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From the 1/14/2022 release of VAERS data:

Found 5,438 cases where Vaccine is COVID19 and Manufacturer is MODERNA and Patient Died

Government Disclaimer on use of this data



Case Details

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VAERS ID: 1522593 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-04-13
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest, Cardiogenic shock, Myocardial fibrosis, Myocarditis
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-04
   Days after onset: 21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Aldactone; ATENURIX; DIALVIT; Nexium; ROCALTROL; ARANESP; FERINJECT; FRAGMIN; VITAMIN B12 NOS; FRAGMIN
Current Illness: D-hypervitaminosis (Vitamin D)); Dialysis; Gastrooesophageal reflux; Gout; Hyperuricaemia; Renal necrosis NOS
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: Myocardial fibrosis; This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS, CARDIAC ARREST, CARDIOGENIC SHOCK and MYOCARDIAL FIBROSIS (Myocardial fibrosis) in a 67-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Renal necrosis NOS, Dialysis, Gastrooesophageal reflux, Hyperuricaemia, Gout and D-hypervitaminosis (Vitamin D)). Concomitant products included Spironolactone (Aldactone), FEBUXOSTAT (ATENURIX), ASCORBIC ACID, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, RIBOFLAVIN, THIAMINE MONONITRATE (DIALVIT), Esomeprazole magnesium (Nexium), CALCITRIOL (ROCALTROL), DARBEPOETIN ALFA (ARANESP), FERRIC CARBOXYMALTOSE (FERINJECT), DALTEPARIN SODIUM (FRAGMIN), VITAMIN B12 NOS and DALTEPARIN SODIUM (FRAGMIN) for an unknown indication. On 17-Mar-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 100 microgram. On 13-Apr-2021, the patient experienced MYOCARDITIS (seriousness criteria death, hospitalization, medically significant and life threatening) and CARDIAC ARREST (seriousness criteria death, hospitalization, medically significant and life threatening). In May 2021, the patient experienced CARDIOGENIC SHOCK (seriousness criteria death, hospitalization, medically significant and life threatening). On an unknown date, the patient experienced MYOCARDIAL FIBROSIS (Myocardial fibrosis) (seriousness criterion death). The patient died on 04-May-2021. The reported cause of death was Cardiogenic shock. An autopsy was performed. The autopsy-determined cause of death was Myocarditis and Myocardial fibrosis. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered MYOCARDITIS, CARDIAC ARREST and CARDIOGENIC SHOCK to be possibly related. No further causality assessment was provided for MYOCARDIAL FIBROSIS (Myocardial fibrosis). Company Comment: Very limited information regarding this events has been provided at this time.; Reporter''s Comments: Covid-19 Vaccine Moderna� mRNA Covid-19; Senders Comments: Very limited information regarding this events has been provided at this time.; Reported Cause(s) of Death: Cardiogenic shock; Autopsy-determined Cause(s) of Death: Myocarditis; Myocardial fibrosis


VAERS ID: 1522606 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-06-10
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 30380777700688 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Acute renal failure; Dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: Respiratorische Verschlechterung; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Respiratorische Verschlechterung) in a 92-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch nos. 30380777700688 and 3001942) for COVID-19 vaccination. The patient''s past medical history included Acute renal failure and Dementia. Concurrent medical conditions included Arterial hypertension. On 04-May-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. Death occurred on 10-Jun-2021 The patient died on 10-Jun-2021. The cause of death was not reported. An autopsy was not performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered DEATH (Respiratorische Verschlechterung) to be unlikely related. Concomitant and treatment medications were not reported Company comments:Although a causal relationship cannot be excluded based on the current available information and temporal association between the use of the product and the start date of the event, it was considered unlikely per the treating physician.; Sender''s Comments: Although a causal relationship cannot be excluded based on the current available information and temporal association between the use of the product and the start date of the event, it was considered unlikely per the treating physician.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1522610 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-04-27
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Atrial fibrillation, C-reactive protein, Cardiac arrest, Echocardiogram, Electrocardiogram
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-05
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASPIRIN CARDIO; BILOL; LISITRIL COMP.; CRESTOR
Current Illness: Arterial hypertension; Chronic renal insufficiency; Chronic venous insufficiency; Coronary disease; Dyslipidemia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: C-reactive protein; Result Unstructured Data: high; Test Date: 202104; Test Name: Echocardiography; Result Unstructured Data; Test Date: 202104; Test Name: Electrocardiogram; Result Unstructured Data:.
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: Cardiac arrest; Atrial fibrillation; This regulatory authority case was reported by a physician and describes the occurrence of CARDIAC ARREST (Cardiac arrest) and ATRIAL FIBRILLATION (Atrial fibrillation) in an 83-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for an unknown indication. Concurrent medical conditions included Coronary disease, Arterial hypertension, Dyslipidemia, Chronic renal insufficiency and Chronic venous insufficiency. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN CARDIO), BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISITRIL COMP) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication. On 22-Apr-2021, the patient received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. On 27-Apr-2021, after starting mRNA-1273 (COVID-19 Vaccine Moderna), the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criteria death and medically significant). On 05-May-2021, the patient experienced CARDIAC ARREST (Cardiac arrest) (seriousness criteria death and medically significant). The patient died on 05-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, C-reactive protein: 32mg/l (High) high. In April 2021, Echocardiogram: abnormal (abnormal). In April 2021, Electrocardiogram: abnormal (abnormal). For mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown), the reporter considered CARDIAC ARREST (Cardiac arrest) and ATRIAL FIBRILLATION (Atrial fibrillation) to be unlikely related. No treatment information was provided. Company Comment: Very limited information regarding these events has been provided at this time. However, multiple underlying co-morbidities may remain as confounding factors. No follow up is possible.; Sender''s Comments: Very limited information regarding these events has been provided at this time. However, multiple underlying co-morbidities may remain as confounding factors.No follow up is possible.; Reported Cause(s) of Death: Unknown


VAERS ID: 1523766 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-07-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003610 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypercholesterolaemia; Infarct myocardial; Osteoporosis; Parkinsonism hyperpyrexia syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Death unexplained; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death unexplained) in an 86-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003610) for COVID-19 vaccination. The patient''s past medical history included Parkinsonism hyperpyrexia syndrome, Infarct myocardial in 2014, Hypercholesterolaemia and Osteoporosis. On 21-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 22-Jul-2021 The patient died on 22-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication reported. No Treatment medication reported. Sender''s (Case) Safety Report Unique Identifier: FR-AFSSAPS-SE20211893. Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded.; Sender''s Comments: Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded.; Reported Cause(s) of Death.


VAERS ID: 1524396 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003601 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: DECESSO; DECESSO; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (DECESSO) and PYREXIA (DECESSO) in a 71-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003601) for COVID-19 vaccination. No Medical History information was reported. On 18-Jul-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 18-Jul-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced DEATH (DECESSO) (seriousness criteria death and medically significant) and PYREXIA (DECESSO) (seriousness criterion death). The patient was treated with PARACETAMOL 17-Jul-2021 for Fever, at an unspecified dose and frequency. The patient died on 18-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided. Very limited information regarding these events have been provided at this time. No further information is expected at this time. Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow up received on 29-Jul-2021, contains information about event pyrexia and concomitant drug paracetamol.; Sender''s Comments: Very limited information regarding these events have been provided at this time. No further information is expected at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1525235 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-19
Onset:2021-05-10
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001652 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Lung disorder, Lung opacity
SMQs:, Interstitial lung disease (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-02
   Days after onset: 23
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Ground glass opacity in thoracic CT; Pneumopathy; This regulatory authority case was reported by a physician and describes the occurrence of LUNG OPACITY (Ground glass opacity in thoracic CT) and LUNG DISORDER (Pneumopathy) in an 82-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001652) for COVID-19 vaccination. No Medical History information was reported. On 19-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 10-May-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced LUNG DISORDER (Pneumopathy) (seriousness criterion death). On 25-May-2021, the patient experienced LUNG OPACITY (Ground glass opacity in thoracic CT) (seriousness criterion death). The patient died on 02-Jun-2021. The reported cause of death was Ground glass opacity in thoracic CT and Pneumopathy. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was provided by reporter. Sender''s (Case) Safety Report Unique Identifier FR-AFSSAPS-NC20212962 Company comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per Authority reporting. Events seriousness per assessment by Authority. Both events retained as resulting in death as per Authority report, although the specific cause of death is not clear from the Regulatory Authority; Sender''s Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per Authority reporting. Events seriousness per assessment by Authority. Both events retained as resulting in death as per Authority report, although the specific cause of death is not clear from the ; Reported Cause(s) of Death: Ground glass opacity in thoracic CT; Pneumopathy


VAERS ID: 1527657 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-20
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004499 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dercum''s disease; Diabetes mellitus; Hypertension; Renal dialysis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of SUDDEN DEATH and CARDIAC ARREST in a 57-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004499) for COVID-19 vaccination. Concurrent medical conditions included Hypertension, Dercum''s disease, Renal dialysis and Diabetes mellitus. On 16-Jul-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 20-Jul-2021, the patient experienced SUDDEN DEATH (seriousness criteria death and medically significant) and CARDIAC ARREST (seriousness criteria death and medically significant). The patient died on 20-Jul-2021. The reported cause of death was. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment details were reported. This a report of dead 4 days after receiving the product in a 57-years old patient with concomitant Hypertension, Diabetes mellitus, Dercum''s disease and Renal dialysis. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: This a report of dead 4 days after receiving the product in a 57-years old patient with concomitant Hypertension, Diabetes mellitus, Dercum''s disease and Renal dialysis. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death.


VAERS ID: 1527663 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-15
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214003 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Bradycardia, Hypotension, Pyrexia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-16
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RANEXA; PRADAXA; CRESTOR; TRITTICO; SILODYX; LANOXIN; CIPROXIN [CIPROFLOXACIN HYDROCHLORIDE]; TOUJEO; DOBETIN [CYANOCOBALAMIN]; APIDRA; BINOCRIT
Current Illness:
Preexisting Conditions: Comments: No relevant medical history was reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of BRADYCARDIA, ASTHENIA, VOMITING, PYREXIA, and HYPOTENSION in an 85-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 214003) for COVID-19 vaccination. No relevant medical history was reported. Concomitant products included RANOLAZINE (RANEXA) from 10-Jun-2021 to 16-Jul-2021, DABIGATRAN ETEXILATE MESILATE (PRADAXA) from 10-Jun-2021 to 16-Jul-2021, ROSUVASTATIN CALCIUM (CRESTOR) from 10-Jun-2021 to 16-Jul-2021, TRAZODONE HYDROCHLORIDE (TRITTICO) from 10-Jun-2021 to 16-Jul-2021, SILODOSIN (SILODYX) from 10-Jun-2021 to 16-Jul-2021, DIGOXIN (LANOXIN) from 10-Jun-2021 to 10-Jun-2021, CIPROFLOXACIN HYDROCHLORIDE (CIPROXIN [CIPROFLOXACIN HYDROCHLORIDE]) from 09-Jul-2021 to 15-Jul-2021, INSULIN GLARGINE (TOUJEO), CYANOCOBALAMIN (DOBETIN [CYANOCOBALAMIN]) from 05-Jul-2021 to 16-Jul-2021, INSULIN GLULISINE (APIDRA) and EPOETIN ALFA (BINOCRIT) from 10-Jun-2021 to 16-Jul-2021 for an unknown indication. On 07-Jul-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milligram in total. On 15-Jul-2021, the patient experienced BRADYCARDIA (seriousness criteria death and medically significant), ASTHENIA (seriousness criterion death), VOMITING (seriousness criterion death), PYREXIA (seriousness criterion death) and HYPOTENSION (seriousness criterion death). The patient died on 16-Jul-2021. The reported cause of death was Asthenia, Vomiting, Fever chills, Bradycardia and Hypotension. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not reported . Treatment information was not provided. Company Comment : This a regulatory/spontaneous report of fatal events, 9 days after receiving an unknown dose of the product in a 85 years old female with multiple concomitant medications, whose medical history was not provided. Autopsy was not provided. Very limited information regarding the event has been provided for inferring causality. Further information is not expected; Sender''s Comments: This a regulatory/spontaneous report of fatal events, 9 days after receiving an unknown dose of the product in a 85 years old female with multiple concomitant medications, whose medical history was not provided. Autopsy was not provided. Very limited information regarding the event has been provided for inferring causality. Further information is not expected; Reported Cause(s) of Death: Asthenia; Vomiting; Fever chills; Bradycardia; Hypotension


VAERS ID: 1527810 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-22
Onset:2021-07-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002617 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Cardiac disorder, Imaging procedure, Pleural effusion
SMQs:, Systemic lupus erythematosus (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hyperlipidaemia; Hypertension (Mild (150s/80s))
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: 36.7 degrees Celsius; Test Name: Postmortem examination; Result Unstructured Data: Cause of death was suspected heart disease and the etiology was unclear. As per additional note, bilateral pleural effusions were noted on autopsy imaging (AI)
CDC Split Type: JPTAKEDA2021TJP065313

Write-up: bilateral pleural effusion; Heart disease; This case was received via regulatory authority (Reference number: 2021TJP065313) on 26-Jul-2021 and was forwarded to Moderna on 03-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of CARDIAC DISORDER (Heart disease) in a 50-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002617) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension (Mild (150s/80s)) and Hyperlipidaemia. On 22-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 23-Jul-2021, the patient experienced CARDIAC DISORDER (Heart disease) (seriousness criterion death). On an unknown date, the patient experienced PLEURAL EFFUSION (bilateral pleural effusion). The patient died on 23-Jul-2021. The reported cause of death was heart disease. An autopsy was performed. At the time of death, PLEURAL EFFUSION (bilateral pleural effusion) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 36.7 (normal) 36.7 degrees Celsius. On an unknown date, Imaging procedure: autopsy imaging Cause of death was suspected heart disease and the etiology was unclear. As per additional note, bilateral pleural effusions were noted on autopsy imaging (AI). For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information was provided. On 22-Jul-2021, after receiving first dose of the vaccine, no problem was observed while under observation for 15 minutes. It was unknown what the patient did after returning home. On 26-Jul-2021, the patient did not came to work in the morning and was visited to be found dead. Reports of postmortem examination showed the cause of death was suspected heart disease and the etiology was unclear. According to the additional note that bilateral pleural effusions were noted on autopsy imaging (AI). The physician who performed the postmortem examination was informed that the patient had received the vaccine, but there was no mention about it. The physician who performed the postmortem examination explained that the fluid had gradually accumulated over time and exceeded the limit. Autopsy was not performed. The estimated date of death was 23-Jul-2021. This is a case of a 50 year old male with history of hypertension and hyperlipidemia who died of Cardiac disorder 1 day after receiving first dose of vaccine. Very limited information regarding the event has been provided at this time. Patient''s comorbidities may have contributed to the event. No further information is expected.; Sender''s Comments: This is a case of a 50 year old male with history of hypertension and hyperlipidemia who died of Cardiac disorder 1 day after receiving first dose of vaccine. Very limited information regarding the event has been provided at this time. Patient''s comorbidities may have contributed to the event. No further information is expected.; Reported Cause(s) of Death: Heart disease


VAERS ID: 1529889 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-04
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Death; This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Death occurred on 04-May-2021 The patient died on 04-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. No relevant concomitant medications reported. No treatment medications reported. The batch number of the suspect product is unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Company comment: This is a case of death in a male patient of an unknown age. The patient''s medical history, concomitant medications, as well as temporal relationship between the use of the product and the event of death were not provided. It is unknown if an autopsy was performed and the cause of death is not provided. Very limited information regarding this event has been provided at this time. No further information is expected.; Sender''s Comments: This is a case of death in a male patient of an unknown age. The patient''s medical history, concomitant medications, as well as temporal relationship between the use of the product and the event of death were not provided. It is unknown if an autopsy was performed and the cause of death is not provided. Very limited information regarding this event has been provided at this time. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1531428 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-03-10
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA G 26761 A; LOT / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood cholesterol, Blood creatine phosphokinase, Blood glucose, Glycosylated haemoglobin, Granulocytes abnormal, Haemoglobin, Lymphocyte count, Myocardial infarction, Platelet count, Troponin T
SMQs:, Haematopoietic leukopenia (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METFIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lumbar spine compression fracture Type II diabetes mellitus; Comments:
Allergies:
Diagnostic Lab Data: Test Date: 20201028; Test Name: Cholesterin; Result Unstructured Data: 4.94 mmol/l,; Test Date: 20201028; Test Name: CK; Result Unstructured Data: 1643 U/L; Test Date: 20210310; Test Name: Glucose; Result Unstructured Data: 18,2; Test Date: 20201028; Test Name: HbA1c; Result Unstructured Data: 4.8%; Test Date: 20210310; Test Name: Granulocytes; Test Result: Inconclusive ; Result Unstructured Data: 84; Test Date: 20201028; Test Name: HB; Result Unstructured Data: 15.1; Test Date: 20210310; Test Name: HB; Result Unstructured Data: 16,4; Test Date: 20201028; Test Name: LC; Result Unstructured Data: 8.5; Test Date: 20210310; Test Name: LC; Result Unstructured Data: 23,5; Test Date: 20201028; Test Name: Platelets; Result Unstructured Data: 313 G/L; Test Date: 20210310; Test Name: Troponin T; Result Unstructured Data: 886
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDIAL INFARCTION in a 77-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. G 26761 A; LOT 300042723) for COVID-19 vaccination. The patient''s past medical history included Type II diabetes mellitus, Adipositas and Lumbar spine compression fracture on 21-Dec-2020. Concomitant products included METFORMIN HYDROCHLORIDE (METFIN) from 01-Jan-2021 to 10-Mar-2021 for Type 2 diabetes mellitus. On 03-Mar-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 200 microgram. On 10-Mar-2021, after starting mRNA-1273 (COVID-19 Vaccine Moderna), the patient experienced MYOCARDIAL INFARCTION (seriousness criteria death and medically significant). The patient died on 10-Mar-2021. The cause of death was not reported. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Oct-2020, Blood cholesterol: 4.94 (normal) 4.94 mmol/l. On 28-Oct-2020, Blood creatine phosphokinase: 1643 (High) 1643 U/L. On 28-Oct-2020, Blood glucose:. On 28-Oct-2020, Glycosylated hemoglobin: 4.8% (normal) 4.8%. On 28-Oct-2020, Granulocytes abnormal:. On 28-Oct-2020, Hemoglobin: 15.1 (normal) 15.1. On 28-Oct-2020, Lymphocyte count: 8.5 (Low) 8.5. On 28-Oct-2020, Platelet disorder: 313 (normal) 313. On 28-Oct-2020, Troponin T:. On 10-Mar-2021, Blood glucose: 18,2 (High) 18,2. On 10-Mar-2021, Granulocytes abnormal: 84 (Inconclusive) 84. On 10-Mar-2021, Hemoglobin: 16,4 (normal) 16,4. On 10-Mar-2021, Lymphocyte count: 23,5 (normal) 23,5. On 10-Mar-2021, Troponin T: 886 (High) 886. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Blood test was conducted on 28-NOV-2020 & 10-MAR-2021. Lab test was conducted on 28.10.2020 Kreatinin 68,Lc 8.5, Tc 313. Treatment information not provided.; Sender''s Comments: COVID-19 Vaccine Moderna das SARS-CoV-2-Virus verursachten Coronavirus-2019-Erkrankung (COVID-19). COVID-19 Vaccine Moderna. 2021 Case Safety Reports, �Anterior myocardial infarction (LLT)�. COVID-19 Vaccine Moderna. CO-VID-19 Vaccine Moderna, Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 1548821 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-29
Onset:2021-06-12
   Days after vaccination:75
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001530 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arterial thrombosis, Ischaemic stroke
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-14
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PANTOPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acid reflux (esophageal) (segnalato reflusso, data diagnosi esatta non nota, trattato dal 10.12.2013,); Hip replacement (protesi anca destra)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: Thrombose der Arteria Basilaris; Thrombose der Arteria Basilaris; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ISCHAEMIC STROKE (Thrombose der Arteria Basilaris) and ARTERIAL THROMBOSIS (Thrombose der Arteria Basilaris) in a 72-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch nos. 3001941 and 3001530) for COVID-19 vaccination. The patient''s past medical history included Acid reflux (esophageal) (segnalato reflusso, data diagnosi esatta non nota, trattato dal 10.12.2013,) and Hip replacement (protesi anca destra) in March 2021. Concomitant products included PANTOPRAZOLE from 10-Dec-2013 to 14-Jun-2021 for an unknown indication. On 29-Mar-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jun-2021, the patient experienced ISCHAEMIC STROKE (Thrombose der Arteria Basilaris) (seriousness criteria death, hospitalization and medically significant) and ARTERIAL THROMBOSIS (Thrombose der Arteria Basilaris) (seriousness criteria death and hospitalization). The patient died on 14-Jun-2021. The reported cause of death was Arterial thrombosis and Ischaemic stroke. An autopsy was not performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment medication details was reported. Company comments: This is a case of ischaemic stroke and arterial thrombosis which caused the death of a 72-year-old male with history of acid reflux.. Very limited information has been provided at this time. No further information is expected. Reviewed pending translation.; Sender''s Comments: This is a case of ischaemic stroke and arterial thrombosis which caused the death of a 72-year-old male with history of acid reflux.. Very limited information has been provided at this time. No further information is expected. Reviewed pending translation.; Reported Cause(s) of Death: Arterial thrombosis; Ischaemic stroke


