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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: 1445257 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-04
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001946 / 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: Chronic bronchitis; Hypertension; Ischemic cardiomyopathy; Nephrosclerosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUMODERNATX, INC.MOD20212

Write-up: Death; This regulatory authority case was reported by a physician and describes the occurrence of DEATH in an 82-year-old patient of an unknown gender who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001946) for COVID-19 vaccination. Concurrent medical conditions included Ischemic cardiomyopathy, Chronic bronchitis, Hypertension and Nephrosclerosis. On 01-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 04-May-2021 The patient died on 04-May-2021. The cause of death was not reported. An autopsy was performed, but no results were provided. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered DEATH to be not related. No concomitants were provided by the reporter. No treatment information was provided by the reporter. As per autopsy, the event is related to patient''s primary diseases. As per reporter''s assessment, death is not related to the vaccine. This case concerns an 82 year old (unknown gender) with medical history of Ischemic Cardiomyopathy, chronic bronchitis, hypertension and nephrosclerosis who died 4 days after being given with the 1st dose of the vaccine. Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Sender''s Comments: This case concerns an 82 year old (unknown gender) with medical history of Ischemic Cardiomyopathy, chronic bronchitis, hypertension and nephrosclerosis who died 4 days after being given with the 1st dose of the vaccine. Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Reported Cause(s) of Death: Death


VAERS ID: 1445263 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-05-02
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-02
   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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEMODERNATX, INC.MOD20212

Write-up: sudden collapse; sudden collapse and death; This regulatory authority case was reported by a physician and describes the occurrence of FALL (sudden collapse) and SUDDEN DEATH (sudden collapse and death) in a 78-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001177) for COVID-19 vaccination. No Medical History information was reported. On 01-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 30-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .5 milliliter. On 02-May-2021, the patient experienced FALL (sudden collapse) (seriousness criterion death) and SUDDEN DEATH (sudden collapse and death) (seriousness criterion death). The patient died on 02-May-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 products were not provided/unknown. Treatment medication were not reported/unknown. This case concerns a 78-year-old female patient who experienced sudden collapse and died after receiving second dose of mRNA-1273. Very limited information regarding these events have been provided at this time. No further information is expected.; Sender''s Comments: This case concerns a 78-year-old female patient who experienced sudden collapse and died after receiving second dose of mRNA-1273. 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: 1445619 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-27
Onset:2021-05-30
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Cerebrovascular accident
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-05
   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: Arterial hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROMODERNATX, INC.MOD20212

Write-up: Stroke; This regulatory authority case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and CARDIO-RESPIRATORY ARREST in a 59-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001943) for COVID-19 vaccination. Concurrent medical conditions included Arterial hypertension. On 27-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 30-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion death). On 05-Jun-2021, the patient experienced CARDIO-RESPIRATORY ARREST (Irresuscitable cardio-respiratory arrest) (seriousness criterion death). The patient died on 05-Jun-2021. The reported cause of death was irresuscitable cardio-respiratory arrest and Stroke. An autopsy was not performed. No concomitant products were reported. No treatment information provided. Action taken with mRNA-1273 in response to the drug was not applicable. Company comment: Very limited information regarding these events has been provided at this time. An autopsy was not performed. No further information is expected. Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Additional information received on 29-June-2021 included gender of patient is changed, medical history, death date and new event Irresuscitable cardio-respiratory arrest was added.; Reporter''s Comments: The medical assessor of the Competent Authority requested the investigation of the case at Regulatory Authority, to no result yet.; Sender''s Comments: Very limited information regarding these events has been provided at this time. An autopsy was not performed. No further information is expected.; Reported Cause(s) of Death: Irresuscitable cardio-respiratory arrest; stroke


VAERS ID: 1447573 (history)  
Form: Version 2.0  
Age: 97.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-06-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002919 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Pneumonia aspiration, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-16
   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: Hypertension arterial
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Hip fracture; Ischemic stroke; Pneumonia aspiration
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Pneumonia aspiration; Diarrhoea; Fever; Emesis; This regulatory authority case was reported by a physician and describes the occurrence of PNEUMONIA ASPIRATION (Pneumonia aspiration), DIARRHOEA (Diarrhoea), PYREXIA (Fever) and VOMITING (Emesis) in a 97-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002919) for COVID-19 vaccination. The patient''s past medical history included Ischemic stroke in 2014, Hip fracture in April 2021, COVID-19 and Pneumonia aspiration in May 2021. Concurrent medical conditions included Hypertension arterial. On 14-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 15-Jun-2021, the patient experienced PNEUMONIA ASPIRATION (Pneumonia aspiration) (seriousness criteria death and medically significant), DIARRHOEA (Diarrhoea) (seriousness criterion death), PYREXIA (Fever) (seriousness criterion death) and VOMITING (Emesis) (seriousness criterion death). The patient died on 16-Jun-2021. The reported cause of death was Fever, Diarrhoea, Pneumonia aspiration and Emesis. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment Medication information was provided. No concomitant medication information was provided. Action taken with mRNA-1273 was not applicable. Company Comment: This is a case of a 97-year-old female patient with medical history of hypertension arterial and recent pneumonia aspiration (one month prior to events) who developed Pneumonia aspiration, Diarrhoea, Pyrexia and Vomiting and died. Autopsy was not performed. Very limited information regarding these events has been provided at this time. No further information is expected. Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Translation received on 29-Jun-2021 and does not contain any new information; Sender''s Comments: This is a case of a 97-year-old female patient with medical history of hypertension arterial and recent pneumonia aspiration (one month prior to events) who developed Pneumonia aspiration, Diarrhoea, Pyrexia and Vomiting and died. Autopsy was not performed. Very limited information regarding these events has been provided at this time. No further information is expected.; Reported Cause(s) of Death: Fever; Diarrhoea; Pneumonia aspiration; emesis


VAERS ID: 1447616 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-05-25
   Days after vaccination:109
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Intestinal ischaemia
SMQs:, Ischaemic colitis (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: ENTRESTO; FUROSEMIDE; KALEORID; KARDEGIC; BISOPROLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure; Follicular lymphoma
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Mesenteric ischaemia; This regulatory authority case was reported by a pharmacist and describes the occurrence of INTESTINAL ISCHAEMIA (Mesenteric ischaemia) in a 77-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Cardiac failure and Follicular lymphoma. Concomitant products included SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO), FUROSEMIDE, POTASSIUM CHLORIDE (KALEORID), ACETYLSALICYLATE LYSINE (KARDEGIC) and BISOPROLOL for an unknown indication. On 05-Feb-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced INTESTINAL ISCHAEMIA (Mesenteric ischaemia) (seriousness criteria death and medically significant). The reported cause of death was death due to mesenteric ischaemia. It is unknown if an autopsy was performed. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the event was not applicable. Treatment medication information were not reported. Sender''s (Case) Safety Report Unique Identifier FR-AFSSAPS-2021078084. 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, the medical history of Cardiac failure and Follicular lymphoma could be a contributory factor. Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Upon follow-up receipt: Follow-up information processed with initial report 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. However, the medical history of Cardiac failure and Follicular lymphoma could be a contributory factor.; Reported Cause(s) of Death: Death due to Mesenteric ischaemia


VAERS ID: 1449565 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Breast pain, Malaise, Myocarditis, Sudden cardiac death, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (narrow), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Cardiomyopathy (broad), Lipodystrophy (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: 2021-06-14
   Days after onset: 3
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: DEPEI202100110047

Write-up: Ventricular fibrillation; Myocarditis; Sudden cardiac death; Breast pain; Malaise; This regulatory authority case was reported by a physician and describes the occurrence of VENTRICULAR FIBRILLATION (Ventricular fibrillation), MYOCARDITIS (Myocarditis), BREAST PAIN (Breast pain), MALAISE (Malaise) and SUDDEN CARDIAC DEATH (Sudden cardiac death) in a 59-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 10-Jun-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) (Intramuscular) 1 dosage form. On 11-Jun-2021, the patient experienced BREAST PAIN (Breast pain) (seriousness criterion death) and MALAISE (Malaise) (seriousness criterion death). On 14-Jun-2021, the patient experienced VENTRICULAR FIBRILLATION (Ventricular fibrillation) (seriousness criteria death and medically significant), MYOCARDITIS (Myocarditis) (seriousness criteria death and medically significant) and SUDDEN CARDIAC DEATH (Sudden cardiac death) (seriousness criteria death and medically significant). The patient died on 14-Jun-2021. The reported cause of death was Sudden cardiac death. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered VENTRICULAR FIBRILLATION (Ventricular fibrillation), MYOCARDITIS (Myocarditis), BREAST PAIN (Breast pain), MALAISE (Malaise) and SUDDEN CARDIAC DEATH (Sudden cardiac death) to have an unknown relationship. Concomitant medication were not provided. Treatment medication was not provided. The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable. Company comment: 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: Sudden cardiac death


VAERS ID: 1449667 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-05-27
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001941 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest, Death, Malaise, Product preparation issue
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), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   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: Decompensation cardiac; Obesity
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic respiratory failure; Thoracic aortic aneurysm
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: General malaise; Arrest cardiac; Death; solution for haemodialysis; This regulatory authority case was reported by a physician and describes the occurrence of MALAISE (General malaise), CARDIAC ARREST (Arrest cardiac), DEATH (Death) and PRODUCT PREPARATION ISSUE (solution for haemodialysis) in an 85-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 3002543 and 3001941) for COVID-19 vaccination. The patient''s past medical history included Thoracic aortic aneurysm and Chronic respiratory failure. Concurrent medical conditions included Obesity and Decompensation cardiac since 20-Feb-2005. On 22-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form in total. On 27-May-2021, the patient experienced PRODUCT PREPARATION ISSUE (solution for haemodialysis) (seriousness criterion death). On 01-Jun-2021, the patient experienced MALAISE (General malaise) (seriousness criterion death), CARDIAC ARREST (Arrest cardiac) (seriousness criteria death and medically significant) and DEATH (Death) (seriousness criteria death and medically significant). The patient died on 01-Jun-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. No treatment information was not given No concomitant medication information was provided. Lab data included Hemoglobin test done on 01-06-2021. Action taken with mRNA-1273 in response to the event was not applicable. This is a report of death in a polymorbid 85 years old male, after second product dose. Concomitant medication was not provided. Autopsy was not provided. This a regulatory/spontaneous report of death, xx days after receiving the product in a 85 years old male with multiple concomitant conditions. Concomitant medication was not provided. Autopsy was not provided. Very limited information regarding the event has been provided for inferring causality. Further information is not expected. The event PT: product preparation issue, for which causality is not applicable, was captured from SD. Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Translation received on 01-07-2021 and does not contain any new information; Reporter''s Comments: paziente con pluripatologie (Scompenso Cardiaco, Insufficienza Respiratoria Cronica, Obesita, Aneurisma Aorta Toracica) deceduto per arresto cardiocircolatorio in data 01/06/2021 dopo somministrazione di Vaccino Moderna 2 dose lotto n 3002543 scad 22/11/2021 somministrato in data 27 Maggio 2021 (1 dose Moderna 22 Aprile 2021 h 16.15 lotto 3001941); Sender''s Comments: This a regulatory/spontaneous report of death, xx days after receiving the product in a 85 years old male with multiple concomitant conditions. Concomitant medication was not provided. Autopsy was not provided. Very limited information regarding the event has been provided for inferring causality. Further information is not expected. The event PT: product preparation issue, for which causality is not applicable, was captured from SD.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1449928 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-05-01
   Days after vaccination:101
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: 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: 2021-05-01
   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: Medical History/Concurrent Conditions: No adverse event
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: Cerebral haemorrhage; This regulatory authority case was reported by a nurse and describes the occurrence of CEREBRAL HAEMORRHAGE (Cerebral haemorrhage) in a 32-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included No adverse event. On 20-Jan-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced CEREBRAL HAEMORRHAGE (Cerebral haemorrhage) (seriousness criteria death and medically significant). The patient died in May 2021. The reported cause of death was Cerebral haemorrhage. It is unknown if an autopsy was performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered CEREBRAL HAEMORRHAGE (Cerebral haemorrhage) to be unlikely related. No concomitant medications were provided. No treatment information was provided. Action taken with mRNA-1273 was not applicable Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Further information (translation) is expected; Sender''s Comments: Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Further information (translation) is expected; Reported Cause(s) of Death: Cerebral haemorrhage


VAERS ID: 1449945 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-05-12
   Days after vaccination:91
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / 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: 2021-05-12
   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: AMIODARONE; ATORVASTATIN; COVERSUM; DUODART; ELIQUIS; PANTOPRAZOLO; SPASMO URGENIN; SYMBICORT; DUPHALAC [LACTULOSE]; MYSOLIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal aortic aneurysm; Cirrhosis of liver; Orthostatic hypotension; Comments: No medical history was reported
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: Vaccination failure; This regulatory authority case was reported by an other health care professional and describes the occurrence of COVID-19 and VACCINATION FAILURE (Vaccination failure) in an 85-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. EK9788) for COVID-19 vaccination. No medical history was reported. The patient''s past medical history included Orthostatic hypotension, Abdominal aortic aneurysm and Cirrhosis of liver. Concomitant products included PERINDOPRIL ERBUMINE (COVERSUM) for COVID-19 vaccination, AMIODARONE, ATORVASTATIN, DUTASTERIDE, TAMSULOSIN HYDROCHLORIDE (DUODART), APIXABAN (ELIQUIS), PANTOPRAZOLE SODIUM SESQUIHYDRATE (PANTOPRAZOLO), ECHINACEA ANGUSTIFOLIA ROOT, SERENOA REPENS FRUIT, TROSPIUM CHLORIDE (SPASMO URGENIN), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), LACTULOSE (DUPHALAC [LACTULOSE]) and PRIMIDONE (MYSOLIN) for an unknown indication. On 10-Feb-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021, after starting mRNA-1273 (COVID-19 Vaccine Moderna), the patient experienced COVID-19 (seriousness criterion death). On an unknown date, the patient experienced VACCINATION FAILURE (Vaccination failure) (seriousness criterion death). The patient died on 12-May-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 considered COVID-19 to be unlikely related and VACCINATION FAILURE (Vaccination failure) to have an unknown relationship. Treatment information was not provided. This is a case of lack of efficacy of the vaccine with an associated adverse event of Covid-19, therefore causal association between the event is assessed as not applicable.; Sender''s Comments: "This is a case of lack of efficacy of the vaccine with an associated adverse event of Covid-19, therefore causal association between the event is assessed as not applicable"; Reported Cause(s) of Death: Unknown Cause of Death


VAERS ID: 1452864 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-06-05
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Coronary artery thrombosis, Death, Ischaemic cardiomyopathy
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (narrow), Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-05
   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: LIPITOR
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRMODERNATX, INC.MOD20212

Write-up: thrombosis in anterior descending branch of the left coronary artery; Death; Ischemic cardiomyopathy; This regulatory authority case was reported by a consumer and describes the occurrence of CORONARY ARTERY THROMBOSIS (thrombosis in anterior descending branch of the left coronary artery), DEATH (Death) and ISCHAEMIC CARDIOMYOPATHY (Ischemic cardiomyopathy) in a 57-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication. On 25-May-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 05-Jun-2021, the patient experienced CORONARY ARTERY THROMBOSIS (thrombosis in anterior descending branch of the left coronary artery) (seriousness criteria death and medically significant), DEATH (Death) (seriousness criteria death and medically significant) and ISCHAEMIC CARDIOMYOPATHY (Ischemic cardiomyopathy) (seriousness criteria death and medically significant). The patient died on 05-Jun-2021. The reported cause of death was atherosclerotic coronary lesions. An autopsy was performed, but no results were provided. Treatment information was not provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. Very limited information regarding this events has been provided at this time. Further information is not expected.; Sender''s Comments: Very limited information regarding this events has been provided at this time. Further information is not expected.; Reported Cause(s) of Death: atherosclerotic coronary lesions


