HEADER RECORD*******LIBRARY HEADER RECORD!!!!!!!000000000000000000000000000000 SAS SAS SASLIB 6.06 MAC1. 02JAN25:16:21:2402JAN25:16:21:24 HEADER RECORD*******MEMBER HEADER RECORD!!!!!!!000000000000000001600000000140 HEADER RECORD*******DSCRPTR HEADER RECORD!!!!!!!000000000000000000000000000000 SAS ADAE SASDATA 6.06 02JAN25:16:21:2402JAN25:16:21:24 Adverse Event Analysis Dataset HEADER RECORD*******NAMESTR HEADER RECORD!!!!!!!000000018300000000000000000000 STUDYID Study Identifier USUBJID Unique Subject Identifier  SUBJID Subject Identifier for the Study 'SITEID Study Site Identifier 0COUNTRY Country 5AGE Age BEST  8AGEU Age Units @AGEGR1 Pooled Age Group 1 E AGEGR1N Pooled Age Group 1 (N) BEST  W AGEGR2 Pooled Age Group 2 _ AGEGR2N Pooled Age Group 2 (N) BEST  r SEX Sex z) RACE Race {'RACESPY Race Specify ETHNIC Ethnicity RANDFL Randomized Population Flag SAFFL Safety Population Flag FASBABFLFull Analysis Set bAb Population Flag FASNABFLFull Analysis Set nAb Population Flag PPBABFL Per Protocol bAb Population Flag PPNABFL Per Protocol nAb Population Flag PPBD29FLPer Protocol bAb Day 29 Flag PPBD57FLPer Protocol bAb Day 57 Flag PBD209FLPer Protocol bAb Day 209 Flag PPND29FLPer Protocol nAb Day 29 Flag PPND57FLPer Protocol nAb Day 57 Flag PND209FLPer Protocol nAb Day 209 Flag SAR1FL First Solicited Safety Population Flag SAR2FL Second Solicited Safety Population Flag SARAFL Solicited Safety Population Flag FASNA2FLFAS nAb 2 Population Flag  PPNAB2FLPP nAb 2 Population Flag !PN2D29FLPer Protocol nAb 2 Day 29 Flag "PN2D57FLPer Protocol nAb 2 Day 57 Flag #PN2209FLPer Protocol nAb 2 Day 209 Flag $DVBABFL Deviation Impact bAb Flag %DVNABFL Deviation Impact nAb Flag &DOSE1FL Vaccination 1 Flag 'DOSE2FL Vaccination 2 Flag (DOSEROFLDosing Error Flag  )COV19BL Baseline COVID Infection *ELECSBL Baseline Elecsys SARS CoV-2 Assay +COV19FL COVID Infection Flag ,SENTLFL Sentinel Participant Flag -D29W7DFLDay 29 Out of 7-Day Window Flag  .TRT01P Planned Treatment for Period 01  /TRT01PN Planned Treatment for Period 01 (N) BEST  0TRT01A Actual Treatment for Period 01 "1TRT01AN Actual Treatment for Period 01 (N) BEST  22TR01SDT Date of First Exposure in Period 01 DATE  :3TR01SDTMDatetime of First Exposure in Period 01 DATETIME B4TR01EDT Date of Last Exposure in Period 01 DATE  J5TR01EDTMDatetime of Last Exposure in Period 01 DATETIME R6TRTSDTM Datetime of First Exposure to Treatment DATETIME Z7TRTEDTM Datetime of Last Exposure to Treatment DATETIME b8DOSE2DT Date of Dose 2 DATE  j9DOS2DTM Datetime of Dose 2 DATETIME r:AELNKGRPLink Group ID z;TRTA Actual Treatment ~AESEQ Sequence Number BEST  ?AECAT Category for Adverse Event _@AETERM Reported Term for the Adverse Event .AAEDECOD Dictionary-Derived Term CBAEBODSYSBody System or Organ Class ?CAEBDSYCDBody System or Organ Class Code BEST  ADAELLT Lowest Level Term EAELLTCD Lowest Level Term Code BEST  FAEPTCD Preferred Term Code BEST  FGAEHLT High Level Term HAEHLTCD High Level Term Code BEST  !VIAEHLGT High Level Group Term )JAEHLGTCDHigh Level Group Term Code BEST  CKAESOC Primary System Organ Class LAESOCCD Primary System Organ Class Code BEST  MAESTDTC Start Date/Time of Adverse Event NAEENDTC End Date/Time of Adverse Event OAESTDY Study Day of Start of Adverse Event BEST  PAEENDY Study Day of End of Adverse Event BEST  QAEENRF End Relative to Reference Period RASTDT Analysis Start Date DATE   SASTTM Analysis Start Time TIME  TASTDTM Analysis Start Date/Time DATETIME UASTDTF Analysis Start Date Imputation Flag !VASTTMF Analysis Start Time Imputation Flag "WASTDY Analysis Start Relative Day BEST  #XAENDT Analysis End Date DATE  +YAENTM Analysis End Time TIME  3ZAENDTM Analysis End Date/Time DATETIME ;[ASTAGE Stage C\ASTAGEN Stage (N) BEST  T ]AEDUR Duration of Adverse Event \ ^MDOSREF Most Recent Dose Reference g_MRDSTDY Relative Start Day from Most Recent DoseBEST  t`MRDENDY Relative End Day from Most Recent Dose BEST  |aTRTEMFL Treatment Emergent Analysis Flag bAEMAFL Medically-Attended Flag cD28FL AE Through 28 Days Analysis Flag dAEDISFL Leading to Study Discontinuation Flag eAESOFL Solicited Adverse Reaction? fAESER Serious Event gAESCONG Congenital Anomaly or Birth Defect hAESDISABPersist or Signif Disability/Incapacity iAESDTH Results in Death jAESHOSP Requires or Prolongs Hospitalization kAESLIFE Is Life Threatening lAESMIE Other Medically Important Serious Event  mAEREL Causality nAERELNSTRelationship to Non-Study Treatment  oAREL Analysis Causality pARELN Analysis Causality (N) BEST  qAETOXGR Standard Toxicity Grade rAESEV Severity/Intensity sATOXGR Analysis Toxicity Grade tATOXGRN Analysis Toxicity Grade (N) BEST  uASEV Analysis Severity/Intensity vASEVN Analysis Severity/Intensity (N) BEST  wTOXGGR1 Pooled Toxicity Grade Group 1 xTOXGGR1NPooled Toxicity Grade 1 (N) BEST  yAEACN Action Taken with Study Treatment -zAEACNOTHOther Action Taken  {AEOUT Outcome of Adverse Event 4|AEOUTSP Recovered/Resolved with Sequelae,Spec T }AEHSTDTCHospital Admission Date  ~AEHENDTCHospital Discharge Date ICUAD Admitted to ICU ICUDAY Duration of Healthcare Encounter AEREFID Reference ID  CQ01NAM Customized Query 01 Name  CQ01FL Customized Query 01 Flag CQ02NAM Customized Query 02 Name CQ02FL Customized Query 02 Flag CQ03NAM Customized Query 03 Name CQ03FL Customized Query 03 Flag SMQ01NAMSMQ 01 Name SMQ01SC SMQ 01 Scope 0SMQ01FL SMQ 01 Flag 5SMQ02NAMSMQ 02 Name 6SMQ02SC SMQ 02 Scope >SMQ02FL SMQ 02 Flag D SMQ03NAMSMQ 03 Name ESMQ03SC SMQ 03 Scope NSMQ03FL SMQ 03 Flag TSMQ04NAMSMQ 04 Name USMQ04SC SMQ 04 Scope VSMQ04FL SMQ 04 Flag WSMQ05NAMSMQ 05 Name XSMQ05SC SMQ 05 Scope YSMQ05FL SMQ 05 Flag ZSMQ06NAMSMQ 06 Name [SMQ06SC SMQ 06 Scope kSMQ06FL SMQ 06 Flag qSMQ07NAMSMQ 07 Name rSMQ07SC SMQ 07 Scope SMQ07FL SMQ 07 Flag SMQ08NAMSMQ 08 Name SMQ08SC SMQ 08 Scope SMQ08FL SMQ 08 Flag )SMQ09NAMSMQ 09 Name SMQ09SC SMQ 09 Scope SMQ09FL SMQ 09 Flag SMQ10NAMSMQ 10 Name SMQ10SC SMQ 10 Scope SMQ10FL SMQ 10 Flag  SMQ11NAMSMQ 11 Name SMQ11SC SMQ 11 Scope SMQ11FL SMQ 11 Flag  SMQ12NAMSMQ 12 Name  SMQ12SC SMQ 12 Scope  SMQ12FL SMQ 12 Flag SMQ13NAMSMQ 13 Name SMQ13SC SMQ 13 Scope (SMQ13FL SMQ 13 Flag .SMQ14NAMSMQ 14 Name /SMQ14SC SMQ 14 Scope =SMQ14FL SMQ 14 Flag B%ARTERM Collected Term for Adverse Reaction CDARFL Delayed AR Flag hANL01FL Analysis Flag 01 iANL02FL Analysis Flag 02 jANL03FL Analysis Flag 03 kANL04FL Analysis Flag 04 l HEADER RECORD*******OBS HEADER RECORD!!!!!!!000000000000000000000000000000 mRNA-1273-P201mRNA-1273-P201-US202-1166US2021166US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FOTHER (b)(6) NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7Hq:DVWHqYHq:HqYDVWHqY mRNA-1273 50 ug A AE-006A ADVERSE EVENT RIGHT BREAST INJURY Breast injury Injury, poisoning and procedural complications FBreast injury F~F~Reproductive system and breast injuries FuInjuries NEC FInjury, poisoning and procedural complications F2020-11-29 2020-12-08 BB DV.. BDV..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA3SEVERE Grade 3A0Grade 3/Severe A0>=3A DOSE NOT CHANGEDCONCOMITANT PROCEDURE RECOVERED/RESOLVED DOSE 2 - 2020-07-07T11:54 mRNA-1273-P201mRNA-1273-P201-US202-1166US2021166US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FOTHER (b)(6) NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7Hq:DVWHqYHq:HqYDVWHqY mRNA-1273 50 ug A AE-001APADVERSE EVENT MUSCLE SPASM (BACK) Muscle spasms Musculoskeletal and connective tissue disorders FkBack muscle spasms FF.Muscle related signs and symptoms NEC F&Muscle disorders FMusculoskeletal and connective tissue disorders Fk2020-06-22 2020-06-26 BB DVH.. BDVL..Vaccination stageA Vaccination 1BBYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA3SEVERE Grade 3A0Grade 3/Severe A0>=3A DOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-06-05T13:06 mRNA-1273-P201mRNA-1273-P201-US202-1166US2021166US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FOTHER (b)(6) NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7Hq:DVWHqYHq:HqYDVWHqY mRNA-1273 50 ug A AE-002A`ADVERSE EVENT TENSION HEADACHE Tension headache Nervous system disorders FTension headache F?F?Headaches NEC FHeadaches FNervous system disorders F2020-07-31 2020-08-02 B9B; DVo.. B9DVq..Vaccination stageA Vaccination 2BBYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-07T11:54 mRNA-1273-P201mRNA-1273-P201-US202-1166US2021166US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FOTHER (b)(6) NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7Hq:DVWHqYHq:HqYDVWHqY mRNA-1273 50 ug A AE-004AADVERSE EVENT WORSENING OF ANXIETY Anxiety Psychiatric disorders F'Anxiety aggravated FSSFAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'2021-01-20 2021-02-10 BB DW.. BDW1..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-07T11:54 mRNA-1273-P201mRNA-1273-P201-US202-1166US2021166US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FOTHER (b)(6) NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7Hq:DVWHqYHq:HqYDVWHqY mRNA-1273 50 ug A AE-005A0ADVERSE EVENT WORSENING OF INSOMNIA Insomnia Psychiatric disorders F'Insomnia exacerbated F(F%Disturbances in initiating and maintaining sleep FFSleep disorders and disturbances F6Psychiatric disorders F'2021-01-20 2021-02-10 BB DW.. BDW1..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-07T11:54 mRNA-1273-P201mRNA-1273-P201-US202-1166US2021166US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FOTHER (b)(6) NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7Hq:DVWHqYHq:HqYDVWHqY mRNA-1273 50 ug A AE-003A@ADVERSE EVENT WORSENING OF MAJOR DEPRESSIVE DISORDER Major depression Psychiatric disorders F'Major depressive disorder aggravated F FxpDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'2021-01-20 2021-02-10 BB DW.. BDW1..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-07T11:54 mRNA-1273-P201mRNA-1273-P201-US201-1004US2011004US201USAB7YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3HqDVOHqhHqHqhDVOHqh mRNA-1273 100 ugA0AE-001AADVERSE EVENT SYNCOPE Syncope Nervous system disorders FSyncope F=F=Disturbances in consciousness NEC FENeurological disorders NEC FNervous system disorders F2020-06-29T09:402020-06-29T09:41BB DVODHqɮp BDVOD,HqɮVaccination stageA Vaccination 1BBYNY NNNNNNNNNOT RELATEDRELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-01T13:36 CardiomyopathyBROAD mRNA-1273-P201mRNA-1273-P201-US201-1007US2011007US201USABEYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNPlacebo APlacebo ADV3Hq dDVOHqHq dHqDVOHq Placebo AAE-001AREACTOGENICITYREDNESS AT INJECTION SITE Injection site erythema General disorders and administration site conditions FInjection site redness FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2020-06-01T20:002020-06-10 AA DV3EHqU ADV<..Vaccination stageAP3D Vaccination 1AAYNY YNNNNNNNRELATED RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-01T14:47 Erythema Y mRNA-1273-P201mRNA-1273-P201-US201-1028US2011028US201USAB<YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3HqDVOHqɦxHqHqɦxDVOHqɦx mRNA-1273 100 ugA0AE-002A ADVERSE EVENT HERNIA, LEFT INGUINAL Inguinal hernia Gastrointestinal disorders FܛLeft inguinal hernia FFInguinal hernias FAbdominal hernias and other abdominal wall conditions FGastrointestinal disorders Fܛ2020-10-30 2020-11-02 BB DV.. BDV..Follow up stage A Vaccination 2B|BYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT PROCEDURE RECOVERED/RESOLVED DOSE 2 - 2020-06-29T09:06 mRNA-1273-P201mRNA-1273-P201-US201-1028US2011028US201USAB<YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3HqDVOHqɦxHqHqɦxDVOHqɦx mRNA-1273 100 ugA0AE-001AADVERSE EVENT GOUT, RIGHT GREAT TOE Gout Metabolism and nutrition disorders FGout FCFCDisorders of purine metabolism FPurine and pyrimidine metabolism disorders F)*Metabolism and nutrition disorders F2020-06-07 2020-06-16 ApB DV9.. ApDVB..Vaccination stageA Vaccination 1ApBYYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-06-01T11:11 ArthritisNARROWY mRNA-1273-P201mRNA-1273-P201-US201-1040US2011040US201USABBYEARS>=55 Years A >=55 Years A@FBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3Hq(DVOHqɿHq(HqɿDVOHqɿ mRNA-1273 50 ug A AE-001AADVERSE EVENT CHEST PAIN, UNKNOWN DETAILS Chest pain General disorders and administration site conditions FUnspecified chest pain FHFPain and discomfort NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2020-06-02T22:492020-06-02T23:35A A DV4E Hq A DV4E@Hq٤Vaccination stageA Vaccination 1A A YYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-01T15:50 CardiomyopathyBROAD mRNA-1273-P201mRNA-1273-P201-US201-1040US2011040US201USABBYEARS>=55 Years A >=55 Years A@FBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3Hq(DVOHqɿHq(HqɿDVOHqɿ mRNA-1273 50 ug A AE-002A ADVERSE EVENT LOW HORMONE LEVELS Hormone level abnormal Investigations FHormone level abnormal FFEndocrine analyses and imaging NEC FEndocrine investigations (incl sex hormones) FInvestigations F2020-11-13 B.ONGOINGDV.. B...Follow up stage A Vaccination 2B.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RECOVERED/NOT RESOLVED DOSE 2 - 2020-06-29T10:51 mRNA-1273-P201mRNA-1273-P201-US201-1040US2011040US201USABBYEARS>=55 Years A >=55 Years A@FBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3Hq(DVOHqɿHq(HqɿDVOHqɿ mRNA-1273 50 ug A AE-003A0ADVERSE EVENT INSULIN RESISTANCE Insulin resistance Metabolism and nutrition disorders FInsulin resistance FYFYHyperglycaemic conditions NEC FGlucose metabolism disorders (incl diabetes mellitus) FxMetabolism and nutrition disorders F2020-11-13 B.ONGOINGDV.. B...Follow up stage A Vaccination 2B.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RECOVERED/NOT RESOLVED DOSE 2 - 2020-06-29T10:51 mRNA-1273-P201mRNA-1273-P201-US201-1051US2011051US201USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE HISPANIC OR LATINO YYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4HqqDVVHq"HqqHq"DVVHq" mRNA-1273 50 ug A AE-008APADVERSE EVENT FATIGUE Fatigue General disorders and administration site conditions FFatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2020-10-17 2020-10-28 BB DV.. BDV..Follow up stage A Vaccination 2BhBsYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-07-06T13:46 Fatigue Y mRNA-1273-P201mRNA-1273-P201-US201-1051US2011051US201USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE HISPANIC OR LATINO YYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4HqqDVVHq"HqqHq"DVVHq" mRNA-1273 50 ug A AE-009ApADVERSE EVENT BODY ACHES Pain General disorders and administration site conditions FGeneral body pain FUFPain and discomfort NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2020-10-18 2020-10-28 BB DV.. BDV..Follow up stage A Vaccination 2BiBsYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-07-06T13:46 Myalgia Y mRNA-1273-P201mRNA-1273-P201-US201-1051US2011051US201USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE HISPANIC OR LATINO YYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4HqqDVVHq"HqqHq"DVVHq" mRNA-1273 50 ug A AE-004AADVERSE EVENT BACK PAIN, SECONDARY TO CAR ACCIDENT Post-traumatic pain Injury, poisoning and procedural complications FPost-traumatic pain FxFxNon-site specific injuries NEC F Injuries NEC FInjury, poisoning and procedural complications F2020-11-19 2020-12-15 BB DV.. BDV..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-06T13:46 mRNA-1273-P201mRNA-1273-P201-US201-1051US2011051US201USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE HISPANIC OR LATINO YYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4HqqDVVHq"HqqHq"DVVHq" mRNA-1273 50 ug A AE-003AADVERSE EVENT NECK PAIN SECONDARY TO CAR ACCIDENT Post-traumatic pain Injury, poisoning and procedural complications FPost-traumatic pain FxFxNon-site specific injuries NEC F Injuries NEC FInjury, poisoning and procedural complications F2020-11-19 2020-12-15 BB DV.. BDV..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-06T13:46 mRNA-1273-P201mRNA-1273-P201-US201-1051US2011051US201USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE HISPANIC OR LATINO YYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4HqqDVVHq"HqqHq"DVVHq" mRNA-1273 50 ug A AE-002AADVERSE EVENT CAR ACCIDENT Road traffic accident Injury, poisoning and procedural complications FMotor vehicle accident FF/Non-site specific injuries NEC F Injuries NEC FInjury, poisoning and procedural complications F2020-11-19 2020-11-19 BB DV.. BDV..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-06T13:46 mRNA-1273-P201mRNA-1273-P201-US201-1051US2011051US201USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE HISPANIC OR LATINO YYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4HqqDVVHq"HqqHq"DVVHq" mRNA-1273 50 ug A AE-010AADVERSE EVENT LOSS OF TASTE Ageusia Nervous system disorders FLoss of taste FFHSensory abnormalities NEC F2Neurological disorders NEC FNervous system disorders F2020-10-17 2020-10-30 BB DV.. BDV..Follow up stage A Vaccination 2BhBuYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-07-06T13:46 mRNA-1273-P201mRNA-1273-P201-US201-1051US2011051US201USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE HISPANIC OR LATINO YYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4HqqDVVHq"HqqHq"DVVHq" mRNA-1273 50 ug A AE-012A0ADVERSE EVENT LIGHTHEADEDNESS Dizziness Nervous system disorders FLightheadedness F,F˅Neurological signs and symptoms NEC FNeurological disorders NEC FNervous system disorders F2020-10-17 2020-10-20 BB DV.. BDV..Follow up stage A Vaccination 2BhBkYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-07-06T13:46 Hearing and Vestibular DisordersBROAD mRNA-1273-P201mRNA-1273-P201-US201-1051US2011051US201USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE HISPANIC OR LATINO YYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4HqqDVVHq"HqqHq"DVVHq" mRNA-1273 50 ug A AE-013A@ADVERSE EVENT DIZZINESS Dizziness Nervous system disorders FDizziness F˅F˅Neurological signs and symptoms NEC FNeurological disorders NEC FNervous system disorders F2020-10-18 2020-10-23 BB DV.. BDV..Follow up stage A Vaccination 2BiBnYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-07-06T13:46 Hearing and Vestibular DisordersBROAD mRNA-1273-P201mRNA-1273-P201-US201-1051US2011051US201USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE HISPANIC OR LATINO YYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4HqqDVVHq"HqqHq"DVVHq" mRNA-1273 50 ug A AE-007A`ADVERSE EVENT HEADACHE Headache Nervous system disorders FHeadache FFHeadaches NEC FHeadaches FNervous system disorders F2020-10-19 2020-10-28 BB DV.. BDV..Follow up stage A Vaccination 2BjBsYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-07-06T13:46 Headache Y mRNA-1273-P201mRNA-1273-P201-US201-1051US2011051US201USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE HISPANIC OR LATINO YYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4HqqDVVHq"HqqHq"DVVHq" mRNA-1273 50 ug A AE-006A ADVERSE EVENT COUGH Cough Respiratory, thoracic and mediastinal disorders F-Cough FXFXCoughing and associated symptoms FaRespiratory disorders NEC F-Respiratory, thoracic and mediastinal disorders F-2020-10-19 2020-10-26 BB DV.. BDV..Follow up stage A Vaccination 2BjBqYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-07-06T13:46 Anaphylactic ReactionBROADY mRNA-1273-P201mRNA-1273-P201-US201-1051US2011051US201USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE HISPANIC OR LATINO YYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4HqqDVVHq"HqqHq"DVVHq" mRNA-1273 50 ug A AE-005AADVERSE EVENT RUNNY NOSE Rhinorrhoea Respiratory, thoracic and mediastinal disorders F-Runny nose F0F/=Upper respiratory tract signs and symptoms FKiRespiratory tract signs and symptoms F}Respiratory, thoracic and mediastinal disorders F-2020-10-15 2020-10-25 BB DV.. BDV..Follow up stage A Vaccination 2BfBpYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-07-06T13:46 mRNA-1273-P201mRNA-1273-P201-US201-1051US2011051US201USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE HISPANIC OR LATINO YYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4HqqDVVHq"HqqHq"DVVHq" mRNA-1273 50 ug A AE-011AADVERSE EVENT SNEEZING Sneezing Respiratory, thoracic and mediastinal disorders F-Sneezing F7F7Upper respiratory tract signs and symptoms FKiRespiratory tract signs and symptoms F}Respiratory, thoracic and mediastinal disorders F-2020-10-16 2020-10-22 BB DV.. BDV..Follow up stage A Vaccination 2BgBmYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-07-06T13:46 Anaphylactic ReactionBROADY HypersensitivityBROAD mRNA-1273-P201mRNA-1273-P201-US201-1051US2011051US201USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE HISPANIC OR LATINO YYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4HqqDVVHq"HqqHq"DVVHq" mRNA-1273 50 ug A AE-001AADVERSE EVENT ALL OVER BODY RASH Rash Skin and subcutaneous tissue disorders F5Rash all over F*XF*TRashes, eruptions and exanthems NEC FcEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F52020-06-22 2020-07-02 BB DVH.. BDVR..Vaccination stageA Vaccination 1BBYYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE DELAYED CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-06-02T16:12 Anaphylactic ReactionBROADY HypersensitivityNARROWY mRNA-1273-P201mRNA-1273-P201-US201-1055US2011055US201USAB-YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4Hq}DVPHq[XHq}Hq[XDVPHq[X mRNA-1273 50 ug A AE-001A ADVERSE EVENT NAUSEA Nausea Gastrointestinal disorders FܛNausea F F Nausea and vomiting symptoms FGastrointestinal signs and symptoms FGastrointestinal disorders Fܛ2020-06-21 2020-06-24 BB DVG.. BDVJ..Vaccination stageA Vaccination 1BBYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-06-02T17:03 Nausea/Vomiting Y mRNA-1273-P201mRNA-1273-P201-US201-1055US2011055US201USAB-YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4Hq}DVPHq[XHq}Hq[XDVPHq[X mRNA-1273 50 ug A AE-002AADVERSE EVENT MUSCLE ACHES, ALL OVER BODY Myalgia Musculoskeletal and connective tissue disorders FkGeneralized muscle aches FiF{Muscle pains F#Muscle disorders FMusculoskeletal and connective tissue disorders Fk2020-06-21 2020-06-24 BB DVG.. BDVJ..Vaccination stageA Vaccination 1BBYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-06-02T17:03 Myalgia Y mRNA-1273-P201mRNA-1273-P201-US201-1056US2011056US201USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV4Hq@DVPHqhHq@HqhDVPHqh Placebo AAE-001AADVERSE EVENT BENIGN CYST, LEFT TESTICLE Testicular cyst Reproductive system and breast disorders F-LTesticular cyst FUhFUhTesticular and epididymal neoplasms F4Testicular and epididymal disorders FʲReproductive system and breast disorders F-L2020-09-05 B`.ONGOINGDV.. B`...Follow up stage A Vaccination 2BD.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION NOT RECOVERED/NOT RESOLVED DOSE 2 - 2020-06-30T17:08 mRNA-1273-P201mRNA-1273-P201-US201-1060US2011060US201USAB1YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV4Hq@ DVPHqb$Hq@ Hqb$DVPHqb$ Placebo AAE-003A ADVERSE EVENT TOOTH PAIN, LEFT LOWER SECOND MOLAR (FROM ROOT CANAL) Toothache Gastrointestinal disorders FܛToothache FBFBDental pain and sensation disorders FBDental and gingival conditions FBrGastrointestinal disorders Fܛ2020-07-23 2020-07-30 B4B; DVg.. B4DVn..Vaccination stageA Vaccination 2BBYYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-06-30T16:39 mRNA-1273-P201mRNA-1273-P201-US201-1060US2011060US201USAB1YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV4Hq@ DVPHqb$Hq@ Hqb$DVPHqb$ Placebo AAE-001AADVERSE EVENT EXASPERATION OF POISON IVY RASH LEFT FOREARM/RIGHT UPPER THIGH Dermatitis contact Skin and subcutaneous tissue disorders F5Poison ivy rash F"?FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F52020-06-06 2020-06-13 APA DV8.. APDV?..Vaccination stageA Vaccination 1APAYYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-02T12:40 HypersensitivityNARROWY mRNA-1273-P201mRNA-1273-P201-US201-1064US2011064US201USAB"YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV4Hq<$DVQHq̌Hq<$Hq̌DVQHq̌ Placebo AAE-001AADVERSE EVENT POISON OAK LEFT ARM Dermatitis contact Skin and subcutaneous tissue disorders F5Poison oak rash F"@FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F52020-07-24 2020-08-06 B5BB DVh.. B5DVu..Vaccination stageA Vaccination 2BB%YNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-01T13:53 HypersensitivityNARROWY mRNA-1273-P201mRNA-1273-P201-US201-1067US2011067US201USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV5HqDVWHq4HqHq4DVWHq4 Placebo AAE-005APADVERSE EVENT BODY ACHES Pain General disorders and administration site conditions FGeneral body pain FUFPain and discomfort NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2020-11-07 2020-11-15 BB DV.. BDV..Follow up stage A Vaccination 2B|BYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-07T09:13 Myalgia Y mRNA-1273-P201mRNA-1273-P201-US201-1067US2011067US201USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV5HqDVWHq4HqHq4DVWHq4 Placebo AAE-001AADVERSE EVENT COUGH Cough Respiratory, thoracic and mediastinal disorders F-Cough FXFXCoughing and associated symptoms FaRespiratory disorders NEC F-Respiratory, thoracic and mediastinal disorders F-2020-06-09 2020-07-17 ApB- DV;.. ApDVa..Vaccination stageA Vaccination 1ApB-YYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-03T13:35 Anaphylactic ReactionBROADY mRNA-1273-P201mRNA-1273-P201-US201-1067US2011067US201USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV5HqDVWHq4HqHq4DVWHq4 Placebo AAE-003A ADVERSE EVENT COUGH Cough Respiratory, thoracic and mediastinal disorders F-Cough FXFXCoughing and associated symptoms FaRespiratory disorders NEC F-Respiratory, thoracic and mediastinal disorders F-2020-11-06 2020-11-16 BB DV.. BDV..Follow up stage A Vaccination 2B{BYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-07T09:13 Anaphylactic ReactionBROADY mRNA-1273-P201mRNA-1273-P201-US201-1067US2011067US201USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV5HqDVWHq4HqHq4DVWHq4 Placebo AAE-002A0ADVERSE EVENT DRY THROAT Dry throat Respiratory, thoracic and mediastinal disorders F-Dry throat F]F]Upper respiratory tract signs and symptoms FKiRespiratory tract signs and symptoms F}Respiratory, thoracic and mediastinal disorders F-2020-06-09 2020-07-30 ApB: DV;.. ApDVn..Vaccination stageA Vaccination 1ApB:YYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-03T13:35 mRNA-1273-P201mRNA-1273-P201-US201-1067US2011067US201USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV5HqDVWHq4HqHq4DVWHq4 Placebo AAE-006A@ADVERSE EVENT SORE THROAT Oropharyngeal pain Respiratory, thoracic and mediastinal disorders F-Sore throat F8F_Upper respiratory tract signs and symptoms FKiRespiratory tract signs and symptoms F}Respiratory, thoracic and mediastinal disorders F-2020-11-06 2020-11-15 BB DV.. BDV..Follow up stage A Vaccination 2B{BYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-07T09:13 mRNA-1273-P201mRNA-1273-P201-US201-1067US2011067US201USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV5HqDVWHq4HqHq4DVWHq4 Placebo AAE-004A`ADVERSE EVENT RUNNY NOSE Rhinorrhoea Respiratory, thoracic and mediastinal disorders F-Runny nose F0F/=Upper respiratory tract signs and symptoms FKiRespiratory tract signs and symptoms F}Respiratory, thoracic and mediastinal disorders F-2020-11-08 2020-11-16 BB DV.. BDV..Follow up stage A Vaccination 2B}BYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-07T09:13 mRNA-1273-P201mRNA-1273-P201-US201-1068US2011068US201USAB,YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV4HqhDVPHq,HqhHq,DVPHq, Placebo AAE-001AADVERSE EVENT BRUISE AT INJECTION SITE Injection site bruising General disorders and administration site conditions FInjection site bruising FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2020-06-30T10:502020-07-17 BB. DVPDXHqX BDVa..Vaccination stageA Vaccination 2ABYNY NNNNNNNNNOT RELATEDRELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-06-30T09:41 mRNA-1273-P201mRNA-1273-P201-US201-1068US2011068US201USAB,YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV4HqhDVPHq,HqhHq,DVPHq,2030Placebo AAE-004A REACTOGENICITYPAIN AT INJECTION SITE Injection site pain General disorders and administration site conditions FPain injection site F-FInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2020-07-01T14:002020-07-10T23:00BB' DVQDHq̎` BDVZE7HqpVaccination stageAP3DT13H19M Vaccination 2A AYNY YNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-06-30T09:41 Pain Y mRNA-1273-P201mRNA-1273-P201-US201-1068US2011068US201USAB,YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV4HqhDVPHq,HqhHq,DVPHq, Placebo AAE-003A0REACTOGENICITYSWELLING AT INJECTION SITE Injection site swelling General disorders and administration site conditions FSwelling of injection site F=HFg1Injection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2020-06-30 2020-07-15 BB, DVP.. BDV_..Vaccination stageAP9D Vaccination 2ABYNY YNNNNNNNRELATED RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-06-30T09:41 Swelling Y mRNA-1273-P201mRNA-1273-P201-US201-1084US2011084US201USAB1YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4Hq DVPHqHq HqDVPHq mRNA-1273 50 ug A AE-001AADVERSE EVENT MACULOPAPULAR RASH ON CHEST AND ABDOMEN, ALLERGIC REACTION TO NEW SOAP Dermatitis contact Skin and subcutaneous tissue disorders F5Soap allergy F>FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F52020-07-01T06:002020-07-13 BB* DVQDT`Hq BDV]..Vaccination stageA Vaccination 2AAYYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-06-30T08:19 HypersensitivityNARROWY mRNA-1273-P201mRNA-1273-P201-US201-1087US2011087US201USAB!YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5HqDVQHq̭PHqHq̭PDVQHq̭P mRNA-1273 50 ug A AE-001AADVERSE EVENT ANXIETY Anxiety Psychiatric disorders F'Anxiety FFAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'2021-01-01 B.ONGOINGDW .. B...Follow up stage A Vaccination 2B.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION NOT RECOVERED/NOT RESOLVED DOSE 2 - 2020-07-01T16:12 mRNA-1273-P201mRNA-1273-P201-US201-1087US2011087US201USAB!YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5HqDVQHq̭PHqHq̭PDVQHq̭P mRNA-1273 50 ug A AE-002A ADVERSE EVENT TROUBLE SLEEPING, DUE TO ANXIETY Insomnia Psychiatric disorders F'Difficulty sleeping FȄF%Disturbances in initiating and maintaining sleep FFSleep disorders and disturbances F6Psychiatric disorders F'2021-01-01 B.ONGOINGDW .. B...Follow up stage A Vaccination 2B.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION NOT RECOVERED/NOT RESOLVED DOSE 2 - 2020-07-01T16:12 mRNA-1273-P201mRNA-1273-P201-US201-1088US2011088US201USAB/YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV6HqDVWHq9HqHq9DVWHq9 Placebo AAE-001AADVERSE EVENT STYE, LEFT EYE Hordeolum Infections and infestations FStye F;FEye and eyelid infections FԥInfections - pathogen unspecified FInfections and infestations F2020-07-18 2020-07-25 B-B4 DVb.. B-DVi..Vaccination stageA Vaccination 2ABYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-07T09:38 mRNA-1273-P201mRNA-1273-P201-US201-1088US2011088US201USAB/YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV6HqDVWHq9HqHq9DVWHq9 Placebo AAE-002A ADVERSE EVENT LEFT LACERATED GREAT TOE TENDON Tendon injury Injury, poisoning and procedural complications FTendon laceration FF?jMuscle, tendon and ligament injuries FInjuries NEC FInjury, poisoning and procedural complications F2021-01-15 B.ONGOINGDW.. B...Follow up stage A Vaccination 2B.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION NOT RECOVERED/NOT RESOLVED DOSE 2 - 2020-07-07T09:38 mRNA-1273-P201mRNA-1273-P201-US201-1089US2011089US201USAB YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7HqDVZHqzhHqHqzhDVZHqzh mRNA-1273 100 ugA0AE-001A ADVERSE EVENT HEADACHE Headache Nervous system disorders FHeadache FFHeadaches NEC FHeadaches FNervous system disorders F2020-06-27 2020-06-30 BB DVM.. BDVP..Vaccination stageA Vaccination 1BBYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-06-05T09:28 Headache Y mRNA-1273-P201mRNA-1273-P201-US201-1089US2011089US201USAB YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7HqDVZHqzhHqHqzhDVZHqzh mRNA-1273 100 ugA0AE-004AADVERSE EVENT MISCARRIAGE (MISSED ABORTION) Abortion missed Pregnancy, puerperium and perinatal conditions F%iMissed abortion FFfAbortions not specified as induced or spontaneous FhAbortions and stillbirth FSPregnancy, puerperium and perinatal conditions F%i2021-02-26 2021-03-10 CCp DWA.. CDWM..Follow up stage A Vaccination 2BBYY NYNNNNNYNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ANOT APPLICABLE CONCOMITANT PROCEDURE RECOVERED/RESOLVED DOSE 2 - 2020-07-10T15:02 mRNA-1273-P201mRNA-1273-P201-US201-1091US2011091US201USAB6YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV6HqDVRHqրHqHqրDVRHqր mRNA-1273 50 ug A AE-001A`ADVERSE EVENT NAUSEA Nausea Gastrointestinal disorders FܛNausea F F Nausea and vomiting symptoms FGastrointestinal signs and symptoms FGastrointestinal disorders Fܛ2020-11-19 2020-11-21 BB DV.. BDV..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-07-02T13:20 Nausea/Vomiting Y mRNA-1273-P201mRNA-1273-P201-US201-1091US2011091US201USAB6YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV6HqDVRHqրHqHqրDVRHqր mRNA-1273 50 ug A AE-005AADVERSE EVENT CHILLS Chills General disorders and administration site conditions FChills FFFeelings and sensations NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2020-11-21 2020-11-22 BB DV.. BDV..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-07-02T13:20 Chills Y mRNA-1273-P201mRNA-1273-P201-US201-1091US2011091US201USAB6YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV6HqDVRHqրHqHqրDVRHqր mRNA-1273 50 ug A AE-003A0ADVERSE EVENT FATIGUE Fatigue General disorders and administration site conditions FFatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2020-11-19 2020-11-23 BB DV.. BDV..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-07-02T13:20 Fatigue Y mRNA-1273-P201mRNA-1273-P201-US201-1091US2011091US201USAB6YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV6HqDVRHqրHqHqրDVRHqր mRNA-1273 50 ug A AE-002A@ADVERSE EVENT HEADACHE Headache Nervous system disorders FHeadache FFHeadaches NEC FHeadaches FNervous system disorders F2020-11-19 2020-11-23 BB DV.. BDV..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-07-02T13:20 Headache Y mRNA-1273-P201mRNA-1273-P201-US201-1091US2011091US201USAB6YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV6HqDVRHqրHqHqրDVRHqր mRNA-1273 50 ug A AE-004A ADVERSE EVENT SHORTNESS OF BREATH Dyspnoea Respiratory, thoracic and mediastinal disorders F-Shortness of breath F5FBreathing abnormalities F>Respiratory disorders NEC F-Respiratory, thoracic and mediastinal disorders F-2020-11-19 2020-11-21 BB DV.. BDV..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-07-02T13:20 Anaphylactic ReactionBROADY CardiomyopathyBROAD mRNA-1273-P201mRNA-1273-P201-US201-1091US2011091US201USAB6YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV6HqDVRHqրHqHqրDVRHqր mRNA-1273 50 ug A AE-006APADVERSE EVENT HYPERTENSION Hypertension Vascular disorders FNYHypertension FFVascular hypertensive disorders NEC FVascular hypertensive disorders FuVascular disorders FNY2020-10-05 B|.ONGOINGDV.. B|...Follow up stage A Vaccination 2B`.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION NOT RECOVERED/NOT RESOLVED DOSE 2 - 2020-07-02T13:20 mRNA-1273-P201mRNA-1273-P201-US201-1092US2011092US201USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7HqRDVWHqԂHqRHqԂDVWHqԂ mRNA-1273 50 ug A AE-001A ADVERSE EVENT GASTRITIS Gastritis Gastrointestinal disorders FܛGastritis F=F=Gastritis (excl infective) F>Gastrointestinal inflammatory conditions FܱGastrointestinal disorders Fܛ2020-11-12 B.ONGOINGDV.. B...Follow up stage A Vaccination 2B.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION NOT RECOVERED/NOT RESOLVED DOSE 2 - 2020-07-07T14:48 mRNA-1273-P201mRNA-1273-P201-US201-1092US2011092US201USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7HqRDVWHqԂHqRHqԂDVWHqԂ mRNA-1273 50 ug A AE-002AADVERSE EVENT BRONCHITIS Bronchitis Infections and infestations FBronchitis FFLower respiratory tract and lung infections FInfections - pathogen unspecified FInfections and infestations F2020-11-20 2020-12-02 BB DV.. BDV..