VAERS ID: 1571139 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20212

Write-up: died after first dose Moderna; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (died after first dose Moderna) in a male patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. No concomitant product information was provided by the reporter. No treatment information was provided by the reporter. Very limited information regarding this event has been provided at this time. Further information is not expected as there is no contact information. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow-up does not contain any new information.; Sender''s Comments: Very limited information regarding this event has been provided at this time. Further information is not expected as there is no contact information.; Reported Cause(s) of Death: Unknown cause of Death


VAERS ID: 1571286 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-19
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214004 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension arterial; Osteoporosis
Preexisting Conditions: Medical History/Concurrent Conditions: Inflammation; Obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Sudden death, cause unknown; This regulatory authority case was reported by a physician and describes the occurrence of SUDDEN DEATH (Sudden death, cause unknown) in a 62-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 214004) for COVID-19 vaccination. The patient''s past medical history included Obesity and Inflammation. Concurrent medical conditions included Osteoporosis and Hypertension arterial. On 09-Jul-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. The patient died on 19-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications are reported. No treatment medications are reported. Sender''s (Case) Safety Report Unique Identifier: FR-AFSSAPS-TO20216066. Company Comment: Very Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded.; Sender''s Comments: Very Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1571450 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-15
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Subarachnoid haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-24
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP067947

Write-up: Subarachnoid hemorrhage; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SUBARACHNOID HAEMORRHAGE (Subarachnoid hemorrhage) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 02-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 15-Jul-2021, the patient experienced HEADACHE (Headache) (seriousness criterion death). On 24-Jul-2021, the patient experienced SUBARACHNOID HAEMORRHAGE (Subarachnoid hemorrhage) (seriousness criteria death and medically significant). The patient died on 24-Jul-2021. The reported cause of death was Headache and Subarachnoid haemorrhage. It is unknown if an autopsy was performed. Patient was experienced mild headache on 15-Jul-2021, headache was exacerbated On 20-Jul-2021, headache subsided On 23-Jul-2021. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. Company comment: Very limited information regarding these events has been provided at this time. However, more information is required for further assessment.; Sender''s Comments: This case concerns a female of unknown age who experienced a serious unexpected event of death 22 days after receiving her 1st dose of mRNA-1273. Very limited information regarding these events has been provided at this time. However, more information is required for further assessment.; Reported Cause(s) of Death: Headache; Subarachnoid haemorrhage


VAERS ID: 1573767 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-05-10
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebrovascular accident
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Arthrosis; Atrial fibrillation; Breast cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT in an 84-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 immunisation. The patient''s past medical history included Atrial fibrillation, Arterial hypertension, Arthrosis and Breast cancer. On 10-Apr-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. On 10-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (seriousness criteria death and medically significant). The reported cause of death was Middle cerebral artery stroke. It is unknown if an autopsy was performed. The treatment history was not reported. The concomitant history was not reported. Company comment: Very limited information regarding this event has been provided at this time. Further information will not be received as it a Regulatory Authority report. Translation of Source Document is pending.; Sender''s Comments: Very limited information regarding this event has been provided at this time. Further information will not be received as it a Regulatory Authority report. Translation of Source Document is pending.; Reported Cause(s) of Death: Middle cerebral artery stroke


VAERS ID: 1573791 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-23
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002339 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Alanine aminotransferase, Amylase, Aspartate aminotransferase, Bacterial test, Band neutrophil count, Basophil count, Bilirubin conjugated, Blood alcohol increased, Blood alkaline phosphatase increased, Blood bilirubin, Blood urine, Brain natriuretic peptide, C-reactive protein increased, Death, Eosinophil count, Gamma-glutamyltransferase, Glomerular filtration rate, Glucose urine absent, Haemoglobin, International normalised ratio, Mean platelet volume, Monocyte count normal, Neutrophil count, Platelet count decreased, Procalcitonin normal, Protein urine, Prothrombin time, Prothrombin time ratio, Pulmonary embolism, Red blood cell count decreased, Tracheal aspirate culture, Troponin I, Urine ketone body absent, White blood cell count increased, White blood cells urine
SMQs:, Liver related investigations, signs and symptoms (broad), Haematopoietic erythropenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Embolic and thrombotic events, venous (narrow), Biliary system related investigations, signs and symptoms (broad), Proteinuria (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-26
   Days after onset: 3
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MILGAMMA N [BENFOTIAMINE;CYANOCOBALAMIN;PYRIDOXINE HYDROCHLORIDE]; ESCITALOPRAM; HELICID [OMEPRAZOLE]
Current Illness: Monoparesis (Lower left limb); Smoker
Preexisting Conditions: Medical History/Concurrent Conditions: Central European encephalitis; Concussion; COVID-19; Ilium fracture; Limb contusion (Shoulder)
Allergies:
Diagnostic Lab Data: Test Date: 20210624; Test Name: Activated partial thromboplastin time; Result Unstructured Data: 4,67; 1,47; 2,31; 3,69; 3,03; Comments: Ratio; Test Date: 20210624; Test Name: Activated partial thromboplastin time; Result Unstructured Data: 3,96; 2,49; 2,36; 2,85; Comments: Ratio; Test Date: 20210625; Test Name: Activated partial thromboplastin time; Result Unstructured Data: 105,1 s; 66,1 s; 62,6 s; 75,5 s; Test Date: 20210625; Test Name: Activated partial thromboplastin time; Result Unstructured Data: 3,82; Comments: Ratio; Test Date: 20210626; Test Name: Activated partial thromboplastin time; Result Unstructured Data: 101.3 seconds; Test Date: 20210623; Test Name: Glutamic-pyruvate transaminase; Result Unstructured Data: 1.74 ukat/l; Test Date: 20210626; Test Name: Glutamic-pyruvate transaminase; Result Unstructured Data: 11,14 ukat/; Test Date: 20210623; Test Name: Blood alpha amylase; Result Unstructured Data: 4,2 ukat/l; Test Date: 20210623; Test Name: ASAT; Result Unstructured Data: 3,88 ukat/l; Test Date: 20210626; Test Name: ASAT; Result Unstructured Data: 3,88 ukat/l, 30,63 ukat/l; Test Date: 20210624; Test Name: Bacterial culture test; Test Result: Negative ; Result Unstructured Data: endotracheal cannula - klebsiella pneumoniae subspecies pneumoniae, uricult negative for bacteria, Tracheal aspirate: c.albicans 10^7 CFU/ml, Kl. pneumoniae 10^5 CFU/ml; Test Date: 20210623; Test Name: Bacterial urine; Result Unstructured Data: 159; Test Date: 20210623; Test Name: Band neutrophil count; Result Unstructured Data: 7.8 billion per liter; Test Date: 20210624; Test Name: Band neutrophil count; Result Unstructured Data: 3.1billion per liter; Test Date: 20210624; Test Name: Basophil count; Result Unstructured Data: 1.4 billion per litrer; Test Date: 20210623; Test Name: Blood basophils; Result Unstructured Data: 1.4 billion per liter.; Test Date: 20210623; Test Name: Bilirubin conjugated; Result Unstructured Data: 3.6 micromole per liter; Test Date: 20210626; Test Name: Bilirubin conjugated; Result Unstructured Data: 10.4 micromole per liter; Test Date: 20210623; Test Name: Blood alcohol; Result Unstructured Data: 2 �; Test Date: 20210623; Test Name: Alk phos; Result Unstructured Data: 1,44 ukat/l; Test Date: 20210623; Test Name: Bilirubin; Result Unstructured Data: 7.1 micromole per liter; Test Date: 20210626; Test Name: Bilirubin; Result Unstructured Data: 22.5 micromole per liter; Test Date: 20210623; Test Name: Blood urine; Result Unstructured Data: 0; Test Date: 2021; Test Name: Body mass index; Result Unstructured Data: 25.25 kilogram per square meter.; Test Date: 20210623; Test Name: Brain natriuretic peptide; Result Unstructured Data: 499.2 nanogram per liter; Test Date: 20210624; Test Name: C-reactive protein; Result Unstructured Data: 14 milligram per liter; Test Date: 20210626; Test Name: C-reactive protein; Result Unstructured Data: 282.5 milligram per liter; Test Date: 20210623; Test Name: Eosinophil count; Result Unstructured Data: 1.4 billion per litre; Test Date: 20210624; Test Name: Eosinophil count; Result Unstructured Data: 0.1; Test Date: 20210623; Test Name: GGT; Result Unstructured Data: 3,05 ukat/l; Test Date: 20210623; Test Name: Glomerular filtration rate; Result Unstructured Data: 0,92 ml/s per 1,73 m2; Test Date: 20210623; Test Name: Glomerular filtration rate; Result Unstructured Data: 1,06 ml/s per 1,73 m2; Test Date: 20210624; Test Name: Glomerular filtration rate; Result Unstructured Data: 0,79 ml/s per 1,73 m2; Comments: corrected; Test Date: 20210624; Test Name: Glomerular filtration rate; Result Unstructured Data: 0,91 ml/s per 1,73 m2; Test Date: 20210625; Test Name: Glomerular filtration rate; Result Unstructured Data: 0,27 ml/s per 1,73 m2; Comments: corrected; Test Date: 20210625; Test Name: Glomerular filtration rate; Result Unstructured Data: 0,31 ml/s per 1,73 m2; Test Date: 20210626; Test Name: Glomerular filtration rate; Result Unstructured Data: 0,5 ml/s per 1,73 m2; Comments: corrected; Test Date: 20210626; Test Name: Glomerular filtration rate; Result Unstructured Data: 0,58 ml/s per 1,73 m2; Test Date: 20210623; Test Name: Glucose urine; Result Unstructured Data: 0 millimole per liter; Test Date: 20210623; Test Name: Hemoglobin; Result Unstructured Data: 0; Test Date: 20210623; Test Name: INR; Result Unstructured Data: 2,15; Test Date: 20210625; Test Name: International normalised ratio; Result Unstructured Data: 2.18; Test Date: 20210626; Test Name: International normalised ratio; Result Unstructured Data: 2,59; Test Date: 20210623; Test Name: Mean platelet volume; Result Unstructured Data: 10.5; Test Date: 20210624; Test Name: Mean platelet volume; Result Unstructured Data: 10.3; Test Date: 20210625; Test Name: Mean platelet volume; Result Unstructured Data: 11.8; Test Date: 20210626; Test Name: Mean platelet volume; Result Unstructured Data: 12.4; Test Date: 20210623; Test Name: Monocyte count; Result Unstructured Data: 3.2 billion per liter; Test Date: 20210624; Test Name: Monocyte count; Result Unstructured Data: 3.2 billion per liter; Test Date: 20210623; Test Name: Neutrophils; Result Unstructured Data: 47.8 billion per liter; Test Date: 20210624; Test Name: Neutrophils; Result Unstructured Data: 88.3 billion per liter; Test Date: 20210623; Test Name: Urine pH; Result Unstructured Data: 6; Test Date: 20210623; Test Name: Platelet count; Result Unstructured Data: 89 billion per liter; Test Date: 20210624; Test Name: Platelet count; Result Unstructured Data: 160 billion per liter; Test Date: 20210626; Test Name: Platelet count; Result Unstructured Data: 47 billion per liter; Test Date: 20210625; Test Name: Thrombocyte count; Result Unstructured Data: 74 billion per liter; Test Date: 20210623; Test Name: Procalcitonin; Result Unstructured Data: 0.1 nanogram per millliiter; Test Date: 20210626; Test Name: Procalcitonin; Result Unstructured Data: $g100; Test Date: 20210623; Test Name: Protein urine; Result Unstructured Data: 0; Test Date: 20210623; Test Name: Quick''s test; Result Unstructured Data: 23.9; Test Date: 20210625; Test Name: Quick''s test; Result Unstructured Data: 24.2; Test Date: 20210626; Test Name: Quick''s test; Result Unstructured Data: 28.2; Test Date: 20210623; Test Name: Prothrombin ratio; Result Unstructured Data: 2,17; Test Date: 20210625; Test Name: Prothrombin ratio; Result Unstructured Data: 2,2; Test Date: 20210626; Test Name: Prothrombin ratio; Result Unstructured Data: 2,61; Test Date: 20210623; Test Name: Red blood cell count; Result Unstructured Data: 4.39; Test Date: 20210624; Test Name: Red blood cell count; Result Unstructured Data: 4.84; Test Date: 20210625; Test Name: Red blood cell count; Result Unstructured Data: 3.7; Test Date: 20210626; Test Name: Red blood cell count; Result Unstructured Data: 3.43; Test Date: 20210623; Test Name: Troponin I; Result Unstructured Data: 180.2; Test Date: 20210623; Test Name: Acetone urine; Result Unstructured Data: 0; Test Date: 20210623; Test Name: WBC count; Result Unstructured Data: 13.9; Test Date: 20210624; Test Name: WBC count; Result Unstructured Data: 13.9; Test Date: 20210625; Test Name: WBC count; Result Unstructured Data: 11.9; Test Date: 20210626; Test Name: WBC count; Result Unstructured Data: 9.5; Test Date: 20210623; Test Name: White blood cells urine; Result Unstructured Data: 0
CDC Split Type: CZMODERNATX, INC.MOD20212

Write-up: Massive pulmonary embolism; This case was received via Regulatory Authority (Reference number: 21008615) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM (Massive pulmonary embolism) in a 66-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3002339) for COVID-19 immunization. The patient''s past medical history included Limb contusion (Shoulder) in 2004, Concussion in 2014, COVID-19 from February 2021 to March 2021, Central European encephalitis and Ilium fracture in 2018. Concurrent medical conditions included Monoparesis (Lower left limb) and Smoker. Concomitant products included BENFOTIAMINE, CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE (MILGAMMA N [BENFOTIAMINE;CYANOCOBALAMIN;PYRIDOXINE HYDROCHLORIDE]), ESCITALOPRAM and OMEPRAZOLE (HELICID [OMEPRAZOLE]) for an unknown indication. On 10-Jun-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 23-Jun-2021, after starting mRNA-1273 (Spikevax), the patient experienced PULMONARY EMBOLISM (Massive pulmonary embolism) (seriousness criteria death, hospitalization, disability, medically significant and life threatening). The patient died on 26-Jun-2021. The reported cause of death was Embolism lung. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body mass index: 25.25 (abnormal) 25.25 kilogram per square meter.. On 23-Jun-2021, Alanine aminotransferase: 1.74 (abnormal) 1.74 ukat/l. On 23-Jun-2021, Amylase: 4,2 (normal) 4,2 ukat/l. On 23-Jun-2021, Aspartate aminotransferase: 3,88 (Low) 3,88 ukat/l. On 23-Jun-2021, Bacterial test: 159 (abnormal) 159. On 23-Jun-2021, Band neutrophil count: 7.8 (High) 7.8 billion per liter. On 23-Jun-2021, Basophil count: 1.4 (abnormal) 1.4 billion per liter.. On 23-Jun-2021, Bilirubin conjugated: 3.6 (Low) 3.6 micromole per liter. On 23-Jun-2021, Blood alcohol: 2 (abnormal) 2 �. On 23-Jun-2021, Blood alkaline phosphatase: 1,44 (High) 1,44 ukat/l. On 23-Jun-2021, Blood bilirubin: 7.1 (abnormal) 7.1 micromole per liter. On 23-Jun-2021, Blood urine: 0 (abnormal) 0. On 23-Jun-2021, Brain natriuretic peptide: 499.2 (High) 499.2 nanogram per liter. On 23-Jun-2021, Eosinophil count: 1.4 (abnormal) 1.4 billion per litre. On 23-Jun-2021, Gamma-glutamyltransferase: 3,05 (abnormal) 3,05 ukat/l. On 23-Jun-2021, Glomerular filtration rate: 0,92 (abnormal) 0,92 ml/s per 1,73 m2 and 1,06 ml/s per 1,73 m2 (normal) 1,06 ml/s per 1,73 m2. On 23-Jun-2021, Glucose urine: 0 (abnormal) 0 millimole per liter. On 23-Jun-2021, Haemoglobin: 0 (abnormal) 0. On 23-Jun-2021, International normalised ratio: 2,15 (abnormal) 2,15. On 23-Jun-2021, Mean platelet volume: 10.5 (normal) 10.5. On 23-Jun-2021, Monocyte count: 3.2 (normal) 3.2 billion per liter. On 23-Jun-2021, Neutrophil count: 47.8 (abnormal) 47.8 billion per liter. On 23-Jun-2021, Platelet count: 89 (Low) 89 billion per liter. On 23-Jun-2021, Procalcitonin: 0.1 (normal) 0.1 nanogram per millliiter. On 23-Jun-2021, Protein urine: 0 (abnormal) 0. On 23-Jun-2021, Prothrombin time: 23.9 (abnormal) 23.9. On 23-Jun-2021, Prothrombin time ratio: 2,17 (normal) 2,17. On 23-Jun-2021, Red blood cell count: 4.39 (Low) 4.39. On 23-Jun-2021, Troponin I: 180.2 (abnormal) 180.2. On 23-Jun-2021, Urine ketone body: 0 (abnormal) 0. On 23-Jun-2021, White blood cell count: 13.9 (High) 13.9. On 23-Jun-2021, White blood cells urine: 0 (abnormal) 0. On 23-Jun-2021, pH urine: 6 (normal) 6. On 24-Jun-2021, Activated partial thromboplastin time: 4,67; 1,47; 2,31; 3,69; 3,03 (High) 4,67; 1,47; 2,31; 3,69; 3,03 and 3,96; 2,49; 2,36; 2,85 (High) 3,96; 2,49; 2,36; 2,85. On 24-Jun-2021, Bacterial test: negative (Negative) endotracheal cannula - klebsiella pneumoniae subspecies pneumoniae, uricult negative for bacteria, Tracheal aspirate: c.albicans 10^7 CFU/ml, Kl. pneumoniae 10^5 CFU/ml. On 24-Jun-2021, Band neutrophil count: 3.1 (abnormal) 3.1billion per liter. On 24-Jun-2021, Basophil count: 1.4 (abnormal) 1.4 billion per litrer. On 24-Jun-2021, C-reactive protein: 14 (abnormal) 14 milligram per liter. On 24-Jun-2021, Eosinophil count: 0.1 (Low) 0.1. On 24-Jun-2021, Glomerular filtration rate: 0,79 ml/s per 1,73 m2 (abnormal) 0,79 ml/s per 1,73 m2 and 0,91 ml/s per 1,73 m2 (abnormal) 0,91 ml/s per 1,73 m2. On 24-Jun-2021, Mean platelet volume: 10.3 (normal) 10.3. On 24-Jun-2021, Monocyte count: 3.2 (normal) 3.2 billion per liter. On 24-Jun-2021, Neutrophil count: 88.3 (abnormal) 88.3 billion per liter. On 24-Jun-2021, Platelet count: 160 (normal) 160 billion per liter. On 24-Jun-2021, Red blood cell count: 4.84 (normal) 4.84. On 24-Jun-2021, White blood cell count: 13.9 (High) 13.9. On 25-Jun-2021, Activated partial thromboplastin time: 105,1 ; 66,1 ; 62,6 ; 75,5 (High) 105,1 s; 66,1 s; 62,6 s; 75,5 s and 3,82 (High) 3,82. On 25-Jun-2021, Glomerular filtration rate: 0,27 ml/s per 1,73 m2 (abnormal) 0,27 ml/s per 1,73 m2 and 0,31 ml/s per 1,73 m2 (abnormal) 0,31 ml/s per 1,73 m2. On 25-Jun-2021, International normalised ratio: 2.18 (abnormal) 2.18. On 25-Jun-2021, Mean platelet volume: 11.8 (normal) 11.8. On 25-Jun-2021, Platelet count: 74 (Low) 74 billion per liter. On 25-Jun-2021, Prothrombin time: 24.2 (abnormal) 24.2. On 25-Jun-2021, Prothrombin time ratio: 2,2 (normal) 2,2. On 25-Jun-2021, Red blood cell count: 3.7 (Low) 3.7. On 25-Jun-2021, White blood cell count: 11.9 (normal) 11.9. On 26-Jun-2021, Activated partial thromboplastin time: 101.3 (High) 101.3 seconds. On 26-Jun-2021, Alanine aminotransferase: 11,14 (abnormal) 11,14 ukat/. On 26-Jun-2021, Aspartate aminotransferase: 3,88, 30,63 (abnormal) 3,88 ukat/l, 30,63 ukat/l. On 26-Jun-2021, Bilirubin conjugated: 10.4 (abnormal) 10.4 micromole per liter. On 26-Jun-2021, Blood bilirubin: 22.5 (abnormal) 22.5 micromole per liter. On 26-Jun-2021, C-reactive protein: 282.5 (abnormal) 282.5 milligram per liter. On 26-Jun-2021, Glomerular filtration rate: 0,5 ml/s per 1,73 m2 (abnormal) 0,5 ml/s per 1,73 m2 and 0,58 ml/s per 1,73 m2 (abnormal) 0,58 ml/s per 1,73 m2. On 26-Jun-2021, International normalised ratio: 2,59 (abnormal) 2,59. On 26-Jun-2021, Mean platelet volume: 12.4 (abnormal) 12.4. On 26-Jun-2021, Platelet count: 47 (Low) 47 billion per liter. On 26-Jun-2021, Procalcitonin: $g100 (abnormal) $g100. On 26-Jun-2021, Prothrombin time: 28.2 28.2. On 26-Jun-2021, Prothrombin time ratio: 2,61 (normal) 2,61. On 26-Jun-2021, Red blood cell count: 3.43 (Low) 3.43. On 26-Jun-2021, White blood cell count: 9.5 (normal) 9.5. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided. Patient lab test includes activated partial thromboplastin time is not coagulated on 23-Jun-2021. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Embolism lung