VAERS ID: 1453068 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-19
Onset:2021-06-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002917 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Condition aggravated, Oxygen saturation decreased
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-19
   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: LANSOX; CONGESCOR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Failure respiratory; Comments: No medical history was provided by the reporter.
Allergies:
Diagnostic Lab Data: Test Name: Desaturation; Result Unstructured Data: <85%
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of CONDITION AGGRAVATED in an 85-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002917) for COVID-19 vaccination. No medical history was provided by the reporter. The patient''s past medical history included Failure respiratory. Concomitant products included LANSOPRAZOLE (LANSOX) and BISOPROLOL FUMARATE (CONGESCOR) for an unknown indication. On 19-Jun-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Jun-2021, the patient experienced CONDITION AGGRAVATED(seriousness criterion death). The patient died on 19-Jun-2021. The reported cause of death was Aggravation of existing disorder. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation decreased: <85% (abnormal) <85%. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Concomitant medication not reported. Treatment medication not reported. Very limited information regarding this patient''s death has been provided at this time.; Reporter''s Comments: Lansox 30 mg Congescor 2.5 Lasix 25; Sender''s Comments: Very limited information regarding this patient''s death has been provided at this time.; Reported Cause(s) of Death: Aggravation of existing disorder


VAERS ID: 1453799 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-05-04
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest, Death, Malaise
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: 2021-05-05
   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: Medical History/Concurrent Conditions: Smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEMODERNATX, INC.MOD20212

Write-up: d�c�s; Arr�t cardiaque; Malaise; This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (d�c�s), CARDIAC ARREST (Arr�t cardiaque) and MALAISE (Malaise) in a 63-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Smoker. On 20-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced CARDIAC ARREST (Arr�t cardiaque) (seriousness criteria death and medically significant) and MALAISE (Malaise) (seriousness criterion death). The patient died on 05-May-2021. The reported cause of death was Cardiac arrest. It is unknown if an autopsy was performed. No concomitant medication reported. No treatment information was provided. Company comment: Very limited information regarding the events has been provided at this time Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up received on 2juL2021 contains translated source document; Sender''s Comments: Very limited information regarding the events has been provided at this time; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1455223 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-30
Onset:2021-05-28
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001532 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hepatic vein thrombosis, Platelet count, Pulmonary embolism, Pyrexia, Raynaud's phenomenon, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Rectal cancer metastatic
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: Platelet count; Test Result: Inconclusive ; Result Unstructured Data: 52000; Test Date: 20210613; Test Name: Platelet count; Test Result: Inconclusive ; Result Unstructured Data: 370000
CDC Split Type: ESMODERNATX, INC.MOD20212

Write-up: Tromboembolia pulmonar; Thrombopenia; Trombosis de vena hep�tica; Raynaud; Fiebre; This regulatory authority case was reported by a physician and describes the occurrence of HEPATIC VEIN THROMBOSIS (Trombosis de vena hep�tica), PULMONARY EMBOLISM (Tromboembolia pulmonar), THROMBOCYTOPENIA (Thrombopenia), RAYNAUD''S PHENOMENON (Raynaud) and PYREXIA (Fiebre) in a 64-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 3002183 and 3001532) for COVID-19 vaccination. The patient''s past medical history included Rectal cancer metastatic and COVID-19 (Covid-19) in September 2020. On 30-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 28-May-2021, the patient experienced RAYNAUD''S PHENOMENON (Raynaud) (seriousness criterion hospitalization) and PYREXIA (Fiebre) (seriousness criterion hospitalization). On 03-Jun-2021, the patient experienced HEPATIC VEIN THROMBOSIS (seriousness criteria death, hospitalization and medically significant) and THROMBOCYTOPENIA (Thrombopenia) (seriousness criteria hospitalization and medically significant). On 17-Jun-2021, the patient experienced PULMONARY EMBOLISM (Tromboembolia pulmonar) (seriousness criteria death, hospitalization and medically significant). On 13-Jun-2021, THROMBOCYTOPENIA (Thrombopenia) had resolved. In June 2021, RAYNAUD''S PHENOMENON (Raynaud) and PYREXIA (Fiebre) had resolved. The patient died on an unknown date. The reported cause of death was thrombosis and tromboembolia pulmonar. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jun-2021, Platelet count: 52000 cells per microlitre (Inconclusive) 52000. On 13-Jun-2021, Platelet count: 370000 cells per microlitre (Inconclusive) 370000. 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. Company comment Very limited information regarding events (hepatic vein thrombosis and pulmonary embolism) 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 rest of the events, a causal relationship cannot be excluded.; Sender''s Comments: Very limited information regarding events (hepatic vein thrombosis and pulmonary embolism) 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 rest of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death; Tromboembolia pulmonar


VAERS ID: 1455899 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2001-01-21
Onset:2001-09-10
   Days after vaccination:232
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 521458 / 1 - / OT
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER NOT KNOWN / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-03-17
   Days after onset: 2014
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: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Brain mass; This regulatory authority case was reported by a consumer and describes the occurrence of INTRACRANIAL MASS (Brain mass) in a 58-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 521458) for COVID-19 vaccination. Co-suspect product included non-company product COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for COVID-19 vaccination. No Medical History information was reported. On 21-Jan-2001, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Dec-2010, the patient started COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) 1 dosage form. On 10-Sep-2001, the patient experienced INTRACRANIAL MASS (Brain mass) (seriousness criterion death). The patient died on 17-Mar-2007. The reported cause of death was Brain mass. 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. 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: Brain mass


VAERS ID: 1457920 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-26
Onset:2021-06-11
   Days after vaccination:46
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002544 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Decreased appetite, Diarrhoea, Restlessness, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Akathisia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-12
   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: Chronic renal impairment
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of DECREASED APPETITE, RESTLESSNESS, SOMNOLENCE and DIARRHOEA in a 95-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3002544) for COVID-19 vaccination. The patient''s past medical history included Chronic renal impairment since an unknown date. On 26-Apr-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 10-Jun-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced DECREASED APPETITE (seriousness criterion death), RESTLESSNESS (seriousness criterion death), SOMNOLENCE (seriousness criterion death) and DIARRHOEA (seriousness criterion death). The patient died on 12-Jun-2021. The reported cause of death was Inappetence, Restlessness, Drowsiness and Diarrhea. 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 details were reported. No treatment medication details was reported. Action taken with mRNA-1273 in response to the event was not applicable. Very limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Further information is expected. Same batch number is given for both dose in source document, this seems to be incorrect.; Reporter''s Comments: Sender''s Comments: Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Further information is expected. Same batch number is given for both dose in source document, this seems to be incorrect.; Reported Cause(s) of Death: Inappetence; Restlessness; Drowsiness; Diarrhea


VAERS ID: 1459314 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-06-20
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-07-09
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: 2021-06-20
   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:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Psychiatric disorder NOS
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Death NOS; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death NOS) in a 67-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002616) for COVID-19 vaccination. The patient''s past medical history included Psychiatric disorder NOS and Arterial hypertension. Previously administered products included for Product used for unknown indication: RISPERDAL. On 09-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 20-Jun-2021 The patient died on 20-Jun-2021. The cause of death was not reported. An autopsy was not performed. mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was withdrawn on an unknown date. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided by the reporter. Treatment information was not provided. Sender''s (Case) Safety Report Unique Identifier FR-AFSSAPS-2021082913 Very limited information regarding this event has been provided at this time. Details regarding the Cause of death/autopsy report or circumstances surrounding the death is required for further assessment. Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Translated document received on 06-Jul-2021, substance information of historical drug updated.; Sender''s Comments: Very limited information regarding this event has been provided at this time. Details regarding the Cause of death/autopsy report or circumstances surrounding the death is required for further assessment.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1462650 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA NOT KNOWN / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   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: GBMODERNATX, INC.MOD20212

Write-up: Death; This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. Not known) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 01-Jan-2021 The patient died on 01-Jan-2021. The cause of death was not reported. It is unknown if an autopsy was performed. No treatment information was provided. No relevant concomitant medications were reported. The patient did not receive any treatment. Lab details were not provided Company Comment: This is a case of sudden death in a female. Due to paucity of medical information is unfeasible to establish neither casual nor temporal association between the event and vaccine administration. No further information is expected.; Sender''s Comments: This is a case of sudden death in a female. Due to paucity of medical information is unfeasible to establish neither casual nor temporal association between the event and vaccine administration. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1463936 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-06-29
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest, Death, Embolism, Loss of consciousness, Malaise, Seizure
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-29
   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: Past medical history included "homocysteinurie."
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEMODERNATX, INC.MOD20212

Write-up: beeld van asystolie; beeld van embool; tijdens hulpverlening convulsieve bewegingen en bewustzijnsverlies; op 29/06 plots onwel; tijdens hulpverlening convulsieve bewegingen en bewustzijnsverlies; overlijden; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (overlijden), CARDIAC ARREST (beeld van asystolie), LOSS OF CONSCIOUSNESS (tijdens hulpverlening convulsieve bewegingen en bewustzijnsverlies), EMBOLISM (beeld van embool), SEIZURE (tijdens hulpverlening convulsieve bewegingen en bewustzijnsverlies) and MALAISE (op 29/06 plots onwel) in a 27-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Past medical history included "homocysteinurie.". On 25-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 23-Jun-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jun-2021, the patient experienced DEATH (overlijden) (seriousness criteria death and medically significant), LOSS OF CONSCIOUSNESS (tijdens hulpverlening convulsieve bewegingen en bewustzijnsverlies) (seriousness criteria death and medically significant), SEIZURE (tijdens hulpverlening convulsieve bewegingen en bewustzijnsverlies) (seriousness criteria death and medically significant) and MALAISE (op 29/06 plots onwel) (seriousness criterion death). On an unknown date, the patient experienced CARDIAC ARREST (beeld van asystolie) (seriousness criteria death and medically significant) and EMBOLISM (beeld van embool) (seriousness criteria death and medically significant). The patient died on 29-Jun-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 were provided. No treatment was reported for the events. Translation is pending. Very limited information regarding this events has been provided at this time. Further information has been requested. Further information is not expected.; Sender''s Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Further information is not expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1466361 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-05-28
   Days after vaccination:59
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000496 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-28
   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: ASPIRIN CARDIO; PERINDOPRIL; AMIODARONE
Current Illness: Coronary disease (Date of diagnosis of stable coronary artery disease was unknown); Hypertension (Diagnosis date was unknown)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: Patient; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Patient .) in an 81-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch nos. 3001656 and 3000496) for COVID-19 vaccination. Concurrent medical conditions included Hypertension (Diagnosis date was unknown) and Coronary disease (Date of diagnosis of stable coronary artery disease was unknown). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN CARDIO), PERINDOPRIL and AMIODARONE for an unknown indication. On 30-Mar-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. Death occurred on 28-May-2021 The patient died on 28-May-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 (Patient.) to be unlikely related. The reporter stated that it was unknown whether the patient had any sort of allergy. On 28 May 2021 the patient collapsed in his backyard and was found dead by his wife. The face turned blue and was given futile cardiopulmonary resuscitation. The reporter assumed that the death may be due to sudden cardiac death or pulmonary embolism. No further treatment information was provided. Company comment: Very limited information regarding this event has been provided at this time. No follow up is possible. Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Translation document was received on 07 Jul 2021. Patients medical history information and narrative was updated.; Sender''s Comments: Company comment: Very limited information regarding this event has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1467489 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-06-09
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / 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: 2021-06-20
   Days after onset: 11
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: Unknown cause of death; Pyrexia; This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Unknown cause of death) in a 75-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. No Medical History information was reported. On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced DEATH (Unknown cause of death) (seriousness criteria death and medically significant) and PYREXIA (Pyrexia). On 20-Jun-2021, PYREXIA (Pyrexia) had not resolved. The patient died on 20-Jun-2021. The cause of death was not reported. An autopsy was not performed. Full strength broad spectrum antibiotic was given as treatment. No relevant concomitant medications were reported. Company comment: Very limited information regarding these events has been provided at this time. Further information has been requested. Further information is not expected; Sender''s Comments: Very limited information regarding these events has been provided at this time. Further information has been requested. Further information is not expected; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1467705 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-23
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebral venous sinus thrombosis, Circulatory collapse
SMQs:, Anaphylactic reaction (narrow), 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), Embolic and thrombotic events, venous (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-25
   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: DEMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of CIRCULATORY COLLAPSE and CEREBRAL VENOUS SINUS 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-Jun-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) (Intramuscular) 1 dosage form. On 23-Jun-2021, the patient experienced CIRCULATORY COLLAPSE (seriousness criteria death and medically significant) and CEREBRAL VENOUS SINUS THROMBOSIS (seriousness criteria death and medically significant). The patient died on 25-Jun-2021. The reported cause of death was Thrombosis of venous sinuses. An autopsy was not performed. The concomitant medications were not reported. The treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. This is a case of sudden death in a 68-year-old male subject, who died 15 days after receiving second dose of vaccine. Very limited information has been provided at this time. Very limited information has been provided at this time. Reported Cause(s) of Death: Thrombosis of venous sinuses


VAERS ID: 1468781 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-06-24
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Cardiac arrest, Depressed level of consciousness, Oxygen saturation, Pyrexia, Stupor
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), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-26
   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: XARELTO; DEMENTIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac pacemaker insertion; Encephalopathy (degenerative encephalopathy); Hip fracture
Allergies:
Diagnostic Lab Data: Test Date: 20210624; Test Name: Body temperature; Result Unstructured Data: 38 degree Celsius; Test Date: 20210625; Test Name: Oxygen saturation; Result Unstructured Data: 83
CDC Split Type: GRMODERNATX, INC.MOD20212

