HEADER RECORD*******LIBRARY HEADER RECORD!!!!!!!000000000000000000000000000000 SAS SAS SASLIB 6.06 MAC1. 14NOV23:08:04:5014NOV23:08:04:50 HEADER RECORD*******MEMBER HEADER RECORD!!!!!!!000000000000000001600000000140 HEADER RECORD*******DSCRPTR HEADER RECORD!!!!!!!000000000000000000000000000000 SAS AE SASDATA 6.06 14NOV23:08:04:5014NOV23:08:04:50 Adverse Events HEADER RECORD*******NAMESTR HEADER RECORD!!!!!!!000000004900000000000000000000 STUDYID Study Identifier DOMAIN Domain Abbreviation USUBJID Unique Subject Identifier AESEQ Sequence Number BEST   AEREFID Reference ID (AESPID Sponsor-Defined Identifier 49AELNKGRPLink Group ID 6dAETERM Reported Term for the Adverse Event o> AELLT Lowest Level Term  AELLTCD Lowest Level Term Code BEST  ( AEDECOD Dictionary-Derived Term  AEPTCD Preferred Term Code BEST  AC AEHLT High Level Term IAEHLTCD High Level Term Code BEST  @AEHLGT High Level Group Term AEHLGTCDHigh Level Group Term Code BEST  AECAT Category for Adverse Event AESCAT Subcategory for Adverse Event AEPRESP Pre-Specified Adverse Event CAEBODSYSBody System or Organ Class AEBDSYCDBody System or Organ Class Code BEST  CCAESOC Primary System Organ Class KAESOCCD Primary System Organ Class Code BEST  AELOC Location of Event AELAT Laterality AESER Serious Event AEACN Action Taken with Study Treatment  AEREL Causality AERELNSTRelationship to Non-Study Treatment  AEOUT Outcome of Adverse Event AESCONG Congenital Anomaly or Birth Defect  AESDISABPersist or Signif Disability/Incapacity !AESDTH Results in Death "AESHOSP Requires or Prolongs Hospitalization #AESLIFE Is Life Threatening $AESMIE Other Medically Important Serious Event %AECONTRTConcomitant or Additional Trtmnt Given  &AETOXGR Standard Toxicity Grade  'EPOCH Epoch  (AESTDTC Start Date/Time of Adverse Event )AEENDTC End Date/Time of Adverse Event /*AESTDY Study Day of Start of Adverse Event BEST  ?+AEENDY Study Day of End of Adverse Event BEST  G,AEDUR Duration of Adverse Event O-AEELTM Planned Elapsed Time from Time Point Ref S.AETPTREFTime Point Reference [/AERFTDTCDate/Time of Reference Time Point p0AEENRTPTEnd Relative to Reference Time Point 1AEENTPT End Reference Time Point  HEADER RECORD*******OBS HEADER RECORD!!!!!!!000000000000000000000000000000 C4591001AEC4591001 1005 10051449A(b)(6) 1 Appendicitis Appendicitis FCAppendicitis FCAbdominal and gastrointestinal infections FܯInfections - pathogen unspecified FADVERSE EVENT Infections and infestations FInfections and infestations F YNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED NNNNNYY2REPEAT SCREENING 1 2021-06-28 2021-06-29 BB P147D VACCINATION 2 2021-02-01T11:21:00 C4591001AEC4591001 1152 11521617A(b)(6) 1 Elbow Fracture Elbow fracture FΈUpper limb fracture FRLimb fractures and dislocations FBone and joint injuries FADVERSE EVENT Injury, poisoning and procedural complications FInjury, poisoning and procedural complications F YNOT APPLICABLE NOT RELATEDOTHER NOT RECOVERED/NOT RESOLVED NNNYNNY2REPEAT SCREENING 1 2021-08-01T10:00 B. P216D VACCINATION 2 2020-12-28T09:03:00ONGOINGLAST SUBJECT ENCOUNTERC4591001AEC4591001 1150 11501242A@(b)(6) 5 Laceration of Left Kidney Laceration of kidney without mention of open wound into cavityFTraumatic renal injury FRenal and urinary tract injuries NEC FInjuries NEC FADVERSE EVENT Injury, poisoning and procedural complications FInjury, poisoning and procedural complications F YNOT APPLICABLE NOT RELATEDOTHER RECOVERING/RESOLVING NNNYNNN2OPEN LABEL FOLLOW-UP2021-07-17 B. P103D VACCINATION 4 2021-04-05T11:42:00ONGOINGLAST SUBJECT ENCOUNTERC4591001AEC4591001 1007 10071505A(b)(6) 8 Excessive Sleepiness Sleepiness F6Somnolence F8Disturbances in consciousness NEC FENeurological disorders NEC FADVERSE EVENT Nervous system disorders FNervous system disorders F YNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED NNNYNNN3OPEN LABEL TREATMENT2021-07-08T21:482021-07-22 BB P15D VACCINATION 4 2021-06-23T13:50:00 C4591001AEC4591001 1016 10161327A(b)(6) 1 epilepsy Epilepsy F=Epilepsy F=Seizures and seizure disorders NEC F2hSeizures (incl subtypes) F2gADVERSE EVENT Nervous system disorders FNervous system disorders F YNOT APPLICABLE NOT RELATEDOTHER NOT RECOVERED/NOT RESOLVED NNNNNYN2OPEN LABEL TREATMENT2021-06-29T13:30 B. P7D VACCINATION 4 2021-06-22T09:22:00ONGOINGLAST SUBJECT ENCOUNTERC4591001AEC4591001 1150 11501250A(b)(6) 1 Suicidal Ideation Suicidal ideation F0Central nervous system disorders congenital NEC FqNeurological disorders congenital FADVERSE EVENT Congenital, familial and genetic disorders FCongenital, familial and genetic disorders F YNOT APPLICABLE NOT RELATEDOTHER NOT RECOVERED/NOT RESOLVED NNNYNNY3 2021-06 .. ONGOINGLAST SUBJECT ENCOUNTERC4591001AEC4591001 1091 10911447A(b)(6) 3 Appendicitis Appendicitis FCAppendicitis FCAbdominal and gastrointestinal infections FܯInfections - pathogen unspecified FADVERSE EVENT Infections and infestations FInfections and infestations F YNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED NNNYNNY2REPEAT SCREENING 1 2021-07-09T03:002021-07-10T08:00BB P176D VACCINATION 2 2021-01-14T11:25:00 C4591001AEC4591001 1156 11561357A(b)(6) 1 APPENDICITIS Appendicitis FCAppendicitis FCAbdominal and gastrointestinal infections FܯInfections - pathogen unspecified FADVERSE EVENT Infections and infestations FInfections and infestations F YNOT APPLICABLE RELATED RECOVERED/RESOLVED NNNNNYY2OPEN LABEL TREATMENT2021-06-10 2021-06-10 BB P3D VACCINATION 4 2021-06-07T10:59:00 C4591001AEC4591001 1223 12231273A(b)(6) 1 Myopericarditis Myopericarditis FjMyocarditis F>Noninfectious myocarditis F Myocardial disorders F1ADVERSE EVENT Cardiac disorders FCardiac disorders F YNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED NNNYNNY3OPEN LABEL TREATMENT2021-06-12T19:002021-06-13 BB P2D VACCINATION 4 2021-06-10T09:58:00 C4591001AEC4591001 1007 10071600A(b)(6) 2 depression Depression FDepression FDepressive disorders FDepressed mood disorders and disturbances FADVERSE EVENT Psychiatric disorders F'Psychiatric disorders F' YNOT APPLICABLE NOT RELATEDOTHER RECOVERING/RESOLVING NNNYNNY2REPEAT SCREENING 1 2021-05-17 B. P118D VACCINATION 2 2021-01-19T12:02:00ONGOINGLAST SUBJECT ENCOUNTERC4591001AEC4591001 1007 10071600A (b)(6) 1 Suicidal Ideation Suicidal ideation FGastrointestinal inflammatory conditions FܱADVERSE EVENT Gastrointestinal disorders FܛGastrointestinal disorders Fܛ NNOT APPLICABLE NOT RELATEDCONCOMITANT DRUG TREATMENT RECOVERED/RESOLVED Y2VACCINATION 2021-01-30 2021-04 B . P10D VACCINATION 2 2021-01-20T16:30:00 C4591001AEC4591001 1007 10071620AP 11 constipation Constipation FConstipation FGastrointestinal atonic and hypomotility disorders NEC F܍Gastrointestinal motility and defaecation conditions FܹADVERSE EVENT Gastrointestinal disorders FܛGastrointestinal disorders Fܛ NNOT APPLICABLE NOT RELATEDOTHER RECOVERING/RESOLVING Y2FOLLOW-UP 2021-03-13 BJ. P52D VACCINATION 2 2021-01-20T16:30:00ONGOINGLAST SUBJECT ENCOUNTERC4591001AEC4591001 1007 10071620J-+M VACCINATION 2-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-21 B. P1D VACCINATION 2 2021-01-20 ONGOINGV3_MONTH1_POSTVAX2_L C4591001AEC4591001 1007 10071620A0 9 worsening anxiety Anxiety aggravated FSSAnxiety FAnxiety symptoms FAnxiety disorders and symptoms FADVERSE EVENT Psychiatric disorders F'Psychiatric disorders F' NNOT APPLICABLE NOT RELATEDOTHER NOT RECOVERED/NOT RESOLVED Y2VACCINATION 2021-01-30 B . P10D VACCINATION 2 2021-01-20T16:30:00ONGOINGLAST SUBJECT ENCOUNTERC4591001AEC4591001 1007 10071620A 2 Abdominal pain Abdominal pain FAbdominal pain FGastrointestinal and abdominal pains (excl oral and throat) F܆Gastrointestinal signs and symptoms FADVERSE EVENT Gastrointestinal disorders FܛGastrointestinal disorders Fܛ NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2VACCINATION 2021-01-21 2021-02-09 BB* P1D VACCINATION 2 2021-01-20T16:30:00 C4591001AEC4591001 1007 10071622J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-30 2021-01-08 AAP3D VACCINATION 1 2020-12-30 C4591001AEC4591001 1007 10071623J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-05 2021-01-06 ApAP1D P6D VACCINATION 1 2020-12-30 C4591001AEC4591001 1007 10071623A0 2 right wrist tendonitis Tendonitis F?wTendonitis F?wTendon disorders F?bTendon, ligament and cartilage disorders F?eADVERSE EVENT Musculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED WITH SEQUELAE Y2VACCINATION 2021-02-15 2021-08-09 B0B P25D VACCINATION 2 2021-01-21T16:27:00 C4591001AEC4591001 1007 10071623A 4 Injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-01T17:002021-06-03T08:30BB PT1H18M VACCINATION 3 2021-06-01T15:42:00 C4591001AEC4591001 1007 10071623A@ 1 teeth pain Tooth pain FToothache FBDental pain and sensation disorders FBDental and gingival conditions FBrADVERSE EVENT Gastrointestinal disorders FܛGastrointestinal disorders Fܛ NNOT APPLICABLE NOT RELATEDCONCOMITANT NON-DRUG TREATMENTRECOVERED/RESOLVED Y2VACCINATION 2021-01-27T12:002021-01-28T06:45BB P6D VACCINATION 2 2021-01-21T16:27:00 C4591001AEC4591001 1007 10071623A 3 Fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-01T16:302021-06-02T08:30BB PT48M VACCINATION 3 2021-06-01T15:42:00 C4591001AEC4591001 1007 10071624A 1 left Arm Pain Painful L arm FiPain in extremity FMusculoskeletal and connective tissue pain and discomfort FMusculoskeletal and connective tissue disorders NEC FiADVERSE EVENT Musculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-20T07:002021-05-21T13:00BB P1D VACCINATION 3 2021-05-19T14:34:00 C4591001AEC4591001 1007 10071625A 2 Injection Site Arm Pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-20T07:002021-05-21T13:00BB P1D VACCINATION 3 2021-05-19T14:31:00 C4591001AEC4591001 1007 10071625A 1 fever Fever F.Pyrexia F)Febrile disorders FBody temperature conditions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-05-20T07:002021-05-20T08:00BB P1D VACCINATION 3 2021-05-19T14:31:00 C4591001AEC4591001 1007 10071628J-+M VACCINATION 2-MUSCLE PAIN MUSCLE PAIN Muscle pain F"Myalgia F{Muscle pains F#Muscle disorders FREACTOGENICITY SYSTEMIC YMusculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk VACCINATION 2021-01-21 2021-01-27 BBP1D P1D VACCINATION 2 2021-01-20 C4591001AEC4591001 1007 10071629J-+M VACCINATION 2-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-20 2021-01-27 BBP1D VACCINATION 2 2021-01-20 C4591001AEC4591001 1007 10071632J-+M VACCINATION 2-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-21 2021-01-28 BBP1D VACCINATION 2 2021-01-21 C4591001AEC4591001 1007 10071632J-+M VACCINATION 2-CHILLS CHILLS Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-21 2021-01-28 BBP1D VACCINATION 2 2021-01-21 C4591001AEC4591001 1007 10071632A 2 tenderness at injection site Injection site tenderness FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT ACUTE REACTIONS General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1VACCINATION 2020-12-30T16:472020-12-31 AA PT02M VACCINATION 1 2020-12-30T16:45:00 C4591001AEC4591001 1007 10071632A 3 pain at blood draw site Venipuncture site pain FU7Vessel puncture site pain FAdministration site reactions NEC FuAdministration site reactions FADVERSE EVENT ACUTE REACTIONS General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N1VACCINATION 2020-12-30T16:472020-12-31 AA PT02M VACCINATION 1 2020-12-30T16:45:00 C4591001AEC4591001 1007 10071632J-+M VACCINATION 2-DELTOID MUSCLE-LEFT-PAIN AT INJECTION SITE PAIN AT INJECTION SITE Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FREACTOGENICITY ADMINISTRATION SITEYGeneral disorders and administration site conditions FGeneral disorders and administration site conditions FDELTOID MUSCLELEFT VACCINATION 2021-01-21 2021-01-28 BBP1D VACCINATION 2 2021-01-21 C4591001AEC4591001 1007 10071632Ap 4 rash to chest and back Rash trunk F`Rash F*TRashes, eruptions and exanthems NEC FcEpidermal and dermal conditions FADVERSE EVENT Skin and subcutaneous tissue disorders F5Skin and subcutaneous tissue disorders F5 NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2VACCINATION 2021-01-22T13:002021-01-26 BB P1D VACCINATION 2 2021-01-21T11:33:00 C4591001AEC4591001 1007 10071632A` 5 Arm pain Pain in arm F Pain in extremity FMusculoskeletal and connective tissue pain and discomfort FMusculoskeletal and connective tissue disorders NEC FiADVERSE EVENT Musculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-19 2021-05-22 BB P1D VACCINATION 3 2021-05-18T10:20:00 C4591001AEC4591001 1007 10071632A@ 7 Body ache Ache F(Pain FPain and discomfort NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-19 2021-05-19 BB P1D VACCINATION 3 2021-05-18T10:20:00 C4591001AEC4591001 1007 10071632A0 10 nausea Nausea F Nausea F Nausea and vomiting symptoms FGastrointestinal signs and symptoms FADVERSE EVENT Gastrointestinal disorders FܛGastrointestinal disorders Fܛ NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-09 2021-06-09 BB P1D VACCINATION 4 2021-06-08T10:08:00 C4591001AEC4591001 1007 10071632AP 9 generalized body aches Generalised aching FPain FPain and discomfort NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-06-09 2021-06-09 BB P1D VACCINATION 4 2021-06-08T10:08:00 C4591001AEC4591001 1007 10071632A 8 Nausea Nausea F Nausea F Nausea and vomiting symptoms FGastrointestinal signs and symptoms FADVERSE EVENT Gastrointestinal disorders FܛGastrointestinal disorders Fܛ NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-19 2021-05-19 BB P1D VACCINATION 3 2021-05-18T10:20:00 C4591001AEC4591001 1007 10071632A 6 Headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-19 2021-05-19 BB P1D VACCINATION 3 2021-05-18T10:20:00 C4591001AEC4591001 1007 10071632A 1 headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT ACUTE REACTIONS Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1VACCINATION 2020-12-30T16:552020-12-30T16:56AA PT10M VACCINATION 1 2020-12-30T16:45:00 C4591001AEC4591001 1007 10071634A 1 Rhinorrhea Rhinorrhea F/<Rhinorrhoea F/=Upper respiratory tract signs and symptoms FKiRespiratory tract signs and symptoms F}ADVERSE EVENT Respiratory, thoracic and mediastinal disorders F-Respiratory, thoracic and mediastinal disorders F- NNOT APPLICABLE NOT RELATEDOTHER RECOVERING/RESOLVING N1VACCINATION 2021-02-18 B.. P24D VACCINATION 2 2021-01-25T11:01:00ONGOINGLAST SUBJECT ENCOUNTERC4591001AEC4591001 1007 10071634A 2 vasovagal response Vasovagal reaction FNPresyncope F%Neurological signs and symptoms NEC FNeurological disorders NEC FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N1FOLLOW-UP 2021-02-22T15:392021-02-22 B2B2 P28D VACCINATION 2 2021-01-25T11:01:00 C4591001AEC4591001 1007 10071640A@ 2 fever Fever F.Pyrexia F)Febrile disorders FBody temperature conditions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-06-22T21:002021-06-23T20:00BB PT7H02M VACCINATION 4 2021-06-22T13:58:00 C4591001AEC4591001 1007 10071640A0 1 Injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-03T19:002021-06-04T19:00BB PT5H08M VACCINATION 3 2021-06-03T13:52:00 C4591001AEC4591001 1007 10071640A 3 headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-06-22T21:002021-06-23T20:00BB PT7H02M VACCINATION 4 2021-06-22T13:58:00 C4591001AEC4591001 1007 10071640A 4 Chills Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-22T21:002021-06-23T20:00BB PT7H02M VACCINATION 4 2021-06-22T13:58:00 C4591001AEC4591001 1007 10071642J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-05 2021-02-01 A BP22DP1D VACCINATION 1 2021-01-04 C4591001AEC4591001 1007 10071642AP 1 fever 103.5 Fever F.Pyrexia F)Febrile disorders FBody temperature conditions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y3REPEAT SCREENING 1 2021-05-28 2021-05-29 BB P1D UNPLANNED VACCINATION2021-05-27T14:42:00 C4591001AEC4591001 1007 10071642A@ 2 body aches Generalized aching F\Pain FPain and discomfort NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2REPEAT SCREENING 1 2021-05-28 2021-05-29 BB P1D UNPLANNED VACCINATION2021-05-27T14:42:00 C4591001AEC4591001 1007 10071642A 3 fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2REPEAT SCREENING 1 2021-05-28 2021-05-29 BB P1D UNPLANNED VACCINATION2021-05-27T14:42:00 C4591001AEC4591001 1007 10071642A0 5 headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1REPEAT SCREENING 1 2021-05-28 2021-05-29 BB P1D UNPLANNED VACCINATION2021-05-27T14:42:00 C4591001AEC4591001 1007 10071642A 4 dizziness Dizziness F˅Dizziness F˅Neurological signs and symptoms NEC FNeurological disorders NEC FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1REPEAT SCREENING 1 2021-05-28 2021-05-29 BB P1D UNPLANNED VACCINATION2021-05-27T14:42:00 C4591001AEC4591001 1007 10071648A 1 Injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1VACCINATION 2021-01-26T09:062021-01-27T07:00BB VACCINATION 2 2021-01-26T09:06:00 C4591001AEC4591001 1007 10071650A` 6 injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-06-16T08:302021-06-16T10:00BB P1D VACCINATION 4 2021-06-15T14:35:00 C4591001AEC4591001 1007 10071650Ap 5 generalized muscle aches Generalized muscle aches FiMyalgia F{Muscle pains F#Muscle disorders FADVERSE EVENT Musculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-06-16T08:302021-06-16T10:00BB P1D VACCINATION 4 2021-06-15T14:35:00 C4591001AEC4591001 1007 10071650AP 1 Headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-06-15T23:592021-06-16T10:00BB PT9H24M VACCINATION 4 2021-06-15T14:35:00 C4591001AEC4591001 1007 10071650A@ 7 fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-06-16T08:302021-06-16T10:00BB P1D VACCINATION 4 2021-06-15T14:35:00 C4591001AEC4591001 1007 10071650A0 4 chills Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-06-16T08:302021-06-16T10:00BB P1D VACCINATION 4 2021-06-15T14:35:00 C4591001AEC4591001 1007 10071650A 2 chest tightness Chest tightness FChest discomfort FPain and discomfort NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-06-16T08:302021-06-16T10:00BB P1D VACCINATION 4 2021-06-15T14:35:00 C4591001AEC4591001 1007 10071650A 3 elevated body temperature unknown temp Body temperature increased FBody temperature increased FPhysical examination procedures and organ system status FPhysical examination and organ system status topics FADVERSE EVENT Investigations FInvestigations F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-06-16T08:302021-06-16T10:00BB P1D VACCINATION 4 2021-06-15T14:35:00 C4591001AEC4591001 1007 10071651A 2 left Cervical lymphadenopathy Lymphadenopathy cervical FLymphadenopathy FLymphatic system disorders NEC FSpleen, lymphatic and reticuloendothelial system disorders F9)ADVERSE EVENT Blood and lymphatic system disorders FQBlood and lymphatic system disorders FQ NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N1FOLLOW-UP 2021-02-23T07:302021-03-09 B2B@ P28D VACCINATION 2 2021-01-26T10:48:00 C4591001AEC4591001 1007 10071651J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2021-01-06 2021-01-13 A AP2D P1D VACCINATION 1 2021-01-05 C4591001AEC4591001 1007 10071651A 1 Left deep cervical chain lymph node swelling Lymph nodes cervical swollen FLymphadenopathy FLymphatic system disorders NEC FSpleen, lymphatic and reticuloendothelial system disorders F9)ADVERSE EVENT Blood and lymphatic system disorders FQBlood and lymphatic system disorders FQ NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1VACCINATION 2021-01-12T12:302021-02-09 AB$ P7D VACCINATION 1 2021-01-05T10:55:00 C4591001AEC4591001 1007 10071652A 1 Erythema at injection site Injection site erythema FInjection site erythema FInjection site reactions FAdministration site reactions FADVERSE EVENT ACUTE REACTIONS General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-21T11:472021-06-22 BB PT30M VACCINATION 4 2021-06-21T11:17:00 C4591001AEC4591001 1007 10071658AP 4 generalized myalgia Myalgia F{Myalgia F{Muscle pains F#Muscle disorders FADVERSE EVENT Musculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y3OPEN LABEL TREATMENT2021-06-07T19:002021-06-10 BB PT3H52M VACCINATION 4 2021-06-07T15:08:00 C4591001AEC4591001 1007 10071658A@ 2 anterior chest wall pain Chest wall pain FMusculoskeletal chest pain F]Musculoskeletal and connective tissue pain and discomfort FMusculoskeletal and connective tissue disorders NEC FiADVERSE EVENT Musculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y3OPEN LABEL TREATMENT2021-06-08T12:002021-06-08T20:00BB P1D VACCINATION 4 2021-06-07T15:08:00 C4591001AEC4591001 1007 10071658A0 5 malaise Malaise F Malaise F Asthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y3OPEN LABEL TREATMENT2021-06-07T19:002021-06-10 BB PT3H52M VACCINATION 4 2021-06-07T15:08:00 C4591001AEC4591001 1007 10071658A 6 headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-06-08 2021-06-10 BB P1D VACCINATION 4 2021-06-07T15:08:00 C4591001AEC4591001 1007 10071658A 7 injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-06-07T19:002021-06-10 BB PT3H52M VACCINATION 4 2021-06-07T15:08:00 C4591001AEC4591001 1007 10071658A` 3 fever Fever F.Pyrexia F)Febrile disorders FBody temperature conditions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-06-07T19:002021-06-09 BB PT3H52M VACCINATION 4 2021-06-07T15:08:00 C4591001AEC4591001 1007 10071658J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-08 2021-01-13 A0AP1D P2D VACCINATION 1 2021-01-06 C4591001AEC4591001 1007 10071660AP 4 injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT ACUTE REACTIONS General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-24T15:002021-06-25 BB PT29M VACCINATION 4 2021-06-24T14:31:00 C4591001AEC4591001 1007 10071660A@ 3 fever 101.4 Fever F.Pyrexia F)Febrile disorders FBody temperature conditions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-06-03T08:002021-06-04 BB P1D VACCINATION 3 2021-06-02T12:29:00 C4591001AEC4591001 1007 10071660A0 1 injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-06-02T14:302021-06-04 BB PT2H01M VACCINATION 3 2021-06-02T12:29:00 C4591001AEC4591001 1007 10071660A 2 chills Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-03 2021-06-04 BB P1D VACCINATION 3 2021-06-02T12:29:00 C4591001AEC4591001 1007 10071660A 5 fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-06-25 2021-06-26 BB P1D VACCINATION 4 2021-06-24T14:31:00 C4591001AEC4591001 1008 10081761A 1 Fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-04-05T20:002021-04-06 BxBy PT4H38M VACCINATION 3 2021-04-05T15:22:00 C4591001AEC4591001 1008 10081763J-+M VACCINATION 1-MUSCLE PAIN MUSCLE PAIN Muscle pain F"Myalgia F{Muscle pains F#Muscle disorders FREACTOGENICITY SYSTEMIC YMusculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk VACCINATION 2020-12-09 2020-12-14 A0AP1D P2D VACCINATION 1 2020-12-07 C4591001AEC4591001 1008 10081767J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-08 2020-12-15 AAP1D VACCINATION 1 2020-12-08 C4591001AEC4591001 1008 10081767J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2020-12-08 2020-12-15 AAP1D VACCINATION 1 2020-12-08 C4591001AEC4591001 1008 10081768J-+M VACCINATION 2-MUSCLE PAIN MUSCLE PAIN Muscle pain F"Myalgia F{Muscle pains F#Muscle disorders FREACTOGENICITY SYSTEMIC YMusculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk VACCINATION 2021-01-04 2021-01-06 BBP2D P6D VACCINATION 2 2020-12-29 C4591001AEC4591001 1008 10081771J-+M VACCINATION 1-DIARRHEA DIARRHEA Diarrhea F7Diarrhoea F?Diarrhoea (excl infective) F@Gastrointestinal motility and defaecation conditions FܹREACTOGENICITY SYSTEMIC YGastrointestinal disorders FܛGastrointestinal disorders Fܛ VACCINATION 2020-12-15 2020-12-16 ApAP1D P6D VACCINATION 1 2020-12-09 C4591001AEC4591001 1008 10081773J-+M VACCINATION 2-DELTOID MUSCLE-LEFT-PAIN AT INJECTION SITE PAIN AT INJECTION SITE Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FREACTOGENICITY ADMINISTRATION SITEYGeneral disorders and administration site conditions FGeneral disorders and administration site conditions FDELTOID MUSCLELEFT VACCINATION 2020-12-29 2021-01-05 BBP1D VACCINATION 2 2020-12-29 C4591001AEC4591001 1008 10081781A 2 injection site fatigue Injection site reaction FInjection site reaction FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-10 2021-06-12 BB P1D VACCINATION 4 2021-06-09T10:06:00 C4591001AEC4591001 1008 10081781J-+M VACCINATION 2-CHILLS CHILLS Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-06 2021-01-07 BBP1D P6D VACCINATION 2 2020-12-31 C4591001AEC4591001 1008 10081781A 1 injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-10 2021-06-12 BB P1D VACCINATION 4 2021-06-09T10:06:00 C4591001AEC4591001 1008 10081788A 1 injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-13T19:002021-05-14 BB PT7H53M VACCINATION 3 2021-05-13T11:07:00 C4591001AEC4591001 1008 10081788J-+M VACCINATION 1-DIARRHEA DIARRHEA Diarrhea F7Diarrhoea F?Diarrhoea (excl infective) F@Gastrointestinal motility and defaecation conditions FܹREACTOGENICITY SYSTEMIC YGastrointestinal disorders FܛGastrointestinal disorders Fܛ VACCINATION 2020-12-20 2020-12-21 ApAP1D P6D VACCINATION 1 2020-12-14 C4591001AEC4591001 1008 10081801A 1 Fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-08 2021-06-09 BB P1D VACCINATION 4 2021-06-07T13:41:00 C4591001AEC4591001 1008 10081803J-+M VACCINATION 2-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-10 2021-01-14 BBP1D P3D VACCINATION 2 2021-01-07 C4591001AEC4591001 1008 10081803J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-19 2020-12-24 A0AP1D P2D VACCINATION 1 2020-12-17 C4591001AEC4591001 1008 10081808A 2 Fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-08 2021-06-09 BB P1D VACCINATION 4 2021-06-07T09:48:00 C4591001AEC4591001 1008 10081808A 1 Fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-18 2021-05-19 BB P1D VACCINATION 3 2021-05-17T09:47:00 C4591001AEC4591001 1008 10081810J-+M VACCINATION 2-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2021-01-09 2021-01-15 BBP1D P1D VACCINATION 2 2021-01-08 C4591001AEC4591001 1008 10081810J-+M VACCINATION 2-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-09 2021-01-15 BBP1D P1D VACCINATION 2 2021-01-08 C4591001AEC4591001 1008 10081810J-+M VACCINATION 2-CHILLS CHILLS Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-14 2021-01-15 BBP1D P6D VACCINATION 2 2021-01-08 C4591001AEC4591001 1008 10081812A 1 headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-05-14 2021-05-15 BB P1D VACCINATION 3 2021-05-13T16:19:00 C4591001AEC4591001 1008 10081817J-+M VACCINATION 2-MUSCLE PAIN MUSCLE PAIN Muscle pain F"Myalgia F{Muscle pains F#Muscle disorders FREACTOGENICITY SYSTEMIC YMusculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk VACCINATION 2021-01-07 2021-01-13 BBP1D P1D VACCINATION 2 2021-01-06 C4591001AEC4591001 1008 10081817J-+M VACCINATION 2-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2021-01-08 2021-01-13 BBP1D P2D VACCINATION 2 2021-01-06 C4591001AEC4591001 1008 10081817J-+M VACCINATION 2-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-07 2021-01-13 BBP1D P1D VACCINATION 2 2021-01-06 C4591001AEC4591001 1008 10081817J-+M VACCINATION 2-CHILLS CHILLS Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-09 2021-01-13 BBP1D P3D VACCINATION 2 2021-01-06 C4591001AEC4591001 1008 10081817J-+M VACCINATION 2-DELTOID MUSCLE-LEFT-PAIN AT INJECTION SITE PAIN AT INJECTION SITE Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FREACTOGENICITY ADMINISTRATION