VAERS ID: 1573852 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-26
Onset:2021-04-28
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Propranolol 40; novaminsulfon 500; Keppra 250 mg; acetylsalicylic acid 100
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial occlusive disease; Cranioencephalic trauma; Grand mal; Hemiparesis; Korsakoff''s syndrome; Nicotine abuse
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEDCGMA21189997

Write-up: Death; Lung embolism; This case was received via Regulatory Authority (Reference number: 202100064309) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death) and PULMONARY EMBOLISM (Lung embolism) in a 63-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for Prophylactic vaccination. The patient''s past medical history included Korsakoff''s syndrome, Cranioencephalic trauma in 1989, Arterial occlusive disease, Grand mal, Hemiparesis and Nicotine abuse. Concomitant products included propranolol hydrochloride (propranolol 40), metamizole sodium, levetiracetam and acetylsalicylic acid for an unknown indication. On 26-Apr-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced DEATH (Death) (seriousness criteria death and medically significant) and PULMONARY EMBOLISM (Lung embolism) (seriousness criteria death and medically significant). The patient died on 28-Apr-2021. The reported cause of death was Lung embolism. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown Route), the reporter did not provide any causality assessments. No treatment medication was provided. Very limited information regarding these events have been provided at this time. No further follow up information is expected.; Sender''s Comments: Very limited information regarding these events have been provided at this time. No further follow up information is expected.; Reported Cause(s) of Death: Lung embolism


VAERS ID: 1574671 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-27
Onset:2021-06-09
   Days after vaccination:43
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arrhythmia, Autopsy, Cardiac arrest, Cardiogenic shock, Death, Myocarditis
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20212

Write-up: Myocarditis; Cardiac arrhythmia; Heart arrest; This case was received via Regulatory Authority (Reference number: 202100134159) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS (Myocarditis), ARRHYTHMIA (Cardiac arrhythmia) and CARDIAC ARREST (Heart arrest) in a 65-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3002620) for an unknown indication. No Medical History information was reported. On 27-Apr-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 09-Jun-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria death and medically significant), ARRHYTHMIA (Cardiac arrhythmia) (seriousness criteria death and medically significant) and CARDIAC ARREST (Heart arrest) (seriousness criteria death and medically significant). The patient died on 09-Jun-2021. The reported cause of death was Myocarditis. An autopsy was performed. The autopsy-determined cause of death was cardiogenic shock in acute left ventricular myocardial infarction. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Treatment information was not provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow-up information received on 04-Aug-2021 and contains no new information.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Myocarditis; Autopsy-determined Cause(s) of Death: cardiogenic shock in acute left ventricular myocardial infarction


VAERS ID: 1574673 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-10
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pulmonary embolism, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20212

Write-up: Lung embolism; Thrombosis; This case was received via Regulatory Authority (Reference number: 202100135167) on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of PULMONARY EMBOLISM (Lung embolism) and THROMBOSIS (Thrombosis) in a 68-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 10-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 17-Jun-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (Lung embolism) (seriousness criteria death, medically significant and life threatening) and THROMBOSIS (Thrombosis) (seriousness criteria death, medically significant and life threatening). The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information was provided. Company Comment: Very limited information regarding this events has been provided at this time. Further information will not be requested.; Sender''s Comments: Very limited information regarding this events has been provided at this time. Further information will not be requested.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1574709 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-06-25
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocarditis, Sudden cardiac death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPEI202100146583

Write-up: Myocarditis; Sudden cardiac death; This case was received via Regulatory Authority case was reported by a physician and describes the occurrence of MYOCARDITIS (Myocarditis) and SUDDEN CARDIAC DEATH (Sudden cardiac death) in a 56-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002183) for COVID-19 vaccination. No Medical History information was reported. On 20-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 17-Jun-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On 25-Jun-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria death, hospitalization and medically significant) and SUDDEN CARDIAC DEATH (Sudden cardiac death) (seriousness criteria death, hospitalization and medically significant). The patient died on 25-Jun-2021. An autopsy was performed. The autopsy-determined cause of death was lymphozyt�re myokarditis. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications reported. Autopsy was done on 07-JUL-2021. No treatment medications reported. Company Comment: Very limited information regarding this event has been provided at this time. Further information will not be requested.; Sender''s Comments: Very limited information regarding this event has been provided at this time. Further information will not be requested.; Autopsy-determined Cause(s) of Death: Lymphozyt�re Myokarditis


VAERS ID: 1574714 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-29
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003609 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Pulmonary embolism, Somnolence, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Embolic and thrombotic events, venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20212

Write-up: Syncope; Groggy; This case was received via Regulatory Authority (Reference number: 202100148174) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of PULMONARY EMBOLISM, SYNCOPE and SOMNOLENCE (Groggy) in a 37-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3003609) for an unknown indication. No Medical History information was reported. On 29-Jun-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (seriousness criteria death, hospitalization and medically significant), SYNCOPE (Syncope) (seriousness criterion medically significant) and SOMNOLENCE (Groggy) (seriousness criterion medically significant). The patient died on an unknown date. The reported cause of death was Lung embolism. It is unknown if an autopsy was performed. At the time of death, SYNCOPE (Syncope) and SOMNOLENCE (Groggy) had not resolved. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant and treatment medications were provided. Reporter''s Sender''s Comments: Very limited information has been provided at this time. Translation has been requested.; Reported Cause(s) of Death: Lung embolism


VAERS ID: 1574958 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-04-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   Days after onset: 87
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20212

Write-up: This case was received via Regulatory Authority (Reference number: 202100134331) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of THROMBOSIS in a 45-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 16-Apr-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced THROMBOSIS (seriousness criteria death and medically significant). The patient died on 12-Jul-2021. The reported cause of death was Clot blood. An autopsy was not performed. Concomitant medication was not provided. Treatment information was not provided. Company comment: This case concerns a 45 year-old male patient who experienced the fatal unexpected event of thrombosis on the vaccination day. The patient died 2 months and 27 days after receiving the dose of the mRNA-1273 vaccine. Very limited information regarding this event has been provided at this time. Translation has been requested.; Sender''s Comments: This case concerns a 45 year-old male patient who experienced the fatal unexpected event of thrombosis on the vaccination day. The patient died 2 months and 27 days after receiving the dose of the mRNA-1273 vaccine. Very limited information regarding this event has been provided at this time. Translation has been requested.; Reported Cause(s) of Death: Clot blood


VAERS ID: 1575016 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-05-30
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002339 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Atrioventricular block complete
SMQs:, Conduction defects (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIOVENTRICULAR BLOCK in a 54-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002339) for COVID-19 vaccination. No Medical History information was reported. On 24-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 30-May-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced ATRIOVENTRICULAR BLOCK COMPLETE (seriousness criteria death and medically significant). The patient died on 30-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was withdrawn on 24-May-2021. Concomitant product was not provided by the reporter. Treatment information was not provided. Company Comment: This is a case of death in a 54-year-old male subject, who died 7 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Sender''s Comments: This is a case of death in a 54-year-old male subject, who died 7 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1575179 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-07-01
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Death, Pulseless electrical activity, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiac arrhythmia terms, nonspecific (narrow), Respiratory failure (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Cardio-respiratory arrest; Electromechanical dissociation; Fibrillation ventricular; This case was received via Regulatory Authority (Reference number: TS20213218) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest), PULSELESS ELECTRICAL ACTIVITY (Electromechanical dissociation) and VENTRICULAR FIBRILLATION (Fibrillation ventricular) in a 58-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 15-Jun-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 01-Jul-2021, the patient experienced CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) (seriousness criteria death and medically significant), PULSELESS ELECTRICAL ACTIVITY (Electromechanical dissociation) (seriousness criteria death and medically significant) and VENTRICULAR FIBRILLATION (Fibrillation ventricular) (seriousness criteria medically significant and life threatening). On 01-Jul-2021, VENTRICULAR FIBRILLATION (Fibrillation ventricular) had not resolved. The patient died on 01-Jul-2021. The reported cause of death was dissociation electromechanical. It is unknown if an autopsy was performed. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported. No treatment information was reported by reporter. France Sender''s (Case) Safety Report Unique Identifier FR-AFSSAPS-TS20213218. This case concerns a 58-year old female who experienced Cardio-respiratory arrest, Electromechanical dissociation and Fibrillation ventricular. The patient died 16 days after receiving the first dose of the vaccine. The reported cause of death was dissociation. It is unknown if an autopsy was performed. Very limited information regarding this event/s has been provided at this time.; Sender''s Comments: This case concerns a 58-year old female who experienced Cardio-respiratory arrest, Electromechanical dissociation and Fibrillation ventricular. The patient died 16 days after receiving the first dose of the vaccine. The reported cause of death was Electromechanical dissociation. It is unknown if an autopsy was performed. Very limited information regarding this event/s has been provided at this time.; Reported Cause(s) of Death: Dissociation Electromechanical.


VAERS ID: 1575708 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-21
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA EW4815 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Angioimmunoblastic T-cell lymphoma recurrent, Condition aggravated, Death, Tubulointerstitial nephritis
SMQs:, Acute renal failure (broad), Chronic kidney disease (broad), Malignant lymphomas (narrow), Tubulointerstitial diseases (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-14
   Days after onset: 54
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic kidney disease; Dermatomyositis; Leucocytoclastic vasculitis; Mesangiocapillary glomerulonephritis; Prostate adenoma
Preexisting Conditions: Medical History/Concurrent Conditions: Angioimmunoblastic T-cell lymphoma; Cardiac failure congestive
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20212

Write-up: Nephritis interstitial acute; Condition aggravated; This case was received via Regulatory Authority (Reference number: ES-AEMPS-961434) on 05-Aug-2021 and was forwarded to Moderna on 05-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of TUBULOINTERSTITIAL NEPHRITIS, ANGIOIMMUNOBLASTIC T-CELL and CONDITION AGGRAVATED in a 78-year-old male patient who received mRNA-1273 (Spikevax) (batch no. EW4815) for COVID-19 vaccination. The patient''s past medical history included Angioimmunoblastic T-cell lymphoma in September 2020 and Cardiac failure congestive. Concurrent medical conditions included Leukocytoclastic vasculitis, Dermatomyositis, Chronic kidney disease, Mesangiocapillary glomerulonephritis and Prostate adenoma. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced TUBULOINTERSTITIAL (seriousness criteria death, hospitalization and medically significant), ANGIOIMMUNOBLASTIC T-CELL LYMPHOMA (seriousness criteria death, hospitalization and medically significant) and CONDITION (seriousness criteria death and hospitalization). The patient died on 14-Jun-2021. The reported cause of death was Nephritis interstitial acute and Condition aggravated. It is unknown if an autopsy was performed. mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on 15-Apr-2021. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was given. No treatment medication was given Company comment- Very limited information regarding these events has been provided at this time. No further follow up information is expected. Sender''s Comments: Very limited information regarding these events has been provided at this time. No further follow up information is expected.


VAERS ID: 1576277 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-22
Onset:2021-07-27
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dehydration, Dermatitis exfoliative generalised, Psoriasis, Respiratory failure, SARS-CoV-2 test
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-31
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FOLIC ACID; SERTRALINE; THIAMINE
Current Illness: Alcohol abuse; Alcoholism; Depression; Psoriasis (Chronic recurrent flares of psoriasis with hospital admissions).
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response).
Allergies:
Diagnostic Lab Data: Test Date: 20210729; Test Name: COVID-19 virus test; Test Result: Negative; Result Unstructured Data: No - Negative COVID-19 test.
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Psoriasis; Respiratory failure; Fluid loss; Erythroderma; This regulatory authority case was reported by a physician and describes the occurrence of DERMATITIS EXFOLIATIVE GENERALISED (Erythroderma), PSORIASIS (Psoriasis), RESPIRATORY FAILURE (Respiratory failure) and DEHYDRATION (Fluid loss) in a 40-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response). Concurrent medical conditions included Alcoholism, Psoriasis (Chronic recurrent flares of psoriasis with hospital admissions.), Depression and Alcohol abuse. Concomitant products included FOLIC ACID from 20-Jul-2021 to an unknown date and THIAMINE from 20-Jul-2021 to an unknown date for Alcoholism, SERTRALINE from 18-Sep-2020 to an unknown date for Depression. On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 27-Jul-2021, the patient experienced DERMATITIS EXFOLIATIVE GENERALISED (Erythroderma) (seriousness criteria death, hospitalization and medically significant). On an unknown date, the patient experienced PSORIASIS (Psoriasis) (seriousness criteria death and hospitalization), RESPIRATORY FAILURE (Respiratory failure) (seriousness criteria death, hospitalization and medically significant) and DEHYDRATION (Fluid loss) (seriousness criteria death and hospitalization). The patient was treated with BETAMETHASONE VALERATE (BETNOVATE) for Psoriasis, at an unspecified dose and frequency; CICLOSPORIN for Psoriasis, at an unspecified dose and frequency and Physical therapy (Resuscitation) for Respiratory failure. The patient died on 31-Jul-2021. The reported cause of death was Erythroderma. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jul-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient was given fluids to correct the fluid loss as a treatment. It was reported that COVID vaccine was a potential trigger for the flares of psoriasis. On 31Jul 2021, patient deteriorated suddenly, with type 2 respiratory failure, and despite treatment and attempts at resuscitation, patient died. Reporter states that it was not clear whether patient died of pulmonary oedema/heart failure, pneumonia, PE, or ARDS associated with erythroderma. Patient''s death has been referred to the coroner and the post-mortem examination will be conducted. Patient was not enrolled in clinical trial Company Comment: Very limited information regarding this event/s has been provided at this time. Further information is not expected.; Sender''s Comments: Very limited information regarding this event/s has been provided at this time. Further information is not expected.; Reported Cause(s) of Death: Erythroderma


VAERS ID: 1576309 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-08
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Inappropriate schedule of product administration, SARS-CoV-2 test
SMQs:, Medication errors (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20200707; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Death; inappropriate schedule of vaccine administered; This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death) in a 39-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-May-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). The patient died on an unknown date. The cause of death was not reported. An autopsy was not performed. At the time of death, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jul-2020, SARS-CoV-2 test: negative (Negative) Negative. No concomitant medications were reported. No treatment information was provided. The patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. This is a case of sudden death in a 39-year-old male patient with no known past medical history, who died 30 days after receiving a dose of the vaccine. This report also refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown). Very limited information has been provided at this time.; Sender''s Comments: This is a case of sudden death in a 39-year-old male patient with no known past medical history, who died 30 days after receiving a dose of the vaccine. This report also refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown). Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1576388 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-16
Onset:2021-03-21
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Death; This case was received via Regeulatory Agency (Reference number: ADR 25765678) on 08-Aug-2021 and was forwarded to Moderna on 08-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death) in a 79-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 21-Mar-2021 The patient died on 21-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication details was reported. No treatment medication details was reported. Company Comment :This is a case of sudden death in a 79-year-old male subject with no known medical history, who died 5 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Sender''s Comments: This is a case of sudden death in a 79-year-old male subject with no known medical history, who died 5 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1576840 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-31
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002337 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest, Cardiac death, Cardiomegaly, Malaise, Pulmonary congestion, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dilated cardiomyopathy (Idiopathic dilated cardiomyopathy)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP069699

Write-up: This case was received via Regulatory Authority (Reference number: 2021TJP069699) on 03-Aug-2021 and was forwarded to Moderna on 05-Aug-2021. This case, reported by a physician, was via adverse reaction reporting site (TASK0020683). On an unknown date, body temperature before the vaccination: 36.5 degrees Celsius. On 02-Jul-2021, at 13:30, the patient received the 1st dose of the vaccine. On 30-Jul-2021, at 13:30, the patient received the 2nd dose of the vaccine. On 31-Jul-2021, low-grade fever and malaise developed, so the patient took a rest. At 12:00, the patient was confirmed as normal for the last time by the conversation with the patients wife. At 13:15, when the wife went to see the patient, there was no response, and the patient was transported by ambulance with asystole. At 13:24, the patient was in a state of asystole when the ambulance crew contacted with him. After transportaion to the hospital, CPR was continued, and 6A of adrenaline was administered in total, but the patient was in a state of asystole throughout the whole time. At 14:07, the patient was confirmed dead. AiCT: there were images of cardiomegaly and congestion in the lung field, no intracranial hemorrhage, no intrathoracic or intraperitoneal hemorrhage, and no images suggestive of aortic dissection or cardiac tamponade. The cause of death was confirmed as acute cardiac death (1 hour from onset to death) at autopsy. Lethal arrhythmia may be one of the other possible contributing factors. The outcome of low-grade fever, malaise, asystole, cardiomegaly, and image of congestion in the lung field was reported as fatal. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: Very limited information regarding these events have been provided at this time. No further follow up information is expected.; Reported Cause(s) of Death: Low grade fever; Malaise; Asystole; Cardiomegaly; Pulmonary congestion; Cardiac death


VAERS ID: 1576841 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-07-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anal incontinence, Body temperature, Cardiac arrest, Malaise, Pupillary reflex impaired, Pyrexia, Respiratory arrest, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Noninfectious diarrhoea (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-08
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210706; Test Name: Body temperature; Result Unstructured Data: 37.8 degrees Celsius; Test Date: 20210707; Test Name: Body temperature; Result Unstructured Data: 36 degrees Celsius, Body temperature slightly decreased
CDC Split Type: JPTAKEDA2021TJP069734

Write-up: Respiratory arrest; Cardiac arrest; Respiratory elimination; Loss of light reflex; Faecal incontinence; Vomiting; Malaise; Pyrexia; This case was received via Regulatory Authority (Reference number: 2021TJP069734) on 04-Aug-2021 and was forwarded to Moderna on 05-Aug-2021. The license partner had received the report (Reference number: v21122358 ). This case, initially reported to the Regulatory Agency by a pharmacist, was received (Ref, v21122358). On an unknown date, body temperature before the vaccination: unknown. On an unknown date, the patient received the 1st dose of this vaccine. On 05-Jul-2021, the patient received the 2nd dose of this vaccine. On 06-Jul-2021, pyrexia of about 37.8 degrees Celsius developed. On 07-Jul-2021, body temperature was in the 36 degrees Celsius range. The patient had malaise but ate as usual. On 08-Jul-2021, around 18:30, the family member heard the patient''s sleep-breath. Around 19:30, the patient was in respiratory arrest, and an emergency call was made. At 19:33, the patient was raced to a hospital (using an automatic cardiac massage machine). CPR for asystole was performed, and oral vomit was aspirated. The patient had faecal incontinence. Route was secured, and adrenaline was administered intravenously 7 times. PAE occurred several times but returned to asystole. The patient''s family memeber did not request intubation or ventilator management. CPR was performed for about 1 hour, and its discontinuation was requested. Spontaneous circulation, spontaneous breathing, and loss of light reflex were noted. At 20:30, the patient was confirmed dead. The outcome of pyrexia, malaise, respiratory arrest, vomiting, faecal incontinence, cardiac arrest, respiratory elimination, and loss of light reflex was reported as fatal. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: Very limited information regarding these events has been provided at this time. No further follow-up information is expected.; Reported Cause(s) of Death: Pyrexia; Malaise; Respiratory arrest; Vomiting; Faecal incontinence; Cardiac arrest; Respiratory arrest; Pupillary light reflex lost


VAERS ID: 1576842 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac failure congestive, Computerised tomogram, Cough, Decreased appetite, Diarrhoea, Dyspepsia, Dyspnoea, Gait inability, Lung neoplasm malignant, Malaise, Myalgia, Nausea, Orthopnoea, Pericardial effusion, Pneumonia, X-ray
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-24
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Atrial fibrillation; Dermatitis atopic; Glucose tolerance impaired; Lung cancer (Postoperative lung cancer).
Preexisting Conditions: Medical History/Concurrent Conditions: Lung neoplasm surgery (Postoperative lung cancer).
Allergies:
Diagnostic Lab Data: Test Name: CT Scan; Result Unstructured Data: Diagnosed with pneumonia and pericardial effusion and further details were not specified.; Test Name: X-ray; Result Unstructured Data: Diagnosed with pneumonia and pericardial effusion and further details were not specified.
CDC Split Type: JPTAKEDA2021TJP069751

Write-up: Cardiac failure congestive; Lung cancer; Diarrhoea; Heartburn; Inappetence; The patient had orthopnea; Nausea; Pericardial effusion; Pneumonia; Patient was unable to walk properly even for about 5 minutes; Shortness of breath; Cough; Malaise; Myalgia in the arm; This case was received via the Regulatory Authority (Reference number: 2021TJP069751) on 03-Aug-2021 and was forwarded to Moderna on 06-Aug-2021. This case, reported by a physician, was received by Regulatory Authority via Moderna''s adverse reaction reporting site (TASK0020687). On an unknown date, body temperature before the vaccination: unknown. On 08-Jul-2021, the patient received the 1st dose of this vaccine. On 09-Jul-2021, the patient experienced myalgia in the arm and malaise. On 10-Jul-2021, short of breath and cough occurred. The symptom tended to get worse. On 19-Jul-2021, the patient was unable to walk properly even for about 5 minutes, and cough also persisted. The patient visited a primary care physician and underwent X-ray and CT, and the patient was seemed to be diagnosed with pneumonia and pericardial effusion (details unspecified). On 20-Jul-2021, the patient had nausea, diarrhoea, heartburn, and inappetence. The patient had orthopnea. On 24-Jul-2021, before dawn, the patient was confirmed dead. According to the postmortem report, the patient died due to cardiac failure congestive and lung cancer around 22-Jul-2021. The outcome of malaise, shortness of breath, cough, pneumonia, and pericardial effusion was fatal. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 61 year-old male patient with a history of lung cancer, who died approximately 16 days after receiving the first dose of the mRNA-1273 vaccine. There is a discrepancy in source document regarding the date of death. For the event lung neoplasm malignant: based on information received and the natural history of lung cancer, the event is assessed as unlikely related to mRNA-1273. For the rest of the events, very limited information has been provided at this time. However, patient''s significant history of lung cancer could be a confounding factor that may play a possible contributory role, providing alternative explanation.; Reported Cause(s) of Death: Malaise; Shortness of breath; Cough; Pneumonia; Pericardial effusion; Cardiac failure congestive; Lung cancer