Write-up: Cardiac arrest; Stupor; Fever; Consciousness decreased; This regulatory authority case was reported by an other health care professional and describes the occurrence of CARDIAC ARREST (Cardiac arrest), DEPRESSED LEVEL OF CONSCIOUSNESS (Consciousness decreased), STUPOR (Stupor) and PYREXIA (Fever) in a 74-year-old patient of an unknown gender who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Encephalopathy (degenerative encephalopathy) in November 2020, Hip fracture in December 2020 and Cardiac pacemaker insertion. Concomitant products included RIVAROXABAN (XARELTO) from 12-Aug-2020 to an unknown date and DONEPEZIL HYDROCHLORIDE (DEMENTIS) for an unknown indication. On 22-Jun-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) (Intramuscular) 1 dosage form. On 24-Jun-2021, the patient experienced DEPRESSED LEVEL OF CONSCIOUSNESS (Consciousness decreased) (seriousness criteria death and medically significant) and PYREXIA (Fever) (seriousness criteria death and medically significant). On 25-Jun-2021, the patient experienced STUPOR (Stupor) (seriousness criteria death and medically significant). On 26-Jun-2021, the patient experienced CARDIAC ARREST (Cardiac arrest) (seriousness criteria death and medically significant). The patient died on 26-Jun-2021. The reported cause of death was Cardiac arrest. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jun-2021, Body temperature: 38 degree Celsius (High) 38. On 25-Jun-2021, Oxygen saturation: 83 (abnormal) 83. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided by the reporter. Action taken with mRNA-1273 in response to the event was not applicable. This is a case of death in a 74-year-old subject with a history of Encephalopathy and Cardiac pacemaker insertion, who died 5 days after receiving second dose of vaccine. Very limited information has been provided at this time.; Reporter''s Comments: Initial Report with additional information; Sender''s Comments: This is a case of death in a 74-year-old subject with a history of Encephalopathy and Cardiac pacemaker insertion, who died 5 days after receiving second dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1468920 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-04-18
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Dyspnoea, Pyrexia, Terminal state
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: 2021-06-18
   Days after onset: 61
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: 20210618; Test Name: Body temperature; Result Unstructured Data: increased
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: second dose Moderna (Covid19)17/06/2021. 18/06/2021 ; dyspnea; This regulatory authority case was reported by a physician and describes the occurrence of TERMINAL STATE 16 del 17/06/2021. 18/06/2021 and DYSPNOEA (dyspnea) in a 96-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 17-Jun-2021 at 4:00 PM, 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 18-Apr-2021, the patient experienced DYSPNOEA (dyspnea) (seriousness criterion death). On 18-Jun-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced TERMINAL STATE . (seriousness criteria death and medically significant) and PYREXIA (seriousness criterion death). The patient died on 18-Jun-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 18-Jun-2021, Body temperature: 39.5�c (High) increased. 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 reported. The patient had the second dose of Moderna (Covid-19 vaccine) at 16:00 on June 17, 2021. At 05:00 on June 18, 2021 the patient had a body temperature of 39.5�C and dyspnea. At 06:50 the 118 physician declared the patient deceased. This is a case of death of a 96-year-old female patient, 1 day after receiving second dose of vaccine (Lot number unknown), and experienced fever and dyspnea. Very limited information regarding the clinical details pertaining to death, patient''s medical history, and concomitant medications were provided at this time. No further information is expected. . Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Lab details updated.; Sender''s Comments: This is a case of death of a 96-year-old female patient, 1 day after receiving second dose of vaccine (Lot number unknown), and experienced fever and dyspnea. Very limited information regarding the clinical details pertaining to death, patient''s medical history, and concomitant medications were provided at this time. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1469367 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-07
Onset:2021-06-30
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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: TRIOBE [CYANOCOBALAMIN;FOLIC ACID;PYRIDOXINE]; ATACAND
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Embolism pulmonary; Hypertension; Prostate cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM in a 76-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Embolism pulmonary in 2014 and Prostate cancer in 2014. Concurrent medical conditions included Hypertension. Concomitant products included CYANOCOBALAMIN, FOLIC ACID, PYRIDOXINE (TRIOBE [CYANOCOBALAMIN;FOLIC ACID;PYRIDOXINE]) and CANDESARTAN CILEXETIL (ATACAND) for an unknown indication. On 07-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 PULMONARY EMBOLISM (seriousness criteria death and medically significant). The patient died on 30-Jun-2021. The reported cause of death was Embolism pulmonary. An autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered PULMONARY EMBOLISM (to be possibly related. No treatment information was provided. 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: EMBOLISM PULMONARY


VAERS ID: 1469552 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA EFTERS�KS / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Embolic stroke
SMQs:, Ischaemic 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: 2021-06-01
   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: Hypertension; Obesity; Psoriasis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20212

Write-up: PATIENTEN AVLED; This regulatory authority case was reported by a physician and describes the occurrence of EMBOLIC STROKE (PATIENTEN AVLED) in a 64-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. EFTERS�KS) for COVID-19 vaccination. Concurrent medical conditions included Obesity, Psoriasis and Hypertension. In June 2021, the patient received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. In June 2021, the patient experienced EMBOLIC STROKE (PATIENTEN AVLED) (seriousness criteria death and medically significant). The patient died in June 2021. The reported cause of death was Thromboembolic stroke. 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 information was provided. No treatment information was provided by the reporter. Action taken with mRNA-1273 in response to the event was not applicable. This is a case of sudden death in a 64-year-old female subject with hx of obesity, psoriasis, hypertension, who died 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 64-year-old female subject with hx of obesity, psoriasis, hypertension, who died after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Thromboembolic stroke


VAERS ID: 1469749 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-02-20
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042723 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute myocardial infarction, Blood creatinine, Diarrhoea, Dyspnoea, Glomerular filtration rate, Glycosylated haemoglobin, Headache, Pyrexia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-20
   Days after onset: 88
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: Arterial hypertension; Chronic renal insufficiency; Diabetes mellitus; Hypothyreosis; Polymyalgia rheumatica
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210310; Test Name: Blood creatinine; Test Result: Inconclusive ; Result Unstructured Data: 112 mcmol/L; Test Date: 20210310; Test Name: Estimated glomerular filtration rate; Test Result: Inconclusive ; Result Unstructured Data: 40ml/min/1.73m2; Test Date: 20210310; Test Name: HbA1c; Test Result: Inconclusive ; Result Unstructured Data: 6.5%
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: The Patient passed away on 20.05.2021; Dyspnoea; Headache; Vomiting; Diarrhoea; Pyrexia; This regulatory authority case was reported by a physician and describes the occurrence of ACUTE MYOCARDIAL INFARCTION (Die Patient passed away on 20.05.2021), HEADACHE (Headache), VOMITING (Vomiting), DIARRHOEA (Diarrhoea), PYREXIA (Pyrexia) and DYSPNOEA (Dyspnoea) in an 80-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 300042723) for COVID-19 vaccination. Concurrent medical conditions included Diabetes mellitus, Hypothyreosis, Polymyalgia rheumatica, Arterial hypertension and Chronic renal insufficiency. On 22-Jan-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced HEADACHE (Headache) (seriousness criterion hospitalization), VOMITING (Vomiting) (seriousness criterion hospitalization), DIARRHOEA (Diarrhoea) (seriousness criterion hospitalization) and PYREXIA (Pyrexia) (seriousness criterion hospitalization). On 02-Mar-2021, the patient experienced DYSPNOEA (Dyspnoea) (seriousness criterion hospitalization). On 20-May-2021, the patient experienced ACUTE MYOCARDIAL INFARCTION (The patient passed away on 20.05.2021) (seriousness criteria death, hospitalization and medically significant). In March 2021, HEADACHE (Headache), VOMITING (Vomiting), DIARRHOEA (Diarrhoea), PYREXIA (Pyrexia) and DYSPNOEA (Dyspnoea) had resolved. The patient died on 20-May-2021. The reported cause of death was Acute myocardial infarction. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Blood creatinine: 112 mcmol/l (Inconclusive) 112 mcmol/L. On 10-Mar-2021, Glomerular filtration rate: 40ml/min/1.73m2 (Inconclusive) 40ml/min/1.73m2. On 10-Mar-2021, Glycosylated haemoglobin: 6.5% (Inconclusive) 6.5%. 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. The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable. Patient died on 20-May-2021 and was Judged the causal link between the Moderna COVID-19 vaccine and acute myocardial infarction to be unlikely. However, this view regarding causality does not entirely rule out the role of the vaccine. On 11 Mar 2021, lab reports showed TTE dilated LV, large scar anteroapically, anteroseptally, and septally. LVEF 25%. Aortic valve sclerosis, mild pericardial effusion inferobasal 4mm. PH approximately 50mmHg, IVC severely congested. Therapy: 10 Mar 2021 right pleural puncture (transudate) 10 Mar 2021 -15 Mar 2021, Lasix i.v. Company comment Very limited information regarding the events has been provided at this time. Further information is not expected. Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Translation for Case Narrative, Reporter''s comments and Sender''s comments.; Sender''s Comments: Very limited information regarding the events has been provided at this time. Further information is not expected.; Reported Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1469763 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-04-16
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac failure acute, Influenza like illness, Pneumonia
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad), 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: 2021-04-26
   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? Yes
Previous Vaccinations:
Other Medications:
Current Illness: Atrial fibrillation; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Lymphoma
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20212

Write-up: Beidseitige bakterielle Lungenentz�ndung; flu-like syndrome; Herzversagen; This regulatory authority case was reported by a consumer and describes the occurrence of PNEUMONIA (Beidseitige bakterielle Lungenentz�ndung) and CARDIAC FAILURE ACUTE (Herzversagen) in a 73-year-old female 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 Lymphoma in 2016. Concurrent medical conditions included Hypertension and Atrial fibrillation. On 10-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced PNEUMONIA (Beidseitige bakterielle Lungenentz�ndung) (seriousness criteria death, hospitalization and medically significant) and CARDIAC FAILURE ACUTE (Herzversagen) (seriousness criteria death, hospitalization prolonged and medically significant). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like syndrome). The patient died on 26-Apr-2021. The reported cause of death was Acute heart failure and Pneumonia. An autopsy was not performed. At the time of death, INFLUENZA LIKE ILLNESS (flu-like syndrome) outcome was unknown. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Reporter stated the day after the second vaccine the patient started experiencing flu-like symptoms. The patient was admitted to the hospital in intensive care with pneumonia. Reporter stated patient experienced cardiac failure as well. Company Comment: Very limited information regarding these events (pneumonia and cardiac failure) has been provided at this time. Noting history of Atrial fibrillation, hypertension may remain as risk factors. Based on the current available information and temporal association between the use of the product and the start date of the event (flu-like syndrome), a causal relationship cannot be excluded. Autopsy report/death certificate is required for further assessment. No further follow-up information is expected. Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Translation received included sender''s comments updated and historical condition updated. Event added.; Sender''s Comments: Very limited information regarding these events (pneumonia and cardiac failure) has been provided at this time. Noting history of Atrial fibrillation, hypertension may remain as risk factors. Based on the current available information and temporal association between the use of the product and the start date of the event (flu-like syndrome), a causal relationship cannot be excluded. Autopsy report/death certificate is required for further assessment. No further follow-up information is expected.; Reported Cause(s) of Death: Acute heart failure; Pneumonia


VAERS ID: 1469954 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, General physical health deterioration, Heart rate, Lung disorder, Oxygen saturation, Pneumonia aspiration, Pyrexia, Respiratory rate
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: 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: 2021; Test Name: Heart rate; Result Unstructured Data: increased; Test Date: 2021; Test Name: Oxygen saturation; Result Unstructured Data: decreased; Test Date: 2021; Test Name: Respiratory rate; Result Unstructured Data: increased
CDC Split Type: CAMODERNATX, INC.MOD20212

Write-up: Pneumonia aspiration; Dyspnoea; General physical health deterioration; Lung disorder; Pyrexia; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Jul-2021 and was forwarded to Moderna on 06-Jul-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PNEUMONIA ASPIRATION (Pneumonia aspiration), DYSPNOEA (Dyspnoea), GENERAL PHYSICAL HEALTH DETERIORATION (General physical health deterioration), LUNG DISORDER (Lung disorder) and PYREXIA (Pyrexia) in a 78-year-old male patient 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 first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA ASPIRATION (Pneumonia aspiration) (seriousness criteria death and medically significant), DYSPNOEA (Dyspnoea) (seriousness criterion death), GENERAL PHYSICAL HEALTH DETERIORATION (General physical health deterioration) (seriousness criterion death), LUNG DISORDER (Lung disorder) (seriousness criterion death) and PYREXIA (Pyrexia) (seriousness criterion death). 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, Heart rate: increased (High) increased. In 2021, Oxygen saturation: decreased (Low) decreased. In 2021, Respiratory rate: increased (High) increased. No concomitant medication details were reported. Oxygen therapy was used for treatment, however, no additional treatment information was reported. This is a case of death in a 78-year-old male subject, who died 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 78-year-old male subject, who died after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Cause of death unknown


VAERS ID: 1470165 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-05-03
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Computerised tomogram head, Decreased appetite, Dizziness, Fatigue, Haemoglobin, Ischaemic cerebral infarction, Magnetic resonance imaging head, SARS-CoV-1 test
SMQs:, Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-16
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASPIRIN CARDIO; DILATREND; ALDACTONE [SPIRONOLACTONE]
Current Illness: Anemia; Arterial hypertension; COPD (Vd. a. COPD); Malnutrition
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210508; Test Name: Computerised tomogram head; Test Result: Positive ; Result Unstructured Data: Brain computerised tomography; Test Date: 202105; Test Name: Haemoglobin; Test Result: Positive ; Result Unstructured Data: Positive; Test Date: 20210508; Test Name: Magnetic resonance imaging head; Test Result: Positive ; Result Unstructured Data: Positive; Test Date: 202105; Test Name: SARS-CoV-1 test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by an other health care professional and describes the occurrence of ISCHAEMIC CEREBRAL INFARCTION in a 79-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Anemia, Arterial hypertension, COPD (Vd. a. COPD) and Malnutrition. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN CARDIO), CARVEDILOL (DILATREND) and SPIRONOLACTONE (ALDACTONE [SPIRONOLACTONE]) for an unknown indication. On 31-Mar-2021, the patient received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. On 28-Apr-2021, received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced DECREASED APPETITE, DIZZINESS and FATIGUE. On 07-May-2021, the patient experienced ISCHAEMIC CEREBRAL INFARCTION (seriousness criteria death and medically significant). The patient died on 16-May-2021. It is unknown if an autopsy was performed. At the time of death, DECREASED APPETITE, DIZZINESS and FATIGUE outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-May-2021, Computerised tomogram head: positive (Positive) Brain computerised tomography. On 08-May-2021, Magnetic resonance imaging head: positive (Positive) Positive. In May 2021, Haemoglobin: positive (Positive) Positive. In May 2021, SARS-CoV-1 test: negative (Negative) Negative. For mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown), the reporter considered FATIGUE to be possibly related and ISCHAEMIC CEREBRAL INFARCTION, DECREASED APPETITE and DIZZINESS to be unlikely related. Treatment information was not provided This a report of dead 28 days after receiving the product in a 79-years old patient with concomitant Anemia, Arterial hypertension, COPD and Malnutrition. 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 28 days after receiving the product in a 79-years old patient with concomitant Anemia, Arterial hypertension, COPD and Malnutrition. 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. Translation of the source document has been requested.


VAERS ID: 1470956 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-02-24
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042723 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: End stage renal disease
SMQs:, Rhabdomyolysis/myopathy (broad), Chronic kidney disease (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-24
   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: Pramipexol; NEO-MERCAZOLE; Vascord; TORASEMIDE SODIUM; SERESTA; PALEXIA; PANTOPRAZOLE SODIUM
Current Illness: Anxiety disorder; Chronic kidney disease stage 5 (CNI Grad V--); Coronary heart disease; Hyperthyroidism; Macular degeneration; Oedema
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: Chronic kidney disease stage 5; This regulatory authority case was reported by a physician and describes the occurrence of END STAGE RENAL DISEASE (Chronic kidney disease stage 5) in an elderly female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 300042723) for COVID-19 vaccination. Concurrent medical conditions included Chronic kidney disease stage 5 (CNI Grad V--), Macular degeneration, Hyperthyroidism, Coronary heart disease, Oedema and Anxiety disorder. Concomitant products included Pramipexole (Pramipexol), CARBIMAZOLE (NEO-MERCAZOLE), Amlodipine besilate, Olmesartan medoxomil (Vascord), TORASEMIDE SODIUM, OXAZEPAM (SERESTA), TAPENTADOL HYDROCHLORIDE (PALEXIA) and PANTOPRAZOLE SODIUM for an unknown indication. On 18-Feb-2021, the patient received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 24-Feb-2021, after starting mRNA-1273 (COVID-19 Vaccine Moderna), the patient experienced END STAGE RENAL DISEASE (Chronic kidney disease stage 5) (seriousness criteria death and medically significant). The patient died on 24-Feb-2021. The reported cause of death was end stage renal disease. An autopsy was not performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Very limited information regarding this event has been provided at this time. Noting history of Chronic kidney disease stage 5, CAD among others may remain as risk factors. Autopsy report/ death certificate is required for further evaluation.; Sender''s Comments: Very limited information regarding this event has been provided at this time. Noting history of Chronic kidney disease stage 5, CAD among others may remain as risk factors. Autopsy report/ death certificate is required for further evaluation.; Reported Cause(s) of Death: End stage renal disease


VAERS ID: 1473784 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-06-09
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001946 / 2 - / OT

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

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: ZYLLT; FURON [FUROSEMIDE]; VITAMIN D3 FRESENIUS; KALDYUM; EMOZUL
Current Illness: Hypertension; Osteoporosis; Polyarthritis
Preexisting Conditions: Medical History/Concurrent Conditions: Acute bronchitis; Atherosclerosis; Toxic shock syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUMODERNATX, INC.MOD20212

Write-up: Death; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death) in a 96-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 3001946 and 3002916) for COVID-19 vaccination. The patient''s past medical history included Toxic shock syndrome, Acute bronchitis and Atherosclerosis. Concurrent medical conditions included Polyarthritis, Hypertension and Osteoporosis. Concomitant products included CLOPIDOGREL BISULFATE (ZYLLT), FUROSEMIDE (FURON [FUROSEMIDE]), COLECALCIFEROL (VITAMIN D3 FRESENIUS), POTASSIUM CHLORIDE (KALDYUM) and ESOMEPRAZOLE MAGNESIUM (EMOZUL) for an unknown indication. On 11-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 08-Jun-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .5 milliliter. Death occurred on 09-Jun-2021 The patient died on 09-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 (Death) to be unlikely related. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable. Company Comment This a report of dead one day after the second dose of the product in an old polymorbid patient with many confounders. Autopsy was not performed. Very limited information regarding the event has been provided for inferring causality. Further information is not expected; Sender''s Comments: This a report of dead one day after the second dose of the product in an old polymorbid patient with many confounders. Autopsy was not performed. Very limited information regarding the event has been provided for inferring causality. Further information is not expected; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1476427 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-07-03
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-07
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fever
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Feverish; This regulatory authority case was reported by an other health care professional and describes the occurrence of PYREXIA (Feverish) in a 41-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Fever. On 11-Jun-2021, the patient 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 received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 03-Jul-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced PYREXIA (Feverish) (seriousness criterion death). The patient died on 07-Jul-2021. The reported cause of death was Feverish. 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. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not reported. Patient died of high fever/brain dead from high fever the vaccine caused. Patient was not enrolled in clinical trial. Treatment medication was not reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) for events was not applicable. Company Comment This case concerns the death of a 41-year-old male after receiving both doses of mRNA-1273 vaccine. Although a temporal association exist, it is not enough to assess the fatal outcome of the event of fever as being causally association with the product use, In addition to fever occurring 26 days post last dose of vaccine, the patient is reported to have a history of fever (origin) not provided as well as critical other relevant details such as detailed medical history and clinical findings are lacking. No additional information is expected.; Sender''s Comments: This case concerns the death of a 41-year-old male after receiving both doses of mRNA-1273 vaccine. Although a temporal association exist, it is not enough to assess the fatal outcome of the event of fever as being causally association with the product use, In addition to fever occurring 26 days post last dose of vaccine, the patient is reported to have a history of fever (origin) not provided as well as critical other relevant details such as detailed medical history and clinical findings are lacking. No additional information is expected; Reported Cause(s) of Death: Feverish


VAERS ID: 1476728 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-04-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001941 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Disseminated intravascular coagulation, Musculoskeletal pain, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-09
   Days after onset: 41
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: Essential thrombocytosis; Neutrophilia; Splenectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: Piressia intermittente (40) per 4 settimane dalla vaccinazione. Severa artromialgia (controllabile solo con oxicodone). Decesso in seguito a ipotetico quadro di coagulazione intravascolare disseminata; Piressia intermittente (40) per 4 settimane dalla vaccinazione. Severa artromialgia (controllabile solo con oxicodone). Decesso in seguito a ipotetico quadro di coagulazione intravascolare disseminata; Piressia intermittente (40) per 4 settimane dalla vaccinazione. Severa artromialgia (controllabile solo con oxicodone). Decesso in seguito a ipotetico quadro di coagulazione intravascolare disseminata; This regulatory authority case was reported by a physician and describes the occurrence of DISSEMINATED INTRAVASCULAR COAGULATION (Piressia intermittente (40) per 4 settimane dalla vaccinazione. Severa artromialgia (controllabile solo con oxicodone). Decesso in seguito a ipotetico quadro di coagulazione intravascolare disseminata), MUSCULOSKELETAL PAIN (Piressia intermittente (40) per 4 settimane dalla vaccinazione. Severa artromialgia (controllabile solo con oxicodone). Decesso in seguito a ipotetico quadro di coagulazione intravascolare disseminata) and PYREXIA (Piressia intermittente (40) per 4 settimane dalla vaccinazione. Severa artromialgia (controllabile solo con oxicodone). Decesso in seguito a ipotetico quadro di coagulazione intravascolare disseminata) in an 82-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001941) for COVID-19 vaccination. The patient''s past medical history included Neutrophilia on 01-Dec-2020, Essential thrombocytosis on 01-Jan-2000 and Splenectomy on 01-Jan-2013. On 29-Apr-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced DISSEMINATED INTRAVASCULAR COAGULATION (Piressia intermittente (40) per 4 settimane dalla vaccinazione. Severa artromialgia (controllabile solo con oxicodone). Decesso in seguito a ipotetico quadro di coagulazione intravascolare disseminata) (seriousness criteria death and medically significant), MUSCULOSKELETAL PAIN (Piressia intermittente (40) per 4 settimane dalla vaccinazione. Severa artromialgia (controllabile solo con oxicodone). Decesso in seguito a ipotetico quadro di coagulazione intravascolare disseminata) (seriousness criterion death) and PYREXIA (Piressia intermittente (40) per 4 settimane dalla vaccinazione. Severa artromialgia (controllabile solo con oxicodone). Decesso in seguito a ipotetico quadro di coagulazione intravascolare disseminata) (seriousness criterion death). The patient died on 09-Jun-2021. The reported cause of death was Disseminated intravascular coagulation, Arthromyalgia and Intermittent pyrexia. 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 medication was given Laboratory data was mentioned as the person undergoes C-reactive protein test on 14 May 2021 and results was not given No treatment information was given. 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.; Reporter''s Comments: Decesso dopo 42 giorni di malattia, iniziata il giorno della vaccinazione.; 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: Intermittent pyrexia; Disseminated intravascular coagulation; Arthromyalgia


VAERS ID: 1477488 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-26
Onset:2021-06-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002181 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Aortic dissection
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-27
   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: JPTAKEDA2021TJP050779

Write-up: Acute aortic dissection; This regulatory authority case was reported by a physician and describes the occurrence of AORTIC DISSECTION (Acute aortic dissection) in a 55-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002181) for COVID-19 vaccination. No Medical History information was reported. On 26-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 27-Jun-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced AORTIC DISSECTION (Acute aortic dissection) (seriousness criteria death and medically significant). The patient died on 27-Jun-2021. The reported cause of death was acute aortic dissection. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered AORTIC DISSECTION (Acute aortic dissection) to be unlikely related. No Treatment information was provided by the reporter. No concomitant medication was reported. The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. Although the event developed immediately after the vaccination, the event is unlikely related to the vaccine. However, a statistical investigation is considered necessary. This is a case of death of a 55-year-old male patient, 1 day after receiving unspecified dose of vaccine (Lot number unknown). The patient expired from acute aortic dissection. Very limited information regarding the clinical details pertaining to death was provided at this time. No further information is expected.; Sender''s Comments: This is a case of death of a 55-year-old male patient, 1 day after receiving unspecified dose of vaccine (Lot number unknown). The patient expired from acute aortic dissection. Very limited information regarding the clinical details pertaining to death was provided at this time. No further information is expected.; Reported Cause(s) of Death: Acute aortic dissection


VAERS ID: 1477526 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-06-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arteriosclerosis coronary artery, Computerised tomogram, Myocardial ischaemia, Nausea, Tryptase, Vaccination site pain
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-10
   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: Dementia; Hypertension; Large intestine polyp
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Whole-body CT scan of the cadaver; Result Unstructured Data: severe calcification of the coronary artery and hypostasis in the dorsal side which was indicative of status post pulmonary congestion.; Test Name: Tryptase; Result Unstructured Data: the patient was diagnosed with ischemic heart disease secondary to coronary arteriosclerosis.
CDC Split Type: JPTAKEDA2021TJP057641

Write-up: Queasy; Coronary arteriosclerosis; Ischaemic heart disease; Pain in the vaccinated arm; This case was received via a regulatory authority (Reference number: v21118572) on 09-Jul-2021 and was forwarded to Moderna on 13-Jul-2021. This regulatory authority case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (Pain in the vaccinated arm), NAUSEA (Queasy), ARTERIOSCLEROSIS CORONARY ARTERY (Coronary arteriosclerosis) and MYOCARDIAL ISCHAEMIA (Ischaemic heart disease) in a 71-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Hypertension, Large intestine polyp and Dementia. On 09-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 09-Jun-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced VACCINATION SITE PAIN (Pain in the vaccinated arm) (seriousness criterion death). On 10-Jun-2021, the patient experienced NAUSEA (Queasy) (seriousness criterion death), ARTERIOSCLEROSIS CORONARY ARTERY (Coronary arteriosclerosis) (seriousness criterion death) and MYOCARDIAL ISCHAEMIA (Ischaemic heart disease) (seriousness criteria death and medically significant). The patient died on 10-Jun-2021. The reported cause of death was pain in the vaccinated arm, Queasy, coronary arteriosclerosis and Ischaemic heart disease. An autopsy was performed. The autopsy-determined cause of death was coronary arteriosclerosis and Ischaemic heart disease. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: abnormal (abnormal) severe calcification of the coronary artery and hypostasis in the dorsal side which was indicative of status post pulmonary congestion. On an unknown date, Tryptase (2.1-9.0): 1.6 mcg/l (Low) the patient was diagnosed with ischemic heart disease secondary to coronary arteriosclerosis.. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered VACCINATION SITE PAIN (Pain in the vaccinated arm), NAUSEA (Queasy), ARTERIOSCLEROSIS CORONARY ARTERY (Coronary arteriosclerosis) and MYOCARDIAL ISCHAEMIA (Ischaemic heart disease) to be not related. Company comment: The reporting physician explained several times to the bereaved family members (first son and second son) that the patient had ischaemic heart disease secondary to coronary arteriosclerosis. The reporting physician also explained that the events did not meet "the criteria for Suspected Adverse Reaction Reporting established by a regulatory authority(the events occurred more than 4 hours after the vaccination)", but the reporting physician was unable to gain their understanding. The family members strongly requested to report this case because they believed that the events were associated with the coronavirus vaccination. Therefore, the reporting physician reported this case at the request of the bereaved family. The reporting physician hopes this is all right. The reporting physician will cooperate with the investigation upon request from destinations to report including a regulatory authority. The reporting physician explained several times to the bereaved family members (first son and second son) that the patient had ischaemic heart disease secondary to coronary arteriosclerosis. The reporting physician also explained that the events did not meet "the criteria for Suspected Adverse Reaction Reporting established by a regulatory authority (the events occurred more than 4 hours after the vaccination)", but the reporting physician was unable to gain their understanding. The family members strongly requested to report this case because they believed that the events were associated with the coronavirus vaccination. Therefore, the reporting physician reported this case at the request of the bereaved family. The reporting physician hopes this is all right. The reporting physician will cooperate with the investigation upon request from destinations to report including a regulatory authority; 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 this event has been provided at this time. No further follow-up information is expected.; Reported Cause(s) of Death: Pain in the vaccinated arm; Queasy; Coronary arteriosclerosis; Ischaemic heart disease; Autopsy-determined Cause(s) of Death: Coronary arteriosclerosis; Ischaemic heart disease


VAERS ID: 1477527 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002337 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Oxygen saturation, Pneumonia aspiration, Sepsis
SMQs:, Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-08
   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: Dementia Alzheimer''s type
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia Alzheimer''s type
Allergies:
Diagnostic Lab Data: Test Name: body temperature; Test Result: Inconclusive ; Result Unstructured Data: 36.7; Test Date: 20210708; Test Name: body temperature; Result Unstructured Data: 37.8; Test Date: 20210708; Test Name: body temperature; Result Unstructured Data: 38; Test Date: 20210708; Test Name: percutaneous oxygen saturation (SpO2); Result Unstructured Data: 87 percent
CDC Split Type: JPTAKEDA2021TJP057666

Write-up: Sepsis; Aspiration pneumonia; This regulatory authority case was reported by a physician and describes the occurrence of SEPSIS (Sepsis) and PNEUMONIA ASPIRATION (Aspiration pneumonia) in a 60-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002337) for COVID-19 vaccination. Family history included Dementia Alzheimer''s type. Concurrent medical conditions included Dementia Alzheimer''s type. On 07-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 08-Jul-2021, the patient experienced SEPSIS (Sepsis) (seriousness criteria death and medically significant) and PNEUMONIA ASPIRATION (Aspiration pneumonia) (seriousness criteria death and medically significant). The patient was treated with ACETAMINOPHEN on 08-Jul-2021 for Pyrexia, at a dose of 100 mg. The patient died on 08-Jul-2021. The reported cause of death was Sepsis and aspiration pneumonia. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jul-2021, Body temperature: 37.8 (High) 37.8 and 38 (High) 38. On 08-Jul-2021, Oxygen saturation: 87 (abnormal) 87 percent. On an unknown date, Body temperature: 36.7 (Inconclusive) 36.7. 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 PNEUMONIA ASPIRATION (Aspiration pneumonia) to be possibly related. The patient''s body temperature before vaccination was 36.7 degree Celsius. On 08-Jul-2021, at 06:00 AM the patient had sputum sticking sensation. On 08-Jul-2021, at 07:00, the signs of circulatory failure were noted. At 08:25, the patient experienced pyrexia of 38.0 degrees Celsius and took antipyretic (acetaminophen 100 mg) through a gastric fistula. At 09:45, the sign of respiratory failure was noted with percutaneous oxygen saturation (SpO2) of 87 percent. At 11:25, the patient had cardiopulmonary arrest. The patient had often had sputum sticking sensation due to juvenile dementia Alzheimer''s type, and thus was diagnosed with aspiration pneumonia and sepsis. The causal relationship of the events with the vaccine is unclear. This a report of dead one day after receiving the product in a 60-years old patient with concomitant Dementia Alzheimer''s type 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. The patient had often had sputum sticking sensation due to juvenile dementia Alzheimer''s type, and thus was diagnosed with aspiration pneumonia and sepsis. The causal relationship of the events with the vaccine is unclear.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This a report of dead one day after receiving the product in a 60-years old patient with concomitant Dementia Alzheimer''s type 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: Sepsis; Aspiration pneumonia


VAERS ID: 1478711 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-06-01
   Days after vaccination:41
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Infection, Mesenteric haemorrhage, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (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), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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: DEPEI202100129257

Write-up: Renal failure; Infection; Mesenteric bleeding; This regulatory authority case was reported by a physician and describes the occurrence of RENAL FAILURE (Renal failure), INFECTION (Infection) and MESENTERIC HAEMORRHAGE (Mesenteric bleeding) in a 72-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Previously administered products included for COVID-19 vaccination: MODERNA COVID-19 VACCINE on 21-Apr-2021. On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-May-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced RENAL FAILURE (Renal failure) (seriousness criteria death, hospitalization and medically significant), INFECTION (Infection) (seriousness criteria death and hospitalization) and MESENTERIC HAEMORRHAGE (Mesenteric bleeding) (seriousness criteria death, hospitalization and medically significant). The patient died on 02-Jul-2021. The reported cause of death was Renal failure. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The concomitant medication and treatment medication were not provided. Very limited information regarding the event Mesenteric hemorrhage has been provided at this time. Case causality is confounded by advanced age for the event Renal failure which could have predisposed to infection.; Sender''s Comments: Very limited information regarding the event Mesenteric haemorrhage has been provided at this time. Case causality is confounded by advanced age for the event Renal failure which could have predisposed to infection.; Reported Cause(s) of Death: Renal failure


