÂDˇ|Hrad|DYD–Hu`˘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_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DVÂDˇ|Hrad|DW›D–Hsn€BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVÂDˇ|..Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDWYPhase 3A@NNEGDW‘BNT162b2 (30 (*ESC*){unicode 03BC}g) DW›...... . .NN.DWDWýBĎBmCŔAĐHrad|Hsn€.. .DXXALL OTHERS A0C4591001C4591001 1007 10071409A ADVERSE EVENT 4 headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-05-28 BŰ2021-05-30 BÝ 1MedDRA v24.0NDWś A ..DWžA@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . APeriod 01DVÂDˇ|Hrad|DYD–Hu`˘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_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DVÂDˇ|Hrad|DW›D–Hsn€BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVÂDˇ|..Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDWYPhase 3A@NNEGDW‘BNT162b2 (30 (*ESC*){unicode 03BC}g) DW›...... . .NN.DWDWýBĎBmCŔAĐHrad|Hsn€.. .DXXALL OTHERS A0C4591001C4591001 1007 10071409A0ADVERSE EVENT 2 pain at injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-28 BŰ2021-05-31 BŢ 1MedDRA v24.0NDWś A ..DWźAP..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . APeriod 01DVÂDˇ|Hrad|DYD–Hu`˘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_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DVÂDˇ|Hrad|DW›D–Hsn€BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVÂDˇ|..Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g) DWDWYPhase 3A@NNEGDW‘BNT162b2 (30 (*ESC*){unicode 03BC}g) DW›...... . .NN.DWDWýBĎBmCŔAĐHrad|Hsn€.. .DXXALL OTHERS A0C4591001C4591001 1007 10071409A@ADVERSE EVENT 1 fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-05-28T23:00BŰ2021-05-30 BÝ 3MedDRA v24.0NDWś A E7HsmpDWžA@..A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA0GRADE 3A0 C@ APeriod 01DVÂDˇ|Hrad|DYD–Hu`˘After unblinding and before Vaccination 3A@ A 2021-06-01T23:34:07Y 100714141007Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVÂD¬ĽHraoĽDWDÍČHs—aHPlacebo APlacebo ADVÂD¬ĽDV×D¸°Y . . .Placebo Placebo DVóDW†YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DWD·üDÍČDWÉDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBĘBkBrCŔAŕHraoĽHr}+0Hsu|Hs—aH .DW†WHITE AC4591001C4591001 1007 10071414AADVERSE EVENT 1 chills Chills FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills F·ÓF·ÓFeelings and sensations NEC F™ŁGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-20 BÓ2021-05-22 BŐ 2MedDRA v24.0NDW” A ..DW–A@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DW“D·üHsu|DYDÍČHux”ČVaccination 3 APY A02021-06-14T21:59:32Y 100714141007Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVÂD¬ĽHraoĽDWDÍČHs—aHPlacebo APlacebo ADVÂD¬ĽDV×D¸°Y . . .Placebo Placebo DVóDW†YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DWD·üDÍČDWÉDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBĘBkBrCŔAŕHraoĽHr}+0Hsu|Hs—aH .DW†WHITE AC4591001C4591001 1007 10071414A ADVERSE EVENT 2 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-20 BÓ2021-05-22 BŐ 3MedDRA v24.0NDW” A ..DW–A@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA0GRADE 3A0 . A Period 02DW“D·üHsu|DYDÍČHux”ČVaccination 3 APY A02021-06-14T21:59:43Y 100714761007BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVéDóHHr• ČDVţDĄ´Hr°‚´BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVéDóHDVţDĄ´Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWDW‹YPhase 3A@NNEGDWŚ ....... . .NY.DW‹DWýBŁBrCPAĐHr• ČHr°‚´.. .DWWHITE AC4591001C4591001 1007 10071476A ADVERSE EVENT 2 lightheadness after vaccination Dizziness F™•NERVOUS SYSTEM DISORDERS Lightheadedness Fö,FË…Neurological signs and symptoms NEC F™úNeurological disorders NEC F™ůNervous system disorders F™•2020-12-21T11:50B2020-12-21T11:53B 1MedDRA v24.0NDVţ AD¦hHr°hDVţAD§WHr°„WADAYSN NNOT RELATEDOTHER Anxiety NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A A0YAPeriod 01DVéDóHHr• ČDXkDĄ´Ht‘¶4Vaccination 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_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVéDóHHr• ČDVţDĄ´Hr°‚´BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVéDóHDVţDĄ´Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWDW‹YPhase 3A@NNEGDWŚ ....... . .NY.DW‹DWýBŁBrCPAĐHr• ČHr°‚´.. .DWWHITE AC4591001C4591001 1007 10071476AADVERSE EVENT 1 Vasovagal syncope without collapse Syncope F™•NERVOUS SYSTEM DISORDERS Syncope vasovagal F™=™F™=”Disturbances in consciousness NEC FËENeurological disorders NEC F™ůNervous system disorders F™•2020-11-30T16:26A2020-11-30T16:34A 1MedDRA v24.0NDVé ADçHr•DVéADé3Hr•łADAYSN NNOT RELATEDOTHER vasovagal event from blood collection NOT APPLICABLE YYRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A Â4 APeriod 01DVéDóHHr• ČDXkDĄ´Ht‘¶4Pre-Vaccination Y.2020-12-21T22:39:51 100714801007Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVéDóüHr•!|DW§Dź$HsŹI¤Placebo APlacebo ADVéDóüDVţDŐŔY . . .Placebo Placebo DWDW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW§DĂxDź$DWĘDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBŁBmBrCPAŕHr•!|Hr°˛ŔHsrlřHsŹI¤ .DWWHITE AC4591001C4591001 1007 10071480AADVERSE EVENT 4 headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-06-09 BŔ2021-06-10 BÁ 2MedDRA v24.0NDW¨ A ..DW©A0..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DW‘DĂxHsrlřDYDź$Hup}$Vaccination 4 A`Y A@2021-06-21T20:09:39Y 100714801007Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVéDóüHr•!|DW§Dź$HsŹI¤Placebo APlacebo ADVéDóüDVţDŐŔY . . .Placebo Placebo DWDW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW§DĂxDź$DWĘDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBŁBmBrCPAŕHr•!|Hr°˛ŔHsrlřHsŹI¤ .DWWHITE AC4591001C4591001 1007 10071480A ADVERSE EVENT 8 shingles Herpes zoster FëůINFECTIONS AND INFESTATIONS Shingles F™4ëFä†Herpes viral infections Fä„Viral infectious disorders F™OÎInfections and infestations Fëů2021-06-18 BÉ2021-06-30 BŐ 2MedDRA v24.0NDW± A°..DW˝B..AĐDAYSN NNOT RELATEDOTHER Varicella-zoster virus NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . A Period 02DW‘DĂxHsrlřDYDź$Hup}$Vaccination 4 A`Y A@2021-07-12T19:31:29Y 100714801007Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVéDóüHr•!|DW§Dź$HsŹI¤Placebo APlacebo ADVéDóüDVţDŐŔY . . .Placebo Placebo DWDW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW§DĂxDź$DWĘDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBŁBmBrCPAŕHr•!|Hr°˛ŔHsrlřHsŹI¤ .DWWHITE AC4591001C4591001 1007 10071480A0ADVERSE EVENT 1 Injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-17T19:00B©2021-05-24T07:00B° 1MedDRA v24.0NDW‘ AEłHsr´°DWA€Db«Hs{F«A€DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C A Period 02DW‘DĂxHsrlřDYDź$Hup}$Vaccination 3 APY A02021-07-28T11:28:15Y 100714801007Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVéDóüHr•!|DW§Dź$HsŹI¤Placebo APlacebo ADVéDóüDVţDŐŔY . . .Placebo Placebo DWDW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW§DĂxDź$DWĘDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBŁBmBrCPAŕHr•!|Hr°˛ŔHsrlřHsŹI¤ .DWWHITE AC4591001C4591001 1007 10071480A@ADVERSE EVENT 2 Injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-08T14:30Bż2021-06-10 BÁ 1MedDRA v24.0NDW§ ADËčHsŹvhDW©A0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Bż A Period 02DW‘DĂxHsrlřDYDź$Hup}$Vaccination 4 A`Y A@2021-06-21T20:08:54Y 100714801007Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVéDóüHr•!|DW§Dź$HsŹI¤Placebo APlacebo ADVéDóüDVţDŐŔY . . .Placebo Placebo DWDW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW§DĂxDź$DWĘDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBŁBmBrCPAŕHr•!|Hr°˛ŔHsrlřHsŹI¤ .DWWHITE AC4591001C4591001 1007 10071480APADVERSE EVENT 5 neck pain Neck pain F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Neck pain F™$F™$Musculoskeletal and connective tissue pain and discomfort F™ŁMusculoskeletal and connective tissue disorders NEC F™iMusculoskeletal and connective tissue disorders F™k2021-06-11 BÂ .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDWŞ A@....... N NNOT RELATEDOTHER Shingles related pain NOT APPLICABLE NNNOT RECOVERED/NOT RESOLVED N A0NOT RELATEDA0A GRADE 2A . A Period 02DW‘DĂxHsrlřDYDź$Hup}$Vaccination 4 A`Y A@2021-06-23T10:29:18Y 100714801007Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVéDóüHr•!|DW§Dź$HsŹI¤Placebo APlacebo ADVéDóüDVţDŐŔY . . .Placebo Placebo DWDW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW§DĂxDź$DWĘDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBŁBmBrCPAŕHr•!|Hr°˛ŔHsrlřHsŹI¤ .DWWHITE AC4591001C4591001 1007 10071480A`ADVERSE EVENT 7 Deltoid of left arm pain Pain in extremity F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Painful L arm F™iF™Musculoskeletal and connective tissue pain and discomfort F™ŁMusculoskeletal and connective tissue disorders NEC F™iMusculoskeletal and connective tissue disorders F™k2021-06-20 BË2021-06-23 BÎ 2MedDRA v24.0NDWł AĐ..DW¶B..A@DAYSN NNOT RELATEDOTHER shingles NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . A Period 02DW‘DĂxHsrlřDYDź$Hup}$Vaccination 4 A`Y A@2021-07-07T19:45:58Y 100714801007Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVéDóüHr•!|DW§Dź$HsŹI¤Placebo APlacebo ADVéDóüDVţDŐŔY . . .Placebo Placebo DWDW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW§DĂxDź$DWĘDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBŁBmBrCPAŕHr•!|Hr°˛ŔHsrlřHsŹI¤ .DWWHITE AC4591001C4591001 1007 10071480ApADVERSE EVENT 3 fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-06-09 BŔ2021-06-10 BÁ 2MedDRA v24.0NDW¨ A ..DW©A0..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DW‘DĂxHsrlřDYDź$Hup}$Vaccination 4 A`Y A@2021-06-21T20:09:12Y 100714831007Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVęDź`Hr–`DWvDŰ$HsNě$Placebo APlacebo ADVęDź`DV˙D4Y . . .Placebo Placebo DW"DWJYPhase 3A@NNEGDWK BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWaDWvDçĚDŰ$DW’DX3BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWJDWýBaBťBłC@AđHr–`Hr±Ű´Hs3ILHsNě$ .DW`WHITE AC4591001C4591001 1007 10071483AADVERSE EVENT 1 Injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-03-30T18:00Bx2021-04-03T08:00B| 1MedDRA v24.0NDWa ADý Hs3^ DWeAPDp»Hs8;APDAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A B[ A Period 02DWaDçĚHs3ILDXăDŰ$Hu0¤Vaccination 3 APY A02021-04-21T10:56:22Y 100714841007Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVęDžpHr–pDW¨Dß HsŰ Placebo APlacebo ADVęDžpDV˙DčY . . .Placebo Placebo DW"DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DW¨DÇěDß DWÄDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB˘BkBrC@AĐHr–pHr±ÜhHsulHsŰ .DW’WHITE AC4591001C4591001 1007 10071484AADVERSE EVENT 4 fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-20T06:00B«2021-06-22 BĚ 1MedDRA v24.0NDW” A DT`Hsuň`DWµB#..B"DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C;0 A Period 02DW“DÇěHsulDYDß Hur Vaccination 3 APY A02021-07-13T19:56:35Y 100714841007Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVęDžpHr–pDW¨Dß HsŰ Placebo APlacebo ADVęDžpDV˙DčY . . .Placebo Placebo DW"DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DW¨DÇěDß DWÄDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB˘BkBrC@AĐHr–pHr±ÜhHsulHsŰ .DW’WHITE AC4591001C4591001 1007 10071484A ADVERSE EVENT 3 injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-20T06:00B«2021-05-20T06:00B« 1MedDRA v24.0NDW” A DT`Hsuň`DW”A DT›Hsuň›ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C;0 A Period 02DW“DÇěHsulDYDß Hur Vaccination 3 APY A02021-07-13T19:54:19Y 100714841007Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVęDžpHr–pDW¨Dß HsŰ Placebo APlacebo ADVęDžpDV˙DčY . . .Placebo Placebo DW"DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DW¨DÇěDß DWÄDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB˘BkBrC@AĐHr–pHr±ÜhHsulHsŰ .DW’WHITE AC4591001C4591001 1007 10071484A0ADVERSE EVENT 1 generalized muscle aches Myalgia F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Generalized muscle aches F™ŠiF™{Muscle pains F™#Muscle disorders F™Musculoskeletal and connective tissue disorders F™k2021-05-20T06:00B«2021-05-22 B 1MedDRA v24.0NDW” A DT`Hsuň`DW–A@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C;0 A Period 02DW“DÇěHsulDYDß Hur Vaccination 3 APY A02021-07-13T19:52:09Y 100714841007Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVęDžpHr–pDW¨Dß HsŰ Placebo APlacebo ADVęDžpDV˙DčY . . .Placebo Placebo DW"DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DW¨DÇěDß DWÄDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB˘BkBrC@AĐHr–pHr±ÜhHsulHsŰ .DW’WHITE AC4591001C4591001 1007 10071484A@ADVERSE EVENT 2 subjective fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Subjective fever F™ŕ0F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-05-20T06:00B«2021-05-22 B 1MedDRA v24.0NDW” A DT`Hsuň`DW–A@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C;0 A Period 02DW“DÇěHsulDYDß Hur Vaccination 3 APY A02021-07-13T19:53:10Y 100714971007BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DVëDô8Hr—Ä¸DV˙DŠHHr±¸ČBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVëDô8DV˙DŠHY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWDW‹YPhase 3A@NNEGDWŚ ....... . .NY.DW‹DWýBˇBrC0AŔHr—Ä¸Hr±¸Č.. .DWŻALL OTHERS A0C4591001C4591001 1007 10071497AADVERSE EVENT 1 swollen lymph node left axilla Lymphadenopathy F«QBLOOD AND LYMPHATIC SYSTEM DISORDERS Swollen lymph nodes F™ťFříLymphatic system disorders NEC FřîSpleen, lymphatic and reticuloendothelial system disorders F™9)Blood and lymphatic system disorders F«Q2020-12-25 B2021-01-20T09:00B2 1MedDRA v24.0NDW A@..DWBD~ËHr×čËBDAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . APeriod 01DVëDô8Hr—Ä¸DXlDŠHHt’ěHVaccination 2 A Y A 2021-03-31T15:05:01 AE outcome changed from EUA to sBLA 100714991007Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVěDĺěHr™ěDV˙D×(Hr˛¨Placebo APlacebo ADVěDĺěDV˙D×(Y . . .Placebo Placebo DWDW‹YPhase 3A@NNEGDWŚ ....... . .NN.DW‹DWýB BrC AŕHr™ěHr˛¨.. .DW»WHITE AC4591001C4591001 1007 10071499AADVERSE EVENT 1 left wrist pain Arthralgia F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Wrist pain F™T´FŁ'Joint related signs and symptoms Fń:Joint disorders Fń-Musculoskeletal and connective tissue disorders F™k2021-05-01 B–2021-05-03 B 1MedDRA v24.0NDW B..DWB…..A0DAYSN NNOT RELATEDOTHER Trauma NOT APPLICABLE YYRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVěDĺěHr™ěDXlD×(Ht“9(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_30AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVěDí¨Hr™¨DV˙D’¸Hr±Á8BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVěDí¨DV˙D’¸Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWDW=YPhase 3A@NNEGDW> ....... . .NY.DW=DWýBRBŔC AđHr™¨Hr±Á8.. .DWµWHITE AC4591001C4591001 1007 10071500AADVERSE EVENT 1 Night Terror Sleep terror F™'·PSYCHIATRIC DISORDERS Night terrors F™ cF™6˛Parasomnias F™Sleep disorders and disturbances F™6źPsychiatric 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 01DVěDí¨Hr™¨DXlD’¸Ht’ô¸Vaccination 2 A Y A 2021-01-29T15:39:13 100715051007Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVđD`Hrťř`DW¶DÂHsŁ3Placebo APlacebo ADVđD`DWDé¬Y . . .Placebo Placebo DW(DWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWˇDW¶DťĽDÂDWÓDXsBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýBžB]BpCŕAŔHrťř`Hrş,Hs‡_<HsŁ3 .DW WHITE AC4591001C4591001 1007 10071505AADVERSE EVENT 7 lightheadedness Dizziness F™•NERVOUS SYSTEM DISORDERS Lightheadedness Fö,FË…Neurological signs and symptoms NEC F™úNeurological disorders NEC F™ůNervous system disorders F™•2021-06-24T17:01BČ2021-06-25 BÉ 1MedDRA v24.0NDW· A DďLHs¤±ĚDW¸A0..A DAYSN NRELATED NOT APPLICABLE NYRECOVERED/RESOLVED N ARELATED AAGRADE 1A Ceđ A Period 02DWˇDťĽHs‡_<DY#DÂHu„gVaccination 4 A`Y A@2021-07-06T13:25:08Y 100715051007Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVđD`Hrťř`DW¶DÂHsŁ3Placebo APlacebo ADVđD`DWDé¬Y . . .Placebo Placebo DW(DWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWˇDW¶DťĽDÂDWÓDXsBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýBžB]BpCŕAŔHrťř`Hrş,Hs‡_<HsŁ3 .DW WHITE AC4591001C4591001 1007 10071505A ADVERSE EVENT 2 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-03 Bł2021-06-04 B´ 1MedDRA v24.0NDW˘ A ..DWŁA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWˇDťĽHs‡_<DY#DÂHu„gVaccination 3 APY A02021-07-06T13:24:17Y 100715051007Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVđD`Hrťř`DW¶DÂHsŁ3Placebo APlacebo ADVđD`DWDé¬Y . . .Placebo Placebo DW(DWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWˇDW¶DťĽDÂDWÓDXsBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýBžB]BpCŕAŔHrťř`Hrş,Hs‡_<HsŁ3 .DW WHITE AC4591001C4591001 1007 10071505A0ADVERSE EVENT 4 headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-06-24T05:00BČ2021-06-25 BÉ 2MedDRA v24.0NDW· A DFPHs¤ĐDW¸A0..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C8ŕ A Period 02DWˇDťĽHs‡_<DY#DÂHu„gVaccination 4 A`Y A@2021-06-29T15:53:45Y 100715051007Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVđD`Hrťř`DW¶DÂHsŁ3Placebo APlacebo ADVđD`DWDé¬Y . . .Placebo Placebo DW(DWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWˇDW¶DťĽDÂDWÓDXsBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýBžB]BpCŕAŔHrťř`Hrş,Hs‡_<HsŁ3 .DW WHITE AC4591001C4591001 1007 10071505A@ADVERSE EVENT 3 injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-23T17:00BÇ2021-06-25 BÉ 1MedDRA v24.0NDW¶ ADďHsŁ`DW¸A0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Bľ A Period 02DWˇDťĽHs‡_<DY#DÂHu„gVaccination 4 A`Y A@2021-06-29T15:53:33Y 100715051007Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVđD`Hrťř`DW¶DÂHsŁ3Placebo APlacebo ADVđD`DWDé¬Y . . .Placebo Placebo DW(DWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWˇDW¶DťĽDÂDWÓDXsBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýBžB]BpCŕAŔHrťř`Hrş,Hs‡_<HsŁ3 .DW WHITE AC4591001C4591001 1007 10071505APADVERSE EVENT 6 nausea Nausea FÜ›GASTROINTESTINAL DISORDERS Nausea F™ F™ Nausea and vomiting symptoms F™Gastrointestinal signs and symptoms FÜÜGastrointestinal disorders FÜ›2021-06-24T17:00BČ2021-06-25 BÉ 1MedDRA v24.0NDW· A DďHs¤±DW¸A0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Ceŕ A Period 02DWˇDťĽHs‡_<DY#DÂHu„gVaccination 4 A`Y A@2021-06-29T15:54:08Y 100715051007Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVđD`Hrťř`DW¶DÂHsŁ3Placebo APlacebo ADVđD`DWDé¬Y . . .Placebo Placebo DW(DWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWˇDW¶DťĽDÂDWÓDXsBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýBžB]BpCŕAŔHrťř`Hrş,Hs‡_<HsŁ3 .DW WHITE AC4591001C4591001 1007 10071505A`ADVERSE EVENT 1 Right Arm Pain Pain in extremity F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Painful R arm F™kF™Musculoskeletal and connective tissue pain and discomfort F™ŁMusculoskeletal and connective tissue disorders NEC F™iMusculoskeletal and connective tissue disorders F™k2021-06-03 Bł2021-06-06 B¶ 1MedDRA v24.0NDW˘ A ..DWĄAP..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWˇDťĽHs‡_<DY#DÂHu„gVaccination 3 APY A02021-06-23T21:38:47Y 100715051007Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVđD`Hrťř`DW¶DÂHsŁ3Placebo APlacebo ADVđD`DWDé¬Y . . .Placebo Placebo DW(DWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWˇDW¶DťĽDÂDWÓDXsBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýBžB]BpCŕAŔHrťř`Hrş,Hs‡_<HsŁ3 .DW WHITE AC4591001C4591001 1007 10071505ApADVERSE EVENT 5 fever 101 Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-06-24T17:00BČ2021-06-25 BÉ 2MedDRA v24.0NDW· A DďHs¤±DW¸A0..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A Ceŕ A Period 02DWˇDťĽHs‡_<DY#DÂHu„gVaccination 4 A`Y A@2021-06-29T15:53:57Y 100715091007Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVđDÎ¸Hrž6¸DW¨D¬€Hs¨€Placebo APlacebo ADVđDÎ¸DWD”ÔY . . .Placebo Placebo DW#DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW”DW¨D¤D¬€DWÄDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBśBjBrCŕAđHrž6¸HrĽOTHsv&¤Hs¨€ .DW“WHITE AC4591001C4591001 1007 10071509AADVERSE EVENT 1 Right Arm Pain Pain in extremity F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Painful R arm F™kF™Musculoskeletal and connective tissue pain and discomfort F™ŁMusculoskeletal and connective tissue disorders NEC F™iMusculoskeletal and connective tissue disorders F™k2021-05-21 B¦2021-05-23 B¨ 1MedDRA v24.0NDW• A ..DW—A@..A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW”D¤Hsv&¤DYD¬€HuqÜVaccination 3 APY A02021-06-10T11:04:18Y 100715111007Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVđDě¸HržT¸DW§DŚÜHsŹ7\Placebo APlacebo ADVđDě¸DWD¤Y . . .Placebo Placebo DW!DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW§D… DŚÜDWĘDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBśBlBrCŕAđHržT¸Hrą»Hss€ HsŹ7\ .DW‘WHITE AC4591001C4591001 1007 10071511AADVERSE EVENT 1 Headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-05-18T21:00BŁ2021-05-19T08:00B¤ 1MedDRA v24.0NDW’ AEuHst"PDW“A Dp»Hst˝;A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C+@ A Period 02DW’D… Hss€ DYDŚÜHupjÜVaccination 3 APY A02021-06-08T17:03:17Y 100715111007Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVđDě¸HržT¸DW§DŚÜHsŹ7\Placebo APlacebo ADVđDě¸DWD¤Y . . .Placebo Placebo DW!DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW§D… DŚÜDWĘDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBśBlBrCŕAđHržT¸Hrą»Hss€ HsŹ7\ .DW‘WHITE AC4591001C4591001 1007 10071511A ADVERSE EVENT 2 Left arm pain Pain in extremity F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Painful L arm F™iF™Musculoskeletal and connective tissue pain and discomfort F™ŁMusculoskeletal and connective tissue disorders NEC F™iMusculoskeletal and connective tissue disorders F™k2021-05-19T12:00B¤2021-05-20T12:00BĄ 1MedDRA v24.0NDW“ A D¨ŔHstő@DW”A0D¨űHsvFűA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Cc€ A Period 02DW’D… Hss€ DYDŚÜHupjÜVaccination 3 APY A02021-06-08T17:04:14Y 100715161007Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVńD¤HrźB$DW§D•LHsŹ?ĚPlacebo APlacebo ADVńD¤DWD PY . . .Placebo Placebo DW"DW‹YPhase 3A@NPOSDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW§DÔ”D•LDWĘDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB›BlBrCĐAđHrźB$Hr» PHssĎ”HsŹ?Ě .DW‘WHITE AC4591001C4591001 1007 10071516AADVERSE EVENT 2 Chills Chills FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills F·ÓF·ÓFeelings and sensations NEC F™ŁGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-19T08:30BŁ2021-05-20T02:00B¤ 1MedDRA v24.0NDW“ A DwHstÄDW”A0D[Hsuş[A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CA0 A Period 02DW’DÔ”HssĎ”DYD•LHupsLVaccination 3 APY A02021-06-08T17:09:25Y 100715161007Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVńD¤HrźB$DW§D•LHsŹ?ĚPlacebo APlacebo ADVńD¤DWD PY . . .Placebo Placebo DW"DW‹YPhase 3A@NPOSDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW§DÔ”D•LDWĘDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB›BlBrCĐAđHrźB$Hr» PHssĎ”HsŹ?Ě .DW‘WHITE AC4591001C4591001 1007 10071516A ADVERSE EVENT 1 Fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-05-19T08:30BŁ2021-05-20T02:00B¤ 1MedDRA v24.0NDW“ A DwHstÄDW”A0D[Hsuş[A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CA0 A Period 02DW’DÔ”HssĎ”DYD•LHupsLVaccination 3 APY A02021-06-08T17:08:59Y 100715191007Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVńD¨HHrźaČDWwDÇtHsP)ôPlacebo APlacebo ADVńD¨HDWD Y . . .Placebo Placebo DW#DW`YPhase 3A@NNEGDWa BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWbDWwD™HDÇtDW“DX4BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW`DWýBpBśBťCĐAđHrźaČHr» Hs4LHHsP)ô .DWaWHITE AC4591001C4591001 1007 10071519AADVERSE EVENT 1 Pain at injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-03-31T19:00Br2021-04-01T19:00Bs 2MedDRA v24.0NDWb AEłHs4ľ0DWcA E¶°Hs6ëA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C` A Period 02DWbD™HHs4LHDXäDÇtHu1]tVaccination 3 APY A02021-04-21T23:28:38Y 100715241007Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVńDíäHrź§dDWUDăHs#rśPlacebo APlacebo ADVńDíäDWD Y . . .Placebo Placebo DW*DW0YPhase 3A@NNEGDW1 BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW@DWUDŃLDăDWvDXBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW0DWýB@BľBÍCĐAđHrź§dHr» Hs±LHs#rś .DW?WHITE AC4591001C4591001 1007 10071524AADVERSE EVENT 2 thrush Candida infection FëůINFECTIONS AND INFESTATIONS Thrush F™AF™¸:Candida infections F˛^Fungal infectious disorders FÚřInfections and infestations Fëů2021-02-01 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 01DVńDíäHrź§dDW@DŃKHs±KVaccination 2 A Y A 2021-03-03T20:29:46 100715311007Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVňD—hHr ˘hDWµD…\Hsˇ¤ÜPlacebo APlacebo ADVňD—hDWDęŘY . . .Placebo Placebo DW#DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW™DWµDŞdD…\DWŮDXrBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB›BeBqCŔAŕHr ˘hHr»SŘHs|ßäHsˇ¤Ü .DWWHITE AC4591001C4591001 1007 10071531AADVERSE EVENT 1 Headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-05-26T11:00B©2021-05-26T22:00B© 2MedDRA v24.0NDWš A Dš°Hs~!°DWšA EY°Hs~Ľ›ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A CUĐ A Period 02DW™DŞdHs|ßäDY"D…\Hu‚Ř\Vaccination 3 APY A02021-06-23T12:12:06Y 100715311007Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVňD—hHr ˘hDWµD…\Hsˇ¤ÜPlacebo APlacebo ADVňD—hDWDęŘY . . .Placebo Placebo DW#DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW™DWµDŞdD…\DWŮDXrBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB›BeBqCŔAŕHr ˘hHr»SŘHs|ßäHsˇ¤Ü .DWWHITE AC4591001C4591001 1007 10071531A ADVERSE EVENT 2 injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-22T01:30BÄ2021-06-24 BĆ 1MedDRA v24.0NDWµ BDHsˇ4DW·B..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A D› A Period 02DW™DŞdHs|ßäDY"D…\Hu‚Ř\Vaccination 3 APY A02021-07-20T14:45:06Y 100715311007Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVňD—hHr ˘hDWµD…\Hsˇ¤ÜPlacebo APlacebo ADVňD—hDWDęŘY . . .Placebo Placebo DW#DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW™DWµDŞdD…\DWŮDXrBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB›BeBqCŔAŕHr ˘hHr»SŘHs|ßäHsˇ¤Ü .DWWHITE AC4591001C4591001 1007 10071531A0ADVERSE EVENT 3 muscle aches to legs Myalgia F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Myalgia of lower extremities F™`F™{Muscle pains F™#Muscle disorders F™Musculoskeletal and connective tissue disorders F™k2021-06-22T19:00BÄ2021-06-24 BĆ 1MedDRA v24.0NDWµ AEłHs˘*°DW·A0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C#° A Period 02DW™DŞdHs|ßäDY"D…\Hu‚Ř\Vaccination 4 A`Y A@2021-07-20T14:46:04Y 100715331007Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVňDĄxHr °xDWŻD›dHs™ŃäPlacebo APlacebo ADVňDĄxDWD§ĐY . . .Placebo Placebo DW#DW‹YPhase 3A@NPOSDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWšDWŻDť€D›dDWĐDXlBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBšBdBrCŔAŕHr °xHrĽbPHs~$€Hs™Ńä .DW™WHITE AC4591001C4591001 1007 10071533AADVERSE EVENT 1 abdominal muscle pain Myalgia F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Muscle pain F™"F™{Muscle pains F™#Muscle disorders F™Musculoskeletal and connective tissue disorders F™k2021-01-06 B2021-01-07 B 1MedDRA v24.0NDW A€..DWA..A DAYSN NNOT RELATEDOTHER Injury while exercising; no fall NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVňDĄxHr °xDWšDťHs~$Vaccination 2 A Y A 2021-01-19T02:33:05 100715471007Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVóDštHrˇöôDW©D› Hs‘é Placebo APlacebo ADVóDštDWDťĽY . . .Placebo Placebo DW#DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW”DW©DÄ¤D› DWĘDXfBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBšBjBqC°AŕHrˇöôHrĽX<Hsvb¤Hs‘é .DW“WHITE AC4591001C4591001 1007 10071547AADVERSE EVENT 1 Injection site redness Injection site erythema FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site redness FěŇFěInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-21T06:00BŁ2021-05-24T06:00B¦ 1MedDRA v24.0NDW• A DT`HswCŕDWAPDT›Hs{8›A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C< A Period 02DW”DÄ¤Hsvb¤DYD› Hus Vaccination 3 APY A02021-06-10T16:58:48Y 100715471007Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVóDštHrˇöôDW©D› Hs‘é Placebo APlacebo ADVóDštDWDťĽY . . .Placebo Placebo DW#DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW”DW©DÄ¤D› DWĘDXfBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBšBjBqC°AŕHrˇöôHrĽX<Hsvb¤Hs‘é .DW“WHITE AC4591001C4591001 1007 10071547A ADVERSE EVENT 2 Injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-20T17:00B˘2021-05-22T20:00B¤ 1MedDRA v24.0NDW” ADďHsvŤDW–A0E—°HsyZ{A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Bµ A Period 02DW”DÄ¤Hsvb¤DYD› Hus Vaccination 3 APY A02021-06-10T16:58:59Y 100715591007Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADV÷D¦ŕHr§I`DW°DĄđHs›-đPlacebo APlacebo ADV÷D¦ŕDWDÜŚY . . .Placebo Placebo DW/DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW›DW°DŢ0DĄđDWÍDXmBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB–BcBqCpAŕHr§I`HrĂ.ŚHs¶°Hs›-đ .DWšWHITE AC4591001C4591001 1007 10071559AADVERSE EVENT 8 chills Chills FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills F·ÓF·ÓFeelings and sensations NEC F™ŁGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-17T23:00Bş2021-06-18 B» 1MedDRA v24.0NDW° AE7Hs›ËpDW±A ..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C* A Period 02DW›DŢ0Hs¶°DYDĄđHu|apVaccination 4 A`Y A@2021-06-22T13:47:30Y 100715591007Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADV÷D¦ŕHr§I`DW°DĄđHs›-đPlacebo APlacebo ADV÷D¦ŕDWDÜŚY . . .Placebo Placebo DW/DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW›DW°DŢ0DĄđDWÍDXmBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB–BcBqCpAŕHr§I`HrĂ.ŚHs¶°Hs›-đ .DWšWHITE AC4591001C4591001 1007 10071559A ADVERSE EVENT 3 dizziness Dizziness F™•NERVOUS SYSTEM DISORDERS Dizziness FË…FË…Neurological signs and symptoms NEC F™úNeurological disorders NEC F™ůNervous system disorders F™•2021-05-28 B¦2021-05-30 B¨ 1MedDRA v24.0NDWś A ..DWžA@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW›DŢ0Hs¶°DYDĄđHu|apVaccination 3 APY A02021-06-10T11:25:09Y 100715591007Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADV÷D¦ŕHr§I`DW°DĄđHs›-đPlacebo APlacebo ADV÷D¦ŕDWDÜŚY . . .Placebo Placebo DW/DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW›DW°DŢ0DĄđDWÍDXmBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB–BcBqCpAŕHr§I`HrĂ.ŚHs¶°Hs›-đ .DWšWHITE AC4591001C4591001 1007 10071559A0ADVERSE EVENT 2 fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-28 B¦2021-05-30 B¨ 2MedDRA v24.0NDWś A ..DWžA@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DW›DŢ0Hs¶°DYDĄđHu|apVaccination 3 APY A02021-06-07T20:55:08Y 100715591007Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADV÷D¦ŕHr§I`DW°DĄđHs›-đPlacebo APlacebo ADV÷D¦ŕDWDÜŚY . . .Placebo Placebo DW/DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW›DW°DŢ0DĄđDWÍDXmBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB–BcBqCpAŕHr§I`HrĂ.ŚHs¶°Hs›-đ .DWšWHITE AC4591001C4591001 1007 10071559A@ADVERSE EVENT 1 headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-05-28 B¦2021-05-30 B¨ 2MedDRA v24.0NDWś A ..DWžA@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DW›DŢ0Hs¶°DYDĄđHu|apVaccination 3 APY A02021-06-07T20:54:58Y 100715591007Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADV÷D¦ŕHr§I`DW°DĄđHs›-đPlacebo APlacebo ADV÷D¦ŕDWDÜŚY . . .Placebo Placebo DW/DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW›DW°DŢ0DĄđDWÍDXmBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB–BcBqCpAŕHr§I`HrĂ.ŚHs¶°Hs›-đ .DWšWHITE AC4591001C4591001 1007 10071559APADVERSE EVENT 4 headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-06-05 B®2021-06-05 B® 2MedDRA v24.0NDW¤ A ..DW¤A ..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 02DW›DŢ0Hs¶°DYDĄđHu|apVaccination 3 APY A02021-06-10T11:26:17Y 100715591007Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADV÷D¦ŕHr§I`DW°DĄđHs›-đPlacebo APlacebo ADV÷D¦ŕDWDÜŚY . . .Placebo Placebo DW/DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW›DW°DŢ0DĄđDWÍDXmBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB–BcBqCpAŕHr§I`HrĂ.ŚHs¶°Hs›-đ .DWšWHITE AC4591001C4591001 1007 10071559A`ADVERSE EVENT 6 headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-06-17T23:00Bş2021-06-18 B» 1MedDRA v24.0NDW° AE7Hs›ËpDW±A ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C* A Period 02DW›DŢ0Hs¶°DYDĄđHu|apVaccination 4 A`Y A@2021-06-22T13:47:05Y 100715591007Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADV÷D¦ŕHr§I`DW°DĄđHs›-đPlacebo APlacebo ADV÷D¦ŕDWDÜŚY . . .Placebo Placebo DW/DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW›DW°DŢ0DĄđDWÍDXmBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB–BcBqCpAŕHr§I`HrĂ.ŚHs¶°Hs›-đ .DWšWHITE AC4591001C4591001 1007 10071559ApADVERSE EVENT 5 injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-17T23:00Bş2021-06-19 BĽ 1MedDRA v24.0NDW° AE7Hs›ËpDW˛A0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C* A Period 02DW›DŢ0Hs¶°DYDĄđHu|apVaccination 4 A`Y A@2021-06-22T13:44:12Y 100715591007Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADV÷D¦ŕHr§I`DW°DĄđHs›-đPlacebo APlacebo ADV÷D¦ŕDWDÜŚY . . .Placebo Placebo DW/DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW›DW°DŢ0DĄđDWÍDXmBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB–BcBqCpAŕHr§I`HrĂ.ŚHs¶°Hs›-đ .DWšWHITE AC4591001C4591001 1007 10071559A€ADVERSE EVENT 9 generalized muscle pain Myalgia F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Muscle pain F™"F™{Muscle pains F™#Muscle disorders F™Musculoskeletal and connective tissue disorders F™k2021-06-17T23:00Bş2021-06-18 B» 2MedDRA v24.0NDW° AE7Hs›ËpDW±A ..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C* A Period 02DW›DŢ0Hs¶°DYDĄđHu|apVaccination 4 A`Y A@2021-06-22T13:47:41Y 100715591007Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADV÷D¦ŕHr§I`DW°DĄđHs›-đPlacebo APlacebo ADV÷D¦ŕDWDÜŚY . . .Placebo Placebo DW/DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW›DW°DŢ0DĄđDWÍDXmBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB–BcBqCpAŕHr§I`HrĂ.ŚHs¶°Hs›-đ .DWšWHITE AC4591001C4591001 1007 10071559AADVERSE EVENT 7 fever 101.9 Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-06-17T23:00Bş2021-06-18 B» 2MedDRA v24.0NDW° AE7Hs›ËpDW±A ..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C* A Period 02DW›DŢ0Hs¶°DYDĄđHu|apVaccination 4 A`Y A@2021-06-22T13:47:18Y 100715621007Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADV÷DčHr§ŠDW¦D®ŘHsŽŘPlacebo APlacebo ADV÷DčDWDđ<Y . . .Placebo Placebo DW(DW‹YPhase 3A@NPOSDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦D D®ŘDWĂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB•BmBrCpAŔHr§ŠHrĂB<HsrI”HsŽŘ .DWWHITE AC4591001C4591001 1007 10071562AADVERSE EVENT 1 elevated body temp Body temperature increased FďëINVESTIGATIONS Body temperature increased F—F—Physical examination procedures and organ system status F™Ż…Physical examination and organ system status topics F™Ż„Investigations Fďë2021-05-18T08:00Bś2021-05-18 Bś 2MedDRA v24.0NDW’ A Dp€Hssk€DW’A ..ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A CMP A Period 02DW‘D HsrI”DYD®ŘHuo;XVaccination 3 APY A02021-05-24T15:48:36Y 100715621007Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADV÷DčHr§ŠDW¦D®ŘHsŽŘPlacebo APlacebo ADV÷DčDWDđ<Y . . .Placebo Placebo DW(DW‹YPhase 3A@NPOSDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦D D®ŘDWĂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB•BmBrCpAŔHr§ŠHrĂB<HsrI”HsŽŘ .DWWHITE AC4591001C4591001 1007 10071562A ADVERSE EVENT 4 elevated body temp 100.0 Body temperature increased FďëINVESTIGATIONS Body temperature increased F—F—Physical examination procedures and organ system status F™Ż…Physical examination and organ system status topics F™Ż„Investigations Fďë2021-06-07T23:59B°2021-06-08T19:01B± 2MedDRA v24.0NDW¦ AE@HsŽŞDDW§A EşpHsŹ¶'A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C+P A Period 02DW‘D HsrI”DYD®ŘHuo;XVaccination 4 A`Y A@2021-06-14T18:40:30Y 100715621007Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADV÷DčHr§ŠDW¦D®ŘHsŽŘPlacebo APlacebo ADV÷DčDWDđ<Y . . .Placebo Placebo DW(DW‹YPhase 3A@NPOSDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦D D®ŘDWĂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB•BmBrCpAŔHr§ŠHrĂB<HsrI”HsŽŘ .DWWHITE AC4591001C4591001 1007 10071562A@ADVERSE EVENT 5 fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-08 B±2021-06-08T19:00B± 2MedDRA v24.0NDW§ A ..DW§A E¶°HsŹµëADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DW‘D HsrI”DYD®ŘHuo;XVaccination 4 A`Y A@2021-06-14T18:40:49Y 100715621007Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADV÷DčHr§ŠDW¦D®ŘHsŽŘPlacebo APlacebo ADV÷DčDWDđ<Y . . .Placebo Placebo DW(DW‹YPhase 3A@NPOSDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦D D®ŘDWĂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB•BmBrCpAŔHr§ŠHrĂB<HsrI”HsŽŘ .DWWHITE AC4591001C4591001 1007 10071562A0ADVERSE EVENT 2 fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-18T08:00Bś2021-05-18 Bś 1MedDRA v24.0NDW’ A Dp€Hssk€DW’A ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CMP A Period 02DW‘D HsrI”DYD®ŘHuo;XVaccination 3 APY A02021-05-24T14:47:38Y 100715621007Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADV÷DčHr§ŠDW¦D®ŘHsŽŘPlacebo APlacebo ADV÷DčDWDđ<Y . . .Placebo Placebo DW(DW‹YPhase 3A@NPOSDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦D D®ŘDWĂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB•BmBrCpAŔHr§ŠHrĂB<HsrI”HsŽŘ .DWWHITE AC4591001C4591001 1007 10071562A`ADVERSE EVENT 6 generalized muscle aches Myalgia F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Generalized muscle aches F™ŠiF™{Muscle pains F™#Muscle disorders F™Musculoskeletal and connective tissue disorders F™k2021-06-08 B±2021-06-08 B± 1MedDRA v24.0NDW§ A ..DW§A ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW‘D HsrI”DYD®ŘHuo;XVaccination 4 A`Y A@2021-06-14T18:41:06Y 100715621007Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADV÷DčHr§ŠDW¦D®ŘHsŽŘPlacebo APlacebo ADV÷DčDWDđ<Y . . .Placebo Placebo DW(DW‹YPhase 3A@NPOSDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦D D®ŘDWĂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB•BmBrCpAŔHr§ŠHrĂB<HsrI”HsŽŘ .DWWHITE AC4591001C4591001 1007 10071562APADVERSE EVENT 3 generalized muscle aches Myalgia F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Generalized muscle aches F™ŠiF™{Muscle pains F™#Muscle disorders F™Musculoskeletal and connective tissue disorders F™k2021-05-18T08:00Bś2021-05-18 Bś 1MedDRA v24.0NDW’ A Dp€Hssk€DW’A ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CMP A Period 02DW‘D HsrI”DYD®ŘHuo;XVaccination 3 APY A02021-05-25T23:23:05Y 100715631007Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADV÷DĺěHr§lDW¦D°HsŽ Placebo APlacebo ADV÷DĺěDWDîY . . .Placebo Placebo DW(DW‹YPhase 3A@NPOSDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DˇD°DWĂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB•BmBrCpAŔHr§lHrĂ@HsrJ„HsŽ .DWWHITE AC4591001C4591001 1007 10071563AADVERSE EVENT 1 lightheadness Dizziness F™•NERVOUS SYSTEM DISORDERS Lightheadedness Fö,FË…Neurological signs and symptoms NEC F™úNeurological disorders NEC F™ůNervous system disorders F™•2020-12-14T16:22A2020-12-14T18:30A 1MedDRA v24.0NDV÷ ADć(Hr§¨DV÷AEF0Hr§¦ăADAYSN NRELATED NOT APPLICABLE NYRECOVERED/RESOLVED N ARELATED AAGRADE 1A AYAPeriod 01DV÷DĺěHr§lDW‘DˇHsrJVaccination 1 AY A2021-03-18T16:28:02 100715681007Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVřD`Hr¨„`DWµD…\Hsˇ¤ÜPlacebo APlacebo ADVřD`DW DâŕY . . .Placebo Placebo DW)DW’YPhase 3A@NNEGDW“ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW DWµDŤD…\DWÓDXrBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW’DWýB›B^BkC`AŕHr¨„`HrÄ†`Hs…ýHsˇ¤Ü .DWźWHITE AC4591001C4591001 1007 10071568AADVERSE EVENT 1 injection site soreness Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2020-12-15T10:21A2020-12-15 A 1MedDRA v24.0NDVř AD‘ŚHr¨…ŚDVřA..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A APYAPeriod 01DVřD`Hr¨„`DW DŤHs…ýVaccination 1 AY A2021-01-06T02:26:33 100715681007Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVřD`Hr¨„`DWµD…\Hsˇ¤ÜPlacebo APlacebo ADVřD`DW DâŕY . . .Placebo Placebo DW)DW’YPhase 3A@NNEGDW“ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW DWµDŤD…\DWÓDXrBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW’DWýB›B^BkC`AŕHr¨„`HrÄ†`Hs…ýHsˇ¤Ü .DWźWHITE AC4591001C4591001 1007 10071568A ADVERSE EVENT 2 maculopapular rash Rash maculo-papular F™5ŃSKIN AND SUBCUTANEOUS TISSUE DISORDERS Maculopapular rash FůĐF™*lRashes, eruptions and exanthems NEC F™cÖEpidermal and dermal conditions FŃSkin and subcutaneous tissue disorders F™5Ń2021-01-05T16:38B2021-02-02 B2 1MedDRA v24.0NDW ADéčHrÄŤhDW)B..BDAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A BYAPeriod 01DVřD`Hr¨„`DW DŤHs…ýVaccination 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_30AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVůDŐ„HrŞDWDŇHrĹÇBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVůDŐ„DWDŇY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW*DW=YPhase 3A@NNEGDW> ....... . .NY.DW=DWýBEBŔCPAđHrŞHrĹÇ.. .DW˝WHITE AC4591001C4591001 1007 10071575AADVERSE EVENT 1 Contusion of Left Arm Contusion FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Contusion of upper limb FÁF™\Skin injuries NEC F™łInjuries NEC FěâInjury, poisoning and procedural complications Fěĺ2021-01-03 B2021-01-13 B 2MedDRA v24.0NDW B..DWB..A°DAYSN NNOT RELATEDOTHER soccer injury NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVůDŐ„HrŞDX{DŇHt¦ú€Vaccination 1 AY A2021-07-13T19:33:43 AEDECOD, AE outcome changed from EUA to sBLA 100715811007Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVúDŢlHr«ulDWD Hs—3”Placebo APlacebo ADVúDŢlDWDŢlY . . .Placebo Placebo DW+DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDŞdD DWĘDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB’BfBrC@AđHr«ulHrÇ$ěHs{ŽdHs—3” .DW—WHITE AC4591001C4591001 1007 10071581A ADVERSE EVENT 3 fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-15 Bµ2021-06-16 B¶ 2MedDRA v24.0NDW® A ..DWŻA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWDŞdHs{ŽdDYD HuxgVaccination 4 A`Y A@2021-06-17T14:18:04Y 100715811007Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVúDŢlHr«ulDWD Hs—3”Placebo APlacebo ADVúDŢlDWDŢlY . . .Placebo Placebo DW+DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDŞdD DWĘDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB’BfBrC@AđHr«ulHrÇ$ěHs{ŽdHs—3” .DW—WHITE AC4591001C4591001 1007 10071581A0ADVERSE EVENT 2 injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-15 Bµ2021-06-16 B¶ 1MedDRA v24.0NDW® A ..DWŻA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDŞdHs{ŽdDYD HuxgVaccination 4 A`Y A@2021-06-17T14:17:27Y 100715811007Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVúDŢlHr«ulDWD Hs—3”Placebo APlacebo ADVúDŢlDWDŢlY . . .Placebo Placebo DW+DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDŞdD DWĘDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB’BfBrC@AđHr«ulHrÇ$ěHs{ŽdHs—3” .DW—WHITE AC4591001C4591001 1007 10071581A@ADVERSE EVENT 4 generalized muscle aches Myalgia F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Generalized muscle aches F™ŠiF™{Muscle pains F™#Muscle disorders F™Musculoskeletal and connective tissue disorders F™k2021-06-15 Bµ2021-06-16 B¶ 2MedDRA v24.0NDW® A ..DWŻA0..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWDŞdHs{ŽdDYD HuxgVaccination 4 A`Y A@2021-06-17T15:15:48Y 100715831007Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVúDęśHr«śDW¨DĂxHsżxPlacebo APlacebo ADVúDęśDWDŕLY . . .Placebo Placebo DW+DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW¨D×(DĂxDWĆDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB’BlBrC@AđHr«śHrÇ&ĚHssŇ(Hsżx .DW‘WHITE AC4591001C4591001 1007 10071583AADVERSE EVENT 2 headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-06-10 B°2021-06-10 B° 1MedDRA v24.0NDW© A ..DW©A ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW’D×(HssŇ(DYDĂxHuqňřVaccination 4 A`Y A@2021-06-14T16:47:18Y 100715831007Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVúDęśHr«śDW¨DĂxHsżxPlacebo APlacebo ADVúDęśDWDŕLY . . .Placebo Placebo DW+DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW¨D×(DĂxDWĆDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB’BlBrC@AđHr«śHrÇ&ĚHssŇ(Hsżx .DW‘WHITE AC4591001C4591001 1007 10071583A ADVERSE EVENT 1 injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-09T21:00BŻ2021-06-11 B± 2MedDRA v24.0NDW¨ AEuHs‘#PDWŞA0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C A Period 02DW’D×(HssŇ(DYDĂxHuqňřVaccination 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_30AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADVúDćÜHr«}ÜDWDăĐHrÇ*PBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVúDćÜDWDăĐY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW+DWŤYPhase 3A@NNEGDWŽ ....... . .NY.DWŤDWýB”BpC@AđHr«}ÜHrÇ*P.. .DWľWHITE AC4591001C4591001 1007 10071584AADVERSE EVENT 1 Soreness at injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-01-07T16:37B2021-01-10T07:00B 1MedDRA v24.0NDW ADé¬HrÇ0,DWA@Db«HrĘť«A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A BYAPeriod 01DVúDćÜHr«}ÜDX|DăĐHt¨]ĐVaccination 2 A Y A 2021-02-04T20:54:22 100715851007Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVúDçTHr«~TDW§DÂHsŹlPlacebo APlacebo ADVúDçTDWDŕY . . .Placebo Placebo DW+DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW§DŐŔDÂDWĂDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB’BmBrC@AŔHr«~THrÇ'Hsr@HsŹl .DWWHITE AC4591001C4591001 1007 10071585AADVERSE EVENT 2 hives; trunk, abdomen, back Urticaria F™5ŃSKIN AND SUBCUTANEOUS TISSUE DISORDERS Hives FĺeF™MUrticarias F™MAngioedema and urticaria FźúSkin and subcutaneous tissue disorders F™5Ń2021-01-16 B2021-02-02 B0 2MedDRA v24.0NDW A ..DW)B..BDAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . APeriod 01DVúDçTHr«~TDW‘DŐżHsr?Vaccination 2 A Y A 2021-04-01T15:23:14 AE outcome changed from EUA to sBLA 100715861007Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVúDčřHr«řDWµDŠHsˇ©ŚPlacebo APlacebo ADVúDčřDWDŢ0Y . . .Placebo Placebo DW+DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW DWµDŽDŠDWŇDXrBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB’B^BrC@AĐHr«řHrÇ$°Hs…ţHsˇ©Ś .DWźWHITE AC4591001C4591001 1007 10071586AADVERSE EVENT 1 Injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-02T11:00B¨2021-06-04T11:00BŞ 1MedDRA v24.0NDWˇ A Dš°Hs‡\0DWŁA@DšëHs‰˙kA0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C]` A Period 02DW DŽHs…ţDY"DŠHu‚ÝVaccination 3 APY A02021-06-22T17:05:53Y 100715931007Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWD¶HrąÍśDWD¶HrąÍśPlacebo APlacebo ADWD¶..Y . . .Placebo DW2DW2YPhase 3A@NNEGDW3 ....... . .NN.DW2DW3B.AB/AđHrąÍśHrąÍś.. .DWŮWHITE AC4591001C4591001 1007 10071593AADVERSE EVENT 1 left Ankle sprain Ligament sprain FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Ankle sprain F uFöMuscle, tendon and ligament injuries F™Injuries NEC FěâInjury, poisoning and procedural complications Fěĺ2020-12-30T17:00A02021-01-15 B 2MedDRA v24.0NDW A0DďHrĽ©DWB..BDAYSN NNOT RELATEDOTHER injury NOT APPLICABLE NYRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A CĂ0 APeriod 01DWD¶HrąÍśDXrD¶Ht›Vaccination 1 AY A2021-02-15T02:09:46 100715951007Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDĐHrąčDW©D™üHs‘ç|Placebo APlacebo ADWDĐDWDĐY . . .Placebo Placebo DW8DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW©Dź$D™üDWĹDXfBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB‡BlBrBůAĐHrąčHrÖ±PHssš$Hs‘ç| .DW‘WHITE AC4591001C4591001 1007 10071595AADVERSE EVENT 1 Vaso-vagal response Presyncope F™•NERVOUS SYSTEM DISORDERS Vasovagal reaction F™NľF™%Neurological signs and symptoms NEC F™úNeurological disorders NEC F™ůNervous system disorders F™•2021-03-30T13:15B]2021-03-30T13:25B] 1MedDRA v24.0NDWa BGDşTHs3ÔDWaBGDĽçHs3gADAYSN NNOT RELATEDOTHER Phlebotomy NOT APPLICABLE NYRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A E¤đ APeriod 01DWDĐHrąčDW’Dź#Hssš#Follow Up 1 A0Y A 2021-03-30T21:09:16Y 100715961007Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDŮHrąđDWDˇôHs—5tPlacebo APlacebo ADWDŮDWDÚpY . . .Placebo Placebo DW8DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDĐÔDˇôDWÉDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB‡BfBrBůAĐHrąđHrŘDpHs{´ÔHs—5t .DW—WHITE AC4591001C4591001 1007 10071596AADVERSE EVENT 2 fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-24T20:30B”2021-05-28 B 2MedDRA v24.0NDW AE€Hs|HDWśAP..APDAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C0 A Period 02DWDĐÔHs{´ÔDYDˇôHuxhôVaccination 3 APY A02021-06-21T11:17:50Y 100715961007Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDŮHrąđDWDˇôHs—5tPlacebo APlacebo ADWDŮDWDÚpY . . .Placebo Placebo DW8DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDĐÔDˇôDWÉDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB‡BfBrBůAĐHrąđHrŘDpHs{´ÔHs—5t .DW—WHITE AC4591001C4591001 1007 10071596A ADVERSE EVENT 1 headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-05-24T20:30B”2021-05-28 B 2MedDRA v24.0NDW AE€Hs|HDWśAP..APDAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C0 A Period 02DWDĐÔHs{´ÔDYDˇôHuxhôVaccination 3 APY A02021-06-21T11:17:24Y 100715961007Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDŮHrąđDWDˇôHs—5tPlacebo APlacebo ADWDŮDWDÚpY . . .Placebo Placebo DW8DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDĐÔDˇôDWÉDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB‡BfBrBůAĐHrąđHrŘDpHs{´ÔHs—5t .DW—WHITE AC4591001C4591001 1007 10071596A0ADVERSE EVENT 4 muscle aches Myalgia F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Muscle ache F™˙F™{Muscle pains F™#Muscle disorders F™Musculoskeletal and connective tissue disorders F™k2021-05-25 B•2021-05-28 B 2MedDRA v24.0NDW™ A ..DWśAP..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWDĐÔHs{´ÔDYDˇôHuxhôVaccination 3 APY A02021-06-21T11:18:33Y 100715961007Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDŮHrąđDWDˇôHs—5tPlacebo APlacebo ADWDŮDWDÚpY . . .Placebo Placebo DW8DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDĐÔDˇôDWÉDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB‡BfBrBůAĐHrąđHrŘDpHs{´ÔHs—5t .DW—WHITE AC4591001C4591001 1007 10071596A@ADVERSE EVENT 3 fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-05-25 B•2021-05-28 B 1MedDRA v24.0NDW™ A ..DWśAP..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDĐÔHs{´ÔDYDˇôHuxhôVaccination 3 APY A02021-06-21T11:18:12Y 100716131007Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDäHr»MDW®D‡HslPlacebo APlacebo ADWDäDWDĎ¨Y . . .Placebo Placebo DW8DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW™DW®DĄ´D‡DWĘDXkBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB†BeBrBřAĐHr»MHrÖč(Hs|Ű4Hsl .DWWHITE AC4591001C4591001 1007 10071613AADVERSE EVENT 1 Pain at injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2020-12-29T17:00A2020-12-29 A 1MedDRA v24.0NDW ADďHr»XDWA..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A B/ APeriod 01DWDäHr»MDW™DĄłHs|Ű3Vaccination 1 AY A2021-01-29T14:26:27 100716141007Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDę`Hr»S`DW»DĆüHs©Ď|Placebo APlacebo ADWDę`DWDçY . . .Placebo Placebo DW>DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW”DW»DÓ,DĆüDW×DXxBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB†BjBrBřAŕHr»S`HrÖ˙Hsvq,Hs©Ď| .DW“WHITE AC4591001C4591001 1007 10071614AADVERSE EVENT 5 chills Chills FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills F·ÓF·ÓFeelings and sensations NEC F™ŁGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-29 B·2021-06-29 B· 1MedDRA v24.0NDWĽ A ..DWĽA ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW”DÓ,Hsvq,DY(DĆüHu‹üVaccination 4 A`Y A@2021-07-13T21:38:29Y 100716141007Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDę`Hr»S`DW»DĆüHs©Ď|Placebo APlacebo ADWDę`DWDçY . . .Placebo Placebo DW>DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW”DW»DÓ,DĆüDW×DXxBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB†BjBrBřAŕHr»S`HrÖ˙Hsvq,Hs©Ď| .DW“WHITE AC4591001C4591001 1007 10071614A ADVERSE EVENT 3 fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-29T06:30B·2021-07-01 Bą 1MedDRA v24.0NDWĽ A D[hHsŞµhDWľA@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C=P A Period 02DW”DÓ,Hsvq,DY(DĆüHu‹üVaccination 4 A`Y A@2021-07-13T21:38:04Y 100716141007Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDę`Hr»S`DW»DĆüHs©Ď|Placebo APlacebo ADWDę`DWDçY . . .Placebo Placebo DW>DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW”DW»DÓ,DĆüDW×DXxBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB†BjBrBřAŕHr»S`HrÖ˙Hsvq,Hs©Ď| .DW“WHITE AC4591001C4591001 1007 10071614A0ADVERSE EVENT 4 headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-06-29T06:30B·2021-06-29T14:40B· 1MedDRA v24.0NDWĽ A D[hHsŞµhDWĽA DÎ{Hs«({ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C=P A Period 02DW”DÓ,Hsvq,DY(DĆüHu‹üVaccination 4 A`Y A@2021-07-13T21:38:16Y 100716141007Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDę`Hr»S`DW»DĆüHs©Ď|Placebo APlacebo ADWDę`DWDçY . . .Placebo Placebo DW>DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW”DW»DÓ,DĆüDW×DXxBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB†BjBrBřAŕHr»S`HrÖ˙Hsvq,Hs©Ď| .DW“WHITE AC4591001C4591001 1007 10071614A@ADVERSE EVENT 1 injection site soreness Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-28T18:00B¶2021-07-01 Bą 1MedDRA v24.0NDW» ADý HsŞ DWľA@..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Bç A Period 02DW”DÓ,Hsvq,DY(DĆüHu‹üVaccination 4 A`Y A@2021-07-13T21:37:41Y 100716141007Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDę`Hr»S`DW»DĆüHs©Ď|Placebo APlacebo ADWDę`DWDçY . . .Placebo Placebo DW>DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW”DW»DÓ,DĆüDW×DXxBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB†BjBrBřAŕHr»S`HrÖ˙Hsvq,Hs©Ď| .DW“WHITE AC4591001C4591001 1007 10071614APADVERSE EVENT 2 fever 101.9 Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-06-29T06:30B·2021-07-01 Bą 2MedDRA v24.0NDWĽ A D[hHsŞµhDWľA@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C=P A Period 02DW”DÓ,Hsvq,DY(DĆüHu‹üVaccination 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_30AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDăĐHr»LĐDWDčřHr×xBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWDăĐDWDčřY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW>DW‹YPhase 3A@NNEGDWŚ ....... . .NY.DW‹DWýB†BrBřAŔHr»LĐHr×x.. .DWĚWHITE AC4591001C4591001 1007 10071615AADVERSE EVENT 1 left axillary lymph node swelling Lymphadenopathy F«QBLOOD AND LYMPHATIC SYSTEM DISORDERS Axillary lymph nodes enlarged FĄŁFříLymphatic system disorders NEC FřîSpleen, lymphatic and reticuloendothelial system disorders F™9)Blood and lymphatic system disorders F«Q2021-01-20 B2021-01-23 B 1MedDRA v24.0NDW A ..DWAP..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . APeriod 01DWDăĐHr»LĐDXDčřHt¸4řVaccination 2 A Y A 2021-03-10T21:43:35 100716171007Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDňXHr»[XDWŠDďÄHsi^ÄPlacebo APlacebo ADWDňXDWDâhY . . .Placebo Placebo DW8DWiYPhase 3A@NNEGDWj BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWuDWŠDhDďÄDW¨DXGBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWiDWýBdB‰B”BřAđHr»[XHrŘLhHsMGčHsi^Ä .DWtWHITE AC4591001C4591001 1007 10071617AADVERSE EVENT 1 worsening of Anxiety Anxiety F™'·PSYCHIATRIC DISORDERS Anxiety aggravated F™SSFˇ§Anxiety symptoms FˇµAnxiety disorders and symptoms FˇPsychiatric 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 01DWDňXHr»[XDWuDgHsMGçVaccination 2 A Y A 2021-05-13T17:32:16Y 100716171007Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDňXHr»[XDWŠDďÄHsi^ÄPlacebo APlacebo ADWDňXDWDâhY . . .Placebo Placebo DW8DWiYPhase 3A@NNEGDWj BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWuDWŠDhDďÄDW¨DXGBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWiDWýBdB‰B”BřAđHr»[XHrŘLhHsMGčHsi^Ä .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 F™ŁAnxiety disorders and symptoms FˇPsychiatric 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 01DWDňXHr»[XDWuDgHsMGçVaccination 2 A Y A 2021-05-13T17:33:03Y 100716181007Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDňHr»[DWD„0HrÖś°Placebo APlacebo ADWDňDWD„0Y . . .Placebo Placebo DW?DW‹YPhase 3A@NNEGDWŚ ....... . .NN.DW‹DWýB†BrBřAĐHr»[HrÖś°.. .DW×WHITE AC4591001C4591001 1007 10071618AADVERSE EVENT 1 Pain at injection nsite Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2020-12-29T17:14A2020-12-30 A 1MedDRA v24.0NDW ADňXHr»[XDWA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A AYAPeriod 01DWDňHr»[DXD„0Ht·Đ0Vaccination 1 AY A2021-01-29T14:26:09 100716201007BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADWD’¸HrĽM8DWDčHrŘRBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWD’¸DWDčY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW9DWYPhase 3A@NNEGDW‘ ....... . .NY.DWDWýBŠBmB÷AŔHrĽM8HrŘR.. .DWËWHITE AC4591001C4591001 1007 10071620AADVERSE EVENT 2 Abdominal pain Abdominal pain FÜ›GASTROINTESTINAL DISORDERS Abdominal pain F–ŃF–ŃGastrointestinal and abdominal pains (excl oral and throat) FÜ†Gastrointestinal signs and symptoms FÜÜGastrointestinal disorders FÜ›2021-01-21 B2021-02-09 B* 2MedDRA v24.0NDW A ..DW0B..BDAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . APeriod 01DWD’¸HrĽM8DX‰DčHtą…Vaccination 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_30AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADWD’¸HrĽM8DWDčHrŘRBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWD’¸DWDčY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW9DWYPhase 3A@NNEGDW‘ ....... . .NY.DWDWýBŠBmB÷AŔHrĽM8HrŘR.. .DWËWHITE AC4591001C4591001 1007 10071620A0ADVERSE EVENT 9 worsening anxiety Anxiety F™'·PSYCHIATRIC DISORDERS Anxiety aggravated F™SSFˇ§Anxiety symptoms FˇµAnxiety disorders and symptoms FˇPsychiatric 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 01DWD’¸HrĽM8DX‰DčHtą…Vaccination 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_30AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADWD’¸HrĽM8DWDčHrŘRBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWD’¸DWDčY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW9DWYPhase 3A@NNEGDW‘ ....... . .NY.DWDWýBŠBmB÷AŔHrĽM8HrŘR.. .DWËWHITE AC4591001C4591001 1007 10071620APADVERSE EVENT 11constipation Constipation FÜ›GASTROINTESTINAL DISORDERS Constipation FŔ–FŔ–Gastrointestinal atonic and hypomotility disorders NEC FÜŤGastrointestinal motility and defaecation conditions FÜąGastrointestinal disorders FÜ›2021-03-13 BJ .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDWP B5....... N NNOT RELATEDOTHER no organic cause identified NOT APPLICABLE YNRECOVERING/RESOLVING N A0NOT RELATEDA0A GRADE 2A . APeriod 01DWD’¸HrĽM8DX‰DčHtą…Follow 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_30AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADWD’¸HrĽM8DWDčHrŘRBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWD’¸DWDčY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW9DWYPhase 3A@NNEGDW‘ ....... . .NY.DWDWýBŠBmB÷AŔHrĽM8HrŘR.. .DWËWHITE AC4591001C4591001 1007 10071620ApADVERSE EVENT 6 contact dermatitis bilateral arms Dermatitis contact F™5ŃSKIN AND SUBCUTANEOUS TISSUE DISORDERS Contact dermatitis FŔ¦FÇDermatitis and eczema FÇEpidermal and dermal conditions FŃSkin and subcutaneous tissue disorders F™5Ń2021-02-12 B-2021-04 . 1MedDRA v24.0NDW3 B....... N NNOT RELATEDOTHER suspected reaction to tape NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DWD’¸HrĽM8DX‰DčHtą…Vaccination 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_30AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADWD’¸HrĽM8DWDčHrŘRBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWD’¸DWDčY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW9DWYPhase 3A@NNEGDW‘ ....... . .NY.DWDWýBŠBmB÷AŔHrĽM8HrŘR.. .DWËWHITE AC4591001C4591001 1007 10071620A€ADVERSE EVENT 4 Gastritis Gastritis FÜ›GASTROINTESTINAL DISORDERS Gastritis FÜ=FÜ=Gastritis (excl infective) FÜ>Gastrointestinal inflammatory conditions FÜ±Gastrointestinal disorders FÜ›2021-01-30 B 2021-04 . 2MedDRA v24.0NDW& A°....... N NNOT RELATEDCONCOMITANT DRUG TREATMENT NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DWD’¸HrĽM8DX‰DčHtą…Vaccination 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_30AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADWD’¸HrĽM8DWDčHrŘRBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWD’¸DWDčY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW9DWYPhase 3A@NNEGDW‘ ....... . .NY.DWDWýBŠBmB÷AŔHrĽM8HrŘR.. .DWËWHITE AC4591001C4591001 1007 10071620AADVERSE EVENT 1 Vulvar boil Vulval abscess FëůINFECTIONS AND INFESTATIONS Vulval boil F™PüF™PôFemale reproductive tract infections F™-:Infections - pathogen unspecified Fë÷Infections and infestations Fëů2021-01-24 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 01DWD’¸HrĽM8DX‰DčHtą…Vaccination 2 A Y A 2021-02-09T17:31:51 100716231007Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDštHrĽTôDWµDÇěHsˇçlPlacebo APlacebo ADWDštDWDçTY . . .Placebo Placebo DW?DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW DWµDÜČDÇěDWŃDXrBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB…B^BrB÷AĐHrĽTôHrŮ˘ÔHs†LČHsˇçl .DWźWHITE AC4591001C4591001 1007 10071623AADVERSE EVENT 3 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-01T16:30Bš2021-06-02T08:30B› 1MedDRA v24.0NDW ADčHs†XDWˇA DwĂHs‡9CA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A B0 A Period 02DW DÜČHs†LČDY"DÇěHuěVaccination 3 APY A02021-06-22T21:47:21Y 100716231007Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDštHrĽTôDWµDÇěHsˇçlPlacebo APlacebo ADWDštDWDçTY . . .Placebo Placebo DW?DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW DWµDÜČDÇěDWŃDXrBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB…B^BrB÷AĐHrĽTôHrŮ˘ÔHs†LČHsˇçl .DWźWHITE AC4591001C4591001 1007 10071623A ADVERSE EVENT 4 Injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-01T17:00Bš2021-06-03T08:30Bś 1MedDRA v24.0NDW ADďHs†_DW˘A0DwĂHsŠĂA0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A BN A Period 02DW DÜČHs†LČDY"DÇěHuěVaccination 3 APY A02021-06-22T21:47:32Y 100716231007Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDštHrĽTôDWµDÇěHsˇçlPlacebo APlacebo ADWDštDWDçTY . . .Placebo Placebo DW?DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW DWµDÜČDÇěDWŃDXrBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB…B^BrB÷AĐHrĽTôHrŮ˘ÔHs†LČHsˇçl .DWźWHITE AC4591001C4591001 1007 10071623A0ADVERSE EVENT 2 right wrist tendonitis Tendonitis F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Tendonitis F™?wF™?wTendon disorders F™?bTendon, ligament and cartilage disorders F™?eMusculoskeletal and connective tissue disorders F™k2021-02-15 B02021-08-09 Bß 2MedDRA v24.0NDW6 B..DWĺBÉ..B°DAYSN NNOT RELATEDOTHER potential lacrosse injury NOT APPLICABLE YNRECOVERED/RESOLVED WITH SEQUELAEN A0NOT RELATEDA0A GRADE 2A . APeriod 01DWDštHrĽTôDW DÜÇHs†LÇVaccination 2 A Y A 2021-08-18T17:01:35Y 100716231007Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDštHrĽTôDWµDÇěHsˇçlPlacebo APlacebo ADWDštDWDçTY . . .Placebo Placebo DW?DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW DWµDÜČDÇěDWŃDXrBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB…B^BrB÷AĐHrĽTôHrŮ˘ÔHs†LČHsˇçl .DWźWHITE AC4591001C4591001 1007 10071623A@ADVERSE EVENT 1 teeth pain Toothache FÜ›GASTROINTESTINAL DISORDERS Tooth pain F™ËF™B—Dental pain and sensation disorders F™B‘Dental and gingival conditions F™BrGastrointestinal disorders FÜ›2021-01-27T12:00B2021-01-28T06:45B 2MedDRA v24.0NDW# ApD¨ŔHráM@DW$A€D_'HrâU'A DAYSN NNOT RELATEDCONCOMITANT NON-DRUG TREATMENT NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A D µ APeriod 01DWDštHrĽTôDW DÜÇHs†LÇVaccination 2 A Y A 2021-02-27T15:46:29 100716241007Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDŞ HrĽe DW¦DË4HsŽ$4Placebo APlacebo ADWDŞ DW"DŚdY . . .Placebo Placebo DW>DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DW¦DĚŘDË4DWÄDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB†BkBqB÷AĐHrĽe HrßßdHsuXHsŽ$4 .DW’WHITE AC4591001C4591001 1007 10071624AADVERSE EVENT 1 left Arm Pain Pain in extremity F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Painful L arm F™iF™Musculoskeletal and connective tissue pain and discomfort F™ŁMusculoskeletal and connective tissue disorders NEC F™iMusculoskeletal and connective tissue disorders F™k2021-05-20T07:00BŽ2021-05-21T13:00BŹ 1MedDRA v24.0NDW” A DbpHsvpDW•A0D·Hsw¦‹A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C= A Period 02DW“DĚŘHsuXDYDË4HuoW´Vaccination 3 APY A02021-06-08T14:53:53Y 100716251007Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWD¬ĽHrĽg<DW¦DÉĚHsŽ"ĚPlacebo APlacebo ADWD¬ĽDW"D‹tY . . .Placebo Placebo DW>DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DW¦DĚ$DÉĚDWÄDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB†BkBqB÷AĐHrĽg<HrßŢtHsu¤HsŽ"Ě .DW’WHITE AC4591001C4591001 1007 10071625AADVERSE EVENT 2 Injection Site Arm Pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-20T07:00BŽ2021-05-21T13:00BŹ 1MedDRA v24.0NDW” A DbpHsvpDW•A0D·Hsw¦‹A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C=Đ A Period 02DW“DĚ$Hsu¤DYDÉĚHuoVLVaccination 3 APY A02021-06-08T15:15:27Y 100716251007Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWD¬ĽHrĽg<DW¦DÉĚHsŽ"ĚPlacebo APlacebo ADWD¬ĽDW"D‹tY . . .Placebo Placebo DW>DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DW¦DĚ$DÉĚDWÄDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB†BkBqB÷AĐHrĽg<HrßŢtHsu¤HsŽ"Ě .DW’WHITE AC4591001C4591001 1007 10071625A ADVERSE EVENT 1 fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-05-20T07:00BŽ2021-05-20T08:00BŽ 1MedDRA v24.0NDW” A DbpHsvpDW”A Dp»Hsv»ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C=Đ A Period 02DW“DĚ$Hsu¤DYDÉĚHuoVLVaccination 3 APY A02021-06-08T15:15:02Y 100716321007Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADWDëŚHrĽ¦DW§DŽ€HsŹ9Placebo APlacebo ADWDëŚDWD˘lY . . .Placebo Placebo DW?DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW§D‘PDŽ€DWÄDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB…BlBrB÷AĐHrĽ¦HrŮ]ěHssŚPHsŹ9 .DW‘WHITE AC4591001C4591001 1007 10071632AADVERSE EVENT 6 Headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-05-19 BŤ2021-05-19 BŤ 1MedDRA v24.0NDW“ A ..DW“A ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW’D‘PHssŚPDYDŽ€Hupl€Vaccination 3 APY A02021-06-08T18:23:53Y 100716321007Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADWDëŚHrĽ¦DW§DŽ€HsŹ9Placebo APlacebo ADWDëŚDWD˘lY . . .Placebo Placebo DW?DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW§D‘PDŽ€DWÄDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB…BlBrB÷AĐHrĽ¦HrŮ]ěHssŚPHsŹ9 .DW‘WHITE AC4591001C4591001 1007 10071632A€ADVERSE EVENT 1 headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2020-12-30T16:55A2020-12-30T16:56A 1MedDRA v24.0NDW ADíäHrĽ¨dDWADî[HrĽ¨ŰADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A A YAPeriod 01DWDëŚHrĽ¦DW’D‘OHssŚOVaccination 1 AY A2021-01-05T22:27:08 100716321007Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADWDëŚHrĽ¦DW§DŽ€HsŹ9Placebo APlacebo ADWDëŚDWD˘lY . . .Placebo Placebo DW?DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW§D‘PDŽ€DWÄDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB…BlBrB÷AĐHrĽ¦HrŮ]ěHssŚPHsŹ9 .DW‘WHITE AC4591001C4591001 1007 10071632AADVERSE EVENT 2 tenderness at injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site tenderness FěÖFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2020-12-30T16:47A2020-12-31 A 1MedDRA v24.0NDW ADěHrĽ¦„DWA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A A YAPeriod 01DWDëŚHrĽ¦DW’D‘OHssŚOVaccination 1 AY A2021-01-27T11:40:32 100716321007Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADWDëŚHrĽ¦DW§DŽ€HsŹ9Placebo APlacebo ADWDëŚDWD˘lY . . .Placebo Placebo DW?DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW§D‘PDŽ€DWÄDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB…BlBrB÷AĐHrĽ¦HrŮ]ěHssŚPHsŹ9 .DW‘WHITE AC4591001C4591001 1007 10071632A0ADVERSE EVENT 10nausea Nausea FÜ›GASTROINTESTINAL DISORDERS Nausea F™ F™ Nausea and vomiting symptoms F™Gastrointestinal signs and symptoms FÜÜGastrointestinal disorders FÜ›2021-06-09 B˘2021-06-09 B˘ 1MedDRA v24.0NDW¨ A ..DW¨A ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW’D‘PHssŚPDYDŽ€Hupl€Vaccination 4 A`Y A@2021-06-14T16:47:41Y 100716321007Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADWDëŚHrĽ¦DW§DŽ€HsŹ9Placebo APlacebo ADWDëŚDWD˘lY . . .Placebo Placebo DW?DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW§D‘PDŽ€DWÄDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB…BlBrB÷AĐHrĽ¦HrŮ]ěHssŚPHsŹ9 .DW‘WHITE AC4591001C4591001 1007 10071632A ADVERSE EVENT 8 Nausea Nausea FÜ›GASTROINTESTINAL DISORDERS Nausea F™ F™ Nausea and vomiting symptoms F™Gastrointestinal signs and symptoms FÜÜGastrointestinal disorders FÜ›2021-05-19 BŤ2021-05-19 BŤ 1MedDRA v24.0NDW“ A ..DW“A ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW’D‘PHssŚPDYDŽ€Hupl€Vaccination 3 APY A02021-06-08T18:24:28Y 100716321007Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADWDëŚHrĽ¦DW§DŽ€HsŹ9Placebo APlacebo ADWDëŚDWD˘lY . . .Placebo Placebo DW?DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW§D‘PDŽ€DWÄDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB…BlBrB÷AĐHrĽ¦HrŮ]ěHssŚPHsŹ9 .DW‘WHITE AC4591001C4591001 1007 10071632A@ADVERSE EVENT 7 Body ache Pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Ache F(F™ŰPain and discomfort NEC F™ÜGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-19 BŤ2021-05-19 BŤ 1MedDRA v24.0NDW“ A ..DW“A ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW’D‘PHssŚPDYDŽ€Hupl€Vaccination 3 APY A02021-06-08T18:24:09Y 100716321007Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADWDëŚHrĽ¦DW§DŽ€HsŹ9Placebo APlacebo ADWDëŚDWD˘lY . . .Placebo Placebo DW?DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW§D‘PDŽ€DWÄDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB…BlBrB÷AĐHrĽ¦HrŮ]ěHssŚPHsŹ9 .DW‘WHITE AC4591001C4591001 1007 10071632APADVERSE EVENT 9 generalized body aches Pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalised aching FÝF™ŰPain and discomfort NEC F™ÜGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-09 B˘2021-06-09 B˘ 2MedDRA v24.0NDW¨ A ..DW¨A ..ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DW’D‘PHssŚPDYDŽ€Hupl€Vaccination 4 A`Y A@2021-06-14T16:47:30Y 100716321007Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADWDëŚHrĽ¦DW§DŽ€HsŹ9Placebo APlacebo ADWDëŚDWD˘lY . . .Placebo Placebo DW?DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW§D‘PDŽ€DWÄDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB…BlBrB÷AĐHrĽ¦HrŮ]ěHssŚPHsŹ9 .DW‘WHITE AC4591001C4591001 1007 10071632A`ADVERSE EVENT 5 Arm pain Pain in extremity F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Pain in arm F™ F™Musculoskeletal and connective tissue pain and discomfort F™ŁMusculoskeletal and connective tissue disorders NEC F™iMusculoskeletal and connective tissue disorders F™k2021-05-19 BŤ2021-05-22 B 1MedDRA v24.0NDW“ A ..DW–AP..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW’D‘PHssŚPDYDŽ€Hupl€Vaccination 3 APY A02021-06-08T18:23:09Y 100716321007Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADWDëŚHrĽ¦DW§DŽ€HsŹ9Placebo APlacebo ADWDëŚDWD˘lY . . .Placebo Placebo DW?DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW§D‘PDŽ€DWÄDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB…BlBrB÷AĐHrĽ¦HrŮ]ěHssŚPHsŹ9 .DW‘WHITE AC4591001C4591001 1007 10071632ApADVERSE EVENT 4 rash to chest and back Rash F™5ŃSKIN AND SUBCUTANEOUS TISSUE DISORDERS Rash trunk F™€`F™*TRashes, eruptions and exanthems NEC F™cÖEpidermal and dermal conditions FŃSkin and subcutaneous tissue disorders F™5Ń2021-01-22T13:00B2021-01-26 B 2MedDRA v24.0NDW A D¶ĐHrÚĂĐDW"A`..APDAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C_p APeriod 01DWDëŚHrĽ¦DW’D‘OHssŚOVaccination 2 A Y A 2021-02-24T22:37:31 100716321007Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADWDëŚHrĽ¦DW§DŽ€HsŹ9Placebo APlacebo ADWDëŚDWD˘lY . . .Placebo Placebo DW?DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW§D‘PDŽ€DWÄDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB…BlBrB÷AĐHrĽ¦HrŮ]ěHssŚPHsŹ9 .DW‘WHITE AC4591001C4591001 1007 10071632A ADVERSE EVENT 3 pain at blood draw site Vessel puncture site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Venipuncture site pain F™U7F™śAdministration site reactions NEC F™uěAdministration site reactions F›¤General disorders and administration site conditions FÝ2020-12-30T16:47A2020-12-31 A 1MedDRA v24.0NDW ADěHrĽ¦„DWA ..A DAYSN NNOT RELATEDOTHER venipuncture NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A A YAPeriod 01DWDëŚHrĽ¦DW’D‘OHssŚOVaccination 1 AY A2021-01-27T11:39:46 100716341007BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWD”HrÂćDW!DšěHrŢślBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWD”DW!DšěY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW=DW‹YPhase 3A@NNEGDWŚ ....... . .NY.DW‹DWýB€BrBňAŕHrÂćHrŢśl.. .DWĐWHITE AC4591001C4591001 1007 10071634AADVERSE EVENT 2 vasovagal response Presyncope F™•NERVOUS SYSTEM DISORDERS Vasovagal reaction F™NľF™%Neurological signs and symptoms NEC F™úNeurological disorders NEC F™ůNervous system disorders F™•2021-02-22T15:39B22021-02-22 B2 1MedDRA v24.0NDW= BDÜHsÇ”DW=B..ADAYSN NNOT RELATEDOTHER Most likely due to anxiety/fear of receiving an injection NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A Dž– APeriod 01DWD”HrÂćDXŽDšěHtżĎěVaccination 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_30AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWD”HrÂćDW!DšěHrŢślBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWD”DW!DšěY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW=DW‹YPhase 3A@NNEGDWŚ ....... . .NY.DW‹DWýB€BrBňAŕHrÂćHrŢśl.. .DWĐWHITE AC4591001C4591001 1007 10071634A ADVERSE EVENT 1 Rhinorrhea Rhinorrhoea F™-ŇRESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS Rhinorrhea F™/<F™/=Upper respiratory tract signs and symptoms F™KiRespiratory tract signs and symptoms F™Ë}Respiratory, thoracic and mediastinal disorders F™-Ň2021-02-18 B. .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDW9 B....... N NNOT RELATEDOTHER viral infection NOT APPLICABLE NNRECOVERING/RESOLVING N A0NOT RELATEDA0AGRADE 1A . APeriod 01DWD”HrÂćDXŽDšěHtżĎěVaccination 2 A Y A 2021-02-27T15:50:57 100716401007Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWD˝ŘHrĂŘDWµDÄhHsˇăčPlacebo APlacebo ADWD˝ŘDW!DäŔY . . .Placebo Placebo DWEDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW˘DWµDĂDÄhDWŇDXrBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBB\BqBňAŕHrĂŘHrŢć@HsÖHsˇăč .DWˇWHITE AC4591001C4591001 1007 10071640AADVERSE EVENT 4 Chills Chills FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills F·ÓF·ÓFeelings and sensations NEC F™ŁGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-22T21:00BŞ2021-06-23T20:00B« 1MedDRA v24.0NDWµ AEuHs˘FĐDW¶A E—°HsŁŠ{A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C` A Period 02DW˘DĂHsÖDY"DÄhHuhVaccination 4 A`Y A@2021-06-29T14:40:41Y 100716401007Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWD˝ŘHrĂŘDWµDÄhHsˇăčPlacebo APlacebo ADWD˝ŘDW!DäŔY . . .Placebo Placebo DWEDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW˘DWµDĂDÄhDWŇDXrBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBB\BqBňAŕHrĂŘHrŢć@HsÖHsˇăč .DWˇWHITE AC4591001C4591001 1007 10071640A ADVERSE EVENT 3 headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-06-22T21:00BŞ2021-06-23T20:00B« 2MedDRA v24.0NDWµ AEuHs˘FĐDW¶A E—°HsŁŠ{A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C` A Period 02DW˘DĂHsÖDY"DÄhHuhVaccination 4 A`Y A@2021-06-29T14:40:30Y 100716401007Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWD˝ŘHrĂŘDWµDÄhHsˇăčPlacebo APlacebo ADWD˝ŘDW!DäŔY . . .Placebo Placebo DWEDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW˘DWµDĂDÄhDWŇDXrBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBB\BqBňAŕHrĂŘHrŢć@HsÖHsˇăč .DWˇWHITE AC4591001C4591001 1007 10071640A0ADVERSE EVENT 1 Injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-03T19:00B—2021-06-04T19:00B 1MedDRA v24.0NDW˘ AEłHs‰0DWŁA E¶°HsŠoëA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C@ A Period 02DW˘DĂHsÖDY"DÄhHuhVaccination 3 APY A02021-06-22T21:47:43Y 100716401007Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWD˝ŘHrĂŘDWµDÄhHsˇăčPlacebo APlacebo ADWD˝ŘDW!DäŔY . . .Placebo Placebo DWEDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW˘DWµDĂDÄhDWŇDXrBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBB\BqBňAŕHrĂŘHrŢć@HsÖHsˇăč .DWˇWHITE AC4591001C4591001 1007 10071640A@ADVERSE EVENT 2 fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-06-22T21:00BŞ2021-06-23T20:00B« 1MedDRA v24.0NDWµ AEuHs˘FĐDW¶A E—°HsŁŠ{A DAYSN NRELATED NOT APPLICABLE YYRECOVERED/RESOLVED N ARELATED AAGRADE 1A C` A Period 02DW˘DĂHsÖDY"DÄhHuhVaccination 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_30AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDÓ,HrĂ%,DW›DÎ¸Hs§8BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWDÓ,..Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g) DWŚDWŚYPhase 3A@NNEGDWŤBNT162b2 (30 (*ESC*){unicode 03BC}g) DW›...... . .NN.DWŚDWýBBqBňAđHrĂ%,Hs§8.. .DXXWHITE AC4591001C4591001 1007 10071642AADVERSE EVENT 4 dizziness Dizziness F™•NERVOUS SYSTEM DISORDERS Dizziness FË…FË…Neurological signs and symptoms NEC F™úNeurological disorders NEC F™ůNervous system disorders F™•2021-05-28 B‘2021-05-29 B’ 1MedDRA v24.0NDWś A ..DWťA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . APeriod 01DWDÓ,HrĂ%,DYDÎ¸Hu`Ú¸After 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_30AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDÓ,HrĂ%,DW›DÎ¸Hs§8BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWDÓ,..Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g) DWŚDWŚYPhase 3A@NNEGDWŤBNT162b2 (30 (*ESC*){unicode 03BC}g) DW›...... . .NN.DWŚDWýBBqBňAđHrĂ%,Hs§8.. .DXXWHITE AC4591001C4591001 1007 10071642A ADVERSE EVENT 3 fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-28 B‘2021-05-29 B’ 2MedDRA v24.0NDWś A ..DWťA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . APeriod 01DWDÓ,HrĂ%,DYDÎ¸Hu`Ú¸After 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_30AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDÓ,HrĂ%,DW›DÎ¸Hs§8BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWDÓ,..Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g) DWŚDWŚYPhase 3A@NNEGDWŤBNT162b2 (30 (*ESC*){unicode 03BC}g) DW›...... . .NN.DWŚDWýBBqBňAđHrĂ%,Hs§8.. .DXXWHITE AC4591001C4591001 1007 10071642A0ADVERSE EVENT 5 headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-05-28 B‘2021-05-29 B’ 1MedDRA v24.0NDWś A ..DWťA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . APeriod 01DWDÓ,HrĂ%,DYDÎ¸Hu`Ú¸After 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_30AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDÓ,HrĂ%,DW›DÎ¸Hs§8BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWDÓ,..Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g) DWŚDWŚYPhase 3A@NNEGDWŤBNT162b2 (30 (*ESC*){unicode 03BC}g) DW›...... . .NN.DWŚDWýBBqBňAđHrĂ%,Hs§8.. .DXXWHITE AC4591001C4591001 1007 10071642A@ADVERSE EVENT 2 body aches Pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalized aching F™Š\F™ŰPain and discomfort NEC F™ÜGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-28 B‘2021-05-29 B’ 2MedDRA v24.0NDWś A ..DWťA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . APeriod 01DWDÓ,HrĂ%,DYDÎ¸Hu`Ú¸After 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_30AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDÓ,HrĂ%,DW›DÎ¸Hs§8BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWDÓ,..Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g) DWŚDWŚYPhase 3A@NNEGDWŤBNT162b2 (30 (*ESC*){unicode 03BC}g) DW›...... . .NN.DWŚDWýBBqBňAđHrĂ%,Hs§8.. .DXXWHITE AC4591001C4591001 1007 10071642APADVERSE EVENT 1 fever 103.5 Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-05-28 B‘2021-05-29 B’ 3MedDRA v24.0NDWś A ..DWťA0..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA0GRADE 3A0 . APeriod 01DWDÓ,HrĂ%,DYDÎ¸Hu`Ú¸After unblinding and before Vaccination 3A@ A 2021-06-07T14:28:37Y 100716481007Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DW D„äHrÄ(dDW‹D¨ŔHsji@Placebo APlacebo ADW D„äDW"DřY . . .Placebo Placebo DW>DWtYPhase 3A@NNEGDWu BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWvDW‹D±¨D¨ŔDW§DXHBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWtDWýBhBB‰BńAđHrÄ(dHrßŇřHsNÂ¨Hsji@ .DWuALL OTHERS A0C4591001C4591001 1007 10071648AADVERSE EVENT 1 Injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-01-26T09:06B2021-01-27T07:00B 1MedDRA v24.0NDW" ADřHrßŇřDW#A Db«Hrá+A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A YAPeriod 01DW D„äHrÄ(dDWvD±§HsNÂ§Vaccination 2 A Y A 2021-03-01T15:45:10 100716501007Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADW DśĚHrÄ@LDW®DÍHs˛Placebo APlacebo ADW DśĚDW"D†Y . . .Placebo Placebo DW@DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW™DW®DËpDÍDWĘDXkBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBBeBrBńAĐHrÄ@LHrßŮHs}đHs˛ .DWWHITE AC4591001C4591001 1007 10071650AADVERSE EVENT 3 elevated body temperature unknown temp Body temperature increased FďëINVESTIGATIONS Body temperature increased F—F—Physical examination procedures and organ system status F™Ż…Physical examination and organ system status topics F™Ż„Investigations Fďë2021-06-16T08:30BŁ2021-06-16T10:00BŁ 1MedDRA v24.0NDWŻ A DwHs™®DWŻA DŚŰHs™Ă[ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CC0 A Period 02DW™DËpHs}đDYDÍHuyĺ”Vaccination 4 A`Y A@2021-06-21T15:34:11Y 100716501007Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADW DśĚHrÄ@LDW®DÍHs˛Placebo APlacebo ADW DśĚDW"D†Y . . .Placebo Placebo DW@DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW™DW®DËpDÍDWĘDXkBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBBeBrBńAĐHrÄ@LHrßŮHs}đHs˛ .DWWHITE AC4591001C4591001 1007 10071650A ADVERSE EVENT 2 chest tightness Chest discomfort FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chest tightness F·¬F·•Pain and discomfort NEC F™ÜGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-16T08:30BŁ2021-06-16T10:00BŁ 1MedDRA v24.0NDWŻ A DwHs™®DWŻA DŚŰHs™Ă[ADAYSN NNOT RELATEDOTHER Anxiety NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A CC0 A Period 02DW™DËpHs}đDYDÍHuyĺ”Vaccination 4 A`Y A@2021-06-21T15:33:49Y 100716501007Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADW DśĚHrÄ@LDW®DÍHs˛Placebo APlacebo ADW DśĚDW"D†Y . . .Placebo Placebo DW@DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW™DW®DËpDÍDWĘDXkBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBBeBrBńAĐHrÄ@LHrßŮHs}đHs˛ .DWWHITE AC4591001C4591001 1007 10071650A0ADVERSE EVENT 4 chills Chills FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills F·ÓF·ÓFeelings and sensations NEC F™ŁGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-16T08:30BŁ2021-06-16T10:00BŁ 1MedDRA v24.0NDWŻ A DwHs™®DWŻA DŚŰHs™Ă[ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CC0 A Period 02DW™DËpHs}đDYDÍHuyĺ”Vaccination 4 A`Y A@2021-06-21T15:34:47Y 100716501007Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADW DśĚHrÄ@LDW®DÍHs˛Placebo APlacebo ADW DśĚDW"D†Y . . .Placebo Placebo DW@DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW™DW®DËpDÍDWĘDXkBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBBeBrBńAĐHrÄ@LHrßŮHs}đHs˛ .DWWHITE AC4591001C4591001 1007 10071650A@ADVERSE EVENT 7 fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-16T08:30BŁ2021-06-16T10:00BŁ 1MedDRA v24.0NDWŻ A DwHs™®DWŻA DŚŰHs™Ă[ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CC0 A Period 02DW™DËpHs}đDYDÍHuyĺ”Vaccination 4 A`Y A@2021-06-21T15:36:42Y 100716501007Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADW DśĚHrÄ@LDW®DÍHs˛Placebo APlacebo ADW DśĚDW"D†Y . . .Placebo Placebo DW@DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW™DW®DËpDÍDWĘDXkBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBBeBrBńAĐHrÄ@LHrßŮHs}đHs˛ .DWWHITE AC4591001C4591001 1007 10071650APADVERSE EVENT 1 Headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-06-15T23:59B˘2021-06-16T10:00BŁ 2MedDRA v24.0NDW® AE@Hs™6DDWŻA DŚŰHs™Ă[A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C#@ A Period 02DW™DËpHs}đDYDÍHuyĺ”Vaccination 4 A`Y A@2021-06-21T14:24:25Y 100716501007Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADW DśĚHrÄ@LDW®DÍHs˛Placebo APlacebo ADW DśĚDW"D†Y . . .Placebo Placebo DW@DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW™DW®DËpDÍDWĘDXkBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBBeBrBńAĐHrÄ@LHrßŮHs}đHs˛ .DWWHITE AC4591001C4591001 1007 10071650A`ADVERSE EVENT 6 injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-16T08:30BŁ2021-06-16T10:00BŁ 1MedDRA v24.0NDWŻ A DwHs™®DWŻA DŚŰHs™Ă[ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CC0 A Period 02DW™DËpHs}đDYDÍHuyĺ”Vaccination 4 A`Y A@2021-06-21T15:36:02Y 100716501007Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADW DśĚHrÄ@LDW®DÍHs˛Placebo APlacebo ADW DśĚDW"D†Y . . .Placebo Placebo DW@DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW™DW®DËpDÍDWĘDXkBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBBeBrBńAĐHrÄ@LHrßŮHs}đHs˛ .DWWHITE AC4591001C4591001 1007 10071650ApADVERSE EVENT 5 generalized muscle aches Myalgia F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Generalized muscle aches F™ŠiF™{Muscle pains F™#Muscle disorders F™Musculoskeletal and connective tissue disorders F™k2021-06-16T08:30BŁ2021-06-16T10:00BŁ 2MedDRA v24.0NDWŻ A DwHs™®DWŻA DŚŰHs™Ă[ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A CC0 A Period 02DW™DËpHs}đDYDÍHuyĺ”Vaccination 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_30AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADW D™„HrÄ=DW"D—ŕHrßęŕBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DW D™„DW"D—ŕY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW>DW‹YPhase 3A@NNEGDWŚ ....... . .NY.DW‹DWýBBrBńAŔHrÄ=Hrßęŕ.. .DWÓWHITE AC4591001C4591001 1007 10071651AADVERSE EVENT 1 Left deep cervical chain lymph node swelling Lymphadenopathy F«QBLOOD AND LYMPHATIC SYSTEM DISORDERS Lymph nodes cervical swollen FřáFříLymphatic system disorders NEC FřîSpleen, lymphatic and reticuloendothelial system disorders F™9)Blood and lymphatic system disorders F«Q2021-01-12T12:30A€2021-02-09 B$ 1MedDRA v24.0NDW A€DŻČHrÍŤČDW0B$..BDAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A D'ż APeriod 01DW D™„HrÄ=DXŹD—ŕHtÁ`Vaccination 1 AY A2021-02-25T17:23:14 100716511007BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADW D™„HrÄ=DW"D—ŕHrßęŕBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DW D™„DW"D—ŕY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW>DW‹YPhase 3A@NNEGDWŚ ....... . .NY.DW‹DWýBBrBńAŔHrÄ=Hrßęŕ.. .DWÓWHITE AC4591001C4591001 1007 10071651A ADVERSE EVENT 2 left Cervical lymphadenopathy Lymphadenopathy F«QBLOOD AND LYMPHATIC SYSTEM DISORDERS Lymphadenopathy cervical FřđFříLymphatic system disorders NEC FřîSpleen, lymphatic and reticuloendothelial system disorders F™9)Blood and lymphatic system disorders F«Q2021-02-23T07:30B22021-03-09 B@ 1MedDRA v24.0NDW> BDixHs¦xDWLB+..AđDAYSN NNOT RELATEDOTHER Local adenopathy. Do not think related to study agent NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A Dśş APeriod 01DW D™„HrÄ=DXŹD—ŕHtÁ`Vaccination 2 A Y A 2021-07-14T13:17:55 AE outcome changed from EUA to sBLA 100716521007Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADW Dž¬HrÄB,DW´Dž¬Hs l¬Placebo APlacebo ADW Dž¬DW"D…\Y . . .Placebo Placebo DW>DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW™DW´D‘ČDž¬DWĐDXqBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBBeBrBńAŔHrÄB,HrßŘ\Hs|ÇHHs l¬ .DWWHITE AC4591001C4591001 1007 10071652AADVERSE EVENT 1 Erythema at injection site Injection site erythema FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site erythema FěFěInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-21T11:47B¨2021-06-22 B© 1MedDRA v24.0NDW´ ADĄ´Hs s´DWµA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A BYA Period 02DW™D‘ČHs|ÇHDY!Dž¬Hu ,Vaccination 4 A`Y A@2021-07-14T13:16:11Y 100716581007Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDńŕHrĹćŕDW¦DÔĐHsŽ-ĐPlacebo APlacebo ADWDńŕDW#D”Y . . .Placebo Placebo DW?DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DÖěDÔĐDWÉDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB~BmBrBđAĐHrĹćŕHrá9Hsr€lHsŽ-Đ .DWWHITE AC4591001C4591001 1007 10071658AADVERSE EVENT 6 headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-06-08 Bš2021-06-10 Bś 2MedDRA v24.0NDW§ A ..DW©A@..A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DW‘DÖěHsr€lDYDÔĐHuoaPVaccination 4 A`Y A@2021-06-14T15:20:32Y 100716581007Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDńŕHrĹćŕDW¦DÔĐHsŽ-ĐPlacebo APlacebo ADWDńŕDW#D”Y . . .Placebo Placebo DW?DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DÖěDÔĐDWÉDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB~BmBrBđAĐHrĹćŕHrá9Hsr€lHsŽ-Đ .DWWHITE AC4591001C4591001 1007 10071658A ADVERSE EVENT 7 injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-07T19:00B™2021-06-10 Bś 1MedDRA v24.0NDW¦ AEłHsŽd0DW©A@..A@DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Bč A Period 02DW‘DÖěHsr€lDYDÔĐHuoaPVaccination 4 A`Y A@2021-06-14T15:21:45Y 100716581007Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDńŕHrĹćŕDW¦DÔĐHsŽ-ĐPlacebo APlacebo ADWDńŕDW#D”Y . . .Placebo Placebo DW?DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DÖěDÔĐDWÉDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB~BmBrBđAĐHrĹćŕHrá9Hsr€lHsŽ-Đ .DWWHITE AC4591001C4591001 1007 10071658A0ADVERSE EVENT 5 malaise Malaise FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Malaise Fú Fú Asthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-07T19:00B™2021-06-10 Bś 3MedDRA v24.0NDW¦ AEłHsŽd0DW©A@..A@DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA0GRADE 3A0 Bč A Period 02DW‘DÖěHsr€lDYDÔĐHuoaPVaccination 4 A`Y A@2021-06-14T15:19:44Y 100716581007Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDńŕHrĹćŕDW¦DÔĐHsŽ-ĐPlacebo APlacebo ADWDńŕDW#D”Y . . .Placebo Placebo DW?DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DÖěDÔĐDWÉDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB~BmBrBđAĐHrĹćŕHrá9Hsr€lHsŽ-Đ .DWWHITE AC4591001C4591001 1007 10071658A@ADVERSE EVENT 2 anterior chest wall pain Musculoskeletal chest pain F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Chest wall pain F·°F™]Musculoskeletal and connective tissue pain and discomfort F™ŁMusculoskeletal and connective tissue disorders NEC F™iMusculoskeletal and connective tissue disorders F™k2021-06-08T12:00Bš2021-06-08T20:00Bš 3MedDRA v24.0NDW§ A D¨ŔHsŹS@DW§A E—°HsŹĂűADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA0GRADE 3A0 CN@ A Period 02DW‘DÖěHsr€lDYDÔĐHuoaPVaccination 4 A`Y A@2021-06-21T17:19:43Y 100716581007Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDńŕHrĹćŕDW¦DÔĐHsŽ-ĐPlacebo APlacebo ADWDńŕDW#D”Y . . .Placebo Placebo DW?DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DÖěDÔĐDWÉDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB~BmBrBđAĐHrĹćŕHrá9Hsr€lHsŽ-Đ .DWWHITE AC4591001C4591001 1007 10071658APADVERSE EVENT 4 generalized myalgia Myalgia F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Myalgia F™{F™{Muscle pains F™#Muscle disorders F™Musculoskeletal and connective tissue disorders F™k2021-06-07T19:00B™2021-06-10 Bś 3MedDRA v24.0NDW¦ AEłHsŽd0DW©A@..A@DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA0GRADE 3A0 Bč A Period 02DW‘DÖěHsr€lDYDÔĐHuoaPVaccination 4 A`Y A@2021-06-14T15:19:01Y 100716581007Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDńŕHrĹćŕDW¦DÔĐHsŽ-ĐPlacebo APlacebo ADWDńŕDW#D”Y . . .Placebo Placebo DW?DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DÖěDÔĐDWÉDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB~BmBrBđAĐHrĹćŕHrá9Hsr€lHsŽ-Đ .DWWHITE AC4591001C4591001 1007 10071658A`ADVERSE EVENT 3 fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-06-07T19:00B™2021-06-09 B› 1MedDRA v24.0NDW¦ AEłHsŽd0DW¨A0..A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Bč A Period 02DW‘DÖěHsr€lDYDÔĐHuoaPVaccination 4 A`Y A@2021-06-14T13:51:22Y 100716601007Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDílHrĹâlDW·DĚ$Hs¤Ž¤Placebo APlacebo ADWDílDW#Dß\Y . . .Placebo Placebo DW?DW‘YPhase 3A@NNEGDW’ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWˇDW·DŻŚDĚ$DWÓDXtBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‘DWýB„B]BlBđAŔHrĹâlHráÜHs‡qHs¤Ž¤ .DW WHITE AC4591001C4591001 1007 10071660AADVERSE EVENT 2 chills Chills FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills F·ÓF·ÓFeelings and sensations NEC F™ŁGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-03 B•2021-06-04 B– 1MedDRA v24.0NDW˘ A ..DWŁA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWˇDŻŚHs‡qDY$DĚ$Hu…Â$Vaccination 3 APY A02021-07-20T14:49:40Y 100716601007Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDílHrĹâlDW·DĚ$Hs¤Ž¤Placebo APlacebo ADWDílDW#Dß\Y . . .Placebo Placebo DW?DW‘YPhase 3A@NNEGDW’ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWˇDW·DŻŚDĚ$DWÓDXtBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‘DWýB„B]BlBđAŔHrĹâlHráÜHs‡qHs¤Ž¤ .DW WHITE AC4591001C4591001 1007 10071660A ADVERSE EVENT 5 fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-25 B«2021-06-26 B¬ 2MedDRA v24.0NDW¸ A ..DWąA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWˇDŻŚHs‡qDY$DĚ$Hu…Â$Vaccination 4 A`Y A@2021-07-20T14:53:10Y 100716601007Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDílHrĹâlDW·DĚ$Hs¤Ž¤Placebo APlacebo ADWDílDW#Dß\Y . . .Placebo Placebo DW?DW‘YPhase 3A@NNEGDW’ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWˇDW·DŻŚDĚ$DWÓDXtBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‘DWýB„B]BlBđAŔHrĹâlHráÜHs‡qHs¤Ž¤ .DW WHITE AC4591001C4591001 1007 10071660A0ADVERSE EVENT 1 injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-02T14:30B”2021-06-04 B– 2MedDRA v24.0NDWˇ ADËčHs‡ŤhDWŁA0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A By A Period 02DWˇDŻŚHs‡qDY$DĚ$Hu…Â$Vaccination 3 APY A02021-07-20T14:48:25Y 100716601007Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDílHrĹâlDW·DĚ$Hs¤Ž¤Placebo APlacebo ADWDílDW#Dß\Y . . .Placebo Placebo DW?DW‘YPhase 3A@NNEGDW’ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWˇDW·DŻŚDĚ$DWÓDXtBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‘DWýB„B]BlBđAŔHrĹâlHráÜHs‡qHs¤Ž¤ .DW WHITE AC4591001C4591001 1007 10071660APADVERSE EVENT 4 injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-24T15:00BŞ2021-06-25 B« 1MedDRA v24.0NDW· ADŇđHs¤•pDW¸A ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A BYA Period 02DWˇDŻŚHs‡qDY$DĚ$Hu…Â$Vaccination 4 A`Y A@2021-07-20T14:52:11Y 100716601007Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDílHrĹâlDW·DĚ$Hs¤Ž¤Placebo APlacebo ADWDílDW#Dß\Y . . .Placebo Placebo DW?DW‘YPhase 3A@NNEGDW’ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWˇDW·DŻŚDĚ$DWÓDXtBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‘DWýB„B]BlBđAŔHrĹâlHráÜHs‡qHs¤Ž¤ .DW WHITE AC4591001C4591001 1007 10071660A@ADVERSE EVENT 3 fever 101.4 Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-06-03T08:00B•2021-06-04 B– 2MedDRA v24.0NDW˘ A Dp€Hs€DWŁA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A CI0 A Period 02DWˇDŻŚHs‡qDY$DĚ$Hu…Â$Vaccination 3 APY A02021-07-20T14:50:47Y 100817611008Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVđDŇđHrž:đDW}DŇHsX€Placebo APlacebo ADVđDŇđDWD’ôY . . .Placebo Placebo DW%DWfYPhase 3A@NNEGDWg BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWgDW}DŘDŇDW™DX:BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWfDWýBwB—B—CŕAđHrž:đHrąŞtHs;"HsX€ .DWfWHITE AC4591001C4591001 1008 10081761AADVERSE EVENT 1 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-04-05T20:00Bx2021-04-06 By 1MedDRA v24.0NDWg AE”Hs;cŔDWhA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C` A Period 02DWgDŘHs;"DXęDŇHu9QVaccination 3 APY A02021-04-27T23:11:55Y 100817811008Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVóDÓhHr˘/čDW¨DŽHsŠPlacebo APlacebo ADVóDÓhDWD©8Y . . .Placebo Placebo DW)DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW”DW¨D‘ČDŽDWÄDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB™BjBrC°AĐHr˘/čHr˝µ8Hsv/ČHsŠ .DW“WHITE AC4591001C4591001 1008 10081781AADVERSE EVENT 1 injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-10 B·2021-06-12 Bą 1MedDRA v24.0NDW© A ..DW«A@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW”D‘ČHsv/ČDYDŽHuq˝Vaccination 4 A`Y A@2021-07-07T15:53:35Y 100817811008Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVóDÓhHr˘/čDW¨DŽHsŠPlacebo APlacebo ADVóDÓhDWD©8Y . . .Placebo Placebo DW)DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW”DW¨D‘ČDŽDWÄDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB™BjBrC°AĐHr˘/čHr˝µ8Hsv/ČHsŠ .DW“WHITE AC4591001C4591001 1008 10081781A ADVERSE EVENT 2 injection site fatigue Injection site reaction FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site reaction FěĎFěĎInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-10 B·2021-06-12 Bą 1MedDRA v24.0NDW© A ..DW«A@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW”D‘ČHsv/ČDYDŽHuq˝Vaccination 4 A`Y A@2021-07-07T15:54:37Y 100817881008Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADV÷DśHr§3DW˘DŃLHsäLPlacebo APlacebo ADV÷DśDWDŁ Y . . .Placebo Placebo DW(DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW˘DśTDŃLDWľDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB–BqBqCpAĐHr§3HrÂő Hsl˙ÔHsäL .DWŚWHITE AC4591001C4591001 1008 10081788AADVERSE EVENT 1 injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-13T19:00B—2021-05-14 B 1MedDRA v24.0NDWŤ AEłHsmn°DWŽA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C A Period 02DWŤDśTHsl˙ÔDYDŃLHujĚVaccination 3 APY A02021-06-04T00:10:42Y 100818011008Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVúD›(Hr«2(DW¦DŔlHsŽlPlacebo APlacebo ADVúD›(DWDY . . .Placebo Placebo DW,DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DÄŕDŔlDWĂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB’BmBrC@AđHr«2(HrČHsrn`HsŽl .DWWHITE AC4591001C4591001 1008 10081801AADVERSE EVENT 1 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-08 B®2021-06-09 BŻ 1MedDRA v24.0NDW§ A ..DW¨A0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW‘DÄŕHsrn`DYDŔlHuoLěVaccination 4 A`Y A@2021-07-06T21:29:21Y 100818081008Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DVűD–Hr¬~€DW¦D‰ĐHsŤâĐPlacebo APlacebo ADVűD–DWD¦¤Y . . .Placebo Placebo DW3DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦D‰”D‰ĐDWĂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB‘BmBrC0AĐHr¬~€HrČ>¤Hsr3HsŤâĐ .DWALL OTHERS A0C4591001C4591001 1008 10081808AADVERSE EVENT 1 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-18 B2021-05-19 B™ 1MedDRA v24.0NDW’ A ..DW“A0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW‘D‰”Hsr3DYD‰ĐHuoPVaccination 3 APY A02021-07-06T21:29:32Y 100818081008Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DVűD–Hr¬~€DW¦D‰ĐHsŤâĐPlacebo APlacebo ADVűD–DWD¦¤Y . . .Placebo Placebo DW3DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦D‰”D‰ĐDWĂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB‘BmBrC0AĐHr¬~€HrČ>¤Hsr3HsŤâĐ .DWALL OTHERS A0C4591001C4591001 1008 10081808A ADVERSE EVENT 2 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-08 B2021-06-09 B® 1MedDRA v24.0NDW§ A ..DW¨A0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW‘D‰”Hsr3DYD‰ĐHuoPVaccination 4 A`Y A@2021-07-06T21:29:44Y 100818121008Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVűDÉHr¬˛DWŁD¤Hs‰í$Placebo APlacebo ADVűDÉDWDÎôY . . .Placebo Placebo DW1DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDWŁDĺtD¤DWżDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB‘BqBrC0AŕHr¬˛HrČfôHsmHôHs‰í$ .DWŚWHITE AC4591001C4591001 1008 10081812AADVERSE EVENT 1 headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-05-14 B”2021-05-15 B• 2MedDRA v24.0NDWŽ A ..DWŹA0..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWŤDĺtHsmHôDYD¤Huk ¤Vaccination 3 APY A02021-06-04T16:56:23Y 100818371008Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADV˙DÜPHr˛ ĐDW¨DÁÔHs˝ÔPlacebo APlacebo ADV˙DÜPDWDŮDY . . .Placebo Placebo DW3DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DW¨DĹĐDÁÔDWÄDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBŤBkBrB˙AŔHr˛ ĐHrÍ·DHsuPHs˝Ô .DW’WHITE AC4591001C4591001 1008 10081837AADVERSE EVENT 1 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-20 B–2021-05-21 B— 2MedDRA v24.0NDW” A ..DW•A0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DW“DĹĐHsuPDYDÁÔHuqńTVaccination 3 APY A02021-06-09T22:45:37Y 100818371008Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADV˙DÜPHr˛ ĐDW¨DÁÔHs˝ÔPlacebo APlacebo ADV˙DÜPDWDŮDY . . .Placebo Placebo DW3DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DW¨DĹĐDÁÔDWÄDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBŤBkBrB˙AŔHr˛ ĐHrÍ·DHsuPHs˝Ô .DW’WHITE AC4591001C4591001 1008 10081837A ADVERSE EVENT 2 headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-05-20 B–2021-05-21 B— 2MedDRA v24.0NDW” A ..DW•A0..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DW“DĹĐHsuPDYDÁÔHuqńTVaccination 3 APY A02021-06-09T22:45:48Y 100818371008Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADV˙DÜPHr˛ ĐDW¨DÁÔHs˝ÔPlacebo APlacebo ADV˙DÜPDWDŮDY . . .Placebo Placebo DW3DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DW¨DĹĐDÁÔDWÄDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBŤBkBrB˙AŔHr˛ ĐHrÍ·DHsuPHs˝Ô .DW’WHITE AC4591001C4591001 1008 10081837A0ADVERSE EVENT 3 body aches Pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalized aching F™Š\F™ŰPain and discomfort NEC F™ÜGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-20 B–2021-05-21 B— 2MedDRA v24.0NDW” A ..DW•A0..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DW“DĹĐHsuPDYDÁÔHuqńTVaccination 3 APY A02021-06-09T22:45:59Y 100818441008Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDŹ¬Hrł¬DW¨D×(HsÓ(Placebo APlacebo ADWDŹ¬DWDÓŕY . . .Placebo Placebo DW1DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DW¨DŽDD×(DWĹDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBŚBkBrBţAŔHrł¬HrĎ`HstÚÄHsÓ( .DW’WHITE AC4591001C4591001 1008 10081844AADVERSE EVENT 1 headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-05-20 B•2021-05-20 B• 1MedDRA v24.0NDW” A ..DW”A ..ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW“DŽDHstÚÄDYD×(Hur¨Vaccination 3 APY A02021-06-10T02:01:52Y 100818441008Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDŹ¬Hrł¬DW¨D×(HsÓ(Placebo APlacebo ADWDŹ¬DWDÓŕY . . .Placebo Placebo DW1DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DW¨DŽDD×(DWĹDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBŚBkBrBţAŔHrł¬HrĎ`HstÚÄHsÓ( .DW’WHITE AC4591001C4591001 1008 10081844A ADVERSE EVENT 2 nausea Nausea FÜ›GASTROINTESTINAL DISORDERS Nausea F™ F™ Nausea and vomiting symptoms F™Gastrointestinal signs and symptoms FÜÜGastrointestinal disorders FÜ›2021-05-19T14:00B”2021-05-20 B• 1MedDRA v24.0NDW“ ADÄŕHsu`DW”A ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Bé A Period 02DW“DŽDHstÚÄDYD×(Hur¨Vaccination 3 APY A02021-06-10T02:02:03Y 100818441008Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDŹ¬Hrł¬DW¨D×(HsÓ(Placebo APlacebo ADWDŹ¬DWDÓŕY . . .Placebo Placebo DW1DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DW¨DŽDD×(DWĹDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBŚBkBrBţAŔHrł¬HrĎ`HstÚÄHsÓ( .DW’WHITE AC4591001C4591001 1008 10081844A0ADVERSE EVENT 3 body aches Pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalized aching F™Š\F™ŰPain and discomfort NEC F™ÜGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-20 B•2021-05-20 B• 1MedDRA v24.0NDW” A ..DW”A ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW“DŽDHstÚÄDYD×(Hur¨Vaccination 3 APY A02021-06-10T02:02:16Y 100818631008Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DWD PHr» PDW¦D‰XHsŤâXPlacebo APlacebo ADWD PDWDťřY . . .Placebo Placebo DW7DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦D‰ĐD‰XDWĂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB†BmBrBřAĐHr» PHrŐdřHsr3PHsŤâX .DWALL OTHERS A0C4591001C4591001 1008 10081863AADVERSE EVENT 1 Headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-06-08 B˘2021-06-09 BŁ 1MedDRA v24.0NDW§ A ..DW¨A0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW‘D‰ĐHsr3PDYD‰XHuoŘVaccination 4 A`Y A@2021-07-06T21:30:40Y 100818631008Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DWD PHr» PDW¦D‰XHsŤâXPlacebo APlacebo ADWD PDWDťřY . . .Placebo Placebo DW7DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦D‰ĐD‰XDWĂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB†BmBrBřAĐHr» PHrŐdřHsr3PHsŤâX .DWALL OTHERS A0C4591001C4591001 1008 10081863A ADVERSE EVENT 2 Body Aches Pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalized aching F™Š\F™ŰPain and discomfort NEC F™ÜGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-08 B˘2021-06-09 BŁ 1MedDRA v24.0NDW§ A ..DW¨A0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW‘D‰ĐHsr3PDYD‰XHuoŘVaccination 4 A`Y A@2021-07-06T21:30:51Y 100818771008Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDÍPHrĽ‡ĐDW¦D˝$HsŽ$Placebo APlacebo ADWDÍPDWDĚŘY . . .Placebo Placebo DW?DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DĂ´D˝$DWÄDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB…BmBrB÷AŕHrĽ‡ĐHrŘ6ŘHsrm4HsŽ$ .DWWHITE AC4591001C4591001 1008 10081877AADVERSE EVENT 1 fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-17T18:30B‹2021-05-19 BŤ 2MedDRA v24.0NDW‘ AEB€Hsr¨DW“A0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C0 A Period 02DW‘DĂ´Hsrm4DYD˝$HuoI¤Vaccination 3 APY A02021-06-08T00:02:51Y 100818771008Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDÍPHrĽ‡ĐDW¦D˝$HsŽ$Placebo APlacebo ADWDÍPDWDĚŘY . . .Placebo Placebo DW?DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DĂ´D˝$DWÄDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB…BmBrB÷AŕHrĽ‡ĐHrŘ6ŘHsrm4HsŽ$ .DWWHITE AC4591001C4591001 1008 10081877A ADVERSE EVENT 2 body aches Pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalized aching F™Š\F™ŰPain and discomfort NEC F™ÜGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-18 BŚ2021-05-19 BŤ 2MedDRA v24.0NDW’ A ..DW“A0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DW‘DĂ´Hsrm4DYD˝$HuoI¤Vaccination 3 APY A02021-06-08T00:03:02Y 100818871008Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWD“äHrÂĺäDW˘D€4Hs“4Placebo APlacebo ADWD“äDW!DÁ\Y . . .Placebo Placebo DW=DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW˘DčD€4DWľDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB€BqBrBňAŔHrÂĺäHrŢÂÜHsmKHs“4 .DWŚWHITE AC4591001C4591001 1008 10081887AADVERSE EVENT 3 chills Chills FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills F·ÓF·ÓFeelings and sensations NEC F™ŁGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-14 B2021-05-17 B† 1MedDRA v24.0NDWŽ A ..DW‘AP..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŤDčHsmKDYD€4HuiĆ´Vaccination 3 APY A02021-06-04T00:11:16Y 100818871008Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWD“äHrÂĺäDW˘D€4Hs“4Placebo APlacebo ADWD“äDW!DÁ\Y . . .Placebo Placebo DW=DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW˘DčD€4DWľDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB€BqBrBňAŔHrÂĺäHrŢÂÜHsmKHs“4 .DWŚWHITE AC4591001C4591001 1008 10081887A ADVERSE EVENT 2 headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-05-14 B2021-05-17 B† 2MedDRA v24.0NDWŽ A ..DW‘AP..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWŤDčHsmKDYD€4HuiĆ´Vaccination 3 APY A02021-06-03T17:25:04Y 100818871008Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWD“äHrÂĺäDW˘D€4Hs“4Placebo APlacebo ADWD“äDW!DÁ\Y . . .Placebo Placebo DW=DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW˘DčD€4DWľDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB€BqBrBňAŔHrÂĺäHrŢÂÜHsmKHs“4 .DWŚWHITE AC4591001C4591001 1008 10081887A0ADVERSE EVENT 1 sweating Hyperhidrosis F™5ŃSKIN AND SUBCUTANEOUS TISSUE DISORDERS Sweating F™=%Fç"Apocrine and eccrine gland disorders F˘&Skin appendage conditions F™5ŢSkin and subcutaneous tissue disorders F™5Ń2021-05-14 B2021-05-17 B† 1MedDRA v24.0NDWŽ A ..DW‘AP..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŤDčHsmKDYD€4HuiĆ´Vaccination 3 APY A02021-06-04T02:24:39Y 100818921008Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAAMERICAN INDIAN OR ALASKA NATIVE A0MAHISPANIC OR LATINO AUSAAMERICAN INDIAN OR ALASKA NATIVE A0DWDĚ`HrĂ`DW®D|8Hsa8Placebo APlacebo ADWDĚ`DW!DĐY . . .Placebo Placebo DW=DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW™DW®D~D|8DWĘDXkBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB€BeBrBňAŕHrĂ`HrŢŇHs|´Hsa8 .DWALL OTHERS A0C4591001C4591001 1008 10081892AADVERSE EVENT 1 injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-25T10:00BŽ2021-05-29 B’ 1MedDRA v24.0NDW™ ADŚ Hs|Â DWťAP..APDAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A B< A Period 02DW™D~Hs|´DYD|8Huy”¸Vaccination 3 APY A02021-06-04T00:11:29Y 100819131008Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWD× HrĹĚ DW¦Dż|HsŽ|Placebo APlacebo ADWD× DW$DÎ@Y . . .Placebo Placebo DWADW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DŠ„Dż|DWĂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB~BmBrBđAĐHrĹĚ HrâÄ@Hsr4HsŽ| .DWWHITE AC4591001C4591001 1008 10081913AADVERSE EVENT 1 injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-16T16:00B2021-05-19 B† 1MedDRA v24.0NDW BmDáHsq9DW“Bp..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A E%ý APeriod 01DWD× HrĹĚ DW‘DŠHsr4After 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_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDŘTHrČpTDW%DĘřHräxBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWDŘTDW%DĘřY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWADW‹YPhase 3A@NNEGDWŚ ....... . .NY.DW‹DWýB|BrBîAĐHrČpTHräx.. .DWŰWHITE AC4591001C4591001 1008 10081928AADVERSE EVENT 1 urticaria multiple sites Urticaria F™5ŃSKIN AND SUBCUTANEOUS TISSUE DISORDERS Urticaria F™MF™MUrticarias F™MAngioedema and urticaria FźúSkin and subcutaneous tissue disorders F™5Ń2021-01-10 A02021-01-22 Ađ 1MedDRA v24.0NDW A0..DWAđ..AĐDAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . APeriod 01DWDŘTHrČpTDX’DĘřHtĹEřVaccination 1 AY A2021-01-29T21:14:23 100819311008Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DWD—ŕHrĚ$`DW¨DŚÜHsÜPlacebo APlacebo ADWD—ŕDW(DśY . . .Placebo Placebo DWDDW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DW¨DŽ€DŚÜDWÉDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýByBkBrBëAŔHrĚ$`Hrç˝śHstŰHsÜ .DW’ALL OTHERS A0C4591001C4591001 1008 10081931AADVERSE EVENT 1 Cellulitis left leg Cellulitis FëůINFECTIONS AND INFESTATIONS Cellulitis of leg FµhFµJBacterial infections NEC F¦OBacterial infectious disorders F¦2Infections and infestations Fëů2021-03-15 B@2021-03-19 BD 1MedDRA v24.0NDWR B+..DWVB/..APDAYSN NNOT RELATEDOTHER Unknown NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DWD—ŕHrĚ$`DW“DŽHstÚ˙Follow Up 1 A0Y A 2021-03-19T21:23:05Y 100819331008Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDÂLHrĚNĚDW¦DĆ„HsŽ„Placebo APlacebo ADWDÂLDW)DÉY . . .Placebo Placebo DWEDW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DĚ`DĆ„DWĂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýByBmBrBëAŔHrĚNĚHréVHsruŕHsŽ„ .DWWHITE AC4591001C4591001 1008 10081933AADVERSE EVENT 1 injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-08 B•2021-06-09 B– 1MedDRA v24.0NDW§ A ..DW¨A0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW‘DĚ`HsruŕDYDĆ„HuoSVaccination 4 A`Y A@2021-07-06T21:31:58Y 100912201009Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVżDĂ<Hr]‘ĽDVŇDť€Hrvx€Placebo APlacebo ADVżDĂ<DVŇDť€Y . . .Placebo Placebo DVóDWŚYPhase 3A@NNEGDWŤ ....... . .NN.DWŚDWýBÎBqCđAđHr]‘ĽHrvx€.. .DWŽWHITE AC4591001C4591001 1009 10091220AADVERSE EVENT 1 POST SURGICAL PAIN, ORAL Procedural pain FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Postoperative pain F™l7F™“ňNon-site specific procedural complications F™ ÷Procedural related injuries and complications NEC F™§€Injury, poisoning and procedural complications Fěĺ2020-11-20 B!2020-11-30 B+ 2MedDRA v24.0NDVß Aŕ..DVéB..A°DAYSN NNOT RELATEDOTHER PHYSIOLOGIC due to wisdom teeth removal NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVżDĂ<Hr]‘ĽDX?Dť€HtW¬Vaccination 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_30AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVżDÄhHr]’čDVŇDťHrvxBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVżDÄhDVŇDťY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DVóDWŚYPhase 3A@NNEGDWŤ ....... . .NY.DWŚDWýBÎBqCđAŕHr]’čHrvx.. .DWŽWHITE AC4591001C4591001 1009 10091221AADVERSE EVENT 1 worsening right ankle pain Arthralgia F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Pain ankle F™ăFŁ'Joint related signs and symptoms Fń:Joint disorders Fń-Musculoskeletal and connective tissue disorders F™k2020-10-19T17:00A2020-10-19 A 3MedDRA v24.0NDVż ADďHr]˝DVżA..ADAYSN NNOT RELATEDOTHER dance injury NOT APPLICABLE NYRECOVERED/RESOLVED N A0NOT RELATEDA0A0GRADE 3A0 B¶ APeriod 01DVżDÄhHr]’čDX?DťHtW«Vaccination 1 AY A2020-11-25T18:24:30 100912291009Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVŔDóüHr_üDWŞDŢ0Hs“}0Placebo APlacebo ADVŔDóü..Y . . .Placebo DWxDWŤYPhase 3A@NNEGDWŽPlacebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWUDW•DWŞDăXDŢ0DWĘDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýBÎBiBpCŕAŔHr_üHs#‚ŚHswŇŘHs“}0 .DW”WHITE AC4591001C4591001 1009 10091229AADVERSE EVENT 1 Body Aches following vaccination Pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalized aching F™Š\F™ŰPain and discomfort NEC F™ÜGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-22 B×2021-05-23 BŘ 2MedDRA v24.0NDW– A ..DW—A0..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DW•DăXHswŇŘDYDŢ0Hut°°Vaccination 3 APY A02021-06-12T14:30:10Y 100912311009BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DVŔEHr_ ŕDVÔDŕHry^BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVŔEDVÔDŕY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DVóDW…YPhase 3A@NNEGDW“ ....... . .NY.DW’DWýBÓBkCŕAđHr_ ŕHry^.. .DW…ALL OTHERS A0C4591001C4591001 1009 10091231AADVERSE EVENT 1 left swollen axillary lymph node Lymphadenopathy F«QBLOOD AND LYMPHATIC SYSTEM DISORDERS Axillary lymph nodes enlarged FĄŁFříLymphatic system disorders NEC FřîSpleen, lymphatic and reticuloendothelial system disorders F™9)Blood and lymphatic system disorders F«Q2020-11-10 B2020-11-10 B 1MedDRA v24.0NDVŐ A ..DVŐA ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . APeriod 01DVŔEHr_ ŕDXADŕHtZ‘Vaccination 2 A Y A 2020-12-15T20:40:58 100912671009Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVęDşĚHr–9ĚDW¦DśHsŤőPlacebo APlacebo ADVęDşĚDV˙D·Y . . .Placebo Placebo DWDWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦D×(DśDWÉDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýB¤BmBpC@AĐHr–9ĚHr±ĺŚHsr€¨HsŤő .DWWHITE AC4591001C4591001 1009 10091267AADVERSE EVENT 1 RUNNY NOSE Rhinorrhoea F™-ŇRESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS Runny nose F™0F™/=Upper respiratory tract signs and symptoms F™KiRespiratory tract signs and symptoms F™Ë}Respiratory, thoracic and mediastinal disorders F™-Ň2020-12-27 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 01DVęDşĚHr–9ĚDW‘D×'Hsr€§Vaccination 2 A Y A 2021-01-22T04:19:01 100912941009Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADVđDŁHržDW~D†ÄHsY#ÄPlacebo APlacebo ADVđDŁDWD‡Y . . .Placebo Placebo DW!DWcYPhase 3A@NNEGDWd BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWhDW~D¸D†ÄDW DX;BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWcDWýBtB–BšCŕAđHržHrąž€Hs<¸HsY#Ä .DWgWHITE AC4591001C4591001 1009 10091294AADVERSE EVENT 1 bilateral shoulder pain Arthralgia F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Shoulder pain F™5)FŁ'Joint related signs and symptoms Fń:Joint disorders Fń-Musculoskeletal and connective tissue disorders F™k2020-12-22 B2020-12-24 B 1MedDRA v24.0NDV˙ B..DWB..A0DAYSN NNOT RELATEDOTHER lifting heavy object NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVđDŁHržDWhD·Hs<·Vaccination 1 AY A2020-12-28T22:18:38 100912941009Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADVđDŁHržDW~D†ÄHsY#ÄPlacebo APlacebo ADVđDŁDWD‡Y . . .Placebo Placebo DW!DWcYPhase 3A@NNEGDWd BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWhDW~D¸D†ÄDW DX;BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWcDWýBtB–BšCŕAđHržHrąž€Hs<¸HsY#Ä .DWgWHITE AC4591001C4591001 1009 10091294A ADVERSE EVENT 2 body aches Pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalized aching F™Š\F™ŰPain and discomfort NEC F™ÜGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-04-06T18:00By2021-04-07 Bz 1MedDRA v24.0NDWh ADý Hs<™ DWiA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C ` A Period 02DWhD¸Hs<¸DXëD†ÄHu:WDVaccination 3 APY A02021-04-16T16:40:05Y 100913011009Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVđDţLHržfLDW´Dć(Hs ´(Placebo APlacebo ADVđDţLDWDĚśY . . .Placebo Placebo DW$DWYPhase 3A@NNEGDW€ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW DW´Dű¸Dć(DW×DXqBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWDWýBB^B~CŕAđHržfLHrąäHs†k¸Hs ´( .DWźWHITE AC4591001C4591001 1009 10091301AADVERSE EVENT 1 spider bite Arthropod bite FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Spider bite F™8FŁÇNon-site specific injuries NEC F™ ÇInjuries NEC FěâInjury, poisoning and procedural complications Fěĺ2021-07-22 Bä2021-08-05 Bň 2MedDRA v24.0NDWÓ B ..DWáB...AđDAYSN NNOT RELATEDOTHER insect bite NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . A Period 02DW Dű¸Hs†k¸DY!Dć(Huç¨Vaccination 4 A`Y A@2021-09-10T21:03:38Y 100913051009Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVńDý Hrź¶ DWkD¬DHs@<ÄPlacebo APlacebo ADVńDý DWD–Y . . .Placebo Placebo DW#DW<YPhase 3A@NNEGDW= BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWVDWkD«TD¬DDW‡DX(BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW<DWýBLB¨BÁCĐAđHrź¶ Hrş˙Hs$ŚTHs@<Ä .DWUWHITE AC4591001C4591001 1009 10091305AADVERSE EVENT 1 Right Axillary Adenitis Lymphadenitis F«QBLOOD AND LYMPHATIC SYSTEM DISORDERS Axillary adenitis F™ZĂFřäLymphatic system disorders NEC FřîSpleen, lymphatic and reticuloendothelial system disorders F™9)Blood and lymphatic system disorders F«Q2021-03-24 Bk2021-04-16 B‚ 2MedDRA v24.0NDW[ A`..DWrB..BDAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWVD«THs$ŚTDXŘD¬DHu!pDVaccination 3 APY A02021-07-12T16:54:19Y 100913191009BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVóDË4Hr˘'´DWDHrşčBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVóDË4DWDY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW)DWYPhase 3A@NNEGDW‘ ....... . .NY.DWDWýBžBmC°AđHr˘'´Hrşč.. .DWµWHITE AC4591001C4591001 1009 10091319AADVERSE EVENT 1 headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-01-22 B,2021-01-22 B, 2MedDRA v24.0NDW B..DWB..ADAYSN NNOT RELATEDOTHER unknown NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVóDË4Hr˘'´DXsDHtśVaccination 2 A Y A 2021-01-27T21:45:18 100913231009Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVóDçHr˘DDW×D‹8HsÎ}¸Placebo APlacebo ADVóDçDWDčY . . .Placebo Placebo DW$DW˝YPhase 3A@NNEGDWż BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWĂDW×D‡D‹8DWóDX”BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWľDWýBĚB;B?C°AđHr˘DHrĽ˘Hs´€HsÎ}¸ .DW˝WHITE AC4591001C4591001 1009 10091323AADVERSE EVENT 1 fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-01-08 B2021-01-08 B 1MedDRA v24.0NDW A ..DWA ..ADAYSN NNOT RELATEDOTHER prolonged fasting NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVóDçHr˘DDWĂD†˙Hs´Vaccination 2 A Y A 2021-01-13T05:29:45 100913231009Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVóDçHr˘DDW×D‹8HsÎ}¸Placebo APlacebo ADVóDçDWDčY . . .Placebo Placebo DW$DW˝YPhase 3A@NNEGDWż BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWĂDW×D‡D‹8DWóDX”BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWľDWýBĚB;B?C°AđHr˘DHrĽ˘Hs´€HsÎ}¸ .DW˝WHITE AC4591001C4591001 1009 10091323A ADVERSE EVENT 2 nausea Nausea FÜ›GASTROINTESTINAL DISORDERS Nausea F™ F™ Nausea and vomiting symptoms F™Gastrointestinal signs and symptoms FÜÜGastrointestinal disorders FÜ›2021-01-08 B2021-01-08 B 1MedDRA v24.0NDW A ..DWA ..ADAYSN NNOT RELATEDOTHER prolonged fasting NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVóDçHr˘DDWĂD†˙Hs´Vaccination 2 A Y A 2021-01-13T05:29:51 100913261009Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVôDš8HrŁH8DW¸DŕÄHsĄôÄPlacebo APlacebo ADVôDš8DWDŤY . . .Placebo Placebo DW%DW”YPhase 3A@NNEGDW• BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW›DW¸DŁ\DŕÄDWŮDXuBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW”DWýBˇBcBiC AŔHrŁH8HrĽHHs{ÜHsĄôÄ .DWšWHITE AC4591001C4591001 1009 10091326AADVERSE EVENT 2 headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-06-26 BĆ2021-06-26 BĆ 1MedDRA v24.0NDWą A ..DWąA ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW›DŁ\Hs{ÜDY%DŕÄHu‡(DVaccination 4 A`Y A@2021-07-01T02:22:59Y 100913261009Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVôDš8HrŁH8DW¸DŕÄHsĄôÄPlacebo APlacebo ADVôDš8DWDŤY . . .Placebo Placebo DW%DW”YPhase 3A@NNEGDW• BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW›DW¸DŁ\DŕÄDWŮDXuBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW”DWýBˇBcBiC AŔHrŁH8HrĽHHs{ÜHsĄôÄ .DWšWHITE AC4591001C4591001 1009 10091326A ADVERSE EVENT 1 Sore (pain) left deltoid- at injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-26 BĆ2021-06-26 BĆ 1MedDRA v24.0NDWą A ..DWąA ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW›DŁ\Hs{ÜDY%DŕÄHu‡(DVaccination 4 A`Y A@2021-07-01T14:59:50Y 100913341009Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVôEÉ€HrŁşDW§Dî\HsŹÜPlacebo APlacebo ADVôEÉ€DWD´<Y . . .Placebo Placebo DW%DW’YPhase 3A@NNEGDW“ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DW§Dń,Dî\DWÉDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW’DWýBźBkBkC AĐHrŁşHr˝Ŕ<Hsu=¬HsŹÜ .DW’WHITE AC4591001C4591001 1009 10091334AADVERSE EVENT 1 runny nose Rhinorrhoea F™-ŇRESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS Runny nose F™0F™/=Upper respiratory tract signs and symptoms F™KiRespiratory tract signs and symptoms F™Ë}Respiratory, thoracic and mediastinal disorders F™-Ň2021-01-11 B 2021-01-11 B 1MedDRA v24.0NDW AŔ..DWAŔ..ADAYSN NNOT RELATEDOTHER cooking fumes from hot peppers NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVôEÉ€HrŁşDW“Dń+Hsu=«Vaccination 2 A Y A 2021-01-18T20:41:00 100913381009Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADV÷DÄ,Hr§f¬DWćD$HsâI$Placebo APlacebo ADV÷DÄ,..Y . . .Placebo DW6DW´YPhase 3A@NNEGDWµ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŃDWćDťD$DX DXŁBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW´DWýBľB-BICpAđHr§f¬Hr§f¬HsĆ¦HsâI$ .DWËWHITE AC4591001C4591001 1009 10091338AADVERSE EVENT 4 Mouth Ulcer Mouth ulceration FÜ›GASTROINTESTINAL DISORDERS Mouth ulcer F™F™Stomatitis and ulceration F™;Oral soft tissue conditions F™ĄGastrointestinal disorders FÜ›2021-06-16 Bą2021-06-21 Bľ 2MedDRA v24.0NDWŻ Bą..DW´Bľ..A`DAYSN NNOT RELATEDOTHER Unknown NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DV÷DÄ,Hr§f¬DWŃDťHsĆ¦‡Follow Up 1 A0Y A2021-07-01T17:27:43Y 100913381009Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADV÷DÄ,Hr§f¬DWćD$HsâI$Placebo APlacebo ADV÷DÄ,..Y . . .Placebo DW6DW´YPhase 3A@NNEGDWµ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŃDWćDťD$DX DXŁBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW´DWýBľB-BICpAđHr§f¬Hr§f¬HsĆ¦HsâI$ .DWËWHITE AC4591001C4591001 1009 10091338A ADVERSE EVENT 3 Wisdom Teeth Removal Wisdom teeth removal F™<őSURGICAL AND MEDICAL PROCEDURES Wisdom teeth removal F™Q÷F™Q÷Dental and gingival therapeutic procedures FĆťHead and neck therapeutic procedures FávSurgical and medical procedures F™<ő2021-06-08 B±2021-06-08 B± 2MedDRA v24.0NDW§ B±..DW§B±..ADAYSN NNOT RELATEDOTHER Surgery NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DV÷DÄ,Hr§f¬DWŃDťHsĆ¦‡Follow Up 1 A0Y A2021-07-01T15:56:56Y 100913411009Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADV÷E7@Hr§ĄôDWŇD~HsÇŮPlacebo APlacebo ADV÷E7@DWDňXY . . .Placebo Placebo DW,DW»YPhase 3A@NNEGDW˝ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWżDWŇD»D~DWóDXŹBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWĽDWýBĆB?BACpAĐHr§ĄôHrĂDXHsŻ HsÇŮ .DW»WHITE AC4591001C4591001 1009 10091341AADVERSE EVENT 1 body aches Pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalized aching F™Š\F™ŰPain and discomfort NEC F™ÜGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-07-03 BĘ2021-07-03 BĘ 1MedDRA v24.0NDWŔ A ..DWŔA ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWżD»HsŻ 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_30AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADV÷E/ŔHr§Ą|DWDń¤HrĂC¤BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DV÷E/ŔDWDń¤Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW,DW»YPhase 3A@NNEGDW˝ ....... . .NY.DWĽDWýBĆBACpAđHr§Ą|HrĂC¤.. .DW»WHITE AC4591001C4591001 1009 10091342AADVERSE EVENT 1 swollen cervical lymph nodes bilateral Lymphadenopathy F«QBLOOD AND LYMPHATIC SYSTEM DISORDERS Lymph nodes cervical swollen FřáFříLymphatic system disorders NEC FřîSpleen, lymphatic and reticuloendothelial system disorders F™9)Blood and lymphatic system disorders F«Q2021-01-31 B12021-02-02 B3 1MedDRA v24.0NDW' B..DW)B..A0DAYSN NNOT RELATEDOTHER unknown NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DV÷E/ŔHr§Ą|DXyDń¤Ht¤w$Vaccination 2 A Y A 2021-02-21T09:53:54 100913571009Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVúD–Hr«-DWgDŽřHs:ŮxPlacebo APlacebo ADVúD–DW DŹčY . . .Placebo Placebo DW)DW<YPhase 3A@NNEGDW= BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWSDWgDČdDŽřDW„DX$BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW<DWýBCB«BÁC@AđHr«-HrÄ3hHs ´äHs:Ůx .DWRWHITE AC4591001C4591001 1009 10091357AADVERSE EVENT 4 headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-04-06T03:00Bo2021-04-07 Bp 1MedDRA v24.0NDWh A D*0Hs;Ć0DWiA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C? A Period 02DWSDČdHs ´äDXÔDŽřHuřVaccination 4 A`Y A@2021-04-16T16:40:37Y 100913571009Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVúD–Hr«-DWgDŽřHs:ŮxPlacebo APlacebo ADVúD–DW DŹčY . . .Placebo Placebo DW)DW<YPhase 3A@NNEGDW= BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWSDWgDČdDŽřDW„DX$BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW<DWýBCB«BÁC@AđHr«-HrÄ3hHs ´äHs:Ůx .DWRWHITE AC4591001C4591001 1009 10091357A ADVERSE EVENT 5 body aches Pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalized aching F™Š\F™ŰPain and discomfort NEC F™ÜGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-04-06T03:00Bo2021-04-07 Bp 1MedDRA v24.0NDWh A D*0Hs;Ć0DWiA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C? A Period 02DWSDČdHs ´äDXÔDŽřHuřVaccination 4 A`Y A@2021-04-16T16:40:48Y 100913571009Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVúD–Hr«-DWgDŽřHs:ŮxPlacebo APlacebo ADVúD–DW DŹčY . . .Placebo Placebo DW)DW<YPhase 3A@NNEGDW= BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWSDWgDČdDŽřDW„DX$BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW<DWýBCB«BÁC@AđHr«-HrÄ3hHs ´äHs:Ůx .DWRWHITE AC4591001C4591001 1009 10091357A0ADVERSE EVENT 1 congenital vertebral pedicle hypoplasia Spine malformation FľŰCONGENITAL, FAMILIAL AND GENETIC DISORDERS Congenital anomalies of spine FľđF™9Musculoskeletal and connective tissue disorders of spine congenitalF™_Musculoskeletal and connective tissue disorders congenital F™lCongenital, familial and genetic disorders FľŰ2021-02-12 B: .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDW3 B'....... N NNOT RELATEDOTHER congenital NOT APPLICABLE NNNOT RECOVERED/NOT RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVúD–Hr«-DWSDČcHs ´ăFollow Up 1 A0Y A 2021-06-18T23:14:04Y 100913611009Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVúDÇěHr«^ěDW¦D«HsŽPlacebo APlacebo ADVúDÇěDW DđxY . . .Placebo Placebo DW)DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DóD«DWĐDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB“BmBqC@AĐHr«^ěHrÄ“řHsrśŚHsŽ .DWWHITE AC4591001C4591001 1009 10091361AADVERSE EVENT 1 sprained right thumb Ligament sprain FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Thumb sprain F™AFöMuscle, tendon and ligament injuries F™Injuries NEC FěâInjury, poisoning and procedural complications Fěĺ2021-01-02T18:30B2021-01-31 B. 2MedDRA v24.0NDW BEB€HrŔł(DW'B...BDAYSN NNOT RELATEDOTHER thumb sprain from volleyball NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A D[ APeriod 01DVúDÇěHr«^ěDW‘DóHsrś‹Vaccination 1 AY A2021-02-03T17:08:33 100913631009Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVúDĺtHr«|tDW÷DáđHsůpPlacebo APlacebo ADVúDĺt..Y . . .Placebo DW0DWĐYPhase 3A@NNEGDWŃ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŰDW÷DśDáđDXDX´BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWĐDWýB×B#B-C@AŕHr«|tHr«|tHsÓŐHsůp .DWĐWHITE AC4591001C4591001 1009 10091363AADVERSE EVENT 1 Vasovagal Reaction Presyncope F™•NERVOUS SYSTEM DISORDERS Vasovagal reaction F™NľF™%Neurological signs and symptoms NEC F™úNeurological disorders NEC F™ůNervous system disorders F™•2021-02-09T09:04B72021-02-09T09:30B7 1MedDRA v24.0NDW0 B7D€HrňG€DW0B7D…ÓHrňMÓADAYSN NNOT RELATEDOTHER Secondary to veinipuncture NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A EŕĐ APeriod 01DVúDĺtHr«|tDWŰDśŹHsÓŐVaccination 1 AY A2021-02-12T23:06:36 100913651009Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVúDě¸Hr«¸DWďDŕLHsîvĚPlacebo APlacebo ADVúDě¸DWDŘY . . .Placebo Placebo DW7DW—YPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŃDWďDÄ¤DŕLDXDX¬BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW—DWýBžB-BfC@AŔHr«¸HrÖđHsĆÎ$HsîvĚ .DWĐWHITE AC4591001C4591001 1009 10091365AADVERSE EVENT 1 right arm fracture Upper limb fracture FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Arm fracture F™VgF™†RLimb fractures and dislocations F™ľîBone and joint injuries F¶Injury, poisoning and procedural complications Fěĺ2021-03-19 B] .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDWV B<....... N NNOT RELATEDOTHER accidental injury NOT APPLICABLE YNRECOVERING/RESOLVING N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVúDě¸Hr«¸DWŃDÄŁHsĆÎ#Follow Up 1 A0Y A 2021-03-29T15:53:38Y 100913661009Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVúDđ<Hr«‡<DWúD|°Hsü“°Placebo APlacebo ADVúDđ<..Y . . .Placebo DWdDWŕYPhase 3A@NNEGDWáPlacebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWADWćDWúD€¬D|°DXDX·BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŕDWýBçBBC@AŕHr«‡<Hs ČHsâ9¬Hsü“° .DWĺWHITE AC4591001C4591001 1009 10091366AADVERSE EVENT 1 Mild Injection Site Pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-02-26T20:00BH2021-02-27 BI 1MedDRA v24.0NDWA AE”Hs JŔDWBA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Bâ APeriod 01DVúDđ<Hr«‡<DWćD€«Hsâ9«Vaccination 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_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADVűD ŚHr¬‰DWD¶XHrČNXBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVűD ŚDWD¶XY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW,DWľYPhase 3A@NNEGDWż ....... . .NY.DWľDWýBÄB?C0AĐHr¬‰HrČNX.. .DWżWHITE AC4591001C4591001 1009 10091370AADVERSE EVENT 1 headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-01-06 B2021-01-06 B 3MedDRA v24.0NDW B..DWB..ADAYSN NNOT RELATEDOTHER braces tightening NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A0GRADE 3A0 . APeriod 01DVűD ŚHr¬‰DX}D¶XHt©ŘVaccination 1 AY A2021-01-10T22:00:09 100913791009Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADV˙DÉTHr±÷ÔDW¨D„lHs€lPlacebo APlacebo ADV˙DÉTDWDzĐY . . .Placebo Placebo DW6DW‘YPhase 3A@NNEGDW’ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DW¨DŹ¬D„lDWĘDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‘DWýB“BkBlB˙AĐHr±÷ÔHrĎűĐHstÜ,Hs€l .DW’WHITE AC4591001C4591001 1009 10091379AADVERSE EVENT 1 BRUISED KNEE, LEFT Contusion FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Contusion of knee FŔěF™\Skin injuries NEC F™łInjuries NEC FěâInjury, poisoning and procedural complications Fěĺ2021-03-22 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 01DV˙DÉTHr±÷ÔDW“DŹ«HstÜ+Follow Up 1 A0Y A 2021-07-09T21:02:10Y 100913791009Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADV˙DÉTHr±÷ÔDW¨D„lHs€lPlacebo APlacebo ADV˙DÉTDWDzĐY . . .Placebo Placebo DW6DW‘YPhase 3A@NNEGDW’ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DW¨DŹ¬D„lDWĘDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‘DWýB“BkBlB˙AĐHr±÷ÔHrĎűĐHstÜ,Hs€l .DW’WHITE AC4591001C4591001 1009 10091379A ADVERSE EVENT 2 GROUND LEVEL FALL Fall FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Fall FŐFŐNon-site specific injuries NEC F™ ÇInjuries NEC FěâInjury, poisoning and procedural complications Fěĺ2021-02-26 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 01DV˙DÉTHr±÷ÔDW“DŹ«HstÜ+Follow Up 1 A0Y A 2021-03-22T21:44:46 100913791009Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADV˙DÉTHr±÷ÔDW¨D„lHs€lPlacebo APlacebo ADV˙DÉTDWDzĐY . . .Placebo Placebo DW6DW‘YPhase 3A@NNEGDW’ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DW¨DŹ¬D„lDWĘDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‘DWýB“BkBlB˙AĐHr±÷ÔHrĎűĐHstÜ,Hs€l .DW’WHITE AC4591001C4591001 1009 10091379A0ADVERSE EVENT 3 bilateral great toe ingrown toenail Ingrowing nail F™5ŃSKIN AND SUBCUTANEOUS TISSUE DISORDERS Ingrown toe nail FěFě}Nail and nail bed conditions (excl infections and infestations) F™ŤSkin appendage conditions F™5ŢSkin and subcutaneous tissue disorders F™5Ń2021-06-03 B¤ .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDW˘ B....... N NNOT RELATEDOTHER physiologic NOT APPLICABLE YNNOT RECOVERED/NOT RESOLVED N A0NOT RELATEDA0AGRADE 1A . A Period 02DW“DŹ¬HstÜ,DYD„lHuqłěVaccination 3 APY A02021-06-15T18:40:08Y 100913801009Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDčDHr»QDDWÉDµ¤HsĽ3$Placebo APlacebo ADWDčDDWDÝ¸Y . . .Placebo Placebo DW=DW™YPhase 3A@NNEGDWš BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW¶DWÉDşTDµ¤DWîDX†BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW™DWýB”BHBdBřAŕHr»QDHrÖö8HsŁ+THsĽ3$ .DWµWHITE AC4591001C4591001 1009 10091380AADVERSE EVENT 1 Right Clavicle Fracture Clavicle fracture FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Clavicle fracture FşťFşťLimb fractures and dislocations F™ľîBone and joint injuries F¶Injury, poisoning and procedural complications Fěĺ2021-01-18T20:30B2021-02-22 B8 2MedDRA v24.0NDW BE€HrŐçHDW=B8..B$DAYSN NNOT RELATEDOTHER Snowboarding Accident NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A Dqo APeriod 01DWDčDHr»QDDW¶DşSHsŁ+SVaccination 1 AY A2021-07-09T20:56:58 AE outcome changed from EUA to sBLA 100913801009Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDčDHr»QDDWÉDµ¤HsĽ3$Placebo APlacebo ADWDčDDWDÝ¸Y . . .Placebo Placebo DW=DW™YPhase 3A@NNEGDWš BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW¶DWÉDşTDµ¤DWîDX†BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW™DWýB”BHBdBřAŕHr»QDHrÖö8HsŁ+THsĽ3$ .DWµWHITE AC4591001C4591001 1009 10091380A ADVERSE EVENT 2 pain after wisdom teeth removal Procedural pain FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Post procedural pain F™XŐF™“ňNon-site specific procedural complications F™ ÷Procedural related injuries and complications NEC F™§€Injury, poisoning and procedural complications Fěĺ2021-02-11 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 01DWDčDHr»QDDW¶DşSHsŁ+SVaccination 2 A Y A 2021-02-24T09:04:45 100913821009Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADWDčHrĂ:DWˇD‹8Hs‡L¸Placebo APlacebo ADWDčDW!DäüY . . .Placebo Placebo DW@DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWˇD€pD‹8DWżDX^BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBBpBqBňAŕHrĂ:HrŢć|Hsn5pHs‡L¸ .DWŤWHITE AC4591001C4591001 1009 10091382AADVERSE EVENT 1 RIGHT KNEE PAIN Arthralgia F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Knee pain Fň5FŁ'Joint related signs and symptoms Fń:Joint disorders Fń-Musculoskeletal and connective tissue disorders F™k2021-01-10 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 01DWDčHrĂ:DWŽD€oHsn5oVaccination 1 AY A2021-03-08T22:08:58 100913821009Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADWDčHrĂ:DWˇD‹8Hs‡L¸Placebo APlacebo ADWDčDW!DäüY . . .Placebo Placebo DW@DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWˇD€pD‹8DWżDX^BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBBpBqBňAŕHrĂ:HrŢć|Hsn5pHs‡L¸ .DWŤWHITE AC4591001C4591001 1009 10091382A ADVERSE EVENT 2 chills Chills FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills F·ÓF·ÓFeelings and sensations NEC F™ŁGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-03 B—2021-06-03 B— 1MedDRA v24.0NDW˘ A ..DW˘A ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŽD€pHsn5pDYD‹8Huh€8Vaccination 4 A`Y A@2021-06-15T18:42:14Y 100913821009Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADWDčHrĂ:DWˇD‹8Hs‡L¸Placebo APlacebo ADWDčDW!DäüY . . .Placebo Placebo DW@DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWˇD€pD‹8DWżDX^BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBBpBqBňAŕHrĂ:HrŢć|Hsn5pHs‡L¸ .DWŤWHITE AC4591001C4591001 1009 10091382A0ADVERSE EVENT 5 dizziness Dizziness F™•NERVOUS SYSTEM DISORDERS Dizziness FË…FË…Neurological signs and symptoms NEC F™úNeurological disorders NEC F™ůNervous system disorders F™•2021-05-15 B„2021-05-16 B… 1MedDRA v24.0NDWŹ A ..DWA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŽD€pHsn5pDYD‹8Huh€8Vaccination 3 APY A02021-07-13T23:16:01Y 100913821009Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADWDčHrĂ:DWˇD‹8Hs‡L¸Placebo APlacebo ADWDčDW!DäüY . . .Placebo Placebo DW@DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWˇD€pD‹8DWżDX^BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBBpBqBňAŕHrĂ:HrŢć|Hsn5pHs‡L¸ .DWŤWHITE AC4591001C4591001 1009 10091382A@ADVERSE EVENT 3 generalized muscle pain Myalgia F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Muscle pain F™"F™{Muscle pains F™#Muscle disorders F™Musculoskeletal and connective tissue disorders F™k2021-05-15 B„2021-05-20 B‰ 1MedDRA v24.0NDWŹ A ..DW”Ap..A`DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŽD€pHsn5pDYD‹8Huh€8Vaccination 3 APY A02021-07-13T23:15:38Y 100913821009Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADWDčHrĂ:DWˇD‹8Hs‡L¸Placebo APlacebo ADWDčDW!DäüY . . .Placebo Placebo DW@DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWˇD€pD‹8DWżDX^BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBBpBqBňAŕHrĂ:HrŢć|Hsn5pHs‡L¸ .DWŤWHITE AC4591001C4591001 1009 10091382APADVERSE EVENT 7 nausea Nausea FÜ›GASTROINTESTINAL DISORDERS Nausea F™ F™ Nausea and vomiting symptoms F™Gastrointestinal signs and symptoms FÜÜGastrointestinal disorders FÜ›2021-05-15 B„2021-05-17 B† 1MedDRA v24.0NDWŹ A ..DW‘A@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŽD€pHsn5pDYD‹8Huh€8Vaccination 3 APY A02021-07-13T23:16:24Y 100913821009Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADWDčHrĂ:DWˇD‹8Hs‡L¸Placebo APlacebo ADWDčDW!DäüY . . .Placebo Placebo DW@DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWˇD€pD‹8DWżDX^BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBBpBqBňAŕHrĂ:HrŢć|Hsn5pHs‡L¸ .DWŤWHITE AC4591001C4591001 1009 10091382A`ADVERSE EVENT 6 rhinorrhea Rhinorrhoea F™-ŇRESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS Rhinorrhea F™/<F™/=Upper respiratory tract signs and symptoms F™KiRespiratory tract signs and symptoms F™Ë}Respiratory, thoracic and mediastinal disorders F™-Ň2021-05-15 B„2021-05-17 B† 1MedDRA v24.0NDWŹ A ..DW‘A@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŽD€pHsn5pDYD‹8Huh€8Vaccination 3 APY A02021-07-13T23:16:13Y 100913991009Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWD¨ŔHrČ@ŔDWđDçHsďĎPlacebo APlacebo ADWD¨ŔDW%DˇY . . .Placebo Placebo DWADWŮYPhase 3A@NNEGDWÚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŰDWđDŻPDçDXDXBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŮDWýBĘB#B$BîAŔHrČ@ŔHrăč„HsÓçĐHsďĎ .DWÚWHITE AC4591001C4591001 1009 10091399AADVERSE EVENT 1 Left Fifth Metatarsal Fracture Foot fracture FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Fractured metatarsal FÚFŘĘLimb fractures and dislocations F™ľîBone and joint injuries F¶Injury, poisoning and procedural complications Fěĺ2021-02-23 B/2021-05-15 B€ 2MedDRA v24.0NDW> B..DWŹBk..BRDAYSN NNOT RELATEDOTHER Injury NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DWD¨ŔHrČ@ŔDWŰDŻOHsÓçĎVaccination 2 A Y A 2021-07-09T20:10:07 AE outcome changed from EUA to sBLA 100914001009Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWD˝`HrČU`DWúDéčHsýčPlacebo APlacebo ADWD˝`DW3DŠŔY . . .Placebo Placebo DWODWâYPhase 3A@NNEGDWç BNT162b2 (30 (*ESC*){unicode 03BC}g) .DWú.Déč.DX4DXÎBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWćDWýB×A@BBîAŔHrČU`HröG@HsýčHsýč .DWâWHITE AC4591001C4591001 1009 10091400AADVERSE EVENT 1 Eczema generalized Eczema F™5ŃSKIN AND SUBCUTANEOUS TISSUE DISORDERS Eczema FÍčFÍčDermatitis and eczema FÇEpidermal and dermal conditions FŃSkin and subcutaneous tissue disorders F™5Ń2021-04-02 BU2021-04-04 BW 2MedDRA v24.0NDWd B2..DWfB4..A0DAYSN NNOT RELATEDOTHER Unknown NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DWD˝`HrČU`DWúDéçHsýçFollow Up 1 A0Y A 2021-04-23T19:21:58Y 100914001009Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWD˝`HrČU`DWúDéčHsýčPlacebo APlacebo ADWD˝`DW3DŠŔY . . .Placebo Placebo DWODWâYPhase 3A@NNEGDWç BNT162b2 (30 (*ESC*){unicode 03BC}g) .DWú.Déč.DX4DXÎBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWćDWýB×A@BBîAŔHrČU`HröG@HsýčHsýč .DWâWHITE AC4591001C4591001 1009 10091400A ADVERSE EVENT 2 Urticaria generalized Urticaria F™5ŃSKIN AND SUBCUTANEOUS TISSUE DISORDERS Urticaria generalised F™cŮF™MUrticarias F™MAngioedema and urticaria FźúSkin and subcutaneous tissue disorders F™5Ń2021-04-07 BZ2021-04-14 Ba 3MedDRA v24.0NDWi B7..DWpB>..A€DAYSN NNOT RELATEDOTHER Unknown NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A0GRADE 3A0 . APeriod 01DWD˝`HrČU`DWúDéçHsýçFollow Up 1 A0Y A 2021-04-23T19:22:09Y 100914011009Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDĐHrČhDWóDć(HsóÂ¨Placebo APlacebo ADWDĐDW%Dß Y . . .Placebo Placebo DWADW×YPhase 3A@NNEGDWŘ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŢDWóD¸8Dć(DXDX°BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW×DWýBČB B&BîAŔHrČhHrä& Hs×ĺ8HsóÂ¨ .DW×WHITE AC4591001C4591001 1009 10091401AADVERSE EVENT 1 motion sickness Motion sickness FÍ)EAR AND LABYRINTH DISORDERS Motion sickness F™ÖF™ÖInner ear signs and symptoms FíţInner ear and VIIIth cranial nerve disorders FíüEar and labyrinth disorders FÍ)2021-08-08 BŐ2021-08-08 BŐ 1MedDRA v24.0NDWä Ap..DWäAp..ADAYSN NNOT RELATEDOTHER unknown NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . A Period 02DWŢD¸8Hs×ĺ8DY`Dć(HuÔö(Vaccination 3 APY A02021-08-23T18:40:28Y 100914031009Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDÜŚHrČtŚDWVDĂ<Hs$¤<Placebo APlacebo ADWDÜŚDW#DY . . .Placebo Placebo DW<DW<YPhase 3A@NNEGDW= BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW?DWVDâ¤DĂ<DWuDXBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW<DWýB-BżBÁBîAđHrČtŚHrá'„Hsq$Hs$¤< .DW>WHITE AC4591001C4591001 1009 10091403AADVERSE EVENT 1 runny nose Rhinorrhoea F™-ŇRESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS Runny nose F™0F™/=Upper respiratory tract signs and symptoms F™KiRespiratory tract signs and symptoms F™Ë}Respiratory, thoracic and mediastinal disorders F™-Ň2021-01-10 A02021-01-13 A` 1MedDRA v24.0NDW A0..DWA`..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . APeriod 01DWDÜŚHrČtŚDW?DâŁHsq#Vaccination 1 AY A2021-02-02T00:45:55 100914051009Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWEHrČŕDWďDäHsîzŚPlacebo APlacebo ADWEDW%D‚ŚY . . .Placebo Placebo DWADW×YPhase 3A@NNEGDWŘ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŮDWďD¬DäDXDX¬BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW×DWýBČB%B&BîAđHrČŕHrăĘHsŃC,HsîzŚ .DW×WHITE AC4591001C4591001 1009 10091405AADVERSE EVENT 2 fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-08-20 Bá2021-08-21 Bâ 2MedDRA v24.0NDWđ A ..DWńA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWŮD¬HsŃC,DY\DäHuĎ®Vaccination 4 A`Y A@2021-08-23T21:20:58Y 100914051009Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWEHrČŕDWďDäHsîzŚPlacebo APlacebo ADWEDW%D‚ŚY . . .Placebo Placebo DWADW×YPhase 3A@NNEGDWŘ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŮDWďD¬DäDXDX¬BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW×DWýBČB%B&BîAđHrČŕHrăĘHsŃC,HsîzŚ .DW×WHITE AC4591001C4591001 1009 10091405A ADVERSE EVENT 3 headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-08-20 Bá2021-08-21 Bâ 1MedDRA v24.0NDWđ A ..DWńA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŮD¬HsŃC,DY\DäHuĎ®Vaccination 4 A`Y A@2021-08-23T21:21:10Y 100914051009Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWEHrČŕDWďDäHsîzŚPlacebo APlacebo ADWEDW%D‚ŚY . . .Placebo Placebo DWADW×YPhase 3A@NNEGDWŘ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŮDWďD¬DäDXDX¬BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW×DWýBČB%B&BîAđHrČŕHrăĘHsŃC,HsîzŚ .DW×WHITE AC4591001C4591001 1009 10091405A0ADVERSE EVENT 4 left axillary adenopathy Lymphadenopathy F«QBLOOD AND LYMPHATIC SYSTEM DISORDERS Axillary adenopathy FĄźFříLymphatic system disorders NEC FřîSpleen, lymphatic and reticuloendothelial system disorders F™9)Blood and lymphatic system disorders F«Q2021-08-20 Bá .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDWđ A ....... N NRELATED NOT APPLICABLE NNNOT RECOVERED/NOT RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŮD¬HsŃC,DY\DäHuĎ®Vaccination 4 A`Y A@2021-08-23T21:21:23Y 100914051009Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWEHrČŕDWďDäHsîzŚPlacebo APlacebo ADWEDW%D‚ŚY . . .Placebo Placebo DWADW×YPhase 3A@NNEGDWŘ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŮDWďD¬DäDXDX¬BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW×DWýBČB%B&BîAđHrČŕHrăĘHsŃC,HsîzŚ .DW×WHITE AC4591001C4591001 1009 10091405A@ADVERSE EVENT 1 fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-08-20 Bá2021-08-20 Bá 1MedDRA v24.0NDWđ A ..DWđA ..ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŮD¬HsŃC,DY\DäHuĎ®Vaccination 4 A`Y A@2021-08-23T21:20:46Y 100914061009Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWE€HrČhDWďDăĐHsîzPPlacebo APlacebo ADWE€DW%D‚PY . . .Placebo Placebo DWADW×YPhase 3A@NNEGDWŘ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŘDWďDądDăĐDXDX¬BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW×DWýBČB&B&BîAđHrČhHrăÉĐHsĎýdHsîzP .DW×WHITE AC4591001C4591001 1009 10091406AADVERSE EVENT 2 fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-08-20 Bá2021-08-21 Bâ 2MedDRA v24.0NDWđ A ..DWńA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWŘDądHsĎýdDY\DăĐHuĎĐVaccination 4 A`Y A@2021-08-23T21:20:22Y 100914061009Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWE€HrČhDWďDăĐHsîzPPlacebo APlacebo ADWE€DW%D‚PY . . .Placebo Placebo DWADW×YPhase 3A@NNEGDWŘ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŘDWďDądDăĐDXDX¬BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW×DWýBČB&B&BîAđHrČhHrăÉĐHsĎýdHsîzP .DW×WHITE AC4591001C4591001 1009 10091406A ADVERSE EVENT 3 headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-08-20 Bá2021-08-21 Bâ 1MedDRA v24.0NDWđ A ..DWńA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŘDądHsĎýdDY\DăĐHuĎĐVaccination 4 A`Y A@2021-08-24T15:12:40Y 100914061009Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWE€HrČhDWďDăĐHsîzPPlacebo APlacebo ADWE€DW%D‚PY . . .Placebo Placebo DWADW×YPhase 3A@NNEGDWŘ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŘDWďDądDăĐDXDX¬BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW×DWýBČB&B&BîAđHrČhHrăÉĐHsĎýdHsîzP .DW×WHITE AC4591001C4591001 1009 10091406A0ADVERSE EVENT 1 Swilling in bilateral knees Joint swelling F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Swelling of knees F™=IFń@Joint related signs and symptoms Fń:Joint disorders Fń-Musculoskeletal and connective tissue disorders F™k2021-01-25 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 01DWE€HrČhDWŘDącHsĎýcVaccination 1 AY A2021-07-09T20:45:30 AE outcome changed from EUA to sBLA 100914061009Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWE€HrČhDWďDăĐHsîzPPlacebo APlacebo ADWE€DW%D‚PY . . .Placebo Placebo DWADW×YPhase 3A@NNEGDWŘ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŘDWďDądDăĐDXDX¬BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW×DWýBČB&B&BîAđHrČhHrăÉĐHsĎýdHsîzP .DW×WHITE AC4591001C4591001 1009 10091406A@ADVERSE EVENT 4 fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-08-20 Bá2021-08-21 Bâ 1MedDRA v24.0NDWđ A ..DWńA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŘDądHsĎýdDY\DăĐHuĎĐVaccination 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_30AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWD÷€HrĚ„DW)DőÜHré\BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWD÷€DW)DőÜY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWHDWâYPhase 3A@NNEGDWç ....... . .NY.DWćDWýBÔBBëAŕHrĚ„Hré\.. .DWâWHITE AC4591001C4591001 1009 10091409AADVERSE EVENT 1 Post Surgical Pain Procedural pain FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Postoperative pain F™l7F™“ňNon-site specific procedural complications F™ ÷Procedural related injuries and complications NEC F™§€Injury, poisoning and procedural complications Fěĺ2021-07-22 BÁ .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDWÓ B«....... N NNOT RELATEDOTHER Developmental-Spinal Fusion Surgery NOT APPLICABLE YNNOT RECOVERED/NOT RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DWD÷€HrĚ„DX–DőÜHtĘ¶ÜFollow 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_30AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWD‰ĐHrÍgĐDW(DęŘHrč&ŘBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWD‰ĐDW(DęŘY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWDDWŚYPhase 3A@NNEGDWŤ ....... . .NY.DWŚDWýByBqBęAŔHrÍgĐHrč&Ř.. .DW×WHITE AC4591001C4591001 1009 10091410AADVERSE EVENT 1 FATIGUE Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-02-01T20:00B2021-02-03 B 2MedDRA v24.0NDW( AE”HrčU@DW*A0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A BĆ APeriod 01DWD‰ĐHrÍgĐDX•DęŘHtÉZXVaccination 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_30AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWD‰ĐHrÍgĐDW(DęŘHrč&ŘBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWD‰ĐDW(DęŘY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWDDWŚYPhase 3A@NNEGDWŤ ....... . .NY.DWŚDWýByBqBęAŔHrÍgĐHrč&Ř.. .DW×WHITE AC4591001C4591001 1009 10091410A ADVERSE EVENT 2 INJECTION SITE PAIN Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-02-01T20:00B2021-02-03 B 2MedDRA v24.0NDW( AE”HrčU@DW*A0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A BĆ APeriod 01DWD‰ĐHrÍgĐDX•DęŘHtÉZXVaccination 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_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDŢ¨HrÍĽ¨DW*Dĺ°HręÄ°BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWDŢ¨DW*Dĺ°Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWHDWYPhase 3A@NNEGDW‘ ....... . .NY.DWDWýB}BmBęAĐHrÍĽ¨HręÄ°.. .DWĺWHITE AC4591001C4591001 1009 10091413A ADVERSE EVENT 3 bilateral rib pain Musculoskeletal chest pain F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Rib pain F™TŇF™]Musculoskeletal and connective tissue pain and discomfort F™ŁMusculoskeletal and connective tissue disorders NEC F™iMusculoskeletal and connective tissue disorders F™k2021-02-05T05:00B2021-02-05T06:30B 2MedDRA v24.0NDW, A0DFPHrěČPDW,A0D[ŁHrěÝŁADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C‰€ APeriod 01DWDŢ¨HrÍĽ¨DX—Dĺ°HtËř0Vaccination 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_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDŢ¨HrÍĽ¨DW*Dĺ°HręÄ°BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWDŢ¨DW*Dĺ°Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWHDWYPhase 3A@NNEGDW‘ ....... . .NY.DWDWýB}BmBęAĐHrÍĽ¨HręÄ°.. .DWĺWHITE AC4591001C4591001 1009 10091413A0ADVERSE EVENT 2 Post Surgical Right Leg Pain Procedural pain FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Postoperative pain F™l7F™“ňNon-site specific procedural complications F™ ÷Procedural related injuries and complications NEC F™§€Injury, poisoning and procedural complications Fěĺ2021-03-16 B@2021-03-30 BN 2MedDRA v24.0NDWS B*..DWaB8..AđDAYSN NNOT RELATEDOTHER Post Surgical pain NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DWDŢ¨HrÍĽ¨DX—Dĺ°HtËř0Follow 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_30AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsABLACK OR AFRICAN AMERICAN A FA NOT HISPANIC OR LATINOA USABLACK OR AFRICAN AMERICAN A DVęD¸°Hr–7°DV˙DĐHr±˙BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVęD¸°DV˙DĐY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWDW’YPhase 3A@NNEGDW“ ....... . .NY.DW’DWýB©BkC@AŕHr–7°Hr±˙.. .DWµBLACK OR AFRICAN AMERICANA C4591001C4591001 1013 10131824AADVERSE EVENT 1 SWELLING LEFT ARM Peripheral swelling FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Swelling arm F™=8F™UżGeneral signs and symptoms NEC FÝGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2020-12-05 AP2020-12-06 A` 1MedDRA v24.0NDVî AP..DVďA`..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . APeriod 01DVęD¸°Hr–7°DXlDĐHt“2Vaccination 1 AY A2020-12-22T23:55:37 101318391013Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVëDşTHr—ŠÔDWDĐ HrłP Placebo APlacebo ADVëDşTDWDĐ Y . . .Placebo Placebo DWDW˝YPhase 3A@NNEGDWľ ....... . .NN.DW˝DWýBÓB@C0AŕHr—ŠÔHrłP .. .DWËWHITE AC4591001C4591001 1013 10131839AADVERSE EVENT 1 SPORTS RELATED CONCUSSION Concussion FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Concussion FľŽFľŽCerebral injuries NEC F™dInjuries NEC FěâInjury, poisoning and procedural complications Fěĺ2021-03-01 BZ .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDWD BE....... N NNOT RELATEDOTHER INJURY NOT APPLICABLE NNRECOVERING/RESOLVING N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVëDşTHr—ŠÔDXmDĐ Ht” Follow Up 1 A0Y A 2021-03-31T18:21:42 Minor AE term changed from EUA to sBLA 101613161016Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVĽDŐHHrYŻHDWSDĚśHs ąPlacebo APlacebo ADVĽDŐH..Y . . .Placebo DV÷DW=YPhase 3A@NNEGDW> BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW@DWSDĎlDĚśDWoDXBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW=DWýB‚BľBŔC AđHrYŻHHrYŻHHsŻlHs ą .DW?WHITE AC4591001C4591001 1016 10161316AADVERSE EVENT 2 chills Chills FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills F·ÓF·ÓFeelings and sensations NEC F™ŁGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-02-26 B†2021-02-26 B† 2MedDRA v24.0NDWA A ..DWAA ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DW@DĎlHsŻlDXŔDĚśHuěśVaccination 3 APY A02021-03-02T22:52:38 101613161016Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVĽDŐHHrYŻHDWSDĚśHs ąPlacebo APlacebo ADVĽDŐH..Y . . .Placebo DV÷DW=YPhase 3A@NNEGDW> BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW@DWSDĎlDĚśDWoDXBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW=DWýB‚BľBŔC AđHrYŻHHrYŻHHsŻlHs ą .DW?WHITE AC4591001C4591001 1016 10161316A ADVERSE EVENT 1 muscle pain Myalgia F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Muscle pain F™"F™{Muscle pains F™#Muscle disorders F™Musculoskeletal and connective tissue disorders F™k2021-02-26 B†2021-02-26 B† 2MedDRA v24.0NDWA A ..DWAA ..ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DW@DĎlHsŻlDXŔDĚśHuěśVaccination 3 APY A02021-03-02T22:52:29 101613271016Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVŔD‰XHr^©XDWµD¸HsˇŁ8Placebo APlacebo ADVŔD‰XDVŐD—¤Y . . .Placebo Placebo DVńDW‡YPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW DWµDÖtD¸DWŃDXrBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBÍB^BqCŕAŔHr^©XHrzg$Hs†FtHsˇŁ8 .DW‡WHITE AC4591001C4591001 1016 10161327A ADVERSE EVENT 2 syncope Syncope F™•NERVOUS SYSTEM DISORDERS Syncope F™=”F™=”Disturbances in consciousness NEC FËENeurological disorders NEC F™ůNervous system disorders F™•2021-04-09 B¬2021-04-09 B¬ 2MedDRA v24.0NDWk B—..DWkB—..ADAYSN NNOT RELATEDOTHER unknown-possible dehydration NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVŔD‰XHr^©XDW DÖsHs†FsFollow Up 1 A0Y A 2021-08-26T21:00:15Y 101613291016Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVŔDŠüHr^ŞüDW¨Dß\HsŰ\Placebo APlacebo ADVŔDŠüDVŐDć Y . . .Placebo Placebo DV÷DW‡YPhase 3A@NNEGDW‘ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DW¨DÔ”Dß\DWÄDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWDWýBŃBkBmCŕAŕHr^ŞüHrz¶ Hsu!HsŰ\ .DW‡WHITE AC4591001C4591001 1016 10161329AADVERSE EVENT 2 cellulitis of left foot Cellulitis FëůINFECTIONS AND INFESTATIONS Cellulitis of foot FµgFµJBacterial infections NEC F¦OBacterial infectious disorders F¦2Infections and infestations Fëů2021-07-06 C@2021-07-16 Cŕ 1MedDRA v24.0NDWĂ B..DWÍB&..A°DAYSN NNOT RELATEDOTHER bacterial infection secondary to puncture wound NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . A Period 02DW“DÔ”Hsu!DYDß\HurÜVaccination 4 A`Y A@2021-09-13T16:25:27Y 101613291016Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVŔDŠüHr^ŞüDW¨Dß\HsŰ\Placebo APlacebo ADVŔDŠüDVŐDć Y . . .Placebo Placebo DV÷DW‡YPhase 3A@NNEGDW‘ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DW¨DÔ”Dß\DWÄDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWDWýBŃBkBmCŕAŕHr^ŞüHrz¶ Hsu!HsŰ\ .DW‡WHITE AC4591001C4591001 1016 10161329A ADVERSE EVENT 1 left foot puncture would Wound FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Puncture wound F™UF™cLNon-site specific injuries NEC F™ ÇInjuries NEC FěâInjury, poisoning and procedural complications Fěĺ2021-07-04 C 2021-07-24 C` 1MedDRA v24.0NDWÁ B..DWŐB...BDAYSN NNOT RELATEDOTHER accidental trauma NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . A Period 02DW“DÔ”Hsu!DYDß\HurÜVaccination 4 A`Y A@2021-09-13T16:24:40Y 101613441016Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVÂDëPHra®PDW¦Dĺ°HsŽ>°Placebo APlacebo ADVÂDëPDVÖDŰśY . . .Placebo Placebo DVóDW†YPhase 3A@NNEGDW‘ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DW¦D‹°Dĺ°DWÂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWDWýBĎBkBmCŔAđHra®PHr{üśHstŘ0HsŽ>° .DW†WHITE AC4591001C4591001 1016 10161344AADVERSE EVENT 2 infectious mononuclesosis Infectious mononucleosis FëůINFECTIONS AND INFESTATIONS Infectious mononucleosis FěFěEpstein-Barr viral infections FŃViral infectious disorders F™OÎInfections and infestations Fëů2020-11-25 B#2021-01-06 BM 1MedDRA v24.0NDVä Ađ..DWB9..B+DAYSN NNOT RELATEDOTHER mono infection NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVÂDëPHra®PDW“D‹ŻHstŘ/Vaccination 2 A Y A 2021-03-05T20:11:26 101613441016Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVÂDëPHra®PDW¦Dĺ°HsŽ>°Placebo APlacebo ADVÂDëPDVÖDŰśY . . .Placebo Placebo DVóDW†YPhase 3A@NNEGDW‘ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DW¦D‹°Dĺ°DWÂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWDWýBĎBkBmCŔAđHra®PHr{üśHstŘ0HsŽ>° .DW†WHITE AC4591001C4591001 1016 10161344A ADVERSE EVENT 1 enlarged lymph nodes, right anterior cervical nodes Lymphadenopathy F«QBLOOD AND LYMPHATIC SYSTEM DISORDERS Lymph nodes cervical swollen FřáFříLymphatic system disorders NEC FřîSpleen, lymphatic and reticuloendothelial system disorders F™9)Blood and lymphatic system disorders F«Q2020-11-25 B#2021-01-06 BM 1MedDRA v24.0NDVä Ađ..DWB9..B+DAYSN NNOT RELATEDOTHER mono NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVÂDëPHra®PDW“D‹ŻHstŘ/Vaccination 2 A Y A 2021-03-05T20:10:44 101613531016Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVéDčĽHr•<DWD—,Hs—*¬Placebo APlacebo ADVéDčĽDWD” Y . . .Placebo Placebo DWDWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDčD—,DWÉDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýBĄBfBpCPAĐHr•<Hrł Hs{ĚHs—*¬ .DW—WHITE AC4591001C4591001 1016 10161353A ADVERSE EVENT 4 chills Chills FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills F·ÓF·ÓFeelings and sensations NEC F™ŁGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-14 BĹ2021-06-15 BĆ 2MedDRA v24.0NDW A..DW®A ..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWDčHs{ĚDYD—,Hux^,Vaccination 4 A`Y A@2021-06-16T19:34:06Y 101613531016Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVéDčĽHr•<DWD—,Hs—*¬Placebo APlacebo ADVéDčĽDWD” Y . . .Placebo Placebo DWDWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDčD—,DWÉDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýBĄBfBpCPAĐHr•<Hrł Hs{ĚHs—*¬ .DW—WHITE AC4591001C4591001 1016 10161353AADVERSE EVENT 3 chills Chills FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills F·ÓF·ÓFeelings and sensations NEC F™ŁGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-25T08:00B±2021-05-26T08:00B˛ 2MedDRA v24.0NDW™ A Dp€Hs|¦DWšA0Dp»Hs}÷»A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C: A Period 02DWDčHs{ĚDYD—,Hux^,Vaccination 3 APY A02021-05-26T23:42:42Y 101613531016Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVéDčĽHr•<DWD—,Hs—*¬Placebo APlacebo ADVéDčĽDWD” Y . . .Placebo Placebo DWDWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDčD—,DWÉDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýBĄBfBpCPAĐHr•<Hrł Hs{ĚHs—*¬ .DW—WHITE AC4591001C4591001 1016 10161353A0ADVERSE EVENT 2 fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-25T08:00B±2021-05-26T08:00B˛ 2MedDRA v24.0NDW™ A Dp€Hs|¦DWšA0Dp»Hs}÷»A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C: A Period 02DWDčHs{ĚDYD—,Hux^,Vaccination 3 APY A02021-05-26T23:42:32Y 101613531016Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVéDčĽHr•<DWD—,Hs—*¬Placebo APlacebo ADVéDčĽDWD” Y . . .Placebo Placebo DWDWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDčD—,DWÉDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýBĄBfBpCPAĐHr•<Hrł Hs{ĚHs—*¬ .DW—WHITE AC4591001C4591001 1016 10161353A@ADVERSE EVENT 7 headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-06-14 BĹ2021-06-15 BĆ 1MedDRA v24.0NDW A..DW®A ..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDčHs{ĚDYD—,Hux^,Vaccination 4 A`Y A@2021-06-16T19:34:41Y 101613531016Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVéDčĽHr•<DWD—,Hs—*¬Placebo APlacebo ADVéDčĽDWD” Y . . .Placebo Placebo DWDWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDčD—,DWÉDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýBĄBfBpCPAĐHr•<Hrł Hs{ĚHs—*¬ .DW—WHITE AC4591001C4591001 1016 10161353APADVERSE EVENT 8 injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-14 BĹ2021-06-17 BČ 1MedDRA v24.0NDW A..DW°A@..A@DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDčHs{ĚDYD—,Hux^,Vaccination 4 A`Y A@2021-07-12T13:32:56Y 101613531016Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVéDčĽHr•<DWD—,Hs—*¬Placebo APlacebo ADVéDčĽDWD” Y . . .Placebo Placebo DWDWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDčD—,DWÉDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýBĄBfBpCPAĐHr•<Hrł Hs{ĚHs—*¬ .DW—WHITE AC4591001C4591001 1016 10161353A`ADVERSE EVENT 1 left deltoid injection site soreness Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-25T08:00B±2021-05-26T08:00B˛ 1MedDRA v24.0NDW™ A Dp€Hs|¦DWšA0Dp»Hs}÷»A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C: A Period 02DWDčHs{ĚDYD—,Hux^,Vaccination 3 APY A02021-05-26T23:42:22Y 101613531016Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVéDčĽHr•<DWD—,Hs—*¬Placebo APlacebo ADVéDčĽDWD” Y . . .Placebo Placebo DWDWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDčD—,DWÉDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýBĄBfBpCPAĐHr•<Hrł Hs{ĚHs—*¬ .DW—WHITE AC4591001C4591001 1016 10161353ApADVERSE EVENT 6 body aches Pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalized aching F™Š\F™ŰPain and discomfort NEC F™ÜGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-14 BĹ2021-06-15 BĆ 1MedDRA v24.0NDW A..DW®A ..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDčHs{ĚDYD—,Hux^,Vaccination 4 A`Y A@2021-06-16T19:34:29Y 101613531016Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVéDčĽHr•<DWD—,Hs—*¬Placebo APlacebo ADVéDčĽDWD” Y . . .Placebo Placebo DWDWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDčD—,DWÉDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýBĄBfBpCPAĐHr•<Hrł Hs{ĚHs—*¬ .DW—WHITE AC4591001C4591001 1016 10161353A€ADVERSE EVENT 5 fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-06-14 BĹ2021-06-15 BĆ 1MedDRA v24.0NDW A..DW®A ..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDčHs{ĚDYD—,Hux^,Vaccination 4 A`Y A@2021-06-16T19:34:17Y 101613661016Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVřDŰŘHr¨ĎŘDWÄDŮ€Hsµż€Placebo APlacebo ADVřDŰŘDWDëPY . . .Placebo Placebo DW8DWYPhase 3A@NNEGDW‘ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DWÄDçDŮ€DWćDXBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWDWýB™BkBmC`AŔHr¨ĎŘHrÇ1ĐHsu3Hsµż€ .DW’WHITE AC4591001C4591001 1016 10161366AADVERSE EVENT 1 vomiting Vomiting FÜ›GASTROINTESTINAL DISORDERS Vomiting F™PÔF™PÔNausea and vomiting symptoms F™Gastrointestinal signs and symptoms FÜÜGastrointestinal disorders FÜ›2021-07-08 BÎ2021-07-09 BĎ 1MedDRA v24.0NDWĹ A ..DWĆA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW“DçHsu3DY1DŮ€Hu–óVaccination 4 A`Y A@2021-08-11T19:08:19Y 101613711016Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDÚčHrĂ,čDWDć(Hs—y¨Placebo APlacebo ADWDÚčDW"DÝôY . . .Placebo Placebo DW>DWYPhase 3A@NNEGDW‘ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW™DWDÜŚDć(DWÉDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWDWýB…BeBmBňAŔHrĂ,čHrŕ0ôHs}Hs—y¨ .DWWHITE AC4591001C4591001 1016 10161371AADVERSE EVENT 2 fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-15 BŁ2021-06-17 BĄ 1MedDRA v24.0NDW® A ..DW°A@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW™DÜŚHs}DYDć(Hux(Vaccination 4 A`Y A@2021-07-12T13:52:34Y 101613711016Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDÚčHrĂ,čDWDć(Hs—y¨Placebo APlacebo ADWDÚčDW"DÝôY . . .Placebo Placebo DW>DWYPhase 3A@NNEGDW‘ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW™DWDÜŚDć(DWÉDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWDWýB…BeBmBňAŔHrĂ,čHrŕ0ôHs}Hs—y¨ .DWWHITE AC4591001C4591001 1016 10161371A ADVERSE EVENT 1 fever, low grade Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Slight fever F™6˝F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-06-15 BŁ2021-06-15 BŁ 1MedDRA v24.0NDW® A ..DW®A ..ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW™DÜŚHs}DYDć(Hux(Vaccination 4 A`Y A@2021-06-16T16:15:56Y 103912461039Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVęD~THr•ýTDWUDš°Hs#*0Placebo APlacebo ADVęD~TDVţD‚Y . . .Placebo Placebo DWDW=YPhase 3A@NNEGDW> BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWADWUDm°Dš°DWqDXBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW=DWýBTB˝BŔC@AđHr•ýTHr°_Hsź0Hs#*0 .DW@WHITE AC4591001C4591001 1039 10391246AADVERSE EVENT 1 fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-02-27 BY2021-03-01 B[ 2MedDRA v24.0NDWB A ..DWDA@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWADm°Hsź0DXÂDš°Hu]°Vaccination 3 APY A02021-03-02T18:33:55 103912461039Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVęD~THr•ýTDWUDš°Hs#*0Placebo APlacebo ADVęD~TDVţD‚Y . . .Placebo Placebo DWDW=YPhase 3A@NNEGDW> BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWADWUDm°Dš°DWqDXBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW=DWýBTB˝BŔC@AđHr•ýTHr°_Hsź0Hs#*0 .DW@WHITE AC4591001C4591001 1039 10391246A ADVERSE EVENT 6 fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-03-19 Bm2021-03-20 Bn 1MedDRA v24.0NDWV A ..DWWA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWADm°Hsź0DXÂDš°Hu]°Vaccination 4 A`Y A@2021-04-15T21:52:16Y 103912461039Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVęD~THr•ýTDWUDš°Hs#*0Placebo APlacebo ADVęD~TDVţD‚Y . . .Placebo Placebo DWDW=YPhase 3A@NNEGDW> BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWADWUDm°Dš°DWqDXBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW=DWýBTB˝BŔC@AđHr•ýTHr°_Hsź0Hs#*0 .DW@WHITE AC4591001C4591001 1039 10391246A0ADVERSE EVENT 4 headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-02-27 BY2021-03-01 B[ 1MedDRA v24.0NDWB A ..DWDA@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWADm°Hsź0DXÂDš°Hu]°Vaccination 3 APY A02021-03-02T18:34:19 103912461039Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVęD~THr•ýTDWUDš°Hs#*0Placebo APlacebo ADVęD~TDVţD‚Y . . .Placebo Placebo DWDW=YPhase 3A@NNEGDW> BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWADWUDm°Dš°DWqDXBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW=DWýBTB˝BŔC@AđHr•ýTHr°_Hsź0Hs#*0 .DW@WHITE AC4591001C4591001 1039 10391246A@ADVERSE EVENT 2 generalized achiness Pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalised aching FÝF™ŰPain and discomfort NEC F™ÜGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-02-27 BY2021-03-02 B\ 2MedDRA v24.0NDWB A ..DWEAP..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWADm°Hsź0DXÂDš°Hu]°Vaccination 3 APY A02021-03-02T18:34:03 103912461039Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVęD~THr•ýTDWUDš°Hs#*0Placebo APlacebo ADVęD~TDVţD‚Y . . .Placebo Placebo DWDW=YPhase 3A@NNEGDW> BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWADWUDm°Dš°DWqDXBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW=DWýBTB˝BŔC@AđHr•ýTHr°_Hsź0Hs#*0 .DW@WHITE AC4591001C4591001 1039 10391246APADVERSE EVENT 3 fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-02-27 BY2021-02-28 BZ 1MedDRA v24.0NDWB A ..DWCA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWADm°Hsź0DXÂDš°Hu]°Vaccination 3 APY A02021-03-02T18:34:11 103912461039Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVęD~THr•ýTDWUDš°Hs#*0Placebo APlacebo ADVęD~TDVţD‚Y . . .Placebo Placebo DWDW=YPhase 3A@NNEGDW> BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWADWUDm°Dš°DWqDXBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW=DWýBTB˝BŔC@AđHr•ýTHr°_Hsź0Hs#*0 .DW@WHITE AC4591001C4591001 1039 10391246A`ADVERSE EVENT 5 fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-03-19 Bm2021-03-20 Bn 1MedDRA v24.0NDWV A ..DWWA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWADm°Hsź0DXÂDš°Hu]°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_30AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVíD†Hr™úDWDwHrąŽBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVíD†DWDwY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW#DW‹YPhase 3A@NNEGDWŚ ....... . .NY.DW‹DWýBźBrCAŕHr™úHrąŽ.. .DWĂWHITE AC4591001C4591001 1039 10391250AADVERSE EVENT 1 exacerbation of tic disorder Tic F™'·PSYCHIATRIC DISORDERS Tic disorder, unspecified F™AşF™AąTic disorders F™A»Changes in physical activity F·QPsychiatric disorders F™'·2021-01-09 B% .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDW AĐ....... N NNOT RELATEDOTHER stress in life NOT APPLICABLE NNRECOVERING/RESOLVING N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVíD†Hr™úDXrDwHtšÂVaccination 2 A Y A 2021-01-19T20:43:24 103912511039Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DVđDsHrťŰDW@DlŔHsLŔPlacebo APlacebo ADVđDsDWDqčY . . .Placebo Placebo DW(DW(YPhase 3A@NNEGDW) BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW)DW@DwDlŔDW\DWđBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW(DWýB9BŐBŐCŕAđHrťŰHrÂĂčHréHsLŔ .DW(ALL OTHERS A0C4591001C4591001 1039 10391251AADVERSE EVENT 2 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-02-25T20:00BQ2021-02-27 BS 1MedDRA v24.0NDW@ AE”Hsů@DWBA0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C. A Period 02DW)DwHréDXDlŔHtč€@Vaccination 4 A`Y A@2021-03-29T17:41:15Y 103912511039Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DVđDsHrťŰDW@DlŔHsLŔPlacebo APlacebo ADVđDsDWDqčY . . .Placebo Placebo DW(DW(YPhase 3A@NNEGDW) BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW)DW@DwDlŔDW\DWđBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW(DWýB9BŐBŐCŕAđHrťŰHrÂĂčHréHsLŔ .DW(ALL OTHERS A0C4591001C4591001 1039 10391251A ADVERSE EVENT 1 Headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-02-25T20:00BQ2021-02-27 BS 1MedDRA v24.0NDW@ AE”Hsů@DWBA0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C. A Period 02DW)DwHréDXDlŔHtč€@Vaccination 4 A`Y A@2021-03-29T17:41:05Y 103912581039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVđD˛ Hrž DW D©8Hs†8Placebo APlacebo ADVđD˛ DWD±¨Y . . .Placebo Placebo DW$DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW Dµ¤D©8DWĂDX]BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBśBqBrCŕAĐHrž HrąÉ(Hsm$Hs†8 .DWŚWHITE AC4591001C4591001 1039 10391258AADVERSE EVENT 5 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-02 B˛2021-06-03 Bł 1MedDRA v24.0NDWˇ A ..DW˘A0..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŤDµ¤Hsm$DY D©8HugL¸Vaccination 4 A`Y A@2021-07-06T21:28:46Y 103912581039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVđD˛ Hrž DW D©8Hs†8Placebo APlacebo ADVđD˛ DWD±¨Y . . .Placebo Placebo DW$DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW Dµ¤D©8DWĂDX]BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBśBqBrCŕAĐHrž HrąÉ(Hsm$Hs†8 .DWŚWHITE AC4591001C4591001 1039 10391258A ADVERSE EVENT 4 Headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-06-01T16:00B±2021-06-02T16:00B˛ 1MedDRA v24.0NDW ADáHs†QDWˇA Dá;Hs‡˘»A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Bî A Period 02DWŤDµ¤Hsm$DY D©8HugL¸Vaccination 4 A`Y A@2021-07-06T21:28:35Y 103912581039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVđD˛ Hrž DW D©8Hs†8Placebo APlacebo ADVđD˛ DWD±¨Y . . .Placebo Placebo DW$DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW Dµ¤D©8DWĂDX]BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBśBqBrCŕAĐHrž HrąÉ(Hsm$Hs†8 .DWŚWHITE AC4591001C4591001 1039 10391258A0ADVERSE EVENT 3 Fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-06-01T16:00B±2021-06-02T16:00B˛ 1MedDRA v24.0NDW ADáHs†QDWˇA Dá;Hs‡˘»A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Bî A Period 02DWŤDµ¤Hsm$DY D©8HugL¸Vaccination 4 A`Y A@2021-07-06T21:28:24Y 103912591039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVđDżôHrž'ôDWŁDądHsŠäPlacebo APlacebo ADVđDżôDWD¤Y . . .Placebo Placebo DW!DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁDĂ<DądDWżDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBśBpBrCŕAĐHrž'ôHrąĽHsnx<HsŠä .DWŤWHITE AC4591001C4591001 1039 10391259A ADVERSE EVENT 6 fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-06 B¶2021-06-06 B¶ 1MedDRA v24.0NDWĄ A0..DWĄA0..ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŽDĂ<Hsnx<DYDądHukQdVaccination 4 A`Y A@2021-07-02T21:10:13Y 103912591039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVđDżôHrž'ôDWŁDądHsŠäPlacebo APlacebo ADVđDżôDWD¤Y . . .Placebo Placebo DW!DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁDĂ<DądDWżDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBśBpBrCŕAĐHrž'ôHrąĽHsnx<HsŠä .DWŤWHITE AC4591001C4591001 1039 10391259AADVERSE EVENT 1 fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-15T10:00B 2021-05-15 B 1MedDRA v24.0NDWŹ A DŚ Hso“ DWŹA ..ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CKp A Period 02DWŽDĂ<Hsnx<DYDądHukQdVaccination 3 APY A02021-06-04T21:31:25Y 103912591039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVđDżôHrž'ôDWŁDądHsŠäPlacebo APlacebo ADVđDżôDWD¤Y . . .Placebo Placebo DW!DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁDĂ<DądDWżDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBśBpBrCŕAĐHrž'ôHrąĽHsnx<HsŠä .DWŤWHITE AC4591001C4591001 1039 10391259A0ADVERSE EVENT 5 headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-06-06 B¶2021-06-06 B¶ 1MedDRA v24.0NDWĄ A0..DWĄA0..ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŽDĂ<Hsnx<DYDądHukQdVaccination 4 A`Y A@2021-07-02T21:10:02Y 103912591039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVđDżôHrž'ôDWŁDądHsŠäPlacebo APlacebo ADVđDżôDWD¤Y . . .Placebo Placebo DW!DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁDĂ<DądDWżDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBśBpBrCŕAĐHrž'ôHrąĽHsnx<HsŠä .DWŤWHITE AC4591001C4591001 1039 10391259A@ADVERSE EVENT 2 injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-14T20:00Bź2021-05-21 B¦ 1MedDRA v24.0NDWŽ AE”HsnÎ@DW•A€..A€DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Cđ A Period 02DWŽDĂ<Hsnx<DYDądHukQdVaccination 3 APY A02021-06-04T21:31:36Y 103912591039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVđDżôHrž'ôDWŁDądHsŠäPlacebo APlacebo ADVđDżôDWD¤Y . . .Placebo Placebo DW!DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁDĂ<DądDWżDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBśBpBrCŕAĐHrž'ôHrąĽHsnx<HsŠä .DWŤWHITE AC4591001C4591001 1039 10391259APADVERSE EVENT 3 injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-04T13:11B´2021-06-05 Bµ 1MedDRA v24.0NDWŁ ADądHsŠäDW¤A ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A YA Period 02DWŽDĂ<Hsnx<DYDądHukQdVaccination 4 A`Y A@2021-06-16T19:45:19Y 103912591039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVđDżôHrž'ôDWŁDądHsŠäPlacebo APlacebo ADVđDżôDWD¤Y . . .Placebo Placebo DW!DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁDĂ<DądDWżDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBśBpBrCŕAĐHrž'ôHrąĽHsnx<HsŠä .DWŤWHITE AC4591001C4591001 1039 10391259A`ADVERSE EVENT 4 fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-06-05 Bµ2021-06-07 B· 1MedDRA v24.0NDW¤ A ..DW¦A@..A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŽDĂ<Hsnx<DYDądHukQdVaccination 4 A`Y A@2021-07-02T21:09:50Y 103912641039Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA HISPANIC OR LATINO AUSAASIAN A@DVńD§”HrźaDWDÄhHs{¨hPlacebo APlacebo ADVńD§”DWDˇY . . .Placebo Placebo DWDDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW.DÄh.DWŇDXlBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NNDW§DWŚDW§BśBBB·AŔHrźaHr» Hs{¨hHs{¨h .DW—ALL OTHERS A0C4591001C4591001 1039 10391264AADVERSE EVENT 1 General muscle aches Myalgia F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Muscle ache F™˙F™{Muscle pains F™#Muscle disorders F™Musculoskeletal and connective tissue disorders F™k2021-05-25T19:00B©2021-05-27 B« 1MedDRA v24.0NDW™ A EłHs}@°DW›A@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Clŕ A Period 02DWDÄhHs{¨hDYDÄhHu\ŰčVaccination 3 APY A02021-06-09T19:39:48Y 103912661039Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVńDşHrźtDW˘DĹĐHsŘĐPlacebo APlacebo ADVńDşDWDXY . . .Placebo Placebo DW"DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDW˘DÇ°DĹĐDWĹDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB›BpBrCĐAŔHrźtHr»XHsn|°HsŘĐ .DWŤWHITE AC4591001C4591001 1039 10391266AADVERSE EVENT 3 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-04T22:00Bł2021-06-05 B´ 1MedDRA v24.0NDWŁ A EVHsŠ™ŕDW¤A0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CwŔ A Period 02DWŽDÇ°Hsn|°DYDĹĐHujPVaccination 4 A`Y A@2021-07-08T22:44:14Y 103912661039Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVńDşHrźtDW˘DĹĐHsŘĐPlacebo APlacebo ADVńDşDWDXY . . .Placebo Placebo DW"DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDW˘DÇ°DĹĐDWĹDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB›BpBrCĐAŔHrźtHr»XHsn|°HsŘĐ .DWŤWHITE AC4591001C4591001 1039 10391266A ADVERSE EVENT 4 Left arm muscle ache Myalgia F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Myalgia upper extremities F™ĚăF™{Muscle pains F™#Muscle disorders F™Musculoskeletal and connective tissue disorders F™k2021-06-04T22:00Bł2021-06-05 B´ 1MedDRA v24.0NDWŁ A EVHsŠ™ŕDW¤A0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CwŔ A Period 02DWŽDÇ°Hsn|°DYDĹĐHujPVaccination 4 A`Y A@2021-07-09T07:04:44Y 103912661039Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVńDşHrźtDW˘DĹĐHsŘĐPlacebo APlacebo ADVńDşDWDXY . . .Placebo Placebo DW"DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDW˘DÇ°DĹĐDWĹDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB›BpBrCĐAŔHrźtHr»XHsn|°HsŘĐ .DWŤWHITE AC4591001C4591001 1039 10391266A0ADVERSE EVENT 2 Body ache Pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Ache F(F™ŰPain and discomfort NEC F™ÜGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-04 Bł2021-06-05 B´ 1MedDRA v24.0NDWŁ A ..DW¤A0..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŽDÇ°Hsn|°DYDĹĐHujPVaccination 4 A`Y A@2021-06-09T16:50:23Y 103912661039Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVńDşHrźtDW˘DĹĐHsŘĐPlacebo APlacebo ADVńDşDWDXY . . .Placebo Placebo DW"DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDW˘DÇ°DĹĐDWĹDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB›BpBrCĐAŔHrźtHr»XHsn|°HsŘĐ .DWŤWHITE AC4591001C4591001 1039 10391266A@ADVERSE EVENT 1 Fever - max 100F Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-06-04 Bł2021-06-05 B´ 1MedDRA v24.0NDWŁ A ..DW¤A0..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŽDÇ°Hsn|°DYDĹĐHujPVaccination 4 A`Y A@2021-06-09T19:39:59Y 103912681039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVńD˝ŘHrźwXDWŁD¸ěHsŠlPlacebo APlacebo ADVńD˝ŘDWDpY . . .Placebo Placebo DW!DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDWŁDŽřD¸ěDWżDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB›BqBrCĐAĐHrźwXHrą‡HslňxHsŠl .DWŚWHITE AC4591001C4591001 1039 10391268AADVERSE EVENT 1 Fever - up to 102.5 Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-05-14T00:00Bž2021-05-15T10:00Bź 3MedDRA v24.0NDWŽ A HsmµDWŹA0DŚŰHso“[A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA0GRADE 3A0 C3ŕ A Period 02DWŤDŽřHslňxDYD¸ěHukPěVaccination 3 APY A02021-06-16T13:46:55Y 103912701039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVňDˇôHr ¬ôDW˘D{„HsŽ„Placebo APlacebo ADVňDˇôDWDŚdY . . .Placebo Placebo DW!DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW˘D{D{„DWľDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBšBqBrCŔAĐHr ¬ôHrąŁäHslŢŚHsŽ„ .DWŚWHITE AC4591001C4591001 1039 10391270AADVERSE EVENT 1 Epistaxis Epistaxis F™-ŇRESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS Epistaxis FŃrFŃrNasal disorders NEC F™»Upper respiratory tract disorders (excl infections) F™K`Respiratory, thoracic and mediastinal disorders F™-Ň2020-12-23T16:00Ađ2020-12-23T20:00Ađ 1MedDRA v24.0NDW AđDáHrłaDWAđE—°Hrł™{ADAYSN NNOT RELATEDOTHER dry mucus membranes NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A DOÍ APeriod 01DVňDˇôHr ¬ôDWŤD{HslŢ‹Vaccination 1 AY A2021-06-08T14:58:12Y 103912701039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVňDˇôHr ¬ôDW˘D{„HsŽ„Placebo APlacebo ADVňDˇôDWDŚdY . . .Placebo Placebo DW!DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW˘D{D{„DWľDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBšBqBrCŔAĐHr ¬ôHrąŁäHslŢŚHsŽ„ .DWŚWHITE AC4591001C4591001 1039 10391270A ADVERSE EVENT 2 fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-14 Bť2021-05-16 Bź 1MedDRA v24.0NDWŽ A ..DWA@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŤD{HslŢŚDYD{„HuiÂVaccination 3 APY A02021-06-08T16:54:54Y 103912701039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVňDˇôHr ¬ôDW˘D{„HsŽ„Placebo APlacebo ADVňDˇôDWDŚdY . . .Placebo Placebo DW!DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW˘D{D{„DWľDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBšBqBrCŔAĐHr ¬ôHrąŁäHslŢŚHsŽ„ .DWŚWHITE AC4591001C4591001 1039 10391270A0ADVERSE EVENT 5 fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-04 B˛2021-06-06 B´ 1MedDRA v24.0NDWŁ A ..DWĄA@..A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŤD{HslŢŚDYD{„HuiÂVaccination 4 A`Y A@2021-07-01T16:11:39Y 103912701039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVňDˇôHr ¬ôDW˘D{„HsŽ„Placebo APlacebo ADVňDˇôDWDŚdY . . .Placebo Placebo DW!DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW˘D{D{„DWľDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBšBqBrCŔAĐHr ¬ôHrąŁäHslŢŚHsŽ„ .DWŚWHITE AC4591001C4591001 1039 10391270A@ADVERSE EVENT 3 Injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-13T19:00Bś2021-05-14 Bť 1MedDRA v24.0NDWŤ AEłHsmn°DWŽA ..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C&p A Period 02DWŤD{HslŢŚDYD{„HuiÂVaccination 3 APY A02021-06-08T19:10:01Y 103912701039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVňDˇôHr ¬ôDW˘D{„HsŽ„Placebo APlacebo ADVňDˇôDWDŚdY . . .Placebo Placebo DW!DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW˘D{D{„DWľDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBšBqBrCŔAĐHr ¬ôHrąŁäHslŢŚHsŽ„ .DWŚWHITE AC4591001C4591001 1039 10391270A`ADVERSE EVENT 6 fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-06-04 B˛2021-06-05 Bł 1MedDRA v24.0NDWŁ A ..DW¤A0..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŤD{HslŢŚDYD{„HuiÂVaccination 4 A`Y A@2021-07-01T16:11:50Y 103912701039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVňDˇôHr ¬ôDW˘D{„HsŽ„Placebo APlacebo ADVňDˇôDWDŚdY . . .Placebo Placebo DW!DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW˘D{D{„DWľDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBšBqBrCŔAĐHr ¬ôHrąŁäHslŢŚHsŽ„ .DWŚWHITE AC4591001C4591001 1039 10391270APADVERSE EVENT 4 Fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-05-14T14:00Bť2021-05-14T16:00Bť 1MedDRA v24.0NDWŽ A DÄŕHsnyŕDWŽA Dá;Hsn–;ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Cm° A Period 02DWŤD{HslŢŚDYD{„HuiÂVaccination 3 APY A02021-06-08T19:10:11Y 103912711039Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVňDĂđHr ÎđDW˘D¬HsżPlacebo APlacebo ADVňDĂđDWDşY . . .Placebo Placebo DW!DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW˘DśTD¬DWľDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBšBqBrCŔAŕHr ÎđHrąŃHsl˙ÔHsż .DWŚWHITE AC4591001C4591001 1039 10391271AADVERSE EVENT 1 Headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-05-14T16:00Bť2021-05-14T21:00Bť 2MedDRA v24.0NDWŽ A DáHsn–DWŽA Ex°HsnÜ‹ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A ClP A Period 02DWŤDśTHsl˙ÔDYD¬HuiňVaccination 3 APY A02021-06-07T18:38:12Y 103912711039Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVňDĂđHr ÎđDW˘D¬HsżPlacebo APlacebo ADVňDĂđDWDşY . . .Placebo Placebo DW!DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW˘DśTD¬DWľDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBšBqBrCŔAŕHr ÎđHrąŃHsl˙ÔHsż .DWŚWHITE AC4591001C4591001 1039 10391271A ADVERSE EVENT 2 headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-06-04T10:00B˛2021-06-04T12:00B˛ 2MedDRA v24.0NDWŁ A DŚ Hs‰ń DWŁA D¨űHsŠ {ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A CQ A Period 02DWŤDśTHsl˙ÔDYD¬HuiňVaccination 4 A`Y A@2021-07-14T20:18:47Y 103912731039Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVňDÄhHr ĎhDW˘D¬HsżPlacebo APlacebo ADVňDÄhDWDąÜY . . .Placebo Placebo DW!DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW˘DśD¬DWľDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBšBqBrCŔAŔHr ĎhHrąŃ\Hsl˙Hsż .DWŚWHITE AC4591001C4591001 1039 10391273AADVERSE EVENT 1 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-14T07:00Bť2021-05-14T17:00Bť 1MedDRA v24.0NDWŽ A DbpHsnpDWŽA DďKHsn¤KADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CJ A Period 02DWŤDśHsl˙DYD¬HuiňVaccination 3 APY A02021-06-07T18:38:34Y 103912731039Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVňDÄhHr ĎhDW˘D¬HsżPlacebo APlacebo ADVňDÄhDWDąÜY . . .Placebo Placebo DW!DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW˘DśD¬DWľDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBšBqBrCŔAŔHr ĎhHrąŃ\Hsl˙Hsż .DWŚWHITE AC4591001C4591001 1039 10391273A ADVERSE EVENT 2 Injection site soreness Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-14T07:00Bť2021-05-15 Bž 1MedDRA v24.0NDWŽ A DbpHsnpDWŹA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CJ A Period 02DWŤDśHsl˙DYD¬HuiňVaccination 3 APY A02021-06-08T14:35:21Y 103912741039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVůD{„Hr©ÁDWŁDqčHs‰ÖhPlacebo APlacebo ADVůD{„DWDpDY . . .Placebo Placebo DW(DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁDštDqčDWĂDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB”BpBqCPAĐHr©ÁHrÂÂDHsnOtHs‰Öh .DWŤWHITE AC4591001C4591001 1039 10391274AADVERSE EVENT 2 exacerbation of pineapple food allergy Food allergy Fę4IMMUNE SYSTEM DISORDERS Fruit allergy FÚvFŘ˛Allergies to foods, food additives, drugs and other chemicals FťIAllergic conditions Fť,Immune system disorders Fę42021-07-01 BĆ2021-07-01 BĆ 1MedDRA v24.0NDWľ B..DWľB..ADAYSN NNOT RELATEDOTHER allergies NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . A Period 02DWŽDštHsnOtDYDqčHuk čVaccination 4 A`Y A@2021-07-07T08:14:27Y 103912741039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVůD{„Hr©ÁDWŁDqčHs‰ÖhPlacebo APlacebo ADVůD{„DWDpDY . . .Placebo Placebo DW(DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁDštDqčDWĂDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB”BpBqCPAĐHr©ÁHrÂÂDHsnOtHs‰Öh .DWŤWHITE AC4591001C4591001 1039 10391274A ADVERSE EVENT 1 post nasal drip Upper-airway cough syndrome F™-ŇRESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS Postnasal drip F™$˛F™©ŘUpper respiratory tract signs and symptoms F™KiRespiratory tract signs and symptoms F™Ë}Respiratory, thoracic and mediastinal disorders F™-Ň2021-07-01 BĆ2021-07-06 BË 1MedDRA v24.0NDWľ B..DWĂB!..A`DAYSN NNOT RELATEDOTHER allergies NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . A Period 02DWŽDštHsnOtDYDqčHuk čVaccination 4 A`Y A@2021-07-06T23:25:56Y 103912791039Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVůDŻPHr©ôĐDW¦D–<HsŤď<Placebo APlacebo ADVůDŻPDWDÁÔY . . .Placebo Placebo DW/DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DžpD–<DWĂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB”BmBqCPAŕHr©ôĐHrĹ¶ÔHsrGđHsŤď< .DWWHITE AC4591001C4591001 1039 10391279AADVERSE EVENT 6 Chills Chills FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills F·ÓF·ÓFeelings and sensations NEC F™ŁGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-07T22:00B®2021-06-08T23:59BŻ 1MedDRA v24.0NDW¦ AEVHsŽŽ`DW§A EđHsŹű˙A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C*p A Period 02DW‘DžpHsrGđDYD–<Huo"ĽVaccination 4 A`Y A@2021-07-14T20:19:33Y 103912791039Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVůDŻPHr©ôĐDW¦D–<HsŤď<Placebo APlacebo ADVůDŻPDWDÁÔY . . .Placebo Placebo DW/DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DžpD–<DWĂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB”BmBqCPAŕHr©ôĐHrĹ¶ÔHsrGđHsŤď< .DWWHITE AC4591001C4591001 1039 10391279A0ADVERSE EVENT 2 fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-18T10:00Bš2021-05-19T10:00B› 1MedDRA v24.0NDW’ A DŚ Hss‡ DW“A0DŚŰHstŮ[A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CU@ A Period 02DW‘DžpHsrGđDYD–<Huo"ĽVaccination 3 APY A02021-06-07T20:55:40Y 103912791039Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVůDŻPHr©ôĐDW¦D–<HsŤď<Placebo APlacebo ADVůDŻPDWDÁÔY . . .Placebo Placebo DW/DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DžpD–<DWĂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB”BmBqCPAŕHr©ôĐHrĹ¶ÔHsrGđHsŤď< .DWWHITE AC4591001C4591001 1039 10391279A ADVERSE EVENT 4 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-07T22:00B®2021-06-08T23:59BŻ 1MedDRA v24.0NDW¦ AEVHsŽŽ`DW§A EđHsŹű˙A DAYSN NRELATED NOT APPLICABLE YYRECOVERED/RESOLVED N ARELATED AAGRADE 1A C*p A Period 02DW‘DžpHsrGđDYD–<Huo"ĽVaccination 4 A`Y A@2021-07-14T20:18:27Y 103912791039Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVůDŻPHr©ôĐDW¦D–<HsŤď<Placebo APlacebo ADVůDŻPDWDÁÔY . . .Placebo Placebo DW/DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DžpD–<DWĂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB”BmBqCPAŕHr©ôĐHrĹ¶ÔHsrGđHsŤď< .DWWHITE AC4591001C4591001 1039 10391279APADVERSE EVENT 1 injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-17T17:00B™2021-05-19 B› 1MedDRA v24.0NDW‘ ADďHsrDW“A0..A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C€ A Period 02DW‘DžpHsrGđDYD–<Huo"ĽVaccination 3 APY A02021-06-07T20:55:29Y 103912791039Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVůDŻPHr©ôĐDW¦D–<HsŤď<Placebo APlacebo ADVůDŻPDWDÁÔY . . .Placebo Placebo DW/DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DžpD–<DWĂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB”BmBqCPAŕHr©ôĐHrĹ¶ÔHsrGđHsŤď< .DWWHITE AC4591001C4591001 1039 10391279A@ADVERSE EVENT 5 Injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-07T17:00B®2021-06-08T23:59BŻ 1MedDRA v24.0NDW¦ ADďHsŽHDW§A EđHsŹű˙A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C° A Period 02DW‘DžpHsrGđDYD–<Huo"ĽVaccination 4 A`Y A@2021-07-06T19:27:14Y 103912791039Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVůDŻPHr©ôĐDW¦D–<HsŤď<Placebo APlacebo ADVůDŻPDWDÁÔY . . .Placebo Placebo DW/DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DžpD–<DWĂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB”BmBqCPAŕHr©ôĐHrĹ¶ÔHsrGđHsŤď< .DWWHITE AC4591001C4591001 1039 10391279A`ADVERSE EVENT 3 Body aches Pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalized aching F™Š\F™ŰPain and discomfort NEC F™ÜGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-07T22:00B®2021-06-08T23:59BŻ 1MedDRA v24.0NDW¦ AEVHsŽŽ`DW§A EđHsŹű˙A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C*p A Period 02DW‘DžpHsrGđDYD–<Huo"ĽVaccination 4 A`Y A@2021-07-06T19:26:51Y 103912801039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVúD„äHr«äDWŁDČdHsŠ,äPlacebo APlacebo ADVúD„äDWD“lY . . .Placebo Placebo DW+DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁD{ŔDČdDWĂDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB“BpBqC@AĐHr«äHrĆŮěHsn0ŔHsŠ,ä .DWŤWHITE AC4591001C4591001 1039 10391280AADVERSE EVENT 2 Injection site soreness Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-15T07:00B–2021-05-18T12:00B™ 1MedDRA v24.0NDWŹ A DbpHsohđDW’APD¨űHssŁűA@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CS@ A Period 02DWŽD{ŔHsn0ŔDYDČdHuk`dVaccination 3 APY A02021-06-07T16:54:55Y 103912801039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVúD„äHr«äDWŁDČdHsŠ,äPlacebo APlacebo ADVúD„äDWD“lY . . .Placebo Placebo DW+DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁD{ŔDČdDWĂDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB“BpBqC@AĐHr«äHrĆŮěHsn0ŔHsŠ,ä .DWŤWHITE AC4591001C4591001 1039 10391280A ADVERSE EVENT 1 Vasovagal episode Presyncope F™•NERVOUS SYSTEM DISORDERS Vaso vagal attack F™N˘F™%Neurological signs and symptoms NEC F™úNeurological disorders NEC F™ůNervous system disorders F™•2021-02-04T09:29B22021-02-04T10:10B2 1MedDRA v24.0NDW+ BD…\HrëµÜDW+BDŹ3HrëżłADAYSN NNOT RELATEDOTHER Blood draw during visit 3 NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A DťD APeriod 01DVúD„äHr«äDWŽD{żHsn0żVaccination 2 A Y A 2021-06-07T16:54:45Y 103912831039Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVűD‚ŚHr¬kDW˘DĽ4HsĎ4Placebo APlacebo ADVűD‚ŚDWDl„Y . . .Placebo Placebo DW+DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW˘DsDĽ4DWľDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB’BqBqC0AđHr¬kHrĆłHslÖ”HsĎ4 .DWŚWHITE AC4591001C4591001 1039 10391283AADVERSE EVENT 2 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-14 B”2021-05-16 B– 2MedDRA v24.0NDWŽ A ..DWA@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWŤDsHslÖ”DYDĽ4Huj´Vaccination 3 APY A02021-06-07T16:55:17Y 103912831039Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVűD‚ŚHr¬kDW˘DĽ4HsĎ4Placebo APlacebo ADVűD‚ŚDWDl„Y . . .Placebo Placebo DW+DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW˘DsDĽ4DWľDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB’BqBqC0AđHr¬kHrĆłHslÖ”HsĎ4 .DWŚWHITE AC4591001C4591001 1039 10391283A ADVERSE EVENT 1 Headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-05-14 B”2021-05-16 B– 2MedDRA v24.0NDWŽ A ..DWA@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWŤDsHslÖ”DYDĽ4Huj´Vaccination 3 APY A02021-06-07T16:55:06Y 103912831039Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVűD‚ŚHr¬kDW˘DĽ4HsĎ4Placebo APlacebo ADVűD‚ŚDWDl„Y . . .Placebo Placebo DW+DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW˘DsDĽ4DWľDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB’BqBqC0AđHr¬kHrĆłHslÖ”HsĎ4 .DWŚWHITE AC4591001C4591001 1039 10391283A0ADVERSE EVENT 3 Injection site soreness Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-13T15:00B“2021-05-15 B• 1MedDRA v24.0NDWŤ ADŇđHsm6pDWŹA0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C A Period 02DWŤDsHslÖ”DYDĽ4Huj´Vaccination 3 APY A02021-06-07T16:55:28Y 103912851039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVűDŚdHr¬täDWŁDt@Hs‰ŘŔPlacebo APlacebo ADVűDŚdDWD|tY . . .Placebo Placebo DW,DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁDx´Dt@DWÉDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB‘BpBrC0AĐHr¬täHrČtHsn-´Hs‰ŘŔ .DWŤWHITE AC4591001C4591001 1039 10391285AADVERSE EVENT 7 Generalized Arthralgia Arthralgia F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Arthralgia FŁ'FŁ'Joint related signs and symptoms Fń:Joint disorders Fń-Musculoskeletal and connective tissue disorders F™k2021-06-04T14:00B©2021-06-05 BŞ 1MedDRA v24.0NDWŁ ADÄŕHsŠ)`DW¤A ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C€ A Period 02DWŽDx´Hsn-´DYDt@Huk@Vaccination 4 A`Y A@2021-07-15T18:13:51Y 103912851039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVűDŚdHr¬täDWŁDt@Hs‰ŘŔPlacebo APlacebo ADVűDŚdDWD|tY . . .Placebo Placebo DW,DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁDx´Dt@DWÉDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB‘BpBrC0AĐHr¬täHrČtHsn-´Hs‰ŘŔ .DWŤWHITE AC4591001C4591001 1039 10391285A ADVERSE EVENT 1 fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-14T18:00B”2021-05-15T18:00B• 1MedDRA v24.0NDWŽ ADý Hsn˛ DWŹA Dý[HspŰA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C#P A Period 02DWŽDx´Hsn-´DYDt@Huk@Vaccination 3 APY A02021-06-04T16:55:52Y 103912851039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVűDŚdHr¬täDWŁDt@Hs‰ŘŔPlacebo APlacebo ADVűDŚdDWD|tY . . .Placebo Placebo DW,DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁDx´Dt@DWÉDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB‘BpBrC0AĐHr¬täHrČtHsn-´Hs‰ŘŔ .DWŤWHITE AC4591001C4591001 1039 10391285A0ADVERSE EVENT 3 injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-15T08:00B•2021-05-15 B• 1MedDRA v24.0NDWŹ A Dp€HsowDWŹA ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CWĐ A Period 02DWŽDx´Hsn-´DYDt@Huk@Vaccination 3 APY A02021-06-04T16:56:13Y 103912851039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVűDŚdHr¬täDWŁDt@Hs‰ŘŔPlacebo APlacebo ADVűDŚdDWD|tY . . .Placebo Placebo DW,DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁDx´Dt@DWÉDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB‘BpBrC0AĐHr¬täHrČtHsn-´Hs‰ŘŔ .DWŤWHITE AC4591001C4591001 1039 10391285A@ADVERSE EVENT 6 muscle aches Myalgia F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Muscle ache F™˙F™{Muscle pains F™#Muscle disorders F™Musculoskeletal and connective tissue disorders F™k2021-06-04T14:00B©2021-06-05 BŞ 1MedDRA v24.0NDWŁ ADÄŕHsŠ)`DW¤A ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C€ A Period 02DWŽDx´Hsn-´DYDt@Huk@Vaccination 4 A`Y A@2021-07-13T19:02:05Y 103912851039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVűDŚdHr¬täDWŁDt@Hs‰ŘŔPlacebo APlacebo ADVűDŚdDWD|tY . . .Placebo Placebo DW,DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁDx´Dt@DWÉDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB‘BpBrC0AĐHr¬täHrČtHsn-´Hs‰ŘŔ .DWŤWHITE AC4591001C4591001 1039 10391285APADVERSE EVENT 2 nausea Nausea FÜ›GASTROINTESTINAL DISORDERS Nausea F™ F™ Nausea and vomiting symptoms F™Gastrointestinal signs and symptoms FÜÜGastrointestinal disorders FÜ›2021-05-14T18:00B”2021-05-15T18:00B• 1MedDRA v24.0NDWŽ ADý Hsn˛ DWŹA Dý[HspŰA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C#P A Period 02DWŽDx´Hsn-´DYDt@Huk@Vaccination 3 APY A02021-06-04T16:56:02Y 103912851039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVűDŚdHr¬täDWŁDt@Hs‰ŘŔPlacebo APlacebo ADVűDŚdDWD|tY . . .Placebo Placebo DW,DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁDx´Dt@DWÉDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB‘BpBrC0AĐHr¬täHrČtHsn-´Hs‰ŘŔ .DWŤWHITE AC4591001C4591001 1039 10391285A`ADVERSE EVENT 5 nausea Nausea FÜ›GASTROINTESTINAL DISORDERS Nausea F™ F™ Nausea and vomiting symptoms F™Gastrointestinal signs and symptoms FÜÜGastrointestinal disorders FÜ›2021-06-04T14:00B©2021-06-05 BŞ 1MedDRA v24.0NDWŁ ADÄŕHsŠ)`DW¤A ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C€ A Period 02DWŽDx´Hsn-´DYDt@Huk@Vaccination 4 A`Y A@2021-07-12T21:49:57Y 103912851039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVűDŚdHr¬täDWŁDt@Hs‰ŘŔPlacebo APlacebo ADVűDŚdDWD|tY . . .Placebo Placebo DW,DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁDx´Dt@DWÉDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB‘BpBrC0AĐHr¬täHrČtHsn-´Hs‰ŘŔ .DWŤWHITE AC4591001C4591001 1039 10391285ApADVERSE EVENT 4 fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-06-04T14:00B©2021-06-05 BŞ 1MedDRA v24.0NDWŁ ADÄŕHsŠ)`DW¤A ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C€ A Period 02DWŽDx´Hsn-´DYDt@Huk@Vaccination 4 A`Y A@2021-07-12T21:49:46Y 103912871039Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVűD™HHr¬ČDW˘D†Hs™Placebo APlacebo ADVűD™HDWD{HY . . .Placebo Placebo DW/DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW˘DşD†DWĂDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB’BqBqC0AŕHr¬ČHrČHHsmHs™ .DWŚWHITE AC4591001C4591001 1039 10391287AADVERSE EVENT 2 fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-13T14:00B“2021-05-14 B” 1MedDRA v24.0NDWŤ ADÄŕHsm(`DWŽA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A B. A Period 02DWŤDşHsmDYD†HuiÍVaccination 3 APY A02021-06-17T19:25:42Y 103912871039Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVűD™HHr¬ČDW˘D†Hs™Placebo APlacebo ADVűD™HDWD{HY . . .Placebo Placebo DW/DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW˘DşD†DWĂDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB’BqBqC0AŕHr¬ČHrČHHsmHs™ .DWŚWHITE AC4591001C4591001 1039 10391287A ADVERSE EVENT 3 fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-03T12:40B¨2021-06-04T14:15B© 1MedDRA v24.0NDW˘ AD˛ HsĹ DWŁA DČźHsŠ-A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Bş A Period 02DWŤDşHsmDYD†HuiÍVaccination 4 A`Y A@2021-07-06T21:29:55Y 103912871039Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVűD™HHr¬ČDW˘D†Hs™Placebo APlacebo ADVűD™HDWD{HY . . .Placebo Placebo DW/DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW˘DşD†DWĂDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB’BqBqC0AŕHr¬ČHrČHHsmHs™ .DWŚWHITE AC4591001C4591001 1039 10391287A0ADVERSE EVENT 5 headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-06-04T09:45B©2021-06-05T15:00BŞ 1MedDRA v24.0NDWŁ A D‰Hs‰íśDW¤A0DÓ+Hs‹‰+A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CZ° A Period 02DWŤDşHsmDYD†HuiÍVaccination 4 A`Y A@2021-07-06T21:30:18Y 103912871039Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVűD™HHr¬ČDW˘D†Hs™Placebo APlacebo ADVűD™HDWD{HY . . .Placebo Placebo DW/DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW˘DşD†DWĂDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB’BqBqC0AŕHr¬ČHrČHHsmHs™ .DWŚWHITE AC4591001C4591001 1039 10391287A@ADVERSE EVENT 1 injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-14 B”2021-05-15 B• 1MedDRA v24.0NDWŽ A ..DWŹA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŤDşHsmDYD†HuiÍVaccination 3 APY A02021-06-17T19:25:31Y 103912871039Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVűD™HHr¬ČDW˘D†Hs™Placebo APlacebo ADVűD™HDWD{HY . . .Placebo Placebo DW/DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW˘DşD†DWĂDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB’BqBqC0AŕHr¬ČHrČHHsmHs™ .DWŚWHITE AC4591001C4591001 1039 10391287APADVERSE EVENT 4 injection site soreness Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-04T07:15B©2021-06-04T21:30B© 1MedDRA v24.0NDWŁ A DeôHs‰ĘtDWŁA Eé0HsŠ“ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CQP A Period 02DWŤDşHsmDYD†HuiÍVaccination 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_30AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVűD¶XHr¬žŘDWD¤HrČ ¤BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVűD¶XDWD¤Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW,DWŚYPhase 3A@NNEGDWŤ ....... . .NY.DWŚDWýB’BqC0AŔHr¬žŘHrČ ¤.. .DWĘWHITE AC4591001C4591001 1039 10391290AADVERSE EVENT 1 Vasovagal episode Presyncope F™•NERVOUS SYSTEM DISORDERS Vaso vagal attack F™N˘F™%Neurological signs and symptoms NEC F™úNeurological disorders NEC F™ůNervous system disorders F™•2021-07-13T08:10BĐ2021-07-13T08:50BĐ 2MedDRA v24.0NDWĘ B»DrŘHs˝AŘDWĘB»D|sHs˝KsADAYSN NNOT RELATEDOTHER Blood draw at Visit 4 NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A EA^0 APeriod 01DVűD¶XHr¬žŘDX}D¤Ht©T$After unblinding and before Vaccination 3A@ A 2021-07-13T16:26:28Y 103912921039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVűDŔ¨Hr¬©(DWŁDvÔHs‰ŰTPlacebo APlacebo ADVűDŔ¨DWDŻPY . . .Placebo Placebo DW,DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁD{DvÔDWĂDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB’BpBqC0AĐHr¬©(HrČGPHsn0Hs‰ŰT .DWŤWHITE AC4591001C4591001 1039 10391292AADVERSE EVENT 2 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-14T18:00B”2021-05-16T08:00B– 1MedDRA v24.0NDWŽ ADý Hsn˛ DWA0Dp»HspČ»A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C"° A Period 02DWŽD{Hsn0DYDvÔHukÔVaccination 3 APY A02021-06-07T16:55:39Y 103912921039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVűDŔ¨Hr¬©(DWŁDvÔHs‰ŰTPlacebo APlacebo ADVűDŔ¨DWDŻPY . . .Placebo Placebo DW,DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁD{DvÔDWĂDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB’BpBqC0AĐHr¬©(HrČGPHsn0Hs‰ŰT .DWŤWHITE AC4591001C4591001 1039 10391292A ADVERSE EVENT 3 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-04T17:00B©2021-06-06 B« 1MedDRA v24.0NDWŁ ADďHsŠSDWĄA0..A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C A Period 02DWŽD{Hsn0DYDvÔHukÔVaccination 4 A`Y A@2021-07-06T19:27:38Y 103912921039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVűDŔ¨Hr¬©(DWŁDvÔHs‰ŰTPlacebo APlacebo ADVűDŔ¨DWDŻPY . . .Placebo Placebo DW,DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁD{DvÔDWĂDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB’BpBqC0AĐHr¬©(HrČGPHsn0Hs‰ŰT .DWŤWHITE AC4591001C4591001 1039 10391292A@ADVERSE EVENT 1 Injection site soreness Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-14T18:00B”2021-05-22 Bś 1MedDRA v24.0NDWŽ ADý Hsn˛ DW–A..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C"° A Period 02DWŽD{Hsn0DYDvÔHukÔVaccination 3 APY A02021-06-08T14:27:07Y 103912921039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVűDŔ¨Hr¬©(DWŁDvÔHs‰ŰTPlacebo APlacebo ADVűDŔ¨DWDŻPY . . .Placebo Placebo DW,DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁD{DvÔDWĂDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB’BpBqC0AĐHr¬©(HrČGPHsn0Hs‰ŰT .DWŤWHITE AC4591001C4591001 1039 10391292A0ADVERSE EVENT 4 Injection arm soreness Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-04T17:00B©2021-06-10 BŻ 1MedDRA v24.0NDWŁ ADďHsŠSDW©Ap..ApDAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C A Period 02DWŽD{Hsn0DYDvÔHukÔVaccination 4 A`Y A@2021-07-06T19:27:54Y 103912921039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVűDŔ¨Hr¬©(DWŁDvÔHs‰ŰTPlacebo APlacebo ADVűDŔ¨DWDŻPY . . .Placebo Placebo DW,DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁD{DvÔDWĂDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB’BpBqC0AĐHr¬©(HrČGPHsn0Hs‰ŰT .DWŤWHITE AC4591001C4591001 1039 10391292APADVERSE EVENT 5 Nausea Nausea FÜ›GASTROINTESTINAL DISORDERS Nausea F™ F™ Nausea and vomiting symptoms F™Gastrointestinal signs and symptoms FÜÜGastrointestinal disorders FÜ›2021-06-04T17:00B©2021-06-06 B« 1MedDRA v24.0NDWŁ ADďHsŠSDWĄA0..A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C A Period 02DWŽD{Hsn0DYDvÔHukÔVaccination 4 A`Y A@2021-07-06T19:28:05Y 103912941039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DVţD˛ÔHr°ŹÔDWŁDŤHs‰ńPlacebo APlacebo ADVţD˛ÔDWDm°Y . . .Placebo Placebo DW1DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁDvDŤDWÄDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBŹBpBqCAĐHr°ŹÔHrÎť0Hsn+Hs‰ń .DWŤALL OTHERS A0C4591001C4591001 1039 10391294A ADVERSE EVENT 1 Injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-14T22:00B‘2021-05-16 B“ 1MedDRA v24.0NDWŽ AEVHsnę`DWA0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C2ŕ A Period 02DWŽDvHsn+DYDŤHuk%Vaccination 3 APY A02021-06-07T16:56:33Y 103912941039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DVţD˛ÔHr°ŹÔDWŁDŤHs‰ńPlacebo APlacebo ADVţD˛ÔDWDm°Y . . .Placebo Placebo DW1DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁDvDŤDWÄDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBŹBpBqCAĐHr°ŹÔHrÎť0Hsn+Hs‰ń .DWŤALL OTHERS A0C4591001C4591001 1039 10391294AADVERSE EVENT 2 Injection arm soreness Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-04T13:30B¦2021-06-05T13:30B§ 1MedDRA v24.0NDWŁ AD˝ŘHsŠ"XDW¤A DľHs‹tA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A BĐ A Period 02DWŽDvHsn+DYDŤHuk%Vaccination 4 A`Y A@2021-07-07T17:33:42Y 103912961039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT REPORTED A0USAWHITE ADWD‚PHrşëPDWŁDŠŔHs‰ď@Placebo APlacebo ADWD‚PDWDr$Y . . .Placebo Placebo DW>DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁDŚÜDŠŔDWżDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB‡BpBqBřAĐHrşëPHrÖŠ¤HsnAÜHs‰ď@ .DWŤWHITE AC4591001C4591001 1039 10391296AADVERSE EVENT 2 Left armpit soreness Axillary pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Armpit pain F™×F™TîPain and discomfort NEC F™ÜGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-04T13:00Bž2021-06-06T08:00B 1MedDRA v24.0NDWŁ AD¶ĐHsŠPDWĄA0Dp»HsŚx;A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A BĽ A Period 02DWŽDŚÜHsnAÜDYDŠŔHuk"ŔVaccination 4 A`Y A@2021-07-14T22:48:40Y 103912961039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT REPORTED A0USAWHITE ADWD‚PHrşëPDWŁDŠŔHs‰ď@Placebo APlacebo ADWD‚PDWDr$Y . . .Placebo Placebo DW>DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁDŚÜDŠŔDWżDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB‡BpBqBřAĐHrşëPHrÖŠ¤HsnAÜHs‰ď@ .DWŤWHITE AC4591001C4591001 1039 10391296A ADVERSE EVENT 3 Chills Chills FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills F·ÓF·ÓFeelings and sensations NEC F™ŁGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-04T21:30Bž2021-06-05T21:30Bź 1MedDRA v24.0NDWŁ AEĺ€HsŠ’ŘDW¤A Eé0Hs‹ä“A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C+ A Period 02DWŽDŚÜHsnAÜDYDŠŔHuk"ŔVaccination 4 A`Y A@2021-07-02T16:39:30Y 103912961039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT REPORTED A0USAWHITE ADWD‚PHrşëPDWŁDŠŔHs‰ď@Placebo APlacebo ADWD‚PDWDr$Y . . .Placebo Placebo DW>DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁDŚÜDŠŔDWżDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB‡BpBqBřAĐHrşëPHrÖŠ¤HsnAÜHs‰ď@ .DWŤWHITE AC4591001C4591001 1039 10391296A0ADVERSE EVENT 1 Injection site soreness Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-14T13:03B‰2021-05-15T09:00BŠ 1MedDRA v24.0NDWŽ AD·„Hsnl„DWŹA D~ËHso…KA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A B¶ A Period 02DWŽDŚÜHsnAÜDYDŠŔHuk"ŔVaccination 3 APY A02021-06-07T16:56:54Y 103912961039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT REPORTED A0USAWHITE ADWD‚PHrşëPDWŁDŠŔHs‰ď@Placebo APlacebo ADWD‚PDWDr$Y . . .Placebo Placebo DW>DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁDŚÜDŠŔDWżDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB‡BpBqBřAĐHrşëPHrÖŠ¤HsnAÜHs‰ď@ .DWŤWHITE AC4591001C4591001 1039 10391296A@ADVERSE EVENT 4 nausea Nausea FÜ›GASTROINTESTINAL DISORDERS Nausea F™ F™ Nausea and vomiting symptoms F™Gastrointestinal signs and symptoms FÜÜGastrointestinal disorders FÜ›2021-06-04T21:30Bž2021-06-06T08:00B 1MedDRA v24.0NDWŁ AEĺ€HsŠ’ŘDWĄA0Dp»HsŚx;A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C+ A Period 02DWŽDŚÜHsnAÜDYDŠŔHuk"ŔVaccination 4 A`Y A@2021-07-02T16:39:41Y 103912961039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT REPORTED A0USAWHITE ADWD‚PHrşëPDWŁDŠŔHs‰ď@Placebo APlacebo ADWD‚PDWDr$Y . . .Placebo Placebo DW>DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁDŚÜDŠŔDWżDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB‡BpBqBřAĐHrşëPHrÖŠ¤HsnAÜHs‰ď@ .DWŤWHITE AC4591001C4591001 1039 10391296APADVERSE EVENT 5 Fever 102 Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-06-05T08:00Bź2021-06-05T21:30Bź 2MedDRA v24.0NDW¤ A Dp€Hs‹&€DW¤A Eé0Hs‹ä“ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A CS A Period 02DWŽDŚÜHsnAÜDYDŠŔHuk"ŔVaccination 4 A`Y A@2021-07-14T20:19:53Y 103913011039Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADWD©tHr»tDWŁD˝śHsŠ"Placebo APlacebo ADWD©tDWDsŚY . . .Placebo Placebo DW=DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDWŁD©tD˝śDWĘDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB†BqBrBřAŕHr»tHrŮ/HsmôHsŠ" .DWŚWHITE AC4591001C4591001 1039 10391301AADVERSE EVENT 7 chills Chills FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills F·ÓF·ÓFeelings and sensations NEC F™ŁGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-05 Bź2021-06-06 B 1MedDRA v24.0NDW¤ A ..DWĄA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŤD©tHsmôDYD˝śHukUśVaccination 4 A`Y A@2021-06-28T19:05:44Y 103913011039Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADWD©tHr»tDWŁD˝śHsŠ"Placebo APlacebo ADWD©tDWDsŚY . . .Placebo Placebo DW=DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDWŁD©tD˝śDWĘDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB†BqBrBřAŕHr»tHrŮ/HsmôHsŠ" .DWŚWHITE AC4591001C4591001 1039 10391301A0ADVERSE EVENT 10headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-06-05 Bź2021-06-06 B 1MedDRA v24.0NDW¤ A ..DWĄA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŤD©tHsmôDYD˝śHukUśVaccination 4 A`Y A@2021-07-13T21:37:01Y 103913011039Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADWD©tHr»tDWŁD˝śHsŠ"Placebo APlacebo ADWD©tDWDsŚY . . .Placebo Placebo DW=DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDWŁD©tD˝śDWĘDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB†BqBrBřAŕHr»tHrŮ/HsmôHsŠ" .DWŚWHITE AC4591001C4591001 1039 10391301A ADVERSE EVENT 4 Headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-05-14T08:00B‰2021-05-16 B‹ 1MedDRA v24.0NDWŽ A Dp€Hsn%€DWA@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CJĐ A Period 02DWŤD©tHsmôDYD˝śHukUśVaccination 3 APY A02021-06-07T16:57:26Y 103913011039Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADWD©tHr»tDWŁD˝śHsŠ"Placebo APlacebo ADWD©tDWDsŚY . . .Placebo Placebo DW=DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDWŁD©tD˝śDWĘDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB†BqBrBřAŕHr»tHrŮ/HsmôHsŠ" .DWŚWHITE AC4591001C4591001 1039 10391301APADVERSE EVENT 8 injection site soreness Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-05 Bź2021-06-08 B˘ 1MedDRA v24.0NDW¤ A ..DW§AP..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŤD©tHsmôDYD˝śHukUśVaccination 4 A`Y A@2021-06-28T19:05:55Y 103913011039Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADWD©tHr»tDWŁD˝śHsŠ"Placebo APlacebo ADWD©tDWDsŚY . . .Placebo Placebo DW=DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDWŁD©tD˝śDWĘDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB†BqBrBřAŕHr»tHrŮ/HsmôHsŠ" .DWŚWHITE AC4591001C4591001 1039 10391301A@ADVERSE EVENT 2 Injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-13T19:00B2021-05-18 BŤ 1MedDRA v24.0NDWŤ AEłHsmn°DW’A`..A`DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C A Period 02DWŤD©tHsmôDYD˝śHukUśVaccination 3 APY A02021-06-07T16:57:05Y 103913011039Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADWD©tHr»tDWŁD˝śHsŠ"Placebo APlacebo ADWD©tDWDsŚY . . .Placebo Placebo DW=DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDWŁD©tD˝śDWĘDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB†BqBrBřAŕHr»tHrŮ/HsmôHsŠ" .DWŚWHITE AC4591001C4591001 1039 10391301A`ADVERSE EVENT 3 General muscle aches Myalgia F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Muscle ache F™˙F™{Muscle pains F™#Muscle disorders F™Musculoskeletal and connective tissue disorders F™k2021-05-14T08:00B‰2021-05-16 B‹ 1MedDRA v24.0NDWŽ A Dp€Hsn%€DWA@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CJĐ A Period 02DWŤD©tHsmôDYD˝śHukUśVaccination 3 APY A02021-06-07T16:57:15Y 103913011039Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADWD©tHr»tDWŁD˝śHsŠ"Placebo APlacebo ADWD©tDWDsŚY . . .Placebo Placebo DW=DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDWŁD©tD˝śDWĘDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB†BqBrBřAŕHr»tHrŮ/HsmôHsŠ" .DWŚWHITE AC4591001C4591001 1039 10391301ApADVERSE EVENT 5 body aches Pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalized aching F™Š\F™ŰPain and discomfort NEC F™ÜGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-05 Bź2021-06-06 B 1MedDRA v24.0NDW¤ A ..DWĄA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŤD©tHsmôDYD˝śHukUśVaccination 4 A`Y A@2021-06-28T19:05:21Y 103913011039Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADWD©tHr»tDWŁD˝śHsŠ"Placebo APlacebo ADWD©tDWDsŚY . . .Placebo Placebo DW=DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDWŁD©tD˝śDWĘDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB†BqBrBřAŕHr»tHrŮ/HsmôHsŠ" .DWŚWHITE AC4591001C4591001 1039 10391301A€ADVERSE EVENT 1 vasovagal episode Presyncope F™•NERVOUS SYSTEM DISORDERS Vaso vagal attack F™N˘F™%Neurological signs and symptoms NEC F™úNeurological disorders NEC F™ůNervous system disorders F™•2021-05-13T11:51B2021-05-13T12:00B 1MedDRA v24.0NDWŤ BqD¦¤Hsm $DWŤBqD¨űHsm{ADAYSN NNOT RELATEDOTHER blood draw NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A E'm APeriod 01DWD©tHr»tDWŤD©sHsmóAfter unblinding and before Vaccination 3A@ A 2021-05-13T18:58:26Y 103913011039Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADWD©tHr»tDWŁD˝śHsŠ"Placebo APlacebo ADWD©tDWDsŚY . . .Placebo Placebo DW=DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDWŁD©tD˝śDWĘDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB†BqBrBřAŕHr»tHrŮ/HsmôHsŠ" .DWŚWHITE AC4591001C4591001 1039 10391301AADVERSE EVENT 6 fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-06-05 Bź2021-06-06 B 1MedDRA v24.0NDW¤ A ..DWĄA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŤD©tHsmôDYD˝śHukUśVaccination 4 A`Y A@2021-06-28T19:05:32Y 103913031039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDżôHr»(ôDWŁDr`Hs‰ÖŕPlacebo APlacebo ADWDżôDWDk”Y . . .Placebo Placebo DW>DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDWŁD±lDr`DWĂDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB‡BqBqBřAĐHr»(ôHrŮ'HsměHs‰Öŕ .DWŚWHITE AC4591001C4591001 1039 10391303AADVERSE EVENT 1 chills Chills FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills F·ÓF·ÓFeelings and sensations NEC F™ŁGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-04T22:00Bž2021-06-05T08:00Bź 1MedDRA v24.0NDWŁ AEVHsŠ™ŕDW¤A Dp»Hs‹&»A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C4 A Period 02DWŤD±lHsměDYDr`Huk `Vaccination 4 A`Y A@2021-07-06T17:54:34Y 103913051039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWD˝$HrĹ˛$DWŁDąÜHsŠ\Placebo APlacebo ADWD˝$DW!DtY . . .Placebo Placebo DW=DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁDáDąÜDWÉDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBBpBqBđAĐHrĹ˛$HrŢu„Hsn–HsŠ\ .DWŤWHITE AC4591001C4591001 1039 10391305AADVERSE EVENT 1 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-15T13:00B‚2021-05-16T12:00B 1MedDRA v24.0NDWŹ A D¶ĐHso˝PDWA0D¨űHsqűA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CNŔ A Period 02DWŽDáHsn–DYDąÜHukQÜVaccination 3 APY A02021-06-07T16:57:37Y 103913071039Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDĆŔHrĹ»ŔDWŁD–´Hs‰ű4Placebo APlacebo ADWDĆŔDW#D´´Y . . .Placebo Placebo DW?DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁDŔ0D–´DWżDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBBpBqBđAđHrĹ»ŔHráY4Hsnu0Hs‰ű4 .DWŤWHITE AC4591001C4591001 1039 10391307AADVERSE EVENT 4 Hashimoto's thyroiditis Autoimmune thyroiditis FĎęENDOCRINE DISORDERS Hashimoto's thyroiditis Fá_F™VAcute and chronic thyroiditis F™AThyroid gland disorders F™A[Endocrine disorders FĎę2021-06-14 B .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDW A°....... N NNOT RELATEDOTHER automimmune disorder NOT APPLICABLE NNNOT RECOVERED/NOT RESOLVED N A0NOT RELATEDA0AGRADE 1A . A Period 02DWŽDŔ0Hsnu0DYD–´Huk.´Vaccination 4 A`Y A@2021-07-06T19:28:18Y 103913071039Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDĆŔHrĹ»ŔDWŁD–´Hs‰ű4Placebo APlacebo ADWDĆŔDW#D´´Y . . .Placebo Placebo DW?DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁDŔ0D–´DWżDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBBpBqBđAđHrĹ»ŔHráY4Hsnu0Hs‰ű4 .DWŤWHITE AC4591001C4591001 1039 10391307A ADVERSE EVENT 7 chills Chills FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills F·ÓF·ÓFeelings and sensations NEC F™ŁGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-04T20:00B–2021-06-06T12:00B 2MedDRA v24.0NDWŁ AE”HsŠ}ŔDWĄA0D¨űHsŚ°{A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C"Đ A Period 02DWŽDŔ0Hsnu0DYD–´Huk.´Vaccination 4 A`Y A@2021-07-06T19:28:41Y 103913071039Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDĆŔHrĹ»ŔDWŁD–´Hs‰ű4Placebo APlacebo ADWDĆŔDW#D´´Y . . .Placebo Placebo DW?DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁDŔ0D–´DWżDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBBpBqBđAđHrĹ»ŔHráY4Hsnu0Hs‰ű4 .DWŤWHITE AC4591001C4591001 1039 10391307A0ADVERSE EVENT 9 headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-06-04T20:00B–2021-06-06T12:00B 2MedDRA v24.0NDWŁ AE”HsŠ}ŔDWĄA0D¨űHsŚ°{A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C"Đ A Period 02DWŽDŔ0Hsnu0DYD–´Huk.´Vaccination 4 A`Y A@2021-07-06T19:29:05Y 103913071039Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDĆŔHrĹ»ŔDWŁD–´Hs‰ű4Placebo APlacebo ADWDĆŔDW#D´´Y . . .Placebo Placebo DW?DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁDŔ0D–´DWżDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBBpBqBđAđHrĹ»ŔHráY4Hsnu0Hs‰ű4 .DWŤWHITE AC4591001C4591001 1039 10391307A ADVERSE EVENT 11injection site soreness Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-04T10:44B–2021-06-07T10:00B™ 2MedDRA v24.0NDWŁ AD–đHs‰űpDW¦A@DŚŰHsŤĺŰA@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A AYA Period 02DWŽDŔ0Hsnu0DYD–´Huk.´Vaccination 4 A`Y A@2021-07-06T19:29:29Y 103913071039Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDĆŔHrĹ»ŔDWŁD–´Hs‰ű4Placebo APlacebo ADWDĆŔDW#D´´Y . . .Placebo Placebo DW?DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁDŔ0D–´DWżDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBBpBqBđAđHrĹ»ŔHráY4Hsnu0Hs‰ű4 .DWŤWHITE AC4591001C4591001 1039 10391307A@ADVERSE EVENT 5 exacerbation of neck muscle strain Muscle strain FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Muscle strain F™YďF™YďMuscle, tendon and ligament injuries F™Injuries NEC FěâInjury, poisoning and procedural complications Fěĺ2021-05-14T22:30B .ONGOINGLAST SUBJECT ENCOUNTER3MedDRA v24.0NDWŽ AEĆ€Hsnńh..... N NNOT RELATEDOTHER prior injury NOT APPLICABLE YNRECOVERING/RESOLVING N A0NOT RELATEDA0A0GRADE 3A0 C! A Period 02DWŽDŔ0Hsnu0DYD–´Huk.´Vaccination 3 APY A02021-07-06T21:15:44Y 103913071039Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDĆŔHrĹ»ŔDWŁD–´Hs‰ű4Placebo APlacebo ADWDĆŔDW#D´´Y . . .Placebo Placebo DW?DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁDŔ0D–´DWżDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBBpBqBđAđHrĹ»ŔHráY4Hsnu0Hs‰ű4 .DWŤWHITE AC4591001C4591001 1039 10391307APADVERSE EVENT 10muscle aches Myalgia F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Muscle ache F™˙F™{Muscle pains F™#Muscle disorders F™Musculoskeletal and connective tissue disorders F™k2021-06-04T20:00B–2021-06-06T12:00B 2MedDRA v24.0NDWŁ AE”HsŠ}ŔDWĄA0D¨űHsŚ°{A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C"Đ A Period 02DWŽDŔ0Hsnu0DYD–´Huk.´Vaccination 4 A`Y A@2021-07-06T19:29:17Y 103913071039Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDĆŔHrĹ»ŔDWŁD–´Hs‰ű4Placebo APlacebo ADWDĆŔDW#D´´Y . . .Placebo Placebo DW?DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁDŔ0D–´DWżDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBBpBqBđAđHrĹ»ŔHráY4Hsnu0Hs‰ű4 .DWŤWHITE AC4591001C4591001 1039 10391307A`ADVERSE EVENT 12fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-06-04T20:00B–2021-06-06T12:00B 1MedDRA v24.0NDWŁ AE”HsŠ}ŔDWĄA0D¨űHsŚ°{A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C"Đ A Period 02DWŽDŔ0Hsnu0DYD–´Huk.´Vaccination 4 A`Y A@2021-07-06T19:29:40Y 103913071039Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDĆŔHrĹ»ŔDWŁD–´Hs‰ű4Placebo APlacebo ADWDĆŔDW#D´´Y . . .Placebo Placebo DW?DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁDŔ0D–´DWżDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBBpBqBđAđHrĹ»ŔHráY4Hsnu0Hs‰ű4 .DWŤWHITE AC4591001C4591001 1039 10391307ApADVERSE EVENT 6 thyroid nodule Thyroid mass FĎęENDOCRINE DISORDERS Thyroid nodule F™AgF™|”Thyroid disorders NEC F™A@Thyroid gland disorders F™A[Endocrine disorders FĎę2021-06-01 B“ .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDW B....... N NNOT RELATEDOTHER Incidental finding NOT APPLICABLE NNNOT RECOVERED/NOT RESOLVED N A0NOT RELATEDA0AGRADE 1A . A Period 02DWŽDŔ0Hsnu0DYD–´Huk.´Vaccination 3 APY A02021-07-14T20:31:00Y 103913071039Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDĆŔHrĹ»ŔDWŁD–´Hs‰ű4Placebo APlacebo ADWDĆŔDW#D´´Y . . .Placebo Placebo DW?DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁDŔ0D–´DWżDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBBpBqBđAđHrĹ»ŔHráY4Hsnu0Hs‰ű4 .DWŤWHITE AC4591001C4591001 1039 10391307A€ADVERSE EVENT 13Vitamin D deficiency Vitamin D deficiency F™©METABOLISM AND NUTRITION DISORDERS Vitamin D deficiency F™PŠF™PŠFat soluble vitamin deficiencies and disorders FŐúVitamin related disorders F™P“Metabolism and nutrition disorders F™©2021-06-11 Bť .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDWŞ A€....... N NNOT RELATEDOTHER Dietary deficiency NOT APPLICABLE YNRECOVERING/RESOLVING N A0NOT RELATEDA0AGRADE 1A . A Period 02DWŽDŔ0Hsnu0DYD–´Huk.´Vaccination 4 A`Y A@2021-07-15T17:36:07Y 103913071039Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDĆŔHrĹ»ŔDWŁD–´Hs‰ű4Placebo APlacebo ADWDĆŔDW#D´´Y . . .Placebo Placebo DW?DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁDŔ0D–´DWżDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBBpBqBđAđHrĹ»ŔHráY4Hsnu0Hs‰ű4 .DWŤWHITE AC4591001C4591001 1039 10391307AADVERSE EVENT 8 vomiting Vomiting FÜ›GASTROINTESTINAL DISORDERS Vomiting F™PÔF™PÔNausea and vomiting symptoms F™Gastrointestinal signs and symptoms FÜÜGastrointestinal disorders FÜ›2021-06-05T03:00B—2021-06-06T03:00B 1MedDRA v24.0NDW¤ A D*0HsŠŕ0DWĄA0D*kHsŚ1ëA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C= A Period 02DWŽDŔ0Hsnu0DYD–´Huk.´Vaccination 4 A`Y A@2021-07-14T20:31:36Y 103913091039Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DWDrŘHrĆąXDW§D¸°HsŹc0Placebo APlacebo ADWDrŘDW#DÇ8Y . . .Placebo Placebo DW?DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW§D„äD¸°DWŃDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB~BmBqBďAŕHrĆąXHrák¸Hsr.dHsŹc0 .DWALL OTHERS A0C4591001C4591001 1039 10391309A ADVERSE EVENT 3 fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-09 Bš2021-06-12 Bť 1MedDRA v24.0NDW¨ A ..DW«AP..