VAERS ID: 1576860 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Condition aggravated, Death, Diarrhoea, Loss of consciousness, Rash
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-04
   Days after onset: 34
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: KRMODERNATX, INC.MOD20212

Write-up: unconscious; condition got even worse at night; Death; Rash; Diarrhea with abdominal pain; Abdominal pain; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death), LOSS OF CONSCIOUSNESS (unconscious), DIARRHOEA (Diarrhea with abdominal pain), ABDOMINAL PAIN (Abdominal pain), CONDITION AGGRAVATED (condition got even worse at night) and RASH (Rash) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced DIARRHOEA (Diarrhea with abdominal pain) (seriousness criterion hospitalization) and ABDOMINAL PAIN (Abdominal pain) (seriousness criterion hospitalization). In July 2021, the patient experienced RASH (Rash) (seriousness criterion hospitalization). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (unconscious) (seriousness criteria hospitalization and medically significant) and CONDITION AGGRAVATED (condition got even worse at night) (seriousness criterion hospitalization). The patient died on 04-Aug-2021. The cause of death was not reported. An autopsy was performed. At the time of death, LOSS OF CONSCIOUSNESS (unconscious), DIARRHOEA (Diarrhea with abdominal pain), ABDOMINAL PAIN (Abdominal pain), CONDITION AGGRAVATED (condition got even worse at night) and RASH (Rash) outcome was unknown. Concomitant product was not provided by the reporter. Lab data was not provided by the reporter. Treatment product was not provided y the reporter. Company Comment Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender''s Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1576955 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-10
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003604 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: This case was received via Regulatory Authority (Reference number: 00646946) on 06-Aug-2021 and was forwarded to Moderna on 06-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DEATH in a 29-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3003604) for COVID-19 vaccination. No Medical History information was reported. On 07-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Death occurred on 10-Jul-2021 The patient died on 10-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Concomitant products were not provided. Treatment medication were not reported. Company comment: This case refers to a 29-year-old male patient who died 4 days after receiving the dose 1 of mRNA-1273. Cause of death was not reported. Very limited information regarding the event has been provided at this time insufficient for causality assessment.; Sender''s Comments: This case refers to a 29-year-old male patient who died 4 days after receiving the dose 1 of mRNA-1273. Cause of death was not reported. Very limited information regarding the event has been provided at this time insufficient for causality assessment.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1577783 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-06-17
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001941 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Haemoglobin, Leukopenia, Sepsis
SMQs:, Haematopoietic leukopenia (narrow), Systemic lupus erythematosus (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-08
   Days after onset: 21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: [IRON]
Current Illness: Hypothyreosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Haemoglobin; Result Unstructured Data: low
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: Sepsis; This regulatory authority case was reported by a physician and describes the occurrence of SEPSIS (Sepsis) and LEUKOPENIA in a 79-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3001941) for COVID-19 vaccination. Concurrent medical conditions included Hypothyreosis. Concomitant products included [IRON] for Haemoglobinaemia. On 27-May-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 200 microgram. On 17-Jun-2021, the patient experienced SEPSIS (Sepsis) (seriousness criteria death, hospitalization and medically significant) and LEUKOPENIA (seriousness criteria death, hospitalization and medically significant). The patient died on 08-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Haemoglobin: 11.2 (Low) low. The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered SEPSIS (Sepsis) and LEUKOPENIA to be possibly related. No treatment medication information was mentioned by reporter Company Comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per Authority reporting. Events seriousness per overall case assessment by Authority. Low hemoglobin not captured as a separate event as it can be a symptom associated with sepsis and / or leukopenia; Sender''s Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per Authority reporting. Events seriousness per overall case assessment by Authority. Low hemoglobin not captured as a separate event as it can be a symptom associated with sepsis and / or leukopenia; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1578848 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-11
Onset:2021-07-14
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: LDL increased; Lipid metabolism disorder NOS; Smoker.
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20212

Write-up: Unknown cause of death; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Unknown cause of death) in a 72-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Smoker, Lipid metabolism disorder NOS and LDL increased. Previously administered products included for an unreported indication: COVID-19 VACCINE ASTRAZENECA. On 11-Jul-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. Death occurred on 14-Jul-2021 The patient died on 14-Jul-2021. The cause of death was not reported. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Concomitant information was not provided. Treatment information was not provided. Company Comment: This is a case of death of an unknown cause in a 72-year-old female subject with hx of smoking and lipid metabolism disorder who died 3 days after receiving mRNA-1273. An autopsy was not performed. Very limited information has been provided at this time.; Sender''s Comments: This is a case of death of an unknown cause in a 72-year-old female subject with hx of smoking and lipid metabolism disorder who died 3 days after receiving mRNA-1273. An autopsy was not performed. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1579233 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003187 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVERSYL [PERINDOPRIL ARGININE]; KARDEGIC; CARDENSIEL; LASILIX [FUROSEMIDE]; PROCORALAN
Current Illness: Hypertension arterial
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic respiratory failure; Death of brother cardiac arrest; Left ventricular ejection fraction (40%); Overweight; smoking
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: This case was received via Regulatory Authority (Reference number: AM20212231) on 09-Aug-2021 and was forwarded to Moderna on 09-Aug-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of CARDIAC ARREST in a 52-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003187) for COVID-19 vaccination. The patient''s past medical history included Smoking, Overweight, Left ventricular ejection fraction (40%) and Chronic respiratory failure. Family history included Death of brother; cardiac arrest. Concurrent medical conditions included Hypertension arterial. Concomitant products included PERINDOPRIL ARGININE (COVERSYL [PERINDOPRIL ARGININE]), ACETYLSALICYLATE LYSINE (KARDEGIC), BISOPROLOL FUMARATE (CARDENSIEL), FUROSEMIDE (LASILIX [FUROSEMIDE]) and IVABRADINE HYDROCHLORIDE (PROCORALAN) for an unknown indication. On 14-Jul-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 14-Jul-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced CARDIAC ARREST (seriousness criteria death and medically significant). The patient died on 14-Jul-2021. The reported cause of death was cardiac arrest. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Treatment to the event was not reported. Based on the current available information and temporal association between the use of the product and the event, a causal relationship cannot be excluded. Event term, onset date and outcome captured per Authority reporting. Event seriousness per assessment by Authority and per list.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the event, a causal relationship cannot be excluded. Event term, onset date and outcome captured per Authority reporting. Event seriousness per assessment by Authority and per list; Reported Cause(s) of Death: cardiac arrest.


VAERS ID: 1579326 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-17
Onset:2021-06-23
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, SARS-CoV-2 test, Ultrasound foetal
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? Yes
Died? Yes
   Date died: 2021-07-28
   Days after onset: 35
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Miscarriage; Pregnancy; Comments: Patient has not had symptoms associated with COVID- 19 and Patient is not currently breastfeeding.
Allergies:
Diagnostic Lab Data: Test Date: 20210726; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test; Test Date: 20210705; Test Name: ultrasound fetal; Result Unstructured Data: 1st scan due to a small bleed, should have been 7+2 weeks pregnant, embryo was measuring approx. . 5 wks; Test Date: 20210719; Test Name: ultrasound fetal; Result Unstructured Data: 2nd scan confirmed no growth and no heartbeat.
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: This case was received via Regulatory Authority (Reference number: 25742447) on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021. This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Early miscarriage), ABORTION SPONTANEOUS (surgical miscarriage) and MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) in a 40-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. Patient has not had symptoms associated with COVID- 19 and Patient is not currently breastfeeding. The patient''s past medical history included Miscarriage and Pregnancy. Concurrent medical conditions included Lactation decreased. Concomitant products included FOLIC ACID for Folic acid supplementation. On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 23-Jun-2021, the patient experienced ABORTION SPONTANEOUS (Early miscarriage) (seriousness criteria death, hospitalization and medically significant). On an unknown date, the patient experienced ABORTION SPONTANEOUS (surgical miscarriage) (seriousness criteria hospitalization, medically significant and congenital anomaly) and MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) (seriousness criteria hospitalization and congenital anomaly). The delivery occurred on 28-Jul-2021, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. The patient died on 28-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, ABORTION SPONTANEOUS (surgical miscarriage) had resolved and MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jul-2021, Ultrasound foetal: 5 wks 1st scan due to a small bleed, should have been 7+2 weeks pregnant, embryo was measuring approx. . 5 wks. On 19-Jul-2021, Ultrasound foetal: abnormal (abnormal) 2nd scan confirmed no growth and no heartbeat.. On 26-Jul-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. It was stated that patient was exposed to the medicine before pregnancy. Details of scans or investigations: Scan at 7 weeks gestation showed 5 week measurements. Further scan at 9 weeks confirmed no growth and no heartbeat. Treatment medication was not provided by the reporter. Company Comment: This is a case of product exposure during pregnancy with associated AEs for this 40-year-old female. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Case is confounded by patients age and history of previous miscarriage. RA reported the event with the seriousness criteria of death which is retained as reported but probably is referring to the child and not the patient (mother).; Sender''s Comments: This is a case of product exposure during pregnancy with associated AEs for this 40-year-old female. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Case is confounded by patients age and history of previous miscarriage. RA reported the event with the seriousness criteria of death which is retained as reported but probably is referring to the child and not the patient (mother).; Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 1579624 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pneumonia
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: No adverse Event, no medical history per source document.
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAMODERNATX, INC.MOD20212

Write-up: Pneumonia; This regulatory authority case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No adverse Event, no medical history per source document. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criteria death and medically significant). The reported cause of death was Pneumonia. It is unknown if an autopsy was performed. No concomitant medications were provided. No treatment information was provided. This is a case of sudden death in a male patient of unknown age with no known past medical history, who died due to pneumonia after receiving a dose of the vaccine. Very limited information has been provided at this time. No further information is expected at this time.; Sender''s Comments: This is a case of sudden death in a male patient of unknown age with no known past medical history, who died due to pneumonia after receiving a dose of the vaccine. Very limited information has been provided at this time. No further information is expected at this time.; Reported Cause(s) of Death: Pneumonia


VAERS ID: 1579851 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004220 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acidosis, Cardiac death, Circulatory collapse, Computerised tomogram, Discoloured vomit, Hypersensitivity, SARS-CoV-2 test, Scan
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Fruit allergy (kiwi); Obesity
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: whole-body CT scan after death; Result Unstructured Data: Whole-body CT scan after death was performed to investigate the cause of the death, which revealed a ground-glass opacity/consolidation in both lungs.; Test Date: 20210802; Test Name: SARS CoV-2 antigen test; Test Result: Negative; Result Unstructured Data: negative; Test Date: 20210802; Test Name: scan; Result Unstructured Data: image findings showed a tendency of cardiac enlargement. The right heart strain was particularly suspected by the right-sided enlargement.
CDC Split Type: JPTAKEDA2021TJP069671

Write-up: cardiac death; Acute circulatory failure; Allergy; Acidosis; Discoloured vomit; This case was received via Regulatory Authority (Reference number: 2021TJP069671) on 05-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This case, reported by a physician via a medical representative, and reported to the Regulatory Authority by a physician, was received via the RA (Ref, v21122425). A patient had allergy to kiwi fruits and obesity. On an unknown date, body temperature before the vaccination: unknown. On 02-Aug-2021, around 18:00, the patient received the 1st dose of the vaccine. Around 19:30, the patient did not complain of any symptom. Around 20:00, a gurgling sound was heard from the bed, and a small amount of yellow colored vomit was noted. The patient did not respond to calls and had ill complexion. An emergency call was made, and cardiopulmonary resuscitation was started as instructed by the operations center. At 20:17, on arrival of the ambulance team, the patient was asystole and was transported with intubation and adrenaline administration by a physician. At 20:42, the patient arrived at the hospital. On arrival, JCS was 300, and the patient was asystole, had no spontaneous breathing, both dilated pupils of 6 mm in diameter, and coldness with poor skin tone of the whole body including the face. The patient was obese. Marked acidosis was found on the blood gas measurement. Resuscitation was continued thereafter , but there was no response. At 22:06, the patient was confirmed dead. The result of the SARS CoV-2 antigen test was negative. A whole-body CT scan after death was performed to investigate the cause of the death, which revealed a ground-glass opacity/consolidation in both lungs. However, there was a possibility that changes associated with cardiac massage, pulmonary congestion, or aspiration occurred. In addition, image findings showed a tendency of cardiac enlargement. The right heart strain was particularly suspected by the right sided enlargement. On 03-Aug-2021, the body was moved through the police to the university, and a legal autopsy was performed. The following were the details: 1) there were findings of acute circulatory failure such as congestion of the face, petechiae of the palpebral conjunctiva, cerebral edema, and pulmonary congestion. 2) reportedly, there were findings of suspected allergy such as edema of the epiglottis and submucosal petechiae of the larynx. The exact cause of death was unclear, but acute circulatory failure/acute cardiac death was suspected from the findings in the legal autopsy. The outcome of acute circulatory failure, acute cardiac death, allergy, acidosis, and yellow-colored vomit was reported as fatal. Follow-up investigation will be made.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the patient''s underlying obesity is a confounder.; Reported Cause(s) of Death: Cardiac death; Acute circulatory failure; Allergy; Acidosis; Vomiting


VAERS ID: 1579945 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-16
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Infarction, Myocarditis, Pericarditis, Pneumonia
SMQs:, Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Myocardial infarction (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-02
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: This case was received via the Regulatory Authority (Reference number: 00648744) on 09-Aug-2021 and was forwarded to Moderna on 09-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PNEUMONIA, MYOCARDITIS, PERICARDITIS and INFARCTION in an elderly male patient who received mRNA-1273 (Spikevax) (batch no. 3001946) for an unknown indication. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-Apr-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 14-May-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PNEUMONIA (seriousness criteria death and medically significant), MYOCARDITIS (seriousness criteria death and medically significant), PERICARDITIS (seriousness criteria death and medically significant), INFARCTION (seriousness criteria death and medically significant) and ABDOMINAL PAIN. The patient died on 02-Jul-2021. The reported cause of death was infarcts organs. It is unknown if an autopsy was performed. At the time of death, ABDOMINAL PAIN outcome was unknown. No concomitant medication reported. No treatment information was provided. Very limited information regarding these events have been provided at this time. No further information is expected.; Sender''s Comments: Very limited information regarding these events have been provided at this time. No further information is expected.; Reported Cause(s) of Death: infarcts organs


VAERS ID: 1581971 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-07-07
   Days after vaccination:98
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Hypoaesthesia, Pulmonary embolism
SMQs:, Peripheral neuropathy (broad), Embolic and thrombotic events, venous (narrow), Guillain-Barre syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma bronchial (well-tolerated); Diabetes mellitus; Hypertension; Lupus erythematosus (well-tolerated).
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CYMODERNATX, INC.MOD20212

Write-up: Pulmonary embolism; Numbness in hand; Fatigue extreme; This case was received via the Regulatory Authority (Reference number: 220721KK6) on 09-Aug-2021 and was forwarded to Moderna on 09-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) in a 63-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes mellitus, Hypertension, Asthma bronchial (well-tolerated) and Lupus erythematosus (well-tolerated). On 31-Mar-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 28-Apr-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to .5 milliliter. On 07-Jul-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria death and medically significant), HYPOAESTHESIA (Numbness in hand) and FATIGUE (Fatigue extreme). The patient died on 07-Jul-2021. The reported cause of death was Acute massive pulmonary embolism. An autopsy was performed. The autopsy-determined cause of death was Acute massive pulmonary embolism. At the time of death, HYPOAESTHESIA (Numbness in hand) and FATIGUE (Fatigue extreme) had not resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications details were not reported by the reporter. Treatment details was not reported y the reporter. This is a case of sudden death in a 62-year-old female subject with HX of diabetes mellitus, hypertension, asthma bronchial and lupus erythematosus, who died 39 days after receiving second dose of vaccine. Very limited information has been provided at this time. Patient''s medical history of lupus erythematosus might have contributed to the events occurrence.; Sender''s Comments: This is a case of sudden death in a 62-year-old female subject with hx of diabetes mellitus, hypertension, asthma bronchial and lupus erythematosus, who died 39 days after receiving second dose of vaccine. Very limited information has been provided at this time. Patient''s medical history of lupus erythematosus might have contributed to the events occurrence.; Reported Cause(s) of Death: Acute massive pulmonary embolism; Autopsy-determined Cause(s) of Death: Acute massive pulmonary embolism


VAERS ID: 1581975 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-06-30
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Back pain, Death, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TORECAN; DRETACEN
Current Illness: Epilepsy (seizure maximum one per year, last time in 03/2021).
Preexisting Conditions: Medical History/Concurrent Conditions: Backache (14 days before vaccination, he got injection).
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of DEATH in a 34-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Backache (14 days before vaccination, he got injection) on 07-Jun-2021. Concurrent medical conditions included Epilepsy (seizure maximum one per year, last time in 03/2021). Concomitant products included THIETHYLPERAZINE MALEATE (TORECAN) for Seizure, LEVETIRACETAM (DRETACEN) for an unknown indication. On 21-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 30-Jun-2021, the patient experienced DEATH (seriousness criteria death and medically significant), BACK PAIN, VOMITING, NAUSEA and ARTHRALGIA. The patient died on 30-Jun-2021. The cause of death was not reported. An autopsy was performed, but no results were provided. At the time of death, BACK PAIN, VOMITING, NAUSEA and ARTHRALGIA outcome was unknown. Treatment information was not provided.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Found dead (cause undetermined)


VAERS ID: 1583272 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Influenza like illness, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-10
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPEI202100133881

Write-up: Flu-like illness; Myalgia; Pyrexia; This case was received via the Regulatory Authority (Reference number: 202100133881) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like illness), MYALGIA (Myalgia) and PYREXIA (Pyrexia) in a 51-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 07-Jul-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 08-Jul-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like illness) (seriousness criterion death), MYALGIA (Myalgia) (seriousness criterion death) and PYREXIA (Pyrexia) (seriousness criterion death). The patient died on 10-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Concomitant product was not provided by the reporter. Treatment product was not provided by the reporter. This case concerns 51 year-old male patient who experienced the fatal events of myalgia, pyrexia and influenza like illness and died 3 days after receiving the dose of the mRNA-1273 vaccine. Cause of death was not specified. Very limited information has been provided at this time.; Sender''s Comments: This case concerns 51 year-old male patient who experienced the fatal events of myalgia, pyrexia and influenza like illness and died 3 days after receiving the dose of the mRNA-1273 vaccine. Cause of death was not specified. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1586050 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-20
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003655 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-30
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Infantile cerebral palsy.
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: This case was received via the Regulatory Authority (Reference number: IT-MINISAL02-764973) on 10-Aug-2021 and was forwarded to Moderna on 10-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of DYSPNOEA and PYREXIA in a 53-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3003655) for COVID-19 vaccination. The patient''s past medical history included Infantile cerebral palsy on 31-May-1968. On 15-Jul-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-Jul-2021, the patient experienced DYSPNOEA (seriousness criteria death and hospitalization) and PYREXIA (seriousness criteria death and hospitalization). The patient died on 30-Jul-2021. The reported cause of death was Dyspnea and Pyrexia. It is unknown if an autopsy was performed. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Relevant concomitant medications were not reported. Treatment information was not provided. Company''s comment: Company''s comment: This case concerns an 53-year old female with medical history of Infantile cerebral palsy who had adverse events of dyspnoea and pyrexia and died 15 days after receiving mRNA-1273 vaccine. The reported cause of death was Dyspnea and Pyrexia. It is unknown if an autopsy was performed. Very limited information regarding this event has been provided at this time. Further information (translation) is expected. Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Upon follow-up received: Updated seriousness criteria to death.; Sender''s Comments: This case concerns an 53-year old female with medical history of Infantile cerebral palsy who had adverse events of dyspnoea and pyrexia and died 15 days after receiving mRNA-1273 vaccine. The reported cause of death was Dyspnea and Pyrexia. It is unknown if an autopsy was performed. Very limited information regarding this event has been provided at this time. Further information (translation) is expected.; Reported Cause(s) of Death: Dyspnea; Pyrexia


VAERS ID: 1586201 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-05-12
   Days after vaccination:70
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 30004272 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATMODERNATX, INC.MOD20212