VAERS ID: 1480157 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-06-05
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Brain natriuretic peptide, Cardiac failure, Dyspnoea
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-14
   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: Test Date: 20210609; Test Name: Brain natriuretic peptide; Result Unstructured Data: BNP-2000 (Increased)
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: Dyspnoea; Heart failure; This regulatory authority case was reported by a physician and describes the occurrence of CARDIAC FAILURE (Heart failure) and DYSPNOEA (Dyspnoea) in a 57-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 immunisation. No Medical History information was reported. On 24-May-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jun-2021, the patient experienced CARDIAC FAILURE (Heart failure) (seriousness criteria death, medically significant and life threatening). On an unknown date, the patient experienced DYSPNOEA (Dyspnoea) (seriousness criteria death and life threatening). The patient died on 14-Jun-2021. The reported cause of death. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jun-2021, Brain natriuretic peptide: 2000 (High) BNP-2000 (Increased). For mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. This is a case of 57-year-old male patient who experienced Cardiac failure and Dyspnoea and subsequently died three weeks following a dose of mRNA-1273 vaccine. Very limited information regarding these events has been provided at this time. No information regarding patient''s relevant medical history nor concomitant medications was provided. Furthermore, it is unknown if an autopsy was performed.; Sender''s Comments: This is a case of 57-year-old male patient who experienced Cardiac failure and Dyspnoea and subsequently died three weeks following a dose of mRNA-1273 vaccine. Very limited information regarding these events has been provided at this time. No information regarding patient''s relevant medical history nor concomitant medications was provided. Furthermore, it is unknown if an autopsy was performed.; Reported Cause(s) of Death


VAERS ID: 1480178 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest, Fatigue, Malaise, Nausea
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: 2021-04-14
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bladder cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: ; This regulatory authority case was reported by a non-health professional and describes the occurrence of CARDIAC ARREST , NAUSEA, MALAISE and FATIGUE in an 84-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Bladder cancer. On 09-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced FATIGUE (seriousness criterion death). On 11-Apr-2021, the patient experienced CARDIAC ARREST (Haar lichaam/hart stopte er gewoon mee) (seriousness criteria death and medically significant), NAUSEA (seriousness criterion death) and MALAISE (seriousness criterion death). The patient died on 14-Apr-2021. The reported cause of death. An autopsy was not performed. 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


VAERS ID: 1480185 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-06-19
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Angiocardiogram, Blood bicarbonate, Blood creatine phosphokinase, Blood creatinine, Blood fibrinogen, Blood gases, Blood lactic acid, Blood test, Chest X-ray, Computerised tomogram head, Death, Glomerular filtration rate, Haemoglobin, International normalised ratio, Neck pain, PCO2, PO2, Platelet count, Prothrombin time, Troponin I, White blood cell count, pH body fluid
SMQs:, Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-22
   Days after onset: 3
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: 20210619; Test Name: aPTT; Result Unstructured Data: 60 sec; Test Date: 20210619; Test Name: CAG; Test Result: Inconclusive ; Result Unstructured Data: date was estimated most likely date, between start of events 19/6 and death 22/6; Test Date: 20210619; Test Name: bicarbonaat; Test Result: Inconclusive ; Result Unstructured Data: 19 mmol/L; Test Date: 20210619; Test Name: CK; Result Unstructured Data: 902 = high (<200= normal); Test Date: 20210619; Test Name: kreatinine; Result Unstructured Data: 97= normal for male; Test Date: 20210619; Test Name: fibrinogeen; Result Unstructured Data: 2.6 g/L = normal; Test Date: 20210619; Test Name: bloedgassen; Test Result: Inconclusive ; Result Unstructured Data: pH 7.28, pCO2 5.5 kPa, bicarbonaat 19 mmol/L. paO2 19.0 kPa.; Test Date: 20210619; Test Name: lactaat; Result Unstructured Data: 3.1 mmol/l; Test Date: 20210619; Test Name: Electrolyten; Result Unstructured Data: electrolytes normal; Test Date: 20210619; Test Name: Thorax X; Test Result: Inconclusive ; Result Unstructured Data: unknown; Test Date: 20210619; Test Name: CT Cerebrum; Test Result: Inconclusive ; Result Unstructured Data: unknown; Test Date: 20210619; Test Name: eGFR; Result Unstructured Data: $g90= normal; Test Date: 20210619; Test Name: hemoglobine; Result Unstructured Data: 11.3 mmlo/l = increased; Test Date: 20210619; Test Name: INR; Test Result: Inconclusive ; Result Unstructured Data: 1.2= normal; Test Date: 20210619; Test Name: pco2; Test Result: Inconclusive ; Result Unstructured Data: 5.5 kPa; Test Date: 20210619; Test Name: PH; Test Result: Inconclusive ; Result Unstructured Data: 7.28; Test Date: 20210619; Test Name: trombocyten; Result Unstructured Data: 454 = increased; Test Date: 20210619; Test Name: pao2; Test Result: Inconclusive ; Result Unstructured Data: 19 kPa; Test Date: 20210619; Test Name: PT; Result Unstructured Data: 16 sec = high; Test Date: 20210619; Test Name: Troponine I; Result Unstructured Data: 4319; Test Date: 20210619; Test Name: leukocyten; Result Unstructured Data: 19.6 = increased
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: ; This regulatory authority case was reported by a physician and describes the occurrence of DEATH in a 29-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. No Medical History information was reported. On 27-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 19-Jun-2021, the patient experienced NECK PAIN (nekpijn). On 22-Jun-2021, NECK PAIN outcome was unknown. The patient died on 22-Jun-2021. The cause of death was not reported. An autopsy was performed, but no results were provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jun-2021, Activated partial thromboplastin time (30-40): 60 (High) 60 sec. On 19-Jun-2021, Angiocardiogram: inconclusive (Inconclusive) date was estimated most likely date, between start of events 19/6 and death 22/6. On 19-Jun-2021, Blood bicarbonate: 19 mmol/l (Inconclusive) 19 mmol/L. On 19-Jun-2021, Blood creatine phosphokinase: 902 (High) 902 = high (<200= normal). On 19-Jun-2021, Blood creatinine: normal (normal) 97= normal for male. On 19-Jun-2021, Blood fibrinogen: 2.6 (normal) 2.6 g/L = normal. On 19-Jun-2021, Blood gases: ph 7.28, pco2 5.5 kpa, bicarbonaat 19 mmol/l. (Inconclusive) pH 7.28, pCO2 5.5 kPa, bicarbonaat 19 mmol/L. paO2 19.0 kPa.. On 19-Jun-2021, Blood lactic acid: 3.1 (High) 3.1 mmol/l. On 19-Jun-2021, Blood test: normal (normal) electrolytes normal. On 19-Jun-2021, Chest X-ray: unknown (Inconclusive) unknown. On 19-Jun-2021, Computerised tomogram head: unknown (Inconclusive) unknown. On 19-Jun-2021, Glomerular filtration rate: normal (normal) $g90= normal. On 19-Jun-2021, Haemoglobin: 11.3 (High) 11.3 mmlo/l = increased. On 19-Jun-2021, International normalised ratio: 1.2 (Inconclusive) 1.2= normal. On 19-Jun-2021, PCO2: 5.5 kpa (Inconclusive) 5.5 kPa. On 19-Jun-2021, PO2: 19 kpa (Inconclusive) 19 kPa. On 19-Jun-2021, Platelet count: 454 (High) 454 = increased. On 19-Jun-2021, Prothrombin time (11-14): 16 sec (High) 16 sec = high. On 19-Jun-2021, Troponin I: 4319 (High) 4319. On 19-Jun-2021, White blood cell count: 19.6 (High) 19.6 = increased. On 19-Jun-2021, pH body fluid: 7.28 (Inconclusive) 7.28. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. Treatment drug information was not given. Company Comment : This is a case of sudden death in 29-year-old male with no hx provided and associated of AE of neck pain, who died 1 month after receiving the first dose of vaccine. Very limited information has been provided at this time; Sender''s Comments: This is a case of sudden death in 29-year-old male with no hx provided and associated of AE of neck pain, who died 1 month after receiving the first dose of vaccine. Very limited information has been provided at this time; Reported Cause(s) of Death


VAERS ID: 1480372 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-05-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002333 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cough, Dyspnoea, Erythema, Haemoptysis, Localised oedema
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-14
   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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLMODERNATX, INC.MOD20212

Write-up: cough (blood in the discharge); redness and swelling in the abdominal area; dyspnoea; redness and swelling in the abdominal area; cough (blood in the discharge); This regulatory authority case was reported by a consumer and describes the occurrence of HAEMOPTYSIS (cough (blood in the secretion)), LOCALIZED OEDEMA (redness and swelling in the abdominal area), DYSPNOEA (shortness of breath), ERYTHEMA (redness and swelling in the abdominal area ) and COUGH (cough (blood in the secretion))in an elderly male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002333) for COVID-19 vaccination. No Medical History information was reported. On 12-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 13-May-2021, the patient experienced HAEMOPTYSIS (cough (blood in the secretion)) (seriousness criterion death), LOCALISED OEDEMA (redness and swelling in the abdominal cavity) (seriousness criterion death), DYSPNOEA (dyspnoea) (seriousness criterion death), ERYTHEMA (redness and swelling in the cavity area abdominal) (seriousness criterion death) and COUGH (cough (blood in the discharge))(seriousness criterion death). The patient died on 14-May-2021. The cause of death was not reported. An autopsy was performed, but no results were provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. No concomitant medications were reported. No treatment information was provided. 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: Unknown cause of death


VAERS ID: 1480374 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-06-04
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   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: TRITTICO
Current Illness: Insomnia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLMODERNATX, INC.MOD20212

Write-up: Suspicion of pulmonary embolism; Headache; This regulatory authority case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Suspicion of pulmonary embolism) and HEADACHE (Headache) in a 28-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Insomnia. Concomitant products included TRAZODONE HYDROCHLORIDE (TRITTICO) for Insomnia. On 26-May-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 04-Jun-2021 at 1:00 AM, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced HEADACHE (Headache) (seriousness criterion death). On 04-Jun-2021 at 11:33 AM, the patient experienced PULMONARY EMBOLISM (Suspicion of pulmonary embolism) (seriousness criteria death and medically significant). The patient died on 04-Jun-2021. The reported cause of death was suspicion of pulmonary embolism. An autopsy was not performed. No Treatment information was provided. This is a case of sudden death in a 28-year-old male subject, who died 9 days after receiving first dose of vaccine, cause of death was not specified, an autopsy was not performed, Very limited information has been provided at this time.; Sender''s Comments: This is a case of sudden death in a 28-year-old male subject,who died 9 days after receiving first dose of vaccine, cause of death was not specified an autopsy was not performed, Very limited information has been provided at this time.; Reported Cause(s) of Death: Suspicion of pulmonary embolism


VAERS ID: 1480488 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-20
Onset:2021-06-16
   Days after vaccination:88
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001414 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Heart rate, Oxygen saturation, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-21
   Days after onset: 5
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: FILOTEMPO; TAMSULOSIN; RAMIPRIL; BUDESONIDE; UMECLIDINIUM BROMIDE;VILANTEROL; CARVEDILOL; FUROSEMIDE; ROSUVASTATIN; ALLOPURINOL; ACETYLSALICYLIC ACID; ESOMEPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: B-cell small lymphocytic lymphoma (with clinical stability.); Benign prostatic hyperplasia; Chronic respiratory failure; Dyslipidemia; Fibrillation atrial; Interstitial lung disease; Comments: It is unknown if there is a history of COVID-19 infection prior to vaccination
Allergies:
Diagnostic Lab Data: Test Date: 20210612; Test Name: Body temperature; Test Result: Inconclusive ; Result Unstructured Data: 38,8�C Iu international unit(s); Test Date: 20210612; Test Name: Heart rate; Test Result: Inconclusive ; Result Unstructured Data: 110bpm Iu international unit(s); Test Date: 20210612; Test Name: Oxygen saturation; Test Result: Inconclusive ; Result Unstructured Data: 93% Iu international unit(s); Test Date: 20210616; Test Name: SARS-CoV-2 test; Result Unstructured Data: unknown
CDC Split Type: PTMODERNATX, INC.MOD20212

Write-up: Severe SARS-CoV-2 pneumonia; This regulatory authority case was reported by a physician and describes the occurrence of VACCINATION FAILURE (Severe SARS-CoV-2 pneumonia) in an 88-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 3001650 and 3001414) for COVID-19 vaccination. It is unknown whether there is a history of COVID-19 infection prior to vaccination. The patient''s past medical history included Interstitial lung disease, Fibrillation atrial, Dyslipidemia, B-cell small lymphocytic lymphoma (with clinical stability.), Benign prostatic hyperplasia and Chronic respiratory failure. Concomitant products included AMINOPHYLLINE (FILOTEMPO), TAMSULOSIN, RAMIPRIL, BUDESONIDE, UMECLIDINIUM BROMIDE;VILANTEROL, CARVEDILOL, FUROSEMIDE, ROSUVASTATIN, ALLOPURINOL, ACETYLSALICYLIC ACID and ESOMEPRAZOLE for an unknown indication. On 20-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Parenteral) 1 milliliter. On 19-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Parenteral) dosage was changed to 1 milligram. On 16-Jun-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced VACCINATION FAILURE (Severe SARS-CoV-2 pneumonia) (seriousness criteria death, hospitalization prolonged and life threatening). The patient died on 21-Jun-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 12-Jun-2021, Body temperature: 38.8 (Inconclusive) 38,8�C Iu international unit(s). On 12-Jun-2021, Heart rate: 110 (Inconclusive) 110bpm Iu international unit(s). On 12-Jun-2021, Oxygen saturation: 93% (Inconclusive) 93% Iu international unit(s). On 16-Jun-2021, SARS-CoV-2 test: unknown unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Parenteral), the reporter did not provide any causality assessments. No treatment information is provided. Previous history of COVID-19 infection prior to vaccination was unknown. Action taken with mRNA-1273 in response to the events were not applicable This fatal case concerns a 88-year-old male hospitalized with a serious unexpected event of severe SARS-CoV-2 pneumonia (vaccination failure). Event onset 59 days after second dose mRNA-1273. Event outcome death. Based on 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 01-Jul-2021: Translation document received on 06-JUL-2021, Other Relevant History updated, Concomitant medication (Filotempo-extended released tablet) added, Reporter''s comment updated.; Sender''s Comments: This fatal case concerns a 88-year-old male hospitalized with a serious unexpected event of severe SARS-CoV-2 pneumonia (vaccination failure). Event onset 59 days after second dose mRNA-1273. Event outcome death. Based on 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: Unknown cause of death


VAERS ID: 1480696 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Septic shock
SMQs:, Toxic-septic shock conditions (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   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: SEMODERNATX, INC.MOD20212

Write-up: Septic shock; D�DSFALL; This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (D�DSFALL) and SEPTIC SHOCK (Septic shock) in an 86-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. In 2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SEPTIC SHOCK (Septic shock) (seriousness criteria death and medically significant). The patient died in May 2021. The reported cause of death was Septic shock. It is unknown if an autopsy was performed. Concomitant medication of the patient was not reported. No treatment information was provided by the reporter. Company comment: Very limited information regarding the event has been provided.; Sender''s Comments: Very Limited information regarding the event has been provided.; Reported Cause(s) of Death: Septic shock


VAERS ID: 1484301 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-12
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002339 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Completed suicide
SMQs:, Suicide/self-injury (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-12
   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: ATMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of COMPLETED SUICIDE in a 43-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002339) for COVID-19 vaccination. No Medical History information was reported. On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jun-2021, the patient experienced COMPLETED SUICIDE (seriousness criteria death and medically significant). The patient died on 12-Jun-2021. The reported cause of death was Suicide. 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 given by the reporter. No Treatment information were provided by the reporter. 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: Suicide


