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2020-06-01T13:36AE-001 SYNCOPE Syncope F™=”Syncope F™=”Disturbances in consciousness NEC F˜ËENeurological disorders NEC F™ùADVERSE EVENT Nervous system disorders F™•Nervous system disorders F™•MILD NDOSE NOT CHANGEDNONE NOT RELATEDRELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-29T09:402020-06-29T09:41BB mRNA-1273-P201AEmRNA-1273-P201-US201-1007US2011007ADOSE 1 - 2020-06-01T14:47AE-001 REDNESS AT INJECTION SITE Injection site redness F˜ìÒInjection site erythema F˜ìInjection site reactions F˜ìÑAdministration site reactions F˜›¤REACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE RELATED RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-01T20:002020-06-10 AA P3D mRNA-1273-P201AEmRNA-1273-P201-US201-1014US2011014ADOSE 1 - 2020-06-01T12:57AE-001 MIGRAINE (REPORTED AS HEADACHE IN DIARY) Migraine headache F™RMigraine F™OMigraine headaches F™SHeadaches F˜áŸREACTOGENICITY Nervous system disorders F™•Nervous system disorders F™•SEVERE NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-06-04 2020-06-04 A@A@P1D mRNA-1273-P201AEmRNA-1273-P201-US201-1014US2011014A DOSE 1 - 2020-06-01T12:57AE-002 MIGRAINE (REPORTED AS HEADACHE IN DIARY) Migraine headache F™RMigraine F™OMigraine headaches F™SHeadaches F˜áŸREACTOGENICITY Nervous system disorders F™•Nervous system disorders F™•SEVERE NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-06-06 2020-06-06 A`A`P1D mRNA-1273-P201AEmRNA-1273-P201-US201-1028US2011028ADOSE 1 - 2020-06-01T11:11AE-001 GOUT, RIGHT GREAT TOE Gout F˜ßCGout F˜ßCDisorders of purine metabolism F™«¸Purine and pyrimidine metabolism disorders F™)*ADVERSE EVENT PIMMCMetabolism and nutrition disorders F™©Metabolism and nutrition disorders F™©MILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-07 2020-06-16 ApB mRNA-1273-P201AEmRNA-1273-P201-US201-1028US2011028A DOSE 2 - 2020-06-29T09:06AE-002 HERNIA, LEFT INGUINAL Left inguinal hernia F˜ôInguinal hernia F˜ì€Inguinal hernias F˜ìAbdominal hernias and other abdominal wall conditions F˜–ÉADVERSE EVENT PIMMCGastrointestinal disorders F˜Ü›Gastrointestinal disorders F˜Ü›MILD NNOT APPLICABLE CONCOMITANT PROCEDURE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-10-30 2020-11-02 B˜B› mRNA-1273-P201AEmRNA-1273-P201-US201-1040US2011040ADOSE 1 - 2020-06-01T15:50AE-001 CHEST PAIN, UNKNOWN DETAILS Unspecified chest pain F™HÕChest pain F˜·ŸPain and discomfort NEC F™ÜGeneral system disorders NEC F˜ÝADVERSE EVENT PIMMCGeneral disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-02T22:492020-06-02T23:35A A mRNA-1273-P201AEmRNA-1273-P201-US201-1040US2011040A DOSE 2 - 2020-06-29T10:51AE-002 LOW HORMONE LEVELS Hormone level abnormal F™…šHormone level abnormal F™…šEndocrine analyses and imaging NEC F˜ÏåEndocrine investigations (incl sex hormones) F˜ÏòADVERSE EVENT PIMMCInvestigations F˜ïëInvestigations F˜ïëMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED NOT RECOVERED/NOT RESOLVED NNNNNN1PART A FOLLOW-UP 2020-11-13 B¦. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US201-1040US2011040A0DOSE 2 - 2020-06-29T10:51AE-003 INSULIN RESISTANCE Insulin resistance F˜îYInsulin resistance F˜îYHyperglycaemic conditions NEC F˜çGlucose metabolism disorders (incl diabetes mellitus) F˜ÞxADVERSE EVENT PIMMCMetabolism and nutrition disorders F™©Metabolism and nutrition disorders F™©MILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED NOT RECOVERED/NOT RESOLVED NNNNNN1PART A FOLLOW-UP 2020-11-13 B¦. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US201-1051US2011051ADOSE 2 - 2020-07-06T13:46AE-010 LOSS OF TASTE Loss of taste F˜÷®Ageusia F˜œHSensory abnormalities NEC F™2ÕNeurological disorders NEC F™ùADVERSE EVENT PIMMCNervous system disorders F™•Nervous system disorders F™•MILD NNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-10-17 2020-10-30 BŠB— mRNA-1273-P201AEmRNA-1273-P201-US201-1051US2011051A DOSE 2 - 2020-07-06T13:46AE-006 COUGH Cough F˜ÂXCough F˜ÂXCoughing and associated symptoms F˜ÂaRespiratory disorders NEC F™-¼ADVERSE EVENT PIMMCRespiratory, thoracic and mediastinal disorders F™-ÒRespiratory, thoracic and mediastinal disorders F™-ÒMILD NNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-10-19 2020-10-26 BŒB“ mRNA-1273-P201AEmRNA-1273-P201-US201-1051US2011051A0DOSE 2 - 2020-07-06T13:46AE-012 LIGHTHEADEDNESS Lightheadedness F˜ö,Dizziness F˜Ë…Neurological signs and symptoms NEC F™úNeurological disorders NEC F™ùADVERSE EVENT PIMMCNervous system disorders F™•Nervous system disorders F™•MILD NNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-10-17 2020-10-20 BŠB mRNA-1273-P201AEmRNA-1273-P201-US201-1051US2011051A@DOSE 2 - 2020-07-06T13:46AE-013 DIZZINESS Dizziness F˜Ë…Dizziness F˜Ë…Neurological signs and symptoms NEC F™úNeurological disorders NEC F™ùADVERSE EVENT PIMMCNervous system disorders F™•Nervous system disorders F™•MILD NNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-10-18 2020-10-23 B‹B mRNA-1273-P201AEmRNA-1273-P201-US201-1051US2011051APDOSE 2 - 2020-07-06T13:46AE-008 FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝADVERSE EVENT PIMMCGeneral disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-10-17 2020-10-28 BŠB• mRNA-1273-P201AEmRNA-1273-P201-US201-1051US2011051A`DOSE 2 - 2020-07-06T13:46AE-007 HEADACHE Headache F˜á‹Headache F˜á‹Headaches NEC F˜á¡Headaches F˜áŸADVERSE EVENT PIMMCNervous system disorders F™•Nervous system disorders F™•MILD NNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-10-19 2020-10-28 BŒB• mRNA-1273-P201AEmRNA-1273-P201-US201-1051US2011051ApDOSE 2 - 2020-07-06T13:46AE-009 BODY ACHES General body pain F™UËPain F™ÛPain and discomfort NEC F™ÜGeneral system disorders NEC F˜ÝADVERSE EVENT PIMMCGeneral disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-10-18 2020-10-28 B‹B• mRNA-1273-P201AEmRNA-1273-P201-US201-1051US2011051A€DOSE 2 - 2020-07-06T13:46AE-004 BACK PAIN, SECONDARY TO CAR ACCIDENT Post-traumatic pain F™”xPost-traumatic pain F™”xNon-site specific injuries NEC F™ ÇInjuries NEC F˜ìâADVERSE EVENT PIMMCInjury, poisoning and procedural complications F˜ìåInjury, poisoning and procedural complications F˜ìåMODERATENNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2020-11-19 2020-12-15 B«BÅ mRNA-1273-P201AEmRNA-1273-P201-US201-1051US2011051ADOSE 2 - 2020-07-06T13:46AE-003 NECK PAIN SECONDARY TO CAR ACCIDENT Post-traumatic pain F™”xPost-traumatic pain F™”xNon-site specific injuries NEC F™ ÇInjuries NEC F˜ìâADVERSE EVENT PIMMCInjury, poisoning and procedural complications F˜ìåInjury, poisoning and procedural complications F˜ìåMODERATENNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2020-11-19 2020-12-15 B«BÅ mRNA-1273-P201AEmRNA-1273-P201-US201-1051US2011051A DOSE 1 - 2020-06-02T16:12AE-001 ALL OVER BODY RASH Rash all over F™*XRash F™*TRashes, eruptions and exanthems NEC F™cÖEpidermal and dermal conditions F˜ÑADVERSE EVENT PIMMCSkin and subcutaneous tissue disorders F™5ÑSkin and subcutaneous tissue disorders F™5ÑMODERATENDOSE DELAYED CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-06-22 2020-07-02 BB mRNA-1273-P201AEmRNA-1273-P201-US201-1051US2011051A°DOSE 2 - 2020-07-06T13:46AE-005 RUNNY NOSE Runny nose F™0Rhinorrhoea F™/=Upper respiratory tract signs and symptoms F™KiRespiratory tract signs and symptoms F™Ë}ADVERSE EVENT PIMMCRespiratory, thoracic and mediastinal disorders F™-ÒRespiratory, thoracic and mediastinal disorders F™-ÒMILD NNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-10-15 2020-10-25 BˆB’ mRNA-1273-P201AEmRNA-1273-P201-US201-1051US2011051AÀDOSE 2 - 2020-07-06T13:46AE-002 CAR ACCIDENT Motor vehicle accident F™èRoad traffic accident F™/£Non-site specific injuries NEC F™ ÇInjuries NEC F˜ìâADVERSE EVENT PIMMCInjury, poisoning and procedural complications F˜ìåInjury, poisoning and procedural complications F˜ìåMODERATENNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2020-11-19 2020-11-19 B«B« mRNA-1273-P201AEmRNA-1273-P201-US201-1051US2011051AÐDOSE 2 - 2020-07-06T13:46AE-011 SNEEZING Sneezing F™7Sneezing F™7Upper respiratory tract signs and symptoms F™KiRespiratory tract signs and symptoms F™Ë}ADVERSE EVENT PIMMCRespiratory, thoracic and mediastinal disorders F™-ÒRespiratory, thoracic and mediastinal disorders F™-ÒMILD NNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-10-16 2020-10-22 B‰B mRNA-1273-P201AEmRNA-1273-P201-US201-1055US2011055ADOSE 1 - 2020-06-02T17:03AE-002 MUSCLE ACHES, ALL OVER BODY Generalized muscle aches F™ŠiMyalgia F™{Muscle pains F™#Muscle disorders F™ADVERSE EVENT Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-21 2020-06-24 BB mRNA-1273-P201AEmRNA-1273-P201-US201-1055US2011055A DOSE 1 - 2020-06-02T17:03AE-001 NAUSEA Nausea F™ Nausea F™ Nausea and vomiting symptoms F™Gastrointestinal signs and symptoms F˜ÜÜADVERSE EVENT Gastrointestinal disorders F˜Ü›Gastrointestinal disorders F˜Ü›MILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-21 2020-06-24 BB mRNA-1273-P201AEmRNA-1273-P201-US201-1056US2011056ADOSE 2 - 2020-06-30T17:08AE-001 BENIGN CYST, LEFT TESTICLE Testicular cyst F™UhTesticular cyst F™UhTesticular and epididymal neoplasms F™4Testicular and epididymal disorders F˜Ê²ADVERSE EVENT PIMMCReproductive system and breast disorders F™-LReproductive system and breast disorders F™-LMILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED NOT RECOVERED/NOT RESOLVED NNNNNN1PART A FOLLOW-UP 2020-09-05 B`. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US201-1060US2011060ADOSE 1 - 2020-06-02T12:40AE-001 EXASPERATION OF POISON IVY RASH LEFT FOREARM/RIGHT UPPER THIGH Poison ivy rash F™"?Dermatitis contact F˜ÇDermatitis and eczema F˜ÇEpidermal and dermal conditions F˜ÑADVERSE EVENT PIMMCSkin and subcutaneous tissue disorders F™5ÑSkin and subcutaneous tissue disorders F™5ÑMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-06 2020-06-13 APAÀ mRNA-1273-P201AEmRNA-1273-P201-US201-1060US2011060A DOSE 2 - 2020-06-30T16:39AE-003 TOOTH PAIN, LEFT LOWER SECOND MOLAR (FROM ROOT CANAL) Toothache F™B—Toothache F™B—Dental pain and sensation disorders F™B‘Dental and gingival conditions F™BrADVERSE EVENT PIMMCGastrointestinal disorders F˜Ü›Gastrointestinal disorders F˜Ü›MILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-23 2020-07-30 B4B; mRNA-1273-P201AEmRNA-1273-P201-US201-1064US2011064ADOSE 2 - 2020-07-01T13:53AE-001 POISON OAK LEFT ARM Poison oak rash F™"@Dermatitis contact F˜ÇDermatitis and eczema F˜ÇEpidermal and dermal conditions F˜ÑADVERSE EVENT Skin and subcutaneous tissue disorders F™5ÑSkin and subcutaneous tissue disorders F™5ÑMILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-24 2020-08-06 B5BB mRNA-1273-P201AEmRNA-1273-P201-US201-1067US2011067ADOSE 1 - 2020-06-03T13:35AE-001 COUGH Cough F˜ÂXCough F˜ÂXCoughing and associated symptoms F˜ÂaRespiratory disorders NEC F™-¼ADVERSE EVENT PIMMCRespiratory, thoracic and mediastinal disorders F™-ÒRespiratory, thoracic and mediastinal disorders F™-ÒMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-09 2020-07-17 ApB- mRNA-1273-P201AEmRNA-1273-P201-US201-1067US2011067A DOSE 2 - 2020-07-07T09:13AE-003 COUGH Cough F˜ÂXCough F˜ÂXCoughing and associated symptoms F˜ÂaRespiratory disorders NEC F™-¼ADVERSE EVENT PIMMCRespiratory, thoracic and mediastinal disorders F™-ÒRespiratory, thoracic and mediastinal disorders F™-ÒMILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-11-06 2020-11-16 BB§ mRNA-1273-P201AEmRNA-1273-P201-US201-1067US2011067A0DOSE 1 - 2020-06-03T13:35AE-002 DRY THROAT Dry throat F˜Ì]Dry throat F˜Ì]Upper respiratory tract signs and symptoms F™KiRespiratory tract signs and symptoms F™Ë}ADVERSE EVENT PIMMCRespiratory, thoracic and mediastinal disorders F™-ÒRespiratory, thoracic and mediastinal disorders F™-ÒMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-09 2020-07-30 ApB: mRNA-1273-P201AEmRNA-1273-P201-US201-1067US2011067A@DOSE 2 - 2020-07-07T09:13AE-006 SORE THROAT Sore throat F™8Oropharyngeal pain F™¡_Upper respiratory tract signs and symptoms F™KiRespiratory tract signs and symptoms F™Ë}ADVERSE EVENT PIMMCRespiratory, thoracic and mediastinal disorders F™-ÒRespiratory, thoracic and mediastinal disorders F™-ÒMILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-11-06 2020-11-15 BB¦ mRNA-1273-P201AEmRNA-1273-P201-US201-1067US2011067APDOSE 2 - 2020-07-07T09:13AE-005 BODY ACHES General body pain F™UËPain F™ÛPain and discomfort NEC F™ÜGeneral system disorders NEC F˜ÝADVERSE EVENT PIMMCGeneral disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-11-07 2020-11-15 BžB¦ mRNA-1273-P201AEmRNA-1273-P201-US201-1067US2011067A`DOSE 2 - 2020-07-07T09:13AE-004 RUNNY NOSE Runny nose F™0Rhinorrhoea F™/=Upper respiratory tract signs and symptoms F™KiRespiratory tract signs and symptoms F™Ë}ADVERSE EVENT PIMMCRespiratory, thoracic and mediastinal disorders F™-ÒRespiratory, thoracic and mediastinal disorders F™-ÒMILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-11-08 2020-11-16 BŸB§ mRNA-1273-P201AEmRNA-1273-P201-US201-1068US2011068ADOSE 2 - 2020-06-30T09:41AE-001 BRUISE AT INJECTION SITE Injection site bruising F˜ì¤Injection site bruising F˜ì¤Injection site reactions F˜ìÑAdministration site reactions F˜›¤ADVERSE EVENT General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NNOT APPLICABLE NONE NOT RELATEDRELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-30T10:502020-07-17 BB. mRNA-1273-P201AEmRNA-1273-P201-US201-1068US2011068A DOSE 2 - 2020-06-30T09:41AE-0042030PAIN AT INJECTION SITE Pain injection site F™-Injection site pain F˜ìÆInjection site reactions F˜ìÑAdministration site reactions F˜›¤REACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NNOT APPLICABLE NONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-01T14:002020-07-10T23:00BB'P3DT13H19M mRNA-1273-P201AEmRNA-1273-P201-US201-1068US2011068A0DOSE 2 - 2020-06-30T09:41AE-003 SWELLING AT INJECTION SITE Swelling of injection site F™=HInjection site swelling F™g1Injection site reactions F˜ìÑAdministration site reactions F˜›¤REACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NNOT APPLICABLE NONE RELATED RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-30 2020-07-15 BB,P9D mRNA-1273-P201AEmRNA-1273-P201-US201-1084US2011084ADOSE 2 - 2020-06-30T08:19AE-001 MACULOPAPULAR RASH ON CHEST AND ABDOMEN, ALLERGIC REACTION TO NEW SOAP Soap allergy F™¨>Dermatitis contact F˜ÇDermatitis and eczema F˜ÇEpidermal and dermal conditions F˜ÑADVERSE EVENT PIMMCSkin and subcutaneous tissue disorders F™5ÑSkin and subcutaneous tissue disorders F™5ÑMILD NNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-01T06:002020-07-13 BB* mRNA-1273-P201AEmRNA-1273-P201-US201-1087US2011087ADOSE 2 - 2020-07-01T16:12AE-001 ANXIETY Anxiety F˜¡§Anxiety F˜¡§Anxiety symptoms F˜¡µAnxiety disorders and symptoms F˜¡ADVERSE EVENT PIMMCPsychiatric disorders F™'·Psychiatric disorders F™'·MILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED NOT RECOVERED/NOT RESOLVED NNNNNN1PART A FOLLOW-UP 2021-01-01 BÕ. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US201-1087US2011087A DOSE 2 - 2020-07-01T16:12AE-002 TROUBLE SLEEPING, DUE TO ANXIETY Difficulty sleeping F˜È„Insomnia F˜î%Disturbances in initiating and maintaining sleep F˜ËFSleep disorders and disturbances F™6ŸADVERSE EVENT PIMMCPsychiatric disorders F™'·Psychiatric disorders F™'·MILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED NOT RECOVERED/NOT RESOLVED NNNNNN1PART A FOLLOW-UP 2021-01-01 BÕ. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US201-1088US2011088ADOSE 2 - 2020-07-07T09:38AE-001 STYE, LEFT EYE Stye F™;Hordeolum F˜æEye and eyelid infections F˜Ô¥Infections - pathogen unspecified F˜ë÷ADVERSE EVENT Infections and infestations F˜ëùInfections and infestations F˜ëùMILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-18 2020-07-25 B-B4 mRNA-1273-P201AEmRNA-1273-P201-US201-1088US2011088A DOSE 2 - 2020-07-07T09:38AE-002 LEFT LACERATED GREAT TOE TENDON Tendon laceration F™³±Tendon injury F™?jMuscle, tendon and ligament injuries F™Injuries NEC F˜ìâADVERSE EVENT PIMMCInjury, poisoning and procedural complications F˜ìåInjury, poisoning and procedural complications F˜ìåMILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED NOT RECOVERED/NOT RESOLVED NNNNNN1PART A FOLLOW-UP 2021-01-15 Bâ. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US201-1089US2011089ADOSE 2 - 2020-07-10T15:02AE-004 MISCARRIAGE (MISSED ABORTION) Missed abortion F™¸Abortion missed F˜—fAbortions not specified as induced or spontaneous F˜—hAbortions and stillbirth F˜—SADVERSE EVENT PIMMCPregnancy, puerperium and perinatal conditions F™%iPregnancy, puerperium and perinatal conditions F™%iMODERATEYNOT APPLICABLE CONCOMITANT PROCEDURE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNY2PART A FOLLOW-UP 2021-02-26 2021-03-10 C°Cp mRNA-1273-P201AEmRNA-1273-P201-US201-1089US2011089A DOSE 1 - 2020-06-05T09:28AE-001 HEADACHE Headache F˜á‹Headache F˜á‹Headaches NEC F˜á¡Headaches F˜áŸADVERSE EVENT Nervous system disorders F™•Nervous system disorders F™•MILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-27 2020-06-30 BB mRNA-1273-P201AEmRNA-1273-P201-US201-1091US2011091ADOSE 2 - 2020-07-02T13:20AE-005 CHILLS Chills F˜·ÓChills F˜·ÓFeelings and sensations NEC F™£General system disorders NEC F˜ÝADVERSE EVENT PIMMCGeneral disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-11-21 2020-11-22 B«B¬ mRNA-1273-P201AEmRNA-1273-P201-US201-1091US2011091A DOSE 2 - 2020-07-02T13:20AE-004 SHORTNESS OF BREATH Shortness of breath F™5Dyspnoea F˜ÍBreathing abnormalities F˜¯>Respiratory disorders NEC F™-¼ADVERSE EVENT PIMMCRespiratory, thoracic and mediastinal disorders F™-ÒRespiratory, thoracic and mediastinal disorders F™-ÒMILD NNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-11-19 2020-11-21 B©B« mRNA-1273-P201AEmRNA-1273-P201-US201-1091US2011091A0DOSE 2 - 2020-07-02T13:20AE-003 FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝADVERSE EVENT PIMMCGeneral disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-11-19 2020-11-23 B©B mRNA-1273-P201AEmRNA-1273-P201-US201-1091US2011091A@DOSE 2 - 2020-07-02T13:20AE-002 HEADACHE Headache F˜á‹Headache F˜á‹Headaches NEC F˜á¡Headaches F˜áŸADVERSE EVENT PIMMCNervous system disorders F™•Nervous system disorders F™•MILD NNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-11-19 2020-11-23 B©B mRNA-1273-P201AEmRNA-1273-P201-US201-1091US2011091APDOSE 2 - 2020-07-02T13:20AE-006 HYPERTENSION Hypertension F˜ç¤Hypertension F˜ç¤Vascular hypertensive disorders NEC F˜ç¦Vascular hypertensive disorders F™uÎADVERSE EVENT PIMMCVascular disorders F™NYVascular disorders F™NYMILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED NOT RECOVERED/NOT RESOLVED NNNNNN1PART A FOLLOW-UP 2020-10-05 B|. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US201-1091US2011091A`DOSE 2 - 2020-07-02T13:20AE-001 NAUSEA Nausea F™ Nausea F™ Nausea and vomiting symptoms F™Gastrointestinal signs and symptoms F˜ÜÜADVERSE EVENT PIMMCGastrointestinal disorders F˜Ü›Gastrointestinal disorders F˜Ü›MILD NNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-11-19 2020-11-21 B©B« mRNA-1273-P201AEmRNA-1273-P201-US201-1092US2011092ADOSE 2 - 2020-07-07T14:48AE-002 BRONCHITIS Bronchitis F˜¯³Bronchitis F˜¯³Lower respiratory tract and lung infections F˜øInfections - pathogen unspecified F˜ë÷ADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-11-20 2020-12-02 B©Bµ mRNA-1273-P201AEmRNA-1273-P201-US201-1092US2011092A DOSE 2 - 2020-07-07T14:48AE-001 GASTRITIS Gastritis F˜Ü=Gastritis F˜Ü=Gastritis (excl infective) F˜Ü>Gastrointestinal inflammatory conditions F˜Ü±ADVERSE EVENT PIMMCGastrointestinal disorders F˜Ü›Gastrointestinal disorders F˜Ü›MILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED NOT RECOVERED/NOT RESOLVED NNNNNN1PART A FOLLOW-UP 2020-11-12 B¡. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US201-1095US2011095ADOSE 1 - 2020-06-05T15:19AE-001 PAIN IN LEFT HIP Pain in hip F™Arthralgia F˜£'Joint related signs and symptoms F˜ñ:Joint disorders F˜ñ-ADVERSE EVENT Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-06-09 2020-06-09 APAP mRNA-1273-P201AEmRNA-1273-P201-US201-1095US2011095A DOSE 1 - 2020-06-05T15:19AE-002 PAIN IN LEFT HIP Pain in hip F™Arthralgia F˜£'Joint related signs and symptoms F˜ñ:Joint disorders F˜ñ-ADVERSE EVENT Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-10 2020-06-10 A`A` mRNA-1273-P201AEmRNA-1273-P201-US201-1095US2011095A0DOSE 2 - 2020-07-06T16:56AE-005 HEARING LOSS, LEFT EAR Hearing loss unilateral F™xuDeafness unilateral F™U,Hearing losses F˜ÄçHearing disorders F˜á«ADVERSE EVENT Ear and labyrinth disorders F˜Í)Ear and labyrinth disorders F˜Í)MILD NNOT APPLICABLE NONE NOT RELATEDNOT RELATED NOT RECOVERED/NOT RESOLVED NNNNNN1PART A FOLLOW-UP 2020-11-17 B¦. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US201-1095US2011095A@DOSE 1 - 2020-06-05T15:19AE-004 RASH, UPPER RT HIP (LIKELY DUE TO POISON IVY CONTACT) Poison ivy rash F™"?Dermatitis contact F˜ÇDermatitis and eczema F˜ÇEpidermal and dermal conditions F˜ÑADVERSE EVENT Skin and subcutaneous tissue disorders F™5ÑSkin and subcutaneous tissue disorders F™5ÑMILD NNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-27 2020-07-12 BB& mRNA-1273-P201AEmRNA-1273-P201-US201-1095US2011095APDOSE 1 - 2020-06-05T15:19AE-003 BRUISE AT INJECTION SITE Injection site bruising F˜ì¤Injection site bruising F˜ì¤Injection site reactions F˜ìÑAdministration site reactions F˜›¤ADVERSE EVENT General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE NOT RELATEDRELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-06 2020-06-20 A B mRNA-1273-P201AEmRNA-1273-P201-US201-1102US2011102ADOSE 2 - 2020-07-06T10:23AE-001 TORN MINISCUS, LEFT KNEE Meniscus tear of knee F™Meniscus injury F™³ŠBone and joint injuries NEC F™¹uBone and joint injuries F˜¶ADVERSE EVENT PIMMCInjury, poisoning and procedural complications F˜ìåInjury, poisoning and procedural complications F˜ìåMODERATENNOT APPLICABLE CONCOMITANT PROCEDURE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2020-09-01 2020-11-30 BVB° mRNA-1273-P201AEmRNA-1273-P201-US201-1102US2011102A DOSE 2 - 2020-07-06T10:23AE-002 POST-OPERATIVE PAIN, TORN LEFT KNEE MENISCUS Postoperative pain F™l7Procedural pain F™“òNon-site specific procedural complications F™ ÷Procedural related injuries and complications NEC F™§€ADVERSE EVENT PIMMCInjury, poisoning and procedural complications F˜ìåInjury, poisoning and procedural complications F˜ìåMILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-11-30 2020-12-07 B°B· mRNA-1273-P201AEmRNA-1273-P201-US201-1116US2011116ADOSE 2 - 2020-07-27T13:10AE-001 LEFT TOENAIL AVULSED Nail avulsion F™ŽNail avulsion F™ŽSkin injuries NEC F™³Injuries NEC F˜ìâADVERSE EVENT Injury, poisoning and procedural complications F˜ìåInjury, poisoning and procedural complications F˜ìåMILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-08-20 2020-09-20 B7BV mRNA-1273-P201AEmRNA-1273-P201-US201-1121US2011121ADOSE 2 - 2020-07-30T15:05AE-004 HEADACHE Headache F˜á‹Headache F˜á‹Headaches NEC F˜á¡Headaches F˜áŸADVERSE EVENT Nervous system disorders F™•Nervous system disorders F™•MODERATENNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-08-13 2020-08-13 B+B+ mRNA-1273-P201AEmRNA-1273-P201-US201-1121US2011121A DOSE 2 - 2020-07-30T15:05AE-005 NAUSEA Nausea F™ Nausea F™ Nausea and vomiting symptoms F™Gastrointestinal signs and symptoms F˜ÜÜADVERSE EVENT Gastrointestinal disorders F˜Ü›Gastrointestinal disorders F˜Ü›MODERATENNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-08-13 2020-08-14 B+B, mRNA-1273-P201AEmRNA-1273-P201-US201-1121US2011121A0DOSE 2 - 2020-07-30T15:05AE-006 VOMITTING Vomiting F™PÔVomiting F™PÔNausea and vomiting symptoms F™Gastrointestinal signs and symptoms F˜ÜÜADVERSE EVENT Gastrointestinal disorders F˜Ü›Gastrointestinal disorders F˜Ü›MODERATENNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-08-13 2020-08-13 B+B+ mRNA-1273-P201AEmRNA-1273-P201-US201-1122US2011122ADOSE 2 - 2020-07-24T08:12AE-001 TINNITUS, BILATERAL Tinnitus F™AêTinnitus F™AêInner ear signs and symptoms F˜íþInner ear and VIIIth cranial nerve disorders F˜íüADVERSE EVENT PIMMCEar and labyrinth disorders F˜Í)Ear and labyrinth disorders F˜Í)MILD NNOT APPLICABLE NONE NOT RELATEDNOT RELATED NOT RECOVERED/NOT RESOLVED NNNNNN1PART A FOLLOW-UP 2021-02-20 Bð. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US201-1123US2011123ADOSE 2 - 2020-07-24T16:13AE-003 JOINT ACHES IN SEVERAL JOINTS Aching joints F˜˜AArthralgia F˜£'Joint related signs and symptoms F˜ñ:Joint disorders F˜ñ-ADVERSE EVENT Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMILD NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-30 2020-07-31 B#B$ mRNA-1273-P201AEmRNA-1273-P201-US201-1123US2011123A DOSE 1 - 2020-06-26T16:56AE-001 LEFT UPPER ARM ECCHYMOSIS, DUE TO INJURY Ecchymosis F˜Í€Ecchymosis F˜Í€Purpura and related conditions F™)3Skin vascular abnormalities F™NCADVERSE EVENT Skin and subcutaneous tissue disorders F™5ÑSkin and subcutaneous tissue disorders F™5ÑMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-03 2020-08-09 A€B- mRNA-1273-P201AEmRNA-1273-P201-US201-1123US2011123A0DOSE 2 - 2020-07-24T16:13AE-002 MUSCLE ACHES ALL OVER BODY Generalized muscle aches F™ŠiMyalgia F™{Muscle pains F™#Muscle disorders F™REACTOGENICITY Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMILD NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-30 2020-07-31 B#B$P1D mRNA-1273-P201AEmRNA-1273-P201-US201-1124US2011124ADOSE 2 - 2020-07-24T09:28AE-001 HERPES SIMPLEX II Herpes simplex type II F˜äyHerpes simplex F˜älHerpes viral infections F˜ä„Viral infectious disorders F™OÎADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-09-17 2020-10-01 BTBb mRNA-1273-P201AEmRNA-1273-P201-US201-1125US2011125ADOSE 1 - 2020-07-02T17:15AE-001 HEMORRHOID Hemorrhoids F˜ãHaemorrhoids F˜àÎHaemorrhoids and gastrointestinal varices (excl oesophageal) F˜ÜíGastrointestinal vascular conditions F˜ÜïADVERSE EVENT Gastrointestinal disorders F˜Ü›Gastrointestinal disorders F˜Ü›MILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-07 2020-07-17 A`B mRNA-1273-P201AEmRNA-1273-P201-US201-1127US2011127ADOSE 2 - 2020-07-24T13:08AE-004 JOINT PAIN Joint pain F˜ñ6Arthralgia F˜£'Joint related signs and symptoms F˜ñ:Joint disorders F˜ñ-ADVERSE EVENT Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMODERATENDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED NOT RECOVERED/NOT RESOLVED NNNNNN2PART A FOLLOW-UP 2021-02 .. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US201-1127US2011127A DOSE 2 - 2020-07-24T13:08AE-003 FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝADVERSE EVENT General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMODERATENNOT APPLICABLE NONE NOT RELATEDNOT RELATED NOT RECOVERED/NOT RESOLVED NNNNNN2PART A FOLLOW-UP 2021-01 .. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US201-1127US2011127A0DOSE 2 - 2020-07-24T13:08AE-002 HEAT EXHAUSTION Heat exhaustion F˜âHeat exhaustion F˜âHeat injuries (excl thermal burns) F˜â Injuries by physical agents F˜ìçADVERSE EVENT Injury, poisoning and procedural complications F˜ìåInjury, poisoning and procedural complications F˜ìåMODERATENDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2020-08-31 2020-11-15 BCB mRNA-1273-P201AEmRNA-1273-P201-US201-1127US2011127A@DOSE 2 - 2020-07-24T13:08AE-001 WORSENING OF IBS Irritable bowel syndrome aggravated F™T;Irritable bowel syndrome F˜ð[Gastrointestinal spastic and hypermotility disorders F˜ÜÖGastrointestinal motility and defaecation conditions F˜Ü¹ADVERSE EVENT Gastrointestinal disorders F˜Ü›Gastrointestinal disorders F˜Ü›MILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-12-07 2021-02-15 B¥Bë mRNA-1273-P201AEmRNA-1273-P201-US201-1131US2011131ADOSE 2 - 2020-07-24T15:05AE-001 HIGH TRIGLYCERIDES Triglycerides high F™cBlood triglycerides increased F˜OTriglyceride analyses F™DñLipid analyses F˜ö„ADVERSE EVENT PIMMCInvestigations F˜ïëInvestigations F˜ïëMILD NNOT APPLICABLE NONE NOT RELATEDNOT RELATED NOT RECOVERED/NOT RESOLVED NNNNNN1PART A FOLLOW-UP 2020-09-10 BM. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US201-1131US2011131A DOSE 2 - 2020-07-24T15:05AE-003 HIRSUTISM (UNWANTED HAIR GROWTH ON FACE) Hirsutism F˜åHirsutism F˜åHypertrichoses F˜çÿSkin appendage conditions F™5ÞADVERSE EVENT PIMMCSkin and subcutaneous tissue disorders F™5ÑSkin and subcutaneous tissue disorders F™5ÑMILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED NOT RECOVERED/NOT RESOLVED NNNNNN1PART A FOLLOW-UP 2020-11-15 B. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US201-1137US2011137ADOSE 1 - 2020-06-26T09:14AE-001 HEADACHE Headache F˜á‹Headache F˜á‹Headaches NEC F˜á¡Headaches F˜áŸADVERSE EVENT Nervous system disorders F™•Nervous system disorders F™•MILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-23 2020-07-23 BB mRNA-1273-P201AEmRNA-1273-P201-US201-1137US2011137A DOSE 1 - 2020-06-26T09:14AE-002 NAUSEA Nausea F™ Nausea F™ Nausea and vomiting symptoms F™Gastrointestinal signs and symptoms F˜ÜÜADVERSE EVENT Gastrointestinal disorders F˜Ü›Gastrointestinal disorders F˜Ü›MILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-23 2020-07-23 BB mRNA-1273-P201AEmRNA-1273-P201-US201-1142US2011142ADOSE 2 - 2020-07-27T15:42AE-005 TOOTH EXTRACTION DENTAL CARIES Tooth caries F™BtDental caries F˜ÆžDental and periodontal infections and inflammations F˜Æ¥Dental and gingival conditions F™BrADVERSE EVENT PIMMCGastrointestinal disorders F˜Ü›Gastrointestinal disorders F˜Ü›MILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2021-01-26 2021-01-26 BÔBÔ mRNA-1273-P201AEmRNA-1273-P201-US201-1149US2011149ADOSE 2 - 2020-07-27T15:17AE-001 FEVER (102.2 F) Fever F˜×.Pyrexia F™)œFebrile disorders F˜ÖBody temperature conditions F˜”REACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝSEVERE NNOT APPLICABLE CONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-28 2020-07-28 BBP1D mRNA-1273-P201AEmRNA-1273-P201-US201-1152US2011152ADOSE 2 - 2020-07-27T12:16AE-002 LEFT UPPER ARM BRUISING @ THE INJECTION SITE Injection site bruising F˜ì¤Injection site bruising F˜ì¤Injection site reactions F˜ìÑAdministration site reactions F˜›¤ADVERSE EVENT General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NNOT APPLICABLE NONE NOT RELATEDRELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-28 2020-09-02 BBB mRNA-1273-P201AEmRNA-1273-P201-US201-1156US2011156ADOSE 2 - 2020-07-28T10:06AE-001 WORSENING OF HIGH CHOLESTEROL High cholesterol F˜äÑBlood cholesterol increased F˜«±Cholesterol analyses F˜¸KLipid analyses F˜ö„ADVERSE EVENT PIMMCInvestigations F˜ïëInvestigations F˜ïëMILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED NOT RECOVERED/NOT RESOLVED NNNNNN1PART A FOLLOW-UP 2020-11-03 B. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US201-1162US2011162ADOSE 2 - 2020-08-03T17:00AE-007 PAIN, RIGHT BREAST Breast pain F˜¯Breast pain F˜¯Breast signs and symptoms F™dŸBreast disorders F˜®ØADVERSE EVENT PIMMCReproductive system and breast disorders F™-LReproductive system and breast disorders F™-LMILD NNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-11-18 2021-01-20 BˆBÇ mRNA-1273-P201AEmRNA-1273-P201-US201-1162US2011162A AE-001 ECCHYMOSIS, LT FOREARM Ecchymosis F˜Í€Ecchymosis F˜Í€Purpura and related conditions F™)3Skin vascular abnormalities F™NCADVERSE EVENT Skin and subcutaneous tissue disorders F™5ÑSkin and subcutaneous tissue disorders F™5ÑMILD NDOSE NOT CHANGEDNONE NOT RELATEDRELATED RECOVERED/RESOLVED NNNNNN1SCREENING 2020-07-06T14:352020-07-14T08:00AA mRNA-1273-P201AEmRNA-1273-P201-US201-1162US2011162A0DOSE 2 - 2020-08-03T17:00AE-004 PULLED MUSCLE, RIGHT PECTORAL Pulled muscle F™vmMuscle strain F™YïMuscle, tendon and ligament injuries F™Injuries NEC F˜ìâADVERSE EVENT PIMMCInjury, poisoning and procedural complications F˜ìåInjury, poisoning and procedural complications F˜ìåMODERATENNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2021-01-20 2021-04-06 BÇC0 mRNA-1273-P201AEmRNA-1273-P201-US201-1162US2011162A@DOSE 2 - 2020-08-03T17:00AE-003 KIDNEY STONES Kidney stones F˜ò Nephrolithiasis F™\Renal lithiasis F™,ÎUrolithiases F™LôADVERSE EVENT PIMMCRenal and urinary disorders F™,WRenal and urinary disorders F™,WSEVERE NDOSE NOT CHANGEDCONCOMITANT MEDICATION, CONCOMITANT PROCEDURENOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN3PART A FOLLOW-UP 2021-01-18 2021-04-14 BÅC° mRNA-1273-P201AEmRNA-1273-P201-US201-1162US2011162APDOSE 1 - 2020-07-06T16:32AE-002 BACK ITCH Localized itching F™{íPruritus F™'_Pruritus NEC F™W Epidermal and dermal conditions F˜ÑADVERSE EVENT Skin and subcutaneous tissue disorders F™5ÑSkin and subcutaneous tissue disorders F™5ÑMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-13 2020-07-22 A€B mRNA-1273-P201AEmRNA-1273-P201-US202-1003US2021003ADOSE 2 - 2020-06-30T08:59AE-001 HEMATURIA Hematuria F˜âzHaematuria F˜à3Urinary abnormalities F˜—DUrinary tract signs and symptoms F™L~ADVERSE EVENT PIMMCRenal and urinary disorders F™,WRenal and urinary disorders F™,WMILD NNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-10-06 2020-10-21 BƒB’ mRNA-1273-P201AEmRNA-1273-P201-US202-1003US2021003A DOSE 2 - 2020-06-30T08:59AE-002 VITAMIN D DEFICIENCY Vitamin D deficiency F™PŠVitamin D deficiency F™PŠFat soluble vitamin deficiencies and disorders F˜ÕúVitamin related disorders F™P“ADVERSE EVENT PIMMCMetabolism and nutrition disorders F™©Metabolism and nutrition disorders F™©MILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED NOT RECOVERED/NOT RESOLVED NNNNNN1PART A FOLLOW-UP 2020-10-21 B’. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US202-1004US2021004ADOSE 2 - 2020-06-26T09:45AE-002 RIGHT FOOT CELLULITIS Cellulitis of foot F˜µgCellulitis F˜µJBacterial infections NEC F˜¦OBacterial infectious disorders F˜¦2ADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-12-26 2021-01-03 BÔBÜ mRNA-1273-P201AEmRNA-1273-P201-US202-1011US2021011ADOSE 1 - 2020-05-29T15:35AE-001 DIVERTICULOSIS Diverticulosis F˜ËmDiverticulum F˜ËrDiverticula F˜ËZDiverticular disorders F˜Ë_ADVERSE EVENT PIMMCGastrointestinal disorders F˜Ü›Gastrointestinal disorders F˜Ü›MILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERING/RESOLVING NNNNNN1BLINDED TREATMENT 2020-06-05 A€. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US202-1011US2021011A DOSE 2 - 2020-06-26T10:49AE-002 GLAUCOMA BILATERAL Glaucoma both eyes F˜ÞGlaucoma F˜ÞGlaucomas (excl congenital) F˜ÞGlaucoma and ocular hypertension F˜ÞADVERSE EVENT PIMMCEye disorders F˜Ô¯Eye disorders F˜Ô¯MODERATENNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED WITH SEQUELAENNNNNN2PART A FOLLOW-UP 2020-11-08 2020-11-08 B¤B¤ mRNA-1273-P201AEmRNA-1273-P201-US202-1012US2021012ADOSE 2 - 2020-06-29T10:18AE-001 OTALGIA Otalgia F™ÈEar pain F˜ÍDEar disorders NEC F™’Aural disorders NEC F™“ADVERSE EVENT Ear and labyrinth disorders F˜Í)Ear and labyrinth disorders F˜Í)MILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-04 2020-07-15 B"B- mRNA-1273-P201AEmRNA-1273-P201-US202-1018US2021018ADOSE 2 - 2020-07-13T14:02AE-003 WORSENING OF BACK PAIN Back pain aggravated F™SœBack pain F˜¦Musculoskeletal and connective tissue pain and discomfort F™£Musculoskeletal and connective tissue disorders NEC F™iADVERSE EVENT PIMMCMusculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-08-04 2020-11-26 BDB¶ mRNA-1273-P201AEmRNA-1273-P201-US202-1018US2021018A DOSE 1 - 2020-05-29T13:35AE-001 PHARYNGITIS Pharyngitis F™“Pharyngitis F™“Upper respiratory tract infections F™KeInfections - pathogen unspecified F˜ë÷ADVERSE EVENT Infections and infestations F˜ëùInfections and infestations F˜ëùMILD NDOSE DELAYED NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-22 2020-06-30 BB! mRNA-1273-P201AEmRNA-1273-P201-US202-1018US2021018A0DOSE 1 - 2020-05-29T13:35AE-002 URINARY TRACT INFECTION Urinary tract infection F™LkUrinary tract infection F™LkUrinary tract infections F™LqInfections - pathogen unspecified F˜ë÷ADVERSE EVENT Infections and infestations F˜ëùInfections and infestations F˜ëùMODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-07-01 2020-07-07 B"B( mRNA-1273-P201AEmRNA-1273-P201-US202-1019US2021019ADOSE 1 - 2020-05-29T15:05AE-002 NEPHROLITHIASIS (RIGHT) Nephrolithiasis F™\Nephrolithiasis F™\Renal lithiasis F™,ÎUrolithiases F™LôADVERSE EVENT PIMMCRenal and urinary disorders F™,WRenal and urinary disorders F™,WMODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION, CONCOMITANT PROCEDURENOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-06-24 2020-07-06 BB' mRNA-1273-P201AEmRNA-1273-P201-US202-1019US2021019A DOSE 1 - 2020-05-29T15:05AE-001 RASH ON RIGHT KNEE NON-URTICARIAL Rash on leg F™ÌuRash F™*TRashes, eruptions and exanthems NEC F™cÖEpidermal and dermal conditions F˜ÑADVERSE EVENT PIMMCSkin and subcutaneous tissue disorders F™5ÑSkin and subcutaneous tissue disorders F™5ÑMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-01 2020-06-06 A@A mRNA-1273-P201AEmRNA-1273-P201-US202-1019US2021019A0DOSE 2 - 2020-07-02T16:34AE-003 ALLERGIC RHINITIS Allergic rhinitis F˜;Rhinitis allergic F™/-Nasal congestion and inflammations F™ÀUpper respiratory tract disorders (excl infections) F™K`ADVERSE EVENT PIMMCRespiratory, thoracic and mediastinal disorders F™-ÒRespiratory, thoracic and mediastinal disorders F™-ÒMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2021-01-22 2021-02-01 BïBù mRNA-1273-P201AEmRNA-1273-P201-US202-1020US2021020ADOSE 1 - 2020-06-01T12:25AE-0011080FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝREACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE RELATED RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-06 2020-06-16 A`BP9D mRNA-1273-P201AEmRNA-1273-P201-US202-1020US2021020A DOSE 1 - 2020-06-01T12:25AE-0021070HEADACHE Headache F˜á‹Headache F˜á‹Headaches NEC F˜á¡Headaches F˜áŸREACTOGENICITY Nervous system disorders F™•Nervous system disorders F™•MILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-06 2020-06-09 A`AP2D mRNA-1273-P201AEmRNA-1273-P201-US202-1021US2021021ADOSE 2 - 2020-06-26T10:04AE-001 PLANAR FACSCITIS Plantar fasciitis F™ÓPlantar fasciitis F™ÓMusculoskeletal and connective tissue infections and inflammations NECF™d¨Musculoskeletal and connective tissue disorders NEC F™iADVERSE EVENT PIMMCMusculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2020-08-25 2020-08-31 BYB_ mRNA-1273-P201AEmRNA-1273-P201-US202-1022US2021022ADOSE 2 - 2020-07-06T11:51AE-001 BROKEN TOOTH Tooth fracture F™ŠÐTooth fracture F™ŠÐAbdominal and gastrointestinal injuries NEC F™ÝInjuries NEC F˜ìâADVERSE EVENT Injury, poisoning and procedural complications F˜ìåInjury, poisoning and procedural complications F˜ìåMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-19 2020-08-16 B1BM mRNA-1273-P201AEmRNA-1273-P201-US202-1031US2021031ADOSE 2 - 2020-06-29T13:57AE-002 ARRHYTHMIA Arrhythmia F˜¢¯Arrhythmia F˜¢¯Rate and rhythm disorders NEC F™*”Cardiac arrhythmias F˜³áADVERSE EVENT PIMMCCardiac disorders F˜³õCardiac disorders F˜³õ YNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNYNN4PART A FOLLOW-UP 2020-07-28 2020-07-30 B:B< mRNA-1273-P201AEmRNA-1273-P201-US202-1031US2021031A DOSE 2 - 2020-06-29T13:57AE-001 STRUCK BY LIGHTNING Struck by lightning F™;Struck by lightning F™;Non-site specific injuries NEC F™ ÇInjuries NEC F˜ìâADVERSE EVENT PIMMCInjury, poisoning and procedural complications F˜ìåInjury, poisoning and procedural complications F˜ìåSEVERE YNOT APPLICABLE CONCOMITANT PROCEDURE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNYNN3PART A FOLLOW-UP 2020-07-28 2020-07-30 B:B< mRNA-1273-P201AEmRNA-1273-P201-US202-1043US2021043ADOSE 1 - 2020-06-01T16:21AE-002 ALLERGIC REACTION WASP BITE Allergic reaction to wasp sting F˜:Allergy to arthropod sting F™z,Allergic conditions NEC F™†Allergic conditions F˜,ADVERSE EVENT PIMMCImmune system disorders F˜ê4Immune system disorders F˜ê4SEVERE NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-06-16 2020-06-16 BB mRNA-1273-P201AEmRNA-1273-P201-US202-1043US2021043A DOSE 1 - 2020-06-01T16:21AE-001 POISON IVY ALLERGIC CONTACT DERMATITIS - BILATERAL LEGS Poison ivy rash F™"?Dermatitis contact F˜ÇDermatitis and eczema F˜ÇEpidermal and dermal conditions F˜ÑADVERSE EVENT Skin and subcutaneous tissue disorders F™5ÑSkin and subcutaneous tissue disorders F™5ÑMODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-06-10 2020-06-17 A B mRNA-1273-P201AEmRNA-1273-P201-US202-1045US2021045ADOSE 2 - 2020-06-29T15:10AE-001 TOOTHACHE Toothache F™B—Toothache F™B—Dental pain and sensation disorders F™B‘Dental and gingival conditions F™BrADVERSE EVENT Gastrointestinal disorders F˜Ü›Gastrointestinal disorders F˜Ü›MODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-07-03 2020-07-11 B!B) mRNA-1273-P201AEmRNA-1273-P201-US202-1058US2021058ADOSE 2 - 2020-07-07T09:22AE-001 JOINT ACHES IN SEVERAL JOINT Aching joints F˜˜AArthralgia F˜£'Joint related signs and symptoms F˜ñ:Joint disorders F˜ñ-REACTOGENICITY Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kSEVERE NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-07T19:002020-07-14T22:22B!B(PT13H mRNA-1273-P201AEmRNA-1273-P201-US202-1058US2021058A DOSE 2 - 2020-07-07T09:22AE-007 CHILLS Chills F˜·ÓChills F˜·ÓFeelings and sensations NEC F™£General system disorders NEC F˜ÝREACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝSEVERE NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-07T21:412020-07-08T22:36B!B"P1DT0H55M mRNA-1273-P201AEmRNA-1273-P201-US202-1058US2021058A0DOSE 2 - 2020-07-07T09:22AE-0042080FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝREACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝSEVERE NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-07T21:412020-07-15T12:00B!B)P1DT2H38M mRNA-1273-P201AEmRNA-1273-P201-US202-1058US2021058A@DOSE 2 - 2020-07-07T09:22AE-0052070HEADACHES Headache F˜á‹Headache F˜á‹Headaches NEC F˜á¡Headaches F˜áŸREACTOGENICITY Nervous system disorders F™•Nervous system disorders F™•MODERATENDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-07-14 2020-07-15 B(B)P2D mRNA-1273-P201AEmRNA-1273-P201-US202-1058US2021058APDOSE 2 - 2020-07-07T09:22AE-006 SWELLING AT PROXIMAL JOINT 2ND DIGIT RIGHT HAND Joint swelling of hand F™[µJoint swelling F˜ñ@Joint related signs and symptoms F˜ñ:Joint disorders F˜ñ-ADVERSE EVENT Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERING/RESOLVING NNNNNN1BLINDED TREATMENT 2020-07-08T20:00 B". ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US202-1058US2021058A`DOSE 2 - 2020-07-07T09:22AE-002 GENERALIZED BODY ACHES General body pain F™UËPain F™ÛPain and discomfort NEC F™ÜGeneral system disorders NEC F˜ÝREACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝSEVERE NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-07T19:002020-07-14T22:22B!B(PT13H mRNA-1273-P201AEmRNA-1273-P201-US202-1058US2021058ApDOSE 2 - 2020-07-07T09:22AE-003 FEVER Fever F˜×.Pyrexia F™)œFebrile disorders F˜ÖBody temperature conditions F˜”REACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝSEVERE NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-07T19:002020-07-08T10:00B!B"PT15H mRNA-1273-P201AEmRNA-1273-P201-US202-1058US2021058A€DOSE 2 - 2020-07-07T09:22AE-008 BROKEN TOOTH RIGHT MOLAR Tooth fracture F™ŠÐTooth fracture F™ŠÐAbdominal and gastrointestinal injuries NEC F™ÝInjuries NEC F˜ìâADVERSE EVENT PIMMCInjury, poisoning and procedural complications F˜ìåInjury, poisoning and procedural complications F˜ìåMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED NOT RECOVERED/NOT RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-22 B0. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US202-1062US2021062ADOSE 1 - 2020-06-04T11:13AE-003 HEADACHE Headache F˜á‹Headache F˜á‹Headaches NEC F˜á¡Headaches F˜áŸADVERSE EVENT Nervous system disorders F™•Nervous system disorders F™•MODERATENDOSE DELAYED NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-06-25 2020-06-28 BB mRNA-1273-P201AEmRNA-1273-P201-US202-1062US2021062A DOSE 1 - 2020-06-04T11:13AE-005 LETHARGY Lethargy F˜õHLethargy F˜õHDisturbances in consciousness NEC F˜ËENeurological disorders NEC F™ùADVERSE EVENT Nervous system disorders F™•Nervous system disorders F™•MODERATENDOSE DELAYED NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-06-25 2020-06-28 BB mRNA-1273-P201AEmRNA-1273-P201-US202-1062US2021062A0DOSE 1 - 2020-06-04T11:13AE-001 MUSCLE STRAIN LEFT HAMSTRING Pulled hamstring F™(9Muscle strain F™YïMuscle, tendon and ligament injuries F™Injuries NEC F˜ìâADVERSE EVENT Injury, poisoning and procedural complications F˜ìåInjury, poisoning and procedural complications F˜ìåMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-09 2020-06-16 A`AÐ mRNA-1273-P201AEmRNA-1273-P201-US202-1062US2021062A@DOSE 1 - 2020-06-04T11:13AE-004 MYALGIA GENERALIZED Myalgia F™{Myalgia F™{Muscle pains F™#Muscle disorders F™ADVERSE EVENT Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMODERATENDOSE DELAYED NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-06-25 2020-06-28 BB mRNA-1273-P201AEmRNA-1273-P201-US202-1062US2021062APDOSE 1 - 2020-06-04T11:13AE-002 SINUS CONGESTION Sinus congestion F™5¦Sinus congestion F™5¦Paranasal sinus disorders (excl infections and neoplasms) F™5§Upper respiratory tract disorders (excl infections) F™K`ADVERSE EVENT Respiratory, thoracic and mediastinal disorders F™-ÒRespiratory, thoracic and mediastinal disorders F™-ÒMODERATENDOSE DELAYED CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-06-25 2020-06-28 BB mRNA-1273-P201AEmRNA-1273-P201-US202-1063US2021063ADOSE 2 - 2020-07-07T08:56AE-003 ACUTE SINUSITIS Acute sinusitis F˜š´Acute sinusitis F˜š´Upper respiratory tract infections F™KeInfections - pathogen unspecified F˜ë÷ADVERSE EVENT Infections and infestations F˜ëùInfections and infestations F˜ëùMODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2021-01-26 2021-02-02 BíBô mRNA-1273-P201AEmRNA-1273-P201-US202-1063US2021063A DOSE 2 - 2020-07-07T08:56AE-001 FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝREACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝSEVERE NDOSE NOT CHANGEDNONE RELATED RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-08T18:442020-07-13T20:25B#B(P5DT1H41M mRNA-1273-P201AEmRNA-1273-P201-US202-1063US2021063A0DOSE 2 - 2020-07-07T08:56AE-002 MUSCLE ACHES ALL OVER BODY Generalized muscle aches F™ŠiMyalgia F™{Muscle pains F™#Muscle disorders F™REACTOGENICITY Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kSEVERE NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-08T18:442020-07-13T20:25B#B(P5DT1H41M mRNA-1273-P201AEmRNA-1273-P201-US202-1064US2021064ADOSE 1 - 2020-06-08T08:48AE-003 CHEST PRESSURE Chest pressure F˜·¦Chest discomfort F˜·•Pain and discomfort NEC F™ÜGeneral system disorders NEC F˜ÝADVERSE EVENT General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-06 2020-07-06 BB mRNA-1273-P201AEmRNA-1273-P201-US202-1064US2021064A DOSE 1 - 2020-06-08T08:48AE-001 DIARRHEA Diarrhea F˜È7Diarrhoea F˜È?Diarrhoea (excl infective) F˜È@Gastrointestinal motility and defaecation conditions F˜Ü¹ADVERSE EVENT Gastrointestinal disorders F˜Ü›Gastrointestinal disorders F˜Ü›MILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-06 2020-07-06 BB mRNA-1273-P201AEmRNA-1273-P201-US202-1064US2021064A0DOSE 1 - 2020-06-08T08:48AE-004 HEADACHE Headache F˜á‹Headache F˜á‹Headaches NEC F˜á¡Headaches F˜áŸADVERSE EVENT Nervous system disorders F™•Nervous system disorders F™•MILD NDOSE DELAYED NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-06 2020-07-06 BB mRNA-1273-P201AEmRNA-1273-P201-US202-1064US2021064A@DOSE 1 - 2020-06-08T08:48AE-002 ITCHY NOSE Nasal itching F™ÇNasal pruritus F™ÀöNasal disorders NEC F™»Upper respiratory tract disorders (excl infections) F™K`ADVERSE EVENT Respiratory, thoracic and mediastinal disorders F™-ÒRespiratory, thoracic and mediastinal disorders F™-ÒMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-06 2020-07-08 BB mRNA-1273-P201AEmRNA-1273-P201-US202-1073US2021073ADOSE 2 - 2020-06-30T09:24AE-003 COVID-19 INFECTION COVID-19 F™ß¬COVID-19 F™ß¬Coronavirus infections F™àžViral infectious disorders F™OÎADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-12-05 2020-12-20 B»BÊ mRNA-1273-P201AEmRNA-1273-P201-US202-1073US2021073A DOSE 1 - 2020-06-02T12:11AE-002 LESION ON GUM (UNKNOWN ) BENGIN Oral lesion F™}Oral disorder F™ž¥Oral soft tissue disorders NEC F™§Oral soft tissue conditions F™¥ADVERSE EVENT PIMMCGastrointestinal disorders F˜Ü›Gastrointestinal disorders F˜Ü›MILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION, CONCOMITANT PROCEDURENOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-25 2020-07-20 BB1 mRNA-1273-P201AEmRNA-1273-P201-US202-1074US2021074ADOSE 2 - 2020-07-07T14:25AE-003 FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝREACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝSEVERE NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-08T20:022020-07-09T19:00B%B&PT22H58M mRNA-1273-P201AEmRNA-1273-P201-US202-1074US2021074A DOSE 1 - 2020-06-02T09:14AE-002 PAIN AT INJECTION SITE Pain injection site F™-Injection site pain F˜ìÆInjection site reactions F˜ìÑAdministration site reactions F˜›¤ADVERSE EVENT General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE RELATED RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-02T18:002020-06-17T08:00AB mRNA-1273-P201AEmRNA-1273-P201-US202-1080US2021080ADOSE 2 - 2020-07-08T09:28AE-006 GASTROINTESTINAL DISTRESS (NOS) Distress gastrointestinal F˜Ë3Abdominal discomfort F˜–»Gastrointestinal signs and symptoms NEC F™žGastrointestinal signs and symptoms F˜ÜÜADVERSE EVENT PIMMCGastrointestinal disorders F˜Ü›Gastrointestinal disorders F˜Ü›MILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2021-02-09 2021-03-09 BúC` mRNA-1273-P201AEmRNA-1273-P201-US202-1080US2021080A DOSE 2 - 2020-07-08T09:28AE-004 JOINT ACHES ALL OVER BODY Generalized joint pain F™ŠfArthralgia F˜£'Joint related signs and symptoms F˜ñ:Joint disorders F˜ñ-REACTOGENICITY Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kSEVERE NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-09T22:122020-07-13T00:13B#B'P3DT2H1M mRNA-1273-P201AEmRNA-1273-P201-US202-1080US2021080A0DOSE 2 - 2020-07-08T09:28AE-005 DRY MOUTH Dry mouth F˜ÌUDry mouth F˜ÌUOral dryness and saliva altered F™Salivary gland conditions F™0lADVERSE EVENT Gastrointestinal disorders F˜Ü›Gastrointestinal disorders F˜Ü›MILD NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-09T08:002020-07-13T00:13B#B' mRNA-1273-P201AEmRNA-1273-P201-US202-1080US2021080A@DOSE 1 - 2020-06-05T15:06AE-0011080FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝREACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-05T21:352020-06-18T08:32AAàP5DT17H26M mRNA-1273-P201AEmRNA-1273-P201-US202-1080US2021080APDOSE 2 - 2020-07-08T09:28AE-002 FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝREACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝSEVERE NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-09T22:122020-07-10T00:13B#B$PT2H1M mRNA-1273-P201AEmRNA-1273-P201-US202-1080US2021080A`DOSE 2 - 2020-07-08T09:28AE-003 MUSCLE ACHES ALL OVER BODY Generalized muscle aches F™ŠiMyalgia F™{Muscle pains F™#Muscle disorders F™REACTOGENICITY Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kSEVERE NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-09T22:122020-07-13T00:23B#B'P3DT2H11M mRNA-1273-P201AEmRNA-1273-P201-US202-1082US2021082ADOSE 2 - 2020-07-07T11:02AE-007 LOW TESTOSTERONE Testosterone low F™?ëBlood testosterone decreased F˜6Reproductive hormone analyses F™-=Endocrine investigations (incl sex hormones) F˜ÏòADVERSE EVENT PIMMCInvestigations F˜ïëInvestigations F˜ïëMODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED NOT RECOVERED/NOT RESOLVED NNNNNN2PART A FOLLOW-UP 2020-10-15 B‡. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US202-1082US2021082A DOSE 2 - 2020-07-07T11:02AE-001 COVID-19 INFECTION COVID-19 F™ß¬COVID-19 F™ß¬Coronavirus infections F™àžViral infectious disorders F™OÎADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2020-09-10 2020-10-08 BdB€ mRNA-1273-P201AEmRNA-1273-P201-US202-1082US2021082A0DOSE 2 - 2020-07-07T11:02AE-003 FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝADVERSE EVENT PIMMCGeneral disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMODERATENDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2020-09-06 2020-09-11 B`Be mRNA-1273-P201AEmRNA-1273-P201-US202-1082US2021082A@DOSE 2 - 2020-07-07T11:02AE-009 HYPERESTROGENISM Hyperestrogenism F˜çHyperoestrogenism F˜çQEndocrine abnormalities of gonadal function NEC F˜ÏãEndocrine disorders of gonadal function F˜ÏíADVERSE EVENT PIMMCEndocrine disorders F˜ÏêEndocrine disorders F˜ÏêMODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED NOT RECOVERED/NOT RESOLVED NNNNNN2PART A FOLLOW-UP 2020-12-14 BÃ. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US202-1082US2021082APDOSE 2 - 2020-07-07T11:02AE-008 LOW VITAMIN D Vitamin D low F™ÇŸVitamin D decreased F™‰mVitamin analyses F™PnMetabolic, nutritional and blood gas investigations F™¨ADVERSE EVENT PIMMCInvestigations F˜ïëInvestigations F˜ïëMODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED NOT RECOVERED/NOT RESOLVED NNNNNN2PART A FOLLOW-UP 2020-10-17 B‰. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US202-1084US2021084ADOSE 2 - 2020-07-07T10:31AE-002 RASH RIGHT ELBOW Localized rash F™‹qRash F™*TRashes, eruptions and exanthems NEC F™cÖEpidermal and dermal conditions F˜ÑADVERSE EVENT Skin and subcutaneous tissue disorders F™5ÑSkin and subcutaneous tissue disorders F™5ÑMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-08T08:002020-07-13T08:00B"B' mRNA-1273-P201AEmRNA-1273-P201-US202-1090US2021090ADOSE 2 - 2020-07-06T09:21AE-002 WORSENING OF TENSION HEADACHE Tension headache F™?…Tension headache F™?…Headaches NEC F˜á¡Headaches F˜áŸADVERSE EVENT PIMMCNervous system disorders F™•Nervous system disorders F™•MODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2021-01-19 2021-01-20 BèBé mRNA-1273-P201AEmRNA-1273-P201-US202-1093US2021093ADOSE 2 - 2020-07-06T09:52AE-001 FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝREACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝSEVERE NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-07T13:552020-07-08T13:56B#B$P1DT0H1M mRNA-1273-P201AEmRNA-1273-P201-US202-1093US2021093A DOSE 2 - 2020-07-06T09:52AE-002 MUSCLE ACHES ALL OVER BODY Generalized muscle aches F™ŠiMyalgia F™{Muscle pains F™#Muscle disorders F™REACTOGENICITY Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kSEVERE NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-07T13:552020-07-08T13:56B#B$P1DT0H1M mRNA-1273-P201AEmRNA-1273-P201-US202-1094US2021094ADOSE 1 - 2020-06-05T15:26AE-001 COUGH Cough F˜ÂXCough F˜ÂXCoughing and associated symptoms F˜ÂaRespiratory disorders NEC F™-¼ADVERSE EVENT Respiratory, thoracic and mediastinal disorders F™-ÒRespiratory, thoracic and mediastinal disorders F™-ÒMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-26 2020-08-08 BBA mRNA-1273-P201AEmRNA-1273-P201-US202-1094US2021094A DOSE 1 - 2020-06-05T15:26AE-003 COVID-19 INFECTION (POSITIVE) COVID-19 F™ß¬COVID-19 F™ß¬Coronavirus infections F™àžViral infectious disorders F™OÎADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMODERATENDRUG WITHDRAWN NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-07-06 2020-07-23 B B1 mRNA-1273-P201AEmRNA-1273-P201-US202-1094US2021094A0DOSE 1 - 2020-06-05T15:26AE-002 SINUS HEADACHE Sinus headache F™5¨Sinus headache F™5¨Headaches NEC F˜á¡Headaches F˜áŸADVERSE EVENT Nervous system disorders F™•Nervous system disorders F™•MILD NDOSE DELAYED CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-29 2020-07-01 BB mRNA-1273-P201AEmRNA-1273-P201-US202-1096US2021096ADOSE 2 - 2020-07-02T13:53AE-0022080FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝREACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝSEVERE NDOSE NOT CHANGEDNONE RELATED RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-08 2020-07-10 B$B&P2D mRNA-1273-P201AEmRNA-1273-P201-US202-1099US2021099ADOSE 2 - 2020-06-30T14:17AE-001 LUMP RIGHT AXILLARY REGION IPSILATERAL-SAME SIDE OF VACCINATION SITE Axillary lump F™YAxillary mass F™UýSoft tissue disorders NEC F™7ÈMusculoskeletal and connective tissue disorders NEC F™iADVERSE EVENT Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMILD NDOSE NOT CHANGEDNONE RELATED RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-17 2020-07-17 B.B. mRNA-1273-P201AEmRNA-1273-P201-US202-1101US2021101ADOSE 1 - 2020-06-08T12:33AE-002 PAIN AT INJECTION SITE Pain injection site F™-Injection site pain F˜ìÆInjection site reactions F˜ìÑAdministration site reactions F˜›¤ADVERSE EVENT General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-20 2020-06-20 AÐAÐ mRNA-1273-P201AEmRNA-1273-P201-US202-1107US2021107ADOSE 2 - 2020-07-02T09:24AE-001 HEADACHE Headache F˜á‹Headache F˜á‹Headaches NEC F˜á¡Headaches F˜áŸADVERSE EVENT Nervous system disorders F™•Nervous system disorders F™•MILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-09-02 2020-09-05 B\B_ mRNA-1273-P201AEmRNA-1273-P201-US202-1107US2021107A DOSE 2 - 2020-07-02T09:24AE-002 NASAL CONGESTION Nasal congestion F™¿Nasal congestion F™¿Nasal congestion and inflammations F™ÀUpper respiratory tract disorders (excl infections) F™K`ADVERSE EVENT Respiratory, thoracic and mediastinal disorders F™-ÒRespiratory, thoracic and mediastinal disorders F™-ÒMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-09-02 2020-09-05 B\B_ mRNA-1273-P201AEmRNA-1273-P201-US202-1111US2021111ADOSE 2 - 2020-07-21T10:48AE-009 BURSITIS LEFT SHOULDER Shoulder bursitis F™5#Bursitis F˜±Bursal disorders F˜ÊqSynovial and bursal disorders F˜Ê±ADVERSE EVENT PIMMCMusculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2021-02-01 2021-02-08 BïBö mRNA-1273-P201AEmRNA-1273-P201-US202-1111US2021111A DOSE 1 - 2020-06-08T09:23AE-002 COUGH Cough F˜ÂXCough F˜ÂXCoughing and associated symptoms F˜ÂaRespiratory disorders NEC F™-¼ADVERSE EVENT Respiratory, thoracic and mediastinal disorders F™-ÒRespiratory, thoracic and mediastinal disorders F™-ÒMODERATENDOSE DELAYED CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-07-12 2020-07-16 B#B' mRNA-1273-P201AEmRNA-1273-P201-US202-1111US2021111A0DOSE 1 - 2020-06-08T09:23AE-004 DIARRHEA Diarrhea F˜È7Diarrhoea F˜È?Diarrhoea (excl infective) F˜È@Gastrointestinal motility and defaecation conditions F˜Ü¹ADVERSE EVENT Gastrointestinal disorders F˜Ü›Gastrointestinal disorders F˜Ü›MILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-13 