Write-up: SARS-CoV-2 infection; Vaccination failure; This case was received via Regulatory Authority (Reference number: 39245) on 11-Aug-2021 and was forwarded to Moderna on 11-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of COVID-19 (SARS-CoV-2 infection) and VACCINATION FAILURE (Vaccination failure) in a 79-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. G26761A and 30004272) for COVID-19 vaccination. No Medical History information was reported. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-May-2021, the patient experienced COVID-19 (SARS-CoV-2 infection) (seriousness criterion death) and VACCINATION FAILURE (Vaccination failure) (seriousness criterion medically significant). The patient died on an unknown date. The reported cause of death was SARS-CoV-2 infection. It is unknown if an autopsy was performed. At the time of death, VACCINATION FAILURE (Vaccination failure) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication reported. No treatment information was provided. Very limited information regarding vaccination failure has been provided at this time. Further information is not expected. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of this event is assessed as not applicable.; Sender''s Comments: Very limited information regarding vaccination failure has been provided at this time. Further information is not expected. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of this event is assessed as not applicable.; Reported Cause(s) of Death: SARS-CoV-2 infection


VAERS ID: 1586225 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Basilar artery thrombosis
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20212

Write-up: Gestorben 10 Stunden nach der Impfung basilaris Thrombose; This case was received via Regulatory Authority Agency (Reference number: 202100153191) on 10-Aug-2021 and was forwarded to Moderna on 10-Aug-2021. This Regulatory Authority case was reported by a consumer and describes the occurrence of BASILAR ARTERY THROMBOSIS (Gestorben 10 Stunden nach der Impfung basilaris Thrombose) in a 90-year-old male patient who received mRNA-1273 (Spikevax) for Prophylactic vaccination. No Medical History information was reported. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced BASILAR ARTERY THROMBOSIS (Gestorben 10 Stunden nach der Impfung basilaris Thrombose) (seriousness criteria death and medically significant). The patient died on 01-Apr-2021. The reported cause of death was Basilar artery thrombosis. It is unknown if an autopsy was performed. Concomitant medications were not reported . Treatment information was not provided. Company comment This fatal case concerns a 90-year-old male with a serious unexpected event of basilar artery thrombosis. Event latency within 10 hours after first dose mRNA-1273. Cause of death reported as basilar artery thrombosis. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding this event has been provided at this time. Further information has been requested; Sender''s Comments: This fatal case concerns a 90-year-old male with a serious unexpected event of basilar artery thrombosis. Event latency within 10 hours after first dose mRNA-1273. Cause of death reported as basilar artery thrombosis. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding this event has been provided at this time. Further information has been requested; Reported Cause(s) of Death: Basilar artery thrombosis


VAERS ID: 1586399 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-06-01
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bed rest, Cerebral haemorrhage, Dizziness, Haemorrhage, Hypoaesthesia, Nausea, Paralysis, Pyrexia
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-02
   Days after onset: 31
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of HAEMORRHAGE, CEREBRAL HAEMORRHAGE and PARALYSIS in a 49-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 214001) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 25-May-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Jun-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced DIZZINESS, BED REST, NAUSEA and PYREXIA. On 30-Jun-2021, the patient experienced HYPOAESTHESIA. On 01-Jul-2021 at 4:00 AM, the patient experienced CEREBRAL HAEMORRHAGE (seriousness criteria death, hospitalization and medically significant). On 02-Jul-2021, the patient experienced HAEMORRHAGE (seriousness criteria death, hospitalization and medically significant) and PARALYSIS (seriousness criteria hospitalization and medically significant). The patient died on 02-Jul-2021. It is unknown if an autopsy was performed. At the time of death, PARALYSIS, DIZZINESS, HYPOAESTHESIA, BED REST, NAUSEA and PYREXIA had not resolved. No concomitant medication was received by the patient. No treatment information was received by the patient. This case concerns an 49-year old female who had adverse events of DIZZINESS, BED REST, NAUSEA, PYREXIA, HYPOAESTHESIA, CEREBRAL HAEMORRHAGE, HAEMORRHAGE and PARALYSIS and died 10 days after receiving the 2nd dose of the vaccine. The reported cause of death was Cerebral haemorrhage and Haemorrhage. It is unknown if an autopsy was performed. Very limited information regarding this event/s has been provided at this time which impairs the overall understanding of the case and preclude proper medical assessment. This case was linked to AT-BASGAGES-2021-40229 (Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: Follow up received on 16-AUG-2021: Start date of first dose and batch number for dose 2 was updated.; Sender''s Comments: This case concerns an 49-year old female who had adverse events of DIZZINESS, BED REST, NAUSEA, PYREXIA, HYPOAESTHESIA, CEREBRAL HAEMORRHAGE, HAEMORRHAGE and PARALYSIS and died 10 days after receiving the 2nd dose of the vaccine. The reported cause of death was Cerebral haemorrhage and Haemorrhage. It is unknown if an autopsy was performed. Very limited information regarding this event/s has been provided at this time which impairs the overall understanding of the case and preclude proper medical assessment. AT-BASGAGES-2021-40229:


VAERS ID: 1590098 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Brain herniation, Cerebral haemorrhage, Chills, Meningitis, Physical deconditioning, Restlessness, Thrombocytopenic purpura, Thrombosis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Akathisia (broad), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-09
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP072379

Write-up: Meningitis (decerebrate rigidity); Thrombosis with thrombocytopenia; Brain herniation; Cerebral hemorrhage; Thrombocytopenic purpura; Restlessness; Physical deconditioning; Chills; This case was received via Regulatory Authority (Reference number: 2021TJP072379) on 11-Aug-2021 and was forwarded to Moderna on 15-Aug-2021. This case, initially reported to the Regulatory Authority by a (physician), was received via the RA (Ref, v21122858). On an unknown date, the patient received the 1st dose of this vaccine. On an unknown date, body temperature before the vaccination: Unknown. On 03-Aug-2021, the patient received the 2nd dose of this vaccine. On 04-Aug-2021, in the morning, the patient had physical deconditioning and rested at home. At 18:00, chills developed. At 20:00, the patient had restlessness and was taken to a hospital by ambulance. On arrival, JCS/100, BT: 38.3 degrees Celsius, and SPO2: 97% (10 L of O2 mask). Decerebrate rigidity was noted, and meningitis was suspected. Cerebrospinal fluid test showed no increase in cell count. Thereafter, bleeding tendency became significant. Platelets decreased. thrombosis with thrombocytopenia (TTS) after the vaccination was suspected. It was considered to be thrombocytopenic purpura. Steroid pulse IVIG and plasma exchange were performed, but no improvement was noted. Brain herniation due to cerebral hemorrhage was suspected. On 09-Aug-2021, the patient died. The outcome of physical deconditioning, chills, restlessness, meningitis (decerebrate rigidity), thrombosis with thrombocytopenia, thrombocytopenic purpura, brain herniation, and cerebral hemorrhage was reported as fatal. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The causal relationship with the vaccine is questionable.; Sender''s Comments: Very limited information regarding these events has been provided at this time. Additional information required.; Reported Cause(s) of Death: Physical deconditioning; Chills; Unrest; Meningitis; Thrombosis; Thrombocytopenic purpura; Brain herniation; Cerebral hemorrhage


VAERS ID: 1590108 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Thrombosis
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-07
   Days after onset: 37
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: KRMODERNATX, INC.MOD20212

Write-up: breathing difficulty; thrombosis; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (breathing difficulty) and THROMBOSIS (thrombosis) in a 20-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced THROMBOSIS (thrombosis) (seriousness criteria death, hospitalization and medically significant). On 31-Jul-2021, the patient experienced DYSPNOEA (breathing difficulty) (seriousness criteria death and hospitalization). The patient was hospitalized on 31-Jul-2021 due to DYSPNOEA and THROMBOSIS. The patient died on 07-Aug-2021. The reported cause of death was breathing difficulty and Thrombosis. It is unknown if an autopsy was performed. Concomitant products were not provided. Treatment medication were not reported. Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender''s Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: breathing difficulty; thrombosis


VAERS ID: 1590617 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-06-01
   Days after vaccination:46
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001442 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute respiratory failure, Angiogram, Arteriosclerosis, Arteriosclerosis coronary artery, Cardiac arrest, Coronary artery stenosis, Dyspnoea, Electrocardiogram, Left ventricular failure, Pulmonary oedema, Renal failure
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-23
   Days after onset: 22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: AMOKSIKLAV 2S; NOVOMIX; EUTHYROX N; NEDAL; TORVACARD; GLUCOPHAGE FORTE; POLAPRIL; INDAPEN SR; STEPCIL
Current Illness: Arterial hypertension; Type II diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Arteriosclerosis; Hypothyroidism; Obesity; Surgery (state after thyroid surgery due to lump (goiter)); Surgery (resection of the lump of the left vocal fold); Thrombosis
Allergies:
Diagnostic Lab Data: Test Date: 20210623; Test Name: Angiography; Result Unstructured Data: critical coronary vessel narrowing; LAD: severe calcifications; LAD: disseminated critical atherosclerotic lesions; Test Date: 20210602; Test Name: ECG; Result Unstructured Data: recent myocardial infarction
CDC Split Type: PLMODERNATX, INC.MOD20212

Write-up: Approximately 1 month after the 2nd dose of the vaccine - oppressive breathlessness; 22/06/2021 - exacerbation of shortness of breath, she could not breathe; LAD: severe calcifications; sudden cardiac arrest in the mechanism of asystole; LAD: disseminated critical atherosclerotic lesions; sudden cardiac arrest in the mechanism of asystole; critical coronary vasoconstriction; Pulmonary oedema; left ventricular damage; Kidney failure; Acute respiratory failure; This case was received via Regulatory Authority. This regulatory authority case was reported by a consumer and describes the occurrence of RENAL FAILURE (Kidney failure), ACUTE RESPIRATORY FAILURE (Acute respiratory failure), ARTERIOSCLEROSIS (LAD: severe calcifications), the first episode of CARDIAC ARREST (sudden cardiac arrest in the mechanism of asystole), LEFT VENTRICULAR FAILURE (left ventricular damage), ARTERIOSCLEROSIS CORONARY ARTERY (LAD: disseminated critical atherosclerotic lesions), PULMONARY OEDEMA (Pulmonary oedema), the second episode of CARDIAC ARREST (sudden cardiac arrest in the mechanism of asystole), CORONARY ARTERY STENOSIS (critical coronary vasoconstriction) and DYSPNOEA (Approximately 1 month after the 2nd dose of the vaccine - oppressive breathlessness; 22/06/2021 - exacerbation of shortness of breath, she could not breathe) in a 72-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3001442) for COVID-19 vaccination. The patient''s past medical history included Thrombosis, Hypothyroidism, Arteriosclerosis, Obesity, Surgery (resection of the lump of the left vocal fold) in 2012 and Surgery (state after thyroid surgery due to lump (goiter)) in 1992. Concurrent medical conditions included Arterial hypertension and Type II diabetes mellitus. Concomitant products included RAMIPRIL (POLAPRIL) for Arterial hypertension, AMOXICILLIN TRIHYDRATE, CLAVULANATE POTASSIUM (AMOKSIKLAV 2S) from 02-Jun-2021 to 08-Jun-2021 for Dyspnea, CILOSTAZOL (STEPCIL) for Thrombosis, INSULIN ASPART, INSULIN ASPART PROTAMINE (CRYSTALLINE) (NOVOMIX) and METFORMIN HYDROCHLORIDE (GLUCOPHAGE FORTE) for Type II diabetes mellitus, LEVOTHYROXINE SODIUM (EUTHYROX N), NEBIVOLOL HYDROCHLORIDE (NEDAL), ATORVASTATIN CALCIUM (TORVACARD) and INDAPAMIDE (INDAPEN SR) for an unknown indication. On 16-Apr-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. In June 2021, the patient experienced RENAL FAILURE (Kidney failure) (seriousness criteria death, hospitalization and medically significant), ACUTE RESPIRATORY FAILURE (Acute respiratory failure) (seriousness criteria death, hospitalization and medically significant), LEFT VENTRICULAR FAILURE (left ventricular damage) (seriousness criteria death, hospitalization and medically significant) and PULMONARY OEDEMA (Pulmonary oedema) (seriousness criteria death, hospitalization and medically significant). On 23-Jun-2021, after starting mRNA-1273 (Spikevax), the patient experienced ARTERIOSCLEROSIS (LAD: severe calcifications) (seriousness criteria death and hospitalization), the first episode of CARDIAC ARREST (sudden cardiac arrest in the mechanism of asystole) (seriousness criteria death, hospitalization and medically significant), ARTERIOSCLEROSIS CORONARY ARTERY (LAD: disseminated critical atherosclerotic lesions) (seriousness criteria death and hospitalization), the second episode of CARDIAC ARREST (sudden cardiac arrest in the mechanism of asystole) (seriousness criteria death, hospitalization and medically significant) and CORONARY ARTERY STENOSIS (critical coronary vasoconstriction) (seriousness criteria death, hospitalization and medically significant). On an unknown date, the patient experienced DYSPNOEA (Approximately 1 month after the 2nd dose of the vaccine - oppressive breathlessness; 22/06/2021 - exacerbation of shortness of breath, she could not breathe) (seriousness criteria death and hospitalization). The patient died on 23-Jun-2021. The reported cause of death was sudden cardiac arrest in the mechanism of asystole. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jun-2021, Electrocardiogram: abnormal (abnormal) recent myocardial infarction. On 23-Jun-2021, Angiogram: abnormal (abnormal) critical coronary vessel narrowing; LAD: severe calcifications; LAD: disseminated critical atherosclerotic lesions. Treatment medication was not provided by the reporter Company Comment: This is a case of death of a 72-year-old female patient after receiving unknown dose of vaccine on 16-APR-2021 (Lot number 3001442). Very limited information regarding the clinical details pertaining to death was provided at this time. No further information is expected. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: This is a case of death of a 72-year-old female patient after receiving unknown dose of vaccine on 16-APR-2021 (Lot number 3001442). Very limited information regarding the clinical details pertaining to death was provided at this time. No further information is expected. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: sudden cardiac arrest in the mechanism of asystole


VAERS ID: 1592685 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: This case was received via Regulatory Authority (Reference number: MP20215979) on 12-Aug-2021 and was forwarded to Moderna on 12-Aug-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH in a 28-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 31-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. Death occurred on August 2021 The patient died in August 2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No treatment drug information provided. No concomitant drug information provided. Company comment: This is a case of Death Not Otherwise Specified in a 28-year-old male patient, that occurred at an unspecified number of days after receiving first dose of vaccine (Lot number unknown). Very limited information regarding the date of death and the clinical details pertaining to death, medical history, and concomitant medication was provided at this time. No further information is expected.; Sender''s Comments: This is a case of Death Not Otherwise Specified in a 28-year-old male patient, that occurred at an unspecified number of days after receiving first dose of vaccine (Lot number unknown). Very limited information regarding the date of death and the clinical details pertaining to death, medical history, and concomitant medication was provided at this time. No further information is expected.; Reported Cause(s) of Death: Unknown cause of Death


VAERS ID: 1593425 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Breathing arrested; This case was received via Regulatory Authority (Reference number: 25784244) on 12-Aug-2021 and was forwarded to Moderna on 12-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of RESPIRATORY ARREST (Breathing arrested) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RESPIRATORY ARREST (Breathing arrested) (seriousness criteria death and medically significant). The reported cause of death was Breathing arrested. It is unknown if an autopsy was performed. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown Route) was unknown. Company Comment:Very limited information regarding this event has been provided at this time. No further follow-up information is expected.; Sender''s Comments: Very limited information regarding this event has been provided at this time. No further follow-up information is expected.; Reported Cause(s) of Death: Breathing arrested


VAERS ID: 1622911 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-07-24
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002616 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Death NOS; This case was received via Regulatory Authority (Reference number: BX20217173) on 13-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death NOS) in an 84-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3002616) for COVID-19 vaccination. No Medical History information was reported. On 18-Jun-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. Death occurred on 24-Jul-2021 The patient died on 24-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product information was not provided by reporter. No treatment information was provided. Company Comment: Very limited information regarding this event has been provided at this time. However, patient''s advanced age remains a contributory factor. Further information can''t be requested.; Sender''s Comments: Very limited information regarding this event has been provided at this time. However, patient''s advanced age remains a contributory factor. Further information can''t be requested.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1622994 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-05-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Death, Fatigue, Headache, Hyperpyrexia, Injection site haematoma, Injection site inflammation, Injection site pain, Injection site warmth, Malaise, Myalgia, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-26
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: hyperpyrexia; Result Unstructured Data
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: This case was received via Regulatory Authority (Reference number: NL-LRB-00658719) on 13-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This Regulatory Authority case was reported by a consumer and describes the occurrence of DEATH, FATIGUE, CHILLS, HEADACHE, INJECTION SITE HAEMATOMA, MALAISE, HYPERPYREXIA, INJECTION SITE PAIN, INJECTION SITE INFLAMMATION, MYALGIA, ARTHRALGIA, INJECTION SITE WARMTH and NAUSEA in a 50-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 11-May-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 11-May-2021, the patient experienced FATIGUE, CHILLS, HEADACHE, INJECTION SITE HAEMATOMA, MALAISE, HYPERPYREXIA ), INJECTION SITE PAIN, INJECTION SITE INFLAMMATION, MYALGIA, ARTHRALGIA, INJECTION SITE WARMT and NAUSEA. The patient died on 26-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Hyperpyrexia: high (High): 40.5, 42 degrees Celsius. Treatment information not provided. Concomitant medication not provided. This case refers to a 50-year-old female patient who died 16 days after receiving the dose 2 of the product mRNA-1273. Cause of death not reported. Very limited information regarding the event of death has been provided at this time insufficient for causality assessment. Based on the current available information and temporal association between the use of the product mRNA-1273 and the start date of the remaining events, a causal relationship cannot be excluded.; Sender''s Comments: This case refers to a 50-year-old female patient who died 16 days after receiving the dose 2 of the product mRNA-1273. Cause of death not reported. Very limited information regarding the event of death has been provided at this time insufficient for causality assessment. Based on the current available information and temporal association between the use of the product mRNA-1273 and the start date of the remaining events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: (Body did not make antibodies against the corona virus (that is what the hospital claims)


VAERS ID: 1623023 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-05-02
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001938 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-09
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROMODERNATX, INC.MOD20212

Write-up: Myocardial infarction; This case was received via Regulatory Authority (Reference number: SPCOV12123) on 13-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This regulatory authority case was reported by a non-health professional and describes the occurrence of MYOCARDIAL INFARCTION (Myocardial infarction) in a 44-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3001938) for Active immunisation. Concurrent medical conditions included Arterial hypertension. On 16-Apr-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 02-May-2021, after starting mRNA-1273 (Spikevax), the patient experienced MYOCARDIAL INFARCTION (Myocardial infarction) (seriousness criteria death and medically significant). The patient died on 09-May-2021. The reported cause of death was Myocardial infarction. It is unknown if an autopsy was performed. Concomitant product use was not provided by the reporter. Treatment information was not provided. The medical assessor of the Competent Authority requested the investigation of the case at National Centre for Communicable Diseases Surveillance and Control (CNSCBT), to no result yet. Company comment Very limited information regarding this event has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, patient''s underlying medical condition of arterial hypertension remains a contributory factor. Further information can''t be requested.; Sender''s Comments: Very limited information regarding this event has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, patient''s underlying medical condition of arterial hypertension remains a contributory factor. Further information can''t be requested.; Reported Cause(s) of Death: Myocardial infarction


VAERS ID: 1624364 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-04-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anorexia
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20212

Write-up: Death; This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (Death) in a 47-year-old female patient who received mRNA-1273 (Spikevax) for Prophylactic vaccination. The patient''s past medical history included Anorexia. On 28-Apr-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Death occurred on 28-Apr-2021 The patient died on 28-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant medication not reported. Treatment medication not reported. Company comment: Based on the current available information and temporal association between the use of the product and the reported death of the patient, a causal relationship cannot be excluded. Event term, onset date and outcome captured per RA Authority reporting. Events seriousness per assessment by Authority and per IME list. Cause of death not provided.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the reported death of the patient, a causal relationship cannot be excluded. Event term, onset date and outcome captured per RA Authority reporting. Events seriousness per assessment by Authority and per IME list. Cause of death not provided; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1624875 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-07-01
   Days after vaccination:122
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes mellitus; Emphysema pulmonary; Hypertension arterial; Liver cirrhosis
Preexisting Conditions: Medical History/Concurrent Conditions: Kidney failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: COVID-19 respiratory infection; Vaccination failure; This case was received via Regulatory Authority (Reference number: PA20211318) on 13-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of COVID-19 (COVID-19 respiratory infection) and VACCINATION FAILURE (Vaccination failure) in a 77-year-old male patient who received mRNA-1273 (Spikevax) for Prophylaxis. The patient''s past medical history included Kidney failure. Concurrent medical conditions included Hypertension arterial, Emphysema pulmonary, Liver cirrhosis and Diabetes mellitus. In March 2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In July 2021, the patient experienced COVID-19 (COVID-19 respiratory infection) (seriousness criterion death) and VACCINATION FAILURE (Vaccination failure) (seriousness criterion life threatening). The patient died on an unknown date. The reported cause of death was COVID-19 respiratory infection. It is unknown if an autopsy was performed. At the time of death, VACCINATION FAILURE (Vaccination failure) had not resolved. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter. Very limited information regarding this event/s has been provided at this time. Further information has been requested. The causality for the event Covid-19 will be considered as "Not Applicable".; Sender''s Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested. The causality for the event Covid-19 will be considered as "Not Applicable".; Reported Cause(s) of Death: COVID-19 respiratory infection


