HEADER RECORD*******LIBRARY HEADER RECORD!!!!!!!000000000000000000000000000000 SAS SAS SASLIB 6.06 MAC1. 02JAN25:16:09:4802JAN25:16:09:48 HEADER RECORD*******MEMBER HEADER RECORD!!!!!!!000000000000000001600000000140 HEADER RECORD*******DSCRPTR HEADER RECORD!!!!!!!000000000000000000000000000000 SAS ADAE SASDATA 6.06 02JAN25:16:09:4802JAN25:16:09:48 Adverse Event Analysis Dataset HEADER RECORD*******NAMESTR HEADER RECORD!!!!!!!000000012600000000000000000000 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 PPND29FLPer Protocol nAb Day 29 Flag PPND57FLPer Protocol nAb Day 57 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 !COMPLFL Completers Population 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 (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  -TRT01A Actual Treatment for Period 01 .TRT01AN Actual Treatment for Period 01 (N) BEST  //TR01SDT Date of First Exposure in Period 01 DATE  70TR01SDTMDatetime of First Exposure in Period 01 DATETIME ?1TR01EDT Date of Last Exposure in Period 01 DATE  G2TR01EDTMDatetime of Last Exposure in Period 01 DATETIME O3TRTSDTM Datetime of First Exposure to Treatment DATETIME W4TRTEDTM Datetime of Last Exposure to Treatment DATETIME _5DOSE2DT Date of Dose 2 DATE  g6DOS2DTM Datetime of Dose 2 DATETIME o7AELNKGRPLink Group ID w8TRTA Actual Treatment {9TRTAN Actual Treatment (N) BEST  :AESPID Sponsor-Defined Identifier ;AESEQ Sequence Number BEST  AEDECOD Dictionary-Derived Term C?AEBODSYSBody System or Organ Class $@AEBDSYCDBody System or Organ Class Code BEST  g$AAELLT Lowest Level Term oBAELLTCD Lowest Level Term Code BEST  CAEPTCD Preferred Term Code BEST  FDAEHLT High Level Term EAEHLTCD High Level Term Code BEST  VFAEHLGT High Level Group Term GAEHLGTCDHigh Level Group Term Code BEST  GCHAESOC Primary System Organ Class OIAESOCCD Primary System Organ Class Code BEST  JAESTDTC Start Date/Time of Adverse Event KAEENDTC End Date/Time of Adverse Event LAESTDY Study Day of Start of Adverse Event BEST  MAEENDY Study Day of End of Adverse Event BEST  NAEENRF End Relative to Reference Period OASTDT Analysis Start Date DATE  PASTTM Analysis Start Time TIME  QASTDTM Analysis Start Date/Time DATETIME RASTDTF Analysis Start Date Imputation Flag SASTTMF Analysis Start Time Imputation Flag TASTDY Analysis Start Relative Day BEST  UAENDT Analysis End Date DATE  VAENTM Analysis End Time TIME  WAENDTM Analysis End Date/Time DATETIME XASTAGE Stage  YASTAGEN Stage (N) BEST   ZAEDUR Duration of Adverse Event $ [MDOSREF Most Recent Dose Reference /\MRDSTDY Relative Start Day from Most Recent DoseBEST  <]MRDENDY Relative End Day from Most Recent Dose BEST  D^TRTEMFL Treatment Emergent Analysis Flag L_AEMAFL Medically-Attended Flag M`D28FL AE Through 28 Days Analysis Flag NaAEDISFL Leading to Study Discontinuation Flag ObAESOFL Solicited Adverse Reaction? PcAESER Serious Event QdAESCONG Congenital Anomaly or Birth Defect ReAESDISABPersist or Signif Disability/Incapacity SfAESDTH Results in Death TgAESHOSP Requires or Prolongs Hospitalization UhAESLIFE Is Life Threatening ViAESMIE Other Medically Important Serious Event W jAEREL Causality XkAERELNSTRelationship to Non-Study Treatment c lAREL Analysis Causality qmARELN Analysis Causality (N) BEST  |nAETOXGR Standard Toxicity Grade oAESEV Severity/Intensity pATOXGR Analysis Toxicity Grade qATOXGRN Analysis Toxicity Grade (N) BEST  rASEV Analysis Severity/Intensity sASEVN Analysis Severity/Intensity (N) BEST  tTOXGGR1 Pooled Toxicity Grade Group 1 uTOXGGR1NPooled Toxicity Grade 1 (N) BEST  vAEACN Action Taken with Study Treatment -wAEACNOTHOther Action Taken xAEOUT Outcome of Adverse Event yAEOUTSP Recovered/Resolved with Sequelae,Spec  zAEHSTDTCHospital Admission Date  {AEHENDTCHospital Discharge Date !|ICUAD Admitted to ICU +}ICUDAY Duration of Healthcare Encounter ,~AEREFID Reference ID - 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 LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7Hq:DVWHqYHq:HqYDVWHqY mRNA-1273 50 ug A AE-001AADVERSE 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 - 2020-06-05T13:06mRNA-1273-P201mRNA-1273-P201-US202-1166US2021166US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FOTHER (b)(6) NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-07T11:54mRNA-1273-P201mRNA-1273-P201-US201-1004US2011004US201USAB7YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNmRNA-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 - 2020-06-01T13:36mRNA-1273-P201mRNA-1273-P201-US201-1007US2011007US201USABEYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNPlacebo 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 - 2020-06-01T14:47mRNA-1273-P201mRNA-1273-P201-US201-1028US2011028US201USAB<YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNmRNA-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 - 2020-06-01T11:11mRNA-1273-P201mRNA-1273-P201-US201-1040US2011040US201USABBYEARS>=55 Years A >=55 Years A@FBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNmRNA-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 - 2020-06-01T15:50mRNA-1273-P201mRNA-1273-P201-US201-1051US2011051US201USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE HISPANIC OR LATINO YYYYYYYYYNYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-06-02T16:12mRNA-1273-P201mRNA-1273-P201-US201-1055US2011055US201USAB-YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-06-02T17:03mRNA-1273-P201mRNA-1273-P201-US201-1055US2011055US201USAB-YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-06-02T17:03mRNA-1273-P201mRNA-1273-P201-US201-1060US2011060US201USAB1YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo 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 - 2020-06-30T16:39mRNA-1273-P201mRNA-1273-P201-US201-1060US2011060US201USAB1YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo 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 - 2020-06-02T12:40mRNA-1273-P201mRNA-1273-P201-US201-1064US2011064US201USAB"YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo 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 - 2020-07-01T13:53mRNA-1273-P201mRNA-1273-P201-US201-1067US2011067US201USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo 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 - 2020-06-03T13:35mRNA-1273-P201mRNA-1273-P201-US201-1067US2011067US201USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADV5HqDVWHq4HqHq4DVWHq4 Placebo AAE-002A ADVERSE 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 - 2020-06-03T13:35mRNA-1273-P201mRNA-1273-P201-US201-1068US2011068US201USAB,YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo 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 - 2020-06-30T09:41mRNA-1273-P201mRNA-1273-P201-US201-1068US2011068US201USAB,YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo 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 - 2020-06-30T09:41mRNA-1273-P201mRNA-1273-P201-US201-1068US2011068US201USAB,YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo 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 - 2020-06-30T09:41mRNA-1273-P201mRNA-1273-P201-US201-1084US2011084US201USAB1YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE HISPANIC OR LATINO YYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-06-30T08:19mRNA-1273-P201mRNA-1273-P201-US201-1088US2011088US201USAB/YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo 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 - 2020-07-07T09:38mRNA-1273-P201mRNA-1273-P201-US201-1089US2011089US201USAB YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7HqDVZHqzhHqHqzhDVZHqzh mRNA-1273 100 ugA0AE-001AADVERSE 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 1BBYYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-06-05T09:28mRNA-1273-P201mRNA-1273-P201-US201-1095US2011095US201USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYNYNYYYYYYNY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7HqYDVVHqO HqYHqO DVVHqO mRNA-1273 50 ug A AE-003A@ADVERSE 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 - 2020-06-05T15:19mRNA-1273-P201mRNA-1273-P201-US201-1095US2011095US201USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYNYNYYYYYYNY NNYYNNot DetectedNNNmRNA-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 - 2020-06-05T15:19mRNA-1273-P201mRNA-1273-P201-US201-1095US2011095US201USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYNYNYYYYYYNY NNYYNNot DetectedNNNmRNA-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 - 2020-06-05T15:19mRNA-1273-P201mRNA-1273-P201-US201-1095US2011095US201USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYNYNYYYYYYNY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7HqYDVVHqO HqYHqO DVVHqO mRNA-1273 50 ug A AE-004A0ADVERSE 