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW‘D„äHsr.dDYD¸°Hup–°Vaccination 4 A`Y A@2021-07-22T17:12:08Y 103913091039Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DWDrŘHrĆąXDW§D¸°HsŹc0Placebo APlacebo ADWDrŘDW#DÇ8Y . . .Placebo Placebo DW?DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW§D„äD¸°DWŃDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB~BmBqBďAŕHrĆąXHrák¸Hsr.dHsŹc0 .DWALL OTHERS A0C4591001C4591001 1039 10391309AADVERSE EVENT 1 fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-17T07:30B2021-05-18T12:00B„ 1MedDRA v24.0NDW‘ BoDixHsrřDW’BpD¨űHssŁűA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A E&“ APeriod 01DWDrŘHrĆąXDW‘D„ăHsr.cAfter unblinding and before Vaccination 3A@ A 2021-06-09T00:04:09Y 103913091039Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DWDrŘHrĆąXDW§D¸°HsŹc0Placebo APlacebo ADWDrŘDW#DÇ8Y . . .Placebo Placebo DW?DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW§D„äD¸°DWŃDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB~BmBqBďAŕHrĆąXHrák¸Hsr.dHsŹc0 .DWALL OTHERS A0C4591001C4591001 1039 10391309A0ADVERSE EVENT 2 injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-17T07:30B2021-05-18T12:00B„ 1MedDRA v24.0NDW‘ BoDixHsrřDW’BpD¨űHssŁűA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A E&“ APeriod 01DWDrŘHrĆąXDW‘D„ăHsr.cAfter unblinding and before Vaccination 3A@ A 2021-06-09T00:04:20Y 103913101039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADWD{HrĆÁŚDW¦DXHsŤńXPlacebo APlacebo ADWD{DW"D|8Y . . .Placebo Placebo DW>DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDW¦DÄ¤DXDWĂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB~BpBqBďAĐHrĆÁŚHrßĎ8Hsny¤HsŤńX .DWŤWHITE AC4591001C4591001 1039 10391310AADVERSE EVENT 2 fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-14T07:00B€2021-05-15T07:00B 1MedDRA v24.0NDWŽ BmDbpHsnpDWŹBnDb«Hsoi+A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A E%ń APeriod 01DWD{HrĆÁŚDWŽDÄŁHsnyŁAfter unblinding and before Vaccination 3A@ A 2021-07-07T15:16:47Y 103913101039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADWD{HrĆÁŚDW¦DXHsŤńXPlacebo APlacebo ADWD{DW"D|8Y . . .Placebo Placebo DW>DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDW¦DÄ¤DXDWĂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB~BpBqBďAĐHrĆÁŚHrßĎ8Hsny¤HsŤńX .DWŤWHITE AC4591001C4591001 1039 10391310A ADVERSE EVENT 6 fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-08T14:00B™2021-06-09T08:00Bš 1MedDRA v24.0NDW§ A DÄŕHsŹo`DW¨A0Dp»Hsl»A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Ceŕ A Period 02DWŽDÄ¤Hsny¤DYDXHuo$ŘVaccination 4 A`Y A@2021-07-06T21:31:36Y 103913101039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADWD{HrĆÁŚDW¦DXHsŤńXPlacebo APlacebo ADWD{DW"D|8Y . . .Placebo Placebo DW>DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDW¦DÄ¤DXDWĂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB~BpBqBďAĐHrĆÁŚHrßĎ8Hsny¤HsŤńX .DWŤWHITE AC4591001C4591001 1039 10391310A0ADVERSE EVENT 1 headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-05-14T13:00B€2021-05-14T18:00B€ 1MedDRA v24.0NDWŽ BmD¶ĐHsnkĐDWŽBmDý[Hsn˛[ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A E& APeriod 01DWD{HrĆÁŚDWŽDÄŁHsnyŁAfter unblinding and before Vaccination 3A@ A 2021-06-17T15:12:42Y 103913101039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADWD{HrĆÁŚDW¦DXHsŤńXPlacebo APlacebo ADWD{DW"D|8Y . . .Placebo Placebo DW>DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDW¦DÄ¤DXDWĂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB~BpBqBďAĐHrĆÁŚHrßĎ8Hsny¤HsŤńX .DWŤWHITE AC4591001C4591001 1039 10391310A@ADVERSE EVENT 7 headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-06-08T14:00B™2021-06-09T08:00Bš 1MedDRA v24.0NDW§ A DÄŕHsŹo`DW¨A0Dp»Hsl»A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Ceŕ A Period 02DWŽDÄ¤Hsny¤DYDXHuo$ŘVaccination 4 A`Y A@2021-07-06T21:31:47Y 103913101039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADWD{HrĆÁŚDW¦DXHsŤńXPlacebo APlacebo ADWD{DW"D|8Y . . .Placebo Placebo DW>DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDW¦DÄ¤DXDWĂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB~BpBqBďAĐHrĆÁŚHrßĎ8Hsny¤HsŤńX .DWŤWHITE AC4591001C4591001 1039 10391310APADVERSE EVENT 3 bruise at injection site Injection site bruising FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site bruising Fě¤Fě¤Injection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-14T18:00B€2021-05-18 B„ 1MedDRA v24.0NDWŽ ADý Hsn˛ DW’AP..APDAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Bń A Period 02DWŽDÄ¤Hsny¤DYDXHuo$ŘVaccination 3 APY A02021-06-11T16:31:05Y 103913101039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADWD{HrĆÁŚDW¦DXHsŤńXPlacebo APlacebo ADWD{DW"D|8Y . . .Placebo Placebo DW>DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDW¦DÄ¤DXDWĂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB~BpBqBďAĐHrĆÁŚHrßĎ8Hsny¤HsŤńX .DWŤWHITE AC4591001C4591001 1039 10391310A`ADVERSE EVENT 5 bruising at injection site Injection site bruising FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site bruising Fě¤Fě¤Injection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-07T15:00B2021-06-14 Bź 1MedDRA v24.0NDW¦ ADŇđHsŽ+đDWA€..A€DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Bú A Period 02DWŽDÄ¤Hsny¤DYDXHuo$ŘVaccination 4 A`Y A@2021-07-06T21:31:25Y 103913101039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADWD{HrĆÁŚDW¦DXHsŤńXPlacebo APlacebo ADWD{DW"D|8Y . . .Placebo Placebo DW>DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDW¦DÄ¤DXDWĂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB~BpBqBďAĐHrĆÁŚHrßĎ8Hsny¤HsŤńX .DWŤWHITE AC4591001C4591001 1039 10391310ApADVERSE EVENT 4 swelling at injection site Injection site swelling FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Swelling of injection site F™=HF™g1Injection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-18 B„2021-05-31 B‘ 1MedDRA v24.0NDW’ AP..DWźB..AŕDAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŽDÄ¤Hsny¤DYDXHuo$ŘVaccination 3 APY A02021-06-08T16:44:37Y 103913131039Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDˇ|HrĆçüDW˘D”ÔHs§ÔPlacebo APlacebo ADWDˇ|DW$D”\Y . . .Placebo Placebo DWEDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDW˘D˛ D”ÔDWĂDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB~BpBqBďAŕHrĆçüHrâŠ\Hsng Hs§Ô .DWŤWHITE AC4591001C4591001 1039 10391313AADVERSE EVENT 4 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-04 B•2021-06-05 B– 2MedDRA v24.0NDWŁ A ..DW¤A0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWŽD˛ Hsng DYD”ÔHuiŰTVaccination 4 A`Y A@2021-06-08T16:51:28Y 103913131039Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDˇ|HrĆçüDW˘D”ÔHs§ÔPlacebo APlacebo ADWDˇ|DW$D”\Y . . .Placebo Placebo DWEDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDW˘D˛ D”ÔDWĂDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB~BpBqBďAŕHrĆçüHrâŠ\Hsng Hs§Ô .DWŤWHITE AC4591001C4591001 1039 10391313A ADVERSE EVENT 3 Injection site soreness Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-03T21:00B”2021-06-05 B– 1MedDRA v24.0NDW˘ AEuHs‰:PDW¤A0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C' A Period 02DWŽD˛ Hsng DYD”ÔHuiŰTVaccination 4 A`Y A@2021-06-08T16:50:54Y 103913131039Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDˇ|HrĆçüDW˘D”ÔHs§ÔPlacebo APlacebo ADWDˇ|DW$D”\Y . . .Placebo Placebo DWEDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDW˘D˛ D”ÔDWĂDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB~BpBqBďAŕHrĆçüHrâŠ\Hsng Hs§Ô .DWŤWHITE AC4591001C4591001 1039 10391313A0ADVERSE EVENT 1 General Body aches Pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalised aching FÝF™ŰPain and discomfort NEC F™ÜGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-15T09:00B2021-05-15T20:00B 2MedDRA v24.0NDWŹ A D~Hso…DWŹA E—°HspűADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A CL@ A Period 02DWŽD˛ Hsng DYD”ÔHuiŰTVaccination 3 APY A02021-06-07T15:20:21Y 103913131039Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDˇ|HrĆçüDW˘D”ÔHs§ÔPlacebo APlacebo ADWDˇ|DW$D”\Y . . .Placebo Placebo DWEDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDW˘D˛ D”ÔDWĂDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB~BpBqBďAŕHrĆçüHrâŠ\Hsng Hs§Ô .DWŤWHITE AC4591001C4591001 1039 10391313A@ADVERSE EVENT 2 General Body aches Pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalised aching FÝF™ŰPain and discomfort NEC F™ÜGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-03T21:00B”2021-06-05 B– 2MedDRA v24.0NDW˘ AEuHs‰:PDW¤A0..A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C' A Period 02DWŽD˛ Hsng DYD”ÔHuiŰTVaccination 4 A`Y A@2021-06-08T16:49:57Y 103913141039Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DWD¨HrĆîŚDW¦DqčHsŤĘčPlacebo APlacebo ADWD¨DW$DłLY . . .Placebo Placebo DW@DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DpDqčDWĂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB~BmBqBďAŕHrĆîŚHrâ©LHsrHsŤĘč .DWALL OTHERS A0C4591001C4591001 1039 10391314AADVERSE EVENT 1 Exacerbation of fibroadenoma of right breast Fibroadenoma of breast F™0NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)Fibroadenoma of breast F×eF×eBreast and nipple neoplasms benign FŻBreast neoplasms benign (incl nipple) FŻNeoplasms benign, malignant and unspecified (incl cysts and polyps)F™02021-02-06 B2021-04-06 BZ 1MedDRA v24.0NDW- A ..DWhBE..B<DAYSN NNOT RELATEDOTHER female hormonal changes NOT APPLICABLE NYRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DWD¨HrĆîŚDW‘DpHsr‡Vaccination 2 A Y A 2021-06-17T19:16:10 AE outcome, Actions to the AE, AERELTXT changed from EUA to sBLA 103913141039Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DWD¨HrĆîŚDW¦DqčHsŤĘčPlacebo APlacebo ADWD¨DW$DłLY . . .Placebo Placebo DW@DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DpDqčDWĂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB~BmBqBďAŕHrĆîŚHrâ©LHsrHsŤĘč .DWALL OTHERS A0C4591001C4591001 1039 10391314A ADVERSE EVENT 2 Injection Site Pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-17T13:00B2021-05-19 B… 1MedDRA v24.0NDW‘ AD¶ĐHsr`PDW“A0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Cŕ A Period 02DW‘DpHsrDYDqčHunţhVaccination 3 APY A02021-06-09T14:59:03Y 103913151039BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDĂ´HrÇ 4DW#DÄhHráhčBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWDĂ´DW#DÄhY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW?DWŤYPhase 3A@NNEGDWŽ ....... . .NY.DWŤDWýBBpBďAŕHrÇ 4Hráhč.. .DWÓWHITE AC4591001C4591001 1039 10391315AADVERSE EVENT 1 vasovagal episode Presyncope F™•NERVOUS SYSTEM DISORDERS Vaso vagal attack F™N˘F™%Neurological signs and symptoms NEC F™úNeurological disorders NEC F™ůNervous system disorders F™•2021-07-22T12:31BĹ2021-07-22T12:45BĹ 2MedDRA v24.0NDWÓ B±D°HsÉ\„DWÓB±Dł‡HsÉ`ADAYSN NNOT RELATEDOTHER Blood draw procedure at visit. NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A E=Ú APeriod 01DWDĂ´HrÇ 4DXDÄhHtÂśhAfter unblinding and before Vaccination 3A@ A 2021-07-22T21:46:48Y 103913171039Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DWDÄ¤HrÇ$DW˘DrśHs…śPlacebo APlacebo ADWDÄ¤DW$DľPY . . .Placebo Placebo DWADWŚYPhase 3A@NPOSDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDW˘DŐüDrśDWľDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB~BpBqBďAŔHrÇ$Hrâ´PHsnŠüHs…ś .DWŤALL OTHERS A0C4591001C4591001 1039 10391317AADVERSE EVENT 4 chills Chills FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills F·ÓF·ÓFeelings and sensations NEC F™ŁGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-15T13:00B2021-05-15T15:00B 1MedDRA v24.0NDWŹ A D¶ĐHso˝PDWŹA DÓ+HsoŮ«ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CQ° A Period 02DWŽDŐüHsnŠüDYDrśHuiąVaccination 3 APY A02021-06-18T19:36:41Y 103913171039Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DWDÄ¤HrÇ$DW˘DrśHs…śPlacebo APlacebo ADWDÄ¤DW$DľPY . . .Placebo Placebo DWADWŚYPhase 3A@NPOSDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDW˘DŐüDrśDWľDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB~BpBqBďAŔHrÇ$Hrâ´PHsnŠüHs…ś .DWŤALL OTHERS A0C4591001C4591001 1039 10391317A ADVERSE EVENT 3 fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-15T08:00B2021-05-15T15:00B 1MedDRA v24.0NDWŹ A Dp€HsowDWŹA DÓ+HsoŮ«ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C>đ A Period 02DWŽDŐüHsnŠüDYDrśHuiąVaccination 3 APY A02021-06-18T19:36:29Y 103913171039Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DWDÄ¤HrÇ$DW˘DrśHs…śPlacebo APlacebo ADWDÄ¤DW$DľPY . . .Placebo Placebo DWADWŚYPhase 3A@NPOSDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDW˘DŐüDrśDWľDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB~BpBqBďAŔHrÇ$Hrâ´PHsnŠüHs…ś .DWŤALL OTHERS A0C4591001C4591001 1039 10391317A0ADVERSE EVENT 2 pre-syncope Presyncope F™•NERVOUS SYSTEM DISORDERS Pre-syncope F™%F™%Neurological signs and symptoms NEC F™úNeurological disorders NEC F™ůNervous system disorders F™•2021-01-07T13:35A2021-01-07T13:48A 1MedDRA v24.0NDW ADżHrÇ„DWADÂKHrÇËADAYSN NNOT RELATEDOTHER blood draw NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A Â APeriod 01DWDÄ¤HrÇ$DWŽDŐűHsnŠűPre-Vaccination Y.2021-06-18T19:36:17Y 103913171039Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DWDÄ¤HrÇ$DW˘DrśHs…śPlacebo APlacebo ADWDÄ¤DW$DľPY . . .Placebo Placebo DWADWŚYPhase 3A@NPOSDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDW˘DŐüDrśDWľDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB~BpBqBďAŔHrÇ$Hrâ´PHsnŠüHs…ś .DWŤALL OTHERS A0C4591001C4591001 1039 10391317A@ADVERSE EVENT 1 vomiting Vomiting FÜ›GASTROINTESTINAL DISORDERS Vomiting F™PÔF™PÔNausea and vomiting symptoms F™Gastrointestinal signs and symptoms FÜÜGastrointestinal disorders FÜ›2021-01-07T13:35A2021-01-07T13:48A 1MedDRA v24.0NDW ADżHrÇ„DWADÂKHrÇËADAYSN NNOT RELATEDOTHER blood draw NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A Â APeriod 01DWDÄ¤HrÇ$DWŽDŐűHsnŠűPre-Vaccination Y.2021-06-18T19:36:05Y 103913191039Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDu0HrČ 0DWŞDĆŔHs“eŔPlacebo APlacebo ADWDu0DW%DźśY . . .Placebo Placebo DWEDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW”DWŞDĹDĆŔDWĆDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB}BjBqBîAŔHrČ 0HrăçHsvcHs“eŔ .DW“WHITE AC4591001C4591001 1039 10391319AADVERSE EVENT 2 chills Chills FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills F·ÓF·ÓFeelings and sensations NEC F™ŁGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-21 B†2021-05-22 B‡ 2MedDRA v24.0NDW• A ..DW–A0..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DW”DĹHsvcDYDĆŔHut™@Vaccination 3 APY A02021-06-03T14:15:39Y 103913191039Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDu0HrČ 0DWŞDĆŔHs“eŔPlacebo APlacebo ADWDu0DW%DźśY . . .Placebo Placebo DWEDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW”DWŞDĹDĆŔDWĆDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB}BjBqBîAŔHrČ 0HrăçHsvcHs“eŔ .DW“WHITE AC4591001C4591001 1039 10391319A ADVERSE EVENT 3 injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-21 B†2021-05-23 B 2MedDRA v24.0NDW• A ..DW—A@..A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DW”DĹHsvcDYDĆŔHut™@Vaccination 3 APY A02021-06-03T14:16:42Y 103913191039Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDu0HrČ 0DWŞDĆŔHs“eŔPlacebo APlacebo ADWDu0DW%DźśY . . .Placebo Placebo DWEDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW”DWŞDĹDĆŔDWĆDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB}BjBqBîAŔHrČ 0HrăçHsvcHs“eŔ .DW“WHITE AC4591001C4591001 1039 10391319A0ADVERSE EVENT 1 fever - max temp 102.3 Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-05-21 B†2021-05-23 B 3MedDRA v24.0NDW• A ..DW—A@..A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA0GRADE 3A0 . A Period 02DW”DĹHsvcDYDĆŔHut™@Vaccination 3 APY A02021-06-03T14:14:01Y 103913211039Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDŚ HrČ$ DW§DÂHsŹmPlacebo APlacebo ADWDŚ DW%Dm8Y . . .Placebo Placebo DWDDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW§Dp€DÂDWĘDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB}BmBqBîAŔHrČ$ Hră´¸HsrHsŹm .DWWHITE AC4591001C4591001 1039 10391321AADVERSE EVENT 1 Chills Chills FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills F·ÓF·ÓFeelings and sensations NEC F™ŁGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-17T20:00B‚2021-05-18T10:00B 2MedDRA v24.0NDW‘ AE”HsrÂŔDW’A DŚŰHss‡ŰA DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C- A Period 02DW‘Dp€HsrDYDÂHup Vaccination 3 APY A02021-06-08T21:15:48Y 103913211039Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDŚ HrČ$ DW§DÂHsŹmPlacebo APlacebo ADWDŚ DW%Dm8Y . . .Placebo Placebo DWDDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW§Dp€DÂDWĘDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB}BmBqBîAŔHrČ$ Hră´¸HsrHsŹm .DWWHITE AC4591001C4591001 1039 10391321A ADVERSE EVENT 2 Injection arm soreness Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-08T17:00B2021-06-09T17:00B™ 1MedDRA v24.0NDW§ ADďHsŹ™DW¨A DďKHsëKA DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Bľ A Period 02DW‘Dp€HsrDYDÂHup Vaccination 4 A`Y A@2021-07-15T21:20:29Y 103913251039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DWD´´HrĚA4DW˘DxxHs‹xPlacebo APlacebo ADWD´´DW(Dv\Y . . .Placebo Placebo DWGDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW˘DŤDxxDWĂDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBzBqBqBëAĐHrĚA4Hrç˛\HslńHs‹x .DWŚALL OTHERS A0C4591001C4591001 1039 10391325AADVERSE EVENT 2 Chills Chills FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills F·ÓF·ÓFeelings and sensations NEC F™ŁGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-13T22:00B{2021-05-15 B} 2MedDRA v24.0NDWŤ AEVHsmŕDWŹA0..A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C,Ŕ A Period 02DWŤDŤHslńDYDxxHuiľřVaccination 3 APY A02021-06-07T18:38:55Y 103913251039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DWD´´HrĚA4DW˘DxxHs‹xPlacebo APlacebo ADWD´´DW(Dv\Y . . .Placebo Placebo DWGDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW˘DŤDxxDWĂDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBzBqBqBëAĐHrĚA4Hrç˛\HslńHs‹x .DWŚALL OTHERS A0C4591001C4591001 1039 10391325A ADVERSE EVENT 5 chills Chills FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills F·ÓF·ÓFeelings and sensations NEC F™ŁGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-03T21:00B2021-06-05 B’ 1MedDRA v24.0NDW˘ AEuHs‰:PDW¤A0..A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C. A Period 02DWŤDŤHslńDYDxxHuiľřVaccination 4 A`Y A@2021-06-17T20:13:21Y 103913251039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DWD´´HrĚA4DW˘DxxHs‹xPlacebo APlacebo ADWD´´DW(Dv\Y . . .Placebo Placebo DWGDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW˘DŤDxxDWĂDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBzBqBqBëAĐHrĚA4Hrç˛\HslńHs‹x .DWŚALL OTHERS A0C4591001C4591001 1039 10391325APADVERSE EVENT 6 fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-04 B‘2021-06-07 B” 2MedDRA v24.0NDWŁ A ..DW¦AP..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWŤDŤHslńDYDxxHuiľřVaccination 4 A`Y A@2021-06-17T20:13:38Y 103913251039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DWD´´HrĚA4DW˘DxxHs‹xPlacebo APlacebo ADWD´´DW(Dv\Y . . .Placebo Placebo DWGDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW˘DŤDxxDWĂDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBzBqBqBëAĐHrĚA4Hrç˛\HslńHs‹x .DWŚALL OTHERS A0C4591001C4591001 1039 10391325A0ADVERSE EVENT 3 fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-13T22:00B{2021-05-15 B} 2MedDRA v24.0NDWŤ AEVHsmŕDWŹA0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C,Ŕ A Period 02DWŤDŤHslńDYDxxHuiľřVaccination 3 APY A02021-06-08T16:44:48Y 103913251039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DWD´´HrĚA4DW˘DxxHs‹xPlacebo APlacebo ADWD´´DW(Dv\Y . . .Placebo Placebo DWGDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW˘DŤDxxDWĂDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBzBqBqBëAĐHrĚA4Hrç˛\HslńHs‹x .DWŚALL OTHERS A0C4591001C4591001 1039 10391325A@ADVERSE EVENT 8 fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-03T14:00B2021-06-04 B‘ 1MedDRA v24.0NDW˘ ADÄŕHs×ŕDWŁA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C` A Period 02DWŤDŤHslńDYDxxHuiľřVaccination 4 A`Y A@2021-07-06T17:54:46Y 103913251039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DWD´´HrĚA4DW˘DxxHs‹xPlacebo APlacebo ADWD´´DW(Dv\Y . . .Placebo Placebo DWGDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW˘DŤDxxDWĂDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBzBqBqBëAĐHrĚA4Hrç˛\HslńHs‹x .DWŚALL OTHERS A0C4591001C4591001 1039 10391325A`ADVERSE EVENT 7 bruise at injection site Injection site bruising FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site bruising Fě¤Fě¤Injection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-04 B‘2021-06-11 B 1MedDRA v24.0NDWŁ A ..DWŞA..A€DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŤDŤHslńDYDxxHuiľřVaccination 4 A`Y A@2021-06-15T15:25:55Y 103913251039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DWD´´HrĚA4DW˘DxxHs‹xPlacebo APlacebo ADWD´´DW(Dv\Y . . .Placebo Placebo DWGDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW˘DŤDxxDWĂDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBzBqBqBëAĐHrĚA4Hrç˛\HslńHs‹x .DWŚALL OTHERS A0C4591001C4591001 1039 10391325ApADVERSE EVENT 4 generalized aches Pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalised aching FÝF™ŰPain and discomfort NEC F™ÜGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-04 B‘2021-06-05 B’ 1MedDRA v24.0NDWŁ A ..DW¤A0..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŤDŤHslńDYDxxHuiľřVaccination 4 A`Y A@2021-06-17T20:13:02Y 103913251039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DWD´´HrĚA4DW˘DxxHs‹xPlacebo APlacebo ADWD´´DW(Dv\Y . . .Placebo Placebo DWGDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW˘DŤDxxDWĂDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBzBqBqBëAĐHrĚA4Hrç˛\HslńHs‹x .DWŚALL OTHERS A0C4591001C4591001 1039 10391325A€ADVERSE EVENT 1 Fever - up to 103.4 Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-05-13T22:00B{2021-05-14T09:00B| 3MedDRA v24.0NDWŤ AEVHsmŕDWŽA D~ËHsn3ËA DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA0GRADE 3A0 C,Ŕ A Period 02DWŤDŤHslńDYDxxHuiľřVaccination 3 APY A02021-06-07T20:45:26Y 103913271039Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADWD¸°HrĚE0DW(DzĐHrç¶ĐPlacebo APlacebo ADWD¸°DW(DzĐY . . .Placebo Placebo DWEDWŚYPhase 3A@NNEGDWŤ ....... . .NN.DWŚDWýBzBqBëAđHrĚE0Hrç¶Đ.. .DWŮWHITE AC4591001C4591001 1039 10391327AADVERSE EVENT 1 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-06 B“2021-06-08 B• 1MedDRA v24.0NDWĄ B~..DW§B€..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . APeriod 01DWD¸°HrĚE0DX•DzĐHtČęPAfter unblinding and before Vaccination 3A@ A 2021-06-23T13:35:18Y 103913281039Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDşTHrĚFÔDWŁD·üHsŠ|Placebo APlacebo ADWDşTDW)DkĐY . . .Placebo Placebo DWEDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁDŻPD·üDWĹDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBzBpBqBëAŕHrĚFÔHrčůPHsndPHsŠ| .DWŤWHITE AC4591001C4591001 1039 10391328A ADVERSE EVENT 2 fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-14T16:00B|2021-05-17 B 1MedDRA v24.0NDWŽ ADáHsn–DW‘A@..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A BÔ A Period 02DWŽDŻPHsndPDYD·üHukOüVaccination 3 APY A02021-06-17T23:59:08Y 103913281039Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDşTHrĚFÔDWŁD·üHsŠ|Placebo APlacebo ADWDşTDW)DkĐY . . .Placebo Placebo DWEDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁDŻPD·üDWĹDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBzBpBqBëAŕHrĚFÔHrčůPHsndPHsŠ| .DWŤWHITE AC4591001C4591001 1039 10391328AADVERSE EVENT 4 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-04T19:00B‘2021-06-05T19:00B’ 1MedDRA v24.0NDWŁ AEłHsŠo°DW¤A E¶°Hs‹ÁkA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C0 A Period 02DWŽDŻPHsndPDYD·üHukOüVaccination 4 A`Y A@2021-07-15T18:00:56Y 103913281039Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDşTHrĚFÔDWŁD·üHsŠ|Placebo APlacebo ADWDşTDW)DkĐY . . .Placebo Placebo DWEDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁDŻPD·üDWĹDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBzBpBqBëAŕHrĚFÔHrčůPHsndPHsŠ| .DWŤWHITE AC4591001C4591001 1039 10391328A@ADVERSE EVENT 1 Injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-14T18:00B|2021-05-17 B 1MedDRA v24.0NDWŽ ADý Hsn˛ DW‘A@..A@DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CŔ A Period 02DWŽDŻPHsndPDYD·üHukOüVaccination 3 APY A02021-06-17T20:16:38Y 103913281039Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDşTHrĚFÔDWŁD·üHsŠ|Placebo APlacebo ADWDşTDW)DkĐY . . .Placebo Placebo DWEDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁDŻPD·üDWĹDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBzBpBqBëAŕHrĚFÔHrčůPHsndPHsŠ| .DWŤWHITE AC4591001C4591001 1039 10391328A0ADVERSE EVENT 3 Injection arm soreness Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-04T19:00B‘2021-06-05T19:00B’ 1MedDRA v24.0NDWŁ AEłHsŠo°DW¤A E¶°Hs‹ÁkA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C0 A Period 02DWŽDŻPHsndPDYD·üHukOüVaccination 4 A`Y A@2021-07-08T22:45:11Y 103913291039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDÔXHrĚ`ŘDW©D˝śHs’Placebo APlacebo ADWDÔXDW(Dy¤Y . . .Placebo Placebo DWEDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW”DW©DĹXD˝śDWĆDXfBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBzBjBqBëAĐHrĚ`ŘHrçµ¤HsvcXHs’ .DW“WHITE AC4591001C4591001 1039 10391329AADVERSE EVENT 2 fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-11 B2021-06-13 Bš 1MedDRA v24.0NDWŞ A ..DW¬A@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW”DĹXHsvcXDYD˝śHus>śVaccination 4 A`Y A@2021-07-09T20:10:38Y 103913291039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDÔXHrĚ`ŘDW©D˝śHs’Placebo APlacebo ADWDÔXDW(Dy¤Y . . .Placebo Placebo DWEDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW”DW©DĹXD˝śDWĆDXfBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBzBjBqBëAĐHrĚ`ŘHrçµ¤HsvcXHs’ .DW“WHITE AC4591001C4591001 1039 10391329A0ADVERSE EVENT 3 injection arm soreness Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-11 B2021-06-13 Bš 1MedDRA v24.0NDWŞ A ..DW¬A@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW”DĹXHsvcXDYD˝śHus>śVaccination 4 A`Y A@2021-07-09T20:10:50Y 103913291039Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDÔXHrĚ`ŘDW©D˝śHs’Placebo APlacebo ADWDÔXDW(Dy¤Y . . .Placebo Placebo DWEDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW”DW©DĹXD˝śDWĆDXfBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBzBjBqBëAĐHrĚ`ŘHrçµ¤HsvcXHs’ .DW“WHITE AC4591001C4591001 1039 10391329A ADVERSE EVENT 1 Injection site soreness Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-21T07:00B2021-05-23 B… 1MedDRA v24.0NDW• A DbpHswQđDW—A@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C? A Period 02DW”DĹXHsvcXDYD˝śHus>śVaccination 3 APY A02021-06-10T21:14:02Y 103913301039BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDŇ´HrĚ_4DW)DľČHréLHBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWDŇ´DW)DľČY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWHDWpYPhase 3A@NNEGDWq ....... . .NY.DWpDWýB^BŤBëAđHrĚ_4HréLH.. .DWćWHITE AC4591001C4591001 1039 10391330AADVERSE EVENT 1 stomach pain Abdominal pain upper FÜ›GASTROINTESTINAL DISORDERS Stomach pain F™;F–×Gastrointestinal and abdominal pains (excl oral and throat) FÜ†Gastrointestinal signs and symptoms FÜÜGastrointestinal disorders FÜ›2021-06-25 B¦2021-06-25 B¦ 1MedDRA v24.0NDW¸ B..DW¸B..ADAYSN NNOT RELATEDOTHER food NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DWDŇ´HrĚ_4DX–DľČHtĘČAfter 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_30AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDŇ´HrĚ_4DW)DľČHréLHBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWDŇ´DW)DľČY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWHDWpYPhase 3A@NNEGDWq ....... . .NY.DWpDWýB^BŤBëAđHrĚ_4HréLH.. .DWćWHITE AC4591001C4591001 1039 10391330A ADVERSE EVENT 2 nausea Nausea FÜ›GASTROINTESTINAL DISORDERS Nausea F™ F™ Nausea and vomiting symptoms F™Gastrointestinal signs and symptoms FÜÜGastrointestinal disorders FÜ›2021-06-25 B¦2021-06-25 B¦ 1MedDRA v24.0NDW¸ B..DW¸B..ADAYSN NNOT RELATEDOTHER food NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DWDŇ´HrĚ_4DX–DľČHtĘČAfter unblinding and before Vaccination 3A@ A 2021-06-30T18:54:09Y 103913331039Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADWD‡HrÍeDWŞDÇtHs“ftPlacebo APlacebo ADWD‡DW)Du0Y . . .Placebo Placebo DWEDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW•DWŞDĆHDÇtDWĆDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýByBiBqBęAđHrÍeHré°HswµČHs“ft .DW”WHITE AC4591001C4591001 1039 10391333AADVERSE EVENT 1 fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-12 B2021-06-13 B™ 1MedDRA v24.0NDW« A ..DW¬A0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW•DĆHHswµČDYDÇtHut™ôVaccination 4 A`Y A@2021-07-09T17:19:01Y 103913371039Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADWDŞÜHrÍÜDWŁDźśHsŠPlacebo APlacebo ADWDŞÜDW*DndY . . .Placebo Placebo DWLDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁD ČDźśDWżDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýByBpBqBęAđHrÍÜHręMdHsnUČHsŠ .DWŤWHITE AC4591001C4591001 1039 10391337AADVERSE EVENT 2 chills Chills FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills F·ÓF·ÓFeelings and sensations NEC F™ŁGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-14T23:30B{2021-05-15T16:00B| 2MedDRA v24.0NDWŽ AE§€Hsn˙xDWŹA Dá;Hsoç»A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C-@ A Period 02DWŽD ČHsnUČDYDźśHuk7śVaccination 3 APY A02021-06-17T23:57:48Y 103913371039Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADWDŞÜHrÍÜDWŁDźśHsŠPlacebo APlacebo ADWDŞÜDW*DndY . . .Placebo Placebo DWLDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁD ČDźśDWżDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýByBpBqBęAđHrÍÜHręMdHsnUČHsŠ .DWŤWHITE AC4591001C4591001 1039 10391337A ADVERSE EVENT 6 Fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-06-05T08:00B‘2021-06-06 B’ 1MedDRA v24.0NDW¤ A Dp€Hs‹&€DWĄA0..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CMp A Period 02DWŽD ČHsnUČDYDźśHuk7śVaccination 4 A`Y A@2021-06-17T20:47:35Y 103913371039Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADWDŞÜHrÍÜDWŁDźśHsŠPlacebo APlacebo ADWDŞÜDW*DndY . . .Placebo Placebo DWLDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁD ČDźśDWżDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýByBpBqBęAđHrÍÜHręMdHsnUČHsŠ .DWŤWHITE AC4591001C4591001 1039 10391337A0ADVERSE EVENT 1 urticaria, both hands Urticaria F™5ŃSKIN AND SUBCUTANEOUS TISSUE DISORDERS Urticaria F™MF™MUrticarias F™MAngioedema and urticaria FźúSkin and subcutaneous tissue disorders F™5Ń2021-02-04 B2021-02-06 B 1MedDRA v24.0NDW+ A ..DW-A@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . APeriod 01DWDŞÜHrÍÜDWŽD ÇHsnUÇVaccination 2 A Y A 2021-02-09T19:32:17 103913371039Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADWDŞÜHrÍÜDWŁDźśHsŠPlacebo APlacebo ADWDŞÜDW*DndY . . .Placebo Placebo DWLDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁD ČDźśDWżDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýByBpBqBęAđHrÍÜHręMdHsnUČHsŠ .DWŤWHITE AC4591001C4591001 1039 10391337A@ADVERSE EVENT 3 vomit Vomiting FÜ›GASTROINTESTINAL DISORDERS Vomiting F™PÔF™PÔNausea and vomiting symptoms F™Gastrointestinal signs and symptoms FÜÜGastrointestinal disorders FÜ›2021-05-15T07:30B|2021-05-15T07:35B| 1MedDRA v24.0NDWŹ A DixHsoořDWŹA DjßHsoq_ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CK@ A Period 02DWŽD ČHsnUČDYDźśHuk7śVaccination 3 APY A02021-05-18T19:26:50Y 103913391039Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADWDŃHrÍŻDW¦DrśHsŤËśPlacebo APlacebo ADWDŃDW*DxY . . .Placebo Placebo DWGDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW¦D~DrśDWĹDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýByBlBqBęAŔHrÍŻHręWHssyHsŤËś .DW‘WHITE AC4591001C4591001 1039 10391339AADVERSE EVENT 2 Nausea Nausea FÜ›GASTROINTESTINAL DISORDERS Nausea F™ F™ Nausea and vomiting symptoms F™Gastrointestinal signs and symptoms FÜÜGastrointestinal disorders FÜ›2021-01-12T20:00A2021-01-12T20:30A 1MedDRA v24.0NDW AE”HrÍ÷@DWAE0HrÍţADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C@ APeriod 01DWDŃHrÍŻDW’D~HssyVaccination 1 AY A2021-06-09T00:05:14Y 103913391039Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADWDŃHrÍŻDW¦DrśHsŤËśPlacebo APlacebo ADWDŃDW*DxY . . .Placebo Placebo DWGDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW¦D~DrśDWĹDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýByBlBqBęAŔHrÍŻHręWHssyHsŤËś .DW‘WHITE AC4591001C4591001 1039 10391339A ADVERSE EVENT 1 Vomiting Vomiting FÜ›GASTROINTESTINAL DISORDERS Vomiting F™PÔF™PÔNausea and vomiting symptoms F™Gastrointestinal signs and symptoms FÜÜGastrointestinal disorders FÜ›2021-01-12T20:00A2021-01-12T20:30A 1MedDRA v24.0NDW AE”HrÍ÷@DWAE0HrÍţADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C@ APeriod 01DWDŃHrÍŻDW’D~HssyVaccination 1 AY A2021-06-09T02:53:27Y 104412651044Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVđDöHrž^DW¨DÇ°HsĂ°Placebo APlacebo ADVđDöDWDžpY . . .Placebo Placebo DW"DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DW¨DĂxDÇ°DWĹDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBťBkBqCŕAŕHrž^HrąµđHsuřHsĂ° .DW’WHITE AC4591001C4591001 1044 10441265AADVERSE EVENT 3 sinusitis Sinusitis FëůINFECTIONS AND INFESTATIONS Sinusitis F™5±F™5±Upper respiratory tract infections F™KeInfections - pathogen unspecified Fë÷Infections and infestations Fëů2021-06-16 BŔ2021-06-27 BË 1MedDRA v24.0NDWŻ A€..DWşB..AŔDAYSN NNOT RELATEDOTHER unk NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . A Period 02DW“DĂxHsuřDYDÇ°Huq÷0Vaccination 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_30AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVńD˘¨Hrź\(DWD»DHrąŇÄBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVńD˘¨DWD»DY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW%DW»YPhase 3A@NNEG. ....... . .NY.DWý.CĐ..CĐAŕHrź\(HrąŇÄ.. .DW»WHITE AC4591001C4591001 1044 10441266AADVERSE EVENT 1 Worsening of acne Acne F™5ŃSKIN AND SUBCUTANEOUS TISSUE DISORDERS Acne aggravated FrFpAcnes FqSkin appendage conditions F™5ŢSkin and subcutaneous tissue disorders F™5Ń2021-01-07 B2021-02-01 B8 1MedDRA v24.0NDW A°..DW(B$..BDAYSN NNOT RELATEDOTHER unk NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVńD˘¨Hrź\(DXrD»DHt›DVaccination 2 A Y A 2021-04-28T22:58:40Y 104412671044Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVńD©°Hrźc0DW¨DčHs©čPlacebo APlacebo ADVńD©°DWDŘY . . .Placebo Placebo DW!DWŽYPhase 3A@NNEGDWŹ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DW¨D ČDčDWÉDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŽDWýBžBkBoCĐAŕHrźc0Hrą¨XHstíHHs©č .DW’WHITE AC4591001C4591001 1044 10441267AADVERSE EVENT 1 Accidental fall Fall FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Fall FŐFŐNon-site specific injuries NEC F™ ÇInjuries NEC FěâInjury, poisoning and procedural complications Fěĺ2021-04-29 BŹ2021-06-02 B± 2MedDRA v24.0NDW B{..DWˇBť..B#DAYSN NNOT RELATEDOTHER unk NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVńD©°Hrźc0DW“D ÇHstíGFollow Up 1 A0Y A 2021-07-12T20:59:07Y 104412671044Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVńD©°Hrźc0DW¨DčHs©čPlacebo APlacebo ADVńD©°DWDŘY . . .Placebo Placebo DW!DWŽYPhase 3A@NNEGDWŹ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DW¨D ČDčDWÉDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŽDWýBžBkBoCĐAŕHrźc0Hrą¨XHstíHHs©č .DW’WHITE AC4591001C4591001 1044 10441267A ADVERSE EVENT 2 thumb fracture Hand fracture FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Fractured thumb FÚ!Fá*Limb fractures and dislocations F™ľîBone and joint injuries F¶Injury, poisoning and procedural complications Fěĺ2021-04-29 BŹ2021-06-02 B± 2MedDRA v24.0NDW B{..DWˇBť..B#DAYSN NNOT RELATEDOTHER accidental fall NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVńD©°Hrźc0DW“D ÇHstíGFollow Up 1 A0Y A 2021-07-12T20:50:59Y 104412751044Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVňD–´Hr ˇ´DW¨DŹpHs‹pPlacebo APlacebo ADVňD–´DWDžpY . . .Placebo Placebo DW%DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¨D·HDŹpDWÄDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB›BmBqCŔAŔHr ˇ´Hr»pHsr`ČHs‹p .DWWHITE AC4591001C4591001 1044 10441275AADVERSE EVENT 1 myalgia Myalgia F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Myalgia F™{F™{Muscle pains F™#Muscle disorders F™Musculoskeletal and connective tissue disorders F™k2021-01-04 B2021-01-04 B 1MedDRA v24.0NDW Ap..DWAp..ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . APeriod 01DVňD–´Hr ˇ´DW‘D·GHsr`ÇVaccination 2 A Y A 2021-01-29T23:53:45 104412821044Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVňEF@HrˇdDW[DŔäHs+9dPlacebo APlacebo ADVňEF@DWDĎ¨Y . . .Placebo Placebo DW#DW<YPhase 3A@NNEGDW= BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWFDW[DťĽDŔäDWwDXBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW<DWýBKB¸BÁCŔAđHrˇdHrĽŠ(HsfĽHs+9d .DWEWHITE AC4591001C4591001 1044 10441282AADVERSE EVENT 1 injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-03-25 Bk2021-03-25 Bk 1MedDRA v24.0NDW\ A ..DW\A ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWFDťĽHsfĽDXČDŔäHuläVaccination 4 A`Y A@2021-04-21T23:28:48Y 104412841044Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVóDÖěHr˘3lDW˘DŃLHsäLPlacebo APlacebo ADVóDÖěDWDËčY . . .Placebo Placebo DW"DW‚YPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW˘DÖěDŃLDWľDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‚DWýBBqB{C°AđHr˘3lHr»4čHsm:lHsäL .DWŚWHITE AC4591001C4591001 1044 10441284AADVERSE EVENT 1 Anxiety Anxiety F™'·PSYCHIATRIC DISORDERS Anxiety Fˇ§Fˇ§Anxiety symptoms FˇµAnxiety disorders and symptoms FˇPsychiatric 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 01DVóDÖěHr˘3lDWŤDÖëHsm:kFollow Up 1 A0Y A 2021-05-14T21:56:59Y 104412841044Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVóDÖěHr˘3lDW˘DŃLHsäLPlacebo APlacebo ADVóDÖěDWDËčY . . .Placebo Placebo DW"DW‚YPhase 3A@NNEGDW BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW˘DÖěDŃLDWľDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‚DWýBBqB{C°AđHr˘3lHr»4čHsm:lHsäL .DWŚWHITE AC4591001C4591001 1044 10441284A ADVERSE EVENT 2 depression Depression F™'·PSYCHIATRIC DISORDERS Depression FĆÚFĆÚDepressive disorders FĆńDepressed mood disorders and disturbances FĆ×Psychiatric 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 01DVóDÖěHr˘3lDWŤDÖëHsm: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_30AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVóDäHHr˘@ČDWD’|HrĽLüBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVóDäHDWD’|Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW%DWżYPhase 3A@NNEG. ....... . .NY.DWý.C°..C°AđHr˘@ČHrĽLü.. .DWżWHITE AC4591001C4591001 1044 10441285AADVERSE EVENT 1 Wisdom teeth extraction Wisdom teeth removal F™<őSURGICAL AND MEDICAL PROCEDURES Wisdom teeth removal F™Q÷F™Q÷Dental and gingival therapeutic procedures FĆťHead and neck therapeutic procedures FávSurgical and medical procedures F™<ő2021-06-22 BĂ2021-06-22 BĂ 2MedDRA v24.0NDWµ BŻ..DWµBŻ..ADAYSN NNOT RELATEDOTHER unk NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVóDäHHr˘@ČDXtD’|Htť€|Follow Up 1 A0Y A 2021-07-12T12:06:07Y 104412921044Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVúDÎHr«eDWcD·„Hs5ĽPlacebo APlacebo ADVúDÎDW D¦,Y . . .Placebo Placebo DW+DWJYPhase 3A@NNEGDWK BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWMDWcDŐHD·„DWDX BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWJDWýBQB±BłC@AđHr«eHrÄI¬HsŘČHs5Ľ .DWLWHITE AC4591001C4591001 1044 10441292AADVERSE EVENT 1 Edema Toes (Bilateral) Oedema peripheral FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Foot edema FŘČF™,Oedema NEC F™!General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2020-12-17 A2020-12-19 A0 1MedDRA v24.0NDVú A..DVüA0..A0DAYSN NNOT RELATEDOTHER unk NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVúDÎHr«eDWMDŐGHsŘÇVaccination 1 AY A2021-01-06T10:52:32 104413001044BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDúPHrşĐDWD¬HrŐt¬BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWDúPDWD¬Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW6DWŚYPhase 3A@NNEGDWŤ ....... . .NY.DWŚDWýBBqBůAđHrşĐHrŐt¬.. .DWŃWHITE AC4591001C4591001 1044 10441300AADVERSE EVENT 1 Stomach pain Abdominal pain upper FÜ›GASTROINTESTINAL DISORDERS Stomach pain F™;F–×Gastrointestinal and abdominal pains (excl oral and throat) FÜ†Gastrointestinal signs and symptoms FÜÜGastrointestinal disorders FÜ›2021-08-31 B÷2021-09-01 Bř 1MedDRA v24.0NDWű Bâ..DWüBă..A DAYSN NNOT RELATEDOTHER unk NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DWDúPHrşĐDX‡D¬Ht¶¨,After unblinding and before Vaccination 3A@ A 2021-09-07T12:48:29Y 104413031044Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDî\Hr»W\DWŤD’Hslő„Placebo APlacebo ADWDî\DWDóüY . . .Placebo Placebo DW=DWqYPhase 3A@NNEGDWr BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWvDWŤDśĚD’DWDXJBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWqDWýBlBBŚBřAđHr»W\Hr×|HsNĚHslő„ .DWuWHITE AC4591001C4591001 1044 10441303AADVERSE EVENT 2 Injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-04-20 Bq2021-04-23 Bt 1MedDRA v24.0NDWv A..DWyA@..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWvDśĚHsNĚDXúD’HuN)Vaccination 3 APY A02021-05-14T20:55:34Y 104413031044Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDî\Hr»W\DWŤD’Hslő„Placebo APlacebo ADWDî\DWDóüY . . .Placebo Placebo DW=DWqYPhase 3A@NNEGDWr BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWvDWŤDśĚD’DWDXJBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWqDWýBlBBŚBřAđHr»W\Hr×|HsNĚHslő„ .DWuWHITE AC4591001C4591001 1044 10441303A ADVERSE EVENT 1 generlized Muscle aches Myalgia F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Generalized muscle aches F™ŠiF™{Muscle pains F™#Muscle disorders F™Musculoskeletal and connective tissue disorders F™k2021-04-20 Bq2021-04-22 Bs 1MedDRA v24.0NDWv A..DWxA0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWvDśĚHsNĚDXúD’HuN)Vaccination 3 APY A02021-05-18T08:15:38Y 104413041044BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDű¸Hr»d¸DWDÓŕHrÖě`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWDű¸DWDÓŕY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW>DW‘YPhase 3A@NNEGDW’ ....... . .NY.DW‘DWýBŚBlBřAđHr»d¸HrÖě`.. .DWËWHITE AC4591001C4591001 1044 10441304AADVERSE EVENT 1 generalized rash Rash F™5ŃSKIN AND SUBCUTANEOUS TISSUE DISORDERS Generalized rash F™V±F™*TRashes, eruptions and exanthems NEC F™cÖEpidermal and dermal conditions FŃSkin and subcutaneous tissue disorders F™5Ń2021-02-25 B;2021-02-27 B= 1MedDRA v24.0NDW@ B&..DWBB(..A0DAYSN NNOT RELATEDOTHER unk NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DWDű¸Hr»d¸DXDÓŕHt¸ŕFollow 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_30AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDąÜHrĽt\DWDÂLHrŐ‰LBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWDąÜDWDÂLY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW6DWÉYPhase 3A@NNEG. ....... . .NY.DWý.B÷..B÷AŔHrĽt\HrŐ‰L.. .DWÉWHITE AC4591001C4591001 1044 10441309AADVERSE EVENT 1 Ocular Pain in Right Eye Eye pain FÔŻEYE DISORDERS Ocular pain F™ť=FÔÖOcular disorders NEC F™ĐEye disorders NEC FÔEye disorders FÔŻ2021-05-12 B†2021-05-14 B 2MedDRA v24.0NDWŚ Bs..DWŽBu..A0DAYSN NNOT RELATEDOTHER unk NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DWDąÜHrĽt\DX‡DÂLHt¶ĽĚFollow Up 1 A0Y A 2021-07-16T20:05:51Y 104413201044Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADW DµŕHrÄY`DWŁDÄ,HsŠ(¬Placebo APlacebo ADW DµŕDW"D¬Y . . .Placebo Placebo DWEDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁDČdDÄ,DWżDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB€BpBqBńAđHrÄY`Hrß˙Hsn}dHsŠ(¬ .DWŤWHITE AC4591001C4591001 1044 10441320AADVERSE EVENT 2 chills Chills FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills F·ÓF·ÓFeelings and sensations NEC F™ŁGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-04 B—2021-06-05 B 1MedDRA v24.0NDWŁ A..DW¤A ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŽDČdHsn}dDYDÄ,Huk\,Vaccination 4 A`Y A@2021-07-03T11:09:09Y 104413201044Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADW DµŕHrÄY`DWŁDÄ,HsŠ(¬Placebo APlacebo ADW DµŕDW"D¬Y . . .Placebo Placebo DWEDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁDČdDÄ,DWżDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB€BpBqBńAđHrÄY`Hrß˙Hsn}dHsŠ(¬ .DWŤWHITE AC4591001C4591001 1044 10441320A ADVERSE EVENT 1 headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-06-04 B—2021-06-05 B 1MedDRA v24.0NDWŁ A..DW¤A ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŽDČdHsn}dDYDÄ,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_30AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWD¦ŕHrĹ›ŕDW"D‘PHrßäPBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWD¦ŕDW"D‘PY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW>DWŚYPhase 3A@NNEGDWŤ ....... . .NY.DWŚDWýBBqBđAđHrĹ›ŕHrßäP.. .DWßWHITE AC4591001C4591001 1044 10441328AADVERSE EVENT 1 Pilonidal cyst Pilonidal cyst FëůINFECTIONS AND INFESTATIONS Pilonidal cyst F™cF™cSkin structures and soft tissue infections F™5ŇInfections - pathogen unspecified Fë÷Infections and infestations Fëů2021-04-22 Bk .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDWx BW....... N NNOT RELATEDOTHER UNKNOWN ETIOLOGY NOT APPLICABLE NYRECOVERING/RESOLVING N A0NOT RELATEDA0A GRADE 2A . APeriod 01DWD¦ŕHrĹ›ŕDXŹD‘PHtÁĐFollow Up 1 A0Y A 2021-04-29T15:50:12Y 104413351044Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADWDŮĽHrÇ <DW¦Dć(HsŽ?(Placebo APlacebo ADWDŮĽDW%D× Y . . .Placebo Placebo DWHDWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW¦DęśDć(DWÄDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýBBlBpBďAđHrÇ <Hrä HssĺśHsŽ?( .DW‘WHITE AC4591001C4591001 1044 10441335AADVERSE EVENT 1 Worsening of acne Acne F™5ŃSKIN AND SUBCUTANEOUS TISSUE DISORDERS Acne aggravated FrFpAcnes FqSkin appendage conditions F™5ŢSkin and subcutaneous tissue disorders F™5Ń2021-02-27 B4 .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDWB B....... N NNOT RELATEDOTHER unk NOT APPLICABLE YNRECOVERING/RESOLVING N A0NOT RELATEDA0AGRADE 1A . APeriod 01DWDŮĽHrÇ <DW’Dę›Hssĺ›Vaccination 2 A Y A 2021-03-05T23:58:05 104413371044Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWD$HrČ($DW¦D¦hHsŤ˙hPlacebo APlacebo ADWD$DW%D“¨Y . . .Placebo Placebo DWADWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DW¦D–<D¦hDWĂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýB~BkBpBîAĐHrČ($HrăŰ(HstâĽHsŤ˙h .DW’WHITE AC4591001C4591001 1044 10441337AADVERSE EVENT 1 Broken humerus (right arm) Humerus fracture FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Humerus fracture FćnFćnLimb fractures and dislocations F™ľîBone and joint injuries F¶Injury, poisoning and procedural complications Fěĺ2021-01-10 A02021-02-12 B$ 2MedDRA v24.0NDW A0..DW3B$..B"DAYSN NNOT RELATEDOTHER accident NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DWD$HrČ($DW“D–;Hstâ»Vaccination 1 AY A2021-05-19T19:28:20 AE outcome changed from EUA to sBLA 104413381044Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWD$HrČ($DW%D˘0Hrăé°Placebo APlacebo ADWD$DW%D˘0Y . . .Placebo Placebo DWADWŮYPhase 3A@NNEG. ....... . .NN.DWý.Bî..BîAĐHrČ($Hrăé°.. .DWŮWHITE AC4591001C4591001 1044 10441338AADVERSE EVENT 1 Wart on second toe (left) Skin papilloma F™0NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)Wart F™QQF™6KSkin neoplasms benign F™6BCutaneous neoplasms benign F™6CNeoplasms benign, malignant and unspecified (incl cysts and polyps)F™02021-02-01 B2021-02-07 B 1MedDRA v24.0NDW( A@..DW.A ..ApDAYSN NNOT RELATEDOTHER unk NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DWD$HrČ($DX’D˘0HtĹ0Vaccination 2 A Y A 2021-02-26T19:49:21 104413451044Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWD˘äHrÉŚdDW¦D“0HsŤě0Placebo APlacebo ADWD˘äDW$DŢ0Y . . .Placebo Placebo DWEDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦D™üD“0DWĂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB|BmBqBíAŔHrÉŚdHrâÔ0HsrC|HsŤě0 .DWWHITE AC4591001C4591001 1044 10441345AADVERSE EVENT 3 dizziness Dizziness F™•NERVOUS SYSTEM DISORDERS Dizziness FË…FË…Neurological signs and symptoms NEC F™úNeurological disorders NEC F™ůNervous system disorders F™•2021-06-07 B–2021-06-07 B– 2MedDRA v24.0NDW¦ A..DW¦A..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DW‘D™üHsrC|DYD“0Huo°Vaccination 4 A`Y A@2021-06-08T21:16:21Y 104413451044Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWD˘äHrÉŚdDW¦D“0HsŤě0Placebo APlacebo ADWD˘äDW$DŢ0Y . . .Placebo Placebo DWEDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦D™üD“0DWĂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB|BmBqBíAŔHrÉŚdHrâÔ0HsrC|HsŤě0 .DWWHITE AC4591001C4591001 1044 10441345A ADVERSE EVENT 4 generalized myalgia Myalgia F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Myalgia F™{F™{Muscle pains F™#Muscle disorders F™Musculoskeletal and connective tissue disorders F™k2021-06-07 B– .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDW¦ A....... N NRELATED NOT APPLICABLE YNRECOVERING/RESOLVING N ARELATED AA GRADE 2A . A Period 02DW‘D™üHsrC|DYD“0Huo°Vaccination 4 A`Y A@2021-06-08T21:16:32Y 104413451044Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWD˘äHrÉŚdDW¦D“0HsŤě0Placebo APlacebo ADWD˘äDW$DŢ0Y . . .Placebo Placebo DWEDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦D™üD“0DWĂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB|BmBqBíAŔHrÉŚdHrâÔ0HsrC|HsŤě0 .DWWHITE AC4591001C4591001 1044 10441345A0ADVERSE EVENT 1 nausea Nausea FÜ›GASTROINTESTINAL DISORDERS Nausea F™ F™ Nausea and vomiting symptoms F™Gastrointestinal signs and symptoms FÜÜGastrointestinal disorders FÜ›2021-06-07 B–2021-06-08 B— 1MedDRA v24.0NDW¦ A..DW§A ..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW‘D™üHsrC|DYD“0Huo°Vaccination 4 A`Y A@2021-06-08T21:16:00Y 104413451044Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWD˘äHrÉŚdDW¦D“0HsŤě0Placebo APlacebo ADWD˘äDW$DŢ0Y . . .Placebo Placebo DWEDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦D™üD“0DWĂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB|BmBqBíAŔHrÉŚdHrâÔ0HsrC|HsŤě0 .DWWHITE AC4591001C4591001 1044 10441345A@ADVERSE EVENT 2 vomitting Vomiting FÜ›GASTROINTESTINAL DISORDERS Vomiting F™PÔF™PÔNausea and vomiting symptoms F™Gastrointestinal signs and symptoms FÜÜGastrointestinal disorders FÜ›2021-06-07 B–2021-06-08 B— 1MedDRA v24.0NDW¦ A..DW§A ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW‘D™üHsrC|DYD“0Huo°Vaccination 4 A`Y A@2021-06-08T21:16:11Y 104413511044Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDŽĽHrĘÉĽDWóDß Hsó» Placebo APlacebo ADWDŽĽDW(DáY . . .Placebo Placebo DWGDWŮYPhase 3A@NNEGDWÚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWßDWóDĺtDß DXDX°BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŮDWýBČBB$BěAđHrĘÉĽHrčHsŮcôHsó» .DWÚWHITE AC4591001C4591001 1044 10441351AADVERSE EVENT 1 Left hip flexor strain Muscle strain FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Muscle strain F™YďF™YďMuscle, tendon and ligament injuries F™Injuries NEC FěâInjury, poisoning and procedural complications Fěĺ2021-02-11 B!2021-02-27 B1 2MedDRA v24.0NDW2 A°..DWBB..BDAYSN NNOT RELATEDOTHER unk NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DWDŽĽHrĘÉĽDWßDĺsHsŮcóVaccination 2 A Y A 2021-03-04T22:57:53 104413541044Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWD˘lHrĘÝlDW¨DŹčHs‹čPlacebo APlacebo ADWD˘lDW%D˛ Y . . .Placebo Placebo DWADWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DW¨D•DŹčDWĆDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB{BkBqBěAĐHrĘÝlHrăů HstâHs‹č .DW’WHITE AC4591001C4591001 1044 10441354AADVERSE EVENT 1 Worsening of ADHD Attention deficit hyperactivity disorderF™'·PSYCHIATRIC DISORDERS ADHD F™čF™Ý&Attention deficit and disruptive behaviour disorders FĄCognitive and attention disorders and disturbances FĽńPsychiatric 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 01DWD˘lHrĘÝlDW“D•‡HstâFollow 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_30AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWD˛ÔHrĚ?TDW*D¶Hrę•BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWD˛ÔDW*D¶Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWLDWŤYPhase 3A@NNEGDWŽ ....... . .NY.DWŤDWýB{BpBëAđHrĚ?THrę•.. .DWŮWHITE AC4591001C4591001 1044 10441361AADVERSE EVENT 1 Concussion Concussion FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Concussion FľŽFľŽCerebral injuries NEC F™dInjuries NEC FěâInjury, poisoning and procedural complications Fěĺ2021-01-23 AĐ2021-02-13 B" 1MedDRA v24.0NDW AĐ..DW4B"..BDAYSN NNOT RELATEDOTHER unk NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DWD˛ÔHrĚ?TDX—D¶HtËČśVaccination 1 AY A2021-03-09T19:56:22 104413611044BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWD˛ÔHrĚ?TDW*D¶Hrę•BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWD˛ÔDW*D¶Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWLDWŤYPhase 3A@NNEGDWŽ ....... . .NY.DWŤDWýB{BpBëAđHrĚ?THrę•.. .DWŮWHITE AC4591001C4591001 1044 10441361A ADVERSE EVENT 2 allergic contact dermatitis involving all extremities (contact with poison sumac) Dermatitis contact F™5ŃSKIN AND SUBCUTANEOUS TISSUE DISORDERS Sumac rash F™<|FÇDermatitis and eczema FÇEpidermal and dermal conditions FŃSkin and subcutaneous tissue disorders F™5Ń2021-04-24 Bh .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDWz BQ....... N NNOT RELATEDOTHER (contact with poison sumac) NOT APPLICABLE YNRECOVERING/RESOLVING N A0NOT RELATEDA0AGRADE 1A . APeriod 01DWD˛ÔHrĚ?TDX—D¶HtËČśFollow 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_30AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDÖ°HrĚc0DW*DÚčHręąčBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWDÖ°DW*DÚčY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWGDW“YPhase 3A@NNEGDW” ....... . .NY.DW“DWýBBjBëAđHrĚc0Hręąč.. .DWŕWHITE AC4591001C4591001 1044 10441364AADVERSE EVENT 1 attention deficit hyperactivity disorder Attention deficit hyperactivity disorderF™'·PSYCHIATRIC DISORDERS Attention deficit hyperactivity disorder F™Ý&F™Ý&Attention deficit and disruptive behaviour disorders FĄCognitive and attention disorders and disturbances FĽńPsychiatric disorders F™'·2021-04-29 Bm2021-07 . 1MedDRA v24.0NDW BV....... N NNOT RELATEDOTHER unk NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DWDÖ°HrĚc0DX—DÚčHtËíhFollow 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_30AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDÖ°HrĚc0DW*DÚčHręąčBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWDÖ°DW*DÚčY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWGDW“YPhase 3A@NNEGDW” ....... . .NY.DW“DWýBBjBëAđHrĚc0Hręąč.. .DWŕWHITE AC4591001C4591001 1044 10441364A ADVERSE EVENT 3 Lightheadedness Dizziness F™•NERVOUS SYSTEM DISORDERS Lightheadedness Fö,FË…Neurological signs and symptoms NEC F™úNeurological disorders NEC F™ůNervous system disorders F™•2021-08-19 BÝ .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDWď BĆ....... N NNOT RELATEDOTHER unk NOT APPLICABLE NNRECOVERING/RESOLVING N A0NOT RELATEDA0AGRADE 1A . APeriod 01DWDÖ°HrĚc0DX—DÚčHtËíhAfter unblinding and before Vaccination 3A@ A 2021-09-17T15:09:57Y 104413641044BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDÖ°HrĚc0DW*DÚčHręąčBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWDÖ°DW*DÚčY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWGDW“YPhase 3A@NNEGDW” ....... . .NY.DW“DWýBBjBëAđHrĚc0Hręąč.. .DWŕWHITE AC4591001C4591001 1044 10441364A0ADVERSE EVENT 2 Tachycardia Tachycardia FłőCARDIAC DISORDERS Tachycardia F™>żF™>żRate and rhythm disorders NEC F™*”Cardiac arrhythmias FłáCardiac disorders Fłő2021-08-19 BÝ .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDWď BĆ....... N NNOT RELATEDOTHER unk NOT APPLICABLE NNRECOVERING/RESOLVING N A0NOT RELATEDA0AGRADE 1A . APeriod 01DWDÖ°HrĚc0DX—DÚčHtËíhAfter unblinding and before Vaccination 3A@ A 2021-09-17T15:09:35Y 104413731044Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWD”\HrÍr\DW§D‡<HsŹ1ĽPlacebo APlacebo ADWD”\DW+DŤY . . .Placebo Placebo DWLDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW§D–´D‡<DWÄDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýByBmBqBęAŕHrÍr\HrëľHsr@4HsŹ1Ľ .DWWHITE AC4591001C4591001 1044 10441373AADVERSE EVENT 2 Worsening of Anxiety Anxiety F™'·PSYCHIATRIC DISORDERS Anxiety aggravated F™SSFˇ§Anxiety symptoms FˇµAnxiety disorders and symptoms FˇPsychiatric disorders F™'·2021-03-05 B5 .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDWH B....... N NNOT RELATEDOTHER medication dosage adjustment NOT APPLICABLE YNRECOVERING/RESOLVING N A0NOT RELATEDA0A GRADE 2A . APeriod 01DWD”\HrÍr\DW‘D–łHsr@3Vaccination 2 A Y A 2021-03-11T18:39:14 104413731044Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWD”\HrÍr\DW§D‡<HsŹ1ĽPlacebo APlacebo ADWD”\DW+DŤY . . .Placebo Placebo DWLDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW§D–´D‡<DWÄDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýByBmBqBęAŕHrÍr\HrëľHsr@4HsŹ1Ľ .DWWHITE AC4591001C4591001 1044 10441373A ADVERSE EVENT 1 hives forehead Urticaria F™5ŃSKIN AND SUBCUTANEOUS TISSUE DISORDERS Urticaria localised F™ăF™MUrticarias F™MAngioedema and urticaria FźúSkin and subcutaneous tissue disorders F™5Ń2021-01-12T11:29A2021-01-12 A 1MedDRA v24.0NDW ADˇ|HrÍ|DWA..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A B8 APeriod 01DWD”\HrÍr\DW‘D–łHsr@3Vaccination 1 AY A2021-02-04T21:49:58 104413841044Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDúČHrÍŘČDW§DÜŚHsŹ‡Placebo APlacebo ADWDúČDW+DílY . . .Placebo Placebo DWGDWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW”DW§DŘĚDÜŚDWĂDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýBzBjBpBęAĐHrÍŘČHrěěHsvvĚHsŹ‡ .DW“WHITE AC4591001C4591001 1044 10441384AADVERSE EVENT 2 nasal congestion Nasal congestion F™-ŇRESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS Nasal congestion F™żF™żNasal congestion and inflammations F™ŔUpper respiratory tract disorders (excl infections) F™K`Respiratory, thoracic and mediastinal disorders F™-Ň2021-05-07 Bt .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDW‡ B]....... N NNOT RELATEDOTHER unk NOT APPLICABLE YNRECOVERING/RESOLVING N A0NOT RELATEDA0AGRADE 1A . APeriod 01DWDúČHrÍŘČDW”DŘËHsvvËFollow Up 1 A0Y A 2021-06-09T02:56:21Y 104413841044Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDúČHrÍŘČDW§DÜŚHsŹ‡Placebo APlacebo ADWDúČDW+DílY . . .Placebo Placebo DWGDWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW”DW§DŘĚDÜŚDWĂDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýBzBjBpBęAĐHrÍŘČHrěěHsvvĚHsŹ‡ .DW“WHITE AC4591001C4591001 1044 10441384A ADVERSE EVENT 1 Achilles tendinitis Tendonitis F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Achilles tendinitis F1F™?wTendon disorders F™?bTendon, ligament and cartilage disorders F™?eMusculoskeletal and connective tissue disorders F™k2021-03-08 B8 .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDWK B!....... N NNOT RELATEDOTHER unk NOT APPLICABLE YNRECOVERING/RESOLVING N A0NOT RELATEDA0A GRADE 2A . APeriod 01DWDúČHrÍŘČDW”DŘËHsvvËFollow Up 1 A0Y A 2021-04-02T08:36:10Y 105713871057Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVňDĹ”Hr Đ”DW¶DăĐHsŁTĐPlacebo APlacebo ADVňDĹ”DWDÁ\Y . . .Placebo Placebo DW#DW™YPhase 3A@NNEGDWš BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWˇDW¶DÚpDăĐDWŇDXsBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW™DWýB¨B]BdCŔAŕHr Đ”HrąŘÜHs‡›đHsŁTĐ .DW WHITE AC4591001C4591001 1057 10571387AADVERSE EVENT 1 ARM SORENESS Pain in extremity F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Pain in arm F™ F™Musculoskeletal and connective tissue pain and discomfort F™ŁMusculoskeletal and connective tissue disorders NEC F™iMusculoskeletal and connective tissue disorders F™k2021-06-23T18:00BĹ2021-06-24T08:00BĆ 1MedDRA v24.0NDW¶ ADý HsŁn DW·A Dp»Hs¤3;A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Bl A Period 02DWˇDÚpHs‡›đDY#DăĐHu„PVaccination 4 A`Y A@2021-08-04T17:32:44Y 105713891057Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVňDË4Hr Ö4DWDęŘHrĂ<ŘPlacebo APlacebo ADVňDË4DWDęŘY . . .Placebo Placebo DW*DWŚYPhase 3A@NNEGDWŤ ....... . .NN.DWŚDWýB›BqCŔAŔHr Ö4HrĂ<Ř.. .DWÉWHITE AC4591001C4591001 1057 10571389AADVERSE EVENT 2 FATIGUE Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-24 B§2021-05-24 B§ 1MedDRA v24.0NDW BŤ..DWBŤ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . APeriod 01DVňDË4Hr Ö4DXyDęŘHt¤pXAfter unblinding and before Vaccination 3A@ A 2021-08-24T18:57:19Y 105713891057Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVňDË4Hr Ö4DWDęŘHrĂ<ŘPlacebo APlacebo ADVňDË4DWDęŘY . . .Placebo Placebo DW*DWŚYPhase 3A@NNEGDWŤ ....... . .NN.DWŚDWýB›BqCŔAŔHr Ö4HrĂ<Ř.. .DWÉWHITE AC4591001C4591001 1057 10571389A ADVERSE EVENT 1 LEFT ARM INJECTION SITE SORNESS Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-24 B§2021-05-24 B§ 1MedDRA v24.0NDW BŤ..DWBŤ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . APeriod 01DVňDË4Hr Ö4DXyDęŘHt¤pXAfter unblinding and before Vaccination 3A@ A 2021-08-24T21:23:44Y 105714071057Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVúDËčHr«bčDWdD—ŕHs6íŕPlacebo APlacebo ADVúDËčDW Dß Y . . .Placebo Placebo DW)DW2YPhase 3A@NNEGDW3 BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWODWdD¨„D—ŕDW€DX!BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW2DWýB9BŻBËC@AđHr«bčHrÄ‚ HsOHs6íŕ .DWNWHITE AC4591001C4591001 1057 10571407AADVERSE EVENT 2 FATIGUE Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-04-02T18:00Bk2021-04-04T18:00Bm 1MedDRA v24.0NDWd ADý Hs7S DWfA0Dý[Hs9ö[A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C A Period 02DWOD¨„HsODXŃD—ŕHu!`Vaccination 4 A`Y A@2021-04-30T18:14:37Y 105714071057Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVúDËčHr«bčDWdD—ŕHs6íŕPlacebo APlacebo ADVúDËčDW Dß Y . . .Placebo Placebo DW)DW2YPhase 3A@NNEGDW3 BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWODWdD¨„D—ŕDW€DX!BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW2DWýB9BŻBËC@AđHr«bčHrÄ‚ HsOHs6íŕ .DWNWHITE AC4591001C4591001 1057 10571407A ADVERSE EVENT 1 RIGHT ARM INJECTION SITE SORENESS Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-04-02T18:00Bk2021-04-04T18:00Bm 1MedDRA v24.0NDWd ADý Hs7S DWfA0Dý[Hs9ö[A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C A Period 02DWOD¨„HsODXŃD—ŕHu!`Vaccination 4 A`Y A@2021-04-30T18:08:07Y 105714081057Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVúDÍČHr«dČDWŻDËčHsšhPlacebo APlacebo ADVúDÍČDW DßY . . .Placebo Placebo DW)DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW™DWŻDÝ@DËčDWËDXlBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB“BeBqC@AŕHr«dČHrÄHs}ŔHsšh .DWWHITE AC4591001C4591001 1057 10571408AADVERSE EVENT 1 HEADACHE Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-05-25T21:00B 2021-05-26T08:00Bˇ 1MedDRA v24.0NDW™ AEuHs}\ĐDWšA Dp»Hs}÷»A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CŔ A Period 02DW™DÝ@Hs}ŔDYDËčHu{5čVaccination 3 APY A02021-06-16T20:56:30Y 105714081057Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVúDÍČHr«dČDWŻDËčHsšhPlacebo APlacebo ADVúDÍČDW DßY . . .Placebo Placebo DW)DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW™DWŻDÝ@DËčDWËDXlBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB“BeBqC@AŕHr«dČHrÄHs}ŔHsšh .DWWHITE AC4591001C4591001 1057 10571408A ADVERSE EVENT 2 NAUSEA Nausea FÜ›GASTROINTESTINAL DISORDERS Nausea F™ F™ Nausea and vomiting symptoms F™Gastrointestinal signs and symptoms FÜÜGastrointestinal disorders FÜ›2021-05-25T21:00B 2021-05-26T08:00Bˇ 1MedDRA v24.0NDW™ AEuHs}\ĐDWšA Dp»Hs}÷»A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CŔ A Period 02DW™DÝ@Hs}ŔDYDËčHu{5čVaccination 3 APY A02021-06-16T22:11:32Y 105714311057Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDĘĽHrĽ…<DW´D×ÜHs ĄÜPlacebo APlacebo ADWDĘĽDWDĂ´Y . . .Placebo Placebo DW6DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW›DW´DÝD×ÜDWĐDXqBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB†BcBqB÷AĐHrĽ…<HrŐŠ´Hsµ„Hs ĄÜ .DWšWHITE AC4591001C4591001 1057 10571431AADVERSE EVENT 1 BODY ACHES Pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalized aching F™Š\F™ŰPain and discomfort NEC F™ÜGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-21T18:00B®2021-06-23T09:00B° 1MedDRA v24.0NDW´ ADý Hs Ë DW¶A0D~ËHs˘ďËA0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Bź A Period 02DW›DÝHsµ„DY!D×ÜHuŮ\Vaccination 4 A`Y A@2021-07-20T16:22:44Y 105714321057Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDÎHrĽ„DW DŢ0Hs†N0Placebo APlacebo ADWDÎDWDáxY . . .Placebo Placebo DW=DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW DÔDŢ0DWĽDX]BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB†BqBqB÷AŔHrĽ„HrŐ¨xHsm7śHs†N0 .DWŚWHITE AC4591001C4591001 1057 10571432AADVERSE EVENT 2 FATIGUE Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-01T18:00Bš2021-06-02T18:00B› 1MedDRA v24.0NDW ADý Hs†m DWˇA Dý[Hs‡ľŰA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A B„ A Period 02DWŤDÔHsm7śDY DŢ0Hug°Vaccination 4 A`Y A@2021-07-01T16:12:13Y 105714321057Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDÎHrĽ„DW DŢ0Hs†N0Placebo APlacebo ADWDÎDWDáxY . . .Placebo Placebo DW=DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW DÔDŢ0DWĽDX]BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB†BqBqB÷AŔHrĽ„HrŐ¨xHsm7śHs†N0 .DWŚWHITE AC4591001C4591001 1057 10571432A ADVERSE EVENT 1 LEFT ARM INJECTION SITE SORENESS Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-01T18:00Bš2021-06-02T18:00B› 1MedDRA v24.0NDW ADý Hs†m DWˇA Dý[Hs‡ľŰA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A B„ A Period 02DWŤDÔHsm7śDY DŢ0Hug°Vaccination 4 A`Y A@2021-07-01T16:12:02Y 105714341057Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAMULTIPLE A`MANOT HISPANIC OR LATINOA USAMULTIRACIAL A`DWDž4Hr˝Ş4DWĽD¦¤Hs«¤Placebo APlacebo ADWDž4DWDŰ`Y . . .Placebo Placebo DW9DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW©DWĽDŁD¦¤DWŘDXyBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB…BUBqBöAĐHr˝Ş4HrŮ–ŕHs‘ńHs«¤ .DW¨ALL OTHERS A0C4591001C4591001 1057 10571434AADVERSE EVENT 1 PAIN AT INJECTION SITE LEFT DELTOID Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-29T20:00Bµ2021-07-01T09:00B· 1MedDRA v24.0NDWĽ AE”Hs«s@DWľA0D~ËHs{ËA0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C A Period 02DW©DŁHs‘ńDY)D¦¤HuŚ4$Vaccination 4 A`Y A@2021-08-04T17:28:28Y 105714341057Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAMULTIPLE A`MANOT HISPANIC OR LATINOA USAMULTIRACIAL A`DWDž4Hr˝Ş4DWĽD¦¤Hs«¤Placebo APlacebo ADWDž4DWDŰ`Y . . .Placebo Placebo DW9DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW©DWĽDŁD¦¤DWŘDXyBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB…BUBqBöAĐHr˝Ş4HrŮ–ŕHs‘ńHs«¤ .DW¨ALL OTHERS A0C4591001C4591001 1057 10571434A ADVERSE EVENT 2 LEFT UPPER ARM PAIN Pain in extremity F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Pain in arm F™ F™Musculoskeletal and connective tissue pain and discomfort F™ŁMusculoskeletal and connective tissue disorders NEC F™iMusculoskeletal and connective tissue disorders F™k2021-06-29T20:00Bµ2021-07-01T09:00B· 1MedDRA v24.0NDWĽ AE”Hs«s@DWľA0D~ËHs{ËA0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C A Period 02DW©DŁHs‘ńDY)D¦¤HuŚ4$Vaccination 4 A`Y A@2021-08-04T17:28:39Y 105714411057Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DWDĺěHrĹÚěDW¨DëŚHsçŚPlacebo APlacebo ADWDĺěDW#DŮřY . . .Placebo Placebo DW?DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DW¨DâhDëŚDWÄDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBBkBqBđAĐHrĹÚěHrá~xHsu.čHsçŚ .DW’ALL OTHERS A0C4591001C4591001 1057 10571441AADVERSE EVENT 1 MUSCLE ACHES Myalgia F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Muscle ache F™˙F™{Muscle pains F™#Muscle disorders F™Musculoskeletal and connective tissue disorders F™k2021-06-09T18:00B›2021-06-11T09:00Bť 1MedDRA v24.0NDW¨ ADý Hsů DWŞA0D~ËHs“ËA0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A BK A Period 02DW“DâhHsu.čDYDëŚHurVaccination 4 A`Y A@2021-07-09T17:18:50Y 105714511057BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDË4HrÍ©4DW)DĆ„HréTBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWDË4DW)DĆ„Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWEDWŤYPhase 3A@NNEGDWŽ ....... . .NY.DWŤDWýBzBpBęAŔHrÍ©4HréT.. .DWŘWHITE AC4591001C4591001 1057 10571451AADVERSE EVENT 1 VAGINAL YEAST INFECTION Vulvovaginal mycotic infection FëůINFECTIONS AND INFESTATIONS Vaginal yeast infection F™MâF™”Fungal infections NEC FŰFungal infectious disorders FÚřInfections and infestations Fëů2021-01-13T13:00A 2021-02-03T13:00B 2MedDRA v24.0NDW A D¶ĐHrÎćPDW*BD·Hrę–BDAYSN NNOT RELATEDOTHER HISTORY OF RECURRENT YEAST INFECTIONS NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A CT APeriod 01DWDË4HrÍ©4DX–DĆ„HtĘ‡„Vaccination 1 AY A2021-03-31T14:32:25 AE outcome changed from EUA to sBLA 106614101066Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVňDÂHr ÍDW§D¬HsŹX,Placebo APlacebo ADVňDÂDWDÚčY . . .Placebo Placebo DW#DWYPhase 3A@NNEGDW‘ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW§Dµ¤D¬DWĹDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWDWýBźBlBmCŔAĐHr ÍHr»CčHss°¤HsŹX, .DW‘WHITE AC4591001C4591001 1066 10661410AADVERSE EVENT 1 pain at injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-09 B·2021-06-11 Bą 1MedDRA v24.0NDW¨ A ..DWŞA@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW’Dµ¤Hss°¤DYD¬Hup‹¬Vaccination 4 A`Y A@2021-07-09T03:44:38Y 106614221066BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADV˙D•LHr±ĂĚDWDŤTHrÎĽÔBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DV˙D•LDWDŤTY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW2DWYPhase 3A@NNEGDW‘ ....... . .NY.DWDWýB’BmB˙AŔHr±ĂĚHrÎĽÔ.. .DWĹWHITE AC4591001C4591001 1066 10661422AADVERSE EVENT 1 rash on torso Rash F™5ŃSKIN AND SUBCUTANEOUS TISSUE DISORDERS Rash F™*TF™*TRashes, eruptions and exanthems NEC F™cÖEpidermal and dermal conditions FŃSkin and subcutaneous tissue disorders F™5Ń2020-12-24 A02020-12-28 Ap 1MedDRA v24.0NDW A0..DWAp..APDAYSN NNOT RELATEDOTHER unknown NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DV˙D•LHr±ĂĚDX‚DŤTHtŻđTVaccination 1 AY A2021-03-31T18:06:04 AE outcome changed from EUA to sBLA 107712751077Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVěDÓ¤Hrő¤DW¦DÂHsŽPlacebo APlacebo ADVěDÓ¤DV˙DęŘY . . .Placebo Placebo DWDWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DČdDÂDWÄDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýB˘BmBpC AĐHrő¤Hr˛XHsrqäHsŽ .DWWHITE AC4591001C4591001 1077 10771275AADVERSE EVENT 2 FALL Fall FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Fall FŐFŐNon-site specific injuries NEC F™ ÇInjuries NEC FěâInjury, poisoning and procedural complications Fěĺ2021-05-07 Bś2021-05-07 Bś 1MedDRA v24.0NDW‡ B‰..DW‡B‰..ADAYSN NNOT RELATEDOTHER ACCIDENTAL MECHANICAL FALL NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVěDÓ¤Hrő¤DW‘DČcHsrqăFollow Up 1 A0Y A 2021-06-07T20:54:47Y 107712751077Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVěDÓ¤Hrő¤DW¦DÂHsŽPlacebo APlacebo ADVěDÓ¤DV˙DęŘY . . .Placebo Placebo DWDWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DČdDÂDWÄDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýB˘BmBpC AĐHrő¤Hr˛XHsrqäHsŽ .DWWHITE AC4591001C4591001 1077 10771275A ADVERSE EVENT 1 RIGHT WRIST SPRAIN Ligament sprain FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Wrist sprain F™R3FöMuscle, tendon and ligament injuries F™Injuries NEC FěâInjury, poisoning and procedural complications Fěĺ2021-05-07 Bś2021-05-25 B® 1MedDRA v24.0NDW‡ B‰..DW™B›..BDAYSN NNOT RELATEDOTHER ACCIDENTAL MECHANICAL FALL NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVěDÓ¤Hrő¤DW‘DČcHsrqăFollow Up 1 A0Y A 2021-06-07T20:54:36Y 107712781077BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVíD‰Hr™üśDWDŽĽHrłĽBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVíD‰DWDŽĽY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWDWŤYPhase 3A@NNEGDWŽ ....... . .NY.DWŤDWýBˇBpCAĐHr™üśHrłĽ.. .DWŻWHITE AC4591001C4591001 1077 10771278AADVERSE EVENT 1 DIARRHEA Diarrhoea FÜ›GASTROINTESTINAL DISORDERS Diarrhea FČ7FČ?Diarrhoea (excl infective) FČ@Gastrointestinal motility and defaecation conditions FÜąGastrointestinal disorders FÜ›2020-12-23T12:30B2020-12-24T12:01B 2MedDRA v24.0NDW ADŻČHrł/ČDWA D©7Hr´z·A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A BŤ APeriod 01DVíD‰Hr™üśDXmDŽĽHt”B<Vaccination 2 A Y A 2021-01-16T00:38:59 107712781077BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVíD‰Hr™üśDWDŽĽHrłĽBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVíD‰DWDŽĽY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWDWŤYPhase 3A@NNEGDWŽ ....... . .NY.DWŤDWýBˇBpCAĐHr™üśHrłĽ.. .DWŻWHITE AC4591001C4591001 1077 10771278A ADVERSE EVENT 2 DISORIENTATION Disorientation F™'·PSYCHIATRIC DISORDERS Disorientation FĘÓFĘÓConfusion and disorientation Fľ˝Deliria (incl confusion) FĆ=Psychiatric disorders F™'·2020-12-23T19:01B2020-12-23T20:00B 2MedDRA v24.0NDW AE¶ŔHrł‹lDWAE—°Hrł™{ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C!@ APeriod 01DVíD‰Hr™üśDXmDŽĽHt”B<Vaccination 2 A Y A 2021-01-16T00:39:03 107712781077BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVíD‰Hr™üśDWDŽĽHrłĽBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVíD‰DWDŽĽY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWDWŤYPhase 3A@NNEGDWŽ ....... . .NY.DWŤDWýBˇBpCAĐHr™üśHrłĽ.. .DWŻWHITE AC4591001C4591001 1077 10771278A0ADVERSE EVENT 3 FATIGUE Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2020-12-23T14:00B2020-12-24 B 2MedDRA v24.0NDW ADÄŕHrłDŕDWA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A Bç APeriod 01DVíD‰Hr™üśDXmDŽĽHt”B<Vaccination 2 A Y A 2021-01-16T00:39:08 107712781077BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVíD‰Hr™üśDWDŽĽHrłĽBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVíD‰DWDŽĽY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWDWŤYPhase 3A@NNEGDWŽ ....... . .NY.DWŤDWýBˇBpCAĐHr™üśHrłĽ.. .DWŻWHITE AC4591001C4591001 1077 10771278A@ADVERSE EVENT 6 RIGHT ARM INJECTION SITE PAIN Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2020-12-23T12:00B2020-12-24T22:00B 1MedDRA v24.0NDW AD¨ŔHrł(ŔDWA EY°HrµA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Bo APeriod 01DVíD‰Hr™üśDXmDŽĽHt”B<Vaccination 2 A Y A 2021-01-16T03:50:31 107712781077BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVíD‰Hr™üśDWDŽĽHrłĽBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVíD‰DWDŽĽY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWDWŤYPhase 3A@NNEGDWŽ ....... . .NY.DWŤDWýBˇBpCAĐHr™üśHrłĽ.. .DWŻWHITE AC4591001C4591001 1077 10771278APADVERSE EVENT 7 INJECTION SITE SWELLING Injection site swelling FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site swelling F™g1F™g1Injection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2020-12-23T12:00B2020-12-24T21:00B 2MedDRA v24.0NDW AD¨ŔHrł(ŔDWA Ex°Hr´ůA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A Bo APeriod 01DVíD‰Hr™üśDXmDŽĽHt”B<Vaccination 2 A Y A 2021-01-16T03:50:35 107712781077BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVíD‰Hr™üśDWDŽĽHrłĽBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVíD‰DWDŽĽY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWDWŤYPhase 3A@NNEGDWŽ ....... . .NY.DWŤDWýBˇBpCAĐHr™üśHrłĽ.. .DWŻWHITE AC4591001C4591001 1077 10771278A`ADVERSE EVENT 4 FEVER Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2020-12-23T19:01B2020-12-24T12:00B 3MedDRA v24.0NDW AE¶ŔHrł‹lDWA D¨űHr´z{A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA0GRADE 3A0 C!@ APeriod 01DVíD‰Hr™üśDXmDŽĽHt”B<Vaccination 2 A Y A 2021-01-16T03:50:21 107712781077BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVíD‰Hr™üśDWDŽĽHrłĽBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVíD‰DWDŽĽY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWDWŤYPhase 3A@NNEGDWŽ ....... . .NY.DWŤDWýBˇBpCAĐHr™üśHrłĽ.. .DWŻWHITE AC4591001C4591001 1077 10771278ApADVERSE EVENT 5 VOMITING Vomiting FÜ›GASTROINTESTINAL DISORDERS Vomiting F™PÔF™PÔNausea and vomiting symptoms F™Gastrointestinal signs and symptoms FÜÜGastrointestinal disorders FÜ›2020-12-23T20:00B2020-12-23T21:00B 1MedDRA v24.0NDW AE”Hrł™@DWAEx°Hrł§‹ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C$đ APeriod 01DVíD‰Hr™üśDXmDŽĽHt”B<Vaccination 2 A Y A 2021-01-16T03:50:26 107712791077BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADV÷DśHr§$DWD‚HrÂÔBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DV÷DśDWD‚Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW)DWŤYPhase 3A@NNEGDWŽ ....... . .NY.DWŤDWýB—BpCpAĐHr§$HrÂÔ.. .DW˝WHITE AC4591001C4591001 1077 10771279AADVERSE EVENT 2 RIGHT 5TH METACARPAL FRACTURE Hand fracture FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Fractured metacarpal FÚFá*Limb fractures and dislocations F™ľîBone and joint injuries F¶Injury, poisoning and procedural complications Fěĺ2021-05-18 Bś2021-06-16 Bą 1MedDRA v24.0NDW’ B‡..DWŻB¤..BDAYSN NNOT RELATEDOTHER BLUNT TRAUMA NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DV÷DśHr§$DXyD‚Ht¤”After unblinding and before Vaccination 3A@ A 2021-06-30T21:02:44Y 107712791077BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADV÷DśHr§$DWD‚HrÂÔBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DV÷DśDWD‚Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW)DWŤYPhase 3A@NNEGDWŽ ....... . .NY.DWŤDWýB—BpCpAĐHr§$HrÂÔ.. .DW˝WHITE AC4591001C4591001 1077 10771279A ADVERSE EVENT 1 ORAL/BUCCAL BLISTERS Oral mucosal blistering FÜ›GASTROINTESTINAL DISORDERS Oral mucosa blister F™ŠF™“Oral soft tissue signs and symptoms F™Oral soft tissue conditions F™ĄGastrointestinal disorders FÜ›2021-01-07 B2021-01-10 B 2MedDRA v24.0NDW A@..DWAp..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . APeriod 01DV÷DśHr§$DXyD‚Ht¤”Vaccination 2 A Y A 2021-03-19T23:00:56 107712801077Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADV÷D€čHr§#hDW±DštHsśsôPlacebo APlacebo ADV÷D€čDWD‚ŚY . . .Placebo Placebo DW)DWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWśDW±D¶XDštDWÍDXnBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýB—BbBpCpAŕHr§#hHrÂÔŚHs€ŕXHsśsô .DW›WHITE AC4591001C4591001 1077 10771280AADVERSE EVENT 2 CONCUSSION Concussion FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Concussion FľŽFľŽCerebral injuries NEC F™dInjuries NEC FěâInjury, poisoning and procedural complications Fěĺ2021-04-08 Bt2021-04-21 B 1MedDRA v24.0NDWj B_..DWwBl..AŕDAYSN NNOT RELATEDOTHER ACCIDENTAL MECHANICAL FALL NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DV÷D€čHr§#hDWśD¶WHs€ŕWFollow Up 1 A0Y A 2021-06-18T16:08:50Y 107712801077Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADV÷D€čHr§#hDW±DštHsśsôPlacebo APlacebo ADV÷D€čDWD‚ŚY . . .Placebo Placebo DW)DWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWśDW±D¶XDštDWÍDXnBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýB—BbBpCpAŕHr§#hHrÂÔŚHs€ŕXHsśsô .DW›WHITE AC4591001C4591001 1077 10771280A ADVERSE EVENT 1 FALL Fall FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Fall FŐFŐNon-site specific injuries NEC F™ ÇInjuries NEC FěâInjury, poisoning and procedural complications Fěĺ2021-04-08 Bt2021-04-08 Bt 1MedDRA v24.0NDWj B_..DWjB_..ADAYSN NNOT RELATEDOTHER ACCIDENTAL MECHANICAL FALL NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DV÷D€čHr§#hDWśD¶WHs€ŕWFollow Up 1 A0Y A 2021-05-19T15:25:35Y 107712851077Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVřD@Hr¨w@DW¦D|8HsŤŐ8Placebo APlacebo ADVřD@DWDyŕY . . .Placebo Placebo DW,DWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW¦Dr`D|8DWÄDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýB–BlBpC`AŕHr¨w@HrĆŔ`Hssm`HsŤŐ8 .DW‘WHITE AC4591001C4591001 1077 10771285AADVERSE EVENT 1 PAIN AT INJECTION SITE Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-19 Bś2021-05-21 Bž 1MedDRA v24.0NDW“ A ..DW•A@..A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW’Dr`Hssm`DYD|8Huo¸Vaccination 3 APY A02021-06-07T20:55:19Y 107712951077Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDĆ„HrąŢDWTDÂHs"Placebo APlacebo ADWDĆ„DWDĹXY . . .Placebo Placebo DW8DW<YPhase 3A@NNEGDW= BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW@DWTDßÔDÂDWpDXBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW<DWýB8BľBÁBůAđHrąŢHrŘ/XHsżÔHs" .DW?WHITE AC4591001C4591001 1077 10771295AADVERSE EVENT 4 RIGHT KNEE ACL TEAR Ligament rupture FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Anterior cruciate ligament tear F™}6F™–Muscle, tendon and ligament injuries F™Injuries NEC FěâInjury, poisoning and procedural complications Fěĺ2021-03-29T15:00B\2021-04-26 Bx 2MedDRA v24.0NDW` AĐDŇđHs1âđDW|B)..BDAYSN NNOT RELATEDOTHER TEAM MATE ACCIDENTALY FELL ON HIM NOT APPLICABLE NYRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A DCĆ A Period 02DW@DßÔHsżÔDXÁDÂHu4Vaccination 4 A`Y A@2021-08-23T17:04:15Y 107712951077Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDĆ„HrąŢDWTDÂHs"Placebo APlacebo ADWDĆ„DWDĹXY . . .Placebo Placebo DW8DW<YPhase 3A@NNEGDW= BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW@DWTDßÔDÂDWpDXBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW<DWýB8BľBÁBůAđHrąŢHrŘ/XHsżÔHs" .DW?WHITE AC4591001C4591001 1077 10771295A ADVERSE EVENT 1 RIGHT KNEE MENISCUS TEAR Meniscus injury FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Meniscus tear of knee F™F™łŠBone and joint injuries NEC F™ąuBone and joint injuries F¶Injury, poisoning and procedural complications Fěĺ2021-03-29T15:00B\2021-04-26 Bx 2MedDRA v24.0NDW` AĐDŇđHs1âđDW|B)..BDAYSN NNOT RELATEDOTHER FOOTBALL INJURY NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A DCĆ A Period 02DW@DßÔHsżÔDXÁDÂHu4Vaccination 4 A`Y A@2021-08-23T17:56:00Y 107712951077Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDĆ„HrąŢDWTDÂHs"Placebo APlacebo ADWDĆ„DWDĹXY . . .Placebo Placebo DW8DW<YPhase 3A@NNEGDW= BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW@DWTDßÔDÂDWpDXBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW<DWýB8BľBÁBůAđHrąŢHrŘ/XHsżÔHs" .DW?WHITE AC4591001C4591001 1077 10771295A0ADVERSE EVENT 3 FOOTBALL INJURY Sports injury FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Sports injury F™9ŠF™9ŠNon-site specific injuries NEC F™ ÇInjuries NEC FěâInjury, poisoning and procedural complications Fěĺ2021-03-29T15:00B\2021-03-29T15:00B\ 2MedDRA v24.0NDW` AĐDŇđHs1âđDW`AĐDÓ+Hs1ă+ADAYSN NNOT RELATEDOTHER TEAMMATE ACCIDENTALLY FELL ON HIM NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A DCĆ A Period 02DW@DßÔHsżÔDXÁDÂHu4Vaccination 4 A`Y A@2021-05-03T23:44:56Y 107712981077Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDpHrĆóđDWŁDß\HsŠCÜPlacebo APlacebo ADWDpDW#D¶XY . . .Placebo Placebo DW?DWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁDĺ8Dß\DWÄDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýBBpBpBďAŕHrĆóđHráZŘHsnš8HsŠCÜ .DWŤWHITE AC4591001C4591001 1077 10771298AADVERSE EVENT 1 FATIGUE Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-04T19:40B•2021-06-05T17:00B– 1MedDRA v24.0NDWŁ AEIHsŠyDW¤A DďKHs‹ĄKA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Bă A Period 02DWŽDĺ8Hsnš8DYDß\Hukw\Vaccination 4 A`Y A@2021-07-07T15:56:32Y 107713001077BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDéčHrÇ0hDW#DäŔHrá‰@BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWDéčDW#DäŔY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW?DW‚YPhase 3A@NNEGDW ....... . .NY.DW‚DWýBtB{BďAđHrÇ0hHrá‰@.. .DWÓWHITE AC4591001C4591001 1077 10771300AADVERSE EVENT 1 AMENORRHEA Amenorrhoea F™-LREPRODUCTIVE SYSTEM AND BREAST DISORDERS Amenorrhea FžFžMenstruation with decreased bleeding F™MMenstrual cycle and uterine bleeding disorders FĘŽReproductive system and breast disorders F™-L2021-01-12 A`2021-04-01T16:00BU 1MedDRA v24.0NDW A`..DWcBUDá;Hs5ĺ»BPDAYSN NNOT RELATEDOTHER UNABLE TO PROVE CAUSALITY NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DWDéčHrÇ0hDXDäŔHtÂĽŔVaccination 1 AY A2021-04-02T19:08:55Y 108415431084Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVűDčDHr¬ĐÄDW¦DŰ`HsŽ4`Placebo APlacebo ADVűDčDDWDŕLY . . .Placebo Placebo DW,DWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DäüDŰ`DWÂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýB“BmBpC0AŔHr¬ĐÄHrČxLHsrŽ|HsŽ4` .DWWHITE AC4591001C4591001 1084 10841543AMEDICATION ERROR Administration of expired drug Expired product administered FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Expired drug administered F™šF™»Product administration errors and issues F™Ë«Medication errors and other product use errors and issues F™Ë©Injury, poisoning and procedural complications Fěĺ2021-06-08 B2021-06-08 B MedDRA v24.0NDW§ A ..DW§A ..ADAYS DOSE NOT CHANGEDNN N . .. .N. A Period 02DW‘DäüHsrŽ|DYDŰ`HuogŕVaccination 4 A`Y A@2021-06-17T05:35:39Y 108415561084BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDťHrą´DWD`HrŐH`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWDťDWD`Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW=DWŚYPhase 3A@NNEGDWŤ ....... . .NY.DWŚDWýBBqBůAđHrą´HrŐH`.. .DWĐWHITE AC4591001C4591001 1084 10841556AADVERSE EVENT 1 L Ear infection Ear infection FëůINFECTIONS AND INFESTATIONS Ear infection FÍ;FÍ;Ear infections FÍ=Infections - pathogen unspecified Fë÷Infections and infestations Fëů2021-01-28 B 2021-02-05 B( 2MedDRA v24.0NDW$ A°..DW,B..ADAYSN NNOT RELATEDOTHER unknown NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DWDťHrą´DX‡D`Ht¶{ŕVaccination 2 A Y A 2021-02-23T04:11:12 108415581084BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDşHrąŃDWDŹ4HrŐV4BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWDşDWDŹ4Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW=DWŚYPhase 3A@NNEGDWŤ ....... . .NY.DWŚDWýBBqBůAđHrąŃHrŐV4.. .DWÉWHITE AC4591001C4591001 1084 10841558AADVERSE EVENT 1 left sprained ankle Ligament sprain FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Sprained ankle F™9¬FöMuscle, tendon and ligament injuries F™Injuries NEC FěâInjury, poisoning and procedural complications Fěĺ2021-01-27 B2021-01-28 B 2MedDRA v24.0NDW# A ..DW$A°..A DAYSN NNOT RELATEDOTHER fall NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DWDşHrąŃDX‡DŹ4Ht¶‰´Vaccination 2 A Y A 2021-03-11T20:58:55 108415601084Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADWD´xHrąËřDW´D ČHs nČPlacebo APlacebo ADWD´xDWDîÔY . . .Placebo Placebo DW@DW“YPhase 3A@NNEGDW” BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWśDW´DĐD ČDWĐDXqBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW“DWýBŹBbBjBůAđHrąËřHrÚűÔHs€úHs nČ .DW›WHITE AC4591001C4591001 1084 10841560AADVERSE EVENT 1 Obsessive compulsive disorder Obsessive-compulsive disorder F™'·PSYCHIATRIC DISORDERS Obsessive-compulsive disorder F™JF™JObsessive-compulsive disorders and symptoms F™ŁAnxiety disorders and symptoms FˇPsychiatric disorders F™'·2021-02-09 B, .