SITEYGeneral disorders and administration site conditions FGeneral disorders and administration site conditions FDELTOID MUSCLELEFT VACCINATION 2021-01-06 2021-01-13 BBP1D VACCINATION 2 2021-01-06 C4591001AEC4591001 1008 10081822J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-21 2020-12-28 AAP1D VACCINATION 1 2020-12-21 C4591001AEC4591001 1008 10081837A 2 headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-05-20 2021-05-21 BB P1D VACCINATION 3 2021-05-19T14:04:00 C4591001AEC4591001 1008 10081837A 1 Fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-05-20 2021-05-21 BB P1D VACCINATION 3 2021-05-19T14:04:00 C4591001AEC4591001 1008 10081837J-+M VACCINATION 2-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2021-01-13 2021-01-19 BBP1D P1D VACCINATION 2 2021-01-12 C4591001AEC4591001 1008 10081837A0 3 body aches Generalized aching F\Pain FPain and discomfort NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-05-20 2021-05-21 BB P1D VACCINATION 3 2021-05-19T14:04:00 C4591001AEC4591001 1008 10081843J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-28 2020-12-30 A`AP1D P5D VACCINATION 1 2020-12-23 C4591001AEC4591001 1008 10081844A0 3 body aches Generalized aching F\Pain FPain and discomfort NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-20 2021-05-20 BB P1D VACCINATION 3 2021-05-19T10:07:00 C4591001AEC4591001 1008 10081844A 2 nausea Nausea F Nausea F Nausea and vomiting symptoms FGastrointestinal signs and symptoms FADVERSE EVENT Gastrointestinal disorders FܛGastrointestinal disorders Fܛ NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-19T14:002021-05-20 BB PT3H53M VACCINATION 3 2021-05-19T10:07:00 C4591001AEC4591001 1008 10081844A 1 headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-05-20 2021-05-20 BB P1D VACCINATION 3 2021-05-19T10:07:00 C4591001AEC4591001 1008 10081845J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2020-12-29 2020-12-30 ApAP1D P6D VACCINATION 1 2020-12-23 C4591001AEC4591001 1008 10081848J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2020-12-23 2020-12-30 AAP1D VACCINATION 1 2020-12-23 C4591001AEC4591001 1008 10081848J-+M VACCINATION 1-DELTOID MUSCLE-LEFT-PAIN AT INJECTION SITE PAIN AT INJECTION SITE Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FREACTOGENICITY ADMINISTRATION SITEYGeneral disorders and administration site conditions FGeneral disorders and administration site conditions FDELTOID MUSCLELEFT VACCINATION 2020-12-23 2020-12-30 AAP1D VACCINATION 1 2020-12-23 C4591001AEC4591001 1008 10081849J-+M VACCINATION 2-DIARRHEA DIARRHEA Diarrhea F7Diarrhoea F?Diarrhoea (excl infective) F@Gastrointestinal motility and defaecation conditions FܹREACTOGENICITY SYSTEMIC YGastrointestinal disorders FܛGastrointestinal disorders Fܛ VACCINATION 2021-01-20 2021-01-21 BBP1D P6D VACCINATION 2 2021-01-14 C4591001AEC4591001 1008 10081849J-+M VACCINATION 2-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-18 2021-01-22 BBP2D P4D VACCINATION 2 2021-01-14 C4591001AEC4591001 1008 10081849J-+M VACCINATION 2-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2021-01-18 2021-01-22 BBP2D P4D VACCINATION 2 2021-01-14 C4591001AEC4591001 1008 10081851J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-23 2020-12-30 AAP1D VACCINATION 1 2020-12-23 C4591001AEC4591001 1008 10081852J-+M VACCINATION 2-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-21 2021-01-22 BBP1D P6D VACCINATION 2 2021-01-15 C4591001AEC4591001 1008 10081853J-+M VACCINATION 2-CHILLS CHILLS Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-19 2021-01-25 BBP1D P1D VACCINATION 2 2021-01-18 C4591001AEC4591001 1008 10081856J-+M VACCINATION 1-CHILLS CHILLS Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-03 2021-01-04 ApAP1D P6D VACCINATION 1 2020-12-28 C4591001AEC4591001 1008 10081856J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-28 2021-01-04 AAP1D VACCINATION 1 2020-12-28 C4591001AEC4591001 1008 10081859J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-29 2021-01-04 A AP1D P1D VACCINATION 1 2020-12-28 C4591001AEC4591001 1008 10081863A 2 Body Aches Generalized aching F\Pain FPain and discomfort NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-08 2021-06-09 BB P1D VACCINATION 4 2021-06-07T09:46:00 C4591001AEC4591001 1008 10081863A 1 Headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-08 2021-06-09 BB P1D VACCINATION 4 2021-06-07T09:46:00 C4591001AEC4591001 1008 10081867J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-30 2021-01-07 A AP3D P1D VACCINATION 1 2020-12-29 C4591001AEC4591001 1008 10081867J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2020-12-29 2021-01-05 AAP1D VACCINATION 1 2020-12-29 C4591001AEC4591001 1008 10081871J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2020-12-30 2021-01-06 AAP1D VACCINATION 1 2020-12-30 C4591001AEC4591001 1008 10081872J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2021-01-05 2021-01-07 ApAP2D P6D VACCINATION 1 2020-12-30 C4591001AEC4591001 1008 10081877J-+M VACCINATION 2-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2021-01-23 2021-01-29 BBP3D P3D VACCINATION 2 2021-01-20 C4591001AEC4591001 1008 10081877J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-01 2021-01-06 A0AP1D P2D VACCINATION 1 2020-12-30 C4591001AEC4591001 1008 10081877A 2 body aches Generalized aching F\Pain FPain and discomfort NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-05-18 2021-05-19 BB P1D VACCINATION 3 2021-05-17T13:55:00 C4591001AEC4591001 1008 10081877A 1 fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-05-17T18:302021-05-19 BB PT4H35M VACCINATION 3 2021-05-17T13:55:00 C4591001AEC4591001 1008 10081883J-+M VACCINATION 1-JOINT PAIN JOINT PAIN Joint pain F6Arthralgia F'Joint related signs and symptoms F:Joint disorders F-REACTOGENICITY SYSTEMIC YMusculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk VACCINATION 2021-01-06 2021-01-10 ApAP4D P6D VACCINATION 1 2020-12-31 C4591001AEC4591001 1008 10081884J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2020-12-31 2021-01-07 AAP1D VACCINATION 1 2020-12-31 C4591001AEC4591001 1008 10081885J-+M VACCINATION 1-DIARRHEA DIARRHEA Diarrhea F7Diarrhoea F?Diarrhoea (excl infective) F@Gastrointestinal motility and defaecation conditions FܹREACTOGENICITY SYSTEMIC YGastrointestinal disorders FܛGastrointestinal disorders Fܛ VACCINATION 2021-01-06 2021-01-07 ApAP1D P6D VACCINATION 1 2020-12-31 C4591001AEC4591001 1008 10081887A0 1 sweating Sweating F=%Hyperhidrosis F"Apocrine and eccrine gland disorders F&Skin appendage conditions F5ADVERSE EVENT Skin and subcutaneous tissue disorders F5Skin and subcutaneous tissue disorders F5 NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-14 2021-05-17 BB P1D VACCINATION 3 2021-05-13T16:30:00 C4591001AEC4591001 1008 10081887A 2 headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-05-14 2021-05-17 BB P1D VACCINATION 3 2021-05-13T16:30:00 C4591001AEC4591001 1008 10081887A 3 chills Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-14 2021-05-17 BB P1D VACCINATION 3 2021-05-13T16:30:00 C4591001AEC4591001 1008 10081889J-+M VACCINATION 1-DIARRHEA DIARRHEA Diarrhea F7Diarrhoea F?Diarrhoea (excl infective) F@Gastrointestinal motility and defaecation conditions FܹREACTOGENICITY SYSTEMIC YGastrointestinal disorders FܛGastrointestinal disorders Fܛ VACCINATION 2021-01-10 2021-01-11 ApAP1D P6D VACCINATION 1 2021-01-04 C4591001AEC4591001 1008 10081892A 1 injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-25T10:002021-05-29 BB PT1H VACCINATION 3 2021-05-25T09:00:00 C4591001AEC4591001 1008 10081900J-+M VACCINATION 2-CHILLS CHILLS Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-26 2021-02-02 BBP1D VACCINATION 2 2021-01-26 C4591001AEC4591001 1008 10081900J-+M VACCINATION 2-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2021-01-26 2021-02-02 BBP1D VACCINATION 2 2021-01-26 C4591001AEC4591001 1008 10081900J-+M VACCINATION 2-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-27 2021-02-02 BBP1D P1D VACCINATION 2 2021-01-26 C4591001AEC4591001 1008 10081901J-+M VACCINATION 1-MUSCLE PAIN MUSCLE PAIN Muscle pain F"Myalgia F{Muscle pains F#Muscle disorders FREACTOGENICITY SYSTEMIC YMusculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk VACCINATION 2021-01-08 2021-01-13 A@AP2D P3D VACCINATION 1 2021-01-05 C4591001AEC4591001 1008 10081902J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2021-01-10 2021-01-12 A`AP1D P5D VACCINATION 1 2021-01-05 C4591001AEC4591001 1008 10081907J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2021-01-06 2021-01-13 AAP1D VACCINATION 1 2021-01-06 C4591001AEC4591001 1008 10081913A 1 injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1REPEAT SCREENING 1 2021-05-16T16:002021-05-19 BB P108D VACCINATION 2 2021-01-28T14:40:00 C4591001AEC4591001 1008 10081915J-+M VACCINATION 1-CHILLS CHILLS Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-07 2021-01-14 AAP1D VACCINATION 1 2021-01-07 C4591001AEC4591001 1008 10081925J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2021-01-09 2021-01-15 A AP1D P1D VACCINATION 1 2021-01-08 C4591001AEC4591001 1008 10081928J-+M VACCINATION 2-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-29 2021-02-05 BBP1D VACCINATION 2 2021-01-29 C4591001AEC4591001 1008 10081928J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-09 2021-01-15 A AP1D P1D VACCINATION 1 2021-01-08 C4591001AEC4591001 1008 10081928J-+M VACCINATION 2-JOINT PAIN JOINT PAIN Joint pain F6Arthralgia F'Joint related signs and symptoms F:Joint disorders F-REACTOGENICITY SYSTEMIC YMusculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk VACCINATION 2021-01-30 2021-02-05 BBP1D P1D VACCINATION 2 2021-01-29 C4591001AEC4591001 1008 10081928J-+M VACCINATION 2-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2021-01-30 2021-02-05 BBP1D P1D VACCINATION 2 2021-01-29 C4591001AEC4591001 1008 10081928A 1 urticaria multiple sites Urticaria FMUrticaria FMUrticarias FMAngioedema and urticaria FADVERSE EVENT Skin and subcutaneous tissue disorders F5Skin and subcutaneous tissue disorders F5 NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1VACCINATION 2021-01-10 2021-01-22 A0A P2D VACCINATION 1 2021-01-08T15:23:00 C4591001AEC4591001 1008 10081931J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-11 2021-01-19 AAP2D VACCINATION 1 2021-01-11 C4591001AEC4591001 1008 10081931A 1 Cellulitis left leg Cellulitis of leg FhCellulitis FJBacterial infections NEC FOBacterial infectious disorders F2ADVERSE EVENT Infections and infestations FInfections and infestations F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y1FOLLOW-UP 2021-03-15 2021-03-19 B@BD P42D VACCINATION 2 2021-02-01T09:13:00 C4591001AEC4591001 1008 10081931J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2021-01-12 2021-01-19 A AP2D P1D VACCINATION 1 2021-01-11 C4591001AEC4591001 1008 10081932J-+M VACCINATION 2-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-02-01 2021-02-08 BBP1D VACCINATION 2 2021-02-01 C4591001AEC4591001 1008 10081932J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-11 2021-01-19 AAP2D VACCINATION 1 2021-01-11 C4591001AEC4591001 1008 10081933A 1 injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-08 2021-06-09 BB P1D VACCINATION 4 2021-06-07T14:07:00 C4591001AEC4591001 1008 10081938J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-11 2021-01-18 AAP1D VACCINATION 1 2021-01-11 C4591001AEC4591001 1009 10091205J-+M VACCINATION 2-DELTOID MUSCLE-LEFT-PAIN AT INJECTION SITE PAIN AT INJECTION SITE Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FREACTOGENICITY ADMINISTRATION SITEYGeneral disorders and administration site conditions FGeneral disorders and administration site conditions FDELTOID MUSCLELEFT VACCINATION 2020-11-07 2020-11-13 BBP1D P1D VACCINATION 2 2020-11-06 C4591001AEC4591001 1009 10091220A 1 POST SURGICAL PAIN, ORAL Postoperative pain Fl7Procedural pain FNon-site specific procedural complications F Procedural related injuries and complications NEC FADVERSE EVENT Injury, poisoning and procedural complications FInjury, poisoning and procedural complications F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y2VACCINATION 2020-11-20 2020-11-30 B!B+ P13D VACCINATION 2 2020-11-07T11:12:00 C4591001AEC4591001 1009 10091221A 1 worsening right ankle pain Pain ankle FArthralgia F'Joint related signs and symptoms F:Joint disorders F-ADVERSE EVENT Musculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y3VACCINATION 2020-10-19T17:002020-10-19 AA PT3H02M VACCINATION 1 2020-10-19T13:58:00 C4591001AEC4591001 1009 10091229J-+M VACCINATION 1-CHILLS CHILLS Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-10-22 2020-10-28 A0AP2D P2D VACCINATION 1 2020-10-20 C4591001AEC4591001 1009 10091229J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-10-20 2020-10-28 AAP2D VACCINATION 1 2020-10-20 C4591001AEC4591001 1009 10091229A 1 Body Aches following vaccination Generalized aching F\Pain FPain and discomfort NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-05-22 2021-05-23 BB P1D VACCINATION 3 2021-05-21T16:10:00 C4591001AEC4591001 1009 10091231A 1 left swollen axillary lymph node Axillary lymph nodes enlarged FLymphadenopathy FLymphatic system disorders NEC FSpleen, lymphatic and reticuloendothelial system disorders F9)ADVERSE EVENT Blood and lymphatic system disorders FQBlood and lymphatic system disorders FQ NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1VACCINATION 2020-11-10 2020-11-10 BB P1D VACCINATION 2 2020-11-09T15:56:00 C4591001AEC4591001 1009 10091237J-+M VACCINATION 1-MUSCLE PAIN MUSCLE PAIN Muscle pain F"Myalgia F{Muscle pains F#Muscle disorders FREACTOGENICITY SYSTEMIC YMusculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk VACCINATION 2020-10-21 2020-10-28 AAP1D VACCINATION 1 2020-10-21 C4591001AEC4591001 1009 10091237J-+M VACCINATION 1-JOINT PAIN JOINT PAIN Joint pain F6Arthralgia F'Joint related signs and symptoms F:Joint disorders F-REACTOGENICITY SYSTEMIC YMusculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk VACCINATION 2020-10-26 2020-10-28 A`AP1D P5D VACCINATION 1 2020-10-21 C4591001AEC4591001 1009 10091267A 1 RUNNY NOSE Runny nose F0Rhinorrhoea F/=Upper respiratory tract signs and symptoms FKiRespiratory tract signs and symptoms F}ADVERSE EVENT Respiratory, thoracic and mediastinal disorders F-Respiratory, thoracic and mediastinal disorders F- NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y1VACCINATION 2020-12-27 2021-01-01 BB P5D VACCINATION 2 2020-12-22T13:01:00 C4591001AEC4591001 1009 10091283J-+M VACCINATION 1-MUSCLE PAIN MUSCLE PAIN Muscle pain F"Myalgia F{Muscle pains F#Muscle disorders FREACTOGENICITY SYSTEMIC YMusculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk VACCINATION 2020-12-08 2020-12-10 A`AP1D P5D VACCINATION 1 2020-12-03 C4591001AEC4591001 1009 10091284J-+M VACCINATION 1-MUSCLE PAIN MUSCLE PAIN Muscle pain F"Myalgia F{Muscle pains F#Muscle disorders FREACTOGENICITY SYSTEMIC YMusculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk VACCINATION 2020-12-09 2020-12-11 ApAP2D P6D VACCINATION 1 2020-12-03 C4591001AEC4591001 1009 10091294A 2 body aches Generalized aching F\Pain FPain and discomfort NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-04-06T18:002021-04-07 ByBz PT8H38M VACCINATION 3 2021-04-06T09:22:00 C4591001AEC4591001 1009 10091294A 1 bilateral shoulder pain Shoulder pain F5)Arthralgia F'Joint related signs and symptoms F:Joint disorders F-ADVERSE EVENT Musculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N1VACCINATION 2020-12-22 2020-12-24 BB P15D VACCINATION 1 2020-12-07T11:38:00 C4591001AEC4591001 1009 10091298J-+M VACCINATION 2-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-28 2021-01-19 BB,P16D VACCINATION 2 2020-12-28 C4591001AEC4591001 1009 10091298J-+M VACCINATION 2-MUSCLE PAIN MUSCLE PAIN Muscle pain F"Myalgia F{Muscle pains F#Muscle disorders FREACTOGENICITY SYSTEMIC YMusculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk VACCINATION 2020-12-29 2021-01-14 BB'P11DP1D VACCINATION 2 2020-12-28 C4591001AEC4591001 1009 10091298J-+M VACCINATION 1-DELTOID MUSCLE-LEFT-PAIN AT INJECTION SITE PAIN AT INJECTION SITE Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FREACTOGENICITY ADMINISTRATION SITEYGeneral disorders and administration site conditions FGeneral disorders and administration site conditions FDELTOID MUSCLELEFT VACCINATION 2020-12-07 2020-12-16 AAP3D VACCINATION 1 2020-12-07 C4591001AEC4591001 1009 10091301J-+M VACCINATION 1-MUSCLE PAIN MUSCLE PAIN Muscle pain F"Myalgia F{Muscle pains F#Muscle disorders FREACTOGENICITY SYSTEMIC YMusculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk VACCINATION 2020-12-12 2020-12-15 A`AP2D P5D VACCINATION 1 2020-12-07 C4591001AEC4591001 1009 10091301A 1 spider bite Spider bite F8Arthropod bite FNon-site specific injuries NEC F Injuries NEC FADVERSE EVENT Injury, poisoning and procedural complications FInjury, poisoning and procedural complications F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-07-22 2021-08-05 BB P31D VACCINATION 4 2021-06-21T16:22:00 C4591001AEC4591001 1009 10091305A 1 Right Axillary Adenitis Axillary adenitis FZLymphadenitis FLymphatic system disorders NEC FSpleen, lymphatic and reticuloendothelial system disorders F9)ADVERSE EVENT Blood and lymphatic system disorders FQBlood and lymphatic system disorders FQ NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-03-24 2021-04-16 BkB P5D VACCINATION 3 2021-03-19T12:11:00 C4591001AEC4591001 1009 10091308J-+M VACCINATION 1-JOINT PAIN JOINT PAIN Joint pain F6Arthralgia F'Joint related signs and symptoms F:Joint disorders F-REACTOGENICITY SYSTEMIC YMusculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk VACCINATION 2020-12-13 2020-12-16 APAP1D P4D VACCINATION 1 2020-12-09 C4591001AEC4591001 1009 10091308J-+M VACCINATION 1-MUSCLE PAIN MUSCLE PAIN Muscle pain F"Myalgia F{Muscle pains F#Muscle disorders FREACTOGENICITY SYSTEMIC YMusculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk VACCINATION 2020-12-13 2020-12-16 APAP1D P4D VACCINATION 1 2020-12-09 C4591001AEC4591001 1009 10091308J-+M VACCINATION 1-DELTOID MUSCLE-LEFT-PAIN AT INJECTION SITE PAIN AT INJECTION SITE Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FREACTOGENICITY ADMINISTRATION SITEYGeneral disorders and administration site conditions FGeneral disorders and administration site conditions FDELTOID MUSCLELEFT VACCINATION 2020-12-09 2020-12-16 AAP1D VACCINATION 1 2020-12-09 C4591001AEC4591001 1009 10091311J-+M VACCINATION 1-DELTOID MUSCLE-LEFT-PAIN AT INJECTION SITE PAIN AT INJECTION SITE Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FREACTOGENICITY ADMINISTRATION SITEYGeneral disorders and administration site conditions FGeneral disorders and administration site conditions FDELTOID MUSCLELEFT VACCINATION 2020-12-09 2020-12-17 AAP2D VACCINATION 1 2020-12-09 C4591001AEC4591001 1009 10091319A 1 headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N2VACCINATION 2021-01-22 2021-01-22 B,B, P24D VACCINATION 2 2020-12-29T09:02:00 C4591001AEC4591001 1009 10091323A 1 fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N1VACCINATION 2021-01-08 2021-01-08 BB P9D VACCINATION 2 2020-12-30T16:30:00 C4591001AEC4591001 1009 10091323A 2 nausea Nausea F Nausea F Nausea and vomiting symptoms FGastrointestinal signs and symptoms FADVERSE EVENT Gastrointestinal disorders FܛGastrointestinal disorders Fܛ NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N1VACCINATION 2021-01-08 2021-01-08 BB P9D VACCINATION 2 2020-12-30T16:30:00 C4591001AEC4591001 1009 10091326A 2 headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-26 2021-06-26 BB P1D VACCINATION 4 2021-06-25T15:59:00 C4591001AEC4591001 1009 10091326A 1 Sore (pain) left deltoid- at injection site Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-26 2021-06-26 BB P1D VACCINATION 4 2021-06-25T15:59:00 C4591001AEC4591001 1009 10091334A 1 runny nose Runny nose F0Rhinorrhoea F/=Upper respiratory tract signs and symptoms FKiRespiratory tract signs and symptoms F}ADVERSE EVENT Respiratory, thoracic and mediastinal disorders F-Respiratory, thoracic and mediastinal disorders F- NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N1VACCINATION 2021-01-11 2021-01-11 B B P11D VACCINATION 2 2020-12-31T12:49:00 C4591001AEC4591001 1009 10091338A 3 Wisdom Teeth Removal Wisdom teeth removal FQWisdom teeth removal FQDental and gingival therapeutic procedures FƝHead and neck therapeutic procedures FvADVERSE EVENT Surgical and medical procedures F<Surgical and medical procedures F< NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y2REPEAT SCREENING 1 2021-06-08 2021-06-08 BB P176D VACCINATION 1 2020-12-14T13:57:00 C4591001AEC4591001 1009 10091338A 4 Mouth Ulcer Mouth ulcer FMouth ulceration FStomatitis and ulceration F;Oral soft tissue conditions FADVERSE EVENT Gastrointestinal disorders FܛGastrointestinal disorders Fܛ NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y2REPEAT SCREENING 1 2021-06-16 2021-06-21 BB P184D VACCINATION 1 2020-12-14T13:57:00 C4591001AEC4591001 1009 10091340J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-14 2020-12-21 AAP1D VACCINATION 1 2020-12-14 C4591001AEC4591001 1009 10091340J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2020-12-15 2020-12-21 A AP1D P1D VACCINATION 1 2020-12-14 C4591001AEC4591001 1009 10091340J-+M VACCINATION 1-CHILLS CHILLS Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-20 2020-12-21 ApAP1D P6D VACCINATION 1 2020-12-14 C4591001AEC4591001 1009 10091341A 1 body aches Generalized aching F\Pain FPain and discomfort NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-07-03 2021-07-03 BB P1D VACCINATION 3 2021-07-02T13:18:00 C4591001AEC4591001 1009 10091342A 1 swollen cervical lymph nodes bilateral Lymph nodes cervical swollen FLymphadenopathy FLymphatic system disorders NEC FSpleen, lymphatic and reticuloendothelial system disorders F9)ADVERSE EVENT Blood and lymphatic system disorders FQBlood and lymphatic system disorders FQ NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N1VACCINATION 2021-01-31 2021-02-02 B1B3 P27D VACCINATION 2 2021-01-04T17:11:00 C4591001AEC4591001 1009 10091343J-+M VACCINATION 1-MUSCLE PAIN MUSCLE PAIN Muscle pain F"Myalgia F{Muscle pains F#Muscle disorders FREACTOGENICITY SYSTEMIC YMusculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk VACCINATION 2020-12-21 2020-12-22 ApAP1D P6D VACCINATION 1 2020-12-15 C4591001AEC4591001 1009 10091357A 5 body aches Generalized aching F\Pain FPain and discomfort NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-04-06T03:002021-04-07 BoBp P1D VACCINATION 4 2021-04-05T10:10:00 C4591001AEC4591001 1009 10091357A0 1 congenital vertebral pedicle hypoplasia Congenital anomalies of spine FSpine malformation F9 Musculoskeletal and connective tissue disorders of spine congenitalF_Musculoskeletal and connective tissue disorders congenital FlADVERSE EVENT Congenital, familial and genetic disorders FCongenital, familial and genetic disorders F NNOT APPLICABLE NOT RELATEDOTHER NOT RECOVERED/NOT RESOLVED N1FOLLOW-UP 2021-02-12 B:. P38D VACCINATION 2 2021-01-05T10:14:00ONGOINGLAST SUBJECT ENCOUNTERC4591001AEC4591001 1009 10091357A 4 headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-04-06T03:002021-04-07 BoBp P1D VACCINATION 4 2021-04-05T10:10:00 C4591001AEC4591001 1009 10091361A 1 sprained right thumb Thumb sprain FA Ligament sprain FMuscle, tendon and ligament injuries FInjuries NEC FADVERSE EVENT Injury, poisoning and procedural complications FInjury, poisoning and procedural complications F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N2VACCINATION 2021-01-02T18:302021-01-31 BB. P16D VACCINATION 1 2020-12-17T14:13:00 C4591001AEC4591001 1009 10091362J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2020-12-18 2020-12-24 A AP1D P1D VACCINATION 1 2020-12-17 C4591001AEC4591001 1009 10091362J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-17 2020-12-24 AAP1D VACCINATION 1 2020-12-17 C4591001AEC4591001 1009 10091362J-+M VACCINATION 1-CHILLS CHILLS Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-17 2020-12-24 AAP1D VACCINATION 1 2020-12-17 C4591001AEC4591001 1009 10091363A 1 Vasovagal Reaction Vasovagal reaction FNPresyncope F%Neurological signs and symptoms NEC FNeurological disorders NEC FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N1FOLLOW-UP 2021-02-09T09:042021-02-09T09:30B7B7 P54D VACCINATION 1 2020-12-17T16:19:00 C4591001AEC4591001 1009 10091365A 1 right arm fracture Arm fracture FVgUpper limb fracture FRLimb fractures and dislocations FBone and joint injuries FADVERSE EVENT Injury, poisoning and procedural complications FInjury, poisoning and procedural complications F NNOT APPLICABLE NOT RELATEDOTHER RECOVERING/RESOLVING Y2FOLLOW-UP 2021-03-19 B]. P59D VACCINATION 2 2021-01-19T15:22:00ONGOINGLAST SUBJECT ENCOUNTERC4591001AEC4591001 1009 10091366A 1 Mild Injection Site Pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1FOLLOW-UP 2021-02-26T20:002021-02-27 BHBI PT3H46M UNPLANNED VACCINATION2021-02-26T16:14:00 C4591001AEC4591001 1009 10091370A 1 headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y3VACCINATION 2021-01-06 2021-01-06 BB P19D VACCINATION 1 2020-12-18T11:25:00 C4591001AEC4591001 1009 10091375J-+M VACCINATION 1-MUSCLE PAIN MUSCLE PAIN Muscle pain F"Myalgia F{Muscle pains F#Muscle disorders FREACTOGENICITY SYSTEMIC YMusculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk VACCINATION 2020-12-27 2020-12-28 ApAP1D P6D VACCINATION 1 2020-12-21 C4591001AEC4591001 1009 10091379A0 3 bilateral great toe ingrown toenail Ingrown toe nail FIngrowing nail F}Nail and nail bed conditions (excl infections and infestations) FSkin appendage conditions F5ADVERSE EVENT Skin and subcutaneous tissue disorders F5Skin and subcutaneous tissue disorders F5 NNOT APPLICABLE NOT RELATEDOTHER NOT RECOVERED/NOT RESOLVED Y1OPEN LABEL TREATMENT2021-06-03 B. P15D VACCINATION 3 2021-05-19T10:13:00ONGOINGLAST SUBJECT ENCOUNTERC4591001AEC4591001 1009 10091379A 2 GROUND LEVEL FALL Fall FխFall FխNon-site specific injuries NEC F Injuries NEC FADVERSE EVENT Injury, poisoning and procedural complications FInjury, poisoning and procedural complications F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N2FOLLOW-UP 2021-02-26 2021-02-26 BCBC P43D VACCINATION 2 2021-01-14T08:44:00 C4591001AEC4591001 1009 10091379A 1 BRUISED KNEE, LEFT Contusion of knee FContusion F\Skin injuries NEC FInjuries NEC FADVERSE EVENT Injury, poisoning and procedural complications FInjury, poisoning and procedural complications F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y2FOLLOW-UP 2021-03-22 2021-04-09 B[Bm P67D VACCINATION 2 2021-01-14T08:44:00 C4591001AEC4591001 1009 10091380A 2 pain after wisdom teeth removal Post procedural pain FXProcedural pain FNon-site specific procedural complications F Procedural related injuries and complications NEC FADVERSE EVENT Injury, poisoning and procedural complications FInjury, poisoning and procedural complications F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y1VACCINATION 2021-02-11 2021-02-15 B-B1 P23D VACCINATION 2 2021-01-19T15:46:00 C4591001AEC4591001 1009 10091380A 1 Right Clavicle Fracture Clavicle fracture FClavicle fracture FLimb fractures and dislocations