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-07T14:48 mRNA-1273-P201mRNA-1273-P201-US201-1095US2011095US201USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYNYYNYNYYYYYNYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7HqYDVVHqO HqYHqO DVVHqO mRNA-1273 50 ug A AE-005A0ADVERSE EVENT HEARING LOSS, LEFT EAR Deafness unilateral Ear and labyrinth disorders F)Hearing loss unilateral FxuFU,Hearing losses FHearing disorders FEar and labyrinth disorders F)2020-11-17 B.ONGOINGDV.. B...Follow up stage A Vaccination 2B.YN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE NOT RECOVERED/NOT RESOLVED DOSE 2 - 2020-07-06T16:56 Hearing and Vestibular DisordersNARROWY mRNA-1273-P201mRNA-1273-P201-US201-1095US2011095US201USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYNYYNYNYYYYYNYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7HqYDVVHqO HqYHqO DVVHqO mRNA-1273 50 ug A AE-003APADVERSE EVENT BRUISE AT INJECTION SITE Injection site bruising General disorders and administration site conditions FInjection site bruising FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2020-06-06 2020-06-20 A B DV8.. A DVF..Vaccination stageA Vaccination 1A BYNY NNNNNNNNNOT RELATEDRELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-05T15:19 mRNA-1273-P201mRNA-1273-P201-US201-1095US2011095US201USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYNYYNYNYYYYYNYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7HqYDVVHqO HqYHqO DVVHqO mRNA-1273 50 ug A AE-001AADVERSE EVENT PAIN IN LEFT HIP Arthralgia Musculoskeletal and connective tissue disorders FkPain in hip FF'Joint related signs and symptoms F:Joint disorders F-Musculoskeletal and connective tissue disorders Fk2020-06-09 2020-06-09 APAP DV;.. APDV;..Vaccination stageA Vaccination 1APAPYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-06-05T15:19 ArthritisBROAD Arthralgia Y mRNA-1273-P201mRNA-1273-P201-US201-1095US2011095US201USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYNYYNYNYYYYYNYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7HqYDVVHqO HqYHqO DVVHqO mRNA-1273 50 ug A AE-002A ADVERSE EVENT PAIN IN LEFT HIP Arthralgia Musculoskeletal and connective tissue disorders FkPain in hip FF'Joint related signs and symptoms F:Joint disorders F-Musculoskeletal and connective tissue disorders Fk2020-06-10 2020-06-10 A`A` DV<.. A`DV<..Vaccination stageA Vaccination 1A`A`YNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-05T15:19 ArthritisBROAD Arthralgia Y mRNA-1273-P201mRNA-1273-P201-US201-1095US2011095US201USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYNYYNYNYYYYYNYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7HqYDVVHqO HqYHqO DVVHqO mRNA-1273 50 ug A AE-004A@ADVERSE EVENT RASH, UPPER RT HIP (LIKELY DUE TO POISON IVY CONTACT) Dermatitis contact Skin and subcutaneous tissue disorders F5Poison ivy rash F"?FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F52020-06-27 2020-07-12 BB& DVM.. BDV\..Vaccination stageA Vaccination 1BB&YNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 1 - 2020-06-05T15:19 HypersensitivityNARROWY mRNA-1273-P201mRNA-1273-P201-US201-1102US2011102US201USAB)YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:HqDVVHqHqHqDVVHq mRNA-1273 50 ug A AE-001AADVERSE EVENT TORN MINISCUS, LEFT KNEE Meniscus injury Injury, poisoning and procedural complications FMeniscus tear of knee FFBone and joint injuries NEC FuBone and joint injuries FInjury, poisoning and procedural complications F2020-09-01 2020-11-30 BVB DV.. BVDV..Follow up stage A Vaccination 2B:BYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ANOT APPLICABLE CONCOMITANT PROCEDURE RECOVERED/RESOLVED DOSE 2 - 2020-07-06T10:23 mRNA-1273-P201mRNA-1273-P201-US201-1102US2011102US201USAB)YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:HqDVVHqHqHqDVVHq mRNA-1273 50 ug A AE-002A ADVERSE EVENT POST-OPERATIVE PAIN, TORN LEFT KNEE MENISCUS Procedural pain Injury, poisoning and procedural complications FPostoperative pain Fl7FNon-site specific procedural complications F Procedural related injuries and complications NEC FInjury, poisoning and procedural complications F2020-11-30 2020-12-07 BB DV.. BDV..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-06T10:23 mRNA-1273-P201mRNA-1273-P201-US201-1116US2011116US201USABEYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVMHq.DVkHqɨHq.HqɨDVkHqɨ Placebo AAE-001AADVERSE EVENT LEFT TOENAIL AVULSED Nail avulsion Injury, poisoning and procedural complications FNail avulsion FFSkin injuries NEC FInjuries NEC FInjury, poisoning and procedural complications F2020-08-20 2020-09-20 B7BV DV.. B7DV..Vaccination stageA Vaccination 2BB8YNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-27T13:10 mRNA-1273-P201mRNA-1273-P201-US201-1121US2011121US201USAB=YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVRHqDVnHqHqHqDVnHq mRNA-1273 100 ugA0AE-005A ADVERSE EVENT NAUSEA Nausea Gastrointestinal disorders FܛNausea F F Nausea and vomiting symptoms FGastrointestinal signs and symptoms FGastrointestinal disorders Fܛ2020-08-13 2020-08-14 B+B, DV|.. B+DV}..Vaccination stageA Vaccination 2ABYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-07-30T15:05 Nausea/Vomiting Y mRNA-1273-P201mRNA-1273-P201-US201-1121US2011121US201USAB=YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVRHqDVnHqHqHqDVnHq mRNA-1273 100 ugA0AE-006A0ADVERSE EVENT VOMITTING Vomiting Gastrointestinal disorders FܛVomiting FPFPNausea and vomiting symptoms FGastrointestinal signs and symptoms FGastrointestinal disorders Fܛ2020-08-13 2020-08-13 B+B+ DV|.. B+DV|..Vaccination stageA Vaccination 2AAYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-07-30T15:05 mRNA-1273-P201mRNA-1273-P201-US201-1121US2011121US201USAB=YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVRHqDVnHqHqHqDVnHq mRNA-1273 100 ugA0AE-004AADVERSE EVENT HEADACHE Headache Nervous system disorders FHeadache FFHeadaches NEC FHeadaches FNervous system disorders F2020-08-13 2020-08-13 B+B+ DV|.. B+DV|..Vaccination stageA Vaccination 2AAYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-30T15:05 Headache Y mRNA-1273-P201mRNA-1273-P201-US201-1122US2011122US201USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqŭDVhHqPHqŭHqPDVhHqP mRNA-1273 100 ugA0AE-001AADVERSE EVENT TINNITUS, BILATERAL Tinnitus Ear and labyrinth disorders F)Tinnitus FAFAInner ear signs and symptoms FInner ear and VIIIth cranial nerve disorders FEar and labyrinth disorders F)2021-02-20 B.ONGOINGDW;.. B...Follow up stage A Vaccination 2B.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE NOT RECOVERED/NOT RESOLVED DOSE 2 - 2020-07-24T08:12 Hearing and Vestibular DisordersNARROWY mRNA-1273-P201mRNA-1273-P201-US201-1123US2011123US201USAB@YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYNYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHq DVhHq Hq Hq DVhHq mRNA-1273 50 ug A AE-003AADVERSE EVENT JOINT ACHES IN SEVERAL JOINTS Arthralgia Musculoskeletal and connective tissue disorders FkAching joints FAF'Joint related signs and symptoms F:Joint disorders F-Musculoskeletal and connective tissue disorders Fk2020-07-30 2020-07-31 B#B$ DVn.. B#DVo..Vaccination stageA Vaccination 2ApAYNY NNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-24T16:13 ArthritisBROAD Arthralgia Y mRNA-1273-P201mRNA-1273-P201-US201-1123US2011123US201USAB@YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYNYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHq DVhHq Hq Hq DVhHq mRNA-1273 50 ug A AE-001A ADVERSE EVENT LEFT UPPER ARM ECCHYMOSIS, DUE TO INJURY Ecchymosis Skin and subcutaneous tissue disorders F5Ecchymosis F̀F̀Purpura and related conditions F)3Skin vascular abnormalities FNCSkin and subcutaneous tissue disorders F52020-07-03 2020-08-09 AB- DVS.. ADVx..Vaccination stageA Vaccination 1AB-YNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-26T16:56 mRNA-1273-P201mRNA-1273-P201-US201-1124US2011124US201USAB<YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVLHqDVhHq HqHq DVhHq Placebo AAE-001AADVERSE EVENT HERPES SIMPLEX II Herpes simplex Infections and infestations FHerpes simplex type II FyFlHerpes viral infections FViral infectious disorders FOInfections and infestations F2020-09-17 2020-10-01 BTBb DV.. BTDV..Follow up stage A Vaccination 2B8BFYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-24T09:28 mRNA-1273-P201mRNA-1273-P201-US201-1125US2011125US201USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYNNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVRHq DVmHqHq HqDVmHq mRNA-1273 50 ug A AE-001AADVERSE EVENT HEMORRHOID Haemorrhoids Gastrointestinal disorders FܛHemorrhoids FFHaemorrhoids and gastrointestinal varices (excl oesophageal) FGastrointestinal vascular conditions FGastrointestinal disorders Fܛ2020-07-07 2020-07-17 A`B DVW.. A`DVa..Vaccination stageA Vaccination 1A`BYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-07-02T17:15 mRNA-1273-P201mRNA-1273-P201-US201-1127US2011127US201USAB?YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHq DVhHq԰Hq Hq԰DVhHq԰ mRNA-1273 50 ug A AE-001A@ADVERSE EVENT WORSENING OF IBS Irritable bowel syndrome Gastrointestinal disorders FܛIrritable bowel syndrome aggravated FT;F[Gastrointestinal spastic and hypermotility disorders FGastrointestinal motility and defaecation conditions FܹGastrointestinal disorders Fܛ2020-12-07 2021-02-15 BB DV.. BDW6..Follow up stage A Vaccination 2BBYN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-24T13:08 mRNA-1273-P201mRNA-1273-P201-US201-1127US2011127US201USAB?YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHq DVhHq԰Hq Hq԰DVhHq԰ mRNA-1273 50 ug A AE-003A ADVERSE EVENT FATIGUE Fatigue General disorders and administration site conditions FFatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2021-01 ..ONGOINGDW ..D B...Follow up stage A Vaccination 2B.YN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ANOT APPLICABLE NONE NOT RECOVERED/NOT RESOLVED DOSE 2 - 2020-07-24T13:08 Fatigue Y mRNA-1273-P201mRNA-1273-P201-US201-1127US2011127US201USAB?YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHq DVhHq԰Hq Hq԰DVhHq԰ mRNA-1273 50 ug A AE-002A0ADVERSE EVENT HEAT EXHAUSTION Heat exhaustion Injury, poisoning and procedural complications FHeat exhaustion FFHeat injuries (excl thermal burns) F Injuries by physical agents FInjury, poisoning and procedural complications F2020-08-31 2020-11-15 BCB DV.. BCDV..Follow up stage A Vaccination 2B'BsYN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-24T13:08 mRNA-1273-P201mRNA-1273-P201-US201-1127US2011127US201USAB?YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHq DVhHq԰Hq Hq԰DVhHq԰ mRNA-1273 50 ug A AE-004AADVERSE EVENT JOINT PAIN Arthralgia Musculoskeletal and connective tissue disorders FkJoint pain F6F'Joint related signs and symptoms F:Joint disorders F-Musculoskeletal and connective tissue disorders Fk2021-02 ..ONGOINGDW(..D B...Follow up stage A Vaccination 2B.YN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDNONE NOT RECOVERED/NOT RESOLVED DOSE 2 - 2020-07-24T13:08 ArthritisBROAD Arthralgia Y mRNA-1273-P201mRNA-1273-P201-US201-1131US2011131US201USAB9YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVLHqDVhHqHqHqDVhHq Placebo AAE-001AADVERSE EVENT HIGH TRIGLYCERIDES Blood triglycerides increased Investigations FTriglycerides high FcFOTriglyceride analyses FDLipid analyses FInvestigations F2020-09-10 BM.ONGOINGDV.. BM...Follow up stage A Vaccination 2B1.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE NOT RECOVERED/NOT RESOLVED DOSE 2 - 2020-07-24T15:05 mRNA-1273-P201mRNA-1273-P201-US201-1131US2011131US201USAB9YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVLHqDVhHqHqHqDVhHq Placebo AAE-003A ADVERSE EVENT HIRSUTISM (UNWANTED HAIR GROWTH ON FACE) Hirsutism Skin and subcutaneous tissue disorders F5Hirsutism FFHypertrichoses FSkin appendage conditions F5Skin and subcutaneous tissue disorders F52020-11-15 B.ONGOINGDV.. B...Follow up stage A Vaccination 2Bs.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION NOT RECOVERED/NOT RESOLVED DOSE 2 - 2020-07-24T15:05 mRNA-1273-P201mRNA-1273-P201-US201-1137US2011137US201USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqųDVhHqꚐHqųHqꚐDVhHqꚐ mRNA-1273 50 ug A AE-002A ADVERSE EVENT NAUSEA Nausea Gastrointestinal disorders FܛNausea F F Nausea and vomiting symptoms FGastrointestinal signs and symptoms FGastrointestinal disorders Fܛ2020-07-23 2020-07-23 BB DVg.. BDVg..Vaccination stageA Vaccination 1BBYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-26T09:14 Nausea/Vomiting Y mRNA-1273-P201mRNA-1273-P201-US201-1137US2011137US201USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqųDVhHqꚐHqųHqꚐDVhHqꚐ mRNA-1273 50 ug A AE-001AADVERSE EVENT HEADACHE Headache Nervous system disorders FHeadache FFHeadaches NEC FHeadaches FNervous system disorders F2020-07-23 2020-07-23 BB DVg.. BDVg..Vaccination stageA Vaccination 1BBYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-06-26T09:14 Headache Y mRNA-1273-P201mRNA-1273-P201-US201-1142US2011142US201USAB@YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVOHq,DVkHqHHq,HqHDVkHqH Placebo AAE-005AADVERSE EVENT TOOTH EXTRACTION DENTAL CARIES Dental caries Gastrointestinal disorders FܛTooth caries FBtFƞDental and periodontal infections and inflammations FƥDental and gingival conditions FBrGastrointestinal disorders Fܛ2021-01-26 2021-01-26 BB DW".. BDW"..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-27T15:42 mRNA-1273-P201mRNA-1273-P201-US201-1152US2011152US201USABBYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYNYNYYYNNNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVOHq4DVkHqHq4HqDVkHq Placebo AAE-002AADVERSE EVENT LEFT UPPER ARM BRUISING @ THE INJECTION SITE Injection site bruising General disorders and administration site conditions FInjection site bruising FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2020-07-28 2020-09-02 BBB DVl.. BDV..Vaccination stageA Vaccination 2A B&YNY NNNNNNNNNOT RELATEDRELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-07-27T12:16 mRNA-1273-P201mRNA-1273-P201-US201-1156US2011156US201USABIYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYNYNYYYNNNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVPHq5`DVlHqHq5`HqDVlHq Placebo AAE-001AADVERSE EVENT WORSENING OF HIGH CHOLESTEROL Blood cholesterol increased Investigations FHigh cholesterol FFCholesterol analyses FKLipid analyses FInvestigations F2020-11-03 B.ONGOINGDV.. B...Follow up stage A Vaccination 2Bc.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION NOT RECOVERED/NOT RESOLVED DOSE 2 - 2020-07-28T10:06 mRNA-1273-P201mRNA-1273-P201-US201-1162US2011162US201USAB>YEARS>=55 Years A >=55 Years A@FWHITE HISPANIC OR LATINO YYNNNNNNNNNNYYYNNNNNNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVVHqIDVrHq:HqIHq:DVrHq: mRNA-1273 100 ugA0AE-004A0ADVERSE EVENT PULLED MUSCLE, RIGHT PECTORAL Muscle strain Injury, poisoning and procedural complications FPulled muscle FvmFYMuscle, tendon and ligament injuries FInjuries NEC FInjury, poisoning and procedural complications F2021-01-20 2021-04-06 BC0 DW.. BDWh..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-08-03T17:00 mRNA-1273-P201mRNA-1273-P201-US201-1162US2011162US201USAB>YEARS>=55 Years A >=55 Years A@FWHITE HISPANIC OR LATINO YYNNNNNNNNNNYYYNNNNNNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVVHqIDVrHq:HqIHq:DVrHq: mRNA-1273 100 ugA0AE-003A@ADVERSE EVENT KIDNEY STONES Nephrolithiasis Renal and urinary disorders F,WKidney stones F F\Renal lithiasis F,Urolithiases FLRenal and urinary disorders F,W2021-01-18 2021-04-14 BC DW.. BDWp..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA3SEVERE Grade 3A0Grade 3/Severe A0>=3A DOSE NOT CHANGEDCONCOMITANT MEDICATION, CONCOMITANT PROCEDURERECOVERED/RESOLVED DOSE 2 - 2020-08-03T17:00 mRNA-1273-P201mRNA-1273-P201-US201-1162US2011162US201USAB>YEARS>=55 Years A >=55 Years A@FWHITE HISPANIC OR LATINO YYNNNNNNNNNNYYYNNNNNNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVVHqIDVrHq:HqIHq:DVrHq: mRNA-1273 100 ugA0AE-007AADVERSE EVENT PAIN, RIGHT BREAST Breast pain Reproductive system and breast disorders F-LBreast pain FFBreast signs and symptoms FdBreast disorders FReproductive system and breast disorders F-L2020-11-18 2021-01-20 BB DV.. BDW..Follow up stage A Vaccination 2BlBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-08-03T17:00 mRNA-1273-P201mRNA-1273-P201-US201-1162US2011162US201USAB>YEARS>=55 Years A >=55 Years A@FWHITE HISPANIC OR LATINO YYNNNNNNNNNNYYYNNNNNNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVVHqIDVrHq:HqIHq:DVrHq: .AE-001A ADVERSE EVENT ECCHYMOSIS, LT FOREARM Ecchymosis Skin and subcutaneous tissue disorders F5Ecchymosis F̀F̀Purpura and related conditions F)3Skin vascular abnormalities FNCSkin and subcutaneous tissue disorders F52020-07-06T14:352020-07-14T08:00AA DVVDHq. ADV^DpHq] . .. N NNNNNNNNNOT RELATEDRELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED mRNA-1273-P201mRNA-1273-P201-US201-1162US2011162US201USAB>YEARS>=55 Years A >=55 Years A@FWHITE HISPANIC OR LATINO YYNNNNNNNNNNYYYNNNNNNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVVHqIDVrHq:HqIHq:DVrHq: mRNA-1273 100 ugA0AE-002APADVERSE EVENT BACK ITCH Pruritus Skin and subcutaneous tissue disorders F5Localized itching F{F'_Pruritus NEC FW Epidermal and dermal conditions FSkin and subcutaneous tissue disorders F52020-07-13 2020-07-22 AB DV].. ADVf..Vaccination stageA Vaccination 1ABYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-07-06T16:32 Anaphylactic ReactionBROADY HypersensitivityBROAD mRNA-1273-P201mRNA-1273-P201-US202-1003US2021003US202USAB:YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV0Hq+XDVPHqTHq+XHqTDVPHqT mRNA-1273 100 ugA0AE-002A ADVERSE EVENT VITAMIN D DEFICIENCY Vitamin D deficiency Metabolism and nutrition disorders FVitamin D deficiency FPFPFat soluble vitamin deficiencies and disorders FVitamin related disorders FPMetabolism and nutrition disorders F2020-10-21 B.ONGOINGDV.. B...Follow up stage A Vaccination 2Br.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RECOVERED/NOT RESOLVED DOSE 2 - 2020-06-30T08:59 mRNA-1273-P201mRNA-1273-P201-US202-1003US2021003US202USAB:YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV0Hq+XDVPHqTHq+XHqTDVPHqT mRNA-1273 100 ugA0AE-001AADVERSE EVENT HEMATURIA Haematuria Renal and urinary disorders F,WHematuria FzF3Urinary abnormalities FDUrinary tract signs and symptoms FL~Renal and urinary disorders F,W2020-10-06 2020-10-21 BB DV.. BDV..Follow up stage A Vaccination 2BcBrYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-06-30T08:59 mRNA-1273-P201mRNA-1273-P201-US202-1004US2021004US202USABHYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV0HqDVLHqŻHqHqŻDVLHqŻ mRNA-1273 50 ug A AE-002AADVERSE EVENT RIGHT FOOT CELLULITIS Cellulitis Infections and infestations FCellulitis of foot FgFJBacterial infections NEC FOBacterial infectious disorders F2Infections and infestations F2020-12-26 2021-01-03 BB DW.. BDW ..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-06-26T09:45 mRNA-1273-P201mRNA-1273-P201-US202-1011US2021011US202USAB:YEARS>=55 Years A >=55 Years A@MWHITE HISPANIC OR LATINO YYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV0Hq#$DVLHqHq#$HqDVLHq mRNA-1273 100 ugA0AE-002A ADVERSE EVENT GLAUCOMA BILATERAL Glaucoma Eye disorders FԯGlaucoma both eyes FFGlaucomas (excl congenital) FGlaucoma and ocular hypertension FEye disorders Fԯ2020-11-08 2020-11-08 BB DV.. BDV..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED WITH SEQUELAETHIS WILL BE APART OF SUBJECT MEDICAL CONDITION DOSE 2 - 2020-06-26T10:49 mRNA-1273-P201mRNA-1273-P201-US202-1011US2021011US202USAB:YEARS>=55 Years A >=55 Years A@MWHITE HISPANIC OR LATINO YYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV0Hq#$DVLHqHq#$HqDVLHq mRNA-1273 100 ugA0AE-001AADVERSE EVENT DIVERTICULOSIS Diverticulum Gastrointestinal disorders FܛDiverticulosis FmFrDiverticula FZDiverticular disorders F_Gastrointestinal disorders Fܛ2020-06-05 A.ONGOINGDV7.. A...Vaccination stageA Vaccination 1A.YYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERING/RESOLVING DOSE 1 - 2020-05-29T15:35 mRNA-1273-P201mRNA-1273-P201-US202-1012US2021012US202USABBYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3HqDVOHqɷXHqHqɷXDVOHqɷX mRNA-1273 50 ug A AE-001AADVERSE EVENT OTALGIA Ear pain Ear and labyrinth disorders F)Otalgia FFDEar disorders NEC FAural disorders NEC FEar and labyrinth disorders F)2020-07-04 2020-07-15 B"B- DVT.. B"DV_..Vaccination stageA Vaccination 2A`BYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-06-29T10:18 mRNA-1273-P201mRNA-1273-P201-US202-1018US2021018US202USABGYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYYmRNA-1273 50 ug A mRNA-1273 50 ug A DV0HqDV]Hq`HqHq`DV]Hq` mRNA-1273 50 ug A AE-001A ADVERSE EVENT PHARYNGITIS Pharyngitis Infections and infestations FPharyngitis FFUpper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations F2020-06-22 2020-06-30 BB! DVH.. BDVP..Vaccination stageA Vaccination 1BB!YNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE DELAYED NONE RECOVERED/RESOLVED DOSE 1 - 2020-05-29T13:35 mRNA-1273-P201mRNA-1273-P201-US202-1018US2021018US202USABGYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYYmRNA-1273 50 ug A mRNA-1273 50 ug A DV0HqDV]Hq`HqHq`DV]Hq` mRNA-1273 50 ug A AE-002A0ADVERSE EVENT URINARY TRACT INFECTION Urinary tract infection Infections and infestations FUrinary tract infection FLkFLkUrinary tract infections FLqInfections - pathogen unspecified FInfections and infestations F2020-07-01 2020-07-07 B"B( DVQ.. B"DVW..Vaccination stageA Vaccination 1B"B(YN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-05-29T13:35 mRNA-1273-P201mRNA-1273-P201-US202-1018US2021018US202USABGYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYYmRNA-1273 50 ug A mRNA-1273 50 ug A DV0HqDV]Hq`HqHq`DV]Hq` mRNA-1273 50 ug A AE-003AADVERSE EVENT WORSENING OF BACK PAIN Back pain Musculoskeletal and connective tissue disorders FkBack pain aggravated FSFMusculoskeletal and connective tissue pain and discomfort FMusculoskeletal and connective tissue disorders NEC FiMusculoskeletal and connective tissue disorders Fk2020-08-04 2020-11-26 BDB DVs.. BDDV..Vaccination stageA Vaccination 2BBYYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-13T14:02 mRNA-1273-P201mRNA-1273-P201-US202-1019US2021019US202USAB;YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV0HqDVRHqHqHqDVRHq mRNA-1273 50 ug A AE-002AADVERSE EVENT NEPHROLITHIASIS (RIGHT) Nephrolithiasis Renal and urinary disorders F,WNephrolithiasis F\F\Renal lithiasis F,Urolithiases FLRenal and urinary disorders F,W2020-06-24 2020-07-06 BB' DVJ.. BDVV..Vaccination stageA Vaccination 1BB'YYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION, CONCOMITANT PROCEDURERECOVERED/RESOLVED DOSE 1 - 2020-05-29T15:05 mRNA-1273-P201mRNA-1273-P201-US202-1019US2021019US202USAB;YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV0HqDVRHqHqHqDVRHq mRNA-1273 50 ug A AE-003A0ADVERSE EVENT ALLERGIC RHINITIS Rhinitis allergic Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;F/-Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-2021-01-22 2021-02-01 BB DW.. BDW(..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-02T16:34 HypersensitivityNARROWY mRNA-1273-P201mRNA-1273-P201-US202-1019US2021019US202USAB;YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV0HqDVRHqHqHqDVRHq mRNA-1273 50 ug A AE-001A ADVERSE EVENT RASH ON RIGHT KNEE NON-URTICARIAL Rash Skin and subcutaneous tissue disorders F5Rash on leg FuF*TRashes, eruptions and exanthems NEC FcEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F52020-06-01 2020-06-06 A@A DV3.. A@DV8..Vaccination stageA Vaccination 1A@AYYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-05-29T15:05 Anaphylactic ReactionBROADY HypersensitivityNARROWY mRNA-1273-P201mRNA-1273-P201-US202-1020US2021020US202USABHYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3HqDVPHqHqHqDVPHq1080mRNA-1273 50 ug A AE-001AREACTOGENICITYFATIGUE Fatigue General disorders and administration site conditions FFatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2020-06-06 2020-06-16 A`B DV8.. A`DVB..Vaccination stageAP9D Vaccination 1A`BYNY YNNNNNNNRELATED RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-01T12:25 Fatigue Y mRNA-1273-P201mRNA-1273-P201-US202-1020US2021020US202USABHYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3HqDVPHqHqHqDVPHq1070mRNA-1273 50 ug A AE-002A REACTOGENICITYHEADACHE Headache Nervous system disorders FHeadache FFHeadaches NEC FHeadaches FNervous system disorders F2020-06-06 2020-06-09 A`A DV8.. A`DV;..Vaccination stageAP2D Vaccination 1A`AYNY YNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-06-01T12:25 Headache Y mRNA-1273-P201mRNA-1273-P201-US202-1021US2021021US202USABGYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNPlacebo APlacebo ADV0Hq,DVLHqſHq,HqſDVLHqſ Placebo AAE-001AADVERSE EVENT PLANAR FACSCITIS Plantar fasciitis Musculoskeletal and connective tissue disorders FkPlantar fasciitis FFMusculoskeletal and connective tissue infections and inflammations NECFdMusculoskeletal and connective tissue disorders NEC FiMusculoskeletal and connective tissue disorders Fk2020-08-25 2020-08-31 BYB_ DV.. BYDV..Follow up stage A Vaccination 2B=BCYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-06-26T10:04 mRNA-1273-P201mRNA-1273-P201-US202-1022US2021022US202USABCYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNPlacebo APlacebo ADV3Hq\DVVHqHq\HqDVVHq Placebo AAE-001AADVERSE EVENT BROKEN TOOTH Tooth fracture Injury, poisoning and procedural complications FTooth fracture FFAbdominal and gastrointestinal injuries NEC FInjuries NEC FInjury, poisoning and procedural complications F2020-07-19 2020-08-16 B1BM DVc.. B1DV..Vaccination stageA Vaccination 2AB*YNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-06T11:51 mRNA-1273-P201mRNA-1273-P201-US202-1031US2021031US202USABHYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3Hq%DVOHqHq%HqDVOHq mRNA-1273 100 ugA0AE-002AADVERSE EVENT ARRHYTHMIA Arrhythmia Cardiac disorders FArrhythmia FFRate and rhythm disorders NEC F*Cardiac arrhythmias FCardiac disorders F2020-07-28 2020-07-30 B:B< DVl.. B:DVn..Follow up stage A Vaccination 2BB YY NYNNNYNNNOT RELATEDNOT RELATED NOT RELATEDA4 Grade 4A@Grade 4 A@>=3A NOT APPLICABLE NONE RECOVERED/RESOLVED 2020-07-282020-07-30N DOSE 2 - 2020-06-29T13:57 CardiomyopathyBROAD mRNA-1273-P201mRNA-1273-P201-US202-1031US2021031US202USABHYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3Hq%DVOHqHq%HqDVOHq mRNA-1273 100 ugA0AE-001A ADVERSE EVENT STRUCK BY LIGHTNING Struck by lightning Injury, poisoning and procedural complications FStruck by lightning F;F;Non-site specific injuries NEC F Injuries NEC FInjury, poisoning and procedural complications F2020-07-28 2020-07-30 B:B< DVl.. B:DVn..Follow up stage A Vaccination 2BB YY NYNNNYNNNOT RELATEDNOT RELATED NOT RELATEDA3SEVERE Grade 3A0Grade 3/Severe A0>=3A NOT APPLICABLE CONCOMITANT PROCEDURE RECOVERED/RESOLVED 2020-07-282020-07-30N DOSE 2 - 2020-06-29T13:57 mRNA-1273-P201mRNA-1273-P201-US202-1043US2021043US202USABAYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNPlacebo APlacebo ADV3Hq"lDVRHqͳXHq"lHqͳXDVRHqͳX Placebo AAE-002AADVERSE EVENT ALLERGIC REACTION WASP BITE Allergy to arthropod sting Immune system disorders F4Allergic reaction to wasp sting F:Fz,Allergic conditions NEC FAllergic conditions F,Immune system disorders F42020-06-16 2020-06-16 BB DVB.. BDVB..Vaccination stageA Vaccination 1BBYYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA3SEVERE Grade 3A0Grade 3/Severe A0>=3A DOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-06-01T16:21 mRNA-1273-P201mRNA-1273-P201-US202-1043US2021043US202USABAYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNPlacebo APlacebo ADV3Hq"lDVRHqͳXHq"lHqͳXDVRHqͳX Placebo AAE-001A ADVERSE EVENT POISON IVY ALLERGIC CONTACT DERMATITIS - BILATERAL LEGS Dermatitis contact Skin and subcutaneous tissue disorders F5Poison ivy rash F"?FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F52020-06-10 2020-06-17 AB DV<.. ADVC..Vaccination stageA Vaccination 1ABYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-06-01T16:21 HypersensitivityNARROWY mRNA-1273-P201mRNA-1273-P201-US202-1045US2021045US202USAB=YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3Hq9(DVOHqHq9(HqDVOHq mRNA-1273 50 ug A AE-001AADVERSE EVENT TOOTHACHE Toothache Gastrointestinal disorders FܛToothache FBFBDental pain and sensation disorders FBDental and gingival conditions FBrGastrointestinal disorders Fܛ2020-07-03 2020-07-11 B!B) DVS.. B!DV[..Vaccination stageA Vaccination 2APAYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-06-29T15:10 mRNA-1273-P201mRNA-1273-P201-US202-1058US2021058US202USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7Hq PDVWHq68Hq PHq68DVWHq682080mRNA-1273 50 ug A AE-004A0REACTOGENICITYFATIGUE Fatigue General disorders and administration site conditions FFatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2020-07-07T21:412020-07-15T12:00B!B) DVWEHql B!DV_DHq@Vaccination stageAP1DT2H38M Vaccination 2AAYNY YNNNNNNNRELATED NOT RELATED RELATED A 3SEVERE Grade 3A0Grade 3/Severe A0>=3A DOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-07T09:22 Fatigue Y mRNA-1273-P201mRNA-1273-P201-US202-1058US2021058US202USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7Hq PDVWHq68Hq PHq68DVWHq68 mRNA-1273 50 ug A AE-002A`REACTOGENICITYGENERALIZED BODY ACHES Pain General disorders and administration site conditions FGeneral body pain FUFPain and discomfort NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2020-07-07T19:002020-07-14T22:22B!B( DVWEHqԽ B!DV^EHq'Vaccination stageAPT13H Vaccination 2AAYNY YNNNNNNNRELATED NOT RELATED RELATED A 3SEVERE Grade 3A0Grade 3/Severe A0>=3A DOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-07T09:22 Myalgia Y mRNA-1273-P201mRNA-1273-P201-US202-1058US2021058US202USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7Hq PDVWHq68Hq PHq68DVWHq68 mRNA-1273 50 ug A AE-008AADVERSE EVENT BROKEN TOOTH RIGHT MOLAR Tooth fracture Injury, poisoning and procedural complications FTooth fracture FFAbdominal and gastrointestinal injuries NEC FInjuries NEC FInjury, poisoning and procedural complications F2020-07-22 B0.ONGOINGDVf.. B0...Vaccination stageA Vaccination 2B.YYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE NOT RECOVERED/NOT RESOLVED DOSE 2 - 2020-07-07T09:22 mRNA-1273-P201mRNA-1273-P201-US202-1058US2021058US202USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7Hq PDVWHq68Hq PHq68DVWHq68 mRNA-1273 50 ug A AE-001AREACTOGENICITYJOINT ACHES IN SEVERAL JOINT Arthralgia Musculoskeletal and connective tissue disorders FkAching joints FAF'Joint related signs and symptoms F:Joint disorders F-Musculoskeletal and connective tissue disorders Fk2020-07-07T19:002020-07-14T22:22B!B( DVWEHqԽ B!DV^EHq'Vaccination stageAPT13H Vaccination 2AAYNY YNNNNNNNRELATED NOT RELATED RELATED A 3SEVERE Grade 3A0Grade 3/Severe A0>=3A DOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-07T09:22 ArthritisBROAD Arthralgia Y mRNA-1273-P201mRNA-1273-P201-US202-1058US2021058US202USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7Hq PDVWHq68Hq PHq68DVWHq68 mRNA-1273 50 ug A AE-006APADVERSE EVENT SWELLING AT PROXIMAL JOINT 2ND DIGIT RIGHT HAND Joint swelling Musculoskeletal and connective tissue disorders FkJoint swelling of hand F[F@Joint related signs and symptoms F:Joint disorders F-Musculoskeletal and connective tissue disorders Fk2020-07-08T20:00 B".ONGOINGDVXEHq@ B"...Vaccination stageA Vaccination 2A .YNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERING/RESOLVING DOSE 2 - 2020-07-07T09:22 ArthritisBROAD mRNA-1273-P201mRNA-1273-P201-US202-1058US2021058US202USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7Hq PDVWHq68Hq PHq68DVWHq682070mRNA-1273 50 ug A AE-005A@REACTOGENICITYHEADACHES Headache Nervous system disorders FHeadache FFHeadaches NEC FHeadaches FNervous system disorders F2020-07-14 2020-07-15 B(B) DV^.. B(DV_..Vaccination stageAP2D Vaccination 2AAYNY YNNNNNNNRELATED NOT RELATED RELATED A 2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-07T09:22 Headache Y mRNA-1273-P201mRNA-1273-P201-US202-1062US2021062US202USAB,YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV6HqμDVRHqİHqμHqİDVRHqİ Placebo AAE-001A0ADVERSE EVENT MUSCLE STRAIN LEFT HAMSTRING Muscle strain Injury, poisoning and procedural complications FPulled hamstring F(9FYMuscle, tendon and ligament injuries FInjuries NEC FInjury, poisoning and procedural complications F2020-06-09 2020-06-16 A`A DV;.. A`DVB..Vaccination stageA Vaccination 1A`AYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-06-04T11:13 mRNA-1273-P201mRNA-1273-P201-US202-1062US2021062US202USAB,YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV6HqμDVRHqİHqμHqİDVRHqİ Placebo AAE-004A@ADVERSE EVENT MYALGIA GENERALIZED Myalgia Musculoskeletal and connective tissue disorders FkMyalgia F{F{Muscle pains F#Muscle disorders FMusculoskeletal and connective tissue disorders Fk2020-06-25 2020-06-28 BB DVK.. BDVN..Vaccination stageA Vaccination 1BBYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE DELAYED NONE RECOVERED/RESOLVED DOSE 1 - 2020-06-04T11:13 Myalgia Y mRNA-1273-P201mRNA-1273-P201-US202-1062US2021062US202USAB,YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV6HqμDVRHqİHqμHqİDVRHqİ Placebo AAE-003AADVERSE EVENT HEADACHE Headache Nervous system disorders FHeadache FFHeadaches NEC FHeadaches FNervous system disorders F2020-06-25 2020-06-28 BB DVK.. BDVN..Vaccination stageA Vaccination 1BBYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE DELAYED NONE RECOVERED/RESOLVED DOSE 1 - 2020-06-04T11:13 Headache Y mRNA-1273-P201mRNA-1273-P201-US202-1062US2021062US202USAB,YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV6HqμDVRHqİHqμHqİDVRHqİ Placebo AAE-005A ADVERSE EVENT LETHARGY Lethargy Nervous system disorders FLethargy FHFHDisturbances in consciousness NEC FENeurological disorders NEC FNervous system disorders F2020-06-25 2020-06-28 BB DVK.. BDVN..Vaccination stageA Vaccination 1BBYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE DELAYED NONE RECOVERED/RESOLVED DOSE 1 - 2020-06-04T11:13 mRNA-1273-P201mRNA-1273-P201-US202-1062US2021062US202USAB,YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV6HqμDVRHqİHqμHqİDVRHqİ Placebo AAE-002APADVERSE EVENT SINUS CONGESTION Sinus congestion Respiratory, thoracic and mediastinal disorders F-Sinus congestion F5F5Paranasal sinus disorders (excl infections and neoplasms) F5Upper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-2020-06-25 2020-06-28 BB DVK.. BDVN..Vaccination stageA Vaccination 1BBYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE DELAYED CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-06-04T11:13 mRNA-1273-P201mRNA-1273-P201-US202-1063US2021063US202USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6HqDVWHq0 HqHq0 DVWHq0 mRNA-1273 100 ugA0AE-003AADVERSE EVENT ACUTE SINUSITIS Acute sinusitis Infections and infestations FAcute sinusitis FFUpper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations F2021-01-26 2021-02-02 BB DW".. BDW)..Follow up stage A Vaccination 2BBYN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-07T08:56 mRNA-1273-P201mRNA-1273-P201-US202-1064US2021064US202USAB6YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:HqDVYHq(HqHq(DVYHq( mRNA-1273 50 ug A AE-001A ADVERSE EVENT DIARRHEA Diarrhoea Gastrointestinal disorders FܛDiarrhea F7F?Diarrhoea (excl infective) F@Gastrointestinal motility and defaecation conditions FܹGastrointestinal disorders Fܛ2020-07-06 2020-07-06 BB DVV.. BDVV..Vaccination stageA Vaccination 1BBYN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-08T08:48 mRNA-1273-P201mRNA-1273-P201-US202-1064US2021064US202USAB6YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:HqDVYHq(HqHq(DVYHq( mRNA-1273 50 ug A AE-003AADVERSE EVENT CHEST PRESSURE Chest discomfort General disorders and administration site conditions FChest pressure FFPain and discomfort NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2020-07-06 2020-07-06 BB DVV.. BDVV..Vaccination stageA Vaccination 1BBYN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-08T08:48 Anaphylactic ReactionBROADY mRNA-1273-P201mRNA-1273-P201-US202-1064US2021064US202USAB6YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:HqDVYHq(HqHq(DVYHq( mRNA-1273 50 ug A AE-004A0ADVERSE EVENT HEADACHE Headache Nervous system disorders FHeadache FFHeadaches NEC FHeadaches FNervous system disorders F2020-07-06 2020-07-06 BB DVV.. BDVV..Vaccination stageA Vaccination 1BBYN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE DELAYED NONE RECOVERED/RESOLVED DOSE 1 - 2020-06-08T08:48 Headache Y mRNA-1273-P201mRNA-1273-P201-US202-1064US2021064US202USAB6YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:HqDVYHq(HqHq(DVYHq( mRNA-1273 50 ug A AE-002A@ADVERSE EVENT ITCHY NOSE Nasal pruritus Respiratory, thoracic and mediastinal disorders F-Nasal itching FFNasal disorders NEC FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-2020-07-06 2020-07-08 BB DVV.. BDVX..Vaccination stageA Vaccination 1BBYN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-08T08:48 mRNA-1273-P201mRNA-1273-P201-US202-1073US2021073US202USAB3YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADV4Hq9TDVPHq0Hq9THq0DVPHq0 Placebo AAE-002A ADVERSE EVENT LESION ON GUM (UNKNOWN ) BENGIN Oral disorder Gastrointestinal disorders FܛOral lesion F}FOral soft tissue disorders NEC FOral soft tissue conditions FGastrointestinal disorders Fܛ2020-06-25 2020-07-20 BB1 DVK.. BDVd..Vaccination stageA Vaccination 1BB1YYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION, CONCOMITANT PROCEDURERECOVERED/RESOLVED DOSE 1 - 2020-06-02T12:11 mRNA-1273-P201mRNA-1273-P201-US202-1073US2021073US202USAB3YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADV4Hq9TDVPHq0Hq9THq0DVPHq0 Placebo AAE-003AADVERSE EVENT COVID-19 INFECTION COVID-19 Infections and infestations FCOVID-19 F߬F߬Coronavirus infections FViral infectious disorders FOInfections and infestations F2020-12-05 2020-12-20 BB DV.. BDV..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-06-30T09:24 mRNA-1273-P201mRNA-1273-P201-US202-1074US2021074US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqDVWHq}<HqHq}<DVWHq}< mRNA-1273 100 ugA0AE-002A ADVERSE EVENT PAIN AT INJECTION SITE Injection site pain General disorders and administration site conditions FPain injection site F-FInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2020-06-02T18:002020-06-17T08:00AB DV4D Hq ADVCDpHqVaccination stageA Vaccination 1AAYNY NNNNNNNNRELATED RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-02T09:14 Pain Y mRNA-1273-P201mRNA-1273-P201-US202-1080US2021080US202USAB1YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7HqVDVXHqՉ HqVHqՉ DVXHqՉ mRNA-1273 100 ugA0AE-006AADVERSE EVENT GASTROINTESTINAL DISTRESS (NOS) Abdominal discomfort Gastrointestinal disorders FܛDistress gastrointestinal F3FGastrointestinal signs and symptoms NEC FGastrointestinal signs and symptoms FGastrointestinal disorders Fܛ2021-02-09 2021-03-09 BC` DW0.. BDWL..