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 - 2020-06-05T15:19mRNA-1273-P201mRNA-1273-P201-US201-1121US2011121US201USAB=YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVRHqDVnHqHqHqDVnHq mRNA-1273 100 ugA0AE-001AADVERSE EVENT HERPES SIMPLEX I Herpes simplex Infections and infestations FHerpes simplex type I FxFlHerpes viral infections FViral infectious disorders FOInfections and infestations F2020-08-23 B5.ONGOINGDV.. B5...Vaccination stageA Vaccination 2B.YYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERING/RESOLVING DOSE 2 - 2020-07-30T15:05mRNA-1273-P201mRNA-1273-P201-US201-1123US2011123US201USAB@YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-06-26T16:56mRNA-1273-P201mRNA-1273-P201-US201-1131US2011131US201USAB9YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADVLHqDVhHqHqHqDVhHq Placebo AAE-001AADVERSE EVENT NECK/SHOULDER PAIN, DUE TO SLEEPING POSITION Neck pain Musculoskeletal and connective tissue disorders FkNeck pain (with radiation) FF$Musculoskeletal and connective tissue pain and discomfort FMusculoskeletal and connective tissue disorders NEC FiMusculoskeletal and connective tissue disorders Fk2020-07-26 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 - 2020-07-24T15:05mRNA-1273-P201mRNA-1273-P201-US201-1137US2011137US201USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-06-26T09:14mRNA-1273-P201mRNA-1273-P201-US201-1137US2011137US201USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-06-26T09:14mRNA-1273-P201mRNA-1273-P201-US201-1152US2011152US201USABBYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYNYNYYNNYYYYYYY NNYYNNot DetectedNNNPlacebo 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 - 2020-07-27T12:16mRNA-1273-P201mRNA-1273-P201-US201-1162US2011162US201USAB>YEARS>=55 Years A >=55 Years A@FWHITE HISPANIC OR LATINO YYNNNNNNNNYYYNNNN NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVVHqIDVrHq:HqIHq:DVrHq: .AE-001AADVERSE 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 YYNNNNNNNNYYYNNNN NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVVHqIDVrHq:HqIHq:DVrHq: mRNA-1273 100 ugA0AE-002A ADVERSE 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 - 2020-07-06T16:32mRNA-1273-P201mRNA-1273-P201-US202-1011US2021011US202USAB:YEARS>=55 Years A >=55 Years A@MWHITE HISPANIC OR LATINO YYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNmRNA-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 - 2020-05-29T15:35mRNA-1273-P201mRNA-1273-P201-US202-1012US2021012US202USABBYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNmRNA-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 - 2020-06-29T10:18mRNA-1273-P201mRNA-1273-P201-US202-1018US2021018US202USABGYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYYmRNA-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 - 2020-05-29T13:35mRNA-1273-P201mRNA-1273-P201-US202-1018US2021018US202USABGYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYYmRNA-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 - 2020-05-29T13:35mRNA-1273-P201mRNA-1273-P201-US202-1018US2021018US202USABGYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYYmRNA-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 BD.ONGOINGDVs.. BD...Vaccination stageA Vaccination 2B.YYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERING/RESOLVING DOSE 2 - 2020-07-13T14:02mRNA-1273-P201mRNA-1273-P201-US202-1019US2021019US202USAB;YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNmRNA-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 2020-07-09 BB* DVJ.. BDVY..Vaccination stageA Vaccination 1BB*YYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION, CONCOMITANT PROCEDURERECOVERED/RESOLVED DOSE 1 - 2020-05-29T15:05mRNA-1273-P201mRNA-1273-P201-US202-1019US2021019US202USAB;YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNmRNA-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 - 2020-05-29T15:05mRNA-1273-P201mRNA-1273-P201-US202-1020US2021020US202USABHYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNmRNA-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 - 2020-06-01T12:25mRNA-1273-P201mRNA-1273-P201-US202-1020US2021020US202USABHYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNmRNA-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 - 2020-06-01T12:25mRNA-1273-P201mRNA-1273-P201-US202-1022US2021022US202USABCYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNPlacebo 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 - 2020-07-06T11:51mRNA-1273-P201mRNA-1273-P201-US202-1043US2021043US202USABAYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNPlacebo 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 - 2020-06-01T16:21mRNA-1273-P201mRNA-1273-P201-US202-1043US2021043US202USABAYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNPlacebo 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 - 2020-06-01T16:21mRNA-1273-P201mRNA-1273-P201-US202-1045US2021045US202USAB=YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNmRNA-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 - 2020-06-29T15:10mRNA-1273-P201mRNA-1273-P201-US202-1058US2021058US202USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-07T09:22mRNA-1273-P201mRNA-1273-P201-US202-1058US2021058US202USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-07T09:22mRNA-1273-P201mRNA-1273-P201-US202-1058US2021058US202USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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.YNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE NOT RECOVERED/NOT RESOLVED DOSE 2 - 2020-07-07T09:22mRNA-1273-P201mRNA-1273-P201-US202-1058US2021058US202USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-07T09:22mRNA-1273-P201mRNA-1273-P201-US202-1058US2021058US202USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-07T09:22mRNA-1273-P201mRNA-1273-P201-US202-1058US2021058US202USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-07T09:22mRNA-1273-P201mRNA-1273-P201-US202-1062US2021062US202USAB,YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo 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 - 2020-06-04T11:13mRNA-1273-P201mRNA-1273-P201-US202-1062US2021062US202USAB,YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo 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 - 2020-06-04T11:13mRNA-1273-P201mRNA-1273-P201-US202-1062US2021062US202USAB,YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo 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 - 2020-06-04T11:13mRNA-1273-P201mRNA-1273-P201-US202-1062US2021062US202USAB,YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo 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 - 2020-06-04T11:13mRNA-1273-P201mRNA-1273-P201-US202-1062US2021062US202USAB,YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo 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 - 2020-06-04T11:13mRNA-1273-P201mRNA-1273-P201-US202-1064US2021064US202USAB6YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-06-08T08:48mRNA-1273-P201mRNA-1273-P201-US202-1064US2021064US202USAB6YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-06-08T08:48mRNA-1273-P201mRNA-1273-P201-US202-1064US2021064US202USAB6YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-06-08T08:48mRNA-1273-P201mRNA-1273-P201-US202-1064US2021064US202USAB6YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-06-08T08:48mRNA-1273-P201mRNA-1273-P201-US202-1073US2021073US202USAB3YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADV4Hq9TDVPHq0Hq9THq0DVPHq0 Placebo AAE-002AADVERSE 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 - 2020-06-02T12:11mRNA-1273-P201mRNA-1273-P201-US202-1074US2021074US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-06-02T09:14mRNA-1273-P201mRNA-1273-P201-US202-1080US2021080US202USAB1YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7HqVDVXHqՉ HqVHqՉ DVXHqՉ mRNA-1273 100 ugA0AE-005A ADVERSE 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 - 2020-07-08T09:28mRNA-1273-P201mRNA-1273-P201-US202-1080US2021080US202USAB1YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7HqVDVXHqՉ HqVHqՉ DVXHqՉ 1080mRNA-1273 100 ugA0AE-001A0REACTOGENICITYFATIGUE 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 - 2020-06-05T15:06mRNA-1273-P201mRNA-1273-P201-US202-1084US2021084US202USAB"YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-07T10:31mRNA-1273-P201mRNA-1273-P201-US202-1094US2021094US202USAB5YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYNNNNNNNNYNYNNNN YYYNNNot DetectedYNNPlacebo 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 - 2020-06-05T15:26mRNA-1273-P201mRNA-1273-P201-US202-1094US2021094US202USAB5YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYNNNNNNNNYNYNNNN YYYNNNot DetectedYNNPlacebo 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 - 2020-06-05T15:26mRNA-1273-P201mRNA-1273-P201-US202-1094US2021094US202USAB5YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYNNNNNNNNYNYNNNN YYYNNNot DetectedYNNPlacebo 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 - 2020-06-05T15:26mRNA-1273-P201mRNA-1273-P201-US202-1096US2021096US202USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo 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$DVZ..Vaccination stageAP2D Vaccination 2ApAYNY YNNNNNNNRELATED RELATED RELATED A 3SEVERE Grade 3A0Grade 3/Severe A0>=3A DOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-02T13:53mRNA-1273-P201mRNA-1273-P201-US202-1099US2021099US202USAB1YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4Hq{0DVPHq@Hq{0Hq@DVPHq@ mRNA-1273 100 ugA0AE-001AADVERSE EVENT LUMP RIGHT AXILLARY REGION IPSILATERAL-SAME SIDE OF VACCINATION SITE Axillary mass Musculoskeletal and connective tissue disorders FkAxillary lump FYFUSoft tissue disorders NEC F7Musculoskeletal and connective tissue disorders NEC FiMusculoskeletal and connective tissue disorders Fk2020-07-17 2020-07-17 B.B. DVa.. B.DVa..Vaccination stageA Vaccination 2BBYNY NNNNNNNNRELATED RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-06-30T14:17mRNA-1273-P201mRNA-1273-P201-US202-1101US2021101US202USAB#YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:Hq'|DVYHqhHq'|HqhDVYHqh mRNA-1273 100 ugA0AE-002AADVERSE EVENT PAIN AT INJECTION SITE Injection site pain General disorders and administration site conditions FPain injection site F-FInjection site reactions FAdministration site reactions FGeneral disorders and administration site conditions F2020-06-20 2020-06-20 AA DVF.. ADVF..Vaccination stageA Vaccination 1AAYNY NNNNNNNNRELATED RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-06-08T12:33mRNA-1273-P201mRNA-1273-P201-US202-1111US2021111US202USAB$YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNYPlacebo APlacebo ADV:HqDVeHq`HqHq`DVeHq` Placebo AAE-004A ADVERSE 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$B*YN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-08T09:23mRNA-1273-P201mRNA-1273-P201-US202-1111US2021111US202USAB$YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNYPlacebo APlacebo ADV:HqDVeHq`HqHq`DVeHq` Placebo AAE-003A0ADVERSE 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 - 2020-06-08T09:23mRNA-1273-P201mRNA-1273-P201-US202-1111US2021111US202USAB$YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNYPlacebo APlacebo ADV:HqDVeHq`HqHq`DVeHq` Placebo AAE-002AADVERSE EVENT COUGH Cough Respiratory, thoracic and mediastinal disorders F-Cough FXFXCoughing and associated symptoms FaRespiratory disorders NEC F-Respiratory, thoracic and mediastinal disorders F-2020-07-12 2020-07-16 B#B' DV\.. B#DV`..Vaccination stageA Vaccination 1B#B'YN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE DELAYED CONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-06-08T09:23mRNA-1273-P201mRNA-1273-P201-US202-1111US2021111US202USAB$YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNYPlacebo 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 - 2020-06-08T09:23mRNA-1273-P201mRNA-1273-P201-US202-1130US2021130US202USABPYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo 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 - 2020-06-26T10:15mRNA-1273-P201mRNA-1273-P201-US202-1130US2021130US202USABPYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo 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 - 2020-07-29T11:35mRNA-1273-P201mRNA-1273-P201-US202-1137US2021137US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYNNNNYYYYYNN NNYYNNot DetectedYNNPlacebo 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 - 2020-06-08T16:13mRNA-1273-P201mRNA-1273-P201-US202-1144US2021144US202USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNPlacebo 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 - 2020-06-05T11:22mRNA-1273-P201mRNA-1273-P201-US202-1144US2021144US202USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNPlacebo 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 - 2020-06-05T11:22mRNA-1273-P201mRNA-1273-P201-US202-1144US2021144US202USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNPlacebo 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 - 2020-06-05T11:22mRNA-1273-P201mRNA-1273-P201-US202-1151US2021151US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:Hqa`DVYHq%dHqa`Hq%dDVYHq%d mRNA-1273 100 ugA0AE-001A0ADVERSE 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 - 2020-06-08T16:40mRNA-1273-P201mRNA-1273-P201-US202-1151US2021151US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:Hqa`DVYHq%dHqa`Hq%dDVYHq%d mRNA-1273 100 ugA0AE-002APADVERSE 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 - 2020-07-09T14:47mRNA-1273-P201mRNA-1273-P201-US202-1154US2021154US202USAB"YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-06-05T14:21mRNA-1273-P201mRNA-1273-P201-US202-1154US2021154US202USAB"YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7HqLLDVXHqԘHqLLHqԘDVXHqԘ2070mRNA-1273 100 ugA0AE-002A REACTOGENICITYHEADACHE 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 - 2020-07-08T14:50mRNA-1273-P201mRNA-1273-P201-US202-1164US2021164US202USAB"YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-06-08T09:13mRNA-1273-P201mRNA-1273-P201-US202-1164US2021164US202USAB"YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-06-08T09:13mRNA-1273-P201mRNA-1273-P201-US202-1175US2021175US202USAB$YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADV:HqBpDVXHqձHqBpHqձDVXHqձ2080Placebo AAE-001AREACTOGENICITYFATIGUE Fatigue General disorders and administration site conditions FFatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2020-07-08T21:312020-07-17T14:13BB( DVXE@Hq2 BDVaDHqlVaccination stageAP2DT1H52M Vaccination 2AAYNY YNNNNNNNRELATED RELATED RELATED A 3SEVERE Grade 3A0Grade 3/Severe A0>=3A DOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-08T12:21mRNA-1273-P201mRNA-1273-P201-US202-1175US2021175US202USAB$YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADV:HqBpDVXHqձHqBpHqձDVXHqձ Placebo AAE-011A ADVERSE 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 - 2020-07-08T12:21mRNA-1273-P201mRNA-1273-P201-US202-1179US2021179US202USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:HqLDVWHqԇHqLHqԇDVWHqԇ mRNA-1273 50 ug A AE-001AADVERSE 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 - 2020-06-08T15:12mRNA-1273-P201mRNA-1273-P201-US202-1180US2021180US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-08T09:58mRNA-1273-P201mRNA-1273-P201-US202-1180US2021180US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-06-08T17:04mRNA-1273-P201mRNA-1273-P201-US202-1180US2021180US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-08T09:58mRNA-1273-P201mRNA-1273-P201-US202-1180US2021180US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-08T09:58mRNA-1273-P201mRNA-1273-P201-US202-1180US2021180US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-08T09:58mRNA-1273-P201mRNA-1273-P201-US202-1185US2021185US202USAB7YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADVLHqDVoHq?HqHq?DVoHq? Placebo AAE-001AADVERSE 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 - 2020-06-26T14:07mRNA-1273-P201mRNA-1273-P201-US202-1196US2021196US202USAB?YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo 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 - 2020-07-02T11:37mRNA-1273-P201mRNA-1273-P201-US202-1205US2021205US202USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYNYYYYYYN NNYYNNot DetectedNNNmRNA-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 - 2020-06-26T15:09mRNA-1273-P201mRNA-1273-P201-US202-1205US2021205US202USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYNYYYYYYN NNYYNNot DetectedNNNmRNA-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 - 2020-07-31T09:34mRNA-1273-P201mRNA-1273-P201-US202-1206US2021206US202USAB@YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo 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 - 2020-07-02T12:16mRNA-1273-P201mRNA-1273-P201-US202-1206US2021206US202USAB@YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo 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 Ap.ONGOINGDVX.. Ap...Vaccination stageA Vaccination 1Ap.YYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT PROCEDURE NOT RECOVERED/NOT RESOLVED DOSE 1 - 2020-07-02T12:16mRNA-1273-P201mRNA-1273-P201-US202-1208US2021208US202USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNmRNA-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 - 2020-07-29T16:20mRNA-1273-P201mRNA-1273-P201-US202-1208US2021208US202USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNmRNA-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 - 