VAERS ID: 1484362 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-04-21
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Coagulopathy
SMQs:, Haemorrhage laboratory terms (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-21
   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: Coagulation factor V level abnormal
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of COAGULOPATHY in a 74-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Coagulation factor V level abnormal. On 07-Apr-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced COAGULOPATHY (seriousness criterion death). The patient died on 21-Apr-2021. The reported cause of death was Coagulation disorder. An autopsy was not performed. No concomitant medications were reported. No treatment information was reported by reporter. This is a case of sudden death in a 74-year-old female patient with a history of coagulation factor V level abnormal, who died of coagulation disorder 15 days after receiving a dose of vaccine. Very limited information has been provided at this time.; Sender''s Comments: This is a case of sudden death in a 74-year-old female patient with a history of coagulation factor V level abnormal, who died of coagulation disorder 15 days after receiving a dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Coagulation disorder


VAERS ID: 1485770 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-12
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003190 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, 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: 2021-07-13
   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: CANDESARTAN CILEXETIL
Current Illness: Dyslipidaemia (Dyslipidemia (10 mg of atorvastatin calcium hydrate)); Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: 36.5 degree celsius
CDC Split Type: JPTAKEDA2021TJP058475

Write-up: Subarachnoid hemorrhage; This spontaneous case was reported by a physician and describes the occurrence of SUBARACHNOID HAEMORRHAGE (Subarachnoid hemorrhage) in a 53-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003190) for COVID-19 vaccination. Concurrent medical conditions included Hypertension and Dyslipidaemia (Dyslipidemia (10 mg of atorvastatin calcium hydrate)). Concomitant products included CANDESARTAN CILEXETIL for Hypertension. On 08-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 12-Jul-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced SUBARACHNOID HAEMORRHAGE (Subarachnoid hemorrhage) (seriousness criteria death and medically significant). The patient died on 13-Jul-2021. The reported cause of death was Subarachnoid haemorrhage. An autopsy was performed. The autopsy-determined cause of death was Subarachnoid haemorrhage. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 36.5 (Low) 36.5 degree celsius. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered SUBARACHNOID HAEMORRHAGE (Subarachnoid hemorrhage) to be possibly related. concomitant product included atorvastatin calcium hydrate. No treatment information was given. Very limited information regarding this event has been provided at this time. No further follow-up information is expected 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; Reported Cause(s) of Death: Subarachnoid haemorrhage; Autopsy-determined Cause(s) of Death: Subarachnoid haemorrhage


VAERS ID: 1488327 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-06-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003187 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Myocardial infarction
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), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-29
   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: Comments: No medical history was reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Cardio-respiratory arrest; Infarct myocardial; This regulatory authority case was reported by a physician and describes the occurrence of CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) and MYOCARDIAL INFARCTION (Infarct myocardial) in a 71-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003187) for COVID-19 vaccination. No medical history was reported. On 28-Jun-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 28-Jun-2021, the patient experienced CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) (seriousness criteria death and medically significant) and MYOCARDIAL INFARCTION (Infarct myocardial) (seriousness criteria death and medically significant). The patient died on 29-Jun-2021. The reported cause of death was Cardio-respiratory arrest and Infarct myocardial. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Relevant concomitant medications were not provided. Treatment information was not provided. The Sender''s (Case) Safety Report Unique Identifier is FR-AFSSAPS-NC20212796. Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Further information (SD translation) is expected.; Sender''s Comments: Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Further information (SD translation) is expected.; Reported Cause(s) of Death: Cardio-respiratory arrest; Infarct myocardial


VAERS ID: 1488348 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-10
Onset:2021-06-07
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001657 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-07
   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: Hypertension arterial; Insufficiency renal
Preexisting Conditions: Medical History/Concurrent Conditions: Cancer of prostate
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 87-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001657) for COVID-19 vaccination. The patient''s past medical history included Cancer of prostate. Concurrent medical conditions included Hypertension arterial and Insufficiency renal. On 10-May-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 ml. Death occurred on 07-Jun-2021 The patient died on 07-Jun-2021. The cause of death was not reported. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication were not reported. This sender''s number was reported as PO20213284 Treatment medication were not reported. Very limited information regarding this event has been provided at this time. More details including concomitant medications, clinical condition prior to death and cause of death/ autopsy report is required for further assessment.; Sender''s Comments: Very limited information regarding this event has been provided at this time. More details including concomitant medications, clinical condition prior to death and cause of death/ autopsy report is required for further assessment.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1488395 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-21
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002616 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Chest pain, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-23
   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: Medical History/Concurrent Conditions: Hypercholesterolaemia; Obesity; Smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Sudden death; Chest pain; Abdominal pain; This regulatory authority case was reported by a pharmacist and describes the occurrence of SUDDEN DEATH (Sudden death), ABDOMINAL PAIN (Abdominal pain) and CHEST PAIN (Chest pain) in a 41-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002616) for COVID-19 vaccination. The patient''s past medical history included Obesity, Smoker and Hypercholesterolaemia. On 04-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 21-Jun-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced ABDOMINAL PAIN (Abdominal pain) (seriousness criterion death). On 22-Jun-2021, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion death). The patient died on 23-Jun-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. The Sender''s (Case) Safety Report Unique Identifier is FR-AFSSAPS-RS20212053 No concomitant medications were provided by the reporter. This is a case of sudden death in a 41-year-old male subject with a history of Obesity, Smoking and Hypercholesterolemia, who died 20 days after receiving first dose of vaccine with other reported serious unexpected events Chest pain and Abdominal pain. The cause of death was not specified and it is not known whether 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 41-year-old male subject with a history of Obesity, Smoking and Hypercholesterolemia, who died 20 days after receiving first dose of vaccine with other reported serious unexpected events Chest pain and Abdominal pain. The cause of death was not specified and it is not known whether an autopsy was performed. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1488561 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-05-01
   Days after vaccination:120
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   Days after onset: 31
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.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Fetal death; This regulatory authority case was reported by a consumer and describes the occurrence of FOETAL DEATH (Fetal death) in a 26-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No medical history was provided. On 01-Jan-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced FOETAL DEATH (Fetal death) (seriousness criteria death and medically significant). The patient died on 01-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Concomitant medications were not reported. Treatment details were not provided. This is a case of Fetal death in a 26-year-old reported as male patient (unable to confirm patient gender), 120 days after receiving second dose of vaccine (Lot number unknown). Very limited information regarding the clinical details pertaining to the fetal death in terms of gestational age at the time of vaccination and death, and the unconfirmed patient''s gender was provided at this time. No further information is expected.; Sender''s Comments: This is a case of Fetal death in a 26-year-old reported as male patient (unable to confirm patient gender), 120 days after receiving second dose of vaccine (Lot number unknown). Very limited information regarding the clinical details pertaining to the fetal death in terms of gestational age at the time of vaccination and death, and the unconfirmed patient''s gender was provided at this time. No further information is expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1489446 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-05-01
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001531 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pulmonary embolism
SMQs:, Embolic and thrombotic events, 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: SODIUM HYDROGEN CARBONATE; MIMPARA; PREDNISOLON ALTERNOVA; MIRTAZAPIN KRKA; ADPORT; MYCOPHENOLATE MOFETIL SANDOZ; ZOPIKLON PILUM; BACTRIM; OMEPRAZOL TEVA [OMEPRAZOLE SODIUM]; OXASCAND; BISOPROLOL SANDOZ; CANDESARTAN SANDOZ; VALGANCICLOVIR T
Current Illness: Anxiety; Cardiomyopathy; Depression; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Blisters (Bl�sor p� kroppen som en tidigare l�kemedelsbiverkan av Furosemid); Kidney transplant
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20212

Write-up: LUNGEMBOLI; This regulatory authority case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM (LUNGEMBOLI) in a 69-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001531) for COVID-19 immunisation. The patient''s past medical history included Blisters (Blisters on the body as a previous drug side effect of Furosemide) and Kidney transplant on 18-Feb-2021. Concurrent medical conditions included Hypertension since 2005, Anxiety, Cardiomyopathy since 2005 and Depression. Concomitant products included SODIUM HYDROGEN CARBONATE, CINACALCET HYDROCHLORIDE (MIMPARA), PREDNISOLONE (PREDNISOLON ALTERNOVA), MIRTAZAPINE (MIRTAZAPIN KRKA), TACROLIMUS (ADPORT), MYCOPHENOLATE MOFETIL (MYCOPHENOLATE MOFETIL SANDOZ), ZOPICLONE (ZOPIKLON PILUM), SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM), OMEPRAZOLE SODIUM (OMEPRAZOL TEVA [OMEPRAZOLE SODIUM]), OXAZEPAM (OXASCAND), BISOPROLOL FUMARATE (BISOPROLOL SANDOZ), CANDESARTAN CILEXETIL (CANDESARTAN SANDOZ), VALGANCICLOVIR HYDROCHLORIDE (VALGANCICLOVIR TEVA) and SERTRALINE HYDROCHLORIDE (SERTRALIN TEVA) for Adverse event. In April 2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. In May 2021, the patient experienced PULMONARY EMBOLISM (LUNGEMBOLI) (seriousness criteria death and medically significant). The reported cause of death was Pulmonary embolism. An autopsy was performed, but no results were provided. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No treatment information was provided. 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 The past history of cardiomyopathy and hypertension are confounders; 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 The past history of cardiomyopathy and hypertension are confounders; Reported Cause(s) of Death: Pulmonary embolism


VAERS ID: 1489467 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-21
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: Comments: No medical history was reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: SKMODERNATX, INC.MOD20212

Write-up: smrt; This regulatory authority case was reported by a consumer and describes the occurrence of DEATH in a female patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. No medical history was reported. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. An autopsy was performed, but no results were provided. No concomitant medications were provided. Treatment for the events were not provided. This is a case of death of an unknown patient, after receiving vaccine (Lot number unknown); Very limited information regarding the clinical details pertaining to death was provided at this time. No further information is expected. Per Regulatory SD, because of insufficient information on this case, the causal relationship cannot be assess. The assessment by the pathologist is not yet available. After addition of information, the causality will be verified.; Sender''s Comments: This is a case of death of an unknown patient, after receiving vaccine (Lot number unknown); Very limited information regarding the clinical details pertaining to death was provided at this time. No further information is expected. Per Regulatory SD, because of insufficient information on this case, the causal relationship cannot be assess. The assessment by the pathologist is not yet available. After addition of information, the causality will be verified.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1489921 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-06-18
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-18
   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: Medical History/Concurrent Conditions: Fibrillation atrial; Hyperlipidemia; Hypertension arterial
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20212

Write-up: Sudden death; Haemorrhage nasal; This regulatory authority case was reported by a physician and describes the occurrence of SUDDEN DEATH (Sudden death) and EPISTAXIS (Haemorrhage nasal) in a 67-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Fibrillation atrial, Hypertension arterial and Hyperlipidemia. On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) .5 milliliter. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 18-Jun-2021, the patient experienced SUDDEN DEATH (Sudden death) (seriousness criteria death and medically significant) and EPISTAXIS (Haemorrhage nasal) (seriousness criterion death). The patient died on 18-Jun-2021. An autopsy was performed. The autopsy-determined cause of death was Sudden cardiac death. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication reported. No treatment information provided. Company Comment : Very limited information regarding these events has been provided at this time.Further information (translation) is expected.; Sender''s Comments: Very limited information regarding these events has been provided at this time.Further information (translation) is expected.; Autopsy-determined Cause(s) of Death: Sudden cardiac death


VAERS ID: 1497104 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-24
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002188 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Dehydration, General physical health deterioration, Pain, Sepsis
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Dehydration (narrow), Sepsis (narrow), Opportunistic infections (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: FUROSEMIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pelvic fracture; Renal failure (3 years ago)
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: increased
CDC Split Type: SKMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of SEPSIS, GENERAL PHYSICAL HEALTH DETERIORATION, DEHYDRATION and PAIN in an 82-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002188) for COVID-19 vaccination. The patient''s past medical history included Pelvic fracture and Renal failure (3 years ago). Concomitant products included FUROSEMIDE for an unknown indication. On 24-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SEPSIS (seriousness criteria death, hospitalization and medically significant), GENERAL PHYSICAL HEALTH DETERIORATION (seriousness criterion hospitalization), DEHYDRATION (seriousness criterion hospitalization) and PAIN (seriousness criterion hospitalization). The patient died on an unknown date. The reported cause of death was Sepsis. An autopsy was performed, but no results were provided. At the time of death, GENERAL PHYSICAL HEALTH DETERIORATION, DEHYDRATION and PAIN outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: increased (High) increased. Treatment information was not provided. This is a case of an 82-year-old male patient with medical history of pelvic fracture and renal failure who developed Sepsis, General physical health deterioration, Dehydration and Pain. The patient died due to sepsis. An autopsy was performed, but no results were provided. Very limited information regarding these events has been provided at this time. No further information is expected.; Sender''s Comments: This is a case of an 82-year-old male patient with medical history of pelvic fracture and renal failure who developed Sepsis, General physical health deterioration, Dehydration and Pain. The patient died due to sepsis. An autopsy was performed, but no results were provided. Very limited information regarding these events has been provided at this time. No further information is expected.; Reported Cause(s) of Death: Sepsis


VAERS ID: 1499915 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-07
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003601 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebral haemorrhage, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-10
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TORVAST; CARDIOASPIRIN; VASORETIC
Current Illness: Dyslipidaemia; Hypertension arterial
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal aortic aneurysm
Allergies:
Diagnostic Lab Data: Test Date: 20210331; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: COVID-19 PCR test positive
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of CEREBRAL HAEMORRHAGE (EMORRAGIA CEREBRALE) in a 76-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003601) for COVID-19 vaccination. The patient''s past medical history included Abdominal aortic aneurysm on 01-Oct-2019 and Dyslipidaemia. Concurrent medical conditions included Hypertension arterial. Concomitant products included ATORVASTATIN CALCIUM (TORVAST), ACETYLSALICYLIC ACID (CARDIOASPIRIN) and ENALAPRIL MALEATE, HYDROCHLOROTHIAZIDE (VASORETIC) for an unknown indication. On 01-Jul-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced CEREBRAL HAEMORRHAGE (EMORRAGIA CEREBRALE) (seriousness criteria death and medically significant). The patient died on 10-Jul-2021. The reported cause of death was Cerebral haemorrhage. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, SARS-CoV-2 test: positive (Positive) COVID-19 PCR test positive. 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. On 07-Jul-2021, laboratory tests of angiogram cerebral, brain CT and hematology were performed and results were not reported. Treatment information was not provided.; Sender''s Comments: This is a case of a 76-year-old male patient who experienced Cerebral haemorrhage 7 days following a dose of mRNA-1273 and subsequently died 10 days following vaccination. Very limited information regarding the event has been provided at this time. Detailed information regarding clinical course of the event was not provided. It is also unknown whether an autopsy was performed. Major confounder in this particular case is patient''s reported medical history of Hypertension arterial, in addition to patient''s advanced age.; Reported Cause(s) of Death: Cerebral haemorrhage


VAERS ID: 1500341 (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: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Epilepsy, Malaise
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Generalised convulsive seizures following immunisation (narrow)

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: CARBAMAZEPINE
Current Illness: Epilepsy (Family History is negative for epilepsy.)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of EPILEPSY and MALAISE in a 29-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Epilepsy (Family History is negative for epilepsy.). Concomitant products included CARBAMAZEPINE for an unknown indication. On 07-Jul-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 10-Jul-2021, the patient experienced EPILEPSY (seriousness criteria death and medically significant) and MALAISE (seriousness criterion death). The patient died on 10-Jul-2021. The reported cause of death was unknown. An autopsy was performed, but no results were provided. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided by the reporter. 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


VAERS ID: 1500367 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-21
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (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: PARACETAMOL
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOMODERNATX, INC.MOD20212