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDW0 B....... N NNOT RELATEDOTHER new neuro diagnosis NOT APPLICABLE YNNOT RECOVERED/NOT RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DWD´xHrąËřDWśDĐ—Hs€ú—Vaccination 2 A Y A 2021-07-14T00:48:03Y 108415691084Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADWDčĽHrĽŁ<DWŞD›ÜHs“:ÜPlacebo APlacebo ADWDčĽDWDę`Y . . .Placebo Placebo DW=DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW•DWŞDęŘD›ÜDWÄDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB†BiBqB÷AŕHrĽŁ<HrÚ÷`HswÚXHs“:Ü .DW”WHITE AC4591001C4591001 1084 10841569AADVERSE EVENT 1 Headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-01-29 B2021-02-12 B- 1MedDRA v24.0NDW% A€..DW3B..AđDAYSN NNOT RELATEDOTHER Unknown NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DWDčĽHrĽŁ<DW•Dę×HswÚWVaccination 2 A Y A 2021-07-14T17:19:48Y 109114061091BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVđDé¬HržQ¬DWD˘lHrąąěBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVđDé¬DWD˘lY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW!DWYPhase 3A@NNEGDW® ....... . .NY.DWDWýBľBPCŕAŕHržQ¬Hrąąě.. .DWWHITE AC4591001C4591001 1091 10911406AADVERSE EVENT 2 Panic attacks Panic attack F™'·PSYCHIATRIC DISORDERS Panic attacks F™F™Panic attacks and disorders F™ˇLAnxiety disorders and symptoms FˇPsychiatric disorders F™'·2021-02-25 BQ .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDW@ B<....... N NNOT RELATEDOTHER Social/environmental events NOT APPLICABLE NNNOT RECOVERED/NOT RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVđDé¬HržQ¬DXrD˘lHtšílFollow Up 1 A0Y A 2021-06-15T17:49:24Y 109114061091BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVđDé¬HržQ¬DWD˘lHrąąěBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVđDé¬DWD˘lY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW!DWYPhase 3A@NNEGDW® ....... . .NY.DWDWýBľBPCŕAŕHržQ¬Hrąąě.. .DWWHITE AC4591001C4591001 1091 10911406A ADVERSE EVENT 1 Broken right arm Upper limb fracture FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Arm fracture F™VgF™†RLimb fractures and dislocations F™ľîBone and joint injuries F¶Injury, poisoning and procedural complications Fěĺ2021-05-25 BŞ .ONGOINGLAST SUBJECT ENCOUNTER3MedDRA v24.0NDW™ B•....... N NNOT RELATEDOTHER Sports injury NOT APPLICABLE NYRECOVERING/RESOLVING N A0NOT RELATEDA0A0GRADE 3A0 . APeriod 01DVđDé¬HržQ¬DXrD˘lHtšílFollow Up 1 A0Y A 2021-06-15T19:21:15Y 109114111091Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVňD¨HHr łHDW·Dž¬Hs¤a,Placebo APlacebo ADVňD¨HDWDˇ¸Y . . .Placebo Placebo DW#DW‘YPhase 3A@NNEGDW’ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW DW·Dš°Dž¬DW×DXtBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‘DWýB B^BlCŔAđHr łHHrąą8Hs† °Hs¤a, .DWźWHITE AC4591001C4591001 1091 10911411AADVERSE EVENT 1 Tooth impaction Tooth impacted FÜ›GASTROINTESTINAL DISORDERS Tooth impacted F™BŠF™BŠDental disorders NEC F™B…Dental and gingival conditions F™BrGastrointestinal disorders FÜ›2021-07-15 BŰ2021-07-15 BŰ 2MedDRA v24.0NDWĚ B..DWĚB..ADAYSN NNOT RELATEDOTHER tooth impaction NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . A Period 02DW Dš°Hs† °DY$Dž¬Hu…”¬Vaccination 4 A`Y A@2021-08-03T08:21:07Y 109114141091BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVňDä„Hr ď„DW™DôěHs}*lBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVňDä„..Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g) DW—DW—YPhase 3A@NNEGDWBNT162b2 (30 (*ESC*){unicode 03BC}g) DW™...... . .NN.DW—DWýB¦BfCŔAŕHr ď„Hs}*l.. .DXVWHITE AC4591001C4591001 1091 10911414AADVERSE EVENT 1 Injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-26 B©2021-05-27 BŞ 1MedDRA v24.0NDWš A ..DW›A0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . APeriod 01DVňDä„Hr ď„DYDôěHu^]ěAfter unblinding and before Vaccination 3A@ A 2021-08-04T17:28:17Y 109114171091Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVóD´<Hr˘ĽDW¨DĂđHsżđPlacebo APlacebo ADVóD´<DWDŇ<Y . . .Placebo Placebo DW#DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW¨DzĐDĂđDWŕDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBšBlBqC°AĐHr˘ĽHrĽŚĽHssuĐHsżđ .DW‘WHITE AC4591001C4591001 1091 10911417AADVERSE EVENT 1 Injection site pain left arm Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-18 B 2021-05-18 B 1MedDRA v24.0NDW’ A..DW’A..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW’DzĐHssuĐDYDĂđHuqópVaccination 3 APY A02021-06-15T16:36:32Y 109114171091Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVóD´<Hr˘ĽDW¨DĂđHsżđPlacebo APlacebo ADVóD´<DWDŇ<Y . . .Placebo Placebo DW#DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW¨DzĐDĂđDWŕDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBšBlBqC°AĐHr˘ĽHrĽŚĽHssuĐHsżđ .DW‘WHITE AC4591001C4591001 1091 10911417A ADVERSE EVENT 2 Fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-05-18T21:00B 2021-05-18 B 1MedDRA v24.0NDW’ AEuHst"PDW’A..ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C. A Period 02DW’DzĐHssuĐDYDĂđHuqópVaccination 3 APY A02021-06-15T16:35:04Y 109114221091BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADV÷D“äHr§6dDWDyhHrĹnhBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DV÷D“äDWDyhY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW*DWŻYPhase 3A@NPOSDW° ....... . .NY.DWŻDWýBąBNCpAđHr§6dHrĹnh.. .DWĂWHITE AC4591001C4591001 1091 10911422AADVERSE EVENT 1 left ear infection Ear infection FëůINFECTIONS AND INFESTATIONS Ear infection FÍ;FÍ;Ear infections FÍ=Infections - pathogen unspecified Fë÷Infections and infestations Fëů2020-12-23 A 2020-12-30 B 1MedDRA v24.0NDW A ..DWB..A€DAYSN NNOT RELATEDOTHER bacterial infection NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DV÷D“äHr§6dDX{DyhHt¦ˇčVaccination 1 AY A2021-02-04T17:33:04 109114221091BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADV÷D“äHr§6dDWDyhHrĹnhBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DV÷D“äDWDyhY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW*DWŻYPhase 3A@NPOSDW° ....... . .NY.DWŻDWýBąBNCpAđHr§6dHrĹnh.. .DWĂWHITE AC4591001C4591001 1091 10911422A ADVERSE EVENT 3 outer ear infection left ear Otitis externa FëůINFECTIONS AND INFESTATIONS Infection of the outer ear FëÝF™°Ear infections FÍ=Infections - pathogen unspecified Fë÷Infections and infestations Fëů2020-12-23 A 2020-12-30 B 1MedDRA v24.0NDW A ..DWB..A€DAYSN NNOT RELATEDOTHER bacterial infection NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DV÷D“äHr§6dDX{DyhHt¦ˇčVaccination 1 AY A2021-02-04T17:31:20 109114221091BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADV÷D“äHr§6dDWDyhHrĹnhBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DV÷D“äDWDyhY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW*DWŻYPhase 3A@NPOSDW° ....... . .NY.DWŻDWýBąBNCpAđHr§6dHrĹnh.. .DWĂWHITE AC4591001C4591001 1091 10911422A0ADVERSE EVENT 2 middle ear infection left ear Otitis media FëůINFECTIONS AND INFESTATIONS Middle ear infection F™AF™¶Ear infections FÍ=Infections - pathogen unspecified Fë÷Infections and infestations Fëů2020-12-23 A 2020-12-30 B 1MedDRA v24.0NDW A ..DWB..A€DAYSN NNOT RELATEDOTHER bacterial infection NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DV÷D“äHr§6dDX{DyhHt¦ˇčVaccination 1 AY A2021-02-04T17:31:15 109114231091Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsABLACK OR AFRICAN AMERICAN A FA NOT HISPANIC OR LATINOA USABLACK OR AFRICAN AMERICAN A DV÷D” Hr§6 DWŇDÜČHsČ7ČPlacebo APlacebo ADV÷D” DWD’|Y . . .Placebo Placebo DW1DW¶YPhase 3A@NNEGDW· BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW˝DWŇDĎ¨DÜČDWóDXŹBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW¶DWýBŔBABGCpAŕHr§6 HrĹ‡|Hs¬{(HsČ7Č .DWĽBLACK OR AFRICAN AMERICANA C4591001C4591001 1091 10911423AADVERSE EVENT 2 Diarrhea Diarrhoea FÜ›GASTROINTESTINAL DISORDERS Diarrhea FČ7FČ?Diarrhoea (excl infective) FČ@Gastrointestinal motility and defaecation conditions FÜąGastrointestinal disorders FÜ›2021-07-22T02:00BÝ2021-07-23T19:00BŢ 1MedDRA v24.0NDWÓ A D HsČČ DWÔA0E¶°HsË kA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C& A Period 02DW˝DĎ¨Hs¬{(DY?DÜČHu©kHVaccination 4 A`Y A@2021-08-23T19:54:32Y 109114231091Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsABLACK OR AFRICAN AMERICAN A FA NOT HISPANIC OR LATINOA USABLACK OR AFRICAN AMERICAN A DV÷D” Hr§6 DWŇDÜČHsČ7ČPlacebo APlacebo ADV÷D” DWD’|Y . . .Placebo Placebo DW1DW¶YPhase 3A@NNEGDW· BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW˝DWŇDĎ¨DÜČDWóDXŹBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW¶DWýBŔBABGCpAŕHr§6 HrĹ‡|Hs¬{(HsČ7Č .DWĽBLACK OR AFRICAN AMERICANA C4591001C4591001 1091 10911423A ADVERSE EVENT 4 Headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-07-22T02:00BÝ2021-07-23T19:00BŢ 1MedDRA v24.0NDWÓ A D HsČČ DWÔA0E¶°HsË kA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C& A Period 02DW˝DĎ¨Hs¬{(DY?DÜČHu©kHVaccination 4 A`Y A@2021-08-23T19:54:56Y 109114231091Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsABLACK OR AFRICAN AMERICAN A FA NOT HISPANIC OR LATINOA USABLACK OR AFRICAN AMERICAN A DV÷D” Hr§6 DWŇDÜČHsČ7ČPlacebo APlacebo ADV÷D” DWD’|Y . . .Placebo Placebo DW1DW¶YPhase 3A@NNEGDW· BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW˝DWŇDĎ¨DÜČDWóDXŹBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW¶DWýBŔBABGCpAŕHr§6 HrĹ‡|Hs¬{(HsČ7Č .DWĽBLACK OR AFRICAN AMERICANA C4591001C4591001 1091 10911423A0ADVERSE EVENT 1 Myalgia Myalgia F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Myalgia F™{F™{Muscle pains F™#Muscle disorders F™Musculoskeletal and connective tissue disorders F™k2021-07-22T02:00BÝ2021-07-23T19:00BŢ 1MedDRA v24.0NDWÓ A D HsČČ DWÔA0E¶°HsË kA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED WITH SEQUELAEN ARELATED AAGRADE 1A C& A Period 02DW˝DĎ¨Hs¬{(DY?DÜČHu©kHVaccination 4 A`Y A@2021-08-27T20:11:13Y 109114231091Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsABLACK OR AFRICAN AMERICAN A FA NOT HISPANIC OR LATINOA USABLACK OR AFRICAN AMERICAN A DV÷D” Hr§6 DWŇDÜČHsČ7ČPlacebo APlacebo ADV÷D” DWD’|Y . . .Placebo Placebo DW1DW¶YPhase 3A@NNEGDW· BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW˝DWŇDĎ¨DÜČDWóDXŹBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW¶DWýBŔBABGCpAŕHr§6 HrĹ‡|Hs¬{(HsČ7Č .DWĽBLACK OR AFRICAN AMERICANA C4591001C4591001 1091 10911423A@ADVERSE EVENT 3 Vomitting Vomiting FÜ›GASTROINTESTINAL DISORDERS Vomiting F™PÔF™PÔNausea and vomiting symptoms F™Gastrointestinal signs and symptoms FÜÜGastrointestinal disorders FÜ›2021-07-22T02:00BÝ2021-07-23T19:00BŢ 1MedDRA v24.0NDWÓ A D HsČČ DWÔA0E¶°HsË kA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C& A Period 02DW˝DĎ¨Hs¬{(DY?DÜČHu©kHVaccination 4 A`Y A@2021-08-23T19:54:44Y 109114331091Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADVúDŮřHr«přDWDčĽHrÇ/<Placebo APlacebo ADVúDŮřDWDčĽY . . .Placebo Placebo DW/DWYPhase 3A@NNEGDW™ ....... . .NN.DWDWýBźBeC@AŕHr«přHrÇ/<.. .DWĚWHITE AC4591001C4591001 1091 10911433AADVERSE EVENT 2 intermittent rash on wrist Rash F™5ŃSKIN AND SUBCUTANEOUS TISSUE DISORDERS Localised rash F™‹pF™*TRashes, eruptions and exanthems NEC F™cÖEpidermal and dermal conditions FŃSkin and subcutaneous tissue disorders F™5Ń2020-12-19T00:00A0 .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDVü A0Hr:..... N NNOT RELATEDOTHER unknown NOT APPLICABLE NNNOT RECOVERED/NOT RESOLVED N A0NOT RELATEDA0AGRADE 1A Cyŕ APeriod 01DVúDŮřHr«přDX|DčĽHt¨bĽVaccination 1 AY A2021-02-10T22:48:10 109114631091Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDé4HrĂ;4DW¦D„äHsŤÝäPlacebo APlacebo ADWDé4DW#DÜPY . . .Placebo Placebo DW@DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦D÷ĽD„äDWÄDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBBmBqBňAđHrĂ;4Hrá€ĐHsrˇ<HsŤÝä .DWWHITE AC4591001C4591001 1091 10911463AADVERSE EVENT 1 Wisdom teethth impaction Tooth impacted FÜ›GASTROINTESTINAL DISORDERS Impacted wisdom tooth FęŠF™BŠDental disorders NEC F™B…Dental and gingival conditions F™BrGastrointestinal disorders FÜ›2021-04-27 Br2021-05-07 B| 1MedDRA v24.0NDW} B[..DW‡Be..A°DAYSN NNOT RELATEDOTHER dental impaction NOT APPLICABLE NYRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DWDé4HrĂ;4DW‘D÷»Hsrˇ;Follow Up 1 A0Y A 2021-06-08T16:40:09Y 112314401123BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVňD‡xHr ’xDWD‚PHrą™ĐBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVňD‡xDWD‚PY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW!DW’YPhase 3A@NNEGDW“ ....... . .NY.DW’DWýBˇBkCŔAĐHr ’xHrą™Đ.. .DWµWHITE AC4591001C4591001 1123 11231440AADVERSE EVENT 1 Left otitis media Otitis media FëůINFECTIONS AND INFESTATIONS Otitis media F™¶F™¶Ear infections FÍ=Infections - pathogen unspecified Fë÷Infections and infestations Fëů2021-08-13 Bř2021-08-21 C 2MedDRA v24.0NDWé Bĺ..DWńBí..ADAYSN NNOT RELATEDOTHER unknown NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVňD‡xHr ’xDXrD‚PHtšÍPAfter unblinding and before Vaccination 3A@ A 2021-08-30T16:08:59Y 112314421123Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVňD°|Hr »|DWµDĂHsˇâ€Placebo APlacebo ADVňD°|DWDÂY . . .Placebo Placebo DW(DW™YPhase 3A@NNEGDWš BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWšDWµDŇđDĂDWÔDXrBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW™DWýB¨BdBdCŔAŔHr »|HrĂHs~YđHsˇâ€ .DW™WHITE AC4591001C4591001 1123 11231442AADVERSE EVENT 1 Depression Depression F™'·PSYCHIATRIC DISORDERS Depression FĆÚFĆÚDepressive disorders FĆńDepressed mood disorders and disturbances FĆ×Psychiatric disorders F™'·2020-12-23 Ađ2021-06-04T08:00B˛ 2MedDRA v24.0NDW Ađ..DWŁB˛Dp»Hs‰Ő;B¤DAYSN NNOT RELATEDOTHER unknown NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVňD°|Hr »|DWšDŇďHs~YďVaccination 1 AY A2021-06-09T19:15:00 AE outcome changed from EUA to sBLA 112314421123Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVňD°|Hr »|DWµDĂHsˇâ€Placebo APlacebo ADVňD°|DWDÂY . . .Placebo Placebo DW(DW™YPhase 3A@NNEGDWš BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWšDWµDŇđDĂDWÔDXrBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW™DWýB¨BdBdCŔAŔHr »|HrĂHs~YđHsˇâ€ .DW™WHITE AC4591001C4591001 1123 11231442A ADVERSE EVENT 3 worsening of depression Depression F™'·PSYCHIATRIC DISORDERS Depression worsened FĆîFĆÚDepressive disorders FĆńDepressed mood disorders and disturbances FĆ×Psychiatric disorders F™'·2021-03 .2021-06-04T08:00B˛ 1MedDRA v24.0NDWDDB9..DWŁBDp»Hs‰Ő;. N NNOT RELATEDOTHER unknown NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVňD°|Hr »|DWšDŇďHs~YďFollow Up 1 A0Y A 2021-06-10T20:43:25Y 112314421123Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVňD°|Hr »|DWµDĂHsˇâ€Placebo APlacebo ADVňD°|DWDÂY . . .Placebo Placebo DW(DW™YPhase 3A@NNEGDWš BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWšDWµDŇđDĂDWÔDXrBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW™DWýB¨BdBdCŔAŔHr »|HrĂHs~YđHsˇâ€ .DW™WHITE AC4591001C4591001 1123 11231442A0ADVERSE EVENT 2 headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2020-12-16 A€2020-12-17 A 1MedDRA v24.0NDVů A€..DVúA..A DAYSN NNOT RELATEDOTHER unknown NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVňD°|Hr »|DWšDŇďHs~YďVaccination 1 AY A2021-05-19T15:03:12Y 112314481123Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsABLACK OR AFRICAN AMERICAN A MANOT HISPANIC OR LATINOA USABLACK OR AFRICAN AMERICAN A DVôDĽHrŁ-ĽDWD„0HrĽ>°Placebo APlacebo ADVôDĽDWD„0Y . . .Placebo Placebo DW*DWÄYPhase 3A@NNEG. ....... . .NN.DWv.B..BAĐHrŁ-ĽHrĽ>°.. .DWÄBLACK OR AFRICAN AMERICANA C4591001C4591001 1123 11231448AADVERSE EVENT 1 Diarrhea Diarrhoea FÜ›GASTROINTESTINAL DISORDERS Diarrhea FČ7FČ?Diarrhoea (excl infective) FČ@Gastrointestinal motility and defaecation conditions FÜąGastrointestinal disorders FÜ›2020-12-16 A`2020-12-18 A€ 1MedDRA v24.0NDVů A`..DVűA€..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . APeriod 01DVôDĽHrŁ-ĽDXtD„0Htťr0Vaccination 1 AY A2020-12-21T18:14:10 112314721123BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVţD´<Hr°‘<DWD… HrÍc BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVţD´<DWD… Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW7DW‘YPhase 3A@NNEGDW’ ....... . .NY.DW‘DWýB”BlCAđHr°‘<HrÍc .. .DWĂWHITE AC4591001C4591001 1123 11231472AADVERSE EVENT 2 worsening of acne vulgaris Acne F™5ŃSKIN AND SUBCUTANEOUS TISSUE DISORDERS Acne vulgaris F‡FpAcnes FqSkin appendage conditions F™5ŢSkin and subcutaneous tissue disorders F™5Ń2021-01-07 B .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDW B....... N NNOT RELATEDOTHER unknown NOT APPLICABLE YNNOT RECOVERED/NOT RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVţD´<Hr°‘<DXD… Ht®– Vaccination 1 AY A2021-01-23T21:14:19 112314721123BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVţD´<Hr°‘<DWD… HrÍc BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVţD´<DWD… Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW7DW‘YPhase 3A@NNEGDW’ ....... . .NY.DW‘DWýB”BlCAđHr°‘<HrÍc .. .DWĂWHITE AC4591001C4591001 1123 11231472A ADVERSE EVENT 1 Tinea capitis Tinea capitis FëůINFECTIONS AND INFESTATIONS Tinea capitis F™AÚF™AÚTinea infections F™AŢFungal infectious disorders FÚřInfections and infestations Fëů2021-01-01 AŔ2021-02-12 B6 1MedDRA v24.0NDW AŔ..DW3B6..B+DAYSN NNOT RELATEDOTHER unknown NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVţD´<Hr°‘<DXD… Ht®– Vaccination 1 AY A2021-03-09T15:47:59 112314731123Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVţDµ,Hr°’,DW§DŞ(HsŹT¨Placebo APlacebo ADVţDµ,DWDŃLY . . .Placebo Placebo DW0DWYPhase 3A@NNEGDW‘ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW§Dî\DŞ(DWĂDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWDWýB“BlBmCAđHr°’,HrÍŻLHssé\HsŹT¨ .DW‘WHITE AC4591001C4591001 1123 11231473AADVERSE EVENT 1 avulsion fracture right middle finger Hand fracture FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Fractured finger FÚFá*Limb fractures and dislocations F™ľîBone and joint injuries F¶Injury, poisoning and procedural complications Fěĺ2021-04-11 Bp .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDWm BZ....... N NNOT RELATEDOTHER Sports Injury NOT APPLICABLE YYRECOVERING/RESOLVING N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVţDµ,Hr°’,DW’Dî[Hssé[Follow Up 1 A0Y A 2021-05-28T16:34:13Y 112314891123BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADV˙DŘHr˛DWD¬HrĚ8BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DV˙DŘDWD¬Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW3DW‘YPhase 3A@NNEGDW’ ....... . .NY.DW‘DWýB“BlB˙AĐHr˛HrĚ8.. .DWĹWHITE AC4591001C4591001 1123 11231489AADVERSE EVENT 1 Torn medial and lateral left knee menisci Meniscus injury FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Meniscus tear of knee F™F™łŠBone and joint injuries NEC F™ąuBone and joint injuries F¶Injury, poisoning and procedural complications Fěĺ2021-03 . .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDWDDB2....... N NNOT RELATEDOTHER unknown NOT APPLICABLE YNRECOVERING/RESOLVING N A0NOT RELATEDA0AGRADE 1A . APeriod 01DV˙DŘHr˛DX€D¬HtlFollow Up 1 A0Y A 2021-07-12T18:55:55Y 112315071123BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDí0Hrş°DWD¦hHrŐmhBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWDí0DWD¦hY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW7DWŤYPhase 3A@NNEGDWŽ ....... . .NY.DWŤDWýB‰BpBůAŕHrş°HrŐmh.. .DW×WHITE AC4591001C4591001 1123 11231507AADVERSE EVENT 2 WORSENING Attention Deficit Hyper Activity Disorder Attention deficit hyperactivity disorderF™'·PSYCHIATRIC DISORDERS Attention deficit hyperactivity disorder F™Ý&F™Ý&Attention deficit and disruptive behaviour disorders FĄCognitive and attention disorders and disturbances FĽńPsychiatric disorders F™'·2021-03-01 B@ .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDWD B+....... N NNOT RELATEDOTHER unknown NOT APPLICABLE YNNOT RECOVERED/NOT RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DWDí0Hrş°DX‡D¦hHt¶ čFollow Up 1 A0Y A 2021-09-22T15:47:32Y 112315201123Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDňXHrĽ¬ŘDWŞD‰XHs“(XPlacebo APlacebo ADWDňXDWDłLY . . .Placebo Placebo DW6DW”YPhase 3A@NNEGDW• BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW•DWŞDŕLD‰XDWÉDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW”DWýBŽBiBiB÷AŔHrĽ¬ŘHrŐzLHswĎĚHs“(X .DW”WHITE AC4591001C4591001 1123 11231520AADVERSE EVENT 1 Bilateral conjunctivitis Conjunctivitis FëůINFECTIONS AND INFESTATIONS Conjunctivitis FŔuFŔuEye and eyelid infections FÔĄInfections - pathogen unspecified Fë÷Infections and infestations Fëů2021-01-12 Aŕ2021-01-17 B 1MedDRA v24.0NDW Aŕ..DWB..A`DAYSN NNOT RELATEDOTHER unknown NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DWDňXHrĽ¬ŘDW•DŕKHswĎËVaccination 1 AY A2021-01-23T20:06:52 112315231123Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADW DÄ¤HrÄh$DW§DżôHsŹjtPlacebo APlacebo ADW DÄ¤DW"DÜPY . . .Placebo Placebo DW@DWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW§D©ěDżôDWÄDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýBBlBpBńAŔHrÄh$Hrŕ/PHss¤ěHsŹjt .DW‘WHITE AC4591001C4591001 1123 11231523AADVERSE EVENT 1 INTRA RETINAL HEMORRHAGE OD Retinal haemorrhage FÔŻEYE DISORDERS Retinal hemorrhage F™.VF™.SRetinal bleeding and vascular disorders (excl retinopathy) F™.5Retina, choroid and vitreous haemorrhages and vascular disordersF™NTEye disorders FÔŻ2021-02-16 B+ .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDW7 B....... N NNOT RELATEDOTHER UNKNOWN NOT APPLICABLE NNRECOVERING/RESOLVING N A0NOT RELATEDA0A GRADE 2A . APeriod 01DW DÄ¤HrÄh$DW’D©ëHss¤ëVaccination 2 A Y A 2021-03-09T17:49:08 112412451124BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVřDńŕHr¨ĺŕDWDű¸HrĹđ¸BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVřDńŕDWDű¸Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW2DWŤYPhase 3A@NNEGDWŽ ....... . .NY.DWŤDWýB–BpC`AŕHr¨ĺŕHrĹđ¸.. .DWËWHITE AC4591001C4591001 1124 11241245AADVERSE EVENT 1 Anxiety Anxiety F™'·PSYCHIATRIC DISORDERS Anxiety Fˇ§Fˇ§Anxiety symptoms FˇµAnxiety disorders and symptoms FˇPsychiatric disorders F™'·2021-03 . .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDWDDB7....... N NNOT RELATEDOTHER Mood disorder NOT APPLICABLE YNRECOVERING/RESOLVING N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVřDńŕHr¨ĺŕDX{Dű¸Ht§$8Follow Up 1 A0Y A 2021-07-16T12:36:43Y 112412451124BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVřDńŕHr¨ĺŕDWDű¸HrĹđ¸BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVřDńŕDWDű¸Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW2DWŤYPhase 3A@NNEGDWŽ ....... . .NY.DWŤDWýB–BpC`AŕHr¨ĺŕHrĹđ¸.. .DWËWHITE AC4591001C4591001 1124 11241245A ADVERSE EVENT 2 Depression Depression F™'·PSYCHIATRIC DISORDERS Depression FĆÚFĆÚDepressive disorders FĆńDepressed mood disorders and disturbances FĆ×Psychiatric disorders F™'·2021-03 . .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDWDDB7....... N NNOT RELATEDOTHER mood disorder NOT APPLICABLE YNRECOVERING/RESOLVING N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVřDńŕHr¨ĺŕDX{Dű¸Ht§$8Follow Up 1 A0Y A 2021-07-16T12:37:31Y 112412511124BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVűDŠHr¬rŚDWDĄ<HrČ=<BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVűDŠDWDĄ<Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW,DWŚYPhase 3A@NNEGDWŤ ....... . .NY.DWŚDWýB’BqC0AđHr¬rŚHrČ=<.. .DWÍWHITE AC4591001C4591001 1124 11241251AADVERSE EVENT 1 Fever (102.2 degrees F) Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-01-09T08:00B2021-01-09T10:00B 3MedDRA v24.0NDW A Dp€HrÉZDWA DŚŰHrÉv[ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA0GRADE 3A0 CKđ APeriod 01DVűDŠHr¬rŚDX}DĄ<Ht©pĽVaccination 2 A Y A 2021-01-26T18:38:53 112512481125Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVôDĘĽHrŁxĽDWDżHrĽy„Placebo APlacebo ADVôDĘĽDWDżY . . .Placebo Placebo DW#DWŚYPhase 3A@NPOSDWŤ ....... . .NN.DWŚDWýB™BqC AđHrŁxĽHrĽy„.. .DWľWHITE AC4591001C4591001 1125 11251248AADVERSE EVENT 1 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-01-05 B2021-01-08 B 1MedDRA v24.0NDW Ap..DWA ..A@DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . APeriod 01DVôDĘĽHrŁxĽDXtDżHtťVaccination 2 A Y A 2021-02-19T20:09:42 112612331126Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVęD§”Hr–&”DW¨DŔ¨HsĽ¨Placebo APlacebo ADVęD§”DV˙D” Y . . .Placebo Placebo DWDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DW¨D’|DŔ¨DWÄDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBŁBkBqC@AŕHr–&”Hr±Â HstŢüHsĽ¨ .DW’WHITE AC4591001C4591001 1126 11261233AADVERSE EVENT 2 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-19T18:00BŞ2021-05-20 B« 1MedDRA v24.0NDW“ ADý HsuI DW”A ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Cp A Period 02DW“D’|HstŢüDYDŔ¨Huqđ(Vaccination 3 APY A02021-06-12T00:31:19Y 112612331126Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVęD§”Hr–&”DW¨DŔ¨HsĽ¨Placebo APlacebo ADVęD§”DV˙D” Y . . .Placebo Placebo DWDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DW¨D’|DŔ¨DWÄDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBŁBkBqC@AŕHr–&”Hr±Â HstŢüHsĽ¨ .DW’WHITE AC4591001C4591001 1126 11261233A ADVERSE EVENT 4 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-09T22:00Bż2021-06-12 BÂ 2MedDRA v24.0NDW¨ AEVHs‘1`DW«A@..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C A Period 02DW“D’|HstŢüDYDŔ¨Huqđ(Vaccination 4 A`Y A@2021-07-09T03:44:26Y 112612331126Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVęD§”Hr–&”DW¨DŔ¨HsĽ¨Placebo APlacebo ADVęD§”DV˙D” Y . . .Placebo Placebo DWDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DW¨D’|DŔ¨DWÄDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBŁBkBqC@AŕHr–&”Hr±Â HstŢüHsĽ¨ .DW’WHITE AC4591001C4591001 1126 11261233A0ADVERSE EVENT 1 Left Upper Arm Injection Site Pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-19T18:00BŞ2021-05-21 B¬ 2MedDRA v24.0NDW“ ADý HsuI DW•A0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A Cp A Period 02DW“D’|HstŢüDYDŔ¨Huqđ(Vaccination 3 APY A02021-06-12T00:31:08Y 112612331126Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVęD§”Hr–&”DW¨DŔ¨HsĽ¨Placebo APlacebo ADVęD§”DV˙D” Y . . .Placebo Placebo DWDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DW¨D’|DŔ¨DWÄDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBŁBkBqC@AŕHr–&”Hr±Â HstŢüHsĽ¨ .DW’WHITE AC4591001C4591001 1126 11261233A@ADVERSE EVENT 3 Muscle Aches Myalgia F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Muscle ache F™˙F™{Muscle pains F™#Muscle disorders F™Musculoskeletal and connective tissue disorders F™k2021-05-20 B«2021-05-21 B¬ 2MedDRA v24.0NDW” A ..DW•A0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DW“D’|HstŢüDYDŔ¨Huqđ(Vaccination 3 APY A02021-06-12T00:31:31Y 112612351126Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVęDÜŚHr–[ŚDW§D¤LHsŹNĚPlacebo APlacebo ADVęDÜŚDWDŠHY . . .Placebo Placebo DWDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW§DŘD¤LDWĆDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBŁBlBqC@AŔHr–[ŚHrł HHss‹ŘHsŹNĚ .DW‘WHITE AC4591001C4591001 1126 11261235AADVERSE EVENT 3 Generalized body aches Pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalised aching FÝF™ŰPain and discomfort NEC F™ÜGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-09T03:00Bż2021-06-09 Bż 1MedDRA v24.0NDW¨ A D*0Hs&0DW¨A ..ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C9p A Period 02DW’DŘHss‹ŘDYD¤LHup‚LVaccination 4 A`Y A@2021-07-12T21:47:53Y 112612351126Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVęDÜŚHr–[ŚDW§D¤LHsŹNĚPlacebo APlacebo ADVęDÜŚDWDŠHY . . .Placebo Placebo DWDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW§DŘD¤LDWĆDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBŁBlBqC@AŔHr–[ŚHrł HHss‹ŘHsŹNĚ .DW‘WHITE AC4591001C4591001 1126 11261235A ADVERSE EVENT 1 Phyto photodermatitis, bilateral hands Photosensitivity reaction F™5ŃSKIN AND SUBCUTANEOUS TISSUE DISORDERS Phytophotodermatitis F™”F™Photosensitivity and photodermatosis conditions F™ł–Epidermal and dermal conditions FŃSkin and subcutaneous tissue disorders F™5Ń2021-05-23 B®2021-05-26 B± 2MedDRA v24.0NDW— A`..DWšA..A@DAYSN NNOT RELATEDOTHER Doxycycline NOT APPLICABLE YYRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . A Period 02DW’DŘHss‹ŘDYD¤LHup‚LVaccination 3 APY A02021-06-10T23:02:38Y 112612351126Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVęDÜŚHr–[ŚDW§D¤LHsŹNĚPlacebo APlacebo ADVęDÜŚDWDŠHY . . .Placebo Placebo DWDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW§DŘD¤LDWĆDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBŁBlBqC@AŔHr–[ŚHrł HHss‹ŘHsŹNĚ .DW‘WHITE AC4591001C4591001 1126 11261235A0ADVERSE EVENT 2 Fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-06-09T03:00Bż2021-06-09 Bż 1MedDRA v24.0NDW¨ A D*0Hs&0DW¨A ..ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C9p A Period 02DW’DŘHss‹ŘDYD¤LHup‚LVaccination 4 A`Y A@2021-07-12T21:47:41Y 112612391126Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVëDŚ Hr—] DW¦DŚ(HsŤĺ(Placebo APlacebo ADVëDŚ DVţD{„Y . . .Placebo Placebo DWDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦D©°DŚ(DWÉDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB˘BmBqC0AđHr—] Hr°X„HsrS0HsŤĺ( .DWWHITE AC4591001C4591001 1126 11261239AADVERSE EVENT 3 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-07T19:00BĽ2021-06-08 B˝ 2MedDRA v24.0NDW¦ AEłHsŽd0DW§A ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C!ŕ A Period 02DW‘D©°HsrS0DYDŚ(Huo¨Vaccination 4 A`Y A@2021-07-14T22:49:15Y 112612391126Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVëDŚ Hr—] DW¦DŚ(HsŤĺ(Placebo APlacebo ADVëDŚ DVţD{„Y . . .Placebo Placebo DWDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦D©°DŚ(DWÉDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB˘BmBqC0AđHr—] Hr°X„HsrS0HsŤĺ( .DWWHITE AC4591001C4591001 1126 11261239A ADVERSE EVENT 1 Left arm injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-17T16:30B§2021-05-19T16:30B© 2MedDRA v24.0NDW‘ ADčHsr‘DW“A0DčCHsu4ĂA0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C A Period 02DW‘D©°HsrS0DYDŚ(Huo¨Vaccination 3 APY A02021-06-09T00:01:34Y 112612391126Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVëDŚ Hr—] DW¦DŚ(HsŤĺ(Placebo APlacebo ADVëDŚ DVţD{„Y . . .Placebo Placebo DWDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦D©°DŚ(DWÉDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB˘BmBqC0AđHr—] Hr°X„HsrS0HsŤĺ( .DWWHITE AC4591001C4591001 1126 11261239A0ADVERSE EVENT 5 Pain, injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Pain injection site F™-FěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-07T19:00BĽ2021-06-08 B˝ 2MedDRA v24.0NDW¦ AEłHsŽd0DW§A ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C!ŕ A Period 02DW‘D©°HsrS0DYDŚ(Huo¨Vaccination 4 A`Y A@2021-07-15T00:51:09Y 112612391126Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVëDŚ Hr—] DW¦DŚ(HsŤĺ(Placebo APlacebo ADVëDŚ DVţD{„Y . . .Placebo Placebo DWDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦D©°DŚ(DWÉDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB˘BmBqC0AđHr—] Hr°X„HsrS0HsŤĺ( .DWWHITE AC4591001C4591001 1126 11261239A@ADVERSE EVENT 4 Generalized body aches Pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalised aching FÝF™ŰPain and discomfort NEC F™ÜGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-07T19:00BĽ2021-06-08 B˝ 2MedDRA v24.0NDW¦ AEłHsŽd0DW§A ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C!ŕ A Period 02DW‘D©°HsrS0DYDŚ(Huo¨Vaccination 4 A`Y A@2021-07-14T22:49:27Y 112612391126Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVëDŚ Hr—] DW¦DŚ(HsŤĺ(Placebo APlacebo ADVëDŚ DVţD{„Y . . .Placebo Placebo DWDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦D©°DŚ(DWÉDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB˘BmBqC0AđHr—] Hr°X„HsrS0HsŤĺ( .DWWHITE AC4591001C4591001 1126 11261239APADVERSE EVENT 2 Fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-06-07T19:00BĽ2021-06-08 B˝ 2MedDRA v24.0NDW¦ AEłHsŽd0DW§A ..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C!ŕ A Period 02DW‘D©°HsrS0DYDŚ(Huo¨Vaccination 4 A`Y A@2021-07-14T22:49:03Y 112612401126Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVëDŚÜHr—]\DW©D·ŔHs’@Placebo APlacebo ADVëDŚÜDVţD{HY . . .Placebo Placebo DWDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW•DW©DÄhD·ŔDWÉDXfBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB˘BiBqC0AđHr—]\Hr°XHHswłčHs’@ .DW”WHITE AC4591001C4591001 1126 11261240AADVERSE EVENT 2 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-10T21:00Bż2021-06-11 BŔ 1MedDRA v24.0NDW© AEuHs’tĐDWŞA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CŔ A Period 02DW•DÄhHswłčDYD·ŔHus8ŔVaccination 4 A`Y A@2021-07-14T22:49:39Y 112612401126Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVëDŚÜHr—]\DW©D·ŔHs’@Placebo APlacebo ADVëDŚÜDVţD{HY . . .Placebo Placebo DWDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW•DW©DÄhD·ŔDWÉDXfBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB˘BiBqC0AđHr—]\Hr°XHHswłčHs’@ .DW”WHITE AC4591001C4591001 1126 11261240A ADVERSE EVENT 1 Pain, injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Pain injection site F™-FěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-21T16:00B«2021-05-22 B¬ 2MedDRA v24.0NDW• ADáHswĐ€DW–A ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A Bz A Period 02DW•DÄhHswłčDYD·ŔHus8ŔVaccination 3 APY A02021-06-16T16:15:09Y 112612401126Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVëDŚÜHr—]\DW©D·ŔHs’@Placebo APlacebo ADVëDŚÜDVţD{HY . . .Placebo Placebo DWDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW•DW©DÄhD·ŔDWÉDXfBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB˘BiBqC0AđHr—]\Hr°XHHswłčHs’@ .DW”WHITE AC4591001C4591001 1126 11261240A0ADVERSE EVENT 3 Pain, injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Pain injection site F™-FěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-10T21:00Bż2021-06-11 BŔ 1MedDRA v24.0NDW© AEuHs’tĐDWŞA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CŔ A Period 02DW•DÄhHswłčDYD·ŔHus8ŔVaccination 4 A`Y A@2021-07-14T22:49:51Y 112612401126Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVëDŚÜHr—]\DW©D·ŔHs’@Placebo APlacebo ADVëDŚÜDVţD{HY . . .Placebo Placebo DWDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW•DW©DÄhD·ŔDWÉDXfBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB˘BiBqC0AđHr—]\Hr°XHHswłčHs’@ .DW”WHITE AC4591001C4591001 1126 11261240A@ADVERSE EVENT 4 Generalized body aches Pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalised aching FÝF™ŰPain and discomfort NEC F™ÜGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-10T21:00Bż2021-06-11 BŔ 1MedDRA v24.0NDW© AEuHs’tĐDWŞA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CŔ A Period 02DW•DÄhHswłčDYD·ŔHus8ŔVaccination 4 A`Y A@2021-07-14T22:50:03Y 112612461126BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVëD×dHr—§äDWD’HrłBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVëD×dDWD’Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWDWŚYPhase 3A@NNEGDWŤ ....... . .NY.DWŚDWýB˘BqC0AĐHr—§äHrł.. .DWµWHITE AC4591001C4591001 1126 11261246AADVERSE EVENT 1 Canker sore under tongue Aphthous ulcer FÜ›GASTROINTESTINAL DISORDERS Canker sores oral F˛~F˘Stomatitis and ulceration F™;Oral soft tissue conditions F™ĄGastrointestinal disorders FÜ›2021-01-12 B*2021-01-15 B- 1MedDRA v24.0NDW B..DWB..A@DAYSN NNOT RELATEDOTHER Unknown NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVëD×dHr—§äDXmD’Ht”E„Vaccination 2 A Y A 2021-01-26T02:35:33 112612461126BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVëD×dHr—§äDWD’HrłBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVëD×dDWD’Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWDWŚYPhase 3A@NNEGDWŤ ....... . .NY.DWŚDWýB˘BqC0AĐHr—§äHrł.. .DWµWHITE AC4591001C4591001 1126 11261246A ADVERSE EVENT 3 Red bump on right index finger at cuticle Nodule FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Nodule on finger F™ µF™iŰMass conditions NEC F™u×Tissue disorders NEC Fµ;General disorders and administration site conditions FÝ2021-01-13 B+2021-03-03 B\ 1MedDRA v24.0NDW B..DWFBG..B2DAYSN NNOT RELATEDOTHER Unknown NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVëD×dHr—§äDXmD’Ht”E„Vaccination 2 A Y A 2021-05-03T18:41:46 AE outcome changed from EUA to sBLA 112612461126BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVëD×dHr—§äDWD’HrłBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVëD×dDWD’Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWDWŚYPhase 3A@NNEGDWŤ ....... . .NY.DWŚDWýB˘BqC0AĐHr—§äHrł.. .DWµWHITE AC4591001C4591001 1126 11261246A0ADVERSE EVENT 2 Right leg pain Pain in extremity F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Unilateral leg pain F™c:F™Musculoskeletal and connective tissue pain and discomfort F™ŁMusculoskeletal and connective tissue disorders NEC F™iMusculoskeletal and connective tissue disorders F™k2020-12-31 B .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDW A....... N NNOT RELATEDOTHER Unknown NOT APPLICABLE NNNOT RECOVERED/NOT RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVëD×dHr—§äDXmD’Ht”E„Vaccination 2 A Y A 2021-01-26T02:35:38 112612501126Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVëDűHr—Ë„DW®DăXHsČXPlacebo APlacebo ADVëDűDV˙DÉY . . .Placebo Placebo DWDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DW®DŞdDăXDWÍDXkBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB˘BkBqC0AŔHr—Ë„Hr±÷HstöäHsČX .DW’WHITE AC4591001C4591001 1126 11261250AADVERSE EVENT 2 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-15T18:00BÄ2021-06-16 BĹ 1MedDRA v24.0NDW® ADý Hsâ DWŻA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Bn A Period 02DW“DŞdHstöäDYDăXHuyűŘVaccination 4 A`Y A@2021-07-20T13:05:06Y 112612501126Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVëDűHr—Ë„DW®DăXHsČXPlacebo APlacebo ADVëDűDV˙DÉY . . .Placebo Placebo DWDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DW®DŞdDăXDWÍDXkBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB˘BkBqC0AŔHr—Ë„Hr±÷HstöäHsČX .DW’WHITE AC4591001C4591001 1126 11261250A ADVERSE EVENT 1 Pain, Injection Site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Pain injection site F™-FěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-19T14:00B©2021-05-20 BŞ 1MedDRA v24.0NDW“ ADÄŕHsu`DW”A ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Bq A Period 02DW“DŞdHstöäDYDăXHuyűŘVaccination 3 APY A02021-06-18T03:03:15Y 112612501126Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVëDűHr—Ë„DW®DăXHsČXPlacebo APlacebo ADVëDűDV˙DÉY . . .Placebo Placebo DWDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DW®DŞdDăXDWÍDXkBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB˘BkBqC0AŔHr—Ë„Hr±÷HstöäHsČX .DW’WHITE AC4591001C4591001 1126 11261250A0ADVERSE EVENT 3 Pain, injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Pain injection site F™-FěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-15T18:00BÄ2021-06-16 BĹ 1MedDRA v24.0NDW® ADý Hsâ DWŻA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Bn A Period 02DW“DŞdHstöäDYDăXHuyűŘVaccination 4 A`Y A@2021-07-20T13:05:18Y 112612531126Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVěD±äHrÓäDW§D¤HsŹ3$Placebo APlacebo ADVěD±äDWDŁ Y . . .Placebo Placebo DWDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW§DŤTD¤DWĂDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBˇBmBqC AĐHrÓäHrł# Hsr6ÔHsŹ3$ .DWWHITE AC4591001C4591001 1126 11261253AADVERSE EVENT 3 Chills Chills FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills F·ÓF·ÓFeelings and sensations NEC F™ŁGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-17T18:00B¦2021-05-17T20:00B¦ 2MedDRA v24.0NDW‘ ADý Hsr¦ DW‘AE—°HsrÂűADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A CĐ A Period 02DW‘DŤTHsr6ÔDYD¤Hupf¤Vaccination 3 APY A02021-06-09T00:02:20Y 112612531126Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVěD±äHrÓäDW§D¤HsŹ3$Placebo APlacebo ADVěD±äDWDŁ Y . . .Placebo Placebo DWDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW§DŤTD¤DWĂDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBˇBmBqC AĐHrÓäHrł# Hsr6ÔHsŹ3$ .DWWHITE AC4591001C4591001 1126 11261253A ADVERSE EVENT 2 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-18T12:00B§2021-05-19T08:00B¨ 2MedDRA v24.0NDW’ A D¨ŔHssŁŔDW“A0Dp»Hst˝;A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A CaP A Period 02DW‘DŤTHsr6ÔDYD¤Hupf¤Vaccination 3 APY A02021-06-09T00:02:09Y 112612531126Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVěD±äHrÓäDW§D¤HsŹ3$Placebo APlacebo ADVěD±äDWDŁ Y . . .Placebo Placebo DWDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW§DŤTD¤DWĂDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBˇBmBqC AĐHrÓäHrł# Hsr6ÔHsŹ3$ .DWWHITE AC4591001C4591001 1126 11261253A0ADVERSE EVENT 5 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-08T18:00BĽ2021-06-09 B˝ 1MedDRA v24.0NDW§ ADý HsŹ§ DW¨A ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C A Period 02DW‘DŤTHsr6ÔDYD¤Hupf¤Vaccination 4 A`Y A@2021-07-09T18:49:59Y 112612531126Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVěD±äHrÓäDW§D¤HsŹ3$Placebo APlacebo ADVěD±äDWDŁ Y . . .Placebo Placebo DWDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW§DŤTD¤DWĂDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBˇBmBqC AĐHrÓäHrł# Hsr6ÔHsŹ3$ .DWWHITE AC4591001C4591001 1126 11261253A@ADVERSE EVENT 4 Left arm injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-17T18:00B¦2021-05-19 B¨ 1MedDRA v24.0NDW‘ ADý Hsr¦ DW“A0..A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CĐ A Period 02DW‘DŤTHsr6ÔDYD¤Hupf¤Vaccination 3 APY A02021-06-09T00:02:31Y 112612531126Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVěD±äHrÓäDW§D¤HsŹ3$Placebo APlacebo ADVěD±äDWDŁ Y . . .Placebo Placebo DWDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW§DŤTD¤DWĂDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBˇBmBqC AĐHrÓäHrł# Hsr6ÔHsŹ3$ .DWWHITE AC4591001C4591001 1126 11261253APADVERSE EVENT 1 Muscle aches Myalgia F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Muscle ache F™˙F™{Muscle pains F™#Muscle disorders F™Musculoskeletal and connective tissue disorders F™k2021-05-17T18:00B¦2021-05-19T08:00B¨ 2MedDRA v24.0NDW‘ ADý Hsr¦ DW“A0Dp»Hst˝;A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A CĐ A Period 02DW‘DŤTHsr6ÔDYD¤Hupf¤Vaccination 3 APY A02021-06-09T00:01:58Y 112612541126Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVěDÜČHrţČDWÉDŚdHsĽ äPlacebo APlacebo ADVěDÜČDW"DÍŚY . . .Placebo Placebo DW?DW´YPhase 3A@NNEGDWµ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWµDWÉDÎ¸DŚdDWĺDX†BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW´DWýBÉBIBIC AđHrţČHrŕ ŚHsˇî8HsĽ ä .DW´WHITE AC4591001C4591001 1126 11261254AADVERSE EVENT 2 Chills Chills FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills F·ÓF·ÓFeelings and sensations NEC F™ŁGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-23 BË2021-06-23 BË 1MedDRA v24.0NDW¶ A ..DW¶A ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWµDÎ¸Hsˇî8DY6DŚdHuť=dVaccination 3 APY A02021-07-12T23:49:08Y 112612541126Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVěDÜČHrţČDWÉDŚdHsĽ äPlacebo APlacebo ADVěDÜČDW"DÍŚY . . .Placebo Placebo DW?DW´YPhase 3A@NNEGDWµ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWµDWÉDÎ¸DŚdDWĺDX†BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW´DWýBÉBIBIC AđHrţČHrŕ ŚHsˇî8HsĽ ä .DW´WHITE AC4591001C4591001 1126 11261254A ADVERSE EVENT 6 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-07-12T23:45BŢ2021-07-13 Bß 1MedDRA v24.0NDWÉ AEßŔHsĽË|DWĘA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C3 A Period 02DWµDÎ¸Hsˇî8DY6DŚdHuť=dVaccination 4 A`Y A@2021-08-13T20:24:12Y 112612541126Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVěDÜČHrţČDWÉDŚdHsĽ äPlacebo APlacebo ADVěDÜČDW"DÍŚY . . .Placebo Placebo DW?DW´YPhase 3A@NNEGDWµ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWµDWÉDÎ¸DŚdDWĺDX†BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW´DWýBÉBIBIC AđHrţČHrŕ ŚHsˇî8HsĽ ä .DW´WHITE AC4591001C4591001 1126 11261254A0ADVERSE EVENT 1 Allergic reaction, nuts Food allergy Fę4IMMUNE SYSTEM DISORDERS Allergy to nuts F™m/FŘ˛Allergies to foods, food additives, drugs and other chemicals FťIAllergic conditions Fť,Immune system disorders Fę42020-12-09T15:00Ap2020-12-09 Ap 2MedDRA v24.0NDVň ApDŇđHr ÝđDVňAp..ADAYSN NNOT RELATEDOTHER Exposure to nuts NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A D!– APeriod 01DVěDÜČHrţČDWµDÎ·Hsˇî7Vaccination 1 AY A2021-01-27T22:15:53 112612541126Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVěDÜČHrţČDWÉDŚdHsĽ äPlacebo APlacebo ADVěDÜČDW"DÍŚY . . .Placebo Placebo DW?DW´YPhase 3A@NNEGDWµ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWµDWÉDÎ¸DŚdDWĺDX†BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW´DWýBÉBIBIC AđHrţČHrŕ ŚHsˇî8HsĽ ä .DW´WHITE AC4591001C4591001 1126 11261254A@ADVERSE EVENT 3 Headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-06-23 BË2021-06-23 BË 1MedDRA v24.0NDW¶ A ..DW¶A ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWµDÎ¸Hsˇî8DY6DŚdHuť=dVaccination 3 APY A02021-07-12T23:49:20Y 112612541126Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVěDÜČHrţČDWÉDŚdHsĽ äPlacebo APlacebo ADVěDÜČDW"DÍŚY . . .Placebo Placebo DW?DW´YPhase 3A@NNEGDWµ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWµDWÉDÎ¸DŚdDWĺDX†BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW´DWýBÉBIBIC AđHrţČHrŕ ŚHsˇî8HsĽ ä .DW´WHITE AC4591001C4591001 1126 11261254APADVERSE EVENT 7 Headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-07-12T23:45BŢ2021-07-13 Bß 1MedDRA v24.0NDWÉ AEßŔHsĽË|DWĘA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C3 A Period 02DWµDÎ¸Hsˇî8DY6DŚdHuť=dVaccination 4 A`Y A@2021-08-13T20:24:23Y 112612541126Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVěDÜČHrţČDWÉDŚdHsĽ äPlacebo APlacebo ADVěDÜČDW"DÍŚY . . .Placebo Placebo DW?DW´YPhase 3A@NNEGDWµ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWµDWÉDÎ¸DŚdDWĺDX†BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW´DWýBÉBIBIC AđHrţČHrŕ ŚHsˇî8HsĽ ä .DW´WHITE AC4591001C4591001 1126 11261254A`ADVERSE EVENT 5 Injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-23 BË2021-06-25 BÍ 1MedDRA v24.0NDW¶ A ..DW¸A@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWµDÎ¸Hsˇî8DY6DŚdHuť=dVaccination 3 APY A02021-07-12T23:49:43Y 112612541126Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVěDÜČHrţČDWÉDŚdHsĽ äPlacebo APlacebo ADVěDÜČDW"DÍŚY . . .Placebo Placebo DW?DW´YPhase 3A@NNEGDWµ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWµDWÉDÎ¸DŚdDWĺDX†BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW´DWýBÉBIBIC AđHrţČHrŕ ŚHsˇî8HsĽ ä .DW´WHITE AC4591001C4591001 1126 11261254ApADVERSE EVENT 4 Malaise Malaise FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Malaise Fú Fú Asthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-23 BË2021-06-23 BË 1MedDRA v24.0NDW¶ A ..DW¶A ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWµDÎ¸Hsˇî8DY6DŚdHuť=dVaccination 3 APY A02021-07-12T23:49:31Y 112612621126Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVíDăHršVśDWFD®śHswśPlacebo APlacebo ADVíDăDWD˝śY . . .Placebo Placebo DWDW/YPhase 3A@NNEGDW0 BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW1DWFDŇxD®śDWbDXBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW/DWýBCBÍBÎCAđHršVśHrł=śHróëřHswś .DW0WHITE AC4591001C4591001 1126 11261262AADVERSE EVENT 3 Headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-03-03T18:00BZ2021-03-04 B[ 1MedDRA v24.0NDWF ADý HsĆ DWGA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Cđ A Period 02DW1DŇxHróëřDXłD®śHtđ«Vaccination 4 A`Y A@2021-04-01T23:21:56Y 112612621126Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVíDăHršVśDWFD®śHswśPlacebo APlacebo ADVíDăDWD˝śY . . .Placebo Placebo DWDW/YPhase 3A@NNEGDW0 BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW1DWFDŇxD®śDWbDXBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW/DWýBCBÍBÎCAđHršVśHrł=śHróëřHswś .DW0WHITE AC4591001C4591001 1126 11261262A ADVERSE EVENT 4 Injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-03-04 B[2021-03-06 B] 1MedDRA v24.0NDWG A ..DWIA@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW1DŇxHróëřDXłD®śHtđ«Vaccination 4 A`Y A@2021-04-01T23:22:06Y 112612621126Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVíDăHršVśDWFD®śHswśPlacebo APlacebo ADVíDăDWD˝śY . . .Placebo Placebo DWDW/YPhase 3A@NNEGDW0 BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW1DWFDŇxD®śDWbDXBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW/DWýBCBÍBÎCAđHršVśHrł=śHróëřHswś .DW0WHITE AC4591001C4591001 1126 11261262A0ADVERSE EVENT 1 Left upper arm injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-02-10T21:00BE2021-02-12T12:00BG 1MedDRA v24.0NDW1 AEuHrô@ĐDW3A0D¨űHröe{A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C A Period 02DW1DŇxHróëřDXłD®śHtđ«Vaccination 3 APY A02021-03-05T19:02:41 112612621126Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVíDăHršVśDWFD®śHswśPlacebo APlacebo ADVíDăDWD˝śY . . .Placebo Placebo DWDW/YPhase 3A@NNEGDW0 BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW1DWFDŇxD®śDWbDXBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW/DWýBCBÍBÎCAđHršVśHrł=śHróëřHswś .DW0WHITE AC4591001C4591001 1126 11261262A@ADVERSE EVENT 2 Malaise Malaise FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Malaise Fú Fú Asthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-03-03T18:00BZ2021-03-04 B[ 2MedDRA v24.0NDWF ADý HsĆ DWGA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A Cđ A Period 02DW1DŇxHróëřDXłD®śHtđ«Vaccination 4 A`Y A@2021-04-01T23:21:45Y 112612631126BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVíDěôHrš`tDWDÜHrł\BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVíDěôDWDÜY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWDW¶YPhase 3A@NNEGDW· ....... . .NY.DW¶DWýBĘBGCAđHrš`tHrł\.. .DW·WHITE AC4591001C4591001 1126 11261263AADVERSE EVENT 3 Mechanical Fall Fall FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Fall FŐFŐNon-site specific injuries NEC F™ ÇInjuries NEC FěâInjury, poisoning and procedural complications Fěĺ2020-12-20 B2020-12-20 B 2MedDRA v24.0NDVý B..DVýB..ADAYSN NNOT RELATEDOTHER Snow boarding NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVíDěôHrš`tDXmDÜHt”Ź”Vaccination 1 AY A2021-01-06T02:26:27 112612631126BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVíDěôHrš`tDWDÜHrł\BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVíDěôDWDÜY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWDW¶YPhase 3A@NNEGDW· ....... . .NY.DW¶DWýBĘBGCAđHrš`tHrł\.. .DW·WHITE AC4591001C4591001 1126 11261263A ADVERSE EVENT 1 LEFT AXILLA LYMPH NODE SWELLING Lymphadenopathy F«QBLOOD AND LYMPHATIC SYSTEM DISORDERS Lymphadenopathy axillary F™VUFříLymphatic system disorders NEC FřîSpleen, lymphatic and reticuloendothelial system disorders F™9)Blood and lymphatic system disorders F«Q2020-12-10 Ap2020-12-13 A 1MedDRA v24.0NDVó Ap..DVöA ..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . APeriod 01DVíDěôHrš`tDXmDÜHt”Ź”Vaccination 1 AY A2020-12-30T21:08:48 112612631126BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVíDěôHrš`tDWDÜHrł\BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVíDěôDWDÜY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWDW¶YPhase 3A@NNEGDW· ....... . .NY.DW¶DWýBĘBGCAđHrš`tHrł\.. .DW·WHITE AC4591001C4591001 1126 11261263A0ADVERSE EVENT 2 RIGHT DISTAL RADIUS TORUS FRACTURE Radius fracture FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Radius fracture F™**F™**Limb fractures and dislocations F™ľîBone and joint injuries F¶Injury, poisoning and procedural complications Fěĺ2020-12-20 B2021-01-20 B0 2MedDRA v24.0NDVý B..DWB0..B DAYSN NNOT RELATEDOTHER MECHANICAL FALL NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVíDěôHrš`tDXmDÜHt”Ź”Vaccination 1 AY A2021-02-23T16:35:18 112612651126Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADV÷D˙<Hr§ˇĽDWDŞ(Hs—=¨Placebo APlacebo ADV÷D˙<DWD€čY . . .Placebo Placebo DW(DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DWDĂDŞ(DWÉDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB–BkBqCpAŕHr§ˇĽHrÂŇčHsu€Hs—=¨ .DW’WHITE AC4591001C4591001 1126 11261265AADVERSE EVENT 1 Pain, injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Pain injection site F™-FěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-20 Bž2021-05-23 Bˇ 1MedDRA v24.0NDW” A ..DW—AP..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW“DĂHsu€DYDŞ(Huxq(Vaccination 3 APY A02021-06-16T16:15:21Y 112612651126Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADV÷D˙<Hr§ˇĽDWDŞ(Hs—=¨Placebo APlacebo ADV÷D˙<DWD€čY . . .Placebo Placebo DW(DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DWDĂDŞ(DWÉDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB–BkBqCpAŕHr§ˇĽHrÂŇčHsu€Hs—=¨ .DW’WHITE AC4591001C4591001 1126 11261265A ADVERSE EVENT 2 Pain, injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Pain injection site F™-FěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-14T13:00B·2021-06-15 B¸ 1MedDRA v24.0NDW AD¶ĐHs—JPDW®A ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A B6 A Period 02DW“DĂHsu€DYDŞ(Huxq(Vaccination 4 A`Y A@2021-07-12T23:49:55Y 112612661126Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADV÷D†Hr§)DWDŞ Hs—> Placebo APlacebo ADV÷D†DWD`Y . . .Placebo Placebo DW(DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DWDĂDŞ DWÉDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB–BkBqCpAŔHr§)HrÂÓ`Hsu€Hs—> .DW’WHITE AC4591001C4591001 1126 11261266A ADVERSE EVENT 2 Pain, injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Pain injection site F™-FěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-15 B¸2021-06-15 B¸ 1MedDRA v24.0NDW® A ..DW®A ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW“DĂHsu€DYDŞ Huxq Vaccination 4 A`Y A@2021-07-12T23:50:06Y 112612661126Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADV÷D†Hr§)DWDŞ Hs—> Placebo APlacebo ADV÷D†DWD`Y . . .Placebo Placebo DW(DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DWDĂDŞ DWÉDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB–BkBqCpAŔHr§)HrÂÓ`Hsu€Hs—> .DW’WHITE AC4591001C4591001 1126 11261266AADVERSE EVENT 1 Pain, Injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Pain injection site F™-FěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-19T18:00Bť2021-05-20 Bž 1MedDRA v24.0NDW“ ADý HsuI DW”A ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Bř A Period 02DW“DĂHsu€DYDŞ Huxq Vaccination 3 APY A02021-06-16T16:15:32Y 112612671126Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADV÷DŘHr§3XDWŞDŕHs“'ŕPlacebo APlacebo ADV÷DŘDWDĺ°Y . . .Placebo Placebo DW*DWYPhase 3A@NNEGDW‘ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW•DWŞDŢlDŕDWÉDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWDWýBšBiBmCpAĐHr§3XHrĂ7°HswÍěHs“'ŕ .DW”WHITE AC4591001C4591001 1126 11261267AADVERSE EVENT 2 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-22 B 2021-05-22 B 2MedDRA v24.0NDW– A ..DW–A ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DW•DŢlHswÍěDYDŕHut[`Vaccination 3 APY A02021-06-16T17:47:54Y 112612671126Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADV÷DŘHr§3XDWŞDŕHs“'ŕPlacebo APlacebo ADV÷DŘDWDĺ°Y . . .Placebo Placebo DW*DWYPhase 3A@NNEGDW‘ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW•DWŞDŢlDŕDWÉDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWDWýBšBiBmCpAĐHr§3XHrĂ7°HswÍěHs“'ŕ .DW”WHITE AC4591001C4591001 1126 11261267A ADVERSE EVENT 4 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-11T21:00B´2021-06-13 B¶ 2MedDRA v24.0NDWŞ AEuHs“ĆPDW¬A0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C*@ A Period 02DW•DŢlHswÍěDYDŕHut[`Vaccination 4 A`Y A@2021-07-30T00:15:35Y 112612671126Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADV÷DŘHr§3XDWŞDŕHs“'ŕPlacebo APlacebo ADV÷DŘDWDĺ°Y . . .Placebo Placebo DW*DWYPhase 3A@NNEGDW‘ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW•DWŞDŢlDŕDWÉDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWDWýBšBiBmCpAĐHr§3XHrĂ7°HswÍěHs“'ŕ .DW”WHITE AC4591001C4591001 1126 11261267A0ADVERSE EVENT 1 Left upper arm injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-21T18:00Bź2021-05-23 Bˇ 2MedDRA v24.0NDW• ADý Hswě DW—A0..A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A B A Period 02DW•DŢlHswÍěDYDŕHut[`Vaccination 3 APY A02021-06-16T17:47:43Y 112612671126Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADV÷DŘHr§3XDWŞDŕHs“'ŕPlacebo APlacebo ADV÷DŘDWDĺ°Y . . .Placebo Placebo DW*DWYPhase 3A@NNEGDW‘ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW•DWŞDŢlDŕDWÉDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWDWýBšBiBmCpAĐHr§3XHrĂ7°HswÍěHs“'ŕ .DW”WHITE AC4591001C4591001 1126 11261267A@ADVERSE EVENT 6 PAIN, INJECTION SITE Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Pain injection site F™-FěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-11T22:00B´2021-06-13 B¶ 2MedDRA v24.0NDWŞ AEVHs“Ô`DW¬A0..A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C. A Period 02DW•DŢlHswÍěDYDŕHut[`Vaccination 4 A`Y A@2021-08-03T07:25:23Y 112612671126Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADV÷DŘHr§3XDWŞDŕHs“'ŕPlacebo APlacebo ADV÷DŘDWDĺ°Y . . .Placebo Placebo DW*DWYPhase 3A@NNEGDW‘ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW•DWŞDŢlDŕDWÉDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWDWýBšBiBmCpAĐHr§3XHrĂ7°HswÍěHs“'ŕ .DW”WHITE AC4591001C4591001 1126 11261267APADVERSE EVENT 5 GENERALIZED BODY ACHES Pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalised aching FÝF™ŰPain and discomfort NEC F™ÜGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-11T22:00B´2021-06-13 B¶ 2MedDRA v24.0NDWŞ AEVHs“Ô`DW¬A0..A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C. A Period 02DW•DŢlHswÍěDYDŕHut[`Vaccination 4 A`Y A@2021-08-03T07:25:11Y 112612671126Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADV÷DŘHr§3XDWŞDŕHs“'ŕPlacebo APlacebo ADV÷DŘDWDĺ°Y . . .Placebo Placebo DW*DWYPhase 3A@NNEGDW‘ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW•DWŞDŢlDŕDWÉDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWDWýBšBiBmCpAĐHr§3XHrĂ7°HswÍěHs“'ŕ .DW”WHITE AC4591001C4591001 1126 11261267A`ADVERSE EVENT 3 Fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-06-11T22:00B´2021-06-12 Bµ 2MedDRA v24.0NDWŞ AEVHs“Ô`DW«A ..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C. A Period 02DW•DŢlHswÍěDYDŕHut[`Vaccination 4 A`Y A@2021-07-12T23:50:17Y 112612681126BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADV÷DśHr§?DW Dâ,HrÄ…¬BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DV÷DśDW Dâ,Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW,DWŚYPhase 3A@NNEGDWŤ ....... . .NY.DWŚDWýB–BqCpAĐHr§?HrÄ…¬.. .DWÄWHITE AC4591001C4591001 1126 11261268AADVERSE EVENT 2 Juvenile Osteochondrosis of bilateral fifth metatarsals Osteochondrosis F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Juvenile osteochondrosis of foot Fń\F™Cartilage disorders F´ťTendon, ligament and cartilage disorders F™?eMusculoskeletal and connective tissue disorders F™k2020-12-28 Ađ .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDW Ađ....... N NNOT RELATEDOTHER Gymnastic injury NOT APPLICABLE YYRECOVERING/RESOLVING N A0NOT RELATEDA0A GRADE 2A . APeriod 01DV÷DśHr§?DXzDâ,HtĄą,Vaccination 1 AY A2021-02-10T08:58:37 112612681126BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADV÷DśHr§?DW Dâ,HrÄ…¬BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DV÷DśDW Dâ,Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW,DWŚYPhase 3A@NNEGDWŤ ....... . .NY.DWŚDWýB–BqCpAĐHr§?HrÄ…¬.. .DWÄWHITE AC4591001C4591001 1126 11261268A ADVERSE EVENT 1 Facial Urticaria, worsening Urticaria F™5ŃSKIN AND SUBCUTANEOUS TISSUE DISORDERS Urticaria aggravated F™MF™MUrticarias F™MAngioedema and urticaria FźúSkin and subcutaneous tissue disorders F™5Ń2020-12-18 AP2020-12-31 B 1MedDRA v24.0NDVű AP..DWB..AŕDAYSN NNOT RELATEDOTHER Trigger unknown NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DV÷DśHr§?DXzDâ,HtĄą,Vaccination 1 AY A2021-01-13T00:18:11 112612701126Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADV÷DĐ Hr§r DW©D‹tHs‘ŘôPlacebo APlacebo ADV÷DĐ DWD¨üY . . .Placebo Placebo DW*DWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW”DW©DâŕD‹tDWĹDXfBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýB—BjBpCpAđHr§r HrĹťüHsv€ŕHs‘Řô .DW“WHITE AC4591001C4591001 1126 11261270AADVERSE EVENT 2 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-11 B´2021-06-12 Bµ 1MedDRA v24.0NDWŞ A ..DW«A0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW”DâŕHsv€ŕDYD‹tHustVaccination 4 A`Y A@2021-07-12T21:48:04Y 112612701126Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADV÷DĐ Hr§r DW©D‹tHs‘ŘôPlacebo APlacebo ADV÷DĐ DWD¨üY . . .Placebo Placebo DW*DWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW”DW©DâŕD‹tDWĹDXfBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýB—BjBpCpAđHr§r HrĹťüHsv€ŕHs‘Řô .DW“WHITE AC4591001C4591001 1126 11261270A ADVERSE EVENT 1 Left upper arm injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-20T16:00Bž2021-05-21 Bź 1MedDRA v24.0NDW” B‡DáHsvDW•B..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A E/*đ APeriod 01DV÷DĐ Hr§r DW”DâßHsv€ßAfter unblinding and before Vaccination 3A@ A 2021-06-16T16:15:44Y 112612711126BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADV÷DäŔHr§‡@DWDČdHrĹ˝dBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DV÷DäŔDWDČdY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW*DWŚYPhase 3A@NNEGDWŤ ....... . .NY.DWŚDWýB–BqCpAđHr§‡@HrĹ˝d.. .DWÍWHITE AC4591001C4591001 1126 11261271AADVERSE EVENT 1 SARS-COV-2 IGG, QL, IA - Positive SARS-CoV-2 antibody test positive FďëINVESTIGATIONS SARS-CoV-2 antibody test positive F™ŕ‹F™ŕ‹Virus identification and serology F™PMicrobiology and serology investigations F™ Investigations Fďë2021-01-21 B' .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDW B....... N NRELATED NOT APPLICABLE NNNOT RECOVERED/NOT RESOLVED N ARELATED AAGRADE 1A . APeriod 01DV÷DäŔHr§‡@DX{DČdHt¦đäVaccination 2 A Y A 2021-07-20T17:37:51Y 112612741126Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVřDŞÜHr¨žÜDW©EE@Hs’aÔPlacebo APlacebo ADVřDŞÜDWD›dY . . .Placebo Placebo DW*DWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW”DW©Dć EE@DWĘDXfBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýB–BjBpC`AđHr¨žÜHrÂídHsv„ Hs’aÔ .DW“WHITE AC4591001C4591001 1126 11261274AADVERSE EVENT 2 Headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-05-21T08:30Bž2021-05-21T16:00Bž 2MedDRA v24.0NDW• A DwHswgDW•A Dá;HswĐ»ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C<` A Period 02DW”Dć Hsv„ DYEE@Hus•TVaccination 3 APY A02021-06-16T17:49:04Y 112612741126Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVřDŞÜHr¨žÜDW©EE@Hs’aÔPlacebo APlacebo ADVřDŞÜDWD›dY . . .Placebo Placebo DW*DWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW”DW©Dć EE@DWĘDXfBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýB–BjBpC`AđHr¨žÜHrÂídHsv„ Hs’aÔ .DW“WHITE AC4591001C4591001 1126 11261274A0ADVERSE EVENT 3 Pain, injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Pain injection site F™-FěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-11 Bł2021-06-13 Bµ 1MedDRA v24.0NDWŞ A ..DW¬A@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW”Dć Hsv„ DYEE@Hus•TVaccination 4 A`Y A@2021-07-15T00:51:20Y 112612741126Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVřDŞÜHr¨žÜDW©EE@Hs’aÔPlacebo APlacebo ADVřDŞÜDWD›dY . . .Placebo Placebo DW*DWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW”DW©Dć EE@DWĘDXfBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýB–BjBpC`AđHr¨žÜHrÂídHsv„ Hs’aÔ .DW“WHITE AC4591001C4591001 1126 11261274A ADVERSE EVENT 1 Left upper arm injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-20T17:00Bť2021-05-22 Bź 2MedDRA v24.0NDW” ADďHsvŤDW–A0..A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A B$ A Period 02DW”Dć Hsv„ DYEE@Hus•TVaccination 3 APY A02021-06-16T17:48:53Y 112612751126Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADVřDćÜHr¨ÚÜDWFDĽ4Hs…4Placebo APlacebo ADVřDćÜDWDń¤Y . . .Placebo Placebo DW*DW*YPhase 3A@NPOSDW+ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW/DWFDáDĽ4DWgDWöBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW*DWýB3BĎBÓC`AđHr¨ÚÜHrĹć¤HrńW€Hs…4 .DW.WHITE AC4591001C4591001 1126 11261275AADVERSE EVENT 2 Chills Chills FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills F·ÓF·ÓFeelings and sensations NEC F™ŁGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-02-09T00:00B92021-02-09T08:00B9 2MedDRA v24.0NDW0 A HrńČDW0A Dp»Hrň8»ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C A Period 02DW/DáHrńW€DXłDĽ4Htđ¸´Vaccination 3 APY A02021-03-05T19:02:58 112612751126Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADVřDćÜHr¨ÚÜDWFDĽ4Hs…4Placebo APlacebo ADVřDćÜDWDń¤Y . . .Placebo Placebo DW*DW*YPhase 3A@NPOSDW+ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW/DWFDáDĽ4DWgDWöBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW*DWýB3BĎBÓC`AđHr¨ÚÜHrĹć¤HrńW€Hs…4 .DW.WHITE AC4591001C4591001 1126 11261275A ADVERSE EVENT 1 Headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-02-09T00:00B92021-02-09T08:00B9 2MedDRA v24.0NDW0 A HrńČDW0A Dp»Hrň8»ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C A Period 02DW/DáHrńW€DXłDĽ4Htđ¸´Vaccination 3 APY A02021-03-05T19:02:50 112612751126Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADVřDćÜHr¨ÚÜDWFDĽ4Hs…4Placebo APlacebo ADVřDćÜDWDń¤Y . . .Placebo Placebo DW*DW*YPhase 3A@NPOSDW+ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW/DWFDáDĽ4DWgDWöBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW*DWýB3BĎBÓC`AđHr¨ÚÜHrĹć¤HrńW€Hs…4 .DW.WHITE AC4591001C4591001 1126 11261275A0ADVERSE EVENT 3 Left upper arm injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-02-08T22:00B82021-02-10T12:00B: 1MedDRA v24.0NDW/ AEVHrń«ŕDW1A0D¨űHróÂ{A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C€ A Period 02DW/DáHrńW€DXłDĽ4Htđ¸´Vaccination 3 APY A02021-03-05T19:03:06 112612761126Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADVřDçHr¨ŰDWFD»řHs„řPlacebo APlacebo ADVřDçDWDń¤Y . . .Placebo Placebo DW*DW*YPhase 3A@NNEGDW+ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW/DWFDá<D»řDWgDWöBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW*DWýB3BĎBÓC`AđHr¨ŰHrĹć¤HrńWĽHs„ř .DW.WHITE AC4591001C4591001 1126 11261276AADVERSE EVENT 2 Headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-02-09T01:00B92021-02-09T12:00B9 2MedDRA v24.0NDW0 A CáHrńÖDW0A D¨űHrňpűADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C!° A Period 02DW/Dá<HrńWĽDXłD»řHtđ¸xVaccination 3 APY A02021-03-05T19:03:23 112612761126Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADVřDçHr¨ŰDWFD»řHs„řPlacebo APlacebo ADVřDçDWDń¤Y . . .Placebo Placebo DW*DW*YPhase 3A@NNEGDW+ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW/DWFDá<D»řDWgDWöBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW*DWýB3BĎBÓC`AđHr¨ŰHrĹć¤HrńWĽHs„ř .DW.WHITE AC4591001C4591001 1126 11261276A ADVERSE EVENT 5 Headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-03-03T21:00BO2021-03-04 BP 1MedDRA v24.0NDWF AEuHsđPDWGA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C A Period 02DW/Dá<HrńWĽDXłD»řHtđ¸xVaccination 4 A`Y A@2021-04-08T02:20:09Y 112612761126Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADVřDçHr¨ŰDWFD»řHs„řPlacebo APlacebo ADVřDçDWDń¤Y . . .Placebo Placebo DW*DW*YPhase 3A@NNEGDW+ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW/DWFDá<D»řDWgDWöBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW*DWýB3BĎBÓC`AđHr¨ŰHrĹć¤HrńWĽHs„ř .DW.WHITE AC4591001C4591001 1126 11261276A0ADVERSE EVENT 1 Left upper arm injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-02-08T21:00B82021-02-10T21:00B: 2MedDRA v24.0NDW/ AEuHrńťĐDW1A0Ex°HrôAA0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C° A Period 02DW/Dá<HrńWĽDXłD»řHtđ¸xVaccination 3 APY A02021-03-05T19:03:15 112612761126Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADVřDçHr¨ŰDWFD»řHs„řPlacebo APlacebo ADVřDçDWDń¤Y . . .Placebo Placebo DW*DW*YPhase 3A@NNEGDW+ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW/DWFDá<D»řDWgDWöBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW*DWýB3BĎBÓC`AđHr¨ŰHrĹć¤HrńWĽHs„ř .DW.WHITE AC4591001C4591001 1126 11261276A@ADVERSE EVENT 4 Malaise Malaise FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Malaise Fú Fú Asthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-03-03T21:00BO2021-03-04 BP 1MedDRA v24.0NDWF AEuHsđPDWGA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C A Period 02DW/Dá<HrńWĽDXłD»řHtđ¸xVaccination 4 A`Y A@2021-04-08T02:19:59Y 112612761126Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADVřDçHr¨ŰDWFD»řHs„řPlacebo APlacebo ADVřDçDWDń¤Y . . .Placebo Placebo DW*DW*YPhase 3A@NNEGDW+ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW/DWFDá<D»řDWgDWöBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW*DWýB3BĎBÓC`AđHr¨ŰHrĹć¤HrńWĽHs„ř .DW.WHITE AC4591001C4591001 1126 11261276APADVERSE EVENT 3 Fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-02-09T03:00B92021-02-09T09:00B9 1MedDRA v24.0NDW0 A D*0Hrńň0DW0A D~ËHrňFËADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C)0 A Period 02DW/Dá<HrńWĽDXłD»řHtđ¸xVaccination 3 APY A02021-03-05T19:03:31 112612791126Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADVůD‹tHr©ĐôDWŞD·ŔHs“VŔPlacebo APlacebo ADVůD‹tDWDŮ€Y . . .Placebo Placebo DW+DWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW”DWŞDÇ°D·ŔDWĆDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýB•BjBpCPAđHr©ĐôHrÇ Hsve°Hs“VŔ .DW“WHITE AC4591001C4591001 1126 11261279AADVERSE EVENT 2 Chills Chills FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills F·ÓF·ÓFeelings and sensations NEC F™ŁGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-21T03:00Bť2021-05-21T04:00Bť 2MedDRA v24.0NDW• A D*0Hsw°DW•A D8{Hsw'űADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C0 A Period 02DW”DÇ°Hsve°DYD·ŔHutŠ@Vaccination 3 APY A02021-06-16T17:48:17Y 112612791126Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADVůD‹tHr©ĐôDWŞD·ŔHs“VŔPlacebo APlacebo ADVůD‹tDWDŮ€Y . . .Placebo Placebo DW+DWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW”DWŞDÇ°D·ŔDWĆDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýB•BjBpCPAđHr©ĐôHrÇ Hsve°Hs“VŔ .DW“WHITE AC4591001C4591001 1126 11261279A ADVERSE EVENT 3 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-11T18:00B˛2021-06-13 B´ 2MedDRA v24.0NDWŞ ADý Hs“ś DW¬A0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C€ A Period 02DW”DÇ°Hsve°DYD·ŔHutŠ@Vaccination 4 A`Y A@2021-07-12T21:48:15Y 112612791126Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADVůD‹tHr©ĐôDWŞD·ŔHs“VŔPlacebo APlacebo ADVůD‹tDWDŮ€Y . . .Placebo Placebo DW+DWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW”DWŞDÇ°D·ŔDWĆDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýB•BjBpCPAđHr©ĐôHrÇ Hsve°Hs“VŔ .DW“WHITE AC4591001C4591001 1126 11261279A0ADVERSE EVENT 1 Left upper arm injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-20T16:00Bś2021-05-23 Bź 1MedDRA v24.0NDW” ADáHsvDW—A@..A@DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Bl A Period 02DW”DÇ°Hsve°DYD·ŔHutŠ@Vaccination 3 APY A02021-06-16T17:48:06Y 112612791126Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADVůD‹tHr©ĐôDWŞD·ŔHs“VŔPlacebo APlacebo ADVůD‹tDWDŮ€Y . . .Placebo Placebo DW+DWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW”DWŞDÇ°D·ŔDWĆDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýB•BjBpCPAđHr©ĐôHrÇ Hsve°Hs“VŔ .DW“WHITE AC4591001C4591001 1126 11261279A@ADVERSE EVENT 5 Body aches Pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalized aching F™Š\F™ŰPain and discomfort NEC F™ÜGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-11T18:00B˛2021-06-13 B´ 2MedDRA v24.0NDWŞ ADý Hs“ś DW¬A0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C€ A Period 02DW”DÇ°Hsve°DYD·ŔHutŠ@Vaccination 4 A`Y A@2021-07-12T21:48:38Y 112612791126Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADVůD‹tHr©ĐôDWŞD·ŔHs“VŔPlacebo APlacebo ADVůD‹tDWDŮ€Y . . .Placebo Placebo DW+DWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW”DWŞDÇ°D·ŔDWĆDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýB•BjBpCPAđHr©ĐôHrÇ Hsve°Hs“VŔ .DW“WHITE AC4591001C4591001 1126 11261279APADVERSE EVENT 4 Fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-06-11T18:00B˛2021-06-11T23:00B˛ 1MedDRA v24.0NDWŞ ADý Hs“ś DWŞAE:°Hs“â«ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C€ A Period 02DW”DÇ°Hsve°DYD·ŔHutŠ@Vaccination 4 A`Y A@2021-07-12T21:48:27Y 112612801126Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADVůDŚ(Hr©Ń¨DWŞD·üHs“VüPlacebo APlacebo ADVůDŚ(DWDÚpY . . .Placebo Placebo DW+DWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW”DWŞDČ(D·üDWĆDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýB•BjBpCPAŔHr©Ń¨HrÇ đHsvf(Hs“Vü .DW“WHITE AC4591001C4591001 1126 11261280AADVERSE EVENT 3 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-11T18:00B˛2021-06-13 B´ 2MedDRA v24.0NDWŞ ADý Hs“ś DW¬A0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A Cp A Period 02DW”DČ(Hsvf(DYD·üHutŠ|Vaccination 4 A`Y A@2021-07-12T21:48:50Y 112612801126Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADVůDŚ(Hr©Ń¨DWŞD·üHs“VüPlacebo APlacebo ADVůDŚ(DWDÚpY . . .Placebo Placebo DW+DWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW”DWŞDČ(D·üDWĆDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýB•BjBpCPAŔHr©Ń¨HrÇ đHsvf(Hs“Vü .DW“WHITE AC4591001C4591001 1126 11261280A ADVERSE EVENT 2 Left upper arm injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-20T19:00Bś2021-05-22 Bž 2MedDRA v24.0NDW” AEłHsv©0DW–A0..A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A Cŕ A Period 02DW”DČ(Hsvf(DYD·üHutŠ|Vaccination 3 APY A02021-06-16T17:48:41Y 112612801126Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADVůDŚ(Hr©Ń¨DWŞD·üHs“VüPlacebo APlacebo ADVůDŚ(DWDÚpY . . .Placebo Placebo DW+DWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW”DWŞDČ(D·üDWĆDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýB•BjBpCPAŔHr©Ń¨HrÇ đHsvf(Hs“Vü .DW“WHITE AC4591001C4591001 1126 11261280A0ADVERSE EVENT 1 Muscle aches Myalgia F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Muscle ache F™˙F™{Muscle pains F™#Muscle disorders F™Musculoskeletal and connective tissue disorders F™k2021-05-21 Bť2021-05-21 Bť 2MedDRA v24.0NDW• A ..DW•A ..ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DW”DČ(Hsvf(DYD·üHutŠ|Vaccination 3 APY A02021-06-16T17:48:29Y 112612801126Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADVůDŚ(Hr©Ń¨DWŞD·üHs“VüPlacebo APlacebo ADVůDŚ(DWDÚpY . . .Placebo Placebo DW+DWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW”DWŞDČ(D·üDWĆDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýB•BjBpCPAŔHr©Ń¨HrÇ đHsvf(Hs“Vü .DW“WHITE AC4591001C4591001 1126 11261280A@ADVERSE EVENT 5 Body aches Pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalized aching F™Š\F™ŰPain and discomfort NEC F™ÜGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-11T18:00B˛2021-06-13 B´ 2MedDRA v24.0NDWŞ ADý Hs“ś DW¬A0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A Cp A Period 02DW”DČ(Hsvf(DYD·üHutŠ|Vaccination 4 A`Y A@2021-07-12T21:49:12Y 112612801126Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADVůDŚ(Hr©Ń¨DWŞD·üHs“VüPlacebo APlacebo ADVůDŚ(DWDÚpY . . .Placebo Placebo DW+DWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW”DWŞDČ(D·üDWĆDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýB•BjBpCPAŔHr©Ń¨HrÇ đHsvf(Hs“Vü .DW“WHITE AC4591001C4591001 1126 11261280APADVERSE EVENT 4 Fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-06-11T18:00B˛2021-06-11T23:00B˛ 1MedDRA v24.0NDWŞ ADý Hs“ś DWŞAE:°Hs“â«ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Cp A Period 02DW”DČ(Hsvf(DYD·üHutŠ|Vaccination 4 A`Y A@2021-07-12T21:49:01Y 112612831126Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DVůDÉTHrŞÔDW¨DŃLHsÍLPlacebo APlacebo ADVůDÉTDWDÜPY . . .Placebo Placebo DW1DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¨Dć DŃLDWÄDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB”BmBqCPAĐHrŞÔHrĹŃPHsr HsÍL .DWALL OTHERS A0C4591001C4591001 1126 11261283AADVERSE EVENT 1 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-18 Bš2021-05-19 B› 2MedDRA v24.0NDW’ A ..DW“A0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DW‘Dć Hsr DYDŃLHurĚVaccination 3 APY A02021-06-14T21:28:58Y 112612831126Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DVůDÉTHrŞÔDW¨DŃLHsÍLPlacebo APlacebo ADVůDÉTDWDÜPY . . .Placebo Placebo DW1DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¨Dć DŃLDWÄDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB”BmBqCPAĐHrŞÔHrĹŃPHsr HsÍL .DWALL OTHERS A0C4591001C4591001 1126 11261283A ADVERSE EVENT 4 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-10 B±2021-06-10 B± 1MedDRA v24.0NDW© A ..DW©A ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW‘Dć Hsr DYDŃLHurĚVaccination 4 A`Y A@2021-07-09T03:44:49Y 112612831126Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DVůDÉTHrŞÔDW¨DŃLHsÍLPlacebo APlacebo ADVůDÉTDWDÜPY . . .Placebo Placebo DW1DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¨Dć DŃLDWÄDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB”BmBqCPAĐHrŞÔHrĹŃPHsr HsÍL .DWALL OTHERS A0C4591001C4591001 1126 11261283A0ADVERSE EVENT 3 Headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-05-18 Bš2021-05-18 Bš 2MedDRA v24.0NDW’ A ..DW’A ..ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DW‘Dć Hsr DYDŃLHurĚVaccination 3 APY A02021-06-12T00:33:30Y 112612831126Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DVůDÉTHrŞÔDW¨DŃLHsÍLPlacebo APlacebo ADVůDÉTDWDÜPY . . .Placebo Placebo DW1DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¨Dć DŃLDWÄDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB”BmBqCPAĐHrŞÔHrĹŃPHsr HsÍL .DWALL OTHERS A0C4591001C4591001 1126 11261283A@ADVERSE EVENT 2 Right Arm Injection Site Pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-18 Bš2021-05-19 B› 2MedDRA v24.0NDW’ A ..DW“A0..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DW‘Dć Hsr DYDŃLHurĚVaccination 3 APY A02021-06-12T00:33:19Y 112612841126Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DVůDÓŕHrŞ`DW¦DŐŔHsŽ.ŔPlacebo APlacebo ADVůDÓŕDWDÖěY . . .Placebo Placebo DW*DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DŰŘDŐŔDWĆDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB”BmBqCPAĐHrŞ`HrĹËěHsr…XHsŽ.Ŕ .DWALL OTHERS A0C4591001C4591001 1126 11261284AADVERSE EVENT 3 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-18 Bš2021-05-20 Bś 1MedDRA v24.0NDW’ A ..DW”A@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW‘DŰŘHsr…XDYDŐŔHuob@Vaccination 3 APY A02021-06-09T00:03:04Y 112612841126Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DVůDÓŕHrŞ`DW¦DŐŔHsŽ.ŔPlacebo APlacebo ADVůDÓŕDWDÖěY . . .Placebo Placebo DW*DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DŰŘDŐŔDWĆDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB”BmBqCPAĐHrŞ`HrĹËěHsr…XHsŽ.Ŕ .DWALL OTHERS A0C4591001C4591001 1126 11261284A ADVERSE EVENT 2 Injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-18 Bš2021-05-20 Bś 1MedDRA v24.0NDW’ A ..DW”A@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW‘DŰŘHsr…XDYDŐŔHuob@Vaccination 3 APY A02021-06-09T00:02:54Y 112612841126Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DVůDÓŕHrŞ`DW¦DŐŔHsŽ.ŔPlacebo APlacebo ADVůDÓŕDWDÖěY . . .Placebo Placebo DW*DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DŰŘDŐŔDWĆDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB”BmBqCPAĐHrŞ`HrĹËěHsr…XHsŽ.Ŕ .DWALL OTHERS A0C4591001C4591001 1126 11261284A0ADVERSE EVENT 4 Pain, injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Pain injection site F™-FěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-01-07T23:00B2021-06-08 BŻ 2MedDRA v24.0NDW A E7HrÇ‰đDW§Bš..B™DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A Cvđ APeriod 01DVůDÓŕHrŞ`DW‘DŰ×Hsr…WVaccination 2 A Y A 2021-07-12T23:50:40Y 112612841126Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DVůDÓŕHrŞ`DW¦DŐŔHsŽ.ŔPlacebo APlacebo ADVůDÓŕDWDÖěY . . .Placebo Placebo DW*DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DŰŘDŐŔDWĆDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB”BmBqCPAĐHrŞ`HrĹËěHsr…XHsŽ.Ŕ .DWALL OTHERS A0C4591001C4591001 1126 11261284A@ADVERSE EVENT 1 Fever, 101F Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-05-18 Bš2021-05-18 Bš 2MedDRA v24.0NDW’ A ..DW’A ..ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DW‘DŰŘHsr…XDYDŐŔHuob@Vaccination 3 APY A02021-06-09T00:02:42Y 112612871126Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADVůDđđHrŞ6pDW©DˇHs‘î„Placebo APlacebo ADVůDđđ..Y . . .Placebo DW1DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW”DW©D§XDˇDWĹDXfBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB”BjBqCPAđHrŞ6pHrŞ6pHsvEXHs‘î„ .DW“WHITE AC4591001C4591001 1126 11261287AADVERSE EVENT 1 Injection Site numbness Injection site hypoaesthesia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site numbness FěÄF™ąÚInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-20T14:00Bś2021-05-21 Bť 1MedDRA v24.0NDW” ADÄŕHsvbŕDW•A ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A B~ A Period 02DW”D§XHsvEXDYDˇHus"Vaccination 3 APY A02021-06-12T00:31:42Y 112612871126Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADVůDđđHrŞ6pDW©DˇHs‘î„Placebo APlacebo ADVůDđđ..Y . . .Placebo DW1DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW”DW©D§XDˇDWĹDXfBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB”BjBqCPAđHrŞ6pHrŞ6pHsvEXHs‘î„ .DW“WHITE AC4591001C4591001 1126 11261287A ADVERSE EVENT 2 Pain, injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Pain injection site F™-FěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-11 B˛2021-06-11 B˛ 2MedDRA v24.0NDWŞ A ..DWŞA ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DW”D§XHsvEXDYDˇHus"Vaccination 4 A`Y A@2021-07-12T21:49:23Y 112612871126Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADVůDđđHrŞ6pDW©DˇHs‘î„Placebo APlacebo ADVůDđđ..Y . . .Placebo DW1DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW”DW©D§XDˇDWĹDXfBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB”BjBqCPAđHrŞ6pHrŞ6pHsvEXHs‘î„ .DW“WHITE AC4591001C4591001 1126 11261287A0ADVERSE EVENT 3 Swelling, injection site Injection site swelling FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site swelling F™g1F™g1Injection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-11 B˛2021-06-11 B˛ 2MedDRA v24.0NDWŞ A ..DWŞA ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DW”D§XHsvEXDYDˇHus"Vaccination 4 A`Y A@2021-07-12T21:49:34Y 112612891126Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVúD»DHr«RDDW¨DĐ\HsĚ\Placebo APlacebo ADVúD»DDWDÍPY . . .Placebo Placebo DW*DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¨DĐ DĐ\DWÄDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB“BmBqC@AŕHr«RDHrĹÂPHsry HsĚ\ .DWWHITE AC4591001C4591001 1126 11261289AADVERSE EVENT 2 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-17T20:00B2021-05-18 B™ 2MedDRA v24.0NDW‘ AE”HsrÂŔDW’A ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C€ A Period 02DW‘DĐ Hsry DYDĐ\Huq˙ÜVaccination 3 APY A02021-06-12T00:32:44Y 112612891126Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVúD»DHr«RDDW¨DĐ\HsĚ\Placebo APlacebo ADVúD»DDWDÍPY . . .Placebo Placebo DW*DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¨DĐ DĐ\DWÄDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB“BmBqC@AŕHr«RDHrĹÂPHsry HsĚ\ .DWWHITE AC4591001C4591001 1126 11261289A ADVERSE EVENT 1 Pain, Injection Site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Pain injection site F™-FěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-17T20:00B2021-05-19 Bš 2MedDRA v24.0NDW‘ AE”HsrÂŔDW“A0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C€ A Period 02DW‘DĐ Hsry DYDĐ\Huq˙ÜVaccination 3 APY A02021-06-12T00:32:30Y 112612901126Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsANOT REPORTED ApMANOT REPORTED A0USANOT REPORTED ApDVúDăĐHr«zĐDW¨DĆŔHsÂŔPlacebo APlacebo ADVúDăĐDW DĎ¨Y . . .Placebo Placebo DW)DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW¨DŮřDĆŔDWÍDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB“BlBqC@AŔHr«zĐHrÄs(HssÔřHsÂŔ .DW‘ALL OTHERS A0C4591001C4591001 1126 11261290AADVERSE EVENT 3 Chills Chills FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills F·ÓF·ÓFeelings and sensations NEC F™ŁGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-19 Bš2021-05-21 Bś 1MedDRA v24.0NDW“ A ..DW•A@..A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW’DŮřHssÔřDYDĆŔHuqö@Vaccination 3 APY A02021-06-12T00:32:05Y 112612901126Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsANOT REPORTED ApMANOT REPORTED A0USANOT REPORTED ApDVúDăĐHr«zĐDW¨DĆŔHsÂŔPlacebo APlacebo ADVúDăĐDW DĎ¨Y . . .Placebo Placebo DW)DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW¨DŮřDĆŔDWÍDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB“BlBqC@AŔHr«zĐHrÄs(HssÔřHsÂŔ .DW‘ALL OTHERS A0C4591001C4591001 1126 11261290A ADVERSE EVENT 2 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-18T16:30B™2021-05-21 Bś 2MedDRA v24.0NDW’ ADčHssăDW•A@..A@DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A B< A Period 02DW’DŮřHssÔřDYDĆŔHuqö@Vaccination 3 APY A02021-06-12T00:31:54Y 112612901126Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsANOT REPORTED ApMANOT REPORTED A0USANOT REPORTED ApDVúDăĐHr«zĐDW¨DĆŔHsÂŔPlacebo APlacebo ADVúDăĐDW DĎ¨Y . . .Placebo Placebo DW)DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW¨DŮřDĆŔDWÍDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB“BlBqC@AŔHr«zĐHrÄs(HssÔřHsÂŔ .DW‘ALL OTHERS A0C4591001C4591001 1126 11261290A0ADVERSE EVENT 5 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-09T18:00BŻ2021-06-10 B° 1MedDRA v24.0NDW¨ ADý Hsů DW©A ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Bč A Period 02DW’DŮřHssÔřDYDĆŔHuqö@Vaccination 4 A`Y A@2021-07-21T19:13:32Y 112612901126Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsANOT REPORTED ApMANOT REPORTED A0USANOT REPORTED ApDVúDăĐHr«zĐDW¨DĆŔHsÂŔPlacebo APlacebo ADVúDăĐDW DĎ¨Y . . .Placebo Placebo DW)DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW¨DŮřDĆŔDWÍDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB“BlBqC@AŔHr«zĐHrÄs(HssÔřHsÂŔ .DW‘ALL OTHERS A0C4591001C4591001 1126 11261290A@ADVERSE EVENT 4 Injection Site Pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-19 Bš2021-05-21 Bś 1MedDRA v24.0NDW“ A ..DW•A@..A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW’DŮřHssÔřDYDĆŔHuqö@Vaccination 3 APY A02021-06-12T00:32:16Y 112612901126Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsANOT REPORTED ApMANOT REPORTED A0USANOT REPORTED ApDVúDăĐHr«zĐDW¨DĆŔHsÂŔPlacebo APlacebo ADVúDăĐDW DĎ¨Y . . .Placebo Placebo DW)DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW¨DŮřDĆŔDWÍDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB“BlBqC@AŔHr«zĐHrÄs(HssÔřHsÂŔ .DW‘ALL OTHERS A0C4591001C4591001 1126 11261290APADVERSE EVENT 6 Pain, injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Pain injection site F™-FěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-09T16:00BŻ2021-06-12 B˛ 1MedDRA v24.0NDW¨ ADáHsÝDW«A@..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Bp A Period 02DW’DŮřHssÔřDYDĆŔHuqö@Vaccination 4 A`Y A@2021-07-21T19:13:44Y 112612901126Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsANOT REPORTED ApMANOT REPORTED A0USANOT REPORTED ApDVúDăĐHr«zĐDW¨DĆŔHsÂŔPlacebo APlacebo ADVúDăĐDW DĎ¨Y . . .Placebo Placebo DW)DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW¨DŮřDĆŔDWÍDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB“BlBqC@AŔHr«zĐHrÄs(HssÔřHsÂŔ .DW‘ALL OTHERS A0C4591001C4591001 1126 11261290A`ADVERSE EVENT 1 Worsening Pityriasis Rosea Pityriasis rosea F™5ŃSKIN AND SUBCUTANEOUS TISSUE DISORDERS Pityriasis rosea F™ŞF™ŞPapulosquamous conditions F™JEpidermal and dermal conditions FŃSkin and subcutaneous tissue disorders F™5Ń2020-12-23 Ap2021-01-19 B" 2MedDRA v24.0NDW Ap..DWB"..BDAYSN NNOT RELATEDOTHER Unknown NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVúDăĐHr«zĐDW’DŮ÷HssÔ÷Vaccination 1 AY A2021-02-03T19:11:25 112612921126Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DVúDóüHr«ŠüDW¦D˘¨HsŤű¨Placebo APlacebo ADVúDóüDWDäüY . . .Placebo Placebo DW+DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦D˝$D˘¨DWĹDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB“BmBqC@AŔHr«ŠüHrÇ+|Hsrf¤HsŤű¨ .DWALL OTHERS A0C4591001C4591001 1126 11261292AADVERSE EVENT 1 Chills Chills FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills F·ÓF·ÓFeelings and sensations NEC F™ŁGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-17T19:00B2021-05-17T23:00B 2MedDRA v24.0NDW‘ AEłHsr´°DW‘AE:°Hsrí+ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A CĐ A Period 02DW‘D˝$Hsrf¤DYD˘¨Huo/(Vaccination 3 APY A02021-06-09T00:03:15Y 112612921126Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DVúDóüHr«ŠüDW¦D˘¨HsŤű¨Placebo APlacebo ADVúDóüDWDäüY . . .Placebo Placebo DW+DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦D˝$D˘¨DWĹDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB“BmBqC@AŔHr«ŠüHrÇ+|Hsrf¤HsŤű¨ .DWALL OTHERS A0C4591001C4591001 1126 11261292A ADVERSE EVENT 6 Chills Chills FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills F·ÓF·ÓFeelings and sensations NEC F™ŁGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-07T21:00B2021-06-08 B® 2MedDRA v24.0NDW¦ AEuHsŽ€PDW§A ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C#` A Period 02DW‘D˝$Hsrf¤DYD˘¨Huo/(Vaccination 4 A`Y A@2021-07-12T21:50:21Y 112612921126Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DVúDóüHr«ŠüDW¦D˘¨HsŤű¨Placebo APlacebo ADVúDóüDWDäüY . . .Placebo Placebo DW+DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦D˝$D˘¨DWĹDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB“BmBqC@AŔHr«ŠüHrÇ+|Hsrf¤HsŤű¨ .DWALL OTHERS A0C4591001C4591001 1126 11261292A@ADVERSE EVENT 10Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-08 B®2021-06-09 BŻ 2MedDRA v24.0NDW§ A ..DW¨A0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DW‘D˝$Hsrf¤DYD˘¨Huo/(Vaccination 4 A`Y A@2021-07-19T22:40:06Y 112612921126Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DVúDóüHr«ŠüDW¦D˘¨HsŤű¨Placebo APlacebo ADVúDóüDWDäüY . . .Placebo Placebo DW+DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦D˝$D˘¨DWĹDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB“BmBqC@AŔHr«ŠüHrÇ+|Hsrf¤HsŤű¨ .DWALL OTHERS A0C4591001C4591001 1126 11261292A0ADVERSE EVENT 3 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-18T14:00B™2021-05-19 Bš 2MedDRA v24.0NDW’ A DÄŕHssżŕDW“A0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C\ A Period 02DW‘D˝$Hsrf¤DYD˘¨Huo/(Vaccination 3 APY A02021-06-09T00:03:37Y 112612921126Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DVúDóüHr«ŠüDW¦D˘¨HsŤű¨Placebo APlacebo ADVúDóüDWDäüY . . .Placebo Placebo DW+DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦D˝$D˘¨DWĹDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB“BmBqC@AŔHr«ŠüHrÇ+|Hsrf¤HsŤű¨ .DWALL OTHERS A0C4591001C4591001 1126 11261292A`ADVERSE EVENT 8 Headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-06-08 B®2021-06-09 BŻ 1MedDRA v24.0NDW§ A ..DW¨A0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW‘D˝$Hsrf¤DYD˘¨Huo/(Vaccination 4 A`Y A@2021-07-12T21:50:44Y 112612921126Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DVúDóüHr«ŠüDW¦D˘¨HsŤű¨Placebo APlacebo ADVúDóüDWDäüY . . .Placebo Placebo DW+DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦D˝$D˘¨DWĹDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB“BmBqC@AŔHr«ŠüHrÇ+|Hsrf¤HsŤű¨ .DWALL OTHERS A0C4591001C4591001 1126 11261292APADVERSE EVENT 2 Headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-05-18T09:00B™2021-05-19 Bš 1MedDRA v24.0NDW’ A D~HssyDW“A0..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CIP A Period 02DW‘D˝$Hsrf¤DYD˘¨Huo/(Vaccination 3 APY A02021-06-09T00:03:26Y 112612921126Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DVúDóüHr«ŠüDW¦D˘¨HsŤű¨Placebo APlacebo ADVúDóüDWDäüY . . .Placebo Placebo DW+DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦D˝$D˘¨DWĹDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB“BmBqC@AŔHr«ŠüHrÇ+|Hsrf¤HsŤű¨ .DWALL OTHERS A0C4591001C4591001 1126 11261292ApADVERSE EVENT 5 Left arm injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-17T19:00B2021-05-19 Bš 2MedDRA v24.0NDW‘ AEłHsr´°DW“A0..A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A CĐ A Period 02DW‘D˝$Hsrf¤DYD˘¨Huo/(Vaccination 3 APY A02021-06-09T00:03:59Y 112612921126Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DVúDóüHr«ŠüDW¦D˘¨HsŤű¨Placebo APlacebo ADVúDóüDWDäüY . . .Placebo Placebo DW+DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦D˝$D˘¨DWĹDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB“BmBqC@AŔHr«ŠüHrÇ+|Hsrf¤HsŤű¨ .DWALL OTHERS A0C4591001C4591001 1126 11261292A€ADVERSE EVENT 4 Muscle aches Myalgia F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Muscle ache F™˙F™{Muscle pains F™#Muscle disorders F™Musculoskeletal and connective tissue disorders F™k2021-05-18T14:00B™2021-05-19 Bš 2MedDRA v24.0NDW’ A DÄŕHssżŕDW“A0..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C\ A Period 02DW‘D˝$Hsrf¤DYD˘¨Huo/(Vaccination 3 APY A02021-06-09T00:03:48Y 112612921126Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DVúDóüHr«ŠüDW¦D˘¨HsŤű¨Placebo APlacebo ADVúDóüDWDäüY . . .Placebo Placebo DW+DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦D˝$D˘¨DWĹDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB“BmBqC@AŔHr«ŠüHrÇ+|Hsrf¤HsŤű¨ .DWALL OTHERS A0C4591001C4591001 1126 11261292AADVERSE EVENT 9 Generalized body aches Pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalised aching FÝF™ŰPain and discomfort NEC F™ÜGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-07T21:00B2021-06-08 B® 2MedDRA v24.0NDW¦ AEuHsŽ€PDW§A ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C#` A Period 02DW‘D˝$Hsrf¤DYD˘¨Huo/(Vaccination 4 A`Y A@2021-07-12T21:50:56Y 112612921126Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DVúDóüHr«ŠüDW¦D˘¨HsŤű¨Placebo APlacebo ADVúDóüDWDäüY . . .Placebo Placebo DW+DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦D˝$D˘¨DWĹDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB“BmBqC@AŔHr«ŠüHrÇ+|Hsrf¤HsŤű¨ .DWALL OTHERS A0C4591001C4591001 1126 11261292A ADVERSE EVENT 7 Fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-06-07T21:00B2021-06-08 B® 1MedDRA v24.0NDW¦ AEuHsŽ€PDW§A ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C#` A Period 02DW‘D˝$Hsrf¤DYD˘¨Huo/(Vaccination 4 A`Y A@2021-07-12T21:50:33Y 112612941126Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADVűD§Hr¬ŹśDWâD’|HsÝ|Placebo APlacebo ADVűD§DWDĽ¬Y . . .Placebo Placebo DW,DWÂYPhase 3A@NNEGDWĂ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWÍDWâD«ĚD’|DXDXźBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWÂDWýBČB1B;C0AĐHr¬ŹśHrČT¬HsÁoLHsÝ| .DWĂWHITE AC4591001C4591001 1126 11261294AADVERSE EVENT 1 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-07-17 BÔ2021-07-18 BŐ 2MedDRA v24.0NDWÎ A ..DWĎA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWÍD«ĚHsÁoLDYOD’|Huľ8üVaccination 3 APY A02021-08-10T23:37:30Y 112612941126Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADVűD§Hr¬ŹśDWâD’|HsÝ|Placebo APlacebo ADVűD§DWDĽ¬Y . . .Placebo Placebo DW,DWÂYPhase 3A@NNEGDWĂ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWÍDWâD«ĚD’|DXDXźBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWÂDWýBČB1B;C0AĐHr¬ŹśHrČT¬HsÁoLHsÝ| .DWĂWHITE AC4591001C4591001 1126 11261294A ADVERSE EVENT 2 Injection Site Pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-07-17 BÔ2021-07-19 BÖ 1MedDRA v24.0NDWÎ A ..DWĐA@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWÍD«ĚHsÁoLDYOD’|Huľ8üVaccination 3 APY A02021-08-10T23:37:41Y 112612941126Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADVűD§Hr¬ŹśDWâD’|HsÝ|Placebo APlacebo ADVűD§DWDĽ¬Y . . .Placebo Placebo DW,DWÂYPhase 3A@NNEGDWĂ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWÍDWâD«ĚD’|DXDXźBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWÂDWýBČB1B;C0AĐHr¬ŹśHrČT¬HsÁoLHsÝ| .DWĂWHITE AC4591001C4591001 1126 11261294A0ADVERSE EVENT 3 Injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-08-07 Bé2021-08-08 Bę 1MedDRA v24.0NDWă A ..DWäA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWÍD«ĚHsÁoLDYOD’|Huľ8üVaccination 4 A`Y A@2021-09-14T01:00:02Y 112612961126Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADVűDŰ$Hr¬Ă¤DW|DÖtHsVĐtPlacebo APlacebo ADVűDŰ$DWDŢ¨Y . . .Placebo Placebo DW,DWgYPhase 3A@NNEGDWh BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWiDW|D•ÄDÖtDWDX9BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWgDWýBmB•B–C0AđHr¬Ă¤HrČv¨Hs=DHsVĐt .DWhWHITE AC4591001C4591001 1126 11261296AADVERSE EVENT 1 Dirt bike nontraffic accident Accident FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Accident F—ńF—ńNon-site specific injuries NEC F™ ÇInjuries NEC FěâInjury, poisoning and procedural complications Fěĺ2021-01-24 B&2021-01-24 B& 2MedDRA v24.0NDW B..DW B..ADAYSN NNOT RELATEDOTHER Fall from dirt bike NOT APPLICABLE YYRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVűDŰ$Hr¬Ă¤DWiD•ĂHs=CVaccination 2 A Y A 2021-02-10T08:58:44 112612961126Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADVűDŰ$Hr¬Ă¤DW|DÖtHsVĐtPlacebo APlacebo ADVűDŰ$DWDŢ¨Y . . .Placebo Placebo DW,DWgYPhase 3A@NNEGDWh BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWiDW|D•ÄDÖtDWDX9BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWgDWýBmB•B–C0AđHr¬Ă¤HrČv¨Hs=DHsVĐt .DWhWHITE AC4591001C4591001 1126 11261296A ADVERSE EVENT 4 Left elbow contusion Contusion FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Contusion of elbow FŔÜF™\Skin injuries NEC F™łInjuries NEC FěâInjury, poisoning and procedural complications Fěĺ2021-01-24 B&2021-01-31 B- 1MedDRA v24.0NDW B..DW'B..A€DAYSN NNOT RELATEDOTHER Fall from dirt bike NOT APPLICABLE NYRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVűDŰ$Hr¬Ă¤DWiD•ĂHs=CVaccination 2 A Y A 2021-02-10T01:08:49 112612961126Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADVűDŰ$Hr¬Ă¤DW|DÖtHsVĐtPlacebo APlacebo ADVűDŰ$DWDŢ¨Y . . .Placebo Placebo DW,DWgYPhase 3A@NNEGDWh BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWiDW|D•ÄDÖtDWDX9BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWgDWýBmB•B–C0AđHr¬Ă¤HrČv¨Hs=DHsVĐt .DWhWHITE AC4591001C4591001 1126 11261296A@ADVERSE EVENT 5 Pain injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Pain injection site F™-FěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-04-08 Bp2021-04-09 Bq 1MedDRA v24.0NDWj A ..DWkA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWiD•ÄHs=DDXéDÖtHu8ôVaccination 3 APY A02021-05-01T13:40:31Y 112612961126Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADVűDŰ$Hr¬Ă¤DW|DÖtHsVĐtPlacebo APlacebo ADVűDŰ$DWDŢ¨Y . . .Placebo Placebo DW,DWgYPhase 3A@NNEGDWh BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWiDW|D•ÄDÖtDWDX9BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWgDWýBmB•B–C0AđHr¬Ă¤HrČv¨Hs=DHsVĐt .DWhWHITE AC4591001C4591001 1126 11261296A0ADVERSE EVENT 6 Injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-04-27 B2021-04-28 B„ 1MedDRA v24.0NDW} A ..DW~A0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWiD•ÄHs=DDXéDÖtHu8ôVaccination 4 A`Y A@2021-06-01T23:34:49Y 112612961126Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADVűDŰ$Hr¬Ă¤DW|DÖtHsVĐtPlacebo APlacebo ADVűDŰ$DWDŢ¨Y . . .Placebo Placebo DW,DWgYPhase 3A@NNEGDWh BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWiDW|D•ÄDÖtDWDX9BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWgDWýBmB•B–C0AđHr¬Ă¤HrČv¨Hs=DHsVĐt .DWhWHITE AC4591001C4591001 1126 11261296APADVERSE EVENT 2 Lower lip laceration Lip injury FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Lip injury F™mŞF™mŞAbdominal and gastrointestinal injuries NEC F™ÝInjuries NEC FěâInjury, poisoning and procedural complications Fěĺ2021-01-24 B&2021-02-05 B2 1MedDRA v24.0NDW B..DW,B..AĐDAYSN NNOT RELATEDOTHER Fall from dirt bike NOT APPLICABLE YYRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVűDŰ$Hr¬Ă¤DWiD•ĂHs=CVaccination 2 A Y A 2021-02-10T01:08:42 112612961126Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADVűDŰ$Hr¬Ă¤DW|DÖtHsVĐtPlacebo APlacebo ADVűDŰ$DWDŢ¨Y . . .Placebo Placebo DW,DWgYPhase 3A@NNEGDWh BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWiDW|D•ÄDÖtDWDX9BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWgDWýBmB•B–C0AđHr¬Ă¤HrČv¨Hs=DHsVĐt .DWhWHITE AC4591001C4591001 1126 11261296A`ADVERSE EVENT 3 Three teeth fractures Tooth fracture FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Tooth fracture F™ŠĐF™ŠĐAbdominal and gastrointestinal injuries NEC F™ÝInjuries NEC FěâInjury, poisoning and procedural complications Fěĺ2021-01-24 B&2021-01-24 B& 2MedDRA v24.0NDW B..DW B..ADAYSN NNOT RELATEDOTHER Fall from dirt bike NOT APPLICABLE YYRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVűDŰ$Hr¬Ă¤DWiD•ĂHs=CVaccination 2 A Y A 2021-02-10T18:17:32 112612971126Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADVűDÚčHr¬ĂhDW¨DßHsŰPlacebo APlacebo ADVűDÚčDWDß Y . . .Placebo Placebo DW,DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DW¨DépDßDWËDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB’BkBqC0AĐHr¬ĂhHrČw Hsu5đHsŰ .DW’WHITE AC4591001C4591001 1126 11261297A ADVERSE EVENT 1 Left Upper Arm Injection Site Pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-19T19:00B™2021-05-21 B› 2MedDRA v24.0NDW“ AEłHsuW°DW•A0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A B A Period 02DW“DépHsu5đDYDßHurVaccination 3 APY A02021-06-12T00:32:55Y 112612971126Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADVűDÚčHr¬ĂhDW¨DßHsŰPlacebo APlacebo ADVűDÚčDWDß Y . . .Placebo Placebo DW,DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DW¨DépDßDWËDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB’BkBqC0AĐHr¬ĂhHrČw Hsu5đHsŰ .DW’WHITE AC4591001C4591001 1126 11261297AADVERSE EVENT 2 Injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-09T17:00B®2021-06-10 BŻ 1MedDRA v24.0NDW¨ ADďHsëDW©A ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A BB A Period 02DW“DépHsu5đDYDßHurVaccination 4 A`Y A@2021-07-20T13:05:31Y 112613001126Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DV˙DwHr±¦DWŞDÓ,Hs“r,Placebo APlacebo ADV˙DwDWDn(Y . . .Placebo Placebo DW/DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DWŞD‰XDÓ,DWĆDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBŽBkBqB˙AĐHr±¦HrËú¨HstŐŘHs“r, .DW’ALL OTHERS A0C4591001C4591001 1126 11261300AADVERSE EVENT 1 Left upper arm injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-19T19:00B•2021-05-20 B– 2MedDRA v24.0NDW“ AEłHsuW°DW”A ..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C" A Period 02DW“D‰XHstŐŘDYDÓ,HutĄ¬Vaccination 3 APY A02021-06-16T17:49:16Y 112613001126Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DV˙DwHr±¦DWŞDÓ,Hs“r,Placebo APlacebo ADV˙DwDWDn(Y . . .Placebo Placebo DW/DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DWŞD‰XDÓ,DWĆDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBŽBkBqB˙AĐHr±¦HrËú¨HstŐŘHs“r, .DW’ALL OTHERS A0C4591001C4591001 1126 11261300A ADVERSE EVENT 2 Generalized body aches Pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalised aching FÝF™ŰPain and discomfort NEC F™ÜGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-12 B2021-06-13 B® 1MedDRA v24.0NDW« A ..DW¬A0..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW“D‰XHstŐŘDYDÓ,HutĄ¬Vaccination 4 A`Y A@2021-07-12T23:50:51Y 112613011126BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADV˙D˝ŘHr±ěXDWDŢ0HrĐ_0BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DV˙D˝ŘDWDŢ0Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW3DWŚYPhase 3A@NNEGDWŤ ....... . .NY.DWŚDWýBŽBqB˙AđHr±ěXHrĐ_0.. .DWĹWHITE AC4591001C4591001 1126 11261301AADVERSE EVENT 1 Nausea Nausea FÜ›GASTROINTESTINAL DISORDERS Nausea F™ F™ Nausea and vomiting symptoms F™Gastrointestinal signs and symptoms FÜÜGastrointestinal disorders FÜ›2020-12-24 A02020-12-25 A@ 2MedDRA v24.0NDW A0..DWA@..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . APeriod 01DV˙D˝ŘHr±ěXDXDŢ0Ht±’°Vaccination 1 AY A2021-01-18T22:47:31 112613021126Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDŔäHrł@äDWŞDĹ”Hs“d”Placebo APlacebo ADWDŔäDWDÎY . . .Placebo Placebo DW9DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW•DWŞDă”DĹ”DWĆDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBŤBiBqBţAŕHrł@äHrŮ‰„HswÓHs“d” .DW”WHITE AC4591001C4591001 1126 11261302A ADVERSE EVENT 1 Left upper arm injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-21T20:00B–2021-05-22 B— 1MedDRA v24.0NDW• AE”HsxŔDW–A ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Bĺ A Period 02DW•Dă”HswÓDYDĹ”HutVaccination 3 APY A02021-06-16T17:49:28Y 112613021126Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDŔäHrł@äDWŞDĹ”Hs“d”Placebo APlacebo ADWDŔäDWDÎY . . .Placebo Placebo DW9DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW•DWŞDă”DĹ”DWĆDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBŤBiBqBţAŕHrł@äHrŮ‰„HswÓHs“d” .DW”WHITE AC4591001C4591001 1126 11261302AADVERSE EVENT 2 Injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-11T15:30B«2021-06-13 B 1MedDRA v24.0NDWŞ ADŮřHs“xřDW¬A0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A BW A Period 02DW•Dă”HswÓDYDĹ”HutVaccination 4 A`Y A@2021-07-12T21:50:10Y 112613051126Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDŁ\HrĽ]ÜDWTD‘Hs!ĎPlacebo APlacebo ADWDŁ\DWDČ(Y . . .Placebo Placebo DW<DW<YPhase 3A@NNEGDW= BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW?DWTDŁ D‘DWrDXBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW<DWýB6BżBÁB÷AđHrĽ]ÜHrŮ¨Hs1 Hs!Ď .DW>WHITE AC4591001C4591001 1126 11261305A ADVERSE EVENT 1 Left Upper Arm Injection Site Pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-02-24T17:00B92021-02-25T17:00B: 2MedDRA v24.0NDW? ADďHs}DW@A DďKHsĎKA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C@ A Period 02DW?DŁ Hs1 DXÁD‘Hu”Vaccination 3 APY A02021-03-20T00:30:57 112613051126Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDŁ\HrĽ]ÜDWTD‘Hs!ĎPlacebo APlacebo ADWDŁ\DWDČ(Y . . .Placebo Placebo DW<DW<YPhase 3A@NNEGDW= BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW?DWTDŁ D‘DWrDXBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW<DWýB6BżBÁB÷AđHrĽ]ÜHrŮ¨Hs1 Hs!Ď .DW>WHITE AC4591001C4591001 1126 11261305AADVERSE EVENT 2 Injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-03-17T18:30BN2021-03-18 BO 1MedDRA v24.0NDWT AEB€Hs"B(DWUA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C° A Period 02DW?DŁ Hs1 DXÁD‘Hu”Vaccination 4 A`Y A@2021-04-19T21:47:33Y 112613061126Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWD¤HrĽ^DW§D‰HsŹ3śPlacebo APlacebo ADWD¤DWDÇ°Y . . .Placebo Placebo DW?DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW§DŚÜD‰DWĂDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB†BlBqB÷AŔHrĽ^HrŮ0Hss‡ÜHsŹ3ś .DW‘WHITE AC4591001C4591001 1126 11261306AADVERSE EVENT 1 Left upper arm injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-18T17:00BŚ2021-05-20 BŽ 2MedDRA v24.0NDW’ ADďHssęDW”A0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C0 A Period 02DW’DŚÜHss‡ÜDYD‰HupgVaccination 3 APY A02021-06-08T21:15:22Y 112613071126BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDçHrĂ9DW!DŐHHrŢÖČBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWDçDW!DŐHY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW=DWŚYPhase 3A@NNEGDWŤ ....... . .NY.DWŚDWýBBqBňAŕHrĂ9HrŢÖČ.. .DWŇWHITE AC4591001C4591001 1126 11261307AADVERSE EVENT 1 Migraine headache, worsening Migraine F™•NERVOUS SYSTEM DISORDERS Migraine aggravated F™PF™OMigraine headaches F™SHeadaches FáźNervous system disorders F™•2021-01-24T13:00B .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDW BD¶ĐHrÝfĐ..... N NNOT RELATEDOTHER Past history of migraine headache NOT APPLICABLE YNRECOVERING/RESOLVING N A0NOT RELATEDA0A GRADE 2A Do˛ APeriod 01DWDçHrĂ9DXŽDŐHHtŔ HVaccination 1 AY A2021-02-18T20:23:21 112613081126Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDčDHrĂ:DDWĆD¸°Hs¸A°Placebo APlacebo ADWDčDDW!DŐHY . . .Placebo Placebo DW=DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW±DWĆD‰XD¸°DWâDXBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBBMBqBňAŔHrĂ:DHrŢÖČHsśbŘHs¸A° .DW°WHITE AC4591001C4591001 1126 11261308AADVERSE EVENT 2 Injection Site Pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-07-10 BĽ2021-07-12 Bľ 1MedDRA v24.0NDWÇ A ..DWÉA@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW±D‰XHsśbŘDY3D¸°Hu™u0Vaccination 4 A`Y A@2021-08-13T21:10:42Y 112613081126Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDčDHrĂ:DDWĆD¸°Hs¸A°Placebo APlacebo ADWDčDDW!DŐHY . . .Placebo Placebo DW=DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW±DWĆD‰XD¸°DWâDXBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBBMBqBňAŔHrĂ:DHrŢÖČHsśbŘHs¸A° .DW°WHITE AC4591001C4591001 1126 11261308A ADVERSE EVENT 1 Fever 101`F Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-06-19 B§2021-06-19 B§ 2MedDRA v24.0NDW˛ A ..DW˛A ..ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DW±D‰XHsśbŘDY3D¸°Hu™u0Vaccination 3 APY A02021-07-13T06:30:26Y 112613091126BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDčřHrĂ:řDW!DŐüHrŢ×|BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWDčřDW!DŐüY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW=DWŚYPhase 3A@NNEGDWŤ ....... . .NY.DWŚDWýBBqBňAŔHrĂ:řHrŢ×|.. .DWŇWHITE AC4591001C4591001 1126 11261309AADVERSE EVENT 1 Swollen lips Lip swelling FÜ›GASTROINTESTINAL DISORDERS Swollen lips F™=cFözOral soft tissue swelling and oedema F™¬Oral soft tissue conditions F™ĄGastrointestinal disorders FÜ›2021-01-26T22:00B2021-01-27T11:00B 1MedDRA v24.0NDW" A EVHrŕ`DW#A0DšëHrá?kA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Csp APeriod 01DWDčřHrĂ:řDXŽDŐüHtŔ üVaccination 2 A Y A 2021-03-02T19:54:37 112613091126BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDčřHrĂ:řDW!DŐüHrŢ×|BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWDčřDW!DŐüY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW=DWŚYPhase 3A@NNEGDWŤ ....... . .NY.DWŚDWýBBqBňAŔHrĂ:řHrŢ×|.. .DWŇWHITE AC4591001C4591001 1126 11261309A ADVERSE EVENT 2 Swollen mouth Mouth swelling FÜ›GASTROINTESTINAL DISORDERS Swollen mouth F™=dF™ĽCOral soft tissue swelling and oedema F™¬Oral soft tissue conditions F™ĄGastrointestinal disorders FÜ›2021-01-26T22:00B2021-01-27T11:00B 1MedDRA v24.0NDW" A EVHrŕ`DW#A0DšëHrá?kA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Csp APeriod 01DWDčřHrĂ:řDXŽDŐüHtŔ üVaccination 2 A Y A 2021-03-02T18:34:27 112613111126Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADW DŐ„HrÄyDW´D‡´Hs U´Placebo APlacebo ADW DŐ„DW#DÄŕY . . .Placebo Placebo DW?DW’YPhase 3A@NNEGDW“ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWˇDW´Dĺ8D‡´DWÓDXqBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW’DWýB†B]BkBńAĐHrÄyHrái`Hs‡¦¸Hs U´ .DW WHITE AC4591001C4591001 1126 11261311AADVERSE EVENT 1 Injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-02T22:00B•2021-06-03 B– 1MedDRA v24.0NDWˇ AEVHs‡öŕDW˘A ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C` A Period 02DWˇDĺ8Hs‡¦¸DY!D‡´Hu‰4Vaccination 3 APY A02021-06-23T00:01:03Y 112613111126Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADW DŐ„HrÄyDW´D‡´Hs U´Placebo APlacebo ADW DŐ„DW#DÄŕY . . .Placebo Placebo DW?DW’YPhase 3A@NNEGDW“ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWˇDW´Dĺ8D‡´DWÓDXqBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW’DWýB†B]BkBńAĐHrÄyHrái`Hs‡¦¸Hs U´ .DW WHITE AC4591001C4591001 1126 11261311A ADVERSE EVENT 2 Malaise Malaise FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Malaise Fú Fú Asthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-22 B©2021-06-23 BŞ 1MedDRA v24.0NDWµ A ..DW¶A0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWˇDĺ8Hs‡¦¸DY!D‡´Hu‰4Vaccination 4 A`Y A@2021-08-03T08:18:25Y 112613121126Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADW DÝHrÄ€„DW¨D‡đHsđPlacebo APlacebo ADW DÝDW!DÔXY . . .Placebo Placebo DW=DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW¨D´xD‡đDWÉDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB€BlBqBńAŕHrÄ€„HrŢŐŘHssŻxHsđ .DW‘WHITE AC4591001C4591001 1126 11261312AADVERSE EVENT 1 Headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-01-17 AĐ2021-01-21 B 2MedDRA v24.0NDW AĐ..DWB..APDAYSN NNOT RELATEDOTHER Unknown NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DW DÝHrÄ€„DW’D´wHssŻwVaccination 1 AY A2021-01-27T21:44:10 112613121126Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADW DÝHrÄ€„DW¨D‡đHsđPlacebo APlacebo ADW DÝDW!DÔXY . . .Placebo Placebo DW=DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW¨D´xD‡đDWÉDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB€BlBqBńAŕHrÄ€„HrŢŐŘHssŻxHsđ .DW‘WHITE AC4591001C4591001 1126 11261312A ADVERSE EVENT 2 Left upper arm injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-18T18:00B†2021-05-20 B 1MedDRA v24.0NDW’ ADý Hssř DW”A0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C` A Period 02DW’D´xHssŻxDYD‡đHuq·pVaccination 3 APY A02021-06-10T21:13:32Y 112613121126Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADW DÝHrÄ€„DW¨D‡đHsđPlacebo APlacebo ADW DÝDW!DÔXY . . .Placebo Placebo DW=DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW¨D´xD‡đDWÉDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB€BlBqBńAŕHrÄ€„HrŢŐŘHssŻxHsđ .DW‘WHITE AC4591001C4591001 1126 11261312A0ADVERSE EVENT 3 Pain, injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Pain injection site F™-FěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-09T19:00Bś2021-06-11 Bž 2MedDRA v24.0NDW¨ AEłHs‘0DWŞA0..A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C# A Period 02DW’D´xHssŻxDYD‡đHuq·pVaccination 4 A`Y A@2021-07-12T23:51:02Y 112613121126Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADW DÝHrÄ€„DW¨D‡đHsđPlacebo APlacebo ADW DÝDW!DÔXY . . .Placebo Placebo DW=DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW¨D´xD‡đDWÉDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB€BlBqBńAŕHrÄ€„HrŢŐŘHssŻxHsđ .DW‘WHITE AC4591001C4591001 1126 11261312A@ADVERSE EVENT 5 Generalized body aches Pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalised aching FÝF™ŰPain and discomfort NEC F™ÜGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-09T19:00Bś2021-06-11 Bž 2MedDRA v24.0NDW¨ AEłHs‘0DWŞA0..A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C# A Period 02DW’D´xHssŻxDYD‡đHuq·pVaccination 4 A`Y A@2021-07-12T23:51:25Y 112613121126Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADW DÝHrÄ€„DW¨D‡đHsđPlacebo APlacebo ADW DÝDW!DÔXY . . .Placebo Placebo DW=DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW¨D´xD‡đDWÉDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB€BlBqBńAŕHrÄ€„HrŢŐŘHssŻxHsđ .DW‘WHITE AC4591001C4591001 1126 11261312APADVERSE EVENT 4 Fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-06-09T19:00Bś2021-06-11 Bž 2MedDRA v24.0NDW¨ AEłHs‘0DWŞA0..A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C# A Period 02DW’D´xHssŻxDYD‡đHuq·pVaccination 4 A`Y A@2021-07-12T23:51:14Y 112613141126Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDÉHrĹľDW¦DăXHsŽ2021-03-13T12:00BA 1MedDRA v24.0NDWM B)D¨ŔHs¬@DWPB,D¨űHs űA@DAYSN NNOT RELATEDOTHER Sports injury NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A Dßă APeriod 01DWDń,HrČ‰,DX’DëŚHtĹfŚVaccination 2 A Y A 2021-06-01T15:16:07 AE outcome, Minor AE term changed from EUA to sBLA 114013301140Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVřD” Hr¨ DW§Dĺ8HsŹŹ¸Placebo APlacebo ADVřD” DWD…\Y . . .Placebo Placebo DW,DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW§DŕDĺ8DWĂDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB•BmBqC`AŔHr¨ HrĆËÜHsrŠHsŹŹ¸ .DWWHITE AC4591001C4591001 1140 11401330AADVERSE EVENT 4 fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-09T08:00B±2021-06-10T10:00B˛ 1MedDRA v24.0NDW¨ A Dp€Hsl€DW©A0DŚŰHs‘Ú[A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C:ŕ A Period 02DW‘DŕHsrŠDYDĺ8HupĂ8Vaccination 4 A`Y A@2021-07-06T23:25:44Y 114013301140Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVřD” Hr¨ DW§Dĺ8HsŹŹ¸Placebo APlacebo ADVřD” DWD…\Y . . .Placebo Placebo DW,DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW§DŕDĺ8DWĂDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB•BmBqC`AŔHr¨ HrĆËÜHsrŠHsŹŹ¸ .DWWHITE AC4591001C4591001 1140 11401330A ADVERSE EVENT 2 pain at injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-17T18:00Bš2021-05-18T10:00B› 1MedDRA v24.0NDW‘ ADý Hsr¦ DW’A DŚŰHss‡ŰA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Bz A Period 02DW‘DŕHsrŠDYDĺ8HupĂ8Vaccination 3 APY A02021-07-06T21:29:09Y 114013301140Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVřD” Hr¨ DW§Dĺ8HsŹŹ¸Placebo APlacebo ADVřD” DWD…\Y . . .Placebo Placebo DW,DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW§DŕDĺ8DWĂDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB•BmBqC`AŔHr¨ HrĆËÜHsrŠHsŹŹ¸ .DWWHITE AC4591001C4591001 1140 11401330A0ADVERSE EVENT 3 fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-06-09T08:00B±2021-06-10T10:00B˛ 1MedDRA v24.0NDW¨ A Dp€Hsl€DW©A0DŚŰHs‘Ú[A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C:ŕ A Period 02DW‘DŕHsrŠDYDĺ8HupĂ8Vaccination 4 A`Y A@2021-07-06T23:25:33Y 114013351140Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVúD˝śHr«TśDW¦D‡HsŤŕPlacebo APlacebo ADVúD˝śDWDĂxY . . .Placebo Placebo DW1DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DÂD‡DWÄDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB“BmBqC@AŕHr«TśHrĹ¸xHsrkHsŤŕ .DWWHITE AC4591001C4591001 1140 11401335AADVERSE EVENT 1 fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-05-17T18:00B2021-05-18T07:00B™ 1MedDRA v24.0NDW‘ ADý Hsr¦ DW’A Db«Hss]«A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Bü A Period 02DW‘DÂHsrkDYD‡Huo€Vaccination 3 APY A02021-06-07T15:19:58Y 114013381140Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVúDăHr«zDW¦D‰”HsŤâ”Placebo APlacebo ADVúDăDWDáđY . . .Placebo Placebo DW+DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DŚ D‰”DWÄDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB“BmBqC@AđHr«zHrÇ(pHsr6 HsŤâ” .DWWHITE AC4591001C4591001 1140 11401338AADVERSE EVENT 3 Headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-05-18T09:00B™2021-05-19T09:00Bš 1MedDRA v24.0NDW’ A D~HssyDW“A0D~ËHstËKA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CV@ A Period 02DW‘DŚ Hsr6 DYD‰”HuoVaccination 3 APY A02021-05-21T19:38:20Y 114013381140Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVúDăHr«zDW¦D‰”HsŤâ”Placebo APlacebo ADVúDăDWDáđY . . .Placebo Placebo DW+DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DŚ D‰”DWÄDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB“BmBqC@AđHr«zHrÇ(pHsr6 HsŤâ” .DWWHITE AC4591001C4591001 1140 11401338A ADVERSE EVENT 1 Pain at the injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-17T20:00B2021-05-19T09:00Bš 1MedDRA v24.0NDW‘ AE”HsrÂŔDW“A0D~ËHstËKA0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED WITH SEQUELAEN ARELATED AAGRADE 1A C%€ A Period 02DW‘DŚ Hsr6 DYD‰”HuoVaccination 3 APY A02021-05-21T19:37:59Y 114013381140Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVúDăHr«zDW¦D‰”HsŤâ”Placebo APlacebo ADVúDăDWDáđY . . .Placebo Placebo DW+DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DŚ D‰”DWÄDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB“BmBqC@AđHr«zHrÇ(pHsr6 HsŤâ” .DWWHITE AC4591001C4591001 1140 11401338A@ADVERSE EVENT 4 pain at injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-07T09:55B .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDW¦ AD‹tHsŤät..... N NRELATED NOT APPLICABLE NNRECOVERING/RESOLVING N ARELATED AAGRADE 1A A€YA Period 02DW‘DŚ Hsr6 DYD‰”HuoVaccination 4 A`Y A@2021-06-18T14:15:24Y 114013381140Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVúDăHr«zDW¦D‰”HsŤâ”Placebo APlacebo ADVúDăDWDáđY . . .Placebo Placebo DW+DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DŚ D‰”DWÄDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB“BmBqC@AđHr«zHrÇ(pHsr6 HsŤâ” .DWWHITE AC4591001C4591001 1140 11401338A0ADVERSE EVENT 2 Mayalgias Myalgia F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Myalgia F™{F™{Muscle pains F™#Muscle disorders F™Musculoskeletal and connective tissue disorders F™k2021-05-18T09:00B™2021-05-19T09:00Bš 1MedDRA v24.0NDW’ A D~HssyDW“A0D~ËHstËKA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CV@ A Period 02DW‘DŚ Hsr6 DYD‰”HuoVaccination 3 APY A02021-05-21T19:37:38Y 114013431140BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAAMERICAN INDIAN OR ALASKA NATIVE A0FA NOT HISPANIC OR LATINOA USAAMERICAN INDIAN OR ALASKA NATIVE A0DVţD×dHr°´dDWDÚpHrĎ đBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVţD×dDWDÚpY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW1DWŚYPhase 3A@NNEGDWŤ ....... . .NY.DWŚDWýBŹBqCAĐHr°´dHrĎ đ.. .DWÍALL OTHERS A0C4591001C4591001 1140 11401343AADVERSE EVENT 1 complex migraine Migraine F™•NERVOUS SYSTEM DISORDERS Migraine F™OF™OMigraine headaches F™SHeadaches FáźNervous system disorders F™•2020-12-23 A02020-12-23 A0 3MedDRA v24.0NDW A0..DWA0..ADAYSN NRELATED NOT APPLICABLE YYRECOVERED/RESOLVED N ARELATED AA0GRADE 3A0 . APeriod 01DVţD×dHr°´dDX‚DÚpHt°=pVaccination 1 AY A2021-01-20T18:53:46 114013531140Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADV˙DŇxHr˛řDWŞD•Hs“4Placebo APlacebo ADV˙DŇxDWDŰŘY . . .Placebo Placebo DW0DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW•DWŞDßÔD•DWĆDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBŽBiBqB˙AŔHr˛řHrÍąŘHswĎTHs“4 .DW”WHITE AC4591001C4591001 1140 11401353AADVERSE EVENT 3 Pain at the injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-21T18:00B—2021-05-23T08:00B™ 1MedDRA v24.0NDW• ADý Hswě DW—A0Dp»Hsz;A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A B} A Period 02DW•DßÔHswĎTDYD•HuthVaccination 3 APY A02021-06-11T17:41:26Y 114013531140Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADV˙DŇxHr˛řDWŞD•Hs“4Placebo APlacebo ADV˙DŇxDWDŰŘY . . .Placebo Placebo DW0DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW•DWŞDßÔD•DWĆDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBŽBiBqB˙AŔHr˛řHrÍąŘHswĎTHs“4 .DW”WHITE AC4591001C4591001 1140 11401353A ADVERSE EVENT 1 neck pain Neck pain F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Neck pain F™$F™$Musculoskeletal and connective tissue pain and discomfort F™ŁMusculoskeletal and connective tissue disorders NEC F™iMusculoskeletal and connective tissue disorders F™k2021-02-03T15:00B,2021-02-05T06:00B. 2MedDRA v24.0NDW* BDŇđHrę±đDW,BDT›HrěÖ›A0DAYSN NNOT RELATEDOTHER playing in snow NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A D{š APeriod 01DV˙DŇxHr˛řDW•DßÓHswĎSVaccination 2 A Y A 2021-02-09T22:59:19 114013531140Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADV˙DŇxHr˛řDWŞD•Hs“4Placebo APlacebo ADV˙DŇxDWDŰŘY . . .Placebo Placebo DW0DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW•DWŞDßÔD•DWĆDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBŽBiBqB˙AŔHr˛řHrÍąŘHswĎTHs“4 .DW”WHITE AC4591001C4591001 1140 11401353A0ADVERSE EVENT 2 Fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-05-22T08:00B2021-05-23T08:00B™ 1MedDRA v24.0NDW– A Dp€Hsx±€DW—A0Dp»Hsz;A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CWHITE AC4591001C4591001 1147 11471270AADVERSE EVENT 3 Increased body temperature Body temperature increased FďëINVESTIGATIONS Body temperature increased F—F—Physical examination procedures and organ system status F™Ż…Physical examination and organ system status topics F™Ż„Investigations Fďë2021-02-25 BS2021-02-26 BT 1MedDRA v24.0NDW@ A ..DWAA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW?DöHs„DXĂD@Hu—ŔVaccination 3 APY A02021-03-03T21:33:59 114712701147Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVîDÄhHr›‰hDWVD@Hs$d@Placebo APlacebo ADVîDÄhDWDÁ Y . . .Placebo Placebo DW&DW7YPhase 3A@NNEGDW8 BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW?DWVDöD@DWuDXBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW7DWýBJBżBĆCAđHr›‰hHrąŘ Hs„Hs$d@ .DW>WHITE AC4591001C4591001 1147 11471270A ADVERSE EVENT 1 Headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-02-25 BS2021-02-26 BT 1MedDRA v24.0NDW@ A ..DWAA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW?DöHs„DXĂD@Hu—ŔVaccination 3 APY A02021-03-03T21:33:42 114712701147Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVîDÄhHr›‰hDWVD@Hs$d@Placebo APlacebo ADVîDÄhDWDÁ Y . . .Placebo Placebo DW&DW7YPhase 3A@NNEGDW8 BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW?DWVDöD@DWuDXBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW7DWýBJBżBĆCAđHr›‰hHrąŘ Hs„Hs$d@ .DW>WHITE AC4591001C4591001 1147 11471270A0ADVERSE EVENT 2 Myalgia Myalgia F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Myalgia F™{F™{Muscle pains F™#Muscle disorders F™Musculoskeletal and connective tissue disorders F™k2021-02-25 BS2021-02-26 BT 1MedDRA v24.0NDW@ A ..DWAA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW?DöHs„DXĂD@Hu—ŔVaccination 3 APY A02021-03-04T17:02:51 114712921147Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DVüD™üHrÓüDW§DŠ„HsŹ5Placebo APlacebo ADVüD™üDWD‚Y . . .Placebo Placebo DW-DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW§DěôDŠ„DWĂDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBBlBrC AŕHrÓüHrÉk”HssçôHsŹ5 .DW‘ALL OTHERS A0C4591001C4591001 1147 11471292AADVERSE EVENT 1 Acne vulgaris (new diagnosis) Acne F™5ŃSKIN AND SUBCUTANEOUS TISSUE DISORDERS Acne vulgaris F‡FpAcnes FqSkin appendage conditions F™5ŢSkin and subcutaneous tissue disorders F™5Ń2021-01-25 B& .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDW! B....... N NNOT RELATEDOTHER New diagnosis NOT APPLICABLE YNNOT RECOVERED/NOT RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVüD™üHrÓüDW’DěóHssçóVaccination 2 A Y A 2021-02-09T20:41:51 114713021147BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVüDĘřHr®řDWD`HrÉyŕBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVüDĘřDWD`Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW-DWŚYPhase 3A@NNEGDWŤ ....... . .NY.DWŚDWýB‘BqC AđHr®řHrÉyŕ.. .DWÄWHITE AC4591001C4591001 1147 11471302AADVERSE EVENT 1 Nasal congestion Nasal congestion F™-ŇRESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS Nasal congestion F™żF™żNasal congestion and inflammations F™ŔUpper respiratory tract disorders (excl infections) F™K`Respiratory, thoracic and mediastinal disorders F™-Ň2021-03-19 B[2021-03-21 B] 1MedDRA v24.0NDWV BF..DWXBH..A0DAYSN NNOT RELATEDOTHER Seasonal allergies NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVüDĘřHr®řDX~D`HtŞ`Follow Up 1 A0Y A 2021-03-23T20:54:35Y 114713021147BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVüDĘřHr®řDWD`HrÉyŕBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVüDĘřDWD`Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW-DWŚYPhase 3A@NNEGDWŤ ....... . .NY.DWŚDWýB‘BqC AđHr®řHrÉyŕ.. .DWÄWHITE AC4591001C4591001 1147 11471302A ADVERSE EVENT 2 Runny nose Rhinorrhoea F™-ŇRESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS Runny nose F™0F™/=Upper respiratory tract signs and symptoms F™KiRespiratory tract signs and symptoms F™Ë}Respiratory, thoracic and mediastinal disorders F™-Ň2021-03-19 B[2021-03-21 B] 1MedDRA v24.0NDWV BF..DWXBH..A0DAYSN NNOT RELATEDOTHER Seasonal allergies NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVüDĘřHr®řDX~D`HtŞ`Follow Up 1 A0Y A 2021-03-23T20:54:45Y 114713021147BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVüDĘřHr®řDWD`HrÉyŕBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVüDĘřDWD`Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW-DWŚYPhase 3A@NNEGDWŤ ....... . .NY.DWŚDWýB‘BqC AđHr®řHrÉyŕ.. .DWÄWHITE AC4591001C4591001 1147 11471302A0ADVERSE EVENT 3 Sneezing Sneezing F™-ŇRESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS Sneezing F™7F™7Upper respiratory tract signs and symptoms F™KiRespiratory tract signs and symptoms F™Ë}Respiratory, thoracic and mediastinal disorders F™-Ň2021-03-19 B[2021-03-21 B] 1MedDRA v24.0NDWV BF..DWXBH..A0DAYSN NNOT RELATEDOTHER Seasonal allergies NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVüDĘřHr®řDX~D`HtŞ`Follow Up 1 A0Y A 2021-03-23T20:54:54Y 114713071147Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVţD™Hr°vDW˘DŇđHsĺđPlacebo APlacebo ADVţD™DWDš8Y . . .Placebo Placebo DW-DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW˘Dĺ8DŇđDWÄDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBŽBqBrCAĐHr°vHrÉ¸HsmH¸Hsĺđ .DWŚWHITE AC4591001C4591001 1147 11471307AADVERSE EVENT 3 Headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-05-13 B2021-05-16 B“ 1MedDRA v24.0NDWŤ A..DWA@..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŤDĺ8HsmH¸DYDŇđHujpVaccination 3 APY A02021-05-18T14:14:18Y 114713071147Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVţD™Hr°vDW˘DŇđHsĺđPlacebo APlacebo ADVţD™DWDš8Y . . .Placebo Placebo DW-DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW˘Dĺ8DŇđDWÄDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBŽBqBrCAĐHr°vHrÉ¸HsmH¸Hsĺđ .DWŚWHITE AC4591001C4591001 1147 11471307A ADVERSE EVENT 2 Redness at injection site Injection site erythema FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site redness FěŇFěInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-13 B2021-05-16 B“ 1MedDRA v24.0NDWŤ A..DWA@..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŤDĺ8HsmH¸DYDŇđHujpVaccination 3 APY A02021-05-18T14:14:29Y 114713071147Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVţD™Hr°vDW˘DŇđHsĺđPlacebo APlacebo ADVţD™DWDš8Y . . .Placebo Placebo DW-DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW˘Dĺ8DŇđDWÄDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBŽBqBrCAĐHr°vHrÉ¸HsmH¸Hsĺđ .DWŚWHITE AC4591001C4591001 1147 11471307A0ADVERSE EVENT 1 Pain at injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-13 B2021-05-16 B“ 1MedDRA v24.0NDWŤ A..DWA@..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŤDĺ8HsmH¸DYDŇđHujpVaccination 3 APY A02021-05-18T14:14:41Y 114713101147BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVţDĂHr° DWDČÜHrÉ˛\BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVţDĂDWDČÜY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW-DWŚYPhase 3A@NNEGDWŤ ....... . .NY.DWŚDWýBŹBqCAđHr° HrÉ˛\.. .DWĐWHITE AC4591001C4591001 1147 11471310AADVERSE EVENT 2 Left ear pain Ear pain FÍ)EAR AND LABYRINTH DISORDERS Ear pain FÍDFÍDEar disorders NEC F™’Aural disorders NEC F™“Ear and labyrinth disorders FÍ)2021-01 . .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDWDA....... N NNOT RELATEDOTHER Sinus pressure NOT APPLICABLE YNRECOVERING/RESOLVING N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVţDĂHr° DX~DČÜHtŞĺÜVaccination 2 A Y A 2021-03-01T16:52:24 114713101147BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVţDĂHr° DWDČÜHrÉ˛\BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVţDĂDWDČÜY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW-DWŚYPhase 3A@NNEGDWŤ ....... . .NY.DWŚDWýBŹBqCAđHr° HrÉ˛\.. .DWĐWHITE AC4591001C4591001 1147 11471310A ADVERSE EVENT 1 Nasal congestion Nasal congestion F™-ŇRESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS Nasal congestion F™żF™żNasal congestion and inflammations F™ŔUpper respiratory tract disorders (excl infections) F™K`Respiratory, thoracic and mediastinal disorders F™-Ň2021-01-02 AĐ2021-01-09 B 1MedDRA v24.0NDW AĐ..DWB..A€DAYSN NNOT RELATEDOTHER Seasonal allergies NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVţDĂHr° DX~DČÜHtŞĺÜVaccination 1 AY A2021-01-12T20:33:15 114713201147BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADW D› HrÄ? DW#DŤĚHrá2LBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DW D› DW#DŤĚY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW@DW~YPhase 3A@NNEGDW ....... . .NY.DW~DWýBrBBńAđHrÄ? Hrá2L.. .DWŇWHITE AC4591001C4591001 1147 11471320AADVERSE EVENT 1 Anxiety Anxiety F™'·PSYCHIATRIC DISORDERS Anxiety Fˇ§Fˇ§Anxiety symptoms FˇµAnxiety disorders and symptoms FˇPsychiatric disorders F™'·2021-05 . .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDWDB_....... N NNOT RELATEDOTHER mental health condition NOT APPLICABLE YNNOT RECOVERED/NOT RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DW D› HrÄ? DXDŤĚHtÂeĚAfter unblinding and before Vaccination 3A@ A 2021-08-12T21:07:09Y 114713211147Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsABLACK OR AFRICAN AMERICAN A MANOT HISPANIC OR LATINOA USABLACK OR AFRICAN AMERICAN A DW DËčHrÄohDW¦D•ÄHsŤîÄPlacebo APlacebo ADW DËčDW$DşY . . .Placebo Placebo DW@DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW¦DŐHD•ÄDWĘDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBBlBrBńAđHrÄohHrâ°HssĐHHsŤîÄ .DW‘BLACK OR AFRICAN AMERICANA C4591001C4591001 1147 11471321AADVERSE EVENT 2 pre-diabetes Glucose tolerance impaired F™©METABOLISM AND NUTRITION DISORDERS Pre-diabetes F™%FŢ}Hyperglycaemic conditions NEC FçGlucose metabolism disorders (incl diabetes mellitus) FŢxMetabolism and nutrition disorders F™©2021-07-02 Bł .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDWż B....... N NNOT RELATEDOTHER unknown NOT APPLICABLE NNNOT RECOVERED/NOT RESOLVED N A0NOT RELATEDA0AGRADE 1A . A Period 02DW’DŐHHssĐHDYD•ÄHuo"DVaccination 4 A`Y A@2021-07-20T21:25:19Y 114713211147Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsABLACK OR AFRICAN AMERICAN A MANOT HISPANIC OR LATINOA USABLACK OR AFRICAN AMERICAN A DW DËčHrÄohDW¦D•ÄHsŤîÄPlacebo APlacebo ADW DËčDW$DşY . . .Placebo Placebo DW@DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW¦DŐHD•ÄDWĘDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýBBlBrBńAđHrÄohHrâ°HssĐHHsŤîÄ .DW‘BLACK OR AFRICAN AMERICANA C4591001C4591001 1147 11471321A ADVERSE EVENT 1 vitamin D deficiency Vitamin D deficiency F™©METABOLISM AND NUTRITION DISORDERS Vitamin D deficiency F™PŠF™PŠFat soluble vitamin deficiencies and disorders FŐúVitamin related disorders F™P“Metabolism and nutrition disorders F™©2021-07-02 Bł .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDWż B....... N NNOT RELATEDOTHER unknown NOT APPLICABLE YNNOT RECOVERED/NOT RESOLVED N A0NOT RELATEDA0AGRADE 1A . A Period 02DW’DŐHHssĐHDYD•ÄHuo"DVaccination 4 A`Y A@2021-07-20T21:25:07Y 114713221147Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADW DĐÔHrÄtTDW#DHrá'„Placebo APlacebo ADW DĐÔDW#DY . . .Placebo Placebo DWKDW‹YPhase 3A@NNEGDWŚ ....... . .NN.DW‹DWýBBrBńAŔHrÄtTHrá'„.. .DWŕWHITE AC4591001C4591001 1147 11471322AADVERSE EVENT 2 Acute conjunctivitis, left Conjunctivitis FëůINFECTIONS AND INFESTATIONS Acute conjunctivitis F™7FŔuEye and eyelid infections FÔĄInfections - pathogen unspecified Fë÷Infections and infestations Fëů2021-02-25T06:00B4 .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDW@ BDT`Hs4`..... N NNOT RELATEDOTHER unspecified acute conjunctivitis type NOT APPLICABLE YNRECOVERING/RESOLVING N A0NOT RELATEDA0AGRADE 1A D˘Y APeriod 01DW DĐÔHrÄtTDXDHtÂ[Vaccination 2 A Y A 2021-03-01T16:51:11 114713221147Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADW DĐÔHrÄtTDW#DHrá'„Placebo APlacebo ADW DĐÔDW#DY . . .Placebo Placebo DWKDW‹YPhase 3A@NNEGDWŚ ....... . .NN.DW‹DWýBBrBńAŔHrÄtTHrá'„.. .DWŕWHITE AC4591001C4591001 1147 11471322A ADVERSE EVENT 1 Right ear pain Ear pain FÍ)EAR AND LABYRINTH DISORDERS Ear pain FÍDFÍDEar disorders NEC F™’Aural disorders NEC F™“Ear and labyrinth disorders FÍ)2021-01-25 B2021-01-31 B 1MedDRA v24.0NDW! B..DW'B..ApDAYSN NNOT RELATEDOTHER Water in ear NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DW DĐÔHrÄtTDXDHtÂ[Vaccination 1 AY A2021-03-09T14:37:52 114713231147Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADW DćdHrÄ‰äDW#Dđ´Hrá•4Placebo APlacebo ADW DćdDW#Dđ´Y . . .Placebo Placebo DW@DW‹YPhase 3A@NNEGDWŚ ....... . .NN.DW‹DWýBBrBńAŕHrÄ‰äHrá•4.. .DWŇWHITE AC4591001C4591001 1147 11471323AADVERSE EVENT 1 Allergic reaction to surgical dressings. Dermatitis contact F™5ŃSKIN AND SUBCUTANEOUS TISSUE DISORDERS Allergic contact dermatitis F™rIFÇDermatitis and eczema FÇEpidermal and dermal conditions FŃSkin and subcutaneous tissue disorders F™5Ń2021-02-09T22:42B$ .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDW0 AŕEó€Hró8..... N NNOT RELATEDOTHER s/p hip hardware removed 03FEB2021 NOT APPLICABLE YNRECOVERING/RESOLVING N A0NOT RELATEDA0A GRADE 2A DJo APeriod 01DW DćdHrÄ‰äDXDđ´HtÂČ´Vaccination 2 A Y A 2021-02-15T19:29:33 114713271147BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADW DńhHrÄ”čDW DńhHrÄ”čBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DW Dńh..Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g) DW@DWŚYPhase 3A@NNEGDWŤ ....... . .NN.DWŚDWýB€BqBńAŕHrÄ”čHrÄ”č.. .DWŮWHITE AC4591001C4591001 1147 11471327AADVERSE EVENT 1 Fever (104.7) Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-01-06T19:30A 2021-01-08 A@ 4MedDRA v24.0YDW A E#€HrĆ8DWA@..A0DAYSN NRELATED DRUG WITHDRAWN YNRECOVERED/RESOLVED N ARELATED AA@GRADE 4A@ CbŔ APeriod 01DW DńhHrÄ”čDXzDńhHtĄČhVaccination 1 AY A2021-03-03T23:00:42 114713311147BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADW DűôHrÄźtDW$DďHrâĺBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DW DűôDW$DďY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW@DWŚYPhase 3A@NNEGDWŤ ....... . .NY.DWŚDWýB€BqBńAĐHrÄźtHrâĺ.. .DWáWHITE AC4591001C4591001 1147 11471331AADVERSE EVENT 1 Fracture of middle phalanx of left index finger Hand fracture FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Fractured finger FÚFá*Limb fractures and dislocations F™ľîBone and joint injuries F¶Injury, poisoning and procedural complications Fěĺ2021-02-24 B3 .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDW? B....... N NNOT RELATEDOTHER Sports injury NOT APPLICABLE NNRECOVERING/RESOLVING N A0NOT RELATEDA0AGRADE 1A . APeriod 01DW DűôHrÄźtDX‘DďHtÄVaccination 2 A Y A 2021-03-01T22:17:56 114713361147Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDłHrĹ¨DW#Dˇ@HráEŔPlacebo APlacebo ADWDłDW#Dˇ@Y . . .Placebo Placebo DW@DW‹YPhase 3A@NNEGDWŚ ....... . .NN.DW‹DWýB~BrBđAđHrĹ¨HráEŔ.. .DWŕWHITE AC4591001C4591001 1147 11471336AADVERSE EVENT 2 Nausea Nausea FÜ›GASTROINTESTINAL DISORDERS Nausea F™ F™ Nausea and vomiting symptoms F™Gastrointestinal signs and symptoms FÜÜGastrointestinal disorders FÜ›2021-04-11 B` .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDWm BK....... N NNOT RELATEDOTHER Anxiety NOT APPLICABLE NNNOT RECOVERED/NOT RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DWDłHrĹ¨DXDˇ@HtÂy@Follow Up 1 A0Y A 2021-08-16T21:27:47Y 114713451147Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWD÷řHrĹěřDW¨DÇ8HsĂ8Placebo APlacebo ADWD÷řDW$DîY . . .Placebo Placebo DW@DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DW¨D×(DÇ8DWÍDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB~BkBrBđAđHrĹěřHrâäHsu#¨HsĂ8 .DW’WHITE AC4591001C4591001 1147 11471345AADVERSE EVENT 1 Generalized muscle pain Myalgia F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Muscle pain F™"F™{Muscle pains F™#Muscle disorders F™Musculoskeletal and connective tissue disorders F™k2021-05-20 B‡2021-05-21 B 1MedDRA v24.0NDW” A ..DW•A0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW“D×(Hsu#¨DYDÇ8Huqö¸Vaccination 3 APY A02021-05-27T13:37:42Y 115011201150Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADV»DĽpHrXDđDW©DÎHs’„Placebo APlacebo ADV»DĽpDVŃD¬Y . . .Placebo Placebo DVňDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW”DW©DŢ¨DÎDWĹDXfBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBŇBjBqC0AđHrXDđHru7,Hsv|¨Hs’„ .DWŽWHITE AC4591001C4591001 1150 11501120AADVERSE EVENT 1 Pain at injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-21 BŰ2021-05-21 BŰ 1MedDRA v24.0NDW• A ..DW•A ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW”DŢ¨Hsv|¨DYDÎHusOVaccination 3 APY A02021-06-10T21:12:29Y 115011201150Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADV»DĽpHrXDđDW©DÎHs’„Placebo APlacebo ADV»DĽpDVŃD¬Y . . .Placebo Placebo DVňDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW”DW©DŢ¨DÎDWĹDXfBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBŇBjBqC0AđHrXDđHru7,Hsv|¨Hs’„ .DWŽWHITE AC4591001C4591001 1150 11501120A ADVERSE EVENT 2 Tendonitis Tendonitis F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Tendonitis F™?wF™?wTendon disorders F™?bTendon, ligament and cartilage disorders F™?eMusculoskeletal and connective tissue disorders F™k2021-03 .2021-06 . 1MedDRA v24.0NDWDDBt....... N NNOT RELATEDOTHER sports injury NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DV»DĽpHrXDđDW”DŢ§Hsv|§Follow Up 1 A0Y A 2021-07-08T18:23:21Y 115011211150Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADV»Dé4HrXq´DW©DňXHs’?ŘPlacebo APlacebo ADV»Dé4DVÎD—ŕY . . .Placebo Placebo DVëDW‹YPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW”DW©DDňXDWÉDXfBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBŇBjBqC0AđHrXq´Hrq,ŕHsv6Hs’?Ř .DW‹WHITE AC4591001C4591001 1150 11501121AADVERSE EVENT 2 Muscle Pain Myalgia F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Muscle pain F™"F™{Muscle pains F™#Muscle disorders F™Musculoskeletal and connective tissue disorders F™k2021-06-10T18:00Bď2021-06-11 Bđ 1MedDRA v24.0NDW© ADý Hs’J DWŞA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A B. A Period 02DW”DHsv6DYDňXHussXVaccination 4 A`Y A@2021-07-14T16:03:48Y 115011211150Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADV»Dé4HrXq´DW©DňXHs’?ŘPlacebo APlacebo ADV»Dé4DVÎD—ŕY . . .Placebo Placebo DVëDW‹YPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW”DW©DDňXDWÉDXfBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBŇBjBqC0AđHrXq´Hrq,ŕHsv6Hs’?Ř .DW‹WHITE AC4591001C4591001 1150 11501121A ADVERSE EVENT 1 Fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-06-10T18:00Bď2021-06-11 Bđ 1MedDRA v24.0NDW© ADý Hs’J DWŞA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A B. A Period 02DW”DHsv6DYDňXHussXVaccination 4 A`Y A@2021-07-14T16:03:36Y 115011251150Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsABLACK OR AFRICAN AMERICAN A MANOT HISPANIC OR LATINOA USABLACK OR AFRICAN AMERICAN A DVżD˘äHr]qdDW©D—¤Hs‘ĺ$Placebo APlacebo ADVżD˘äDVÔDé¬Y . . .Placebo Placebo DVńDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW©Dě@D—¤DWĚDXfBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBÎBlBqCđAŕHr]qdHryg¬Hssç@Hs‘ĺ$ .DW‘BLACK OR AFRICAN AMERICANA C4591001C4591001 1150 11501125AADVERSE EVENT 2 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-10T20:00Bë2021-06-11 Bě 1MedDRA v24.0NDW© AE”Hs’fŔDWŞA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C" A Period 02DW’Dě@Hssç@DYD—¤Hus¤Vaccination 4 A`Y A@2021-07-21T14:38:08Y 115011251150Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsABLACK OR AFRICAN AMERICAN A MANOT HISPANIC OR LATINOA USABLACK OR AFRICAN AMERICAN A DVżD˘äHr]qdDW©D—¤Hs‘ĺ$Placebo APlacebo ADVżD˘äDVÔDé¬Y . . .Placebo Placebo DVńDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW©Dě@D—¤DWĚDXfBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBÎBlBqCđAŕHr]qdHryg¬Hssç@Hs‘ĺ$ .DW‘BLACK OR AFRICAN AMERICANA C4591001C4591001 1150 11501125A ADVERSE EVENT 1 Injection Site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-18T20:00BÔ2021-05-19 BŐ 1MedDRA v24.0NDW’ AE”Hst@DW“A ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A BŔ A Period 02DW’Dě@Hssç@DYD—¤Hus¤Vaccination 3 APY A02021-06-11T15:40:47Y 115011271150BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVżDÄ,Hr]’¬DVÖDčĽHr| ĽBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVżDÄ,DVÖDčĽY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DVňDWŚYPhase 3A@NNEGDWŤ ....... . .NY.DWŚDWýBÎBqCđAđHr]’¬Hr| Ľ.. .DW‘WHITE AC4591001C4591001 1150 11501127AADVERSE EVENT 1 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2020-11-12 B2020-11-12 B 1MedDRA v24.0NDV× A ..DV×A ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . APeriod 01DVżDÄ,Hr]’¬DXCDčĽHt]=<Vaccination 2 A Y A 2020-11-18T23:19:47 115011291150Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVŔD{„Hr^›„DW DépHs†YpPlacebo APlacebo ADVŔD{„DVŐDt|Y . . .Placebo Placebo DVřDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW DŚ(DépDWÄDX]BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBÍBqBqCŕAŔHr^›„HrzCüHslď¨Hs†Yp .DWŚWHITE AC4591001C4591001 1150 11501129AADVERSE EVENT 1 Concussion Concussion FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Concussion FľŽFľŽCerebral injuries NEC F™dInjuries NEC FěâInjury, poisoning and procedural complications Fěĺ2021-01-11 BT2021-03-11 BŹ 2MedDRA v24.0NDW B?..DWNBz..B<DAYSN NNOT RELATEDOTHER Sports related injury NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVŔD{„Hr^›„DWŤDŚ'Hslď§Follow Up 1 A0Y A 2021-03-30T14:24:59 AERELTXT changed from EUA to sBLA 115011291150Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVŔD{„Hr^›„DW DépHs†YpPlacebo APlacebo ADVŔD{„DVŐDt|Y . . .Placebo Placebo DVřDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW DŚ(DépDWÄDX]BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBÍBqBqCŕAŔHr^›„HrzCüHslď¨Hs†Yp .DWŚWHITE AC4591001C4591001 1150 11501129A ADVERSE EVENT 2 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-14 BĎ2021-05-16 BŃ 2MedDRA v24.0NDWŽ A ..DWA@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWŤDŚ(Hslď¨DY DépHugŚđVaccination 3 APY A02021-06-01T23:33:24Y 115011291150Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVŔD{„Hr^›„DW DépHs†YpPlacebo APlacebo ADVŔD{„DVŐDt|Y . . .Placebo Placebo DVřDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW DŚ(DépDWÄDX]BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBÍBqBqCŕAŔHr^›„HrzCüHslď¨Hs†Yp .DWŚWHITE AC4591001C4591001 1150 11501129A0ADVERSE EVENT 3 Pain at injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-14 BĎ2021-05-16 BŃ 2MedDRA v24.0NDWŽ A ..DWA@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWŤDŚ(Hslď¨DY DépHugŚđVaccination 3 APY A02021-06-01T23:33:34Y 115011291150Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVŔD{„Hr^›„DW DépHs†YpPlacebo APlacebo ADVŔD{„DVŐDt|Y . . .Placebo Placebo DVřDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW DŚ(DépDWÄDX]BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBÍBqBqCŕAŔHr^›„HrzCüHslď¨Hs†Yp .DWŚWHITE AC4591001C4591001 1150 11501129A@ADVERSE EVENT 4 Body Aches Pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalized aching F™Š\F™ŰPain and discomfort NEC F™ÜGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-14 BĎ2021-05-16 BŃ 2MedDRA v24.0NDWŽ A ..DWA@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWŤDŚ(Hslď¨DY DépHugŚđVaccination 3 APY A02021-06-01T23:33:46Y 115011291150Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVŔD{„Hr^›„DW DépHs†YpPlacebo APlacebo ADVŔD{„DVŐDt|Y . . .Placebo Placebo DVřDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW DŚ(DépDWÄDX]BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBÍBqBqCŕAŔHr^›„HrzCüHslď¨Hs†Yp .DWŚWHITE AC4591001C4591001 1150 11501129APADVERSE EVENT 5 Fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-05-14 BĎ2021-05-14 BĎ 1MedDRA v24.0NDWŽ A ..DWŽA ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŤDŚ(Hslď¨DY DépHugŚđVaccination 3 APY A02021-06-01T23:33:57Y 115011301150BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVŔDöHr_DVÔDŠHHryHBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVŔDöDVÔDŠHY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DVôDWŚYPhase 3A@NPOSDWŤ ....... . .NY.DWŚDWýBÍBqCŕAŔHr_HryH.. .DWŽWHITE AC4591001C4591001 1150 11501130AADVERSE EVENT 2 Dizziness Dizziness F™•NERVOUS SYSTEM DISORDERS Dizziness FË…FË…Neurological signs and symptoms NEC F™úNeurological disorders NEC F™ůNervous system disorders F™•2020-11-09T18:00B2020-11-11 B 1MedDRA v24.0NDVÔ ADý Hry{ DVÖA0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C APeriod 01DVŔDöHr_DXADŠHHtZ;ČVaccination 2 A Y A 2020-11-16T21:52:25 115011301150BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVŔDöHr_DVÔDŠHHryHBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVŔDöDVÔDŠHY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DVôDWŚYPhase 3A@NPOSDWŤ ....... . .NY.DWŚDWýBÍBqCŕAŔHr_HryH.. .DWŽWHITE AC4591001C4591001 1150 11501130A ADVERSE EVENT 1 Nausea Nausea FÜ›GASTROINTESTINAL DISORDERS Nausea F™ F™ Nausea and vomiting symptoms F™Gastrointestinal signs and symptoms FÜÜGastrointestinal disorders FÜ›2020-11-09T18:00B2020-11-11 B 2MedDRA v24.0NDVÔ ADý Hry{ DVÖA0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C APeriod 01DVŔDöHr_DXADŠHHtZ;ČVaccination 2 A Y A 2020-11-16T21:51:45 115011311150Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVŔD÷Hr_DWRDôHsôPlacebo APlacebo ADVŔD÷DVÔDŠY . . .Placebo Placebo DVôDW6YPhase 3A@NNEGDW7 BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW>DWRD PDôDWnDXBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW6DWýBwBŔBÇCŕAđHr_HryHsÝPHsô .DW=WHITE AC4591001C4591001 1150 11501131AADVERSE EVENT 2 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-02-23T18:00B2021-02-25 B 2MedDRA v24.0NDW> ADý Hs: DW@A0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A CŔ A Period 02DW>D PHsÝPDXżDôHuRtVaccination 3 APY A02021-03-15T15:32:23 115011311150Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVŔD÷Hr_DWRDôHsôPlacebo APlacebo ADVŔD÷DVÔDŠY . . .Placebo Placebo DVôDW6YPhase 3A@NNEGDW7 BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW>DWRD PDôDWnDXBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW6DWýBwBŔBÇCŕAđHr_HryHsÝPHsô .DW=WHITE AC4591001C4591001 1150 11501131A ADVERSE EVENT 6 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-03-15T18:00B“2021-03-16 B” 2MedDRA v24.0NDWR ADý Hs DWSA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C P A Period 02DW>D PHsÝPDXżDôHuRtVaccination 4 A`Y A@2021-04-12T19:01:37Y 115011311150Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVŔD÷Hr_DWRDôHsôPlacebo APlacebo ADVŔD÷DVÔDŠY . . .Placebo Placebo DVôDW6YPhase 3A@NNEGDW7 BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW>DWRD PDôDWnDXBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW6DWýBwBŔBÇCŕAđHr_HryHsÝPHsô .DW=WHITE AC4591001C4591001 1150 11501131A0ADVERSE EVENT 3 Headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-02-23T18:00B2021-02-25 B 2MedDRA v24.0NDW> ADý Hs: DW@A0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A CŔ A Period 02DW>D PHsÝPDXżDôHuRtVaccination 3 APY A02021-03-15T15:32:32 115011311150Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVŔD÷Hr_DWRDôHsôPlacebo APlacebo ADVŔD÷DVÔDŠY . . .Placebo Placebo DVôDW6YPhase 3A@NNEGDW7 BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW>DWRD PDôDWnDXBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW6DWýBwBŔBÇCŕAđHr_HryHsÝPHsô .DW=WHITE AC4591001C4591001 1150 11501131A@ADVERSE EVENT 5 Headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-03-15T18:00B“2021-03-16 B” 2MedDRA v24.0NDWR ADý Hs DWSA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C P A Period 02DW>D PHsÝPDXżDôHuRtVaccination 4 A`Y A@2021-04-12T19:01:27Y 115011311150Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVŔD÷Hr_DWRDôHsôPlacebo APlacebo ADVŔD÷DVÔDŠY . . .Placebo Placebo DVôDW6YPhase 3A@NNEGDW7 BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW>DWRD PDôDWnDXBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW6DWýBwBŔBÇCŕAđHr_HryHsÝPHsô .DW=WHITE AC4591001C4591001 1150 11501131APADVERSE EVENT 1 Pain at injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-02-23T18:00B2021-02-25 B 2MedDRA v24.0NDW> ADý Hs: DW@A0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A CŔ A Period 02DW>D PHsÝPDXżDôHuRtVaccination 3 APY A02021-03-15T15:32:14 115011311150Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVŔD÷Hr_DWRDôHsôPlacebo APlacebo ADVŔD÷DVÔDŠY . . .Placebo Placebo DVôDW6YPhase 3A@NNEGDW7 BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW>DWRD PDôDWnDXBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW6DWýBwBŔBÇCŕAđHr_HryHsÝPHsô .DW=WHITE AC4591001C4591001 1150 11501131A`ADVERSE EVENT 8 Pain at injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-03-15T18:00B“2021-03-16 B” 2MedDRA v24.0NDWR ADý Hs DWSA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C P A Period 02DW>D PHsÝPDXżDôHuRtVaccination 4 A`Y A@2021-04-12T19:01:57Y 115011311150Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVŔD÷Hr_DWRDôHsôPlacebo APlacebo ADVŔD÷DVÔDŠY . . .Placebo Placebo DVôDW6YPhase 3A@NNEGDW7 BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW>DWRD PDôDWnDXBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW6DWýBwBŔBÇCŕAđHr_HryHsÝPHsô .DW=WHITE AC4591001C4591001 1150 11501131A€ADVERSE EVENT 4 Generalized Body Aches Pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalised aching FÝF™ŰPain and discomfort NEC F™ÜGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-02-23T18:00B2021-02-25 B 2MedDRA v24.0NDW> ADý Hs: DW@A0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A CŔ A Period 02DW>D PHsÝPDXżDôHuRtVaccination 3 APY A02021-03-15T15:32:41 115011311150Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVŔD÷Hr_DWRDôHsôPlacebo APlacebo ADVŔD÷DVÔDŠY . . .Placebo Placebo DVôDW6YPhase 3A@NNEGDW7 BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW>DWRD PDôDWnDXBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW6DWýBwBŔBÇCŕAđHr_HryHsÝPHsô .DW=WHITE AC4591001C4591001 1150 11501131AADVERSE EVENT 7 Generalized Body Aches Pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalised aching FÝF™ŰPain and discomfort NEC F™ÜGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-03-15T18:00B“2021-03-16 B” 2MedDRA v24.0NDWR ADý Hs DWSA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C P A Period 02DW>D PHsÝPDXżDôHuRtVaccination 4 A`Y A@2021-04-12T19:01:47Y 115011321150BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVŔDöĚHr_ĚDVÔDŠHryBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVŔDöĚDVÔDŠY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DVôDWŚYPhase 3A@NNEGDWŤ ....... . .NY.DWŚDWýBÍBqCŕAŕHr_ĚHry.. .DWŽWHITE AC4591001C4591001 1150 11501132AADVERSE EVENT 1 Diarrhea Diarrhoea FÜ›GASTROINTESTINAL DISORDERS Diarrhea FČ7FČ?Diarrhoea (excl infective) FČ@Gastrointestinal motility and defaecation conditions FÜąGastrointestinal disorders FÜ›2020-11-09T18:00B2020-11-10 B 2MedDRA v24.0NDVÔ ADý Hry{ DVŐA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C° APeriod 01DVŔDöĚHr_ĚDXADŠHtZ;ŚVaccination 2 A Y A 2020-11-16T22:52:29 115011341150Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVÁD±0Hr`"°DW¦Dá´HsŽ:´Placebo APlacebo ADVÁD±0DVŐDŞdY . . .Placebo Placebo DVňDW…YPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DĚŘDá´DWÂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBĚBmBqCĐAđHr`"°HrzyäHsrvXHsŽ:´ .DW…WHITE AC4591001C4591001 1150 11501134AADVERSE EVENT 1 Chills Chills FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills F·ÓF·ÓFeelings and sensations NEC F™ŁGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-18 BŇ2021-05-19 BÓ 1MedDRA v24.0NDW’ A ..DW“A0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW‘DĚŘHsrvXDYDá´Huon4Vaccination 3 APY A02021-06-08T00:01:56Y 115011661150Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVéD ŚHr”ÎDW§DřHsŹ*xPlacebo APlacebo ADVéD ŚDV˙D@Y . . .Placebo Placebo DWDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW”DW§D‚DřDWĂDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB¤BjBqCPAŕHr”ÎHr±±ŔHsv HsŹ*x .DW“WHITE AC4591001C4591001 1150 11501166AADVERSE EVENT 1 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-21 B2021-05-22 B® 1MedDRA v24.0NDW• A ..DW–A0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW”D‚Hsv DYDřHup]řVaccination 3 APY A02021-06-08T19:09:08Y 115011661150Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVéD ŚHr”ÎDW§DřHsŹ*xPlacebo APlacebo ADVéD ŚDV˙D@Y . . .Placebo Placebo DWDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW”DW§D‚DřDWĂDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB¤BjBqCPAŕHr”ÎHr±±ŔHsv HsŹ*x .DW“WHITE AC4591001C4591001 1150 11501166A ADVERSE EVENT 2 Muscle Pain Myalgia F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Muscle pain F™"F™{Muscle pains F™#Muscle disorders F™Musculoskeletal and connective tissue disorders F™k2021-06-09 BŔ2021-06-10 BÁ 2MedDRA v24.0NDW¨ A ..DW©A0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DW”D‚Hsv DYDřHup]řVaccination 4 A`Y A@2021-07-07T12:33:06Y 115011681150BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVëDÇ8Hr——¸DWD¦¤Hrł&¤BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVëDÇ8DWD¦¤Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW(DWŚYPhase 3A@NNEGDWŤ ....... . .NY.DWŚDWýB˘BqC0AĐHr——¸Hrł&¤.. .DWŞWHITE AC4591001C4591001 1150 11501168AADVERSE EVENT 1 Depression Depression F™'·PSYCHIATRIC DISORDERS Depression FĆÚFĆÚDepressive disorders FĆńDepressed mood disorders and disturbances FĆ×Psychiatric disorders F™'·2021-03 . .