2020-07-29T16:20mRNA-1273-P201mRNA-1273-P201-US202-1208US2021208US202USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNmRNA-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 - 2020-07-29T16:20mRNA-1273-P201mRNA-1273-P201-US202-1208US2021208US202USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVQHq̨DVmHq0Hq̨Hq0DVmHq0 mRNA-1273 100 ugA0AE-001A@ADVERSE 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 - 2020-07-29T16:20mRNA-1273-P201mRNA-1273-P201-US202-1211US2021211US202USABNYEARS>=55 Years A >=55 Years A@FWHITE HISPANIC OR LATINO YYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVRHqDVoHqHqHqDVoHq mRNA-1273 100 ugA0AE-001AADVERSE 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 - 2020-07-02T15:28mRNA-1273-P201mRNA-1273-P201-US202-1214US2021214US202USABIYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYNYYYYYYN NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHq DDVhHqHq DHqDVhHq mRNA-1273 100 ugA0AE-001AADVERSE 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 - 2020-06-26T15:27mRNA-1273-P201mRNA-1273-P201-US202-1217US2021217US202USABBYEARS>=55 Years A >=55 Years A@FWHITE NOT REPORTED YYYYYYYYYNYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-29T13:15mRNA-1273-P201mRNA-1273-P201-US202-1218US2021218US202USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-06-30T11:34mRNA-1273-P201mRNA-1273-P201-US202-1222US2021222US202USABAYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYYYYYYY NNYYNNot DetectedNNNPlacebo 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 - 2020-07-31T12:30mRNA-1273-P201mRNA-1273-P201-US202-1226US2021226US202USABDYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVVHq+DVsHq-Hq+Hq-DVsHq- mRNA-1273 50 ug A AE-001A0ADVERSE 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 - 2020-08-04T10:19mRNA-1273-P201mRNA-1273-P201-US202-1234US2021234US202USABFYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 2020-08-28 B%B5 DV{.. B%DV..Vaccination stageA Vaccination 2ABYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-08-04T11:23mRNA-1273-P201mRNA-1273-P201-US203-1004US2031004US203USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-06-29T09:40mRNA-1273-P201mRNA-1273-P201-US203-1004US2031004US203USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-06-29T09:40mRNA-1273-P201mRNA-1273-P201-US203-1004US2031004US203USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-05-29T14:24mRNA-1273-P201mRNA-1273-P201-US203-1029US2031029US203USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo 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 - 2020-07-07T08:49mRNA-1273-P201mRNA-1273-P201-US203-1029US2031029US203USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo 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 B.ONGOINGDVC.. B...Vaccination stageA Vaccination 1B.YNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RECOVERED/NOT RESOLVED DOSE 1 - 2020-06-02T09:07mRNA-1273-P201mRNA-1273-P201-US203-1035US2031035US203USAB0YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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$YN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-06-29T10:42mRNA-1273-P201mRNA-1273-P201-US203-1035US2031035US203USAB0YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3HqDVOHqɼHqHqɼDVOHqɼ mRNA-1273 100 ugA0AE-002A ADVERSE EVENT RHINORRHEA Rhinorrhoea Respiratory, thoracic and mediastinal disorders F-Rhinorrhea F/<F/=Upper respiratory tract signs and symptoms FKiRespiratory tract signs and symptoms F}Respiratory, thoracic and mediastinal disorders F-2020-07-27 2020-08-03 B9B@ DVk.. B9DVr..Follow up stage A Vaccination 2BB$YN NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-06-29T10:42mRNA-1273-P201mRNA-1273-P201-US203-1041US2031041US203USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADV4HqDVQHqKHqHqKDVQHqK 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 F2020-07-05 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 - 2020-07-01T09:13mRNA-1273-P201mRNA-1273-P201-US203-1042US2031042US203USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-06T14:34mRNA-1273-P201mRNA-1273-P201-US203-1042US2031042US203USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-06-04T15:59mRNA-1273-P201mRNA-1273-P201-US203-1057US2031057US203USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-01T08:25mRNA-1273-P201mRNA-1273-P201-US203-1057US2031057US203USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-01T08:25mRNA-1273-P201mRNA-1273-P201-US203-1057US2031057US203USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-01T08:25mRNA-1273-P201mRNA-1273-P201-US203-1072US2031072US203USAB6YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-06-03T12:40mRNA-1273-P201mRNA-1273-P201-US203-1074US2031074US203USAB4YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo 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 - 2020-06-02T17:03mRNA-1273-P201mRNA-1273-P201-US203-1074US2031074US203USAB4YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo 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 - 2020-06-02T17:03mRNA-1273-P201mRNA-1273-P201-US203-1074US2031074US203USAB4YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo 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 - 2020-06-30T15:23mRNA-1273-P201mRNA-1273-P201-US203-1079US2031079US203USAB"YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-02T10:50mRNA-1273-P201mRNA-1273-P201-US203-1081US2031081US203USAB$YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedYNNPlacebo 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 - 2020-07-02T09:49mRNA-1273-P201mRNA-1273-P201-US203-1089US2031089US203USABAYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo 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 B1.ONGOINGDV|.. B1...Vaccination stageA Vaccination 2B.YNY NNNNNNNNRELATED RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERING/RESOLVING DOSE 2 - 2020-07-29T10:16mRNA-1273-P201mRNA-1273-P201-US203-1097US2031097US203USABVYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVPHq%DVrHq/HHq%Hq/HDVrHq/H mRNA-1273 50 ug A AE-001AADVERSE 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 - 2020-08-03T16:14mRNA-1273-P201mRNA-1273-P201-US203-1097US2031097US203USABVYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 B8.ONGOINGDV.. B8...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 - 2020-08-03T16:14mRNA-1273-P201mRNA-1273-P201-US203-1102US2031102US203USAB9YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedYNNPlacebo 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 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 2 - 2020-08-03T17:52mRNA-1273-P201mRNA-1273-P201-US203-1103US2031103US203USABBYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo 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 - 2020-06-29T13:09mRNA-1273-P201mRNA-1273-P201-US203-1105US2031105US203USABCYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-06-26T09:19mRNA-1273-P201mRNA-1273-P201-US203-1121US2031121US203USABCYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYNYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVPHq=XDVlHq)8Hq=XHq)8DVlHq)8 mRNA-1273 50 ug A AE-001AADVERSE 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 - 2020-06-30T14:02mRNA-1273-P201mRNA-1273-P201-US204-1008US2041008US204USAB%YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNmRNA-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 - 2020-07-01T15:55mRNA-1273-P201mRNA-1273-P201-US204-1019US2041019US204USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAMWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNPlacebo 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 - 2020-06-30T13:43mRNA-1273-P201mRNA-1273-P201-US204-1047US2041047US204USAB!YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedYNNmRNA-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 F2020-06-02 2020-08-13 ABI DV4.. ADV|..Vaccination stageA Vaccination 1ABIYYY NNNNNNNNNOT RELATEDNOT APPLICABLENOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-02T08:31mRNA-1273-P201mRNA-1273-P201-US204-1060US2041060US204USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNmRNA-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 - 2020-06-02T09:25mRNA-1273-P201mRNA-1273-P201-US204-1060US2041060US204USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNmRNA-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 - 2020-06-02T09:25mRNA-1273-P201mRNA-1273-P201-US204-1061US2041061US204USAB4YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNmRNA-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 - 2020-07-06T12:06mRNA-1273-P201mRNA-1273-P201-US204-1073US2041073US204USAB,YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-06-02T17:30mRNA-1273-P201mRNA-1273-P201-US204-1073US2041073US204USAB,YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-06-30T16:35mRNA-1273-P201mRNA-1273-P201-US204-1076US2041076US204USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4Hq6 