FBone and joint injuries FADVERSE EVENT Injury, poisoning and procedural complications FInjury, poisoning and procedural complications F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y2VACCINATION 2021-01-18T20:302021-02-22 BB8 P20D VACCINATION 1 2020-12-29T16:31:00 C4591001AEC4591001 1009 10091382A` 6 rhinorrhea Rhinorrhea F/<Rhinorrhoea F/=Upper respiratory tract signs and symptoms FKiRespiratory tract signs and symptoms F}ADVERSE EVENT Respiratory, thoracic and mediastinal disorders F-Respiratory, thoracic and mediastinal disorders F- NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-15 2021-05-17 BB P1D VACCINATION 3 2021-05-14T09:08:00 C4591001AEC4591001 1009 10091382AP 7 nausea Nausea F Nausea F Nausea and vomiting symptoms FGastrointestinal signs and symptoms FADVERSE EVENT Gastrointestinal disorders FܛGastrointestinal disorders Fܛ NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-15 2021-05-17 BB P1D VACCINATION 3 2021-05-14T09:08:00 C4591001AEC4591001 1009 10091382A@ 3 generalized muscle pain Muscle pain F"Myalgia F{Muscle pains F#Muscle disorders FADVERSE EVENT Musculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-15 2021-05-20 BB P1D VACCINATION 3 2021-05-14T09:08:00 C4591001AEC4591001 1009 10091382A0 5 dizziness Dizziness F˅Dizziness F˅Neurological signs and symptoms NEC FNeurological disorders NEC FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-15 2021-05-16 BB P1D VACCINATION 3 2021-05-14T09:08:00 C4591001AEC4591001 1009 10091382A 2 chills Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-03 2021-06-03 BB P1D VACCINATION 4 2021-06-02T09:54:00 C4591001AEC4591001 1009 10091382A 1 RIGHT KNEE PAIN Knee pain F5Arthralgia F'Joint related signs and symptoms F:Joint disorders F-ADVERSE EVENT Musculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N2VACCINATION 2021-01-10 2021-01-25 ApB P6D VACCINATION 1 2021-01-04T16:30:00 C4591001AEC4591001 1009 10091399A 1 Left Fifth Metatarsal Fracture Fractured metatarsal FFoot fracture FLimb fractures and dislocations FBone and joint injuries FADVERSE EVENT Injury, poisoning and procedural complications FInjury, poisoning and procedural complications F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y2VACCINATION 2021-02-23 2021-05-15 B/B P25D VACCINATION 2 2021-01-29T11:27:00 C4591001AEC4591001 1009 10091400J-+M VACCINATION 2-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2021-02-12 2021-02-19 B$B+P1D VACCINATION 2 2021-02-12 C4591001AEC4591001 1009 10091400J-+M VACCINATION 2-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-02-12 2021-02-20 B$B,P2D VACCINATION 2 2021-02-12 C4591001AEC4591001 1009 10091400J-+M VACCINATION 2-DELTOID MUSCLE-LEFT-PAIN AT INJECTION SITE PAIN AT INJECTION SITE Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FREACTOGENICITY ADMINISTRATION SITEYGeneral disorders and administration site conditions FGeneral disorders and administration site conditions FDELTOID MUSCLELEFT VACCINATION 2021-02-18 2021-02-19 B*B+P1D P6D VACCINATION 2 2021-02-12 C4591001AEC4591001 1009 10091400A 2 Urticaria generalized Urticaria generalised FcUrticaria FMUrticarias FMAngioedema and urticaria FADVERSE EVENT Skin and subcutaneous tissue disorders F5Skin and subcutaneous tissue disorders F5 NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y3FOLLOW-UP 2021-04-07 2021-04-14 BZBa P54D VACCINATION 2 2021-02-12T09:52:00 C4591001AEC4591001 1009 10091400A 1 Eczema generalized Eczema FEczema FDermatitis and eczema FEpidermal and dermal conditions FADVERSE EVENT Skin and subcutaneous tissue disorders F5Skin and subcutaneous tissue disorders F5 NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N2FOLLOW-UP 2021-04-02 2021-04-04 BUBW P49D VACCINATION 2 2021-02-12T09:52:00 C4591001AEC4591001 1009 10091401A 1 motion sickness Motion sickness FMotion sickness FInner ear signs and symptoms FInner ear and VIIIth cranial nerve disorders FADVERSE EVENT Ear and labyrinth disorders F)Ear and labyrinth disorders F) NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-08-08 2021-08-08 BB P6D VACCINATION 3 2021-08-02T13:06:00 C4591001AEC4591001 1009 10091403A 1 runny nose Runny nose F0Rhinorrhoea F/=Upper respiratory tract signs and symptoms FKiRespiratory tract signs and symptoms F}ADVERSE EVENT Respiratory, thoracic and mediastinal disorders F-Respiratory, thoracic and mediastinal disorders F- NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1VACCINATION 2021-01-10 2021-01-13 A0A` P2D VACCINATION 1 2021-01-08T15:41:00 C4591001AEC4591001 1009 10091404J-+M VACCINATION 1-DELTOID MUSCLE-LEFT-PAIN AT INJECTION SITE PAIN AT INJECTION SITE Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FREACTOGENICITY ADMINISTRATION SITEYGeneral disorders and administration site conditions FGeneral disorders and administration site conditions FDELTOID MUSCLELEFT VACCINATION 2021-01-09 2021-01-15 A AP1D P1D VACCINATION 1 2021-01-08 C4591001AEC4591001 1009 10091404J-+M VACCINATION 1-DELTOID MUSCLE-LEFT-REDNESS REDNESS Redness F+Erythema FѮErythemas FѯEpidermal and dermal conditions FREACTOGENICITY ADMINISTRATION SITEYSkin and subcutaneous tissue disorders F5Skin and subcutaneous tissue disorders F5DELTOID MUSCLELEFT VACCINATION 2021-01-09 2021-01-15 A AP1D P1D VACCINATION 1 2021-01-08 C4591001AEC4591001 1009 10091405A@ 1 fever Fever F.Pyrexia F)Febrile disorders FBody temperature conditions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-08-20 2021-08-20 BB P1D VACCINATION 4 2021-08-19T16:13:00 C4591001AEC4591001 1009 10091405A0 4 left axillary adenopathy Axillary adenopathy FLymphadenopathy FLymphatic system disorders NEC FSpleen, lymphatic and reticuloendothelial system disorders F9)ADVERSE EVENT Blood and lymphatic system disorders FQBlood and lymphatic system disorders FQ NNOT APPLICABLE RELATED NOT RECOVERED/NOT RESOLVED N1OPEN LABEL TREATMENT2021-08-20 B. P1D VACCINATION 4 2021-08-19T16:13:00ONGOINGLAST SUBJECT ENCOUNTERC4591001AEC4591001 1009 10091405A 3 headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-08-20 2021-08-21 BB P1D VACCINATION 4 2021-08-19T16:13:00 C4591001AEC4591001 1009 10091405A 2 fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-08-20 2021-08-21 BB P1D VACCINATION 4 2021-08-19T16:13:00 C4591001AEC4591001 1009 10091406A@ 4 fever Fever F.Pyrexia F)Febrile disorders FBody temperature conditions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-08-20 2021-08-21 BB P1D VACCINATION 4 2021-08-19T16:12:00 C4591001AEC4591001 1009 10091406A0 1 Swilling in bilateral knees Swelling of knees F=IJoint swelling F@Joint related signs and symptoms F:Joint disorders F-ADVERSE EVENT Musculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y1VACCINATION 2021-01-25 2021-03-01 BB5 P17D VACCINATION 1 2021-01-08T18:14:00 C4591001AEC4591001 1009 10091406A 3 headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-08-20 2021-08-21 BB P1D VACCINATION 4 2021-08-19T16:12:00 C4591001AEC4591001 1009 10091406A 2 fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-08-20 2021-08-21 BB P1D VACCINATION 4 2021-08-19T16:12:00 C4591001AEC4591001 1009 10091409A 1 Post Surgical Pain Postoperative pain Fl7Procedural pain FNon-site specific procedural complications F Procedural related injuries and complications NEC FADVERSE EVENT Injury, poisoning and procedural complications FInjury, poisoning and procedural complications F NNOT APPLICABLE NOT RELATEDOTHER NOT RECOVERED/NOT RESOLVED Y2FOLLOW-UP 2021-07-22 B. P170D VACCINATION 2 2021-02-02T17:29:00ONGOINGLAST SUBJECT ENCOUNTERC4591001AEC4591001 1009 10091410A 2 INJECTION SITE PAIN Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2VACCINATION 2021-02-01T20:002021-02-03 BB PT3H18M VACCINATION 2 2021-02-01T16:42:00 C4591001AEC4591001 1009 10091410A 1 FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2VACCINATION 2021-02-01T20:002021-02-03 BB PT3H18M VACCINATION 2 2021-02-01T16:42:00 C4591001AEC4591001 1009 10091411J-+M VACCINATION 2-JOINT PAIN JOINT PAIN Joint pain F6Arthralgia F'Joint related signs and symptoms F:Joint disorders F-REACTOGENICITY SYSTEMIC YMusculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk VACCINATION 2021-02-02 2021-02-08 BBP1D P1D VACCINATION 2 2021-02-01 C4591001AEC4591001 1009 10091412J-+M VACCINATION 1-MUSCLE PAIN MUSCLE PAIN Muscle pain F"Myalgia F{Muscle pains F#Muscle disorders FREACTOGENICITY SYSTEMIC YMusculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk VACCINATION 2021-01-17 2021-01-19 A`AP1D P5D VACCINATION 1 2021-01-12 C4591001AEC4591001 1009 10091413J-+M VACCINATION 2-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-02-03 2021-02-10 BBP1D VACCINATION 2 2021-02-03 C4591001AEC4591001 1009 10091413A0 2 Post Surgical Right Leg Pain Postoperative pain Fl7Procedural pain FNon-site specific procedural complications F Procedural related injuries and complications NEC FADVERSE EVENT Injury, poisoning and procedural complications FInjury, poisoning and procedural complications F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y2FOLLOW-UP 2021-03-16 2021-03-30 B@BN P41D VACCINATION 2 2021-02-03T16:20:00 C4591001AEC4591001 1009 10091413A 3 bilateral rib pain Rib pain FTMusculoskeletal chest pain F]Musculoskeletal and connective tissue pain and discomfort FMusculoskeletal and connective tissue disorders NEC FiADVERSE EVENT Musculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2VACCINATION 2021-02-05T05:002021-02-05T06:30BB P2D VACCINATION 2 2021-02-03T16:20:00 C4591001AEC4591001 1013 10131824A 1 SWELLING LEFT ARM Swelling arm F=8Peripheral swelling FUGeneral signs and symptoms NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1VACCINATION 2020-12-05 2020-12-06 APA` P4D VACCINATION 1 2020-12-01T13:08:00 C4591001AEC4591001 1013 10131828J-+M VACCINATION 2-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2020-12-31 2021-01-06 BB$P1D P1D VACCINATION 2 2020-12-30 C4591001AEC4591001 1013 10131839J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-03 2020-12-10 A AP2D P1D VACCINATION 1 2020-12-02 C4591001AEC4591001 1013 10131839A 1 SPORTS RELATED CONCUSSION Concussion FConcussion FCerebral injuries NEC FdInjuries NEC FADVERSE EVENT Injury, poisoning and procedural complications FInjury, poisoning and procedural complications F NNOT APPLICABLE NOT RELATEDOTHER RECOVERING/RESOLVING N2FOLLOW-UP 2021-03-01 BZ. P68D VACCINATION 2 2020-12-23T14:48:00ONGOINGLAST SUBJECT ENCOUNTERC4591001AEC4591001 1013 10131843J-+M VACCINATION 2-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2020-12-23 2020-12-30 BBP2D P1D VACCINATION 2 2020-12-22 C4591001AEC4591001 1013 10131843J-+M VACCINATION 2-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-23 2020-12-30 BBP2D P1D VACCINATION 2 2020-12-22 C4591001AEC4591001 1013 10131843J-+M VACCINATION 2-DELTOID MUSCLE-LEFT-PAIN AT INJECTION SITE PAIN AT INJECTION SITE Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FREACTOGENICITY ADMINISTRATION SITEYGeneral disorders and administration site conditions FGeneral disorders and administration site conditions FDELTOID MUSCLELEFT VACCINATION 2020-12-23 2020-12-30 BBP2D P1D VACCINATION 2 2020-12-22 C4591001AEC4591001 1013 10131863J-+M VACCINATION 2-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-30 2021-01-06 BBP1D VACCINATION 2 2020-12-30 C4591001AEC4591001 1013 10131878J-+M VACCINATION 2-VOMITING VOMITING Vomiting FPVomiting FPNausea and vomiting symptoms FGastrointestinal signs and symptoms FREACTOGENICITY SYSTEMIC YGastrointestinal disorders FܛGastrointestinal disorders Fܛ VACCINATION 2021-01-19 2021-01-20 BBP1D P6D VACCINATION 2 2021-01-13 C4591001AEC4591001 1013 10131878J-+M VACCINATION 2-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-17 2021-01-20 BBP1D P4D VACCINATION 2 2021-01-13 C4591001AEC4591001 1016 10161307J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-10-15 2020-10-22 AAP1D VACCINATION 1 2020-10-15 C4591001AEC4591001 1016 10161310J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-10-15 2020-10-23 AAP2D VACCINATION 1 2020-10-15 C4591001AEC4591001 1016 10161316A 1 muscle pain Muscle pain F"Myalgia F{Muscle pains F#Muscle disorders FADVERSE EVENT Musculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-02-26 2021-02-26 BB P1D VACCINATION 3 2021-02-25T14:45:00 C4591001AEC4591001 1016 10161316A 2 chills Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-02-26 2021-02-26 BB P1D VACCINATION 3 2021-02-25T14:45:00 C4591001AEC4591001 1016 10161319J-+M VACCINATION 2-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2020-11-10 2020-11-12 BBP2D P6D VACCINATION 2 2020-11-04 C4591001AEC4591001 1016 10161319J-+M VACCINATION 2-CHILLS CHILLS Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-11-10 2020-11-11 BBP1D P6D VACCINATION 2 2020-11-04 C4591001AEC4591001 1016 10161322J-+M VACCINATION 1-DELTOID MUSCLE-LEFT-PAIN AT INJECTION SITE PAIN AT INJECTION SITE Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FREACTOGENICITY ADMINISTRATION SITEYGeneral disorders and administration site conditions FGeneral disorders and administration site conditions FDELTOID MUSCLELEFT VACCINATION 2020-10-19 2020-10-26 AAP1D VACCINATION 1 2020-10-19 C4591001AEC4591001 1016 10161327A 2 syncope Syncope F=Syncope F=Disturbances in consciousness NEC FENeurological disorders NEC FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N2FOLLOW-UP 2021-04-09 2021-04-09 BB P150D VACCINATION 2 2020-11-10T10:47:00 C4591001AEC4591001 1016 10161329A 1 left foot puncture would Puncture wound FUWound FcLNon-site specific injuries NEC F Injuries NEC FADVERSE EVENT Injury, poisoning and procedural complications FInjury, poisoning and procedural complications F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-07-04 2021-07-24 C C` P25D VACCINATION 4 2021-06-09T15:53:00 C4591001AEC4591001 1016 10161329A 2 cellulitis of left foot Cellulitis of foot FgCellulitis FJBacterial infections NEC FOBacterial infectious disorders F2ADVERSE EVENT Infections and infestations FInfections and infestations F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-07-06 2021-07-16 C@C P27D VACCINATION 4 2021-06-09T15:53:00 C4591001AEC4591001 1016 10161330J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2020-10-26 2020-10-27 ApAP1D P6D VACCINATION 1 2020-10-20 C4591001AEC4591001 1016 10161330J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-10-21 2020-10-27 A AP1D P1D VACCINATION 1 2020-10-20 C4591001AEC4591001 1016 10161344J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-10-23 2020-10-29 A AP1D P1D VACCINATION 1 2020-10-22 C4591001AEC4591001 1016 10161344A 1 enlarged lymph nodes, right anterior cervical nodes Lymph nodes cervical swollen FLymphadenopathy FLymphatic system disorders NEC FSpleen, lymphatic and reticuloendothelial system disorders F9)ADVERSE EVENT Blood and lymphatic system disorders FQBlood and lymphatic system disorders FQ NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N1VACCINATION 2020-11-25 2021-01-06 B#BM P14D VACCINATION 2 2020-11-11T15:37:00 C4591001AEC4591001 1016 10161344A 2 infectious mononuclesosis Infectious mononucleosis FInfectious mononucleosis FEpstein-Barr viral infections FуViral infectious disorders FOADVERSE EVENT Infections and infestations FInfections and infestations F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N1VACCINATION 2020-11-25 2021-01-06 B#BM P14D VACCINATION 2 2020-11-11T15:37:00 C4591001AEC4591001 1016 10161353A 5 fever Fever F.Pyrexia F)Febrile disorders FBody temperature conditions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-06-14 2021-06-15 BB VACCINATION 4 2021-06-14T10:45:00 C4591001AEC4591001 1016 10161353Ap 6 body aches Generalized aching F\Pain FPain and discomfort NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-06-14 2021-06-15 BB VACCINATION 4 2021-06-14T10:45:00 C4591001AEC4591001 1016 10161353A` 1 left deltoid injection site soreness Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-25T08:002021-05-26T08:00BB P1D VACCINATION 3 2021-05-24T16:30:00 C4591001AEC4591001 1016 10161353AP 8 injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-06-14 2021-06-17 BB VACCINATION 4 2021-06-14T10:45:00 C4591001AEC4591001 1016 10161353A@ 7 headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-06-14 2021-06-15 BB VACCINATION 4 2021-06-14T10:45:00 C4591001AEC4591001 1016 10161353A0 2 fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-05-25T08:002021-05-26T08:00BB P1D VACCINATION 3 2021-05-24T16:30:00 C4591001AEC4591001 1016 10161353A 4 chills Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-06-14 2021-06-15 BB VACCINATION 4 2021-06-14T10:45:00 C4591001AEC4591001 1016 10161353A 3 chills Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-05-25T08:002021-05-26T08:00BB P1D VACCINATION 3 2021-05-24T16:30:00 C4591001AEC4591001 1016 10161357J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2020-12-08 2020-12-09 ApAP1D P6D VACCINATION 1 2020-12-02 C4591001AEC4591001 1016 10161365J-+M VACCINATION 2-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2021-01-04 2021-01-05 BBP1D P6D VACCINATION 2 2020-12-29 C4591001AEC4591001 1016 10161366A 1 vomiting Vomiting FPVomiting FPNausea and vomiting symptoms FGastrointestinal signs and symptoms FADVERSE EVENT Gastrointestinal disorders FܛGastrointestinal disorders Fܛ NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-07-08 2021-07-09 BB P1D VACCINATION 4 2021-07-07T15:28:00 C4591001AEC4591001 1016 10161367J-+M VACCINATION 2-DIARRHEA DIARRHEA Diarrhea F7Diarrhoea F?Diarrhoea (excl infective) F@Gastrointestinal motility and defaecation conditions FܹREACTOGENICITY SYSTEMIC YGastrointestinal disorders FܛGastrointestinal disorders Fܛ VACCINATION 2021-01-23 2021-01-27 BBP2D P4D VACCINATION 2 2021-01-19 C4591001AEC4591001 1016 10161369J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-31 2021-01-06 A AP1D P1D VACCINATION 1 2020-12-30 C4591001AEC4591001 1016 10161371A 1 fever, low grade Slight fever F6Pyrexia F)Febrile disorders FBody temperature conditions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-06-15 2021-06-15 BB P1D VACCINATION 4 2021-06-14T16:22:00 C4591001AEC4591001 1016 10161371A 2 fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-15 2021-06-17 BB P1D VACCINATION 4 2021-06-14T16:22:00 C4591001AEC4591001 1016 10161375J-+M VACCINATION 2-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-28 2021-02-04 BBP2D P1D VACCINATION 2 2021-01-27 C4591001AEC4591001 1016 10161375J-+M VACCINATION 2-CHILLS CHILLS Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-28 2021-02-04 BBP2D P1D VACCINATION 2 2021-01-27 C4591001AEC4591001 1016 10161382J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-08 2021-01-15 AAP1D VACCINATION 1 2021-01-08 C4591001AEC4591001 1016 10161387J-+M VACCINATION 2-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2021-01-28 2021-02-09 BB!P7D P1D VACCINATION 2 2021-01-27 C4591001AEC4591001 1039 10391246A` 5 fever Fever F.Pyrexia F)Febrile disorders FBody temperature conditions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-03-19 2021-03-20 BmBn P1D VACCINATION 4 2021-03-18T11:00:00 C4591001AEC4591001 1039 10391246AP 3 fever Fever F.Pyrexia F)Febrile disorders FBody temperature conditions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-02-27 2021-02-28 BYBZ P1D VACCINATION 3 2021-02-26T07:48:00 C4591001AEC4591001 1039 10391246A@ 2 generalized achiness Generalised aching FPain FPain and discomfort NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-02-27 2021-03-02 BYB\ P1D VACCINATION 3 2021-02-26T07:48:00 C4591001AEC4591001 1039 10391246A0 4 headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-02-27 2021-03-01 BYB[ P1D VACCINATION 3 2021-02-26T07:48:00 C4591001AEC4591001 1039 10391246A 6 fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-03-19 2021-03-20 BmBn P1D VACCINATION 4 2021-03-18T11:00:00 C4591001AEC4591001 1039 10391246A 1 fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-02-27 2021-03-01 BYB[ P1D VACCINATION 3 2021-02-26T07:48:00 C4591001AEC4591001 1039 10391250A 1 exacerbation of tic disorder Tic disorder, unspecified FATic FATic disorders FAChanges in physical activity FQADVERSE EVENT Psychiatric disorders F'Psychiatric disorders F' NNOT APPLICABLE NOT RELATEDOTHER RECOVERING/RESOLVING N1VACCINATION 2021-01-09 B%. P12D VACCINATION 2 2020-12-28T08:28:00ONGOINGLAST SUBJECT ENCOUNTERC4591001AEC4591001 1039 10391251A 1 Headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-02-25T20:002021-02-27 BQBS PT12H16MVACCINATION 4 2021-02-25T07:44:00 C4591001AEC4591001 1039 10391251A 2 Fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-02-25T20:002021-02-27 BQBS PT12H16MVACCINATION 4 2021-02-25T07:44:00 C4591001AEC4591001 1039 10391258A0 3 Fever Fever F.Pyrexia F)Febrile disorders FBody temperature conditions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-06-01T16:002021-06-02T16:00BB PT3H58M VACCINATION 4 2021-06-01T12:02:00 C4591001AEC4591001 1039 10391258A 4 Headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-06-01T16:002021-06-02T16:00BB PT3H58M VACCINATION 4 2021-06-01T12:02:00 C4591001AEC4591001 1039 10391258A 5 Fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-06-02 2021-06-03 BB P1D VACCINATION 4 2021-06-01T12:02:00 C4591001AEC4591001 1039 10391259A` 4 fever Fever F.Pyrexia F)Febrile disorders FBody temperature conditions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-06-05 2021-06-07 BB P1D VACCINATION 4 2021-06-04T13:11:00 C4591001AEC4591001 1039 10391259AP 3 injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-04T13:112021-06-05 BB VACCINATION 4 2021-06-04T13:11:00 C4591001AEC4591001 1039 10391259A@ 2 injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-05-14T20:002021-05-21 BB PT6H07M VACCINATION 3 2021-05-14T13:53:00 C4591001AEC4591001 1039 10391259A0 5 headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-06-06 2021-06-06 BB P2D VACCINATION 4 2021-06-04T13:11:00 C4591001AEC4591001 1039 10391259A 6 fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-06-06 2021-06-06 BB P2D VACCINATION 4 2021-06-04T13:11:00 C4591001AEC4591001 1039 10391259A 1 fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-05-15T10:002021-05-15 BB P1D VACCINATION 3 2021-05-14T13:53:00 C4591001AEC4591001 1039 10391264J-+M VACCINATION 1-MUSCLE PAIN MUSCLE PAIN Muscle pain F"Myalgia F{Muscle pains F#Muscle disorders FREACTOGENICITY SYSTEMIC YMusculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk VACCINATION 2020-12-09 2020-12-15 A AP1D P1D VACCINATION 1 2020-12-08 C4591001AEC4591001 1039 10391264J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2020-12-11 2020-12-15 A@AP1D P3D VACCINATION 1 2020-12-08 C4591001AEC4591001 1039 10391264J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-08 2020-12-15 AAP1D VACCINATION 1 2020-12-08 C4591001AEC4591001 1039 10391264J-+M VACCINATION 1-CHILLS CHILLS Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-13 2020-12-15 A`AP1D P5D VACCINATION 1 2020-12-08 C4591001AEC4591001 1039 10391264A 1 General muscle aches Muscle ache FMyalgia F{Muscle pains F#Muscle disorders FADVERSE EVENT Musculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-25T19:002021-05-27 BB P1D VACCINATION 3 2021-05-24T13:58:00 C4591001AEC4591001 1039 10391266A@ 1 Fever - max 100F Fever F.Pyrexia F)Febrile disorders FBody temperature conditions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-06-04 2021-06-05 BB P1D VACCINATION 4 2021-06-03T14:04:00 C4591001AEC4591001 1039 10391266A0 2 Body ache Ache F(Pain FPain and discomfort NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-06-04 2021-06-05 BB P1D VACCINATION 4 2021-06-03T14:04:00 C4591001AEC4591001 1039 10391266A 4 Left arm muscle ache Myalgia upper extremities FMyalgia F{Muscle pains F#Muscle disorders FADVERSE EVENT Musculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-04T22:002021-06-05 BB P1D VACCINATION 4 2021-06-03T14:04:00 C4591001AEC4591001 1039 10391266A 3 Fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-04T22:002021-06-05 BB P1D VACCINATION 4 2021-06-03T14:04:00 C4591001AEC4591001 1039 10391267J-+M VACCINATION 2-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-28 2021-01-04 BBP1D VACCINATION 2 2020-12-28 C4591001AEC4591001 1039 10391268A 1 Fever - up to 102.5 Fever F.Pyrexia F)Febrile disorders FBody temperature conditions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N3OPEN LABEL TREATMENT2021-05-14T00:002021-05-15T10:00BB P1D VACCINATION 3 2021-05-13T10:10:00 C4591001AEC4591001 1039 10391270A 2 fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-14 2021-05-16 BB P1D VACCINATION 3 2021-05-13T08:45:00 C4591001AEC4591001 1039 10391270A 1 Epistaxis Epistaxis FrEpistaxis FrNasal disorders NEC FUpper respiratory tract disorders (excl infections) FK`ADVERSE EVENT Respiratory, thoracic and mediastinal disorders F-Respiratory, thoracic and mediastinal disorders F- NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N1VACCINATION 2020-12-23T16:002020-12-23T20:00AA P14D VACCINATION 1 2020-12-09T11:31:00 C4591001AEC4591001 1039 10391270J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2020-12-09 2020-12-16 AAP1D VACCINATION 1 2020-12-09 C4591001AEC4591001 1039 10391270J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-09 2020-12-16 AAP1D VACCINATION 1 2020-12-09 C4591001AEC4591001 1039 10391270A` 6 fever Fever F.Pyrexia F)Febrile disorders FBody temperature conditions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-06-04 2021-06-05 BB P1D VACCINATION 4 2021-06-03T08:47:00 C4591001AEC4591001 1039 10391270AP 4 Fever Fever F.Pyrexia F)Febrile disorders FBody temperature conditions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-05-14T14:002021-05-14T16:00BB P1D VACCINATION 3 2021-05-13T08:45:00 C4591001AEC4591001 1039 10391270A@ 3 Injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-05-13T19:002021-05-14 BB PT10H15MVACCINATION 3 2021-05-13T08:45:00 C4591001AEC4591001 1039 10391270A0 5 fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-06-04 2021-06-06 BB P1D VACCINATION 4 2021-06-03T08:47:00 C4591001AEC4591001 1039 10391271A 2 headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-06-04T10:002021-06-04T12:00BB P1D VACCINATION 4 2021-06-03T12:14:00 C4591001AEC4591001 1039 10391271A 1 Headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-05-14T16:002021-05-14T21:00BB P1D VACCINATION 3 2021-05-13T11:07:00 C4591001AEC4591001 1039 10391273A 2 Injection site soreness Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-14T07:002021-05-15 BB P1D VACCINATION 3 2021-05-13T11:06:00 C4591001AEC4591001 1039 10391273A 1 Fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-14T07:002021-05-14T17:00BB P1D VACCINATION 3 2021-05-13T11:06:00 C4591001AEC4591001 1039 10391274A 1 post nasal drip Postnasal drip F$Upper-airway cough syndrome FUpper respiratory tract signs and symptoms FKiRespiratory tract signs and symptoms F}ADVERSE EVENT Respiratory, thoracic and mediastinal disorders F-Respiratory, thoracic and mediastinal disorders F- NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-07-01 2021-07-06 BB P27D VACCINATION 4 2021-06-04T08:06:00 C4591001AEC4591001 1039 10391274A 2 exacerbation of pineapple food allergy Fruit allergy FvFood allergy FزAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,ADVERSE EVENT Immune system disorders F4Immune system disorders