VAERS ID: 1624882 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214010 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Arrest cardiac; This case was received via Regulatory Authority (Reference number: PB20215062) on 13-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of CARDIAC ARREST (Arrest cardiac) in a 61-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 214010) for COVID-19 vaccination. The patient''s past medical history included Hypertension and Obesity. On 29-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced CARDIAC ARREST (Arrest cardiac) (seriousness criteria death and medically significant). The patient died on 30-Jul-2021. The reported cause of death was Arrest cardiac. It is unknown if an autopsy was performed. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not reported . Treatment information was not provided. Company comments: Very limited information regarding this event has been provided at this time. No further follow up information is expected.; Sender''s Comments: Very limited information regarding this event has been provided at this time. No further follow up information is expected.; Reported Cause(s) of Death: Arrest cardiac


VAERS ID: 1625406 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-23
Onset:2021-06-15
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocardial infarction, SARS-CoV-2 test
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-27
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210615; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Heart attack; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25801136) on 15-Aug-2021 and was forwarded to Moderna on 15-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 38-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Suspected COVID-19 since 07-Jun-2021. On 23-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria death and medically significant). The patient died on 27-Jun-2021. The reported cause of death was Heart attack. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2021, SARS-CoV-2 test: negative (Negative) Negative. Concomitant product use was not provided by the reporter. Patient had blood clot caused heart attack. Patient is not enrolled in clinical trial. No treatment information was provided. This is a case of myocardial infarction with fatal outcome in a 37-year-old male who died 24 days after receiving one dose of vaccine. Very limited information regarding this event has been provided. No further information is expected at this time.; Sender''s Comments: This is a case of myocardial infarction with fatal outcome in a 37-year-old male who died 24 days after receiving one dose of vaccine. Very limited information regarding this event has been provided. No further information is expected at this time.; Reported Cause(s) of Death: Heart attack


VAERS ID: 1625501 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002188 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Computerised tomogram head, Delirium tremens
SMQs:, Noninfectious encephalopathy/delirium (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-10
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol withdrawal syndrome; Alcoholic cardiomyopathy; Carotid artery stenosis; Cerebral atherosclerosis; Spondylosis; Syncope
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: Brain CT; Result Unstructured Data: known carotid artery stenosis
CDC Split Type: HUMODERNATX, INC.MOD20212

Write-up: Delirium tremens; This case was received via Regulatory Authority (Reference number: 673521) on 13-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of DELIRIUM TREMENS (Delirium tremens) in a 68-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3002188) for COVID-19 vaccination. The patient''s past medical history included Spondylosis, Alcoholic cardiomyopathy, Syncope, Carotid artery stenosis, Alcohol withdrawal syndrome and Cerebral atherosclerosis. Concurrent medical conditions included Hypertension. On 01-Jun-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 02-Jun-2021, after starting mRNA-1273 (Spikevax), the patient experienced DELIRIUM TREMENS (Delirium tremens) (seriousness criteria death, hospitalization and medically significant). The patient died on 10-Jun-2021. The reported cause of death was Delirium tremens. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jun-2021, Computerised tomogram head: abnormal (abnormal) known carotid artery stenosis. For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered DELIRIUM TREMENS (Delirium tremens) to be not related. There was no concomitant medication reported. There was no treatment medication reported. Company Comment : This is a case of death in a 68-year-old male subject, with a history of Alcoholic cardiomyopathy, Carotid artery stenosis, Cerebral atherosclerosis and Hypertension who died 9 days after receiving first dose of vaccine due to delirium tremens. Based on reporter''s causality, the event is assessed as unlikely related to mRNA-1273.; Reporter''s Comments: The patient died 9 days after vaccination with COVID-19 Vaccine Moderna due to delirium tremens. The event and the vaccine is considered not related. The case is serious due to hospitalization and fatal outcome.; Sender''s Comments: This is a case of death in a 68-year-old male subject, with a history of Alcoholic cardiomyopathy, Carotid artery stenosis, Cerebral atherosclerosis and Hypertension who died 9 days after receiving first dose of vaccine due to delirium tremens. Based on reporter''s causality, the event is assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: Delirium tremens


VAERS ID: 1629437 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-26
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Death NOS; This case was received via Agency (Reference number: FR-AFSSAPS-BX20217295) on 16-Aug-2021 and was forwarded to Moderna on 16-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death NOS) in a 73-year-old male patient who received mRNA-1273 (Spikevax) (batch no. Not found) for COVID-19 immunization. No Medical History information was reported. On 13-Jul-2021, the patient received dose of mRNA-1273 (Spikevax) (Parenteral) 1 dosage form. Death occurred on 26-Jul-2021 The patient died on 26-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Concomitant product use was not provided by the reporter. No treatment information was provided. Company comment- Very limited information regarding this event/s has been provided at this time. No further information is expected.; Sender''s Comments: Very limited information regarding this event/s has been provided at this time. No further information is expected.; Reported Cause(s) of Death: death NOS


VAERS ID: 1630389 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-05
Onset:2021-08-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214014 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Aortic stenosis, Death, Incorrect dose administered
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-07
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: Inappropriate dose of vaccine administered; This case was received via Regulatory Authority (Reference number: IT-MINISAL02-768969) on 16-Aug-2021 and was forwarded to Moderna on 16-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of DEATH and AORTIC STENOSIS in a 72-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 214014) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .3 milliliter in total. On 06-Aug-2021, after starting mRNA-1273 (Spikevax), the patient experienced DEATH (seriousness criteria death and medically significant) and AORTIC STENOSIS (seriousness criteria death and medically significant). On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Inappropriate dose of vaccine administered). The patient died on 07-Aug-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, INCORRECT DOSE ADMINISTERED (Inappropriate dose of vaccine administered) had resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment was reported. Company comment: This is a case of sudden death in a 72-year-old female subject, with reported serious unlisted event Aortic stenosis , who died 2 days after receiving unknown dose of vaccine, no medical history was reported, cause of death was not specified, It is unknown if an autopsy was performed, Very limited information has been provided at this time.; Sender''s Comments: This is a case of sudden death in a 72-year-old female subject, with reported serious unlisted event Aortic stenosis , who died 2 days after receiving unknown dose of vaccine, no medical history was reported, cause of death was not specified, It is unknown if an autopsy was performed, Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1630767 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Fatigue, Pulmonary oedema
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-28
   Days after onset: 25
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: COPD (stabiele COPD)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: This case was received via Agency (Reference number: 00662375) on 16-Aug-2021 and was forwarded to Moderna on 16-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PULMONARY OEDEMA, FATIGUE and DYSPNOEA in a 71-year-old female patient who received mRNA-1273 for COVID-19 vaccination. Concurrent medical conditions included COPD. On 03-Jul-2021, the patient received second dose of mRNA-1273 (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (unknown route) .5 ml. On 03-Jul-2021, the patient experienced FATIGUE (seriousness criteria death and hospitalization prolonged). On 05-Jul-2021, the patient experienced PULMONARY OEDEMA (seriousness criteria death, hospitalization prolonged and medically significant). On an unknown date, the patient experienced DYSPNOEA (seriousness criteria death and hospitalization prolonged). The patient died on 28-Jul-2021. It is unknown if an autopsy was performed. No concomitant medication was given. No treatment medication was given. Company comment: Very limited information regarding these events have been provided at this time. Further information cannot be requested.; Sender''s Comments: Very limited information regarding these events have been provided at this time. Further information cannot be requested.; Reported Cause(s) of Death:


VAERS ID: 1630930 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-16
Onset:2021-06-01
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hepatocellular carcinoma, Ultrasound abdomen
SMQs:, Liver malignant tumours (narrow), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-29
   Days after onset: 28
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hepatitis C
Allergies:
Diagnostic Lab Data: Test Date: 20200720; Test Name: Ultrasound abdomen; Result Unstructured Data: No focal lesions
CDC Split Type: SIMODERNATX, INC.MOD20212

Write-up: onset of hepatic disease - HCC; This case was received via regulatory authority (Reference number: SI-JAZMP-NCPHV-2021SI0809_0809) on 16-Aug-2021 and was forwarded to Moderna on 16-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of HEPATOCELLULAR CARCINOMA (onset of hepatic disease - HCC) in a 63-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The patient''s past medical history included Hepatitis C on 02-Dec-2020. On 16-May-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 01-Jun-2021, after starting mRNA-1273 (Spikevax), the patient experienced HEPATOCELLULAR CARCINOMA (onset of hepatic disease - HCC) (seriousness criteria death and medically significant). The patient died on 29-Jun-2021. The reported cause of death was onset of hepatic disease - hcc. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jul-2020, Ultrasound abdomen: normal (normal) No focal lesions. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter. On an unknown date in Jun-2021 the laboratory exams performed to further understand the event included were Ultrasound scan and CT scan and the results were unknown. Company comment: Very limited information regarding this event has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, patient''s underlying disease remains a contributory factor. Further information can''t be requested.; Sender''s Comments: Very limited information regarding this event has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, patient''s underlying disease remains a contributory factor. Further information can''t be requested.; Reported Cause(s) of Death: onset of hepatic disease - HCC


VAERS ID: 1632184 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-12
Onset:2021-07-19
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002912 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Encephalitis
SMQs:, Noninfectious encephalitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-24
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Migraine
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: Death; This regulatory authority case was reported by a pharmacist and describes the occurrence of ENCEPHALITIS and DEATH (Death) in a 21-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch nos. 3003606 and 3002912) for COVID-19 vaccination. The patient''s past medical history included Migraine in 2019. On 12-Jun-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 10-Jul-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jul-2021, after starting mRNA-1273 (COVID-19 Vaccine Moderna), the patient experienced ENCEPHALITIS (seriousness criteria death and medically significant). The patient died on 24-Jul-2021. The reported cause of death was Meningoencephalitis. It is unknown if an autopsy was performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. On an unknown date, laboratory test performed (result not reported). Regarding the event of Encephalitis, based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However regarding the event of death, Very limited information regarding this event has been provided at this time. Further information has been requested. No treatment information was provided. Company Comment: Regarding the event of Encephalitis, based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However regarding the event of death, Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender''s Comments: Regarding the event of Encephalitis, based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However regarding the event of death, Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Meningoencephalitis; Death


VAERS ID: 1634564 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-07-20
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003183 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest, Malaise, Nausea, Vaccination site plaque
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-24
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BRILIQUE
Current Illness: Vascular device user (cardiac stent)
Preexisting Conditions: Medical History/Concurrent Conditions: Coagulation disorder (cardiac stent); Coagulation disorder; Dyslipidemia (cardiac stent)
Allergies:
Diagnostic Lab Data:
CDC Split Type: LUMODERNATX, INC.MOD20212

Write-up: CARDIAC ARREST; Malaise; envie de vomir; Vaccination site plaque; This case was received via Regulatory Authority (Reference number: LU-ALMPS-202102975) on 17-Aug-2021 and was forwarded to Moderna on 17-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MALAISE (Malaise), NAUSEA and CARDIAC ARREST in a 34-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 3003183 and 3003610) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Coagulation disorder (cardiac stent), Coagulation disorder and Dyslipidemia (cardiac stent). Concurrent medical conditions included Vascular device user (cardiac stent). Concomitant products included TICAGRELOR (BRILIQUE) for Vascular device user. On 21-Jun-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 19-Jul-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 20-Jul-2021, after starting mRNA-1273 (Spikevax), the patient experienced VACCINATION SITE PLAQUE (Vaccination site plaque). On 23-Jul-2021, the patient experienced MALAISE (seriousness criterion death) and NAUSEA (seriousness criterion death). On an unknown date, the patient experienced CARDIAC ARREST (seriousness criteria death and medically significant). The patient died on 24-Jul-2021. The reported cause of death was Cardiac arrest. An autopsy was not performed. At the time of death, VACCINATION SITE PLAQUE (Vaccination site plaque) outcome was unknown. No treatment medications were not provided. Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded; Sender''s Comments: Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1640660 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-10
Onset:2021-08-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 057D21A / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pyrexia, Seizure
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-12
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHMODERNATX, INC.MOD20212

Write-up: Seizure; Fever; This regulatory authority case was reported by an other health care professional and describes the occurrence of SEIZURE (Seizure) and PYREXIA (Fever) in a 61-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 057D21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Aug-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced PYREXIA (Fever) (seriousness criterion death). On 12-Aug-2021 at 10:00 PM, the patient experienced SEIZURE (Seizure) (seriousness criteria death and medically significant). The patient died on 12-Aug-2021. The reported cause of death was Seizure and Fever. It is unknown if an autopsy was performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. Company comment: Very scant information is available and no further information is expected. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender''s Comments: Very scant information is available and no further information is expected. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Reported Cause(s) of Death: Seizure; Fever


VAERS ID: 1640662 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-10
Onset:2021-08-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Febrile convulsion, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-12
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210811; Test Name: Body temperature; Result Unstructured Data: Greater than 38 degree Celsius
CDC Split Type: PHPHFDA300099740

Write-up: seizure febrile; Fever greater than 38-degree celsius; This regulatory authority case was reported by an other health care professional and describes the occurrence of FEBRILE CONVULSION (seizure febrile) and PYREXIA (Fever greater than 38-degree celsius) in a 61-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 10-Aug-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced PYREXIA (Fever greater than 38-degree celsius) (seriousness criterion death). On 12-Aug-2021, the patient experienced FEBRILE CONVULSION (seizure febrile) (seriousness criterion death). The patient died on 12-Aug-2021. The reported cause of death was seizure febrile and fever greater than 38-degree celsius. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Aug-2021, Body temperature: greater than 38 degree celsius (High) Greater than 38 degree Celsius. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. This is a case of a 61 year old male patient who died 2 days after receiving the vaccine. Very limited information regarding these events have been provided at this time. Febrile seizures are usually diagnosed in children up to age 7, however , since this is an RA case, it was captured as such. No further information is expected.; Sender''s Comments: This is a case of a 61 year old male patient who died 2 days after receiving the vaccine. Very limited information regarding these events have been provided at this time. Febrile seizures are usually diagnosed in children up to age 7, however , since this is an RA case, it was captured as such. No further information is expected.; Reported Cause(s) of Death: Seizure febrile; Fever greater than 38-degree celsius


VAERS ID: 1640900 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAMODERNATX, INC.MOD20212

Write-up: Died after getting the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Died after getting the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. Treatment information was not provided. The reporter stated that there were limited information on adverse event. Company comment: Extremely limited and second hand information with no validation is give and not further information is expected. based on current available information and the lack of temporal association between product use, if any, and the date and cause of the event a causal relationship cannot be excluded. Reporter did not allow further contact; Sender''s Comments: Extremely limited and second hand information with no validation is give and not further information is expected. based on current available information and the lack of temporal association between product use, if any, and the date and cause of the event a causal relationship cannot be excluded.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1642138 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-23
Onset:2021-07-26
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214011 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Ischaemic stroke
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-28
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SEROPLEX
Current Illness: Depression; Early menopause; Tabaquism
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Ischemic stroke; This case was received via Regulatory Authority (Reference number: FR-AFSSAPS-LY20218616) on 20-Aug-2021 and was forwarded to Moderna on 20-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of ISCHAEMIC STROKE (Ischemic stroke) in a 42-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 214011) for COVID-19 vaccination. Concurrent medical conditions included Depression, Tabaquism and Early menopause. Concomitant products included ESCITALOPRAM OXALATE (SEROPLEX) for an unknown indication. On 23-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 26-Jul-2021, the patient experienced ISCHAEMIC STROKE (Ischemic stroke) (seriousness criteria death and medically significant). The patient died on 28-Jul-2021. The reported cause of death was avc isch�mique. It is unknown if an autopsy was performed. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication also includes Seroplex. Treatment information was not provided by reporter. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: AVC isch�mique


VAERS ID: 1642147 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-06
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Rhabdomyolysis
SMQs:, Rhabdomyolysis/myopathy (narrow), Neuroleptic malignant syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-12
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cholesteatoma; Epilepsy; Fracture multiple; Rhabdomyolysis
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Rhabdomyolysis; This case was received via regulatory authority (Reference number) on 20-Aug-2021 and was forwarded to Moderna on 20-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of RHABDOMYOLYSIS (Rhabdomyolysis) in a 33-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The patient''s past medical history included Epilepsy, Fracture multiple, Cholesteatoma and Rhabdomyolysis. On 03-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced RHABDOMYOLYSIS (Rhabdomyolysis) (seriousness criteria death and medically significant). The patient died on 12-Aug-2021. The reported cause of death was d�faillance multivisc�rale. An autopsy was not performed. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. Treatment medications was not provided. This is a case of death in a 33-year-old male subject, with a history of Epilepsy, Fracture multiple, Cholesteatoma and Rhabdomyolysis who died 4 days after receiving first dose of vaccine due to multiorgan failure. Very limited information has been provided at this time.; Sender''s Comments: This is a case of death in a 33-year-old male subject, with a history of Epilepsy, Fracture multiple, Cholesteatoma and Rhabdomyolysis who died 4 days after receiving first dose of vaccine due to multiorgan failure. Very limited information has been provided at this time.; Reported Cause(s) of Death: d�faillance multivisc�rale


VAERS ID: 1642739 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-07-31
   Days after vaccination:78
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute myocardial infarction, Cardiac arrest, Cardiac hypertrophy, Cardiomegaly, Cholelithiasis, Myocardial infarction, Obesity, Pulmonary oedema, Renal cyst, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Gallbladder related disorders (narrow), Gallstone related disorders (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (narrow), Respiratory failure (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLMODERNATX, INC.MOD20212

Write-up: Oedema pulmonary; Myocardial hypertrophy - cor bovinum; Cholecystolithiasis; Obesity; Renal cyst; Cardiac dilatation; Acute transmural myocardial infarction (approximately 30 days after the second dose of vaccine); Sudden cardiac arrest (approximately 30 days after the second dose of vaccine); Thrombotic myocardial infarction of the anterior interventricular branch of the coronary artery (approximately 30 days after the second dose of vaccine); Ventricular fibrillation (approximately 30 days after the second dose of vaccine); This regulatory authority case was reported by a physician and describes the occurrence of ACUTE MYOCARDIAL INFARCTION (Acute transmural myocardial infarction (approximately 30 days after the second dose of vaccine)), CARDIAC ARREST (Sudden cardiac arrest (approximately 30 days after the second dose of vaccine)), MYOCARDIAL INFARCTION (Thrombotic myocardial infarction of the anterior interventricular branch of the coronary artery (approximately 30 days after the second dose of vaccine)), VENTRICULAR FIBRILLATION (Ventricular fibrillation (approximately 30 days after the second dose of vaccine)), PULMONARY OEDEMA (Oedema pulmonary), CARDIAC HYPERTROPHY (Myocardial hypertrophy - cor bovinum), CHOLELITHIASIS (Cholecystolithiasis), OBESITY (Obesity), RENAL CYST (Renal cyst) and CARDIOMEGALY (Cardiac dilatation) in a 43-year-old male patient who received mRNA-1273 (Spikevax) for Prophylaxis. No Medical History information was reported. On 14-May-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 14-Jun-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to .5 milliliter. On 31-Jul-2021, the patient experienced ACUTE MYOCARDIAL INFARCTION (Acute transmural myocardial infarction (approximately 30 days after the second dose of vaccine)) (seriousness criteria death, medically significant and life threatening), CARDIAC ARREST (Sudden cardiac arrest (approximately 30 days after the second dose of vaccine)) (seriousness criteria death, medically significant and life threatening), MYOCARDIAL INFARCTION (Thrombotic myocardial infarction of the anterior interventricular branch of the coronary artery (approximately 30 days after the second dose of vaccine)) (seriousness criteria death, medically significant and life threatening) and VENTRICULAR FIBRILLATION (Ventricular fibrillation (approximately 30 days after the second dose of vaccine)) (seriousness criteria death, medically significant and life threatening). On an unknown date, the patient experienced PULMONARY OEDEMA (Oedema pulmonary) (seriousness criteria death, medically significant and life threatening), CARDIAC HYPERTROPHY (Myocardial hypertrophy - cor bovinum) (seriousness criteria death and life threatening), CHOLELITHIASIS (Cholecystolithiasis) (seriousness criteria death and life threatening), OBESITY (Obesity) (seriousness criteria death and life threatening), RENAL CYST (Renal cyst) (seriousness criteria death and life threatening) and CARDIOMEGALY (Cardiac dilatation) (seriousness criteria death and life threatening). The patient died on 31-Jul-2021. The reported cause of death was acute transmural myocardial infarction of other sites. An autopsy was performed. The autopsy-determined cause of death was Oedema pulmonary, Cholecystolithiasis, myocardial hypertrophy - cor bovinum, Renal cyst, Cardiac dilatation and Obesity. For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered ACUTE MYOCARDIAL INFARCTION (Acute transmural myocardial infarction (approximately 30 days after the second dose of vaccine)), CARDIAC ARREST (Sudden cardiac arrest (approximately 30 days after the second dose of vaccine)), MYOCARDIAL INFARCTION (Thrombotic myocardial infarction of the anterior interventricular branch of the coronary artery (approximately 30 days after the second dose of vaccine)), VENTRICULAR FIBRILLATION (Ventricular fibrillation (approximately 30 days after the second dose of vaccine)), PULMONARY OEDEMA (Oedema pulmonary), CARDIAC HYPERTROPHY (Myocardial hypertrophy - cor bovinum), CHOLELITHIASIS (Cholecystolithiasis), OBESITY (Obesity), RENAL CYST (Renal cyst) and CARDIOMEGALY (Cardiac dilatation) to be unlikely related. Concomitant products were not provided. Treatment medication were not reported. Company Comment: The reported events appear temporally dissociated. Medical history was not reported, however mentioned in the Autopsy results (Myocardial hypertrophy, Cardiac dilatation, Obesity), and may play a contributory role in the development of the reported events. Based on reporter''s causality and temporal dissociation the events were assessed as unlikely related to mRNA-1273.; Sender''s Comments: The reported events appear temporally dissociated. Medical history was not reported, however mentioned in the Autopsy results (Myocardial hypertrophy, Cardiac dilatation, Obesity), and may play a contributory role in the development of the reported events. Based on reporter''s causality and temporal dissociation the events were assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: Acute transmural myocardial infarction of other sites; Autopsy-determined Cause(s) of Death: Oedema pulmonary; Cholecystolithiasis; Myocardial hypertrophy - cor bovinum; Renal cyst; Cardiac dilatation; Obesity