Write-up: Bl�dning; This regulatory authority case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Bl�dning) in a 72-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No medical history was provided by reporter. Concomitant products included PARACETAMOL for an unknown indication. On 21-Jun-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (Bl�dning) (seriousness criteria death and medically significant). The cause of death was not reported. It is unknown if an autopsy was performed. Treatment medication use information was not provided by reporter. Action taken with mRNA-1273 in response to the events was not applicable. The reporter did not provide causality assessment between mRNA-1273 and the events. This is a case of death in a 72-year-old female subject, who died 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 72-year-old female subject, 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: 1503175 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA NC / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Haemorrhagic stroke, Incorrect route of product administration, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Drug abuse and dependence (broad), Medication errors (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-13
   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:
Current Illness: Asthma; Drug hypersensitivity; Fibromyalgia; Hypothyroidism; Obesity; Seasonal allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Bilateral cataracts
Allergies:
Diagnostic Lab Data: Test Date: 20210709; Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Hemorrhagic stroke; Incorrect route of product administration; This regulatory authority case was reported by a physician and describes the occurrence of HAEMORRHAGIC STROKE (Hemorrhagic stroke) in a 65-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. NC) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Bilateral cataracts. Concurrent medical conditions included Asthma, Hypothyroidism, Obesity, Fibromyalgia, Seasonal allergy and Drug hypersensitivity. On 09-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Subcutaneous) 1 dosage form. On 09-Jul-2021, the patient experienced HAEMORRHAGIC STROKE (Hemorrhagic stroke) (seriousness criteria death and medically significant) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Incorrect route of product administration). On 09-Jul-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Incorrect route of product administration) had resolved. The patient died on 13-Jul-2021. The reported cause of death was avc h�morragique. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jul-2021, SARS-CoV-2 test: negative (Negative) Negative. For mRNA-1273 (COVID 19 Vaccine Moderna) (Subcutaneous), the reporter did not provide any causality assessments. No concomitant medications or treatment details were reported. The case has been received from Regulatory Authority (Case#: FR-AFSSAPS-BX20216765) Company Comment: This is a case of sudden death in a 65-year-old female subject with hx of asthma, hypothyroidism, obesity, fibromyalgia, bilateral cataracts, seasonal allergy, drug hypersensitivity who died 4 days after receiving first dose of vaccine. Very limited information has been provided at this time. Furthermore, the report refers to a case of incorrect route of product administration for mRNA-1273 (lot # unknown) with associated AEs reported: Haemorrhagic stroke.; Sender''s Comments: This is a case of sudden death in a 65-year-old female subject with hx of asthma, hypothyroidism, obesity, fibromyalgia, bilateral cataracts, seasonal allergy, drug hypersensitivity who died 4 days after receiving first dose of vaccine. Very limited information has been provided at this time. Furthermore, the report refers to a case of incorrect route of product administration for mRNA-1273 (lot # unknown) with associated AEs reported: Haemorrhagic stroke.; Reported Cause(s) of Death: AVC h�morragique


VAERS ID: 1503181 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-19
Onset:2021-06-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002919 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: SARS-CoV-2 test, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-20
   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: Obesity (Ob�sit�)
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20201201; Test Name: SARS-CoV-2 test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Death sudden; This regulatory authority case was reported by a physician and describes the occurrence of SUDDEN DEATH (Death sudden) in a 64-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002919) for COVID-19 vaccination. The patient''s past medical history included COVID-19. Concurrent medical conditions included Obesity. On 19-Jun-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. The patient died on 20-Jun-2021. The reported cause of death was idm. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Dec-2020, SARS-CoV-2 test: positive (Positive) Positive. mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was withdrawn on 19-Jun-2021. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported. Sender''s (Case) Safety Report Unique Identifier FR-FR-AFSSAPS-GR20213001. 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: IDM


VAERS ID: 1503266 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-07-03
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003181 / 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: 2021-07-03
   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: TIA
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Sudden death; This regulatory authority case was reported by a physician and describes the occurrence of SUDDEN DEATH (Sudden death) in a 51-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003181) for COVID-19 vaccination. The patient''s past medical history included TIA. On 18-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. The patient died on 03-Jul-2021. The reported cause of death was mort subite. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication information were provided by the reporter. No treatment information was provided. Sender''s (Case) Safety Report Unique Identifier: FR-AFSSAPS-RS20212320. This is a case of sudden death in a 51-year-old male patient with a medical history of Transient Ischemic Attack, that occurred 16 days after receiving first dose of vaccine (Lot number 3003181). Very limited information regarding the clinical details pertaining to death, complete medical history, and concomitant medication was provided at this time. No further information is expected.; Sender''s Comments: This is a case of sudden death in a 51-year-old male patient with a medical history of Transient Ischemic Attack, that occurred 16 days after receiving first dose of vaccine (Lot number 3003181). Very limited information regarding the clinical details pertaining to death, complete medical history, and concomitant medication was provided at this time. No further information is expected.; Reported Cause(s) of Death: mort subite


VAERS ID: 1504349 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-24
Submitted: 0000-00-00
Entered: 2021-07-27
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: 2021-06-24
   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: Comments: No medical history was provided.
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: Morte; This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Morte) in a 23-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No medical history was provided. On an unknown date, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. Death occurred on 24-Jun-2021 The patient died on 24-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. No relevant concomitant medications were reported. No treatment information was provided. Very limited information regarding this event has been provided at this time. Further information has been requested. Further information is not expected; Sender''s Comments: Very limited information regarding this event has been provided at this time. Further information has been requested. Further information is not expected; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1504956 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002916 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Death
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of DEATH and CHEST PAIN in an 18-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002916) for COVID-19 vaccination. No Medical History information was reported. On 12-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, the patient experienced DEATH and CHEST PAIN (seriousness criterion death). The patient died on 14-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. No concomitant medications were provided. No treatment information was provided. Company Comment: This is a case of death in a 18-year-old male subject, who died after receiving second dose of vaccine. Very limited information has been provided at this time.; Sender''s Comments: This is a case of death in a 18-year-old male subject, who died after receiving second dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: UNKNOWN


VAERS ID: 1510903 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214003 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Respiratory failure
SMQs:, Anaphylactic reaction (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 (broad), Respiratory failure (narrow), Hypokalaemia (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: ITMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of RESPIRATORY FAILURE in an 87-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 214003) for COVID-19 vaccination. No Medical History information was reported. On 08-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form in total. On 08-Jul-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced RESPIRATORY FAILURE (seriousness criteria death and medically significant). The patient died on 10-Jul-2021. The reported cause of death was Respiration failure. 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 information was provided. This case refers to an 87-year-old male patient who experienced serious unexpected event of respiratory failure 3 days after receiving the product mRNA-1273. Limited information regarding the patient''s medical history and underlying cause was reported for causality assessment at this time. Further information is expected.; Sender''s Comments: This case refers to an 87-year-old male patient who experienced serious unexpected event of respiratory failure 3 days after receiving the product mRNA-1273. Limited information regarding the patient''s medical history and underlying cause was reported for causality assessment at this time. Further information is expected.; Reported Cause(s) of Death: Respiration failure


VAERS ID: 1511228 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-07-12
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory arrest, Malaise, Pyrexia, SARS-CoV-2 test, Swelling, Vaccination site pain
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (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), Haemodynamic oedema, effusions and fluid overload (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-13
   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: Medical History/Concurrent Conditions: Arrhythmia; Pneumothorax
Allergies:
Diagnostic Lab Data: Test Date: 20210712; Test Name: Body temperature; Result Unstructured Data: pyrexia in the 38 degrees Celsius range; Test Date: 2021; Test Name: SARS-COV-2 antigen test; Test Result: Negative ; Result Unstructured Data: nasopharyngeal swab was negative
CDC Split Type: JPTAKEDA2021TJP062969

Write-up: Injection site pain; Swelling; Generalized malaise; Cardio-respiratory arrest; Pyrexia; This regulatory authority case was reported by a physician and describes the occurrence of CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest), VACCINATION SITE PAIN (Injection site pain), SWELLING (Swelling), MALAISE (Generalized malaise) and PYREXIA (Pyrexia) in a 32-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Arrhythmia and Pneumothorax. On 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jul-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jul-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced PYREXIA (Pyrexia) (seriousness criterion death). On 13-Jul-2021, the patient experienced CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) (seriousness criteria death and medically significant). On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection site pain) (seriousness criterion death), SWELLING (Swelling) (seriousness criterion death) and MALAISE (Generalized malaise) (seriousness criterion death). The patient died on 13-Jul-2021. The reported cause of death was Vaccination site pain, Swelling, Cardio-respiratory arrest, Pyrexia and General malaise. An autopsy was performed, but no results were provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) nasopharyngeal swab was negative. On 12-Jul-2021, Body temperature: 38 degrees celsius (High) pyrexia in the 38 degrees Celsius range. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular), the reporter considered CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest), VACCINATION SITE PAIN (Injection site pain), SWELLING (Swelling), MALAISE (Generalized malaise) and PYREXIA (Pyrexia) to be possibly related. After death, CT scan showed no findings of imaging abnormalities leading to death. No relevant concomitant medications were reported. No treatment information was provided. Case comment/sender''s comment: Since the patient had been in cardiac arrest for a long time at the time of the visit, sufficient examination could not be performed, and the apparent cause of death was unknown. It was considered that the possibility of vaccine-related death could not be ruled out in view of the sudden death of the young adult with no particular medical history and the occurrence of accompanying symptoms after the 2nd vaccination, followed by cardio-respiratory arrest. The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. 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. Worldwide unique case identification number: 2021TJP062969; 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: Vaccination site pain; Swelling; Cardio-respiratory arrest; Pyrexia; General malaise


VAERS ID: 1512126 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 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: 2021-05-01
   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: Diabetes.
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of SUDDEN DEATH (Suddenly died at night after 11 days from the second dose. At the first dose diarrhea after 5 days and then dry but suffocating cough, unresponsive to antibiotic. Second dose taken on 05/31/2021 in an 86-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Diabetes. On an unknown date, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. The patient died on 01-May-2021. The reported cause of death was died suddenly at night after 11 days from the second dose to the first dose diarrhea after 5 days and then dry but suffocating cough, unresponsive to antibiotic. second dose 05/31/2021.... It is unknown if an autopsy was performed. Concomitant product use was not provided by the reporter. Treatment information was not provided. Company comment: Limited information regarding the death has been provided at this time and a causal relationship cannot be excluded. Event term, onset date and outcome captured per Authority reporting. Event seriousness per assessment by Authority and per IME list Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-up information received on 26 Jul 2021 included updates to patient''s medical history.; Sender''s Comments: Limited information regarding the death has been provided at this time and a causal relationship cannot be excluded. Event term, onset date and outcome captured per Authority reporting. Event seriousness per assessment by Authority and per IME list; Reported Cause(s) of Death: Suddenly died at night after 11 days from the second dose At the first dose diarrhea after 5 days and then dry but suffocating cough, unresponsive to antibiotic. Second dose taken on 05/31/2021.


VAERS ID: 1512149 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Altered state of consciousness
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant 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: 2021-07-02
   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: Diabetes; Stroke; Urinary tract infection
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by an other and describes the occurrence of ALTERED STATE OF CONSCIOUSNESS (Change of consciousness) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Stroke, Diabetes and Urinary tract infection. 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 ALTERED STATE OF CONSCIOUSNESS (Change of consciousness) (seriousness criteria death and medically significant). The patient died on 02-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Concomitant product use was not provided. Treatment information was unknown. 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: unknown


VAERS ID: 1512158 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-08
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-29
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: 2021-07-12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
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 73-year-old female 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. Death occurred on 12-Jul-2021 The patient died on 12-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 product was not provided by the reporter. Treatment information was not provided. Company Comment This is a case of sudden death of a 73yo F who died 4 days after receiving vaccine. Very limited information regarding the event has been provided at this time.; Sender''s Comments: This is a case of sudden death of a 73yo F who died 4 days after receiving vaccine. Very limited information regarding the event has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1512159 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-08
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Death, Heart rate
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: Chronic obstructive pulmonary disease; Hypertension (Hypertension with Losartan control); Type 2 diabetes mellitus (Type 2 diabetes mellitus with Glibudon control)
Preexisting Conditions: Medical History/Concurrent Conditions: Lung cancer (Stage IV with left side pleural effusi)
Allergies:
Diagnostic Lab Data: Test Date: 20210710; Test Name: BP; Result Unstructured Data: BP 158/91mmH; Test Date: 20210710; Test Name: body temperature; Test Date: 20210710; Test Name: heart rate
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: death; This regulatory authority case was reported by a pharmacist and describes the occurrence of DEATH (death) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lung cancer (Stage IV with left side pleural effusi). Concurrent medical conditions included Hypertension (Hypertension with Losartan control), Type 2 diabetes mellitus (Type 2 diabetes mellitus with Glibudon control) and Chronic obstructive pulmonary disease. On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on an unknown date 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 10-Jul-2021, Blood pressure measurement: (High) BP 158/91mmH. On 10-Jul-2021, Body temperature: 37.4. On 10-Jul-2021, Heart rate: 140. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. Heart Rate 140 falling outside ER, initial rhythm bradycardia, no pulse. Company Comment This is a case of sudden death in a male of unknown age with medical hx of stage 4 lung cancer, DM, HTN, and COPD, who died on unknown date after receiving the 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 male of unknown age with medical hx of stage 4 lung cancer, DM, HTN, and COPD, who died on unknown date after receiving the first dose of vaccine. Very limited information has been provided at this time; Reported Cause(s) of Death: unknown cuase of death


VAERS ID: 1513918 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-05-11
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001650 / 2 - / 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: 2021-05-11
   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: Diabetes mellitus; Hypertension; Ischemic heart disease; Kidney failure chronic
Preexisting Conditions: Medical History/Concurrent Conditions: Congestive heart failure
Allergies:
Diagnostic Lab Data: Test Date: 20210505; Test Name: COVID-19 antigen test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 antigen test; Test Date: 20210505; Test Name: COVID-19 PCR test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 PCR test; Test Date: 20210506; Test Name: COVID-19 PCR test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 PCR test
CDC Split Type: HUMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH in a 54-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 3001650 and 3001946) for COVID-19 vaccination. The patient''s past medical history included Congestive heart failure. Concurrent medical conditions included Kidney failure chronic, Diabetes mellitus since 2010, Hypertension and Ischemic heart disease. On 07-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. Death occurred on 11-May-2021 The patient died on 11-May-2021. The reported cause of death was Congestive heart failure. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 antigen test and negative (Negative) Negative COVID-19 PCR test. On 06-May-2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 PCR test. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered DEATH to be not related. Concomitant product use was not provided by the reporter. No treatment information was provided. Sender''s comments: The reporter physician assessed the event as not related to the suspected vaccine. The case was considered serious because the outcome was fatal. Further information was not expected. This a report of death 7 days after receiving the second dose of the product in a 54-years old multimorbidity patient. Although a temporal association exists, there are important confounders/co-suspects for the event, and death certificate states congestive heart failure (a pre-existing condition) as cause of death. Very limited information regarding the events has been provided for inferring causality. Further information is not expected.; Sender''s Comments: This a report of death 7 days after receiving the second dose of the product in a 54-years old multimorbidity patient. Although a temporal association exists, there are important confounders/co-suspects for the event, and death certificate states congestive heart failure (a pre-existing condition) as cause of death. Very limited information regarding the events has been provided for inferring causality. Further information is not expected.; Reported Cause(s) of Death: Congestive heart failure


VAERS ID: 1514320 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-07
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-30
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: 2021-07-07
   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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: Death; This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 07-Jul-2021 The patient died on 07-Jul-2021. 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) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications are reported by the reporter. No treatment information is provided. This is a case of death in a 71-year-old male subject, 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 death in a 71-year-old male subject, 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: 1514321 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-12
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocarditis
SMQs:, 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: 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: TWMODERNATX, INC.MOD20212