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-08T09:28 mRNA-1273-P201mRNA-1273-P201-US202-1080US2021080US202USAB1YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7HqVDVXHqՉ HqVHqՉ DVXHqՉ mRNA-1273 100 ugA0AE-005A0ADVERSE EVENT DRY MOUTH Dry mouth Gastrointestinal disorders FܛDry mouth FUFUOral dryness and saliva altered FSalivary gland conditions F0lGastrointestinal disorders Fܛ2020-07-09T08:002020-07-13T00:13B#B' DVYDpHq B#DV]C0Hq۞Vaccination stageA Vaccination 2AAPYNY NNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-08T09:28 mRNA-1273-P201mRNA-1273-P201-US202-1080US2021080US202USAB1YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7HqVDVXHqՉ HqVHqՉ DVXHqՉ 1080mRNA-1273 100 ugA0AE-001A@REACTOGENICITYFATIGUE Fatigue General disorders and administration site conditions FFatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2020-06-05T21:352020-06-18T08:32AA DV7E@Hq ADVDDxHqVaccination stageAP5DT17H26M Vaccination 1AAYNY YNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-05T15:06 Fatigue Y mRNA-1273-P201mRNA-1273-P201-US202-1082US2021082US202USAB/YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADV5HqzDVWHqMHqzHqMDVWHqM Placebo AAE-009A@ADVERSE EVENT HYPERESTROGENISM Hyperoestrogenism Endocrine disorders FHyperestrogenism FFQEndocrine abnormalities of gonadal function NEC FEndocrine disorders of gonadal function FEndocrine disorders F2020-12-14 B.ONGOINGDV.. B...Follow up stage A Vaccination 2B.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RECOVERED/NOT RESOLVED DOSE 2 - 2020-07-07T11:02 mRNA-1273-P201mRNA-1273-P201-US202-1082US2021082US202USAB/YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADV5HqzDVWHqMHqzHqMDVWHqM Placebo AAE-003A0ADVERSE EVENT FATIGUE Fatigue General disorders and administration site conditions FFatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2020-09-06 2020-09-11 B`Be DV.. B`DV..Follow up stage A Vaccination 2B>BCYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-07T11:02 Fatigue Y mRNA-1273-P201mRNA-1273-P201-US202-1082US2021082US202USAB/YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADV5HqzDVWHqMHqzHqMDVWHqM Placebo AAE-001A ADVERSE EVENT COVID-19 INFECTION COVID-19 Infections and infestations FCOVID-19 F߬F߬Coronavirus infections FViral infectious disorders FOInfections and infestations F2020-09-10 2020-10-08 BdB DV.. BdDV..Follow up stage A Vaccination 2BBB^YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-07T11:02 mRNA-1273-P201mRNA-1273-P201-US202-1082US2021082US202USAB/YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADV5HqzDVWHqMHqzHqMDVWHqM Placebo AAE-007AADVERSE EVENT LOW TESTOSTERONE Blood testosterone decreased Investigations FTestosterone low F?F6Reproductive hormone analyses F-=Endocrine investigations (incl sex hormones) FInvestigations F2020-10-15 B.ONGOINGDV.. B...Follow up stage A Vaccination 2Be.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RECOVERED/NOT RESOLVED DOSE 2 - 2020-07-07T11:02 mRNA-1273-P201mRNA-1273-P201-US202-1082US2021082US202USAB/YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADV5HqzDVWHqMHqzHqMDVWHqM Placebo AAE-008APADVERSE EVENT LOW VITAMIN D Vitamin D decreased Investigations FVitamin D low FǟFmVitamin analyses FPnMetabolic, nutritional and blood gas investigations FInvestigations F2020-10-17 B.ONGOINGDV.. B...Follow up stage A Vaccination 2Bg.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RECOVERED/NOT RESOLVED DOSE 2 - 2020-07-07T11:02 mRNA-1273-P201mRNA-1273-P201-US202-1084US2021084US202USAB"YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7Hqh0DVWHqFdHqh0HqFdDVWHqFd mRNA-1273 50 ug A AE-002AADVERSE EVENT RASH RIGHT ELBOW Rash Skin and subcutaneous tissue disorders F5Localized rash FqF*TRashes, eruptions and exanthems NEC FcEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F52020-07-08T08:002020-07-13T08:00B"B' DVXDpHqt B"DV]DpHq Vaccination stageA Vaccination 2AA`YNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-07T10:31 Anaphylactic ReactionBROADY HypersensitivityNARROWY mRNA-1273-P201mRNA-1273-P201-US202-1090US2021090US202USAB6YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4HqDVVHq|HqHq|DVVHq| mRNA-1273 50 ug A AE-002AADVERSE EVENT WORSENING OF TENSION HEADACHE Tension headache Nervous system disorders FTension headache F?F?Headaches NEC FHeadaches FNervous system disorders F2021-01-19 2021-01-20 BB DW.. BDW..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-06T09:21 mRNA-1273-P201mRNA-1273-P201-US202-1094US2021094US202USAB5YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYNNNNNNNNNYNYYNNNNYYYNNNot Detected YNNPlacebo APlacebo ADV7Hq[DV7Hq[Hq[Hq[.. Placebo AAE-003A ADVERSE EVENT COVID-19 INFECTION (POSITIVE) COVID-19 Infections and infestations FCOVID-19 F߬F߬Coronavirus infections FViral infectious disorders FOInfections and infestations F2020-07-06 2020-07-23 B B1 DVV.. B DVg..Follow up stage A Vaccination 1B B1YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADRUG WITHDRAWN NONE RECOVERED/RESOLVED DOSE 1 - 2020-06-05T15:26 mRNA-1273-P201mRNA-1273-P201-US202-1094US2021094US202USAB5YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYNNNNNNNNNYNYYNNNNYYYNNNot Detected YNNPlacebo APlacebo ADV7Hq[DV7Hq[Hq[Hq[.. Placebo AAE-002A0ADVERSE EVENT SINUS HEADACHE Sinus headache Nervous system disorders FSinus headache F5F5Headaches NEC FHeadaches FNervous system disorders F2020-06-29 2020-07-01 BB DVO.. BDVQ..Vaccination stageA Vaccination 1BBYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE DELAYED CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-06-05T15:26 mRNA-1273-P201mRNA-1273-P201-US202-1094US2021094US202USAB5YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYNNNNNNNNNYNYYNNNNYYYNNNot Detected YNNPlacebo APlacebo ADV7Hq[DV7Hq[Hq[Hq[.. Placebo AAE-001AADVERSE EVENT COUGH Cough Respiratory, thoracic and mediastinal disorders F-Cough FXFXCoughing and associated symptoms FaRespiratory disorders NEC F-Respiratory, thoracic and mediastinal disorders F-2020-06-26 2020-08-08 BBA DVL.. BDVw..Vaccination stageA Vaccination 1BBAYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-05T15:26 Anaphylactic ReactionBROADY mRNA-1273-P201mRNA-1273-P201-US202-1096US2021096US202USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV5Hq DVRHq<Hq Hq<DVRHq<2080Placebo AAE-002AREACTOGENICITYFATIGUE Fatigue General disorders and administration site conditions FFatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2020-07-08 2020-07-10 B$B& DVX.. B$DVZ..Vaccination stageAP2D Vaccination 2ApAYNY YNNNNNNNRELATED RELATED RELATED A 3SEVERE Grade 3A0Grade 3/Severe A0>=3A DOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-02T13:53 Fatigue Y mRNA-1273-P201mRNA-1273-P201-US202-1099US2021099US202USAB1YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4Hq{0DVPHq@Hq{0Hq@DVPHq@ mRNA-1273 100 ugA0AE-001AADVERSE EVENT LUMP RIGHT AXILLARY REGION IPSILATERAL-SAME SIDE OF VACCINATION SITE Axillary mass Musculoskeletal and connective tissue disorders FkAxillary lump FYFUSoft tissue disorders NEC F7Musculoskeletal and connective tissue disorders NEC FiMusculoskeletal and connective tissue disorders Fk2020-07-17 2020-07-17 B.B. DVa.. B.DVa..Vaccination stageA Vaccination 2BBYNY NNNNNNNNRELATED RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-06-30T14:17 mRNA-1273-P201mRNA-1273-P201-US202-1101US2021101US202USAB#YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:Hq'|DVYHqhHq'|HqhDVYHqh mRNA-1273 100 ugA0AE-002AADVERSE EVENT PAIN AT INJECTION SITE Injection site pain General disorders and administration site conditions FPain injection site F-FInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2020-06-20 2020-06-20 AA DVF.. ADVF..Vaccination stageA Vaccination 1AAYNY NNNNNNNNRELATED RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-06-08T12:33 Pain YY Y mRNA-1273-P201mRNA-1273-P201-US202-1107US2021107US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FASIAN NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV5Hq^DVRHq͟0Hq^Hq͟0DVRHq͟0 Placebo AAE-001AADVERSE EVENT HEADACHE Headache Nervous system disorders FHeadache FFHeadaches NEC FHeadaches FNervous system disorders F2020-09-02 2020-09-05 B\B_ DV.. B\DV..Follow up stage A Vaccination 2B?BBYN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-02T09:24 Headache Y mRNA-1273-P201mRNA-1273-P201-US202-1107US2021107US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FASIAN NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV5Hq^DVRHq͟0Hq^Hq͟0DVRHq͟0 Placebo AAE-002A ADVERSE EVENT NASAL CONGESTION Nasal congestion Respiratory, thoracic and mediastinal disorders F-Nasal congestion FFNasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-2020-09-02 2020-09-05 B\B_ DV.. B\DV..Follow up stage A Vaccination 2B?BBYN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-02T09:24 mRNA-1273-P201mRNA-1273-P201-US202-1111US2021111US202USAB$YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNYPlacebo APlacebo ADV:HqDVeHq`HqHq`DVeHq` Placebo AAE-004A0ADVERSE EVENT DIARRHEA Diarrhoea Gastrointestinal disorders FܛDiarrhea F7F?Diarrhoea (excl infective) F@Gastrointestinal motility and defaecation conditions FܹGastrointestinal disorders Fܛ2020-07-13 2020-07-19 B$B* DV].. B$DVc..Vaccination stageA Vaccination 1B$B*YN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-08T09:23 mRNA-1273-P201mRNA-1273-P201-US202-1111US2021111US202USAB$YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNYPlacebo APlacebo ADV:HqDVeHq`HqHq`DVeHq` Placebo AAE-008A@ADVERSE EVENT FATIGUE Fatigue General disorders and administration site conditions FFatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2020-07-10 2020-07-17 B!B( DVZ.. B!DVa..Vaccination stageA Vaccination 1B!B(YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-08T09:23 Fatigue Y mRNA-1273-P201mRNA-1273-P201-US202-1111US2021111US202USAB$YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNYPlacebo APlacebo ADV:HqDVeHq`HqHq`DVeHq` Placebo AAE-005ApADVERSE EVENT COVID 19 LIKE ILLNESS Suspected COVID-19 Infections and infestations FSuspected COVID-19 FcFcCoronavirus infections FViral infectious disorders FOInfections and infestations F2021-01-20 2021-01-25 BB DW.. BDW!..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-21T10:48 mRNA-1273-P201mRNA-1273-P201-US202-1111US2021111US202USAB$YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNYPlacebo APlacebo ADV:HqDVeHq`HqHq`DVeHq` Placebo AAE-009AADVERSE EVENT BURSITIS LEFT SHOULDER Bursitis Musculoskeletal and connective tissue disorders FkShoulder bursitis F5#FBursal disorders FqSynovial and bursal disorders FʱMusculoskeletal and connective tissue disorders Fk2021-02-01 2021-02-08 BB DW(.. BDW/..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-21T10:48 mRNA-1273-P201mRNA-1273-P201-US202-1111US2021111US202USAB$YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNYPlacebo APlacebo ADV:HqDVeHq`HqHq`DVeHq` Placebo AAE-003APADVERSE EVENT HEADACHE Headache Nervous system disorders FHeadache FFHeadaches NEC FHeadaches FNervous system disorders F2020-07-12 2020-07-18 B#B) DV\.. B#DVb..Vaccination stageA Vaccination 1B#B)YN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE DELAYED CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-06-08T09:23 Headache Y mRNA-1273-P201mRNA-1273-P201-US202-1111US2021111US202USAB$YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNYPlacebo APlacebo ADV:HqDVeHq`HqHq`DVeHq` Placebo AAE-002A ADVERSE EVENT COUGH Cough Respiratory, thoracic and mediastinal disorders F-Cough FXFXCoughing and associated symptoms FaRespiratory disorders NEC F-Respiratory, thoracic and mediastinal disorders F-2020-07-12 2020-07-16 B#B' DV\.. B#DV`..Vaccination stageA Vaccination 1B#B'YN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE DELAYED CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-06-08T09:23 Anaphylactic ReactionBROADY mRNA-1273-P201mRNA-1273-P201-US202-1111US2021111US202USAB$YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNYPlacebo APlacebo ADV:HqDVeHq`HqHq`DVeHq` Placebo AAE-001A`ADVERSE EVENT SORE THROAT Oropharyngeal pain Respiratory, thoracic and mediastinal disorders F-Sore throat F8F_Upper respiratory tract signs and symptoms FKiRespiratory tract signs and symptoms F}Respiratory, thoracic and mediastinal disorders F-2020-07-12 2020-07-14 B#B% DV\.. B#DV^..Vaccination stageA Vaccination 1B#B%YN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE DELAYED NONE RECOVERED/RESOLVED DOSE 1 - 2020-06-08T09:23 mRNA-1273-P201mRNA-1273-P201-US202-1115US2021115US202USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHq@DVoHqHq@HqDVoHq mRNA-1273 100 ugA0AE-002AADVERSE EVENT ACUTE SINUSITIS Acute sinusitis Infections and infestations FAcute sinusitis FFUpper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations F2021-02-14 2021-02-28 BB DW5.. BDWC..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-31T11:50 mRNA-1273-P201mRNA-1273-P201-US202-1115US2021115US202USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHq@DVoHqHq@HqDVoHq mRNA-1273 100 ugA0AE-001A ADVERSE EVENT RIGHT OTITIS MEDIA Otitis media Infections and infestations FOtitis media FFEar infections F=Infections - pathogen unspecified FInfections and infestations F2021-02-14 2021-02-18 BB DW5.. BDW9..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-31T11:50 mRNA-1273-P201mRNA-1273-P201-US202-1130US2021130US202USABPYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVLHq$DVmHqVdHq$HqVdDVmHqVd Placebo AAE-002AADVERSE EVENT POST DOSE ELEVATED BLOOD PRESSURE Blood pressure increased Investigations FBlood pressure increased FFVascular tests NEC (incl blood pressure) FNCardiac and vascular investigations (excl enzyme tests) FInvestigations F2020-06-26T12:102020-07-06T12:10AA DVLDHq ADVVDHq Vaccination stageA Vaccination 1AAYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA3SEVERE Grade 3A0Grade 3/Severe A0>=3A DOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-26T10:15 mRNA-1273-P201mRNA-1273-P201-US202-1130US2021130US202USABPYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVLHq$DVmHqVdHq$HqVdDVmHqVd Placebo AAE-004A0ADVERSE EVENT RHINORRHEA Rhinorrhoea Respiratory, thoracic and mediastinal disorders F-Rhinorrhea F/<F/=Upper respiratory tract signs and symptoms FKiRespiratory tract signs and symptoms F}Respiratory, thoracic and mediastinal disorders F-2020-11-11 2020-11-11 BB DV.. BDV..Follow up stage A Vaccination 2BjBjYN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-07-29T11:35 mRNA-1273-P201mRNA-1273-P201-US202-1130US2021130US202USABPYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVLHq$DVmHqVdHq$HqVdDVmHqVd Placebo AAE-003A ADVERSE EVENT RASH RIGHT WRIST Rash Skin and subcutaneous tissue disorders F5Localized rash FqF*TRashes, eruptions and exanthems NEC FcEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F52020-08-25 2020-08-27 B=B? DV.. B=DV..Vaccination stageA Vaccination 2BBYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-29T11:35 Anaphylactic ReactionBROADY HypersensitivityNARROWY mRNA-1273-P201mRNA-1273-P201-US202-1137US2021137US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYNNNNNNYYYYYNNNNNYYNNot Detected YNNPlacebo APlacebo ADV:Hq[ DVWHqԘlHq[ HqԘlDVWHqԘl Placebo AAE-001AADVERSE EVENT COVID-19 INFECTION (POSITIVE) COVID-19 Infections and infestations FCOVID-19 F߬F߬Coronavirus infections FViral infectious disorders FOInfections and infestations F2020-07-07T15:392020-07-15T14:00BB& DVWDHqԎ BDV_DHq`Vaccination stageA Vaccination 1BB%YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-08T16:13 mRNA-1273-P201mRNA-1273-P201-US202-1138US2021138US202USAB4YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV6Hq,DVVHqHq,HqDVVHq Placebo AAE-001AADVERSE EVENT COVID 19 LIKE ILLNESS Suspected COVID-19 Infections and infestations FSuspected COVID-19 FcFcCoronavirus infections FViral infectious disorders FOInfections and infestations F2021-02-06 2021-02-17 BC0 DW-.. BDW8..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-07-06T09:32 mRNA-1273-P201mRNA-1273-P201-US202-1144US2021144US202USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNPlacebo APlacebo ADV7Hq"XDVVHqxHq"XHqxDVVHqx1080Placebo AAE-001A REACTOGENICITYFATIGUE Fatigue General disorders and administration site conditions FFatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2020-06-06T20:122020-06-14T07:48A A DV8EHq A DV@DmHqͰVaccination stageAP1DT20H26M Vaccination 1A AYNY YNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-05T11:22 Fatigue Y mRNA-1273-P201mRNA-1273-P201-US202-1144US2021144US202USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNPlacebo APlacebo ADV7Hq"XDVVHqxHq"XHqxDVVHqx1100Placebo AAE-002AREACTOGENICITYJOINT ACHES ALL OVER BODY Arthralgia Musculoskeletal and connective tissue disorders FkGeneralized joint pain FfF'Joint related signs and symptoms F:Joint disorders F-Musculoskeletal and connective tissue disorders Fk2020-06-06T20:122020-06-14T07:12A A DV8EHq A DV@De@Hq@Vaccination stageAP1DT19H50M Vaccination 1A AYNY YNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-05T11:22 ArthritisBROAD Arthralgia Y mRNA-1273-P201mRNA-1273-P201-US202-1144US2021144US202USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNPlacebo APlacebo ADV7Hq"XDVVHqxHq"XHqxDVVHqx1090Placebo AAE-003A0REACTOGENICITYMUSCLE ACHES ALL OVER BODY Myalgia Musculoskeletal and connective tissue disorders FkGeneralized muscle aches FiF{Muscle pains F#Muscle disorders FMusculoskeletal and connective tissue disorders Fk2020-06-09 2020-06-14 APA DV;.. APDV@..Vaccination stageAP3D Vaccination 1APAYNY YNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-05T11:22 Myalgia Y mRNA-1273-P201mRNA-1273-P201-US202-1151US2021151US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:Hqa`DVYHq%dHqa`Hq%dDVYHq%d mRNA-1273 100 ugA0AE-011A0ADVERSE EVENT DIARRHEA Diarrhoea Gastrointestinal disorders FܛDiarrhea F7F?Diarrhoea (excl infective) F@Gastrointestinal motility and defaecation conditions FܹGastrointestinal disorders Fܛ2020-10-18 2020-10-23 BB DV.. BDV..Follow up stage A Vaccination 2BfBkYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-09T14:47 mRNA-1273-P201mRNA-1273-P201-US202-1151US2021151US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:Hqa`DVYHq%dHqa`Hq%dDVYHq%d mRNA-1273 100 ugA0AE-007ApADVERSE EVENT NAUSEA Nausea Gastrointestinal disorders FܛNausea F F Nausea and vomiting symptoms FGastrointestinal signs and symptoms FGastrointestinal disorders Fܛ2020-10-17 2020-10-19 BB DV.. BDV..Follow up stage A Vaccination 2BeBgYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-09T14:47 Nausea/Vomiting Y mRNA-1273-P201mRNA-1273-P201-US202-1151US2021151US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:Hqa`DVYHq%dHqa`Hq%dDVYHq%d mRNA-1273 100 ugA0AE-012AADVERSE EVENT VOMITING Vomiting Gastrointestinal disorders FܛVomiting FPFPNausea and vomiting symptoms FGastrointestinal signs and symptoms FGastrointestinal disorders Fܛ2020-10-17 2020-10-19 BB DV.. BDV..Follow up stage A Vaccination 2BeBgYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-09T14:47 mRNA-1273-P201mRNA-1273-P201-US202-1151US2021151US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:Hqa`DVYHq%dHqa`Hq%dDVYHq%d mRNA-1273 100 ugA0AE-008A ADVERSE EVENT CHILLS Chills General disorders and administration site conditions FChills FFFeelings and sensations NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2020-10-17 2020-10-19 BB DV.. BDV..Follow up stage A Vaccination 2BeBgYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-07-09T14:47 Chills Y mRNA-1273-P201mRNA-1273-P201-US202-1151US2021151US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:Hqa`DVYHq%dHqa`Hq%dDVYHq%d mRNA-1273 100 ugA0AE-001APADVERSE EVENT LEFT POSTERIOR HEAD LUMP Mass General disorders and administration site conditions FMass FqFqMass conditions NEC FuTissue disorders NEC F;General disorders and administration site conditions F2020-07-05 2020-07-08 BB DVU.. BDVX..Vaccination stageA Vaccination 1BBYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-08T16:40 mRNA-1273-P201mRNA-1273-P201-US202-1151US2021151US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:Hqa`DVYHq%dHqa`Hq%dDVYHq%d mRNA-1273 100 ugA0AE-009AADVERSE EVENT FEVER Pyrexia General disorders and administration site conditions FFever F.F)Febrile disorders FBody temperature conditions FGeneral disorders and administration site conditions F2020-10-18 2020-10-20 BB DV.. BDV..Follow up stage A Vaccination 2BfBhYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-09T14:47 Fever Y mRNA-1273-P201mRNA-1273-P201-US202-1151US2021151US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:Hqa`DVYHq%dHqa`Hq%dDVYHq%d mRNA-1273 100 ugA0AE-010AADVERSE EVENT NECK PAIN Neck pain Musculoskeletal and connective tissue disorders FkNeck pain F$F$Musculoskeletal and connective tissue pain and discomfort FMusculoskeletal and connective tissue disorders NEC FiMusculoskeletal and connective tissue disorders Fk2020-10-17 2020-10-19 BB DV.. BDV..Follow up stage A Vaccination 2BeBgYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-07-09T14:47 ArthritisBROAD mRNA-1273-P201mRNA-1273-P201-US202-1151US2021151US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:Hqa`DVYHq%dHqa`Hq%dDVYHq%d mRNA-1273 100 ugA0AE-006A`ADVERSE EVENT MIGRAINE Migraine Nervous system disorders FMigraine FOFOMigraine headaches FSHeadaches FNervous system disorders F2020-10-17 2020-10-19 BB DV.. BDV..Follow up stage A Vaccination 2BeBgYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-09T14:47 Headache Y mRNA-1273-P201mRNA-1273-P201-US202-1151US2021151US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:Hqa`DVYHq%dHqa`Hq%dDVYHq%d mRNA-1273 100 ugA0AE-002AADVERSE EVENT RUNNY NOSE Rhinorrhoea Respiratory, thoracic and mediastinal disorders F-Runny nose F0F/=Upper respiratory tract signs and symptoms FKiRespiratory tract signs and symptoms F}Respiratory, thoracic and mediastinal disorders F-2020-07-10T03:152020-07-10T08:00B!B! DVZD-HqԴ B!DVZDpHqVaccination stageA Vaccination 2AAYNY NNNNNNNNRELATED NOT RELATED RELATED A 3SEVERE Grade 3A0Grade 3/Severe A0>=3A DOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-09T14:47 mRNA-1273-P201mRNA-1273-P201-US202-1154US2021154US202USAB"YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7HqLLDVXHqԘHqLLHqԘDVXHqԘ mRNA-1273 100 ugA0AE-001AADVERSE EVENT BUG BITE ( BOTH ARMS) Arthropod bite Injury, poisoning and procedural complications FBug bite F FNon-site specific injuries NEC F Injuries NEC FInjury, poisoning and procedural complications F2020-06-24 2020-06-28 BB DVJ.. BDVN..Vaccination stageA Vaccination 1BBYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-06-05T14:21 mRNA-1273-P201mRNA-1273-P201-US202-1154US2021154US202USAB"YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7HqLLDVXHqԘHqLLHqԘDVXHqԘ2070mRNA-1273 100 ugA0AE-002A0REACTOGENICITYHEADACHE Headache Nervous system disorders FHeadache FFHeadaches NEC FHeadaches FNervous system disorders F2020-07-08T20:562020-07-16T12:00B"B* DVXEfHq*` B"DV`DHq8Vaccination stageAPT21H10M Vaccination 2AAYNY YNNNNNNNRELATED RELATED RELATED A 3SEVERE Grade 3A0Grade 3/Severe A0>=3A DOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-08T14:50 Headache Y mRNA-1273-P201mRNA-1273-P201-US202-1154US2021154US202USAB"YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7HqLLDVXHqԘHqLLHqԘDVXHqԘ mRNA-1273 100 ugA0AE-003A ADVERSE EVENT CONTACT DERMATITIS RIGHT HAND Dermatitis contact Skin and subcutaneous tissue disorders F5Contact dermatitis FFDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F52020-12-15 2020-12-21 BB DV.. BDV..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-08T14:50 HypersensitivityNARROWY mRNA-1273-P201mRNA-1273-P201-US202-1155US2021155US202USAB.YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADV:HqnDV]HqwHqnHqwDV]Hqw Placebo AAE-005AADVERSE EVENT COVID-19 INFECTION COVID-19 Infections and infestations FCOVID-19 F߬F߬Coronavirus infections FViral infectious disorders FOInfections and infestations F2020-08-17 2020-09-23 BGBl DV.. BGDV..Follow up stage A Vaccination 2B$BIYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-07-13T15:40 mRNA-1273-P201mRNA-1273-P201-US202-1164US2021164US202USAB"YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:HqDVXHq՝HHqHq՝HDVXHq՝H mRNA-1273 100 ugA0AE-001A REACTOGENICITYUNDERARM TENDERNESS Axillary pain General disorders and administration site conditions FAxillary pain FTFTPain and discomfort NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2020-06-14 2020-06-18 ApA DV@.. ApDVD..Vaccination stageAP4D Vaccination 1ApAYYY YNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-06-08T09:13 Pain Y mRNA-1273-P201mRNA-1273-P201-US202-1164US2021164US202USAB"YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:HqDVXHq՝HHqHq՝HDVXHq՝H mRNA-1273 100 ugA0AE-002AADVERSE EVENT WORSENING OF ACNE AROUND MOUTH Acne Skin and subcutaneous tissue disorders F5Acne aggravated FrFpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F52020-06-10 2020-07-01 A0B DV<.. A0DVQ..Vaccination stageA Vaccination 1A0BYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-06-08T09:13 mRNA-1273-P201mRNA-1273-P201-US202-1167US2021167US202USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:Hq DVWHqԀHq HqԀDVWHqԀ mRNA-1273 50 ug A AE-002AADVERSE EVENT LEFT ANTERIOR CERVICAL CHAIN LYMPH NODE Lymphadenopathy Blood and lymphatic system disorders FQLymphadenopathy cervical FFLymphatic system disorders NEC FSpleen, lymphatic and reticuloendothelial system disorders F9)Blood and lymphatic system disorders FQ2021-01-04 2021-01-11 BB DW .. BDW..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-07T14:41 Underarm Gland Swelling or TendernessYY YmRNA-1273-P201mRNA-1273-P201-US202-1175US2021175US202USAB$YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADV:HqBpDVXHqձHqBpHqձDVXHqձ2080Placebo AAE-001A REACTOGENICITYFATIGUE Fatigue General disorders and administration site conditions FFatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2020-07-08T21:312020-07-17T14:13BB( DVXE@Hq2 BDVaDHqlVaccination stageAP2DT1H52M Vaccination 2AAYNY YNNNNNNNRELATED RELATED RELATED A 3SEVERE Grade 3A0Grade 3/Severe A0>=3A DOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-08T12:21 Fatigue Y mRNA-1273-P201mRNA-1273-P201-US202-1175US2021175US202USAB$YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADV:HqBpDVXHqձHqBpHqձDVXHqձ Placebo AAE-013AADVERSE EVENT COVID-19 INFECTION COVID-19 Infections and infestations FCOVID-19 F߬F߬Coronavirus infections FViral infectious disorders FOInfections and infestations F2020-10-12 2020-11-01 BB DV.. BDV..Follow up stage A Vaccination 2BaBuYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-07-08T12:21 mRNA-1273-P201mRNA-1273-P201-US202-1175US2021175US202USAB$YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADV:HqBpDVXHqձHqBpHqձDVXHqձ Placebo AAE-011A0ADVERSE EVENT HEADACHE Headache Nervous system disorders FHeadache FFHeadaches NEC FHeadaches FNervous system disorders F2020-08-02 2020-08-02 B8B8 DVq.. B8DVq..Vaccination stageA Vaccination 2BBYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-08T12:21 Headache Y mRNA-1273-P201mRNA-1273-P201-US202-1179US2021179US202USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:HqLDVWHqԇHqLHqԇDVWHqԇ mRNA-1273 50 ug A AE-003AADVERSE EVENT ABDOMINAL PAIN Abdominal pain Gastrointestinal disorders FܛAbdominal pain FFGastrointestinal and abdominal pains (excl oral and throat) F܆Gastrointestinal signs and symptoms FGastrointestinal disorders Fܛ2020-10-04 2020-10-07 BwBz DV.. BwDV..Follow up stage A Vaccination 2BZB]YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-07-07T15:07 mRNA-1273-P201mRNA-1273-P201-US202-1179US2021179US202USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:HqLDVWHqԇHqLHqԇDVWHqԇ mRNA-1273 50 ug A AE-002A@ADVERSE EVENT DIARRHEA Diarrhoea Gastrointestinal disorders FܛDiarrhea F7F?Diarrhoea (excl infective) F@Gastrointestinal motility and defaecation conditions FܹGastrointestinal disorders Fܛ2020-10-04 2020-10-07 BwBz DV.. BwDV..Follow up stage A Vaccination 2BZB]YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-07T15:07 mRNA-1273-P201mRNA-1273-P201-US202-1179US2021179US202USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:HqLDVWHqԇHqLHqԇDVWHqԇ mRNA-1273 50 ug A AE-001A0ADVERSE EVENT BENIGN SKIN LESION RIGHT THIGH Benign neoplasm of skin Neoplasms benign, malignant and unspecified (incl cysts and polyps)F0Benign neoplasm of skin FFSkin neoplasms benign F6BCutaneous neoplasms benign F6CNeoplasms benign, malignant and unspecified (incl cysts and polyps)F02020-06-11 2020-07-03 A@B DV=.. A@DVS..Vaccination stageA Vaccination 1A@BYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-08T15:12 mRNA-1273-P201mRNA-1273-P201-US202-1179US2021179US202USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:HqLDVWHqԇHqLHqԇDVWHqԇ mRNA-1273 50 ug A AE-004A ADVERSE EVENT ACNE BUTTOCKS Acne Skin and subcutaneous tissue disorders F5Acne FpFpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F52020-09-19 2020-11-01 BhB DV.. BhDV..Follow up stage A Vaccination 2BKBvYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-07T15:07 mRNA-1273-P201mRNA-1273-P201-US202-1180US2021180US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:HqgDVXHqՐ(HqgHqՐ(DVXHqՐ( mRNA-1273 100 ugA0AE-008A REACTOGENICITYHARDNESS AT INJECTION SITE Injection site induration General disorders and administration site conditions FInjection site induration FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2020-07-08T21:002020-07-17T09:00BB( DVXEuHq+P BDVaD~Hq`Vaccination stageAP1DT23H2M Vaccination 2AAYNY YNNNNNNNRELATED RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-08T09:58 Swelling Y mRNA-1273-P201mRNA-1273-P201-US202-1180US2021180US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:HqgDVXHqՐ(HqgHqՐ(DVXHqՐ( mRNA-1273 100 ugA0AE-001A0REACTOGENICITYSWELLING AT INJECTION SITE Injection site swelling General disorders and administration site conditions FSwelling of injection site F=HFg1Injection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2020-06-14 2020-07-01 ApB DV@.. ApDVQ..Vaccination stageAP17D Vaccination 1ApBYNY YNNNNNNNRELATED RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-08T17:04 Swelling Y mRNA-1273-P201mRNA-1273-P201-US202-1180US2021180US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:HqgDVXHqՐ(HqgHqՐ(DVXHqՐ( mRNA-1273 100 ugA0AE-007A@REACTOGENICITYSWELLING AT INJECTION SITE Injection site swelling General disorders and administration site conditions FSwelling of injection site F=HFg1Injection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2020-07-08T21:002020-07-17T09:00BB( DVXEuHq+P BDVaD~Hq`Vaccination stageAP1DT23H2M Vaccination 2AAYNY YNNNNNNNRELATED RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-08T09:58 Swelling Y mRNA-1273-P201mRNA-1273-P201-US202-1180US2021180US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:HqgDVXHqՐ(HqgHqՐ(DVXHqՐ( mRNA-1273 100 ugA0AE-005APADVERSE EVENT BRUISING RIGHT POSTERIOR HAMSTRING UNKNOWN Muscle contusion Injury, poisoning and procedural complications FMuscle contusion FFMuscle, tendon and ligament injuries FInjuries NEC FInjury, poisoning and procedural complications F2020-07-14 B%.ONGOINGDV^.. B%...Vaccination stageA Vaccination 2Ap.YNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERING/RESOLVING DOSE 2 - 2020-07-08T09:58 mRNA-1273-P201mRNA-1273-P201-US202-1180US2021180US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:HqgDVXHqՐ(HqgHqՐ(DVXHqՐ( mRNA-1273 100 ugA0AE-006A`ADVERSE EVENT BACK STRAIN Muscle strain Injury, poisoning and procedural complications FBack strain FWFYMuscle, tendon and ligament injuries FInjuries NEC FInjury, poisoning and procedural complications F2020-07-29 2020-08-01 B4B7 DVm.. B4DVp..Vaccination stageA Vaccination 2BBYYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-08T09:58 mRNA-1273-P201mRNA-1273-P201-US202-1185US2021185US202USAB7YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected YNNPlacebo APlacebo ADVLHqDVoHq?HqHq?DVoHq? Placebo AAE-003AADVERSE EVENT POSITIVE COVID-19 ILLNESS COVID-19 Infections and infestations FCOVID-19 F߬F߬Coronavirus infections FViral infectious disorders FOInfections and infestations F2021-01-27 2021-02-12 BB DW#.. BDW3..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-31T16:32 mRNA-1273-P201mRNA-1273-P201-US202-1185US2021185US202USAB7YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected YNNPlacebo APlacebo ADVLHqDVoHq?HqHq?DVoHq? Placebo AAE-002A ADVERSE EVENT WORSENING OF DEPRESSION Depression Psychiatric disorders F'Depression worsened FFDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'2020-08-31 2020-08-31 BCBC DV.. BCDV..Follow up stage A Vaccination 2B B YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED WITH SEQUELAEDUE TO SUBJECT BEING DIAGNOSIS IN 2000 BUT WAS NOT PRESCRIBED ANY MEDICATION. THIS WILL CONTINUE TO BE APART OF SUBJECT'S MEDICAL HISTORY DOSE 2 - 2020-07-31T16:32 mRNA-1273-P201mRNA-1273-P201-US202-1185US2021185US202USAB7YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected YNNPlacebo APlacebo ADVLHqDVoHq?HqHq?DVoHq? Placebo AAE-001A0ADVERSE EVENT POSTMENOPAUSAL BLEEDING Postmenopausal haemorrhage Reproductive system and breast disorders F-LPostmenopausal bleeding F$FpMenopausal effects on the genitourinary tract F$Menopause related conditions FeReproductive system and breast disorders F-L2020-07-04 2020-07-11 AB DVT.. ADV[..Vaccination stageA Vaccination 1ABYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-26T14:07 mRNA-1273-P201mRNA-1273-P201-US202-1196US2021196US202USAB?YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNPlacebo APlacebo ADVRHq;\DVrHq(Hq;\Hq(DVrHq( Placebo AAE-001AADVERSE EVENT 2 POLYPS COLON BENIGN Large intestine polyp Gastrointestinal disorders FܛBenign colonic polyp FvbF`Benign neoplasms gastrointestinal (excl oral cavity) FBenign neoplasms gastrointestinal F܎Gastrointestinal disorders Fܛ2020-07-08 2020-07-15 ApA DVX.. ApDV_..Vaccination stageA Vaccination 1ApAYYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT PROCEDURE RECOVERED/RESOLVED DOSE 1 - 2020-07-02T11:37 mRNA-1273-P201mRNA-1273-P201-US202-1205US2021205US202USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHq DVoHqHq HqDVoHq mRNA-1273 50 ug A AE-003A0ADVERSE EVENT COVID-19 LIKE ILLNESS Suspected COVID-19 Infections and infestations FSuspected COVID-19 FcFcCoronavirus infections FViral infectious disorders FOInfections and infestations F2021-01-30 2021-02-10 BB DW&.. BDW1..Follow up stage A Vaccination 2BBYN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-31T09:34 mRNA-1273-P201mRNA-1273-P201-US202-1205US2021205US202USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHq DVoHqHq HqDVoHq mRNA-1273 50 ug A AE-001AADVERSE EVENT GENERALIZED PRURITIS (UNKNOWN) Pruritus Skin and subcutaneous tissue disorders F5General pruritus FF'_Pruritus NEC FW Epidermal and dermal conditions FSkin and subcutaneous tissue disorders F52020-06-30 2020-07-16 APB DVP.. APDV`..Vaccination stageA Vaccination 1APBYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-06-26T15:09 Anaphylactic ReactionBROADY HypersensitivityBROAD mRNA-1273-P201mRNA-1273-P201-US202-1205US2021205US202USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHq DVoHqHq HqDVoHq mRNA-1273 50 ug A AE-002A ADVERSE EVENT GENERALIZED PURTITIS Pruritus Skin and subcutaneous tissue disorders F5Generalized pruritus FKF'_Pruritus NEC FW Epidermal and dermal conditions FSkin and subcutaneous tissue disorders F52020-08-01T08:002020-08-05T17:00B%B) DVpDpHq B%DVtDHqVaccination stageA Vaccination 2AA`YNY NNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-31T09:34 Anaphylactic ReactionBROADY HypersensitivityBROAD mRNA-1273-P201mRNA-1273-P201-US202-1206US2021206US202USAB@YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVRHqǀDVsHq4$HqǀHq4$DVsHq4$ Placebo AAE-002AADVERSE EVENT BURSITIS RIGHT HIP Bursitis Musculoskeletal and connective tissue disorders FkHip bursitis F(FBursal disorders FqSynovial and bursal disorders FʱMusculoskeletal and connective tissue disorders Fk2020-07-13 2020-07-16 AA DV].. ADV`..Vaccination stageA Vaccination 1AAYYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-07-02T12:16 mRNA-1273-P201mRNA-1273-P201-US202-1206US2021206US202USAB@YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVRHqǀDVsHq4$HqǀHq4$DVsHq4$ Placebo AAE-001A ADVERSE EVENT BONE SPUR 2ND RIGHT TOE Exostosis Musculoskeletal and connective tissue disorders FkBone spur FFBone disorders NEC FBone disorders (excl congenital and fractures) FMusculoskeletal and connective tissue disorders Fk2020-07-08 2020-07-30 ApB DVX.. ApDVn..Vaccination stageA Vaccination 1ApBYYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION, CONCOMITANT PROCEDURERECOVERED/RESOLVED DOSE 1 - 2020-07-02T12:16 mRNA-1273-P201mRNA-1273-P201-US202-1206US2021206US202USAB@YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVRHqǀDVsHq4$HqǀHq4$DVsHq4$ Placebo AAE-004A0ADVERSE EVENT SORE THROAT Oropharyngeal pain Respiratory, thoracic and mediastinal disorders F-Sore throat F8F_Upper respiratory tract signs and symptoms FKiRespiratory tract signs and symptoms F}Respiratory, thoracic and mediastinal disorders F-2020-10-05 2020-10-06 B`Ba DV.. B`DV..Follow up stage A Vaccination 2B?B@YN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-08-04T10:47 mRNA-1273-P201mRNA-1273-P201-US202-1208US2021208US202USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVQHq̨DVmHq0Hq̨Hq0DVmHq0 mRNA-1273 100 ugA0AE-002A ADVERSE EVENT NAUSEA Nausea Gastrointestinal disorders FܛNausea F F Nausea and vomiting symptoms FGastrointestinal signs and symptoms FGastrointestinal disorders Fܛ2020-08-04 2020-08-07 B#B& DVs.. B#DVv..Vaccination stageA Vaccination 2ApAYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-29T16:20 Nausea/Vomiting Y mRNA-1273-P201mRNA-1273-P201-US202-1208US2021208US202USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVQHq̨DVmHq0Hq̨Hq0DVmHq0 mRNA-1273 100 ugA0AE-004A0ADVERSE EVENT PHARYNGITIS Pharyngitis Infections and infestations FPharyngitis FFUpper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations F2020-08-04 2020-08-07 B#B& DVs.. B#DVv..Vaccination stageA Vaccination 2ApAYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-29T16:20 mRNA-1273-P201mRNA-1273-P201-US202-1208US2021208US202USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVQHq̨DVmHq0Hq̨Hq0DVmHq0 mRNA-1273 100 ugA0AE-005A@ADVERSE EVENT PLANTAR FASCIITIS Plantar fasciitis Musculoskeletal and connective tissue disorders FkPlantar fasciitis FFMusculoskeletal and connective tissue infections and inflammations NECFdMusculoskeletal and connective tissue disorders NEC FiMusculoskeletal and connective tissue disorders Fk2020-09-14 2020-09-22 BLBT DV.. BLDV..Follow up stage A Vaccination 2B0B8YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-29T16:20 mRNA-1273-P201mRNA-1273-P201-US202-1208US2021208US202USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVQHq̨DVmHq0Hq̨Hq0DVmHq02070mRNA-1273 100 ugA0AE-003AREACTOGENICITYHEADACHE Headache Nervous system disorders FHeadache FFHeadaches NEC FHeadaches FNervous system disorders F2020-07-29T17:282020-08-09T13:55BB( DVmDHq BDVxDôHqVaccination stageAP3DT21H35M Vaccination 2AAYNY YNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-29T16:20 Headache Y mRNA-1273-P201mRNA-1273-P201-US202-1208US2021208US202USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVQHq̨DVmHq0Hq̨Hq0DVmHq0 mRNA-1273 100 ugA0AE-001APADVERSE EVENT NASAL DRAINAGE (UNKNOWN) Rhinorrhoea Respiratory, thoracic and mediastinal disorders F-Nasal discharge FF/=Upper respiratory tract signs and symptoms FKiRespiratory tract signs and symptoms F}Respiratory, thoracic and mediastinal disorders F-2020-08-04 2020-08-07 B#B& DVs.. B#DVv..Vaccination stageA Vaccination 2ApAYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-29T16:20 mRNA-1273-P201mRNA-1273-P201-US202-1211US2021211US202USABNYEARS>=55 Years A >=55 Years A@FWHITE HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVRHqDVoHqHqHqDVoHq mRNA-1273 100 ugA0AE-002AADVERSE EVENT WORSENING OF GASTROESOPHAGEAL REFLUX DISEASE Gastrooesophageal reflux disease Gastrointestinal disorders FܛEsophageal reflux aggravated Fo2F]Gastrointestinal atonic and hypomotility disorders NEC F܍Gastrointestinal motility and defaecation conditions FܹGastrointestinal disorders Fܛ2020-12-19 2020-12-20 BB DV.. BDV..