VAERS ID: 1642855 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-12
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: Loss of consciousness; could not breath; This regulatory authority case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness) and DYSPNOEA (could not breath) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 08-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jul-2021, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criteria death, hospitalization and medically significant) and DYSPNOEA (could not breath) (seriousness criteria death and hospitalization). The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment details were reported. Company Comment: Very limited information regarding these events have been provided at this time. No further information is expected.; Sender''s Comments: Very limited information regarding these events have been provided at this time. No further information is expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1642863 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Private       Purchased by: ?
Symptoms: Adverse event, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arrhythmia; Diabetes; Kidney disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: Death; Others; This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (Death) and ADVERSE EVENT (Others) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Kidney disorder, Diabetes and Arrhythmia. On 16-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced DEATH (Death) (seriousness criteria death and medically significant) and ADVERSE EVENT (Others) (seriousness criterion death). The patient died on 17-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Batch number of the suspect product is unknown. The concomitant medications on use were not provided. No treatment information was provided. The patient did not showed symptoms after receiving the vaccine. Death occurred on 17 July 2021. Company comment: This is the case of a sudden death in this 68-year-old female patient. Reportedly, the patient died the day after vaccine administration, however, the cause of death and the autopsy results were not provided at this moment. The causality is strongly confounded with the underlying comorbidities of Kidney disorder, Diabetes and Arrhythmia. However, based on the current available information and temporal association between the use of the product and the occurrence of the event, a causal relationship cannot be excluded. Furthermore, very limited information regarding the "others" event reported (Adverse event NOS) and a causal relationship cannot be excluded, as well.; Sender''s Comments: This is the case of a sudden death in this 68-year-old female patient. Reportedly, the patient died the day after vaccine administration, however, the cause of death and the autopsy results were not provided at this moment. The causality is strongly confounded with the underlying comorbidities of Kidney disorder, Diabetes and Arrhythmia. However, based on the current available information and temporal association between the use of the product and the occurrence of the event, a causal relationship cannot be excluded. Furthermore, very limited information regarding the "others" event reported (Adverse event NOS) and a causal relationship cannot be excluded, as well.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1642881 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-16
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Adverse event, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Blood pressure high (high blood pressure); Cholangiocarcinoma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: adverse event NOS; Death; This regulatory authority case was reported by an other and describes the occurrence of DEATH (Death) and ADVERSE EVENT (adverse event NOS) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure high (high blood pressure) and Cholangiocarcinoma. On 02-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (adverse event NOS) (seriousness criterion death). The patient died on 16-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. The reporter stated that the patient behaved normally from 3July2021 to 15July2021. The batch number of the suspect product is unknown. No concomitant medications were provided by the reporter. No treatment information was provided was provided by the reporter. This is the case of death in this 81-year-old female patient. Reportedly, the patient died 14 days after vaccine administration, however, the cause of death and the autopsy results were not provided at this moment. The causality is strongly confounded with the underlying comorbidities of high blood pressure and cholangiocarcinoma, as well as with the patient''s elderly age. However, based on the current available information and temporal association between the use of the product and the occurrence of the event, a causal relationship cannot be excluded. Furthermore, very limited information regarding the "others" event reported (Adverse event NOS) and a causal relationship cannot be excluded, as well.; Sender''s Comments: This is the case of death in this 81-year-old female patient. Reportedly, the patient died 14 days after vaccine administration, however, the cause of death and the autopsy results were not provided at this moment. The causality is strongly confounded with the underlying comorbidities of high blood pressure and cholangiocarcinoma, as well as with the patient''s elderly age. However, based on the current available information and temporal association between the use of the product and the occurrence of the event, a causal relationship cannot be excluded. Furthermore, very limited information regarding the "others" event reported (Adverse event NOS) and a causal relationship cannot be excluded, as well.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1642883 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-18
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Fatigue
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Bedridden (for more than a year and was cared for at home by family and long term care resources.)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: Fatigue; DEATH; This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (DEATH) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Bedridden (for more than a year and was cared for at home by family and long term care resources.). On 12-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue). The patient died on 18-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, FATIGUE (Fatigue) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant products were not provided. Treatment medication were not reported. The patient received the Moderna vaccine at home from the home care service on July 12 and did not show any specific abnormalities. The patient felt more fatigued but could eat without assistance and did not display any specific symptoms of discomfort. At 7:00 a.m. on 18 Jul 2021, the family went to assist the patient with brushing their teeth as normal and found that the patient was not breathing when washing their face. The family called an ambulance. The patient was not taken to the hospital because they were Out of hospital cardiac arrest .; Sender''s Comments: This case concerns a 82 year-old female patient with reported fatal outcome (Preferred term: Death) 5 days after receiving the first dose of the mRNA-1273 vaccine. Cause of death was not further specified. Very limited information has been provided at this time. Patient�s age and history of being bedridden could be confounding factors for the case.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1657700 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-04
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiovascular disorder, Death
SMQs:, Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes; Hypercholesterolaemia; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: Death; Cardiovascular disease; This regulatory authority case was reported by a pharmacist and describes the occurrence of DEATH (Death) and CARDIOVASCULAR DISORDER (Cardiovascular disease) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Hypertension, Diabetes and Hypercholesterolaemia. On 04-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEATH (Death) (seriousness criteria death and medically significant) and CARDIOVASCULAR DISORDER (Cardiovascular disease) (seriousness criterion death). The reported cause of death was cardiovascular disease. An autopsy was performed. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication was not provided Treatment medication was not provided Company Comment: This case refers to a 66-year-old female with a medical history of hypertension, diabetes and hypercholesterolaemia who died approximately 3 weeks after receiving the dose 1 of the product mRNA-1273. The cause of death reported as cardiovascular disease according to the autopsy. Although there is a temporal relationship between the vaccine administration and the events, a role of underlying conditions cannot be completely excluded. Very limited information regarding the baseline status of underlying conditions and relevant diagnostic results and the events has been provided at this time.; Sender''s Comments: This case refers to a 66-year-old female with a medical history of hypertension, diabetes and hypercholesterolaemia who died approximately 3 weeks after receiving the dose 1 of the product mRNA-1273. The cause of death reported as cardiovascular disease according to the autopsy. Although there is a temporal relationship between the vaccine administration and the events, a role of underlying conditions cannot be completely excluded. Very limited information regarding the baseline status of underlying conditions and relevant diagnostic results and the events has been provided at this time.; Reported Cause(s) of Death: cardiovascular disease


VAERS ID: 1657701 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939600-CDC / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Foetal death, Ultrasound foetal
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Maternal exposure during pregnancy
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: Fetal ultrasound; Result Unstructured Data: Normal Fetal ultrasound indicated normal fetal heartbeat.; Test Date: 20210715; Test Name: Fetal ultrasound; Result Unstructured Data: Abnormal Fetal ultrasound indicated: no fetal heartbeat.
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: Fetal demise; This regulatory authority case was reported by a physician and describes the occurrence of FOETAL DEATH (Fetal demise) in a patient of an unknown age and gender exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939600-CDC) , while the mother received the product for COVID-19 vaccination. The patient''s past medical history included Maternal exposure during pregnancy. On 14-Jul-2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 14-Jul-2021, the patient was diagnosed with FOETAL DEATH (Fetal demise) (seriousness criteria death and medically significant). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Intrauterine Fetal Death. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jul-2021, Ultrasound foetal: normal (normal) Normal Fetal ultrasound indicated normal fetal heartbeat.. On 15-Jul-2021, Ultrasound foetal: abnormal (abnormal) Abnormal Fetal ultrasound indicated: no fetal heartbeat.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported . Treatment information was not provided. Patient reported that the hospital was going to perform a fetal autopsy and labor induction will be performed on the patient the next day (07/16). The case is still pending confirmation on whether a fetal autopsy will be performed. Company Comment: This is a case of maternal exposure during breastfeeding with associated adverse event of foetal death. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: This is a case of maternal exposure during breastfeeding with associated adverse event of foetal death. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1657969 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-08-16
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004228 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pyrexia, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-18
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20212

Write-up: Sudden death; Pyrexia; This case was received via Pharmaceuticals (Reference number: 2021TJP082021AA) on 21-Aug-2021 and was forwarded to Moderna on 28-Aug-2021. This case, initially reported to the Regulatory Authority by a physician, was received via the Regulatory Authority (Ref, v21124408). On 18-Jul-2021, the patient received the 1st dose of the vaccine. On 15-Aug-2021, the patient received the 2nd dose of the vaccine. On 16-Aug-2021, the patient experienced pyrexia of 38.5 degrees Celsius. On 17-Aug-2021, pyrexia subsided. On 18-Aug-2021, the patient was found dead at home. It was a sudden death. The outcome of pyrexia was reported as recovered. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The patient was a 38-year-old male with no apparent past medical history and died suddenly 3 days after receiving the vaccine, and the possibility of an adverse reaction cannot be ruled out. The patient experienced pyrexia on the day following vaccination. Whether the pyrexia was associated with an adverse reaction or other diseases is unknown at present. An autopsy was performed, and the cause of death is currently being investigated.; Sender''s Comments: Very limited information regarding these events have been provided at this time. No further follow up information is expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1657978 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Cerebral haemorrhage, Death, Dizziness, Fall
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-14
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: Cerebral hemorrhage; accidently fell; Death; dizzy; weakness; This regulatory authority case was reported by an other health care professional and describes the occurrence of CEREBRAL HAEMORRHAGE (Cerebral hemorrhage), DEATH (Death), DIZZINESS (dizzy), ASTHENIA (weakness) and FALL (accidently fell) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jul-2021, the patient experienced DIZZINESS (dizzy) (seriousness criterion death) and ASTHENIA (weakness) (seriousness criterion death). On 07-Jul-2021, the patient experienced CEREBRAL HAEMORRHAGE (Cerebral hemorrhage) (seriousness criteria death, hospitalization and medically significant). On an unknown date, the patient experienced FALL (accidently fell) (seriousness criterion death). The patient died on 14-Jul-2021. The reported cause of death was Cerebral haemorrhage, Dizzy and Weakness. An autopsy was not performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Very limited information regarding these events has been provided at this time. No further follow-up information is expected.; Sender''s Comments: Very limited information regarding these events has been provided at this time. No further follow-up information is expected.; Reported Cause(s) of Death: Cerebral haemorrhage; dizzy; Weakness


VAERS ID: 1657980 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Altered state of consciousness, Haematemesis, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal haemorrhage (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-25
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Altered state of consciousness; Vomited blood; Weakness of limbs; This regulatory authority case was reported by an other health care professional and describes the occurrence of ALTERED STATE OF CONSCIOUSNESS (Altered state of consciousness) and MUSCULAR WEAKNESS (Weakness of limbs) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 13-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced MUSCULAR WEAKNESS (Weakness of limbs) (seriousness criteria death and hospitalization). On 24-Jul-2021, the patient experienced ALTERED STATE OF CONSCIOUSNESS (Altered state of consciousness) (seriousness criteria death, hospitalization and medically significant). The patient was hospitalized from 24-Jul-2021 to 25-Jul-2021 due to ALTERED STATE OF CONSCIOUSNESS, HAEMATEMESIS and MUSCULAR WEAKNESS. The patient died on 25-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Treatment information was not provided. The patient could not lift his arms for three days, starting from July 14 2021. Subsequently, everything was rather normal and the patient only experienced mild symptoms, but he was found collapsed on the ground in his home at noon on July 24. He was taken to Hospital and was only 3 � 4 on the coma scale. He underwent a full body examination and brain examination, and two out of six parts of his brain were found to be black. Patient also vomited blood when he was fed liquid food. The patient passed away in the morning on July 25 2021. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1657981 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-10
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Fall, Head injury
SMQs:, Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Eye disorder (regularly sought medical attention at Hospital); Mental disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: death; head trauma from impact; death was preliminarily suspected to be caused by a fall from the bed to the ground; This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (death), HEAD INJURY (head trauma from impact) and FALL (death was preliminarily suspected to be caused by a fall from the bed to the ground) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Mental disorder and Eye disorder (regularly sought medical attention at Hospital). On 10-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEATH (death) (seriousness criteria death and medically significant), HEAD INJURY (head trauma from impact) (seriousness criterion death) and FALL (death was preliminarily suspected to be caused by a fall from the bed to the ground) (seriousness criterion death). The reported cause of death was head trauma and Fall. An autopsy was not performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered DEATH (death), HEAD INJURY (head trauma from impact) and FALL (death was preliminarily suspected to be caused by a fall from the bed to the ground) to be possibly related. Very limited information regarding these events has been provided at this time. No further follow-up information is expected.; Sender''s Comments: Very limited information regarding these events has been provided at this time. No further follow-up information is expected.; Reported Cause(s) of Death: unknown cause of death; head trauma; fall


VAERS ID: 1658076 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-22
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Death; This regulatory authority case was reported by a pharmacist and describes the occurrence of DEATH (Death) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 01-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 22-Jul-2021 The patient was treated with ADRENALIN [EPINEPHRINE] on 22-Jul-2021 for Adverse event, at a dose of 1mg/1mL/Amp 0.1%(Epinephrine), total of 10 Amp. The patient died on 22-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. It was reported that Start of CPR 22 Jul 2021 at 09:47 a.m. Adrenalin 1mg/1mL/Amp 0.1%(Epinephrine), total of 10 Amp. End of CPR 22 Jul 2021 at 10:20 a.m. the patient''s vital signs did not recover after CPR. Treatment information was not provided by the reporter. Company comment: This case of death of a 79-year-old female patient 21 days after administration of mRNA-1273. Although a temporal association exist between the vaccine administration and the reported events, critical details such as the patient''s detailed medical history, autopsy findings and cause of death are lacking. No further information is expected.; Sender''s Comments: This case of death of a 79-year-old female patient 21 days after administration of mRNA-1273. Although a temporal association exist between the vaccine administration and the reported events, critical details such as the patient''s detailed medical history, autopsy findings and cause of death are lacking. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1658077 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-18
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939600-CDC / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Brain stem haemorrhage, Cerebral haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: brain stem hemorrhage; Intracerebral and brain stem hemorrhage; This regulatory authority case was reported by an other health care professional and describes the occurrence of BRAIN STEM HAEMORRHAGE (brain stem hemorrhage) and CEREBRAL HAEMORRHAGE (Intracerebral and brain stem hemorrhage) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939600-CDC) for COVID-19 vaccination. No Medical History information was reported. On 12-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jul-2021, the patient experienced BRAIN STEM HAEMORRHAGE (brain stem hemorrhage) (seriousness criteria death and medically significant) and CEREBRAL HAEMORRHAGE (Intracerebral and brain stem hemorrhage) (seriousness criteria death and medically significant). The patient died on 18-Jul-2021. The reported cause of death was intracerebral and brain stem hemorrhage and intracerebral and brain stem hemorrhage. An autopsy was performed, but no results were provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered BRAIN STEM HAEMORRHAGE (brain stem hemorrhage) and CEREBRAL HAEMORRHAGE (Intracerebral and brain stem hemorrhage) to be possibly related. Concomitant product was not provided. Treatment medication was not reported. The patient received the vaccine on 12-Jul-2021, and he had no breathing or pulse when his family discovered him on 18-Jul-2021. The patient''s family suspected his death to be related to the vaccine and judicial autopsy was performed on 22-Jul-2021 to clarify the cause of death. The medical examiner preliminary determined the cause of death as intracerebral and brain stem hemorrhage. Sender''s unique identifier number: TW-TFDA-TVS-1100003778.; Sender''s Comments: Medical history was not reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Intracerebral and brain stem hemorrhage; Intracerebral and brain stem hemorrhage


VAERS ID: 1660665 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-09
Onset:2021-08-11
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Death, Diarrhoea, Rhinorrhoea, Vomiting, X-ray
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-18
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: X-ray; Result Unstructured Data: no unusual findings on the X-ray test.
CDC Split Type: KRMODERNATX, INC.MOD20213

Write-up: COVID-19; Death NOS; Diarrhea; Vomiting; Rhinorrhea; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death NOS) and COVID-19 (COVID-19) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Aug-2021, the patient experienced COVID-19 (COVID-19) (seriousness criterion hospitalization). On 13-Aug-2021, the patient experienced RHINORRHOEA (Rhinorrhea). On 16-Aug-2021, the patient experienced DIARRHOEA (Diarrhea) and VOMITING (Vomiting). On 18-Aug-2021, COVID-19 (COVID-19) and VOMITING (Vomiting) outcome was unknown. The patient died on 18-Aug-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, RHINORRHOEA (Rhinorrhea) and DIARRHOEA (Diarrhea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, X-ray: normal (normal) no unusual findings on the X-ray test.. Concomitant product was not provided by the reporter. This case was received on 20-AUG-2021 And was forwarded to Moderna on 20-AUG-2021. Treatment product was not provided by the reporter. Patient was diagnosed with asymptomatic COVID-19 on 11AUG2021, 2 days after taking the 1st dose of Moderna vaccine. Since the case was asymptomatic, on 12AUG2021 he was admitted to the residential treatment center. In 13AUG2021 it was reported that the patient experience rhinorrhea, vomiting and diarrhea. On 18AUG2021 patient was found dead. Autopsy has been requested. Company Comment: This case concerns a 60ish year-old male patient with no relevant medical history that was found dead 9 days after taking the 1st dose of the vaccine. He was, also, diagnosed with asymptomatic COVID-19 2 days after receiving the vaccine, and was admitted to a residential treatment center for follow up. During this period it was reported the patient experience rhinorrhea, vomiting and diarrhea. An autopsy was requested since the cause of death is unknown. The mRNA-1273 does not contain a virus capable of causing infection so the occurrence of COVID-19 infection after vaccination is assessed as not related to the vaccine. Regarding the event death, very limited information has been provided, since there''s a temporal association a causal relationship cannot be excluded, but the event CVOID-19 is also a confounder.; Sender''s Comments: This case concerns a 60ish year-old male patient with no relevant medical history that was found dead 9 days after taking the 1st dose of the vaccine. He was, also, diagnosed with asymptomatic COVID-19 2 days after receiving the vaccine, and was admitted to a residential treatment center for follow up. During this period it was reported the patient experience rhinorrhea, vomiting and diarrhea. An autopsy was requested since the cause of death is unknown. The mRNA-1273 does not contain a virus capable of causing infection so the occurrence of COVID-19 infection after vaccination is assessed as not related to the vaccine. Regarding the event death, very limited information has been provided, since there''s a temporal association a causal relationship cannot be excluded, but the event CVOID-19 is also a confounder.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1663846 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-27
Onset:2021-06-09
   Days after vaccination:43
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Angiocardiogram, Arrhythmia, Cardiac arrest, Echocardiogram, Myocardial infarction, Myocarditis
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiogenic shock (Cardiogenic shock with acute left ventricular myocardial infarction)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Coronary angiogram; Result Unstructured Data: No stenosing CHD, but reversible coronary spasm, high-grade restriction of LV function, no indication of pulmonary embolism; Test Name: Heart echo; Result Unstructured Data: Poor EF, cardiac arrest (first VT), then treated therapy-refractory PEA
CDC Split Type: DEMODERNATX, INC.MOD20212

Write-up: Myocarditis; Cardiac arrhythmia; Heart arrest; Infarct myocardial; This case was initially received via Regulatory Authority (Reference number: DE-PEI-202100134159) on 04-Aug-2021. The most recent information was received on 06-Aug-2021 and was forwarded to Moderna on 25-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS (Myocarditis), ARRHYTHMIA (Cardiac arrhythmia), CARDIAC ARREST (Heart arrest) and MYOCARDIAL INFARCTION (Infarct myocardial) in a 65-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3002620) for Prophylactic vaccination. Concurrent medical conditions included Cardiogenic shock (Cardiogenic shock with acute left ventricular myocardial infarction). On 27-Apr-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 09-Jun-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria death and medically significant), ARRHYTHMIA (Cardiac arrhythmia) (seriousness criteria death and medically significant) and CARDIAC ARREST (Heart arrest) (seriousness criteria death and medically significant). 09-Jun-2021, the patient experienced MYOCARDIAL INFARCTION (Infarct myocardial) (seriousness criteria death and medically significant). The patient died on 09-Jun-2021. The reported cause of death was Myocarditis. An autopsy was performed. The autopsy-determined cause of death was Cardiogenic shock. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Angiocardiogram: abnormal (abnormal) No stenosing CHD, but reversible coronary spasm, high-grade restriction of LV function, no indication of pulmonary embolism. On an unknown date, Echocardiogram: abnormal (abnormal) Poor EF, cardiac arrest (first VT), then treated therapy-refractory PEA. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Treatment information was treated therapy refractory PEA. Company comment: This case refers to a 65-year-old male patient with reported ongoing history of myocardial infarction and cardiogenic shock who experienced the serious unexpected events of Myocardial infarction, Myocarditis, Arrhythmia and Cardiac arrest on the same day after receiving the dose 2 of the product mRNA-1273. Very limited information regarding the status of patient''s pre-existing conditions at baseline and the events been provided at this time insufficient for causality assessment. Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Translation document received on 25 Aug 2021 include reporter''s comment updated. On 25-Aug-2021: Non-significant follow-up added on 25 Aug 2021 include no new information.; Sender''s Comments: This case refers to a 65-year-old male patient with reported ongoing history of myocardial infarction and cardiogenic shock who experienced the serious unexpected events of Myocardial infarction, Myocarditis, Arrhythmia and Cardiac arrest on the same day after receiving the dose 2 of the product mRNA-1273. Very limited information regarding the status of patient''s pre-existing conditions at baseline and the events been provided at this time insufficient for causality assessment.; Reported Cause(s) of Death: Myocarditis; Autopsy-determined Cause(s) of Death: Cardiogenic shock