2020-07-19 B$B* mRNA-1273-P201AEmRNA-1273-P201-US202-1111US2021111A@DOSE 1 - 2020-06-08T09:23AE-008 FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝADVERSE EVENT PIMMCGeneral disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMODERATENDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-07-10 2020-07-17 B!B( mRNA-1273-P201AEmRNA-1273-P201-US202-1111US2021111APDOSE 1 - 2020-06-08T09:23AE-003 HEADACHE Headache F˜á‹Headache F˜á‹Headaches NEC F˜á¡Headaches F˜áŸADVERSE EVENT Nervous system disorders F™•Nervous system disorders F™•MODERATENDOSE DELAYED CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-07-12 2020-07-18 B#B) mRNA-1273-P201AEmRNA-1273-P201-US202-1111US2021111A`DOSE 1 - 2020-06-08T09:23AE-001 SORE THROAT Sore throat F™8Oropharyngeal pain F™¡_Upper respiratory tract signs and symptoms F™KiRespiratory tract signs and symptoms F™Ë}ADVERSE EVENT Respiratory, thoracic and mediastinal disorders F™-ÒRespiratory, thoracic and mediastinal disorders F™-ÒMODERATENDOSE DELAYED NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-07-12 2020-07-14 B#B% mRNA-1273-P201AEmRNA-1273-P201-US202-1111US2021111ApDOSE 2 - 2020-07-21T10:48AE-005 COVID 19 LIKE ILLNESS Suspected COVID-19 F™àcSuspected COVID-19 F™àcCoronavirus infections F™àžViral infectious disorders F™OÎADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2021-01-20 2021-01-25 BãBè mRNA-1273-P201AEmRNA-1273-P201-US202-1115US2021115ADOSE 2 - 2020-07-31T11:50AE-002 ACUTE SINUSITIS Acute sinusitis F˜š´Acute sinusitis F˜š´Upper respiratory tract infections F™KeInfections - pathogen unspecified F˜ë÷ADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2021-02-14 2021-02-28 BêBø mRNA-1273-P201AEmRNA-1273-P201-US202-1115US2021115A DOSE 2 - 2020-07-31T11:50AE-001 RIGHT OTITIS MEDIA Otitis media F™¶Otitis media F™¶Ear infections F˜Í=Infections - pathogen unspecified F˜ë÷ADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2021-02-14 2021-02-18 BêBî mRNA-1273-P201AEmRNA-1273-P201-US202-1130US2021130ADOSE 1 - 2020-06-26T10:15AE-002 POST DOSE ELEVATED BLOOD PRESSURE Blood pressure increased F˜¬öBlood pressure increased F˜¬öVascular tests NEC (incl blood pressure) F™N†Cardiac and vascular investigations (excl enzyme tests) F˜³ØADVERSE EVENT Investigations F˜ïëInvestigations F˜ïëSEVERE NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-06-26T12:102020-07-06T12:10AA° mRNA-1273-P201AEmRNA-1273-P201-US202-1130US2021130A DOSE 2 - 2020-07-29T11:35AE-003 RASH RIGHT WRIST Localized rash F™‹qRash F™*TRashes, eruptions and exanthems NEC F™cÖEpidermal and dermal conditions F˜ÑADVERSE EVENT Skin and subcutaneous tissue disorders F™5ÑSkin and subcutaneous tissue disorders F™5ÑMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-08-25 2020-08-27 B=B? mRNA-1273-P201AEmRNA-1273-P201-US202-1130US2021130A0DOSE 2 - 2020-07-29T11:35AE-004 RHINORRHEA Rhinorrhea F™/<Rhinorrhoea F™/=Upper respiratory tract signs and symptoms F™KiRespiratory tract signs and symptoms F™Ë}ADVERSE EVENT Respiratory, thoracic and mediastinal disorders F™-ÒRespiratory, thoracic and mediastinal disorders F™-ÒMILD NNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-11-11 2020-11-11 B‹B‹ mRNA-1273-P201AEmRNA-1273-P201-US202-1137US2021137ADOSE 1 - 2020-06-08T16:13AE-001 COVID-19 INFECTION (POSITIVE) COVID-19 F™ß¬COVID-19 F™ß¬Coronavirus infections F™àžViral infectious disorders F™OÎADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-07T15:392020-07-15T14:00BB& mRNA-1273-P201AEmRNA-1273-P201-US202-1138US2021138ADOSE 2 - 2020-07-06T09:32AE-001 COVID 19 LIKE ILLNESS Suspected COVID-19 F™àcSuspected COVID-19 F™àcCoronavirus infections F™àžViral infectious disorders F™OÎADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2021-02-06 2021-02-17 BøC0 mRNA-1273-P201AEmRNA-1273-P201-US202-1144US2021144ADOSE 1 - 2020-06-05T11:22AE-0021100JOINT ACHES ALL OVER BODY Generalized joint pain F™ŠfArthralgia F˜£'Joint related signs and symptoms F˜ñ:Joint disorders F˜ñ-REACTOGENICITY Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMILD NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-06T20:122020-06-14T07:12A A P1DT19H50M mRNA-1273-P201AEmRNA-1273-P201-US202-1144US2021144A DOSE 1 - 2020-06-05T11:22AE-0011080FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝREACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-06T20:122020-06-14T07:48A A P1DT20H26M mRNA-1273-P201AEmRNA-1273-P201-US202-1144US2021144A0DOSE 1 - 2020-06-05T11:22AE-0031090MUSCLE ACHES ALL OVER BODY Generalized muscle aches F™ŠiMyalgia F™{Muscle pains F™#Muscle disorders F™REACTOGENICITY Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMILD NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-09 2020-06-14 APA P3D mRNA-1273-P201AEmRNA-1273-P201-US202-1151US2021151ADOSE 2 - 2020-07-09T14:47AE-004 JOINT ACHES ALL OVER BODY Generalized joint pain F™ŠfArthralgia F˜£'Joint related signs and symptoms F˜ñ:Joint disorders F˜ñ-REACTOGENICITY Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kSEVERE NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-10T03:152020-07-10T08:00B!B!PT4H45M mRNA-1273-P201AEmRNA-1273-P201-US202-1151US2021151A DOSE 2 - 2020-07-09T14:47AE-008 CHILLS Chills F˜·ÓChills F˜·ÓFeelings and sensations NEC F™£General system disorders NEC F˜ÝADVERSE EVENT PIMMCGeneral disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMODERATENNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2020-10-17 2020-10-19 B„B† mRNA-1273-P201AEmRNA-1273-P201-US202-1151US2021151A0DOSE 2 - 2020-07-09T14:47AE-011 DIARRHEA Diarrhea F˜È7Diarrhoea F˜È?Diarrhoea (excl infective) F˜È@Gastrointestinal motility and defaecation conditions F˜Ü¹ADVERSE EVENT PIMMCGastrointestinal disorders F˜Ü›Gastrointestinal disorders F˜Ü›MODERATENDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2020-10-18 2020-10-23 B…BŠ mRNA-1273-P201AEmRNA-1273-P201-US202-1151US2021151A@DOSE 2 - 2020-07-09T14:47AE-005 HEADACHE Headache F˜á‹Headache F˜á‹Headaches NEC F˜á¡Headaches F˜áŸREACTOGENICITY Nervous system disorders F™•Nervous system disorders F™•SEVERE NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-10T03:152020-07-13T07:36B!B$P3DT4H21M mRNA-1273-P201AEmRNA-1273-P201-US202-1151US2021151APDOSE 1 - 2020-06-08T16:40AE-001 LEFT POSTERIOR HEAD LUMP Mass F˜ÿqMass F˜ÿqMass conditions NEC F™u×Tissue disorders NEC F˜µ;ADVERSE EVENT General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-05 2020-07-08 BB mRNA-1273-P201AEmRNA-1273-P201-US202-1151US2021151A`DOSE 2 - 2020-07-09T14:47AE-006 MIGRAINE Migraine F™OMigraine F™OMigraine headaches F™SHeadaches F˜áŸADVERSE EVENT PIMMCNervous system disorders F™•Nervous system disorders F™•MODERATENNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2020-10-17 2020-10-19 B„B† mRNA-1273-P201AEmRNA-1273-P201-US202-1151US2021151ApDOSE 2 - 2020-07-09T14:47AE-007 NAUSEA Nausea F™ Nausea F™ Nausea and vomiting symptoms F™Gastrointestinal signs and symptoms F˜ÜÜADVERSE EVENT PIMMCGastrointestinal disorders F˜Ü›Gastrointestinal disorders F˜Ü›MODERATENNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2020-10-17 2020-10-19 B„B† mRNA-1273-P201AEmRNA-1273-P201-US202-1151US2021151A€DOSE 2 - 2020-07-09T14:47AE-010 NECK PAIN Neck pain F™$Neck pain F™$Musculoskeletal and connective tissue pain and discomfort F™£Musculoskeletal and connective tissue disorders NEC F™iADVERSE EVENT PIMMCMusculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMILD NNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-10-17 2020-10-19 B„B† mRNA-1273-P201AEmRNA-1273-P201-US202-1151US2021151ADOSE 2 - 2020-07-09T14:47AE-003 FEVER Fever F˜×.Pyrexia F™)œFebrile disorders F˜ÖBody temperature conditions F˜”REACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝSEVERE NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-10T03:152020-07-10T08:00B!B!PT4H45M mRNA-1273-P201AEmRNA-1273-P201-US202-1151US2021151A DOSE 2 - 2020-07-09T14:47AE-009 FEVER Fever F˜×.Pyrexia F™)œFebrile disorders F˜ÖBody temperature conditions F˜”ADVERSE EVENT PIMMCGeneral disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMODERATENNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2020-10-18 2020-10-20 B…B‡ mRNA-1273-P201AEmRNA-1273-P201-US202-1151US2021151A°DOSE 2 - 2020-07-09T14:47AE-002 RUNNY NOSE Runny nose F™0Rhinorrhoea F™/=Upper respiratory tract signs and symptoms F™KiRespiratory tract signs and symptoms F™Ë}ADVERSE EVENT Respiratory, thoracic and mediastinal disorders F™-ÒRespiratory, thoracic and mediastinal disorders F™-ÒSEVERE NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-10T03:152020-07-10T08:00B!B! mRNA-1273-P201AEmRNA-1273-P201-US202-1151US2021151AÀDOSE 2 - 2020-07-09T14:47AE-012 VOMITING Vomiting F™PÔVomiting F™PÔNausea and vomiting symptoms F™Gastrointestinal signs and symptoms F˜ÜÜADVERSE EVENT PIMMCGastrointestinal disorders F˜Ü›Gastrointestinal disorders F˜Ü›MODERATENNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2020-10-17 2020-10-19 B„B† mRNA-1273-P201AEmRNA-1273-P201-US202-1154US2021154ADOSE 1 - 2020-06-05T14:21AE-001 BUG BITE ( BOTH ARMS) Bug bite F˜°Arthropod bite F˜£ÇNon-site specific injuries NEC F™ ÇInjuries NEC F˜ìâADVERSE EVENT Injury, poisoning and procedural complications F˜ìåInjury, poisoning and procedural complications F˜ìåMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-24 2020-06-28 BB mRNA-1273-P201AEmRNA-1273-P201-US202-1154US2021154A DOSE 2 - 2020-07-08T14:50AE-003 CONTACT DERMATITIS RIGHT HAND Contact dermatitis F˜À¦Dermatitis contact F˜ÇDermatitis and eczema F˜ÇEpidermal and dermal conditions F˜ÑADVERSE EVENT PIMMCSkin and subcutaneous tissue disorders F™5ÑSkin and subcutaneous tissue disorders F™5ÑMODERATENNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2020-12-15 2020-12-21 BÂBÈ mRNA-1273-P201AEmRNA-1273-P201-US202-1154US2021154A0DOSE 2 - 2020-07-08T14:50AE-0022070HEADACHE Headache F˜á‹Headache F˜á‹Headaches NEC F˜á¡Headaches F˜áŸREACTOGENICITY Nervous system disorders F™•Nervous system disorders F™•SEVERE NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-08T20:562020-07-16T12:00B"B*PT21H10M mRNA-1273-P201AEmRNA-1273-P201-US202-1155US2021155ADOSE 2 - 2020-07-13T15:40AE-005 COVID-19 INFECTION COVID-19 F™ß¬COVID-19 F™ß¬Coronavirus infections F™àžViral infectious disorders F™OÎADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMODERATENNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2020-08-17 2020-09-23 BGBl mRNA-1273-P201AEmRNA-1273-P201-US202-1164US2021164ADOSE 1 - 2020-06-08T09:13AE-002 WORSENING OF ACNE AROUND MOUTH Acne aggravated F˜˜rAcne F˜˜pAcnes F˜˜qSkin appendage conditions F™5ÞADVERSE EVENT Skin and subcutaneous tissue disorders F™5ÑSkin and subcutaneous tissue disorders F™5ÑMODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-06-10 2020-07-01 A0B mRNA-1273-P201AEmRNA-1273-P201-US202-1164US2021164A DOSE 1 - 2020-06-08T09:13AE-001 UNDERARM TENDERNESS Axillary pain F™TîAxillary pain F™TîPain and discomfort NEC F™ÜGeneral system disorders NEC F˜ÝREACTOGENICITYPIMMCGeneral disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-14 2020-06-18 ApA°P4D mRNA-1273-P201AEmRNA-1273-P201-US202-1166US2021166ADOSE 2 - 2020-07-07T11:54AE-004 WORSENING OF ANXIETY Anxiety aggravated F™SSAnxiety F˜¡§Anxiety symptoms F˜¡µAnxiety disorders and symptoms F˜¡ADVERSE EVENT PIMMCPsychiatric disorders F™'·Psychiatric disorders F™'·MODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2021-01-20 2021-02-10 BæBû mRNA-1273-P201AEmRNA-1273-P201-US202-1166US2021166A DOSE 2 - 2020-07-07T11:54AE-006 RIGHT BREAST INJURY Breast injury F™~Breast injury F™~Reproductive system and breast injuries F™uéInjuries NEC F˜ìâADVERSE EVENT PIMMCInjury, poisoning and procedural complications F˜ìåInjury, poisoning and procedural complications F˜ìåSEVERE NDOSE NOT CHANGEDCONCOMITANT PROCEDURE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN3PART A FOLLOW-UP 2020-11-29 2020-12-08 B²B» mRNA-1273-P201AEmRNA-1273-P201-US202-1166US2021166A0DOSE 2 - 2020-07-07T11:54AE-005 WORSENING OF INSOMNIA Insomnia exacerbated F˜î(Insomnia F˜î%Disturbances in initiating and maintaining sleep F˜ËFSleep disorders and disturbances F™6ŸADVERSE EVENT PIMMCPsychiatric disorders F™'·Psychiatric disorders F™'·MODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2021-01-20 2021-02-10 BæBû mRNA-1273-P201AEmRNA-1273-P201-US202-1166US2021166A@DOSE 2 - 2020-07-07T11:54AE-003 WORSENING OF MAJOR DEPRESSIVE DISORDER Major depressive disorder aggravated F™ž Major depression F™xpDepressive disorders F˜ÆñDepressed mood disorders and disturbances F˜Æ×ADVERSE EVENT PIMMCPsychiatric disorders F™'·Psychiatric disorders F™'·MODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2021-01-20 2021-02-10 BæBû mRNA-1273-P201AEmRNA-1273-P201-US202-1166US2021166APDOSE 1 - 2020-06-05T13:06AE-001 MUSCLE SPASM (BACK) Back muscle spasms F™ŸµMuscle spasms F™.Muscle related signs and symptoms NEC F™&Muscle disorders F™ADVERSE EVENT Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kSEVERE NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-06-22 2020-06-26 BB mRNA-1273-P201AEmRNA-1273-P201-US202-1166US2021166A`DOSE 2 - 2020-07-07T11:54AE-002 TENSION HEADACHE Tension headache F™?…Tension headache F™?…Headaches NEC F˜á¡Headaches F˜áŸADVERSE EVENT Nervous system disorders F™•Nervous system disorders F™•MILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-31 2020-08-02 B9B; mRNA-1273-P201AEmRNA-1273-P201-US202-1167US2021167ADOSE 2 - 2020-07-07T14:41AE-002 LEFT ANTERIOR CERVICAL CHAIN LYMPH NODE Lymphadenopathy cervical F˜øðLymphadenopathy F˜øíLymphatic system disorders NEC F˜øîSpleen, lymphatic and reticuloendothelial system disorders F™9)ADVERSE EVENT PIMMCBlood and lymphatic system disorders F˜«QBlood and lymphatic system disorders F˜«QMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2021-01-04 2021-01-11 BÓBÚ mRNA-1273-P201AEmRNA-1273-P201-US202-1167US2021167A DOSE 2 - 2020-07-07T14:41AE-001 FEVER Fever F˜×.Pyrexia F™)œFebrile disorders F˜ÖBody temperature conditions F˜”REACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝSEVERE NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-08T02:002020-07-08T17:00BBPT15H mRNA-1273-P201AEmRNA-1273-P201-US202-1175US2021175ADOSE 2 - 2020-07-08T12:21AE-013 COVID-19 INFECTION COVID-19 F™ß¬COVID-19 F™ß¬Coronavirus infections F™àžViral infectious disorders F™OÎADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMODERATENNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2020-10-12 2020-11-01 BB“ mRNA-1273-P201AEmRNA-1273-P201-US202-1175US2021175A DOSE 2 - 2020-07-08T12:21AE-0012080FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝREACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝSEVERE NDOSE NOT CHANGEDNONE RELATED RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-08T21:312020-07-17T14:13BB(P2DT1H52M mRNA-1273-P201AEmRNA-1273-P201-US202-1175US2021175A0DOSE 2 - 2020-07-08T12:21AE-011 HEADACHE Headache F˜á‹Headache F˜á‹Headaches NEC F˜á¡Headaches F˜áŸADVERSE EVENT Nervous system disorders F™•Nervous system disorders F™•MILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-08-02 2020-08-02 B8B8 mRNA-1273-P201AEmRNA-1273-P201-US202-1179US2021179ADOSE 2 - 2020-07-07T15:07AE-003 ABDOMINAL PAIN Abdominal pain F˜–ÑAbdominal pain F˜–ÑGastrointestinal and abdominal pains (excl oral and throat) F˜Ü†Gastrointestinal signs and symptoms F˜ÜÜADVERSE EVENT PIMMCGastrointestinal disorders F˜Ü›Gastrointestinal disorders F˜Ü›MILD NNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-10-04 2020-10-07 BwBz mRNA-1273-P201AEmRNA-1273-P201-US202-1179US2021179A DOSE 2 - 2020-07-07T15:07AE-004 ACNE BUTTOCKS Acne F˜˜pAcne F˜˜pAcnes F˜˜qSkin appendage conditions F™5ÞADVERSE EVENT PIMMCSkin and subcutaneous tissue disorders F™5ÑSkin and subcutaneous tissue disorders F™5ÑMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-09-19 2020-11-01 BhB“ mRNA-1273-P201AEmRNA-1273-P201-US202-1179US2021179A0DOSE 1 - 2020-06-08T15:12AE-001 BENIGN SKIN LESION RIGHT THIGH Benign neoplasm of skin F˜§®Benign neoplasm of skin F˜§®Skin neoplasms benign F™6BCutaneous neoplasms benign F™6CADVERSE EVENT Neoplasms benign, malignant and unspecified (incl cysts and polyps)F™0Neoplasms benign, malignant and unspecified (incl cysts and polyps)F™0MILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-11 2020-07-03 A@B mRNA-1273-P201AEmRNA-1273-P201-US202-1179US2021179A@DOSE 2 - 2020-07-07T15:07AE-002 DIARRHEA Diarrhea F˜È7Diarrhoea F˜È?Diarrhoea (excl infective) F˜È@Gastrointestinal motility and defaecation conditions F˜Ü¹ADVERSE EVENT PIMMCGastrointestinal disorders F˜Ü›Gastrointestinal disorders F˜Ü›MILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-10-04 2020-10-07 BwBz mRNA-1273-P201AEmRNA-1273-P201-US202-1180US2021180ADOSE 2 - 2020-07-08T09:58AE-002 JOINT ACHES ALL OVER BODY Generalized joint pain F™ŠfArthralgia F˜£'Joint related signs and symptoms F˜ñ:Joint disorders F˜ñ-REACTOGENICITY Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kSEVERE NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-09T20:522020-07-10T08:00B B!PT11H8M mRNA-1273-P201AEmRNA-1273-P201-US202-1180US2021180A DOSE 2 - 2020-07-08T09:58AE-008 HARDNESS AT INJECTION SITE Injection site induration F˜ì»Injection site induration F˜ì»Injection site reactions F˜ìÑAdministration site reactions F˜›¤REACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE RELATED RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-08T21:002020-07-17T09:00BB(P1DT23H2M mRNA-1273-P201AEmRNA-1273-P201-US202-1180US2021180A0DOSE 1 - 2020-06-08T17:04AE-001 SWELLING AT INJECTION SITE Swelling of injection site F™=HInjection site swelling F™g1Injection site reactions F˜ìÑAdministration site reactions F˜›¤REACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE RELATED RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-14 2020-07-01 ApBP17D mRNA-1273-P201AEmRNA-1273-P201-US202-1180US2021180A@DOSE 2 - 2020-07-08T09:58AE-007 SWELLING AT INJECTION SITE Swelling of injection site F™=HInjection site swelling F™g1Injection site reactions F˜ìÑAdministration site reactions F˜›¤REACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE RELATED RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-08T21:002020-07-17T09:00BB(P1DT23H2M mRNA-1273-P201AEmRNA-1273-P201-US202-1180US2021180APDOSE 2 - 2020-07-08T09:58AE-005 BRUISING RIGHT POSTERIOR HAMSTRING UNKNOWN Muscle contusion F™ªåMuscle contusion F™ªåMuscle, tendon and ligament injuries F™Injuries NEC F˜ìâADVERSE EVENT Injury, poisoning and procedural complications F˜ìåInjury, poisoning and procedural complications F˜ìåMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERING/RESOLVING NNNNNN1BLINDED TREATMENT 2020-07-14 B%. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US202-1180US2021180A`DOSE 2 - 2020-07-08T09:58AE-006 BACK STRAIN Back strain F™W¬Muscle strain F™YïMuscle, tendon and ligament injuries F™Injuries NEC F˜ìâADVERSE EVENT PIMMCInjury, poisoning and procedural complications F˜ìåInjury, poisoning and procedural complications F˜ìåMODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-07-29 2020-08-01 B4B7 mRNA-1273-P201AEmRNA-1273-P201-US202-1180US2021180ApDOSE 2 - 2020-07-08T09:58AE-003 MUSCLE ACHES ALL OVER BODY Generalized muscle aches F™ŠiMyalgia F™{Muscle pains F™#Muscle disorders F™REACTOGENICITY Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kSEVERE NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-09T20:522020-07-10T20:52B B!P1D mRNA-1273-P201AEmRNA-1273-P201-US202-1180US2021180A€DOSE 2 - 2020-07-08T09:58AE-004 FEVER Fever F˜×.Pyrexia F™)œFebrile disorders F˜ÖBody temperature conditions F˜”REACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝSEVERE NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-08T23:302020-07-10T08:00BB!P1DT8H30M mRNA-1273-P201AEmRNA-1273-P201-US202-1185US2021185ADOSE 2 - 2020-07-31T16:32AE-003 POSITIVE COVID-19 ILLNESS COVID-19 F™ß¬COVID-19 F™ß¬Coronavirus infections F™àžViral infectious disorders F™OÎADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2021-01-27 2021-02-12 BØBè mRNA-1273-P201AEmRNA-1273-P201-US202-1185US2021185A DOSE 2 - 2020-07-31T16:32AE-002 WORSENING OF DEPRESSION Depression worsened F˜ÆîDepression F˜ÆÚDepressive disorders F˜ÆñDepressed mood disorders and disturbances F˜Æ×ADVERSE EVENT PIMMCPsychiatric disorders F™'·Psychiatric disorders F™'·MODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED WITH SEQUELAENNNNNN2PART A FOLLOW-UP 2020-08-31 2020-08-31 BCBC mRNA-1273-P201AEmRNA-1273-P201-US202-1185US2021185A0DOSE 1 - 2020-06-26T14:07AE-001 POSTMENOPAUSAL BLEEDING Postmenopausal bleeding F™$¯Postmenopausal haemorrhage F™p¾Menopausal effects on the genitourinary tract F™$Menopause related conditions F™¹eADVERSE EVENT Reproductive system and breast disorders F™-LReproductive system and breast disorders F™-LMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-04 2020-07-11 AB mRNA-1273-P201AEmRNA-1273-P201-US202-1196US2021196ADOSE 1 - 2020-07-02T11:37AE-001 2 POLYPS COLON BENIGN Benign colonic polyp F™vbLarge intestine polyp F™`Benign neoplasms gastrointestinal (excl oral cavity) F˜ÜÄBenign neoplasms gastrointestinal F˜ÜŽADVERSE EVENT PIMMCGastrointestinal disorders F˜Ü›Gastrointestinal disorders F˜Ü›MODERATENDOSE NOT CHANGEDCONCOMITANT PROCEDURE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-07-08 2020-07-15 ApAà mRNA-1273-P201AEmRNA-1273-P201-US202-1205US2021205ADOSE 1 - 2020-06-26T15:09AE-001 GENERALIZED PRURITIS (UNKNOWN) General pruritus F˜ÝPruritus F™'_Pruritus NEC F™W Epidermal and dermal conditions F˜ÑADVERSE EVENT Skin and subcutaneous tissue disorders F™5ÑSkin and subcutaneous tissue disorders F™5ÑMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-30 2020-07-16 APB mRNA-1273-P201AEmRNA-1273-P201-US202-1205US2021205A DOSE 2 - 2020-07-31T09:34AE-002 GENERALIZED PURTITIS Generalized pruritus F˜ÝKPruritus F™'_Pruritus NEC F™W Epidermal and dermal conditions F˜ÑADVERSE EVENT Skin and subcutaneous tissue disorders F™5ÑSkin and subcutaneous tissue disorders F™5ÑMILD NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-08-01T08:002020-08-05T17:00B%B) mRNA-1273-P201AEmRNA-1273-P201-US202-1205US2021205A0DOSE 2 - 2020-07-31T09:34AE-003 COVID-19 LIKE ILLNESS Suspected COVID-19 F™àcSuspected COVID-19 F™àcCoronavirus infections F™àžViral infectious disorders F™OÎADVERSE EVENT Infections and infestations F˜ëùInfections and infestations F˜ëùMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2021-01-30 2021-02-10 BÛBæ mRNA-1273-P201AEmRNA-1273-P201-US202-1206US2021206ADOSE 1 - 2020-07-02T12:16AE-002 BURSITIS RIGHT HIP Hip bursitis F™¼(Bursitis F˜±Bursal disorders F˜ÊqSynovial and bursal disorders F˜Ê±ADVERSE EVENT PIMMCMusculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-07-13 2020-07-16 AÀAð mRNA-1273-P201AEmRNA-1273-P201-US202-1206US2021206A DOSE 1 - 2020-07-02T12:16AE-001 BONE SPUR 2ND RIGHT TOE Bone spur F˜üExostosis F˜ÓÈBone disorders NEC F™ŠBone disorders (excl congenital and fractures) F˜ÇADVERSE EVENT PIMMCMusculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION, CONCOMITANT PROCEDURENOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-08 2020-07-30 ApB mRNA-1273-P201AEmRNA-1273-P201-US202-1206US2021206A0DOSE 2 - 2020-08-04T10:47AE-004 SORE THROAT Sore throat F™8Oropharyngeal pain F™¡_Upper respiratory tract signs and symptoms F™KiRespiratory tract signs and symptoms F™Ë}ADVERSE EVENT Respiratory, thoracic and mediastinal disorders F™-ÒRespiratory, thoracic and mediastinal disorders F™-ÒMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-10-05 2020-10-06 B`Ba mRNA-1273-P201AEmRNA-1273-P201-US202-1208US2021208ADOSE 2 - 2020-07-29T16:20AE-0032070HEADACHE Headache F˜á‹Headache F˜á‹Headaches NEC F˜á¡Headaches F˜áŸREACTOGENICITY Nervous system disorders F™•Nervous system disorders F™•MILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-29T17:282020-08-09T13:55BB(P3DT21H35M mRNA-1273-P201AEmRNA-1273-P201-US202-1208US2021208A DOSE 2 - 2020-07-29T16:20AE-002 NAUSEA Nausea F™ Nausea F™ Nausea and vomiting symptoms F™Gastrointestinal signs and symptoms F˜ÜÜADVERSE EVENT Gastrointestinal disorders F˜Ü›Gastrointestinal disorders F˜Ü›MILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-08-04 2020-08-07 B#B& mRNA-1273-P201AEmRNA-1273-P201-US202-1208US2021208A0DOSE 2 - 2020-07-29T16:20AE-004 PHARYNGITIS Pharyngitis F™“Pharyngitis F™“Upper respiratory tract infections F™KeInfections - pathogen unspecified F˜ë÷ADVERSE EVENT Infections and infestations F˜ëùInfections and infestations F˜ëùMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-08-04 2020-08-07 B#B& mRNA-1273-P201AEmRNA-1273-P201-US202-1208US2021208A@DOSE 2 - 2020-07-29T16:20AE-005 PLANTAR FASCIITIS Plantar fasciitis F™ÓPlantar fasciitis F™ÓMusculoskeletal and connective tissue infections and inflammations NECF™d¨Musculoskeletal and connective tissue disorders NEC F™iADVERSE EVENT PIMMCMusculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-09-14 2020-09-22 BLBT mRNA-1273-P201AEmRNA-1273-P201-US202-1208US2021208APDOSE 2 - 2020-07-29T16:20AE-001 NASAL DRAINAGE (UNKNOWN) Nasal discharge F™ÁRhinorrhoea F™/=Upper respiratory tract signs and symptoms F™KiRespiratory tract signs and symptoms F™Ë}ADVERSE EVENT Respiratory, thoracic and mediastinal disorders F™-ÒRespiratory, thoracic and mediastinal disorders F™-ÒMODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-08-04 2020-08-07 B#B& mRNA-1273-P201AEmRNA-1273-P201-US202-1211US2021211ADOSE 2 - 2020-07-31T10:25AE-002 WORSENING OF GASTROESOPHAGEAL REFLUX DISEASE Esophageal reflux aggravated F™o2Gastrooesophageal reflux disease F˜Ü]Gastrointestinal atonic and hypomotility disorders NEC F˜ÜGastrointestinal motility and defaecation conditions F˜Ü¹ADVERSE EVENT PIMMCGastrointestinal disorders F˜Ü›Gastrointestinal disorders F˜Ü›MODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2020-12-19 2020-12-20 B«B¬ mRNA-1273-P201AEmRNA-1273-P201-US202-1211US2021211A DOSE 1 - 2020-07-02T15:28AE-001 INFECTION FROM FILLING IN TOOTH Tooth infection F™TúTooth infection F™TúDental and oral soft tissue infections F˜Æ¦Infections - pathogen unspecified F˜ë÷ADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-07-21 2020-07-27 BB mRNA-1273-P201AEmRNA-1273-P201-US202-1214US2021214ADOSE 2 - 2020-07-24T15:43AE-004 CHILLS Chills F˜·ÓChills F˜·ÓFeelings and sensations NEC F™£General system disorders NEC F˜ÝADVERSE EVENT General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-09-10 2020-09-11 BMBN mRNA-1273-P201AEmRNA-1273-P201-US202-1214US2021214A DOSE 2 - 2020-07-24T15:43AE-003 FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝADVERSE EVENT General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-09-09 2020-09-12 BLBO mRNA-1273-P201AEmRNA-1273-P201-US202-1214US2021214A0DOSE 1 - 2020-06-26T15:27AE-001 RE-INJURED RIGHT HIP Hip injury F™fdJoint injury F™„Bone and joint injuries NEC F™¹uBone and joint injuries F˜¶ADVERSE EVENT Injury, poisoning and procedural complications F˜ìåInjury, poisoning and procedural complications F˜ìåMODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-07-14 2020-07-29 BB" mRNA-1273-P201AEmRNA-1273-P201-US202-1214US2021214A@DOSE 2 - 2020-07-24T15:43AE-002 GENERALIZED BODY ACHES General body pain F™UËPain F™ÛPain and discomfort NEC F™ÜGeneral system disorders NEC F˜ÝADVERSE EVENT General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-09-10 2020-09-12 BMBO mRNA-1273-P201AEmRNA-1273-P201-US202-1214US2021214APDOSE 2 - 2020-07-24T15:43AE-005 FEVER Fever F˜×.Pyrexia F™)œFebrile disorders F˜ÖBody temperature conditions F˜”ADVERSE EVENT General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-09-10 2020-09-11 BMBN mRNA-1273-P201AEmRNA-1273-P201-US202-1217US2021217ADOSE 2 - 2020-07-29T13:15AE-002 FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝREACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝSEVERE NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-29T17:002020-08-05T16:23BB&PT3H8M mRNA-1273-P201AEmRNA-1273-P201-US202-1217US2021217A DOSE 2 - 2020-07-29T13:15AE-001 MUSCLE ACHES ALL OVER BODY Generalized muscle aches F™ŠiMyalgia F™{Muscle pains F™#Muscle disorders F™REACTOGENICITY Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kSEVERE NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-29T17:002020-07-31T17:00BB!P2D mRNA-1273-P201AEmRNA-1273-P201-US202-1218US2021218ADOSE 1 - 2020-06-30T11:34AE-001 WORSENING OF SEASONAL ALLERGIES Seasonal allergy F™UŒSeasonal allergy F™UŒAtopic disorders F™dAllergic conditions F˜,ADVERSE EVENT Immune system disorders F˜ê4Immune system disorders F˜ê4MILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-05 2020-07-14 A`Að mRNA-1273-P201AEmRNA-1273-P201-US202-1220US2021220ADOSE 1 - 2020-06-29T12:06AE-002 HEADACHE Headache F˜á‹Headache F˜á‹Headaches NEC F˜á¡Headaches F˜áŸADVERSE EVENT Nervous system disorders F™•Nervous system disorders F™•MILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-06 2020-07-06 A€A€ mRNA-1273-P201AEmRNA-1273-P201-US202-1220US2021220A DOSE 2 - 2020-07-29T14:15AE-001 LEFT POSTERIOR TIBIAL TENDONITIS Posterior tibial tendonitis F™×nTendonitis F™?wTendon disorders F™?bTendon, ligament and cartilage disorders F™?eADVERSE EVENT PIMMCMusculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2021-02-16 2021-03-15 