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-31T10:25 mRNA-1273-P201mRNA-1273-P201-US202-1211US2021211US202USABNYEARS>=55 Years A >=55 Years A@FWHITE HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVRHqDVoHqHqHqDVoHq mRNA-1273 100 ugA0AE-001A ADVERSE EVENT INFECTION FROM FILLING IN TOOTH Tooth infection Infections and infestations FTooth infection FTFTDental and oral soft tissue infections FƦInfections - pathogen unspecified FInfections and infestations F2020-07-21 2020-07-27 BB DVe.. BDVk..Vaccination stageA Vaccination 1BBYYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-07-02T15:28 mRNA-1273-P201mRNA-1273-P201-US202-1214US2021214US202USABIYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHq DDVhHqHq DHqDVhHq mRNA-1273 100 ugA0AE-004AADVERSE EVENT CHILLS Chills General disorders and administration site conditions FChills FFFeelings and sensations NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2020-09-10 2020-09-11 BMBN DV.. BMDV..Follow up stage A Vaccination 2B1B2YN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-24T15:43 Chills Y mRNA-1273-P201mRNA-1273-P201-US202-1214US2021214US202USABIYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHq DDVhHqHq DHqDVhHq mRNA-1273 100 ugA0AE-003A ADVERSE EVENT FATIGUE Fatigue General disorders and administration site conditions FFatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2020-09-09 2020-09-12 BLBO DV.. BLDV..Follow up stage A Vaccination 2B0B3YN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-24T15:43 Fatigue Y mRNA-1273-P201mRNA-1273-P201-US202-1214US2021214US202USABIYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHq DDVhHqHq DHqDVhHq mRNA-1273 100 ugA0AE-002A@ADVERSE EVENT GENERALIZED BODY ACHES Pain General disorders and administration site conditions FGeneral body pain FUFPain and discomfort NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2020-09-10 2020-09-12 BMBO DV.. BMDV..Follow up stage A Vaccination 2B1B3YN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-24T15:43 Myalgia Y mRNA-1273-P201mRNA-1273-P201-US202-1214US2021214US202USABIYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHq DDVhHqHq DHqDVhHq mRNA-1273 100 ugA0AE-005APADVERSE EVENT FEVER Pyrexia General disorders and administration site conditions FFever F.F)Febrile disorders FBody temperature conditions FGeneral disorders and administration site conditions F2020-09-10 2020-09-11 BMBN DV.. BMDV..Follow up stage A Vaccination 2B1B2YN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-24T15:43 Fever Y mRNA-1273-P201mRNA-1273-P201-US202-1214US2021214US202USABIYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHq DDVhHqHq DHqDVhHq mRNA-1273 100 ugA0AE-001A0ADVERSE EVENT RE-INJURED RIGHT HIP Joint injury Injury, poisoning and procedural complications FHip injury FfdFBone and joint injuries NEC FuBone and joint injuries FInjury, poisoning and procedural complications F2020-07-14 2020-07-29 BB" DV^.. BDVm..Vaccination stageA Vaccination 1BB"YNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-06-26T15:27 mRNA-1273-P201mRNA-1273-P201-US202-1217US2021217US202USABBYEARS>=55 Years A >=55 Years A@FWHITE NOT REPORTED YYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVOHq DVmHqmHq HqmDVmHqm mRNA-1273 50 ug A AE-002AREACTOGENICITYFATIGUE Fatigue General disorders and administration site conditions FFatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2020-07-29T17:002020-08-05T16:23BB& DVmDHq BDVtDdHqdVaccination stageAPT3H8M Vaccination 2AAYNY YNNNNNNNRELATED NOT RELATED RELATED A 3SEVERE Grade 3A0Grade 3/Severe A0>=3A DOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-29T13:15 Fatigue Y mRNA-1273-P201mRNA-1273-P201-US202-1218US2021218US202USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVPHqDVoHqJ@HqHqJ@DVoHqJ@ mRNA-1273 100 ugA0AE-001AADVERSE EVENT WORSENING OF SEASONAL ALLERGIES Seasonal allergy Immune system disorders F4Seasonal allergy FUFUAtopic disorders FdAllergic conditions F,Immune system disorders F42020-07-05 2020-07-14 A`A DVU.. A`DV^..Vaccination stageA Vaccination 1A`AYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-06-30T11:34 HypersensitivityBROAD mRNA-1273-P201mRNA-1273-P201-US202-1220US2021220US202USABLYEARS>=55 Years A >=55 Years A@MBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYNYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVOHqШDVmHq{HqШHq{DVmHq{ mRNA-1273 50 ug A AE-001A ADVERSE EVENT LEFT POSTERIOR TIBIAL TENDONITIS Tendonitis Musculoskeletal and connective tissue disorders FkPosterior tibial tendonitis FnF?wTendon disorders F?bTendon, ligament and cartilage disorders F?eMusculoskeletal and connective tissue disorders Fk2021-02-16 2021-03-15 BC@ DW7.. BDWR..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-29T14:15 mRNA-1273-P201mRNA-1273-P201-US202-1220US2021220US202USABLYEARS>=55 Years A >=55 Years A@MBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYNYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVOHqШDVmHq{HqШHq{DVmHq{ mRNA-1273 50 ug A AE-002AADVERSE EVENT HEADACHE Headache Nervous system disorders FHeadache FFHeadaches NEC FHeadaches FNervous system disorders F2020-07-06 2020-07-06 AA DVV.. ADVV..Vaccination stageA Vaccination 1AAYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-06-29T12:06 Headache Y mRNA-1273-P201mRNA-1273-P201-US202-1222US2021222US202USABAYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYNYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVRHqDVoHqHHqHqHDVoHqH Placebo AAE-002A ADVERSE EVENT RIGHT EYE INFECTION Eye infection Infections and infestations FEye infection FԹFԹEye and eyelid infections FԥInfections - pathogen unspecified FInfections and infestations F2020-12-23 2020-12-29 BB DW.. BDW..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-31T12:30 mRNA-1273-P201mRNA-1273-P201-US202-1222US2021222US202USABAYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYNYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVRHqDVoHqHHqHqHDVoHqH Placebo AAE-001AADVERSE EVENT FIRE ANT BITES EXTREMITIES Arthropod bite Injury, poisoning and procedural complications FAnt bite FUHFNon-site specific injuries NEC F Injuries NEC FInjury, poisoning and procedural complications F2020-08-22 2020-08-31 B4B= DV.. B4DV..Vaccination stageA Vaccination 2BB YNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-31T12:30 mRNA-1273-P201mRNA-1273-P201-US202-1226US2021226US202USABDYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVVHq+DVsHq-Hq+Hq-DVsHq- mRNA-1273 50 ug A AE-007A0ADVERSE EVENT COVID LIKE ILLNESS Suspected COVID-19 Infections and infestations FSuspected COVID-19 FcFcCoronavirus infections FViral infectious disorders FOInfections and infestations F2021-01-13 2021-01-16 BB DW.. BDW..Follow up stage A Vaccination 2BBYN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-08-04T10:19 mRNA-1273-P201mRNA-1273-P201-US202-1226US2021226US202USABDYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVVHq+DVsHq-Hq+Hq-DVsHq- mRNA-1273 50 ug A AE-001A ADVERSE EVENT SORE THROAT Oropharyngeal pain Respiratory, thoracic and mediastinal disorders F-Sore throat F8F_Upper respiratory tract signs and symptoms FKiRespiratory tract signs and symptoms F}Respiratory, thoracic and mediastinal disorders F-2020-08-05T08:002020-08-06T08:00BB DVtDpHq^ BDVuDpHqVaccination stageA Vaccination 2AA YNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA3SEVERE Grade 3A0Grade 3/Severe A0>=3A DOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-08-04T10:19 mRNA-1273-P201mRNA-1273-P201-US202-1230US2021230US202USABDYEARS>=55 Years A >=55 Years A@FWHITE HISPANIC OR LATINO YYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVVHq=PDVrHqHq=PHqDVrHq mRNA-1273 100 ugA0AE-001AADVERSE EVENT COVID 19 INFECTION COVID-19 Infections and infestations FCOVID-19 F߬F߬Coronavirus infections FViral infectious disorders FOInfections and infestations F2020-12-23 2021-02-05 BB DW.. BDW,..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-08-03T11:55 mRNA-1273-P201mRNA-1273-P201-US202-1234US2021234US202USABFYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVWHqgDVsHq<HqgHq<DVsHq< mRNA-1273 100 ugA0AE-001AADVERSE EVENT WORSENING OF NECK PAIN Neck pain Musculoskeletal and connective tissue disorders FkNeck pain F$F$Musculoskeletal and connective tissue pain and discomfort FMusculoskeletal and connective tissue disorders NEC FiMusculoskeletal and connective tissue disorders Fk2020-08-12 2020-10-01 B%BW DV{.. B%DV..Vaccination stageA Vaccination 2AB;YNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-08-04T11:23 ArthritisBROAD mRNA-1273-P201mRNA-1273-P201-US203-1004US2031004US203USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV0HqDVOHqɮpHqHqɮpDVOHqɮp mRNA-1273 50 ug A AE-003A REACTOGENICITYBILATERAL AXILLARY TENDERNESS Axillary pain General disorders and administration site conditions FAxillary pain FTFTPain and discomfort NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2020-06-29T18:002020-07-07T10:00B B( DVOD Hq# B DVWDHq? Vaccination stageAP1DT0H20M Vaccination 2AAYNY YNNNNNNNRELATED NOT RELATED RELATED A 3SEVERE Grade 3A0Grade 3/Severe A0>=3A DOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-06-29T09:40 Pain Y mRNA-1273-P201mRNA-1273-P201-US203-1004US2031004US203USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV0HqDVOHqɮpHqHqɮpDVOHqɮp mRNA-1273 50 ug A AE-005APADVERSE EVENT URINARY TRACT INFECTION Urinary tract infection Infections and infestations FUrinary tract infection FLkFLkUrinary tract infections FLqInfections - pathogen unspecified FInfections and infestations F2020-07-12 2020-07-22 B-B7 DV\.. B-DVf..Vaccination stageA Vaccination 2ABYYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-06-29T09:40 mRNA-1273-P201mRNA-1273-P201-US203-1004US2031004US203USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV0HqDVOHqɮpHqHqɮpDVOHqɮp mRNA-1273 50 ug A AE-001A@ADVERSE EVENT SYNCOPAL EPISODE Syncope Nervous system disorders FSyncopal attack F=F=Disturbances in consciousness NEC FENeurological disorders NEC FNervous system disorders F2020-06-12 2020-06-12 AA DV>.. ADV>..Vaccination stageA Vaccination 1AAYNY NNNNNNNNNOT RELATEDRELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-05-29T14:24 CardiomyopathyBROAD mRNA-1273-P201mRNA-1273-P201-US203-1011US2031011US203USAB4YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV0Hq'\DVQHqnHq'\HqnDVQHqn mRNA-1273 50 ug A AE-001AADVERSE EVENT HEADACHE Headache Nervous system disorders FHeadache FFHeadaches NEC FHeadaches FNervous system disorders F2021-01-05 2021-01-08 BB DW .. BDW..Follow up stage A Vaccination 2BBYN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-07-01T11:44 Headache Y mRNA-1273-P201mRNA-1273-P201-US203-1013US2031013US203USAB)YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqDVPHqHqHqDVPHq mRNA-1273 100 ugA0AE-001AADVERSE EVENT TORN MENISCUS RIGHT KNEE Meniscus injury Injury, poisoning and procedural complications FMeniscus tear of knee FFBone and joint injuries NEC FuBone and joint injuries FInjury, poisoning and procedural complications F2020-08-10 BF.ONGOINGDVy.. BF...Follow up stage A Vaccination 2B*.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERING/RESOLVING DOSE 2 - 2020-06-30T08:52 mRNA-1273-P201mRNA-1273-P201-US203-1016US2031016US203USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAMWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV6Hq\DVRHqͭ@Hq\Hqͭ@DVRHqͭ@ mRNA-1273 50 ug A AE-001AADVERSE EVENT WORSENING OF DEPRESSION Depression Psychiatric disorders F'Depression worsened FFDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'2020-11-19 2021-03-19 BC DV.. BDWV..Follow up stage A Vaccination 2BCPYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-02T10:24 mRNA-1273-P201mRNA-1273-P201-US203-1029US2031029US203USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV4Hq4DVWHq.|Hq4Hq.|DVWHq.| Placebo AAE-002A ADVERSE EVENT UPPER RESPIRATORY INFECTION Upper respiratory tract infection Infections and infestations FUpper respiratory infection FK\FKbUpper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations F2020-08-04 2020-08-10 B@BF DVs.. B@DVy..Follow up stage A Vaccination 2BB#YN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-07T08:49 mRNA-1273-P201mRNA-1273-P201-US203-1029US2031029US203USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV4Hq4DVWHq.|Hq4Hq.|DVWHq.| Placebo AAE-001AADVERSE EVENT OVER ACTIVE BLADDER Hypertonic bladder Renal and urinary disorders F,WOveractive bladder FaFMyoneurogenic bladder disorders F_Bladder and bladder neck disorders (excl calculi) FRenal and urinary disorders F,W2020-06-17 2020-07-14 BB+ DVC.. BDV^..Vaccination stageA Vaccination 1BB+YNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-06-02T09:07 mRNA-1273-P201mRNA-1273-P201-US203-1035US2031035US203USAB0YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3HqDVOHqɼHqHqɼDVOHqɼ mRNA-1273 100 ugA0AE-003A0ADVERSE EVENT UPPER RESPIRATORY INFECTION Upper respiratory tract infection Infections and infestations FUpper respiratory infection FK\FKbUpper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations F2020-09-11 2020-09-24 BgBt DV.. BgDV..Follow up stage A Vaccination 2BKBXYN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-06-29T10:42 mRNA-1273-P201mRNA-1273-P201-US203-1035US2031035US203USAB0YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3HqDVOHqɼHqHqɼDVOHqɼ mRNA-1273 100 ugA0AE-004A@ADVERSE EVENT URINARY TRACT INFECTION Urinary tract infection Infections and infestations FUrinary tract infection FLkFLkUrinary tract infections FLqInfections - pathogen unspecified FInfections and infestations F2020-11-13 2020-11-20 BB DV.. BDV..Follow up stage A Vaccination 2BBYN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-06-29T10:42 mRNA-1273-P201mRNA-1273-P201-US203-1035US2031035US203USAB0YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3HqDVOHqɼHqHqɼDVOHqɼ mRNA-1273 100 ugA0AE-001AADVERSE EVENT HEADACHE Headache Nervous system disorders FHeadache FFHeadaches NEC FHeadaches FNervous system disorders F2020-07-27 2020-08-03 B9B@ DVk.. B9DVr..Follow up stage A Vaccination 2BB$YN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-06-29T10:42 Headache Y mRNA-1273-P201mRNA-1273-P201-US203-1035US2031035US203USAB0YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3HqDVOHqɼHqHqɼDVOHqɼ mRNA-1273 100 ugA0AE-002A ADVERSE EVENT RHINORRHEA Rhinorrhoea Respiratory, thoracic and mediastinal disorders F-Rhinorrhea F/<F/=Upper respiratory tract signs and symptoms FKiRespiratory tract signs and symptoms F}Respiratory, thoracic and mediastinal disorders F-2020-07-27 2020-08-03 B9B@ DVk.. B9DVr..Follow up stage A Vaccination 2BB$YN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-06-29T10:42 mRNA-1273-P201mRNA-1273-P201-US203-1041US2031041US203USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV4HqDVQHqKHqHqKDVQHqK Placebo AAE-001A ADVERSE EVENT UPPER RESPIRATORY INFECTION Upper respiratory tract infection Infections and infestations FUpper respiratory infection FK\FKbUpper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations F2020-07-05 2020-07-11 B"B( DVU.. B"DV[..Vaccination stageA Vaccination 2APAYYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-01T09:13 mRNA-1273-P201mRNA-1273-P201-US203-1041US2031041US203USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV4HqDVQHqKHqHqKDVQHqK Placebo AAE-002AADVERSE EVENT RIGHT FOOT NERVE PAIN Neuralgia Nervous system disorders FNerve pain F}FSensory abnormalities NEC F2Neurological disorders NEC FNervous system disorders F2021-01-27 B.ONGOINGDW#.. B...Follow up stage A Vaccination 2B.YN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERING/RESOLVING DOSE 2 - 2020-07-01T09:13AutoimmuneY Peripheral NeuropathyNARROWY mRNA-1273-P201mRNA-1273-P201-US203-1042US2031042US203USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV6HqDVVHq-HqHq-DVVHq-2090mRNA-1273 50 ug A AE-002A REACTOGENICITYMUSCLE ACHES ALL OVER BODY Myalgia Musculoskeletal and connective tissue disorders FkGeneralized muscle aches FiF{Muscle pains F#Muscle disorders FMusculoskeletal and connective tissue disorders Fk2020-07-07T13:272020-07-17T22:56B"B, DVWD$Hqo B"DVaE(Hq$Vaccination stageAP4DT8H22M Vaccination 2AAYNY YNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-06T14:34 Myalgia Y mRNA-1273-P201mRNA-1273-P201-US203-1042US2031042US203USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV6HqDVVHq-HqHq-DVVHq- mRNA-1273 50 ug A AE-001AREACTOGENICITYHEADACHE Headache Nervous system disorders FHeadache FFHeadaches NEC FHeadaches FNervous system disorders F2020-07-06T08:002020-07-13T08:00B!B( DVVDpHqр B!DV]DpHq Vaccination stageAP31DT16H1M Vaccination 1B B'YN YNNNNNNNRELATED NOT RELATED RELATED A 2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-06-04T15:59 Headache Y mRNA-1273-P201mRNA-1273-P201-US203-1049US2031049US203USAB%YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV3Hq#DVQHq̥Hq#Hq̥DVQHq̥ Placebo AAE-001AADVERSE EVENT ANXIETY Anxiety Psychiatric disorders F'Anxiety FFAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'2020-12-08 2021-02-02 BB DV.. BDW)..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-01T15:37 mRNA-1273-P201mRNA-1273-P201-US203-1049US2031049US203USAB%YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV3Hq#DVQHq̥Hq#Hq̥DVQHq̥ Placebo AAE-002A ADVERSE EVENT DEPRESSION Depression Psychiatric disorders F'Depression FFDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'2020-12-08 2021-02-02 BB DV.. BDW)..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-01T15:37 mRNA-1273-P201mRNA-1273-P201-US203-1050US2031050US203USAB3YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5HqqDVQHqTHqqHqTDVQHqT mRNA-1273 100 ugA0AE-005A0ADVERSE EVENT INFLUENZA A Influenza Infections and infestations FInfluenza A virus infection FrFpInfluenza viral infections FuViral infectious disorders FOInfections and infestations F2021-02-21 2021-03-01 CC DW<.. CDWD..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE DELAYED CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-01T09:55 mRNA-1273-P201mRNA-1273-P201-US203-1056US2031056US203USAB0YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3HqDVPHqVHqHqVDVPHqV mRNA-1273 50 ug A AE-001AADVERSE EVENT LEFT KNEE INFECTION FROM BUG BITE Infected bite Infections and infestations FInfected insect bite Fv)FInfections NEC FInfections - pathogen unspecified FInfections and infestations F2020-08-26 2020-09-07 BWBc DV.. BWDV..Follow up stage A Vaccination 2B:BFYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-06-30T15:50 mRNA-1273-P201mRNA-1273-P201-US203-1057US2031057US203USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5HqyDVQHq?HqyHq?DVQHq? mRNA-1273 50 ug A AE-001A ADVERSE EVENT FATIGUE Fatigue General disorders and administration site conditions FFatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2020-07-30 2020-08-01 B:B< DVn.. B:DVp..Follow up stage A Vaccination 2BB YN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGED RECOVERED/RESOLVED DOSE 2 - 2020-07-01T08:25 Fatigue Y mRNA-1273-P201mRNA-1273-P201-US203-1057US2031057US203USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5HqyDVQHq?HqyHq?DVQHq? mRNA-1273 50 ug A AE-003AADVERSE EVENT COUGH Cough Respiratory, thoracic and mediastinal disorders F-Cough FXFXCoughing and associated symptoms FaRespiratory disorders NEC F-Respiratory, thoracic and mediastinal disorders F-2020-07-30 2020-08-01 B:B< DVn.. B:DVp..Follow up stage A Vaccination 2BB YN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-01T08:25 Anaphylactic ReactionBROADY mRNA-1273-P201mRNA-1273-P201-US203-1057US2031057US203USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5HqyDVQHq?HqyHq?DVQHq? mRNA-1273 50 ug A AE-002A0ADVERSE EVENT NASAL CONGESTION Nasal congestion Respiratory, thoracic and mediastinal disorders F-Nasal congestion FFNasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-2020-07-30 2020-08-01 B:B< DVn.. B:DVp..Follow up stage A Vaccination 2BB YN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-01T08:25 mRNA-1273-P201mRNA-1273-P201-US203-1066US2031066US203USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4HqDVPHq HqHq DVPHq mRNA-1273 50 ug A AE-003A0ADVERSE EVENT CHEST TIGHTNESS-NON CARDIAC MUSCULOSKELETAL Musculoskeletal chest pain Musculoskeletal and connective tissue disorders FkMusculoskeletal chest pain F]F]Musculoskeletal and connective tissue pain and discomfort FMusculoskeletal and connective tissue disorders NEC FiMusculoskeletal and connective tissue disorders Fk2020-11-13 2020-12-01 BB DV.. BDV..Follow up stage A Vaccination 2BBYN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-06-30T10:53 mRNA-1273-P201mRNA-1273-P201-US203-1066US2031066US203USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4HqDVPHq HqHq DVPHq mRNA-1273 50 ug A AE-005AADVERSE EVENT HEADACHE Headache Nervous system disorders FHeadache FFHeadaches NEC FHeadaches FNervous system disorders F2020-11-13 2020-12-01 BB DV.. BDV..Follow up stage A Vaccination 2BBYN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-06-30T10:53 Headache Y mRNA-1273-P201mRNA-1273-P201-US203-1066US2031066US203USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4HqDVPHq HqHq DVPHq mRNA-1273 50 ug A AE-004A ADVERSE EVENT LETHARGY Lethargy Nervous system disorders FLethargy FHFHDisturbances in consciousness NEC FENeurological disorders NEC FNervous system disorders F2020-11-13 2020-12-01 BB DV.. BDV..Follow up stage A Vaccination 2BBYN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-06-30T10:53 mRNA-1273-P201mRNA-1273-P201-US203-1072US2031072US203USAB6YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5HqDVVHq`HqHq`DVVHq` mRNA-1273 50 ug A AE-004APADVERSE EVENT UPPER RESPIRATORY INFECTION Upper respiratory tract infection Infections and infestations FUpper respiratory infection FK\FKbUpper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations F2020-11-17 2020-11-22 BB DV.. BDV..Follow up stage A Vaccination 2BBYN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-07-06T12:24 mRNA-1273-P201mRNA-1273-P201-US203-1072US2031072US203USAB6YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5HqDVVHq`HqHq`DVVHq` mRNA-1273 50 ug A AE-001A ADVERSE EVENT RIGHT EYE IRRITATION SECONDARY TO FOREIGN OBJECT IN EYE Foreign body in eye Injury, poisoning and procedural complications FForeign body in eye FFEye injuries NEC FInjuries NEC FInjury, poisoning and procedural complications F2020-06-17 2020-06-20 AB DVC.. ADVF..Vaccination stageA Vaccination 1ABYYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-06-03T12:40 mRNA-1273-P201mRNA-1273-P201-US203-1072US2031072US203USAB6YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5HqDVVHq`HqHq`DVVHq` mRNA-1273 50 ug A AE-006A0ADVERSE EVENT HYPERTENSION Hypertension Vascular disorders FNYHypertension FFVascular hypertensive disorders NEC FVascular hypertensive disorders FuVascular disorders FNY2021-01-25 B.ONGOINGDW!.. B...Follow up stage A Vaccination 2B.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERING/RESOLVING DOSE 2 - 2020-07-06T12:24 mRNA-1273-P201mRNA-1273-P201-US203-1074US2031074US203USAB4YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV4Hq}DVPHqPTHq}HqPTDVPHqPT Placebo AAE-002A ADVERSE EVENT BILATERAL ACUTE OTITIS MEDIA Otitis media Infections and infestations FBilateral otitis media F]FEar infections F=Infections - pathogen unspecified FInfections and infestations F2020-06-10 2020-06-19 AB DV<.. ADVE..Vaccination stageA Vaccination 1ABYYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-06-02T17:03 mRNA-1273-P201mRNA-1273-P201-US203-1074US2031074US203USAB4YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV4Hq}DVPHqPTHq}HqPTDVPHqPT Placebo AAE-001A0ADVERSE EVENT SINUS INFECTION Sinusitis Infections and infestations FSinus infection F5F5Upper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations F2020-06-10 2020-06-19 AB DV<.. ADVE..Vaccination stageA Vaccination 1ABYYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-06-02T17:03 mRNA-1273-P201mRNA-1273-P201-US203-1074US2031074US203USAB4YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV4Hq}DVPHqPTHq}HqPTDVPHqPT Placebo AAE-004A@ADVERSE EVENT URINARY TRACT INFECTION Urinary tract infection Infections and infestations FUrinary tract infection FLkFLkUrinary tract infections FLqInfections - pathogen unspecified FInfections and infestations F2021-02-05 2021-02-15 BC0 DW,.. BDW6..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-06-30T15:23 mRNA-1273-P201mRNA-1273-P201-US203-1074US2031074US203USAB4YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV4Hq}DVPHqPTHq}HqPTDVPHqPT2070Placebo AAE-003AREACTOGENICITYHEADACHE Headache Nervous system disorders FHeadache FFHeadaches NEC FHeadaches FNervous system disorders F2020-06-30T22:002020-07-08T18:00BB% DVPEVHq˭` BDVXD Hq Vaccination stageAP1DT2H37M Vaccination 2AAYNY YNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-06-30T15:23 Headache Y mRNA-1273-P201mRNA-1273-P201-US203-1079US2031079US203USAB"YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6Hq$DVRHqͳXHq$HqͳXDVRHqͳX mRNA-1273 100 ugA0AE-002A ADVERSE EVENT INTESTINAL OBSTRUCTION Intestinal obstruction Gastrointestinal disorders FܛIntestinal obstruction FFGastrointestinal stenosis and obstruction NEC FGastrointestinal stenosis and obstruction FGastrointestinal disorders Fܛ2020-11-13 2020-11-13 BB DV.. BDV..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-02T10:50 mRNA-1273-P201mRNA-1273-P201-US203-1079US2031079US203USAB"YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6Hq$DVRHqͳXHq$HqͳXDVRHqͳX mRNA-1273 100 ugA0AE-001AADVERSE EVENT WORSENING OF DEPRESSION Depression Psychiatric disorders F'Depression worsened FFDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'2020-07-30 B9.ONGOINGDVn.. B9...Follow up stage A Vaccination 2B.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERING/RESOLVING DOSE 2 - 2020-07-02T10:50 mRNA-1273-P201mRNA-1273-P201-US203-1081US2031081US203USAB$YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYNNYNNYYYYYYNNNNYYNNot Detected YNNPlacebo APlacebo ADV6HqDVRHqͥ HqHqͥ DVRHqͥ Placebo AAE-001AADVERSE EVENT COVID 19 INFECTION COVID-19 Infections and infestations FCOVID-19 F߬F߬Coronavirus infections FViral infectious disorders FOInfections and infestations F2020-08-03 2020-08-03 B=B= DVr.. B=DVr..Follow up stage A Vaccination 2B!B!YN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-07-02T09:49 mRNA-1273-P201mRNA-1273-P201-US203-1089US2031089US203USABAYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVLHqDVmHqCHqHqCDVmHqC Placebo AAE-001AADVERSE EVENT LEFT SHOULDER PAIN Musculoskeletal pain Musculoskeletal and connective tissue disorders FkShoulder pain F5)FgMusculoskeletal and connective tissue pain and discomfort FMusculoskeletal and connective tissue disorders NEC FiMusculoskeletal and connective tissue disorders Fk2020-08-13 2020-08-20 B1B8 DV|.. B1DV..Vaccination stageA Vaccination 2BBYNY NNNNNNNNRELATED RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-29T10:16 mRNA-1273-P201mRNA-1273-P201-US203-1097US2031097US203USABVYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVPHq%DVrHq/HHq%Hq/HDVrHq/H mRNA-1273 50 ug A AE-003AADVERSE EVENT NON-ST ELEVATION MYOCARDIAL INFARCTION Acute myocardial infarction Cardiac disorders FNon ST segment elevation myocardial infarction FFIschaemic coronary artery disorders FCoronary artery disorders FCardiac disorders F2020-11-25 2020-11-25 BB DV.. BDV..Follow up stage A Vaccination 2BsBsYY NYNNNYNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED 2020-11-252020-11-27N DOSE 2 - 2020-08-03T16:14 Embolic and Thrombotic EventsNARROWY mRNA-1273-P201mRNA-1273-P201-US203-1097US2031097US203USABVYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVPHq%DVrHq/HHq%Hq/HDVrHq/H mRNA-1273 50 ug A AE-001A0ADVERSE EVENT TOOTH DECAY Dental caries Gastrointestinal disorders FܛTooth decay FB{FƞDental and periodontal infections and inflammations FƥDental and gingival conditions FBrGastrointestinal disorders Fܛ2020-08-19 2020-08-19 B3B3 DV.. B3DV..Vaccination stageA Vaccination 2BBYYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT PROCEDURE RECOVERED/RESOLVED DOSE 2 - 2020-08-03T16:14 mRNA-1273-P201mRNA-1273-P201-US203-1097US2031097US203USABVYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVPHq%DVrHq/HHq%Hq/HDVrHq/H mRNA-1273 50 ug A AE-002A@ADVERSE EVENT RIGHT ROTATOR CUFF TEAR Rotator cuff syndrome Musculoskeletal and connective tissue disorders FkRotator cuff tear F/F/Joint related disorders NEC FJoint disorders F-Musculoskeletal and connective tissue disorders Fk2020-08-24 2020-10-05 B8Bb DV.. B8DV..Vaccination stageA Vaccination 2BB@YYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-08-03T16:14 mRNA-1273-P201mRNA-1273-P201-US203-1097US2031097US203USABVYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVPHq%DVrHq/HHq%Hq/HDVrHq/H mRNA-1273 50 ug A AE-004A ADVERSE EVENT CEREBRAL VASCULAR ACCIDENT Cerebrovascular accident Nervous system disorders FCerebrovascular accident F~F~Central nervous system haemorrhages and cerebrovascular accidents FCentral nervous system vascular disorders FNervous system disorders F2020-12-01 2020-12-01 BB DV.. BDV..Follow up stage A Vaccination 2ByByYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-08-03T16:14 Central Nervous System Vascular DisordersNARROWYEmbolic and Thrombotic EventsNARROWY mRNA-1273-P201mRNA-1273-P201-US203-1102US2031102US203USAB9YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYNNYNNYYYYYYNNNNYYNNot Detected YNNPlacebo APlacebo ADVRHq XDVrHqF@Hq XHqF@DVrHqF@ Placebo AAE-001AADVERSE EVENT COVID 19 INFECTION COVID-19 Infections and infestations FCOVID-19 F߬F߬Coronavirus infections FViral infectious disorders FOInfections and infestations F2020-08-28 2020-08-28 B:B: DV.. B:DV..Vaccination stageA Vaccination 2BBYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-08-03T17:52 mRNA-1273-P201mRNA-1273-P201-US203-1103US2031103US203USABBYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVOHqlDVnHqHqlHqDVnHq Placebo AAE-001AADVERSE EVENT SINUS CONGESTION Sinus congestion Respiratory, thoracic and mediastinal disorders F-Sinus congestion F5F5Paranasal sinus disorders (excl infections and neoplasms) F5Upper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-2020-07-27 2020-07-28 BB DVk.. BDVl..Vaccination stageA Vaccination 1BBYN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE DELAYED CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-06-29T13:09 mRNA-1273-P201mRNA-1273-P201-US203-1104US2031104US203USAB7YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqŪDVoHqHqŪHqDVoHq mRNA-1273 50 ug A AE-001AADVERSE EVENT ABSCESSED TOOTH Tooth abscess Infections and infestations FTooth abscess FBpFBpDental and oral soft tissue infections FƦInfections - pathogen unspecified FInfections and infestations F2020-10-07 2020-10-07 BhBh DV.. BhDV..Follow up stage A Vaccination 2BEBEYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION, CONCOMITANT PROCEDURERECOVERED/RESOLVED DOSE 2 - 2020-07-31T13:14 mRNA-1273-P201mRNA-1273-P201-US203-1105US2031105US203USABCYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqŵDVlHqHqŵHqDVlHq1080mRNA-1273 50 ug A AE-001AREACTOGENICITYFATIGUE Fatigue General disorders and administration site conditions FFatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2020-06-28 2020-07-09 A0A DVN.. A0DVY..Vaccination stageAP7D Vaccination 1A0AYNY YNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-26T09:19 Fatigue Y mRNA-1273-P201mRNA-1273-P201-US203-1108US2031108US203USABCYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVVHq)(DVrHqHq)(HqDVrHq mRNA-1273 50 ug A AE-001AADVERSE EVENT ACID REFLUX Gastrooesophageal reflux disease Gastrointestinal disorders FܛAcid reflux (esophageal) FF]Gastrointestinal atonic and hypomotility disorders NEC F܍Gastrointestinal motility and defaecation conditions FܹGastrointestinal disorders Fܛ2020-10-20 2020-11-01 BkBw DV.. BkDV..Follow up stage A Vaccination 2BOB[YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-08-03T10:36 mRNA-1273-P201mRNA-1273-P201-US203-1116US2031116US203USABBYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVOHqɡDVnHqHqɡHqDVnHq Placebo AAE-001AADVERSE EVENT UPPER RESPIRATORY INFECTION Upper respiratory tract infection Infections and infestations FUpper respiratory infection FK\FKbUpper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations F2020-10-11 2020-10-18 BiBp DV.. BiDV..Follow up stage A Vaccination 2BJBQYN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-30T11:14 mRNA-1273-P201mRNA-1273-P201-US203-1121US2031121US203USABCYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVPHq=XDVlHq)8Hq=XHq)8DVlHq)8 mRNA-1273 50 ug A AE-004AADVERSE EVENT ACID REFLUX Gastrooesophageal reflux disease Gastrointestinal disorders FܛAcid reflux (esophageal) FF]Gastrointestinal atonic and hypomotility disorders NEC F܍Gastrointestinal motility and defaecation conditions FܹGastrointestinal disorders Fܛ2021-01-01 2021-02-12 BB DW .. BDW3..Follow up stage A Vaccination 2BBYN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-28T14:10 mRNA-1273-P201mRNA-1273-P201-US203-1121US2031121US203USABCYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVPHq=XDVlHq)8Hq=XHq)8DVlHq)8 mRNA-1273 50 ug A AE-001A0ADVERSE EVENT LOCALIZED SWELLING TO RIGHT LOWER EXTREMITY Peripheral swelling General disorders and administration site conditions FUnilateral leg swelling F2FUGeneral signs and symptoms NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2020-07-02 2020-07-15 A0B DVR.. A0DV_..Vaccination stageA Vaccination 1A0BYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-30T14:02 AngioedeBROAD mRNA-1273-P201mRNA-1273-P201-US203-1121US2031121US203USABCYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVPHq=XDVlHq)8Hq=XHq)8DVlHq)8 mRNA-1273 50 ug A AE-003A ADVERSE EVENT ORAL CANDIDIASIS Oral candidiasis Infections and infestations FOral candidiasis FsFsCandida infections F^Fungal infectious disorders FInfections and infestations F2021-02-06 2021-02-23 BB DW-.. BDW>..