F4 NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-07-01 2021-07-01 BB P27D VACCINATION 4 2021-06-04T08:06:00 C4591001AEC4591001 1039 10391279A` 3 Body aches Generalized aching F\Pain FPain and discomfort NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-06-07T22:002021-06-08T23:59BB PT11H19MVACCINATION 4 2021-06-07T10:41:00 C4591001AEC4591001 1039 10391279AP 1 injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-05-17T17:002021-05-19 BB PT5H44M VACCINATION 3 2021-05-17T11:16:00 C4591001AEC4591001 1039 10391279A@ 5 Injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-07T17:002021-06-08T23:59BB PT6H19M VACCINATION 4 2021-06-07T10:41:00 C4591001AEC4591001 1039 10391279A0 2 fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-18T10:002021-05-19T10:00BB P1D VACCINATION 3 2021-05-17T11:16:00 C4591001AEC4591001 1039 10391279A 4 Fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-06-07T22:002021-06-08T23:59BB PT11H19MVACCINATION 4 2021-06-07T10:41:00 C4591001AEC4591001 1039 10391279A 6 Chills Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-06-07T22:002021-06-08T23:59BB PT11H19MVACCINATION 4 2021-06-07T10:41:00 C4591001AEC4591001 1039 10391280J-+M VACCINATION 2-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2021-01-08 2021-01-14 BBP1D P1D VACCINATION 2 2021-01-07 C4591001AEC4591001 1039 10391280J-+M VACCINATION 2-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-10 2021-01-14 BBP1D P3D VACCINATION 2 2021-01-07 C4591001AEC4591001 1039 10391280J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-17 2020-12-24 AAP1D VACCINATION 1 2020-12-17 C4591001AEC4591001 1039 10391280A 1 Vasovagal episode Vaso vagal attack FNPresyncope F%Neurological signs and symptoms NEC FNeurological disorders NEC FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N1FOLLOW-UP 2021-02-04T09:292021-02-04T10:10B2B2 P28D VACCINATION 2 2021-01-07T10:29:00 C4591001AEC4591001 1039 10391280A 2 Injection site soreness Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-15T07:002021-05-18T12:00BB P1D VACCINATION 3 2021-05-14T08:48:00 C4591001AEC4591001 1039 10391283A0 3 Injection site soreness Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-13T15:002021-05-15 BB PT6H49M VACCINATION 3 2021-05-13T08:11:00 C4591001AEC4591001 1039 10391283A 1 Headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-05-14 2021-05-16 BB P1D VACCINATION 3 2021-05-13T08:11:00 C4591001AEC4591001 1039 10391283A 2 Fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-05-14 2021-05-16 BB P1D VACCINATION 3 2021-05-13T08:11:00 C4591001AEC4591001 1039 10391284J-+M VACCINATION 1-JOINT PAIN JOINT PAIN Joint pain F6Arthralgia F'Joint related signs and symptoms F:Joint disorders F-REACTOGENICITY SYSTEMIC YMusculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk VACCINATION 2020-12-24 2020-12-25 ApAP1D P6D VACCINATION 1 2020-12-18 C4591001AEC4591001 1039 10391285Ap 4 fever Fever F.Pyrexia F)Febrile disorders FBody temperature conditions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-04T14:002021-06-05 BB PT5H44M VACCINATION 4 2021-06-04T08:16:00 C4591001AEC4591001 1039 10391285A` 5 nausea Nausea F Nausea F Nausea and vomiting symptoms FGastrointestinal signs and symptoms FADVERSE EVENT Gastrointestinal disorders FܛGastrointestinal disorders Fܛ NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-04T14:002021-06-05 BB PT5H44M VACCINATION 4 2021-06-04T08:16:00 C4591001AEC4591001 1039 10391285AP 2 nausea Nausea F Nausea F Nausea and vomiting symptoms FGastrointestinal signs and symptoms FADVERSE EVENT Gastrointestinal disorders FܛGastrointestinal disorders Fܛ NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-14T18:002021-05-15T18:00BB PT9H25M VACCINATION 3 2021-05-14T08:35:00 C4591001AEC4591001 1039 10391285A@ 6 muscle aches Muscle ache FMyalgia F{Muscle pains F#Muscle disorders FADVERSE EVENT Musculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-04T14:002021-06-05 BB PT5H44M VACCINATION 4 2021-06-04T08:16:00 C4591001AEC4591001 1039 10391285A0 3 injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-15T08:002021-05-15 BB P1D VACCINATION 3 2021-05-14T08:35:00 C4591001AEC4591001 1039 10391285A 1 fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-14T18:002021-05-15T18:00BB PT9H25M VACCINATION 3 2021-05-14T08:35:00 C4591001AEC4591001 1039 10391285A 7 Generalized Arthralgia Arthralgia F'Arthralgia F'Joint related signs and symptoms F:Joint disorders F-ADVERSE EVENT Musculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-04T14:002021-06-05 BB PT5H44M VACCINATION 4 2021-06-04T08:16:00 C4591001AEC4591001 1039 10391287AP 4 injection site soreness Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-04T07:152021-06-04T21:30BB P1D VACCINATION 4 2021-06-03T09:34:00 C4591001AEC4591001 1039 10391287A@ 1 injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-14 2021-05-15 BB P1D VACCINATION 3 2021-05-13T13:14:00 C4591001AEC4591001 1039 10391287A0 5 headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-04T09:452021-06-05T15:00BB P1D VACCINATION 4 2021-06-03T09:34:00 C4591001AEC4591001 1039 10391287A 3 fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-03T12:402021-06-04T14:15BB PT3H06M VACCINATION 4 2021-06-03T09:34:00 C4591001AEC4591001 1039 10391287A 2 fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-13T14:002021-05-14 BB PT46M VACCINATION 3 2021-05-13T13:14:00 C4591001AEC4591001 1039 10391290A 1 Vasovagal episode Vaso vagal attack FNPresyncope F%Neurological signs and symptoms NEC FNeurological disorders NEC FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N2REPEAT SCREENING 1 2021-07-13T08:102021-07-13T08:50BB P186D VACCINATION 2 2021-01-08T09:43:00 C4591001AEC4591001 1039 10391292AP 5 Nausea Nausea F Nausea F Nausea and vomiting symptoms FGastrointestinal signs and symptoms FADVERSE EVENT Gastrointestinal disorders FܛGastrointestinal disorders Fܛ NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-06-04T17:002021-06-06 BB PT8H33M VACCINATION 4 2021-06-04T08:27:00 C4591001AEC4591001 1039 10391292A@ 1 Injection site soreness Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-14T18:002021-05-22 BB PT9H15M VACCINATION 3 2021-05-14T08:45:00 C4591001AEC4591001 1039 10391292A0 4 Injection arm soreness Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-06-04T17:002021-06-10 BB PT8H33M VACCINATION 4 2021-06-04T08:27:00 C4591001AEC4591001 1039 10391292A 3 Fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-06-04T17:002021-06-06 BB PT8H33M VACCINATION 4 2021-06-04T08:27:00 C4591001AEC4591001 1039 10391292A 2 Fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-14T18:002021-05-16T08:00BB PT9H15M VACCINATION 3 2021-05-14T08:45:00 C4591001AEC4591001 1039 10391294J-+M VACCINATION 2-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-18 2021-01-20 BBP1D P5D VACCINATION 2 2021-01-13 C4591001AEC4591001 1039 10391294J-+M VACCINATION 2-JOINT PAIN JOINT PAIN Joint pain F6Arthralgia F'Joint related signs and symptoms F:Joint disorders F-REACTOGENICITY SYSTEMIC YMusculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk VACCINATION 2021-01-16 2021-01-22 BB!P3D P3D VACCINATION 2 2021-01-13 C4591001AEC4591001 1039 10391294A 1 Injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-14T22:002021-05-16 BB PT13H34MVACCINATION 3 2021-05-14T08:26:00 C4591001AEC4591001 1039 10391294A 2 Injection arm soreness Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-04T13:302021-06-05T13:30BB PT3H28M VACCINATION 4 2021-06-04T10:02:00 C4591001AEC4591001 1039 10391296AP 5 Fever 102 Fever F.Pyrexia F)Febrile disorders FBody temperature conditions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-06-05T08:002021-06-05T21:30BB P1D VACCINATION 4 2021-06-04T09:52:00 C4591001AEC4591001 1039 10391296A@ 4 nausea Nausea F Nausea F Nausea and vomiting symptoms FGastrointestinal signs and symptoms FADVERSE EVENT Gastrointestinal disorders FܛGastrointestinal disorders Fܛ NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-04T21:302021-06-06T08:00BB PT11H38MVACCINATION 4 2021-06-04T09:52:00 C4591001AEC4591001 1039 10391296A0 1 Injection site soreness Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-14T13:032021-05-15T09:00BB PT3H02M VACCINATION 3 2021-05-14T10:01:00 C4591001AEC4591001 1039 10391296A 3 Chills Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-06-04T21:302021-06-05T21:30BB PT11H38MVACCINATION 4 2021-06-04T09:52:00 C4591001AEC4591001 1039 10391296A 2 Left armpit soreness Armpit pain FAxillary pain FTPain and discomfort NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-04T13:002021-06-06T08:00BB PT3H08M VACCINATION 4 2021-06-04T09:52:00 C4591001AEC4591001 1039 10391300J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-30 2021-01-05 A AP1D P1D VACCINATION 1 2020-12-29 C4591001AEC4591001 1039 10391301A 6 fever Fever F.Pyrexia F)Febrile disorders FBody temperature conditions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-05 2021-06-06 BB P1D VACCINATION 4 2021-06-04T13:29:00 C4591001AEC4591001 1039 10391301A 1 vasovagal episode Vaso vagal attack FNPresyncope F%Neurological signs and symptoms NEC FNeurological disorders NEC FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N1REPEAT SCREENING 1 2021-05-13T11:512021-05-13T12:00BB P112D VACCINATION 2 2021-01-21T08:13:00 C4591001AEC4591001 1039 10391301Ap 5 body aches Generalized aching F\Pain FPain and discomfort NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-05 2021-06-06 BB P1D VACCINATION 4 2021-06-04T13:29:00 C4591001AEC4591001 1039 10391301A` 3 General muscle aches Muscle ache FMyalgia F{Muscle pains F#Muscle disorders FADVERSE EVENT Musculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-14T08:002021-05-16 BB P1D VACCINATION 3 2021-05-13T12:03:00 C4591001AEC4591001 1039 10391301AP 8 injection site soreness Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-05 2021-06-08 BB P1D VACCINATION 4 2021-06-04T13:29:00 C4591001AEC4591001 1039 10391301A@ 2 Injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-13T19:002021-05-18 BB PT6H57M VACCINATION 3 2021-05-13T12:03:00 C4591001AEC4591001 1039 10391301A0 10 headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-05 2021-06-06 BB P1D VACCINATION 4 2021-06-04T13:29:00 C4591001AEC4591001 1039 10391301A 4 Headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-14T08:002021-05-16 BB P1D VACCINATION 3 2021-05-13T12:03:00 C4591001AEC4591001 1039 10391301A 7 chills Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-05 2021-06-06 BB P1D VACCINATION 4 2021-06-04T13:29:00 C4591001AEC4591001 1039 10391302J-+M VACCINATION 2-DELTOID MUSCLE-RIGHT-PAIN AT INJECTION SITEPAIN AT INJECTION SITE Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FREACTOGENICITY ADMINISTRATION SITEYGeneral disorders and administration site conditions FGeneral disorders and administration site conditions FDELTOID MUSCLERIGHT VACCINATION 2021-01-19 2021-01-27 BBP3D P1D VACCINATION 2 2021-01-18 C4591001AEC4591001 1039 10391303A 1 chills Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-04T22:002021-06-05T08:00BB PT13H52MVACCINATION 4 2021-06-04T08:08:00 C4591001AEC4591001 1039 10391305A 1 Fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-15T13:002021-05-16T12:00BB P1D VACCINATION 3 2021-05-14T16:00:00 C4591001AEC4591001 1039 10391307J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-06 2021-01-13 AAP1D VACCINATION 1 2021-01-06 C4591001AEC4591001 1039 10391307A 11 injection site soreness Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT ACUTE REACTIONS General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-06-04T10:442021-06-07T10:00BB PT01M VACCINATION 4 2021-06-04T10:43:00 C4591001AEC4591001 1039 10391307A 8 vomiting Vomiting FPVomiting FPNausea and vomiting symptoms FGastrointestinal signs and symptoms FADVERSE EVENT Gastrointestinal disorders FܛGastrointestinal disorders Fܛ NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-05T03:002021-06-06T03:00BB P1D VACCINATION 4 2021-06-04T10:43:00 C4591001AEC4591001 1039 10391307A 13 Vitamin D deficiency Vitamin D deficiency FPVitamin D deficiency FPFat soluble vitamin deficiencies and disorders FVitamin related disorders FPADVERSE EVENT Metabolism and nutrition disorders FMetabolism and nutrition disorders F NNOT APPLICABLE NOT RELATEDOTHER RECOVERING/RESOLVING Y1OPEN LABEL TREATMENT2021-06-11 B. P7D VACCINATION 4 2021-06-04T10:43:00ONGOINGLAST SUBJECT ENCOUNTERC4591001AEC4591001 1039 10391307Ap 6 thyroid nodule Thyroid nodule FAgThyroid mass F|Thyroid disorders NEC FA@Thyroid gland disorders FA[ADVERSE EVENT Endocrine disorders FEndocrine disorders F NNOT APPLICABLE NOT RELATEDOTHER NOT RECOVERED/NOT RESOLVED N1OPEN LABEL TREATMENT2021-06-01 B. P18D VACCINATION 3 2021-05-14T13:40:00ONGOINGLAST SUBJECT ENCOUNTERC4591001AEC4591001 1039 10391307A` 12 fever Fever F.Pyrexia F)Febrile disorders FBody temperature conditions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-06-04T20:002021-06-06T12:00BB PT9H17M VACCINATION 4 2021-06-04T10:43:00 C4591001AEC4591001 1039 10391307AP 10 muscle aches Muscle ache FMyalgia F{Muscle pains F#Muscle disorders FADVERSE EVENT Musculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-06-04T20:002021-06-06T12:00BB PT9H17M VACCINATION 4 2021-06-04T10:43:00 C4591001AEC4591001 1039 10391307A@ 5 exacerbation of neck muscle strain Muscle strain FYMuscle strain FYMuscle, tendon and ligament injuries FInjuries NEC FADVERSE EVENT Injury, poisoning and procedural complications FInjury, poisoning and procedural complications F NNOT APPLICABLE NOT RELATEDOTHER RECOVERING/RESOLVING Y3OPEN LABEL TREATMENT2021-05-14T22:30 B. PT8H50M VACCINATION 3 2021-05-14T13:40:00ONGOINGLAST SUBJECT ENCOUNTERC4591001AEC4591001 1039 10391307A0 9 headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-06-04T20:002021-06-06T12:00BB PT9H17M VACCINATION 4 2021-06-04T10:43:00 C4591001AEC4591001 1039 10391307A 7 chills Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-06-04T20:002021-06-06T12:00BB PT9H17M VACCINATION 4 2021-06-04T10:43:00 C4591001AEC4591001 1039 10391307A 4 Hashimoto's thyroiditis Hashimoto's thyroiditis F_Autoimmune thyroiditis FVAcute and chronic thyroiditis FAThyroid gland disorders FA[ADVERSE EVENT Endocrine disorders FEndocrine disorders F NNOT APPLICABLE NOT RELATEDOTHER NOT RECOVERED/NOT RESOLVED N1OPEN LABEL TREATMENT2021-06-14 B. P10D VACCINATION 4 2021-06-04T10:43:00ONGOINGLAST SUBJECT ENCOUNTERC4591001AEC4591001 1039 10391309A0 2 injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1REPEAT SCREENING 1 2021-05-17T07:302021-05-18T12:00BB P110D VACCINATION 2 2021-01-27T14:10:00 C4591001AEC4591001 1039 10391309A 3 fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-09 2021-06-12 BB P1D VACCINATION 4 2021-06-08T13:08:00 C4591001AEC4591001 1039 10391309A 1 fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1REPEAT SCREENING 1 2021-05-17T07:302021-05-18T12:00BB P110D VACCINATION 2 2021-01-27T14:10:00 C4591001AEC4591001 1039 10391310Ap 4 swelling at injection site Swelling of injection site F=HInjection site swelling Fg1Injection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-18 2021-05-31 BB P4D VACCINATION 3 2021-05-14T13:59:00 C4591001AEC4591001 1039 10391310A` 5 bruising at injection site Injection site bruising FInjection site bruising FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-07T15:002021-06-14 BB PT4H10M VACCINATION 4 2021-06-07T10:50:00 C4591001AEC4591001 1039 10391310AP 3 bruise at injection site Injection site bruising FInjection site bruising FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-14T18:002021-05-18 BB PT4H01M VACCINATION 3 2021-05-14T13:59:00 C4591001AEC4591001 1039 10391310A@ 7 headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-06-08T14:002021-06-09T08:00BB P1D VACCINATION 4 2021-06-07T10:50:00 C4591001AEC4591001 1039 10391310A0 1 headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1REPEAT SCREENING 1 2021-05-14T13:002021-05-14T18:00BB P108D VACCINATION 2 2021-01-26T08:50:00 C4591001AEC4591001 1039 10391310A 6 fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-08T14:002021-06-09T08:00BB P1D VACCINATION 4 2021-06-07T10:50:00 C4591001AEC4591001 1039 10391310A 2 fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1REPEAT SCREENING 1 2021-05-14T07:002021-05-15T07:00BB P108D VACCINATION 2 2021-01-26T08:50:00 C4591001AEC4591001 1039 10391313A@ 2 General Body aches Generalised aching FPain FPain and discomfort NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-06-03T21:002021-06-05 BB PT10H25MVACCINATION 4 2021-06-03T10:35:00 C4591001AEC4591001 1039 10391313A0 1 General Body aches Generalised aching FPain FPain and discomfort NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-05-15T09:002021-05-15T20:00BB P1D VACCINATION 3 2021-05-14T12:40:00 C4591001AEC4591001 1039 10391313A 3 Injection site soreness Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-03T21:002021-06-05 BB PT10H25MVACCINATION 4 2021-06-03T10:35:00 C4591001AEC4591001 1039 10391313A 4 Fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-06-04 2021-06-05 BB P1D VACCINATION 4 2021-06-03T10:35:00 C4591001AEC4591001 1039 10391314A 2 Injection Site Pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-17T13:002021-05-19 BB PT5H02M VACCINATION 3 2021-05-17T07:58:00 C4591001AEC4591001 1039 10391314A 1 Exacerbation of fibroadenoma of right breast Fibroadenoma of breast FeFibroadenoma of breast FeBreast and nipple neoplasms benign FBreast neoplasms benign (incl nipple) FADVERSE EVENT Neoplasms benign, malignant and unspecified (incl cysts and polyps)F0Neoplasms benign, malignant and unspecified (incl cysts and polyps)F0 NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y1VACCINATION 2021-02-06 2021-04-06 BBZ P9D VACCINATION 2 2021-01-28T12:45:00 C4591001AEC4591001 1039 10391315A 1 vasovagal episode Vaso vagal attack FNPresyncope F%Neurological signs and symptoms NEC FNeurological disorders NEC FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N2REPEAT SCREENING 1 2021-07-22T12:312021-07-22T12:45BB P176D VACCINATION 2 2021-01-27T13:58:00 C4591001AEC4591001 1039 10391317A@ 1 vomiting Vomiting FPVomiting FPNausea and vomiting symptoms FGastrointestinal signs and symptoms FADVERSE EVENT Gastrointestinal disorders FܛGastrointestinal disorders Fܛ NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N1SCREENING 2021-01-07T13:352021-01-07T13:48AA C4591001AEC4591001 1039 10391317A0 2 pre-syncope Pre-syncope F%Presyncope F%Neurological signs and symptoms NEC FNeurological disorders NEC FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N1SCREENING 2021-01-07T13:352021-01-07T13:48AA C4591001AEC4591001 1039 10391317A 3 fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-15T08:002021-05-15T15:00BB P1D VACCINATION 3 2021-05-14T15:13:00 C4591001AEC4591001 1039 10391317A 4 chills Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-05-15T13:002021-05-15T15:00BB P1D VACCINATION 3 2021-05-14T15:13:00 C4591001AEC4591001 1039 10391318J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2021-01-07 2021-01-14 AAP1D VACCINATION 1 2021-01-07 C4591001AEC4591001 1039 10391318J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-07 2021-01-14 AAP1D VACCINATION 1 2021-01-07 C4591001AEC4591001 1039 10391319A0 1 fever - max temp 102.3 Fever F.Pyrexia F)Febrile disorders FBody temperature conditions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y3OPEN LABEL TREATMENT2021-05-21 2021-05-23 BB P1D VACCINATION 3 2021-05-20T14:01:00 C4591001AEC4591001 1039 10391319A 3 injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-05-21 2021-05-23 BB P1D VACCINATION 3 2021-05-20T14:01:00 C4591001AEC4591001 1039 10391319A 2 chills Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-05-21 2021-05-22 BB P1D VACCINATION 3 2021-05-20T14:01:00 C4591001AEC4591001 1039 10391320J-+M VACCINATION 2-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2021-01-29 2021-02-05 BBP1D VACCINATION 2 2021-01-29 C4591001AEC4591001 1039 10391320J-+M VACCINATION 1-DELTOID MUSCLE-LEFT-PAIN AT INJECTION SITE PAIN AT INJECTION SITE Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FREACTOGENICITY ADMINISTRATION SITEYGeneral disorders and administration site conditions FGeneral disorders and administration site conditions FDELTOID MUSCLELEFT VACCINATION 2021-01-08 2021-01-15 AAP1D VACCINATION 1 2021-01-08 C4591001AEC4591001 1039 10391321A 2 Injection arm soreness Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-06-08T17:002021-06-09T17:00BB PT3H10M VACCINATION 4 2021-06-08T13:50:00 C4591001AEC4591001 1039 10391321A 1 Chills Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-05-17T20:002021-05-18T10:00BB PT12H VACCINATION 3 2021-05-17T08:00:00 C4591001AEC4591001 1039 10391324J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2021-01-13 2021-01-15 A`AP1D P5D VACCINATION 1 2021-01-08 C4591001AEC4591001 1039 10391325A 1 Fever - up to 103.4 Fever F.Pyrexia F)Febrile disorders FBody temperature conditions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y3OPEN LABEL TREATMENT2021-05-13T22:002021-05-14T09:00B{B| PT11H56MVACCINATION 3 2021-05-13T10:04:00 C4591001AEC4591001 1039 10391325Ap 4 generalized aches Generalised aching FPain FPain and discomfort NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-06-04 2021-06-05 BB P1D VACCINATION 4 2021-06-03T08:34:00 C4591001AEC4591001 1039 10391325A` 7 bruise at injection site Injection site bruising FInjection site bruising FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-04 2021-06-11 BB P1D VACCINATION 4 2021-06-03T08:34:00 C4591001AEC4591001 1039 10391325AP 6 fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-06-04 2021-06-07 BB P1D VACCINATION 4 2021-06-03T08:34:00 C4591001AEC4591001 1039 10391325A@ 8 fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-03T14:002021-06-04 BB PT5H26M VACCINATION 4 2021-06-03T08:34:00 C4591001AEC4591001 1039 10391325A0 3 fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-05-13T22:002021-05-15 B{B} PT11H56MVACCINATION 3 2021-05-13T10:04:00 C4591001AEC4591001 1039 10391325A 5 chills Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-06-03T21:002021-06-05 BB PT12H26MVACCINATION 4 2021-06-03T08:34:00 C4591001AEC4591001 1039 10391325A 2 Chills Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-05-13T22:002021-05-15 B{B} PT11H56MVACCINATION 3 2021-05-13T10:04:00 C4591001AEC4591001 1039 10391327A 1 Fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1REPEAT SCREENING 1 2021-06-06 2021-06-08 BB P125D VACCINATION 2 2021-02-01T08:44:00 C4591001AEC4591001 1039 10391328J-+M VACCINATION 2-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2021-02-02 2021-02-09 BBP1D VACCINATION 2 2021-02-02 C4591001AEC4591001 1039 10391328J-+M VACCINATION 2-DIARRHEA DIARRHEA Diarrhea F7Diarrhoea F?Diarrhoea (excl infective) F@Gastrointestinal motility and defaecation conditions FܹREACTOGENICITY SYSTEMIC YGastrointestinal disorders FܛGastrointestinal disorders Fܛ VACCINATION 2021-02-08 2021-02-09 BBP1D P6D VACCINATION 2 2021-02-02 C4591001AEC4591001 1039 10391328A@ 1 Injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-05-14T18:002021-05-17 B|B PT5H32M VACCINATION 3 2021-05-14T12:28:00 C4591001AEC4591001 1039 10391328A0 3 Injection arm soreness Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-04T19:002021-06-05T19:00BB PT5H55M VACCINATION 4 2021-06-04T13:05:00 C4591001AEC4591001 1039 10391328A 2 fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-14T16:002021-05-17 B|B PT3H32M VACCINATION 3 2021-05-14T12:28:00 C4591001AEC4591001 1039 10391328A 4 Fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-04T19:002021-06-05T19:00BB PT5H55M VACCINATION 4 2021-06-04T13:05:00 C4591001AEC4591001 1039 10391329A0 3 injection arm soreness Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-11 2021-06-13 BB P1D VACCINATION 4 2021-06-10T13:29:00 C4591001AEC4591001 1039 10391329A 1 Injection site soreness Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-21T07:002021-05-23 BB P1D VACCINATION 3 2021-05-20T14:02:00 C4591001AEC4591001 1039 10391329A 2 fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-11 2021-06-13 BB P1D VACCINATION 4 2021-06-10T13:29:00 C4591001AEC4591001 1039 10391330J-+M VACCINATION 2-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2021-02-03 2021-02-09 BBP1D P1D VACCINATION 2 2021-02-02 C4591001AEC4591001 1039 10391330J-+M VACCINATION 2-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-02-03 2021-02-09 BBP1D P1D VACCINATION 2 2021-02-02 C4591001AEC4591001 1039 10391330A 2 nausea Nausea F Nausea F Nausea and vomiting symptoms FGastrointestinal signs and symptoms FADVERSE EVENT Gastrointestinal disorders FܛGastrointestinal disorders Fܛ NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N1REPEAT SCREENING 1 2021-06-25 2021-06-25 BB P143D VACCINATION 2 2021-02-02T13:34:00 C4591001AEC4591001 1039 10391330A 1 stomach pain Stomach pain F;Abdominal pain upper FGastrointestinal and abdominal pains (excl oral and throat) F܆Gastrointestinal signs and symptoms FADVERSE EVENT Gastrointestinal disorders FܛGastrointestinal disorders Fܛ NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N1REPEAT SCREENING 1 2021-06-25 2021-06-25 BB P143D VACCINATION 2 2021-02-02T13:34:00 C4591001AEC4591001 1039 10391333A 1 fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-12 2021-06-13 BB P1D VACCINATION 4 2021-06-11T14:11:00 C4591001AEC4591001 1039 10391336J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2021-01-12 2021-01-19 AAP1D VACCINATION 1 2021-01-12 C4591001AEC4591001 1039 10391336J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-13 2021-01-19 A AP1D P1D VACCINATION 1 2021-01-12 C4591001AEC4591001 1039 10391337A@ 3 vomit Vomiting FPVomiting FPNausea and vomiting symptoms FGastrointestinal signs and symptoms FADVERSE EVENT Gastrointestinal disorders FܛGastrointestinal disorders Fܛ NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-05-15T07:302021-05-15T07:35B|B| P1D VACCINATION 3 2021-05-14T11:26:00 C4591001AEC4591001 1039 10391337A0 1 urticaria, both hands Urticaria FMUrticaria FMUrticarias FMAngioedema and urticaria FADVERSE EVENT Skin and subcutaneous tissue disorders F5Skin and subcutaneous tissue disorders F5 NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1VACCINATION 2021-02-04 2021-02-06 BB P1D VACCINATION 2 2021-02-03T07:51:00 C4591001AEC4591001 1039 10391337A 6 Fever Fever F.Pyrexia F)Febrile disorders FBody temperature conditions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-06-05T08:002021-06-06 BB P1D VACCINATION 4 2021-06-04T11:21:00 C4591001AEC4591001 1039 10391337A 2 chills Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-05-14T23:302021-05-15T16:00B{B| PT12H04MVACCINATION 3 2021-05-14T11:26:00 C4591001AEC4591001 1039 10391339A 1 Vomiting Vomiting FPVomiting FPNausea and vomiting symptoms FGastrointestinal signs and symptoms FADVERSE EVENT Gastrointestinal disorders FܛGastrointestinal disorders Fܛ NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1VACCINATION 2021-01-12T20:002021-01-12T20:30AA PT5H08M VACCINATION 1 2021-01-12T14:52:00 C4591001AEC4591001 1039 10391339A 2 Nausea Nausea F Nausea F Nausea and vomiting symptoms FGastrointestinal signs and symptoms FADVERSE EVENT Gastrointestinal disorders FܛGastrointestinal disorders Fܛ NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1VACCINATION 2021-01-12T20:002021-01-12T20:30AA PT5H08M VACCINATION 1 2021-01-12T14:52:00 C4591001AEC4591001 1044 10441251J-+M VACCINATION 2-FEVER FEVER Fever F.Pyrexia F)Febrile disorders FBody temperature conditions FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-23 2021-01-21 BB5P24DP1D VACCINATION 2 2020-12-22 C4591001AEC4591001 1044 10441251J-+M VACCINATION 2-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2020-12-23 2021-01-21 BB5P24DP1D VACCINATION 2 2020-12-22 C4591001AEC4591001 1044 10441251J-+M VACCINATION 2-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-23 2021-01-21 BB5P24DP1D VACCINATION 2 2020-12-22 C4591001AEC4591001 1044 10441251J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-02 2020-12-22 A0BP16DP2D VACCINATION 1 2020-11-30 C4591001AEC4591001 1044 10441251J-+M VACCINATION 2-CHILLS CHILLS Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-23 2021-01-21 BB5P24DP1D VACCINATION 2 2020-12-22 C4591001AEC4591001 1044 10441251J-+M VACCINATION 2-DELTOID MUSCLE-LEFT-PAIN AT INJECTION SITE PAIN AT INJECTION SITE Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FREACTOGENICITY ADMINISTRATION SITEYGeneral disorders and administration site conditions FGeneral disorders and administration site conditions FDELTOID MUSCLELEFT VACCINATION 2020-12-22 B. VACCINATION 2 2020-12-22 ONGOINGV3_MONTH1_POSTVAX2_L C4591001AEC4591001 1044 10441255J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2020-12-07 2020-12-21 ApBP14DP6D VACCINATION 1 2020-12-01 C4591001AEC4591001 1044 10441255J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-01 2020-12-21 ABP14D VACCINATION 1 2020-12-01 C4591001AEC4591001 1044 10441261J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-02 2020-12-22 A BP15DP1D VACCINATION 1 2020-12-01 C4591001AEC4591001 1044 10441264J-+M VACCINATION 2-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2021-01-02 2021-02-02 BB:P30DP5D VACCINATION 2 2020-12-28 C4591001AEC4591001 1044 10441265A 3 sinusitis Sinusitis F5Sinusitis F5Upper respiratory tract infections FKeInfections - pathogen unspecified FADVERSE EVENT Infections and infestations FInfections and infestations F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-06-16 2021-06-27 BB P7D VACCINATION 4 2021-06-09T14:12:00 C4591001AEC4591001 1044 10441266A 1 Worsening of acne Acne aggravated FrAcne FpAcnes FqSkin appendage conditions F5ADVERSE EVENT Skin and subcutaneous tissue disorders F5Skin and subcutaneous tissue disorders F5 NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y1VACCINATION 2021-01-07 2021-02-01 BB8 P10D VACCINATION 2 2020-12-28T13:19:00 C4591001AEC4591001 1044 10441267A 2 thumb fracture Fractured thumb F!Hand fracture F*Limb fractures and dislocations FBone and joint injuries FADVERSE EVENT Injury, poisoning and procedural complications FInjury, poisoning and procedural complications F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y2FOLLOW-UP 2021-04-29 2021-06-02 BB P122D VACCINATION 2 2020-12-28T10:18:00 C4591001AEC4591001 1044 10441267A 1 Accidental fall Fall FխFall FխNon-site specific injuries NEC F Injuries NEC FADVERSE EVENT Injury, poisoning and procedural complications FInjury, poisoning and procedural complications F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y2FOLLOW-UP 2021-04-29 2021-06-02 BB P122D VACCINATION 2 2020-12-28T10:18:00 C4591001AEC4591001 1044 10441275A 1 myalgia Myalgia F{Myalgia F{Muscle pains F#Muscle disorders FADVERSE EVENT Musculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1VACCINATION 2021-01-04 2021-01-04 BB P6D VACCINATION 2 2020-12-29T11:16:00 C4591001AEC4591001 1044 10441282J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2020-12-15 2020-12-30 ApBP15DP6D VACCINATION 1 2020-12-09 C4591001AEC4591001 1044 10441282J-+M VACCINATION 2-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-02 2021-01-28 BB3P23DP3D VACCINATION 2 2020-12-30 C4591001AEC4591001 1044 10441282A 1 injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-03-25 2021-03-25 BkBk P1D VACCINATION 4 2021-03-24T13:43:00 C4591001AEC4591001 1044 10441284A 2 depression Depression FDepression FDepressive disorders FDepressed mood disorders and disturbances FADVERSE EVENT Psychiatric disorders F'Psychiatric disorders F' NNOT APPLICABLE NOT RELATEDOTHER RECOVERING/RESOLVING Y1FOLLOW-UP 2021-02-01 B6. P34D VACCINATION 2 2020-12-29T14:30:00ONGOINGLAST SUBJECT ENCOUNTERC4591001AEC4591001 1044 10441284A 1 Anxiety Anxiety FAnxiety FAnxiety symptoms FAnxiety disorders and symptoms FADVERSE EVENT Psychiatric disorders F'Psychiatric disorders F' NNOT APPLICABLE NOT RELATEDOTHER RECOVERING/RESOLVING Y2FOLLOW-UP 2021-04-27 B. P119D VACCINATION 2 2020-12-29T14:30:00ONGOINGLAST SUBJECT ENCOUNTERC4591001AEC4591001 1044 10441285A 1 Wisdom teeth extraction Wisdom teeth removal FQWisdom teeth removal FQDental and gingival therapeutic procedures FƝHead and neck therapeutic procedures FvADVERSE EVENT Surgical and medical procedures F<Surgical and medical procedures F< NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N2REPEAT SCREENING 1 2021-06-22 2021-06-22 BB P174D VACCINATION 2 2020-12-30T10:25:00 C4591001AEC4591001 1044 10441292A 1 Edema Toes (Bilateral) Foot edema FOedema peripheral F ,Oedema NEC F !General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y1VACCINATION 2020-12-17 2020-12-19 AA0 VACCINATION 1 2020-12-17T14:39:00 C4591001AEC4591001 1044 10441300A 1 Stomach pain Stomach pain F;Abdominal pain upper FGastrointestinal and abdominal pains (excl oral and throat) F܆Gastrointestinal signs and symptoms FADVERSE EVENT Gastrointestinal disorders FܛGastrointestinal disorders Fܛ NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N1REPEAT SCREENING 1 2021-08-31 2021-09-01 BB P225D VACCINATION 2 2021-01-18T12:21:00 C4591001AEC4591001 1044 10441302J-+M VACCINATION 1-MUSCLE PAIN MUSCLE PAIN Muscle pain F"Myalgia F{Muscle pains F#Muscle disorders FREACTOGENICITY SYSTEMIC YMusculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk VACCINATION 2020-12-29 2021-01-19 ABP15D VACCINATION 1 2020-12-29 C4591001AEC4591001 1044 10441302J-+M VACCINATION 1-JOINT PAIN JOINT PAIN Joint pain F6Arthralgia F'Joint related signs and symptoms F:Joint disorders F-REACTOGENICITY SYSTEMIC YMusculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk VACCINATION 2020-12-29 2021-01-19 ABP15D VACCINATION 1 2020-12-29 C4591001AEC4591001 1044 10441303A 1 generlized Muscle aches Generalized muscle aches FiMyalgia F{Muscle pains F#Muscle disorders FADVERSE EVENT Musculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-04-20 2021-04-22 BqBs VACCINATION 3 2021-04-20T11:09:00 C4591001AEC4591001 1044 10441303A 2 Injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-04-20 2021-04-23 BqBt VACCINATION 3 2021-04-20T11:09:00 C4591001AEC4591001 1044 10441304A 1 generalized rash Generalized rash FVRash F*TRashes, eruptions and exanthems NEC FcEpidermal and dermal conditions FADVERSE EVENT Skin and subcutaneous tissue disorders F5Skin and subcutaneous tissue disorders F5 NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y1FOLLOW-UP 2021-02-25 2021-02-27 B;B= P37D VACCINATION 2 2021-01-19T15:04:00 C4591001AEC4591001 1044 10441309A 1 Ocular Pain in Right Eye Ocular pain F=Eye pain FOcular disorders NEC F Eye disorders NEC FԭADVERSE EVENT Eye disorders FԯEye disorders Fԯ NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N2FOLLOW-UP 2021-05-12 2021-05-14 BB P114D VACCINATION 2 2021-01-18T13:49:00 C4591001AEC4591001 1044 10441320A 1 headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-04 2021-06-05 BB VACCINATION 4 2021-06-04T13:57:00 C4591001AEC4591001 1044 10441320A 2 chills Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-04 2021-06-05 BB VACCINATION 4 2021-06-04T13:57:00 C4591001AEC4591001 1044 10441328A 1 Pilonidal cyst Pilonidal cyst FcPilonidal cyst FcSkin structures and soft tissue infections F5Infections - pathogen unspecified FADVERSE EVENT Infections and infestations FInfections and infestations F NNOT APPLICABLE NOT RELATEDOTHER RECOVERING/RESOLVING Y2FOLLOW-UP 2021-04-22 Bk. P86D VACCINATION 2 2021-01-26T10:20:00ONGOINGLAST SUBJECT ENCOUNTERC4591001AEC4591001 1044 10441330J-+M VACCINATION 2-DIARRHEA DIARRHEA Diarrhea F7Diarrhoea F?Diarrhoea (excl infective) F@Gastrointestinal motility and defaecation conditions FܹREACTOGENICITY SYSTEMIC YGastrointestinal disorders FܛGastrointestinal disorders Fܛ VACCINATION 2021-01-28 2021-02-25 BB3P23DP1D VACCINATION 2 2021-01-27 C4591001AEC4591001 1044 10441335A 1 Worsening of acne Acne aggravated FrAcne FpAcnes FqSkin appendage conditions F5ADVERSE EVENT Skin and subcutaneous tissue disorders F5Skin and subcutaneous tissue disorders F5 NNOT APPLICABLE NOT RELATEDOTHER RECOVERING/RESOLVING Y1VACCINATION 2021-02-27 B4. P29D VACCINATION 2 2021-01-29T15:20:00ONGOINGLAST SUBJECT ENCOUNTERC4591001AEC4591001 1044 10441337A 1 Broken humerus (right arm) Humerus fracture FnHumerus fracture FnLimb fractures and dislocations FBone and joint injuries FADVERSE EVENT Injury, poisoning and procedural complications FInjury, poisoning and procedural complications F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y2VACCINATION 2021-01-10 2021-02-12 A0B$ P2D VACCINATION 1 2021-01-08T10:15:00 C4591001AEC4591001 1044 10441338A 1 Wart on second toe (left) Wart FQQSkin papilloma F6KSkin neoplasms benign F6BCutaneous neoplasms benign F6CADVERSE EVENT Neoplasms benign, malignant and unspecified (incl cysts and polyps)F0Neoplasms benign, malignant and unspecified (incl cysts and polyps)F0 NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y1VACCINATION 2021-02-01 2021-02-07 BB P3D VACCINATION 2 2021-01-29T11:32:00 C4591001AEC4591001 1044 10441343J-+M VACCINATION 2-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-29 2021-02-26 BB1P22D VACCINATION 2 2021-01-29 C4591001AEC4591001 1044 10441343J-+M VACCINATION 2-JOINT PAIN JOINT PAIN Joint pain F6Arthralgia F'Joint related signs and symptoms F:Joint disorders F-REACTOGENICITY SYSTEMIC YMusculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk VACCINATION 2021-01-30 2021-02-26 BB1P22DP1D VACCINATION 2 2021-01-29 C4591001AEC4591001 1044 10441345A@ 2 vomitting Vomiting FPVomiting FPNausea and vomiting symptoms FGastrointestinal signs and symptoms FADVERSE EVENT Gastrointestinal disorders FܛGastrointestinal disorders Fܛ NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-07 2021-06-08 BB VACCINATION 4 2021-06-07T10:28:00 C4591001AEC4591001 1044 10441345A0 1 nausea Nausea F Nausea F Nausea and vomiting symptoms FGastrointestinal signs and symptoms FADVERSE EVENT Gastrointestinal disorders FܛGastrointestinal disorders Fܛ NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-06-07 2021-06-08 BB VACCINATION 4 2021-06-07T10:28:00 C4591001AEC4591001 1044 10441345A 4 generalized myalgia Myalgia F{Myalgia F{Muscle pains F#Muscle disorders FADVERSE EVENT Musculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk NNOT APPLICABLE RELATED RECOVERING/RESOLVING Y2OPEN LABEL TREATMENT2021-06-07 B. VACCINATION 4 2021-06-07T10:28:00ONGOINGLAST SUBJECT ENCOUNTERC4591001AEC4591001 1044 10441345A 3 dizziness Dizziness F˅Dizziness F˅Neurological signs and symptoms NEC FNeurological disorders NEC FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-06-07 2021-06-07 BB VACCINATION 4 2021-06-07T10:28:00 C4591001AEC4591001 1044 10441350J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2021-01-12 2021-01-29 A@BP14DP3D VACCINATION 1 2021-01-09 C4591001AEC4591001 1044 10441350J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-10 2021-01-29 A BP14DP1D VACCINATION 1 2021-01-09 C4591001AEC4591001 1044 10441351A 1 Left hip flexor strain Muscle strain FYMuscle strain FYMuscle, tendon and ligament injuries FInjuries NEC FADVERSE EVENT Injury, poisoning and procedural complications FInjury, poisoning and procedural complications F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y2VACCINATION 2021-02-11 2021-02-27 B!B1 P10D VACCINATION 2 2021-02-01T16:00:00 C4591001AEC4591001 1044 10441354A 1 Worsening of ADHD ADHD FAttention deficit hyperactivity disorderF&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FADVERSE EVENT Psychiatric disorders F'Psychiatric disorders F' NNOT APPLICABLE NOT RELATEDOTHER NOT RECOVERED/NOT RESOLVED Y1FOLLOW-UP 2021-04-24 Bi. P85D VACCINATION 2 2021-01-29T12:40:00ONGOINGLAST SUBJECT ENCOUNTERC4591001AEC4591001 1044 10441359J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-12 2021-02-25 A B.P39DP1D VACCINATION 1 2021-01-11 C4591001AEC4591001 1044 10441361A 2 allergic contact dermatitis involving all extremities (contact with poison sumac) Sumac rash F<|Dermatitis contact FDermatitis and eczema FEpidermal and dermal conditions FADVERSE EVENT Skin and subcutaneous tissue disorders F5Skin and subcutaneous tissue disorders F5 NNOT APPLICABLE NOT RELATEDOTHER RECOVERING/RESOLVING Y1FOLLOW-UP 2021-04-24 Bh. P80D VACCINATION 2 2021-02-03T12:57:00ONGOINGLAST SUBJECT ENCOUNTERC4591001AEC4591001 1044 10441361A 1 Concussion Concussion FConcussion FCerebral injuries NEC FdInjuries NEC FADVERSE EVENT Injury, poisoning and procedural complications FInjury, poisoning and procedural complications F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N1VACCINATION 2021-01-23 2021-02-13 AB" P12D VACCINATION 1 2021-01-11T12:43:00 C4591001AEC4591001 1044 10441364A0 2 Tachycardia Tachycardia F>Tachycardia F>Rate and rhythm disorders NEC F*Cardiac arrhythmias FADVERSE EVENT Cardiac disorders FCardiac disorders F NNOT APPLICABLE NOT RELATEDOTHER RECOVERING/RESOLVING N1REPEAT SCREENING 1 2021-08-19 B. P197D VACCINATION 2 2021-02-03T15:34:00ONGOINGLAST SUBJECT ENCOUNTERC4591001AEC4591001 1044 10441364A 3 Lightheadedness Lightheadedness F,Dizziness F˅Neurological signs and symptoms NEC FNeurological disorders NEC FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE NOT RELATEDOTHER RECOVERING/RESOLVING N1REPEAT SCREENING 1 2021-08-19 B. P197D VACCINATION 2 2021-02-03T15:34:00ONGOINGLAST SUBJECT ENCOUNTERC4591001AEC4591001 1044 10441364A 1 attention deficit hyperactivity disorder Attention deficit hyperactivity disorder F&Attention deficit hyperactivity disorderF&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FADVERSE EVENT Psychiatric disorders F'Psychiatric disorders F' NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y1FOLLOW-UP 2021-04-29 2021-07 Bm. P85D VACCINATION 2 2021-02-03T15:34:00 C4591001AEC4591001 1044 10441373A 1 hives forehead Urticaria localised FUrticaria FMUrticarias FMAngioedema and urticaria FADVERSE EVENT Skin and subcutaneous tissue disorders F5Skin and subcutaneous tissue disorders F5 NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1VACCINATION 2021-01-12T11:292021-01-12 AA PT56M VACCINATION 1 2021-01-12T10:33:00 C4591001AEC4591001 1044 10441373A 2 Worsening of Anxiety Anxiety aggravated FSSAnxiety FAnxiety symptoms FAnxiety disorders and symptoms FADVERSE EVENT Psychiatric disorders F'Psychiatric disorders F' NNOT APPLICABLE NOT RELATEDOTHER RECOVERING/RESOLVING Y2VACCINATION 2021-03-05 B5. P29D VACCINATION 2 2021-02-04T10:04:00ONGOINGLAST SUBJECT ENCOUNTERC4591001AEC4591001 1044 10441379J-+M VACCINATION 2-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2021-02-04 2021-03-09 BB9P27D VACCINATION 2 2021-02-04 C4591001AEC4591001 1044 10441379J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2021-01-12 2021-02-04 ABP17D VACCINATION 1 2021-01-12 C4591001AEC4591001 1044 10441379J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-12 2021-02-04 ABP17D VACCINATION 1 2021-01-12 C4591001AEC4591001 1044 10441384A 1 Achilles tendinitis Achilles tendinitis F1Tendonitis F?wTendon disorders F?bTendon, ligament and cartilage disorders F?eADVERSE EVENT Musculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk NNOT APPLICABLE NOT RELATEDOTHER RECOVERING/RESOLVING Y2FOLLOW-UP 2021-03-08 B8. P32D VACCINATION 2 2021-02-04T16:53:00ONGOINGLAST SUBJECT ENCOUNTERC4591001AEC4591001 1044 10441384A 2 nasal congestion Nasal congestion FNasal congestion FNasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`ADVERSE EVENT Respiratory, thoracic and mediastinal disorders F-Respiratory, thoracic and mediastinal disorders F- NNOT APPLICABLE NOT RELATEDOTHER RECOVERING/RESOLVING Y1FOLLOW-UP 2021-05-07 Bt. P92D VACCINATION 2 2021-02-04T16:53:00ONGOINGLAST SUBJECT ENCOUNTERC4591001AEC4591001 1057 10571377J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-08 2020-12-15 A AP2D P1D VACCINATION 1 2020-12-07 C4591001AEC4591001 1057 10571378J-+M VACCINATION 2-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2020-12-28 2021-01-04 BBP1D VACCINATION 2 2020-12-28 C4591001AEC4591001 1057 10571378J-+M VACCINATION 2-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-28 2021-01-04 BBP1D VACCINATION 2 2020-12-28 C4591001AEC4591001 1057 10571382J-+M VACCINATION 2-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2021-01-05 2021-01-13 BB%P2D VACCINATION 2 2021-01-05 C4591001AEC4591001 1057 10571382J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2020-12-09 2020-12-15 A AP1D P1D VACCINATION 1 2020-12-08 C4591001AEC4591001 1057 10571382J-+M VACCINATION 2-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-06 2021-01-13 BB%P2D P1D VACCINATION 2 2021-01-05 C4591001AEC4591001 1057 10571383J-+M VACCINATION 2-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2020-12-31 2021-01-06 BBP1D P1D VACCINATION 2 2020-12-30 C4591001AEC4591001 1057 10571387J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-09 2020-12-17 AAP2D VACCINATION 1 2020-12-09 C4591001AEC4591001 1057 10571387A 1 ARM SORENESS Pain in arm F Pain in extremity FMusculoskeletal and connective tissue pain and discomfort FMusculoskeletal and connective tissue disorders NEC FiADVERSE EVENT Musculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-23T18:002021-06-24T08:00BB PT1H48M VACCINATION 4 2021-06-23T16:12:00 C4591001AEC4591001 1057 10571388J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2020-12-09 2020-12-16 AAP1D VACCINATION 1 2020-12-09 C4591001AEC4591001 1057 10571388J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-10 2020-12-16 A AP1D P1D VACCINATION 1 2020-12-09 C4591001AEC4591001 1057 10571388J-+M VACCINATION 1-CHILLS CHILLS Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-10 2020-12-16 A AP1D P1D VACCINATION 1 2020-12-09 C4591001AEC4591001 1057 10571389A 1 LEFT ARM INJECTION SITE SORNESS Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1REPEAT SCREENING 1 2021-05-24 2021-05-24 BB P140D VACCINATION 2 2021-01-04T16:42:00 C4591001AEC4591001 1057 10571389A 2 FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1REPEAT SCREENING 1 2021-05-24 2021-05-24 BB P140D VACCINATION 2 2021-01-04T16:42:00 C4591001AEC4591001 1057 10571393J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2020-12-10 2020-12-16 A AP1D P1D VACCINATION 1 2020-12-09 C4591001AEC4591001 1057 10571394J-+M VACCINATION 2-MUSCLE PAIN MUSCLE PAIN Muscle pain F"Myalgia F{Muscle pains F#Muscle disorders FREACTOGENICITY SYSTEMIC YMusculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk VACCINATION 2020-12-29 2021-01-06 BBP2D VACCINATION 2 2020-12-29 C4591001AEC4591001 1057 10571394J-+M VACCINATION 1-MUSCLE PAIN MUSCLE PAIN Muscle pain F"Myalgia F{Muscle pains F#Muscle disorders FREACTOGENICITY SYSTEMIC YMusculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk VACCINATION 2020-12-11 2020-12-19 A0AP4D P2D VACCINATION 1 2020-12-09 C4591001AEC4591001 1057 10571394J-+M VACCINATION 2-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2020-12-29 2021-01-06 BBP2D VACCINATION 2 2020-12-29 C4591001AEC4591001 1057 10571394J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2020-12-10 2020-12-19 A AP4D P1D VACCINATION 1 2020-12-09 C4591001AEC4591001 1057 10571394J-+M VACCINATION 2-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-29 2021-01-06 BBP2D VACCINATION 2 2020-12-29 C4591001AEC4591001 1057 10571394J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-09 2020-12-19 AAP4D VACCINATION 1 2020-12-09 C4591001AEC4591001 1057 10571394J-+M VACCINATION 2-JOINT PAIN JOINT PAIN Joint pain F6Arthralgia F'Joint related signs and symptoms F:Joint disorders F-REACTOGENICITY SYSTEMIC YMusculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk VACCINATION 2020-12-29 2021-01-06 BBP2D VACCINATION 2 2020-12-29 C4591001AEC4591001 1057 10571394J-+M VACCINATION 1-JOINT PAIN JOINT PAIN Joint pain F6Arthralgia F'Joint related signs and symptoms F:Joint disorders F-REACTOGENICITY SYSTEMIC YMusculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk VACCINATION 2020-12-10 2020-12-19 A AP4D P1D VACCINATION 1 2020-12-09 C4591001AEC4591001 1057 10571398J-+M VACCINATION 2-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2020-12-30 2021-01-07 BBP2D VACCINATION 2 2020-12-30 C4591001AEC4591001 1057 10571399J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2020-12-10 2020-12-20 AAP4D VACCINATION 1 2020-12-10 C4591001AEC4591001 1057 10571399J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-10 2020-12-20 AAP4D VACCINATION 1 2020-12-10 C4591001AEC4591001 1057 10571403J-+M VACCINATION 1-DELTOID MUSCLE-LEFT-PAIN AT INJECTION SITE PAIN AT INJECTION SITE Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FREACTOGENICITY ADMINISTRATION SITEYGeneral disorders and administration site conditions FGeneral disorders and administration site conditions FDELTOID MUSCLELEFT VACCINATION 2020-12-14 2020-12-23 AAP3D VACCINATION 1 2020-12-14 C4591001AEC4591001 1057 10571403J-+M VACCINATION 1-DELTOID MUSCLE-LEFT-REDNESS REDNESS Redness F+Erythema FѮErythemas FѯEpidermal and dermal conditions FREACTOGENICITY ADMINISTRATION SITEYSkin and subcutaneous tissue disorders F5Skin and subcutaneous tissue disorders F5DELTOID MUSCLELEFT VACCINATION 2020-12-16 2020-12-23 A0AP3D P2D VACCINATION 1 2020-12-14 C4591001AEC4591001 1057 10571404J-+M VACCINATION 1-MUSCLE PAIN MUSCLE PAIN Muscle pain F"Myalgia F{Muscle pains F#Muscle disorders FREACTOGENICITY SYSTEMIC YMusculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk VACCINATION 2020-12-21 2020-12-23 A`AP1D P5D VACCINATION 1 2020-12-16 C4591001AEC4591001 1057 10571404J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-19 2020-12-23 A@AP1D P3D VACCINATION 1 2020-12-16 C4591001AEC4591001 1057 10571407A 1 RIGHT ARM INJECTION SITE SORENESS Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-04-02T18:002021-04-04T18:00BkBm PT7H12M VACCINATION 4 2021-04-02T10:48:00 C4591001AEC4591001 1057 10571407A 2 FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-04-02T18:002021-04-04T18:00BkBm PT7H12M VACCINATION 4 2021-04-02T10:48:00 C4591001AEC4591001 1057 10571408A 2 NAUSEA Nausea F Nausea F Nausea and vomiting symptoms FGastrointestinal signs and symptoms FADVERSE EVENT Gastrointestinal disorders FܛGastrointestinal disorders Fܛ NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-25T21:002021-05-26T08:00BB PT5H16M VACCINATION 3 2021-05-25T15:44:00 C4591001AEC4591001 1057 10571408A 1 HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-25T21:002021-05-26T08:00BB PT5H16M VACCINATION 3 2021-05-25T15:44:00 C4591001AEC4591001 1057 10571414J-+M VACCINATION 1-MUSCLE PAIN MUSCLE PAIN Muscle pain F"Myalgia F{Muscle pains F#Muscle disorders FREACTOGENICITY SYSTEMIC YMusculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk VACCINATION 2020-12-26 2020-12-30 A`AP3D P5D VACCINATION 1 2020-12-21 C4591001AEC4591001 1057 10571414J-+M VACCINATION 2-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-14 2021-01-20 BBP2D P2D VACCINATION 2 2021-01-12 C4591001AEC4591001 1057 10571414J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-21 2020-12-30 AAP3D VACCINATION 1 2020-12-21 C4591001AEC4591001 1057 10571414J-+M VACCINATION 1-DELTOID MUSCLE-LEFT-PAIN AT INJECTION SITE PAIN AT INJECTION SITE Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FREACTOGENICITY ADMINISTRATION SITEYGeneral disorders and administration site conditions FGeneral disorders and administration site conditions FDELTOID MUSCLELEFT VACCINATION 2020-12-21 2020-12-30 AAP3D VACCINATION 1 2020-12-21 C4591001AEC4591001 1057 10571417J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2020-12-21 2020-12-29 AAP2D VACCINATION 1 2020-12-21 C4591001AEC4591001 1057 10571417J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-27 2020-12-29 ApAP2D P6D VACCINATION 1 2020-12-21 C4591001AEC4591001 1057 10571424J-+M VACCINATION 1-CHILLS CHILLS Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-25 2021-01-01 A AP2D P1D VACCINATION 1 2020-12-24 C4591001AEC4591001 1057 10571424J-+M VACCINATION 2-DELTOID MUSCLE-LEFT-SWELLING SWELLING Swelling F=2Swelling F=2General signs and symptoms NEC FGeneral system disorders NEC FREACTOGENICITY ADMINISTRATION SITEYGeneral disorders and administration site conditions FGeneral disorders and administration site conditions FDELTOID MUSCLELEFT VACCINATION 2021-01-21 2021-01-22 BBP1D P6D VACCINATION 2 2021-01-15 C4591001AEC4591001 1057 10571424J-+M VACCINATION 1-DELTOID MUSCLE-LEFT-PAIN AT INJECTION SITE PAIN AT INJECTION SITE Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FREACTOGENICITY ADMINISTRATION SITEYGeneral disorders and administration site conditions FGeneral disorders and administration site conditions FDELTOID MUSCLELEFT VACCINATION 2020-12-24 2021-01-01 AAP2D VACCINATION 1 2020-12-24 C4591001AEC4591001 1057 10571428J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2020-12-29 2020-12-31 A`AP1D P5D VACCINATION 1 2020-12-24 C4591001AEC4591001 1057 10571428J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-29 2020-12-31 A`AP1D P5D VACCINATION 1 2020-12-24 C4591001AEC4591001 1057 10571431A 1 BODY ACHES Generalized aching F\Pain FPain and discomfort NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-21T18:002021-06-23T09:00BB PT2H39M VACCINATION 4 2021-06-21T15:21:00 C4591001AEC4591001 1057 10571432A 1 LEFT ARM INJECTION SITE SORENESS Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-01T18:002021-06-02T18:00BB PT2H12M VACCINATION 4 2021-06-01T15:48:00 C4591001AEC4591001 1057 10571432A 2 FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-01T18:002021-06-02T18:00BB PT2H12M VACCINATION 4 2021-06-01T15:48:00 C4591001AEC4591001 1057 10571433J-+M VACCINATION 1-MUSCLE PAIN MUSCLE PAIN Muscle pain F"Myalgia F{Muscle pains F#Muscle disorders FREACTOGENICITY SYSTEMIC YMusculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk VACCINATION 2021-01-04 2021-01-06 A`AP1D P5D VACCINATION 1 2020-12-30 C4591001AEC4591001 1057 10571434A 2 LEFT UPPER ARM PAIN Pain in arm F Pain in extremity FMusculoskeletal and connective tissue pain and discomfort FMusculoskeletal and connective tissue disorders NEC FiADVERSE EVENT Musculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-29T20:002021-07-01T09:00BB PT8H09M VACCINATION 4 2021-06-29T11:51:00 C4591001AEC4591001 1057 10571434A 1 PAIN AT INJECTION SITE LEFT DELTOID Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-29T20:002021-07-01T09:00BB PT8H09M VACCINATION 4 2021-06-29T11:51:00 C4591001AEC4591001 1057 10571441A 1 MUSCLE ACHES Muscle ache FMyalgia F{Muscle pains F#Muscle disorders FADVERSE EVENT Musculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-09T18:002021-06-11T09:00BB PT1H15M VACCINATION 4 2021-06-09T16:45:00 