VAERS ID: 1665136 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Altered state of consciousness, Arthralgia, Death, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-18
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Acute kidney injury; Allergy NOS (Non-foods (no known allergies)); Allergy NOS (Medication(no known allergies)); Chronic kidney disease stage 3; Coronary heart disease; Diabetes mellitus; Food allergy (Foods (no known allergies)); Gout; Herpes simplex (Herpes simplex over left buttock); Hypertension; Urinary tract infection
Preexisting Conditions: Medical History/Concurrent Conditions: Automated external defibrillator user (They applied AED and electric shock was administered twice); Cardiopulmonary resuscitation (CPCR)
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: Changes in consciousness; Death NOS; Unresponsive; Pain in the left knee; This regulatory authority case was reported by a pharmacist and describes the occurrence of ALTERED STATE OF CONSCIOUSNESS (Changes in consciousness), DEATH (Death NOS) and UNRESPONSIVE TO STIMULI (Unresponsive) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Cardiopulmonary resuscitation (CPCR) and Automated external defibrillator user (They applied AED and electric shock was administered twice). Concurrent medical conditions included Hypertension, Diabetes mellitus, Gout, Urinary tract infection, Herpes simplex (Herpes simplex over left buttock), Acute kidney injury, Chronic kidney disease stage 3, Coronary heart disease, Food allergy (Foods (no known allergies)), Allergy NOS (Non-foods (no known allergies)) and Allergy NOS (Medication(no known allergies)). On 06-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. In July 2021, the patient experienced ARTHRALGIA (Pain in the left knee). On 18-Jul-2021, the patient experienced ALTERED STATE OF CONSCIOUSNESS (Changes in consciousness) (seriousness criteria death, medically significant and life threatening), DEATH (Death NOS) (seriousness criteria death and medically significant) and UNRESPONSIVE TO STIMULI (Unresponsive) (seriousness criterion medically significant). The patient died on 18-Jul-2021. The reported cause of death was Coronary heart disease, high blood pressure and Diabetes. An autopsy was not performed. At the time of death, UNRESPONSIVE TO STIMULI (Unresponsive) and ARTHRALGIA (Pain in the left knee) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The family of patient were reported that patient developed pain in left knee for 1 to 2 days. Patient left his bed on July 18 in morning between 5 to 6 am and was brush his teeth after spending period of time in the bathroom patient wife went to check on him she found the patient on the floor was unresponsive she called ambulance taken to emergency room for treatment. The patient was still not breathing did not have heartbeat he was declared dead. On July 19 patient wife was contacted through phone she expressed her wish to not have an autopsy performed. Concomitant product use was not provided. Treatment information was not provided. Company comment: Very limited information regarding this events has been provided at this time. However, patient''s multiple underlying medical conditions remains a contributory factor. Further information can''t be requested.; Sender''s Comments: Very limited information regarding this events has been provided at this time. However, patient''s multiple underlying medical conditions remains a contributory factor. Further information can''t be requested.; Reported Cause(s) of Death: Coronary heart disease; High blood pressure; Diabetes


VAERS ID: 1665153 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal distension, Asthenia, Decreased appetite, Dyspnoea, Gait inability, Loss of consciousness, Nausea, Somnolence, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-14
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Mastectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: unconscious; Drowsiness; Loss of appetite; shortness of breath; general weakness; unable to walk; Vomiting; nausea; bloating; This regulatory authority case was reported by a consumer and describes the occurrence of SOMNOLENCE (Drowsiness), DECREASED APPETITE (Loss of appetite), DYSPNOEA (shortness of breath), ASTHENIA (general weakness), GAIT INABILITY (unable to walk), VOMITING (Vomiting), NAUSEA (nausea), LOSS OF CONSCIOUSNESS (unconscious) and ABDOMINAL DISTENSION (bloating) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Mastectomy. Concurrent medical conditions included Hypertension. On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, the patient experienced ABDOMINAL DISTENSION (bloating) (seriousness criterion death). On 14-Jul-2021, the patient experienced DYSPNOEA (shortness of breath) (seriousness criterion death), ASTHENIA (general weakness) (seriousness criterion death), GAIT INABILITY (unable to walk) (seriousness criterion death), VOMITING (Vomiting) (seriousness criterion death) and NAUSEA (nausea) (seriousness criterion death). On 15-Jul-2021, the patient experienced SOMNOLENCE (Drowsiness) (seriousness criterion death) and DECREASED APPETITE (Loss of appetite) (seriousness criterion death). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (unconscious) (seriousness criteria death and medically significant). The patient died on 14-Jul-2021. The reported cause of death was Breathlessness. It is unknown if an autopsy was performed. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was not provided Treatment medication was not provided. It was reported that patients family member called emergency number and was instructed by personnel to perform CPR [on the patient]. The patient was sent to the Emergency Department of Hospital but she still passed away. The physician wrote on the diagnosis that: there was no breathing when she arrived at the hospital. Company Comment: Very limited information regarding these events has been provided at this time. The fatal outcome may be related to the patient''s pre-existing comorbidities. Further information required; Sender''s Comments: Very limited information regarding these events has been provided at this time. The fatal outcome may be related to the patient''s pre-existing comorbidities. Further information required; Reported Cause(s) of Death: breathlessness


VAERS ID: 1665164 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-15
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939676-CDC / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: death; This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (death) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939676-CDC) for COVID-19 vaccination. No Medical History information was reported. On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. Death occurred on 15-Jul-2021 The patient died on 15-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications was not reported. It was reported that the family member said that he/she brought the patient to Health Center for the COVID-19 vaccination on July 13. The patient died two days after the vaccination. He was 90 years old, and his medical history was unknown. Company Comment : This is a case of sudden death in a 90-year-old male who died 2 days after receiving first dose of the vaccine. Very limited information has been provided at this time; Sender''s Comments: This is a case of sudden death in a 90-year-old male who died 2 days after receiving first dose of the vaccine. Very limited information has been provided at this time; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1665165 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939676-CDC / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Decreased appetite
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-16
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergic skin reaction; Atrial fibrillation; Hyperlipidemia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: Loss of appetite; This regulatory authority case was reported by a physician and describes the occurrence of DECREASED APPETITE (Loss of appetite) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939676-CDC) for COVID-19 vaccination. Concurrent medical conditions included Atrial fibrillation, Hyperlipidemia and Allergic skin reaction. On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, the patient experienced DECREASED APPETITE (Loss of appetite) (seriousness criterion death). The patient died on 16-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications was not reported. Patient Medical history included long-term skin allergy symptoms According to the patient''s husband, the patient received her vaccination around 9:00 a.m., and did not develop any special symptoms except for loss of appetite till 8:00 p.m. Around 12:00 a.m., the patient was found to be dead on the ground This case concerns a 67-year-old, female subject with a history of atrial fibrillation, hyperlipidemia, who experienced the unexpected event of loss of appetite with fatal outcome. The event occurred within 24 hours after the first dose of COVID-19 vaccine. The reporter''s assessment was not provided for the event. Very limited information regarding this event has been provided at this time precluding establishing causal association between the reported event and vaccination. The medical history, atrial fibrillation, hyperlipidemia, remains a confounder. The benefit-risk relationship of COVID-19 vaccine in not affected by this report. Event onset dates and vaccination date captured per SD from Regulatory Authority reporting and differ from what is described on the narrative.; Sender''s Comments: This case concerns a 67-year-old, female subject with a history of atrial fibrillation, hyperlipidemia, who experienced the unexpected event of loss of appetite with fatal outcome. The event occurred within 24 hours after the first dose of COVID-19 vaccine. The reporter''s assessment was not provided for the event. Very limited information regarding this event has been provided at this time precluding establishing causal association between the reported event and vaccination. The medical history, atrial fibrillation, hyperlipidemia, remains a confounder. The benefit-risk relationship of COVID-19 vaccine in not affected by this report. Event onset dates and vaccination date captured per SD from Regulatory Authority reporting and differ from what is described on the narrative.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1665169 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiogenic shock, Dyspnoea, Palpitations, Respiratory failure, SARS-CoV-2 test
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-14
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Atrial fibrillation; Heart failure
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210713; Test Name: COVID-19 PCR test; Test Result: Negative ; Result Unstructured Data: negative
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: cardiogenic shock; respiratory failure; palpitations; difficulty breathing; This regulatory authority case was reported by a pharmacist and describes the occurrence of CARDIOGENIC SHOCK (cardiogenic shock), RESPIRATORY FAILURE (respiratory failure), PALPITATIONS (palpitations) and DYSPNOEA (difficulty breathing) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Heart failure and Atrial fibrillation. On 12-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jul-2021, the patient experienced PALPITATIONS (palpitations) (seriousness criterion death) and DYSPNOEA (difficulty breathing) (seriousness criterion death). On 13-Jul-2021, the patient experienced CARDIOGENIC SHOCK (cardiogenic shock) (seriousness criteria death and medically significant) and RESPIRATORY FAILURE (respiratory failure) (seriousness criteria death and medically significant). The patient died on 14-Jul-2021. The reported cause of death was Cardiogenic shock and Respiratory failure. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jul-2021, SARS-CoV-2 test: negative (Negative) negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. On 12-Jul-2021, after receiving vaccine, the patient developed palpitations and difficulty breathing on the same days at 2:17 PM. On 13-Jul-2021patient was admitted to hospital. The COVID-19 test was negative. The patient was diagnosed with cardiogenic shock and respiratory failure. On 14-Jul-2021, the patient family member decided to discharge the patient against medical advice and returned home. On 14-Jul-2021, the patient died at home. Treatment medication was not provided by the reporter. This is a case of death in a 67-year-old male subject, with a history of Heart failure and Atrial fibrillation who died 2 days after receiving first dose of vaccine due to Cardiogenic shock and Respiratory failure. Very limited information has been provided at this time.; Sender''s Comments: This is a case of death in a 67-year-old male subject, with a history of Heart failure and Atrial fibrillation who died 2 days after receiving first dose of vaccine due to Cardiogenic shock and Respiratory failure. Very limited information has been provided at this time.; Reported Cause(s) of Death: cardiogenic shock; Respiratory failure


VAERS ID: 1665179 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-13
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Hypoxia
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Hypoxemia; Out of breath; This regulatory authority case was reported by an other health care professional and describes the occurrence of HYPOXIA (Hypoxemia) and DYSPNOEA (Out of breath) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 04-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2021, the patient experienced HYPOXIA (Hypoxemia) (seriousness criteria death, hospitalization and medically significant) and DYSPNOEA (Out of breath) (seriousness criteria death and hospitalization). The patient was hospitalized on 13-Jul-2021 due to DYSPNOEA and HYPOXIA. The reported cause of death was Hypoxemia and out of breath. An autopsy was not performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported. Treatment medications were not reported. Company comment: This is a case of sudden death in a 76-year-old male with unknown past medical history, who died due to Dyspnea and Hypoxemia 10 days after receiving a dose of the vaccine. Very limited information has been provided at this time.; Sender''s Comments: This is a case of sudden death in a 76-year-old male with unknown past medical history, who died due to Dyspnea and Hypoxemia 10 days after receiving a dose of the vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Hypoxemia; Out of breath


VAERS ID: 1667223 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-24
Onset:2021-01-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Dizziness, Loss of consciousness, Somnolence
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MORPHINE
Current Illness:
Preexisting Conditions: Comments: No Medical History information was reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20210

Write-up: Death; This case was initially received via Regulatory Authority (Reference number: 202100027838) on 09-Apr-2021. The most recent information was received on 25-Aug-2021 and was forwarded to Moderna on 25-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death), LOSS OF CONSCIOUSNESS, SOMNOLENCE and DIZZINESS in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. Concomitant products included MORPHINE for an unknown indication. On 24-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DEATH (Death) (seriousness criterion death), LOSS OF CONSCIOUSNESS (seriousness criteria death and medically significant), SOMNOLENCE (seriousness criteria death and medically significant) and DIZZINESS (seriousness criteria death and medically significant). The patient died on 24-Jan-2021. The cause of death was not reported. An autopsy was not performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the events was not applicable. Within two hours of the vaccination, the patient was no longer normal and was delirious. He kept losing consciousness and gradually became colder and colder until he no longer woke up. No treatment information was provided. Company Comment: This is a case of sudden death in a 81-year-old male subject with no known hx of any medical illness who died after receiving first dose of vaccine. Very limited information has been provided at this time. Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Translation received on 16-Apr-2021 contains no new information.. On 25-Aug-2021: Follow up received contains seriousness for all events as medically significant in narrative (previously missed to generate narrative); Sender''s Comments: This is a case of sudden death in a 81-year-old male subject with no known hx of any medical illness who died after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1667956 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-06-15
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension
Preexisting Conditions: Comments: No medical history was reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Unknown cause of death; This case was received via Regulatory Authority (Reference number: FR-AFSSAPS-MP20216135) on 25-Aug-2021 and was forwarded to Moderna on 25-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Unknown cause of death) in a 70-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No medical history was reported. Concurrent medical conditions included Hypertension. On 11-Jun-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Death occurred on 15-Jun-2021 The patient died on 15-Jun-2021. The reported cause of death was avc. An autopsy was not performed. No concomitant medication was mentioned. No treatment medication was mentioned. Company Comment Very limited information regarding this event has been provided at this time. Further information is not expected.; Sender''s Comments: Very limited information regarding this event has been provided at this time. Further information is not expected.; Reported Cause(s) of Death: AVC


VAERS ID: 1668040 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-13
Onset:2021-08-16
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004233 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Congestive (dilated) cardiomyopathy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: MORT INEXPLIQUEE; This case was received via Regulatory Authority (Reference number: FR-AFSSAPS-RN20212564) on 25-Aug-2021 and was forwarded to Moderna on 25-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of DEATH (MORT INEXPLIQUEE) in a 31-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004233) for COVID-19 vaccination. Concurrent medical conditions included Congestive (dilated) cardiomyopathy. On 13-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. Death occurred on 16-Aug-2021 The patient died on 16-Aug-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant drug was not reported. Treatment medication was not reported. Company Comment: Although a temporal association exist between the fatal outcome and the administration of mRNA-1273 vaccine, critical details such as the actual cause of death was not provided. No further information is expected.; Sender''s Comments: Although a temporal association exist between the fatal outcome and the administration of mRNA-1273 vaccine, critical details such as the actual cause of death was not provided. No further information is expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1668728 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-11
Onset:2021-08-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004669 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Hyperpyrexia, Malaise
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-14
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: Death; This case was received via Regulatory Authority (Reference number: IT-MINISAL02-771719) on 25-Aug-2021 and was forwarded to Moderna on 25-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death), HYPERPYREXIA and MALAISE in a 31-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004669) for COVID-19 immunisation. No Medical History information was reported. On 11-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form in total. On 12-Aug-2021, the patient experienced HYPERPYREXIA (seriousness criterion medically significant) and MALAISE (seriousness criterion medically significant). On 14-Aug-2021, HYPERPYREXIA and MALAISE outcome was unknown. The patient died on 14-Aug-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication provided. No treatment information mentioned. Company Comment This case concerns a 31-year old male who had adverse events of hyperpyrexia and malaise and died 3 days after receiving first dose of mRNA-1273 (Spikevax). It is unknown if an autopsy was performed. Very limited information regarding this events has been provided at this time.; Reporter''s Comments: Sender''s Comments: This case concerns a 31-year old male who had adverse events of hyperpyrexia and malaise and died 3 days after receiving first dose of mRNA-1273 (Spikevax). It is unknown if an autopsy was performed. Very limited information regarding this events has been provided at this time.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1668976 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-31
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002617 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac failure acute
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Alcohol dependence syndrome (Suspicion of alcoholism); Spinal stenosis (Suspicion of spinal stenosis)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP079031

Write-up: Acute cardiac failure; This regulatory authority case was reported by a physician and describes the occurrence of CARDIAC FAILURE ACUTE (Acute cardiac failure) in a 57-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 3002617 and 3004229) for COVID-19 vaccination. Concurrent medical conditions included Spinal stenosis (Suspicion of spinal stenosis) and Alcohol dependence syndrome (Suspicion of alcoholism). On 01-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 29-Jul-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 31-Jul-2021, the patient experienced CARDIAC FAILURE ACUTE (Acute cardiac failure) (seriousness criteria death and medically significant). The patient died on 31-Jul-2021. The reported cause of death was Cardiac failure acute. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered CARDIAC FAILURE ACUTE (Acute cardiac failure) to be possibly related. Reporter''s comments: There is a possibility that the patient had primary hyperaldosteronism and abnormal liver function. Other than the above diseases, spinal canal stenosis and alcoholism are suspected as other factors. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: Very limited information regarding this event has been provided at this time. No further follow-up information is expected. However, the patients medical history of Alcohol dependence is a confounder.; Reported Cause(s) of Death: Cardiac failure acute


VAERS ID: 1668981 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-07-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002540 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Atrial fibrillation; Hyperlipidaemia; Hypertension (Hypertension); Hyperuricaemia; Tachycardia paroxysmal (Paroxysmal tachycardia)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Sudden death; This case was received via Regulatory Authority (Reference number: JP-TAKEDA-2021TJP082042) on 24-Aug-2021 and was forwarded to Moderna on 30-Aug-2021. This case, initially reported to the Regulatory Authority (RA) by a physician, was received via the PMDA (Ref, v21124455). Oral medicine (irbesartan/amlodipine besilate, allopurinol, rivaroxaban, flecainide acetate, triazolam) On an unspecified date, body temperature before vaccination: 36.2 degrees Celsius. On 29-JUN-2021, at 18:50, the patient received 1st dose of Moderna vaccine. The patient did not complain of any symptom at outpatient visit as well as at home. The patient had lived a normal life almost until right before. On 01-JUL-2021, at around 15:00, the patient was presumed suddenly dead. Follow-up investigation will be made. The patient had visited the reporting hospital since 2015 and had been treated with oral medication for the above diseases. The patient was followed up without changing the dosing regimen, and no change was observed in the physical condition. Investigation for the causality, etc. was requested as the patient passed away suddenly after receiving the Moderna vaccine. Ischaemic heart disease is considered as another possible causal factor based on the diagnosis of postmortem certificate. Although the event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273), it is also considered that the event is due to effects from patient background, etc.; Sender''s Comments: This is a case of sudden death in a 55-year old male with a medical history of hypertension, hyperlipidaemia, hyperuricaemia, atrial fibrillation, paroxysmal tachycardia, 1 day after receiving the mRNA-1273. Possible cause was reported as ischemic heart disease per the autopsy. Case causality is confounded by the underlying comorbidities.; Reported Cause(s) of Death: Sudden death; Heart Disease


VAERS ID: 1669014 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute myeloid leukaemia, Body temperature, Hyperthermia, Pyrexia, White blood cell count
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Accidents and injuries (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: General body pain; Sore throat; Sore tongue; Tiredness
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: 39.4 degrees Celsius, High; Test Name: white blood cell count; Result Unstructured Data: 125/�L, 20 times more than the previous result; Test Date: 20210522; Test Name: white blood cell count; Result Unstructured Data: 5.9/�L, normal
CDC Split Type: KRMODERNATX, INC.MOD20212

Write-up: Acute myeloid leukemia; Hyperthermia; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ACUTE MYELOID LEUKAEMIA (Acute myeloid leukemia), HYPERTHERMIA (Hyperthermia) and PYREXIA (Fever) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included General body pain, Sore tongue, Sore throat and Tiredness. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACUTE MYELOID LEUKAEMIA (Acute myeloid leukemia) (seriousness criteria death, hospitalization and medically significant). an unknown date, the patient experienced HYPERTHERMIA (Hyperthermia) (seriousness criteria death and hospitalization) and PYREXIA (Fever) (seriousness criteria death and hospitalization). The reported cause of death was Hyperthermia, Acute myeloid leukemia and Fever. It is unknown if an autopsy was performed. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-May-2021, White blood cell count (4.0-10.8): 5.9/�l (normal) 5.9/�L, normal. On an unknown date, Body temperature: 39.4 degrees celsius (High) 39.4 degrees Celsius, High. On an unknown date, White blood cell count (4.0-10.8): 125/�l (High) 125/�L, 20 times more than the previous result. Concomitant medications were not provided by the reporter. The patient''s wife asked the doctor if the patient could receive a COVID-19 vaccine, and the doctor said without hesitation that he could get vaccine and then strongly recommended to get vaccine on that day. The patient had a fever for all three days after vaccination, and while having fever, took the antipyretics precribed by the hospital. Company Comment : Very limited information regarding these events has been provided at this time. No further follow-up information is expected; Sender''s Comments: Very limited information regarding these events has been provided at this time. No further follow-up information is expected; Reported Cause(s) of Death: Hyperthermia; Acute myeloid leukemia; Fever


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