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-28T14:10 mRNA-1273-P201mRNA-1273-P201-US203-1121US2031121US203USABCYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVPHq=XDVlHq)8Hq=XHq)8DVlHq)8 mRNA-1273 50 ug A AE-002A@ADVERSE EVENT UPPER RESPIRATORY INFECTION Upper respiratory tract infection Infections and infestations FUpper respiratory infection FK\FKbUpper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations F2020-11-22 2020-11-30 BB DV.. BDV..Follow up stage A Vaccination 2BvB~YN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-07-28T14:10 mRNA-1273-P201mRNA-1273-P201-US203-1129US2031129US203USAB=YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVQHq̎DVnHqdHq̎HqdDVnHqd Placebo AAE-001AADVERSE EVENT SINUSITIS Sinusitis Infections and infestations FSinusitis F5F5Upper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations F2020-08-23 2020-08-27 B6B: DV.. B6DV..Vaccination stageA Vaccination 2BBYYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-30T15:19 mRNA-1273-P201mRNA-1273-P201-US204-1005US2041005US204USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV0Hq|DVLHq8Hq|Hq8DVLHq8 Placebo AAE-001AADVERSE EVENT HEADACHE Headache Nervous system disorders FHeadache FFHeadaches NEC FHeadaches FNervous system disorders F2020-10-12 2020-10-15 BB DV.. BDV..Follow up stage A Vaccination 2BmBpYN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-06-26T12:02 Headache Y mRNA-1273-P201mRNA-1273-P201-US204-1005US2041005US204USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV0Hq|DVLHq8Hq|Hq8DVLHq8 Placebo AAE-002A ADVERSE EVENT LETHARGY Lethargy Nervous system disorders FLethargy FHFHDisturbances in consciousness NEC FENeurological disorders NEC FNervous system disorders F2020-10-12 2020-10-15 BB DV.. BDV..Follow up stage A Vaccination 2BmBpYN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-06-26T12:02 mRNA-1273-P201mRNA-1273-P201-US204-1007US2041007US204USAB!YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3HqLDVOHqŤHqLHqŤDVOHqŤ mRNA-1273 50 ug A AE-002AADVERSE EVENT SPONTANEOUS ABORTION Abortion spontaneous Pregnancy, puerperium and perinatal conditions F%iSpontaneous abortion F9WFjAbortions spontaneous FkAbortions and stillbirth FSPregnancy, puerperium and perinatal conditions F%i2020-12-17 2020-12-17 BB DV.. BDV..Follow up stage A Vaccination 2BBYY NYNNNNNYNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-06-29T11:19 mRNA-1273-P201mRNA-1273-P201-US204-1008US2041008US204USAB%YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3HqDVQHq̩THqHq̩TDVQHq̩T2080mRNA-1273 100 ugA0AE-001AREACTOGENICITYFATIGUE Fatigue General disorders and administration site conditions FFatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2020-07-02 2020-07-10 B B( DVR.. B DVZ..Vaccination stageAP3D Vaccination 2A AYNY YNNNNNNNRELATED RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-01T15:55 Fatigue Y mRNA-1273-P201mRNA-1273-P201-US204-1016US2041016US204USAB'YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected YNYmRNA-1273 50 ug A mRNA-1273 50 ug A DV4HquTDV^HqݨHquTHqݨDV^Hqݨ mRNA-1273 50 ug A AE-001AADVERSE EVENT VIRAL SYNDROME OF UNKNOWN ETIOLOGY Viral infection Infections and infestations FViral syndrome FFOViral infections NEC FOViral infectious disorders FOInfections and infestations F2020-12-09 2021-01-21 BB DV.. BDW..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT APPLICABLENOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-07-14T13:22 mRNA-1273-P201mRNA-1273-P201-US204-1019US2041019US204USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAMWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNPlacebo APlacebo ADV4Hq]DVPHq8Hq]Hq8DVPHq8 Placebo AAE-001AADVERSE EVENT LEFT HAND LACERATION Skin laceration Injury, poisoning and procedural complications FLaceration of hand FF|BSkin injuries NEC FInjuries NEC FInjury, poisoning and procedural complications F2020-07-06 2020-07-13 B#B* DVV.. B#DV]..Vaccination stageA Vaccination 2ApAYYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT PROCEDURE RECOVERED/RESOLVED DOSE 2 - 2020-06-30T13:43 mRNA-1273-P201mRNA-1273-P201-US204-1022US2041022US204USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADV7Hq7pDVVHqHq7pHqDVVHq Placebo AAE-001AADVERSE EVENT COVID-19 INFECTION COVID-19 Infections and infestations FCOVID-19 F߬F߬Coronavirus infections FViral infectious disorders FOInfections and infestations F2020-10-31 2020-11-15 BB DV.. BDV..Follow up stage A Vaccination 2BvBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-07-06T12:39 mRNA-1273-P201mRNA-1273-P201-US204-1023US2041023US204USAB5YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3Hq$DVOHqHq$HqDVOHq mRNA-1273 50 ug A AE-001AADVERSE EVENT VIRAL SYNDROME OF UNKNOWN ETIOLOGY Viral infection Infections and infestations FViral syndrome FFOViral infections NEC FOViral infectious disorders FOInfections and infestations F2020-09-24 2020-10-02 BtB| DV.. BtDV..Follow up stage A Vaccination 2BXB`YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-06-29T16:32 mRNA-1273-P201mRNA-1273-P201-US204-1027US2041027US204USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3Hq@DVOHqɿHq@HqɿDVOHqɿ mRNA-1273 50 ug A AE-001A@ADVERSE EVENT VOMITING Vomiting Gastrointestinal disorders FܛVomiting FPFPNausea and vomiting symptoms FGastrointestinal signs and symptoms FGastrointestinal disorders Fܛ2020-09-27 2020-11-03 BwB DV.. BwDV..Follow up stage A Vaccination 2B[BYN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-06-29T10:54 mRNA-1273-P201mRNA-1273-P201-US204-1027US2041027US204USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3Hq@DVOHqɿHq@HqɿDVOHqɿ mRNA-1273 50 ug A AE-002AADVERSE EVENT CHEST TIGHTNESS/PRESSURE Chest discomfort General disorders and administration site conditions FChest tightness FFPain and discomfort NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2020-09-27 2020-11-03 BwB DV.. BwDV..Follow up stage A Vaccination 2B[BYN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-06-29T10:54 Anaphylactic ReactionBROADY mRNA-1273-P201mRNA-1273-P201-US204-1027US2041027US204USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3Hq@DVOHqɿHq@HqɿDVOHqɿ mRNA-1273 50 ug A AE-004A0ADVERSE EVENT VIRAL SYNDROME OF UNKNOWN ETIOLOGY Viral infection Infections and infestations FViral syndrome FFOViral infections NEC FOViral infectious disorders FOInfections and infestations F2020-12-05 2020-12-11 BB DV.. BDV..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-06-29T10:54 mRNA-1273-P201mRNA-1273-P201-US204-1027US2041027US204USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3Hq@DVOHqɿHq@HqɿDVOHqɿ mRNA-1273 50 ug A AE-003A ADVERSE EVENT COUGH Cough Respiratory, thoracic and mediastinal disorders F-Cough FXFXCoughing and associated symptoms FaRespiratory disorders NEC F-Respiratory, thoracic and mediastinal disorders F-2020-09-27 2020-11-03 BwB DV.. BwDV..Follow up stage A Vaccination 2B[BYN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-06-29T10:54 Anaphylactic ReactionBROADY mRNA-1273-P201mRNA-1273-P201-US204-1046US2041046US204USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6HqDVRHq͡LHqHq͡LDVRHq͡L mRNA-1273 100 ugA0AE-002AADVERSE EVENT BRONCHITIS Bronchitis Infections and infestations FBronchitis FFLower respiratory tract and lung infections FInfections - pathogen unspecified FInfections and infestations F2020-11-06 2020-11-15 BB DV.. BDV..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-07-02T09:33 mRNA-1273-P201mRNA-1273-P201-US204-1046US2041046US204USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6HqDVRHq͡LHqHq͡LDVRHq͡L mRNA-1273 100 ugA0AE-001A@ADVERSE EVENT LEFT OTITIS MEDIA Otitis media Infections and infestations FOtitis media FFEar infections F=Infections - pathogen unspecified FInfections and infestations F2020-10-14 2020-10-25 BB DV.. BDV..Follow up stage A Vaccination 2BiBtYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-02T09:33 mRNA-1273-P201mRNA-1273-P201-US204-1046US2041046US204USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6HqDVRHq͡LHqHq͡LDVRHq͡L mRNA-1273 100 ugA0AE-003A0ADVERSE EVENT LOW BACK SPASMS Muscle spasms Musculoskeletal and connective tissue disorders FkBack muscle spasms FF.Muscle related signs and symptoms NEC F&Muscle disorders FMusculoskeletal and connective tissue disorders Fk2021-02-03 B.ONGOINGDW*.. B...Follow up stage A Vaccination 2B.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERING/RESOLVING DOSE 2 - 2020-07-02T09:33 mRNA-1273-P201mRNA-1273-P201-US204-1046US2041046US204USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6HqDVRHq͡LHqHq͡LDVRHq͡L mRNA-1273 100 ugA0AE-004A ADVERSE EVENT WORSENING DEPRESSION Depression Psychiatric disorders F'Depression worsened FFDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'2020-12-02 B.ONGOINGDV.. B...Follow up stage A Vaccination 2B.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERING/RESOLVING DOSE 2 - 2020-07-02T09:33 mRNA-1273-P201mRNA-1273-P201-US204-1047US2041047US204USAB!YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYNNYNNYYYYYYNNNNYYNNot Detected YNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4HqDVPHqHqHqDVPHq mRNA-1273 50 ug A AE-001AADVERSE EVENT COVID-19 INFECTION COVID-19 Infections and infestations FCOVID-19 F߬F߬Coronavirus infections FViral infectious disorders FOInfections and infestations F2020-08-04 2020-08-13 B@BI DVs.. B@DV|..Follow up stage A Vaccination 2B$B-YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-06-30T08:56 mRNA-1273-P201mRNA-1273-P201-US204-1048US2041048US204USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4Hq%,DVQHq̦Hq%,Hq̦DVQHq̦ mRNA-1273 100 ugA0AE-001AADVERSE EVENT VIRAL SYNDROME OF UNKNOWN ETIOLOY Viral infection Infections and infestations FViral syndrome FFOViral infections NEC FOViral infectious disorders FOInfections and infestations F2021-01-25 2021-01-29 BB DW!.. BDW%..Follow up stage A Vaccination 2BBYN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-01T15:45 mRNA-1273-P201mRNA-1273-P201-US204-1049US2041049US204USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNYmRNA-1273 50 ug A mRNA-1273 50 ug A DV6HqDV^HqHqHqDV^Hq mRNA-1273 50 ug A AE-001AADVERSE EVENT BILATERAL LEG TREMORS Tremor Nervous system disorders FTremor limb FDFDTremor (excl congenital) FDMovement disorders (incl parkinsonism) FNervous system disorders F2020-09-09 Bb.ONGOINGDV.. Bb...Follow up stage A Vaccination 2B:.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERING/RESOLVING DOSE 2 - 2020-07-14T16:00 mRNA-1273-P201mRNA-1273-P201-US204-1051US2041051US204USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4HqUtDVPHq HqUtHq DVPHq mRNA-1273 50 ug A AE-001AADVERSE EVENT VITAMIN B12 DEFICIENCY Vitamin B12 deficiency Metabolism and nutrition disorders FVitamin B12 deficiency FPyFPyWater soluble vitamin deficiencies FQbVitamin related disorders FPMetabolism and nutrition disorders F2020-10-16 B.ONGOINGDV.. B...Follow up stage A Vaccination 2Bm.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERING/RESOLVING DOSE 2 - 2020-06-30T11:57 mRNA-1273-P201mRNA-1273-P201-US204-1056US2041056US204USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNPlacebo APlacebo ADV4HqODVPHq4HqOHq4DVPHq4 Placebo AAE-001AADVERSE EVENT GENERALIZED ACNE Acne Skin and subcutaneous tissue disorders F5Acne FpFpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F52021-02-08 B.ONGOINGDW/.. B...Follow up stage A Vaccination 2B.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERING/RESOLVING DOSE 2 - 2020-06-30T10:11 mRNA-1273-P201mRNA-1273-P201-US204-1060US2041060US204USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqlDVQHqNdHqlHqNdDVQHqNd mRNA-1273 100 ugA0AE-002AREACTOGENICITYHARDNESS AT INJECTION SITE Injection site induration General disorders and administration site conditions FInjection site induration FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2020-06-03 2020-06-09 A A DV5.. A DV;..Vaccination stageAP1D Vaccination 1A AYNY YNNNNNNNRELATED RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-02T09:25 Swelling Y mRNA-1273-P201mRNA-1273-P201-US204-1060US2041060US204USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqlDVQHqNdHqlHqNdDVQHqNd mRNA-1273 100 ugA0AE-001A REACTOGENICITYSWELLING AT INJECTION SITE Injection site swelling General disorders and administration site conditions FSwelling of injection site F=HFg1Injection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2020-06-03 2020-06-09 A A DV5.. A DV;..Vaccination stageAP1D Vaccination 1A AYNY YNNNNNNNRELATED RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-02T09:25 Swelling Y mRNA-1273-P201mRNA-1273-P201-US204-1061US2041061US204USAB4YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqpDVVHq (HqpHq (DVVHq ( mRNA-1273 100 ugA0AE-001AADVERSE EVENT URINARY TRACT INFECTION Urinary tract infection Infections and infestations FUrinary tract infection FLkFLkUrinary tract infections FLqInfections - pathogen unspecified FInfections and infestations F2020-07-06 2020-07-16 B#B- DVV.. B#DV`..Vaccination stageA Vaccination 2AAYYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-06T12:06 mRNA-1273-P201mRNA-1273-P201-US204-1073US2041073US204USAB,YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqDVPHqa4HqHqa4DVPHqa41080mRNA-1273 100 ugA0AE-001AREACTOGENICITYFATIGUE Fatigue General disorders and administration site conditions FFatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2020-06-03T09:382020-06-12T12:38A A DV5DxHqf A DV>DHqnVaccination stageAP2DT19H8M Vaccination 1AAYNY YNNNNNNNRELATED NOT APPLICABLERELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-02T17:30 Fatigue Y mRNA-1273-P201mRNA-1273-P201-US204-1073US2041073US204USAB,YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqDVPHqa4HqHqa4DVPHqa42080mRNA-1273 100 ugA0AE-002A REACTOGENICITYFATIGUE Fatigue General disorders and administration site conditions FFatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2020-07-03 2020-07-11 B B( DVS.. B DV[..Vaccination stageAP5D Vaccination 2A@AYNY YNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-06-30T16:35 Fatigue Y mRNA-1273-P201mRNA-1273-P201-US204-1076US2041076US204USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4Hq6 DVVHqHq6 HqDVVHq mRNA-1273 50 ug A AE-008AADVERSE EVENT CHEST TIGHTNESS-UNKNOWN ORIGIN Chest discomfort General disorders and administration site conditions FChest tightness FFPain and discomfort NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2020-08-10 2020-08-13 BFBI DVy.. BFDV|..Follow up stage A Vaccination 2B$B'YN NNNNNNNNNOT RELATEDNOT APPLICABLENOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-06T12:29 Anaphylactic ReactionBROADY mRNA-1273-P201mRNA-1273-P201-US204-1076US2041076US204USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4Hq6 DVVHqHq6 HqDVVHq1080mRNA-1273 50 ug A AE-004A0REACTOGENICITYFATIGUE Fatigue General disorders and administration site conditions FFatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2020-06-02T17:002020-06-11T22:00AA DV4DHq} ADV=EVHqVaccination stageAP2DT10H3M Vaccination 1AAYNY YNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-02T11:57 Fatigue Y mRNA-1273-P201mRNA-1273-P201-US204-1076US2041076US204USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4Hq6 DVVHqHq6 HqDVVHq mRNA-1273 50 ug A AE-001A@ADVERSE EVENT FATIGUE DUE TO SEASONAL ALLERGIES Fatigue General disorders and administration site conditions FFatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2020-07-06 2020-07-25 B#B6 DVV.. B#DVi..Vaccination stageA Vaccination 2ABYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-06T12:29 Fatigue Y mRNA-1273-P201mRNA-1273-P201-US204-1076US2041076US204USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4Hq6 DVVHqHq6 HqDVVHq mRNA-1273 50 ug A AE-007A ADVERSE EVENT BILATERAL EYE INFECTION Eye infection Infections and infestations FEye infection FԹFԹEye and eyelid infections FԥInfections - pathogen unspecified FInfections and infestations F2020-10-19 2020-11-16 BB DV.. BDV..Follow up stage A Vaccination 2BjBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-06T12:29 mRNA-1273-P201mRNA-1273-P201-US204-1076US2041076US204USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4Hq6 DVVHqHq6 HqDVVHq2090mRNA-1273 50 ug A AE-002AREACTOGENICITYMYALGIA LEFT ARM Myalgia Musculoskeletal and connective tissue disorders FkMyalgia F{F{Muscle pains F#Muscle disorders FMusculoskeletal and connective tissue disorders Fk2020-07-06T13:302020-07-14T13:30B#B+ DVVDHq B#DV^DHqݪVaccination stageAP1DT1H1M Vaccination 2AAYNY YNNNNNNNRELATED RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-06T12:29 Myalgia Y mRNA-1273-P201mRNA-1273-P201-US204-1076US2041076US204USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4Hq6 DVVHqHq6 HqDVVHq1070mRNA-1273 50 ug A AE-005APREACTOGENICITYHEADACHE Headache Nervous system disorders FHeadache FFHeadaches NEC FHeadaches FNervous system disorders F2020-06-03 2020-06-12 A A DV5.. A DV>..Vaccination stageAP4D Vaccination 1A AYNY YNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-06-02T11:57 Headache Y mRNA-1273-P201mRNA-1273-P201-US204-1076US2041076US204USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4Hq6 DVVHqHq6 HqDVVHq2070mRNA-1273 50 ug A AE-003A`REACTOGENICITYHEADACHE Headache Nervous system disorders FHeadache FFHeadaches NEC FHeadaches FNervous system disorders F2020-07-06T13:302020-07-15 B#B, DVVDHq B#DV_..Vaccination stageAP3D Vaccination 2AAYNY YNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-06T12:29 Headache Y mRNA-1273-P201mRNA-1273-P201-US204-1076US2041076US204USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4Hq6 DVVHqHq6 HqDVVHq mRNA-1273 50 ug A AE-010ApADVERSE EVENT HEADACHE Headache Nervous system disorders FHeadache FFHeadaches NEC FHeadaches FNervous system disorders F2020-08-10 2020-08-13 BFBI DVy.. BFDV|..Follow up stage A Vaccination 2B$B'YN NNNNNNNNNOT RELATEDNOT APPLICABLENOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-06T12:29 Headache Y mRNA-1273-P201mRNA-1273-P201-US204-1076US2041076US204USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4Hq6 DVVHqHq6 HqDVVHq mRNA-1273 50 ug A AE-009AADVERSE EVENT SORE THROAT Oropharyngeal pain Respiratory, thoracic and mediastinal disorders F-Sore throat F8F_Upper respiratory tract signs and symptoms FKiRespiratory tract signs and symptoms F}Respiratory, thoracic and mediastinal disorders F-2020-08-10 2020-08-13 BFBI DVy.. BFDV|..Follow up stage A Vaccination 2B$B'YN NNNNNNNNNOT RELATEDNOT APPLICABLENOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-06T12:29 mRNA-1273-P201mRNA-1273-P201-US204-1077US2041077US204USAB%YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5HqLDVQHqe\HqLHqe\DVQHqe\ mRNA-1273 50 ug A AE-002AADVERSE EVENT ELEVATED BLOOD PRESSURE Blood pressure increased Investigations FIncreased blood pressure FFVascular tests NEC (incl blood pressure) FNCardiac and vascular investigations (excl enzyme tests) FInvestigations F2020-07-14 B*.ONGOINGDV^.. B*...Vaccination stageA Vaccination 2A.YYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA3SEVERE Grade 3A0Grade 3/Severe A0>=3A DOSE NOT CHANGEDNONE NOT RECOVERED/NOT RESOLVED DOSE 2 - 2020-07-01T11:05 mRNA-1273-P201mRNA-1273-P201-US204-1077US2041077US204USAB%YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5HqLDVQHqe\HqLHqe\DVQHqe\ mRNA-1273 50 ug A AE-001A ADVERSE EVENT BILATERAL NUMBNESS/TINGLING IN HANDS Paraesthesia Nervous system disorders FParesthesia hand FkFoParaesthesias and dysaesthesias F|Neurological disorders NEC FNervous system disorders F2020-07-05 B!.ONGOINGDVU.. B!...Vaccination stageA Vaccination 2AP.YYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE NOT RECOVERED/NOT RESOLVED DOSE 2 - 2020-07-01T11:05 Peripheral NeuropathyBROAD mRNA-1273-P201mRNA-1273-P201-US204-1080US2041080US204USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected YNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5HqDVQHq̳,HqHq̳,DVQHq̳, mRNA-1273 100 ugA0AE-001AADVERSE EVENT COVID-19 INFECTION COVID-19 Infections and infestations FCOVID-19 F߬F߬Coronavirus infections FViral infectious disorders FOInfections and infestations F2021-01-02 2021-01-06 BB DW .. BDW..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-07-01T16:37 mRNA-1273-P201mRNA-1273-P201-US204-1092US2041092US204USAB4YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNYmRNA-1273 50 ug A mRNA-1273 50 ug A DV:HqY,DV^Hqݥ8HqY,Hqݥ8DV^Hqݥ8 mRNA-1273 50 ug A AE-001AADVERSE EVENT HYPERTENSION Hypertension Vascular disorders FNYHypertension FFVascular hypertensive disorders NEC FVascular hypertensive disorders FuVascular disorders FNY2020-06-24 B.ONGOINGDVJ.. B...Vaccination stageA Vaccination 1B.YYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERING/RESOLVING DOSE 1 - 2020-06-08T16:05 mRNA-1273-P201mRNA-1273-P201-US204-1103US2041103US204USABBYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYNYNYYYNNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqlDVhHqxHqlHqxDVhHqx mRNA-1273 50 ug A AE-003AADVERSE EVENT GASTROESOPHAGEAL REFLUX DISEASE Gastrooesophageal reflux disease Gastrointestinal disorders FܛGastroesophageal reflux disease FF]Gastrointestinal atonic and hypomotility disorders NEC F܍Gastrointestinal motility and defaecation conditions FܹGastrointestinal disorders Fܛ2020-08-28 2020-10-15 B@Bp DV.. B@DV..Follow up stage A Vaccination 2B$BTYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-24T11:46 mRNA-1273-P201mRNA-1273-P201-US204-1103US2041103US204USABBYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYNYNYYYNNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqlDVhHqxHqlHqxDVhHqx mRNA-1273 50 ug A AE-002A ADVERSE EVENT ESOPHAGEAL FOOD BOLUS OBSTRUCTION Oesophageal food impaction Gastrointestinal disorders FܛEsophageal food impaction FFGastrointestinal signs and symptoms NEC FGastrointestinal signs and symptoms FGastrointestinal disorders Fܛ2020-08-16 2020-08-16 B4B4 DV.. B4DV..Vaccination stageA Vaccination 2BBYYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-24T11:46 mRNA-1273-P201mRNA-1273-P201-US204-1103US2041103US204USABBYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYNYNYYYNNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqlDVhHqxHqlHqxDVhHqx mRNA-1273 50 ug A AE-001A0ADVERSE EVENT LOW PLATELETS Platelet count decreased Investigations FLow platelets FF!HPlatelet analyses F!CHaematology investigations (incl blood groups) F#Investigations F2020-07-24T10:40 B.ONGOINGDVhDHq B...Vaccination stageA Vaccination 1B.YNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE UNKNOWN DOSE 1 - 2020-06-26T11:33 Haematopoietic CytopeniasNARROWY mRNA-1273-P201mRNA-1273-P201-US204-1104US2041104US204USABDYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHq״DVhHqHq״HqDVhHq mRNA-1273 50 ug A AE-001AADVERSE EVENT INSOMNIA Insomnia Psychiatric disorders F'Insomnia F%F%Disturbances in initiating and maintaining sleep FFSleep disorders and disturbances F6Psychiatric disorders F'2020-07-01 A`.ONGOINGDVQ.. A`...Vaccination stageA Vaccination 1A`.YYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RECOVERED/NOT RESOLVED DOSE 1 - 2020-06-26T11:47 mRNA-1273-P201mRNA-1273-P201-US204-1109US2041109US204USABBYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqDVkHqHqHqDVkHq mRNA-1273 50 ug A AE-001AADVERSE EVENT SINUS INFECTION Sinusitis Infections and infestations FSinus infection F5F5Upper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations F2020-12-25 2021-01-05 BB DW.. BDW ..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-27T11:44 mRNA-1273-P201mRNA-1273-P201-US204-1112US2041112US204USAB=YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqHDVlHqD,HqHHqD,DVlHqD, mRNA-1273 100 ugA0AE-001AADVERSE EVENT ELEVATED DIASTOLIC BLOOD PRESSURE GRADE 0 TO GRADE 2 POST VACCINATION Blood pressure diastolic increased Investigations FBlood pressure diastolic increased FFVascular tests NEC (incl blood pressure) FNCardiac and vascular investigations (excl enzyme tests) FInvestigations F2020-06-26T14:172020-07-06T12:40AA DVLDHq ADVVD Hq Vaccination stageA Vaccination 1AAYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-26T13:02 CardiomyopathyBROAD mRNA-1273-P201mRNA-1273-P201-US204-1114US2041114US204USAB>YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNYPlacebo APlacebo ADVLHqDVrHqHqHqDVrHq Placebo AAE-001AADVERSE EVENT THORACIC BACK PAIN Back pain Musculoskeletal and connective tissue disorders FkThoracic back pain F?FMusculoskeletal and connective tissue pain and discomfort FMusculoskeletal and connective tissue disorders NEC FiMusculoskeletal and connective tissue disorders Fk2021-02-13 2021-02-19 BB DW4.. BDW:..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-08-03T11:51 mRNA-1273-P201mRNA-1273-P201-US204-1119US2041119US204USABDYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVVHq#LDVsHq*LHq#LHq*LDVsHq*L mRNA-1273 50 ug A AE-003AADVERSE EVENT HYPOTHYROIDISM Hypothyroidism Endocrine disorders FHypothyroidism FFThyroid hypofunction disorders FA]Thyroid gland disorders FA[Endocrine disorders F2020-11-11 B.ONGOINGDV.. B...Follow up stage A Vaccination 2Bd.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERING/RESOLVING DOSE 2 - 2020-08-04T10:05 mRNA-1273-P201mRNA-1273-P201-US204-1119US2041119US204USABDYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVVHq#LDVsHq*LHq#LHq*LDVsHq*L mRNA-1273 50 ug A AE-001A0ADVERSE EVENT SPONDYLOLISTHESIS Spondylolisthesis Musculoskeletal and connective tissue disorders FkSpondylolisthesis FFSpine and neck deformities FMusculoskeletal and connective tissue deformities (incl intervertebral disc disorders)FYMusculoskeletal and connective tissue disorders Fk2020-08-10 2020-11-16 B$B DVy.. B$DV..Vaccination stageA Vaccination 2ApBiYYY NYNNNYNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION, CONCOMITANT PROCEDURERECOVERED/RESOLVED 2020-11-162020-11-17N DOSE 2 - 2020-08-04T10:05 mRNA-1273-P201mRNA-1273-P201-US204-1119US2041119US204USABDYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVVHq#LDVsHq*LHq#LHq*LDVsHq*L mRNA-1273 50 ug A AE-002A ADVERSE EVENT CYST ON SPINAL NERVE Nervous system cyst Nervous system disorders FNervous system cyst FFNervous system cysts and polyps FNervous system neoplasms benign FNervous system disorders F2020-08-10 2020-11-16 B$B DVy.. B$DV..Vaccination stageA Vaccination 2ApBiYYY NYNNNYNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT PROCEDURE RECOVERED/RESOLVED 2020-11-162020-11-17N DOSE 2 - 2020-08-04T10:05 mRNA-1273-P201mRNA-1273-P201-US204-1122US2041122US204USABRYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVOHqɪ8DVkHqHqɪ8HqDVkHq mRNA-1273 100 ugA0AE-001AADVERSE EVENT CIRCUMFERENTIAL REDNESS ABOVE INJECTION SITE ON LEFT ARM Injection site erythema General disorders and administration site conditions FInjection site redness FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2020-07-08 2020-07-16 AB DVX.. ADV`..Vaccination stageA Vaccination 1ABYNY NNNNNNNNRELATED RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-06-29T09:22 Erythema YY YmRNA-1273-P201mRNA-1273-P201-US204-1126US2041126US204USAB>YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqLDVlHqDHqLHqDDVlHqD1070mRNA-1273 100 ugA0AE-001AREACTOGENICITYHEADACHE Headache Nervous system disorders FHeadache FFHeadaches NEC FHeadaches FNervous system disorders F2020-06-29 2020-07-04 A@A DVO.. A@DVT..Vaccination stageAP2D Vaccination 1A@AYNY YNNNNNNNRELATED RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-26T12:45 Headache Y mRNA-1273-P201mRNA-1273-P201-US204-1142US2041142US204USAB?YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNPlacebo APlacebo ADVRHqLDVoHqHqLHqDVoHq Placebo AAE-001AADVERSE EVENT HYPERCHOLESTEROLEMIA Hypercholesterolaemia Metabolism and nutrition disorders FHypercholesterolemia FFElevated cholesterol F Lipid metabolism disorders FʅMetabolism and nutrition disorders F2021-01-27 2021-02-15 BB DW#.. BDW6..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-31T11:50 mRNA-1273-P201mRNA-1273-P201-US204-1145US2041145US204USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVRHqDVoHqHqHqDVoHq .AE-001AADVERSE EVENT RIGHT THUMB PIP ARTHRITIS Arthritis Musculoskeletal and connective tissue disorders FkFinger arthritis FrF.Arthropathies NEC FTJoint disorders F-Musculoskeletal and connective tissue disorders Fk2020-07-01 .ONGOINGDVQ.. ... . .. Y NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION NOT RECOVERED/NOT RESOLVED ArthritisNARROWY mRNA-1273-P201mRNA-1273-P201-US204-1146US2041146US204USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVRHq DVoHqHq HqDVoHq Placebo AAE-002A ADVERSE EVENT LEUKOPENIA Leukopenia Blood and lymphatic system disorders FQLeukopenia FFLeukopenias NEC FWhite blood cell disorders FQBlood and lymphatic system disorders FQ2020-07-31 B.ONGOINGDVo.. B...Vaccination stageA Vaccination 2A.YNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERING/RESOLVING DOSE 2 - 2020-07-31T08:42 Haematopoietic CytopeniasNARROWY mRNA-1273-P201mRNA-1273-P201-US204-1146US2041146US204USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVRHq DVoHqHq HqDVoHq Placebo AAE-001AADVERSE EVENT CELLULITIS- RIGHT FOREARM Cellulitis Infections and infestations FCellulitis of arm FUFJBacterial infections NEC FOBacterial infectious disorders F2Infections and infestations F2020-07-05 2020-07-10 A@A DVU.. A@DVZ..Vaccination stageA Vaccination 1A@AYYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-07-02T17:03 mRNA-1273-P201mRNA-1273-P201-US204-1155US2041155US204USAB@YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYNYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVVHq;DVrHqdHq;HqdDVrHqd2070mRNA-1273 50 ug A AE-001A REACTOGENICITYHEADACHE Headache Nervous system disorders FHeadache FFHeadaches NEC FHeadaches FNervous system disorders F2020-08-03T18:132020-08-11T13:09BB% DVrEHqK, BDVzDHrVaccination stageAPT22H54M Vaccination 2AAYNY YNNNNNNNRELATED RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-08-03T14:15 Headache Y mRNA-1273-P201mRNA-1273-P201-US204-1155US2041155US204USAB@YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYNYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVVHq;DVrHqdHq;HqdDVrHqd mRNA-1273 50 ug A AE-002AADVERSE EVENT DEPRESSION Depression Psychiatric disorders F'Depression FFDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'2021-01-03 B.ONGOINGDW .. B...Follow up stage A Vaccination 2B.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERING/RESOLVING DOSE 2 - 2020-08-03T14:15 mRNA-1273-P201mRNA-1273-P201-US205-1009US2051009US205USAB3YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4Hq#DVPHqHq#HqDVPHq mRNA-1273 50 ug A AE-002AADVERSE EVENT MUSCULOSKELETAL BACK PAIN Back pain Musculoskeletal and connective tissue disorders FkBack pain FFMusculoskeletal and connective tissue pain and discomfort FMusculoskeletal and connective tissue disorders NEC FiMusculoskeletal and connective tissue disorders Fk2020-06-19 2020-07-24 BB5 DVE.. BDVh..Vaccination stageA Vaccination 1BB5YNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-06-02T10:38 mRNA-1273-P201mRNA-1273-P201-US205-1010US2051010US205USAB*YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4HqM|DVPHqHqM|HqDVPHq mRNA-1273 50 ug A AE-001AADVERSE EVENT URINARY TRACT INFECTION Urinary tract infection Infections and infestations FUrinary tract infection FLkFLkUrinary tract infections FLqInfections - pathogen unspecified FInfections and infestations F2020-06-14 2020-08-03 AB? DV@.. ADVr..Vaccination stageA Vaccination 1AB?YYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-06-02T13:37 mRNA-1273-P201mRNA-1273-P201-US205-1011US2051011US205USAB.YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYNNYNNYYYYYYNNNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5Hq0DVWHqEHq0HqEDVWHqE mRNA-1273 50 ug A AE-001AADVERSE EVENT TENNIS ELBOW BILATERAL Epicondylitis Injury, poisoning and procedural complications FTennis elbow F?zFMuscle, tendon and ligament injuries FInjuries NEC FInjury, poisoning and procedural complications F2020-08-21 2020-10-31 BPB DV.. BPDV..Follow up stage A Vaccination 2B.BuYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-07T10:28 mRNA-1273-P201mRNA-1273-P201-US205-1012US2051012US205USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4Hq[DVQHqrHq[HqrDVQHqr mRNA-1273 100 ugA0AE-001AADVERSE EVENT CONTACT DERMATITIS LEFT ARM Dermatitis contact Skin and subcutaneous tissue disorders F5Contact dermatitis FFDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F52020-06-03 2020-06-05T00:00A A@ DV5.. A DV7HqVaccination stageA Vaccination 1A A0YNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-02T14:37 HypersensitivityNARROWY mRNA-1273-P201mRNA-1273-P201-US205-1018US2051018US205USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:Hq\DVWHqԇHq\HqԇDVWHqԇ mRNA-1273 50 ug A AE-002AADVERSE EVENT LEFT CORNEAL ABRASION Corneal abrasion Injury, poisoning and procedural complications FCorneal abrasion FhFhEye injuries NEC FInjuries NEC FInjury, poisoning and procedural complications F2020-10-13 2020-10-13 BB DV.. BDV..Follow up stage A Vaccination 2BcBcYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-07T15:07 mRNA-1273-P201mRNA-1273-P201-US205-1022US2051022US205USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNPlacebo APlacebo ADV5HqeTDVWHq;HqeTHq;DVWHq; Placebo AAE-001A ADVERSE EVENT ODYNOPHAGIA Odynophagia Gastrointestinal disorders FܛOdynophagia F F Oral soft tissue signs and symptoms FOral soft tissue conditions FGastrointestinal disorders Fܛ2020-07-28 2020-08-04 B8B? DVl.. B8DVs..Vaccination stageA Vaccination 2BBYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-07T09:45 mRNA-1273-P201mRNA-1273-P201-US205-1022US2051022US205USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNPlacebo APlacebo ADV5HqeTDVWHq;HqeTHq;DVWHq; Placebo AAE-002AADVERSE EVENT TOE INFECTION RIGHT FOOT (2-4 DIGITS) Localised infection Infections and infestations FInfected toe FFFInfections NEC FInfections - pathogen unspecified FInfections and infestations F2020-12-04 2021-01-14 BB DV.. BDW..Follow up stage A Vaccination 2BBYY NNNNNNNNRELATED RELATED RELATED A 2MODERATEGrade 2A Grade 2/ModerateA <3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-07T09:45 mRNA-1273-P201mRNA-1273-P201-US205-1032US2051032US205USAB)YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4Hq*DVPHq|Hq*Hq|DVPHq| mRNA-1273 50 ug A AE-002AADVERSE EVENT RUNNY NOSE (UNKNOWN ETIOLOGY) Rhinorrhoea Respiratory, thoracic and mediastinal disorders F-Runny nose F0F/=Upper respiratory tract signs and symptoms FKiRespiratory tract signs and symptoms F}Respiratory, thoracic and mediastinal disorders F-2020-06-23 2020-07-02 BB DVI.. BDVR..Vaccination stageA Vaccination 1BBYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-06-02T11:06 mRNA-1273-P201mRNA-1273-P201-US205-1033US2051033US205USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV6Hq DVWHqBHq HqBDVWHqB mRNA-1273 50 ug A AE-003A ADVERSE EVENT DIARRHEA Diarrhoea Gastrointestinal disorders FܛDiarrhea F7F?Diarrhoea (excl infective) F@Gastrointestinal motility and defaecation conditions FܹGastrointestinal disorders Fܛ2020-07-09 2020-07-10 B$B% DVY.. B$DVZ..Vaccination stageA Vaccination 2A0A@YNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-07T10:16 mRNA-1273-P201mRNA-1273-P201-US205-1033US2051033US205USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV6Hq DVWHqBHq HqBDVWHqB2080mRNA-1273 50 ug A AE-005A0REACTOGENICITYFATIGUE Fatigue General disorders and administration site conditions FFatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2020-07-07 2020-07-15 B"B* DVW.. B"DV_..Vaccination stageAP2D Vaccination 2AAYNY YNNNNNNNRELATED RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-07T10:16 Fatigue Y mRNA-1273-P201mRNA-1273-P201-US205-1033US2051033US205USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV6Hq DVWHqBHq HqBDVWHqB mRNA-1273 50 ug A AE-002AREACTOGENICITYJOINT ACHES IN SEVERAL JOINTS Arthralgia Musculoskeletal and connective tissue disorders FkAching joints FAF'Joint related signs and symptoms F:Joint disorders F-Musculoskeletal and connective tissue disorders Fk2020-07-07 2020-07-15 B"B* DVW.. B"DV_..Vaccination stageAP2D Vaccination 2AAYNY YNNNNNNNRELATED NOT RELATED RELATED A 3SEVERE Grade 3A0Grade 3/Severe A0>=3A DOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-07T10:16 ArthritisBROAD Arthralgia Y mRNA-1273-P201mRNA-1273-P201-US205-1034US2051034US205USAB$YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5HqfDDVQHq{HqfDHq{DVQHq{ mRNA-1273 50 ug A AE-001AADVERSE EVENT UPPER RESPIRATORY INFECTION Upper respiratory tract infection Infections and infestations FUpper respiratory infection FK\FKbUpper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations F2020-06-09 2020-06-15 ApA DV;.. ApDVA..Vaccination stageA Vaccination 1ApAYYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-06-03T09:35 mRNA-1273-P201mRNA-1273-P201-US205-1035US2051035US205USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYNNYNNYYYYYYNNNNYYNNot Detected YNNPlacebo APlacebo ADV6HqDVXHqHqHqDVXHq Placebo AAE-004AADVERSE EVENT POSITIVE COVID 19 INFECTION COVID-19 Infections and infestations FCOVID-19 F߬F߬Coronavirus infections FViral infectious disorders FOInfections and infestations F2020-09-03 2021-03-26 B\C DV.. B\DW]..Follow up stage A Vaccination 2B:C`YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-07-08T14:01 mRNA-1273-P201mRNA-1273-P201-US205-1036US2051036US205USAB1YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV4HqdDVRHqHqdHqDVRHq Placebo AAE-001AADVERSE EVENT ACNE VULGARIS ON BACK Acne Skin and subcutaneous tissue disorders F5Acne vulgaris FFpAcnes FqSkin appendage conditions F5Skin and subcutaneous tissue disorders F52020-07-23 2021-02-04 B4B DVg.. B4DW+..Vaccination stageA Vaccination 2BBYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-02T14:22 mRNA-1273-P201mRNA-1273-P201-US205-1040US2051040US205USAB0YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7HqMDVWHqxHqMHqxDVWHqx mRNA-1273 50 ug A AE-002AADVERSE EVENT CONTACT DERMATITIS (THIGHS, TRUNK, FOREARMS, ANKLES) Dermatitis contact Skin and subcutaneous tissue disorders F5Contact dermatitis FFDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F52020-06-20 2020-06-27 BB DVF.. BDVM..Vaccination stageA Vaccination 1BBYYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-06-05T14:28 HypersensitivityNARROWY mRNA-1273-P201mRNA-1273-P201-US205-1042US2051042US205USAB#YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4Hq4DVQHq̅xHq4Hq̅xDVQHq̅x mRNA-1273 50 ug A AE-001A ADVERSE EVENT TOOTHACHE Toothache Gastrointestinal disorders FܛToothache FBFBDental pain and sensation disorders FBDental and gingival conditions FBrGastrointestinal disorders Fܛ2020-06-04 2020-06-24 A0B DV6.. A0DVJ..Vaccination stageA Vaccination 1A0BYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION, CONCOMITANT PROCEDURERECOVERED/RESOLVED DOSE 1 - 2020-06-02T11:52 mRNA-1273-P201mRNA-1273-P201-US205-1042US2051042US205USAB#YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4Hq4DVQHq̅xHq4Hq̅xDVQHq̅x mRNA-1273 50 ug A AE-002A0ADVERSE EVENT URETHRITIS Urethritis Infections and infestations FUrethritis FLFLUrinary tract infections FLqInfections - pathogen unspecified FInfections and infestations F2020-08-16 2020-08-21 BLBQ DV.. BLDV..Follow up stage A Vaccination 2B/B4YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA3SEVERE Grade 3A0Grade 3/Severe A0>=3A DOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-01T13:22 mRNA-1273-P201mRNA-1273-P201-US205-1042US2051042US205USAB#YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4Hq4DVQHq̅xHq4Hq̅xDVQHq̅x mRNA-1273 50 ug A AE-003AADVERSE EVENT STAPH POSITIVE URINALYSIS Staphylococcus test positive Investigations FStaphylococcus test positive F$F$Bacteria identification and serology (excl mycobacteria) F Microbiology and serology investigations F Investigations F2020-09-16 2020-09-30 BkBy DV.. BkDV..Follow up stage A Vaccination 2BNB\YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-01T13:22 mRNA-1273-P201mRNA-1273-P201-US205-1043US2051043US205USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5HqDVQHq̣HqHq̣DVQHq̣ mRNA-1273 50 ug A AE-001AADVERSE EVENT HEADACHE Headache Nervous system disorders FHeadache FFHeadaches NEC FHeadaches FNervous system disorders F2020-10-16 2020-10-16 BB DV.. BDV..Follow up stage A Vaccination 2BlBlYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-07-01T15:32 Headache Y mRNA-1273-P201mRNA-1273-P201-US205-1045US2051045US205USAB$YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV<HqdDVXHqHqdHqDVXHq mRNA-1273 100 ugA0AE-001AADVERSE EVENT DIASTOLIC HYPERTENSION Diastolic hypertension Vascular disorders FNYDiastolic hypertension FVFVVascular hypertensive disorders NEC FVascular hypertensive disorders FuVascular disorders FNY2020-07-16 B%.ONGOINGDV`.. B%...Vaccination stageA Vaccination 2A.YNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA3SEVERE Grade 3A0Grade 3/Severe A0>=3A DOSE NOT CHANGEDNONE NOT RECOVERED/NOT RESOLVED DOSE 2 - 2020-07-08T15:50 mRNA-1273-P201mRNA-1273-P201-US205-1057US2051057US205USAB=YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqŹDVhHqꚐHqŹHqꚐDVhHqꚐ1080mRNA-1273 50 ug A AE-005A REACTOGENICITYFATIGUE Fatigue General disorders and administration site conditions FFatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2020-06-26 2020-07-08 AA DVL.. ADVX..Vaccination stageAP6D Vaccination 1AAYNY YNNNNNNNRELATED RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-06-26T09:36 Fatigue Y mRNA-1273-P201mRNA-1273-P201-US205-1057US2051057US205USAB=YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqŹDVhHqꚐHqŹHqꚐDVhHqꚐ2080mRNA-1273 50 ug A AE-002A0REACTOGENICITYFATIGUE Fatigue General disorders and administration site conditions FFatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2020-07-24 2020-07-31 BB$ DVh.. BDVo..Vaccination stageAP1D Vaccination 2AAYNY YNNNNNNNRELATED RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-24T09:00 Fatigue Y mRNA-1273-P201mRNA-1273-P201-US205-1057US2051057US205USAB=YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqŹDVhHqꚐHqŹHqꚐDVhHqꚐ2030mRNA-1273 50 ug A AE-001A@REACTOGENICITYPAIN AT THE INJECTION SITE Injection site pain General disorders and administration site conditions FPain injection site F-FInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2020-07-24T10:002020-08-05T00:00BB) DVhDHqꨠ BDVtHqVaccination stageAP4DT15H Vaccination 2AAYNY YNNNNNNNRELATED RELATED RELATED A 2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-24T09:00 Pain Y mRNA-1273-P201mRNA-1273-P201-US205-1057US2051057US205USAB=YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqŹDVhHqꚐHqŹHqꚐDVhHqꚐ1100mRNA-1273 50 ug A AE-004AREACTOGENICITYJOINT ACHES IN SEVERAL JOINTS Arthralgia Musculoskeletal and connective tissue disorders FkAching joints FAF'Joint related signs and symptoms F:Joint disorders F-Musculoskeletal and connective tissue disorders Fk2020-06-26 2020-07-06 AA DVL.. ADVV..Vaccination stageAP4D Vaccination 1AAYNY YNNNNNNNRELATED RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-06-26T09:36 ArthritisBROAD Arthralgia Y mRNA-1273-P201mRNA-1273-P201-US205-1057US2051057US205USAB=YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqŹDVhHqꚐHqŹHqꚐDVhHqꚐ2090mRNA-1273 50 ug A AE-003APREACTOGENICITYMUSCLE ACHES ALL OVER BODY Myalgia Musculoskeletal and connective tissue disorders FkGeneralized muscle aches FiF{Muscle pains F#Muscle disorders FMusculoskeletal and connective tissue disorders Fk2020-07-24 2020-07-31 BB$ DVh.. BDVo..Vaccination stageAP1D Vaccination 2AAYNY YNNNNNNNRELATED RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-24T09:00 Myalgia Y mRNA-1273-P201mRNA-1273-P201-US205-1059US2051059US205USAB9YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqDVkHq,HqHq,DVkHq, mRNA-1273 50 ug A AE-002AADVERSE EVENT HIGH CHOLESTEROL Blood cholesterol increased Investigations FHigh cholesterol FFCholesterol analyses FKLipid analyses FInvestigations F2020-12-17 B.ONGOINGDV.. B...Follow up stage A Vaccination 2B.