C4591001AEC4591001 1057 10571448J-+M VACCINATION 1-MUSCLE PAIN MUSCLE PAIN Muscle pain F"Myalgia F{Muscle pains F#Muscle disorders FREACTOGENICITY SYSTEMIC YMusculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk VACCINATION 2021-01-12 2021-01-19 A AP2D P1D VACCINATION 1 2021-01-11 C4591001AEC4591001 1057 10571451J-+M VACCINATION 2-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-02-04 2021-02-10 BBP2D P2D VACCINATION 2 2021-02-02 C4591001AEC4591001 1057 10571451A 1 VAGINAL YEAST INFECTION Vaginal yeast infection FMVulvovaginal mycotic infection FFungal infections NEC FFungal infectious disorders FADVERSE EVENT Infections and infestations FInfections and infestations F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y2VACCINATION 2021-01-13T13:002021-02-03T13:00A B P1D VACCINATION 1 2021-01-12T14:27:00 C4591001AEC4591001 1057 10571452J-+M VACCINATION 1-DELTOID MUSCLE-LEFT-PAIN AT INJECTION SITE PAIN AT INJECTION SITE Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FREACTOGENICITY ADMINISTRATION SITEYGeneral disorders and administration site conditions FGeneral disorders and administration site conditions FDELTOID MUSCLELEFT VACCINATION 2021-01-12 2021-01-20 AAP2D VACCINATION 1 2021-01-12 C4591001AEC4591001 1057 10571454J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2021-01-15 2021-01-19 A@AP1D P3D VACCINATION 1 2021-01-12 C4591001AEC4591001 1057 10571454J-+M VACCINATION 1-DIARRHEA DIARRHEA Diarrhea F7Diarrhoea F?Diarrhoea (excl infective) F@Gastrointestinal motility and defaecation conditions FܹREACTOGENICITY SYSTEMIC YGastrointestinal disorders FܛGastrointestinal disorders Fܛ VACCINATION 2021-01-15 2021-01-19 A@AP1D P3D VACCINATION 1 2021-01-12 C4591001AEC4591001 1066 10661405J-+M VACCINATION 1-CHILLS CHILLS Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-04 2020-12-10 A AP1D P1D VACCINATION 1 2020-12-03 C4591001AEC4591001 1066 10661409J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2020-12-09 2020-12-16 A AP2D P1D VACCINATION 1 2020-12-08 C4591001AEC4591001 1066 10661409J-+M VACCINATION 1-DELTOID MUSCLE-LEFT-PAIN AT INJECTION SITE PAIN AT INJECTION SITE Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FREACTOGENICITY ADMINISTRATION SITEYGeneral disorders and administration site conditions FGeneral disorders and administration site conditions FDELTOID MUSCLELEFT VACCINATION 2020-12-08 2020-12-15 AAP1D VACCINATION 1 2020-12-08 C4591001AEC4591001 1066 10661410J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2020-12-11 2020-12-16 A0AP1D P2D VACCINATION 1 2020-12-09 C4591001AEC4591001 1066 10661410A 1 pain at injection site Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-09 2021-06-11 BB P1D VACCINATION 4 2021-06-08T12:21:00 C4591001AEC4591001 1066 10661415J-+M VACCINATION 2-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2021-01-10 2021-01-11 BBP1D P6D VACCINATION 2 2021-01-04 C4591001AEC4591001 1066 10661415J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-14 2020-12-21 AAP1D VACCINATION 1 2020-12-14 C4591001AEC4591001 1066 10661415J-+M VACCINATION 2-DIARRHEA DIARRHEA Diarrhea F7Diarrhoea F?Diarrhoea (excl infective) F@Gastrointestinal motility and defaecation conditions FܹREACTOGENICITY SYSTEMIC YGastrointestinal disorders FܛGastrointestinal disorders Fܛ VACCINATION 2021-01-10 2021-01-11 BBP1D P6D VACCINATION 2 2021-01-04 C4591001AEC4591001 1066 10661416J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2020-12-16 2020-12-22 A AP1D P1D VACCINATION 1 2020-12-15 C4591001AEC4591001 1066 10661416J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-15 2020-12-22 AAP1D VACCINATION 1 2020-12-15 C4591001AEC4591001 1066 10661416J-+M VACCINATION 1-CHILLS CHILLS Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-20 2020-12-22 A`AP1D P5D VACCINATION 1 2020-12-15 C4591001AEC4591001 1066 10661417J-+M VACCINATION 2-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-07 2021-01-13 BBP1D P1D VACCINATION 2 2021-01-06 C4591001AEC4591001 1066 10661419J-+M VACCINATION 1-MUSCLE PAIN MUSCLE PAIN Muscle pain F"Myalgia F{Muscle pains F#Muscle disorders FREACTOGENICITY SYSTEMIC YMusculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk VACCINATION 2020-12-18 2020-12-23 A0AP1D P2D VACCINATION 1 2020-12-16 C4591001AEC4591001 1066 10661419J-+M VACCINATION 2-CHILLS CHILLS Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-11 2021-01-13 BBP1D P5D VACCINATION 2 2021-01-06 C4591001AEC4591001 1066 10661419J-+M VACCINATION 1-JOINT PAIN JOINT PAIN Joint pain F6Arthralgia F'Joint related signs and symptoms F:Joint disorders F-REACTOGENICITY SYSTEMIC YMusculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk VACCINATION 2020-12-18 2020-12-23 A0AP1D P2D VACCINATION 1 2020-12-16 C4591001AEC4591001 1066 10661421J-+M VACCINATION 2-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-15 2021-01-20 BBP1D P2D VACCINATION 2 2021-01-13 C4591001AEC4591001 1066 10661421J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-23 2021-01-01 A AP4D P1D VACCINATION 1 2020-12-22 C4591001AEC4591001 1066 10661422A 1 rash on torso Rash F*TRash F*TRashes, eruptions and exanthems NEC FcEpidermal and dermal conditions FADVERSE EVENT Skin and subcutaneous tissue disorders F5Skin and subcutaneous tissue disorders F5 NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N1VACCINATION 2020-12-24 2020-12-28 A0Ap P2D VACCINATION 1 2020-12-22T10:37:00 C4591001AEC4591001 1066 10661423J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-30 2021-01-06 AAP1D VACCINATION 1 2020-12-30 C4591001AEC4591001 1066 10661424J-+M VACCINATION 2-CHILLS CHILLS Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-21 2021-01-27 BBP1D P1D VACCINATION 2 2021-01-20 C4591001AEC4591001 1066 10661424J-+M VACCINATION 2-DELTOID MUSCLE-LEFT-PAIN AT INJECTION SITE PAIN AT INJECTION SITE Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FREACTOGENICITY ADMINISTRATION SITEYGeneral disorders and administration site conditions FGeneral disorders and administration site conditions FDELTOID MUSCLELEFT VACCINATION 2021-01-20 2021-01-27 BBP1D VACCINATION 2 2021-01-20 C4591001AEC4591001 1077 10771275A 1 RIGHT WRIST SPRAIN Wrist sprain FR3Ligament sprain FMuscle, tendon and ligament injuries FInjuries NEC FADVERSE EVENT Injury, poisoning and procedural complications FInjury, poisoning and procedural complications F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y1FOLLOW-UP 2021-05-07 2021-05-25 BB P136D VACCINATION 2 2020-12-22T16:42:00 C4591001AEC4591001 1077 10771275A 2 FALL Fall FխFall FխNon-site specific injuries NEC F Injuries NEC FADVERSE EVENT Injury, poisoning and procedural complications FInjury, poisoning and procedural complications F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N1FOLLOW-UP 2021-05-07 2021-05-07 BB P136D VACCINATION 2 2020-12-22T16:42:00 C4591001AEC4591001 1077 10771278Ap 5 VOMITING Vomiting FPVomiting FPNausea and vomiting symptoms FGastrointestinal signs and symptoms FADVERSE EVENT Gastrointestinal disorders FܛGastrointestinal disorders Fܛ NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1VACCINATION 2020-12-23T20:002020-12-23T21:00BB PT9H51M VACCINATION 2 2020-12-23T10:09:00 C4591001AEC4591001 1077 10771278A` 4 FEVER Fever F.Pyrexia F)Febrile disorders FBody temperature conditions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y3VACCINATION 2020-12-23T19:012020-12-24T12:00BB PT8H52M VACCINATION 2 2020-12-23T10:09:00 C4591001AEC4591001 1077 10771278AP 7 INJECTION SITE SWELLING Injection site swelling Fg1Injection site swelling Fg1Injection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2VACCINATION 2020-12-23T12:002020-12-24T21:00BB PT1H51M VACCINATION 2 2020-12-23T10:09:00 C4591001AEC4591001 1077 10771278A@ 6 RIGHT ARM INJECTION SITE PAIN Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1VACCINATION 2020-12-23T12:002020-12-24T22:00BB PT1H51M VACCINATION 2 2020-12-23T10:09:00 C4591001AEC4591001 1077 10771278A0 3 FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2VACCINATION 2020-12-23T14:002020-12-24 BB PT3H51M VACCINATION 2 2020-12-23T10:09:00 C4591001AEC4591001 1077 10771278A 2 DISORIENTATION Disorientation FDisorientation FConfusion and disorientation FDeliria (incl confusion) F=ADVERSE EVENT Psychiatric disorders F'Psychiatric disorders F' NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2VACCINATION 2020-12-23T19:012020-12-23T20:00BB PT8H52M VACCINATION 2 2020-12-23T10:09:00 C4591001AEC4591001 1077 10771278A 1 DIARRHEA Diarrhea F7Diarrhoea F?Diarrhoea (excl infective) F@Gastrointestinal motility and defaecation conditions FܹADVERSE EVENT Gastrointestinal disorders FܛGastrointestinal disorders Fܛ NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2VACCINATION 2020-12-23T12:302020-12-24T12:01BB PT2H21M VACCINATION 2 2020-12-23T10:09:00 C4591001AEC4591001 1077 10771279A 1 ORAL/BUCCAL BLISTERS Oral mucosa blister FOral mucosal blistering FOral soft tissue signs and symptoms FOral soft tissue conditions FADVERSE EVENT Gastrointestinal disorders FܛGastrointestinal disorders Fܛ NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2VACCINATION 2021-01-07 2021-01-10 BB P3D VACCINATION 2 2021-01-04T09:15:00 C4591001AEC4591001 1077 10771279A 2 RIGHT 5TH METACARPAL FRACTURE Fractured metacarpal FHand fracture F*Limb fractures and dislocations FBone and joint injuries FADVERSE EVENT Injury, poisoning and procedural complications FInjury, poisoning and procedural complications F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N1REPEAT SCREENING 1 2021-05-18 2021-06-16 BB P134D VACCINATION 2 2021-01-04T09:15:00 C4591001AEC4591001 1077 10771280A 1 FALL Fall FխFall FխNon-site specific injuries NEC F Injuries NEC FADVERSE EVENT Injury, poisoning and procedural complications FInjury, poisoning and procedural complications F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N1FOLLOW-UP 2021-04-08 2021-04-08 BtBt P94D VACCINATION 2 2021-01-04T09:17:00 C4591001AEC4591001 1077 10771280A 2 CONCUSSION Concussion FConcussion FCerebral injuries NEC FdInjuries NEC FADVERSE EVENT Injury, poisoning and procedural complications FInjury, poisoning and procedural complications F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N1FOLLOW-UP 2021-04-08 2021-04-21 BtB P94D VACCINATION 2 2021-01-04T09:17:00 C4591001AEC4591001 1077 10771285A 1 PAIN AT INJECTION SITE Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-05-19 2021-05-21 BB P1D VACCINATION 3 2021-05-18T08:08:00 C4591001AEC4591001 1077 10771290J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-22 2020-12-25 APAP1D P4D VACCINATION 1 2020-12-18 C4591001AEC4591001 1077 10771295A0 3 FOOTBALL INJURY Sports injury F9Sports injury F9Non-site specific injuries NEC F Injuries NEC FADVERSE EVENT Injury, poisoning and procedural complications FInjury, poisoning and procedural complications F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-03-29T15:002021-03-29T15:00B\B\ P12D VACCINATION 4 2021-03-17T13:50:00 C4591001AEC4591001 1077 10771295A 1 RIGHT KNEE MENISCUS TEAR Meniscus tear of knee FMeniscus injury FBone and joint injuries NEC FuBone and joint injuries FADVERSE EVENT Injury, poisoning and procedural complications FInjury, poisoning and procedural complications F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-03-29T15:002021-04-26 B\Bx P12D VACCINATION 4 2021-03-17T13:50:00 C4591001AEC4591001 1077 10771295A 4 RIGHT KNEE ACL TEAR Anterior cruciate ligament tear F}6Ligament rupture FMuscle, tendon and ligament injuries FInjuries NEC FADVERSE EVENT Injury, poisoning and procedural complications FInjury, poisoning and procedural complications F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-03-29T15:002021-04-26 B\Bx P12D VACCINATION 4 2021-03-17T13:50:00 C4591001AEC4591001 1077 10771298A 1 FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-04T19:402021-06-05T17:00BB PT3H47M VACCINATION 4 2021-06-04T15:53:00 C4591001AEC4591001 1077 10771300A 1 AMENORRHEA Amenorrhea FAmenorrhoea FMenstruation with decreased bleeding FMMenstrual cycle and uterine bleeding disorders FʎADVERSE EVENT Reproductive system and breast disorders F-LReproductive system and breast disorders F-L NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N1VACCINATION 2021-01-12 2021-04-01T16:00A`BU P5D VACCINATION 1 2021-01-07T16:38:00 C4591001AEC4591001 1084 10841543A Administration of expired drug Expired drug administered FExpired product administered FProduct administration errors and issues F˫Medication errors and other product use errors and issues F˩MEDICATION ERROR Injury, poisoning and procedural complications FInjury, poisoning and procedural complications F DOSE NOT CHANGED N OPEN LABEL TREATMENT2021-06-08 2021-06-08 BB P1D VACCINATION 4 2021-06-07T15:36:00 C4591001AEC4591001 1084 10841546J-+M VACCINATION 2-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2021-01-06 2021-01-13 BBP1D VACCINATION 2 2021-01-06 C4591001AEC4591001 1084 10841546J-+M VACCINATION 2-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-06 2021-01-13 BBP1D VACCINATION 2 2021-01-06 C4591001AEC4591001 1084 10841556A 1 L Ear infection Ear infection F;Ear infection F;Ear infections F=Infections - pathogen unspecified FADVERSE EVENT Infections and infestations FInfections and infestations F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y2VACCINATION 2021-01-28 2021-02-05 B B( P10D VACCINATION 2 2021-01-18T09:12:00 C4591001AEC4591001 1084 10841557J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-28 2021-01-18 ABP15D VACCINATION 1 2020-12-28 C4591001AEC4591001 1084 10841558A 1 left sprained ankle Sprained ankle F9Ligament sprain FMuscle, tendon and ligament injuries FInjuries NEC FADVERSE EVENT Injury, poisoning and procedural complications FInjury, poisoning and procedural complications F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y2VACCINATION 2021-01-27 2021-01-28 BB P9D VACCINATION 2 2021-01-18T10:11:00 C4591001AEC4591001 1084 10841560A 1 Obsessive compulsive disorder Obsessive-compulsive disorder F JObsessive-compulsive disorder F JObsessive-compulsive disorders and symptoms FAnxiety disorders and symptoms FADVERSE EVENT Psychiatric disorders F'Psychiatric disorders F' NNOT APPLICABLE NOT RELATEDOTHER NOT RECOVERED/NOT RESOLVED Y2VACCINATION 2021-02-09 B,. P18D VACCINATION 2 2021-01-22T16:59:00ONGOINGLAST SUBJECT ENCOUNTERC4591001AEC4591001 1084 10841561J-+M VACCINATION 1-MUSCLE PAIN MUSCLE PAIN Muscle pain F"Myalgia F{Muscle pains F#Muscle disorders FREACTOGENICITY SYSTEMIC YMusculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk VACCINATION 2021-01-02 2021-01-04 A`AP1D P5D VACCINATION 1 2020-12-28 C4591001AEC4591001 1084 10841563J-+M VACCINATION 2-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-18 2021-01-25 BBP1D VACCINATION 2 2021-01-18 C4591001AEC4591001 1084 10841569A 1 Headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N1VACCINATION 2021-01-29 2021-02-12 BB- P7D VACCINATION 2 2021-01-22T16:40:00 C4591001AEC4591001 1091 10911400J-+M VACCINATION 2-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-04 2021-01-05 B B!P1D P6D VACCINATION 2 2020-12-29 C4591001AEC4591001 1091 10911406A 1 Broken right arm Arm fracture FVgUpper limb fracture FRLimb fractures and dislocations FBone and joint injuries FADVERSE EVENT Injury, poisoning and procedural complications FInjury, poisoning and procedural complications F NNOT APPLICABLE NOT RELATEDOTHER RECOVERING/RESOLVING Y3FOLLOW-UP 2021-05-25 B. P148D VACCINATION 2 2020-12-28T11:33:00ONGOINGLAST SUBJECT ENCOUNTERC4591001AEC4591001 1091 10911406A 2 Panic attacks Panic attacks FPanic attack FPanic attacks and disorders FLAnxiety disorders and symptoms FADVERSE EVENT Psychiatric disorders F'Psychiatric disorders F' NNOT APPLICABLE NOT RELATEDOTHER NOT RECOVERED/NOT RESOLVED N2FOLLOW-UP 2021-02-25 BQ. P59D VACCINATION 2 2020-12-28T11:33:00ONGOINGLAST SUBJECT ENCOUNTERC4591001AEC4591001 1091 10911409J-+M VACCINATION 2-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-28 2021-01-04 BBP1D VACCINATION 2 2020-12-28 C4591001AEC4591001 1091 10911411A 1 Tooth impaction Tooth impacted FBTooth impacted FBDental disorders NEC FBDental and gingival conditions FBrADVERSE EVENT Gastrointestinal disorders FܛGastrointestinal disorders Fܛ NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-07-15 2021-07-15 BB P21D VACCINATION 4 2021-06-24T11:17:00 C4591001AEC4591001 1091 10911412J-+M VACCINATION 2-CHILLS CHILLS Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-05 2021-01-06 BBP1D P6D VACCINATION 2 2020-12-30 C4591001AEC4591001 1091 10911414A 1 Injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1REPEAT SCREENING 1 2021-05-26 2021-05-27 BB P1D UNPLANNED VACCINATION2021-05-25T17:25:00 C4591001AEC4591001 1091 10911417A 2 Fever Fever F.Pyrexia F)Febrile disorders FBody temperature conditions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-05-18T21:002021-05-18 BB PT12H16MVACCINATION 3 2021-05-18T08:44:00 C4591001AEC4591001 1091 10911417A 1 Injection site pain left arm Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-18 2021-05-18 BB VACCINATION 3 2021-05-18T08:44:00 C4591001AEC4591001 1091 10911422A0 2 middle ear infection left ear Middle ear infection FAOtitis media FEar infections F=Infections - pathogen unspecified FADVERSE EVENT Infections and infestations FInfections and infestations F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y1VACCINATION 2020-12-23 2020-12-30 AB P9D VACCINATION 1 2020-12-14T10:31:00 C4591001AEC4591001 1091 10911422A 3 outer ear infection left ear Infection of the outer ear FOtitis externa FEar infections F=Infections - pathogen unspecified FADVERSE EVENT Infections and infestations FInfections and infestations F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y1VACCINATION 2020-12-23 2020-12-30 AB P9D VACCINATION 1 2020-12-14T10:31:00 C4591001AEC4591001 1091 10911422A 1 left ear infection Ear infection F;Ear infection F;Ear infections F=Infections - pathogen unspecified FADVERSE EVENT Infections and infestations FInfections and infestations F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y1VACCINATION 2020-12-23 2020-12-30 AB P9D VACCINATION 1 2020-12-14T10:31:00 C4591001AEC4591001 1091 10911423A@ 3 Vomitting Vomiting FPVomiting FPNausea and vomiting symptoms FGastrointestinal signs and symptoms FADVERSE EVENT Gastrointestinal disorders FܛGastrointestinal disorders Fܛ NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-07-22T02:002021-07-23T19:00BB P1D VACCINATION 4 2021-07-21T15:42:00 C4591001AEC4591001 1091 10911423A0 1 Myalgia Myalgia F{Myalgia F{Muscle pains F#Muscle disorders FADVERSE EVENT Musculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk NNOT APPLICABLE RELATED RECOVERED/RESOLVED WITH SEQUELAE N1OPEN LABEL TREATMENT2021-07-22T02:002021-07-23T19:00BB P1D VACCINATION 4 2021-07-21T15:42:00 C4591001AEC4591001 1091 10911423A 4 Headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-07-22T02:002021-07-23T19:00BB P1D VACCINATION 4 2021-07-21T15:42:00 C4591001AEC4591001 1091 10911423A 2 Diarrhea Diarrhea F7Diarrhoea F?Diarrhoea (excl infective) F@Gastrointestinal motility and defaecation conditions FܹADVERSE EVENT Gastrointestinal disorders FܛGastrointestinal disorders Fܛ NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-07-22T02:002021-07-23T19:00BB P1D VACCINATION 4 2021-07-21T15:42:00 C4591001AEC4591001 1091 10911432J-+M VACCINATION 2-DIARRHEA DIARRHEA Diarrhea F7Diarrhoea F?Diarrhoea (excl infective) F@Gastrointestinal motility and defaecation conditions FܹREACTOGENICITY SYSTEMIC YGastrointestinal disorders FܛGastrointestinal disorders Fܛ VACCINATION 2021-01-09 2021-01-16 BBP4D P3D VACCINATION 2 2021-01-06 C4591001AEC4591001 1091 10911433J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-17 2021-01-07 ABP15D VACCINATION 1 2020-12-17 C4591001AEC4591001 1091 10911433A 2 intermittent rash on wrist Localised rash FpRash F*TRashes, eruptions and exanthems NEC FcEpidermal and dermal conditions FADVERSE EVENT Skin and subcutaneous tissue disorders F5Skin and subcutaneous tissue disorders F5 NNOT APPLICABLE NOT RELATEDOTHER NOT RECOVERED/NOT RESOLVED N1VACCINATION 2020-12-19T00:00 A0. P2D VACCINATION 1 2020-12-17T15:30:00ONGOINGLAST SUBJECT ENCOUNTERC4591001AEC4591001 1091 10911440J-+M VACCINATION 2-MUSCLE PAIN MUSCLE PAIN Muscle pain F"Myalgia F{Muscle pains F#Muscle disorders FREACTOGENICITY SYSTEMIC YMusculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk VACCINATION 2021-01-08 2021-01-15 BBP1D VACCINATION 2 2021-01-08 C4591001AEC4591001 1091 10911440J-+M VACCINATION 2-JOINT PAIN JOINT PAIN Joint pain F6Arthralgia F'Joint related signs and symptoms F:Joint disorders F-REACTOGENICITY SYSTEMIC YMusculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk VACCINATION 2021-01-08 2021-01-15 BBP1D VACCINATION 2 2021-01-08 C4591001AEC4591001 1091 10911441J-+M VACCINATION 2-MUSCLE PAIN MUSCLE PAIN Muscle pain F"Myalgia F{Muscle pains F#Muscle disorders FREACTOGENICITY SYSTEMIC YMusculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk VACCINATION 2021-01-08 2021-01-15 BBP1D VACCINATION 2 2021-01-08 C4591001AEC4591001 1091 10911441J-+M VACCINATION 1-MUSCLE PAIN MUSCLE PAIN Muscle pain F"Myalgia F{Muscle pains F#Muscle disorders FREACTOGENICITY SYSTEMIC YMusculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk VACCINATION 2020-12-18 2021-01-08 ABP15D VACCINATION 1 2020-12-18 C4591001AEC4591001 1091 10911441J-+M VACCINATION 2-JOINT PAIN JOINT PAIN Joint pain F6Arthralgia F'Joint related signs and symptoms F:Joint disorders F-REACTOGENICITY SYSTEMIC YMusculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk VACCINATION 2021-01-09 2021-01-15 BBP1D P1D VACCINATION 2 2021-01-08 C4591001AEC4591001 1091 10911457J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-29 2021-01-05 AAP1D VACCINATION 1 2020-12-29 C4591001AEC4591001 1091 10911463A 1 Wisdom teethth impaction Impacted wisdom tooth FTooth impacted FBDental disorders NEC FBDental and gingival conditions FBrADVERSE EVENT Gastrointestinal disorders FܛGastrointestinal disorders Fܛ NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y1FOLLOW-UP 2021-04-27 2021-05-07 BrB| P90D VACCINATION 2 2021-01-27T15:40:00 C4591001AEC4591001 1091 10911466J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-17 2021-01-20 ApAP3D P6D VACCINATION 1 2021-01-11 C4591001AEC4591001 1123 11231422J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-07 2020-12-08 ApAP1D P6D VACCINATION 1 2020-12-01 C4591001AEC4591001 1123 11231422J-+M VACCINATION 1-JOINT PAIN JOINT PAIN Joint pain F6Arthralgia F'Joint related signs and symptoms F:Joint disorders F-REACTOGENICITY SYSTEMIC YMusculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk VACCINATION 2020-12-05 2020-12-08 APAP1D P4D VACCINATION 1 2020-12-01 C4591001AEC4591001 1123 11231428J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2020-12-09 2020-12-10 ApAP1D P6D VACCINATION 1 2020-12-03 C4591001AEC4591001 1123 11231428J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-03 2020-12-10 AAP1D VACCINATION 1 2020-12-03 C4591001AEC4591001 1123 11231428J-+M VACCINATION 1-CHILLS CHILLS Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-03 2020-12-10 AAP1D VACCINATION 1 2020-12-03 C4591001AEC4591001 1123 11231434J-+M VACCINATION 2-DIARRHEA DIARRHEA Diarrhea F7Diarrhoea F?Diarrhoea (excl infective) F@Gastrointestinal motility and defaecation conditions FܹREACTOGENICITY SYSTEMIC YGastrointestinal disorders FܛGastrointestinal disorders Fܛ VACCINATION 2020-12-31 2021-01-04 BBP1D P3D VACCINATION 2 2020-12-28 C4591001AEC4591001 1123 11231439J-+M VACCINATION 2-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2021-01-06 2021-01-13 BB%P1D VACCINATION 2 2021-01-06 C4591001AEC4591001 1123 11231439J-+M VACCINATION 2-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-06 2021-01-13 BB%P1D VACCINATION 2 2021-01-06 C4591001AEC4591001 1123 11231440A 1 Left otitis media Otitis media FOtitis media FEar infections F=Infections - pathogen unspecified FADVERSE EVENT Infections and infestations FInfections and infestations F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y2REPEAT SCREENING 1 2021-08-13 2021-08-21 BC P228D VACCINATION 2 2020-12-28T09:16:00 C4591001AEC4591001 1123 11231442J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2020-12-09 2020-12-17 AAP2D VACCINATION 1 2020-12-09 C4591001AEC4591001 1123 11231442A0 2 headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y1VACCINATION 2020-12-16 2020-12-17 AA P7D VACCINATION 1 2020-12-09T12:33:00 C4591001AEC4591001 1123 11231442A 3 worsening of depression Depression worsened FDepression FDepressive disorders FDepressed mood disorders and disturbances FADVERSE EVENT Psychiatric disorders F'Psychiatric disorders F' NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y1 2021-03 2021-06-04T08:00.B C4591001AEC4591001 1123 11231442A 1 Depression Depression FDepression FDepressive disorders FDepressed mood disorders and disturbances FADVERSE EVENT Psychiatric disorders F'Psychiatric disorders F' NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y2VACCINATION 2020-12-23 2021-06-04T08:00AB P14D VACCINATION 1 2020-12-09T12:33:00 C4591001AEC4591001 1123 11231448A 1 Diarrhea Diarrhea F7Diarrhoea F?Diarrhoea (excl infective) F@Gastrointestinal motility and defaecation conditions FܹADVERSE EVENT Gastrointestinal disorders FܛGastrointestinal disorders Fܛ NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1VACCINATION 2020-12-16 2020-12-18 A`A P5D VACCINATION 1 2020-12-11T09:05:00 C4591001AEC4591001 1123 11231449J-+M VACCINATION 2-DELTOID MUSCLE-LEFT-PAIN AT INJECTION SITE PAIN AT INJECTION SITE Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FREACTOGENICITY ADMINISTRATION SITEYGeneral disorders and administration site conditions FGeneral disorders and administration site conditions FDELTOID MUSCLELEFT VACCINATION 2020-12-31 2021-01-07 BBP2D P1D VACCINATION 2 2020-12-30 C4591001AEC4591001 1123 11231452J-+M VACCINATION 1-JOINT PAIN JOINT PAIN Joint pain F6Arthralgia F'Joint related signs and symptoms F:Joint disorders F-REACTOGENICITY SYSTEMIC YMusculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk VACCINATION 2020-12-21 2020-12-22 ApAP1D P6D VACCINATION 1 2020-12-15 C4591001AEC4591001 1123 11231456J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2020-12-22 2020-12-24 ApAP2D P6D VACCINATION 1 2020-12-16 C4591001AEC4591001 1123 11231456J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-17 2020-12-24 A AP2D P1D VACCINATION 1 2020-12-16 C4591001AEC4591001 1123 11231472A 1 Tinea capitis Tinea capitis FATinea capitis FATinea infections FAFungal infectious disorders FADVERSE EVENT Infections and infestations FInfections and infestations F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y1VACCINATION 2021-01-01 2021-02-12 AB6 P11D VACCINATION 1 2020-12-21T12:49:00 C4591001AEC4591001 1123 11231472A 2 worsening of acne vulgaris Acne vulgaris FAcne FpAcnes FqSkin appendage conditions F5ADVERSE EVENT Skin and subcutaneous tissue disorders F5Skin and subcutaneous tissue disorders F5 NNOT APPLICABLE NOT RELATEDOTHER NOT RECOVERED/NOT RESOLVED Y1VACCINATION 2021-01-07 B. P17D VACCINATION 1 2020-12-21T12:49:00ONGOINGLAST SUBJECT ENCOUNTERC4591001AEC4591001 1123 11231473A 1 avulsion fracture right middle finger Fractured finger