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDWDDBE....... N NNOT RELATEDOTHER social events NOT APPLICABLE NNRECOVERING/RESOLVING N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVëDÇ8Hr——¸DXmD¦¤Ht”Z$Follow Up 1 A0Y A 2021-05-20T22:49:54Y 115011761150Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVíD™üHrš |DW§DĄ<HsŹOĽPlacebo APlacebo ADVíD™üDWDÂY . . .Placebo Placebo DWDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW§DŔ¨DĄ<DWĂDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB BlBqCAŕHrš |HrłBHss»¨HsŹOĽ .DW‘WHITE AC4591001C4591001 1150 11501176AADVERSE EVENT 4 Chills Chills FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills F·ÓF·ÓFeelings and sensations NEC F™ŁGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-19 B§2021-05-19 B§ 1MedDRA v24.0NDW“ A ..DW“A ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW’DŔ¨Hss»¨DYDĄ<Hup<Vaccination 3 APY A02021-06-08T19:09:50Y 115011761150Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVíD™üHrš |DW§DĄ<HsŹOĽPlacebo APlacebo ADVíD™üDWDÂY . . .Placebo Placebo DWDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW§DŔ¨DĄ<DWĂDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB BlBqCAŕHrš |HrłBHss»¨HsŹOĽ .DW‘WHITE AC4591001C4591001 1150 11501176A ADVERSE EVENT 3 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-19 B§2021-05-19 B§ 2MedDRA v24.0NDW“ A ..DW“A ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DW’DŔ¨Hss»¨DYDĄ<Hup<Vaccination 3 APY A02021-06-08T19:09:40Y 115011761150Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVíD™üHrš |DW§DĄ<HsŹOĽPlacebo APlacebo ADVíD™üDWDÂY . . .Placebo Placebo DWDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW§DŔ¨DĄ<DWĂDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB BlBqCAŕHrš |HrłBHss»¨HsŹOĽ .DW‘WHITE AC4591001C4591001 1150 11501176A0ADVERSE EVENT 1 Pain at injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-18T18:00B¦2021-05-20 B¨ 2MedDRA v24.0NDW’ ADý Hssř DW”A0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C A Period 02DW’DŔ¨Hss»¨DYDĄ<Hup<Vaccination 3 APY A02021-06-08T19:09:18Y 115011761150Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVíD™üHrš |DW§DĄ<HsŹOĽPlacebo APlacebo ADVíD™üDWDÂY . . .Placebo Placebo DWDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW§DŔ¨DĄ<DWĂDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB BlBqCAŕHrš |HrłBHss»¨HsŹOĽ .DW‘WHITE AC4591001C4591001 1150 11501176A@ADVERSE EVENT 2 Fainting Syncope F™•NERVOUS SYSTEM DISORDERS Fainting FŐ©F™=”Disturbances in consciousness NEC FËENeurological disorders NEC F™ůNervous system disorders F™•2021-05-19 B§2021-05-19 B§ 2MedDRA v24.0NDW“ A ..DW“A ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DW’DŔ¨Hss»¨DYDĄ<Hup<Vaccination 3 APY A02021-06-08T19:09:29Y 115011821150Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVńD´´Hrźn4DWUD¬Hs#;Placebo APlacebo ADVńD´´DWDXY . . .Placebo Placebo DW$DW6YPhase 3A@NNEGDW7 BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW@DWUDčD¬DWqDXBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW6DWýBFBľBÇCĐAđHrźn4HrąŻŘHsŤčHs#; .DW?WHITE AC4591001C4591001 1150 11501182AADVERSE EVENT 1 Injection Site Pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-02-25T19:00BP2021-02-26 BQ 1MedDRA v24.0NDW@ AEłHsë0DWAA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Cŕ A Period 02DW@DčHsŤčDXÂD¬HuoVaccination 3 APY A02021-03-18T18:16:08 115011851150Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVńDďHrź¨DW˘D¬HsżPlacebo APlacebo ADVńDďDWD®`Y . . .Placebo Placebo DW!DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW˘DÉTD¬DWżDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBśBqBqCĐAŕHrź¨HrąĹŕHsm,ÔHsż .DWŚWHITE AC4591001C4591001 1150 11501185AADVERSE EVENT 1 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-13T18:00Bť2021-05-14 Bž 1MedDRA v24.0NDWŤ ADý Hsm` DWŽA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A BÝ A Period 02DWŤDÉTHsm,ÔDYD¬HuiňVaccination 3 APY A02021-06-03T21:29:56Y 115011851150Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVńDďHrź¨DW˘D¬HsżPlacebo APlacebo ADVńDďDWD®`Y . . .Placebo Placebo DW!DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW˘DÉTD¬DWżDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBśBqBqCĐAŕHrź¨HrąĹŕHsm,ÔHsż .DWŚWHITE AC4591001C4591001 1150 11501185A ADVERSE EVENT 3 Bruise at injection site Injection site bruising FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site bruising Fě¤Fě¤Injection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-13T18:00Bť2021-05-17 Bˇ 1MedDRA v24.0NDWŤ ADý Hsm` DW‘AP..APDAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A BÝ A Period 02DWŤDÉTHsm,ÔDYD¬HuiňVaccination 3 APY A02021-06-03T21:30:18Y 115011851150Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVńDďHrź¨DW˘D¬HsżPlacebo APlacebo ADVńDďDWD®`Y . . .Placebo Placebo DW!DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW˘DÉTD¬DWżDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBśBqBqCĐAŕHrź¨HrąĹŕHsm,ÔHsż .DWŚWHITE AC4591001C4591001 1150 11501185A0ADVERSE EVENT 2 Pain at injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-13T18:00Bť2021-05-14 Bž 1MedDRA v24.0NDWŤ ADý Hsm` DWŽA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A BÝ A Period 02DWŤDÉTHsm,ÔDYD¬HuiňVaccination 3 APY A02021-06-03T21:30:07Y 115011891150Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVóD…ÔHrˇâTDW¦DúHsŽSPlacebo APlacebo ADVóD…ÔDWDílY . . .Placebo Placebo DW)DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DłDúDWÄDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBšBmBqC°AđHrˇâTHr»VlHsr\HsŽS .DWWHITE AC4591001C4591001 1150 11501189AADVERSE EVENT 1 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-17T18:00Bź2021-05-18 B 1MedDRA v24.0NDW‘ ADý Hsr¦ DW’A ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CŔ A Period 02DW‘DłHsr\DYDúHuo†”Vaccination 3 APY A02021-06-08T02:21:15Y 115011891150Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVóD…ÔHrˇâTDW¦DúHsŽSPlacebo APlacebo ADVóD…ÔDWDílY . . .Placebo Placebo DW)DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DłDúDWÄDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBšBmBqC°AđHrˇâTHr»VlHsr\HsŽS .DWWHITE AC4591001C4591001 1150 11501189A ADVERSE EVENT 3 Pain at injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-17T18:00Bź2021-05-18 B 2MedDRA v24.0NDW‘ ADý Hsr¦ DW’A ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A CŔ A Period 02DW‘DłHsr\DYDúHuo†”Vaccination 3 APY A02021-06-08T02:21:37Y 115011891150Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVóD…ÔHrˇâTDW¦DúHsŽSPlacebo APlacebo ADVóD…ÔDWDílY . . .Placebo Placebo DW)DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DłDúDWÄDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBšBmBqC°AđHrˇâTHr»VlHsr\HsŽS .DWWHITE AC4591001C4591001 1150 11501189A0ADVERSE EVENT 2 Nausea Nausea FÜ›GASTROINTESTINAL DISORDERS Nausea F™ F™ Nausea and vomiting symptoms F™Gastrointestinal signs and symptoms FÜÜGastrointestinal disorders FÜ›2021-05-17T18:00Bź2021-05-18 B 1MedDRA v24.0NDW‘ ADý Hsr¦ DW’A ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CŔ A Period 02DW‘DłHsr\DYDúHuo†”Vaccination 3 APY A02021-06-08T02:21:26Y 115011901150Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVóD…\HrˇáÜDW¦DůŘHsŽRŘPlacebo APlacebo ADVóD…\DWDěôY . . .Placebo Placebo DW)DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦D˛ÔDůŘDWÄDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBšBmBqC°AĐHrˇáÜHr»UôHsr\THsŽRŘ .DWWHITE AC4591001C4591001 1150 11501190AADVERSE EVENT 2 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-18 B 2021-05-18 B 1MedDRA v24.0NDW’ A ..DW’A ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW‘D˛ÔHsr\TDYDůŘHuo†XVaccination 3 APY A02021-06-08T02:21:59Y 115011901150Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVóD…\HrˇáÜDW¦DůŘHsŽRŘPlacebo APlacebo ADVóD…\DWDěôY . . .Placebo Placebo DW)DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦D˛ÔDůŘDWÄDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBšBmBqC°AĐHrˇáÜHr»UôHsr\THsŽRŘ .DWWHITE AC4591001C4591001 1150 11501190A ADVERSE EVENT 1 Pain at injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-17T18:00Bź2021-05-18 B 1MedDRA v24.0NDW‘ ADý Hsr¦ DW’A ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CĐ A Period 02DW‘D˛ÔHsr\TDYDůŘHuo†XVaccination 3 APY A02021-06-08T02:21:49Y 115011931150Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVóDÓhHr˘/čDW Dv\Hs…ć\Placebo APlacebo ADVóDÓhDWD’|Y . . .Placebo Placebo DW(DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW DčDv\DW˝DX]BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBšBqBqC°AŕHr˘/čHr˝ž|HsmhHs…ć\ .DWŚWHITE AC4591001C4591001 1150 11501193AADVERSE EVENT 1 ADHD Attention deficit hyperactivity disorderF™'·PSYCHIATRIC DISORDERS ADHD F™čF™Ý&Attention deficit and disruptive behaviour disorders FĄCognitive and attention disorders and disturbances FĽńPsychiatric disorders F™'·2020-12 . .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDVóDA....... N NNOT RELATEDOTHER ADHD NOT APPLICABLE NNRECOVERING/RESOLVING N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVóDÓhHr˘/čDWŤDçHsmgVaccination 1 AY A2021-02-02T19:54:21 115012041150Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADV÷D†Hr§(DW¦DrśHsŤËśPlacebo APlacebo ADV÷D†DWD|tY . . .Placebo Placebo DW*DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DŘDrśDWĂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB–BmBqCpAŕHr§(HrÂÎtHsr:XHsŤËś .DWWHITE AC4591001C4591001 1150 11501204AADVERSE EVENT 1 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-17T19:00B›2021-05-18 Bś 1MedDRA v24.0NDW‘ AEłHsr´°DW’A ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C A Period 02DW‘DŘHsr:XDYDrśHun˙Vaccination 3 APY A02021-06-07T16:54:34Y 115012071150Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADV÷DňHr§”śDW¨DčHsäPlacebo APlacebo ADV÷DňDWDý\Y . . .Placebo Placebo DW(DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW¨Dq¬DčDWÄDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB–BlBqCpAŕHr§”śHrĂO\Hssl¬Hsä .DW‘WHITE AC4591001C4591001 1150 11501207AADVERSE EVENT 1 Pain at injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-18T18:00Bś2021-05-19 Bť 1MedDRA v24.0NDW’ ADý Hssř DW“A ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C%0 A Period 02DW’Dq¬Hssl¬DYDčHurVaccination 3 APY A02021-06-10T02:01:42Y 115012101150Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVřDŐHHr¨ÉHDWDÚ¬Hs—n,Placebo APlacebo ADVřDŐHDWDŁY . . .Placebo Placebo DW+DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDŐüDÚ¬DWĘDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB•BfBqC`AŔHr¨ÉHHrĆęHs{ąüHs—n, .DW—WHITE AC4591001C4591001 1150 11501210AADVERSE EVENT 4 Generalized joint Pain Arthralgia F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Generalized joint pain F™ŠfFŁ'Joint related signs and symptoms Fń:Joint disorders Fń-Musculoskeletal and connective tissue disorders F™k2021-06-14T18:00B¶2021-06-16 B¸ 1MedDRA v24.0NDW ADý Hs— DWŻA0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A B“ A Period 02DWDŐüHs{ąüDYDÚ¬Huxˇ¬Vaccination 4 A`Y A@2021-07-14T23:01:44Y 115012101150Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVřDŐHHr¨ÉHDWDÚ¬Hs—n,Placebo APlacebo ADVřDŐHDWDŁY . . .Placebo Placebo DW+DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDŐüDÚ¬DWĘDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB•BfBqC`AŔHr¨ÉHHrĆęHs{ąüHs—n, .DW—WHITE AC4591001C4591001 1150 11501210A ADVERSE EVENT 6 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-14T18:00B¶2021-06-16 B¸ 2MedDRA v24.0NDW ADý Hs— DWŻA0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A B“ A Period 02DWDŐüHs{ąüDYDÚ¬Huxˇ¬Vaccination 4 A`Y A@2021-07-13T13:55:34Y 115012101150Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVřDŐHHr¨ÉHDWDÚ¬Hs—n,Placebo APlacebo ADVřDŐHDWDŁY . . .Placebo Placebo DW+DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDŐüDÚ¬DWĘDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB•BfBqC`AŔHr¨ÉHHrĆęHs{ąüHs—n, .DW—WHITE AC4591001C4591001 1150 11501210A0ADVERSE EVENT 1 Pain at injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-24T18:00Bˇ2021-05-26 BŁ 2MedDRA v24.0NDW ADý Hs{á DWšA0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A B§ A Period 02DWDŐüHs{ąüDYDÚ¬Huxˇ¬Vaccination 3 APY A02021-06-14T21:59:54Y 115012101150Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVřDŐHHr¨ÉHDWDÚ¬Hs—n,Placebo APlacebo ADVřDŐHDWDŁY . . .Placebo Placebo DW+DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDŐüDÚ¬DWĘDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB•BfBqC`AŔHr¨ÉHHrĆęHs{ąüHs—n, .DW—WHITE AC4591001C4591001 1150 11501210A@ADVERSE EVENT 2 Pain at injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-14T18:00B¶2021-06-16 B¸ 2MedDRA v24.0NDW ADý Hs— DWŻA0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A B“ A Period 02DWDŐüHs{ąüDYDÚ¬Huxˇ¬Vaccination 4 A`Y A@2021-07-13T13:54:46Y 115012101150Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVřDŐHHr¨ÉHDWDÚ¬Hs—n,Placebo APlacebo ADVřDŐHDWDŁY . . .Placebo Placebo DW+DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDŐüDÚ¬DWĘDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB•BfBqC`AŔHr¨ÉHHrĆęHs{ąüHs—n, .DW—WHITE AC4591001C4591001 1150 11501210APADVERSE EVENT 3 Muscle Pain Myalgia F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Muscle pain F™"F™{Muscle pains F™#Muscle disorders F™Musculoskeletal and connective tissue disorders F™k2021-06-14T18:00B¶2021-06-16 B¸ 1MedDRA v24.0NDW ADý Hs— DWŻA0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A B“ A Period 02DWDŐüHs{ąüDYDÚ¬Huxˇ¬Vaccination 4 A`Y A@2021-07-13T13:54:59Y 115012101150Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVřDŐHHr¨ÉHDWDÚ¬Hs—n,Placebo APlacebo ADVřDŐHDWDŁY . . .Placebo Placebo DW+DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDŐüDÚ¬DWĘDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB•BfBqC`AŔHr¨ÉHHrĆęHs{ąüHs—n, .DW—WHITE AC4591001C4591001 1150 11501210A`ADVERSE EVENT 5 Fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-06-15 B·2021-06-15 B· 1MedDRA v24.0NDW® A ..DW®A ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWDŐüHs{ąüDYDÚ¬Huxˇ¬Vaccination 4 A`Y A@2021-07-13T13:55:22Y 115012121150Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVřDâ,Hr¨Ö,DWˇDâ,Hs‡Ł¬Placebo APlacebo ADVřDâ,DWDwÄY . . .Placebo Placebo DW+DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDWˇDŔlDâ,DWÂDX^BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB•BqBqC`AŔHr¨Ö,HrĆľDHsm#ěHs‡Ł¬ .DWŚWHITE AC4591001C4591001 1150 11501212AADVERSE EVENT 1 Pain at injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-13T18:00B–2021-05-14 B— 1MedDRA v24.0NDWŤ ADý Hsm` DWŽA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C0 A Period 02DWŤDŔlHsm#ěDYDâ,Huh×,Vaccination 3 APY A02021-06-02T23:29:54Y 115012141150Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVřD˙´Hr¨ó´DW©DůŘHs’GXPlacebo APlacebo ADVřD˙´DWDę`Y . . .Placebo Placebo DW1DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW©Dý DůŘDWËDXfBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB•BlBqC`AŔHr¨ó´HrÇ0ŕHssř Hs’GX .DW‘WHITE AC4591001C4591001 1150 11501214AADVERSE EVENT 2 Headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-06-11 Bł2021-06-12 B´ 1MedDRA v24.0NDWŞ A ..DW«A0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW’Dý Hssř DYDůŘHuszŘVaccination 4 A`Y A@2021-07-21T16:09:33Y 115012141150Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVřD˙´Hr¨ó´DW©DůŘHs’GXPlacebo APlacebo ADVřD˙´DWDę`Y . . .Placebo Placebo DW1DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW©Dý DůŘDWËDXfBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB•BlBqC`AŔHr¨ó´HrÇ0ŕHssř Hs’GX .DW‘WHITE AC4591001C4591001 1150 11501214A ADVERSE EVENT 1 Injection Site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-19 Bś2021-05-21 Bž 1MedDRA v24.0NDW“ A ..DW•A@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW’Dý Hssř DYDůŘHuszŘVaccination 3 APY A02021-06-11T19:50:05Y 115012151150Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVřD˙xHr¨óxDW©DúHs’G”Placebo APlacebo ADVřD˙xDWDę$Y . . .Placebo Placebo DW1DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW©Dý\DúDWËDXfBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB•BlBqC`AŕHr¨óxHrÇ0¤Hssř\Hs’G” .DW‘WHITE AC4591001C4591001 1150 11501215AADVERSE EVENT 1 Injection Site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-19 Bś2021-05-20 Bť 1MedDRA v24.0NDW“ A ..DW”A0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW’Dý\Hssř\DYDúHus{Vaccination 3 APY A02021-06-11T19:50:16Y 115012181150Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVúD†ÄHr«ÄDW§D¤HsŹ3$Placebo APlacebo ADVúD†ÄDWDŢäY . . .Placebo Placebo DW*DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW§DÁ\D¤DWĂDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB“BmBqC@AđHr«ÄHrĹÓäHsrjÜHsŹ3$ .DWWHITE AC4591001C4591001 1150 11501218AADVERSE EVENT 2 Headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-06-09 BŻ2021-06-09 BŻ 1MedDRA v24.0NDW¨ A ..DW¨A ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW‘DÁ\HsrjÜDYD¤Hupf¤Vaccination 4 A`Y A@2021-07-08T22:44:37Y 115012181150Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVúD†ÄHr«ÄDW§D¤HsŹ3$Placebo APlacebo ADVúD†ÄDWDŢäY . . .Placebo Placebo DW*DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW§DÁ\D¤DWĂDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB“BmBqC@AđHr«ÄHrĹÓäHsrjÜHsŹ3$ .DWWHITE AC4591001C4591001 1150 11501218A ADVERSE EVENT 1 Injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-18 B™2021-05-19 Bš 2MedDRA v24.0NDW’ A ..DW“A0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED WITH SEQUELAEN ARELATED AA GRADE 2A . A Period 02DW‘DÁ\HsrjÜDYD¤Hupf¤Vaccination 3 APY A02021-06-08T21:15:11Y 115012221150Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVúDË4Hr«b4DW DťHs† Placebo APlacebo ADVúDË4DWDÎ@Y . . .Placebo Placebo DW*DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW DżôDťDWĽDX]BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB“BqBqC@AŕHr«b4HrĹĂ@Hsm#tHs† .DWŚWHITE AC4591001C4591001 1150 11501222AADVERSE EVENT 1 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-02 B¨2021-06-03 B© 1MedDRA v24.0NDWˇ A ..DW˘A0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŤDżôHsm#tDY DťHug@Vaccination 4 A`Y A@2021-06-29T14:39:45Y 115012221150Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVúDË4Hr«b4DW DťHs† Placebo APlacebo ADVúDË4DWDÎ@Y . . .Placebo Placebo DW*DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW DżôDťDWĽDX]BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB“BqBqC@AŕHr«b4HrĹĂ@Hsm#tHs† .DWŚWHITE AC4591001C4591001 1150 11501222A ADVERSE EVENT 2 Headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-06-02 B¨2021-06-03 B© 1MedDRA v24.0NDWˇ A ..DW˘A0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŤDżôHsm#tDY DťHug@Vaccination 4 A`Y A@2021-06-29T14:39:56Y 115012221150Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVúDË4Hr«b4DW DťHs† Placebo APlacebo ADVúDË4DWDÎ@Y . . .Placebo Placebo DW*DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW DżôDťDWĽDX]BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB“BqBqC@AŕHr«b4HrĹĂ@Hsm#tHs† .DWŚWHITE AC4591001C4591001 1150 11501222A0ADVERSE EVENT 3 Pain at injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-01T18:00B§2021-06-03 B© 1MedDRA v24.0NDW ADý Hs†m DW˘A0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C A Period 02DWŤDżôHsm#tDY DťHug@Vaccination 4 A`Y A@2021-06-29T14:40:07Y 115012241150Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVúDđ´Hr«‡´DW¦DÝ|HsŽ6|Placebo APlacebo ADVúDđ´DWDÝ|Y . . .Placebo Placebo DW3DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW¦D|8DÝ|DWÂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB“BlBqC@AŔHr«‡´HrČu|Hssw8HsŽ6| .DW‘WHITE AC4591001C4591001 1150 11501224AADVERSE EVENT 3 Chills Chills FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills F·ÓF·ÓFeelings and sensations NEC F™ŁGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-07T20:00B2021-06-08 B® 1MedDRA v24.0NDW¦ AE”HsŽr@DW§A ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A B˙ A Period 02DW’D|8Hssw8DYDÝ|HuoiüVaccination 4 A`Y A@2021-07-05T17:59:48Y 115012241150Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVúDđ´Hr«‡´DW¦DÝ|HsŽ6|Placebo APlacebo ADVúDđ´DWDÝ|Y . . .Placebo Placebo DW3DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW¦D|8DÝ|DWÂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB“BlBqC@AŔHr«‡´HrČu|Hssw8HsŽ6| .DW‘WHITE AC4591001C4591001 1150 11501224A ADVERSE EVENT 2 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-07T20:00B2021-06-08 B® 1MedDRA v24.0NDW¦ AE”HsŽr@DW§A ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A B˙ A Period 02DW’D|8Hssw8DYDÝ|HuoiüVaccination 4 A`Y A@2021-07-05T17:59:37Y 115012241150Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVúDđ´Hr«‡´DW¦DÝ|HsŽ6|Placebo APlacebo ADVúDđ´DWDÝ|Y . . .Placebo Placebo DW3DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW¦D|8DÝ|DWÂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB“BlBqC@AŔHr«‡´HrČu|Hssw8HsŽ6| .DW‘WHITE AC4591001C4591001 1150 11501224A0ADVERSE EVENT 1 Pain at injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-18T18:00B™2021-05-20 B› 1MedDRA v24.0NDW’ ADý Hssř DW”A0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C"` A Period 02DW’D|8Hssw8DYDÝ|HuoiüVaccination 3 APY A02021-06-08T00:02:41Y 115012291150Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVýD‡HrŻ€DWˇDňĐHs‡´PPlacebo APlacebo ADVýD‡DWDťDY . . .Placebo Placebo DW1DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWˇDĆ„DňĐDWľDX^BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBBpBqCAŕHrŻ€HrÍ{DHsn{„Hs‡´P .DWŤWHITE AC4591001C4591001 1150 11501229AADVERSE EVENT 8 Chills Chills FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills F·ÓF·ÓFeelings and sensations NEC F™ŁGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-02T18:00BĄ2021-06-03 B¦ 2MedDRA v24.0NDWˇ ADý Hs‡ľ DW˘A ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A B, A Period 02DWŽDĆ„Hsn{„DYDňĐHuhçĐVaccination 4 A`Y A@2021-07-01T22:33:26Y 115012291150Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVýD‡HrŻ€DWˇDňĐHs‡´PPlacebo APlacebo ADVýD‡DWDťDY . . .Placebo Placebo DW1DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWˇDĆ„DňĐDWľDX^BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBBpBqCAŕHrŻ€HrÍ{DHsn{„Hs‡´P .DWŤWHITE AC4591001C4591001 1150 11501229A ADVERSE EVENT 3 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-14T18:00B’2021-05-15 B“ 2MedDRA v24.0NDWŽ ADý Hsn˛ DWŹA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A Bé A Period 02DWŽDĆ„Hsn{„DYDňĐHuhçĐVaccination 3 APY A02021-06-02T23:30:27Y 115012291150Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVýD‡HrŻ€DWˇDňĐHs‡´PPlacebo APlacebo ADVýD‡DWDťDY . . .Placebo Placebo DW1DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWˇDĆ„DňĐDWľDX^BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBBpBqCAŕHrŻ€HrÍ{DHsn{„Hs‡´P .DWŤWHITE AC4591001C4591001 1150 11501229A0ADVERSE EVENT 5 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-02T18:00BĄ2021-06-04 B§ 2MedDRA v24.0NDWˇ ADý Hs‡ľ DWŁA0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A B, A Period 02DWŽDĆ„Hsn{„DYDňĐHuhçĐVaccination 4 A`Y A@2021-07-01T22:32:51Y 115012291150Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVýD‡HrŻ€DWˇDňĐHs‡´PPlacebo APlacebo ADVýD‡DWDťDY . . .Placebo Placebo DW1DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWˇDĆ„DňĐDWľDX^BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBBpBqCAŕHrŻ€HrÍ{DHsn{„Hs‡´P .DWŤWHITE AC4591001C4591001 1150 11501229A@ADVERSE EVENT 10Hand, foot and mouth disease Hand-foot-and-mouth disease FëůINFECTIONS AND INFESTATIONS Hand, foot and mouth disease Fá4Fá)Coxsackie viral infections FÂ~Viral infectious disorders F™OÎInfections and infestations Fëů2021-06-10 B2021-06-17 B´ 2MedDRA v24.0NDW© A..DW°B..A€DAYSN NNOT RELATEDOTHER viral illness NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . A Period 02DWŽDĆ„Hsn{„DYDňĐHuhçĐVaccination 4 A`Y A@2021-07-01T22:33:50Y 115012291150Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVýD‡HrŻ€DWˇDňĐHs‡´PPlacebo APlacebo ADVýD‡DWDťDY . . .Placebo Placebo DW1DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWˇDĆ„DňĐDWľDX^BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBBpBqCAŕHrŻ€HrÍ{DHsn{„Hs‡´P .DWŤWHITE AC4591001C4591001 1150 11501229APADVERSE EVENT 6 Headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-06-02T18:00BĄ2021-06-04 B§ 2MedDRA v24.0NDWˇ ADý Hs‡ľ DWŁA0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A B, A Period 02DWŽDĆ„Hsn{„DYDňĐHuhçĐVaccination 4 A`Y A@2021-07-01T22:33:02Y 115012291150Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVýD‡HrŻ€DWˇDňĐHs‡´PPlacebo APlacebo ADVýD‡DWDťDY . . .Placebo Placebo DW1DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWˇDĆ„DňĐDWľDX^BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBBpBqCAŕHrŻ€HrÍ{DHsn{„Hs‡´P .DWŤWHITE AC4591001C4591001 1150 11501229A`ADVERSE EVENT 9 Redness at injection site Injection site erythema FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site redness FěŇFěInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-02T18:00BĄ2021-06-04 B§ 2MedDRA v24.0NDWˇ ADý Hs‡ľ DWŁA0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A B, A Period 02DWŽDĆ„Hsn{„DYDňĐHuhçĐVaccination 4 A`Y A@2021-07-01T22:33:38Y 115012291150Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVýD‡HrŻ€DWˇDňĐHs‡´PPlacebo APlacebo ADVýD‡DWDťDY . . .Placebo Placebo DW1DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWˇDĆ„DňĐDWľDX^BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBBpBqCAŕHrŻ€HrÍ{DHsn{„Hs‡´P .DWŤWHITE AC4591001C4591001 1150 11501229ApADVERSE EVENT 2 Pain at injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-14T18:00B’2021-05-16 B” 2MedDRA v24.0NDWŽ ADý Hsn˛ DWA0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A Bé A Period 02DWŽDĆ„Hsn{„DYDňĐHuhçĐVaccination 3 APY A02021-06-02T23:30:16Y 115012291150Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVýD‡HrŻ€DWˇDňĐHs‡´PPlacebo APlacebo ADVýD‡DWDťDY . . .Placebo Placebo DW1DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWˇDĆ„DňĐDWľDX^BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBBpBqCAŕHrŻ€HrÍ{DHsn{„Hs‡´P .DWŤWHITE AC4591001C4591001 1150 11501229A€ADVERSE EVENT 4 Pain at injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-02T18:00BĄ2021-06-04 B§ 2MedDRA v24.0NDWˇ ADý Hs‡ľ DWŁA0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A B, A Period 02DWŽDĆ„Hsn{„DYDňĐHuhçĐVaccination 4 A`Y A@2021-07-01T22:32:40Y 115012291150Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVýD‡HrŻ€DWˇDňĐHs‡´PPlacebo APlacebo ADVýD‡DWDťDY . . .Placebo Placebo DW1DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWˇDĆ„DňĐDWľDX^BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBBpBqCAŕHrŻ€HrÍ{DHsn{„Hs‡´P .DWŤWHITE AC4591001C4591001 1150 11501229AADVERSE EVENT 1 Fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-05-14T18:00B’2021-05-15 B“ 1MedDRA v24.0NDWŽ ADý Hsn˛ DWŹA ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Bé A Period 02DWŽDĆ„Hsn{„DYDňĐHuhçĐVaccination 3 APY A02021-06-02T23:30:05Y 115012291150Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVýD‡HrŻ€DWˇDňĐHs‡´PPlacebo APlacebo ADVýD‡DWDťDY . . .Placebo Placebo DW1DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWˇDĆ„DňĐDWľDX^BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBBpBqCAŕHrŻ€HrÍ{DHsn{„Hs‡´P .DWŤWHITE AC4591001C4591001 1150 11501229A ADVERSE EVENT 7 Fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-06-02T18:00BĄ2021-06-03 B¦ 2MedDRA v24.0NDWˇ ADý Hs‡ľ DW˘A ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A B, A Period 02DWŽDĆ„Hsn{„DYDňĐHuhçĐVaccination 4 A`Y A@2021-07-01T22:33:14Y 115012311150Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DVýD˝$HrŻH¤DW¦DŽ€HsŤç€Placebo APlacebo ADVýD˝$DWDÚ¬Y . . .Placebo Placebo DW2DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦Dx´DŽ€DWÂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBBmBqCAŕHrŻH¤HrÍ¸¬Hsr"4HsŤç€ .DWALL OTHERS A0C4591001C4591001 1150 11501231AADVERSE EVENT 4 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-17T18:00B•2021-05-18 B– 1MedDRA v24.0NDW‘ ADý Hsr¦ DW’A ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C#P A Period 02DW‘Dx´Hsr"4DYDŽ€HuoVaccination 3 APY A02021-06-07T16:56:22Y 115012311150Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DVýD˝$HrŻH¤DW¦DŽ€HsŤç€Placebo APlacebo ADVýD˝$DWDÚ¬Y . . .Placebo Placebo DW2DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦Dx´DŽ€DWÂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBBmBqCAŕHrŻH¤HrÍ¸¬Hsr"4HsŤç€ .DWALL OTHERS A0C4591001C4591001 1150 11501231A ADVERSE EVENT 1 Pain at injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-17T18:00B•2021-05-18 B– 1MedDRA v24.0NDW‘ ADý Hsr¦ DW’A ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C#P A Period 02DW‘Dx´Hsr"4DYDŽ€HuoVaccination 3 APY A02021-06-07T16:55:50Y 115012311150Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DVýD˝$HrŻH¤DW¦DŽ€HsŤç€Placebo APlacebo ADVýD˝$DWDÚ¬Y . . .Placebo Placebo DW2DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦Dx´DŽ€DWÂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBBmBqCAŕHrŻH¤HrÍ¸¬Hsr"4HsŤç€ .DWALL OTHERS A0C4591001C4591001 1150 11501231A0ADVERSE EVENT 3 Body Aches Pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalized aching F™Š\F™ŰPain and discomfort NEC F™ÜGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-17T18:00B•2021-05-18 B– 1MedDRA v24.0NDW‘ ADý Hsr¦ DW’A ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C#P A Period 02DW‘Dx´Hsr"4DYDŽ€HuoVaccination 3 APY A02021-06-07T16:56:11Y 115012311150Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DVýD˝$HrŻH¤DW¦DŽ€HsŤç€Placebo APlacebo ADVýD˝$DWDÚ¬Y . . .Placebo Placebo DW2DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦Dx´DŽ€DWÂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBBmBqCAŕHrŻH¤HrÍ¸¬Hsr"4HsŤç€ .DWALL OTHERS A0C4591001C4591001 1150 11501231A@ADVERSE EVENT 2 Fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-05-17T18:00B•2021-05-17 B• 1MedDRA v24.0NDW‘ ADý Hsr¦ DW‘A..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C#P A Period 02DW‘Dx´Hsr"4DYDŽ€HuoVaccination 3 APY A02021-06-07T16:56:00Y 115012321150Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVţD‚PHr°_PDW¦D$HsŤÚ$Placebo APlacebo ADVţD‚PDWDwLY . . .Placebo Placebo DW/DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW¦D—¤D$DWÂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBŹBlBqCAŕHr°_PHrĚĚHss’¤HsŤÚ$ .DW‘WHITE AC4591001C4591001 1150 11501232AADVERSE EVENT 1 Chills Chills FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills F·ÓF·ÓFeelings and sensations NEC F™ŁGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-19 B–2021-05-19 B– 1MedDRA v24.0NDW“ A ..DW“A ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW’D—¤Hss’¤DYD$Huo ¤Vaccination 3 APY A02021-06-07T18:38:44Y 115012321150Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVţD‚PHr°_PDW¦D$HsŤÚ$Placebo APlacebo ADVţD‚PDWDwLY . . .Placebo Placebo DW/DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW¦D—¤D$DWÂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBŹBlBqCAŕHr°_PHrĚĚHss’¤HsŤÚ$ .DW‘WHITE AC4591001C4591001 1150 11501232A ADVERSE EVENT 2 Fever (101.0) Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-06-08 BŞ2021-06-08 BŞ 1MedDRA v24.0NDW§ A ..DW§A ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW’D—¤Hss’¤DYD$Huo ¤Vaccination 4 A`Y A@2021-07-05T18:25:48Y 115012351150Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVţD±0Hr°Ž0DW¦DĄ´HsŤţ´Placebo APlacebo ADVţD±0DWDěY . . .Placebo Placebo DW6DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW¦Dß DĄ´DWÂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBŹBlBqCAđHr°Ž0HrĚx„HssÚ HsŤţ´ .DW‘WHITE AC4591001C4591001 1150 11501235AADVERSE EVENT 1 Injection Site Pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-08 BŞ2021-06-09 B« 2MedDRA v24.0NDW§ A ..DW¨A0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DW’Dß HssÚ DYDĄ´Huo24Vaccination 4 A`Y A@2021-07-05T20:17:28Y 115012421150Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWD¬Hrł,DWgD¤Hs:ďPlacebo APlacebo ADWD¬DWD™üY . . .Placebo Placebo DW3DWDYPhase 3A@NNEGDWE BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWMDWgDÎD¤DWDX$BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWDDWýBEB±BąBţAđHrł,HrŃl|HsŃ„Hs:ď .DWLWHITE AC4591001C4591001 1150 11501242AADVERSE EVENT 2 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-03-11 BO2021-03-12 BP 1MedDRA v24.0NDWN A ..DWOA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWMDÎHsŃ„DXÔD¤Hu"Vaccination 3 APY A02021-04-07T23:59:05Y 115012421150Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWD¬Hrł,DWgD¤Hs:ďPlacebo APlacebo ADWD¬DWD™üY . . .Placebo Placebo DW3DWDYPhase 3A@NNEGDWE BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWMDWgDÎD¤DWDX$BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWDDWýBEB±BąBţAđHrł,HrŃl|HsŃ„Hs:ď .DWLWHITE AC4591001C4591001 1150 11501242A ADVERSE EVENT 3 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-04-06 Bi2021-04-07 Bj 1MedDRA v24.0NDWh A ..DWiA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWMDÎHsŃ„DXÔD¤Hu"Vaccination 4 A`Y A@2021-05-04T23:09:49Y 115012421150Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWD¬Hrł,DWgD¤Hs:ďPlacebo APlacebo ADWD¬DWD™üY . . .Placebo Placebo DW3DWDYPhase 3A@NNEGDWE BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWMDWgDÎD¤DWDX$BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWDDWýBEB±BąBţAđHrł,HrŃl|HsŃ„Hs:ď .DWLWHITE AC4591001C4591001 1150 11501242A0ADVERSE EVENT 4 Injection Site Pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-04-06 Bi2021-04-07 Bj 1MedDRA v24.0NDWh A ..DWiA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWMDÎHsŃ„DXÔD¤Hu"Vaccination 4 A`Y A@2021-05-04T23:09:39Y 115012431150Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDÎ@HrłN@DW˘DŇxHsĺxPlacebo APlacebo ADWDÎ@DWDépY . . .Placebo Placebo DW3DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDW˘DxDŇxDWľDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBŤBpBqBţAŔHrłN@HrĚuđHsn-Hsĺx .DWŤWHITE AC4591001C4591001 1150 11501243AADVERSE EVENT 2 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-15 B2021-05-16 B‘ 1MedDRA v24.0NDWŹ A ..DWA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŽDxHsn-DYDŇxHujřVaccination 3 APY A02021-06-04T16:56:44Y 115012431150Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDÎ@HrłN@DW˘DŇxHsĺxPlacebo APlacebo ADWDÎ@DWDépY . . .Placebo Placebo DW3DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDW˘DxDŇxDWľDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBŤBpBqBţAŔHrłN@HrĚuđHsn-Hsĺx .DWŤWHITE AC4591001C4591001 1150 11501243A ADVERSE EVENT 1 Injection Site Pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-15 B2021-05-16 B‘ 1MedDRA v24.0NDWŹ A ..DWA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŽDxHsn-DYDŇxHujřVaccination 3 APY A02021-06-04T16:56:34Y 115012431150Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDÎ@HrłN@DW˘DŇxHsĺxPlacebo APlacebo ADWDÎ@DWDépY . . .Placebo Placebo DW3DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDW˘DxDŇxDWľDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBŤBpBqBţAŔHrłN@HrĚuđHsn-Hsĺx .DWŤWHITE AC4591001C4591001 1150 11501243A0ADVERSE EVENT 3 Injection Site Pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-04 B¤2021-06-05 BĄ 1MedDRA v24.0NDWŁ A ..DW¤A0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŽDxHsn-DYDŇxHujřVaccination 4 A`Y A@2021-07-01T21:21:09Y 115012481150Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDˇ@Hr» @DW¨DÎ|HsĘ|Placebo APlacebo ADWDˇ@DWDëČY . . .Placebo Placebo DW7DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DW¨DäŔDÎ|DWÄDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB‡BkBqBřAĐHr» @Hr×HHsu1@HsĘ| .DW’WHITE AC4591001C4591001 1150 11501248AADVERSE EVENT 3 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-20 BŹ2021-05-21 B 1MedDRA v24.0NDW” A ..DW•A0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW“DäŔHsu1@DYDÎ|HuqýüVaccination 3 APY A02021-06-10T02:02:37Y 115012481150Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDˇ@Hr» @DW¨DÎ|HsĘ|Placebo APlacebo ADWDˇ@DWDëČY . . .Placebo Placebo DW7DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DW¨DäŔDÎ|DWÄDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB‡BkBqBřAĐHr» @Hr×HHsu1@HsĘ| .DW’WHITE AC4591001C4591001 1150 11501248A ADVERSE EVENT 2 Pain at injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-19T18:00BŽ2021-05-21 B 1MedDRA v24.0NDW“ ADý HsuI DW•A0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Bh A Period 02DW“DäŔHsu1@DYDÎ|HuqýüVaccination 3 APY A02021-06-10T02:02:26Y 115012481150Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDˇ@Hr» @DW¨DÎ|HsĘ|Placebo APlacebo ADWDˇ@DWDëČY . . .Placebo Placebo DW7DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DW¨DäŔDÎ|DWÄDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB‡BkBqBřAĐHr» @Hr×HHsu1@HsĘ| .DW’WHITE AC4591001C4591001 1150 11501248A0ADVERSE EVENT 1 Broken Left Tibia Tibia fracture FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Tibia fracture F™AłF™AłLimb fractures and dislocations F™ľîBone and joint injuries F¶Injury, poisoning and procedural complications Fěĺ2021-04-07 Bd .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDWi BO....... N NNOT RELATEDOTHER sports injury NOT APPLICABLE NNRECOVERING/RESOLVING N A0NOT RELATEDA0A GRADE 2A . APeriod 01DWDˇ@Hr» @DW“DäżHsu1?Follow Up 1 A0Y A 2021-05-24T16:39:08Y 115012491150Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDÇ8Hr»08DWŁDé4HsŠM´Placebo APlacebo ADWDÇ8DWDęŘY . . .Placebo Placebo DW7DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁDÔĐDé4DWĂDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB‡BpBqBřAđHr»08Hr×XHsn‰ĐHsŠM´ .DWŤWHITE AC4591001C4591001 1150 11501249AADVERSE EVENT 1 Injection Site Pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-05 Bź2021-06-06 B 2MedDRA v24.0NDW¤ A ..DWĄA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWŽDÔĐHsn‰ĐDYDé4Huk4Vaccination 4 A`Y A@2021-07-06T21:31:02Y 115012491150Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDÇ8Hr»08DWŁDé4HsŠM´Placebo APlacebo ADWDÇ8DWDęŘY . . .Placebo Placebo DW7DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWŁDÔĐDé4DWĂDX`BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB‡BpBqBřAđHr»08Hr×XHsn‰ĐHsŠM´ .DWŤWHITE AC4591001C4591001 1150 11501249A ADVERSE EVENT 2 Fever (100.7) Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-06-05 Bź2021-06-06 B 1MedDRA v24.0NDW¤ A ..DWĄA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŽDÔĐHsn‰ĐDYDé4Huk4Vaccination 4 A`Y A@2021-07-06T21:31:13Y 115012571150Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDÂÄHrĽ}DDWˇD‘Hs‡R”Placebo APlacebo ADWDÂÄDWDz”Y . . .Placebo Placebo DW6DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWˇD’ôD‘DW˝DX^BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB†BpBqB÷AđHrĽ}DHrŐA”HsnGôHs‡R” .DWŤWHITE AC4591001C4591001 1150 11501257AADVERSE EVENT 1 Injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-15 B‰2021-05-16 BŠ 1MedDRA v24.0NDWŹ A ..DWA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŽD’ôHsnGôDYD‘Huh†Vaccination 3 APY A02021-06-02T17:38:35Y 115012611150Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWD•Hr˝ˇDW˘D”Hs§Placebo APlacebo ADWD•DWDđ´Y . . .Placebo Placebo DW9DWŚYPhase 3A@NPOSDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDW˘DńŕD”DWÂDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB…BpBqBöAĐHr˝ˇHrŘZ´Hsn¦ŕHs§ .DWŤWHITE AC4591001C4591001 1150 11501261AADVERSE EVENT 1 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-04 Bś2021-06-04 Bś 2MedDRA v24.0NDWŁ A ..DWŁA ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DWŽDńŕHsn¦ŕDYD”HuiŰVaccination 4 A`Y A@2021-07-05T19:48:29Y 115012611150Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWD•Hr˝ˇDW˘D”Hs§Placebo APlacebo ADWD•DWDđ´Y . . .Placebo Placebo DW9DWŚYPhase 3A@NPOSDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDW˘DńŕD”DWÂDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB…BpBqBöAĐHr˝ˇHrŘZ´Hsn¦ŕHs§ .DWŤWHITE AC4591001C4591001 1150 11501261A ADVERSE EVENT 2 Headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-06-04 Bś2021-06-04 Bś 1MedDRA v24.0NDWŁ A ..DWŁA ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŽDńŕHsn¦ŕDYD”HuiŰVaccination 4 A`Y A@2021-07-05T19:48:40Y 115012631150Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWD$HrÂÓ$DWŞD@Hs“"@Placebo APlacebo ADWD$DW"D±äY . . .Placebo Placebo DW?DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DWŞDßD@DWĆDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBBkBqBňAŔHrÂÓ$HrŕäHsu,Hs“"@ .DW’WHITE AC4591001C4591001 1150 11501263AADVERSE EVENT 2 Headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-05-20 B‰2021-05-21 BŠ 1MedDRA v24.0NDW” A ..DW•A0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW“DßHsu,DYD@HutUŔVaccination 3 APY A02021-06-11T22:13:40Y 115012631150Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWD$HrÂÓ$DWŞD@Hs“"@Placebo APlacebo ADWD$DW"D±äY . . .Placebo Placebo DW?DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DWŞDßD@DWĆDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBBkBqBňAŔHrÂÓ$HrŕäHsu,Hs“"@ .DW’WHITE AC4591001C4591001 1150 11501263A ADVERSE EVENT 1 Injection Site Pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-20 B‰2021-05-21 BŠ 1MedDRA v24.0NDW” A ..DW•A0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW“DßHsu,DYD@HutUŔVaccination 3 APY A02021-06-11T22:13:29Y 115012631150Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWD$HrÂÓ$DWŞD@Hs“"@Placebo APlacebo ADWD$DW"D±äY . . .Placebo Placebo DW?DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DWŞDßD@DWĆDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBBkBqBňAŔHrÂÓ$HrŕäHsu,Hs“"@ .DW’WHITE AC4591001C4591001 1150 11501263A0ADVERSE EVENT 3 Injection Site Pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-12 B 2021-06-13 Bˇ 2MedDRA v24.0NDW« A ..DW¬A0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DW“DßHsu,DYD@HutUŔVaccination 4 A`Y A@2021-07-21T14:38:21Y 115012711150Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADW DĽHrÄ#<DWˇDÝHs‡ž„Placebo APlacebo ADW DĽDW!DzĐY . . .Placebo Placebo DW>DWŚYPhase 3A@NPOSDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWˇDäDÝDWżDX^BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB€BpBqBńAŔHrÄ#<HrŢ|PHsn™Hs‡ž„ .DWŤWHITE AC4591001C4591001 1150 11501271AADVERSE EVENT 2 Chills Chills FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills F·ÓF·ÓFeelings and sensations NEC F™ŁGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-15 B2021-05-16 B„ 1MedDRA v24.0NDWŹ A ..DWA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŽDäHsn™DYDÝHuhŇVaccination 3 APY A02021-06-02T23:30:49Y 115012711150Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADW DĽHrÄ#<DWˇDÝHs‡ž„Placebo APlacebo ADW DĽDW!DzĐY . . .Placebo Placebo DW>DWŚYPhase 3A@NPOSDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWˇDäDÝDWżDX^BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB€BpBqBńAŔHrÄ#<HrŢ|PHsn™Hs‡ž„ .DWŤWHITE AC4591001C4591001 1150 11501271A ADVERSE EVENT 1 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-15 B2021-05-16 B„ 1MedDRA v24.0NDWŹ A ..DWA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŽDäHsn™DYDÝHuhŇVaccination 3 APY A02021-06-02T23:30:38Y 115012711150Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADW DĽHrÄ#<DWˇDÝHs‡ž„Placebo APlacebo ADW DĽDW!DzĐY . . .Placebo Placebo DW>DWŚYPhase 3A@NPOSDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWˇDäDÝDWżDX^BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB€BpBqBńAŔHrÄ#<HrŢ|PHsn™Hs‡ž„ .DWŤWHITE AC4591001C4591001 1150 11501271A0ADVERSE EVENT 3 Muscle Pain Myalgia F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Muscle pain F™"F™{Muscle pains F™#Muscle disorders F™Musculoskeletal and connective tissue disorders F™k2021-06-03 B–2021-06-04 B— 1MedDRA v24.0NDW˘ A ..DWŁA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŽDäHsn™DYDÝHuhŇVaccination 4 A`Y A@2021-07-07T12:08:27Y 115012721150Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADW DDHrÄ"ÄDWˇDÝHs‡ž„Placebo APlacebo ADW DDDW!D{Y . . .Placebo Placebo DW>DWŚYPhase 3A@NPOSDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDWˇDăĐDÝDWżDX^BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB€BpBqBńAŕHrÄ"ÄHrŢ|ŚHsnĐHs‡ž„ .DWŤWHITE AC4591001C4591001 1150 11501272AADVERSE EVENT 1 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-15 B2021-05-15 B 1MedDRA v24.0NDWŹ A ..DWŹA ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŽDăĐHsnĐDYDÝHuhŇVaccination 3 APY A02021-06-02T23:31:20Y 115012801150Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDťĽHrĹ’ĽDW©DëHs’8”Placebo APlacebo ADWDťĽDW$Dě|Y . . .Placebo Placebo DWEDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DW©DŔäDëDWĹDXfBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBBkBqBđAŕHrĹ’ĽHrââ|Hsu dHs’8” .DW’WHITE AC4591001C4591001 1150 11501280AADVERSE EVENT 2 Headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-05-20 B‡2021-05-20 B‡ 2MedDRA v24.0NDW” A ..DW”A ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DW“DŔäHsu dDYDëHuslVaccination 3 APY A02021-06-11T03:18:06Y 115012801150Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDťĽHrĹ’ĽDW©DëHs’8”Placebo APlacebo ADWDťĽDW$Dě|Y . . .Placebo Placebo DWEDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DW©DŔäDëDWĹDXfBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBBkBqBđAŕHrĹ’ĽHrââ|Hsu dHs’8” .DW’WHITE AC4591001C4591001 1150 11501280A ADVERSE EVENT 1 Pain at injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-19T18:00B†2021-05-20 B‡ 1MedDRA v24.0NDW“ ADý HsuI DW”A ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C A Period 02DW“DŔäHsu dDYDëHuslVaccination 3 APY A02021-06-11T03:17:52Y 115012801150Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDťĽHrĹ’ĽDW©DëHs’8”Placebo APlacebo ADWDťĽDW$Dě|Y . . .Placebo Placebo DWEDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DW©DŔäDëDWĹDXfBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBBkBqBđAŕHrĹ’ĽHrââ|Hsu dHs’8” .DW’WHITE AC4591001C4591001 1150 11501280A0ADVERSE EVENT 3 Muscle Aches Myalgia F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Muscle ache F™˙F™{Muscle pains F™#Muscle disorders F™Musculoskeletal and connective tissue disorders F™k2021-06-11 Bť2021-06-11 Bť 1MedDRA v24.0NDWŞ A ..DWŞA ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW“DŔäHsu dDYDëHuslVaccination 4 A`Y A@2021-07-08T22:44:59Y 115012821150Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDÜPHrĹŃPDW¨DzHsvPlacebo APlacebo ADWDÜPDW$DđđY . . .Placebo Placebo DWADWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¨D¤ÄDzDWÄDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBBmBqBđAŕHrĹŃPHrâćđHsrNDHsv .DWWHITE AC4591001C4591001 1150 11501282AADVERSE EVENT 1 Pain at injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-17T17:00B„2021-05-19 B† 1MedDRA v24.0NDW‘ ADďHsrDW“A0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CĐ A Period 02DW‘D¤ÄHsrNDDYDzHuq©śVaccination 3 APY A02021-06-10T02:02:48Y 115012821150Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDÜPHrĹŃPDW¨DzHsvPlacebo APlacebo ADWDÜPDW$DđđY . . .Placebo Placebo DWADWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¨D¤ÄDzDWÄDXeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBBmBqBđAŕHrĹŃPHrâćđHsrNDHsv .DWWHITE AC4591001C4591001 1150 11501282A ADVERSE EVENT 2 Ringworm Tinea infection FëůINFECTIONS AND INFESTATIONS Ringworm NOS F™/F™„YTinea infections F™AŢFungal infectious disorders FÚřInfections and infestations Fëů2021-06-07 B™ .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDW¦ B....... N NNOT RELATEDOTHER skin irritation NOT APPLICABLE NNRECOVERING/RESOLVING N A0NOT RELATEDA0AGRADE 1A . A Period 02DW‘D¤ÄHsrNDDYDzHuq©śVaccination 3 APY A02021-06-10T13:43:34Y 115012841150Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDťřHrĆäxDW¦Dż|HsŽ|Placebo APlacebo ADWDťřDW#D{Y . . .Placebo Placebo DW@DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DŹčDż|DWÄDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB~BmBqBďAŕHrĆäxHráŚHsr9hHsŽ| .DWWHITE AC4591001C4591001 1150 11501284AADVERSE EVENT 2 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-17T18:00B2021-05-19 B… 2MedDRA v24.0NDW‘ ADý Hsr¦ DW“A0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C A Period 02DW‘DŹčHsr9hDYDż|HuoKüVaccination 3 APY A02021-06-07T20:56:33Y 115012841150Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDťřHrĆäxDW¦Dż|HsŽ|Placebo APlacebo ADWDťřDW#D{Y . . .Placebo Placebo DW@DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DŹčDż|DWÄDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB~BmBqBďAŕHrĆäxHráŚHsr9hHsŽ| .DWWHITE AC4591001C4591001 1150 11501284A ADVERSE EVENT 5 Headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-05-17T18:00B2021-05-18 B„ 1MedDRA v24.0NDW‘ ADý Hsr¦ DW’A ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C A Period 02DW‘DŹčHsr9hDYDż|HuoKüVaccination 3 APY A02021-06-07T20:57:05Y 115012841150Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDťřHrĆäxDW¦Dż|HsŽ|Placebo APlacebo ADWDťřDW#D{Y . . .Placebo Placebo DW@DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DŹčDż|DWÄDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB~BmBqBďAŕHrĆäxHráŚHsr9hHsŽ| .DWWHITE AC4591001C4591001 1150 11501284A0ADVERSE EVENT 3 Pain at injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-17T18:00B2021-05-19 B… 2MedDRA v24.0NDW‘ ADý Hsr¦ DW“A0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C A Period 02DW‘DŹčHsr9hDYDż|HuoKüVaccination 3 APY A02021-06-07T20:56:43Y 115012841150Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDťřHrĆäxDW¦Dż|HsŽ|Placebo APlacebo ADWDťřDW#D{Y . . .Placebo Placebo DW@DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DŹčDż|DWÄDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB~BmBqBďAŕHrĆäxHráŚHsr9hHsŽ| .DWWHITE AC4591001C4591001 1150 11501284A@ADVERSE EVENT 7 Muscle Aches Myalgia F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Muscle ache F™˙F™{Muscle pains F™#Muscle disorders F™Musculoskeletal and connective tissue disorders F™k2021-06-07T19:30B2021-06-10 B› 2MedDRA v24.0NDW¦ AE#€HsŽk8DW©A@..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C A Period 02DW‘DŹčHsr9hDYDż|HuoKüVaccination 4 A`Y A@2021-07-07T19:28:09Y 115012841150Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDťřHrĆäxDW¦Dż|HsŽ|Placebo APlacebo ADWDťřDW#D{Y . . .Placebo Placebo DW@DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DŹčDż|DWÄDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB~BmBqBďAŕHrĆäxHráŚHsr9hHsŽ| .DWWHITE AC4591001C4591001 1150 11501284APADVERSE EVENT 4 Body Aches Pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalized aching F™Š\F™ŰPain and discomfort NEC F™ÜGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-17T18:00B2021-05-18 B„ 2MedDRA v24.0NDW‘ ADý Hsr¦ DW’A ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C A Period 02DW‘DŹčHsr9hDYDż|HuoKüVaccination 3 APY A02021-06-07T20:56:54Y 115012841150Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDťřHrĆäxDW¦Dż|HsŽ|Placebo APlacebo ADWDťřDW#D{Y . . .Placebo Placebo DW@DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DŹčDż|DWÄDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB~BmBqBďAŕHrĆäxHráŚHsr9hHsŽ| .DWWHITE AC4591001C4591001 1150 11501284A`ADVERSE EVENT 1 Fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-05-17T18:00B2021-05-18 B„ 1MedDRA v24.0NDW‘ ADý Hsr¦ DW’A ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C A Period 02DW‘DŹčHsr9hDYDż|HuoKüVaccination 3 APY A02021-06-07T20:56:22Y 115012841150Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDťřHrĆäxDW¦Dż|HsŽ|Placebo APlacebo ADWDťřDW#D{Y . . .Placebo Placebo DW@DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DŹčDż|DWÄDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB~BmBqBďAŕHrĆäxHráŚHsr9hHsŽ| .DWWHITE AC4591001C4591001 1150 11501284ApADVERSE EVENT 6 Fever (100.7) Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-06-07T19:30B2021-06-10 B› 1MedDRA v24.0NDW¦ AE#€HsŽk8DW©A@..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C A Period 02DW‘DŹčHsr9hDYDż|HuoKüVaccination 4 A`Y A@2021-07-07T19:27:57Y 115012871150BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDŇxHrÇřDW$Dé4Hrâß4BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWDŇxDW$Dé4Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWDDWŚYPhase 3A@NNEGDWŤ ....... . .NY.DWŚDWýB~BqBďAŔHrÇřHrâß4.. .DWŮWHITE AC4591001C4591001 1150 11501287AADVERSE EVENT 1 Injection Site Pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-01-08 A 2021-01-08 A 1MedDRA v24.0NDW A ..DWA ..ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . APeriod 01DWDŇxHrÇřDX‘Dé4HtÄ´Vaccination 1 AY A2021-01-29T20:40:18 115012911150Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWD˘¨HrĚ/(DW§DľČHsŹiHPlacebo APlacebo ADWD˘¨DW*DŰ$Y . . .Placebo Placebo DWFDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DW§DúČDľČDWĂDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBzBkBqBëAđHrĚ/(Hręş$HsuGHHsŹiH .DW’WHITE AC4591001C4591001 1150 11501291AADVERSE EVENT 2 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-20 B‚2021-05-22 B„ 2MedDRA v24.0NDW” A ..DW–A@..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DW“DúČHsuGHDYDľČHupśČVaccination 3 APY A02021-06-08T21:16:53Y 115012911150Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWD˘¨HrĚ/(DW§DľČHsŹiHPlacebo APlacebo ADWD˘¨DW*DŰ$Y . . .Placebo Placebo DWFDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DW§DúČDľČDWĂDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBzBkBqBëAđHrĚ/(Hręş$HsuGHHsŹiH .DW’WHITE AC4591001C4591001 1150 11501291A ADVERSE EVENT 3 Headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-05-20 B‚2021-05-21 B 2MedDRA v24.0NDW” A ..DW•A0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DW“DúČHsuGHDYDľČHupśČVaccination 3 APY A02021-06-08T21:17:03Y 115012911150Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWD˘¨HrĚ/(DW§DľČHsŹiHPlacebo APlacebo ADWD˘¨DW*DŰ$Y . . .Placebo Placebo DWFDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DW§DúČDľČDWĂDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBzBkBqBëAđHrĚ/(Hręş$HsuGHHsŹiH .DW’WHITE AC4591001C4591001 1150 11501291A0ADVERSE EVENT 1 Pain at injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-19T18:00B2021-05-22 B„ 2MedDRA v24.0NDW“ ADý HsuI DW–A@..A@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A A YA Period 02DW“DúČHsuGHDYDľČHupśČVaccination 3 APY A02021-06-08T21:16:42Y 115012941150Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsABLACK OR AFRICAN AMERICAN A FA HISPANIC OR LATINO AUSABLACK OR AFRICAN AMERICAN A DWDĹĐHrĚRPDWŻDă”HsšPlacebo APlacebo ADWDĹĐDW(DóY . . .Placebo Placebo DWFDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW›DWŻDÄŕDă”DWĚDXlBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBzBcBqBëAŔHrĚRPHrč/Hsť`Hsš .DWšBLACK OR AFRICAN AMERICANA C4591001C4591001 1150 11501294AADVERSE EVENT 1 Left sided mild conductive hearing loss Conductive deafness FÍ)EAR AND LABYRINTH DISORDERS Conductive hearing loss FľŞFľ¨Hearing losses FÄçHearing disorders Fá«Ear and labyrinth disorders FÍ)2021-01-14 A@2021-05 . 2MedDRA v24.0NDW A@....... N NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . APeriod 01DWDĹĐHrĚRPDW›DÄßHsť_Vaccination 1 AY A2021-05-27T19:21:04Y 115012941150Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsABLACK OR AFRICAN AMERICAN A FA HISPANIC OR LATINO AUSABLACK OR AFRICAN AMERICAN A DWDĹĐHrĚRPDWŻDă”HsšPlacebo APlacebo ADWDĹĐDW(DóY . . .Placebo Placebo DWFDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW›DWŻDÄŕDă”DWĚDXlBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBzBcBqBëAŔHrĚRPHrč/Hsť`Hsš .DWšBLACK OR AFRICAN AMERICANA C4591001C4591001 1150 11501294A ADVERSE EVENT 2 Pain at injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-27T18:00B‰2021-05-29 B‹ 1MedDRA v24.0NDW› ADý HsŐ DWťA0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Bđ A Period 02DW›DÄŕHsť`DYDă”Hu{M”Vaccination 3 APY A02021-06-16T22:11:43Y 115012941150Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsABLACK OR AFRICAN AMERICAN A FA HISPANIC OR LATINO AUSABLACK OR AFRICAN AMERICAN A DWDĹĐHrĚRPDWŻDă”HsšPlacebo APlacebo ADWDĹĐDW(DóY . . .Placebo Placebo DWFDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW›DWŻDÄŕDă”DWĚDXlBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBzBcBqBëAŔHrĚRPHrč/Hsť`Hsš .DWšBLACK OR AFRICAN AMERICANA C4591001C4591001 1150 11501294A0ADVERSE EVENT 4 Pain at injection site Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-16T18:00Bť2021-06-17 Bž 1MedDRA v24.0NDWŻ ADý Hsš3 DW°A ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Bm A Period 02DW›DÄŕHsť`DYDă”Hu{M”Vaccination 4 A`Y A@2021-07-15T15:38:10Y 115012941150Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsABLACK OR AFRICAN AMERICAN A FA HISPANIC OR LATINO AUSABLACK OR AFRICAN AMERICAN A DWDĹĐHrĚRPDWŻDă”HsšPlacebo APlacebo ADWDĹĐDW(DóY . . .Placebo Placebo DWFDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW›DWŻDÄŕDă”DWĚDXlBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBzBcBqBëAŔHrĚRPHrč/Hsť`Hsš .DWšBLACK OR AFRICAN AMERICANA C4591001C4591001 1150 11501294A@ADVERSE EVENT 3 Swollen at injection site Injection site swelling FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site swelling F™g1F™g1Injection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-27T18:00B‰2021-05-29 B‹ 1MedDRA v24.0NDW› ADý HsŐ DWťA0..A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Bđ A Period 02DW›DÄŕHsť`DYDă”Hu{M”Vaccination 3 APY A02021-06-16T22:11:54Y 115012981150Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DWDž4HrÍ|4DW D†Hs…öPlacebo APlacebo ADWDž4DW(DŤY . . .Placebo Placebo DWFDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW Dě|D†DWĽDX]BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýByBqBqBęAĐHrÍ|4HrçÉHsmOüHs…ö .DWŚALL OTHERS A0C4591001C4591001 1150 11501298AADVERSE EVENT 2 Chills Chills FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills F·ÓF·ÓFeelings and sensations NEC F™ŁGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-14 B{2021-05-14 B{ 1MedDRA v24.0NDWŽ A ..DWŽA ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŤDě|HsmOüDY D†Hug)Vaccination 3 APY A02021-06-01T15:19:06Y 115012981150Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DWDž4HrÍ|4DW D†Hs…öPlacebo APlacebo ADWDž4DW(DŤY . . .Placebo Placebo DWFDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW Dě|D†DWĽDX]BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýByBqBqBęAĐHrÍ|4HrçÉHsmOüHs…ö .DWŚALL OTHERS A0C4591001C4591001 1150 11501298A ADVERSE EVENT 5 Chills Chills FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills F·ÓF·ÓFeelings and sensations NEC F™ŁGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-01T18:00BŤ2021-06-01 BŤ 1MedDRA v24.0NDW ADý Hs†m DW A..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CŔ A Period 02DWŤDě|HsmOüDY D†Hug)Vaccination 4 A`Y A@2021-06-29T23:21:13Y 115012981150Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DWDž4HrÍ|4DW D†Hs…öPlacebo APlacebo ADWDž4DW(DŤY . . .Placebo Placebo DWFDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW Dě|D†DWĽDX]BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýByBqBqBęAĐHrÍ|4HrçÉHsmOüHs…ö .DWŚALL OTHERS A0C4591001C4591001 1150 11501298A0ADVERSE EVENT 3 Headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-05-14 B{2021-05-14 B{ 1MedDRA v24.0NDWŽ A ..DWŽA ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŤDě|HsmOüDY D†Hug)Vaccination 3 APY A02021-06-01T15:19:16Y 115012981150Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DWDž4HrÍ|4DW D†Hs…öPlacebo APlacebo ADWDž4DW(DŤY . . .Placebo Placebo DWFDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW Dě|D†DWĽDX]BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýByBqBqBęAĐHrÍ|4HrçÉHsmOüHs…ö .DWŚALL OTHERS A0C4591001C4591001 1150 11501298A@ADVERSE EVENT 1 Fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-05-14 B{2021-05-14 B{ 1MedDRA v24.0NDWŽ A ..DWŽA ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DWŤDě|HsmOüDY D†Hug)Vaccination 3 APY A02021-06-01T15:18:55Y 115012981150Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DWDž4HrÍ|4DW D†Hs…öPlacebo APlacebo ADWDž4DW(DŤY . . .Placebo Placebo DWFDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW Dě|D†DWĽDX]BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýByBqBqBęAĐHrÍ|4HrçÉHsmOüHs…ö .DWŚALL OTHERS A0C4591001C4591001 1150 11501298APADVERSE EVENT 4 Fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-06-01T18:00BŤ2021-06-01 BŤ 1MedDRA v24.0NDW ADý Hs†m DW A..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CŔ A Period 02DWŤDě|HsmOüDY D†Hug)Vaccination 4 A`Y A@2021-06-29T23:21:02Y 115216151152Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVěDß Hr™ DW©D‡xHs‘ÔřPlacebo APlacebo ADVěDß DV˙DŇxY . . .Placebo Placebo DWDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW•DW©D†LD‡xDWĹDXfBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBˇBiBqC AđHr™ Hr˛řHswuĚHs‘Ôř .DW”WHITE AC4591001C4591001 1152 11521615AADVERSE EVENT 1 generalized rash upper body Rash F™5ŃSKIN AND SUBCUTANEOUS TISSUE DISORDERS Generalized rash F™V±F™*TRashes, eruptions and exanthems NEC F™cÖEpidermal and dermal conditions FŃSkin and subcutaneous tissue disorders F™5Ń2020-12-03T17:00A2020-12-10 A€ 1MedDRA v24.0NDVě ADďHr™DVóA€..A€DAYSN NNOT RELATEDOTHER Environmental, unknown source, per investigator. NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A BD APeriod 01DVěDß Hr™ DW•D†KHswuËVaccination 1 AY A2021-01-28T19:01:15 115216401152BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVđDŘHrž@DWDŻČHrąÇHBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVđDŘDWDŻČY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW%DWŤYPhase 3A@NNEGDWŽ ....... . .NN.DWŤDWšBžAĐB«AđHrž@HrąÇH.. .DWÂWHITE AC4591001C4591001 1152 11521640AADVERSE EVENT 1 right ear infection, NFI Ear infection FëůINFECTIONS AND INFESTATIONS Ear infection FÍ;FÍ;Ear infections FÍ=Infections - pathogen unspecified Fë÷Infections and infestations Fëů2020-12-20 Aŕ2020-12-26 B 2MedDRA v24.0NDVý Aŕ..DWB..ApDAYSN NNOT RELATEDOTHER microbial NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVđDŘHrž@DXrDŻČHtšúČVaccination 1 AY A2021-01-06T10:08:21 115216411152BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVđDŰ$HržC$DVđDŰ$HržC$BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVđDŰ$..Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g) DW%DWŚYPhase 3A@NNEGDWŤ ....... . .NN.DWŚDWšBťAŕB«AŔHržC$HržC$.. .DWÄWHITE AC4591001C4591001 1152 11521641AADVERSE EVENT 1 rash right eyelid Eyelid rash FÔŻEYE DISORDERS Eyelid rash F™ąüF™ąüLid, lash and lacrimal infections, irritations and inflammations FőýOcular infections, irritations and inflammations FëőEye disorders FÔŻ2020-12-07T20:00A2020-12-08T20:00A 1MedDRA v24.0NDVđ AE”Hrž@DVńA E—°HrźŇűA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C APeriod 01DVđDŰ$HržC$DX]DŰ$Htv¤Vaccination 1 AY A2021-01-05T18:23:39 115216411152BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVđDŰ$HržC$DVđDŰ$HržC$BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVđDŰ$..Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g) DW%DWŚYPhase 3A@NNEGDWŤ ....... . .NN.DWŚDWšBťAŕB«AŔHržC$HržC$.. .DWÄWHITE AC4591001C4591001 1152 11521641A ADVERSE EVENT 2 rash bilateral extremities Rash F™5ŃSKIN AND SUBCUTANEOUS TISSUE DISORDERS Rash on legs & arms F™*rF™*TRashes, eruptions and exanthems NEC F™cÖEpidermal and dermal conditions FŃSkin and subcutaneous tissue disorders F™5Ń2020-12-08T09:00A 2020-12-08T20:00A 1MedDRA v24.0NDVń A D~Hrź8DVńA E—°HrźŇűADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CAP APeriod 01DVđDŰ$HržC$DX]DŰ$Htv¤Vaccination 1 AY A2021-01-05T18:23:45 115216541152Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVňDĄ<Hr °<DWĐDŽ€HsĹF€Placebo APlacebo ADVňDĄ<DWDŽĽY . . .Placebo Placebo DW#DW´YPhase 3A@NNEGDWµ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW»DWĐD§XDŽ€DWěDXŤBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW´DWýBĂBCBICŔAŕHr °<Hrş÷ĽHs©ŻŘHsĹF€ .DWµWHITE AC4591001C4591001 1152 11521654AADVERSE EVENT 1 Worsened Depression Depression F™'·PSYCHIATRIC DISORDERS Depression worsened FĆîFĆÚDepressive disorders FĆńDepressed mood disorders and disturbances FĆ×Psychiatric disorders F™'·2020-12-26 B .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDW B....... N NNOT RELATEDOTHER Pre-existing condition NOT APPLICABLE YNNOT RECOVERED/NOT RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVňDĄ<Hr °<DW»D§WHs©Ż×Vaccination 1 AY A2021-01-29T00:43:13 115216641152Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADVôD—hHrŁEhDWŇDŚ(HsÇç(Placebo APlacebo ADVôD—hDWDŽ€Y . . .Placebo Placebo DW#DW¶YPhase 3A@NNEGDW· BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWżDWŇD™HDŚ(DWđDXŹBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW¶DWýBĂB?BGC AĐHrŁEhHrĽIHs®çČHsÇç( .DW·WHITE AC4591001C4591001 1152 11521664AADVERSE EVENT 1 FRACTURED LEFT ANKLE Ankle fracture FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Ankle fracture F pF pLimb fractures and dislocations F™ľîBone and joint injuries F¶Injury, poisoning and procedural complications Fěĺ2021-06-18 Bľ .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDW± B«....... N NNOT RELATEDOTHER TRAMPOLINE ACCIDENT NOT APPLICABLE YYNOT RECOVERED/NOT RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVôD—hHrŁEhDWżD™GHs®çÇFollow Up 1 A0Y A 2021-07-06T23:25:21Y 115216641152Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADVôD—hHrŁEhDWŇDŚ(HsÇç(Placebo APlacebo ADVôD—hDWDŽ€Y . . .Placebo Placebo DW#DW¶YPhase 3A@NNEGDW· BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWżDWŇD™HDŚ(DWđDXŹBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW¶DWýBĂB?BGC AĐHrŁEhHrĽIHs®çČHsÇç( .DW·WHITE AC4591001C4591001 1152 11521664A ADVERSE EVENT 2 FALL Fall FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Fall FŐFŐNon-site specific injuries NEC F™ ÇInjuries NEC FěâInjury, poisoning and procedural complications Fěĺ2021-06-18 Bľ2021-06-18 Bľ 2MedDRA v24.0NDW± B«..DW±B«..ADAYSN NNOT RELATEDOTHER TRAMPOLINE ACCIDENT NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVôD—hHrŁEhDWżD™GHs®çÇFollow Up 1 A0Y A 2021-07-08T22:44:25Y 115216691152Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DVôD°|HrŁ^|DWŻDëŚHsš"Placebo APlacebo ADVôD°|DWD„¨Y . . .Placebo Placebo DW$DWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWšDWŻDÝDëŚDWËDXlBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýBšBdBpC AđHrŁ^|HrĽ?(Hs~dHsš" .DW™ALL OTHERS A0C4591001C4591001 1152 11521669AADVERSE EVENT 1 headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-03-30T15:00Bn2021-03-30T17:00Bn 1MedDRA v24.0NDWa B[DŇđHs34pDWaB[DďKHs3PËADAYSN NNOT RELATEDOTHER heat induced headache NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A E¸ŕ APeriod 01DVôD°|HrŁ^|DWšDÝHs~dFollow Up 1 A0Y A 2021-04-01T21:34:44Y 115216831152BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVřDđxHr¨äxDW DŕHrÄBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVřDđxDW DŕY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW)DWŤYPhase 3A@NNEGDWŽ ....... . .NY.DWŤDWýB–BpC`AŕHr¨äxHrÄ.. .DWĽWHITE AC4591001C4591001 1152 11521683AADVERSE EVENT 1 Swollen Lymph Node (Left Clavicle) Lymphadenopathy F«QBLOOD AND LYMPHATIC SYSTEM DISORDERS Swollen lymph nodes F™ťFříLymphatic system disorders NEC FřîSpleen, lymphatic and reticuloendothelial system disorders F™9)Blood and lymphatic system disorders F«Q2020-12-26 AŔ .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDW AŔ....... N NNOT RELATEDOTHER Mild swollen lymph node from probable microbial infection, per investigator. (b)(6)NOT APPLICABLE NNNOT RECOVERED/NOT RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVřDđxHr¨äxDXzDŕHtĄ·Vaccination 1 AY A2021-01-12T23:23:54 115216871152Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVůDŢlHrŞ#ěDWDóHHs—†ČPlacebo APlacebo ADVůDŢlDWDĺ°Y . . .Placebo Placebo DW/DWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDń,DóHDWÉDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýB•BfBpCPAđHrŞ#ěHrĹÚ°Hs{Ő,Hs—†Č .DW—WHITE AC4591001C4591001 1152 11521687AADVERSE EVENT 1 Nasal Congestion Nasal congestion F™-ŇRESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS Nasal congestion F™żF™żNasal congestion and inflammations F™ŔUpper respiratory tract disorders (excl infections) F™K`Respiratory, thoracic and mediastinal disorders F™-Ň2021-05-03 B‹ .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDW Bv....... N NNOT RELATEDOTHER Unknown NOT APPLICABLE YNNOT RECOVERED/NOT RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVůDŢlHrŞ#ěDWDń+Hs{Ő+Follow Up 1 A0Y A 2021-05-06T00:42:56Y 115216881152Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVůDÜŚHrŞ"DWDĺtHs—xôPlacebo APlacebo ADVůDÜŚDWDäY . . .Placebo Placebo DW/DWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDîÔDĺtDWÉDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýB•BfBpCPAŔHrŞ"HrĹŮHs{ŇÔHs—xô .DW—WHITE AC4591001C4591001 1152 11521688AADVERSE EVENT 2 Chills Chills FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills F·ÓF·ÓFeelings and sensations NEC F™ŁGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-15T06:00B¶2021-06-16T06:00B· 2MedDRA v24.0NDW® A DT`Hs9`DWŻA0DT›Hs™‹A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C3P A Period 02DWDîÔHs{ŇÔDYDĺtHux¬tVaccination 4 A`Y A@2021-06-18T19:35:29Y 115216881152Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVůDÜŚHrŞ"DWDĺtHs—xôPlacebo APlacebo ADVůDÜŚDWDäY . . .Placebo Placebo DW/DWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDîÔDĺtDWÉDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýB•BfBpCPAŔHrŞ"HrĹŮHs{ŇÔHs—xô .DW—WHITE AC4591001C4591001 1152 11521688A ADVERSE EVENT 4 fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-15T06:00B¶ .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDW® A DT`Hs9`..... N NRELATED NOT APPLICABLE YNRECOVERING/RESOLVING N ARELATED AA GRADE 2A C3P A Period 02DWDîÔHs{ŇÔDYDĺtHux¬tVaccination 4 A`Y A@2021-06-18T19:35:53Y 115216881152Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVůDÜŚHrŞ"DWDĺtHs—xôPlacebo APlacebo ADVůDÜŚDWDäY . . .Placebo Placebo DW/DWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDîÔDĺtDWÉDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýB•BfBpCPAŔHrŞ"HrĹŮHs{ŇÔHs—xô .DW—WHITE AC4591001C4591001 1152 11521688A0ADVERSE EVENT 3 headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-06-15T06:00B¶ .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDW® A DT`Hs9`..... N NRELATED NOT APPLICABLE YNRECOVERING/RESOLVING N ARELATED AA GRADE 2A C3P A Period 02DWDîÔHs{ŇÔDYDĺtHux¬tVaccination 4 A`Y A@2021-06-18T19:35:42Y 115216881152Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVůDÜŚHrŞ"DWDĺtHs—xôPlacebo APlacebo ADVůDÜŚDWDäY . . .Placebo Placebo DW/DWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDîÔDĺtDWÉDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýB•BfBpCPAŔHrŞ"HrĹŮHs{ŇÔHs—xô .DW—WHITE AC4591001C4591001 1152 11521688A@ADVERSE EVENT 1 Nasal Congestion Nasal congestion F™-ŇRESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS Nasal congestion F™żF™żNasal congestion and inflammations F™ŔUpper respiratory tract disorders (excl infections) F™K`Respiratory, thoracic and mediastinal disorders F™-Ň2021-05-01 B‰ .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDW Bt....... N NNOT RELATEDOTHER Unknown NOT APPLICABLE YNNOT RECOVERED/NOT RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVůDÜŚHrŞ"DWDîÓHs{ŇÓFollow Up 1 A0Y A 2021-05-06T00:42:15Y 115216901152Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVůDę`HrŞ/ŕDWŻDŕÄHsšDPlacebo APlacebo ADVůDę`DWD×ÜY . . .Placebo Placebo DW*DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWśDWŻDÝ¸DŕÄDWËDXlBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB”BbBqCPAŕHrŞ/ŕHrĹĚÜHs¸HsšD .DW›WHITE AC4591001C4591001 1152 11521690AADVERSE EVENT 1 Left ear infection Ear infection FëůINFECTIONS AND INFESTATIONS Ear infection FÍ;FÍ;Ear infections FÍ=Infections - pathogen unspecified Fë÷Infections and infestations Fëů2021-06-11 B˛ .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDWŞ Ađ....... N NNOT RELATEDOTHER microbial source NOT APPLICABLE YYNOT RECOVERED/NOT RESOLVED N A0NOT RELATEDA0A GRADE 2A . A Period 02DWśDÝ¸Hs¸DYDŕÄHu{JÄVaccination 3 APY A02021-07-01T21:09:22Y 115216961152Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVúD˙đHr«–đDWDÚčHs—nhPlacebo APlacebo ADVúD˙đDWDÚ¬Y . . .Placebo Placebo DW+DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDŢäDÚčDWÉDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB“BfBqC@AŕHr«–đHrÇ!,Hs{ÂäHs—nh .DW—WHITE AC4591001C4591001 1152 11521696AADVERSE EVENT 2 site injection arm pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-25T06:00B 2021-05-26T00:00Bˇ 2MedDRA v24.0NDW™ A DT`Hs|‰ŕDWšA0B;Hs}‡;A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C5 A Period 02DWDŢäHs{ÂäDYDÚčHuxˇčVaccination 3 APY A02021-05-26T23:43:03Y 115216961152Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVúD˙đHr«–đDWDÚčHs—nhPlacebo APlacebo ADVúD˙đDWDÚ¬Y . . .Placebo Placebo DW+DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDŢäDÚčDWÉDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB“BfBqC@AŕHr«–đHrÇ!,Hs{ÂäHs—nh .DW—WHITE AC4591001C4591001 1152 11521696A ADVERSE EVENT 1 Myalgias Myalgia F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Myalgia F™{F™{Muscle pains F™#Muscle disorders F™Musculoskeletal and connective tissue disorders F™k2021-05-25T06:00B 2021-05-26T00:00Bˇ 2MedDRA v24.0NDW™ A DT`Hs|‰ŕDWšA0B;Hs}‡;A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C5 A Period 02DWDŢäHs{ÂäDYDÚčHuxˇčVaccination 3 APY A02021-05-26T23:42:53Y 115216971152BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DVűD× Hr¬Ŕ DWDÍHrČeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVűD× DWDÍY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW3DWŤYPhase 3A@NNEGDWŽ ....... . .NY.DWŤDWýB“BpC0AŔHr¬Ŕ HrČe.. .DWĆALL OTHERS A0C4591001C4591001 1152 11521697AADVERSE EVENT 4 Chills Chills FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills F·ÓF·ÓFeelings and sensations NEC F™ŁGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2020-12-19 A 2020-12-19 A 2MedDRA v24.0NDVü A ..DVüA ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . APeriod 01DVűD× Hr¬Ŕ DX}DÍHt©”Vaccination 1 AY A2021-04-27T18:08:30Y 115216971152BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DVűD× Hr¬Ŕ DWDÍHrČeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVűD× DWDÍY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW3DWŤYPhase 3A@NNEGDWŽ ....... . .NY.DWŤDWýB“BpC0AŔHr¬Ŕ HrČe.. .DWĆALL OTHERS A0C4591001C4591001 1152 11521697A ADVERSE EVENT 5 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2020-12-19 A 2020-12-19 A 2MedDRA v24.0NDVü A ..DVüA ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . APeriod 01DVűD× Hr¬Ŕ DX}DÍHt©”Vaccination 1 AY A2021-04-27T18:08:41Y 115216971152BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DVűD× Hr¬Ŕ DWDÍHrČeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVűD× DWDÍY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW3DWŤYPhase 3A@NNEGDWŽ ....... . .NY.DWŤDWýB“BpC0AŔHr¬Ŕ HrČe.. .DWĆALL OTHERS A0C4591001C4591001 1152 11521697A0ADVERSE EVENT 3 Injection Site Pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2020-12-18T22:00A2020-12-21 A@ 2MedDRA v24.0NDVű AEVHrŕDVţA@..A@DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C APeriod 01DVűD× Hr¬Ŕ DX}DÍHt©”Vaccination 1 AY A2021-04-27T18:08:19Y 115216971152BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DVűD× Hr¬Ŕ DWDÍHrČeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVűD× DWDÍY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW3DWŤYPhase 3A@NNEGDWŽ ....... . .NY.DWŤDWýB“BpC0AŔHr¬Ŕ HrČe.. .DWĆALL OTHERS A0C4591001C4591001 1152 11521697A@ADVERSE EVENT 2 Injection Site Swelling Injection site swelling FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site swelling F™g1F™g1Injection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2020-12-19 A 2020-12-20 A0 2MedDRA v24.0NDVü A ..DVýA0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . APeriod 01DVűD× Hr¬Ŕ DX}DÍHt©”Vaccination 1 AY A2021-04-27T18:17:17Y 115216971152BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DVűD× Hr¬Ŕ DWDÍHrČeBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVűD× DWDÍY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW3DWŤYPhase 3A@NNEGDWŽ ....... . .NY.DWŤDWýB“BpC0AŔHr¬Ŕ HrČe.. .DWĆALL OTHERS A0C4591001C4591001 1152 11521697APADVERSE EVENT 1 Fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2020-12-19 A 2020-12-19 A 1MedDRA v24.0NDVü A ..DVüA ..ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . APeriod 01DVűD× Hr¬Ŕ DX}DÍHt©”Vaccination 1 AY A2021-04-27T18:17:05Y 115217041152BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVţDźśHr°|śDWD¨HHrĚ4ČBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVţDźśDWD¨HY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW/DW’YPhase 3A@NNEGDW“ ....... . .NY.DW’DWýB•BkCAŕHr°|śHrĚ4Č.. .DWĂWHITE AC4591001C4591001 1152 11521704AADVERSE EVENT 1 swollen lymph node left axilla Lymphadenopathy F«QBLOOD AND LYMPHATIC SYSTEM DISORDERS Swollen lymph nodes F™ťFříLymphatic system disorders NEC FřîSpleen, lymphatic and reticuloendothelial system disorders F™9)Blood and lymphatic system disorders F«Q2020-12-26 A`2021-01-04 Ađ 2MedDRA v24.0NDW A`..DWAđ..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . APeriod 01DVţDźśHr°|śDX€D¨HHthHVaccination 1 AY A2021-01-12T00:22:39 115217061152Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVţD°ôHr°ŤôDWŻDĺ8Hsš¸Placebo APlacebo ADVţD°ôDWDŮDY . . .Placebo Placebo DW/DW’YPhase 3A@NNEGDW“ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW›DWŻDí¨Dĺ8DWŇDXlBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW’DWýB•BcBkCAĐHr°ŤôHrĚeÄHsĆ(Hsš¸ .DWšWHITE AC4591001C4591001 1152 11521706AADVERSE EVENT 1 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2020-12-21T16:00A2020-12-27T22:00Ap 3MedDRA v24.0NDVţ ADáHr°ľDWApEY°Hr¸ű›ApDAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA0GRADE 3A0 BÍ APeriod 01DVţD°ôHr°ŤôDW›Dí§HsĆ'Vaccination 1 AY A2020-12-29T02:18:25 115217061152Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVţD°ôHr°ŤôDWŻDĺ8Hsš¸Placebo APlacebo ADVţD°ôDWDŮDY . . .Placebo Placebo DW/DW’YPhase 3A@NNEGDW“ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW›DWŻDí¨Dĺ8DWŇDXlBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW’DWýB•BcBkCAĐHr°ŤôHrĚeÄHsĆ(Hsš¸ .DWšWHITE AC4591001C4591001 1152 11521706A ADVERSE EVENT 2 HEADACHE Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2020-12-26T18:00A`2020-12-27T22:00Ap 3MedDRA v24.0NDW A`Dý Hr·q DWApEY°Hr¸ű›A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA0GRADE 3A0 De APeriod 01DVţD°ôHr°ŤôDW›Dí§HsĆ'Vaccination 1 AY A2020-12-29T02:18:31 115217391152Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDÜČHrÇ#HDWŞDß Hs“~ Placebo APlacebo ADWDÜČDW$DíäY . . .Placebo Placebo DWADW‘YPhase 3A@NNEGDW’ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW•DWŞDŢäDß DWĆDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‘DWýBBiBlBďAŔHrÇ#HHrâăäHswÎdHs“~ .DW”WHITE AC4591001C4591001 1152 11521739AADVERSE EVENT 1 Left arm stiffness Musculoskeletal stiffness F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Limbs stiffness Fö=F™e(Musculoskeletal and connective tissue conditions NEC F™ŃÇMusculoskeletal and connective tissue disorders NEC F™iMusculoskeletal and connective tissue disorders F™k2021-05-22T00:00B2021-05-28T00:00BŽ 1MedDRA v24.0NDW– A HsxADWśA€B;Hs€*;ApDAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C A Period 02DW•DŢäHswÎdDYDß Hut± Vaccination 3 APY A02021-06-14T18:29:20Y 115217401152Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDëHrÇ1”DWD¤Hs—7Placebo APlacebo ADWDëDW#DĺtY . . .Placebo Placebo DW?DWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDÎôD¤DWÉDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýBBfBpBďAđHrÇ1”Hrá‰ôHs{˛ôHs—7 .DW—WHITE AC4591001C4591001 1152 11521740AADVERSE EVENT 2 fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-25T08:00B‹2021-05-26T08:00BŚ 2MedDRA v24.0NDW™ A Dp€Hs|¦DWšA0Dp»Hs}÷»A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C@Đ A Period 02DWDÎôHs{˛ôDYD¤HuxkVaccination 3 APY A02021-05-28T01:06:08Y 115217401152Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDëHrÇ1”DWD¤Hs—7Placebo APlacebo ADWDëDW#DĺtY . . .Placebo Placebo DW?DWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDÎôD¤DWÉDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýBBfBpBďAđHrÇ1”Hrá‰ôHs{˛ôHs—7 .DW—WHITE AC4591001C4591001 1152 11521740A ADVERSE EVENT 3 site injection arm pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-25T08:00B‹ .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDW™ A Dp€Hs|¦..... N NRELATED NOT APPLICABLE YNRECOVERING/RESOLVING N ARELATED AA GRADE 2A C@Đ A Period 02DWDÎôHs{˛ôDYD¤HuxkVaccination 3 APY A02021-05-28T01:06:19Y 115217401152Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDëHrÇ1”DWD¤Hs—7Placebo APlacebo ADWDëDW#DĺtY . . .Placebo Placebo DW?DWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWDWDÎôD¤DWÉDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýBBfBpBďAđHrÇ1”Hrá‰ôHs{˛ôHs—7 .DW—WHITE AC4591001C4591001 1152 11521740A0ADVERSE EVENT 1 Chipped baby tooth Tooth fracture FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Chipped tooth F™¶‚F™ŠĐAbdominal and gastrointestinal injuries NEC F™ÝInjuries NEC FěâInjury, poisoning and procedural complications Fěĺ2021-02-17 B*2021-02-17 B* 1MedDRA v24.0NDW8 B..DW8B..ADAYSN NNOT RELATEDOTHER subject chipped tooth while eating hard candy NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DWDëHrÇ1”DWDÎóHs{˛óVaccination 2 A Y A 2021-03-01T22:18:06 115217491152BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@FA NOT HISPANIC OR LATINOA USAASIAN A@DWD˙đHrČ—đDW$DŰ$HrâŃ$BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWD˙đDW$DŰ$Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWDDW’YPhase 3A@NNEGDW“ ....... . .NY.DW’DWýBBkBîAĐHrČ—đHrâŃ$.. .DWÓALL OTHERS A0C4591001C4591001 1152 11521749AADVERSE EVENT 1 ABDOMINAL CRAMPS Abdominal pain FÜ›GASTROINTESTINAL DISORDERS Abdominal cramps F–ąF–ŃGastrointestinal and abdominal pains (excl oral and throat) FÜ†Gastrointestinal signs and symptoms FÜÜGastrointestinal disorders FÜ›2021-01-09 A 2021-01-09 A 1MedDRA v24.0NDW A ..DWA ..ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . APeriod 01DWD˙đHrČ—đDX‘DŰ$HtÄ¤Vaccination 1 AY A2021-01-29T02:39:12 115217521152Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DWD‰HrĚśDWDyhHs—čPlacebo APlacebo ADWD‰DW)D|°Y . . .Placebo Placebo DWEDWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW™DWDŠŔDyhDWĐDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýB{BeBpBëAđHrĚśHré 0Hs|Ŕ@Hs—č .DWALL OTHERS A0C4591001C4591001 1152 11521752AADVERSE EVENT 1 left wrist joint injured Joint injury FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Wrist injury F™]ĐF™„Bone and joint injuries NEC F™ąuBone and joint injuries F¶Injury, poisoning and procedural complications Fěĺ2021-05-26 B .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDWš A ....... N NNOT RELATEDOTHER sport injury NOT APPLICABLE NYRECOVERING/RESOLVING N A0NOT RELATEDA0AGRADE 1A . A Period 02DW™DŠŔHs|Ŕ@DYDyhHux@hVaccination 3 APY A02021-06-18T20:05:37Y 115217561152BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADWE,HrĚŹ@DW(DöHrč2BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWE,DW(DöY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWEDW‘YPhase 3A@NPOSDW’ ....... . .NY.DW‘DWýBBlBëAŔHrĚŹ@Hrč2.. .DW×WHITE AC4591001C4591001 1152 11521756AADVERSE EVENT 1 Diarrhea Diarrhoea FÜ›GASTROINTESTINAL DISORDERS Diarrhea FČ7FČ?Diarrhoea (excl infective) FČ@Gastrointestinal motility and defaecation conditions FÜąGastrointestinal disorders FÜ›2021-02-06 B2021-02-08 B 1MedDRA v24.0NDW- A`..DW/A€..A0DAYSN NNOT RELATEDOTHER Dietary Indiscretion NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DWE,HrĚŹ@DX•DöHtÉfVaccination 2 A Y A 2021-02-11T06:13:54 115613101156BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsABLACK OR AFRICAN AMERICAN A FA HISPANIC OR LATINO AUSABLACK OR AFRICAN AMERICAN A DVęDę$Hr–i$DWD•HrĆŰBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVęDę$DWD•Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW,DWˇYPhase 3A@NNEGDW˘ ....... . .NY.DWˇDWýB¸B\C@AŔHr–i$HrĆŰ.. .DWżBLACK OR AFRICAN AMERICANA C4591001C4591001 1156 11561310AADVERSE EVENT 1 TINEA CORPORIS Body tinea FëůINFECTIONS AND INFESTATIONS Tinea corporis F™AŰF™Tinea infections F™AŢFungal infectious disorders FÚřInfections and infestations Fëů2020-12-08 A€2020-12-25 B 1MedDRA v24.0NDVń A€..DWB..BDAYSN NNOT RELATEDOTHER POOR HYGIENE NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVęDę$Hr–i$DX|D•Ht¨Vaccination 1 AY A2021-01-07T23:11:39 122312671223BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDâ¤HrÇ)$DW#DÜHrá€”BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWDâ¤DW#DÜY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW@DW’YPhase 3A@NNEGDW“ ....... . .NY.DW’DWýB„BkBďAŔHrÇ)$Hrá€”.. .DWÔWHITE AC4591001C4591001 1223 12231267AADVERSE EVENT 3 fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-01-27T17:00B2021-01-29T05:00B 2MedDRA v24.0NDW# ADďHrá“DW%A0DF‹HrăŽA0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A BQ APeriod 01DWDâ¤HrÇ)$DXDÜHtÂ´Vaccination 2 A Y A 2021-03-11T22:40:30 122312671223BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDâ¤HrÇ)$DW#DÜHrá€”BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWDâ¤DW#DÜY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW@DW’YPhase 3A@NNEGDW“ ....... . .NY.DW’DWýB„BkBďAŔHrÇ)$Hrá€”.. .DWÔWHITE AC4591001C4591001 1223 12231267A ADVERSE EVENT 2 generalized muscle aches Myalgia F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Generalized muscle aches F™ŠiF™{Muscle pains F™#Muscle disorders F™Musculoskeletal and connective tissue disorders F™k2021-01-27T17:00B2021-01-29T05:00B 1MedDRA v24.0NDW# ADďHrá“DW%A0DF‹HrăŽA0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A BQ APeriod 01DWDâ¤HrÇ)$DXDÜHtÂ´Vaccination 2 A Y A 2021-03-12T20:10:40 122312671223BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDâ¤HrÇ)$DW#DÜHrá€”BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWDâ¤DW#DÜY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW@DW’YPhase 3A@NNEGDW“ ....... . .NY.DW’DWýB„BkBďAŔHrÇ)$Hrá€”.. .DWÔWHITE AC4591001C4591001 1223 12231267A0ADVERSE EVENT 1 fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-01-27T15:30B2021-01-29T05:00B 1MedDRA v24.0NDW# BDŮřHrá~xDW%BDF‹HrăŽA0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Dp[ APeriod 01DWDâ¤HrÇ)$DXDÜHtÂ´Vaccination 1 AY A2021-03-11T22:40:13 122312691223Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWD÷HrÇ=DW§D´<HsŹ^ĽPlacebo APlacebo ADWD÷DW%DŕY . . .Placebo Placebo DWHDW‘YPhase 3A@NNEGDW’ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW”DW§DĎ0D´<DWĆDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‘DWýBBjBlBďAđHrÇ=Hrä'Hsvm0HsŹ^Ľ .DW“WHITE AC4591001C4591001 1223 12231269AADVERSE EVENT 1 fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-21T09:00B‡2021-05-22T09:00B 1MedDRA v24.0NDW• A D~HswnDW–A0D~ËHsxżËA DAYSN NRELATED NOT APPLICABLE NYRECOVERED/RESOLVED N ARELATED AAGRADE 1A CD€ A Period 02DW”DĎ0Hsvm0DYD´<Hup’<Vaccination 3 APY A02021-06-08T21:15:34Y 122312711223BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDáHrČyDW%D°¸Hrăř8BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWDáDW%D°¸Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWHDW’YPhase 3A@NNEGDW“ ....... . .NY.DW’DWýBBkBîAŔHrČyHrăř8.. .DWŮWHITE AC4591001C4591001 1223 12231271AADVERSE EVENT 1 injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-01-29T12:00B2021-02-01T09:00B 1MedDRA v24.0NDW% BD¨ŔHrăđ@DW(BD~ËHrçşËA@DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Du0 APeriod 01DWDáHrČyDX’D°¸HtĹ+¸Vaccination 1 AY A2021-03-05T20:10:59 122312771223Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDśTHrÉ…ÔDWD«THs—>ÔPlacebo APlacebo ADWDśTDW)DÓŕY . . .Placebo Placebo DWEDW’YPhase 3A@NNEGDW“ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW™DWDŞ D«TDWËDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW’DWýB‚BeBkBíAŔHrÉ…ÔHréa`Hs|ŕ Hs—>Ô .DWWHITE AC4591001C4591001 1223 12231277AADVERSE EVENT 3 headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-06-14T18:00Bť2021-06-16T09:00Bź 1MedDRA v24.0NDW ADý Hs— DWŻA0D~ËHs™µKA0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CĐ A Period 02DW™DŞ Hs|ŕ DYD«THuxrTVaccination 4 A`Y A@2021-07-14T20:54:18Y 122312771223Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDśTHrÉ…ÔDWD«THs—>ÔPlacebo APlacebo ADWDśTDW)DÓŕY . . .Placebo Placebo DWEDW’YPhase 3A@NNEGDW“ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW™DWDŞ D«TDWËDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW’DWýB‚BeBkBíAŔHrÉ…ÔHréa`Hs|ŕ Hs—>Ô .DWWHITE AC4591001C4591001 1223 12231277A ADVERSE EVENT 1 injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-26T09:00BŠ2021-05-27T15:00B‹ 1MedDRA v24.0NDWš A D~Hs~DW›A0DÓ+Hs««A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CN@ A Period 02DW™DŞ Hs|ŕ DYD«THuxrTVaccination 3 APY A02021-06-14T20:20:31Y 122312771223Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWDśTHrÉ…ÔDWD«THs—>ÔPlacebo APlacebo ADWDśTDW)DÓŕY . . .Placebo Placebo DWEDW’YPhase 3A@NNEGDW“ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW™DWDŞ D«TDWËDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW’DWýB‚BeBkBíAŔHrÉ…ÔHréa`Hs|ŕ Hs—>Ô .DWWHITE AC4591001C4591001 1223 12231277A0ADVERSE EVENT 2 fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-06-14T18:00Bť2021-06-16T09:00Bź 1MedDRA v24.0NDW ADý Hs— DWŻA0D~ËHs™µKA0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CĐ A Period 02DW™DŞ Hs|ŕ DYD«THuxrTVaccination 4 A`Y A@2021-07-14T20:54:05Y 122312791223Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWD¨HrÉ‘ŚDWŞDśĚHs“;ĚPlacebo APlacebo ADWD¨DW)DęśY . . .Placebo Placebo DWFDW‘YPhase 3A@NNEGDW’ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DWŞDŹčDśĚDWËDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‘DWýBBkBlBíAĐHrÉ‘ŚHréxHstÜhHs“;Ě .DW’WHITE AC4591001C4591001 1223 12231279AADVERSE EVENT 2 fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-11T18:00Bš2021-06-13T08:00Bś 1MedDRA v24.0NDWŞ ADý Hs“ś DW¬A0Dp»Hs•˛»A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C° A Period 02DW“DŹčHstÜhDYDśĚHutoLVaccination 4 A`Y A@2021-07-14T16:04:11Y 122312791223Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWD¨HrÉ‘ŚDWŞDśĚHs“;ĚPlacebo APlacebo ADWD¨DW)DęśY . . .Placebo Placebo DWFDW‘YPhase 3A@NNEGDW’ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DWŞDŹčDśĚDWËDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‘DWýBBkBlBíAĐHrÉ‘ŚHréxHstÜhHs“;Ě .DW’WHITE AC4591001C4591001 1223 12231279A ADVERSE EVENT 1 sore arm Pain in extremity F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Pain in arm F™ F™Musculoskeletal and connective tissue pain and discomfort F™ŁMusculoskeletal and connective tissue disorders NEC F™iMusculoskeletal and connective tissue disorders F™k2021-06-11T18:00Bš2021-06-13T08:00Bś 1MedDRA v24.0NDWŞ ADý Hs“ś DW¬A0Dp»Hs•˛»A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C° A Period 02DW“DŹčHstÜhDYDśĚHutoLVaccination 4 A`Y A@2021-07-14T16:03:59Y 122312811223BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDµŕHrÉź`DW)EHréŹPBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWDµŕDW)EY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWFDW‘YPhase 3A@NNEGDW’ ....... . .NY.DW‘DWýBBlBíAŕHrÉź`HréŹP.. .DWćWHITE AC4591001C4591001 1223 12231281AADVERSE EVENT 2 headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-02-03T15:00B2021-02-05T09:00B 1MedDRA v24.0NDW* A DŇđHrę±đDW,A@D~ËHríËA0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CM€ APeriod 01DWDµŕHrÉź`DX–EHtĘÂĐVaccination 2 A Y A 2021-03-03T23:22:46 122312811223BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDµŕHrÉź`DW)EHréŹPBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWDµŕDW)EY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWFDW‘YPhase 3A@NNEGDW’ ....... . .NY.DW‘DWýBBlBíAŕHrÉź`HréŹP.. .DWćWHITE AC4591001C4591001 1223 12231281A ADVERSE EVENT 3 muscle ache generalized Myalgia F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Generalized muscle aches F™ŠiF™{Muscle pains F™#Muscle disorders F™Musculoskeletal and connective tissue disorders F™k2021-02-03T15:00B2021-02-05T09:00B 1MedDRA v24.0NDW* A DŇđHrę±đDW,A@D~ËHríËA0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CM€ APeriod 01DWDµŕHrÉź`DX–EHtĘÂĐVaccination 2 A Y A 2021-03-05T08:30:28 122312811223BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDµŕHrÉź`DW)EHréŹPBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWDµŕDW)EY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWFDW‘YPhase 3A@NNEGDW’ ....... . .NY.DW‘DWýBBlBíAŕHrÉź`HréŹP.. .DWćWHITE AC4591001C4591001 1223 12231281A0ADVERSE EVENT 1 fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-02-03T15:00B2021-02-04T09:00B 1MedDRA v24.0NDW* A DŇđHrę±đDW+A0D~ËHrëŻKA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CM€ APeriod 01DWDµŕHrÉź`DX–EHtĘÂĐVaccination 2 A Y A 2021-03-03T23:22:38 122312831223Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWD˝śHrÉ§DW¨DŽHsŠPlacebo APlacebo ADWD˝śDW%DÓ¤Y . . .Placebo Placebo DWEDW‘YPhase 3A@NNEGDW’ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW”DW¨DŘDŽDWĹDWĹBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‘DWýBBjBlBíAŕHrÉ§Hrä$Hsv.ŘHsŠ .DW“WHITE AC4591001C4591001 1223 12231283AADVERSE EVENT 2 fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-20T19:00B„2021-05-21T12:00B… 1MedDRA v24.0NDW” AEłHsv©0DW•A D¨űHsw{A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C A Period 02DW”DŘHsv.ŘDYDŽHuq˝Vaccination 3 APY A02021-06-09T16:51:31Y 122312831223Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWD˝śHrÉ§DW¨DŽHsŠPlacebo APlacebo ADWD˝śDW%DÓ¤Y . . .Placebo Placebo DWEDW‘YPhase 3A@NNEGDW’ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW”DW¨DŘDŽDWĹDWĹBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‘DWýBBjBlBíAŕHrÉ§Hrä$Hsv.ŘHsŠ .DW“WHITE AC4591001C4591001 1223 12231283A ADVERSE EVENT 1 injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-20T18:00B„2021-05-22T08:00B† 1MedDRA v24.0NDW” ADý Hsv› DW–A0Dp»Hsx±»A0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Cŕ A Period 02DW”DŘHsv.ŘDYDŽHuq˝Vaccination 3 APY A02021-06-09T16:51:20Y 122312861223Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDçHrÍĹDWŞDŤHs“,Placebo APlacebo ADWDçDW*DÚčY . . .Placebo Placebo DWFDW’YPhase 3A@NNEGDW“ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW•DWŞD‘PDŤDWÉDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW’DWýBBiBkBęAđHrÍĹHręąčHsw€ĐHs“, .DW”WHITE AC4591001C4591001 1223 12231286AADVERSE EVENT 3 fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-21T19:00B‚2021-05-23T09:00B„ 1MedDRA v24.0NDW• AEłHswú°DW—A0D~ËHszKA0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C € A Period 02DW•D‘PHsw€ĐDYDŤHut_Vaccination 3 APY A02021-06-12T00:34:07Y 122312861223Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDçHrÍĹDWŞDŤHs“,Placebo APlacebo ADWDçDW*DÚčY . . .Placebo Placebo DWFDW’YPhase 3A@NNEGDW“ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW•DWŞD‘PDŤDWÉDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW’DWýBBiBkBęAđHrÍĹHręąčHsw€ĐHs“, .DW”WHITE AC4591001C4591001 1223 12231286A ADVERSE EVENT 5 fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-06-11T17:00B—2021-06-12T17:00B 1MedDRA v24.0NDWŞ ADďHs“ŽDW«A DďKHs”ßËA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C A Period 02DW•D‘PHsw€ĐDYDŤHut_Vaccination 4 A`Y A@2021-07-12T18:46:27Y 122312861223Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDçHrÍĹDWŞDŤHs“,Placebo APlacebo ADWDçDW*DÚčY . . .Placebo Placebo DWFDW’YPhase 3A@NNEGDW“ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW•DWŞD‘PDŤDWÉDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW’DWýBBiBkBęAđHrÍĹHręąčHsw€ĐHs“, .DW”WHITE AC4591001C4591001 1223 12231286A0ADVERSE EVENT 1 headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-02-05T09:00B2021-02-07T09:00B 1MedDRA v24.0NDW, A0D~HríDW.APD~ËHrďŁËA0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C›` APeriod 01DWDçHrÍĹDW•D‘OHsw€ĎVaccination 2 A Y A 2021-03-03T23:23:02 122312861223Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDçHrÍĹDWŞDŤHs“,Placebo APlacebo ADWDçDW*DÚčY . . .Placebo Placebo DWFDW’YPhase 3A@NNEGDW“ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW•DWŞD‘PDŤDWÉDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW’DWýBBiBkBęAđHrÍĹHręąčHsw€ĐHs“, .DW”WHITE AC4591001C4591001 1223 12231286A@ADVERSE EVENT 4 injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-06-11T17:00B—2021-06-12T17:00B 1MedDRA v24.0NDWŞ ADďHs“ŽDW«A DďKHs”ßËA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C A Period 02DW•D‘PHsw€ĐDYDŤHut_Vaccination 4 A`Y A@2021-07-12T18:46:15Y 122312861223Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDçHrÍĹDWŞDŤHs“,Placebo APlacebo ADWDçDW*DÚčY . . .Placebo Placebo DWFDW’YPhase 3A@NNEGDW“ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW•DWŞD‘PDŤDWÉDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW’DWýBBiBkBęAđHrÍĹHręąčHsw€ĐHs“, .DW”WHITE AC4591001C4591001 1223 12231286APADVERSE EVENT 2 fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-05-21T19:00B‚2021-05-22T09:00B 1MedDRA v24.0NDW• AEłHswú°DW–A D~ËHsxżËA DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C € A Period 02DW•D‘PHsw€ĐDYDŤHut_Vaccination 3 APY A02021-06-12T00:33:53Y 123512351235Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVéDĆHHr”óČDW¦D’|HsŤë|Placebo APlacebo ADVéDĆHDVţDĽpY . . .Placebo Placebo DWDWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW¦DÉD’|DWĂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýBĄBlBpCPAĐHr”óČHr°™pHssÄHsŤë| .DW‘WHITE AC4591001C4591001 1235 12351235AADVERSE EVENT 3 antibiotic side effect Adverse drug reaction FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Adverse reaction to antibiotics F™ŇF™‡7Therapeutic and nontherapeutic responses F™@Therapeutic and nontherapeutic effects (excl toxicity) F™ŚCGeneral disorders and administration site conditions FÝ2021-06-02 Bą2021-06-05 BĽ 2MedDRA v24.0NDWˇ B..DW¤B..A@DAYSN NNOT RELATEDOTHER unknown NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . A Period 02DW’DÉHssÄDYD’|HuoüVaccination 3 APY A02021-06-09T17:02:41Y 123512351235Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVéDĆHHr”óČDW¦D’|HsŤë|Placebo APlacebo ADVéDĆHDVţDĽpY . . .Placebo Placebo DWDWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW¦DÉD’|DWĂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýBĄBlBpCPAĐHr”óČHr°™pHssÄHsŤë| .DW‘WHITE AC4591001C4591001 1235 12351235A ADVERSE EVENT 1 ingrown toenail infection Paronychia FëůINFECTIONS AND INFESTATIONS Infection ingrowing toenail FëÉF™`Bacterial infections NEC F¦OBacterial infectious disorders F¦2Infections and infestations Fëů2021-05-24 B°2021-06-07 Bľ 2MedDRA v24.0NDW Ap..DW¦B..AđDAYSN NNOT RELATEDOTHER staph aureus NOT APPLICABLE YYRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . A Period 02DW’DÉHssÄDYD’|HuoüVaccination 3 APY A02021-06-08T00:02:07Y 123512351235Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVéDĆHHr”óČDW¦D’|HsŤë|Placebo APlacebo ADVéDĆHDVţDĽpY . . .Placebo Placebo DWDWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW¦DÉD’|DWĂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýBĄBlBpCPAĐHr”óČHr°™pHssÄHsŤë| .DW‘WHITE AC4591001C4591001 1235 12351235A0ADVERSE EVENT 2 cutaneous candidiasis Skin candida FëůINFECTIONS AND INFESTATIONS Skin candida NOS F™5éF™jCandida infections F˛^Fungal infectious disorders FÚřInfections and infestations Fëů2021-05-24 B°2021-06-07 Bľ 2MedDRA v24.0NDW Ap..DW¦B..AđDAYSN NNOT RELATEDOTHER candida species NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . A Period 02DW’DÉHssÄDYD’|HuoüVaccination 3 APY A02021-06-08T00:02:18Y 123512521235Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVţDÉHr°¦DW§DŚÜHsŹ7\Placebo APlacebo ADVţDÉDWDÖ°Y . . .Placebo Placebo DW1DWYPhase 3A@NNEGDW‘ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW§Dš8DŚÜDWĂDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWDWýB“BmBmCAĐHr°¦HrÍ´°HsrC¸HsŹ7\ .DWWHITE AC4591001C4591001 1235 12351252AADVERSE EVENT 1 allergic urticaria Urticaria F™5ŃSKIN AND SUBCUTANEOUS TISSUE DISORDERS Allergic urticaria FťFF™MUrticarias F™MAngioedema and urticaria FźúSkin and subcutaneous tissue disorders F™5Ń2021-06-27 B˝2021-06-29 Bż 2MedDRA v24.0NDWş B..DWĽB..A0DAYSN NNOT RELATEDOTHER bug bites NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . A Period 02DW‘Dš8HsrC¸DYDŚÜHupjÜVaccination 4 A`Y A@2021-07-09T17:18:38Y 127011731270Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADVéD¦hHr”ÓčDW D¤ÄHs†ÄPlacebo APlacebo ADVéD¦hDVţDŚÜY . . .Placebo Placebo DWDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW D¸ěD¤ÄDWĽDX]BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB¤BqBqCPAđHr”ÓčHr°iÜHsmlHs†Ä .DWŚWHITE AC4591001C4591001 1270 12701173AADVERSE EVENT 3 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-13T16:00BĄ2021-05-15T09:00B§ 1MedDRA v24.0NDWŤ ADáHsmD€DWŹA0D~ËHso…KA0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A B« A Period 02DWŤD¸ěHsmlDY D¤ÄHugHDVaccination 3 APY A02021-06-05T01:08:31Y 127011731270Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADVéD¦hHr”ÓčDW D¤ÄHs†ÄPlacebo APlacebo ADVéD¦hDVţDŚÜY . . .Placebo Placebo DWDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW D¸ěD¤ÄDWĽDX]BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB¤BqBqCPAđHr”ÓčHr°iÜHsmlHs†Ä .DWŚWHITE AC4591001C4591001 1270 12701173A ADVERSE EVENT 2 Injection Site Pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-13T16:00BĄ2021-05-14T09:00B¦ 1MedDRA v24.0NDWŤ ADáHsmD€DWŽA D~ËHsn3ËA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A B« A Period 02DWŤD¸ěHsmlDY D¤ÄHugHDVaccination 3 APY A02021-06-05T01:08:20Y 127011731270Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADVéD¦hHr”ÓčDW D¤ÄHs†ÄPlacebo APlacebo ADVéD¦hDVţDŚÜY . . .Placebo Placebo DWDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŤDW D¸ěD¤ÄDWĽDX]BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB¤BqBqCPAđHr”ÓčHr°iÜHsmlHs†Ä .DWŚWHITE AC4591001C4591001 1270 12701173A0ADVERSE EVENT 4 Generalized Body Aches Pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalised aching FÝF™ŰPain and discomfort NEC F™ÜGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-13T16:00BĄ2021-05-15T09:00B§ 1MedDRA v24.0NDWŤ ADáHsmD€DWŹA0D~ËHso…KA0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A B« A Period 02DWŤD¸ěHsmlDY D¤ÄHugHDVaccination 3 APY A02021-06-05T01:08:42Y 127011811270Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVëDĽ4Hr—Ś´DWhDÂHs<^Placebo APlacebo ADVëDĽ4DV˙DĽpY . . .Placebo Placebo DWDWRYPhase 3A@NNEGDWS BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWUDWhD·üDÂDW„DX%BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWRDWýBhB©B«C0AđHr—Ś´Hr±ęđHs#G|Hs<^ .DWTWHITE AC4591001C4591001 1270 12701181AADVERSE EVENT 1 Low Back Pain Back pain F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Low back pain F÷»F¦Musculoskeletal and connective tissue pain and discomfort F™ŁMusculoskeletal and connective tissue disorders NEC F™iMusculoskeletal and connective tissue disorders F™k2021-02-22 BS2021-03-29 Bv 1MedDRA v24.0NDW= B?..DW`Bb..B$DAYSN NNOT RELATEDOTHER Playing Soccer NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVëDĽ4Hr—Ś´DWUD·űHs#G{Follow Up 1 A0Y A 2021-04-08T02:19:39Y 127011881270Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MAHISPANIC OR LATINO AUSAASIAN A@DVěDx´Hrš´DWD‘ČHs—%HPlacebo APlacebo ADVěDx´DV˙D~ĚY . . .Placebo Placebo DW%DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DWDÂÄD‘ČDWËDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBˇBlBqC AĐHrš´Hr±LHss˝ÄHs—%H .DW‘ALL OTHERS A0C4591001C4591001 1270 12701188AADVERSE EVENT 2 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-18 B§2021-05-19T12:00B¨ 1MedDRA v24.0NDW’ A..DW“A D¨űHstő{A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW’DÂÄHss˝ÄDYD‘ČHuxXČVaccination 3 APY A02021-06-17T19:24:33Y 127011881270Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MAHISPANIC OR LATINO AUSAASIAN A@DVěDx´Hrš´DWD‘ČHs—%HPlacebo APlacebo ADVěDx´DV˙D~ĚY . . .Placebo Placebo DW%DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DWDÂÄD‘ČDWËDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBˇBlBqC AĐHrš´Hr±LHss˝ÄHs—%H .DW‘ALL OTHERS A0C4591001C4591001 1270 12701188A ADVERSE EVENT 1 Headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-05-18 B§2021-05-19T12:00B¨ 1MedDRA v24.0NDW’ A..DW“A D¨űHstő{A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW’DÂÄHss˝ÄDYD‘ČHuxXČVaccination 3 APY A02021-06-17T19:24:22Y 127012021270BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADVôDĹHrŁsDWDćÜHr˝ňÜBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVôDĹDWDćÜY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW%DWŚYPhase 3A@NNEGDWŤ ....... . .NY.DWŚDWýB™BqC AđHrŁsHr˝ňÜ.. .DW·WHITE AC4591001C4591001 1270 12701202AADVERSE EVENT 1 Left finger paronychia Paronychia FëůINFECTIONS AND INFESTATIONS Paronychia F™`F™`Bacterial infections NEC F¦OBacterial infectious disorders F¦2Infections and infestations Fëů2021-03-17 Ba2021-03-25 Bi 1MedDRA v24.0NDWT BM..DW\BU..ADAYSN NNOT RELATEDOTHER Hang nail NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVôDĹHrŁsDXuDćÜHtź&\Follow Up 1 A0Y A 2021-08-02T23:43:55Y 127012041270Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsANOT REPORTED ApMANOT HISPANIC OR LATINOA USANOT REPORTED ApDVřD~Hr¨rDW¦DÉHsŽ"Placebo APlacebo ADVřD~DWDŮY . . .Placebo Placebo DW*DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DĘ€DÉDWÉDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB•BmBqC`AŔHr¨rHrĹÎHsrtHsŽ" .DWALL OTHERS A0C4591001C4591001 1270 12701204AADVERSE EVENT 2 Chills Chills FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills F·ÓF·ÓFeelings and sensations NEC F™ŁGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-18T13:00B›2021-05-18 B› 1MedDRA v24.0NDW’ A D¶ĐHss±ĐDW’A ..ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CTŔ A Period 02DW‘DĘ€HsrtDYDÉHuoVVaccination 3 APY A02021-06-08T19:10:33Y 127012041270Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsANOT REPORTED ApMANOT HISPANIC OR LATINOA USANOT REPORTED ApDVřD~Hr¨rDW¦DÉHsŽ"Placebo APlacebo ADVřD~DWDŮY . . .Placebo Placebo DW*DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DĘ€DÉDWÉDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB•BmBqC`AŔHr¨rHrĹÎHsrtHsŽ" .DWALL OTHERS A0C4591001C4591001 1270 12701204A ADVERSE EVENT 3 Injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-18 B›2021-05-18 B› 1MedDRA v24.0NDW’ A ..DW’A ..ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW‘DĘ€HsrtDYDÉHuoVVaccination 3 APY A02021-06-08T19:10:47Y 127012041270Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsANOT REPORTED ApMANOT HISPANIC OR LATINOA USANOT REPORTED ApDVřD~Hr¨rDW¦DÉHsŽ"Placebo APlacebo ADVřD~DWDŮY . . .Placebo Placebo DW*DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DĘ€DÉDWÉDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB•BmBqC`AŔHr¨rHrĹÎHsrtHsŽ" .DWALL OTHERS A0C4591001C4591001 1270 12701204A0ADVERSE EVENT 1 Fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-05-18T13:00B›2021-05-18T20:00B› 2MedDRA v24.0NDW’ A D¶ĐHss±ĐDW’A E—°Hst{ADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A CTŔ A Period 02DW‘DĘ€HsrtDYDÉHuoVVaccination 3 APY A02021-06-08T19:10:22Y 127012051270Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAMULTIPLE A`FA NOT HISPANIC OR LATINOA USAMULTIRACIAL A`DVřDĘHr¨ľDWD‡<Hs—ĽPlacebo APlacebo ADVřDĘDW Dć(Y . . .Placebo Placebo DW*DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DWD|tD‡<DWĘDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB•BmBqC`AĐHr¨ľHrÄ‰¨Hsr%ôHs—Ľ .DWALL OTHERS A0C4591001C4591001 1270 12701205AADVERSE EVENT 3 Right Ingrown Toenail Ingrowing nail F™5ŃSKIN AND SUBCUTANEOUS TISSUE DISORDERS Ingrowing nail Fě}Fě}Nail and nail bed conditions (excl infections and infestations) F™ŤSkin appendage conditions F™5ŢSkin and subcutaneous tissue disorders F™5Ń2021-06-09 B±2021-06-30 BĆ 1MedDRA v24.0NDW¨ B..DW˝B-..BDAYSN NNOT RELATEDOTHER Unknown NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . A Period 02DW‘D|tHsr%ôDYD‡<HuxN<Vaccination 3 APY A02021-07-19T22:34:47Y 127012051270Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAMULTIPLE A`FA NOT HISPANIC OR LATINOA USAMULTIRACIAL A`DVřDĘHr¨ľDWD‡<Hs—ĽPlacebo APlacebo ADVřDĘDW Dć(Y . . .Placebo Placebo DW*DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DWD|tD‡<DWĘDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB•BmBqC`AĐHr¨ľHrÄ‰¨Hsr%ôHs—Ľ .DWALL OTHERS A0C4591001C4591001 1270 12701205A ADVERSE EVENT 2 Injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-17T10:51Bš2021-05-20T22:30Bť 1MedDRA v24.0NDW‘ AD”HsrBDW”A@EĘ0HsvÚŁA@DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Bx A Period 02DW‘D|tHsr%ôDYD‡<HuxN<Vaccination 3 APY A02021-06-17T19:24:44Y 127012051270Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAMULTIPLE A`FA NOT HISPANIC OR LATINOA USAMULTIRACIAL A`DVřDĘHr¨ľDWD‡<Hs—ĽPlacebo APlacebo ADVřDĘDW Dć(Y . . .Placebo Placebo DW*DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DWD|tD‡<DWĘDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB•BmBqC`AĐHr¨ľHrÄ‰¨Hsr%ôHs—Ľ .DWALL OTHERS A0C4591001C4591001 1270 12701205A0ADVERSE EVENT 1 Subcutaneous Tissue Abcess Right Earlobe Subcutaneous abscess FëůINFECTIONS AND INFESTATIONS Abscess of external ear F—¨F™;çSkin structures and soft tissue infections F™5ŇInfections - pathogen unspecified Fë÷Infections and infestations Fëů2020-12-19 AP2021-01-04 B 1MedDRA v24.0NDVü AP..DWB..BDAYSN NNOT RELATEDOTHER Ear piercing NOT APPLICABLE NYRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVřDĘHr¨ľDW‘D|sHsr%óVaccination 1 AY A2021-01-09T07:58:31 127012061270Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVřDÓŕHr¨ÇŕDWŻDŰ`HsšŕPlacebo APlacebo ADVřDÓŕDWDÝ¸Y . . .Placebo Placebo DW*DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWšDWŻD× DŰ`DWŇDXlBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB•BdBqC`AđHr¨ÇŕHrĹŇ¸Hs~^ Hsšŕ .DW™WHITE AC4591001C4591001 1270 12701206AADVERSE EVENT 2 FATIGUE Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-27T06:30B¤2021-05-27T15:00B¤ 2MedDRA v24.0NDW› A D[hHs3čDW›A DÓ+Hs««ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A C8ŕ A Period 02DWšD× Hs~^ DYDŰ`Hu{E`Vaccination 3 APY A02021-07-23T01:23:40Y 127012061270Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVřDÓŕHr¨ÇŕDWŻDŰ`HsšŕPlacebo APlacebo ADVřDÓŕDWDÝ¸Y . . .Placebo Placebo DW*DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWšDWŻD× DŰ`DWŇDXlBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB•BdBqC`AđHr¨ÇŕHrĹŇ¸Hs~^ Hsšŕ .DW™WHITE AC4591001C4591001 1270 12701206A ADVERSE EVENT 1 Injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-27T06:30B¤2021-05-27T15:00B¤ 1MedDRA v24.0NDW› A D[hHs3čDW›A DÓ+Hs««ADAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C8ŕ A Period 02DWšD× Hs~^ DYDŰ`Hu{E`Vaccination 3 APY A02021-06-21T18:53:49Y 127012061270Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVřDÓŕHr¨ÇŕDWŻDŰ`HsšŕPlacebo APlacebo ADVřDÓŕDWDÝ¸Y . . .Placebo Placebo DW*DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWšDWŻD× DŰ`DWŇDXlBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB•BdBqC`AđHr¨ÇŕHrĹŇ¸Hs~^ Hsšŕ .DW™WHITE AC4591001C4591001 1270 12701206A0ADVERSE EVENT 3 RIHT WRIST SPRAIN Ligament sprain FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Wrist sprain F™R3FöMuscle, tendon and ligament injuries F™Injuries NEC FěâInjury, poisoning and procedural complications Fěĺ2021-07-14 BÔ .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDWË B....... N NNOT RELATEDOTHER COLLISION WITH TEAMMATE DURING SOFTBALL NOT APPLICABLE YYRECOVERING/RESOLVING N A0NOT RELATEDA0AGRADE 1A . A Period 02DWšD× Hs~^ DYDŰ`Hu{E`Vaccination 4 A`Y A@2021-07-23T05:20:48Y 127012081270Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVůDłHr©ůDWDÚ4Hs—m´Placebo APlacebo ADVůDłDWDĽ¬Y . . .Placebo Placebo DW1DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DWDˇ¸DÚ4DWÍDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB”BkBqCPAŕHr©ůHrĹ±¬Hstî8Hs—m´ .DW’WHITE AC4591001C4591001 1270 12701208AADVERSE EVENT 1 Concussion without loss of conciousness Concussion FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Concussion FľŽFľŽCerebral injuries NEC F™dInjuries NEC FěâInjury, poisoning and procedural complications Fěĺ2021-03-11 BV2021-05 . 2MedDRA v24.0NDWN BA....... N NNOT RELATEDOTHER Hit in head by soccer ball NOT APPLICABLE NYRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVůDłHr©ůDW“Dˇ·Hstî7Follow Up 1 A0Y A 2021-07-20T00:20:28Y 127012081270Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVůDłHr©ůDWDÚ4Hs—m´Placebo APlacebo ADVůDłDWDĽ¬Y . . .Placebo Placebo DW1DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DWDˇ¸DÚ4DWÍDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB”BkBqCPAŕHr©ůHrĹ±¬Hstî8Hs—m´ .DW’WHITE AC4591001C4591001 1270 12701208A ADVERSE EVENT 2 Left Middle Finger Middle Phalanx Fracture Hand fracture FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Fractured finger FÚFá*Limb fractures and dislocations F™ľîBone and joint injuries F¶Injury, poisoning and procedural complications Fěĺ2021-03-11 BV2021-05-19 B› 2MedDRA v24.0NDWN BA..DW“B†..BFDAYSN NNOT RELATEDOTHER Hit by Soccer Ball NOT APPLICABLE NYRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVůDłHr©ůDW“Dˇ·Hstî7Follow Up 1 A0Y A 2021-05-21T20:41:39Y 127012081270Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVůDłHr©ůDWDÚ4Hs—m´Placebo APlacebo ADVůDłDWDĽ¬Y . . .Placebo Placebo DW1DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DWDˇ¸DÚ4DWÍDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB”BkBqCPAŕHr©ůHrĹ±¬Hstî8Hs—m´ .DW’WHITE AC4591001C4591001 1270 12701208A0ADVERSE EVENT 3 Right Middle Finger Phalanx Fracture Hand fracture FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Fractured finger FÚFá*Limb fractures and dislocations F™ľîBone and joint injuries F¶Injury, poisoning and procedural complications Fěĺ2021-03-11 BV2021-05-19 B› 2MedDRA v24.0NDWN BA..DW“B†..BFDAYSN NNOT RELATEDOTHER Hit by soccer Ball NOT APPLICABLE NYRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A . APeriod 01DVůDłHr©ůDW“Dˇ·Hstî7Follow Up 1 A0Y A 2021-06-25T17:15:36Y 127012131270Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVúD€čHr«čDWDˇ¸Hs—58Placebo APlacebo ADVúD€čDWD} Y . . .Placebo Placebo DW+DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DWD{„Dˇ¸DWĐDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB“BmBqC@AŔHr«čHrĆÄ Hsr%Hs—58 .DWWHITE AC4591001C4591001 1270 12701213AADVERSE EVENT 5 Chronic Abdominal Pain Abdominal pain FÜ›GASTROINTESTINAL DISORDERS Chronic abdominal pain F™šF–ŃGastrointestinal and abdominal pains (excl oral and throat) FÜ†Gastrointestinal signs and symptoms FÜÜGastrointestinal disorders FÜ›2021-01 . .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDWDA....... N NNOT RELATEDOTHER Dairy Intake NOT APPLICABLE YNNOT RECOVERED/NOT RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVúD€čHr«čDW‘D{Hsr%Vaccination 2 A Y A 2021-07-20T13:06:20Y 127012131270Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVúD€čHr«čDWDˇ¸Hs—58Placebo APlacebo ADVúD€čDWD} Y . . .Placebo Placebo DW+DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DWD{„Dˇ¸DWĐDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB“BmBqC@AŔHr«čHrĆÄ Hsr%Hs—58 .DWWHITE AC4591001C4591001 1270 12701213A ADVERSE EVENT 3 Fatigue Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-17T17:00B2021-05-18T08:00B™ 1MedDRA v24.0NDW‘ ADďHsrDW’A Dp»Hssk»A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A CĐ A Period 02DW‘D{„Hsr%DYDˇ¸Huxh¸Vaccination 3 APY A02021-06-17T19:25:19Y 127012131270Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVúD€čHr«čDWDˇ¸Hs—58Placebo APlacebo ADVúD€čDWD} Y . . .Placebo Placebo DW+DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DWD{„Dˇ¸DWĐDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB“BmBqC@AŔHr«čHrĆÄ Hsr%Hs—58 .DWWHITE AC4591001C4591001 1270 12701213A0ADVERSE EVENT 2 Headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-05-17T13:00B2021-05-18T08:00B™ 1MedDRA v24.0NDW‘ AD¶ĐHsr`PDW’A Dp»Hssk»A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Bý A Period 02DW‘D{„Hsr%DYDˇ¸Huxh¸Vaccination 3 APY A02021-06-17T19:25:06Y 127012131270Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVúD€čHr«čDWDˇ¸Hs—58Placebo APlacebo ADVúD€čDWD} Y . . .Placebo Placebo DW+DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DWD{„Dˇ¸DWĐDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB“BmBqC@AŔHr«čHrĆÄ Hsr%Hs—58 .DWWHITE AC4591001C4591001 1270 12701213A@ADVERSE EVENT 1 Injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-17T13:00B2021-05-18T08:00B™ 1MedDRA v24.0NDW‘ AD¶ĐHsr`PDW’A Dp»Hssk»A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Bý A Period 02DW‘D{„Hsr%DYDˇ¸Huxh¸Vaccination 3 APY A02021-06-17T19:24:55Y 127012131270Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVúD€čHr«čDWDˇ¸Hs—58Placebo APlacebo ADVúD€čDWD} Y . . .Placebo Placebo DW+DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DWD{„Dˇ¸DWĐDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB“BmBqC@AŔHr«čHrĆÄ Hsr%Hs—58 .DWWHITE AC4591001C4591001 1270 12701213APADVERSE EVENT 4 tendinitis of Left Ankle Tendonitis F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Tendinitis F™?`F™?wTendon disorders F™?bTendon, ligament and cartilage disorders F™?eMusculoskeletal and connective tissue disorders F™k2021-01 . .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDWDA....... N NNOT RELATEDOTHER Overuse injury from dance NOT APPLICABLE YYRECOVERING/RESOLVING N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVúD€čHr«čDW‘D{Hsr%Vaccination 2 A Y A 2021-07-27T00:44:04Y 127012161270Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAMULTIPLE A`FA NOT HISPANIC OR LATINOA USAMULTIRACIAL A`DVúDÂHr«YDW¦D ŚHsŤůŚPlacebo APlacebo ADVúDÂDWDĆY . . .Placebo Placebo DW*DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DÉD ŚDWÄDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB“BmBqC@AŔHr«YHrĹ»HsrsHsŤůŚ .DWALL OTHERS A0C4591001C4591001 1270 12701216AADVERSE EVENT 1 Syncope Syncope F™•NERVOUS SYSTEM DISORDERS Syncope F™=”F™=”Disturbances in consciousness NEC FËENeurological disorders NEC F™ůNervous system disorders F™•2021-05-17T13:19B2021-05-17T13:20B 2MedDRA v24.0NDW‘ B„D»DHsrdÄDW‘B„D»»Hsre;ADAYSN NNOT RELATEDOTHER Venipuncture NOT APPLICABLE NYRECOVERED/RESOLVED N A0NOT RELATEDA0A GRADE 2A E. APeriod 01DVúDÂHr«YDW‘DÉŹHsrsAfter unblinding and before Vaccination 3A@ A 2021-05-20T21:44:36Y 127012171270Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADVúDŐüHr«lüDWŻD¨HHs™ŢČPlacebo APlacebo ADVúDŐüDWDĘDY . . .Placebo Placebo DW,DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DWŻDĚ$D¨HDWËDXlBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB“BmBqC@AŔHr«lüHrČbDHsru¤Hs™ŢČ .DWWHITE AC4591001C4591001 1270 12701217AADVERSE EVENT 2 Acne Vulgaris Acne F™5ŃSKIN AND SUBCUTANEOUS TISSUE DISORDERS Acne vulgaris F‡FpAcnes FqSkin appendage conditions F™5ŢSkin and subcutaneous tissue disorders F™5Ń2021-02-10 B8 .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDW1 B"....... N NNOT RELATEDOTHER Unknown NOT APPLICABLE YNRECOVERING/RESOLVING N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVúDŐüHr«lüDW‘DĚ#HsruŁFollow Up 1 A0Y A 2021-05-20T21:44:58Y 127012171270Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADVúDŐüHr«lüDWŻD¨HHs™ŢČPlacebo APlacebo ADVúDŐüDWDĘDY . . .Placebo Placebo DW,DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DWŻDĚ$D¨HDWËDXlBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB“BmBqC@AŔHr«lüHrČbDHsru¤Hs™ŢČ .DWWHITE AC4591001C4591001 1270 12701217A ADVERSE EVENT 4 Injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-17T17:30B2021-05-19T17:30Bš 1MedDRA v24.0NDW‘ ADöHsrźDW“A0DöSHsuBÓA0DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A Bł A Period 02DW‘DĚ$Hsru¤DYD¨HHu{HVaccination 3 APY A02021-06-21T18:54:03Y 127012171270Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADVúDŐüHr«lüDWŻD¨HHs™ŢČPlacebo APlacebo ADVúDŐüDWDĘDY . . .Placebo Placebo DW,DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DWŻDĚ$D¨HDWËDXlBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB“BmBqC@AŔHr«lüHrČbDHsru¤Hs™ŢČ .DWWHITE AC4591001C4591001 1270 12701217A0ADVERSE EVENT 1 Melanocytic Nevus Melanocytic naevus F™0NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)Melanocytic nevus F™‹ÍF™‰Skin neoplasms benign F™6BCutaneous neoplasms benign F™6CNeoplasms benign, malignant and unspecified (incl cysts and polyps)F™02021-02-10 B8 .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDW1 B"....... N NNOT RELATEDOTHER Unknown NOT APPLICABLE NNNOT RECOVERED/NOT RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVúDŐüHr«lüDW‘DĚ#HsruŁFollow Up 1 A0Y A 2021-05-20T21:45:41Y 127012171270Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADVúDŐüHr«lüDWŻD¨HHs™ŢČPlacebo APlacebo ADVúDŐüDWDĘDY . . .Placebo Placebo DW,DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DWŻDĚ$D¨HDWËDXlBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB“BmBqC@AŔHr«lüHrČbDHsru¤Hs™ŢČ .DWWHITE AC4591001C4591001 1270 12701217A@ADVERSE EVENT 3 Seborrheic Dermatitis to scalp Seborrhoeic dermatitis F™5ŃSKIN AND SUBCUTANEOUS TISSUE DISORDERS Seborrhoeic dermatitis capitis F™1ňF™1ńDermatitis and eczema FÇEpidermal and dermal conditions FŃSkin and subcutaneous tissue disorders F™5Ń2021-02-10 B8 .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDW1 B"....... N NNOT RELATEDOTHER UNKNOWN NOT APPLICABLE YNRECOVERING/RESOLVING N A0NOT RELATEDA0AGRADE 1A . APeriod 01DVúDŐüHr«lüDW‘DĚ#HsruŁFollow Up 1 A0Y A 2021-05-21T22:20:58Y 127012211270Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVűD´´Hr¬ť4DWDÔĐHs—hPPlacebo APlacebo ADVűD´´DWDĄđY . . .Placebo Placebo DW*DWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWšDWD§ĐDÔĐDWÉDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýB“BdBpC0AŔHr¬ť4HrĹšđHs~.ĐHs—hP .DW™WHITE AC4591001C4591001 1270 12701221AADVERSE EVENT 1 Chills Chills FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills F·ÓF·ÓFeelings and sensations NEC F™ŁGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-26T19:00B 2021-05-27T19:00Bˇ 1MedDRA v24.0NDWš AEłHs~’0DW›A E¶°HsăëA DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C€ A Period 02DWšD§ĐHs~.ĐDYDÔĐHux›ĐVaccination 3 APY A02021-06-17T19:25:53Y 127012211270Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVűD´´Hr¬ť4DWDÔĐHs—hPPlacebo APlacebo ADVűD´´DWDĄđY . . .Placebo Placebo DW*DWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWšDWD§ĐDÔĐDWÉDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýB“BdBpC0AŔHr¬ť4HrĹšđHs~.ĐHs—hP .DW™WHITE AC4591001C4591001 1270 12701221A ADVERSE EVENT 2 Right otalgia Ear pain FÍ)EAR AND LABYRINTH DISORDERS Otalgia F™ČFÍDEar disorders NEC F™’Aural disorders NEC F™“Ear and labyrinth disorders FÍ)2021-07-02 BĹ2021-07-08 BË 1MedDRA v24.0NDWż B..DWĹB..ApDAYSN NNOT RELATEDOTHER Swimming in Ocean NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . A Period 02DWšD§ĐHs~.ĐDYDÔĐHux›ĐVaccination 4 A`Y A@2021-07-14T19:06:52Y 127012231270Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADVűDčřHr¬ŃxDW®D,Hsm,Placebo APlacebo ADVűDčřDWDĺěY . . .Placebo Placebo DW1DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW”DW®DÚčD,DWĘDXkBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB’BjBqC0AĐHr¬ŃxHrČ}ěHsvxčHsm, .DW“WHITE AC4591001C4591001 1270 12701223AADVERSE EVENT 2 Body Aches Pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalized aching F™Š\F™ŰPain and discomfort NEC F™ÜGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-21 B›2021-05-22 Bś 1MedDRA v24.0NDW• A ..DW–A0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW”DÚčHsvxčDYD,Huy ¬Vaccination 3 APY A02021-05-27T16:22:53Y 127012231270Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADVűDčřHr¬ŃxDW®D,Hsm,Placebo APlacebo ADVűDčřDWDĺěY . . .Placebo Placebo DW1DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW”DW®DÚčD,DWĘDXkBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB’BjBqC0AĐHr¬ŃxHrČ}ěHsvxčHsm, .DW“WHITE AC4591001C4591001 1270 12701223A ADVERSE EVENT 1 Fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-05-21 B›2021-05-22 Bś 1MedDRA v24.0NDW• A ..DW–A0..A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW”DÚčHsvxčDYD,Huy ¬Vaccination 3 APY A02021-05-27T16:22:42Y 127012271270Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DW DřHrÄ#xDW§Dr`HsŹŕPlacebo APlacebo ADW DřDW$DáY . . .Placebo Placebo DWEDWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW§D×(Dr`DWÄDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýBBlBpBńAĐHrÄ#xHrâ×HssŇ(HsŹŕ .DW‘ALL OTHERS A0C4591001C4591001 1270 12701227AADVERSE EVENT 1 Headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-05-19T07:15B‡2021-05-19T21:00B‡ 1MedDRA v24.0NDW“ A DeôHst˛tDW“A Ex°HsutADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C;Đ A Period 02DW’D×(HssŇ(DYDr`HupP`Vaccination 3 APY A02021-06-17T19:26:04Y 127012271270Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAASIAN A@MANOT HISPANIC OR LATINOA USAASIAN A@DW DřHrÄ#xDW§Dr`HsŹŕPlacebo APlacebo ADW DřDW$DáY . . .Placebo Placebo DWEDWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW§D×(Dr`DWÄDXdBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýBBlBpBńAĐHrÄ#xHrâ×HssŇ(HsŹŕ .DW‘ALL OTHERS A0C4591001C4591001 1270 12701227A ADVERSE EVENT 2 Generalized Myalgia Myalgia F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Myalgia F™{F™{Muscle pains F™#Muscle disorders F™Musculoskeletal and connective tissue disorders F™k2021-05-19T07:15B‡2021-05-19T21:00B‡ 1MedDRA v24.0NDW“ A DeôHst˛tDW“A Ex°HsutADAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C;Đ A Period 02DW’D×(HssŇ(DYDr`HupP`Vaccination 3 APY A02021-06-17T19:26:15Y 127012281270Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADW DXHrÄ;ŘDW˘DľŚHsŃŚPlacebo APlacebo ADW DXDW"DťY . . .Placebo Placebo DW>DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDW˘DłLDľŚDWĂDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB€BpBqBńAŔHrÄ;ŘHrßđHsnhLHsŃŚ .DWŤWHITE AC4591001C4591001 1270 12701228AADVERSE EVENT 1 Dysuria Dysuria F™,WRENAL AND URINARY DISORDERS Dysuria FÍ&FÍ&Bladder and urethral symptoms FŞUrinary tract signs and symptoms F™L~Renal and urinary disorders F™,W2021-06-09 Bś2021-06-11 Bž 1MedDRA v24.0NDW¨ Ap..DWŞA..A0DAYSN NNOT RELATEDOTHER Prolong time in wet swimsuit NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . A Period 02DWŽDłLHsnhLDYDľŚHujVaccination 4 A`Y A@2021-07-13T19:09:27Y 127012331270BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADW Dâ¤HrÄ†$DW"DÜPHrŕ/PBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DW Dâ¤DW"DÜPY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW@DWŚYPhase 3A@NNEGDWŤ ....... . .NY.DWŚDWýB€BqBńAŕHrÄ†$Hrŕ/P.. .DWÚWHITE AC4591001C4591001 1270 12701233AADVERSE EVENT 1 Rectal Prolapse Rectal prolapse FÜ›GASTROINTESTINAL DISORDERS Rectal prolapse F™+=F™+=Anal and rectal disorders NEC FžÁAnal and rectal conditions NEC FžŔGastrointestinal disorders FÜ›2021-02-22 B1 .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDW= B....... N NNOT RELATEDOTHER Chronic Intermittent Constipation NOT APPLICABLE YNRECOVERING/RESOLVING N A0NOT RELATEDA0AGRADE 1A . APeriod 01DW Dâ¤HrÄ†$DXŹDÜPHtÁbĐVaccination 2 A Y A 2021-03-03T03:23:59 127012361270Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWD×(HrĹĚ(DW¦DĘHsŽ#Placebo APlacebo ADWD×(DW!DË¬Y . . .Placebo Placebo DW>DWŤYPhase 3A@NNEGDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW¦DÂLDĘDWÄDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWýB€BlBpBđAŕHrĹĚ(HrŢÍ,Hss˝LHsŽ# .DW‘WHITE AC4591001C4591001 1270 12701236AADVERSE EVENT 1 Anxiety Anxiety F™'·PSYCHIATRIC DISORDERS Anxiety Fˇ§Fˇ§Anxiety symptoms FˇµAnxiety disorders and symptoms FˇPsychiatric disorders F™'·2021-01-11 A` .ONGOINGLAST SUBJECT ENCOUNTER1MedDRA v24.0NDW A`....... N NNOT RELATEDOTHER Social Situations NOT APPLICABLE NNRECOVERING/RESOLVING N A0NOT RELATEDA0AGRADE 1A . APeriod 01DWD×(HrĹĚ(DW’DÂKHss˝KVaccination 1 AY A2021-01-27T00:52:50 127012371270Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAAMERICAN INDIAN OR ALASKA NATIVE A0FA HISPANIC OR LATINO AUSAAMERICAN INDIAN OR ALASKA NATIVE A0DWD¤HrĆĎ$DW“D‹tHst×ôPlacebo APlacebo ADWD¤..Y . . .Placebo DWZDWŤYPhase 3A@NPOSDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW“.D‹t.DWÍDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWĘBB8B=BĽAĐHrĆĎ$HrĆĎ$Hst×ôHst×ô .DW’ALL OTHERS A0C4591001C4591001 1270 12701237AADVERSE EVENT 10INTERMITTENT STOMACH PAIN Abdominal pain upper FÜ›GASTROINTESTINAL DISORDERS Stomach pain F™;F–×Gastrointestinal and abdominal pains (excl oral and throat) FÜ†Gastrointestinal signs and symptoms FÜÜGastrointestinal disorders FÜ›2021-05-25 B‹2021-07-13 BĽ 2MedDRA v24.0NDW™ Ap..DWĘB8..B2DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DW“D‹tHst×ôDYD‹tHuVtVaccination 3 APY A02021-07-16T23:15:47Y 127012371270Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAAMERICAN INDIAN OR ALASKA NATIVE A0FA HISPANIC OR LATINO AUSAAMERICAN INDIAN OR ALASKA NATIVE A0DWD¤HrĆĎ$DW“D‹tHst×ôPlacebo APlacebo ADWD¤..Y . . .Placebo DWZDWŤYPhase 3A@NPOSDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW“.D‹t.DWÍDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWĘBB8B=BĽAĐHrĆĎ$HrĆĎ$Hst×ôHst×ô .DW’ALL OTHERS A0C4591001C4591001 1270 12701237A ADVERSE EVENT 4 CHILLS Chills FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills F·ÓF·ÓFeelings and sensations NEC F™ŁGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-19 B…2021-05-21 B‡ 1MedDRA v24.0NDW“ A..DW•A0..A0DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW“D‹tHst×ôDYD‹tHuVtVaccination 3 APY A02021-07-16T20:37:36Y 127012371270Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAAMERICAN INDIAN OR ALASKA NATIVE A0FA HISPANIC OR LATINO AUSAAMERICAN INDIAN OR ALASKA NATIVE A0DWD¤HrĆĎ$DW“D‹tHst×ôPlacebo APlacebo ADWD¤..Y . . .Placebo DWZDWŤYPhase 3A@NPOSDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW“.D‹t.DWÍDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWĘBB8B=BĽAĐHrĆĎ$HrĆĎ$Hst×ôHst×ô .DW’ALL OTHERS A0C4591001C4591001 1270 12701237A0ADVERSE EVENT 8 LOSS OF APPETITE Decreased appetite F™©METABOLISM AND NUTRITION DISORDERS Appetite lost F˘TF™†tAppetite disorders F˘NAppetite and general nutritional disorders F˘JMetabolism and nutrition disorders F™©2021-05-25 B‹2021-07-13 BĽ 2MedDRA v24.0NDW™ Ap..DWĘB8..B2DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DW“D‹tHst×ôDYD‹tHuVtVaccination 3 APY A02021-07-16T23:14:49Y 127012371270Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAAMERICAN INDIAN OR ALASKA NATIVE A0FA HISPANIC OR LATINO AUSAAMERICAN INDIAN OR ALASKA NATIVE A0DWD¤HrĆĎ$DW“D‹tHst×ôPlacebo APlacebo ADWD¤..Y . . .Placebo DWZDWŤYPhase 3A@NPOSDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW“.D‹t.DWÍDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWĘBB8B=BĽAĐHrĆĎ$HrĆĎ$Hst×ôHst×ô .DW’ALL OTHERS A0C4591001C4591001 1270 12701237A@ADVERSE EVENT 11FATIGUE Fatigue FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue FÖFÖAsthenic conditions F¤^General system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-25 B‹2021-07-13 BĽ 3MedDRA v24.0NDW™ Ap..DWĘB8..B2DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA0GRADE 3A0 . A Period 02DW“D‹tHst×ôDYD‹tHuVtVaccination 3 APY A02021-07-16T23:14:09Y 127012371270Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAAMERICAN INDIAN OR ALASKA NATIVE A0FA HISPANIC OR LATINO AUSAAMERICAN INDIAN OR ALASKA NATIVE A0DWD¤HrĆĎ$DW“D‹tHst×ôPlacebo APlacebo ADWD¤..Y . . .Placebo DWZDWŤYPhase 3A@NPOSDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW“.D‹t.DWÍDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWĘBB8B=BĽAĐHrĆĎ$HrĆĎ$Hst×ôHst×ô .DW’ALL OTHERS A0C4591001C4591001 1270 12701237APADVERSE EVENT 5 INTERMITTENT HEADACHES Headache F™•NERVOUS SYSTEM DISORDERS Intermittent headache F™~ Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-05-19 B…2021-07-13 BĽ 2MedDRA v24.0NDW“ A..DWĘB8..B8DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DW“D‹tHst×ôDYD‹tHuVtVaccination 3 APY A02021-07-16T23:16:30Y 127012371270Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAAMERICAN INDIAN OR ALASKA NATIVE A0FA HISPANIC OR LATINO AUSAAMERICAN INDIAN OR ALASKA NATIVE A0DWD¤HrĆĎ$DW“D‹tHst×ôPlacebo APlacebo ADWD¤..Y . . .Placebo DWZDWŤYPhase 3A@NPOSDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW“.D‹t.DWÍDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWĘBB8B=BĽAĐHrĆĎ$HrĆĎ$Hst×ôHst×ô .DW’ALL OTHERS A0C4591001C4591001 1270 12701237A`ADVERSE EVENT 1 Rib pain on right side Musculoskeletal chest pain F™kMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Rib pain F™TŇF™]Musculoskeletal and connective tissue pain and discomfort F™ŁMusculoskeletal and connective tissue disorders NEC F™iMusculoskeletal and connective tissue disorders F™k2021-02-10 B#2021-03-10 B? 1MedDRA v24.0NDW1 B#..DWMB?..BDAYSN NNOT RELATEDOTHER Unknown NOT APPLICABLE NNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DWD¤HrĆĎ$DW“D‹sHst×óVaccination 1 AY A2021-03-23T17:26:27 127012371270Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAAMERICAN INDIAN OR ALASKA NATIVE A0FA HISPANIC OR LATINO AUSAAMERICAN INDIAN OR ALASKA NATIVE A0DWD¤HrĆĎ$DW“D‹tHst×ôPlacebo APlacebo ADWD¤..Y . . .Placebo DWZDWŤYPhase 3A@NPOSDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW“.D‹t.DWÍDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWĘBB8B=BĽAĐHrĆĎ$HrĆĎ$Hst×ôHst×ô .DW’ALL OTHERS A0C4591001C4591001 1270 12701237ApADVERSE EVENT 7 INTERMITTENT NAUSEA Nausea FÜ›GASTROINTESTINAL DISORDERS Nausea F™ F™ Nausea and vomiting symptoms F™Gastrointestinal signs and symptoms FÜÜGastrointestinal disorders FÜ›2021-05-19 B…2021-07-13 BĽ 2MedDRA v24.0NDW“ A..DWĘB8..B8DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DW“D‹tHst×ôDYD‹tHuVtVaccination 3 APY A02021-07-16T23:17:55Y 127012371270Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAAMERICAN INDIAN OR ALASKA NATIVE A0FA HISPANIC OR LATINO AUSAAMERICAN INDIAN OR ALASKA NATIVE A0DWD¤HrĆĎ$DW“D‹tHst×ôPlacebo APlacebo ADWD¤..Y . . .Placebo DWZDWŤYPhase 3A@NPOSDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW“.D‹t.DWÍDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWĘBB8B=BĽAĐHrĆĎ$HrĆĎ$Hst×ôHst×ô .DW’ALL OTHERS A0C4591001C4591001 1270 12701237A€ADVERSE EVENT 6 INTERMITTENT NON-CARDIAC CHEST DISCOMFORT Non-cardiac chest pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Non-cardiac chest pain F™ŠĄF™ŠĄPain and discomfort NEC F™ÜGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-19 B…2021-07-13 BĽ 2MedDRA v24.0NDW“ A..DWĘB8..B8DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AA GRADE 2A . A Period 02DW“D‹tHst×ôDYD‹tHuVtVaccination 3 APY A02021-07-20T13:02:43Y 127012371270Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAAMERICAN INDIAN OR ALASKA NATIVE A0FA HISPANIC OR LATINO AUSAAMERICAN INDIAN OR ALASKA NATIVE A0DWD¤HrĆĎ$DW“D‹tHst×ôPlacebo APlacebo ADWD¤..Y . . .Placebo DWZDWŤYPhase 3A@NPOSDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW“.D‹t.DWÍDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWĘBB8B=BĽAĐHrĆĎ$HrĆĎ$Hst×ôHst×ô .DW’ALL OTHERS A0C4591001C4591001 1270 12701237AADVERSE EVENT 12LEFT OTITIS MEDIA Otitis media FëůINFECTIONS AND INFESTATIONS Otitis media F™¶F™¶Ear infections FÍ=Infections - pathogen unspecified Fë÷Infections and infestations Fëů2021-06-29 B®2021-07-06 Bµ 1MedDRA v24.0NDWĽ B*..DWĂB1..A€DAYSN NNOT RELATEDOTHER UNKNOWN NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . A Period 02DW“D‹tHst×ôDYD‹tHuVtVaccination 3 APY A02021-07-15T00:53:18Y 127012371270Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAAMERICAN INDIAN OR ALASKA NATIVE A0FA HISPANIC OR LATINO AUSAAMERICAN INDIAN OR ALASKA NATIVE A0DWD¤HrĆĎ$DW“D‹tHst×ôPlacebo APlacebo ADWD¤..Y . . .Placebo DWZDWŤYPhase 3A@NPOSDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW“.D‹t.DWÍDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWĘBB8B=BĽAĐHrĆĎ$HrĆĎ$Hst×ôHst×ô .DW’ALL OTHERS A0C4591001C4591001 1270 12701237A ADVERSE EVENT 3 Fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-05-20 B†2021-05-21 B‡ 1MedDRA v24.0NDW” A ..DW•A0..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW“D‹tHst×ôDYD‹tHuVtVaccination 3 APY A02021-06-24T14:40:30Y 127012371270Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAAMERICAN INDIAN OR ALASKA NATIVE A0FA HISPANIC OR LATINO AUSAAMERICAN INDIAN OR ALASKA NATIVE A0DWD¤HrĆĎ$DW“D‹tHst×ôPlacebo APlacebo ADWD¤..Y . . .Placebo DWZDWŤYPhase 3A@NPOSDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW“.D‹t.DWÍDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWĘBB8B=BĽAĐHrĆĎ$HrĆĎ$Hst×ôHst×ô .DW’ALL OTHERS A0C4591001C4591001 1270 12701237A°ADVERSE EVENT 2 Rash on Right Foot Rash F™5ŃSKIN AND SUBCUTANEOUS TISSUE DISORDERS Rash F™*TF™*TRashes, eruptions and exanthems NEC F™cÖEpidermal and dermal conditions FŃSkin and subcutaneous tissue disorders F™5Ń2021-04-05 BY2021-04-08 B\ 1MedDRA v24.0NDWg BY..DWjB\..A@DAYSN NNOT RELATEDOTHER UNKNOWN NOT APPLICABLE YNRECOVERED/RESOLVED N A0NOT RELATEDA0AGRADE 1A . APeriod 01DWD¤HrĆĎ$DW“D‹sHst×óFollow Up 1 A0Y A2021-05-19T21:47:38Y 127012371270Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAAMERICAN INDIAN OR ALASKA NATIVE A0FA HISPANIC OR LATINO AUSAAMERICAN INDIAN OR ALASKA NATIVE A0DWD¤HrĆĎ$DW“D‹tHst×ôPlacebo APlacebo ADWD¤..Y . . .Placebo DWZDWŤYPhase 3A@NPOSDWŽ BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW“.D‹t.DWÍDXgBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŤDWĘBB8B=BĽAĐHrĆĎ$HrĆĎ$Hst×ôHst×ô .DW’ALL OTHERS A0C4591001C4591001 1270 12701237AŔADVERSE EVENT 9 INCREASED THIRST Thirst FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Increased thirst Fë9F™@BFeelings and sensations NEC F™ŁGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-25 B‹2021-06-12 Bť 1MedDRA v24.0NDW™ Ap..DW«B..BDAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A . A Period 02DW“D‹tHst×ôDYD‹tHuVtVaccination 3 APY A02021-07-15T21:19:43Y 127012411270Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADWDŢ¨HrÇ%(DWDŃHs—ePlacebo APlacebo ADWDŢ¨DW#DÔY . . .Placebo Placebo DW?DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DWD‘ČDŃDWËDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB~BkBqBďAĐHrÇ%(HráxśHstŢHHs—e .DW’WHITE AC4591001C4591001 1270 12701241AADVERSE EVENT 2 Chills Chills FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills F·ÓF·ÓFeelings and sensations NEC F™ŁGeneral system disorders NEC FÝGeneral disorders and administration site conditions FÝ2021-05-19T21:00B…2021-05-20T16:00B† 1MedDRA v24.0NDW“ AEuHsusĐDW”A Dá;Hsv;A DAYSN NRELATED NOT APPLICABLE NNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C'ŕ A Period 02DW“D‘ČHstŢHDYDŃHuxVaccination 3 APY A02021-06-17T19:26:37Y 127012411270Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADWDŢ¨HrÇ%(DWDŃHs—ePlacebo APlacebo ADWDŢ¨DW#DÔY . . .Placebo Placebo DW?DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DWD‘ČDŃDWËDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB~BkBqBďAĐHrÇ%(HráxśHstŢHHs—e .DW’WHITE AC4591001C4591001 1270 12701241A ADVERSE EVENT 3 Headache Headache F™•NERVOUS SYSTEM DISORDERS Headache Fá‹Fá‹Headaches NEC FáˇHeadaches FáźNervous system disorders F™•2021-05-19T21:00B…2021-05-20T16:00B† 1MedDRA v24.0NDW“ AEuHsusĐDW”A Dá;Hsv;A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C'ŕ A Period 02DW“D‘ČHstŢHDYDŃHuxVaccination 3 APY A02021-06-17T19:26:48Y 127012411270Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADWDŢ¨HrÇ%(DWDŃHs—ePlacebo APlacebo ADWDŢ¨DW#DÔY . . .Placebo Placebo DW?DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW“DWD‘ČDŃDWËDXjBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB~BkBqBďAĐHrÇ%(HráxśHstŢHHs—e .DW’WHITE AC4591001C4591001 1270 12701241A0ADVERSE EVENT 1 Fever Pyrexia FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fever F×.F™)śFebrile disorders FÖBody temperature conditions F”General disorders and administration site conditions FÝ2021-05-19T21:00B…2021-05-20T16:00B† 1MedDRA v24.0NDW“ AEuHsusĐDW”A Dá;Hsv;A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C'ŕ A Period 02DW“D‘ČHstŢHDYDŃHuxVaccination 3 APY A02021-06-17T19:26:26Y 127012441270Placebo PLACEBO Placebo PLACEBO AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDĺ8HrĚq¸DW¦DáxHsŽ:xPlacebo APlacebo ADWDĺ8DW)DĂ´Y . . .Placebo Placebo DWEDWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW’DW¦DÚčDáxDWÉDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýBzBlBqBëAŕHrĚq¸HréQ4HssŐčHsŽ:x .DW‘WHITE AC4591001C4591001 1270 12701244AADVERSE EVENT 1 Injection site pain Injection site pain FÝGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain FěĆFěĆInjection site reactions FěŃAdministration site reactions F›¤General disorders and administration site conditions FÝ2021-05-18T21:00B€2021-05-19 B 1MedDRA v24.0NDW’ AEuHst"PDW“A ..A DAYSN NRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N ARELATED AAGRADE 1A C` A Period 02DW’DÚčHssŐčDYDáxHuomřVaccination 3 APY A02021-06-08T19:10:57Y 100612721006BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsABLACK OR AFRICAN AMERICAN A FA NOT HISPANIC OR LATINOA USABLACK OR AFRICAN AMERICAN A DVůDŞdHr©ďäDW‘DęśHsr”BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVůDŞd..Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g) DWŤDWŤYPhase 3A@NNEGDWŽBNT162b2 (30 (*ESC*){unicode 03BC}g) DW‘...... . .NN.DWŤDWýB•BpCPAĐHr©ďäHsr”.. .DXNBLACK OR AFRICAN AMERICANA C4591001C4591001 1006 10061272AADVERSE EVENT 2 Worsening of anxiety Anxiety F™'·PSYCHIATRIC DISORDERS Anxiety aggravated F™SSFˇ§Anxiety symptoms FˇµAnxiety disorders and symptoms FˇPsychiatric disorders F™'·2020-12-23 A€2021-01-18 B" 3MedDRA v24.0NDW A€..DWB"..BDAYSYNNNYNNNNOT RELATEDOTHER Stress NOT APPLICABLE YYRECOVERED/RESOLVED N(b)(6) A0NOT RELATEDA0A0GRADE 3A0 . APeriod 01DVůDŞdHr©ďäDXţDęśHuSÇśVaccination 1 AY A2021-05-25T17:10:07 Actions to the AE changed from EUA to sBLA 100612721006BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsABLACK OR AFRICAN AMERICAN A FA NOT HISPANIC OR LATINOA USABLACK OR AFRICAN AMERICAN A DVůDŞdHr©ďäDW‘DęśHsr”BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVůDŞd..Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g) DWŤDWŤYPhase 3A@NNEGDWŽBNT162b2 (30 (*ESC*){unicode 03BC}g) DW‘...... . .NN.DWŤDWýB•BpCPAĐHr©ďäHsr”.. .DXNBLACK OR AFRICAN AMERICANA C4591001C4591001 1006 10061272A0ADVERSE EVENT 1 Worsening of Depression Depression F™'·PSYCHIATRIC DISORDERS Depression worsened FĆîFĆÚDepressive disorders FĆńDepressed mood disorders and disturbances FĆ×Psychiatric disorders F™'·2020-12-23 A€2021-01-18 B" 3MedDRA v24.0NDW A€..DWB"..BDAYSYNNNYNNNNOT RELATEDOTHER Stress NOT APPLICABLE YYRECOVERED/RESOLVED N(b)(6) A0NOT RELATEDA0A0GRADE 3A0 . APeriod 01DVůDŞdHr©ďäDXţDęśHuSÇśVaccination 1 AY A2021-05-18T14:26:44 Actions to the AE changed from EUA to sBLA 100716201007BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA HISPANIC OR LATINO AUSAWHITE ADWD’¸HrĽM8DWDčHrŘRBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWD’¸DWDčY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW9DWYPhase 3A@NNEGDW‘ ....... . .NY.DWDWýBŠBmB÷AŔHrĽM8HrŘR.. .DWËWHITE AC4591001C4591001 1007 10071620A`ADVERSE EVENT 3 generalized Functional neurologic disorder Conversion disorder F™'·PSYCHIATRIC DISORDERS Functional neurological symptom disorder F™Ç„FÁ Somatic symptom disorders F™ĹkSomatic symptom and related disorders F™ĹjPsychiatric disorders F™'·2021-01-21 B .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDW A ....... YNNNYNNNNOT RELATEDOTHER functional; multiple life stressors NOT APPLICABLE YNNOT RECOVERED/NOT RESOLVED N(b)(6) A0NOT RELATEDA0A GRADE 2A . APeriod 01DWD’¸HrĽM8DX‰DčHtą…Vaccination 2 A Y A 2021-06-08T19:26:51 AEDECOD, AE outcome, AERELTXT changed from EUA to sBLA 114712811147Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVőD–đHr¤–pDW˘D” Hs§ Placebo APlacebo ADVőD–đDWDé¬Y . . .Placebo Placebo DW-DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDW˘DÍPD” DWÄDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB—BpBrCAĐHr¤–pHrĂ;¬Hsn‚PHs§ .DWŤWHITE AC4591001C4591001 1147 11471281AADVERSE EVENT 1 Acute appendicitis Appendicitis FëůINFECTIONS AND INFESTATIONS Acute appendicitis F™%F˘CAbdominal and gastrointestinal infections FÜŻInfections - pathogen unspecified Fë÷Infections and infestations Fëů2021-01-22T16:00B*2021-01-23T00:01B+ 4MedDRA v24.0NDW BDáHrÚîDWBBwHrŰ^÷A DAYSYNNNYYYNNOT RELATEDOTHER Acute appendicitis NOT APPLICABLE YYRECOVERED/RESOLVED N(b)(6) A0NOT RELATEDA0A@GRADE 4A@ De APeriod 01DVőD–đHr¤–pDWŽDÍOHsn‚OVaccination 2 A Y A 2021-02-19T18:08:58 114712811147Placebo PLACEBO Placebo PLACEBO AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADVőD–đHr¤–pDW˘D” Hs§ Placebo APlacebo ADVőD–đDWDé¬Y . . .Placebo Placebo DW-DW‹YPhase 3A@NNEGDWŚ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWŽDW˘DÍPD” DWÄDX_BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW‹DWýB—BpBrCAĐHr¤–pHrĂ;¬Hsn‚PHs§ .DWŤWHITE AC4591001C4591001 1147 11471281A ADVERSE EVENT 2 localized peritonitis, without perforation or gangrene Focal peritonitis FëůINFECTIONS AND INFESTATIONS Localized peritonitis F™á[F™áYAbdominal and gastrointestinal infections FÜŻInfections - pathogen unspecified Fë÷Infections and infestations Fëů2021-01-22T16:00B*2021-01-23T00:01B+ 4MedDRA v24.0NDW BDáHrÚîDWBBwHrŰ^÷A DAYSYNNNNYYNNOT RELATEDOTHER Acute appendicitis NOT APPLICABLE YYRECOVERED/RESOLVED N(b)(6) A0NOT RELATEDA0A@GRADE 4A@ De APeriod 01DVőD–đHr¤–pDWŽDÍOHsn‚OVaccination 2 A Y A 2021-02-21T12:33:28 112315071123BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDí0Hrş°DWD¦hHrŐmhBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWDí0DWD¦hY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW7DWŤYPhase 3A@NNEGDWŽ ....... . .NY.DWŤDWýB‰BpBůAŕHrş°HrŐmh.. .DW×WHITE AC4591001C4591001 1123 11231507A ADVERSE EVENT 1 Worsening of Depression Depression F™'·PSYCHIATRIC DISORDERS Depression worsened FĆîFĆÚDepressive disorders FĆńDepressed mood disorders and disturbances FĆ×Psychiatric disorders F™'·2021-01-19 B2021-01-23 B 2MedDRA v24.0NDW A ..DWA`..APDAYSYNNNYNNNNOT RELATEDOTHER unknown NOT APPLICABLE YNRECOVERED/RESOLVED N(b)(6) A0NOT RELATEDA0A GRADE 2A . APeriod 01DWDí0Hrş°DX‡D¦hHt¶ čVaccination 2 A Y A 2021-02-24T21:20:57 127012221270BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADVűDčHr¬ĐDWDÉHrČaBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVűDčDWDÉY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW,DWŚYPhase 3A@NNEGDWŤ ....... . .NY.DWŚDWýB’BqC0AŕHr¬ĐHrČa.. .DWĆWHITE AC4591001C4591001 1270 12701222AADVERSE EVENT 1 SUICIDAL IDEATION Suicidal ideation F™'·PSYCHIATRIC DISORDERS Suicidal ideation F™DWRD PDôDWnDXBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DW6DWýBwBŔBÇCŕAđHr_HryHsÝPHsô .DW=WHITE AC4591001C4591001 1150 11501131ApADVERSE EVENT 9 Current severe episode of major depressive disorder without psychotic features without prior episodeMajor depression F™'·PSYCHIATRIC DISORDERS Major depressive disorder F™ÓöF™xpDepressive disorders FĆńDepressed mood disorders and disturbances FĆ×Psychiatric disorders F™'·2021-03 .2021-08-10 Cp 3MedDRA v24.0NDWRDA..DWćB•... YNNNYNNNNOT RELATEDOTHER pre-existing anxiety NOT APPLICABLE YNRECOVERED/RESOLVED N(b)(6) A0NOT RELATEDA0A0GRADE 3A0 . A Period 02DW>D PHsÝPDXżDôHuRtVaccination 4 A`Y A@2021-09-16T18:25:43Y 103913321039BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWD|°HrÍZ°DW)Dp€HrčţBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWD|°DW)Dp€Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWLDWqYPhase 3A@NNEGDWr ....... . .NN.DWqDW©B^B8B–AĐHrÍZ°Hrčţ.. .DWćWHITE AC4591001C4591001 1039 10391332AADVERSE EVENT 1 Active Suicidal Ideation Suicidal ideation F™'·PSYCHIATRIC DISORDERS Active suicidal ideation F™ F™Noninfectious myocarditis F™ ěMyocardial disorders F™1Cardiac disorders Fłő2021-06-12T19:00B›2021-06-13 Bś 3MedDRA v24.0NDW« A0EłHs”ű°DW¬A@..A DAYSYNNNYNNNNOT RELATEDOTHER Rhinovirus infection NOT APPLICABLE YNRECOVERED/RESOLVED N(b)(6) A0NOT RELATEDA0A0GRADE 3A0 CŐŕ A Period 02DW•Dą Hsw© DYDŚ(Hus (Vaccination 4 A`Y A@2021-07-13T13:53:44Y 115613571156Placebo PLACEBO Placebo PLACEBO AŔYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWDďÄHrÇ6DDW¦DštHsŤótPlacebo APlacebo ADWDďÄDW#Dá´Y . . .Placebo Placebo DW@DWŚYPhase 3A@NNEGDWŤ BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DW‘DW¦DóŔDštDWĂDXcBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWŚDWýB~BmBqBďAŔHrÇ6DHrá†4Hsrť@HsŤót .DWWHITE AC4591001C4591001 1156 11561357AADVERSE EVENT 1 APPENDICITIS Appendicitis FëůINFECTIONS AND INFESTATIONS Appendicitis F˘CF˘CAbdominal and gastrointestinal infections FÜŻInfections - pathogen unspecified Fë÷Infections and infestations Fëů2021-06-10 B›2021-06-10 B› 2MedDRA v24.0NDW© A@..DW©A@..ADAYSYNNNNNYNRELATED NOT APPLICABLE YNRECOVERED/RESOLVED N(b)(6) ARELATED AA GRADE 2A . A Period 02DW‘DóŔHsrť@DYDštHuo&ôVaccination 4 A`Y A@2021-06-25T15:41:20Y 109114471091BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADV˙D–<Hr±ÄĽDWD ŚHrĐ!ŚBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DV˙D–<DWD ŚY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW6DWSYPhase 3A@NNEGDWT ....... . .NY.DWSDWýBUBŞB˙AđHr±ÄĽHrĐ!Ś.. .DWĹWHITE AC4591001C4591001 1091 10911447AADVERSE EVENT 3 Appendicitis Appendicitis FëůINFECTIONS AND INFESTATIONS Appendicitis F˘CF˘CAbdominal and gastrointestinal infections FÜŻInfections - pathogen unspecified Fë÷Infections and infestations Fëů2021-07-09T03:00BČ2021-07-10T08:00BÉ 2MedDRA v24.0NDWĆ B±D*0Hs·ł0DWÇB˛Dp»HsąK;A DAYSYNNNYNNNNOT RELATEDOTHER Appendicitis NOT APPLICABLE NYRECOVERED/RESOLVED N(b)(6) A0NOT RELATEDA0A GRADE 2A E=Ŕp APeriod 01DV˙D–<Hr±ÄĽDXD ŚHt±UAfter unblinding and before Vaccination 3A@ A 2021-09-07T12:17:00Y 114013541140BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AFA NOT HISPANIC OR LATINOA USAWHITE ADWD‹°Hrł°DWDŃHrĎBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWD‹°DWDŃY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW9DW…YPhase 3A@NNEGDW† ....... . .NY.DW…DWýB†BxBţAđHrł°HrĎ.. .DWÄWHITE AC4591001C4591001 1140 11401354AADVERSE EVENT 1 Thoracic spinal syrinx Syringomyelia FľŰCONGENITAL, FAMILIAL AND GENETIC DISORDERS Syrinx F™ťöF™>0Central nervous system disorders congenital NEC FĽqNeurological disorders congenital F™óCongenital, familial and genetic disorders FľŰ2021-06 . .ONGOINGLAST SUBJECT ENCOUNTER3MedDRA v24.0NDW DBŚ....... YNNNYNNNNOT RELATEDOTHER New medical diagnosis NOT APPLICABLE YYNOT RECOVERED/NOT RESOLVED N(b)(6) A0NOT RELATEDA0A0GRADE 3A0 . APeriod 01DWD‹°Hrł°DX‚DŃHt°4After unblinding and before Vaccination 3A@ A 2021-08-24T17:43:41Y 115012501150BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsANOT REPORTED ApFA HISPANIC OR LATINO AUSANOT REPORTED ApDWDĆŔHr»/ŔDWDę`Hr×ŕBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWDĆŔDWDę`Y . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW7DWŚYPhase 3A@NNEGDWŤ ....... . .NY.DWŚDWýB‡BqBřAĐHr»/ŔHr×ŕ.. .DWĐALL OTHERS A0C4591001C4591001 1150 11501250AADVERSE EVENT 1 Suicidal Ideation Suicidal ideation F™'·PSYCHIATRIC DISORDERS Suicidal ideation F™ A Period 02DWˇDťĽHs‡_<DY#DÂHu„gVaccination 4 A`Y A@2021-08-04T15:29:10Y 115012421150Placebo PLACEBO Placebo PLACEBO AđYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMANOT HISPANIC OR LATINOA USAWHITE ADWD¬Hrł,DWgD¤Hs:ďPlacebo APlacebo ADWD¬DWD™üY . . .Placebo Placebo DW3DWDYPhase 3A@NNEGDWE BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g).DWMDWgDÎD¤DWDX$BNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€NN.DWDDWýBEB±BąBţAđHrł,HrŃl|HsŃ„Hs:ď .DWLWHITE AC4591001C4591001 1150 11501242A@ADVERSE EVENT 5 Laceration of Left Kidney Traumatic renal injury FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Laceration of kidney without mention of open wound into cavityFň©F™©îRenal and urinary tract injuries NEC F™®Injuries NEC FěâInjury, poisoning and procedural complications Fěĺ2021-07-17 BĎ .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDWÎ Bh....... YNNNYNNNNOT RELATEDOTHER injury NOT APPLICABLE NNRECOVERING/RESOLVING N(b)(6) A0NOT RELATEDA0A GRADE 2A . A Period 02DWMDÎHsŃ„DXÔD¤Hu"Follow Up 3 ApY A@2021-08-03T11:40:38Y 115216171152BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AĐYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADVěD÷ĽHr™ĽDWDDHrą–ÄBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DVěD÷ĽDWDDY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DW"DWĘYPhase 3A@NNEGDWË ....... . .NY.DWĘDWýBßB3C AĐHr™ĽHrą–Ä.. .DWËWHITE AC4591001C4591001 1152 11521617AADVERSE EVENT 1 Elbow Fracture Upper limb fracture FěĺINJURY, POISONING AND PROCEDURAL COMPLICATIONS Elbow fracture FÎF™†RLimb fractures and dislocations F™ľîBone and joint injuries F¶Injury, poisoning and procedural complications Fěĺ2021-08-01T10:00Bň .ONGOINGLAST SUBJECT ENCOUNTER2MedDRA v24.0NDWÝ BŮDŚ HsÖh ..... YNNNYNNNNOT RELATEDOTHER Fall from Trampoline NOT APPLICABLE YYNOT RECOVERED/NOT RESOLVED N(b)(6) A0NOT RELATEDA0A GRADE 2A EKó APeriod 01DVěD÷ĽHr™ĽDXrDDHtšĘDAfter unblinding and before Vaccination 3A@ A 2021-08-10T04:56:17Y 100514491005BNT162b2 Phase 2/3 (30 mcg)B2_P23_30BNT162b2 Phase 2/3 (30 mcg)B2_P23_30AŕYEARS12-15 YearsA<65 YearsA .12-15 YearsAWHITE AMAHISPANIC OR LATINO AUSAWHITE ADWD´HrĚ@€DW(DźśHrçŰśBNT162b2 Phase 2/3 (30 mcg)A€BNT162b2 Phase 2/3 (30 mcg)A€DWD´DW(DźśY . . .BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g)DWDDWYPhase 3A@NNEGDW‘ ....... . .NY.DWDWýB~BmBëAŕHrĚ@€HrçŰś.. .DWŢWHITE AC4591001C4591001 1005 10051449AADVERSE EVENT 1 Appendicitis Appendicitis FëůINFECTIONS AND INFESTATIONS Appendicitis F˘CF˘CAbdominal and gastrointestinal infections FÜŻInfections - pathogen unspecified Fë÷Infections and infestations Fëů2021-06-28 B©2021-06-29 BŞ 2MedDRA v24.0NDW» B”..DWĽB•..A DAYSYNNNNNYNNOT RELATEDOTHER unknown NOT APPLICABLE NYRECOVERED/RESOLVED N(b)(6) A0NOT RELATEDA0A GRADE 2A . APeriod 01DWD´HrĚ@€DX•DźśHtÉAfter unblinding and before Vaccination 3A@ A 2021-08-27T11:37:43Y