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RECOVERED/NOT RESOLVED DOSE 2 - 2020-07-27T13:25 mRNA-1273-P201mRNA-1273-P201-US205-1059US2051059US205USAB9YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqDVkHq,HqHq,DVkHq, mRNA-1273 50 ug A AE-001A ADVERSE EVENT SKIN RASH LEFT CHEEK ON FACE (UNKNOWN ETIOLOGY) Rash Skin and subcutaneous tissue disorders F5Facial rash F@F*TRashes, eruptions and exanthems NEC FcEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F52020-09-10 2020-10-31 BMB DV.. BMDV..Follow up stage A Vaccination 2B.BaYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-27T13:25 Anaphylactic ReactionBROADY HypersensitivityNARROWY mRNA-1273-P201mRNA-1273-P201-US205-1060US2051060US205USABAYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHq`DVlHqTHq`HqTDVlHqT mRNA-1273 50 ug A AE-001AADVERSE EVENT CATARACT RIGHT EYE Cataract Eye disorders FԯRight cataract F/nFCataract conditions FAnterior eye structural change, deposit and degeneration FEye disorders Fԯ2020-10-09 2021-02-23 BjB DV.. BjDW>..Follow up stage A Vaccination 2BJBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT PROCEDURE RECOVERED/RESOLVED DOSE 2 - 2020-07-28T10:03 mRNA-1273-P201mRNA-1273-P201-US205-1063US2051063US205USAB8YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADVPHqC4DVlHq<HqC4Hq<DVlHq< Placebo AAE-001AADVERSE EVENT COVID-19 INFECTION COVID-19 Infections and infestations FCOVID-19 F߬F߬Coronavirus infections FViral infectious disorders FOInfections and infestations F2020-12-10 B.ONGOINGDV.. B...Follow up stage A Vaccination 2B.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE NOT RECOVERED/NOT RESOLVED DOSE 2 - 2020-07-28T10:41 mRNA-1273-P201mRNA-1273-P201-US205-1068US2051068US205USABDYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVPHq:DVlHqHq:HqDVlHq2080mRNA-1273 50 ug A AE-001A REACTOGENICITYFATIGUE Fatigue General disorders and administration site conditions FFatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2020-07-28T19:282020-08-04T19:05BB$ DVlEHqs BDVsEHqVaccination stageAPT5H57M Vaccination 2AAYNY YNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-28T13:08 Fatigue Y mRNA-1273-P201mRNA-1273-P201-US205-1068US2051068US205USABDYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVPHq:DVlHqHq:HqDVlHq2100mRNA-1273 50 ug A AE-003AREACTOGENICITYJOINT ACHES (IN SEVERAL JOINTS) Arthralgia Musculoskeletal and connective tissue disorders FkAching joints FAF'Joint related signs and symptoms F:Joint disorders F-Musculoskeletal and connective tissue disorders Fk2020-07-28T19:282020-08-04T19:06BB$ DVlEHqs BDVsEɀHqVaccination stageAPT5H58M Vaccination 2AAYNY YNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-28T13:08 ArthritisBROAD Arthralgia Y mRNA-1273-P201mRNA-1273-P201-US205-1068US2051068US205USABDYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVPHq:DVlHqHq:HqDVlHq2090mRNA-1273 50 ug A AE-002A0REACTOGENICITYMUSCLE ACHES (ALL OVER BODY0 Myalgia Musculoskeletal and connective tissue disorders FkGeneralized muscle aches FiF{Muscle pains F#Muscle disorders FMusculoskeletal and connective tissue disorders Fk2020-07-29T22:372020-08-04T19:06BB$ DVmEHq BDVsEɀHqVaccination stageAPT5H58M Vaccination 2A AYNY YNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-28T13:08 Myalgia Y mRNA-1273-P201mRNA-1273-P201-US205-1069US2051069US205USAB@YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqLDVlHqHqLHqDVlHq mRNA-1273 100 ugA0AE-002A ADVERSE EVENT STOMACH VIRUS Gastroenteritis viral Infections and infestations FStomach virus F; F~Viral infections NEC FOViral infectious disorders FOInfections and infestations F2020-08-18 2020-08-20 B6B8 DV.. B6DV..Vaccination stageA Vaccination 2BBYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-28T09:17 mRNA-1273-P201mRNA-1273-P201-US205-1071US2051071US205USABGYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVOHqxDVkHq,HqxHq,DVkHq, mRNA-1273 50 ug A AE-002AADVERSE EVENT ROTATOR CUFF PAIN Musculoskeletal pain Musculoskeletal and connective tissue disorders FkShoulder pain F5)FgMusculoskeletal and connective tissue pain and discomfort FMusculoskeletal and connective tissue disorders NEC FiMusculoskeletal and connective tissue disorders Fk2021-01-01 2021-02-08 BB DW .. BDW/..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA3SEVERE Grade 3A0Grade 3/Severe A0>=3A DOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-27T14:29 mRNA-1273-P201mRNA-1273-P201-US205-1072US2051072US205USABEYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYNNYNNYYYYYYNNNNYYNNot Detected YNNPlacebo APlacebo ADVVHqEDVrHq HqEHq DVrHq Placebo AAE-001AADVERSE EVENT COVID-19 INFECTION COVID-19 Infections and infestations FCOVID-19 F߬F߬Coronavirus infections FViral infectious disorders FOInfections and infestations F2020-08-24 2020-09-21 B2BN DV.. B2DV..Vaccination stageA Vaccination 2BB2YYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-08-03T09:49 mRNA-1273-P201mRNA-1273-P201-US205-1084US2051084US205USAB=YEARS>=55 Years A >=55 Years A@FWHITE HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVQHqt DVmHqHqt HqDVmHq mRNA-1273 100 ugA0AE-001AADVERSE EVENT DYSGUESIA Dysgeusia Nervous system disorders FDysgeusia FFSensory abnormalities NEC F2Neurological disorders NEC FNervous system disorders F2020-07-13 2020-07-27 AB DV].. ADVk..Vaccination stageA Vaccination 1ABYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-07-01T12:08 mRNA-1273-P201mRNA-1273-P201-US205-1088US2051088US205USAB:YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYNYNYYNNNNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVPHq5`DVlHqHq5`HqDVlHq mRNA-1273 100 ugA0AE-001AADVERSE EVENT BACK PAIN Back pain Musculoskeletal and connective tissue disorders FkBack pain FFMusculoskeletal and connective tissue pain and discomfort FMusculoskeletal and connective tissue disorders NEC FiMusculoskeletal and connective tissue disorders Fk2020-08-01 2020-08-02 B!B" DVp.. B!DVq..Vaccination stageA Vaccination 2APA`YNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-28T10:05 mRNA-1273-P201mRNA-1273-P201-US205-1092US2051092US205USABAYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVWHq] DVuHqHHq] HqHDVuHqH mRNA-1273 50 ug A AE-001AADVERSE EVENT TORN HAMSTRING RIGHT LEG Muscle rupture Injury, poisoning and procedural complications FTorn muscle FBF+Muscle, tendon and ligament injuries FInjuries NEC FInjury, poisoning and procedural complications F2020-11-10 B.ONGOINGDV.. B...Follow up stage A Vaccination 2Ba.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ANOT APPLICABLE CONCOMITANT MEDICATION NOT RECOVERED/NOT RESOLVED DOSE 2 - 2020-08-06T10:22 mRNA-1273-P201mRNA-1273-P201-US205-1095US2051095US205USAB:YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVRHqDDVnHqHqDHqDVnHq mRNA-1273 50 ug A AE-001A ADVERSE EVENT SINUS INFECTION Sinusitis Infections and infestations FSinus infection F5F5Upper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations F2020-11-05 2020-11-18 BB DV.. BDV..Follow up stage A Vaccination 2BcBpYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-30T12:22 mRNA-1273-P201mRNA-1273-P201-US205-1095US2051095US205USAB:YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVRHqDDVnHqHqDHqDVnHq mRNA-1273 50 ug A AE-002AADVERSE EVENT LEFT SHOULDER ADHESIVE CAPSULITIS Periarthritis Musculoskeletal and connective tissue disorders FkAdhesive capsulitis of shoulder FF Joint related disorders NEC FJoint disorders F-Musculoskeletal and connective tissue disorders Fk2021-01-10 B.ONGOINGDW.. B...Follow up stage A Vaccination 2B.YN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT PROCEDURE NOT RECOVERED/NOT RESOLVED DOSE 2 - 2020-07-30T12:22 ArthritisNARROWY mRNA-1273-P201mRNA-1273-P201-US205-1103US2051103US205USAB:YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVRHqDVnHqHqHqDVnHq mRNA-1273 50 ug A AE-001AADVERSE EVENT BUG BITE ON NECK Arthropod bite Injury, poisoning and procedural complications FBug bite F FNon-site specific injuries NEC F Injuries NEC FInjury, poisoning and procedural complications F2020-07-03 2020-07-13T00:00A A DVS.. A DV]HqۛVaccination stageA Vaccination 1A AYYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-07-02T15:41 mRNA-1273-P201mRNA-1273-P201-US205-1103US2051103US205USAB:YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVRHqDVnHqHqHqDVnHq mRNA-1273 50 ug A AE-004A@ADVERSE EVENT NECK PAIN Neck pain Musculoskeletal and connective tissue disorders FkNeck pain F$F$Musculoskeletal and connective tissue pain and discomfort FMusculoskeletal and connective tissue disorders NEC FiMusculoskeletal and connective tissue disorders Fk2020-10-19 2021-04-30 BnC DV.. BnDW..Follow up stage A Vaccination 2BRC0YN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-30T09:09 ArthritisBROAD mRNA-1273-P201mRNA-1273-P201-US205-1103US2051103US205USAB:YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVRHqDVnHqHqHqDVnHq mRNA-1273 50 ug A AE-002A ADVERSE EVENT CONTACT DERMATITIS BILATERAL ARMS AND BACK Dermatitis contact Skin and subcutaneous tissue disorders F5Contact dermatitis FFDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F52020-07-14 2020-07-22 AB DV^.. ADVf..Vaccination stageA Vaccination 1ABYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-07-02T15:41 HypersensitivityNARROWY mRNA-1273-P201mRNA-1273-P201-US205-1105US2051105US205USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYNYNYYYNNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVRHqDVoHqtHqHqtDVoHqt mRNA-1273 50 ug A AE-001AADVERSE EVENT SORE THROAT Oropharyngeal pain Respiratory, thoracic and mediastinal disorders F-Sore throat F8F_Upper respiratory tract signs and symptoms FKiRespiratory tract signs and symptoms F}Respiratory, thoracic and mediastinal disorders F-2020-12-01 2020-12-03 BB DV.. BDV..Follow up stage A Vaccination 2B|B~YN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-07-31T10:27 mRNA-1273-P201mRNA-1273-P201-US205-1108US2051108US205USABAYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVVHq/|DVyHrQHq/|HrQDVyHrQ mRNA-1273 100 ugA0AE-001AADVERSE EVENT CONTACT DERMATITIS RIGHT FOREARM AND RIGHT THIGH Dermatitis contact Skin and subcutaneous tissue disorders F5Contact dermatitis FFDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F52020-07-16 2020-08-17 AB+ DV`.. ADV..Vaccination stageA Vaccination 1AB+YYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-07-06T14:41 HypersensitivityNARROWY mRNA-1273-P201mRNA-1273-P201-US205-1109US2051109US205USAB7YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVVHq9DVsHqTHq9HqTDVsHqT mRNA-1273 50 ug A AE-002AADVERSE EVENT WORSENING OF MEDICAL HISTORY OF VERTIGO Vertigo Ear and labyrinth disorders F)Vertigo aggravated FOnFOlInner ear signs and symptoms FInner ear and VIIIth cranial nerve disorders FEar and labyrinth disorders F)2021-01-01 B.ONGOINGDW .. B...Follow up stage A Vaccination 2B.YN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE UNKNOWN DOSE 2 - 2020-08-04T13:07 Hearing and Vestibular DisordersNARROWY mRNA-1273-P201mRNA-1273-P201-US205-1112US2051112US205USAB<YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVVHq\DVrHq Hq\Hq DVrHq Placebo AAE-001AADVERSE EVENT ABDOMINAL TENDERNESS (ETIOLOGY UNKNOWN) Abdominal tenderness Gastrointestinal disorders FܛAbdominal tenderness FFGastrointestinal and abdominal pains (excl oral and throat) F܆Gastrointestinal signs and symptoms FGastrointestinal disorders Fܛ2020-08-26 2020-10-16 B4Bg DV.. B4DV..Vaccination stageA Vaccination 2BBKYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-08-03T12:40 mRNA-1273-P201mRNA-1273-P201-US205-1112US2051112US205USAB<YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVVHq\DVrHq Hq\Hq DVrHq Placebo AAE-002A ADVERSE EVENT GASTROENTERITIS' Gastroenteritis Infections and infestations FGastroenteritis F`F`Abdominal and gastrointestinal infections FܯInfections - pathogen unspecified FInfections and infestations F2020-10-01 2020-10-16 BXBg DV.. BXDV..Follow up stage A Vaccination 2B<BKYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-08-03T12:40 mRNA-1273-P201mRNA-1273-P201-US206-1001US2061001US206USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNYmRNA-1273 50 ug A mRNA-1273 50 ug A DV6Hq1,DVZHqsHq1,HqsDVZHqs mRNA-1273 50 ug A AE-002AADVERSE EVENT GASTRITIS Gastritis Gastrointestinal disorders FܛGastritis F=F=Gastritis (excl infective) F>Gastrointestinal inflammatory conditions FܱGastrointestinal disorders Fܛ2020-12-24 B.ONGOINGDW.. B...Follow up stage A Vaccination 2B.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION NOT RECOVERED/NOT RESOLVED DOSE 2 - 2020-07-10T14:33 mRNA-1273-P201mRNA-1273-P201-US206-1001US2061001US206USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNYmRNA-1273 50 ug A mRNA-1273 50 ug A DV6Hq1,DVZHqsHq1,HqsDVZHqs mRNA-1273 50 ug A AE-001A ADVERSE EVENT COMMON COLD Nasopharyngitis Infections and infestations FCommon cold FF Upper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations F2020-07-18 2020-08-01 B-B; DVb.. B-DVp..Vaccination stageA Vaccination 2ABYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-10T14:33 mRNA-1273-P201mRNA-1273-P201-US206-1003US2061003US206USAB#YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected YNNPlacebo APlacebo ADV6HqDVVHqHqHqDVVHq Placebo AAE-001AADVERSE EVENT COVID - 19 INFECTION COVID-19 Infections and infestations FCOVID-19 F߬F߬Coronavirus infections FViral infectious disorders FOInfections and infestations F2021-01-06 2021-01-16 BB DW.. BDW..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-07-06T10:38 mRNA-1273-P201mRNA-1273-P201-US206-1006US2061006US206USAB#YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5HqnxDVQHqwHqnxHqwDVQHqw mRNA-1273 50 ug A AE-002AADVERSE EVENT SHINGLES Herpes zoster Infections and infestations FShingles F4FHerpes viral infections FViral infectious disorders FOInfections and infestations F2021-01-18 2021-01-25 BB DW.. BDW!..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-01T12:23 mRNA-1273-P201mRNA-1273-P201-US206-1008US2061008US206USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5Hq<DVVHqHq<HqDVVHq2100mRNA-1273 100 ugA0AE-002AREACTOGENICITYJOINT ACHES, GENERALIZED Arthralgia Musculoskeletal and connective tissue disorders FkGeneralized joint pain FfF'Joint related signs and symptoms F:Joint disorders F-Musculoskeletal and connective tissue disorders Fk2020-07-06T20:002020-07-29T20:00B"B9 DVVEHqz@ B"DVmEHqVaccination stageAP16DT10H24MVaccination 2ABYNY YNNNNNNNRELATED RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-06T09:36 ArthritisBROAD Arthralgia Y mRNA-1273-P201mRNA-1273-P201-US206-1008US2061008US206USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5Hq<DVVHqHq<HqDVVHq2090mRNA-1273 100 ugA0AE-001A REACTOGENICITYMUSCLE ACHES, GENERALIZED Myalgia Musculoskeletal and connective tissue disorders FkGeneralized muscle aches FiF{Muscle pains F#Muscle disorders FMusculoskeletal and connective tissue disorders Fk2020-07-12T06:002020-07-14T07:00B(B* DV\DT`Hqڞ` B(DV^DbpHqOpVaccination stageAPT21H24M Vaccination 2A`AYNY YNNNNNNNRELATED RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-06T09:36 Myalgia Y mRNA-1273-P201mRNA-1273-P201-US206-1009US2061009US206USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5Hq$DVWHqzHq$HqzDVWHqz mRNA-1273 50 ug A AE-003A0ADVERSE EVENT UPPER RESPIRATORY INFECTION Upper respiratory tract infection Infections and infestations FUpper respiratory infection FK\FKbUpper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations F2020-10-05 2020-10-10 B}B DV.. B}DV..Follow up stage A Vaccination 2B[B`YY NNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-07T14:14 mRNA-1273-P201mRNA-1273-P201-US206-1018US2061018US206USAB2YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADV7HqoDVXHqՈHqoHqՈDVXHqՈ Placebo AAE-002AADVERSE EVENT COVID-19 POSITIVE INFECTION COVID-19 Infections and infestations FCOVID-19 F߬F߬Coronavirus infections FViral infectious disorders FOInfections and infestations F2020-12-01 2020-12-05 BB DV.. BDV..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-07-08T09:27 mRNA-1273-P201mRNA-1273-P201-US206-1018US2061018US206USAB2YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADV7HqoDVXHqՈHqoHqՈDVXHqՈ Placebo AAE-001A ADVERSE EVENT UPPER RESPIRATORY INFECTION Upper respiratory tract infection Infections and infestations FUpper respiratory infection FK\FKbUpper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations F2020-11-28 2020-12-01 BB DV.. BDV..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-07-08T09:27 mRNA-1273-P201mRNA-1273-P201-US206-1019US2061019US206USAB-YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5Hq|DVQHq̔<Hq|Hq̔<DVQHq̔< mRNA-1273 50 ug A AE-002A ADVERSE EVENT SORE THROAT Oropharyngeal pain Respiratory, thoracic and mediastinal disorders F-Sore throat F8F_Upper respiratory tract signs and symptoms FKiRespiratory tract signs and symptoms F}Respiratory, thoracic and mediastinal disorders F-2020-09-21 2020-10-01 BoBy DV.. BoDV..Follow up stage A Vaccination 2BSB]YY NNNNNNNNRELATED NOT RELATED RELATED A 2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-01T14:25 mRNA-1273-P201mRNA-1273-P201-US206-1020US2061020US206USAB6YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:HqvDVWHq5 HqvHq5 DVWHq5 mRNA-1273 100 ugA0AE-002AADVERSE EVENT BASAL CELL CARCINOMA Basal cell carcinoma Neoplasms benign, malignant and unspecified (incl cysts and polyps)F0Basal cell carcinoma FFSkin neoplasms malignant and unspecified (excl melanoma) F6ESkin neoplasms malignant and unspecified F6DNeoplasms benign, malignant and unspecified (incl cysts and polyps)F02021-01-20 2021-01-27 BB DW.. BDW#..Follow up stage A Vaccination 2BBYN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-07T09:17 mRNA-1273-P201mRNA-1273-P201-US206-1021US2061021US206USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV6HqDVRHqHqHqDVRHq Placebo AAE-001AADVERSE EVENT DECREASED HEART RATE Heart rate decreased Investigations FHeart rate decreased FFHeart rate and pulse investigations FeCardiac and vascular investigations (excl enzyme tests) FInvestigations F2020-07-02T15:052020-07-11T09:05BB& DVRDHq BDV[DHqx<Vaccination stageA Vaccination 2AAYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-02T14:03 mRNA-1273-P201mRNA-1273-P201-US206-1023US2061023US206USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7Hq%DVVHqHq%HqDVVHq mRNA-1273 100 ugA0AE-002AREACTOGENICITYUNDERARM PAIN - LEFT ARM Axillary pain General disorders and administration site conditions FAxillary pain FTFTPain and discomfort NEC FGeneral system disorders NEC FGeneral disorders and administration site conditions F2020-06-10 2020-06-12 A`A DV<.. A`DV>..Vaccination stageAP1D Vaccination 1A`AYYY YNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-05T11:36 Pain Y mRNA-1273-P201mRNA-1273-P201-US206-1023US2061023US206USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7Hq%DVVHqHq%HqDVVHq2090mRNA-1273 100 ugA0AE-001A0REACTOGENICITYMUSCLE ACHES, GENERALIZED Myalgia Musculoskeletal and connective tissue disorders FkGeneralized muscle aches FiF{Muscle pains F#Muscle disorders FMusculoskeletal and connective tissue disorders Fk2020-07-12 2020-07-18 B&B, DV\.. B&DVb..Vaccination stageAP6D Vaccination 2ApAYNY YNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-06T09:40 Myalgia Y mRNA-1273-P201mRNA-1273-P201-US206-1023US2061023US206USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7Hq%DVVHqHq%HqDVVHq mRNA-1273 100 ugA0AE-003A ADVERSE EVENT DEPRESSION Depression Psychiatric disorders F'Depression FFDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'2020-11-05 2021-01-20 BB DV.. BDW..Follow up stage A Vaccination 2B{BYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-06T09:40 mRNA-1273-P201mRNA-1273-P201-US206-1024US2061024US206USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYYNot Detected NNNmRNA-1273 100 ugA0Placebo ADV5Hq˄DVRHqHq˄HqDVRHq Placebo AAE-001AADVERSE EVENT SHORTNESS OF BREATH - NOS Dyspnoea Respiratory, thoracic and mediastinal disorders F-Shortness of breath F5FBreathing abnormalities F>Respiratory disorders NEC F-Respiratory, thoracic and mediastinal disorders F-2020-11-25 2020-12-20 BB DV.. BDV..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-07-02T16:16 Anaphylactic ReactionBROADY CardiomyopathyBROAD mRNA-1273-P201mRNA-1273-P201-US206-1026US2061026US206USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7Hq#HDVWHqRHq#HHqRDVWHqR mRNA-1273 50 ug A AE-002AADVERSE EVENT NASAL CONGESTION Nasal congestion Respiratory, thoracic and mediastinal disorders F-Nasal congestion FFNasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-2020-09-14 2020-09-18 BfBj DV.. BfDV..Follow up stage A Vaccination 2BFBJYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-07-07T11:23 mRNA-1273-P201mRNA-1273-P201-US206-1026US2061026US206USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7Hq#HDVWHqRHq#HHqRDVWHqR mRNA-1273 50 ug A AE-001A ADVERSE EVENT SORE THROAT Oropharyngeal pain Respiratory, thoracic and mediastinal disorders F-Sore throat F8F_Upper respiratory tract signs and symptoms FKiRespiratory tract signs and symptoms F}Respiratory, thoracic and mediastinal disorders F-2020-09-15 2020-09-18 BgBj DV.. BgDV..Follow up stage A Vaccination 2BGBJYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-07-07T11:23 mRNA-1273-P201mRNA-1273-P201-US206-1035US2061035US206USABGYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected YNNPlacebo APlacebo ADVLHqDVdHqepHqHqepDVdHqep Placebo AAE-002AADVERSE EVENT COVID-19 INFECTION COVID-19 Infections and infestations FCOVID-19 F߬F߬Coronavirus infections FViral infectious disorders FOInfections and infestations F2020-12-31 2021-01-17 BB DW.. BDW..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-20T10:12 mRNA-1273-P201mRNA-1273-P201-US206-1035US2061035US206USABGYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected YNNPlacebo APlacebo ADVLHqDVdHqepHqHqepDVdHqep Placebo AAE-001A ADVERSE EVENT DECREASED HEART RATE Heart rate decreased Investigations FHeart rate decreased FFHeart rate and pulse investigations FeCardiac and vascular investigations (excl enzyme tests) FInvestigations F2020-06-26T13:412020-06-26T19:00AA DVLDlHql ADVLEHq=0Vaccination stageA Vaccination 1AAYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-26T12:34 mRNA-1273-P201mRNA-1273-P201-US206-1036US2061036US206USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqHDVkHqdHqHHqdDVkHqd mRNA-1273 100 ugA0AE-001AADVERSE EVENT COMMON COLD Nasopharyngitis Infections and infestations FCommon cold FF Upper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations F2020-10-30 B.ONGOINGDV.. B...Follow up stage A Vaccination 2B`.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERING/RESOLVING DOSE 2 - 2020-07-27T11:35 mRNA-1273-P201mRNA-1273-P201-US206-1037US2061037US206USAB8YEARS>=55 Years A >=55 Years A@FNATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER NOT HISPANIC OR LATINOYYYYYYYYNYNNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqŻDVmHq8HqŻHq8DVmHq8 .AE-001AADVERSE EVENT NOSE PAIN Rhinalgia Respiratory, thoracic and mediastinal disorders F-Nasal pain FF_Upper respiratory tract signs and symptoms FKiRespiratory tract signs and symptoms F}Respiratory, thoracic and mediastinal disorders F-2020-06-26T00:002020-06-26T00:01AA DVLHq2 ADVLB<Hq2< . .. N NNNNNNNNNOT RELATEDRELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED mRNA-1273-P201mRNA-1273-P201-US206-1043US2061043US206USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVOHqDVkHq(HqHq(DVkHq(2080Placebo AAE-001A REACTOGENICITYFATIGUE Fatigue General disorders and administration site conditions FFatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2020-07-28T11:002020-08-03T18:00BB$ DVlDHq BDVrD HqH Vaccination stageAPT3H14M Vaccination 2AAYNY YNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-27T14:46 Fatigue Y mRNA-1273-P201mRNA-1273-P201-US206-1043US2061043US206USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVOHqDVkHq(HqHq(DVkHq(2100Placebo AAE-003AREACTOGENICITYJOINT ACHES - GENERALIZED Arthralgia Musculoskeletal and connective tissue disorders FkGeneralized joint pain FfF'Joint related signs and symptoms F:Joint disorders F-Musculoskeletal and connective tissue disorders Fk2020-07-28T11:002020-08-03T18:00BB$ DVlDHq BDVrD HqH Vaccination stageAPT3H14M Vaccination 2AAYNY YNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-27T14:46 ArthritisBROAD Arthralgia Y mRNA-1273-P201mRNA-1273-P201-US206-1043US2061043US206USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVOHqDVkHq(HqHq(DVkHq(2090Placebo AAE-002A0REACTOGENICITYMUSCLE ACHES Myalgia Musculoskeletal and connective tissue disorders FkMuscle ache FF{Muscle pains F#Muscle disorders FMusculoskeletal and connective tissue disorders Fk2020-07-28T11:002020-08-03T18:00BB$ DVlDHq BDVrD HqH Vaccination stageAPT3H14M Vaccination 2AAYNY YNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-27T14:46 Myalgia Y mRNA-1273-P201mRNA-1273-P201-US206-1046US2061046US206USAB>YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADVOHq@DVkHqHq@HqDVkHq Placebo AAE-001AADVERSE EVENT ASYMPTOMATIC COVID-19 Asymptomatic COVID-19 Infections and infestations FAsymptomatic COVID-19 FkFkCoronavirus infections FViral infectious disorders FOInfections and infestations F2020-12-15 2020-12-15 BB DV.. BDV..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-07-27T09:28 mRNA-1273-P201mRNA-1273-P201-US206-1053US2061053US206USAB@YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVQHq\DVmHq`xHq\Hq`xDVmHq`x mRNA-1273 50 ug A AE-001AADVERSE EVENT PLANTAR FASCIITIS - RIGHT Plantar fasciitis Musculoskeletal and connective tissue disorders FkPlantar fasciitis FFMusculoskeletal and connective tissue infections and inflammations NECFdMusculoskeletal and connective tissue disorders NEC FiMusculoskeletal and connective tissue disorders Fk2020-07-10 A.ONGOINGDVZ.. A...Vaccination stageA Vaccination 1A.YNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE NOT RECOVERED/NOT RESOLVED DOSE 1 - 2020-07-01T10:29 mRNA-1273-P201mRNA-1273-P201-US206-1068US2061068US206USAB?YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVPHqDVoHqlHqHqlDVoHql mRNA-1273 50 ug A AE-001A ADVERSE EVENT DIZZINESS Dizziness Nervous system disorders FDizziness F˅F˅Neurological signs and symptoms NEC FNeurological disorders NEC FNervous system disorders F2020-07-31T08:352020-07-31T08:40B B DVoDxHq4 B DVoDyHq`Vaccination stageA Vaccination 1BBYY NNNNNNNNNOT RELATEDRELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-30T09:48 Hearing and Vestibular DisordersBROAD mRNA-1273-P201mRNA-1273-P201-US206-1068US2061068US206USAB?YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVPHqDVoHqlHqHqlDVoHql mRNA-1273 50 ug A AE-002AADVERSE EVENT ANXIETY Anxiety Psychiatric disorders F'Anxiety FFAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'2020-07-31T09:452020-07-31T14:30B B DVoDHqߜ B DVoDHq"hVaccination stageA Vaccination 1BB YY NNNNNNNNNOT RELATEDRELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-30T09:48 mRNA-1273-P201mRNA-1273-P201-US207-1001US2071001US207USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV0Hq+DVPHq7Hq+Hq7DVPHq7 mRNA-1273 50 ug A AE-001A ADVERSE EVENT SINUS INFECTION Sinusitis Infections and infestations FSinus infection F5F5Upper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations F2020-09-11 2020-09-15 BjBn DV.. BjDV..Follow up stage A Vaccination 2BJBNYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-06-30T13:38 mRNA-1273-P201mRNA-1273-P201-US207-1001US2071001US207USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV0Hq+DVPHq7Hq+Hq7DVPHq7 mRNA-1273 50 ug A AE-003A0ADVERSE EVENT VIRAL UPPER RESPIRATIORY INFECTION Viral upper respiratory tract infection Infections and infestations FViral upper respiratory tract infection FOFOViral infections NEC FOViral infectious disorders FOInfections and infestations F2020-12-26 2021-01-19 BB DW.. BDW..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-06-30T13:38 mRNA-1273-P201mRNA-1273-P201-US207-1001US2071001US207USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV0Hq+DVPHq7Hq+Hq7DVPHq7 mRNA-1273 50 ug A AE-002AADVERSE EVENT ANXIETY Anxiety Psychiatric disorders F'Anxiety FFAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'2020-08-01 BA.ONGOINGDVp.. BA...Follow up stage A Vaccination 2B!.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RECOVERED/NOT RESOLVED DOSE 2 - 2020-06-30T13:38 mRNA-1273-P201mRNA-1273-P201-US207-1002US2071002US207USAB'YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3HqDVPHq:HqHq:DVPHq:2110mRNA-1273 100 ugA0AE-007A`REACTOGENICITYNAUSEA Nausea Gastrointestinal disorders FܛNausea F F Nausea and vomiting symptoms FGastrointestinal signs and symptoms FGastrointestinal disorders Fܛ2020-07-04 2020-07-09 B"B' DVT.. B"DVY..Vaccination stageAP3D Vaccination 2APAYYY YNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-06-30T13:48 Nausea/Vomiting Y mRNA-1273-P201mRNA-1273-P201-US207-1002US2071002US207USAB'YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3HqDVPHq:HqHq:DVPHq:2080mRNA-1273 100 ugA0AE-003A REACTOGENICITYFATIGUE Fatigue General disorders and administration site conditions FFatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2020-07-02 2020-08-02 B B? DVR.. B DVq..Vaccination stageAP27D Vaccination 2A0B"YYY YNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-06-30T13:48 Fatigue Y mRNA-1273-P201mRNA-1273-P201-US207-1002US2071002US207USAB'YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3HqDVPHq:HqHq:DVPHq: mRNA-1273 100 ugA0AE-005AREACTOGENICITYJOINT ACHES IN SEVERAL JOINTS ALL OVER BODY Arthralgia Musculoskeletal and connective tissue disorders FkGeneralized joint pain FfF'Joint related signs and symptoms F:Joint disorders F-Musculoskeletal and connective tissue disorders Fk2020-07-01T08:002020-07-08T08:00BB& DVQDpHq: BDVXDpHqtVaccination stageAPT18H12M Vaccination 2AAYYY YNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-06-30T13:48 ArthritisBROAD Arthralgia Y mRNA-1273-P201mRNA-1273-P201-US207-1002US2071002US207USAB'YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3HqDVPHq:HqHq:DVPHq:2070mRNA-1273 100 ugA0AE-001A0REACTOGENICITYHEADACHE Headache Nervous system disorders FHeadache FFHeadaches NEC FHeadaches FNervous system disorders F2020-07-01T20:002020-07-12T08:00BB* DVQEHq BDV\DpHqںVaccination stageAP4DT18H12M Vaccination 2A AYYY YNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-06-30T13:48 Headache Y mRNA-1273-P201mRNA-1273-P201-US207-1004US2071004US207USAB'YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV6HqDVXHqՆHqHqՆDVXHqՆ2080mRNA-1273 50 ug A AE-002AREACTOGENICITYFATIGUE Fatigue General disorders and administration site conditions FFatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2020-07-09 2020-07-16 B$B+ DVY.. B$DV`..Vaccination stageAP2D Vaccination 2A AYYY YNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-08T09:18 Fatigue Y mRNA-1273-P201mRNA-1273-P201-US207-1004US2071004US207USAB'YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV6HqDVXHqՆHqHqՆDVXHqՆ mRNA-1273 50 ug A AE-004A@ADVERSE EVENT VIRAL UPPER RESPIRATORY INFECTION Viral upper respiratory tract infection Infections and infestations FViral upper respiratory tract infection FOFOViral infections NEC FOViral infectious disorders FOInfections and infestations F2020-10-14 2020-10-16 BB DV.. BDV..Follow up stage A Vaccination 2BcBeYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-08T09:18 mRNA-1273-P201mRNA-1273-P201-US207-1004US2071004US207USAB'YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV6HqDVXHqՆHqHqՆDVXHqՆ mRNA-1273 50 ug A AE-003A0REACTOGENICITYMUSCLE ACHES ALL OVER BODY Myalgia Musculoskeletal and connective tissue disorders FkGeneralized muscle aches FiF{Muscle pains F#Muscle disorders FMusculoskeletal and connective tissue disorders Fk2020-07-14 2020-07-15 B)B* DV^.. B)DV_..Vaccination stageAP1D Vaccination 2ApAYYY YNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-08T09:18 Myalgia Y mRNA-1273-P201mRNA-1273-P201-US207-1004US2071004US207USAB'YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV6HqDVXHqՆHqHqՆDVXHqՆ2070mRNA-1273 50 ug A AE-001A REACTOGENICITYHEADACHE Headache Nervous system disorders FHeadache FFHeadaches NEC FHeadaches FNervous system disorders F2020-07-09T08:002020-07-16 B$B+ DVYDpHq B$DV`..Vaccination stageAP2D Vaccination 2AAYYY YNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-08T09:18 Headache Y mRNA-1273-P201mRNA-1273-P201-US207-1005US2071005US207USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YYNPlacebo APlacebo ADV4Hq DVVHq0Hq Hq0DVVHq0 Placebo AAE-001AADVERSE EVENT COVID-19 INFECTION COVID-19 Infections and infestations FCOVID-19 F߬F߬Coronavirus infections FViral infectious disorders FOInfections and infestations F2020-11-22 2020-12-06 BB DV.. BDV..