BéC@ mRNA-1273-P201AEmRNA-1273-P201-US202-1222US2021222ADOSE 2 - 2020-07-31T12:30AE-001 FIRE ANT BITES EXTREMITIES Ant bite F™UHArthropod bite F˜£ÇNon-site specific injuries NEC F™ ÇInjuries NEC F˜ìâADVERSE EVENT Injury, poisoning and procedural complications F˜ìåInjury, poisoning and procedural complications F˜ìåMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-08-22 2020-08-31 B4B= mRNA-1273-P201AEmRNA-1273-P201-US202-1222US2021222A DOSE 2 - 2020-07-31T12:30AE-002 RIGHT EYE INFECTION Eye infection F˜Ô¹Eye infection F˜Ô¹Eye and eyelid infections F˜Ô¥Infections - pathogen unspecified F˜ë÷ADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2020-12-23 2020-12-29 B¯Bµ mRNA-1273-P201AEmRNA-1273-P201-US202-1226US2021226ADOSE 2 - 2020-08-04T10:19AE-002 CHILLS Chills F˜·ÓChills F˜·ÓFeelings and sensations NEC F™£General system disorders NEC F˜ÝREACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-08-05T08:002020-08-08T08:00BB"P3D mRNA-1273-P201AEmRNA-1273-P201-US202-1226US2021226A DOSE 2 - 2020-08-04T10:19AE-001 SORE THROAT Sore throat F™8Oropharyngeal pain F™¡_Upper respiratory tract signs and symptoms F™KiRespiratory tract signs and symptoms F™Ë}ADVERSE EVENT Respiratory, thoracic and mediastinal disorders F™-ÒRespiratory, thoracic and mediastinal disorders F™-ÒSEVERE NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-08-05T08:002020-08-06T08:00BB mRNA-1273-P201AEmRNA-1273-P201-US202-1226US2021226A0DOSE 2 - 2020-08-04T10:19AE-007 COVID LIKE ILLNESS Suspected COVID-19 F™àcSuspected COVID-19 F™àcCoronavirus infections F™àžViral infectious disorders F™OÎADVERSE EVENT Infections and infestations F˜ëùInfections and infestations F˜ëùMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2021-01-13 2021-01-16 BÀBÃ mRNA-1273-P201AEmRNA-1273-P201-US202-1230US2021230ADOSE 2 - 2020-08-03T11:55AE-001 COVID 19 INFECTION COVID-19 F™ß¬COVID-19 F™ß¬Coronavirus infections F™àžViral infectious disorders F™OÎADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMODERATENNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2020-12-23 2021-02-05 B«B× mRNA-1273-P201AEmRNA-1273-P201-US202-1234US2021234ADOSE 2 - 2020-08-04T11:23AE-001 WORSENING OF NECK PAIN Neck pain F™$Neck pain F™$Musculoskeletal and connective tissue pain and discomfort F™£Musculoskeletal and connective tissue disorders NEC F™iADVERSE EVENT Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-08-12 2020-10-01 B%BW mRNA-1273-P201AEmRNA-1273-P201-US203-1004US2031004ADOSE 2 - 2020-06-29T09:40AE-002 GENERALIZED ARTHRALGIA Arthralgia F˜£'Arthralgia F˜£'Joint related signs and symptoms F˜ñ:Joint disorders F˜ñ-REACTOGENICITY Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kSEVERE NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-06-29T18:002020-07-02T10:10B B#P2DT16H10M mRNA-1273-P201AEmRNA-1273-P201-US203-1004US2031004A DOSE 2 - 2020-06-29T09:40AE-003 BILATERAL AXILLARY TENDERNESS Axillary pain F™TîAxillary pain F™TîPain and discomfort NEC F™ÜGeneral system disorders NEC F˜ÝREACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝSEVERE NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-06-29T18:002020-07-07T10:00B B(P1DT0H20M mRNA-1273-P201AEmRNA-1273-P201-US203-1004US2031004A0DOSE 2 - 2020-06-29T09:40AE-004 GENERALIZED MYALGIA Myalgia F™{Myalgia F™{Muscle pains F™#Muscle disorders F™REACTOGENICITY Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kSEVERE NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-06-29T18:002020-07-02T10:10B B#P2DT16H10M mRNA-1273-P201AEmRNA-1273-P201-US203-1004US2031004A@DOSE 1 - 2020-05-29T14:24AE-001 SYNCOPAL EPISODE Syncopal attack F™=“Syncope F™=”Disturbances in consciousness NEC F˜ËENeurological disorders NEC F™ùADVERSE EVENT Nervous system disorders F™•Nervous system disorders F™•MILD NDOSE NOT CHANGEDNONE NOT RELATEDRELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-12 2020-06-12 AðAð mRNA-1273-P201AEmRNA-1273-P201-US203-1004US2031004APDOSE 2 - 2020-06-29T09:40AE-005 URINARY TRACT INFECTION Urinary tract infection F™LkUrinary tract infection F™LkUrinary tract infections F™LqInfections - pathogen unspecified F˜ë÷ADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-12 2020-07-22 B-B7 mRNA-1273-P201AEmRNA-1273-P201-US203-1011US2031011ADOSE 2 - 2020-07-01T11:44AE-001 HEADACHE Headache F˜á‹Headache F˜á‹Headaches NEC F˜á¡Headaches F˜áŸADVERSE EVENT Nervous system disorders F™•Nervous system disorders F™•MILD NNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2021-01-05 2021-01-08 BÞBá mRNA-1273-P201AEmRNA-1273-P201-US203-1013US2031013ADOSE 2 - 2020-06-30T08:52AE-001 TORN MENISCUS RIGHT KNEE Meniscus tear of knee F™Meniscus injury F™³ŠBone and joint injuries NEC F™¹uBone and joint injuries F˜¶ADVERSE EVENT PIMMCInjury, poisoning and procedural complications F˜ìåInjury, poisoning and procedural complications F˜ìåMILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERING/RESOLVING NNNNNN1PART A FOLLOW-UP 2020-08-10 BF. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US203-1016US2031016ADOSE 2 - 2020-07-02T10:24AE-001 WORSENING OF DEPRESSION Depression worsened F˜ÆîDepression F˜ÆÚDepressive disorders F˜ÆñDepressed mood disorders and disturbances F˜Æ×ADVERSE EVENT PIMMCPsychiatric disorders F™'·Psychiatric disorders F™'·MODERATENNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2020-11-19 2021-03-19 B©C mRNA-1273-P201AEmRNA-1273-P201-US203-1029US2031029ADOSE 1 - 2020-06-02T09:07AE-001 OVER ACTIVE BLADDER Overactive bladder F™aHypertonic bladder F˜çõMyoneurogenic bladder disorders F™_Bladder and bladder neck disorders (excl calculi) F˜ªADVERSE EVENT Renal and urinary disorders F™,WRenal and urinary disorders F™,WMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-17 2020-07-14 BB+ mRNA-1273-P201AEmRNA-1273-P201-US203-1029US2031029A DOSE 2 - 2020-07-07T08:49AE-002 UPPER RESPIRATORY INFECTION Upper respiratory infection F™K\Upper respiratory tract infection F™KbUpper respiratory tract infections F™KeInfections - pathogen unspecified F˜ë÷ADVERSE EVENT Infections and infestations F˜ëùInfections and infestations F˜ëùMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-08-04 2020-08-10 B@BF mRNA-1273-P201AEmRNA-1273-P201-US203-1035US2031035ADOSE 2 - 2020-06-29T10:42AE-001 HEADACHE Headache F˜á‹Headache F˜á‹Headaches NEC F˜á¡Headaches F˜áŸADVERSE EVENT Nervous system disorders F™•Nervous system disorders F™•MILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-27 2020-08-03 B9B@ mRNA-1273-P201AEmRNA-1273-P201-US203-1035US2031035A DOSE 2 - 2020-06-29T10:42AE-002 RHINORRHEA Rhinorrhea F™/<Rhinorrhoea F™/=Upper respiratory tract signs and symptoms F™KiRespiratory tract signs and symptoms F™Ë}ADVERSE EVENT Respiratory, thoracic and mediastinal disorders F™-ÒRespiratory, thoracic and mediastinal disorders F™-ÒMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-27 2020-08-03 B9B@ mRNA-1273-P201AEmRNA-1273-P201-US203-1035US2031035A0DOSE 2 - 2020-06-29T10:42AE-003 UPPER RESPIRATORY INFECTION Upper respiratory infection F™K\Upper respiratory tract infection F™KbUpper respiratory tract infections F™KeInfections - pathogen unspecified F˜ë÷ADVERSE EVENT Infections and infestations F˜ëùInfections and infestations F˜ëùMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-09-11 2020-09-24 BgBt mRNA-1273-P201AEmRNA-1273-P201-US203-1035US2031035A@DOSE 2 - 2020-06-29T10:42AE-004 URINARY TRACT INFECTION Urinary tract infection F™LkUrinary tract infection F™LkUrinary tract infections F™LqInfections - pathogen unspecified F˜ë÷ADVERSE EVENT Infections and infestations F˜ëùInfections and infestations F˜ëùMILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-11-13 2020-11-20 B¦B mRNA-1273-P201AEmRNA-1273-P201-US203-1041US2031041ADOSE 2 - 2020-07-01T09:13AE-002 RIGHT FOOT NERVE PAIN Nerve pain F™}Neuralgia F™§Sensory abnormalities NEC F™2ÕNeurological disorders NEC F™ùADVERSE EVENT Nervous system disorders F™•Nervous system disorders F™•MILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERING/RESOLVING NNNNNN1PART A FOLLOW-UP 2021-01-27 Bð. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US203-1041US2031041A DOSE 2 - 2020-07-01T09:13AE-001 UPPER RESPIRATORY INFECTION Upper respiratory infection F™K\Upper respiratory tract infection F™KbUpper respiratory tract infections F™KeInfections - pathogen unspecified F˜ë÷ADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-05 2020-07-11 B"B( mRNA-1273-P201AEmRNA-1273-P201-US203-1042US2031042ADOSE 1 - 2020-06-04T15:59AE-001 HEADACHE Headache F˜á‹Headache F˜á‹Headaches NEC F˜á¡Headaches F˜áŸREACTOGENICITY Nervous system disorders F™•Nervous system disorders F™•MODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-07-06T08:002020-07-13T08:00B!B(P31DT16H1M mRNA-1273-P201AEmRNA-1273-P201-US203-1042US2031042A DOSE 2 - 2020-07-06T14:34AE-0022090MUSCLE ACHES ALL OVER BODY Generalized muscle aches F™ŠiMyalgia F™{Muscle pains F™#Muscle disorders F™REACTOGENICITY Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-07T13:272020-07-17T22:56B"B,P4DT8H22M mRNA-1273-P201AEmRNA-1273-P201-US203-1049US2031049ADOSE 2 - 2020-07-01T15:37AE-001 ANXIETY Anxiety F˜¡§Anxiety F˜¡§Anxiety symptoms F˜¡µAnxiety disorders and symptoms F˜¡ADVERSE EVENT PIMMCPsychiatric disorders F™'·Psychiatric disorders F™'·MILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-12-08 2021-02-02 B¿B÷ mRNA-1273-P201AEmRNA-1273-P201-US203-1049US2031049A DOSE 2 - 2020-07-01T15:37AE-002 DEPRESSION Depression F˜ÆÚDepression F˜ÆÚDepressive disorders F˜ÆñDepressed mood disorders and disturbances F˜Æ×ADVERSE EVENT PIMMCPsychiatric disorders F™'·Psychiatric disorders F™'·MILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-12-08 2021-02-02 B¿B÷ mRNA-1273-P201AEmRNA-1273-P201-US203-1050US2031050ADOSE 2 - 2020-07-01T09:55AE-003 GENERALIZED ARTHRALGIA Arthralgia F˜£'Arthralgia F˜£'Joint related signs and symptoms F˜ñ:Joint disorders F˜ñ-REACTOGENICITY Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kSEVERE NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-02T22:002020-07-03T08:00BBPT10H mRNA-1273-P201AEmRNA-1273-P201-US203-1050US2031050A DOSE 2 - 2020-07-01T09:55AE-002 FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝREACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝSEVERE NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-02T12:052020-07-03T13:59BBP1DT1H54M mRNA-1273-P201AEmRNA-1273-P201-US203-1050US2031050A0DOSE 2 - 2020-07-01T09:55AE-005 INFLUENZA A Influenza A virus infection F˜ìrInfluenza F˜ìpInfluenza viral infections F˜ìuViral infectious disorders F™OÎADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NDOSE DELAYED CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2021-02-21 2021-03-01 C€C mRNA-1273-P201AEmRNA-1273-P201-US203-1050US2031050A@DOSE 2 - 2020-07-01T09:55AE-001 GENERALIZED MYALGIA Myalgia F™{Myalgia F™{Muscle pains F™#Muscle disorders F™REACTOGENICITY Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kSEVERE NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-02T22:002020-07-03T08:00BBPT10H mRNA-1273-P201AEmRNA-1273-P201-US203-1050US2031050APDOSE 2 - 2020-07-01T09:55AE-004 FEVER Fever F˜×.Pyrexia F™)œFebrile disorders F˜ÖBody temperature conditions F˜”REACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝSEVERE NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-02T22:002020-07-04T08:00BB P1DT10H mRNA-1273-P201AEmRNA-1273-P201-US203-1056US2031056ADOSE 2 - 2020-06-30T15:50AE-001 LEFT KNEE INFECTION FROM BUG BITE Infected insect bite F™v)Infected bite F™ÂïInfections NEC F˜ìInfections - pathogen unspecified F˜ë÷ADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMODERATENNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2020-08-26 2020-09-07 BWBc mRNA-1273-P201AEmRNA-1273-P201-US203-1057US2031057ADOSE 2 - 2020-07-01T08:25AE-003 COUGH Cough F˜ÂXCough F˜ÂXCoughing and associated symptoms F˜ÂaRespiratory disorders NEC F™-¼ADVERSE EVENT Respiratory, thoracic and mediastinal disorders F™-ÒRespiratory, thoracic and mediastinal disorders F™-ÒMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-07-30 2020-08-01 B:B< mRNA-1273-P201AEmRNA-1273-P201-US203-1057US2031057A DOSE 2 - 2020-07-01T08:25AE-001 FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝADVERSE EVENT General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGED NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-07-30 2020-08-01 B:B< mRNA-1273-P201AEmRNA-1273-P201-US203-1057US2031057A0DOSE 2 - 2020-07-01T08:25AE-002 NASAL CONGESTION Nasal congestion F™¿Nasal congestion F™¿Nasal congestion and inflammations F™ÀUpper respiratory tract disorders (excl infections) F™K`ADVERSE EVENT Respiratory, thoracic and mediastinal disorders F™-ÒRespiratory, thoracic and mediastinal disorders F™-ÒMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-07-30 2020-08-01 B:B< mRNA-1273-P201AEmRNA-1273-P201-US203-1066US2031066ADOSE 2 - 2020-06-30T10:53AE-005 HEADACHE Headache F˜á‹Headache F˜á‹Headaches NEC F˜á¡Headaches F˜áŸADVERSE EVENT Nervous system disorders F™•Nervous system disorders F™•MILD NNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-11-13 2020-12-01 B¥B· mRNA-1273-P201AEmRNA-1273-P201-US203-1066US2031066A DOSE 2 - 2020-06-30T10:53AE-004 LETHARGY Lethargy F˜õHLethargy F˜õHDisturbances in consciousness NEC F˜ËENeurological disorders NEC F™ùADVERSE EVENT Nervous system disorders F™•Nervous system disorders F™•MILD NNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-11-13 2020-12-01 B¥B· mRNA-1273-P201AEmRNA-1273-P201-US203-1066US2031066A0DOSE 2 - 2020-06-30T10:53AE-003 CHEST TIGHTNESS-NON CARDIAC MUSCULOSKELETAL Musculoskeletal chest pain F™]Musculoskeletal chest pain F™]Musculoskeletal and connective tissue pain and discomfort F™£Musculoskeletal and connective tissue disorders NEC F™iADVERSE EVENT Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMILD NNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-11-13 2020-12-01 B¥B· mRNA-1273-P201AEmRNA-1273-P201-US203-1072US2031072ADOSE 2 - 2020-07-06T12:24AE-002 FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝREACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝSEVERE NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-07T02:302020-07-07T23:00B#B#PT20H30M mRNA-1273-P201AEmRNA-1273-P201-US203-1072US2031072A DOSE 1 - 2020-06-03T12:40AE-001 RIGHT EYE IRRITATION SECONDARY TO FOREIGN OBJECT IN EYE Foreign body in eye F˜ØôForeign body in eye F˜ØôEye injuries NEC F™šInjuries NEC F˜ìâADVERSE EVENT PIMMCInjury, poisoning and procedural complications F˜ìåInjury, poisoning and procedural complications F˜ìåMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-17 2020-06-20 AðB mRNA-1273-P201AEmRNA-1273-P201-US203-1072US2031072A0DOSE 2 - 2020-07-06T12:24AE-006 HYPERTENSION Hypertension F˜ç¤Hypertension F˜ç¤Vascular hypertensive disorders NEC F˜ç¦Vascular hypertensive disorders F™uÎADVERSE EVENT PIMMCVascular disorders F™NYVascular disorders F™NYMILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERING/RESOLVING NNNNNN1PART A FOLLOW-UP 2021-01-25 Bí. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US203-1072US2031072A@DOSE 2 - 2020-07-06T12:24AE-003 GENERALIZED MUSCLE ACHES Generalized muscle aches F™ŠiMyalgia F™{Muscle pains F™#Muscle disorders F™REACTOGENICITY Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kSEVERE NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-07T02:302020-07-08T08:00B#B$P1DT5H30M mRNA-1273-P201AEmRNA-1273-P201-US203-1072US2031072APDOSE 2 - 2020-07-06T12:24AE-004 UPPER RESPIRATORY INFECTION Upper respiratory infection F™K\Upper respiratory tract infection F™KbUpper respiratory tract infections F™KeInfections - pathogen unspecified F˜ë÷ADVERSE EVENT Infections and infestations F˜ëùInfections and infestations F˜ëùMILD NNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-11-17 2020-11-22 B¨B mRNA-1273-P201AEmRNA-1273-P201-US203-1074US2031074ADOSE 2 - 2020-06-30T15:23AE-0032070HEADACHE Headache F˜á‹Headache F˜á‹Headaches NEC F˜á¡Headaches F˜áŸREACTOGENICITY Nervous system disorders F™•Nervous system disorders F™•MILD NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-30T22:002020-07-08T18:00BB%P1DT2H37M mRNA-1273-P201AEmRNA-1273-P201-US203-1074US2031074A DOSE 1 - 2020-06-02T17:03AE-002 BILATERAL ACUTE OTITIS MEDIA Bilateral otitis media F˜¨]Otitis media F™¶Ear infections F˜Í=Infections - pathogen unspecified F˜ë÷ADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-10 2020-06-19 AB mRNA-1273-P201AEmRNA-1273-P201-US203-1074US2031074A0DOSE 1 - 2020-06-02T17:03AE-001 SINUS INFECTION Sinus infection F™5©Sinusitis F™5±Upper respiratory tract infections F™KeInfections - pathogen unspecified F˜ë÷ADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-10 2020-06-19 AB mRNA-1273-P201AEmRNA-1273-P201-US203-1074US2031074A@DOSE 2 - 2020-06-30T15:23AE-004 URINARY TRACT INFECTION Urinary tract infection F™LkUrinary tract infection F™LkUrinary tract infections F™LqInfections - pathogen unspecified F˜ë÷ADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2021-02-05 2021-02-15 BùC0 mRNA-1273-P201AEmRNA-1273-P201-US203-1079US2031079ADOSE 2 - 2020-07-02T10:50AE-001 WORSENING OF DEPRESSION Depression worsened F˜ÆîDepression F˜ÆÚDepressive disorders F˜ÆñDepressed mood disorders and disturbances F˜Æ×ADVERSE EVENT PIMMCPsychiatric disorders F™'·Psychiatric disorders F™'·MILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERING/RESOLVING NNNNNN1BLINDED TREATMENT 2020-07-30 B9. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US203-1079US2031079A DOSE 2 - 2020-07-02T10:50AE-002 INTESTINAL OBSTRUCTION Intestinal obstruction F˜ïIntestinal obstruction F˜ïGastrointestinal stenosis and obstruction NEC F˜ÜÙGastrointestinal stenosis and obstruction F˜ÜØADVERSE EVENT PIMMCGastrointestinal disorders F˜Ü›Gastrointestinal disorders F˜Ü›MILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-11-13 2020-11-13 B£B£ mRNA-1273-P201AEmRNA-1273-P201-US203-1081US2031081ADOSE 2 - 2020-07-02T09:49AE-001 COVID 19 INFECTION COVID-19 F™ß¬COVID-19 F™ß¬Coronavirus infections F™àžViral infectious disorders F™OÎADVERSE EVENT Infections and infestations F˜ëùInfections and infestations F˜ëùMILD NNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-08-03 2020-08-03 B=B= mRNA-1273-P201AEmRNA-1273-P201-US203-1089US2031089ADOSE 2 - 2020-07-29T10:16AE-001 LEFT SHOULDER PAIN Shoulder pain F™5)Musculoskeletal pain F™gMusculoskeletal and connective tissue pain and discomfort F™£Musculoskeletal and connective tissue disorders NEC F™iADVERSE EVENT Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMILD NDOSE NOT CHANGEDNONE RELATED RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-08-13 2020-08-20 B1B8 mRNA-1273-P201AEmRNA-1273-P201-US203-1091US2031091ADOSE 2 - 2020-07-27T10:29AE-002 FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝREACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝSEVERE NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-28T16:002020-07-28T20:00B!B!PT4H mRNA-1273-P201AEmRNA-1273-P201-US203-1091US2031091A DOSE 2 - 2020-07-27T10:29AE-001 HEADACHE Headache F˜á‹Headache F˜á‹Headaches NEC F˜á¡Headaches F˜áŸREACTOGENICITY Nervous system disorders F™•Nervous system disorders F™•SEVERE NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-28T08:002020-08-03T08:00B!B'P6D mRNA-1273-P201AEmRNA-1273-P201-US203-1091US2031091A0DOSE 2 - 2020-07-27T10:29AE-003 MUSCLE ACHES ALL OVER BODY Generalized muscle aches F™ŠiMyalgia F™{Muscle pains F™#Muscle disorders F™REACTOGENICITY Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kSEVERE NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-28T22:302020-07-29T08:00B!B"PT9H30M mRNA-1273-P201AEmRNA-1273-P201-US203-1097US2031097ADOSE 2 - 2020-08-03T16:14AE-003 NON-ST ELEVATION MYOCARDIAL INFARCTION Non ST segment elevation myocardial infarction F™‘ÛAcute myocardial infarction F˜™ûIschaemic coronary artery disorders F˜ÁÍCoronary artery disorders F˜ÁÊADVERSE EVENT PIMMCCardiac disorders F˜³õCardiac disorders F˜³õMODERATEYNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNYNN2PART A FOLLOW-UP 2020-11-25 2020-11-25 B•B• mRNA-1273-P201AEmRNA-1273-P201-US203-1097US2031097A DOSE 2 - 2020-08-03T16:14AE-004 CEREBRAL VASCULAR ACCIDENT Cerebrovascular accident F˜¶~Cerebrovascular accident F˜¶~Central nervous system haemorrhages and cerebrovascular accidents F˜µŒCentral nervous system vascular disorders F˜µ›ADVERSE EVENT PIMMCNervous system disorders F™•Nervous system disorders F™•MODERATENNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2020-12-01 2020-12-01 B›B› mRNA-1273-P201AEmRNA-1273-P201-US203-1097US2031097A0DOSE 2 - 2020-08-03T16:14AE-001 TOOTH DECAY Tooth decay F™B{Dental caries F˜ÆžDental and periodontal infections and inflammations F˜Æ¥Dental and gingival conditions F™BrADVERSE EVENT PIMMCGastrointestinal disorders F˜Ü›Gastrointestinal disorders F˜Ü›MILD NDOSE NOT CHANGEDCONCOMITANT PROCEDURE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-08-19 2020-08-19 B3B3 mRNA-1273-P201AEmRNA-1273-P201-US203-1097US2031097A@DOSE 2 - 2020-08-03T16:14AE-002 RIGHT ROTATOR CUFF TEAR Rotator cuff tear F™/½Rotator cuff syndrome F™/»Joint related disorders NEC F™¥Joint disorders F˜ñ-ADVERSE EVENT PIMMCMusculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMILD NNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-08-24 2020-10-05 B8Bb mRNA-1273-P201AEmRNA-1273-P201-US203-1102US2031102ADOSE 2 - 2020-08-03T17:52AE-001 COVID 19 INFECTION COVID-19 F™ß¬COVID-19 F™ß¬Coronavirus infections F™àžViral infectious disorders F™OÎADVERSE EVENT Infections and infestations F˜ëùInfections and infestations F˜ëùMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-08-28 2020-08-28 B:B: mRNA-1273-P201AEmRNA-1273-P201-US203-1103US2031103ADOSE 1 - 2020-06-29T13:09AE-001 SINUS CONGESTION Sinus congestion F™5¦Sinus congestion F™5¦Paranasal sinus disorders (excl infections and neoplasms) F™5§Upper respiratory tract disorders (excl infections) F™K`ADVERSE EVENT Respiratory, thoracic and mediastinal disorders F™-ÒRespiratory, thoracic and mediastinal disorders F™-ÒMILD NDOSE DELAYED CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-27 2020-07-28 BB mRNA-1273-P201AEmRNA-1273-P201-US203-1104US2031104ADOSE 2 - 2020-07-31T13:14AE-001 ABSCESSED TOOTH Tooth abscess F™BpTooth abscess F™BpDental and oral soft tissue infections F˜Æ¦Infections - pathogen unspecified F˜ë÷ADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION, CONCOMITANT PROCEDURENOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-10-07 2020-10-07 BhBh mRNA-1273-P201AEmRNA-1273-P201-US203-1105US2031105ADOSE 1 - 2020-06-26T09:19AE-0011080FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝREACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-28 2020-07-09 A0AàP7D mRNA-1273-P201AEmRNA-1273-P201-US203-1108US2031108ADOSE 2 - 2020-08-03T10:36AE-001 ACID REFLUX Acid reflux (esophageal) F™›¸Gastrooesophageal reflux disease F˜Ü]Gastrointestinal atonic and hypomotility disorders NEC F˜ÜGastrointestinal motility and defaecation conditions F˜Ü¹ADVERSE EVENT PIMMCGastrointestinal disorders F˜Ü›Gastrointestinal disorders F˜Ü›MILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-10-20 2020-11-01 BkBw mRNA-1273-P201AEmRNA-1273-P201-US203-1112US2031112ADOSE 2 - 2020-07-27T09:46AE-003 GENERALIZED ARTHALGIA Generalized joint pain F™ŠfArthralgia F˜£'Joint related signs and symptoms F˜ñ:Joint disorders F˜ñ-REACTOGENICITY Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kSEVERE NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-27T22:302020-07-29T08:00B B"P1DT9H30M mRNA-1273-P201AEmRNA-1273-P201-US203-1112US2031112A DOSE 2 - 2020-07-27T09:46AE-001 FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝREACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝSEVERE NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-28T22:302020-07-29T08:00B!B"PT9H30M mRNA-1273-P201AEmRNA-1273-P201-US203-1112US2031112A0DOSE 2 - 2020-07-27T09:46AE-004 HEADACHE Headache F˜á‹Headache F˜á‹Headaches NEC F˜á¡Headaches F˜áŸREACTOGENICITY Nervous system disorders F™•Nervous system disorders F™•SEVERE NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-27T22:302020-07-29T08:00B B"P1DT9H30M mRNA-1273-P201AEmRNA-1273-P201-US203-1112US2031112A@DOSE 2 - 2020-07-27T09:46AE-002 GENERALIZED MYALGIA Myalgia F™{Myalgia F™{Muscle pains F™#Muscle disorders F™REACTOGENICITY Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kSEVERE NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-27T22:302020-07-29T08:00B B"P1DT9H30M mRNA-1273-P201AEmRNA-1273-P201-US203-1116US2031116ADOSE 2 - 2020-07-30T11:14AE-001 UPPER RESPIRATORY INFECTION Upper respiratory infection F™K\Upper respiratory tract infection F™KbUpper respiratory tract infections F™KeInfections - pathogen unspecified F˜ë÷ADVERSE EVENT Infections and infestations F˜ëùInfections and infestations F˜ëùMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-10-11 2020-10-18 BiBp mRNA-1273-P201AEmRNA-1273-P201-US203-1121US2031121ADOSE 2 - 2020-07-28T14:10AE-004 ACID REFLUX Acid reflux (esophageal) F™›¸Gastrooesophageal reflux disease F˜Ü]Gastrointestinal atonic and hypomotility disorders NEC F˜ÜGastrointestinal motility and defaecation conditions F˜Ü¹ADVERSE EVENT Gastrointestinal disorders F˜Ü›Gastrointestinal disorders F˜Ü›MILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2021-01-01 2021-02-12 BºBä mRNA-1273-P201AEmRNA-1273-P201-US203-1121US2031121A DOSE 2 - 2020-07-28T14:10AE-003 ORAL CANDIDIASIS Oral candidiasis F™sOral candidiasis F™sCandida infections F˜²^Fungal infectious disorders F˜ÚøADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2021-02-06 2021-02-23 BÞBï mRNA-1273-P201AEmRNA-1273-P201-US203-1121US2031121A0DOSE 1 - 2020-06-30T14:02AE-001 LOCALIZED SWELLING TO RIGHT LOWER EXTREMITY Unilateral leg swelling F™Ò2Peripheral swelling F™U¿General signs and symptoms NEC F˜ÝGeneral system disorders NEC F˜ÝADVERSE EVENT General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-02 2020-07-15 A0B mRNA-1273-P201AEmRNA-1273-P201-US203-1121US2031121A@DOSE 2 - 2020-07-28T14:10AE-002 UPPER RESPIRATORY INFECTION Upper respiratory infection F™K\Upper respiratory tract infection F™KbUpper respiratory tract infections F™KeInfections - pathogen unspecified F˜ë÷ADVERSE EVENT Infections and infestations F˜ëùInfections and infestations F˜ëùMILD NNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-11-22 2020-11-30 B’Bš mRNA-1273-P201AEmRNA-1273-P201-US203-1129US2031129ADOSE 2 - 2020-07-30T15:19AE-001 SINUSITIS Sinusitis F™5±Sinusitis F™5±Upper respiratory tract infections F™KeInfections - pathogen unspecified F˜ë÷ADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-08-23 2020-08-27 B6B: mRNA-1273-P201AEmRNA-1273-P201-US204-1005US2041005ADOSE 2 - 2020-06-26T12:02AE-001 HEADACHE Headache F˜á‹Headache F˜á‹Headaches NEC F˜á¡Headaches F˜áŸADVERSE EVENT Nervous system disorders F™•Nervous system disorders F™•MILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-10-12 2020-10-15 B‰BŒ mRNA-1273-P201AEmRNA-1273-P201-US204-1005US2041005A DOSE 2 - 2020-06-26T12:02AE-002 LETHARGY Lethargy F˜õHLethargy F˜õHDisturbances in consciousness NEC F˜ËENeurological disorders NEC F™ùADVERSE EVENT Nervous system disorders F™•Nervous system disorders F™•MILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-10-12 2020-10-15 B‰BŒ mRNA-1273-P201AEmRNA-1273-P201-US204-1007US2041007ADOSE 2 - 2020-06-29T11:19AE-002 SPONTANEOUS ABORTION Spontaneous abortion F™9WAbortion spontaneous F˜—jAbortions spontaneous F˜—kAbortions and stillbirth F˜—SADVERSE EVENT PIMMCPregnancy, puerperium and perinatal conditions F™%iPregnancy, puerperium and perinatal conditions F™%iMILD YNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNY1PART A FOLLOW-UP 2020-12-17 2020-12-17 BÈBÈ mRNA-1273-P201AEmRNA-1273-P201-US204-1008US2041008ADOSE 2 - 2020-07-01T15:55AE-0012080FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝREACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE RELATED RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-02 2020-07-10 B B(P3D mRNA-1273-P201AEmRNA-1273-P201-US204-1016US2041016ADOSE 2 - 2020-07-14T13:22AE-001 VIRAL SYNDROME OF UNKNOWN ETIOLOGY Viral syndrome F™ŒûViral infection F™OåViral infections NEC F™OéViral infectious disorders F™OÎADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NNOT APPLICABLE NONE NOT RELATEDNOT APPLICABLERECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-12-09 2021-01-21 B¿Bê mRNA-1273-P201AEmRNA-1273-P201-US204-1019US2041019ADOSE 2 - 2020-06-30T13:43AE-001 LEFT HAND LACERATION Laceration of hand F˜ò¢Skin laceration F™|BSkin injuries NEC F™³Injuries NEC F˜ìâADVERSE EVENT PIMMCInjury, poisoning and procedural complications F˜ìåInjury, poisoning and procedural complications F˜ìåMILD NDOSE NOT CHANGEDCONCOMITANT PROCEDURE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-06 2020-07-13 B#B* mRNA-1273-P201AEmRNA-1273-P201-US204-1022US2041022ADOSE 2 - 2020-07-06T12:39AE-001 COVID-19 INFECTION COVID-19 F™ß¬COVID-19 F™ß¬Coronavirus infections F™àžViral infectious disorders F™OÎADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-10-31 2020-11-15 B•B¤ mRNA-1273-P201AEmRNA-1273-P201-US204-1023US2041023ADOSE 2 - 2020-06-29T16:32AE-001 VIRAL SYNDROME OF UNKNOWN ETIOLOGY Viral syndrome F™ŒûViral infection F™OåViral infections NEC F™OéViral infectious disorders F™OÎADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-09-24 2020-10-02 BtB| mRNA-1273-P201AEmRNA-1273-P201-US204-1027US2041027ADOSE 2 - 2020-06-29T10:54AE-002 CHEST TIGHTNESS/PRESSURE Chest tightness F˜·¬Chest discomfort F˜·•Pain and discomfort NEC F™ÜGeneral system disorders NEC F˜ÝADVERSE EVENT General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-09-27 2020-11-03 BwBœ mRNA-1273-P201AEmRNA-1273-P201-US204-1027US2041027A DOSE 2 - 2020-06-29T10:54AE-003 COUGH Cough F˜ÂXCough F˜ÂXCoughing and associated symptoms F˜ÂaRespiratory disorders NEC F™-¼ADVERSE EVENT Respiratory, thoracic and mediastinal disorders F™-ÒRespiratory, thoracic and mediastinal disorders F™-ÒMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-09-27 2020-11-03 BwBœ mRNA-1273-P201AEmRNA-1273-P201-US204-1027US2041027A0DOSE 2 - 2020-06-29T10:54AE-004 VIRAL SYNDROME OF UNKNOWN ETIOLOGY Viral syndrome F™ŒûViral infection F™OåViral infections NEC F™OéViral infectious disorders F™OÎADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-12-05 2020-12-11 B¼BÂ mRNA-1273-P201AEmRNA-1273-P201-US204-1027US2041027A@DOSE 2 - 2020-06-29T10:54AE-001 VOMITING Vomiting F™PÔVomiting F™PÔNausea and vomiting symptoms F™Gastrointestinal signs and symptoms F˜ÜÜADVERSE EVENT Gastrointestinal disorders F˜Ü›Gastrointestinal disorders F˜Ü›MILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-09-27 2020-11-03 BwBœ mRNA-1273-P201AEmRNA-1273-P201-US204-1046US2041046ADOSE 2 - 2020-07-02T09:33AE-002 BRONCHITIS Bronchitis F˜¯³Bronchitis F˜¯³Lower respiratory tract and lung infections F˜øInfections - pathogen unspecified F˜ë÷ADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-11-06 2020-11-15 BœB¥ mRNA-1273-P201AEmRNA-1273-P201-US204-1046US2041046A DOSE 2 - 2020-07-02T09:33AE-004 WORSENING DEPRESSION Depression worsened F˜ÆîDepression F˜ÆÚDepressive disorders F˜ÆñDepressed mood disorders and disturbances F˜Æ×ADVERSE EVENT PIMMCPsychiatric disorders F™'·Psychiatric disorders F™'·MILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERING/RESOLVING NNNNNN1PART A FOLLOW-UP 2020-12-02 B¶. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US204-1046US2041046A0DOSE 2 - 2020-07-02T09:33AE-003 LOW BACK SPASMS Back muscle spasms F™ŸµMuscle spasms F™.Muscle related signs and symptoms NEC F™&Muscle disorders F™ADVERSE EVENT PIMMCMusculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERING/RESOLVING NNNNNN1PART A FOLLOW-UP 2021-02-03 Bõ. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US204-1046US2041046A@DOSE 2 - 2020-07-02T09:33AE-001 LEFT OTITIS MEDIA Otitis media F™¶Otitis media F™¶Ear infections F˜Í=Infections - pathogen unspecified F˜ë÷ADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-10-14 2020-10-25 B…B mRNA-1273-P201AEmRNA-1273-P201-US204-1047US2041047ADOSE 2 - 2020-06-30T08:56AE-001 COVID-19 INFECTION COVID-19 F™ß¬COVID-19 F™ß¬Coronavirus infections F™àžViral infectious disorders F™OÎADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-08-04 2020-08-13 B@BI mRNA-1273-P201AEmRNA-1273-P201-US204-1048US2041048ADOSE 2 - 2020-07-01T15:45AE-001 VIRAL SYNDROME OF UNKNOWN ETIOLOY Viral syndrome F™ŒûViral infection F™OåViral infections NEC F™OéViral infectious disorders F™OÎADVERSE EVENT Infections and infestations F˜ëùInfections and infestations F˜ëùMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2021-01-25 2021-01-29 BîBò mRNA-1273-P201AEmRNA-1273-P201-US204-1049US2041049ADOSE 2 - 2020-07-14T16:00AE-001 BILATERAL LEG TREMORS Tremor limb F™DœTremor F™D•Tremor (excl congenital) F™D–Movement disorders (incl parkinsonism) F™ADVERSE EVENT PIMMCNervous system disorders F™•Nervous system disorders F™•MILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERING/RESOLVING NNNNNN1PART A FOLLOW-UP 2020-09-09 Bb. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US204-1051US2041051ADOSE 2 - 2020-06-30T11:57AE-001 VITAMIN B12 DEFICIENCY Vitamin B12 deficiency F™PyVitamin B12 deficiency F™PyWater soluble vitamin deficiencies F™QbVitamin related disorders F™P“ADVERSE EVENT PIMMCMetabolism and nutrition disorders F™©Metabolism and nutrition disorders F™©MILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERING/RESOLVING NNNNNN1PART A FOLLOW-UP 2020-10-16 B‰. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US204-1056US2041056ADOSE 2 - 2020-06-30T10:11AE-001 GENERALIZED ACNE Acne F˜˜pAcne F˜˜pAcnes F˜˜qSkin appendage conditions F™5ÞADVERSE EVENT PIMMCSkin and subcutaneous tissue disorders F™5ÑSkin and subcutaneous tissue disorders F™5ÑMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERING/RESOLVING NNNNNN1PART A FOLLOW-UP 2021-02-08 Bü. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US204-1060US2041060ADOSE 1 - 2020-06-02T09:25AE-002 HARDNESS AT INJECTION SITE Injection site induration F˜ì»Injection site induration F˜ì»Injection site reactions F˜ìÑAdministration site reactions F˜›¤REACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE RELATED RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-03 2020-06-09 A A€P1D mRNA-1273-P201AEmRNA-1273-P201-US204-1060US2041060A DOSE 1 - 2020-06-02T09:25AE-001 SWELLING AT INJECTION SITE Swelling of injection site F™=HInjection site swelling F™g1Injection site reactions F˜ìÑAdministration site reactions F˜›¤REACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE RELATED RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-03 2020-06-09 A A€P1D mRNA-1273-P201AEmRNA-1273-P201-US204-1061US2041061ADOSE 2 - 2020-07-06T12:06AE-001 URINARY TRACT INFECTION Urinary tract infection F™LkUrinary tract infection F™LkUrinary tract infections F™LqInfections - pathogen unspecified F˜ë÷ADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-06 2020-07-16 B#B- mRNA-1273-P201AEmRNA-1273-P201-US204-1073US2041073ADOSE 1 - 2020-06-02T17:30AE-0011080FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝREACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE RELATED NOT APPLICABLERECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-03T09:382020-06-12T12:38A A°P2DT19H8M mRNA-1273-P201AEmRNA-1273-P201-US204-1073US2041073A DOSE 2 - 2020-06-30T16:35AE-0022080FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝREACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-03 2020-07-11 B B(P5D mRNA-1273-P201AEmRNA-1273-P201-US204-1076US2041076ADOSE 2 - 2020-07-06T12:29AE-008 CHEST TIGHTNESS-UNKNOWN ORIGIN Chest tightness F˜·¬Chest discomfort F˜·•Pain and discomfort NEC F™ÜGeneral system disorders NEC F˜ÝADVERSE EVENT General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT APPLICABLERECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-08-10 2020-08-13 BFBI mRNA-1273-P201AEmRNA-1273-P201-US204-1076US2041076A DOSE 2 - 2020-07-06T12:29AE-007 BILATERAL EYE INFECTION Eye infection F˜Ô¹Eye infection F˜Ô¹Eye and eyelid infections F˜Ô¥Infections - pathogen unspecified F˜ë÷ADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-10-19 2020-11-16 BŒB¨ mRNA-1273-P201AEmRNA-1273-P201-US204-1076US2041076A0DOSE 1 - 2020-06-02T11:57AE-0041080FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝREACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-02T17:002020-06-11T22:00AA P2DT10H3M mRNA-1273-P201AEmRNA-1273-P201-US204-1076US2041076A@DOSE 2 - 2020-07-06T12:29AE-001 FATIGUE DUE TO SEASONAL ALLERGIES Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝADVERSE EVENT General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-06 2020-07-25 B#B6 mRNA-1273-P201AEmRNA-1273-P201-US204-1076US2041076APDOSE 1 - 2020-06-02T11:57AE-0051070HEADACHE Headache F˜á‹Headache F˜á‹Headaches NEC F˜á¡Headaches F˜áŸREACTOGENICITY Nervous system disorders F™•Nervous system disorders F™•MILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-03 2020-06-12 A A°P4D mRNA-1273-P201AEmRNA-1273-P201-US204-1076US2041076A`DOSE 2 - 2020-07-06T12:29AE-0032070HEADACHE Headache F˜á‹Headache F˜á‹Headaches NEC F˜á¡Headaches F˜áŸREACTOGENICITY Nervous system disorders F™•Nervous system disorders F™•MILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-06T13:302020-07-15 B#B,P3D mRNA-1273-P201AEmRNA-1273-P201-US204-1076US2041076ApDOSE 2 - 2020-07-06T12:29AE-010 HEADACHE Headache F˜á‹Headache F˜á‹Headaches NEC F˜á¡Headaches F˜áŸADVERSE EVENT Nervous system disorders F™•Nervous system disorders F™•MILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT APPLICABLERECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-08-10 2020-08-13 BFBI mRNA-1273-P201AEmRNA-1273-P201-US204-1076US2041076A€DOSE 2 - 2020-07-06T12:29AE-0022090MYALGIA LEFT ARM Myalgia F™{Myalgia F™{Muscle pains F™#Muscle disorders F™REACTOGENICITY Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMILD NDOSE NOT CHANGEDNONE RELATED RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-06T13:302020-07-14T13:30B#B+P1DT1H1M mRNA-1273-P201AEmRNA-1273-P201-US204-1076US2041076ADOSE 2 - 2020-07-06T12:29AE-009 SORE THROAT Sore throat F™8Oropharyngeal pain F™¡_Upper respiratory tract signs and symptoms F™KiRespiratory tract signs and symptoms F™Ë}ADVERSE EVENT Respiratory, thoracic and mediastinal disorders F™-ÒRespiratory, thoracic and mediastinal disorders F™-ÒMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT APPLICABLERECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-08-10 2020-08-13 BFBI mRNA-1273-P201AEmRNA-1273-P201-US204-1077US2041077ADOSE 2 - 2020-07-01T11:05AE-002 ELEVATED BLOOD PRESSURE Increased blood pressure F˜ëBlood pressure increased F˜¬öVascular tests NEC (incl blood pressure) F™N†Cardiac and vascular investigations (excl enzyme tests) F˜³ØADVERSE EVENT PIMMCInvestigations F˜ïëInvestigations F˜ïëSEVERE NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED NOT RECOVERED/NOT RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-14 B*. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US204-1077US2041077A DOSE 2 - 2020-07-01T11:05AE-001 BILATERAL NUMBNESS/TINGLING IN HANDS Paresthesia hand F™k‚Paraesthesia F™oParaesthesias and dysaesthesias F™|Neurological disorders NEC F™ùADVERSE EVENT PIMMCNervous system disorders F™•Nervous system disorders F™•MILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED NOT RECOVERED/NOT RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-05 B!. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US204-1080US2041080ADOSE 2 - 2020-07-01T16:37AE-001 COVID-19 INFECTION COVID-19 F™ß¬COVID-19 F™ß¬Coronavirus infections F™àžViral infectious disorders F™OÎADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2021-01-02 2021-01-06 BÖBÚ mRNA-1273-P201AEmRNA-1273-P201-US204-1092US2041092ADOSE 1 - 2020-06-08T16:05AE-001 HYPERTENSION Hypertension F˜ç¤Hypertension F˜ç¤Vascular hypertensive disorders NEC F˜ç¦Vascular hypertensive disorders F™uÎADVERSE EVENT PIMMCVascular disorders F™NYVascular disorders F™NYMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERING/RESOLVING NNNNNN1BLINDED TREATMENT 2020-06-24 B. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US204-1103US2041103ADOSE 2 - 2020-07-24T11:46AE-003 GASTROESOPHAGEAL REFLUX DISEASE Gastroesophageal reflux disease F™›ºGastrooesophageal reflux disease F˜Ü]Gastrointestinal atonic and hypomotility disorders NEC F˜ÜGastrointestinal motility and defaecation conditions F˜Ü¹ADVERSE EVENT PIMMCGastrointestinal disorders F˜Ü›Gastrointestinal disorders F˜Ü›MILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-08-28 2020-10-15 B@Bp mRNA-1273-P201AEmRNA-1273-P201-US204-1103US2041103A DOSE 2 - 2020-07-24T11:46AE-002 ESOPHAGEAL FOOD BOLUS OBSTRUCTION Esophageal food impaction F™–§Oesophageal food impaction F™–ŸGastrointestinal signs and symptoms NEC F™žGastrointestinal signs and symptoms F˜ÜÜADVERSE EVENT PIMMCGastrointestinal disorders F˜Ü›Gastrointestinal disorders F˜Ü›MILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-08-16 2020-08-16 B4B4 mRNA-1273-P201AEmRNA-1273-P201-US204-1103US2041103A0DOSE 1 - 2020-06-26T11:33AE-001 LOW PLATELETS Low platelets F˜÷ÚPlatelet count decreased F™!HPlatelet analyses F™!CHaematology investigations (incl blood groups) F˜à#ADVERSE EVENT Investigations F˜ïëInvestigations F˜ïëMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED UNKNOWN NNNNNN1BLINDED TREATMENT 2020-07-24T10:40 B. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US204-1104US2041104ADOSE 1 - 2020-06-26T11:47AE-001 INSOMNIA Insomnia F˜î%Insomnia F˜î%Disturbances in initiating and maintaining sleep F˜ËFSleep disorders and disturbances F™6ŸADVERSE EVENT PIMMCPsychiatric disorders F™'·Psychiatric disorders F™'·MILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED NOT RECOVERED/NOT RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-01 A`. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US204-1109US2041109ADOSE 2 - 2020-07-27T11:44AE-001 SINUS INFECTION Sinus infection F™5©Sinusitis F™5±Upper respiratory tract infections F™KeInfections - pathogen unspecified F˜ë÷ADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-12-25 2021-01-05 B·BÂ mRNA-1273-P201AEmRNA-1273-P201-US204-1112US2041112ADOSE 1 - 2020-06-26T13:02AE-001 ELEVATED DIASTOLIC BLOOD PRESSURE GRADE 0 TO GRADE 2 POST VACCINATION Blood pressure diastolic increased F˜¬ëBlood pressure diastolic increased F˜¬ëVascular tests NEC (incl blood pressure) F™N†Cardiac and vascular investigations (excl enzyme tests) F˜³ØADVERSE EVENT Investigations F˜ïëInvestigations F˜ïëMODERATENDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-06-26T14:172020-07-06T12:40AA° mRNA-1273-P201AEmRNA-1273-P201-US204-1114US2041114ADOSE 2 - 2020-08-03T11:51AE-001 THORACIC BACK PAIN Thoracic back pain F™Ó?Back pain F˜¦Musculoskeletal and connective tissue pain and discomfort F™£Musculoskeletal and connective tissue disorders NEC F™iADVERSE EVENT PIMMCMusculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2021-02-13 2021-02-19 BéBï mRNA-1273-P201AEmRNA-1273-P201-US204-1119US2041119ADOSE 2 - 2020-08-04T10:05AE-003 HYPOTHYROIDISM Hypothyroidism F˜èúHypothyroidism F˜èúThyroid hypofunction disorders F™A]Thyroid gland disorders F™A[ADVERSE EVENT PIMMCEndocrine disorders F˜ÏêEndocrine disorders F˜ÏêMILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERING/RESOLVING NNNNNN1PART A FOLLOW-UP 2020-11-11 B. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US204-1119US2041119A DOSE 2 - 2020-08-04T10:05AE-002 CYST ON SPINAL NERVE Nervous system cyst F™Ç×Nervous system cyst F™Ç×Nervous system cysts and polyps F™ íNervous system neoplasms benign F™™ADVERSE EVENT PIMMCNervous system disorders F™•Nervous system disorders F™•MILD YNOT APPLICABLE CONCOMITANT PROCEDURE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNYNN1BLINDED TREATMENT 2020-08-10 2020-11-16 B$B† mRNA-1273-P201AEmRNA-1273-P201-US204-1119US2041119A0DOSE 2 - 2020-08-04T10:05AE-001 SPONDYLOLISTHESIS Spondylolisthesis F™Ž¾Spondylolisthesis F™Ž¾Spine and neck deformities F˜ÅìMusculoskeletal and connective tissue deformities (incl intervertebral disc disorders)F™YADVERSE EVENT PIMMCMusculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMILD YNOT APPLICABLE CONCOMITANT MEDICATION, CONCOMITANT PROCEDURENOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNYNN1BLINDED TREATMENT 2020-08-10 2020-11-16 B$B† mRNA-1273-P201AEmRNA-1273-P201-US204-1122US2041122ADOSE 1 - 2020-06-29T09:22AE-001 CIRCUMFERENTIAL REDNESS ABOVE INJECTION SITE ON LEFT ARM Injection site redness F˜ìÒInjection site erythema F˜ìInjection site reactions F˜ìÑAdministration site reactions F˜›¤ADVERSE EVENT General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-08 2020-07-16 A B mRNA-1273-P201AEmRNA-1273-P201-US204-1126US2041126ADOSE 1 - 2020-06-26T12:45AE-0011070HEADACHE Headache F˜á‹Headache F˜á‹Headaches NEC F˜á¡Headaches F˜áŸREACTOGENICITY Nervous system disorders F™•Nervous system disorders F™•MILD NDOSE NOT CHANGEDNONE RELATED RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-29 2020-07-04 A@AP2D mRNA-1273-P201AEmRNA-1273-P201-US204-1142US2041142ADOSE 2 - 2020-07-31T11:50AE-001 HYPERCHOLESTEROLEMIA Hypercholesterolemia F˜æüHypercholesterolaemia F˜æûElevated cholesterol F˜ÏLipid metabolism disorders F˜Ê…ADVERSE EVENT PIMMCMetabolism and nutrition disorders F™©Metabolism and nutrition disorders F™©MILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2021-01-27 2021-02-15 BÒBå mRNA-1273-P201AEmRNA-1273-P201-US204-1145US2041145A AE-001 RIGHT THUMB PIP ARTHRITIS Finger arthritis F™•rArthritis F˜£.Arthropathies NEC F˜£TJoint disorders F˜ñ-ADVERSE EVENT PIMMCMusculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED NOT RECOVERED/NOT RESOLVED NNNNNN1SCREENING 2020-07-01 Á. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US204-1146US2041146ADOSE 1 - 2020-07-02T17:03AE-001 CELLULITIS- RIGHT FOREARM Cellulitis of arm F™UÝCellulitis F˜µJBacterial infections NEC F˜¦OBacterial infectious disorders F˜¦2ADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-05 2020-07-10 A@A mRNA-1273-P201AEmRNA-1273-P201-US204-1146US2041146A DOSE 2 - 2020-07-31T08:42AE-002 LEUKOPENIA Leukopenia F˜õÀLeukopenia F˜õÀLeukopenias NEC F˜õÁWhite blood cell disorders F™QÒADVERSE EVENT Blood and lymphatic system disorders F˜«QBlood and lymphatic system disorders F˜«QMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERING/RESOLVING NNNNNN1BLINDED TREATMENT 2020-07-31 B. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US204-1155US2041155ADOSE 2 - 2020-08-03T14:15AE-002 DEPRESSION Depression F˜ÆÚDepression F˜ÆÚDepressive disorders F˜ÆñDepressed mood disorders and disturbances F˜Æ×ADVERSE EVENT PIMMCPsychiatric disorders F™'·Psychiatric disorders F™'·MILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERING/RESOLVING NNNNNN1PART A FOLLOW-UP 2021-01-03 B¶. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US204-1155US2041155A DOSE 2 - 2020-08-03T14:15AE-0012070HEADACHE Headache F˜á‹Headache F˜á‹Headaches NEC F˜á¡Headaches F˜áŸREACTOGENICITY Nervous system disorders F™•Nervous system disorders F™•MILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-08-03T18:132020-08-11T13:09BB%PT22H54M mRNA-1273-P201AEmRNA-1273-P201-US205-1009US2051009ADOSE 1 - 2020-06-02T10:38AE-002 MUSCULOSKELETAL BACK PAIN Back pain F˜¦Back pain F˜¦Musculoskeletal and connective tissue pain and discomfort F™£Musculoskeletal and connective tissue disorders NEC F™iADVERSE EVENT Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-06-19 2020-07-24 BB5 mRNA-1273-P201AEmRNA-1273-P201-US205-1010US2051010ADOSE 1 - 2020-06-02T13:37AE-001 URINARY TRACT INFECTION Urinary tract infection F™LkUrinary tract infection F™LkUrinary tract infections F™LqInfections - pathogen unspecified F˜ë÷ADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-14 2020-08-03 AÐB? mRNA-1273-P201AEmRNA-1273-P201-US205-1011US2051011ADOSE 2 - 2020-07-07T10:28AE-001 TENNIS ELBOW BILATERAL Tennis elbow F™?zEpicondylitis F˜ÐûMuscle, tendon and ligament injuries F™Injuries NEC F˜ìâADVERSE EVENT PIMMCInjury, poisoning and procedural complications F˜ìåInjury, poisoning and procedural complications F˜ìåMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-08-21 2020-10-31 BPB— mRNA-1273-P201AEmRNA-1273-P201-US205-1012US2051012ADOSE 1 - 2020-06-02T14:37AE-001 CONTACT DERMATITIS LEFT ARM Contact dermatitis F˜À¦Dermatitis contact F˜ÇDermatitis and eczema F˜ÇEpidermal and dermal conditions F˜ÑADVERSE EVENT Skin and subcutaneous tissue disorders F™5ÑSkin and subcutaneous tissue disorders F™5ÑMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-03 2020-06-05T00:00A A@ mRNA-1273-P201AEmRNA-1273-P201-US205-1018US2051018ADOSE 2 - 2020-07-07T15:07AE-002 LEFT CORNEAL ABRASION Corneal abrasion F˜ÁhCorneal abrasion F˜ÁhEye injuries NEC F™šInjuries NEC F˜ìâADVERSE EVENT PIMMCInjury, poisoning and procedural complications F˜ìåInjury, poisoning and procedural complications F˜ìåMODERATENNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2020-10-13 2020-10-13 B€B€ mRNA-1273-P201AEmRNA-1273-P201-US205-1022US2051022ADOSE 2 - 2020-07-07T09:45AE-002 TOE INFECTION RIGHT FOOT (2-4 DIGITS) Infected toe F˜ëšLocalised infection F˜÷FInfections NEC F˜ìInfections - pathogen unspecified F˜ë÷ADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMODERATENNOT APPLICABLE CONCOMITANT MEDICATION RELATED RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2020-12-04 2021-01-14 B¹Bâ mRNA-1273-P201AEmRNA-1273-P201-US205-1022US2051022A DOSE 2 - 2020-07-07T09:45AE-001 ODYNOPHAGIA Odynophagia F™Odynophagia F™Oral soft tissue signs and symptoms F™Oral soft tissue conditions F™¥ADVERSE EVENT Gastrointestinal disorders F˜Ü›Gastrointestinal disorders F˜Ü›MILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-28 2020-08-04 B8B? mRNA-1273-P201AEmRNA-1273-P201-US205-1026US2051026ADOSE 2 - 2020-06-30T10:13AE-002 FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝREACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝSEVERE NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-02 2020-07-03 BB P2D mRNA-1273-P201AEmRNA-1273-P201-US205-1027US2051027ADOSE 2 - 2020-07-07T11:27AE-005 JOINT ACHES IN SEVERAL JOINTS Aching joints F˜˜AArthralgia F˜£'Joint related signs and symptoms F˜ñ:Joint disorders F˜ñ-REACTOGENICITY Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kSEVERE NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-08 2020-07-09T00:00BB P2D mRNA-1273-P201AEmRNA-1273-P201-US205-1027US2051027A DOSE 2 - 2020-07-07T11:27AE-003 FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝREACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝSEVERE NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-07 2020-07-09T00:00BB P3D mRNA-1273-P201AEmRNA-1273-P201-US205-1027US2051027A0DOSE 2 - 2020-07-07T11:27AE-002 HEADACHE Headache F˜á‹Headache F˜á‹Headaches NEC F˜á¡Headaches F˜áŸREACTOGENICITY Nervous system disorders F™•Nervous system disorders F™•SEVERE NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-07 2020-07-09T00:00BB P3D mRNA-1273-P201AEmRNA-1273-P201-US205-1027US2051027A@DOSE 2 - 2020-07-07T11:27AE-004 MUSCLE ACHES ALL OVER BODY Generalized muscle aches F™ŠiMyalgia F™{Muscle pains F™#Muscle disorders F™REACTOGENICITY Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kSEVERE NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-07 2020-07-09T00:00BB P3D mRNA-1273-P201AEmRNA-1273-P201-US205-1032US2051032ADOSE 1 - 2020-06-02T11:06AE-002 RUNNY NOSE (UNKNOWN ETIOLOGY) Runny nose F™0Rhinorrhoea F™/=Upper respiratory tract signs and symptoms F™KiRespiratory tract signs and symptoms F™Ë}ADVERSE EVENT Respiratory, thoracic and mediastinal disorders F™-ÒRespiratory, thoracic and mediastinal disorders F™-ÒMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-23 2020-07-02 BB mRNA-1273-P201AEmRNA-1273-P201-US205-1033US2051033ADOSE 2 - 2020-07-07T10:16AE-002 JOINT ACHES IN SEVERAL JOINTS Aching joints F˜˜AArthralgia F˜£'Joint related signs and symptoms F˜ñ:Joint disorders F˜ñ-REACTOGENICITY Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kSEVERE NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-07 2020-07-15 B"B*P2D mRNA-1273-P201AEmRNA-1273-P201-US205-1033US2051033A DOSE 2 - 2020-07-07T10:16AE-003 DIARRHEA Diarrhea F˜È7Diarrhoea F˜È?Diarrhoea (excl infective) F˜È@Gastrointestinal motility and defaecation conditions F˜Ü¹ADVERSE EVENT Gastrointestinal disorders F˜Ü›Gastrointestinal disorders F˜Ü›MILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-09 2020-07-10 B$B% mRNA-1273-P201AEmRNA-1273-P201-US205-1033US2051033A0DOSE 2 - 2020-07-07T10:16AE-0052080FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝREACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE RELATED RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-07 2020-07-15 B"B*P2D mRNA-1273-P201AEmRNA-1273-P201-US205-1033US2051033A@DOSE 2 - 2020-07-07T10:16AE-004 MUSCLE ACHES ALL OVER BODY Generalized muscle aches F™ŠiMyalgia F™{Muscle pains F™#Muscle disorders F™REACTOGENICITY Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kSEVERE NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-07 2020-07-08T00:00B"B#P2D mRNA-1273-P201AEmRNA-1273-P201-US205-1034US2051034ADOSE 1 - 2020-06-03T09:35AE-001 UPPER RESPIRATORY INFECTION Upper respiratory infection F™K\Upper respiratory tract infection F™KbUpper respiratory tract infections F™KeInfections - pathogen unspecified F˜ë÷ADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-06-09 2020-06-15 ApAÐ mRNA-1273-P201AEmRNA-1273-P201-US205-1035US2051035ADOSE 2 - 2020-07-08T14:01AE-004 POSITIVE COVID 19 INFECTION COVID-19 F™ß¬COVID-19 F™ß¬Coronavirus infections F™àžViral infectious disorders F™OÎADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-09-03 2021-03-26 B\C€ mRNA-1273-P201AEmRNA-1273-P201-US205-1036US2051036ADOSE 2 - 2020-07-02T14:22AE-001 ACNE VULGARIS ON BACK Acne vulgaris F˜˜‡Acne F˜˜pAcnes F˜˜qSkin appendage conditions F™5ÞADVERSE EVENT Skin and subcutaneous tissue disorders F™5ÑSkin and subcutaneous tissue disorders F™5ÑMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-23 2021-02-04 B4Bø mRNA-1273-P201AEmRNA-1273-P201-US205-1040US2051040ADOSE 1 - 2020-06-05T14:28AE-002 CONTACT DERMATITIS (THIGHS, TRUNK, FOREARMS, ANKLES) Contact dermatitis F˜À¦Dermatitis contact F˜ÇDermatitis and eczema F˜ÇEpidermal and dermal conditions F˜ÑADVERSE EVENT PIMMCSkin and subcutaneous tissue disorders F™5ÑSkin and subcutaneous tissue disorders F™5ÑMODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-06-20 2020-06-27 BB mRNA-1273-P201AEmRNA-1273-P201-US205-1042US2051042ADOSE 2 - 2020-07-01T13:22AE-003 STAPH POSITIVE URINALYSIS Staphylococcus test positive F™¨$Staphylococcus test positive F™¨$Bacteria identification and serology (excl mycobacteria) F˜¦ Microbiology and serology investigations F™ ADVERSE EVENT PIMMCInvestigations F˜ïëInvestigations F˜ïëMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-09-16 2020-09-30 BkBy mRNA-1273-P201AEmRNA-1273-P201-US205-1042US2051042A DOSE 1 - 2020-06-02T11:52AE-001 TOOTHACHE Toothache F™B—Toothache F™B—Dental pain and sensation disorders F™B‘Dental and gingival conditions F™BrADVERSE EVENT Gastrointestinal disorders F˜Ü›Gastrointestinal disorders F˜Ü›MODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION, CONCOMITANT PROCEDURENOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-06-04 2020-06-24 A0B mRNA-1273-P201AEmRNA-1273-P201-US205-1042US2051042A0DOSE 2 - 2020-07-01T13:22AE-002 URETHRITIS Urethritis F™LUrethritis F™LUrinary tract infections F™LqInfections - pathogen unspecified F˜ë÷ADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùSEVERE NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN3PART A FOLLOW-UP 2020-08-16 2020-08-21 BLBQ mRNA-1273-P201AEmRNA-1273-P201-US205-1043US2051043ADOSE 2 - 2020-07-01T15:32AE-001 HEADACHE Headache F˜á‹Headache F˜á‹Headaches NEC F˜á¡Headaches F˜áŸADVERSE EVENT PIMMCNervous system disorders F™•Nervous system disorders F™•MILD NNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-10-16 2020-10-16 BˆBˆ mRNA-1273-P201AEmRNA-1273-P201-US205-1045US2051045ADOSE 2 - 2020-07-08T15:50AE-001 DIASTOLIC HYPERTENSION Diastolic hypertension F˜ÈVDiastolic hypertension F˜ÈVVascular hypertensive disorders NEC F˜ç¦Vascular hypertensive disorders F™uÎADVERSE EVENT Vascular disorders F™NYVascular disorders F™NYSEVERE NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED NOT RECOVERED/NOT RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-16 B%. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US205-1057US2051057ADOSE 1 - 2020-06-26T09:36AE-0041100JOINT ACHES IN SEVERAL JOINTS Aching joints F˜˜AArthralgia F˜£'Joint related signs and symptoms F˜ñ:Joint disorders F˜ñ-REACTOGENICITY Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-26 2020-07-06 AA°P4D mRNA-1273-P201AEmRNA-1273-P201-US205-1057US2051057A DOSE 1 - 2020-06-26T09:36AE-0051080FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝREACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-26 2020-07-08 AAÐP6D mRNA-1273-P201AEmRNA-1273-P201-US205-1057US2051057A0DOSE 2 - 2020-07-24T09:00AE-0022080FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝREACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-24 2020-07-31 BB$P1D mRNA-1273-P201AEmRNA-1273-P201-US205-1057US2051057A@DOSE 2 - 2020-07-24T09:00AE-0012030PAIN AT THE INJECTION SITE Pain injection site F™-Injection site pain F˜ìÆInjection site reactions F˜ìÑAdministration site reactions F˜›¤REACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-07-24T10:002020-08-05T00:00BB)P4DT15H mRNA-1273-P201AEmRNA-1273-P201-US205-1057US2051057APDOSE 2 - 2020-07-24T09:00AE-0032090MUSCLE ACHES ALL OVER BODY Generalized muscle aches F™ŠiMyalgia F™{Muscle pains F™#Muscle disorders F™REACTOGENICITY Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-24 2020-07-31 BB$P1D mRNA-1273-P201AEmRNA-1273-P201-US205-1059US2051059ADOSE 2 - 2020-07-27T13:25AE-002 HIGH CHOLESTEROL High cholesterol F˜äÑBlood cholesterol increased F˜«±Cholesterol analyses F˜¸KLipid analyses F˜ö„ADVERSE EVENT PIMMCInvestigations F˜ïëInvestigations F˜ïëMODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED NOT RECOVERED/NOT RESOLVED NNNNNN2PART A FOLLOW-UP 2020-12-17 B¯. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US205-1059US2051059A DOSE 2 - 2020-07-27T13:25AE-001 SKIN RASH LEFT CHEEK ON FACE (UNKNOWN ETIOLOGY) Facial rash F˜Õ@Rash F™*TRashes, eruptions and exanthems NEC F™cÖEpidermal and dermal conditions F˜ÑADVERSE EVENT PIMMCSkin and subcutaneous tissue disorders F™5ÑSkin and subcutaneous tissue disorders F™5ÑMILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-09-10 2020-10-31 BMB€ mRNA-1273-P201AEmRNA-1273-P201-US205-1060US2051060ADOSE 2 - 2020-07-28T10:03AE-001 CATARACT RIGHT EYE Right cataract F™/nCataract F˜´»Cataract conditions F˜´ÜAnterior eye structural change, deposit and degeneration F˜¡ADVERSE EVENT PIMMCEye disorders F˜Ô¯Eye disorders F˜Ô¯MILD NDOSE NOT CHANGEDCONCOMITANT PROCEDURE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-10-09 2021-02-23 BjBó mRNA-1273-P201AEmRNA-1273-P201-US205-1063US2051063ADOSE 2 - 2020-07-28T10:41AE-001 COVID-19 INFECTION COVID-19 F™ß¬COVID-19 F™ß¬Coronavirus infections F™àžViral infectious disorders F™OÎADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED NOT RECOVERED/NOT RESOLVED NNNNNN1PART A FOLLOW-UP 2020-12-10 B¤. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US205-1068US2051068ADOSE 2 - 2020-07-28T13:08AE-0032100JOINT ACHES (IN SEVERAL JOINTS) Aching joints F˜˜AArthralgia F˜£'Joint related signs and symptoms F˜ñ:Joint disorders F˜ñ-REACTOGENICITY Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMILD NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-28T19:282020-08-04T19:06BB$PT5H58M mRNA-1273-P201AEmRNA-1273-P201-US205-1068US2051068A DOSE 2 - 2020-07-28T13:08AE-0012080FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝREACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-28T19:282020-08-04T19:05BB$PT5H57M mRNA-1273-P201AEmRNA-1273-P201-US205-1068US2051068A0DOSE 2 - 2020-07-28T13:08AE-0022090MUSCLE ACHES (ALL OVER BODY0 Generalized muscle aches F™ŠiMyalgia F™{Muscle pains F™#Muscle disorders F™REACTOGENICITY Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMILD NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-29T22:372020-08-04T19:06BB$PT5H58M mRNA-1273-P201AEmRNA-1273-P201-US205-1069US2051069ADOSE 1 - 2020-06-26T13:49AE-0011080FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝREACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE RELATED RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-27T00:002020-07-03T00:00A A€P6D mRNA-1273-P201AEmRNA-1273-P201-US205-1069US2051069A DOSE 2 - 2020-07-28T09:17AE-002 STOMACH VIRUS Stomach virus F™; Gastroenteritis viral F˜Ü~Viral infections NEC F™OéViral infectious disorders F™OÎADVERSE EVENT Infections and infestations F˜ëùInfections and infestations F˜ëùMODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-08-18 2020-08-20 B6B8 mRNA-1273-P201AEmRNA-1273-P201-US205-1071US2051071ADOSE 2 - 2020-07-27T14:29AE-002 ROTATOR CUFF PAIN Shoulder pain F™5)Musculoskeletal pain F™gMusculoskeletal and connective tissue pain and discomfort F™£Musculoskeletal and connective tissue disorders NEC F™iADVERSE EVENT PIMMCMusculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kSEVERE NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN3PART A FOLLOW-UP 2021-01-01 2021-02-08 B»Bá mRNA-1273-P201AEmRNA-1273-P201-US205-1072US2051072ADOSE 2 - 2020-08-03T09:49AE-001 COVID-19 INFECTION COVID-19 F™ß¬COVID-19 F™ß¬Coronavirus infections F™àžViral infectious disorders F™OÎADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMODERATENDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-08-24 2020-09-21 B2BN mRNA-1273-P201AEmRNA-1273-P201-US205-1084US2051084ADOSE 1 - 2020-07-01T12:08AE-001 DYSGUESIA Dysgeusia F˜Ì×Dysgeusia F˜Ì×Sensory abnormalities NEC F™2ÕNeurological disorders NEC F™ùADVERSE EVENT Nervous system disorders F™•Nervous system disorders F™•MILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-13 2020-07-27 AÐB mRNA-1273-P201AEmRNA-1273-P201-US205-1088US2051088ADOSE 2 - 2020-07-28T10:05AE-001 BACK PAIN Back pain F˜¦Back pain F˜¦Musculoskeletal and connective tissue pain and discomfort F™£Musculoskeletal and connective tissue disorders NEC F™iADVERSE EVENT Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-08-01 2020-08-02 B!B" mRNA-1273-P201AEmRNA-1273-P201-US205-1092US2051092ADOSE 2 - 2020-08-06T10:22AE-001 TORN HAMSTRING RIGHT LEG Torn muscle F™BŸMuscle rupture F™+Muscle, tendon and ligament injuries F™Injuries NEC F˜ìâADVERSE EVENT PIMMCInjury, poisoning and procedural complications F˜ìåInjury, poisoning and procedural complications F˜ìåMODERATENNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED NOT RECOVERED/NOT RESOLVED NNNNNN2PART A FOLLOW-UP 2020-11-10 B. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US205-1095US2051095ADOSE 2 - 2020-07-30T12:22AE-002 LEFT SHOULDER ADHESIVE CAPSULITIS Adhesive capsulitis of shoulder F˜›†Periarthritis F™ Joint related disorders NEC F™¥Joint disorders F˜ñ-ADVERSE EVENT Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMILD NDOSE NOT CHANGEDCONCOMITANT PROCEDURE NOT RELATEDNOT RELATED NOT RECOVERED/NOT RESOLVED NNNNNN1PART A FOLLOW-UP 2021-01-10 BÁ. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US205-1095US2051095A DOSE 2 - 2020-07-30T12:22AE-001 SINUS INFECTION Sinus infection F™5©Sinusitis F™5±Upper respiratory tract infections F™KeInfections - pathogen unspecified F˜ë÷ADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMODERATENNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2020-11-05 2020-11-18 BBŒ mRNA-1273-P201AEmRNA-1273-P201-US205-1103US2051103ADOSE 1 - 2020-07-02T15:41AE-001 BUG BITE ON NECK Bug bite F˜°Arthropod bite F˜£ÇNon-site specific injuries NEC F™ ÇInjuries NEC F˜ìâADVERSE EVENT PIMMCInjury, poisoning and procedural complications F˜ìåInjury, poisoning and procedural complications F˜ìåMODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-07-03 2020-07-13T00:00A AÀ mRNA-1273-P201AEmRNA-1273-P201-US205-1103US2051103A DOSE 1 - 2020-07-02T15:41AE-002 CONTACT DERMATITIS BILATERAL ARMS AND BACK Contact dermatitis F˜À¦Dermatitis contact F˜ÇDermatitis and eczema F˜ÇEpidermal and dermal conditions F˜ÑADVERSE EVENT Skin and subcutaneous tissue disorders F™5ÑSkin and subcutaneous tissue disorders F™5ÑMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-14 2020-07-22 AÐB mRNA-1273-P201AEmRNA-1273-P201-US205-1103US2051103A0DOSE 1 - 2020-07-02T15:41AE-003 HEADACHE Headache F˜á‹Headache F˜á‹Headaches NEC F˜á¡Headaches F˜áŸREACTOGENICITY Nervous system disorders F™•Nervous system disorders F™•SEVERE NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-07 2020-07-08 A`ApP2D mRNA-1273-P201AEmRNA-1273-P201-US205-1103US2051103A@DOSE 2 - 2020-07-30T09:09AE-004 NECK PAIN Neck pain F™$Neck pain F™$Musculoskeletal and connective tissue pain and discomfort F™£Musculoskeletal and connective tissue disorders NEC F™iADVERSE EVENT Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMODERATENNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2020-10-19 2021-04-30 BnCð mRNA-1273-P201AEmRNA-1273-P201-US205-1104US2051104ADOSE 1 - 2020-07-07T12:55AE-003 JOINT ACHES IN SEVERAL JOINTS Aching joints F˜˜AArthralgia F˜£'Joint related signs and symptoms F˜ñ:Joint disorders F˜ñ-REACTOGENICITY Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kSEVERE NDRUG WITHDRAWN CONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-07 2020-07-11T00:00AAPP5D mRNA-1273-P201AEmRNA-1273-P201-US205-1104US2051104A DOSE 1 - 2020-07-07T12:55AE-001 FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝREACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝSEVERE NDRUG WITHDRAWN CONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-07 2020-07-11T00:00AAPP5D mRNA-1273-P201AEmRNA-1273-P201-US205-1104US2051104A0DOSE 1 - 2020-07-07T12:55AE-002 MUSCLE ACHES ALL OVER BODY Generalized muscle aches F™ŠiMyalgia F™{Muscle pains F™#Muscle disorders F™REACTOGENICITY Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kSEVERE NDRUG WITHDRAWN CONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-07 2020-07-11T00:00AAPP5D mRNA-1273-P201AEmRNA-1273-P201-US205-1105US2051105ADOSE 2 - 2020-07-31T10:27AE-001 SORE THROAT Sore throat F™8Oropharyngeal pain F™¡_Upper respiratory tract signs and symptoms F™KiRespiratory tract signs and symptoms F™Ë}ADVERSE EVENT Respiratory, thoracic and mediastinal disorders F™-ÒRespiratory, thoracic and mediastinal disorders F™-ÒMILD NNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-12-01 2020-12-03 B™B› mRNA-1273-P201AEmRNA-1273-P201-US205-1108US2051108ADOSE 1 - 2020-07-06T14:41AE-001 CONTACT DERMATITIS RIGHT FOREARM AND RIGHT THIGH Contact dermatitis F˜À¦Dermatitis contact F˜ÇDermatitis and eczema F˜ÇEpidermal and dermal conditions F˜ÑADVERSE EVENT PIMMCSkin and subcutaneous tissue disorders F™5ÑSkin and subcutaneous tissue disorders F™5ÑMODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-07-16 2020-08-17 A°B+ mRNA-1273-P201AEmRNA-1273-P201-US205-1109US2051109ADOSE 2 - 2020-08-04T13:07AE-002 WORSENING OF MEDICAL HISTORY OF VERTIGO Vertigo aggravated F™OnVertigo F™OlInner ear signs and symptoms F˜íþInner ear and VIIIth cranial nerve disorders F˜íüADVERSE EVENT Ear and labyrinth disorders F˜Í)Ear and labyrinth disorders F˜Í)MILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED UNKNOWN NNNNNN1PART A FOLLOW-UP 2021-01-01 B´. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US205-1112US2051112ADOSE 2 - 2020-08-03T12:40AE-001 ABDOMINAL TENDERNESS (ETIOLOGY UNKNOWN) Abdominal tenderness F˜–áAbdominal tenderness F˜–áGastrointestinal and abdominal pains (excl oral and throat) F˜Ü†Gastrointestinal signs and symptoms F˜ÜÜADVERSE EVENT Gastrointestinal disorders F˜Ü›Gastrointestinal disorders F˜Ü›MODERATENNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-08-26 2020-10-16 B4Bg mRNA-1273-P201AEmRNA-1273-P201-US205-1112US2051112A DOSE 2 - 2020-08-03T12:40AE-002 GASTROENTERITIS' Gastroenteritis F˜Ü`Gastroenteritis F˜Ü`Abdominal and gastrointestinal infections F˜Ü¯Infections - pathogen unspecified F˜ë÷ADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMODERATENNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2020-10-01 2020-10-16 BXBg mRNA-1273-P201AEmRNA-1273-P201-US206-1001US2061001ADOSE 2 - 2020-07-10T14:33AE-002 GASTRITIS Gastritis F˜Ü=Gastritis F˜Ü=Gastritis (excl infective) F˜Ü>Gastrointestinal inflammatory conditions F˜Ü±ADVERSE EVENT PIMMCGastrointestinal disorders F˜Ü›Gastrointestinal disorders F˜Ü›MILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED NOT RECOVERED/NOT RESOLVED NNNNNN1PART A FOLLOW-UP 2020-12-24 BÌ. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US206-1001US2061001A DOSE 2 - 2020-07-10T14:33AE-001 COMMON COLD Common cold F˜½úNasopharyngitis F™ Upper respiratory tract infections F™KeInfections - pathogen unspecified F˜ë÷ADVERSE EVENT Infections and infestations F˜ëùInfections and infestations F˜ëùMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-18 2020-08-01 B-B; mRNA-1273-P201AEmRNA-1273-P201-US206-1003US2061003ADOSE 2 - 2020-07-06T10:38AE-001 COVID - 19 INFECTION COVID-19 F™ß¬COVID-19 F™ß¬Coronavirus infections F™àžViral infectious disorders F™OÎADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2021-01-06 2021-01-16 BÙBã mRNA-1273-P201AEmRNA-1273-P201-US206-1006US2061006ADOSE 2 - 2020-07-01T12:23AE-002 SHINGLES Shingles F™4ëHerpes zoster F˜ä†Herpes viral infections F˜ä„Viral infectious disorders F™OÎADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2021-01-18 2021-01-25 BæBí mRNA-1273-P201AEmRNA-1273-P201-US206-1008US2061008ADOSE 2 - 2020-07-06T09:36AE-0022100JOINT ACHES, GENERALIZED Generalized joint pain F™ŠfArthralgia F˜£'Joint related signs and symptoms F˜ñ:Joint disorders F˜ñ-REACTOGENICITY Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-06T20:002020-07-29T20:00B"B9P16DT10H24M mRNA-1273-P201AEmRNA-1273-P201-US206-1008US2061008A DOSE 2 - 2020-07-06T09:36AE-0012090MUSCLE ACHES, GENERALIZED Generalized muscle aches F™ŠiMyalgia F™{Muscle pains F™#Muscle disorders F™REACTOGENICITY Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMILD NDOSE NOT CHANGEDNONE RELATED RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-12T06:002020-07-14T07:00B(B*PT21H24M mRNA-1273-P201AEmRNA-1273-P201-US206-1009US2061009ADOSE 2 - 2020-07-07T14:14AE-001 FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝREACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝSEVERE NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-08T07:002020-07-08T21:00B$B$PT14H mRNA-1273-P201AEmRNA-1273-P201-US206-1009US2061009A DOSE 2 - 2020-07-07T14:14AE-002 MUSCLE ACHES, GENERALIZED Generalized muscle aches F™ŠiMyalgia F™{Muscle pains F™#Muscle disorders F™REACTOGENICITY Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kSEVERE NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-08T07:002020-07-08T21:00B$B$PT14H mRNA-1273-P201AEmRNA-1273-P201-US206-1009US2061009A0DOSE 2 - 2020-07-07T14:14AE-003 UPPER RESPIRATORY INFECTION Upper respiratory infection F™K\Upper respiratory tract infection F™KbUpper respiratory tract infections F™KeInfections - pathogen unspecified F˜ë÷ADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-10-05 2020-10-10 B}B‚ mRNA-1273-P201AEmRNA-1273-P201-US206-1015US2061015ADOSE 1 - 2020-06-03T14:57AE-0031080FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝREACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-07 2020-06-10 APA€P1D mRNA-1273-P201AEmRNA-1273-P201-US206-1015US2061015A DOSE 1 - 2020-06-03T14:57AE-0011070MIGRAINE Migraine F™OMigraine F™OMigraine headaches F™SHeadaches F˜áŸREACTOGENICITY Nervous system disorders F™•Nervous system disorders F™•SEVERE NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-06-09 2020-06-09 ApApP1D mRNA-1273-P201AEmRNA-1273-P201-US206-1018US2061018ADOSE 2 - 2020-07-08T09:27AE-002 COVID-19 POSITIVE INFECTION COVID-19 F™ß¬COVID-19 F™ß¬Coronavirus infections F™àžViral infectious disorders F™OÎADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-12-01 2020-12-05 B´B¸ mRNA-1273-P201AEmRNA-1273-P201-US206-1018US2061018A DOSE 2 - 2020-07-08T09:27AE-001 UPPER RESPIRATORY INFECTION Upper respiratory infection F™K\Upper respiratory tract infection F™KbUpper respiratory tract infections F™KeInfections - pathogen unspecified F˜ë÷ADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-11-28 2020-12-01 B±B´ mRNA-1273-P201AEmRNA-1273-P201-US206-1019US2061019ADOSE 2 - 2020-07-01T14:25AE-001 HEADACHE Headache F˜á‹Headache F˜á‹Headaches NEC F˜á¡Headaches F˜áŸREACTOGENICITY Nervous system disorders F™•Nervous system disorders F™•SEVERE NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-07 2020-07-07 B#B#P1D mRNA-1273-P201AEmRNA-1273-P201-US206-1019US2061019A DOSE 2 - 2020-07-01T14:25AE-002 SORE THROAT Sore throat F™8Oropharyngeal pain F™¡_Upper respiratory tract signs and symptoms F™KiRespiratory tract signs and symptoms F™Ë}ADVERSE EVENT PIMMCRespiratory, thoracic and mediastinal disorders F™-ÒRespiratory, thoracic and mediastinal disorders F™-ÒMODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2020-09-21 2020-10-01 BoBy mRNA-1273-P201AEmRNA-1273-P201-US206-1020US2061020ADOSE 2 - 2020-07-07T09:17AE-002 BASAL CELL CARCINOMA Basal cell carcinoma F˜¦²Basal cell carcinoma F˜¦²Skin neoplasms malignant and unspecified (excl melanoma) F™6ESkin neoplasms malignant and unspecified F™6DADVERSE EVENT Neoplasms benign, malignant and unspecified (incl cysts and polyps)F™0Neoplasms benign, malignant and unspecified (incl cysts and polyps)F™0MILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2021-01-20 2021-01-27 BãBê mRNA-1273-P201AEmRNA-1273-P201-US206-1020US2061020A DOSE 2 - 2020-07-07T09:17AE-001 PAIN AT INJECTION SITE Pain injection site F™-Injection site pain F˜ìÆInjection site reactions F˜ìÑAdministration site reactions F˜›¤REACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝSEVERE NDOSE NOT CHANGEDNONE RELATED RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-08T09:002020-07-10T09:00BB!P2D mRNA-1273-P201AEmRNA-1273-P201-US206-1021US2061021ADOSE 2 - 2020-07-02T14:03AE-001 DECREASED HEART RATE Heart rate decreased F˜áåHeart rate decreased F˜áåHeart rate and pulse investigations F™eïCardiac and vascular investigations (excl enzyme tests) F˜³ØADVERSE EVENT Investigations F˜ïëInvestigations F˜ïëMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-02T15:052020-07-11T09:05BB& mRNA-1273-P201AEmRNA-1273-P201-US206-1023US2061023ADOSE 1 - 2020-06-05T11:36AE-002 UNDERARM PAIN - LEFT ARM Axillary pain F™TîAxillary pain F™TîPain and discomfort NEC F™ÜGeneral system disorders NEC F˜ÝREACTOGENICITYPIMMCGeneral disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-10 2020-06-12 A`A€P1D mRNA-1273-P201AEmRNA-1273-P201-US206-1023US2061023A DOSE 2 - 2020-07-06T09:40AE-003 DEPRESSION Depression F˜ÆÚDepression F˜ÆÚDepressive disorders F˜ÆñDepressed mood disorders and disturbances F˜Æ×ADVERSE EVENT PIMMCPsychiatric disorders F™'·Psychiatric disorders F™'·MILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-11-05 2021-01-20 BšBæ mRNA-1273-P201AEmRNA-1273-P201-US206-1023US2061023A0DOSE 2 - 2020-07-06T09:40AE-0012090MUSCLE ACHES, GENERALIZED Generalized muscle aches F™ŠiMyalgia F™{Muscle pains F™#Muscle disorders F™REACTOGENICITY Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMILD NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-12 2020-07-18 B&B,P6D mRNA-1273-P201AEmRNA-1273-P201-US206-1024US2061024ADOSE 2 - 2020-07-02T16:16AE-001 SHORTNESS OF BREATH - NOS Shortness of breath F™5Dyspnoea F˜ÍBreathing abnormalities F˜¯>Respiratory disorders NEC F™-¼ADVERSE EVENT PIMMCRespiratory, thoracic and mediastinal disorders F™-ÒRespiratory, thoracic and mediastinal disorders F™-ÒMILD NNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-11-25 2020-12-20 B°BÉ mRNA-1273-P201AEmRNA-1273-P201-US206-1026US2061026ADOSE 2 - 2020-07-07T11:23AE-002 NASAL CONGESTION Nasal congestion F™¿Nasal congestion F™¿Nasal congestion and inflammations F™ÀUpper respiratory tract disorders (excl infections) F™K`ADVERSE EVENT PIMMCRespiratory, thoracic and mediastinal disorders F™-ÒRespiratory, thoracic and mediastinal disorders F™-ÒMILD NNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-09-14 2020-09-18 BfBj mRNA-1273-P201AEmRNA-1273-P201-US206-1026US2061026A DOSE 2 - 2020-07-07T11:23AE-001 SORE THROAT Sore throat F™8Oropharyngeal pain F™¡_Upper respiratory tract signs and symptoms F™KiRespiratory tract signs and symptoms F™Ë}ADVERSE EVENT PIMMCRespiratory, thoracic and mediastinal disorders F™-ÒRespiratory, thoracic and mediastinal disorders F™-ÒMILD NNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-09-15 2020-09-18 BgBj mRNA-1273-P201AEmRNA-1273-P201-US206-1035US2061035ADOSE 2 - 2020-07-20T10:12AE-002 COVID-19 INFECTION COVID-19 F™ß¬COVID-19 F™ß¬Coronavirus infections F™àžViral infectious disorders F™OÎADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-12-31 2021-01-17 B½BÎ mRNA-1273-P201AEmRNA-1273-P201-US206-1035US2061035A DOSE 1 - 2020-06-26T12:34AE-001 DECREASED HEART RATE Heart rate decreased F˜áåHeart rate decreased F˜áåHeart rate and pulse investigations F™eïCardiac and vascular investigations (excl enzyme tests) F˜³ØADVERSE EVENT Investigations F˜ïëInvestigations F˜ïëMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-26T13:412020-06-26T19:00AA mRNA-1273-P201AEmRNA-1273-P201-US206-1036US2061036ADOSE 2 - 2020-07-27T11:35AE-001 COMMON COLD Common cold F˜½úNasopharyngitis F™ Upper respiratory tract infections F™KeInfections - pathogen unspecified F˜ë÷ADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERING/RESOLVING NNNNNN1PART A FOLLOW-UP 2020-10-30 B. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US206-1037US2061037A AE-001 NOSE PAIN Nasal pain F™¥Rhinalgia F™_¨Upper respiratory tract signs and symptoms F™KiRespiratory tract signs and symptoms F™Ë}ADVERSE EVENT Respiratory, thoracic and mediastinal disorders F™-ÒRespiratory, thoracic and mediastinal disorders F™-ÒMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDRELATED RECOVERED/RESOLVED NNNNNN1SCREENING 2020-06-26T00:002020-06-26T00:01AA mRNA-1273-P201AEmRNA-1273-P201-US206-1043US2061043ADOSE 2 - 2020-07-27T14:46AE-0032100JOINT ACHES - GENERALIZED Generalized joint pain F™ŠfArthralgia F˜£'Joint related signs and symptoms F˜ñ:Joint disorders F˜ñ-REACTOGENICITY Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMILD NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-28T11:002020-08-03T18:00BB$PT3H14M mRNA-1273-P201AEmRNA-1273-P201-US206-1043US2061043A DOSE 2 - 2020-07-27T14:46AE-0012080FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝREACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-28T11:002020-08-03T18:00BB$PT3H14M mRNA-1273-P201AEmRNA-1273-P201-US206-1043US2061043A0DOSE 2 - 2020-07-27T14:46AE-0022090MUSCLE ACHES Muscle ache F™ÿMyalgia F™{Muscle pains F™#Muscle disorders F™REACTOGENICITY Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMILD NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-28T11:002020-08-03T18:00BB$PT3H14M mRNA-1273-P201AEmRNA-1273-P201-US206-1046US2061046ADOSE 2 - 2020-07-27T09:28AE-001 ASYMPTOMATIC COVID-19 Asymptomatic COVID-19 F™àkAsymptomatic COVID-19 F™àkCoronavirus infections F™àžViral infectious disorders F™OÎADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-12-15 2020-12-15 BªBª mRNA-1273-P201AEmRNA-1273-P201-US206-1053US2061053ADOSE 1 - 2020-07-01T10:29AE-001 PLANTAR FASCIITIS - RIGHT Plantar fasciitis F™ÓPlantar fasciitis F™ÓMusculoskeletal and connective tissue infections and inflammations NECF™d¨Musculoskeletal and connective tissue disorders NEC F™iADVERSE EVENT Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED NOT RECOVERED/NOT RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-10 A . ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US206-1068US2061068ADOSE 1 - 2020-06-30T09:48AE-002 ANXIETY Anxiety F˜¡§Anxiety F˜¡§Anxiety symptoms F˜¡µAnxiety disorders and symptoms F˜¡ADVERSE EVENT PIMMCPsychiatric disorders F™'·Psychiatric disorders F™'·MODERATENDOSE NOT CHANGEDNONE NOT RELATEDRELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-07-31T09:452020-07-31T14:30B B mRNA-1273-P201AEmRNA-1273-P201-US206-1068US2061068A DOSE 1 - 2020-06-30T09:48AE-001 DIZZINESS Dizziness F˜Ë…Dizziness F˜Ë…Neurological signs and symptoms NEC F™úNeurological disorders NEC F™ùADVERSE EVENT PIMMCNervous system disorders F™•Nervous system disorders F™•MODERATENDOSE NOT CHANGEDNONE NOT RELATEDRELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-07-31T08:352020-07-31T08:40B B mRNA-1273-P201AEmRNA-1273-P201-US207-1001US2071001ADOSE 2 - 2020-06-30T13:38AE-002 ANXIETY Anxiety F˜¡§Anxiety F˜¡§Anxiety symptoms F˜¡µAnxiety disorders and symptoms F˜¡ADVERSE EVENT PIMMCPsychiatric disorders F™'·Psychiatric disorders F™'·MILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED NOT RECOVERED/NOT RESOLVED NNNNNN1PART A FOLLOW-UP 2020-08-01 BA. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US207-1001US2071001A DOSE 2 - 2020-06-30T13:38AE-001 SINUS INFECTION Sinus infection F™5©Sinusitis F™5±Upper respiratory tract infections F™KeInfections - pathogen unspecified F˜ë÷ADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-09-11 2020-09-15 BjBn mRNA-1273-P201AEmRNA-1273-P201-US207-1001US2071001A0DOSE 2 - 2020-06-30T13:38AE-003 VIRAL UPPER RESPIRATIORY INFECTION Viral upper respiratory tract infection F™OúViral upper respiratory tract infection F™OúViral infections NEC F™OéViral infectious disorders F™OÎADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-12-26 2021-01-19 BÔBì mRNA-1273-P201AEmRNA-1273-P201-US207-1002US2071002ADOSE 2 - 2020-06-30T13:48AE-005 JOINT ACHES IN SEVERAL JOINTS ALL OVER BODY Generalized joint pain F™ŠfArthralgia F˜£'Joint related signs and symptoms F˜ñ:Joint disorders F˜ñ-REACTOGENICITYPIMMCMusculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMILD NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-01T08:002020-07-08T08:00BB&PT18H12M mRNA-1273-P201AEmRNA-1273-P201-US207-1002US2071002A DOSE 2 - 2020-06-30T13:48AE-0032080FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝREACTOGENICITYPIMMCGeneral disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-02 2020-08-02 B B?P27D mRNA-1273-P201AEmRNA-1273-P201-US207-1002US2071002A0DOSE 2 - 2020-06-30T13:48AE-0012070HEADACHE Headache F˜á‹Headache F˜á‹Headaches NEC F˜á¡Headaches F˜áŸREACTOGENICITYPIMMCNervous system disorders F™•Nervous system disorders F™•MILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-01T20:002020-07-12T08:00BB*P4DT18H12M mRNA-1273-P201AEmRNA-1273-P201-US207-1002US2071002A@DOSE 2 - 2020-06-30T13:48AE-008 SWELLING AT INJECTION SITE Swelling of injection site F™=HInjection site swelling F™g1Injection site reactions F˜ìÑAdministration site reactions F˜›¤REACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE RELATED RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-30 2020-07-07 BB%P1D mRNA-1273-P201AEmRNA-1273-P201-US207-1002US2071002APDOSE 2 - 2020-06-30T13:48AE-004 MUSCLE PAIN TO WHOLE BODY Generalized muscle aches F™ŠiMyalgia F™{Muscle pains F™#Muscle disorders F™REACTOGENICITYPIMMCMusculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMILD NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-01T08:002020-07-06T12:00BB$P5DT4H mRNA-1273-P201AEmRNA-1273-P201-US207-1002US2071002A`DOSE 2 - 2020-06-30T13:48AE-0072110NAUSEA Nausea F™ Nausea F™ Nausea and vomiting symptoms F™Gastrointestinal signs and symptoms F˜ÜÜREACTOGENICITYPIMMCGastrointestinal disorders F˜Ü›Gastrointestinal disorders F˜Ü›MILD NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-04 2020-07-09 B"B'P3D mRNA-1273-P201AEmRNA-1273-P201-US207-1004US2071004ADOSE 2 - 2020-07-08T09:18AE-0022080FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝREACTOGENICITYPIMMCGeneral disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-09 2020-07-16 B$B+P2D mRNA-1273-P201AEmRNA-1273-P201-US207-1004US2071004A DOSE 2 - 2020-07-08T09:18AE-0012070HEADACHE Headache F˜á‹Headache F˜á‹Headaches NEC F˜á¡Headaches F˜áŸREACTOGENICITYPIMMCNervous system disorders F™•Nervous system disorders F™•MILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-09T08:002020-07-16 B$B+P2D mRNA-1273-P201AEmRNA-1273-P201-US207-1004US2071004A0DOSE 2 - 2020-07-08T09:18AE-003 MUSCLE ACHES ALL OVER BODY Generalized muscle aches F™ŠiMyalgia F™{Muscle pains F™#Muscle disorders F™REACTOGENICITYPIMMCMusculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMILD NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-14 2020-07-15 B)B*P1D mRNA-1273-P201AEmRNA-1273-P201-US207-1004US2071004A@DOSE 2 - 2020-07-08T09:18AE-004 VIRAL UPPER RESPIRATORY INFECTION Viral upper respiratory tract infection F™OúViral upper respiratory tract infection F™OúViral infections NEC F™OéViral infectious disorders F™OÎADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2020-10-14 2020-10-16 B…B‡ mRNA-1273-P201AEmRNA-1273-P201-US207-1005US2071005ADOSE 2 - 2020-07-06T14:46AE-001 COVID-19 INFECTION COVID-19 F™ß¬COVID-19 F™ß¬Coronavirus infections F™àžViral infectious disorders F™OÎADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMODERATENDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2020-11-22 2020-12-06 B®B¼ mRNA-1273-P201AEmRNA-1273-P201-US207-1012US2071012ADOSE 2 - 2020-07-07T13:45AE-001 COVID 19 INFECTION COVID-19 F™ß¬COVID-19 F™ß¬Coronavirus infections F™àžViral infectious disorders F™OÎADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-12-04 2020-12-16 B¹BÅ mRNA-1273-P201AEmRNA-1273-P201-US207-1013US2071013ADOSE 2 - 2020-07-09T15:04AE-003 ELEVATED BLOOD PRESSURE WITHOUT DIAGNOSIS OF HYPERTENSION Elevated blood pressure reading without diagnosis of hypertensionF˜Ï Blood pressure increased F˜¬öVascular tests NEC (incl blood pressure) F™N†Cardiac and vascular investigations (excl enzyme tests) F˜³ØADVERSE EVENT PIMMCInvestigations F˜ïëInvestigations F˜ïëMILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED NOT RECOVERED/NOT RESOLVED NNNNNN1PART A FOLLOW-UP 2021-01-19 Bè. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US207-1022US2071022ADOSE 1 - 2020-06-03T12:19AE-0011060LYMPHADENOPATHY IPSILATERAL Lymphadenopathy F˜øíLymphadenopathy F˜øíLymphatic system disorders NEC F˜øîSpleen, lymphatic and reticuloendothelial system disorders F™9)REACTOGENICITY Blood and lymphatic system disorders F˜«QBlood and lymphatic system disorders F˜«QMILD NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-09 2020-06-10 ApA€P1D mRNA-1273-P201AEmRNA-1273-P201-US207-1025US2071025ADOSE 2 - 2020-07-08T11:01AE-002 HEADACHE Headache F˜á‹Headache F˜á‹Headaches NEC F˜á¡Headaches F˜áŸADVERSE EVENT Nervous system disorders F™•Nervous system disorders F™•MILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-09T10:302020-07-10T08:00B%B& mRNA-1273-P201AEmRNA-1273-P201-US207-1025US2071025A DOSE 2 - 2020-07-08T11:01AE-001 SYNCOPE OF UNCLEAR ORIGIN Syncope F™=”Syncope F™=”Disturbances in consciousness NEC F˜ËENeurological disorders NEC F™ùADVERSE EVENT Nervous system disorders F™•Nervous system disorders F™•MODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-07-09T10:002020-07-09T10:05B%B% mRNA-1273-P201AEmRNA-1273-P201-US207-1030US2071030ADOSE 1 - 2020-06-03T17:16AE-002 REDNESS AT INJECTION SITE Injection site redness F˜ìÒInjection site erythema F˜ìInjection site reactions F˜ìÑAdministration site reactions F˜›¤ADVERSE EVENT General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE RELATED RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-12 2020-06-18 A B mRNA-1273-P201AEmRNA-1273-P201-US207-1030US2071030A DOSE 1 - 2020-06-03T17:16AE-003 ENDURATION AT INJECTION SITE Injection site induration F˜ì»Injection site induration F˜ì»Injection site reactions F˜ìÑAdministration site reactions F˜›¤ADVERSE EVENT General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE RELATED RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-12 2020-07-18 A B. mRNA-1273-P201AEmRNA-1273-P201-US207-1030US2071030A0DOSE 1 - 2020-06-03T17:16AE-001 PAIN AT INJECTION SITE Pain injection site F™-Injection site pain F˜ìÆInjection site reactions F˜ìÑAdministration site reactions F˜›¤ADVERSE EVENT General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-12 2020-06-18 A B mRNA-1273-P201AEmRNA-1273-P201-US207-1030US2071030A@DOSE 2 - 2020-07-06T17:13AE-004 WORSENING OF TINEA PEDIS LEFT BIG TOE Tinea pedis F™AáTinea pedis F™AáTinea infections F™AÞFungal infectious disorders F˜ÚøADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-09-27 2020-12-31 BuBÔ mRNA-1273-P201AEmRNA-1273-P201-US207-1036US2071036ADOSE 2 - 2020-07-13T12:48AE-002 ANXIETY Anxiety F˜¡§Anxiety F˜¡§Anxiety symptoms F˜¡µAnxiety disorders and symptoms F˜¡ADVERSE EVENT Psychiatric disorders F™'·Psychiatric disorders F™'·MILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED NOT RECOVERED/NOT RESOLVED NNNNNN1BLINDED TREATMENT 2020-08-01 B7. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US207-1039US2071039ADOSE 1 - 2020-06-05T16:53AE-001 ERYTHEMA TO INJECTION SITE Injection site erythema F˜ìInjection site erythema F˜ìInjection site reactions F˜ìÑAdministration site reactions F˜›¤ADVERSE EVENT General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMODERATENDOSE NOT CHANGEDNONE RELATED RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-06-15 2020-06-17 A°AÐ mRNA-1273-P201AEmRNA-1273-P201-US207-1039US2071039A DOSE 1 - 2020-06-05T16:53AE-002 MILD PAIN AT INJECTION SITE Injection site pain F˜ìÆInjection site pain F˜ìÆInjection site reactions F˜ìÑAdministration site reactions F˜›¤ADVERSE EVENT General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE RELATED RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-15 2020-06-16 A°AÀ mRNA-1273-P201AEmRNA-1273-P201-US207-1041US2071041ADOSE 2 - 2020-07-02T08:44AE-001 COVID 19 INFECTION COVID-19 F™ß¬COVID-19 F™ß¬Coronavirus infections F™àžViral infectious disorders F™OÎADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùSEVERE NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN3PART A FOLLOW-UP 2020-09-27 2020-10-12 BvB… mRNA-1273-P201AEmRNA-1273-P201-US207-1043US2071043ADOSE 2 - 2020-07-06T12:01AE-001 LEFT MEDIAL MENISCUS TEAR Meniscus tear F™°)Meniscus injury F™³ŠBone and joint injuries NEC F™¹uBone and joint injuries F˜¶ADVERSE EVENT PIMMCInjury, poisoning and procedural complications F˜ìåInjury, poisoning and procedural complications F˜ìåMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-08-01 2020-09-10 B<Bd mRNA-1273-P201AEmRNA-1273-P201-US207-1044US2071044ADOSE 2 - 2020-07-09T14:00AE-001 VITAMIN D DEFICIENCY Vitamin D deficiency F™PŠVitamin D deficiency F™PŠFat soluble vitamin deficiencies and disorders F˜ÕúVitamin related disorders F™P“ADVERSE EVENT PIMMCMetabolism and nutrition disorders F™©Metabolism and nutrition disorders F™©MILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED NOT RECOVERED/NOT RESOLVED NNNNNN1PART A FOLLOW-UP 2021-01-28 Bë. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US207-1050US2071050ADOSE 2 - 2020-07-07T11:43AE-001 COVID 19 INFECTION COVID-19 F™ß¬COVID-19 F™ß¬Coronavirus infections F™àžViral infectious disorders F™OÎADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2020-12-04 2020-12-18 B·BÅ mRNA-1273-P201AEmRNA-1273-P201-US207-1050US2071050A DOSE 2 - 2020-07-07T11:43AE-002 GINGIVITIS Gingivitis F˜ÝôGingivitis F˜ÝôDental and oral soft tissue infections F˜Æ¦Infections - pathogen unspecified F˜ë÷ADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-12-04 2020-12-14 B·BÁ mRNA-1273-P201AEmRNA-1273-P201-US207-1062US2071062ADOSE 2 - 2020-07-07T14:35AE-002 COVID-19 INFECTION COVID-19 F™ß¬COVID-19 F™ß¬Coronavirus infections F™àžViral infectious disorders F™OÎADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMODERATENNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2020-11-24 2020-11-30 B®B´ mRNA-1273-P201AEmRNA-1273-P201-US207-1062US2071062A DOSE 1 - 2020-06-04T16:40AE-001 RASH ON GLUTEUS Localized rash F™‹qRash F™*TRashes, eruptions and exanthems NEC F™cÖEpidermal and dermal conditions F˜ÑADVERSE EVENT Skin and subcutaneous tissue disorders F™5ÑSkin and subcutaneous tissue disorders F™5ÑMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-05 2020-06-06 A A0 mRNA-1273-P201AEmRNA-1273-P201-US207-1066US2071066ADOSE 2 - 2020-07-08T14:16AE-001 DIVERTICULOSIS Diverticulosis F˜ËmDiverticulum F˜ËrDiverticula F˜ËZDiverticular disorders F˜Ë_ADVERSE EVENT PIMMCGastrointestinal disorders F˜Ü›Gastrointestinal disorders F˜Ü›MILD NNOT APPLICABLE CONCOMITANT MEDICATION, CONCOMITANT PROCEDURENOT RELATEDNOT RELATED RECOVERING/RESOLVING NNNNNN1PART A FOLLOW-UP 2020-09-03 BW. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US207-1070US2071070ADOSE 2 - 2020-07-07T08:49AE-001 COVID 19 INFECTION COVID-19 F™ß¬COVID-19 F™ß¬Coronavirus infections F™àžViral infectious disorders F™OÎADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2020-12-11 2021-02-02 B»Bð mRNA-1273-P201AEmRNA-1273-P201-US207-1072US2071072ADOSE 2 - 2020-07-06T09:07AE-001 COVID 19 INFECTION COVID-19 F™ß¬COVID-19 F™ß¬Coronavirus infections F™àžViral infectious disorders F™OÎADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-11-30 2020-12-11 B³B¾ mRNA-1273-P201AEmRNA-1273-P201-US207-1073US2071073ADOSE 1 - 2020-06-08T12:07AE-001 REDNESS AT INJECTION SITE Injection site redness F˜ìÒInjection site erythema F˜ìInjection site reactions F˜ìÑAdministration site reactions F˜›¤ADVERSE EVENT General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE RELATED RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-18 2020-06-20 A°AÐ mRNA-1273-P201AEmRNA-1273-P201-US207-1073US2071073A DOSE 1 - 2020-06-08T12:07AE-002 SWELLING AT INJECTION SITE Swelling of injection site F™=HInjection site swelling F™g1Injection site reactions F˜ìÑAdministration site reactions F˜›¤ADVERSE EVENT General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE RELATED RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-18 2020-06-20 A°AÐ mRNA-1273-P201AEmRNA-1273-P201-US207-1074US2071074ADOSE 2 - 2020-07-09T13:16AE-001 VIRAL UPPER RESPIRATORY INFECTION Viral upper respiratory tract infection F™OúViral upper respiratory tract infection F™OúViral infections NEC F™OéViral infectious disorders F™OÎADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-12-06 2020-12-23 B¶BÇ mRNA-1273-P201AEmRNA-1273-P201-US207-1082US2071082ADOSE 2 - 2020-07-28T10:00AE-002 TENDERNESS LEFT METATARSOPHALANGEAL JOINTS Joint tenderness F™U‘Arthralgia F˜£'Joint related signs and symptoms F˜ñ:Joint disorders F˜ñ-ADVERSE EVENT PIMMCMusculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-08-18 2020-09-02 B6BE mRNA-1273-P201AEmRNA-1273-P201-US207-1082US2071082A DOSE 2 - 2020-07-28T10:00AE-001 ERYTHEMA LEFT METATARSOPHALANGEAL JOINTS Localized erythema F˜÷MErythema F˜Ñ®Erythemas F˜Ñ¯Epidermal and dermal conditions F˜ÑADVERSE EVENT PIMMCSkin and subcutaneous tissue disorders F™5ÑSkin and subcutaneous tissue disorders F™5ÑMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-08-18 2020-09-02 B6BE mRNA-1273-P201AEmRNA-1273-P201-US207-1083US2071083ADOSE 2 - 2020-07-21T09:42AE-003 WORSENING OF BRADYCARDIA, CHRONIC Bradycardia F˜®MBradycardia F˜®MRate and rhythm disorders NEC F™*”Cardiac arrhythmias F˜³áADVERSE EVENT PIMMCCardiac disorders F˜³õCardiac disorders F˜³õMODERATEYNOT APPLICABLE CONCOMITANT PROCEDURE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNYNN2PART A FOLLOW-UP 2020-09-03 2020-10-31 BFB€ mRNA-1273-P201AEmRNA-1273-P201-US207-1083US2071083A DOSE 2 - 2020-07-21T09:42AE-001 MILD DEPRESSION Depression F˜ÆÚDepression F˜ÆÚDepressive disorders F˜ÆñDepressed mood disorders and disturbances F˜Æ×ADVERSE EVENT PIMMCPsychiatric disorders F™'·Psychiatric disorders F™'·MILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED NOT RECOVERED/NOT RESOLVED NNNNNN1PART A FOLLOW-UP 2020-10-14 Bo. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US207-1083US2071083A0DOSE 2 - 2020-07-21T09:42AE-004 GRADE 1 DIASTOLIC DYSFUNCTION Diastolic dysfunction F™bñDiastolic dysfunction F™bñMyocardial disorders NEC F™.Myocardial disorders F™1ADVERSE EVENT PIMMCCardiac disorders F˜³õCardiac disorders F˜³õMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED NOT RECOVERED/NOT RESOLVED NNNNNN1PART A FOLLOW-UP 2020-10-30 B. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US207-1083US2071083A@DOSE 2 - 2020-07-21T09:42AE-002 HYPERTENSION Hypertension F˜ç¤Hypertension F˜ç¤Vascular hypertensive disorders NEC F˜ç¦Vascular hypertensive disorders F™uÎADVERSE EVENT PIMMCVascular disorders F™NYVascular disorders F™NYMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED NOT RECOVERED/NOT RESOLVED NNNNNN1PART A FOLLOW-UP 2020-09-03 BF. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US207-1085US2071085ADOSE 1 - 2020-06-26T14:43AE-002 ARTHRALGIA KNEE JOINT PAIN Painful knee F™hArthralgia F˜£'Joint related signs and symptoms F˜ñ:Joint disorders F˜ñ-ADVERSE EVENT Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMILD NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-29 2020-07-06 A@A° mRNA-1273-P201AEmRNA-1273-P201-US207-1085US2071085A DOSE 2 - 2020-07-28T14:11AE-001 SYSTOLIC MURMUR 2/4 Systolic murmur F™>NCardiac murmur F˜´"Cardiac auscultatory investigations F˜¥YCardiac and vascular investigations (excl enzyme tests) F˜³ØADVERSE EVENT Investigations F˜ïëInvestigations F˜ïëMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED NOT RECOVERED/NOT RESOLVED NNNNNN1PART A FOLLOW-UP 2020-08-24 B<. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US207-1086US2071086ADOSE 2 - 2020-07-29T10:39AE-001 VIRAL UPPER RESPIRATORY INFECTION Viral upper respiratory tract infection F™OúViral upper respiratory tract infection F™OúViral infections NEC F™OéViral infectious disorders F™OÎADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-11-09 2020-11-16 B‰B mRNA-1273-P201AEmRNA-1273-P201-US207-1087US2071087ADOSE 2 - 2020-07-30T10:58AE-001 UPPER RESPIRATORY INFECTION Upper respiratory infection F™K\Upper respiratory tract infection F™KbUpper respiratory tract infections F™KeInfections - pathogen unspecified F˜ë÷ADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-09-28 2020-10-04 B_Be mRNA-1273-P201AEmRNA-1273-P201-US207-1088US2071088ADOSE 2 - 2020-07-27T12:07AE-001 ACID REFLUX Acid reflux (esophageal) F™›¸Gastrooesophageal reflux disease F˜Ü]Gastrointestinal atonic and hypomotility disorders NEC F˜ÜGastrointestinal motility and defaecation conditions F˜Ü¹ADVERSE EVENT PIMMCGastrointestinal disorders F˜Ü›Gastrointestinal disorders F˜Ü›MILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-09-18 2020-09-21 BUBX mRNA-1273-P201AEmRNA-1273-P201-US207-1092US2071092ADOSE 2 - 2020-07-21T10:18AE-002 COVID 19 INFECTION COVID-19 F™ß¬COVID-19 F™ß¬Coronavirus infections F™àžViral infectious disorders F™OÎADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMODERATENDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2020-11-20 2020-11-30 B”Bž mRNA-1273-P201AEmRNA-1273-P201-US207-1092US2071092A DOSE 2 - 2020-07-21T10:18AE-003 PNEUMONIA Pneumonia F™!ÐPneumonia F™!ÐLower respiratory tract and lung infections F˜øInfections - pathogen unspecified F˜ë÷ADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2020-11-24 2020-11-30 B˜Bž mRNA-1273-P201AEmRNA-1273-P201-US207-1093US2071093ADOSE 1 - 2020-06-29T10:32AE-002 HARDNESS AT INJECTION SITE Injection site induration F˜ì»Injection site induration F˜ì»Injection site reactions F˜ìÑAdministration site reactions F˜›¤ADVERSE EVENT General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE RELATED RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-30 2020-07-02 A A@ mRNA-1273-P201AEmRNA-1273-P201-US207-1093US2071093A DOSE 1 - 2020-06-29T10:32AE-001 SWELLING AT INJECTION SITE Swelling of injection site F™=HInjection site swelling F™g1Injection site reactions F˜ìÑAdministration site reactions F˜›¤REACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE RELATED RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-30 2020-07-01 A A0P2D mRNA-1273-P201AEmRNA-1273-P201-US207-1100US2071100ADOSE 2 - 2020-08-04T10:47AE-003 ANXIETY Anxiety F˜¡§Anxiety F˜¡§Anxiety symptoms F˜¡µAnxiety disorders and symptoms F˜¡ADVERSE EVENT PIMMCPsychiatric disorders F™'·Psychiatric disorders F™'·MILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED NOT RECOVERED/NOT RESOLVED NNNNNN1PART A FOLLOW-UP 2021-01-08 B». ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US207-1100US2071100A DOSE 2 - 2020-08-04T10:47AE-002 JOINT ACHES IN SEVERAL JOINTS Aching joints F˜˜AArthralgia F˜£'Joint related signs and symptoms F˜ñ:Joint disorders F˜ñ-ADVERSE EVENT Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMILD NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-08-09 2020-08-12 B#B& mRNA-1273-P201AEmRNA-1273-P201-US207-1100US2071100A0DOSE 2 - 2020-08-04T10:47AE-001 HYPERLIPIDEMIA Hyperlipidemia F˜ç;Hyperlipidaemia F™ˆìHyperlipidaemias NEC F˜ç:Lipid metabolism disorders F˜Ê…ADVERSE EVENT PIMMCMetabolism and nutrition disorders F™©Metabolism and nutrition disorders F™©MILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED NOT RECOVERED/NOT RESOLVED NNNNNN1BLINDED TREATMENT 2020-08-24 B2. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US207-1100US2071100A@DOSE 2 - 2020-08-04T10:47AE-004 ENLARGED PROSTATE Enlarged prostate F™VØProstatomegaly F™_šProstatic signs, symptoms and disorders NEC F™&ßProstatic disorders (excl infections and inflammations) F™&ÞADVERSE EVENT PIMMCReproductive system and breast disorders F™-LReproductive system and breast disorders F™-LMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED NOT RECOVERED/NOT RESOLVED NNNNNN1PART A FOLLOW-UP 2021-01-08 B». ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US207-1102US2071102ADOSE 2 - 2020-07-28T14:14AE-002 WORSENING OF RESTLESS LEG SYNDROME Restless leg syndrome F™-ÕRestless legs syndrome F™|¨Sensory abnormalities NEC F™2ÕNeurological disorders NEC F™ùADVERSE EVENT Nervous system disorders F™•Nervous system disorders F™•MILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED NOT RECOVERED/NOT RESOLVED NNNNNN1PART A FOLLOW-UP 2020-09-30 B^. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US207-1103US2071103ADOSE 2 - 2020-08-06T10:00AE-002 DUODENITIS Duodenitis F˜Ì¨Duodenitis F˜Ì¨Gastrointestinal inflammatory disorders NEC F˜ÜGastrointestinal inflammatory conditions F˜Ü±ADVERSE EVENT PIMMCGastrointestinal disorders F˜Ü›Gastrointestinal disorders F˜Ü›MODERATENNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2020-11-12 2020-12-02 B†Bš mRNA-1273-P201AEmRNA-1273-P201-US207-1104US2071104ADOSE 2 - 2020-08-10T10:46AE-001 BRONCHITIS Bronchitis F˜¯³Bronchitis F˜¯³Lower respiratory tract and lung infections F˜øInfections - pathogen unspecified F˜ë÷ADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERING/RESOLVING NNNNNN1PART A FOLLOW-UP 2020-09-15 BH. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US207-1104US2071104A DOSE 1 - 2020-07-06T13:13AE-003 WORSENING OF HYPERLIPIDEMIA Hyperlipidemia F˜ç;Hyperlipidaemia F™ˆìHyperlipidaemias NEC F˜ç:Lipid metabolism disorders F˜Ê…ADVERSE EVENT Metabolism and nutrition disorders F™©Metabolism and nutrition disorders F™©MODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERING/RESOLVING NNNNNN2BLINDED TREATMENT 2020-08-01 B. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US207-1104US2071104A0DOSE 1 - 2020-07-06T13:13AE-002 HYPERTENSION Hypertension F˜ç¤Hypertension F˜ç¤Vascular hypertensive disorders NEC F˜ç¦Vascular hypertensive disorders F™uÎADVERSE EVENT Vascular disorders F™NYVascular disorders F™NYMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERING/RESOLVING NNNNNN1BLINDED TREATMENT 2020-08-01 B. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US207-1106US2071106ADOSE 1 - 2020-07-06T16:51AE-001 COVID 19 INFECTION COVID-19 F™ß¬COVID-19 F™ß¬Coronavirus infections F™àžViral infectious disorders F™OÎADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-11 2020-07-20 A`Að mRNA-1273-P201AEmRNA-1273-P201-US208-1001US2081001ADOSE 2 - 2020-06-24T08:24AE-003 UNREPORTED FEVER OF 101.4 Fever F˜×.Pyrexia F™)œFebrile disorders F˜ÖBody temperature conditions F˜”ADVERSE EVENT General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-25T06:002020-06-25T09:00BB mRNA-1273-P201AEmRNA-1273-P201-US208-1003US2081003ADOSE 2 - 2020-06-29T09:42AE-001 EAR WAX BUILD UP Ear wax F˜ÍLExcessive cerumen production F™ÂáExternal ear disorders NEC F™˜External ear disorders (excl congenital) F˜ÓôADVERSE EVENT PIMMCEar and labyrinth disorders F˜Í)Ear and labyrinth disorders F˜Í)MILD NNOT APPLICABLE CONCOMITANT PROCEDURE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-08-13 2020-08-13 BMBM mRNA-1273-P201AEmRNA-1273-P201-US208-1003US2081003A DOSE 2 - 2020-06-29T09:42AE-002 TOE FUNGUS (LEFT BIG TOE) Fungal foot infection F™žœFungal skin infection F˜ÛFungal infections NEC F˜ÛFungal infectious disorders F˜ÚøADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMODERATENNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2020-12-03 2021-02-26 B½C mRNA-1273-P201AEmRNA-1273-P201-US208-1004US2081004ADOSE 1 - 2020-05-29T14:09AE-004 LOWER BACK PAIN Low back pain F˜÷»Back pain F˜¦Musculoskeletal and connective tissue pain and discomfort F™£Musculoskeletal and connective tissue disorders NEC F™iADVERSE EVENT Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-26 2020-06-28 BB mRNA-1273-P201AEmRNA-1273-P201-US208-1004US2081004A DOSE 1 - 2020-05-29T14:09AE-003 HEMATURIA Hematuria F˜âzHaematuria F˜à3Urinary abnormalities F˜—DUrinary tract signs and symptoms F™L~ADVERSE EVENT Renal and urinary disorders F™,WRenal and urinary disorders F™,WMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-09 2020-07-01 AÀB" mRNA-1273-P201AEmRNA-1273-P201-US208-1005US2081005ADOSE 1 - 2020-06-01T10:31AE-001 SWOLLEN BLISTERED LIPS (INTERMITTENT ANGIOEDEMA) Lip angioedema F™ÌÓAngioedema F˜ŸøAngioedemas F˜ŸùAngioedema and urticaria F˜ŸúADVERSE EVENT PIMMCSkin and subcutaneous tissue disorders F™5ÑSkin and subcutaneous tissue disorders F™5ÑMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-09 2020-10-09 ABƒ mRNA-1273-P201AEmRNA-1273-P201-US208-1007US2081007ADOSE 1 - 2020-06-01T08:01AE-001 BLOOD PRESSURE ELEVATION Blood pressure increased F˜¬öBlood pressure increased F˜¬öVascular tests NEC (incl blood pressure) F™N†Cardiac and vascular investigations (excl enzyme tests) F˜³ØADVERSE EVENT Investigations F˜ïëInvestigations F˜ïëMILD NDOSE NOT CHANGEDNONE NOT RELATEDRELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-01T10:052020-06-01T20:00AA mRNA-1273-P201AEmRNA-1273-P201-US208-1007US2081007A DOSE 1 - 2020-06-01T08:01AE-003 PI NOTED INFLAMMATION OF OROPHARNYX AT DAY 15 VISIT Upper respiratory tract inflammation F™X6Upper respiratory tract inflammation F™X6Upper respiratory tract signs and symptoms F™KiRespiratory tract signs and symptoms F™Ë}ADVERSE EVENT Respiratory, thoracic and mediastinal disorders F™-ÒRespiratory, thoracic and mediastinal disorders F™-ÒMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-17 2020-06-30 BB mRNA-1273-P201AEmRNA-1273-P201-US208-1009US2081009ADOSE 2 - 2020-07-02T13:24AE-001 CONTACT DERMATITIS Contact dermatitis F˜À¦Dermatitis contact F˜ÇDermatitis and eczema F˜ÇEpidermal and dermal conditions F˜ÑADVERSE EVENT PIMMCSkin and subcutaneous tissue disorders F™5ÑSkin and subcutaneous tissue disorders F™5ÑMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-02T13:302020-07-09 B B' mRNA-1273-P201AEmRNA-1273-P201-US208-1009US2081009A DOSE 2 - 2020-07-02T13:24AE-002 BURNING TONGUE SYNDROME Burning tongue F˜± Tongue discomfort F™ÆŸTongue signs and symptoms F™BQTongue conditions F™B*ADVERSE EVENT PIMMCGastrointestinal disorders F˜Ü›Gastrointestinal disorders F˜Ü›MILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERING/RESOLVING NNNNNN1PART A FOLLOW-UP 2020-09-30 Bz. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US208-1014US2081014ADOSE 2 - 2020-06-30T10:15AE-002 CONCUSSION Concussion F˜¾ŽConcussion F˜¾ŽCerebral injuries NEC F™dInjuries NEC F˜ìâADVERSE EVENT PIMMCInjury, poisoning and procedural complications F˜ìåInjury, poisoning and procedural complications F˜ìåSEVERE NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN3PART A FOLLOW-UP 2020-08-22 2020-08-26 BSBW mRNA-1273-P201AEmRNA-1273-P201-US208-1014US2081014A DOSE 1 - 2020-06-01T14:08AE-001 LOW WHITE BLOOD CELL COUNT White blood cell count low F™`!White blood cell count decreased F™QÆWhite blood cell analyses F™QÂHaematology investigations (incl blood groups) F˜à#ADVERSE EVENT Investigations F˜ïëInvestigations F˜ïëMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-30T09:202020-07-28T09:13BB: mRNA-1273-P201AEmRNA-1273-P201-US208-1016US2081016ADOSE 2 - 2020-06-29T14:08AE-001 SINUS INFECTION Sinus infection F™5©Sinusitis F™5±Upper respiratory tract infections F™KeInfections - pathogen unspecified F˜ë÷ADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-14 2020-07-23 B,B5 mRNA-1273-P201AEmRNA-1273-P201-US208-1017US2081017ADOSE 1 - 2020-06-02T08:14AE-001 SORE THROAT Sore throat F™8Oropharyngeal pain F™¡_Upper respiratory tract signs and symptoms F™KiRespiratory tract signs and symptoms F™Ë}ADVERSE EVENT Respiratory, thoracic and mediastinal disorders F™-ÒRespiratory, thoracic and mediastinal disorders F™-ÒMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-16 2020-06-18 AðB mRNA-1273-P201AEmRNA-1273-P201-US208-1025US2081025ADOSE 2 - 2020-07-07T14:04AE-007 ALLERGIC CONJUNCTIVITIS Allergic conjunctivitis F˜-Conjunctivitis allergic F˜ÀxConjunctival infections, irritations and inflammations F˜ÀbOcular infections, irritations and inflammations F˜ëõADVERSE EVENT PIMMCEye disorders F˜Ô¯Eye disorders F˜Ô¯MODERATENNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERING/RESOLVING NNNNNN2PART A FOLLOW-UP 2021-03-10 C. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US208-1025US2081025A DOSE 2 - 2020-07-07T14:04AE-003 HEMORRHOIDS Hemorrhoids F˜ãHaemorrhoids F˜àÎHaemorrhoids and gastrointestinal varices (excl oesophageal) F˜ÜíGastrointestinal vascular conditions F˜ÜïADVERSE EVENT PIMMCGastrointestinal disorders F˜Ü›Gastrointestinal disorders F˜Ü›MODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2020-08-21 2020-12-28 BPBÑ mRNA-1273-P201AEmRNA-1273-P201-US208-1025US2081025A0DOSE 2 - 2020-07-07T14:04AE-002 HEADACHE Headache F˜á‹Headache F˜á‹Headaches NEC F˜á¡Headaches F˜áŸREACTOGENICITY Nervous system disorders F™•Nervous system disorders F™•SEVERE NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-08 2020-07-08 B$B$P1D mRNA-1273-P201AEmRNA-1273-P201-US208-1025US2081025A@DOSE 2 - 2020-07-07T14:04AE-004 INJURY OF RIGHT PINKY FINGER Injury to finger NOS F˜í1Limb injury F™…©Site specific injuries NEC F™5·Injuries NEC F˜ìâADVERSE EVENT PIMMCInjury, poisoning and procedural complications F˜ìåInjury, poisoning and procedural complications F˜ìåMODERATENDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2020-09-22 2020-12-28 BpBÑ mRNA-1273-P201AEmRNA-1273-P201-US208-1025US2081025APDOSE 2 - 2020-07-07T14:04AE-005 ALLERGIC RHINITIS Allergic rhinitis F˜;Rhinitis allergic F™/-Nasal congestion and inflammations F™ÀUpper respiratory tract disorders (excl infections) F™K`ADVERSE EVENT PIMMCRespiratory, thoracic and mediastinal disorders F™-ÒRespiratory, thoracic and mediastinal disorders F™-ÒMODERATENNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERING/RESOLVING NNNNNN2PART A FOLLOW-UP 2021-02-19 C`. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US208-1028US2081028ADOSE 1 - 2020-06-02T14:03AE-001 MUSCLE SPASM [LOWER BACK] Back muscle spasms F™ŸµMuscle spasms F™.Muscle related signs and symptoms NEC F™&Muscle disorders F™ADVERSE EVENT Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-16 2020-07-07 AðB$ mRNA-1273-P201AEmRNA-1273-P201-US208-1029US2081029ADOSE 2 - 2020-07-07T11:52AE-002 CORONARY CALCIUM SCAN ABNORMAL (ELEVATED) Coronary calcium scan abnormal F™¤RComputerised tomogram coronary artery abnormalF™„Cardiac imaging procedures F˜´Cardiac and vascular investigations (excl enzyme tests) F˜³ØADVERSE EVENT PIMMCInvestigations F˜ïëInvestigations F˜ïëMODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERING/RESOLVING NNNNNN2PART A FOLLOW-UP 2021-02-01 Bõ. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US208-1033US2081033ADOSE 2 - 2020-07-07T10:39AE-002 COVID-19 INFECTION COVID-19 F™ß¬COVID-19 F™ß¬Coronavirus infections F™àžViral infectious disorders F™OÎADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMODERATENDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2021-01-05 2021-03-15 BÚCð mRNA-1273-P201AEmRNA-1273-P201-US208-1033US2081033A DOSE 2 - 2020-07-07T10:39AE-001 SWIMMER'S EAR (LEFT EAR) Swimmer's ear F™Ù4Otitis externa F™°Ear infections F˜Í=Infections - pathogen unspecified F˜ë÷ADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-13 2020-07-18 B*B/ mRNA-1273-P201AEmRNA-1273-P201-US208-1036US2081036ADOSE 2 - 2020-07-09T13:48AE-003 COVID 19 INFECTION COVID-19 F™ß¬COVID-19 F™ß¬Coronavirus infections F™àžViral infectious disorders F™OÎADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-12-15 2020-12-25 BÃBÍ mRNA-1273-P201AEmRNA-1273-P201-US208-1036US2081036A DOSE 2 - 2020-07-09T13:48AE-004 WORSENING OF MIGRAINES Migraine aggravated F™PMigraine F™OMigraine headaches F™SHeadaches F˜áŸADVERSE EVENT PIMMCNervous system disorders F™•Nervous system disorders F™•MODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2020-10-26 2020-11-23 B‘B mRNA-1273-P201AEmRNA-1273-P201-US208-1036US2081036A0DOSE 1 - 2020-06-04T09:40AE-001 MACULAR RASH (LEFT TORSO) Macular rash F˜ùÊRash macular F™*kRashes, eruptions and exanthems NEC F™cÖEpidermal and dermal conditions F˜ÑREACTOGENICITYPIMMCSkin and subcutaneous tissue disorders F™5ÑSkin and subcutaneous tissue disorders F™5ÑMILD NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-05T08:002020-06-06T21:00A A0P1DT13H mRNA-1273-P201AEmRNA-1273-P201-US208-1038US2081038ADOSE 1 - 2020-06-08T08:02AE-001 CUT ON LEFT FOREARM Laceration of arm F˜ò–Skin laceration F™|BSkin injuries NEC F™³Injuries NEC F˜ìâADVERSE EVENT PIMMCInjury, poisoning and procedural complications F˜ìåInjury, poisoning and procedural complications F˜ìåMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION, CONCOMITANT PROCEDURENOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-08T14:002020-06-15 AA€ mRNA-1273-P201AEmRNA-1273-P201-US208-1041US2081041ADOSE 2 - 2020-07-07T12:12AE-001 NASAL CONGESTION Nasal congestion F™¿Nasal congestion F™¿Nasal congestion and inflammations F™ÀUpper respiratory tract disorders (excl infections) F™K`ADVERSE EVENT PIMMCRespiratory, thoracic and mediastinal disorders F™-ÒRespiratory, thoracic and mediastinal disorders F™-ÒMILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2020-12-14 2020-12-28 BÂBÐ mRNA-1273-P201AEmRNA-1273-P201-US208-1042US2081042ADOSE 2 - 2020-07-08T08:00AE-001 FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝADVERSE EVENT General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-09T12:002020-07-10T12:00BB mRNA-1273-P201AEmRNA-1273-P201-US208-1045US2081045ADOSE 2 - 2020-07-07T14:18AE-002 STOMACH PRESSURE Stomach pressure sensation of F™;Abdominal discomfort F˜–»Gastrointestinal signs and symptoms NEC F™žGastrointestinal signs and symptoms F˜ÜÜADVERSE EVENT Gastrointestinal disorders F˜Ü›Gastrointestinal disorders F˜Ü›MILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-12 2020-07-14 B'B) mRNA-1273-P201AEmRNA-1273-P201-US208-1045US2081045A DOSE 2 - 2020-07-07T14:18AE-003 FEELING OF "PINS AND NEEDLES" IN EXTREMITIES [CAUSALITY, INVESTIGATIONAL PRODUCT] Pins and needles F™{Paraesthesia F™oParaesthesias and dysaesthesias F™|Neurological disorders NEC F™ùADVERSE EVENT Nervous system disorders F™•Nervous system disorders F™•MILD NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-08T22:002020-07-15T07:00B#B* mRNA-1273-P201AEmRNA-1273-P201-US208-1045US2081045A0DOSE 2 - 2020-07-07T14:18AE-004 FEELING OF "PINS AND NEEDLES" IN TONGUE [CAUSALITY, INVESTIGATIONAL PROTOCOL] Paraesthesia tongue F™{Paraesthesia oral F™vœOral soft tissue signs and symptoms F™Oral soft tissue conditions F™¥ADVERSE EVENT Gastrointestinal disorders F˜Ü›Gastrointestinal disorders F˜Ü›MILD NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-08T22:002020-07-15T07:00B#B* mRNA-1273-P201AEmRNA-1273-P201-US208-1045US2081045A@DOSE 1 - 2020-06-04T10:02AE-001 WHITE FINGERTIPS Fingertip discoloration F™ËþSkin discolouration F™5ýDermal and epidermal conditions NEC F˜ÇEpidermal and dermal conditions F˜ÑADVERSE EVENT Skin and subcutaneous tissue disorders F™5ÑSkin and subcutaneous tissue disorders F™5ÑMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-28 2020-06-28 BB mRNA-1273-P201AEmRNA-1273-P201-US208-1046US2081046ADOSE 2 - 2020-07-09T07:58AE-002 CONFIRMED COVID 19 INFECTION (SYMPTOMATIC- FEVER, HEADACHE, HEAVY FEELING IN CHEST, BODY ACHES)COVID-19 F™ß¬COVID-19 F™ß¬Coronavirus infections F™àžViral infectious disorders F™OÎADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMODERATENNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2020-10-06 2020-11-06 ByB˜ mRNA-1273-P201AEmRNA-1273-P201-US208-1046US2081046A DOSE 1 - 2020-06-08T15:42AE-001 PAPULAR RASH ON FOREARM (BILATERAL) Papular rash on arms F™@Rash papular F™*tRashes, eruptions and exanthems NEC F™cÖEpidermal and dermal conditions F˜ÑADVERSE EVENT PIMMCSkin and subcutaneous tissue disorders F™5ÑSkin and subcutaneous tissue disorders F™5ÑMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-08 2020-06-16 AA mRNA-1273-P201AEmRNA-1273-P201-US208-1049US2081049ADOSE 2 - 2020-07-08T07:51AE-004 WORSENING OF ANXIETY Anxiety aggravated F™SSAnxiety F˜¡§Anxiety symptoms F˜¡µAnxiety disorders and symptoms F˜¡ADVERSE EVENT PIMMCPsychiatric disorders F™'·Psychiatric disorders F™'·MODERATENNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2020-11-17 2020-12-22 B¢BÅ mRNA-1273-P201AEmRNA-1273-P201-US208-1049US2081049A DOSE 2 - 2020-07-08T07:51AE-001 GASTROENTERITIS Gastroenteritis F˜Ü`Gastroenteritis F˜Ü`Abdominal and gastrointestinal infections F˜Ü¯Infections - pathogen unspecified F˜ë÷ADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-07-17 2020-07-28 B'B2 mRNA-1273-P201AEmRNA-1273-P201-US208-1049US2081049A0DOSE 2 - 2020-07-08T07:51AE-003 THRUSH (TONGUE) Oral thrush F™²Oral candidiasis F™sCandida infections F˜²^Fungal infectious disorders F˜ÚøADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-08-05 2020-08-12 B:BA mRNA-1273-P201AEmRNA-1273-P201-US208-1049US2081049A@DOSE 2 - 2020-07-08T07:51AE-002 URINARY TRACT INFECTION Urinary tract infection F™LkUrinary tract infection F™LkUrinary tract infections F™LqInfections - pathogen unspecified F˜ë÷ADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-27 2020-08-03 B1B8 mRNA-1273-P201AEmRNA-1273-P201-US208-1052US2081052ADOSE 2 - 2020-07-09T13:55AE-003 MILD CONCUSSION Concussion F˜¾ŽConcussion F˜¾ŽCerebral injuries NEC F™dInjuries NEC F˜ìâADVERSE EVENT PIMMCInjury, poisoning and procedural complications F˜ìåInjury, poisoning and procedural complications F˜ìåMODERATENDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2020-10-12 2020-10-19 B‚B‰ mRNA-1273-P201AEmRNA-1273-P201-US208-1052US2081052A DOSE 2 - 2020-07-09T13:55AE-007 FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝADVERSE EVENT PIMMCGeneral disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMODERATENNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2020-10-27 2020-11-16 B‘B¥ mRNA-1273-P201AEmRNA-1273-P201-US208-1052US2081052A0DOSE 1 - 2020-06-05T11:58AE-001 LEFT TRAPEZIUS REGION,TRANSIENT LOCAL MUSCLE PAIN RELATED TO INJECTION Injection site muscle pain F™ÁXInjection site pain F˜ìÆInjection site reactions F˜ìÑAdministration site reactions F˜›¤ADVERSE EVENT General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE NOT RELATEDRELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-05T12:032020-06-05T12:18AA mRNA-1273-P201AEmRNA-1273-P201-US208-1052US2081052A@DOSE 2 - 2020-07-09T13:55AE-002 NECK STRAIN (CAR ACCIDENT) Neck strain F™Ž=Muscle strain F™YïMuscle, tendon and ligament injuries F™Injuries NEC F˜ìâADVERSE EVENT PIMMCInjury, poisoning and procedural complications F˜ìåInjury, poisoning and procedural complications F˜ìåMODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2020-10-12 2020-10-23 B‚B mRNA-1273-P201AEmRNA-1273-P201-US208-1052US2081052APDOSE 2 - 2020-07-09T13:55AE-004 SORE THROAT Sore throat F™8Oropharyngeal pain F™¡_Upper respiratory tract signs and symptoms F™KiRespiratory tract signs and symptoms F™Ë}ADVERSE EVENT Respiratory, thoracic and mediastinal disorders F™-ÒRespiratory, thoracic and mediastinal disorders F™-ÒMODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERING/RESOLVING NNNNNN2PART A FOLLOW-UP 2020-10-21 B‹. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US208-1057US2081057ADOSE 1 - 2020-06-05T13:45AE-0021080FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝREACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-06 2020-06-12 A A€P1D mRNA-1273-P201AEmRNA-1273-P201-US208-1057US2081057A DOSE 1 - 2020-06-05T13:45AE-0031060LYMPHADENOPATHY Lymphadenopathy F˜øíLymphadenopathy F˜øíLymphatic system disorders NEC F˜øîSpleen, lymphatic and reticuloendothelial system disorders F™9)REACTOGENICITYPIMMCBlood and lymphatic system disorders F˜«QBlood and lymphatic system disorders F˜«QMILD NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-10 2020-06-12 A`A€P1D mRNA-1273-P201AEmRNA-1273-P201-US208-1058US2081058ADOSE 1 - 2020-06-08T11:54AE-002 SINUS INFECTION Sinus infection F™5©Sinusitis F™5±Upper respiratory tract infections F™KeInfections - pathogen unspecified F˜ë÷ADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMODERATENNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2020-11-16 2020-12-02 B¢B² mRNA-1273-P201AEmRNA-1273-P201-US208-1059US2081059ADOSE 2 - 2020-07-13T11:33AE-004 NECK PAIN Neck pain F™$Neck pain F™$Musculoskeletal and connective tissue pain and discomfort F™£Musculoskeletal and connective tissue disorders NEC F™iADVERSE EVENT Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMODERATENNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2021-02-21 2021-02-28 C0C mRNA-1273-P201AEmRNA-1273-P201-US208-1059US2081059A DOSE 2 - 2020-07-13T11:33AE-002 RUNNY NOSE (SEASONAL ALLERGIES) Seasonal allergy F™UŒSeasonal allergy F™UŒAtopic disorders F™dAllergic conditions F˜,ADVERSE EVENT Immune system disorders F˜ê4Immune system disorders F˜ê4MILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-08-05 2020-08-09 B;B? mRNA-1273-P201AEmRNA-1273-P201-US208-1059US2081059A0DOSE 2 - 2020-07-13T11:33AE-001 SORE THROAT (SEASONAL ALLERGIES) Seasonal allergy F™UŒSeasonal allergy F™UŒAtopic disorders F™dAllergic conditions F˜,ADVERSE EVENT Immune system disorders F˜ê4Immune system disorders F˜ê4MILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-08-05 2020-08-09 B;B? mRNA-1273-P201AEmRNA-1273-P201-US208-1063US2081063ADOSE 2 - 2020-07-08T09:55AE-002 ANXIETY Anxiety F˜¡§Anxiety F˜¡§Anxiety symptoms F˜¡µAnxiety disorders and symptoms F˜¡ADVERSE EVENT PIMMCPsychiatric disorders F™'·Psychiatric disorders F™'·MODERATENNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERING/RESOLVING NNNNNN2PART A FOLLOW-UP 2020-10-12 B. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US208-1063US2081063A DOSE 2 - 2020-07-08T09:55AE-001 DEPRESSION Depression F˜ÆÚDepression F˜ÆÚDepressive disorders F˜ÆñDepressed mood disorders and disturbances F˜Æ×ADVERSE EVENT Psychiatric disorders F™'·Psychiatric disorders F™'·SEVERE NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED NOT RECOVERED/NOT RESOLVED NNNNNN3BLINDED TREATMENT 2020-07-20 B+. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US208-1064US2081064ADOSE 2 - 2020-07-09T09:56AE-003 ACUTE GASTROENTERITIS Acute gastroenteritis F™›JGastroenteritis F˜Ü`Abdominal and gastrointestinal infections F˜Ü¯Infections - pathogen unspecified F˜ë÷ADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-07-09 2020-07-10 B B! mRNA-1273-P201AEmRNA-1273-P201-US208-1064US2081064A DOSE 2 - 2020-07-09T09:56AE-001 MUSCLE ACHES (ALL OVER BODY) Generalized muscle aches F™ŠiMyalgia F™{Muscle pains F™#Muscle disorders F™REACTOGENICITYPIMMCMusculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMODERATENDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-07-09 2020-07-10 B B!P2D mRNA-1273-P201AEmRNA-1273-P201-US208-1066US2081066ADOSE 2 - 2020-07-24T09:29AE-001 HEADACHE Headache F˜á‹Headache F˜á‹Headaches NEC F˜á¡Headaches F˜áŸADVERSE EVENT Nervous system disorders F™•Nervous system disorders F™•MILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-08-02 2020-08-02 B&B& mRNA-1273-P201AEmRNA-1273-P201-US208-1069US2081069ADOSE 1 - 2020-06-26T14:54AE-0021080FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝREACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-06-26 2020-07-03 AA€P1D mRNA-1273-P201AEmRNA-1273-P201-US208-1069US2081069A DOSE 1 - 2020-06-26T14:54AE-003 LUMP AT INJECTION SITE Injection site lump F™¬üInjection site mass F˜ìÁInjection site reactions F˜ìÑAdministration site reactions F˜›¤ADVERSE EVENT General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMODERATENDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED NOT RECOVERED/NOT RESOLVED NNNNNN2BLINDED TREATMENT 2020-06-27 A . ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US208-1069US2081069A0DOSE 2 - 2020-07-24T14:17AE-001 SINUS HEADACHE Sinus headache F™5¨Sinus headache F™5¨Headaches NEC F˜á¡Headaches F˜áŸADVERSE EVENT Nervous system disorders F™•Nervous system disorders F™•MILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-26 2020-07-26 BB mRNA-1273-P201AEmRNA-1273-P201-US208-1070US2081070ADOSE 2 - 2020-07-24T14:01AE-001 BED BUG BITES (BACK) Bedbug bite F˜¦æArthropod bite F˜£ÇNon-site specific injuries NEC F™ ÇInjuries NEC F˜ìâADVERSE EVENT Injury, poisoning and procedural complications F˜ìåInjury, poisoning and procedural complications F˜ìåMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-08-10 2020-08-21 B.B9 mRNA-1273-P201AEmRNA-1273-P201-US208-1071US2081071ADOSE 2 - 2020-07-29T11:55AE-001 SORE THROAT WITH MUCUS Sore throat F™8Oropharyngeal pain F™¡_Upper respiratory tract signs and symptoms F™KiRespiratory tract signs and symptoms F™Ë}ADVERSE EVENT Respiratory, thoracic and mediastinal disorders F™-ÒRespiratory, thoracic and mediastinal disorders F™-ÒMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-08-01 2020-08-03 B!B# mRNA-1273-P201AEmRNA-1273-P201-US208-1071US2081071A DOSE 2 - 2020-07-29T11:55AE-002 POSTERIOR OROPHARYNX SLIGHT ERYTHEMA (THROAT) Pharyngeal erythema F™u1Pharyngeal erythema F™u1Pharyngeal disorders (excl infections and neoplasms) F™‡Upper respiratory tract disorders (excl infections) F™K`ADVERSE EVENT Respiratory, thoracic and mediastinal disorders F™-ÒRespiratory, thoracic and mediastinal disorders F™-ÒMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-08-05 2020-08-12 B%B, mRNA-1273-P201AEmRNA-1273-P201-US208-1072US2081072ADOSE 2 - 2020-07-24T11:44AE-002 HEADACHE Headache F˜á‹Headache F˜á‹Headaches NEC F˜á¡Headaches F˜áŸREACTOGENICITY Nervous system disorders F™•Nervous system disorders F™•MODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-07-25T03:002020-07-25T21:00BBPT18H mRNA-1273-P201AEmRNA-1273-P201-US208-1072US2081072A DOSE 1 - 2020-06-26T09:50AE-001 WHEEZING (SEASONAL ALLERGY RELATED) Seasonal allergy F™UŒSeasonal allergy F™UŒAtopic disorders F™dAllergic conditions F˜,ADVERSE EVENT Immune system disorders F˜ê4Immune system disorders F˜ê4MILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-03 2020-07-12 A€B mRNA-1273-P201AEmRNA-1273-P201-US208-1076US2081076ADOSE 2 - 2020-08-05T14:22AE-001 FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝREACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-08-06T09:002020-08-07T07:00B%B&PT22H mRNA-1273-P201AEmRNA-1273-P201-US208-1076US2081076A DOSE 2 - 2020-08-05T14:22AE-003 REDNESS AT INJECTION SITE (120MM) Injection site redness F˜ìÒInjection site erythema F˜ìInjection site reactions F˜ìÑAdministration site reactions F˜›¤REACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE RELATED RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-08-07 2020-08-09 B&B(P3D mRNA-1273-P201AEmRNA-1273-P201-US208-1076US2081076A0DOSE 2 - 2020-08-05T14:22AE-005 HARDNESS AT INJECTION SITE (DAY 8) Injection site induration F˜ì»Injection site induration F˜ì»Injection site reactions F˜ìÑAdministration site reactions F˜›¤REACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE RELATED RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-08-05 2020-08-13 B$B,P2D mRNA-1273-P201AEmRNA-1273-P201-US208-1076US2081076A@DOSE 2 - 2020-08-05T14:22AE-004 SWELLING AT INJECTION SITE (DAY 8) Injection site swelling F™g1Injection site swelling F™g1Injection site reactions F˜ìÑAdministration site reactions F˜›¤REACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE RELATED RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-08-05 2020-08-13 B$B,P2D mRNA-1273-P201AEmRNA-1273-P201-US208-1076US2081076APDOSE 2 - 2020-08-05T14:22AE-002 GRADE 3 ALL OVER BODY MUSCLE ACHES Generalized muscle aches F™ŠiMyalgia F™{Muscle pains F™#Muscle disorders F™REACTOGENICITY Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-08-06T09:002020-08-07T07:00B%B&PT22H mRNA-1273-P201AEmRNA-1273-P201-US208-1077US2081077ADOSE 2 - 2020-08-03T11:54AE-002 URINARY TRACT INFECTION Urinary tract infection F™LkUrinary tract infection F™LkUrinary tract infections F™LqInfections - pathogen unspecified F˜ë÷ADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùMODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2PART A FOLLOW-UP 2020-12-08 2020-12-19 B¢B mRNA-1273-P201AEmRNA-1273-P201-US208-1081US2081081ADOSE 2 - 2020-07-29T10:14AE-001 HYPERTENSION Hypertension F˜ç¤Hypertension F˜ç¤Vascular hypertensive disorders NEC F˜ç¦Vascular hypertensive disorders F™uÎADVERSE EVENT PIMMCVascular disorders F™NYVascular disorders F™NYMODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERING/RESOLVING NNNNNN2PART A FOLLOW-UP 2021-01-27 BÕ. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US208-1081US2081081A DOSE 2 - 2020-07-29T10:14AE-002 TORN ACHILLES (LEFT FOOT) Ruptured Achilles tendon F™0 Tendon rupture F™?pMuscle, tendon and ligament injuries F™Injuries NEC F˜ìâADVERSE EVENT PIMMCInjury, poisoning and procedural complications F˜ìåInjury, poisoning and procedural complications F˜ìåMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION, CONCOMITANT PROCEDURENOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1PART A FOLLOW-UP 2021-01-06 2021-03-02 BÀB÷ mRNA-1273-P201AEmRNA-1273-P201-US208-1085US2081085ADOSE 2 - 2020-08-11T08:58AE-001 FATIGUE (GRADE 3) Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝREACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝSEVERE NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-08-11T16:002020-08-11T20:00B(B(PT4H mRNA-1273-P201AEmRNA-1273-P201-US208-1088US2081088ADOSE 2 - 2020-08-03T07:54AE-002 GRADE 3 FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝREACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-08-03T20:002020-08-04T16:00B!B"PT20H mRNA-1273-P201AEmRNA-1273-P201-US208-1088US2081088A DOSE 1 - 2020-07-02T10:12AE-001 CHEST TIGHTNESS (MUSCULOSKELETAL) Musculoskeletal chest pain F™]Musculoskeletal chest pain F™]Musculoskeletal and connective tissue pain and discomfort F™£Musculoskeletal and connective tissue disorders NEC F™iADVERSE EVENT Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMILD NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-07 2020-07-07 A`A` mRNA-1273-P201AEmRNA-1273-P201-US208-1091US2081091ADOSE 2 - 2020-08-03T09:55AE-003 GRADE 3 JOINT ACHE (HIPS,KNEES,SHOULDERS, ELBOWS, LEGS) Arthralgia F˜£'Arthralgia F˜£'Joint related signs and symptoms F˜ñ:Joint disorders F˜ñ-REACTOGENICITY Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-08-04T09:002020-08-05T17:00B!B"P1DT8H mRNA-1273-P201AEmRNA-1273-P201-US208-1091US2081091A DOSE 2 - 2020-08-03T09:55AE-001 FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝREACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-08-04T09:002020-08-05T17:00B!B"P1DT8H mRNA-1273-P201AEmRNA-1273-P201-US208-1091US2081091A0DOSE 2 - 2020-08-03T09:55AE-002 GRADE 3 ALL OVER BODY MUSCLE ACHES Generalized muscle aches F™ŠiMyalgia F™{Muscle pains F™#Muscle disorders F™REACTOGENICITY Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-08-04T09:002020-08-05T17:00B!B"P1DT8H mRNA-1273-P201AEmRNA-1273-P201-US208-1092US2081092ADOSE 1 - 2020-07-02T10:27AE-004 NONSPECIFIC DERMATITIS (RASH ACROSS FOREHEAD AND UPPER BACK) Dermatitis NOS F˜Ç>Dermatitis F˜ÇDermatitis and eczema F˜ÇEpidermal and dermal conditions F˜ÑADVERSE EVENT PIMMCSkin and subcutaneous tissue disorders F™5ÑSkin and subcutaneous tissue disorders F™5ÑMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-06 2020-07-12 APA° mRNA-1273-P201AEmRNA-1273-P201-US208-1092US2081092A DOSE 1 - 2020-07-02T10:27AE-0031080FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝREACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-02 2020-07-14 AAÐP6D mRNA-1273-P201AEmRNA-1273-P201-US208-1092US2081092A0DOSE 1 - 2020-07-02T10:27AE-001 SHOULDER PAIN R/T PLAYING PICKLE BALL Shoulder pain F™5)Musculoskeletal pain F™gMusculoskeletal and connective tissue pain and discomfort F™£Musculoskeletal and connective tissue disorders NEC F™iADVERSE EVENT Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-02 2020-07-02T12:00AA mRNA-1273-P201AEmRNA-1273-P201-US208-1092US2081092A@DOSE 1 - 2020-07-02T10:27AE-002 SHOULDER PAIN R/T PLAYING PICKLE BALL Shoulder pain F™5)Musculoskeletal pain F™gMusculoskeletal and connective tissue pain and discomfort F™£Musculoskeletal and connective tissue disorders NEC F™iADVERSE EVENT Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-07 2020-07-07 A`A` mRNA-1273-P201AEmRNA-1273-P201-US208-1093US2081093ADOSE 1 - 2020-07-02T11:50AE-002 SHOULDER PAIN R/T PLAYING PICKLE BALL Shoulder pain F™5)Musculoskeletal pain F™gMusculoskeletal and connective tissue pain and discomfort F™£Musculoskeletal and connective tissue disorders NEC F™iADVERSE EVENT Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-03 2020-07-03T12:00A A mRNA-1273-P201AEmRNA-1273-P201-US208-1093US2081093A DOSE 1 - 2020-07-02T11:50AE-001 SHOULDER PAIN R/T PLAYING PICKLE BALL Shoulder pain F™5)Musculoskeletal pain F™gMusculoskeletal and connective tissue pain and discomfort F™£Musculoskeletal and connective tissue disorders NEC F™iADVERSE EVENT Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-09 2020-07-09 A€A€ mRNA-1273-P201AEmRNA-1273-P201-US208-1099US2081099ADOSE 2 - 2020-07-29T08:04AE-0032100GENERALIZED JOINT ACHES (DAY 8-DAY 14 AFTER INJECTION) Generalized joint pain F™ŠfArthralgia F˜£'Joint related signs and symptoms F˜ñ:Joint disorders F˜ñ-REACTOGENICITY Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-29 2020-08-11 B"B/P7D mRNA-1273-P201AEmRNA-1273-P201-US208-1099US2081099A DOSE 2 - 2020-07-29T08:04AE-0022070HEADACHE (DAY 8 AFTER INJECTION) Headache F˜á‹Headache F˜á‹Headaches NEC F˜á¡Headaches F˜áŸREACTOGENICITY Nervous system disorders F™•Nervous system disorders F™•MILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-08-06 2020-08-08 B*B,P4D mRNA-1273-P201AEmRNA-1273-P201-US208-1100US2081100ADOSE 2 - 2020-08-03T10:06AE-006 WORSENING OF ANXIETY Anxiety aggravated F™SSAnxiety F˜¡§Anxiety symptoms F˜¡µAnxiety disorders and symptoms F˜¡ADVERSE EVENT PIMMCPsychiatric disorders F™'·Psychiatric disorders F™'·MODERATENNOT APPLICABLE CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERING/RESOLVING NNNNNN2PART A FOLLOW-UP 2021-02-01 B×. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US208-1100US2081100A DOSE 1 - 2020-07-02T13:51AE-001 DIARRHEA Diarrhea F˜È7Diarrhoea F˜È?Diarrhoea (excl infective) F˜È@Gastrointestinal motility and defaecation conditions F˜Ü¹ADVERSE EVENT Gastrointestinal disorders F˜Ü›Gastrointestinal disorders F˜Ü›MILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-05 2020-07-05 A@A@ mRNA-1273-P201AEmRNA-1273-P201-US208-1100US2081100A0DOSE 1 - 2020-07-02T13:51AE-0031080FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝREACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-05 2020-07-09 A@A€P1D mRNA-1273-P201AEmRNA-1273-P201-US208-1100US2081100A@DOSE 2 - 2020-08-03T10:06AE-0052080FATIGUE REPORTED BEYOND DAY 7 IN EDIARY Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝREACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-08-05 2020-08-11 B#B)P2D mRNA-1273-P201AEmRNA-1273-P201-US208-1100US2081100APDOSE 1 - 2020-07-02T13:51AE-0021070HEADACHE Headache F˜á‹Headache F˜á‹Headaches NEC F˜á¡Headaches F˜áŸREACTOGENICITY Nervous system disorders F™•Nervous system disorders F™•MILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-05 2020-07-11 A@A P3D mRNA-1273-P201AEmRNA-1273-P201-US208-1100US2081100A`DOSE 2 - 2020-08-03T10:06AE-004 ITCHING AROUND INJECTION SITE, NO REDNESS Injection site itching F˜ìÀInjection site pruritus F˜ìÍInjection site reactions F˜ìÑAdministration site reactions F˜›¤ADVERSE EVENT General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE RELATED RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-08-05 2020-08-07 B#B% mRNA-1273-P201AEmRNA-1273-P201-US208-1103US2081103ADOSE 1 - 2020-07-02T08:04AE-002 HEADACHE Headache F˜á‹Headache F˜á‹Headaches NEC F˜á¡Headaches F˜áŸADVERSE EVENT Nervous system disorders F™•Nervous system disorders F™•MODERATENDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-07-18 2020-07-24 BB mRNA-1273-P201AEmRNA-1273-P201-US208-1103US2081103A DOSE 1 - 2020-07-02T08:04AE-001 FEVER Fever F˜×.Pyrexia F™)œFebrile disorders F˜ÖBody temperature conditions F˜”ADVERSE EVENT General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-18 2020-07-24 BB mRNA-1273-P201AEmRNA-1273-P201-US208-1118US2081118ADOSE 1 - 2020-07-01T14:01AE-001 OVERACTIVE BLADDER Overactive bladder F™aHypertonic bladder F˜çõMyoneurogenic bladder disorders F™_Bladder and bladder neck disorders (excl calculi) F˜ªADVERSE EVENT PIMMCRenal and urinary disorders F™,WRenal and urinary disorders F™,WMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERING/RESOLVING NNNNNN1BLINDED TREATMENT 2020-07-10 A . ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US208-1120US2081120ADOSE 2 - 2020-07-29T14:00AE-002 CS HEMATOCRIT LAB (INCREASED) Hematocrit increased F˜â`Haematocrit increased F˜àRed blood cell analyses F™+„Haematology investigations (incl blood groups) F˜à#ADVERSE EVENT Investigations F˜ïëInvestigations F˜ïëMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED NOT RECOVERED/NOT RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-29 B. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US208-1120US2081120A DOSE 2 - 2020-07-29T14:00AE-001 CS HEMOGLOBIN LAB (INCREASED) Hemoglobin increased F™o¯Haemoglobin increased F˜àHRed blood cell analyses F™+„Haematology investigations (incl blood groups) F˜à#ADVERSE EVENT Investigations F˜ïëInvestigations F˜ïëMILD NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED NOT RECOVERED/NOT RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-29 B. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US208-1120US2081120A0DOSE 2 - 2020-07-29T14:00AE-003 ENLARGED PROSTATE Enlarged prostate F™VØProstatomegaly F™_šProstatic signs, symptoms and disorders NEC F™&ßProstatic disorders (excl infections and inflammations) F™&ÞADVERSE EVENT PIMMCReproductive system and breast disorders F™-LReproductive system and breast disorders F™-LMODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION, CONCOMITANT PROCEDURENOT RELATEDNOT RELATED NOT RECOVERED/NOT RESOLVED NNNNNN2PART A FOLLOW-UP 2020-12-01 Bš. ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US208-1121US2081121ADOSE 1 - 2020-07-06T09:50AE-001 CANKER SORE Canker sores oral F˜²~Aphthous ulcer F˜¢Stomatitis and ulceration F™;Oral soft tissue conditions F™¥ADVERSE EVENT Gastrointestinal disorders F˜Ü›Gastrointestinal disorders F˜Ü›MILD NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-09 2020-07-15 A@A mRNA-1273-P201AEmRNA-1273-P201-US208-1121US2081121A DOSE 2 - 2020-08-10T12:59AE-006 ELEVATED BLOOD PRESSURE POST DOSE Blood pressure increased F˜¬öBlood pressure increased F˜¬öVascular tests NEC (incl blood pressure) F™N†Cardiac and vascular investigations (excl enzyme tests) F˜³ØADVERSE EVENT Investigations F˜ïëInvestigations F˜ïëSEVERE NDOSE NOT CHANGEDNONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN3BLINDED TREATMENT 2020-08-10T14:002020-08-11T09:50B$B% mRNA-1273-P201AEmRNA-1273-P201-US208-1121US2081121A0DOSE 1 - 2020-07-06T09:50AE-005 HEADACHE Headache F˜á‹Headache F˜á‹Headaches NEC F˜á¡Headaches F˜áŸADVERSE EVENT Nervous system disorders F™•Nervous system disorders F™•MILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-13 2020-07-15 A€A mRNA-1273-P201AEmRNA-1273-P201-US208-1121US2081121A@DOSE 1 - 2020-07-06T09:50AE-002 STIFF NECK Stiff neck F™:»Musculoskeletal stiffness F™e(Musculoskeletal and connective tissue conditions NEC F™ÑÇMusculoskeletal and connective tissue disorders NEC F™iADVERSE EVENT Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-09 2020-07-11 A@A` mRNA-1273-P201AEmRNA-1273-P201-US208-1121US2081121APDOSE 1 - 2020-07-06T09:50AE-004 STIFF NECK Stiff neck F™:»Musculoskeletal stiffness F™e(Musculoskeletal and connective tissue conditions NEC F™ÑÇMusculoskeletal and connective tissue disorders NEC F™iADVERSE EVENT Musculoskeletal and connective tissue disorders F™kMusculoskeletal and connective tissue disorders F™kMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-13 2020-07-15 A€A mRNA-1273-P201AEmRNA-1273-P201-US208-1121US2081121A`DOSE 1 - 2020-07-06T09:50AE-003 SORE THROAT Sore throat F™8Oropharyngeal pain F™¡_Upper respiratory tract signs and symptoms F™KiRespiratory tract signs and symptoms F™Ë}ADVERSE EVENT Respiratory, thoracic and mediastinal disorders F™-ÒRespiratory, thoracic and mediastinal disorders F™-ÒMILD NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-07-09 2020-07-11 A@A` mRNA-1273-P201AEmRNA-1273-P201-US208-1123US2081123ADOSE 1 - 2020-06-30T12:18AE-003 ELEVATED ALKALINE PHOSPHATASE Alkaline phosphatase increased F˜Blood alkaline phosphatase increased F™2Tissue enzyme analyses NEC F™AóEnzyme investigations NEC F˜ÐÚADVERSE EVENT PIMMCInvestigations F˜ïëInvestigations F˜ïëMODERATENNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-08-11 2020-09-08 B+BG mRNA-1273-P201AEmRNA-1273-P201-US208-1123US2081123A DOSE 1 - 2020-06-30T12:18AE-002 ELEVATED PLATELET COUNT Platelet count increased F™`Platelet count increased F™`Platelet analyses F™!CHaematology investigations (incl blood groups) F˜à#ADVERSE EVENT PIMMCInvestigations F˜ïëInvestigations F˜ïëMODERATENNOT APPLICABLE NONE NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-08-11 2020-09-08 B+BG mRNA-1273-P201AEmRNA-1273-P201-US208-1123US2081123A0DOSE 1 - 2020-06-30T12:18AE-001 DOUBLE PNEUMONIA (COMMUNITY ACQUIRED) Community acquired pneumonia F˜¾Pneumonia F™!ÐLower respiratory tract and lung infections F˜øInfections - pathogen unspecified F˜ë÷ADVERSE EVENT PIMMCInfections and infestations F˜ëùInfections and infestations F˜ëùSEVERE YDRUG WITHDRAWN CONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNYYN3BLINDED TREATMENT 2020-08-01 2020-08-26 B!B: mRNA-1273-P201AEmRNA-1273-P201-US208-1125US2081125ADOSE 2 - 2020-08-03T13:49AE-001 COMMON COLD Common cold F˜½úNasopharyngitis F™ Upper respiratory tract infections F™KeInfections - pathogen unspecified F˜ë÷ADVERSE EVENT Infections and infestations F˜ëùInfections and infestations F˜ëùMILD NDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-08-04 2020-08-10 B"B( mRNA-1273-P201AEmRNA-1273-P201-US208-1129US2081129ADOSE 2 - 2020-08-03T13:59AE-009 CHEMICAL BURN (MIDDLE STERNUM AND LEFT LATERAL SUPERIOR CHEST) Chemical burn F˜·dChemical burn F˜·dChemical injuries F˜·hExposures, chemical injuries and poisoning F™¯‹ADVERSE EVENT PIMMCInjury, poisoning and procedural complications F˜ìåInjury, poisoning and procedural complications F˜ìåMODERATENDOSE NOT CHANGEDCONCOMITANT MEDICATION NOT RELATEDNOT RELATED RECOVERING/RESOLVING NNNNNN2PART A FOLLOW-UP 2020-12-08 B . ONGOINGmRNA-1273-P201AEmRNA-1273-P201-US208-1129US2081129A DOSE 2 - 2020-08-03T13:59AE-001 DIZZINESS Dizziness F˜Ë…Dizziness F˜Ë…Neurological signs and symptoms NEC F™úNeurological disorders NEC F™ùADVERSE EVENT PIMMCNervous system disorders F™•Nervous system disorders F™•MILD NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-08-07T07:002020-08-12 B%B* mRNA-1273-P201AEmRNA-1273-P201-US208-1129US2081129A0DOSE 2 - 2020-08-03T13:59AE-0052080FATIGUE Fatigue F˜ÖFatigue F˜ÖAsthenic conditions F˜¤^General system disorders NEC F˜ÝREACTOGENICITY General disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMODERATENDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-08-04 2020-08-10 B"B(P1D mRNA-1273-P201AEmRNA-1273-P201-US208-1129US2081129A@DOSE 2 - 2020-08-03T13:59AE-0042070HEADACHE Headache F˜á‹Headache F˜á‹Headaches NEC F˜á¡Headaches F˜áŸREACTOGENICITY Nervous system disorders F™•Nervous system disorders F™•MODERATENDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-08-09 2020-08-10 B'B(P1D mRNA-1273-P201AEmRNA-1273-P201-US208-1129US2081129APDOSE 2 - 2020-08-03T13:59AE-002 MALAISE Malaise F˜ú Malaise F˜ú Asthenic conditions F˜¤^General system disorders NEC F˜ÝADVERSE EVENT PIMMCGeneral disorders and administration site conditions F˜ÝGeneral disorders and administration site conditions F˜ÝMILD NDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN1BLINDED TREATMENT 2020-08-10 2020-08-10 B(B( mRNA-1273-P201AEmRNA-1273-P201-US208-1129US2081129A`DOSE 2 - 2020-08-03T13:59AE-0062110NAUSEA Nausea F™ Nausea F™ Nausea and vomiting symptoms F™Gastrointestinal signs and symptoms F˜ÜÜREACTOGENICITY Gastrointestinal disorders F˜Ü›Gastrointestinal disorders F˜Ü›MODERATENDOSE NOT CHANGEDNONE RELATED NOT RELATED RECOVERED/RESOLVED NNNNNN2BLINDED TREATMENT 2020-08-09 2020-08-10 B'B(P1D