DVVHqHq6 HqDVVHq1080mRNA-1273 50 ug A AE-004AREACTOGENICITYFATIGUE 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 - 2020-06-02T11:57mRNA-1273-P201mRNA-1273-P201-US204-1076US2041076US204USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-06T12:29mRNA-1273-P201mRNA-1273-P201-US204-1076US2041076US204USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4Hq6 DVVHqHq6 HqDVVHq2090mRNA-1273 50 ug A AE-002APREACTOGENICITYMYALGIA 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 - 2020-07-06T12:29mRNA-1273-P201mRNA-1273-P201-US204-1076US2041076US204USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4Hq6 DVVHqHq6 HqDVVHq1070mRNA-1273 50 ug A AE-005A0REACTOGENICITYHEADACHE 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 - 2020-06-02T11:57mRNA-1273-P201mRNA-1273-P201-US204-1076US2041076US204USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-06T12:29mRNA-1273-P201mRNA-1273-P201-US204-1077US2041077US204USAB%YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-01T11:05mRNA-1273-P201mRNA-1273-P201-US204-1077US2041077US204USAB%YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-01T11:05mRNA-1273-P201mRNA-1273-P201-US204-1092US2041092US204USAB4YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNYYYYNNN YYYYNNot DetectedNNYmRNA-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 - 2020-06-08T16:05mRNA-1273-P201mRNA-1273-P201-US204-1103US2041103US204USABBYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYNYNYYNNYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqlDVhHqxHqlHqxDVhHqx mRNA-1273 50 ug A AE-002AADVERSE 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 - 2020-07-24T11:46mRNA-1273-P201mRNA-1273-P201-US204-1103US2041103US204USABBYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYNYNYYNNYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqlDVhHqxHqlHqxDVhHqx mRNA-1273 50 ug A AE-001A ADVERSE 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 - 2020-06-26T11:33mRNA-1273-P201mRNA-1273-P201-US204-1104US2041104US204USABDYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-06-26T11:47mRNA-1273-P201mRNA-1273-P201-US204-1112US2041112US204USAB=YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-06-26T13:02mRNA-1273-P201mRNA-1273-P201-US204-1119US2041119US204USABDYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVVHq#LDVsHq*LHq#LHq*LDVsHq*L mRNA-1273 50 ug A AE-001A ADVERSE 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 B$.ONGOINGDVy.. B$...Vaccination stageA Vaccination 2Ap.YYY NNNNNNNNNOT RELATEDNOT APPLICABLENOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE CONCOMITANT MEDICATION RECOVERING/RESOLVING DOSE 2 - 2020-08-04T10:05mRNA-1273-P201mRNA-1273-P201-US204-1119US2041119US204USABDYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVVHq#LDVsHq*LHq#LHq*LDVsHq*L mRNA-1273 50 ug A AE-002AADVERSE EVENT CYST ON SPINAL NERVE Nervous system cyst Nervous system disorders FNervous system cyst FFNervous system cysts and polyps FNervous system neoplasms benign FNervous system disorders F2020-08-10 B$.ONGOINGDVy.. B$...Vaccination stageA Vaccination 2Ap.YYY NNNNNNNNNOT RELATEDNOT APPLICABLENOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ANOT APPLICABLE NONE RECOVERING/RESOLVING DOSE 2 - 2020-08-04T10:05mRNA-1273-P201mRNA-1273-P201-US204-1122US2041122US204USABRYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-06-29T09:22mRNA-1273-P201mRNA-1273-P201-US204-1126US2041126US204USAB>YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-06-26T12:45mRNA-1273-P201mRNA-1273-P201-US204-1146US2041146US204USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo 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 - 2020-07-31T08:42mRNA-1273-P201mRNA-1273-P201-US204-1146US2041146US204USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo 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 - 2020-07-02T17:03mRNA-1273-P201mRNA-1273-P201-US204-1155US2041155US204USAB@YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYYYYYNY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVVHq;DVrHqdHq;HqdDVrHqd2070mRNA-1273 50 ug A AE-001AREACTOGENICITYHEADACHE 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 - 2020-08-03T14:15mRNA-1273-P201mRNA-1273-P201-US205-1009US2051009US205USAB3YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-06-02T10:38mRNA-1273-P201mRNA-1273-P201-US205-1010US2051010US205USAB*YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-06-02T13:37mRNA-1273-P201mRNA-1273-P201-US205-1012US2051012US205USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYNYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-06-02T14:37mRNA-1273-P201mRNA-1273-P201-US205-1022US2051022US205USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNPlacebo APlacebo ADV5HqeTDVWHq;HqeTHq;DVWHq; Placebo AAE-001AADVERSE 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 - 2020-07-07T09:45mRNA-1273-P201mRNA-1273-P201-US205-1032US2051032US205USAB)YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-06-02T11:06mRNA-1273-P201mRNA-1273-P201-US205-1033US2051033US205USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNmRNA-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$DVZ..Vaccination stageA Vaccination 2A0A@YNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-07T10:16mRNA-1273-P201mRNA-1273-P201-US205-1033US2051033US205USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV6Hq DVWHqBHq HqBDVWHqB2080mRNA-1273 50 ug A AE-005A0REACTOGENICITYFATIGUE Fatigue General disorders and administration site conditions FFatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2020-07-07 2020-07-15 B"B* DVW.. B"DV_..Vaccination stageAP2D Vaccination 2AAYNY YNNNNNNNRELATED RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-07T10:16mRNA-1273-P201mRNA-1273-P201-US205-1033US2051033US205USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV6Hq DVWHqBHq HqBDVWHqB mRNA-1273 50 ug A AE-002AREACTOGENICITYJOINT ACHES IN SEVERAL JOINTS Arthralgia Musculoskeletal and connective tissue disorders FkAching joints FAF'Joint related signs and symptoms F:Joint disorders F-Musculoskeletal and connective tissue disorders Fk2020-07-07 2020-07-15 B"B* DVW.. B"DV_..Vaccination stageAP2D Vaccination 2AAYNY YNNNNNNNRELATED NOT RELATED RELATED A 3SEVERE Grade 3A0Grade 3/Severe A0>=3A DOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-07T10:16mRNA-1273-P201mRNA-1273-P201-US205-1034US2051034US205USAB$YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-06-03T09:35mRNA-1273-P201mRNA-1273-P201-US205-1036US2051036US205USAB1YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo 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 B4.ONGOINGDVg.. B4...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 - 2020-07-02T14:22mRNA-1273-P201mRNA-1273-P201-US205-1040US2051040US205USAB0YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-06-05T14:28mRNA-1273-P201mRNA-1273-P201-US205-1042US2051042US205USAB#YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYNYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4Hq4DVQHq̅xHq4Hq̅xDVQHq̅x mRNA-1273 50 ug A AE-001AADVERSE EVENT TOOTHACHE Toothache Gastrointestinal disorders FܛToothache FBFBDental pain and sensation disorders FBDental and gingival conditions FBrGastrointestinal disorders Fܛ2020-06-04 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 - 2020-06-02T11:52mRNA-1273-P201mRNA-1273-P201-US205-1045US2051045US205USAB$YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV<HqdDVXHqHqdHqDVXHq mRNA-1273 100 ugA0AE-001AADVERSE EVENT DIASTOLIC HYPERTENSION Diastolic hypertension Vascular disorders FNYDiastolic hypertension FVFVVascular hypertensive disorders NEC FVascular hypertensive disorders FuVascular disorders FNY2020-07-16 B%.ONGOINGDV`.. B%...Vaccination stageA Vaccination 2A.YNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA3SEVERE Grade 3A0Grade 3/Severe A0>=3A DOSE NOT CHANGEDNONE NOT RECOVERED/NOT RESOLVED DOSE 2 - 2020-07-08T15:50mRNA-1273-P201mRNA-1273-P201-US205-1057US2051057US205USAB=YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqŹDVhHqꚐHqŹHqꚐDVhHqꚐ1080mRNA-1273 50 ug A AE-005A REACTOGENICITYFATIGUE Fatigue General disorders and administration site conditions FFatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2020-06-26 2020-07-08 AA DVL.. ADVX..Vaccination stageAP6D Vaccination 1AAYNY YNNNNNNNRELATED RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 1 - 2020-06-26T09:36mRNA-1273-P201mRNA-1273-P201-US205-1057US2051057US205USAB=YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqŹDVhHqꚐHqŹHqꚐDVhHqꚐ2080mRNA-1273 50 ug A AE-002A0REACTOGENICITYFATIGUE Fatigue General