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-06T14:46 mRNA-1273-P201mRNA-1273-P201-US207-1012US2071012US207USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE HISPANIC OR LATINO YYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADV5HqDVWHqsHqHqsDVWHqs Placebo AAE-001AADVERSE EVENT COVID 19 INFECTION COVID-19 Infections and infestations FCOVID-19 F߬F߬Coronavirus infections FViral infectious disorders FOInfections and infestations F2020-12-04 2020-12-16 BB DV.. BDV..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-07T13:45 mRNA-1273-P201mRNA-1273-P201-US207-1013US2071013US207USABIYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NYYmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqYDVYHq)`HqYHq)`DVYHq)` mRNA-1273 100 ugA0AE-003AADVERSE EVENT ELEVATED BLOOD PRESSURE WITHOUT DIAGNOSIS OF HYPERTENSION Blood pressure increased Investigations FElevated blood pressure reading without diagnosis of hypertensionF FVascular tests NEC (incl blood pressure) FNCardiac and vascular investigations (excl enzyme tests) FInvestigations F2021-01-19 B.ONGOINGDW.. B...Follow up stage A Vaccination 2B.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION NOT RECOVERED/NOT RESOLVED DOSE 2 - 2020-07-09T15:04 mRNA-1273-P201mRNA-1273-P201-US207-1025US2071025US207USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5HqPDVXHq՞HqPHq՞DVXHq՞ mRNA-1273 50 ug A AE-002AADVERSE EVENT HEADACHE Headache Nervous system disorders FHeadache FFHeadaches NEC FHeadaches FNervous system disorders F2020-07-09T10:302020-07-10T08:00B%B& DVYDHq( B%DVZDpHqVaccination stageA Vaccination 2AA YNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-08T11:01 Headache Y mRNA-1273-P201mRNA-1273-P201-US207-1025US2071025US207USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5HqPDVXHq՞HqPHq՞DVXHq՞ mRNA-1273 50 ug A AE-001A ADVERSE EVENT SYNCOPE OF UNCLEAR ORIGIN Syncope Nervous system disorders FSyncope F=F=Disturbances in consciousness NEC FENeurological disorders NEC FNervous system disorders F2020-07-09T10:002020-07-09T10:05B%B% DVYDHq B%DVYDHqLVaccination stageA Vaccination 2AAYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-08T11:01 CardiomyopathyBROAD mRNA-1273-P201mRNA-1273-P201-US207-1030US2071030US207USAB%YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5HqPDVVHqSHqPHqSDVVHqS mRNA-1273 50 ug A AE-002AADVERSE EVENT REDNESS AT INJECTION SITE Injection site erythema General disorders and administration site conditions FInjection site redness FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2020-06-12 2020-06-18 AB DV>.. ADVD..Vaccination stageA Vaccination 1ABYNY NNNNNNNNRELATED RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-03T17:16 Erythema YY Y mRNA-1273-P201mRNA-1273-P201-US207-1030US2071030US207USAB%YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5HqPDVVHqSHqPHqSDVVHqS mRNA-1273 50 ug A AE-003A ADVERSE EVENT ENDURATION AT INJECTION SITE Injection site induration General disorders and administration site conditions FInjection site induration FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2020-06-12 2020-07-18 AB. DV>.. ADVb..Vaccination stageA Vaccination 1AB.YNY NNNNNNNNRELATED RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-03T17:16 Swelling YY Y mRNA-1273-P201mRNA-1273-P201-US207-1030US2071030US207USAB%YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5HqPDVVHqSHqPHqSDVVHqS mRNA-1273 50 ug A AE-001A0ADVERSE EVENT PAIN AT INJECTION SITE Injection site pain General disorders and administration site conditions FPain injection site F-FInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2020-06-12 2020-06-18 AB DV>.. ADVD..Vaccination stageA Vaccination 1ABYNY NNNNNNNNRELATED RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-06-03T17:16 Pain YY Y mRNA-1273-P201mRNA-1273-P201-US207-1030US2071030US207USAB%YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5HqPDVVHqSHqPHqSDVVHqS mRNA-1273 50 ug A AE-004A@ADVERSE EVENT WORSENING OF TINEA PEDIS LEFT BIG TOE Tinea pedis Infections and infestations FTinea pedis FAFATinea infections FAFungal infectious disorders FInfections and infestations F2020-09-27 2020-12-31 BuB DV.. BuDW..Follow up stage A Vaccination 2BTBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-06T17:13 mRNA-1273-P201mRNA-1273-P201-US207-1036US2071036US207USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAMWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:HqODV]HqOHqOHqODV]HqO mRNA-1273 100 ugA0AE-002AADVERSE EVENT ANXIETY Anxiety Psychiatric disorders F'Anxiety FFAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'2020-08-01 B7.ONGOINGDVp.. B7...Vaccination stageA Vaccination 2B.YNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RECOVERED/NOT RESOLVED DOSE 2 - 2020-07-13T12:48 mRNA-1273-P201mRNA-1273-P201-US207-1039US2071039US207USAB5YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNYmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7HqoDV]HqqHqoHqqDV]Hqq mRNA-1273 100 ugA0AE-001AADVERSE EVENT ERYTHEMA TO INJECTION SITE Injection site erythema General disorders and administration site conditions FInjection site erythema FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2020-06-15 2020-06-17 AA DVA.. ADVC..Vaccination stageA Vaccination 1AAYNY NNNNNNNNRELATED RELATED RELATED A 2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-05T16:53 Erythema YY YmRNA-1273-P201mRNA-1273-P201-US207-1039US2071039US207USAB5YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNYmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7HqoDV]HqqHqoHqqDV]Hqq mRNA-1273 100 ugA0AE-002A ADVERSE EVENT MILD PAIN AT INJECTION SITE Injection site pain General disorders and administration site conditions FInjection site pain FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2020-06-15 2020-06-16 AA DVA.. ADVB..Vaccination stageA Vaccination 1AAYNY NNNNNNNNRELATED RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-05T16:53 Pain YY YmRNA-1273-P201mRNA-1273-P201-US207-1041US2071041US207USAB@YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YYNPlacebo APlacebo ADV4HqHDVRHq͕HqHHq͕DVRHq͕ Placebo AAE-001AADVERSE EVENT COVID 19 INFECTION COVID-19 Infections and infestations FCOVID-19 F߬F߬Coronavirus infections FViral infectious disorders FOInfections and infestations F2020-09-27 2020-10-12 BvB DV.. BvDV..Follow up stage A Vaccination 2BXBgYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA3SEVERE Grade 3A0Grade 3/Severe A0>=3A DOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-02T08:44 mRNA-1273-P201mRNA-1273-P201-US207-1043US2071043US207USABEYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5HqDVVHq HqHq DVVHq mRNA-1273 100 ugA0AE-001AADVERSE EVENT LEFT MEDIAL MENISCUS TEAR Meniscus injury Injury, poisoning and procedural complications FMeniscus tear F)FBone and joint injuries NEC FuBone and joint injuries FInjury, poisoning and procedural complications F2020-08-01 2020-09-10 B<Bd DVp.. B<DV..Vaccination stageA Vaccination 2BBCYYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-06T12:01 mRNA-1273-P201mRNA-1273-P201-US207-1044US2071044US207USAB YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV:HqE|DVYHq`HqE|Hq`DVYHq` Placebo AAE-001AADVERSE EVENT VITAMIN D DEFICIENCY Vitamin D deficiency Metabolism and nutrition disorders FVitamin D deficiency FPFPFat soluble vitamin deficiencies and disorders FVitamin related disorders FPMetabolism and nutrition disorders F2021-01-28 B.ONGOINGDW$.. B...Follow up stage A Vaccination 2B.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RECOVERED/NOT RESOLVED DOSE 2 - 2020-07-09T14:00 mRNA-1273-P201mRNA-1273-P201-US207-1050US2071050US207USAB-YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADV7Hq<DVWHqWDHq<HqWDDVWHqWD Placebo AAE-001AADVERSE EVENT COVID 19 INFECTION COVID-19 Infections and infestations FCOVID-19 F߬F߬Coronavirus infections FViral infectious disorders FOInfections and infestations F2020-12-04 2020-12-18 BB DV.. BDV..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-07T11:43 mRNA-1273-P201mRNA-1273-P201-US207-1050US2071050US207USAB-YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADV7Hq<DVWHqWDHq<HqWDDVWHqWD Placebo AAE-002A ADVERSE EVENT GINGIVITIS Gingivitis Infections and infestations FGingivitis FFDental and oral soft tissue infections FƦInfections - pathogen unspecified FInfections and infestations F2020-12-04 2020-12-14 BB DV.. BDV..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-07T11:43 mRNA-1273-P201mRNA-1273-P201-US207-1062US2071062US207USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE HISPANIC OR LATINO YYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADV6Hq`DVWHqHq`HqDVWHq Placebo AAE-002AADVERSE EVENT COVID-19 INFECTION COVID-19 Infections and infestations FCOVID-19 F߬F߬Coronavirus infections FViral infectious disorders FOInfections and infestations F2020-11-24 2020-11-30 BB DV.. BDV..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-07-07T14:35 mRNA-1273-P201mRNA-1273-P201-US207-1062US2071062US207USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE HISPANIC OR LATINO YYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADV6Hq`DVWHqHq`HqDVWHq Placebo AAE-001A ADVERSE EVENT RASH ON GLUTEUS Rash Skin and subcutaneous tissue disorders F5Localized rash FqF*TRashes, eruptions and exanthems NEC FcEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F52020-06-05 2020-06-06 A A0 DV7.. A DV8..Vaccination stageA Vaccination 1A A0YNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-04T16:40 Anaphylactic ReactionBROADY HypersensitivityNARROWY mRNA-1273-P201mRNA-1273-P201-US207-1066US2071066US207USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA MWHITE HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV;HqDVXHq̠HqHq̠DVXHq̠ Placebo AAE-001AADVERSE EVENT DIVERTICULOSIS Diverticulum Gastrointestinal disorders FܛDiverticulosis FmFrDiverticula FZDiverticular disorders F_Gastrointestinal disorders Fܛ2020-09-03 BW.ONGOINGDV.. BW...Follow up stage A Vaccination 2B:.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION, CONCOMITANT PROCEDURERECOVERING/RESOLVING DOSE 2 - 2020-07-08T14:16 mRNA-1273-P201mRNA-1273-P201-US207-1070US2071070US207USAB"YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE HISPANIC OR LATINO YYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADV:Hq4DVWHq.|Hq4Hq.|DVWHq.| Placebo AAE-001AADVERSE EVENT COVID 19 INFECTION COVID-19 Infections and infestations FCOVID-19 F߬F߬Coronavirus infections FViral infectious disorders FOInfections and infestations F2020-12-11 2021-02-02 BB DV.. BDW)..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-07T08:49 mRNA-1273-P201mRNA-1273-P201-US207-1072US2071072US207USAB'YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE HISPANIC OR LATINO YYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADV7Hq:@DVVHq4Hq:@Hq4DVVHq4 Placebo AAE-001AADVERSE EVENT COVID 19 INFECTION COVID-19 Infections and infestations FCOVID-19 F߬F߬Coronavirus infections FViral infectious disorders FOInfections and infestations F2020-11-30 2020-12-11 BB DV.. BDV..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-06T09:07 mRNA-1273-P201mRNA-1273-P201-US207-1073US2071073US207USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:Hq!dDVWHqGTHq!dHqGTDVWHqGT mRNA-1273 100 ugA0AE-001AADVERSE EVENT REDNESS AT INJECTION SITE Injection site erythema General disorders and administration site conditions FInjection site redness FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2020-06-18 2020-06-20 AA DVD.. ADVF..Vaccination stageA Vaccination 1AAYNY NNNNNNNNRELATED RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-08T12:07 Erythema YY YmRNA-1273-P201mRNA-1273-P201-US207-1073US2071073US207USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:Hq!dDVWHqGTHq!dHqGTDVWHqGT mRNA-1273 100 ugA0AE-002A ADVERSE EVENT SWELLING AT INJECTION SITE Injection site swelling General disorders and administration site conditions FSwelling of injection site F=HFg1Injection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2020-06-18 2020-06-20 AA DVD.. ADVF..Vaccination stageA Vaccination 1AAYNY NNNNNNNNRELATED RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-08T12:07 Swelling YY YmRNA-1273-P201mRNA-1273-P201-US207-1074US2071074US207USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:Hq?DVYHqHq?HqDVYHq mRNA-1273 50 ug A AE-001AADVERSE EVENT VIRAL UPPER RESPIRATORY INFECTION Viral upper respiratory tract infection Infections and infestations FViral upper respiratory tract infection FOFOViral infections NEC FOViral infectious disorders FOInfections and infestations F2020-12-06 2020-12-23 BB DV.. BDW..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-07-09T13:16 mRNA-1273-P201mRNA-1273-P201-US207-1082US2071082US207USAB9YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqPDVlHqHqPHqDVlHq mRNA-1273 100 ugA0AE-002AADVERSE EVENT TENDERNESS LEFT METATARSOPHALANGEAL JOINTS Arthralgia Musculoskeletal and connective tissue disorders FkJoint tenderness FUF'Joint related signs and symptoms F:Joint disorders F-Musculoskeletal and connective tissue disorders Fk2020-08-18 2020-09-02 B6BE DV.. B6DV..Vaccination stageA Vaccination 2BB%YYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-28T10:00 ArthritisBROAD Arthralgia Y mRNA-1273-P201mRNA-1273-P201-US207-1082US2071082US207USAB9YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqPDVlHqHqPHqDVlHq mRNA-1273 100 ugA0AE-001A ADVERSE EVENT ERYTHEMA LEFT METATARSOPHALANGEAL JOINTS Erythema Skin and subcutaneous tissue disorders F5Localized erythema FMFѮErythemas FѯEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F52020-08-18 2020-09-02 B6BE DV.. B6DV..Vaccination stageA Vaccination 2BB%YYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-28T10:00 Anaphylactic ReactionBROADY HypersensitivityBROAD mRNA-1273-P201mRNA-1273-P201-US207-1083US2071083US207USABWYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqŨDVeHqHqŨHqDVeHq mRNA-1273 50 ug A AE-003AADVERSE EVENT WORSENING OF BRADYCARDIA, CHRONIC Bradycardia Cardiac disorders FBradycardia FMFMRate and rhythm disorders NEC F*Cardiac arrhythmias FCardiac disorders F2020-09-03 2020-10-31 BFB DV.. BFDV..Follow up stage A Vaccination 2B-BgYY NYNNNYNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ANOT APPLICABLE CONCOMITANT PROCEDURE RECOVERED/RESOLVED 2020-10-302020-10-31N DOSE 2 - 2020-07-21T09:42 mRNA-1273-P201mRNA-1273-P201-US207-1083US2071083US207USABWYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqŨDVeHqHqŨHqDVeHq mRNA-1273 50 ug A AE-004A0ADVERSE EVENT GRADE 1 DIASTOLIC DYSFUNCTION Diastolic dysfunction Cardiac disorders FDiastolic dysfunction FbFbMyocardial disorders NEC F.Myocardial disorders F1Cardiac disorders F2020-10-30 B.ONGOINGDV.. B...Follow up stage A Vaccination 2Bf.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE NOT RECOVERED/NOT RESOLVED DOSE 2 - 2020-07-21T09:42 CardiomyopathyBROAD mRNA-1273-P201mRNA-1273-P201-US207-1083US2071083US207USABWYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqŨDVeHqHqŨHqDVeHq mRNA-1273 50 ug A AE-001A ADVERSE EVENT MILD DEPRESSION Depression Psychiatric disorders F'Depression FFDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'2020-10-14 Bo.ONGOINGDV.. Bo...Follow up stage A Vaccination 2BV.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RECOVERED/NOT RESOLVED DOSE 2 - 2020-07-21T09:42 mRNA-1273-P201mRNA-1273-P201-US207-1083US2071083US207USABWYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqŨDVeHqHqŨHqDVeHq mRNA-1273 50 ug A AE-002A@ADVERSE EVENT HYPERTENSION Hypertension Vascular disorders FNYHypertension FFVascular hypertensive disorders NEC FVascular hypertensive disorders FuVascular disorders FNY2020-09-03 BF.ONGOINGDV.. BF...Follow up stage A Vaccination 2B-.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RECOVERED/NOT RESOLVED DOSE 2 - 2020-07-21T09:42 mRNA-1273-P201mRNA-1273-P201-US207-1085US2071085US207USABKYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVLHqDVlHq)tHqHq)tDVlHq)t Placebo AAE-001A ADVERSE EVENT SYSTOLIC MURMUR 2/4 Cardiac murmur Investigations FSystolic murmur F>NF"Cardiac auscultatory investigations FYCardiac and vascular investigations (excl enzyme tests) FInvestigations F2020-08-24 B<.ONGOINGDV.. B<...Vaccination stageA Vaccination 2B.YNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE NOT RECOVERED/NOT RESOLVED DOSE 2 - 2020-07-28T14:11 mRNA-1273-P201mRNA-1273-P201-US207-1085US2071085US207USABKYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVLHqDVlHq)tHqHq)tDVlHq)t Placebo AAE-002AADVERSE EVENT ARTHRALGIA KNEE JOINT PAIN Arthralgia Musculoskeletal and connective tissue disorders FkPainful knee FhF'Joint related signs and symptoms F:Joint disorders F-Musculoskeletal and connective tissue disorders Fk2020-06-29 2020-07-06 A@A DVO.. A@DVV..Vaccination stageA Vaccination 1A@AYNY NNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-26T14:43 ArthritisBROAD Arthralgia Y mRNA-1273-P201mRNA-1273-P201-US207-1086US2071086US207USABDYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVLHqDVmHqIDHqHqIDDVmHqID Placebo AAE-001AADVERSE EVENT VIRAL UPPER RESPIRATORY INFECTION Viral upper respiratory tract infection Infections and infestations FViral upper respiratory tract infection FOFOViral infections NEC FOViral infectious disorders FOInfections and infestations F2020-11-09 2020-11-16 BB DV.. BDV..Follow up stage A Vaccination 2BhBoYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-29T10:39 mRNA-1273-P201mRNA-1273-P201-US207-1087US2071087US207USABQYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHq޼DVnHq8Hq޼Hq8DVnHq8 mRNA-1273 100 ugA0AE-001AADVERSE EVENT UPPER RESPIRATORY INFECTION Upper respiratory tract infection Infections and infestations FUpper respiratory infection FK\FKbUpper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations F2020-09-28 2020-10-04 B_Be DV.. B_DV..Follow up stage A Vaccination 2B=BCYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-30T10:58 mRNA-1273-P201mRNA-1273-P201-US207-1088US2071088US207USABFYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVLHqDVkHqHqHqDVkHq Placebo AAE-001AADVERSE EVENT ACID REFLUX Gastrooesophageal reflux disease Gastrointestinal disorders FܛAcid reflux (esophageal) FF]Gastrointestinal atonic and hypomotility disorders NEC F܍Gastrointestinal motility and defaecation conditions FܹGastrointestinal disorders Fܛ2020-09-18 2020-09-21 BUBX DV.. BUDV..Follow up stage A Vaccination 2B6B9YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-27T12:07 mRNA-1273-P201mRNA-1273-P201-US207-1092US2071092US207USAB=YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADVLHqπDVeHqXHqπHqXDVeHqX Placebo AAE-002AADVERSE EVENT COVID 19 INFECTION COVID-19 Infections and infestations FCOVID-19 F߬F߬Coronavirus infections FViral infectious disorders FOInfections and infestations F2020-11-20 2020-11-30 BB DV.. BDV..Follow up stage A Vaccination 2B{BYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-21T10:18 mRNA-1273-P201mRNA-1273-P201-US207-1092US2071092US207USAB=YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADVLHqπDVeHqXHqπHqXDVeHqX Placebo AAE-003A ADVERSE EVENT PNEUMONIA Pneumonia Infections and infestations FPneumonia F!F!Lower respiratory tract and lung infections FInfections - pathogen unspecified FInfections and infestations F2020-11-24 2020-11-30 BB DV.. BDV..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-21T10:18 mRNA-1273-P201mRNA-1273-P201-US207-1093US2071093US207USABCYEARS>=55 Years A >=55 Years A@FWHITE HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVOHqɺDVmHqEHqɺHqEDVmHqE mRNA-1273 100 ugA0AE-002AADVERSE EVENT HARDNESS AT INJECTION SITE Injection site induration General disorders and administration site conditions FInjection site induration FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2020-06-30 2020-07-02 A A@ DVP.. A DVR..Vaccination stageA Vaccination 1A A@YNY NNNNNNNNRELATED RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-29T10:32 Swelling Y mRNA-1273-P201mRNA-1273-P201-US207-1100US2071100US207USAB=YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVVHqC,DVsHq4$HqC,Hq4$DVsHq4$ Placebo AAE-001A0ADVERSE EVENT HYPERLIPIDEMIA Hyperlipidaemia Metabolism and nutrition disorders FHyperlipidemia F;FHyperlipidaemias NEC F:Lipid metabolism disorders FʅMetabolism and nutrition disorders F2020-08-24 B2.ONGOINGDV.. B2...Vaccination stageA Vaccination 2B.YYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RECOVERED/NOT RESOLVED DOSE 2 - 2020-08-04T10:47 mRNA-1273-P201mRNA-1273-P201-US207-1100US2071100US207USAB=YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVVHqC,DVsHq4$HqC,Hq4$DVsHq4$ Placebo AAE-002A ADVERSE EVENT JOINT ACHES IN SEVERAL JOINTS Arthralgia Musculoskeletal and connective tissue disorders FkAching joints FAF'Joint related signs and symptoms F:Joint disorders F-Musculoskeletal and connective tissue disorders Fk2020-08-09 2020-08-12 B#B& DVx.. B#DV{..Vaccination stageA Vaccination 2A`AYNY NNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-08-04T10:47 ArthritisBROAD Arthralgia Y mRNA-1273-P201mRNA-1273-P201-US207-1100US2071100US207USAB=YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVVHqC,DVsHq4$HqC,Hq4$DVsHq4$ Placebo AAE-003AADVERSE EVENT ANXIETY Anxiety Psychiatric disorders F'Anxiety FFAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'2021-01-08 B.ONGOINGDW.. B...Follow up stage A Vaccination 2B.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RECOVERED/NOT RESOLVED DOSE 2 - 2020-08-04T10:47 mRNA-1273-P201mRNA-1273-P201-US207-1100US2071100US207USAB=YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVVHqC,DVsHq4$HqC,Hq4$DVsHq4$ Placebo AAE-004A@ADVERSE EVENT ENLARGED PROSTATE Prostatomegaly Reproductive system and breast disorders F-LEnlarged prostate FVF_Prostatic signs, symptoms and disorders NEC F&Prostatic disorders (excl infections and inflammations) F&Reproductive system and breast disorders F-L2021-01-08 B.ONGOINGDW.. B...Follow up stage A Vaccination 2B.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RECOVERED/NOT RESOLVED DOSE 2 - 2020-08-04T10:47 mRNA-1273-P201mRNA-1273-P201-US207-1102US2071102US207USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVOHq@DVlHq*(Hq@Hq*(DVlHq*( Placebo AAE-002AADVERSE EVENT WORSENING OF RESTLESS LEG SYNDROME Restless legs syndrome Nervous system disorders FRestless leg syndrome F-F|Sensory abnormalities NEC F2Neurological disorders NEC FNervous system disorders F2020-09-30 B^.ONGOINGDV.. B^...Follow up stage A Vaccination 2BA.YN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RECOVERED/NOT RESOLVED DOSE 2 - 2020-07-28T14:14 mRNA-1273-P201mRNA-1273-P201-US207-1103US2071103US207USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYNYNYNYNNNYYYYYYNYNNYYNNot Detected NNNPlacebo APlacebo ADVRHqDVuHq HqHq DVuHq Placebo AAE-002AADVERSE EVENT DUODENITIS Duodenitis Gastrointestinal disorders FܛDuodenitis F̨F̨Gastrointestinal inflammatory disorders NEC F܁Gastrointestinal inflammatory conditions FܱGastrointestinal disorders Fܛ2020-11-12 2020-12-02 BB DV.. BDV..Follow up stage A Vaccination 2BcBwYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-08-06T10:00 mRNA-1273-P201mRNA-1273-P201-US207-1104US2071104US207USABBYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVVHqDVyHrHqHrDVyHr mRNA-1273 50 ug A AE-001AADVERSE EVENT BRONCHITIS Bronchitis Infections and infestations FBronchitis FFLower respiratory tract and lung infections FInfections - pathogen unspecified FInfections and infestations F2020-09-15 BH.ONGOINGDV.. BH...Follow up stage A Vaccination 2B%.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERING/RESOLVING DOSE 2 - 2020-08-10T10:46 mRNA-1273-P201mRNA-1273-P201-US207-1104US2071104US207USABBYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVVHqDVyHrHqHrDVyHr mRNA-1273 50 ug A AE-003A ADVERSE EVENT WORSENING OF HYPERLIPIDEMIA Hyperlipidaemia Metabolism and nutrition disorders FHyperlipidemia F;FHyperlipidaemias NEC F:Lipid metabolism disorders FʅMetabolism and nutrition disorders F2020-08-01 B.ONGOINGDVp.. B...Vaccination stageA Vaccination 1B.YNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERING/RESOLVING DOSE 1 - 2020-07-06T13:13 mRNA-1273-P201mRNA-1273-P201-US207-1104US2071104US207USABBYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVVHqDVyHrHqHrDVyHr mRNA-1273 50 ug A AE-002A0ADVERSE EVENT HYPERTENSION Hypertension Vascular disorders FNYHypertension FFVascular hypertensive disorders NEC FVascular hypertensive disorders FuVascular disorders FNY2020-08-01 B.ONGOINGDVp.. B...Vaccination stageA Vaccination 1B.YNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERING/RESOLVING DOSE 1 - 2020-07-06T13:13 mRNA-1273-P201mRNA-1273-P201-US207-1106US2071106US207USAB@YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYNYYNNNNYYYNNNot Detected YNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVVHqMDVVHqMHqMHqM.. mRNA-1273 50 ug A AE-001AADVERSE EVENT COVID 19 INFECTION COVID-19 Infections and infestations FCOVID-19 F߬F߬Coronavirus infections FViral infectious disorders FOInfections and infestations F2020-07-11 2020-07-20 A`A DV[.. A`DVd..Vaccination stageA Vaccination 1A`AYYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-07-06T16:51 mRNA-1273-P201mRNA-1273-P201-US208-1001US2081001US208USAB9YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV0HqDVJHq HqHq DVJHq mRNA-1273 100 ugA0AE-003AADVERSE EVENT UNREPORTED FEVER OF 101.4 Pyrexia General disorders and administration site conditions FFever F.F)Febrile disorders FBody temperature conditions FGeneral disorders and administration site conditions F2020-06-25T06:002020-06-25T09:00BB DVKDT`Hq4 BDVKD~Hq_Vaccination stageA Vaccination 2AA YNY NNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-06-24T08:24 Fever Y mRNA-1273-P201mRNA-1273-P201-US208-1003US2081003US208USAB@YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV0Hq$DVOHqɮHq$HqɮDVOHqɮ mRNA-1273 50 ug A AE-001AADVERSE EVENT EAR WAX BUILD UP Excessive cerumen production Ear and labyrinth disorders F)Ear wax FLFExternal ear disorders NEC FExternal ear disorders (excl congenital) FEar and labyrinth disorders F)2020-08-13 2020-08-13 BMBM DV|.. BMDV|..Follow up stage A Vaccination 2B.B.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT PROCEDURE RECOVERED/RESOLVED DOSE 2 - 2020-06-29T09:42 mRNA-1273-P201mRNA-1273-P201-US208-1003US2081003US208USAB@YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV0Hq$DVOHqɮHq$HqɮDVOHqɮ mRNA-1273 50 ug A AE-002A ADVERSE EVENT TOE FUNGUS (LEFT BIG TOE) Fungal skin infection Infections and infestations FFungal foot infection FFFungal infections NEC FFungal infectious disorders FInfections and infestations F2020-12-03 2021-02-26 BC DV.. BDWA..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-06-29T09:42 mRNA-1273-P201mRNA-1273-P201-US208-1004US2081004US208USAB<YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNPlacebo APlacebo ADV0HqDVOHqШHqHqШDVOHqШ Placebo AAE-004AADVERSE EVENT LOWER BACK PAIN Back pain Musculoskeletal and connective tissue disorders FkLow back pain FFMusculoskeletal and connective tissue pain and discomfort FMusculoskeletal and connective tissue disorders NEC FiMusculoskeletal and connective tissue disorders Fk2020-06-26 2020-06-28 BB DVL.. BDVN..Vaccination stageA Vaccination 1BBYN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-05-29T14:09 mRNA-1273-P201mRNA-1273-P201-US208-1004US2081004US208USAB<YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNPlacebo APlacebo ADV0HqDVOHqШHqHqШDVOHqШ Placebo AAE-003A ADVERSE EVENT HEMATURIA Haematuria Renal and urinary disorders F,WHematuria FzF3Urinary abnormalities FDUrinary tract signs and symptoms FL~Renal and urinary disorders F,W2020-06-09 2020-07-01 AB" DV;.. ADVQ..Vaccination stageA Vaccination 1AB"YNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-05-29T14:09 mRNA-1273-P201mRNA-1273-P201-US208-1005US2081005US208USAB7YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNPlacebo APlacebo ADV3HqdDVQHq̐|HqdHq̐|DVQHq̐| Placebo AAE-001AADVERSE EVENT SWOLLEN BLISTERED LIPS (INTERMITTENT ANGIOEDEMA) Angioedema Skin and subcutaneous tissue disorders F5Lip angioedema FFAngioedemas FAngioedema and urticaria FSkin and subcutaneous tissue disorders F52020-06-09 2020-10-09 AB DV;.. ADV..Vaccination stageA Vaccination 1ABYYY NNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-06-01T10:31 Anaphylactic ReactionBROADYAngioedeNARROWY HypersensitivityNARROWY mRNA-1273-P201mRNA-1273-P201-US208-1007US2081007US208USAB@YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNNYYYYYYYNNYYNNot Detected NYNPlacebo APlacebo ADV3Hq<DVPHqQHq<HqQDVPHqQ Placebo AAE-001AADVERSE EVENT BLOOD PRESSURE ELEVATION Blood pressure increased Investigations FBlood pressure increased FFVascular tests NEC (incl blood pressure) FNCardiac and vascular investigations (excl enzyme tests) FInvestigations F2020-06-01T10:052020-06-01T20:00AA DV3DHqL ADV3EHqUVaccination stageA Vaccination 1AAYNY NNNNNNNNNOT RELATEDRELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-01T08:01 mRNA-1273-P201mRNA-1273-P201-US208-1007US2081007US208USAB@YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNNYYYYYYYNNYYNNot Detected NYNPlacebo APlacebo ADV3Hq<DVPHqQHq<HqQDVPHqQ Placebo AAE-003A ADVERSE EVENT PI NOTED INFLAMMATION OF OROPHARNYX AT DAY 15 VISIT Upper respiratory tract inflammation Respiratory, thoracic and mediastinal disorders F-Upper respiratory tract inflammation FX6FX6Upper respiratory tract signs and symptoms FKiRespiratory tract signs and symptoms F}Respiratory, thoracic and mediastinal disorders F-2020-06-17 2020-06-30 BB DVC.. BDVP..Vaccination stageA Vaccination 1BBYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-01T08:01 mRNA-1273-P201mRNA-1273-P201-US208-1009US2081009US208USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3Hq,DVRHqpHq,HqpDVRHqp mRNA-1273 50 ug A AE-002A ADVERSE EVENT BURNING TONGUE SYNDROME Tongue discomfort Gastrointestinal disorders FܛBurning tongue F FƟTongue signs and symptoms FBQTongue conditions FB*Gastrointestinal disorders Fܛ2020-09-30 Bz.ONGOINGDV.. Bz...Follow up stage A Vaccination 2B[.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERING/RESOLVING DOSE 2 - 2020-07-02T13:24 mRNA-1273-P201mRNA-1273-P201-US208-1009US2081009US208USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3Hq,DVRHqpHq,HqpDVRHqp mRNA-1273 50 ug A AE-001AADVERSE EVENT CONTACT DERMATITIS Dermatitis contact Skin and subcutaneous tissue disorders F5Contact dermatitis FFDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F52020-07-02T13:302020-07-09 B B' DVRDHq B DVY..Vaccination stageA Vaccination 2AAYYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-02T13:24 HypersensitivityNARROWY mRNA-1273-P201mRNA-1273-P201-US208-1014US2081014US208USABCYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3Hq@DVPHq$Hq@Hq$DVPHq$ mRNA-1273 100 ugA0AE-002AADVERSE EVENT CONCUSSION Concussion Injury, poisoning and procedural complications FConcussion FFCerebral injuries NEC FdInjuries NEC FInjury, poisoning and procedural complications F2020-08-22 2020-08-26 BSBW DV.. BSDV..Follow up stage A Vaccination 2B6B:YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA3SEVERE Grade 3A0Grade 3/Severe A0>=3A DOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-06-30T10:15 mRNA-1273-P201mRNA-1273-P201-US208-1014US2081014US208USABCYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3Hq@DVPHq$Hq@Hq$DVPHq$ mRNA-1273 100 ugA0AE-001A ADVERSE EVENT LOW WHITE BLOOD CELL COUNT White blood cell count decreased Investigations FWhite blood cell count low F`!FQWhite blood cell analyses FQHaematology investigations (incl blood groups) F#Investigations F2020-06-30T09:202020-07-28T09:13BB: DVPD@Hq@ BDVlDHqVaccination stageA Vaccination 1BB9YN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-01T14:08 Haematopoietic CytopeniasNARROWY mRNA-1273-P201mRNA-1273-P201-US208-1016US2081016US208USAB7YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3HqDVOHq@HqHq@DVOHq@ mRNA-1273 100 ugA0AE-001AADVERSE EVENT SINUS INFECTION Sinusitis Infections and infestations FSinus infection F5F5Upper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations F2020-07-14 2020-07-23 B,B5 DV^.. B,DVg..Vaccination stageA Vaccination 2BBYYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-06-29T14:08 mRNA-1273-P201mRNA-1273-P201-US208-1017US2081017US208USAB>YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNPlacebo APlacebo ADV4HqDVVHq=PHqHq=PDVVHq=P Placebo AAE-001AADVERSE EVENT SORE THROAT Oropharyngeal pain Respiratory, thoracic and mediastinal disorders F-Sore throat F8F_Upper respiratory tract signs and symptoms FKiRespiratory tract signs and symptoms F}Respiratory, thoracic and mediastinal disorders F-2020-06-16 2020-06-18 AB DVB.. ADVD..Vaccination stageA Vaccination 1ABYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-02T08:14 mRNA-1273-P201mRNA-1273-P201-US208-1025US2081025US208USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5HqzDVWHqxPHqzHqxPDVWHqxP mRNA-1273 100 ugA0AE-007AADVERSE EVENT ALLERGIC CONJUNCTIVITIS Conjunctivitis allergic Eye disorders FԯAllergic conjunctivitis F-FxConjunctival infections, irritations and inflammations FbOcular infections, irritations and inflammations FEye disorders Fԯ2021-03-10 C.ONGOINGDWM.. C...Follow up stage A Vaccination 2B.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERING/RESOLVING DOSE 2 - 2020-07-07T14:04 HypersensitivityNARROWY mRNA-1273-P201mRNA-1273-P201-US208-1025US2081025US208USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5HqzDVWHqxPHqzHqxPDVWHqxP mRNA-1273 100 ugA0AE-003A ADVERSE EVENT HEMORRHOIDS Haemorrhoids Gastrointestinal disorders FܛHemorrhoids FFHaemorrhoids and gastrointestinal varices (excl oesophageal) FGastrointestinal vascular conditions FGastrointestinal disorders Fܛ2020-08-21 2020-12-28 BPB DV.. BPDW..Follow up stage A Vaccination 2B.BYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-07T14:04 mRNA-1273-P201mRNA-1273-P201-US208-1025US2081025US208USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5HqzDVWHqxPHqzHqxPDVWHqxP mRNA-1273 100 ugA0AE-004A@ADVERSE EVENT INJURY OF RIGHT PINKY FINGER Limb injury Injury, poisoning and procedural complications FInjury to finger NOS F1FSite specific injuries NEC F5Injuries NEC FInjury, poisoning and procedural complications F2020-09-22 2020-12-28 BpB DV.. BpDW..Follow up stage A Vaccination 2BNBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-07T14:04 mRNA-1273-P201mRNA-1273-P201-US208-1025US2081025US208USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5HqzDVWHqxPHqzHqxPDVWHqxP mRNA-1273 100 ugA0AE-005APADVERSE EVENT ALLERGIC RHINITIS Rhinitis allergic Respiratory, thoracic and mediastinal disorders F-Allergic rhinitis F;F/-Nasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-2021-02-19 C`.ONGOINGDW:.. C`...Follow up stage A Vaccination 2B.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERING/RESOLVING DOSE 2 - 2020-07-07T14:04 HypersensitivityNARROWY mRNA-1273-P201mRNA-1273-P201-US208-1028US2081028US208USAB3YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqSDVWHq>lHqSHq>lDVWHq>l mRNA-1273 100 ugA0AE-001AADVERSE EVENT MUSCLE SPASM [LOWER BACK] Muscle spasms Musculoskeletal and connective tissue disorders FkBack muscle spasms FF.Muscle related signs and symptoms NEC F&Muscle disorders FMusculoskeletal and connective tissue disorders Fk2020-06-16 2020-07-07 AB$ DVB.. ADVW..Vaccination stageA Vaccination 1AB$YNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-02T14:03 mRNA-1273-P201mRNA-1273-P201-US208-1029US2081029US208USAB7YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNPlacebo APlacebo ADV4HqWDVWHqY`HqWHqY`DVWHqY` Placebo AAE-002AADVERSE EVENT CORONARY CALCIUM SCAN ABNORMAL (ELEVATED) Computerised tomogram coronary artery abnormalInvestigations FCoronary calcium scan abnormal FRFCardiac imaging procedures FCardiac and vascular investigations (excl enzyme tests) FInvestigations F2021-02-01 B.ONGOINGDW(.. B...Follow up stage A Vaccination 2B.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERING/RESOLVING DOSE 2 - 2020-07-07T11:52 mRNA-1273-P201mRNA-1273-P201-US208-1033US2081033US208USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected YNNPlacebo APlacebo ADV4HqDVWHqHDHqHqHDDVWHqHD Placebo AAE-002AADVERSE EVENT COVID-19 INFECTION COVID-19 Infections and infestations FCOVID-19 F߬F߬Coronavirus infections FViral infectious disorders FOInfections and infestations F2021-01-05 2021-03-15 BC DW .. BDWR..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-07T10:39 mRNA-1273-P201mRNA-1273-P201-US208-1033US2081033US208USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected YNNPlacebo APlacebo ADV4HqDVWHqHDHqHqHDDVWHqHD Placebo AAE-001A ADVERSE EVENT SWIMMER'S EAR (LEFT EAR) Otitis externa Infections and infestations FSwimmer's ear F4FEar infections F=Infections - pathogen unspecified FInfections and infestations F2020-07-13 2020-07-18 B*B/ DV].. B*DVb..Vaccination stageA Vaccination 2ApAYYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-07T10:39 mRNA-1273-P201mRNA-1273-P201-US208-1036US2081036US208USAB0YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV6HqDVYHqHqHqDVYHq mRNA-1273 50 ug A AE-003AADVERSE EVENT COVID 19 INFECTION COVID-19 Infections and infestations FCOVID-19 F߬F߬Coronavirus infections FViral infectious disorders FOInfections and infestations F2020-12-15 2020-12-25 BB DV.. BDW..