FHand fracture F*Limb fractures and dislocations FBone and joint injuries FADVERSE EVENT Injury, poisoning and procedural complications FInjury, poisoning and procedural complications F NNOT APPLICABLE NOT RELATEDOTHER RECOVERING/RESOLVING Y2FOLLOW-UP 2021-04-11 Bp. P89D VACCINATION 2 2021-01-12T14:53:00ONGOINGLAST SUBJECT ENCOUNTERC4591001AEC4591001 1123 11231475J-+M VACCINATION 2-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2021-01-11 2021-01-19 BBP2D VACCINATION 2 2021-01-11 C4591001AEC4591001 1123 11231475J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2020-12-22 2020-12-29 A AP2D P1D VACCINATION 1 2020-12-21 C4591001AEC4591001 1123 11231489A 1 Torn medial and lateral left knee menisci Meniscus tear of knee FMeniscus injury FBone and joint injuries NEC FuBone and joint injuries FADVERSE EVENT Injury, poisoning and procedural complications FInjury, poisoning and procedural complications F NNOT APPLICABLE NOT RELATEDOTHER RECOVERING/RESOLVING Y1 2021-03 .. ONGOINGLAST SUBJECT ENCOUNTERC4591001AEC4591001 1123 11231494J-+M VACCINATION 2-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2021-01-15 2021-01-22 BBP2D P1D VACCINATION 2 2021-01-14 C4591001AEC4591001 1123 11231505J-+M VACCINATION 1-DIARRHEA DIARRHEA Diarrhea F7Diarrhoea F?Diarrhoea (excl infective) F@Gastrointestinal motility and defaecation conditions FܹREACTOGENICITY SYSTEMIC YGastrointestinal disorders FܛGastrointestinal disorders Fܛ VACCINATION 2021-01-03 2021-01-04 ApAP1D P6D VACCINATION 1 2020-12-28 C4591001AEC4591001 1123 11231507J-+M VACCINATION 2-DELTOID MUSCLE-LEFT-PAIN AT INJECTION SITE PAIN AT INJECTION SITE Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FREACTOGENICITY ADMINISTRATION SITEYGeneral disorders and administration site conditions FGeneral disorders and administration site conditions FDELTOID MUSCLELEFT VACCINATION 2021-01-18 B. VACCINATION 2 2021-01-18 ONGOINGV3_MONTH1_POSTVAX2_L C4591001AEC4591001 1123 11231507A 2 WORSENING Attention Deficit Hyper Activity Disorder Attention deficit hyperactivity disorder F&Attention deficit hyperactivity disorderF&Attention deficit and disruptive behaviour disorders FCognitive and attention disorders and disturbances FADVERSE EVENT Psychiatric disorders F'Psychiatric disorders F' NNOT APPLICABLE NOT RELATEDOTHER NOT RECOVERED/NOT RESOLVED Y1FOLLOW-UP 2021-03-01 B@. P42D VACCINATION 2 2021-01-18T11:50:00ONGOINGLAST SUBJECT ENCOUNTERC4591001AEC4591001 1123 11231508J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2020-12-28 2021-01-04 AAP1D VACCINATION 1 2020-12-28 C4591001AEC4591001 1123 11231520A 1 Bilateral conjunctivitis Conjunctivitis FuConjunctivitis FuEye and eyelid infections FԥInfections - pathogen unspecified FADVERSE EVENT Infections and infestations FInfections and infestations F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y1VACCINATION 2021-01-12 2021-01-17 AB P13D VACCINATION 1 2020-12-30T17:14:00 C4591001AEC4591001 1123 11231523A 1 INTRA RETINAL HEMORRHAGE OD Retinal hemorrhage F.VRetinal haemorrhage F.SRetinal bleeding and vascular disorders (excl retinopathy) F.5Retina, choroid and vitreous haemorrhages and vascular disordersFNTADVERSE EVENT Eye disorders FԯEye disorders Fԯ NNOT APPLICABLE NOT RELATEDOTHER RECOVERING/RESOLVING N2VACCINATION 2021-02-16 B+. P21D VACCINATION 2 2021-01-26T15:40:00ONGOINGLAST SUBJECT ENCOUNTERC4591001AEC4591001 1123 11231526J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-11 2021-01-29 A@BP15DP3D VACCINATION 1 2021-01-08 C4591001AEC4591001 1124 11241236J-+M VACCINATION 1-FEVER FEVER Fever F.Pyrexia F)Febrile disorders FBody temperature conditions FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-20 2020-12-24 ApAP4D P6D VACCINATION 1 2020-12-14 C4591001AEC4591001 1124 11241236J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2020-12-18 2020-12-24 APAP4D P4D VACCINATION 1 2020-12-14 C4591001AEC4591001 1124 11241240J-+M VACCINATION 2-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2021-01-10 2021-01-11 BBP1D P6D VACCINATION 2 2021-01-04 C4591001AEC4591001 1124 11241245A 2 Depression Depression FDepression FDepressive disorders FDepressed mood disorders and disturbances FADVERSE EVENT Psychiatric disorders F'Psychiatric disorders F' NNOT APPLICABLE NOT RELATEDOTHER RECOVERING/RESOLVING Y2 2021-03 .. ONGOINGLAST SUBJECT ENCOUNTERC4591001AEC4591001 1124 11241245A 1 Anxiety Anxiety FAnxiety FAnxiety symptoms FAnxiety disorders and symptoms FADVERSE EVENT Psychiatric disorders F'Psychiatric disorders F' NNOT APPLICABLE NOT RELATEDOTHER RECOVERING/RESOLVING Y2 2021-03 .. ONGOINGLAST SUBJECT ENCOUNTERC4591001AEC4591001 1124 11241251A 1 Fever (102.2 degrees F) Fever F.Pyrexia F)Febrile disorders FBody temperature conditions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y3VACCINATION 2021-01-09T08:002021-01-09T10:00BB P1D VACCINATION 2 2021-01-08T11:45:00 C4591001AEC4591001 1125 11251248J-+M VACCINATION 2-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-30 2021-01-08 BBP3D VACCINATION 2 2020-12-30 C4591001AEC4591001 1125 11251248A 1 Fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1VACCINATION 2021-01-05 2021-01-08 BB P6D VACCINATION 2 2020-12-30T13:35:00 C4591001AEC4591001 1125 11251255J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2021-01-07 2021-01-13 A AP1D P1D VACCINATION 1 2021-01-06 C4591001AEC4591001 1126 11261233A@ 3 Muscle Aches Muscle ache FMyalgia F{Muscle pains F#Muscle disorders FADVERSE EVENT Musculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-05-20 2021-05-21 BB P1D VACCINATION 3 2021-05-19T10:25:00 C4591001AEC4591001 1126 11261233A0 1 Left Upper Arm Injection Site Pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-05-19T18:002021-05-21 BB PT7H35M VACCINATION 3 2021-05-19T10:25:00 C4591001AEC4591001 1126 11261233A 4 Fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-06-09T22:002021-06-12 BB PT8H18M VACCINATION 4 2021-06-09T13:42:00 C4591001AEC4591001 1126 11261233A 2 Fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-19T18:002021-05-20 BB PT7H35M VACCINATION 3 2021-05-19T10:25:00 C4591001AEC4591001 1126 11261235A0 2 Fever Fever F.Pyrexia F)Febrile disorders FBody temperature conditions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-06-09T03:002021-06-09 BB P1D VACCINATION 4 2021-06-08T11:41:00 C4591001AEC4591001 1126 11261235A 1 Phyto photodermatitis, bilateral hands Phytophotodermatitis FPhotosensitivity reaction FPhotosensitivity and photodermatosis conditions FEpidermal and dermal conditions FADVERSE EVENT Skin and subcutaneous tissue disorders F5Skin and subcutaneous tissue disorders F5 NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-05-23 2021-05-26 BB P5D VACCINATION 3 2021-05-18T10:18:00 C4591001AEC4591001 1126 11261235A 3 Generalized body aches Generalised aching FPain FPain and discomfort NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-06-09T03:002021-06-09 BB P1D VACCINATION 4 2021-06-08T11:41:00 C4591001AEC4591001 1126 11261239J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2020-12-02 2020-12-13 AAP5D VACCINATION 1 2020-12-02 C4591001AEC4591001 1126 11261239AP 2 Fever Fever F.Pyrexia F)Febrile disorders FBody temperature conditions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-06-07T19:002021-06-08 BB PT9H02M VACCINATION 4 2021-06-07T09:58:00 C4591001AEC4591001 1126 11261239A@ 4 Generalized body aches Generalised aching FPain FPain and discomfort NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-06-07T19:002021-06-08 BB PT9H02M VACCINATION 4 2021-06-07T09:58:00 C4591001AEC4591001 1126 11261239A0 5 Pain, injection site Pain injection site F-Injection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-06-07T19:002021-06-08 BB PT9H02M VACCINATION 4 2021-06-07T09:58:00 C4591001AEC4591001 1126 11261239A 1 Left arm injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-05-17T16:302021-05-19T16:30BB PT4H26M VACCINATION 3 2021-05-17T12:04:00 C4591001AEC4591001 1126 11261239A 3 Fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-06-07T19:002021-06-08 BB PT9H02M VACCINATION 4 2021-06-07T09:58:00 C4591001AEC4591001 1126 11261240A@ 4 Generalized body aches Generalised aching FPain FPain and discomfort NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-10T21:002021-06-11 BB PT7H56M VACCINATION 4 2021-06-10T13:04:00 C4591001AEC4591001 1126 11261240A0 3 Pain, injection site Pain injection site F-Injection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-10T21:002021-06-11 BB PT7H56M VACCINATION 4 2021-06-10T13:04:00 C4591001AEC4591001 1126 11261240A 1 Pain, injection site Pain injection site F-Injection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-05-21T16:002021-05-22 BB PT2H02M VACCINATION 3 2021-05-21T13:58:00 C4591001AEC4591001 1126 11261240A 2 Fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-10T21:002021-06-11 BB PT7H56M VACCINATION 4 2021-06-10T13:04:00 C4591001AEC4591001 1126 11261246A0 2 Right leg pain Unilateral leg pain Fc:Pain in extremity FMusculoskeletal and connective tissue pain and discomfort FMusculoskeletal and connective tissue disorders NEC FiADVERSE EVENT Musculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk NNOT APPLICABLE NOT RELATEDOTHER NOT RECOVERED/NOT RESOLVED N1VACCINATION 2020-12-31 B. P8D VACCINATION 2 2020-12-23T10:23:00ONGOINGLAST SUBJECT ENCOUNTERC4591001AEC4591001 1126 11261246A 3 Red bump on right index finger at cuticle Nodule on finger F Nodule FiMass conditions NEC FuTissue disorders NEC F;ADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N1VACCINATION 2021-01-13 2021-03-03 B+B\ P21D VACCINATION 2 2020-12-23T10:23:00 C4591001AEC4591001 1126 11261246A 1 Canker sore under tongue Canker sores oral F~Aphthous ulcer FStomatitis and ulceration F;Oral soft tissue conditions FADVERSE EVENT Gastrointestinal disorders FܛGastrointestinal disorders Fܛ NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N1VACCINATION 2021-01-12 2021-01-15 B*B- P20D VACCINATION 2 2020-12-23T10:23:00 C4591001AEC4591001 1126 11261250A0 3 Pain, injection site Pain injection site F-Injection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-15T18:002021-06-16 BB PT1H50M VACCINATION 4 2021-06-15T16:10:00 C4591001AEC4591001 1126 11261250A 1 Pain, Injection Site Pain injection site F-Injection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-19T14:002021-05-20 BB PT1H53M VACCINATION 3 2021-05-19T12:07:00 C4591001AEC4591001 1126 11261250A 2 Fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-15T18:002021-06-16 BB PT1H50M VACCINATION 4 2021-06-15T16:10:00 C4591001AEC4591001 1126 11261253AP 1 Muscle aches Muscle ache FMyalgia F{Muscle pains F#Muscle disorders FADVERSE EVENT Musculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-05-17T18:002021-05-19T08:00BB PT7H57M VACCINATION 3 2021-05-17T10:03:00 C4591001AEC4591001 1126 11261253A@ 4 Left arm injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-05-17T18:002021-05-19 BB PT7H57M VACCINATION 3 2021-05-17T10:03:00 C4591001AEC4591001 1126 11261253A0 5 Fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-08T18:002021-06-09 BB PT8H17M VACCINATION 4 2021-06-08T09:43:00 C4591001AEC4591001 1126 11261253A 2 Fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-05-18T12:002021-05-19T08:00BB P1D VACCINATION 3 2021-05-17T10:03:00 C4591001AEC4591001 1126 11261253A 3 Chills Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-05-17T18:002021-05-17T20:00BB PT7H57M VACCINATION 3 2021-05-17T10:03:00 C4591001AEC4591001 1126 11261254Ap 4 Malaise Malaise F Malaise F Asthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-23 2021-06-23 BB P1D VACCINATION 3 2021-06-22T14:42:00 C4591001AEC4591001 1126 11261254A` 5 Injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-23 2021-06-25 BB P1D VACCINATION 3 2021-06-22T14:42:00 C4591001AEC4591001 1126 11261254AP 7 Headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-07-12T23:452021-07-13 BB PT13H46MVACCINATION 4 2021-07-12T09:59:00 C4591001AEC4591001 1126 11261254A@ 3 Headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-23 2021-06-23 BB P1D VACCINATION 3 2021-06-22T14:42:00 C4591001AEC4591001 1126 11261254A0 1 Allergic reaction, nuts Allergy to nuts Fm/Food allergy FزAllergies to foods, food additives, drugs and other chemicals FIAllergic conditions F,ADVERSE EVENT Immune system disorders F4Immune system disorders F4 NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y2VACCINATION 2020-12-09T15:002020-12-09 ApAp P6D VACCINATION 1 2020-12-03T15:42:00 C4591001AEC4591001 1126 11261254A 6 Fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-07-12T23:452021-07-13 BB PT13H46MVACCINATION 4 2021-07-12T09:59:00 C4591001AEC4591001 1126 11261254A 2 Chills Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-23 2021-06-23 BB P1D VACCINATION 3 2021-06-22T14:42:00 C4591001AEC4591001 1126 11261262A@ 2 Malaise Malaise F Malaise F Asthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-03-03T18:002021-03-04 BZB[ PT5H35M VACCINATION 4 2021-03-03T12:25:00 C4591001AEC4591001 1126 11261262A0 1 Left upper arm injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-02-10T21:002021-02-12T12:00BEBG PT6H02M VACCINATION 3 2021-02-10T14:58:00 C4591001AEC4591001 1126 11261262A 4 Injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-03-04 2021-03-06 B[B] P1D VACCINATION 4 2021-03-03T12:25:00 C4591001AEC4591001 1126 11261262A 3 Headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-03-03T18:002021-03-04 BZB[ PT5H35M VACCINATION 4 2021-03-03T12:25:00 C4591001AEC4591001 1126 11261263A0 2 RIGHT DISTAL RADIUS TORUS FRACTURE Radius fracture F**Radius fracture F**Limb fractures and dislocations FBone and joint injuries FADVERSE EVENT Injury, poisoning and procedural complications FInjury, poisoning and procedural complications F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y2VACCINATION 2020-12-20 2021-01-20 BB0 P16D VACCINATION 1 2020-12-04T16:51:00 C4591001AEC4591001 1126 11261263A 1 LEFT AXILLA LYMPH NODE SWELLING Lymphadenopathy axillary FVULymphadenopathy FLymphatic system disorders NEC FSpleen, lymphatic and reticuloendothelial system disorders F9)ADVERSE EVENT Blood and lymphatic system disorders FQBlood and lymphatic system disorders FQ NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1VACCINATION 2020-12-10 2020-12-13 ApA P6D VACCINATION 1 2020-12-04T16:51:00 C4591001AEC4591001 1126 11261263A 3 Mechanical Fall Fall FխFall FխNon-site specific injuries NEC F Injuries NEC FADVERSE EVENT Injury, poisoning and procedural complications FInjury, poisoning and procedural complications F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N2VACCINATION 2020-12-20 2020-12-20 BB P16D VACCINATION 1 2020-12-04T16:51:00 C4591001AEC4591001 1126 11261265A 2 Pain, injection site Pain injection site F-Injection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-14T13:002021-06-15 BB PT54M VACCINATION 4 2021-06-14T12:06:00 C4591001AEC4591001 1126 11261265A 1 Pain, injection site Pain injection site F-Injection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-20 2021-05-23 BB P1D VACCINATION 3 2021-05-19T13:52:00 C4591001AEC4591001 1126 11261266A 2 Pain, injection site Pain injection site F-Injection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-15 2021-06-15 BB P1D VACCINATION 4 2021-06-14T12:08:00 C4591001AEC4591001 1126 11261266A 1 Pain, Injection site Pain injection site F-Injection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-19T18:002021-05-20 BB PT4H08M VACCINATION 3 2021-05-19T13:52:00 C4591001AEC4591001 1126 11261267A` 3 Fever Fever F.Pyrexia F)Febrile disorders FBody temperature conditions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-06-11T22:002021-06-12 BB PT12H16MVACCINATION 4 2021-06-11T09:44:00 C4591001AEC4591001 1126 11261267AP 5 GENERALIZED BODY ACHES Generalised aching FPain FPain and discomfort NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-06-11T22:002021-06-13 BB PT12H16MVACCINATION 4 2021-06-11T09:44:00 C4591001AEC4591001 1126 11261267A@ 6 PAIN, INJECTION SITE Pain injection site F-Injection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-06-11T22:002021-06-13 BB PT12H16MVACCINATION 4 2021-06-11T09:44:00 C4591001AEC4591001 1126 11261267A0 1 Left upper arm injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-05-21T18:002021-05-23 BB PT2H11M VACCINATION 3 2021-05-21T15:49:00 C4591001AEC4591001 1126 11261267A 4 Fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-06-11T21:002021-06-13 BB PT11H16MVACCINATION 4 2021-06-11T09:44:00 C4591001AEC4591001 1126 11261267A 2 Fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-05-22 2021-05-22 BB P1D VACCINATION 3 2021-05-21T15:49:00 C4591001AEC4591001 1126 11261268A 1 Facial Urticaria, worsening Urticaria aggravated FMUrticaria FMUrticarias FMAngioedema and urticaria FADVERSE EVENT Skin and subcutaneous tissue disorders F5Skin and subcutaneous tissue disorders F5 NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N1VACCINATION 2020-12-18 2020-12-31 APB P4D VACCINATION 1 2020-12-14T11:08:00 C4591001AEC4591001 1126 11261268A 2 Juvenile Osteochondrosis of bilateral fifth metatarsals Juvenile osteochondrosis of foot F\Osteochondrosis FCartilage disorders FTendon, ligament and cartilage disorders F?eADVERSE EVENT Musculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk NNOT APPLICABLE NOT RELATEDOTHER RECOVERING/RESOLVING Y2VACCINATION 2020-12-28 A. P14D VACCINATION 1 2020-12-14T11:08:00ONGOINGLAST SUBJECT ENCOUNTERC4591001AEC4591001 1126 11261269J-+M VACCINATION 2-MUSCLE PAIN MUSCLE PAIN Muscle pain F"Myalgia F{Muscle pains F#Muscle disorders FREACTOGENICITY SYSTEMIC YMusculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk VACCINATION 2021-01-09 2021-01-14 BB P2D P3D VACCINATION 2 2021-01-06 C4591001AEC4591001 1126 11261269J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2020-12-15 2020-12-22 A AP2D P1D VACCINATION 1 2020-12-14 C4591001AEC4591001 1126 11261269J-+M VACCINATION 1-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2020-12-14 2020-12-22 AAP2D VACCINATION 1 2020-12-14 C4591001AEC4591001 1126 11261270A 1 Left upper arm injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1REPEAT SCREENING 1 2021-05-20T16:002021-05-21 BB P134D VACCINATION 2 2021-01-06T12:01:00 C4591001AEC4591001 1126 11261270A 2 Fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-11 2021-06-12 BB P1D VACCINATION 4 2021-06-10T09:55:00 C4591001AEC4591001 1126 11261271A 1 SARS-COV-2 IGG, QL, IA - Positive SARS-CoV-2 antibody test positive FSARS-CoV-2 antibody test positive FVirus identification and serology FPMicrobiology and serology investigations F ADVERSE EVENT Investigations FInvestigations F NNOT APPLICABLE RELATED NOT RECOVERED/NOT RESOLVED N1VACCINATION 2021-01-21 B'. P15D VACCINATION 2 2021-01-06T14:15:00ONGOINGLAST SUBJECT ENCOUNTERC4591001AEC4591001 1126 11261274A0 3 Pain, injection site Pain injection site F-Injection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-11 2021-06-13 BB P1D VACCINATION 4 2021-06-10T19:39:00 C4591001AEC4591001 1126 11261274A 1 Left upper arm injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-05-20T17:002021-05-22 BB PT36M VACCINATION 3 2021-05-20T16:24:00 C4591001AEC4591001 1126 11261274A 2 Headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-05-21T08:302021-05-21T16:00BB P1D VACCINATION 3 2021-05-20T16:24:00 C4591001AEC4591001 1126 11261275A0 3 Left upper arm injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-02-08T22:002021-02-10T12:00B8B: PT6H VACCINATION 3 2021-02-08T16:00:00 C4591001AEC4591001 1126 11261275A 1 Headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-02-09T00:002021-02-09T08:00B9B9 P1D VACCINATION 3 2021-02-08T16:00:00 C4591001AEC4591001 1126 11261275A 2 Chills Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-02-09T00:002021-02-09T08:00B9B9 P1D VACCINATION 3 2021-02-08T16:00:00 C4591001AEC4591001 1126 11261276AP 3 Fever Fever F.Pyrexia F)Febrile disorders FBody temperature conditions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-02-09T03:002021-02-09T09:00B9B9 P1D VACCINATION 3 2021-02-08T16:01:00 C4591001AEC4591001 1126 11261276A@ 4 Malaise Malaise F Malaise F Asthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-03-03T21:002021-03-04 BOBP PT7H38M VACCINATION 4 2021-03-03T13:22:00 C4591001AEC4591001 1126 11261276A0 1 Left upper arm injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-02-08T21:002021-02-10T21:00B8B: PT4H59M VACCINATION 3 2021-02-08T16:01:00 C4591001AEC4591001 1126 11261276A 5 Headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-03-03T21:002021-03-04 BOBP PT7H38M VACCINATION 4 2021-03-03T13:22:00 C4591001AEC4591001 1126 11261276A 2 Headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-02-09T01:002021-02-09T12:00B9B9 P1D VACCINATION 3 2021-02-08T16:01:00 C4591001AEC4591001 1126 11261279AP 4 Fever Fever F.Pyrexia F)Febrile disorders FBody temperature conditions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-11T18:002021-06-11T23:00BB PT4H56M VACCINATION 4 2021-06-11T13:04:00 C4591001AEC4591001 1126 11261279A@ 5 Body aches Generalized aching F\Pain FPain and discomfort NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-06-11T18:002021-06-13 BB PT4H56M VACCINATION 4 2021-06-11T13:04:00 C4591001AEC4591001 1126 11261279A0 1 Left upper arm injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-05-20T16:002021-05-23 BB PT1H48M VACCINATION 3 2021-05-20T14:12:00 C4591001AEC4591001 1126 11261279A 3 Fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-06-11T18:002021-06-13 BB PT4H56M VACCINATION 4 2021-06-11T13:04:00 C4591001AEC4591001 1126 11261279A 2 Chills Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-05-21T03:002021-05-21T04:00BB P1D VACCINATION 3 2021-05-20T14:12:00 C4591001AEC4591001 1126 11261280AP 4 Fever Fever F.Pyrexia F)Febrile disorders FBody temperature conditions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-11T18:002021-06-11T23:00BB PT4H55M VACCINATION 4 2021-06-11T13:05:00 C4591001AEC4591001 1126 11261280A@ 5 Body aches Generalized aching F\Pain FPain and discomfort NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-06-11T18:002021-06-13 BB PT4H55M VACCINATION 4 2021-06-11T13:05:00 C4591001AEC4591001 1126 11261280A0 1 Muscle aches Muscle ache FMyalgia F{Muscle pains F#Muscle disorders FADVERSE EVENT Musculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-05-21 2021-05-21 BB P1D VACCINATION 3 2021-05-20T14:14:00 C4591001AEC4591001 1126 11261280A 2 Left upper arm injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-05-20T19:002021-05-22 BB PT4H46M VACCINATION 3 2021-05-20T14:14:00 C4591001AEC4591001 1126 11261280A 3 Fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-06-11T18:002021-06-13 BB PT4H55M VACCINATION 4 2021-06-11T13:05:00 C4591001AEC4591001 1126 11261283A@ 2 Right Arm Injection Site Pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-05-18 2021-05-19 BB P1D VACCINATION 3 2021-05-17T16:24:00 C4591001AEC4591001 1126 11261283A0 3 Headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-05-18 2021-05-18 BB P1D VACCINATION 3 2021-05-17T16:24:00 C4591001AEC4591001 1126 11261283A 4 Fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-10 2021-06-10 BB P1D VACCINATION 4 2021-06-09T14:53:00 C4591001AEC4591001 1126 11261283A 1 Fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-05-18 2021-05-19 BB P1D VACCINATION 3 2021-05-17T16:24:00 C4591001AEC4591001 1126 11261284A@ 1 Fever, 101F Fever F.Pyrexia F)Febrile disorders FBody temperature conditions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-05-18 2021-05-18 BB P1D VACCINATION 3 2021-05-17T15:38:00 C4591001AEC4591001 1126 11261284A0 4 Pain, injection site Pain injection site F-Injection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2VACCINATION 2021-01-07T23:002021-06-08 BB P1D VACCINATION 2 2021-01-06T15:17:00 C4591001AEC4591001 1126 11261284A 2 Injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-18 2021-05-20 BB P1D VACCINATION 3 2021-05-17T15:38:00 C4591001AEC4591001 1126 11261284A 3 Fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-18 2021-05-20 BB P1D VACCINATION 3 2021-05-17T15:38:00 C4591001AEC4591001 1126 11261287A0 3 Swelling, injection site Injection site swelling Fg1Injection site swelling Fg1Injection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-06-11 2021-06-11 BB P1D VACCINATION 4 2021-06-10T11:27:00 C4591001AEC4591001 1126 11261287A 2 Pain, injection site Pain injection site F-Injection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-06-11 2021-06-11 BB P1D VACCINATION 4 2021-06-10T11:27:00 C4591001AEC4591001 1126 11261287A 1 Injection Site numbness Injection site numbness FInjection site hypoaesthesia FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-20T14:002021-05-21 BB PT2H06M VACCINATION 3 2021-05-20T11:54:00 C4591001AEC4591001 1126 11261289J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2020-12-17 2020-12-24 AAP1D VACCINATION 1 2020-12-17 C4591001AEC4591001 1126 11261289A 1 Pain, Injection Site Pain injection site F-Injection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-05-17T20:002021-05-19 BB PT5H12M VACCINATION 3 2021-05-17T14:48:00 C4591001AEC4591001 1126 11261289A 2 Fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-05-17T20:002021-05-18 BB PT5H12M VACCINATION 3 2021-05-17T14:48:00 C4591001AEC4591001 1126 11261290A` 1 Worsening Pityriasis Rosea Pityriasis rosea FPityriasis rosea FPapulosquamous conditions FJEpidermal and dermal conditions FADVERSE EVENT Skin and subcutaneous tissue disorders F5Skin and subcutaneous tissue disorders F5 NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y2VACCINATION 2020-12-23 2021-01-19 ApB" P6D VACCINATION 1 2020-12-17T16:12:00 C4591001AEC4591001 1126 11261290AP 6 Pain, injection site Pain injection site F-Injection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-09T16:002021-06-12 BB PT1H52M VACCINATION 4 2021-06-09T14:08:00 C4591001AEC4591001 1126 11261290A@ 4 Injection Site Pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-05-19 2021-05-21 BB P1D VACCINATION 3 2021-05-18T15:30:00 C4591001AEC4591001 1126 11261290A0 5 Fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-09T18:002021-06-10 BB PT3H52M VACCINATION 4 2021-06-09T14:08:00 C4591001AEC4591001 1126 11261290A 2 Fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-05-18T16:302021-05-21 BB PT1H VACCINATION 3 2021-05-18T15:30:00 C4591001AEC4591001 1126 11261290A 3 Chills Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-05-19 2021-05-21 BB P1D VACCINATION 3 2021-05-18T15:30:00 C4591001AEC4591001 1126 11261292A 7 Fever Fever F.Pyrexia F)Febrile disorders FBody temperature conditions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-07T21:002021-06-08 BB PT9H26M VACCINATION 4 2021-06-07T11:34:00 C4591001AEC4591001 1126 11261292A 9 Generalized body aches Generalised aching FPain FPain and discomfort NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-06-07T21:002021-06-08 BB PT9H26M VACCINATION 4 2021-06-07T11:34:00 C4591001AEC4591001 1126 11261292A 4 Muscle aches Muscle ache FMyalgia F{Muscle pains F#Muscle disorders FADVERSE EVENT Musculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-05-18T14:002021-05-19 BB P1D VACCINATION 3 2021-05-17T13:27:00 C4591001AEC4591001 1126 11261292Ap 5 Left arm injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-05-17T19:002021-05-19 BB PT5H33M VACCINATION 3 2021-05-17T13:27:00 C4591001AEC4591001 1126 11261292A` 8 Headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-08 2021-06-09 BB P1D VACCINATION 4 2021-06-07T11:34:00 C4591001AEC4591001 1126 11261292AP 2 Headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-05-18T09:002021-05-19 BB P1D VACCINATION 3 2021-05-17T13:27:00 C4591001AEC4591001 1126 11261292A@ 10 Fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-06-08 2021-06-09 BB P1D VACCINATION 4 2021-06-07T11:34:00 C4591001AEC4591001 1126 11261292A0 3 Fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-05-18T14:002021-05-19 BB P1D VACCINATION 3 2021-05-17T13:27:00 C4591001AEC4591001 1126 11261292A 6 Chills Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-06-07T21:002021-06-08 BB PT9H26M VACCINATION 4 2021-06-07T11:34:00 C4591001AEC4591001 1126 11261292A 1 Chills Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-05-17T19:002021-05-17T23:00BB PT5H33M VACCINATION 3 2021-05-17T13:27:00 C4591001AEC4591001 1126 11261294A0 3 Injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-08-07 2021-08-08 BB P1D VACCINATION 4 2021-08-06T10:25:00 C4591001AEC4591001 1126 11261294A 2 Injection Site Pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-07-17 2021-07-19 BB P1D VACCINATION 3 2021-07-16T12:13:00 C4591001AEC4591001 1126 11261294A 1 Fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-07-17 2021-07-18 BB P1D VACCINATION 3 2021-07-16T12:13:00 C4591001AEC4591001 1126 11261296A` 3 Three teeth fractures Tooth fracture FTooth fracture FAbdominal and gastrointestinal injuries NEC FInjuries NEC FADVERSE EVENT Injury, poisoning and procedural complications FInjury, poisoning and procedural complications F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y2VACCINATION 2021-01-24 2021-01-24 B&B& P16D VACCINATION 2 2021-01-08T15:50:00 C4591001AEC4591001 1126 11261296AP 2 Lower lip laceration Lip injury FmLip injury FmAbdominal and gastrointestinal injuries NEC FInjuries NEC FADVERSE EVENT Injury, poisoning and procedural complications FInjury, poisoning and procedural complications F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y1VACCINATION 2021-01-24 2021-02-05 B&B2 P16D VACCINATION 2 2021-01-08T15:50:00 C4591001AEC4591001 1126 11261296A@ 5 Pain injection site Pain injection site F-Injection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-04-08 2021-04-09 BpBq P1D VACCINATION 3 2021-04-07T10:39:00 C4591001AEC4591001 1126 11261296A0 6 Injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-04-27 2021-04-28 BB P1D VACCINATION 4 2021-04-26T15:15:00 C4591001AEC4591001 1126 11261296A 4 Left elbow contusion Contusion of elbow FContusion F\Skin injuries NEC FInjuries NEC FADVERSE EVENT Injury, poisoning and procedural complications FInjury, poisoning and procedural complications F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y1VACCINATION 2021-01-24 2021-01-31 B&B- P16D VACCINATION 2 2021-01-08T15:50:00 C4591001AEC4591001 1126 11261296A 1 Dirt bike nontraffic accident Accident FAccident FNon-site specific injuries NEC F Injuries NEC FADVERSE EVENT Injury, poisoning and procedural complications FInjury, poisoning and procedural complications F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y2VACCINATION 2021-01-24 2021-01-24 B&B& P16D VACCINATION 2 2021-01-08T15:50:00 C4591001AEC4591001 1126 11261297A 1 Left Upper Arm Injection Site Pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-05-19T19:002021-05-21 BB PT2H24M VACCINATION 3 2021-05-19T16:36:00 C4591001AEC4591001 1126 11261297A 2 Injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-09T17:002021-06-10 BB PT1H06M VACCINATION 4 2021-06-09T15:54:00 C4591001AEC4591001 1126 11261300A 2 Generalized body aches Generalised aching FPain FPain and discomfort NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-06-12 2021-06-13 BB P1D VACCINATION 4 2021-06-11T15:01:00 C4591001AEC4591001 1126 11261300A 1 Left upper arm injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-05-19T19:002021-05-20 BB PT9H14M VACCINATION 3 2021-05-19T09:46:00 C4591001AEC4591001 1126 11261301A 1 Nausea Nausea F Nausea F Nausea and vomiting symptoms FGastrointestinal signs and symptoms FADVERSE EVENT Gastrointestinal disorders FܛGastrointestinal disorders Fܛ NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2VACCINATION 2020-12-24 2020-12-25 A0A@ P2D VACCINATION 1 2020-12-22T13:30:00 C4591001AEC4591001 1126 11261302A 1 Left upper arm injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-21T20:002021-05-22 BB PT3H49M VACCINATION 3 2021-05-21T16:11:00 C4591001AEC4591001 1126 11261302A 2 Injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-11T15:302021-06-13 BB PT1H27M VACCINATION 4 2021-06-11T14:03:00 C4591001AEC4591001 1126 11261305A 1 Left Upper Arm Injection Site Pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-02-24T17:002021-02-25T17:00B9B: PT5H24M VACCINATION 3 2021-02-24T11:36:00 C4591001AEC4591001 1126 11261305A 2 Injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-03-17T18:302021-03-18 BNBO PT8H11M VACCINATION 4 2021-03-17T10:19:00 C4591001AEC4591001 1126 11261306A 1 Left upper arm injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-05-18T17:002021-05-20 BB PT6H59M VACCINATION 3 2021-05-18T10:01:00 C4591001AEC4591001 1126 11261307A 1 Migraine headache, worsening Migraine aggravated FPMigraine FOMigraine headaches FSHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE NOT RELATEDOTHER RECOVERING/RESOLVING Y2VACCINATION 2021-01-24T13:00 B. P20D VACCINATION 1 2021-01-04T16:26:00ONGOINGLAST SUBJECT ENCOUNTERC4591001AEC4591001 1126 11261308A 1 Fever 101`F Fever F.Pyrexia F)Febrile disorders FBody temperature conditions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-06-19 2021-06-19 BB P1D VACCINATION 3 2021-06-18T09:46:00 C4591001AEC4591001 1126 11261308A 2 Injection Site Pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-07-10 2021-07-12 BB P1D VACCINATION 4 2021-07-09T13:08:00 C4591001AEC4591001 1126 11261309A 2 Swollen mouth Swollen mouth F=dMouth swelling FCOral soft tissue swelling and oedema FOral soft tissue conditions FADVERSE EVENT Gastrointestinal disorders FܛGastrointestinal disorders Fܛ NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1VACCINATION 2021-01-26T22:002021-01-27T11:00BB P1D VACCINATION 2 2021-01-25T15:13:00 C4591001AEC4591001 1126 11261309A 1 Swollen lips Swollen lips F=cLip swelling FzOral soft tissue swelling and oedema FOral soft tissue conditions FADVERSE EVENT Gastrointestinal disorders FܛGastrointestinal disorders Fܛ NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1VACCINATION 2021-01-26T22:002021-01-27T11:00BB P1D VACCINATION 2 2021-01-25T15:13:00 C4591001AEC4591001 1126 11261311A 2 Malaise Malaise F Malaise F Asthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-22 2021-06-23 BB P1D VACCINATION 4 2021-06-21T09:39:00 C4591001AEC4591001 1126 11261311A 1 Injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-02T22:002021-06-03 BB PT5H42M VACCINATION 3 2021-06-02T16:18:00 C4591001AEC4591001 1126 11261312AP 4 Fever Fever F.Pyrexia F)Febrile disorders FBody temperature conditions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-06-09T19:002021-06-11 BB PT9H20M VACCINATION 4 2021-06-09T09:40:00 C4591001AEC4591001 1126 11261312A@ 5 Generalized body aches Generalised aching FPain FPain and discomfort NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-06-09T19:002021-06-11 BB PT9H20M VACCINATION 4 2021-06-09T09:40:00 C4591001AEC4591001 1126 11261312A0 3 Pain, injection site Pain injection site F-Injection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-06-09T19:002021-06-11 BB PT9H20M VACCINATION 4 2021-06-09T09:40:00 C4591001AEC4591001 1126 11261312A 2 Left upper arm injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-18T18:002021-05-20 BB PT5H10M VACCINATION 3 2021-05-18T12:50:00 C4591001AEC4591001 1126 11261312A 1 Headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N2VACCINATION 2021-01-17 2021-01-21 AB P12D VACCINATION 1 2021-01-05T15:43:00 C4591001AEC4591001 1126 11261313J-+M VACCINATION 2-DELTOID MUSCLE-LEFT-PAIN AT INJECTION SITE PAIN AT INJECTION SITE Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FREACTOGENICITY ADMINISTRATION SITEYGeneral disorders and administration site conditions FGeneral disorders and administration site conditions FDELTOID MUSCLELEFT VACCINATION 2021-01-28 2021-02-05 BBP2D VACCINATION 2 2021-01-28 C4591001AEC4591001 1126 11261314AP 1 Skin rash L side of neck to L scapula Skin rash F6QRash F*TRashes, eruptions and exanthems NEC FcEpidermal and dermal conditions FADVERSE EVENT Skin and subcutaneous tissue disorders F5Skin and subcutaneous tissue disorders F5 NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1VACCINATION 2021-02-01 2021-02-03 BB P3D VACCINATION 2 2021-01-29T15:34:00 C4591001AEC4591001 1126 11261314A@ 2 Fever Fever F.Pyrexia F)Febrile disorders FBody temperature conditions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-05-20 2021-05-20 BB P1D VACCINATION 3 2021-05-19T11:52:00 C4591001AEC4591001 1126 11261314A0 3 Pain, injection site Pain injection site F-Injection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-05-19T17:002021-05-21 BB PT5H08M VACCINATION 3 2021-05-19T11:52:00 C4591001AEC4591001 1126 11261314A 5 Headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-05-20 2021-05-20 BB P1D VACCINATION 3 2021-05-19T11:52:00 C4591001AEC4591001 1126 11261314A 4 Fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-05-19T17:002021-05-19T21:00BB PT5H08M VACCINATION 3 2021-05-19T11:52:00 C4591001AEC4591001 1126 11261317A0 2 Malaise Malaise F Malaise F Asthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-10 2021-06-12 BB P1D VACCINATION 4 2021-06-09T15:49:00 C4591001AEC4591001 1126 11261317A 3 Injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-09T21:002021-06-11 BB PT5H11M VACCINATION 4 2021-06-09T15:49:00 C4591001AEC4591001 1126 11261317A 1 Injection Site Pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-17T14:002021-05-19 BB PT3H32M VACCINATION 3 2021-05-17T10:28:00 C4591001AEC4591001 1126 11261318A 1 Injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-08-05T21:302021-08-07 BB PT12H VACCINATION 3 2021-08-05T09:30:00 C4591001AEC4591001 1126 11261318A 2 Chills Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-08-05T21:302021-08-07 BB PT12H VACCINATION 3 2021-08-05T09:30:00 C4591001AEC4591001 1126 11261320A0 3 Pain, injection site Pain injection site F-Injection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-09 2021-06-09 BB P1D VACCINATION 4 2021-06-08T14:07:00 C4591001AEC4591001 1126 11261320A 1 Pain, injection site Pain injection site F-Injection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-18T18:002021-05-19 BB PT3H12M VACCINATION 3 2021-05-18T14:48:00 C4591001AEC4591001 1126 11261320A 2 Fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-18T18:002021-05-19 BB PT3H12M VACCINATION 3 2021-05-18T14:48:00 C4591001AEC4591001 1126 11261322A@ 3 Generalized body aches Generalised aching FPain FPain and discomfort NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-14T18:302021-06-15 BB PT8H48M VACCINATION 4 2021-06-14T09:42:00 C4591001AEC4591001 1126 11261322A0 1 Pain, Injection site Pain injection site F-Injection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-05-25 2021-05-28 BB P1D VACCINATION 3 2021-05-24T16:45:00 C4591001AEC4591001 1126 11261322A 4 Headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-14T18:302021-06-15 BB PT8H48M VACCINATION 4 2021-06-14T09:42:00 C4591001AEC4591001 1126 11261322A 2 Fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-14T18:302021-06-15 BB PT8H48M VACCINATION 4 2021-06-14T09:42:00 C4591001AEC4591001 1126 11261325AP 3 Left upper arm injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-05-18T19:002021-05-20 BB PT4H54M VACCINATION 3 2021-05-18T14:06:00 C4591001AEC4591001 1126 11261325A@ 4 Headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-05-19 2021-05-19 BB P1D VACCINATION 3 2021-05-18T14:06:00 C4591001AEC4591001 1126 11261325A0 2 Fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-19 2021-05-19 BB P1D VACCINATION 3 2021-05-18T14:06:00 C4591001AEC4591001 1126 11261325A 1 Chills Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-05-18T18:002021-05-18T20:00BB PT3H54M VACCINATION 3 2021-05-18T14:06:00 C4591001AEC4591001 1126 11261325A 5 Body Chills Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-09 2021-06-09 BB P1D VACCINATION 4 2021-06-08T14:12:00 C4591001AEC4591001 1131 11311279A 2 injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1VACCINATION 2021-01-12 2021-01-14 BB P1D VACCINATION 2 2021-01-11T16:49:00 C4591001AEC4591001 1131 11311279A 1 fatigue Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1VACCINATION 2021-01-12 2021-01-15 BB P1D VACCINATION 2 2021-01-11T16:49:00 C4591001AEC4591001 1131 11311280A 1 vasovagal reaction secondary to vaccine Vasovagal reaction FNPresyncope F%Neurological signs and symptoms NEC FNeurological disorders NEC FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N2VACCINATION 2020-12-17T19:052020-12-17T19:15AA PT41M VACCINATION 1 2020-12-17T18:24:00 C4591001AEC4591001 1131 11311283A 1 pilonidal cyst Pilonidal cyst FcPilonidal cyst FcSkin structures and soft tissue infections F5Infections - pathogen unspecified FADVERSE EVENT Infections and infestations FInfections and infestations F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y2VACCINATION 2020-12-29 2021-02-18 AB; P7D VACCINATION 1 2020-12-22T16:59:00 C4591001AEC4591001 1131 11311285A0 2 body aches Generalized aching F\Pain FPain and discomfort NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-15 2021-06-16 BB P1D VACCINATION 3 2021-06-14T14:43:00 C4591001AEC4591001 1131 11311285A 3 injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-15 2021-06-16 BB P1D VACCINATION 3 2021-06-14T14:43:00 C4591001AEC4591001 1131 11311285A 1 headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-15 2021-06-16 BB P1D VACCINATION 3 2021-06-14T14:43:00 C4591001AEC4591001 1131 11311286J-+M VACCINATION 1-CHILLS CHILLS Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-01-04 2021-01-18 ApBP14DP6D VACCINATION 1 2020-12-29 C4591001AEC4591001 1131 11311287A0 2 rhinorrhea Rhinorrhea F/<Rhinorrhoea F/=Upper respiratory tract signs and symptoms FKiRespiratory tract signs and symptoms F}ADVERSE EVENT Respiratory, thoracic and mediastinal disorders F-Respiratory, thoracic and mediastinal disorders F- NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N1VACCINATION 2021-01-17 2021-02-03 BB% P19D VACCINATION 1 2020-12-29T11:35:00 C4591001AEC4591001 1131 11311287A 1 enlarge lymph nods-neck(bilateral) Lymphadenopathy cervical FLymphadenopathy FLymphatic system disorders NEC FSpleen, lymphatic and reticuloendothelial system disorders F9)ADVERSE EVENT Blood and lymphatic system disorders FQBlood and lymphatic system disorders FQ NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1VACCINATION 2021-01-27 2021-02-03 BB% P9D VACCINATION 2 2021-01-18T13:20:00 C4591001AEC4591001 1131 11311287A 3 ear infection Ear infection F;Ear infection F;Ear infections F=Infections - pathogen unspecified FADVERSE EVENT Infections and infestations FInfections and infestations F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-07-01 2021-07-11 BB P15D VACCINATION 4 2021-06-16T10:53:00 C4591001AEC4591001 1131 11311288A 7 vomiting Vomiting FPVomiting FPNausea and vomiting symptoms FGastrointestinal signs and symptoms FADVERSE EVENT Gastrointestinal disorders FܛGastrointestinal disorders Fܛ NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-17 2021-06-17 BB P1D VACCINATION 4 2021-06-16T10:52:00 C4591001AEC4591001 1131 11311288Ap 4 fever Fever F.Pyrexia F)Febrile disorders FBody temperature conditions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-17 2021-06-17 BB P1D VACCINATION 4 2021-06-16T10:52:00 C4591001AEC4591001 1131 11311288A` 3 strep throat Pharyngitis streptococcal FPharyngitis streptococcal FStreptococcal infections F;DBacterial infectious disorders F2ADVERSE EVENT Infections and infestations FInfections and infestations F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-17 2021-06-19 BB P1D VACCINATION 4 2021-06-16T10:52:00 C4591001AEC4591001 1131 11311288AP 1 nasal congestion Nasal congestion FNasal congestion FNasal congestion and inflammations FUpper respiratory tract disorders (excl infections) FK`ADVERSE EVENT Respiratory, thoracic and mediastinal disorders F-Respiratory, thoracic and mediastinal disorders F- NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-17 2021-06-20 BB P1D VACCINATION 4 2021-06-16T10:52:00 C4591001AEC4591001 1131 11311288A@ 2 general myalgia Myalgia F{Myalgia F{Muscle pains F#Muscle disorders FADVERSE EVENT Musculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-17 2021-06-18 BB P1D VACCINATION 4 2021-06-16T10:52:00 C4591001AEC4591001 1131 11311288A0 6 headache Headache FHeadache FHeadaches NEC FHeadaches FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-17 2021-06-19 BB P1D VACCINATION 4 2021-06-16T10:52:00 C4591001AEC4591001 1131 11311288A 8 cough Cough FXCough FXCoughing and associated symptoms FaRespiratory disorders NEC F-ADVERSE EVENT Respiratory, thoracic and mediastinal disorders F-Respiratory, thoracic and mediastinal disorders F- NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-17 2021-06-17 BB P1D VACCINATION 4 2021-06-16T10:52:00 C4591001AEC4591001 1131 11311288A 5 chest pain Chest pain FChest pain FPain and discomfort NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N2OPEN LABEL TREATMENT2021-06-17 2021-06-18 BB P1D VACCINATION 4 2021-06-16T10:52:00 C4591001AEC4591001 1131 11311289J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2020-12-31 2021-01-06 A AP1D P1D VACCINATION 1 2020-12-30 C4591001AEC4591001 1131 11311292J-+M VACCINATION 2-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2021-03-03 B;. P2D VACCINATION 2 2021-03-01 ONGOINGV3_MONTH1_POSTVAX2_L C4591001AEC4591001 1131 11311292J-+M VACCINATION 2-FATIGUE FATIGUE Fatigue FFatigue FAsthenic conditions F^General system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-03-03 B;. P2D VACCINATION 2 2021-03-01 ONGOINGV3_MONTH1_POSTVAX2_L C4591001AEC4591001 1131 11311292J-+M VACCINATION 2-CHILLS CHILLS Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FREACTOGENICITY SYSTEMIC YGeneral disorders and administration site conditions FGeneral disorders and administration site conditions F VACCINATION 2021-03-07 B?. P6D VACCINATION 2 2021-03-01 ONGOINGV3_MONTH1_POSTVAX2_L C4591001AEC4591001 1131 11311293A 2 Low grade temperature elevation Slight temperature FgPyrexia F)Febrile disorders FBody temperature conditions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-08-03T22:002021-08-03T23:00BB PT11H19MVACCINATION 4 2021-08-03T10:41:00 C4591001AEC4591001 1131 11311293A 1 Stomach ache Stomach ache F:Abdominal pain upper FGastrointestinal and abdominal pains (excl oral and throat) F܆Gastrointestinal signs and symptoms FADVERSE EVENT Gastrointestinal disorders FܛGastrointestinal disorders Fܛ NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-08-03T22:002021-08-04 BB PT11H19MVACCINATION 4 2021-08-03T10:41:00 C4591001AEC4591001 1131 11311299A0 2 febrile Pyrexia F)Pyrexia F)Febrile disorders FBody temperature conditions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-06-11 2021-06-11 BB P1D VACCINATION 4 2021-06-10T10:41:00 C4591001AEC4591001 1131 11311299A 3 nausea Nausea F Nausea F Nausea and vomiting symptoms FGastrointestinal signs and symptoms FADVERSE EVENT Gastrointestinal disorders FܛGastrointestinal disorders Fܛ NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-06-11 2021-06-11 BB P1D VACCINATION 4 2021-06-10T10:41:00 C4591001AEC4591001 1131 11311299A 1 injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED N1OPEN LABEL TREATMENT2021-05-20 2021-05-22 BB VACCINATION 3 2021-05-20T13:38:00 C4591001AEC4591001 1131 11311300AP 2 sun burn(face and shoulders) Sunburn F<Sunburn F<Radiation injuries F)Injuries by physical agents FADVERSE EVENT Injury, poisoning and procedural complications FInjury, poisoning and procedural complications F NNOT APPLICABLE NOT RELATEDOTHER RECOVERING/RESOLVING Y3OPEN LABEL TREATMENT2021-06-07 B. P18D VACCINATION 3 2021-05-20T13:37:00ONGOINGLAST SUBJECT ENCOUNTERC4591001AEC4591001 1131 11311300A@ 3 fever Fever F.Pyrexia F)Febrile disorders FBody temperature conditions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-06-10T12:002021-06-11T11:00BB PT1H17M VACCINATION 4 2021-06-10T10:43:00 C4591001AEC4591001 1131 11311300A 1 injection site pain Injection site pain FInjection site pain FInjection site reactions FAdministration site reactions FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-05-20 2021-05-23 BB VACCINATION 3 2021-05-20T13:37:00 C4591001AEC4591001 1131 11311300A 4 chills Chills FChills FFeelings and sensations NEC FGeneral system disorders NEC FADVERSE EVENT General disorders and administration site conditions FGeneral disorders and administration site conditions F NNOT APPLICABLE RELATED RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-06-10T21:002021-06-11T11:00BB PT10H17MVACCINATION 4 2021-06-10T10:43:00 C4591001AEC4591001 1131 11311301A0 3 right clavicle fracture Clavicle fracture FClavicle fracture FLimb fractures and dislocations FBone and joint injuries FADVERSE EVENT Injury, poisoning and procedural complications FInjury, poisoning and procedural complications F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y2VACCINATION 2021-02-19T11:002021-04-23 B(Bg P14D VACCINATION 2 2021-02-05T14:06:00 C4591001AEC4591001 1131 11311301A 1 sacroiliac joint pain Pain sacroiliac FSArthralgia F'Joint related signs and symptoms F:Joint disorders F-ADVERSE EVENT Musculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N2VACCINATION 2021-01-15 2021-02-08 APB P4D VACCINATION 1 2021-01-11T14:50:00 C4591001AEC4591001 1131 11311301A 4 skiing accident Skiing accident FɎAccident FNon-site specific injuries NEC F Injuries NEC FADVERSE EVENT Injury, poisoning and procedural complications FInjury, poisoning and procedural complications F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y2VACCINATION 2021-02-18T11:002021-02-19 B'B( P13D VACCINATION 2 2021-02-05T14:06:00 C4591001AEC4591001 1139 11391155J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2020-12-06 2020-12-11 A0AP1D P2D VACCINATION 1 2020-12-04 C4591001AEC4591001 1139 11391171A 1 laceration of forehead Laceration of face FSkin laceration F|BSkin injuries NEC FInjuries NEC FADVERSE EVENT Injury, poisoning and procedural complications FInjury, poisoning and procedural complications F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N2FOLLOW-UP 2021-03-10T12:002021-03-16T12:00BVB\ P64D VACCINATION 2 2021-01-05T12:43:00 C4591001AEC4591001 1139 11391172J-+M VACCINATION 2-MUSCLE PAIN MUSCLE PAIN Muscle pain F"Myalgia F{Muscle pains F#Muscle disorders FREACTOGENICITY SYSTEMIC YMusculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk VACCINATION 2021-01-06 2021-01-12 BBP1D P1D VACCINATION 2 2021-01-05 C4591001AEC4591001 1139 11391172J-+M VACCINATION 2-JOINT PAIN JOINT PAIN Joint pain F6Arthralgia F'Joint related signs and symptoms F:Joint disorders F-REACTOGENICITY SYSTEMIC YMusculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk VACCINATION 2021-01-06 2021-01-12 BBP1D P1D VACCINATION 2 2021-01-05 C4591001AEC4591001 1139 11391179A 1 syncope Syncope F=Syncope F=Disturbances in consciousness NEC FENeurological disorders NEC FADVERSE EVENT Nervous system disorders FNervous system disorders F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED N2REPEAT SCREENING 1 2021-07-12T12:252021-07-12T12:35BB P185D VACCINATION 2 2021-01-08T15:40:00 C4591001AEC4591001 1139 11391189J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2020-12-27 2020-12-28 ApAP1D P6D VACCINATION 1 2020-12-21 C4591001AEC4591001 1139 11391195J-+M VACCINATION 1-DIARRHEA DIARRHEA Diarrhea F7Diarrhoea F?Diarrhoea (excl infective) F@Gastrointestinal motility and defaecation conditions FܹREACTOGENICITY SYSTEMIC YGastrointestinal disorders FܛGastrointestinal disorders Fܛ VACCINATION 2020-12-22 2020-12-28 A AP1D P1D VACCINATION 1 2020-12-21 C4591001AEC4591001 1139 11391204J-+M VACCINATION 2-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2021-01-12 2021-01-19 BBP1D VACCINATION 2 2021-01-12 C4591001AEC4591001 1139 11391210J-+M VACCINATION 2-JOINT PAIN JOINT PAIN Joint pain F6Arthralgia F'Joint related signs and symptoms F:Joint disorders F-REACTOGENICITY SYSTEMIC YMusculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk VACCINATION 2021-01-21 2021-02-01 BB$P7D P2D VACCINATION 2 2021-01-19 C4591001AEC4591001 1139 11391210A 2 traumatic hyphema of left eye Hyphema F<Hyphaema F;Eye injuries NEC FInjuries NEC FADVERSE EVENT Injury, poisoning and procedural complications FInjury, poisoning and procedural complications F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y2OPEN LABEL TREATMENT2021-06-08T12:002021-06-25T12:00BB P13D VACCINATION 3 2021-05-26T15:41:00 C4591001AEC4591001 1139 11391210A 1 Concussion Concussion FConcussion FCerebral injuries NEC FdInjuries NEC FADVERSE EVENT Injury, poisoning and procedural complications FInjury, poisoning and procedural complications F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y3OPEN LABEL TREATMENT2021-06-08T12:002021-06-25T12:00BB P13D VACCINATION 3 2021-05-26T15:41:00 C4591001AEC4591001 1139 11391213J-+M VACCINATION 1-MUSCLE PAIN MUSCLE PAIN Muscle pain F"Myalgia F{Muscle pains F#Muscle disorders FREACTOGENICITY SYSTEMIC YMusculoskeletal and connective tissue disorders FkMusculoskeletal and connective tissue disorders Fk VACCINATION 2021-01-03 2021-01-04 ApAP1D P6D VACCINATION 1 2020-12-28 C4591001AEC4591001 1139 11391217J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2020-12-31 2021-01-05 A0AP1D P2D VACCINATION 1 2020-12-29 C4591001AEC4591001 1139 11391217A 1 Otitis Externa Otitis externa FOtitis externa FEar infections F=Infections - pathogen unspecified FADVERSE EVENT Infections and infestations FInfections and infestations F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y1OPEN LABEL TREATMENT2021-06-29T12:002021-07-06T12:00BB P21D VACCINATION 4 2021-06-08T15:33:00 C4591001AEC4591001 1139 11391225J-+M VACCINATION 2-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2021-02-02 2021-02-09 BB%P6D P5D VACCINATION 2 2021-01-28 C4591001AEC4591001 1139 11391225A 1 concussion Concussion FConcussion FCerebral injuries NEC FdInjuries NEC FADVERSE EVENT Injury, poisoning and procedural complications FInjury, poisoning and procedural complications F NNOT APPLICABLE NOT RELATEDOTHER RECOVERED/RESOLVED Y2VACCINATION 2021-02-01T12:002021-02-09T12:00BB% P4D VACCINATION 2 2021-01-28T14:25:00 C4591001AEC4591001 1139 11391233J-+M VACCINATION 2-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F VACCINATION 2021-01-27 2021-02-02 BBP1D P1D VACCINATION 2 2021-01-26 C4591001AEC4591001 1139 11391233J-+M VACCINATION 1-HEADACHE HEADACHE Headache FHeadache FHeadaches NEC FHeadaches FREACTOGENICITY SYSTEMIC YNervous system disorders FNervous system disorders F