disorders and administration site conditions FFatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2020-07-24 2020-07-31 BB$ 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 - 2020-07-24T09:00mRNA-1273-P201mRNA-1273-P201-US205-1057US2051057US205USAB=YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-24T09:00mRNA-1273-P201mRNA-1273-P201-US205-1057US2051057US205USAB=YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-06-26T09:36mRNA-1273-P201mRNA-1273-P201-US205-1057US2051057US205USAB=YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-24T09:00mRNA-1273-P201mRNA-1273-P201-US205-1068US2051068US205USABDYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-28T13:08mRNA-1273-P201mRNA-1273-P201-US205-1068US2051068US205USABDYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-28T13:08mRNA-1273-P201mRNA-1273-P201-US205-1068US2051068US205USABDYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-28T13:08mRNA-1273-P201mRNA-1273-P201-US205-1069US2051069US205USAB@YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-28T09:17mRNA-1273-P201mRNA-1273-P201-US205-1072US2051072US205USABEYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedYNNPlacebo 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 - 2020-08-03T09:49mRNA-1273-P201mRNA-1273-P201-US205-1084US2051084US205USAB=YEARS>=55 Years A >=55 Years A@FWHITE HISPANIC OR LATINO YYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-01T12:08mRNA-1273-P201mRNA-1273-P201-US205-1088US2051088US205USAB:YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYNYNYYNNYYYYYNN NNYYNNot DetectedNNNmRNA-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 - 2020-07-28T10:05mRNA-1273-P201mRNA-1273-P201-US205-1103US2051103US205USAB:YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYNYYYYYYN NNYYNNot DetectedNNNmRNA-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 - 2020-07-02T15:41mRNA-1273-P201mRNA-1273-P201-US205-1103US2051103US205USAB:YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYNYYYYYYN NNYYNNot DetectedNNNmRNA-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 - 2020-07-02T15:41mRNA-1273-P201mRNA-1273-P201-US205-1108US2051108US205USABAYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-06T14:41mRNA-1273-P201mRNA-1273-P201-US205-1112US2051112US205USAB<YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo 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 - 2020-08-03T12:40mRNA-1273-P201mRNA-1273-P201-US206-1001US2061001US206USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNYYYYNNN YYYYNNot DetectedNNYmRNA-1273 50 ug A mRNA-1273 50 ug A DV6Hq1,DVZHqsHq1,HqsDVZHqs mRNA-1273 50 ug A AE-001AADVERSE 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 - 2020-07-10T14:33mRNA-1273-P201mRNA-1273-P201-US206-1008US2061008US206USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-06T09:36mRNA-1273-P201mRNA-1273-P201-US206-1008US2061008US206USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-06T09:36mRNA-1273-P201mRNA-1273-P201-US206-1021US2061021US206USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo 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 - 2020-07-02T14:03mRNA-1273-P201mRNA-1273-P201-US206-1023US2061023US206USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYNYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-06-05T11:36mRNA-1273-P201mRNA-1273-P201-US206-1023US2061023US206USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYNYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7Hq%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 Fk2020-07-12 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 - 2020-07-06T09:40mRNA-1273-P201mRNA-1273-P201-US206-1035US2061035US206USABGYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNYYYYNNN YYYYNNot DetectedNNNPlacebo APlacebo ADVLHqDVdHqepHqHqepDVdHqep 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 F2020-06-26T13:412020-06-26T19:00AA DVLDlHql ADVLEHq=0Vaccination stageA Vaccination 1AAYNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-26T12:34mRNA-1273-P201mRNA-1273-P201-US206-1037US2061037US206USAB8YEARS>=55 Years A >=55 Years A@FNATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER NOT HISPANIC OR LATINOYYYYYYYYYNYYYYYYY NNYYNNot DetectedNNNmRNA-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 LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo 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 - 2020-07-27T14:46mRNA-1273-P201mRNA-1273-P201-US206-1043US2061043US206USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo 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 - 2020-07-27T14:46mRNA-1273-P201mRNA-1273-P201-US206-1043US2061043US206USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADVOHqDVkHq(HqHq(DVkHq(2090Placebo AAE-002A0REACTOGENICITYMUSCLE ACHES Myalgia Musculoskeletal and connective tissue disorders FkGeneralized muscle aches FiF{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 - 2020-07-27T14:46mRNA-1273-P201mRNA-1273-P201-US206-1051US2061051US206USAB:YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADVPHqdDVnHq8HqdHq8DVnHq8 Placebo AAE-001AREACTOGENICITYFATIGUE Fatigue General disorders and administration site conditions FFatigue FFAsthenic conditions F^General system disorders NEC FGeneral disorders and administration site conditions F2020-07-06 2020-07-07 ApA DVV.. ApDVW..Vaccination stageAP1D Vaccination 1ApAYNY YNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 1 - 2020-06-30T11:03mRNA-1273-P201mRNA-1273-P201-US206-1053US2061053US206USAB@YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYNYYYYYYN NNYYNNot DetectedNNNmRNA-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 - 2020-07-01T10:29mRNA-1273-P201mRNA-1273-P201-US206-1068US2061068US206USAB?YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-06-30T09:48mRNA-1273-P201mRNA-1273-P201-US206-1068US2061068US206USAB?YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-06-30T09:48mRNA-1273-P201mRNA-1273-P201-US207-1002US2071002US207USAB'YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3HqDVPHq:HqHq:DVPHq:2110mRNA-1273 100 ugA0AE-007APREACTOGENICITYNAUSEA 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 - 2020-06-30T13:48mRNA-1273-P201mRNA-1273-P201-US207-1002US2071002US207USAB'YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-06-30T13:48mRNA-1273-P201mRNA-1273-P201-US207-1002US2071002US207USAB'YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3HqDVPHq:HqHq:DVPHq:2070mRNA-1273 100 ugA0AE-001A REACTOGENICITYHEADACHE 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 - 2020-06-30T13:48mRNA-1273-P201mRNA-1273-P201-US207-1004US2071004US207USAB'YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-08T09:18mRNA-1273-P201mRNA-1273-P201-US207-1004US2071004US207USAB'YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-08T09:18mRNA-1273-P201mRNA-1273-P201-US207-1004US2071004US207USAB'YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-08T09:18mRNA-1273-P201mRNA-1273-P201-US207-1025US2071025US207USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNmRNA-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 - 2020-07-08T11:01mRNA-1273-P201mRNA-1273-P201-US207-1025US2071025US207USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNmRNA-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 - 2020-07-08T11:01mRNA-1273-P201mRNA-1273-P201-US207-1030US2071030US207USAB%YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNmRNA-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 - 2020-06-03T17:16mRNA-1273-P201mRNA-1273-P201-US207-1030US2071030US207USAB%YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNmRNA-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 - 2020-06-03T17:16mRNA-1273-P201mRNA-1273-P201-US207-1030US2071030US207USAB%YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNmRNA-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 - 2020-06-03T17:16mRNA-1273-P201mRNA-1273-P201-US207-1036US2071036US207USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAMWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-13T12:48mRNA-1273-P201mRNA-1273-P201-US207-1039US2071039US207USAB5YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNYYYYNNN YYYYNNot DetectedNNYmRNA-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 - 2020-06-05T16:53mRNA-1273-P201mRNA-1273-P201-US207-1039US2071039US207USAB5YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNYYYYNNN YYYYNNot DetectedNNYmRNA-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 - 2020-06-05T16:53mRNA-1273-P201mRNA-1273-P201-US207-1043US2071043US207USABEYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNmRNA-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 - 2020-07-06T12:01mRNA-1273-P201mRNA-1273-P201-US207-1062US2071062US207USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE HISPANIC OR LATINO YYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADV6Hq`DVWHqHq`HqDVWHq Placebo AAE-001AADVERSE 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 - 2020-06-04T16:40mRNA-1273-P201mRNA-1273-P201-US207-1073US2071073US207USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-06-08T12:07mRNA-1273-P201mRNA-1273-P201-US207-1073US2071073US207USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-06-08T12:07mRNA-1273-P201mRNA-1273-P201-US207-1082US2071082US207USAB9YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 B6.ONGOINGDV.. B6...Vaccination stageA Vaccination 2B.YYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERING/RESOLVING DOSE 2 - 2020-07-28T10:00mRNA-1273-P201mRNA-1273-P201-US207-1082US2071082US207USAB9YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 B6.ONGOINGDV.. B6...Vaccination stageA Vaccination 2B.YYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERING/RESOLVING DOSE 2 - 2020-07-28T10:00mRNA-1273-P201mRNA-1273-P201-US207-1085US2071085US207USABKYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo 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 - 2020-07-28T14:11mRNA-1273-P201mRNA-1273-P201-US207-1085US2071085US207USABKYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo 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 - 2020-06-26T14:43mRNA-1273-P201mRNA-1273-P201-US207-1100US2071100US207USAB=YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADVVHqC,DVsHq4$HqC,Hq4$DVsHq4$ Placebo AAE-001A ADVERSE 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 - 2020-08-04T10:47mRNA-1273-P201mRNA-1273-P201-US207-1100US2071100US207USAB=YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADVVHqC,DVsHq4$HqC,Hq4$DVsHq4$ Placebo AAE-002AADVERSE 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 - 2020-08-04T10:47mRNA-1273-P201mRNA-1273-P201-US207-1106US2071106US207USAB@YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNYNYYNNN NNYNNNot DetectedYNNmRNA-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 - 2020-07-06T16:51mRNA-1273-P201mRNA-1273-P201-US208-1001US2081001US208USAB9YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNmRNA-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 - 2020-06-24T08:24mRNA-1273-P201mRNA-1273-P201-US208-1004US2081004US208USAB<YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNPlacebo 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 - 2020-05-29T14:09mRNA-1273-P201mRNA-1273-P201-US208-1004US2081004US208USAB<YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNPlacebo 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 - 2020-05-29T14:09mRNA-1273-P201mRNA-1273-P201-US208-1005US2081005US208USAB7YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNPlacebo 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 A.ONGOINGDV;.. A...Vaccination stageA Vaccination 1A.YYY NNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RECOVERED/NOT RESOLVED DOSE 1 - 2020-06-01T10:31mRNA-1273-P201mRNA-1273-P201-US208-1007US2081007US208USAB@YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNYYYYYY NNYYNNot DetectedNYNPlacebo 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 - 2020-06-01T08:01mRNA-1273-P201mRNA-1273-P201-US208-1007US2081007US208USAB@YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNYYYYYY NNYYNNot DetectedNYNPlacebo APlacebo ADV3Hq<DVPHqQHq<HqQDVPHqQ Placebo AAE-003A ADVERSE EVENT PI NOTED INFLAMMATION OF OROPHARNYX AT DAY 15 VISIT Upper respiratory tract inflammationRespiratory, thoracic and mediastinal disorders F-Upper respiratory tract inflammationFX6FX6Upper 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 - 2020-06-01T08:01mRNA-1273-P201mRNA-1273-P201-US208-1009US2081009US208USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNmRNA-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 - 2020-07-02T13:24mRNA-1273-P201mRNA-1273-P201-US208-1014US2081014US208USABCYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3Hq@DVPHq$Hq@Hq$DVPHq$ mRNA-1273 100 ugA0AE-001AADVERSE 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 - 2020-06-01T14:08mRNA-1273-P201mRNA-1273-P201-US208-1016US2081016US208USAB7YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNmRNA-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 - 2020-06-29T14:08mRNA-1273-P201mRNA-1273-P201-US208-1017US2081017US208USAB>YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNPlacebo 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 - 2020-06-02T08:14mRNA-1273-P201mRNA-1273-P201-US208-1025US2081025US208USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5HqzDVWHqxPHqzHqxPDVWHqxP mRNA-1273 100 ugA0AE-003AADVERSE EVENT HEMORRHOIDS Haemorrhoids Gastrointestinal disorders FܛHemorrhoids FFHaemorrhoids and gastrointestinal varices (excl oesophageal) FGastrointestinal vascular conditions FGastrointestinal disorders Fܛ2020-08 ..ONGOINGDVp..D B<...Vaccination stageA Vaccination 2B.YYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERING/RESOLVING DOSE 2 - 2020-07-07T14:04mRNA-1273-P201mRNA-1273-P201-US208-1028US2081028US208USAB3YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-06-02T14:03mRNA-1273-P201mRNA-1273-P201-US208-1033US2081033US208USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADV4HqDVWHqHDHqHqHDDVWHqHD Placebo AAE-001AADVERSE 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 - 2020-07-07T10:39mRNA-1273-P201mRNA-1273-P201-US208-1038US2081038US208USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo 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 - 2020-06-08T08:02mRNA-1273-P201mRNA-1273-P201-US208-1042US2081042US208USAB1YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo 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 - 2020-07-08T08:00mRNA-1273-P201mRNA-1273-P201-US208-1045US2081045US208USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-07T14:18mRNA-1273-P201mRNA-1273-P201-US208-1045US2081045US208USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-07T14:18mRNA-1273-P201mRNA-1273-P201-US208-1045US2081045US208USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-07T14:18mRNA-1273-P201mRNA-1273-P201-US208-1045US2081045US208USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-06-04T10:02mRNA-1273-P201mRNA-1273-P201-US208-1046US2081046US208USAB-YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADV:HqSDVYHqňHqSHqňDVYHqň Placebo AAE-001AADVERSE 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 - 2020-06-08T15:42mRNA-1273-P201mRNA-1273-P201-US208-1049US2081049US208USAB/YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADV;HqNDVXHqrdHqNHqrdDVXHqrd Placebo AAE-001AADVERSE 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 - 2020-07-08T07:51mRNA-1273-P201mRNA-1273-P201-US208-1049US2081049US208USAB/YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADV;HqNDVXHqrdHqNHqrdDVXHqrd Placebo AAE-003A ADVERSE 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 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-07-08T07:51mRNA-1273-P201mRNA-1273-P201-US208-1049US2081049US208USAB/YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADV;HqNDVXHqrdHqNHqrdDVXHqrd Placebo AAE-002A0ADVERSE EVENT URINARY TRACT INFECTION Urinary tract infection Infections and infestations FUrinary tract infection FLkFLkUrinary tract infections FLqInfections - pathogen unspecified FInfections and infestations F2020-07-27 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 - 2020-07-08T07:51mRNA-1273-P201mRNA-1273-P201-US208-1052US2081052US208USAB%YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7Hq*DVYHq4Hq*Hq4DVYHq4 mRNA-1273 50 ug A AE-001AADVERSE 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 - 2020-06-05T11:58mRNA-1273-P201mRNA-1273-P201-US208-1059US2081059US208USAB'YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:HqCDV]Hq=HqCHq=DV]Hq= mRNA-1273 50 ug A AE-002AADVERSE 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 - 2020-07-13T11:33mRNA-1273-P201mRNA-1273-P201-US208-1059US2081059US208USAB'YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:HqCDV]Hq=HqCHq=DV]Hq= mRNA-1273 50 ug A AE-001A ADVERSE 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 - 2020-07-13T11:33mRNA-1273-P201mRNA-1273-P201-US208-1063US2081063US208USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAMWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:Hq DVXHqՏtHq HqՏtDVXHqՏt mRNA-1273 100 ugA0AE-001AADVERSE 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 - 2020-07-08T09:55mRNA-1273-P201mRNA-1273-P201-US208-1064US2081064US208USAB0YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-09T09:56mRNA-1273-P201mRNA-1273-P201-US208-1066US2081066US208USABBYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo 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 - 2020-07-24T09:29mRNA-1273-P201mRNA-1273-P201-US208-1069US2081069US208USABFYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-06-26T14:54mRNA-1273-P201mRNA-1273-P201-US208-1069US2081069US208USABFYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-24T14:17mRNA-1273-P201mRNA-1273-P201-US208-1070US2081070US208USABGYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-24T14:01mRNA-1273-P201mRNA-1273-P201-US208-1071US2081071US208USABAYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYNYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-29T11:55mRNA-1273-P201mRNA-1273-P201-US208-1071US2081071US208USABAYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYNYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVPHq!tDVmHq[Hq!tHq[DVmHq[ mRNA-1273 50 ug A AE-002A ADVERSE EVENT POST OPT 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 - 2020-07-29T11:55mRNA-1273-P201mRNA-1273-P201-US208-1072US2081072US208USAB;YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-06-26T09:50mRNA-1273-P201mRNA-1273-P201-US208-1076US2081076US208USAB7YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYNYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-08-05T14:22mRNA-1273-P201mRNA-1273-P201-US208-1076US2081076US208USAB7YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYNYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-08-05T14:22mRNA-1273-P201mRNA-1273-P201-US208-1088US2081088US208USAB?YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYNYYYYYYN NNYYNNot DetectedNNNmRNA-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 - 2020-07-02T10:12mRNA-1273-P201mRNA-1273-P201-US208-1092US2081092US208USABMYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-02T10:27mRNA-1273-P201mRNA-1273-P201-US208-1092US2081092US208USABMYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-02T10:27mRNA-1273-P201mRNA-1273-P201-US208-1092US2081092US208USABMYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-02T10:27mRNA-1273-P201mRNA-1273-P201-US208-1092US2081092US208USABMYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-02T10:27mRNA-1273-P201mRNA-1273-P201-US208-1093US2081093US208USABBYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-02T11:50mRNA-1273-P201mRNA-1273-P201-US208-1093US2081093US208USABBYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-02T11:50mRNA-1273-P201mRNA-1273-P201-US208-1099US2081099US208USAB7YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYNYYYYYYN NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqŮ8DVmHq$HqŮ8Hq$DVmHq$2100mRNA-1273 100 ugA0AE-003AREACTOGENICITYGENERALIZED JOINT ACHES (DAY 8-DAY 14 AFTER INJECTION) Arthralgia Musculoskeletal and connective tissue disorders FkGeneralized joint pain FfF'Joint related signs and symptoms F:Joint disorders F-Musculoskeletal and connective tissue disorders Fk2020-08-06 2020-08-11 B*B/ DVu.. B*DVz..Vaccination stageAP7D Vaccination 2AAYNY YNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERED/RESOLVED DOSE 2 - 2020-07-29T08:04mRNA-1273-P201mRNA-1273-P201-US208-1099US2081099US208USAB7YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYNYYYYYYN NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqŮ8DVmHq$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 - 2020-07-29T08:04mRNA-1273-P201mRNA-1273-P201-US208-1100US2081100US208USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYNYNYNNNYYYYYYN NYYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVRHqDVrHqHqHqDVrHq mRNA-1273 50 ug A AE-001AADVERSE 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 - 2020-07-02T13:51mRNA-1273-P201mRNA-1273-P201-US208-1100US2081100US208USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYNYNYNNNYYYYYYN NYYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVRHqDVrHqHqHqDVrHq2080mRNA-1273 50 ug A AE-005A0REACTOGENICITYFATIGUE 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 F2020-08-09 2020-08-11 B'B) DVx.. B'DVz..Vaccination stageAP2D Vaccination 2ApAYNY YNNNNNNNRELATED NOT RELATED RELATED A 1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDNONE RECOVERED/RESOLVED DOSE 2 - 2020-08-03T10:06mRNA-1273-P201mRNA-1273-P201-US208-1100US2081100US208USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYNYNYNNNYYYYYYN NYYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVRHqDVrHqHqHqDVrHq mRNA-1273 50 ug A AE-004APADVERSE 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 - 2020-08-03T10:06mRNA-1273-P201mRNA-1273-P201-US208-1100US2081100US208USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYNYNYNNNYYYYYYN NYYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVRHqDVrHqHqHqDVrHq1070mRNA-1273 50 ug A AE-002A@REACTOGENICITYHEADACHE 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 - 2020-07-02T13:51mRNA-1273-P201mRNA-1273-P201-US208-1103US2081103US208USAB:YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo 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 - 2020-07-02T08:04mRNA-1273-P201mRNA-1273-P201-US208-1103US2081103US208USAB:YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo 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 - 2020-07-02T08:04mRNA-1273-P201mRNA-1273-P201-US208-1118US2081118US208USABFYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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.YNY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA1MILD Grade 1AGrade 1/Mild A<3 ADOSE NOT CHANGEDCONCOMITANT MEDICATION RECOVERING/RESOLVING DOSE 1 - 2020-07-01T14:01mRNA-1273-P201mRNA-1273-P201-US208-1120US2081120US208USABHYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-29T14:00mRNA-1273-P201mRNA-1273-P201-US208-1120US2081120US208USABHYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-29T14:00mRNA-1273-P201mRNA-1273-P201-US208-1121US2081121US208USAB?YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-06T09:50mRNA-1273-P201mRNA-1273-P201-US208-1121US2081121US208USAB?YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-08-10T12:59mRNA-1273-P201mRNA-1273-P201-US208-1121US2081121US208USAB?YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-06T09:50mRNA-1273-P201mRNA-1273-P201-US208-1121US2081121US208USAB?YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-06T09:50mRNA-1273-P201mRNA-1273-P201-US208-1121US2081121US208USAB?YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-06T09:50mRNA-1273-P201mRNA-1273-P201-US208-1121US2081121US208USAB?YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-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 - 2020-07-06T09:50mRNA-1273-P201mRNA-1273-P201-US208-1123US2081123US208USABAYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNYNYYNNN YYYNNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVPHq$DVPHq$Hq$Hq$.. mRNA-1273 50 ug A AE-001A0ADVERSE EVENT DOUBLE PNEUMONIA (COMMUNITY ACQUIRED) Pneumonia Infections and infestations FCommunity acquired pneumonia FF!Lower respiratory tract and lung infections FInfections - pathogen unspecified FInfections and infestations F2020-08-01 2020-08-26 B!B: DVp.. B!DV..Follow up stage A Vaccination 1B!B:YY NYNNNYYNNOT RELATEDNOT RELATED NOT RELATEDA3SEVERE Grade 3A0Grade 3/Severe A0>=3A DRUG WITHDRAWN CONCOMITANT MEDICATION RECOVERED/RESOLVED 2020-08-012020-08-05N DOSE 1 - 2020-06-30T12:18mRNA-1273-P201mRNA-1273-P201-US208-1123US2081123US208USABAYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNYNYYNNN YYYNNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVPHq$DVPHq$Hq$Hq$.. mRNA-1273 50 ug A AE-003AADVERSE EVENT ELEVATED ALKALINE PHOSPHATASE Blood alkaline phosphatase increasedInvestigations FAlkaline phosphatase increased F F2Tissue enzyme analyses NEC FAEnzyme investigations NEC FInvestigations F2020-08-11 2020-09-08 B+BG DVz.. B+DV..Follow up stage A Vaccination 1B+BGYY NNNNNNNNNOT RELATEDNOT RELATED NOT RELATEDA2MODERATEGrade 2A Grade 2/ModerateA <3 ANOT APPLICABLE NONE RECOVERED/RESOLVED DOSE 1 - 2020-06-30T12:18mRNA-1273-P201mRNA-1273-P201-US208-1123US2081123US208USABAYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNYNYYNNN YYYNNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVPHq$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 - 2020-06-30T12:18mRNA-1273-P201mRNA-1273-P201-US208-1125US2081125US208USAB>YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo 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 - 2020-08-03T13:49mRNA-1273-P201mRNA-1273-P201-US208-1129US2081129US208USAB:YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVRHqDVrHqHqHqDVrHq mRNA-1273 100 ugA0AE-002A@ADVERSE 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 - 2020-08-03T13:59mRNA-1273-P201mRNA-1273-P201-US208-1129US2081129US208USAB:YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVRHqDVrHqHqHqDVrHq mRNA-1273 100 ugA0AE-001AADVERSE 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