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-09T13:48 mRNA-1273-P201mRNA-1273-P201-US208-1036US2081036US208USAB0YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV6HqDVYHqHqHqDVYHq mRNA-1273 50 ug A AE-004A ADVERSE EVENT WORSENING OF MIGRAINES Migraine Nervous system disorders FMigraine aggravated FPFOMigraine headaches FSHeadaches FNervous system disorders F2020-10-26 2020-11-23 BB DV.. BDV..Follow up stage A Vaccination 2BnBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-09T13:48 Headache Y mRNA-1273-P201mRNA-1273-P201-US208-1038US2081038US208USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV:HqDVYHq0HqHq0DVYHq0 Placebo AAE-001AADVERSE EVENT CUT ON LEFT FOREARM Skin laceration Injury, poisoning and procedural complications FLaceration of arm FF|BSkin injuries NEC FInjuries NEC FInjury, poisoning and procedural complications F2020-06-08T14:002020-06-15 AA DV:DHq; ADVA..Vaccination stageA Vaccination 1AAYYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION, CONCOMITANT PROCEDURERECOVERED/RESOLVED DOSE 1 - 2020-06-08T08:02 mRNA-1273-P201mRNA-1273-P201-US208-1041US2081041US208USAB)YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV6HqDVWHq^HqHq^DVWHq^ mRNA-1273 50 ug A AE-001AADVERSE EVENT NASAL CONGESTION Nasal congestion Respiratory, thoracic and mediastinal disorders F-Nasal congestion FFNasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-2020-12-14 2020-12-28 BB DV.. BDW..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-07T12:12 mRNA-1273-P201mRNA-1273-P201-US208-1042US2081042US208USAB1YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV<HqDVXHqtHqHqtDVXHqt Placebo AAE-001AADVERSE EVENT FATIGUE Fatigue General disorders and administration site conditions FFatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2020-07-09T12:002020-07-10T12:00BB DVYDHq@ BDVZDHqOVaccination stageA Vaccination 2A A0YNY NNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-08T08:00 Fatigue Y mRNA-1273-P201mRNA-1273-P201-US208-1045US2081045US208USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6HqDVWHq{HqHq{DVWHq{ mRNA-1273 100 ugA0AE-002AADVERSE EVENT STOMACH PRESSURE Abdominal discomfort Gastrointestinal disorders FܛStomach pressure sensation of F;FGastrointestinal signs and symptoms NEC FGastrointestinal signs and symptoms FGastrointestinal disorders Fܛ2020-07-12 2020-07-14 B'B) DV\.. B'DV^..Vaccination stageA Vaccination 2A`AYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-07T14:18 mRNA-1273-P201mRNA-1273-P201-US208-1045US2081045US208USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6HqDVWHq{HqHq{DVWHq{ mRNA-1273 100 ugA0AE-004A0ADVERSE EVENT FEELING OF "PINS AND NEEDLES" IN TONGUE [CAUSALITY, INVESTIGATIONAL PROTOCOL] Paraesthesia oral Gastrointestinal disorders FܛParaesthesia tongue F{FvOral soft tissue signs and symptoms FOral soft tissue conditions FGastrointestinal disorders Fܛ2020-07-08T22:002020-07-15T07:00B#B* DVXEVHq9` B#DV_DbpHqޠVaccination stageA Vaccination 2A AYNY NNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-07T14:18 mRNA-1273-P201mRNA-1273-P201-US208-1045US2081045US208USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6HqDVWHq{HqHq{DVWHq{ mRNA-1273 100 ugA0AE-003A ADVERSE EVENT FEELING OF "PINS AND NEEDLES" IN EXTREMITIES [CAUSALITY, INVESTIGATIONAL PRODUCT] Paraesthesia Nervous system disorders FPins and needles F{FoParaesthesias and dysaesthesias F|Neurological disorders NEC FNervous system disorders F2020-07-08T22:002020-07-15T07:00B#B* DVXEVHq9` B#DV_DbpHqޠVaccination stageA Vaccination 2A AYNY NNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-07T14:18 Peripheral NeuropathyBROAD mRNA-1273-P201mRNA-1273-P201-US208-1045US2081045US208USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6HqDVWHq{HqHq{DVWHq{ mRNA-1273 100 ugA0AE-001A@ADVERSE EVENT WHITE FINGERTIPS Skin discolouration Skin and subcutaneous tissue disorders F5Fingertip discoloration FF5Dermal and epidermal conditions NEC FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F52020-06-28 2020-06-28 BB DVN.. BDVN..Vaccination stageA Vaccination 1BBYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-04T10:02 mRNA-1273-P201mRNA-1273-P201-US208-1046US2081046US208USAB-YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADV:HqSDVYHqňHqSHqňDVYHqň Placebo AAE-002AADVERSE EVENT CONFIRMED COVID 19 INFECTION (SYMPTOMATIC- FEVER, HEADACHE, HEAVY FEELING IN CHEST, BODY ACHES)COVID-19 Infections and infestations FCOVID-19 F߬F߬Coronavirus infections FViral infectious disorders FOInfections and infestations F2020-10-06 2020-11-06 ByB DV.. ByDV..Follow up stage A Vaccination 2BZByYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-09T07:58 mRNA-1273-P201mRNA-1273-P201-US208-1046US2081046US208USAB-YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADV:HqSDVYHqňHqSHqňDVYHqň Placebo AAE-001A ADVERSE EVENT PAPULAR RASH ON FOREARM (BILATERAL) Rash papular Skin and subcutaneous tissue disorders F5Papular rash on arms F@F*tRashes, eruptions and exanthems NEC FcEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F52020-06-08 2020-06-16 AA DV:.. ADVB..Vaccination stageA Vaccination 1AAYYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-08T15:42 mRNA-1273-P201mRNA-1273-P201-US208-1049US2081049US208USAB/YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV;HqNDVXHqrdHqNHqrdDVXHqrd Placebo AAE-001A ADVERSE EVENT GASTROENTERITIS Gastroenteritis Infections and infestations FGastroenteritis F`F`Abdominal and gastrointestinal infections FܯInfections - pathogen unspecified FInfections and infestations F2020-07-17 2020-07-28 B'B2 DVa.. B'DVl..Vaccination stageA Vaccination 2ABYYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-08T07:51 mRNA-1273-P201mRNA-1273-P201-US208-1049US2081049US208USAB/YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV;HqNDVXHqrdHqNHqrdDVXHqrd Placebo AAE-003A0ADVERSE EVENT THRUSH (TONGUE) Oral candidiasis Infections and infestations FOral thrush FFsCandida infections F^Fungal infectious disorders FInfections and infestations F2020-08-05 2020-08-12 B:BA DVt.. B:DV{..Follow up stage A Vaccination 2BB$YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-08T07:51 mRNA-1273-P201mRNA-1273-P201-US208-1049US2081049US208USAB/YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV;HqNDVXHqrdHqNHqrdDVXHqrd Placebo AAE-002A@ADVERSE EVENT URINARY TRACT INFECTION Urinary tract infection Infections and infestations FUrinary tract infection FLkFLkUrinary tract infections FLqInfections - pathogen unspecified FInfections and infestations F2020-07-27 2020-08-03 B1B8 DVk.. B1DVr..Vaccination stageA Vaccination 2BBYYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-08T07:51 mRNA-1273-P201mRNA-1273-P201-US208-1049US2081049US208USAB/YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV;HqNDVXHqrdHqNHqrdDVXHqrd Placebo AAE-004AADVERSE EVENT WORSENING OF ANXIETY Anxiety Psychiatric disorders F'Anxiety aggravated FSSFAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'2020-11-17 2020-12-22 BB DV.. BDV..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-08T07:51 mRNA-1273-P201mRNA-1273-P201-US208-1052US2081052US208USAB%YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7Hq*DVYHq4Hq*Hq4DVYHq4 mRNA-1273 50 ug A AE-007A ADVERSE EVENT FATIGUE Fatigue General disorders and administration site conditions FFatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2020-10-27 2020-11-16 BB DV.. BDV..Follow up stage A Vaccination 2BoBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-07-09T13:55 Fatigue Y mRNA-1273-P201mRNA-1273-P201-US208-1052US2081052US208USAB%YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7Hq*DVYHq4Hq*Hq4DVYHq4 mRNA-1273 50 ug A AE-001A0ADVERSE EVENT LEFT TRAPEZIUS REGION,TRANSIENT LOCAL MUSCLE PAIN RELATED TO INJECTION Injection site pain General disorders and administration site conditions FInjection site muscle pain FXFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2020-06-05T12:032020-06-05T12:18AA DV7DtHq+ ADV7DHq/xVaccination stageA Vaccination 1AAYNY NNNNNNNNNOT RELATEDRELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-05T11:58 Pain Y mRNA-1273-P201mRNA-1273-P201-US208-1052US2081052US208USAB%YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7Hq*DVYHq4Hq*Hq4DVYHq4 mRNA-1273 50 ug A AE-003AADVERSE EVENT MILD CONCUSSION Concussion Injury, poisoning and procedural complications FConcussion FFCerebral injuries NEC FdInjuries NEC FInjury, poisoning and procedural complications F2020-10-12 2020-10-19 BB DV.. BDV..Follow up stage A Vaccination 2B`BgYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-09T13:55 mRNA-1273-P201mRNA-1273-P201-US208-1052US2081052US208USAB%YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7Hq*DVYHq4Hq*Hq4DVYHq4 mRNA-1273 50 ug A AE-002A@ADVERSE EVENT NECK STRAIN (CAR ACCIDENT) Muscle strain Injury, poisoning and procedural complications FNeck strain F=FYMuscle, tendon and ligament injuries FInjuries NEC FInjury, poisoning and procedural complications F2020-10-12 2020-10-23 BB DV.. BDV..Follow up stage A Vaccination 2B`BkYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-09T13:55 mRNA-1273-P201mRNA-1273-P201-US208-1052US2081052US208USAB%YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7Hq*DVYHq4Hq*Hq4DVYHq4 mRNA-1273 50 ug A AE-004APADVERSE EVENT SORE THROAT Oropharyngeal pain Respiratory, thoracic and mediastinal disorders F-Sore throat F8F_Upper respiratory tract signs and symptoms FKiRespiratory tract signs and symptoms F}Respiratory, thoracic and mediastinal disorders F-2020-10-21 B.ONGOINGDV.. B...Follow up stage A Vaccination 2Bi.YN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERING/RESOLVING DOSE 2 - 2020-07-09T13:55 mRNA-1273-P201mRNA-1273-P201-US208-1058US2081058US208USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYNYYNNNNYYYNNNot Detected NNNPlacebo APlacebo ADV:HqXDV:HqXHqXHqX.. Placebo AAE-002AADVERSE EVENT SINUS INFECTION Sinusitis Infections and infestations FSinus infection F5F5Upper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations F2020-11-16 2020-12-02 BB DV.. BDV..Follow up stage A Vaccination 1BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 1 - 2020-06-08T11:54 mRNA-1273-P201mRNA-1273-P201-US208-1059US2081059US208USAB'YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:HqCDV]Hq=HqCHq=DV]Hq= mRNA-1273 50 ug A AE-002A ADVERSE EVENT RUNNY NOSE (SEASONAL ALLERGIES) Seasonal allergy Immune system disorders F4Seasonal allergy FUFUAtopic disorders FdAllergic conditions F,Immune system disorders F42020-08-05 2020-08-09 B;B? DVt.. B;DVx..Vaccination stageA Vaccination 2BBYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-13T11:33 HypersensitivityBROAD mRNA-1273-P201mRNA-1273-P201-US208-1059US2081059US208USAB'YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:HqCDV]Hq=HqCHq=DV]Hq= mRNA-1273 50 ug A AE-001A0ADVERSE EVENT SORE THROAT (SEASONAL ALLERGIES) Seasonal allergy Immune system disorders F4Seasonal allergy FUFUAtopic disorders FdAllergic conditions F,Immune system disorders F42020-08-05 2020-08-09 B;B? DVt.. B;DVx..Vaccination stageA Vaccination 2BBYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-13T11:33 HypersensitivityBROAD mRNA-1273-P201mRNA-1273-P201-US208-1059US2081059US208USAB'YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:HqCDV]Hq=HqCHq=DV]Hq= mRNA-1273 50 ug A AE-004AADVERSE EVENT NECK PAIN Neck pain Musculoskeletal and connective tissue disorders FkNeck pain F$F$Musculoskeletal and connective tissue pain and discomfort FMusculoskeletal and connective tissue disorders NEC FiMusculoskeletal and connective tissue disorders Fk2021-02-21 2021-02-28 C0C DW<.. C0DWC..Follow up stage A Vaccination 2BBYN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-13T11:33 ArthritisBROAD mRNA-1273-P201mRNA-1273-P201-US208-1063US2081063US208USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAMWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:Hq DVXHqՏtHq HqՏtDVXHqՏt mRNA-1273 100 ugA0AE-002AADVERSE EVENT ANXIETY Anxiety Psychiatric disorders F'Anxiety FFAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'2020-10-12 B.ONGOINGDV.. B...Follow up stage A Vaccination 2Ba.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERING/RESOLVING DOSE 2 - 2020-07-08T09:55 mRNA-1273-P201mRNA-1273-P201-US208-1063US2081063US208USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAMWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:Hq DVXHqՏtHq HqՏtDVXHqՏt mRNA-1273 100 ugA0AE-001A ADVERSE EVENT DEPRESSION Depression Psychiatric disorders F'Depression FFDepressive disorders FDepressed mood disorders and disturbances FPsychiatric disorders F'2020-07-20 B+.ONGOINGDVd.. B+...Vaccination stageA Vaccination 2A.YNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA3SEVERE Grade 3A0Grade 3/Severe A0>=3A DOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RECOVERED/NOT RESOLVED DOSE 2 - 2020-07-08T09:55 mRNA-1273-P201mRNA-1273-P201-US208-1064US2081064US208USAB0YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:HqDVYHq0HqHq0DVYHq0 mRNA-1273 100 ugA0AE-003AADVERSE EVENT ACUTE GASTROENTERITIS Gastroenteritis Infections and infestations FAcute gastroenteritis FJF`Abdominal and gastrointestinal infections FܯInfections - pathogen unspecified FInfections and infestations F2020-07-09 2020-07-10 B B! DVY.. B DVZ..Vaccination stageA Vaccination 2AA YYY NNNNNNNNRELATED NOT RELATED RELATED A 2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-09T09:56 mRNA-1273-P201mRNA-1273-P201-US208-1066US2081066US208USABBYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVLHqdDVhHq\HqdHq\DVhHq\ Placebo AAE-001AADVERSE EVENT HEADACHE Headache Nervous system disorders FHeadache FFHeadaches NEC FHeadaches FNervous system disorders F2020-08-02 2020-08-02 B&B& DVq.. B&DVq..Vaccination stageA Vaccination 2AAYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-24T09:29 Headache Y mRNA-1273-P201mRNA-1273-P201-US208-1069US2081069US208USABFYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqDVhHqHqHqDVhHq mRNA-1273 100 ugA0AE-003A ADVERSE EVENT LUMP AT INJECTION SITE Injection site mass General disorders and administration site conditions FInjection site lump FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2020-06-27 A .ONGOINGDVM.. A ...Vaccination stageA Vaccination 1A .YNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDNONE NOT RECOVERED/NOT RESOLVED DOSE 1 - 2020-06-26T14:54 mRNA-1273-P201mRNA-1273-P201-US208-1069US2081069US208USABFYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqDVhHqHqHqDVhHq mRNA-1273 100 ugA0AE-001A0ADVERSE EVENT SINUS HEADACHE Sinus headache Nervous system disorders FSinus headache F5F5Headaches NEC FHeadaches FNervous system disorders F2020-07-26 2020-07-26 BB DVj.. BDVj..Vaccination stageA Vaccination 2A0A0YNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-24T14:17 mRNA-1273-P201mRNA-1273-P201-US208-1070US2081070US208USABGYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYNNYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqXDVhHqHqXHqDVhHq mRNA-1273 50 ug A AE-001AADVERSE EVENT BED BUG BITES (BACK) Arthropod bite Injury, poisoning and procedural complications FBedbug bite FFNon-site specific injuries NEC F Injuries NEC FInjury, poisoning and procedural complications F2020-08-10 2020-08-21 B.B9 DVy.. B.DV..Vaccination stageA Vaccination 2BBYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-24T14:01 mRNA-1273-P201mRNA-1273-P201-US208-1071US2081071US208USABAYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVPHq!tDVmHq[Hq!tHq[DVmHq[ mRNA-1273 50 ug A AE-001AADVERSE EVENT SORE THROAT WITH MUCUS Oropharyngeal pain Respiratory, thoracic and mediastinal disorders F-Sore throat F8F_Upper respiratory tract signs and symptoms FKiRespiratory tract signs and symptoms F}Respiratory, thoracic and mediastinal disorders F-2020-08-01 2020-08-03 B!B# DVp.. B!DVr..Vaccination stageA Vaccination 2A@A`YNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-29T11:55 mRNA-1273-P201mRNA-1273-P201-US208-1071US2081071US208USABAYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVPHq!tDVmHq[Hq!tHq[DVmHq[ mRNA-1273 50 ug A AE-002A ADVERSE EVENT POSTERIOR OROPHARYNX SLIGHT ERYTHEMA (THROAT) Pharyngeal erythema Respiratory, thoracic and mediastinal disorders F-Pharyngeal erythema Fu1Fu1Pharyngeal disorders (excl infections and neoplasms) FUpper respiratory tract disorders (excl infections) FK`Respiratory, thoracic and mediastinal disorders F-2020-08-05 2020-08-12 B%B, DVt.. B%DV{..Vaccination stageA Vaccination 2AAYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-29T11:55 mRNA-1273-P201mRNA-1273-P201-US208-1072US2081072US208USAB;YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYNNYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqżHDVhHqHqżHHqDVhHq mRNA-1273 100 ugA0AE-001A ADVERSE EVENT WHEEZING (SEASONAL ALLERGY RELATED) Seasonal allergy Immune system disorders F4Seasonal allergy FUFUAtopic disorders FdAllergic conditions F,Immune system disorders F42020-07-03 2020-07-12 AB DVS.. ADV\..Vaccination stageA Vaccination 1ABYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-26T09:50 HypersensitivityBROAD mRNA-1273-P201mRNA-1273-P201-US208-1076US2081076US208USAB7YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVQHqV DVtHqHqV HqDVtHq mRNA-1273 100 ugA0AE-005A0REACTOGENICITYHARDNESS AT INJECTION SITE (DAY 8) Injection site induration General disorders and administration site conditions FInjection site induration FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2020-08-05 2020-08-13 B$B, DVt.. B$DV|..Vaccination stageAP2D Vaccination 2AAYNY YNNNNNNNRELATED RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-08-05T14:22 Swelling Y mRNA-1273-P201mRNA-1273-P201-US208-1076US2081076US208USAB7YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVQHqV DVtHqHqV HqDVtHq mRNA-1273 100 ugA0AE-004A@REACTOGENICITYSWELLING AT INJECTION SITE (DAY 8) Injection site swelling General disorders and administration site conditions FInjection site swelling Fg1Fg1Injection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2020-08-05 2020-08-13 B$B, DVt.. B$DV|..Vaccination stageAP2D Vaccination 2AAYNY YNNNNNNNRELATED RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-08-05T14:22 Swelling Y mRNA-1273-P201mRNA-1273-P201-US208-1077US2081077US208USABBYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVPHqBDVrHqXHqBHqXDVrHqX Placebo AAE-002AADVERSE EVENT URINARY TRACT INFECTION Urinary tract infection Infections and infestations FUrinary tract infection FLkFLkUrinary tract infections FLqInfections - pathogen unspecified FInfections and infestations F2020-12-08 2020-12-19 BB DV.. BDV..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-08-03T11:54 mRNA-1273-P201mRNA-1273-P201-US208-1081US2081081US208USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYNYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVOHqɽDVmHqChHqɽHqChDVmHqCh mRNA-1273 100 ugA0AE-002A ADVERSE EVENT TORN ACHILLES (LEFT FOOT) Tendon rupture Injury, poisoning and procedural complications FRuptured Achilles tendon F0 F?pMuscle, tendon and ligament injuries FInjuries NEC FInjury, poisoning and procedural complications F2021-01-06 2021-03-02 BB DW.. BDWE..Follow up stage A Vaccination 2BBYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION, CONCOMITANT PROCEDURERECOVERED/RESOLVED DOSE 2 - 2020-07-29T10:14 mRNA-1273-P201mRNA-1273-P201-US208-1081US2081081US208USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYNYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVOHqɽDVmHqChHqɽHqChDVmHqCh mRNA-1273 100 ugA0AE-001AADVERSE EVENT HYPERTENSION Hypertension Vascular disorders FNYHypertension FFVascular hypertensive disorders NEC FVascular hypertensive disorders FuVascular disorders FNY2021-01-27 B.ONGOINGDW#.. B...Follow up stage A Vaccination 2B.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERING/RESOLVING DOSE 2 - 2020-07-29T10:14 mRNA-1273-P201mRNA-1273-P201-US208-1088US2081088US208USAB?YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVRHqͪpDVrHqHqͪpHqDVrHq mRNA-1273 100 ugA0AE-001A ADVERSE EVENT CHEST TIGHTNESS (MUSCULOSKELETAL) Musculoskeletal chest pain Musculoskeletal and connective tissue disorders FkMusculoskeletal chest pain F]F]Musculoskeletal and connective tissue pain and discomfort FMusculoskeletal and connective tissue disorders NEC FiMusculoskeletal and connective tissue disorders Fk2020-07-07 2020-07-07 A`A` DVW.. A`DVW..Vaccination stageA Vaccination 1A`A`YNY NNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-07-02T10:12 mRNA-1273-P201mRNA-1273-P201-US208-1092US2081092US208USABMYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVRHqͭDVoHqHqͭHqDVoHq1080mRNA-1273 50 ug A AE-003A REACTOGENICITYFATIGUE Fatigue General disorders and administration site conditions FFatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2020-07-02 2020-07-14 AA DVR.. ADV^..Vaccination stageAP6D Vaccination 1AAYNY YNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-07-02T10:27 Fatigue Y mRNA-1273-P201mRNA-1273-P201-US208-1092US2081092US208USABMYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVRHqͭDVoHqHqͭHqDVoHq mRNA-1273 50 ug A AE-001A0ADVERSE EVENT SHOULDER PAIN R/T PLAYING PICKLE BALL Musculoskeletal pain Musculoskeletal and connective tissue disorders FkShoulder pain F5)FgMusculoskeletal and connective tissue pain and discomfort FMusculoskeletal and connective tissue disorders NEC FiMusculoskeletal and connective tissue disorders Fk2020-07-02 2020-07-02T12:00AA DVR.. ADVRDHqVaccination stageA Vaccination 1AAYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-07-02T10:27 mRNA-1273-P201mRNA-1273-P201-US208-1092US2081092US208USABMYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVRHqͭDVoHqHqͭHqDVoHq mRNA-1273 50 ug A AE-002A@ADVERSE EVENT SHOULDER PAIN R/T PLAYING PICKLE BALL Musculoskeletal pain Musculoskeletal and connective tissue disorders FkShoulder pain F5)FgMusculoskeletal and connective tissue pain and discomfort FMusculoskeletal and connective tissue disorders NEC FiMusculoskeletal and connective tissue disorders Fk2020-07-07 2020-07-07 A`A` DVW.. A`DVW..Vaccination stageA Vaccination 1A`A`YNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-07-02T10:27 mRNA-1273-P201mRNA-1273-P201-US208-1092US2081092US208USABMYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVRHqͭDVoHqHqͭHqDVoHq mRNA-1273 50 ug A AE-004AADVERSE EVENT NONSPECIFIC DERMATITIS (RASH ACROSS FOREHEAD AND UPPER BACK) Dermatitis Skin and subcutaneous tissue disorders F5Dermatitis NOS F>FDermatitis and eczema FEpidermal and dermal conditions FSkin and subcutaneous tissue disorders F52020-07-06 2020-07-12 APA DVV.. APDV\..Vaccination stageA Vaccination 1APAYYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-07-02T10:27 HypersensitivityNARROWY mRNA-1273-P201mRNA-1273-P201-US208-1093US2081093US208USABBYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVRHqhDVrHqTHqhHqTDVrHqT mRNA-1273 100 ugA0AE-002AADVERSE EVENT SHOULDER PAIN R/T PLAYING PICKLE BALL Musculoskeletal pain Musculoskeletal and connective tissue disorders FkShoulder pain F5)FgMusculoskeletal and connective tissue pain and discomfort FMusculoskeletal and connective tissue disorders NEC FiMusculoskeletal and connective tissue disorders Fk2020-07-03 2020-07-03T12:00A A DVS.. A DVSDHq@Vaccination stageA Vaccination 1A A YNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-07-02T11:50 mRNA-1273-P201mRNA-1273-P201-US208-1093US2081093US208USABBYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVRHqhDVrHqTHqhHqTDVrHqT mRNA-1273 100 ugA0AE-001A ADVERSE EVENT SHOULDER PAIN R/T PLAYING PICKLE BALL Musculoskeletal pain Musculoskeletal and connective tissue disorders FkShoulder pain F5)FgMusculoskeletal and connective tissue pain and discomfort FMusculoskeletal and connective tissue disorders NEC FiMusculoskeletal and connective tissue disorders Fk2020-07-09 2020-07-09 AA DVY.. ADVY..Vaccination stageA Vaccination 1AAYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-07-02T11:50 mRNA-1273-P201mRNA-1273-P201-US208-1099US2081099US208USAB7YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqŮ8DVmHq$HqŮ8Hq$DVmHq$2100mRNA-1273 100 ugA0AE-003AREACTOGENICITYGENERALIZED JOINT ACHES (DAY 8-DAY 14 AFTER INJECTION) Arthralgia Musculoskeletal and connective tissue disorders FkGeneralized joint pain FfF'Joint related signs and symptoms F:Joint disorders F-Musculoskeletal and connective tissue disorders Fk2020-07-29 2020-08-11 B"B/ DVm.. B"DVz..Vaccination stageAP7D Vaccination 2AAYNY YNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-29T08:04 ArthritisBROAD Arthralgia Y mRNA-1273-P201mRNA-1273-P201-US208-1099US2081099US208USAB7YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqŮ8DVmHq$HqŮ8Hq$DVmHq$2070mRNA-1273 100 ugA0AE-002A REACTOGENICITYHEADACHE (DAY 8 AFTER INJECTION) Headache Nervous system disorders FHeadache FFHeadaches NEC FHeadaches FNervous system disorders F2020-08-06 2020-08-08 B*B, DVu.. B*DVw..Vaccination stageAP4D Vaccination 2AAYNY YNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-29T08:04 Headache Y mRNA-1273-P201mRNA-1273-P201-US208-1100US2081100US208USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYNYNYNYNNNYYYYYYNYNYYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVRHqDVrHqHqHqDVrHq mRNA-1273 50 ug A AE-001A ADVERSE EVENT DIARRHEA Diarrhoea Gastrointestinal disorders FܛDiarrhea F7F?Diarrhoea (excl infective) F@Gastrointestinal motility and defaecation conditions FܹGastrointestinal disorders Fܛ2020-07-05 2020-07-05 A@A@ DVU.. A@DVU..Vaccination stageA Vaccination 1A@A@YNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-07-02T13:51 mRNA-1273-P201mRNA-1273-P201-US208-1100US2081100US208USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYNYNYNYNNNYYYYYYNYNYYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVRHqDVrHqHqHqDVrHq2080mRNA-1273 50 ug A AE-005A@REACTOGENICITYFATIGUE REPORTED BEYOND DAY 7 IN EDIARY Fatigue General disorders and administration site conditions FFatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2020-08-05 2020-08-11 B#B) DVt.. B#DVz..Vaccination stageAP2D Vaccination 2A0AYNY YNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-08-03T10:06 Fatigue Y mRNA-1273-P201mRNA-1273-P201-US208-1100US2081100US208USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYNYNYNYNNNYYYYYYNYNYYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVRHqDVrHqHqHqDVrHq mRNA-1273 50 ug A AE-004A`ADVERSE EVENT ITCHING AROUND INJECTION SITE, NO REDNESS Injection site pruritus General disorders and administration site conditions FInjection site itching FFInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2020-08-05 2020-08-07 B#B% DVt.. B#DVv..Vaccination stageA Vaccination 2A0APYNY NNNNNNNNRELATED RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-08-03T10:06 mRNA-1273-P201mRNA-1273-P201-US208-1100US2081100US208USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYNYNYNYNNNYYYYYYNYNYYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVRHqDVrHqHqHqDVrHq1070mRNA-1273 50 ug A AE-002APREACTOGENICITYHEADACHE Headache Nervous system disorders FHeadache FFHeadaches NEC FHeadaches FNervous system disorders F2020-07-05 2020-07-11 A@A DVU.. A@DV[..Vaccination stageAP3D Vaccination 1A@AYNY YNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-07-02T13:51 Headache Y mRNA-1273-P201mRNA-1273-P201-US208-1100US2081100US208USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYNYNYNYNNNYYYYYYNYNYYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVRHqDVrHqHqHqDVrHq mRNA-1273 50 ug A AE-006AADVERSE EVENT WORSENING OF ANXIETY Anxiety Psychiatric disorders F'Anxiety aggravated FSSFAnxiety symptoms FAnxiety disorders and symptoms FPsychiatric disorders F'2021-02-01 B.ONGOINGDW(.. B...Follow up stage A Vaccination 2B.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERING/RESOLVING DOSE 2 - 2020-08-03T10:06 mRNA-1273-P201mRNA-1273-P201-US208-1103US2081103US208USAB:YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVRHq͌pDVuHqHq͌pHqDVuHq Placebo AAE-001A ADVERSE EVENT FEVER Pyrexia General disorders and administration site conditions FFever F.F)Febrile disorders FBody temperature conditions FGeneral disorders and administration site conditions F2020-07-18 2020-07-24 BB DVb.. BDVh..Vaccination stageA Vaccination 1BBYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-07-02T08:04 Fever Y mRNA-1273-P201mRNA-1273-P201-US208-1103US2081103US208USAB:YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVRHq͌pDVuHqHq͌pHqDVuHq Placebo AAE-002AADVERSE EVENT HEADACHE Headache Nervous system disorders FHeadache FFHeadaches NEC FHeadaches FNervous system disorders F2020-07-18 2020-07-24 BB DVb.. BDVh..Vaccination stageA Vaccination 1BBYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-07-02T08:04 Headache Y mRNA-1273-P201mRNA-1273-P201-US208-1118US2081118US208USABFYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVQHq̎DVoHqHq̎HqDVoHq mRNA-1273 50 ug A AE-001AADVERSE EVENT OVERACTIVE BLADDER Hypertonic bladder Renal and urinary disorders F,WOveractive bladder FaFMyoneurogenic bladder disorders F_Bladder and bladder neck disorders (excl calculi) FRenal and urinary disorders F,W2020-07-10 A.ONGOINGDVZ.. A...Vaccination stageA Vaccination 1A.YYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERING/RESOLVING DOSE 1 - 2020-07-01T14:01 mRNA-1273-P201mRNA-1273-P201-US208-1120US2081120US208USABHYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVQHq̦DVmHqx`Hq̦Hqx`DVmHqx` mRNA-1273 100 ugA0AE-002AADVERSE EVENT CS HEMATOCRIT LAB (INCREASED) Haematocrit increased Investigations FHematocrit increased F`FRed blood cell analyses F+Haematology investigations (incl blood groups) F#Investigations F2020-07-29 B.ONGOINGDVm.. B...Vaccination stageA Vaccination 2A.YNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE NOT RECOVERED/NOT RESOLVED DOSE 2 - 2020-07-29T14:00 mRNA-1273-P201mRNA-1273-P201-US208-1120US2081120US208USABHYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVQHq̦DVmHqx`Hq̦Hqx`DVmHqx` mRNA-1273 100 ugA0AE-001A ADVERSE EVENT CS HEMOGLOBIN LAB (INCREASED) Haemoglobin increased Investigations FHemoglobin increased FoFHRed blood cell analyses F+Haematology investigations (incl blood groups) F#Investigations F2020-07-29 B.ONGOINGDVm.. B...Vaccination stageA Vaccination 2A.YNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE NOT RECOVERED/NOT RESOLVED DOSE 2 - 2020-07-29T14:00 mRNA-1273-P201mRNA-1273-P201-US208-1120US2081120US208USABHYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVQHq̦DVmHqx`Hq̦Hqx`DVmHqx` mRNA-1273 100 ugA0AE-003A0ADVERSE EVENT ENLARGED PROSTATE Prostatomegaly Reproductive system and breast disorders F-LEnlarged prostate FVF_Prostatic signs, symptoms and disorders NEC F&Prostatic disorders (excl infections and inflammations) F&Reproductive system and breast disorders F-L2020-12-01 B.ONGOINGDV.. B...Follow up stage A Vaccination 2B~.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION, CONCOMITANT PROCEDURENOT RECOVERED/NOT RESOLVED DOSE 2 - 2020-07-29T14:00 mRNA-1273-P201mRNA-1273-P201-US208-1121US2081121US208USAB?YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVVHqHDVyHr<HqHHr<DVyHr< mRNA-1273 100 ugA0AE-001AADVERSE EVENT CANKER SORE Aphthous ulcer Gastrointestinal disorders FܛCanker sores oral F~FStomatitis and ulceration F;Oral soft tissue conditions FGastrointestinal disorders Fܛ2020-07-09 2020-07-15 A@A DVY.. A@DV_..Vaccination stageA Vaccination 1A@AYNY NNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-07-06T09:50 mRNA-1273-P201mRNA-1273-P201-US208-1121US2081121US208USAB?YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVVHqHDVyHr<HqHHr<DVyHr< mRNA-1273 100 ugA0AE-006A ADVERSE EVENT ELEVATED BLOOD PRESSURE POST DOSE Blood pressure increased Investigations FBlood pressure increased FFVascular tests NEC (incl blood pressure) FNCardiac and vascular investigations (excl enzyme tests) FInvestigations F2020-08-10T14:002020-08-11T09:50B$B% DVyDHrJ` B$DVzDHHraHVaccination stageA Vaccination 2AAYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA3SEVERE Grade 3A0Grade 3/Severe A0>=3A DOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-08-10T12:59 mRNA-1273-P201mRNA-1273-P201-US208-1121US2081121US208USAB?YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVVHqHDVyHr<HqHHr<DVyHr< mRNA-1273 100 ugA0AE-002A@ADVERSE EVENT STIFF NECK Musculoskeletal stiffness Musculoskeletal and connective tissue disorders FkStiff neck F:Fe(Musculoskeletal and connective tissue conditions NEC FMusculoskeletal and connective tissue disorders NEC FiMusculoskeletal and connective tissue disorders Fk2020-07-09 2020-07-11 A@A` DVY.. A@DV[..Vaccination stageA Vaccination 1A@A`YNY NNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-07-06T09:50 ArthritisBROAD mRNA-1273-P201mRNA-1273-P201-US208-1121US2081121US208USAB?YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVVHqHDVyHr<HqHHr<DVyHr< mRNA-1273 100 ugA0AE-004APADVERSE EVENT STIFF NECK Musculoskeletal stiffness Musculoskeletal and connective tissue disorders FkStiff neck F:Fe(Musculoskeletal and connective tissue conditions NEC FMusculoskeletal and connective tissue disorders NEC FiMusculoskeletal and connective tissue disorders Fk2020-07-13 2020-07-15 AA DV].. ADV_..Vaccination stageA Vaccination 1AAYNY NNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-07-06T09:50 ArthritisBROAD mRNA-1273-P201mRNA-1273-P201-US208-1121US2081121US208USAB?YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVVHqHDVyHr<HqHHr<DVyHr< mRNA-1273 100 ugA0AE-005A0ADVERSE EVENT HEADACHE Headache Nervous system disorders FHeadache FFHeadaches NEC FHeadaches FNervous system disorders F2020-07-13 2020-07-15 AA DV].. ADV_..Vaccination stageA Vaccination 1AAYNY NNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-07-06T09:50 Headache Y mRNA-1273-P201mRNA-1273-P201-US208-1121US2081121US208USAB?YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVVHqHDVyHr<HqHHr<DVyHr< mRNA-1273 100 ugA0AE-003A`ADVERSE EVENT SORE THROAT Oropharyngeal pain Respiratory, thoracic and mediastinal disorders F-Sore throat F8F_Upper respiratory tract signs and symptoms FKiRespiratory tract signs and symptoms F}Respiratory, thoracic and mediastinal disorders F-2020-07-09 2020-07-11 A@A` DVY.. A@DV[..Vaccination stageA Vaccination 1A@A`YNY NNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-07-06T09:50 mRNA-1273-P201mRNA-1273-P201-US208-1123US2081123US208USABAYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYNYYNNNNYYYNNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVPHq$DVPHq$Hq$Hq$.. mRNA-1273 50 ug A AE-001A0ADVERSE EVENT DOUBLE PNEUMONIA (COMMUNITY ACQUIRED) Pneumonia Infections and infestations FCommunity acquired pneumonia FF!Lower respiratory tract and lung infections FInfections - pathogen unspecified FInfections and infestations F2020-08-01 2020-08-26 B!B: DVp.. B!DV..Follow up stage A Vaccination 1B!B:YY NYNNNYYNNOT RELATEDNOT RELATED NOT RELATEDA3SEVERE Grade 3A0Grade 3/Severe A0>=3A DRUG WITHDRAWN CONCOMITANT MEDICATION RECOVERED/RESOLVED 2020-08-012020-08-05N DOSE 1 - 2020-06-30T12:18 mRNA-1273-P201mRNA-1273-P201-US208-1123US2081123US208USABAYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYNYYNNNNYYYNNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVPHq$DVPHq$Hq$Hq$.. mRNA-1273 50 ug A AE-003AADVERSE EVENT ELEVATED ALKALINE PHOSPHATASE Blood alkaline phosphatase increased Investigations FAlkaline phosphatase increased F F2Tissue enzyme analyses NEC FAEnzyme investigations NEC FInvestigations F2020-08-11 2020-09-08 B+BG DVz.. B+DV..Follow up stage A Vaccination 1B+BGYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 1 - 2020-06-30T12:18 mRNA-1273-P201mRNA-1273-P201-US208-1123US2081123US208USABAYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYNYYNNNNYYYNNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVPHq$DVPHq$Hq$Hq$.. mRNA-1273 50 ug A AE-002A ADVERSE EVENT ELEVATED PLATELET COUNT Platelet count increased Investigations FPlatelet count increased F`F`Platelet analyses F!CHaematology investigations (incl blood groups) F#Investigations F2020-08-11 2020-09-08 B+BG DVz.. B+DV..Follow up stage A Vaccination 1B+BGYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 1 - 2020-06-30T12:18 mRNA-1273-P201mRNA-1273-P201-US208-1125US2081125US208USAB>YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNPlacebo APlacebo ADVRHqDVrHq LHqHq LDVrHq L Placebo AAE-001AADVERSE EVENT COMMON COLD Nasopharyngitis Infections and infestations FCommon cold FF Upper respiratory tract infections FKeInfections - pathogen unspecified FInfections and infestations F2020-08-04 2020-08-10 B"B( DVs.. B"DVy..Vaccination stageA Vaccination 2A AYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-08-03T13:49 mRNA-1273-P201mRNA-1273-P201-US208-1129US2081129US208USAB:YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVRHqDVrHqHqHqDVrHq mRNA-1273 100 ugA0AE-002APADVERSE EVENT MALAISE Malaise General disorders and administration site conditions FMalaise F F Asthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2020-08-10 2020-08-10 B(B( DVy.. B(DVy..Vaccination stageA Vaccination 2AAYYY NNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-08-03T13:59 mRNA-1273-P201mRNA-1273-P201-US208-1129US2081129US208USAB:YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVRHqDVrHqHqHqDVrHq mRNA-1273 100 ugA0AE-009AADVERSE EVENT CHEMICAL BURN (MIDDLE STERNUM AND LEFT LATERAL SUPERIOR CHEST) Chemical burn Injury, poisoning and procedural complications FChemical burn FdFdChemical injuries FhExposures, chemical injuries and poisoning FInjury, poisoning and procedural complications F2020-12-08 B.ONGOINGDV.. B...Follow up stage A Vaccination 2B.YY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERING/RESOLVING DOSE 2 - 2020-08-03T13:59 mRNA-1273-P201mRNA-1273-P201-US208-1129US2081129US208USAB:YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVRHqDVrHqHqHqDVrHq mRNA-1273 100 ugA0AE-001A ADVERSE EVENT DIZZINESS Dizziness Nervous system disorders FDizziness F˅F˅Neurological signs and symptoms NEC FNeurological disorders NEC FNervous system disorders F2020-08-07T07:002020-08-12 B%B* DVvDbpHqp B%DV{..Vaccination stageA Vaccination 2A@AYYY NNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-08-03T13:59 Hearing and Vestibular DisordersBROAD