Write-up: Myocarditis; This regulatory authority case was reported by a pharmacist and describes the occurrence of MYOCARDITIS (Myocarditis) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jul-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria death and medically significant). The reported cause of death was Myocarditis. 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 relevant concomitant medications were reported. No treatment information was provided. This is a case of sudden death in a 70-year-old male subject, who died 3 days after receiving the dose of vaccine. Very limited information has been provided at this time. Awaiting case translation.; Sender''s Comments: This is a case of sudden death in a 70-year-old male subject, who died 3 days after receiving the dose of vaccine. Very limited information has been provided at this time. Awaiting case translation.; Reported Cause(s) of Death: Myocarditis


VAERS ID: 1514322 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939697 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-11
   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 a pharmacist and describes the occurrence of DEATH (Death) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939697) for COVID-19 vaccination. No Medical History information was reported. On 10-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 11-Jul-2021 The patient died on 11-Jul-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. Concomitant product use was not provided. Treatment information was not provided. 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 death


VAERS ID: 1514323 (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: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939600CDC / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   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:
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 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939600CDC) for COVID-19 vaccination. Previously administered products included for Influenza immunization: influenza vaccine (Patient had no history of injections or adverse drug reactions.); for an unreported indication: Streptococcus pneumoniae (Patient had no history of adverse drug reactions.). Concurrent medical conditions included Hypertension. On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. Death occurred on 12-Jul-2021 The patient died on 12-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. The concomitant medication use was not provided. Treatment information was not provided by the reporter. This is a case of a 67-year-old male patient who received first dose of mRNA-1273 and died on the same day. Very limited information regarding this event has been provided at this time. No detailed information regarding patient''s medical history nor concomitant medications was provided. Furthermore, the exact cause of death was not provided. It is also unknown if an autopsy was performed. Causality is confounded with patient''s advanced age and medical history of hypertension.; Sender''s Comments: This is a case of a 67-year-old male patient who received first dose of mRNA-1273 and died on the same day. Very limited information regarding this event has been provided at this time. No detailed information regarding patient''s medical history nor concomitant medicatons was provided. Furthermore, the exact cause of death was not provided. It is also unknown if an autopsy was performed. Causality is confounded with patient''s advanced age and medical history of hypertension.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1514324 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-09
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-30
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: 2021-07-09
   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: 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 78-year-old female 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) (unknown route) 1 dosage form. Death occurred on 09-Jul-2021 The patient died on 09-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. The concomitant medications on use were not provided. No treatment information was provided. Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Sender''s Comments: Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1514326 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-30
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: 2021-07-10
   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: 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 78-year-old female 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. 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. 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. Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Sender''s Comments: Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1514327 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-14
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Ill-defined disorder
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: Comments: No medical history was provided.
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: ill-defined disorder; This regulatory authority case was reported by an other and describes the occurrence of ILL-DEFINED DISORDER (ill-defined disorder) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided. On 09-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 ILL-DEFINED DISORDER (ill-defined disorder) (seriousness criterion death). The patient died on 14-Jul-2021. The reported cause of death was Ill-defined disorder. It is unknown if an autopsy was performed. No concomitant medication was given. No treatment medication was given. Company Comment: This is a case of sudden death in a 79-year-old female subject, who died 5 days after receiving the dose of vaccine. Very limited information has been provided at this time. Awaiting case translation.; Sender''s Comments: This is a case of sudden death in a 79-year-old female subject, who died 5 days after receiving the dose of vaccine. Very limited information has been provided at this time. Awaiting case translation.; Reported Cause(s) of Death: ill-defined disorder


VAERS ID: 1514328 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-06
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-30
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: 2021-07-06
   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: COPD
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: Other; This regulatory authority case was reported by a pharmacist and describes the occurrence of DEATH (Other) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included COPD. On 04-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 06-Jul-2021 The patient died on 06-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 were not provided. Treatment information was not provided. Company comment:This is a case of an 81-year-old female patient who died after vaccination with mRNA-1273. Very limited information regarding this event has been provided at this time. The patient''s advanced age and underlying medical history of Chronic obstructive pulmonary disease significantly confound causality. No further information is expected.; Sender''s Comments: This is a case of an 81-year-old female patient who died after vaccination with mRNA-1273. Very limited information regarding this event has been provided at this time. The patient''s advanced age and underlying medical history of Chronic obstructive pulmonary disease significantly confound causality. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1514329 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-10
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939599-CDC / UNK - / 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: 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 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939599-CDC) 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) (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. No concomitant medication reported. No treatment information was provided. Company comments:This is a case of a 74-year-old female patient who died 8 days following vaccination with mRNA-1273. Very limited information regarding this event has been provided at this time. No information regarding patient''s medical history nor concomitant medications was provided. Furthermore, the exact cause of death was not provided. It is also unknown if an autopsy was performed. Causality is confounded with patient''s advanced age.; Sender''s Comments: This is a case of a 74-year-old female patient who died 8 days following vaccination with mRNA-1273. Very limited information regarding this event has been provided at this time. No information regarding patient''s medical history nor concomitant medicatons was provided. Furthermore, the exact cause of death was not provided. It is also unknown if an autopsy was performed. Causality is confounded with patient''s advanced age.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1514330 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939599-CDC / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-03
   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: other; This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (other) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939599-CDC) for COVID-19 vaccination. No Medical History information was reported. On 02-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. Death occurred on 03-Jul-2021 The patient died on 03-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) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. Treatment for the events were not provided. 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: 1514331 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-07
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-30
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: 2021-07-07
   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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: Death; This regulatory authority case was reported by a pharmacist and describes the occurrence of DEATH (Death) in a 56-year-old female 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) (unknown route) 1 dosage form. Death occurred on 07-Jul-2021 The patient died on 07-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. This is a case of a 56-year-old female patient who died 5 days following vaccination with mRNA-1273. Very limited information regarding this event has been provided at this time. No information regarding patient''s medical history nor concomitant medications was provided. Furthermore, the exact cause of death was not provided. It is also unknown if an autopsy was performed.; Sender''s Comments: This is a case of a 56-year-old female patient who died 5 days following vaccination with mRNA-1273. Very limited information regarding this event has been provided at this time. No information regarding patient''s medical history nor concomitant medications was provided. Furthermore, the exact cause of death was not provided. It is also unknown if an autopsy was performed.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1514334 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939599-CDC / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
   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: Diabetes; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Peritoneal dialysis; Renal disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: Death; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (Death) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939599-CDC) for COVID-19 vaccination. The patient''s past medical history included Renal disease and Peritoneal dialysis. Concurrent medical conditions included Diabetes and Hypertension. On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 06-Jul-2021 The patient died on 06-Jul-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. Concomitant product was not provided by the reporter. Treatment product was not provided by the reporter. A 74-year-old female patient who received mRNA-1273 died the same day after the first dose of vaccine. Medical history included RENAL DISEASE undergoing PERITONEAL DIALYSIS, DIABETES AND HYPERTENSION. Patient''s comorbidities may confound the event. The cause of death was not reported. Very limited information has been reported at this time. Further information is not expected.; Sender''s Comments: A 74-year-old female patient who received mRNA-1273 died the same day after the first dose of vaccine. Medical history included RENAL DISEASE undergoing PERITONEAL DIALYSIS, DIABETES AND HYPERTENSION. Patient''s comorbidities may confound the event. The cause of death was not reported. Very limited information has been reported at this time. Further information is not expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1514335 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-09
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-30
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: 2021-07-09
   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: TWMODERNATX, INC.MOD20212

Write-up: UNEVALUABLE EVENT; This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of DEATH (UNEVALUABLE EVENT) 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 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 09-Jul-2021 The patient died on 09-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 were not reported. Treatment medications were not reported. An 80-year-old male patient who received mRNA-1273 died three days after the first dose of vaccine. No medical history or conmeds were provided. Patient''s advanced age could carry with it some comorbidities which may confound the event. Very limited information has been reported at this time. Further information is not expected.; Sender''s Comments: An 80-year-old male patient who received mRNA-1273 died three days after the first dose of vaccine. No medical history or conmeds were provided. Patient''s advanced age could carry with it some comorbidities which may confound the event. Very limited information has been reported at this time. Further information is not expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1514336 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-11
Onset:2021-07-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Carbon dioxide, Death, Echocardiogram, Vaccination complication
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-11
   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:
Allergies:
Diagnostic Lab Data: Test Name: CO2; Test Result: Inconclusive ; Result Unstructured Data: 21; Test Name: Echocardiogram; Test Result: Inconclusive ; Result Unstructured Data: No pericardial effusion
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: Unknown cause of death; Vaccination adverse reaction; This regulatory authority case was reported by a pharmacist and describes the occurrence of DEATH (Unknown cause of death) in a 69-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 Hypertension. On 11-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jul-2021, the patient experienced DEATH (Unknown cause of death) (seriousness criteria death and medically significant) and VACCINATION COMPLICATION (Vaccination adverse reaction). The patient died on 11-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Carbon dioxide: 21 (Inconclusive) 21. On an unknown date, Echocardiogram: no pericardial effusion (Inconclusive) No pericardial effusion. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. There was no concomitant medication reported. CPR was performed. Asystole throughout the clinical course was noted. This is a case of Death in a 69-year-old female patient with a medical history of hypertension who died 1 day after receiving the dose 1 of the product mRNA-1273. Very limited information regarding the event (cause of death and clinical and diagnostic information) has been provided at this time insufficient for causality assessment. Additional information (translation) is awaited.; Sender''s Comments: This is a case of Death in a 69-year-old female patient with a medical history of hypertension who died 1 day after receiving the dose 1 of the product mRNA-1273. Very limited information regarding the event (cause of death and clinical and diagnostic information) has been provided at this time insufficient for causality assessment. Additional information (translation) is awaited.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1514337 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-02
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-30
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: TWMODERNATX, INC.MOD20212

Write-up: death; This regulatory authority case was reported by an other 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 02-Jul-2021, 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. Concomitant product use was not provided by the reporter. Treatment medication was not provided by the reporter. Very limited information regarding the event has been provided at this time. Further information may be provided after translation.; Sender''s Comments: Very limited information regarding the event has been provided at this time. Further information may be provided after translation.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1514338 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-04
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-30
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: 2021-07-04
   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: 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 64-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) (unknown route) 1 dosage form. Death occurred on 04-Jul-2021 The patient died on 04-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 concomitant medication information was mentioned by reporter. No treatment medication information was mentioned by reporter. Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Sender''s Comments: Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1514340 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-09
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-09
   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: TWMODERNATX, INC.MOD20212

Write-up: Headache; This regulatory authority case was reported by an other health care professional and describes the occurrence of HEADACHE (Headache) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jul-2021, the patient experienced HEADACHE (Headache) (seriousness criterion death). The patient died on 09-Jul-2021. The reported cause of death was Headache. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment information was provided. Action taken with vaccine was not applicable. This is a case of a 90-year-old male patient who developed headache six days following the administration of mRNA-1273 (Moderna COVID-19 Vaccine). The patient subsequently died. Very limited information regarding this event has been provided at this time. No information regarding the patient''s medical history, concomitant medications or autopsy results is available at this moment. The translation of the source document has been requested.; Sender''s Comments: This is a case of a 90-year-old male patient who developed headache six days following the administration of mRNA-1273 (Moderna COVID-19 Vaccine). The patient subsequently died. Very limited information regarding this event has been provided at this time. No information regarding the patient''s medical history, concomitant medications or autopsy results is available at this moment. The translation of the source document has been requested.; Reported Cause(s) of Death: Headache


VAERS ID: 1514341 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-05
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-30
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: 2021-07-05
   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 a consumer and describes the occurrence of DEATH (Death) in a 60-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. Death occurred on 05-Jul-2021 The patient died on 05-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Concomitant product was not provided. Treatment medication was not reported. Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Sender''s Comments: Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1514343 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-09
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Lethargy
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-09
   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: Medical History/Concurrent Conditions: No adverse event (Medical history not reported)
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: fatigue; Lethargy; This regulatory authority case was reported by an other health care professional and describes the occurrence of FATIGUE (fatigue) and LETHARGY (Lethargy) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jul-2021, the patient experienced FATIGUE (fatigue) (seriousness criterion death) and LETHARGY (Lethargy) (seriousness criterion death). The patient died on 09-Jul-2021. The reported cause of death was Fatigue and Lethargy. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not provided by the reporter. Treatment information was not provided.; Sender''s Comments: This is a case of sudden death in a 88-year-old male subject, who died 6 days after receiving the dose of vaccine. Very limited information has been provided at this time. Awaiting case translation.; Reported Cause(s) of Death: Fatigue; Lethargy


VAERS ID: 1514345 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-12
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-30
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: 2021-07-12
   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 a pharmacist and describes the occurrence of DEATH (Death) in a 66-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. Death occurred on 12-Jul-2021 The patient died on 12-Jul-2021. 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) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product was not provided by the reporter Treatment medication was not provided by the reporter. Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Sender''s Comments: Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1514347 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-09
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Fatigue
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (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: TWMODERNATX, INC.MOD20212

Write-up: fatigue; Diarrhea; This regulatory authority case was reported by an other and describes the occurrence of FATIGUE (fatigue) and DIARRHOEA (Diarrhea) in a 69-year-old female 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 09-Jul-2021, the patient experienced FATIGUE (fatigue) (seriousness criterion death) and DIARRHOEA (Diarrhea) (seriousness criterion death). The reported cause of death was Fatigue and Diarrhea. It is unknown if an autopsy was performed. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication were not provided Treatment medication were not reported This is a case of death in a 69-year-old female patient, 8 days after receiving an unspecified dose of vaccine (Lot number unknown). Very limited information regarding the clinical details pertaining to death, medical history, and the concomitant medications was provided at this time. No further information is expected.; Sender''s Comments: This is a case of death in a 69-year-old female patient, 8 days after receiving an unspecified dose of vaccine (Lot number unknown). Very limited information regarding the clinical details pertaining to death, medical history, and the concomitant medications was provided at this time. No further information is expected.; Reported Cause(s) of Death: Fatigue; Diarrhea


VAERS ID: 1514357 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-13
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Decreased appetite, Pyrexia, Vaccination complication
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: 2021-07-13
   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: Fever; Loss of appetite; Other; This regulatory authority case was reported by an other health care professional and describes the occurrence of PYREXIA (Fever), DECREASED APPETITE (Loss of appetite) and VACCINATION COMPLICATION (Other) in a 77-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 PYREXIA (Fever) (seriousness criterion death), DECREASED APPETITE (Loss of appetite) (seriousness criterion death) and VACCINATION COMPLICATION (Other) (seriousness criterion death). The patient died on 13-Jul-2021. The reported cause of death was Fever and loss of appetite. It is unknown if an autopsy was performed. 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 treatment information not provided. No concomitant medication not provided.; Sender''s Comments: This fatal case concerns a 77-year-old male with serious unexpected events of pyrexia, decreased appetite, and vaccination complication. Event latency 10 days after mRNA-1273. Cause of death reported as fever and loss of appetite. Based on 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: Fever; Loss of appetite


VAERS ID: 1517185 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003655 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (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)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-05
   Days after onset: 3
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:
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 CARDIAC ARREST and PYREXIA in a 53-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003655) for COVID-19 vaccination. Concurrent medical conditions included Hypertension. On 01-Jul-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 02-Jul-2021, the patient experienced CARDIAC ARREST (seriousness criteria death and medically significant) and PYREXIA (seriousness criterion death). The patient died on 05-Jul-2021. The reported cause of death was Arrest cardiac 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. Company Comment: Although, a temporal association exist, based on the available information, it is not possible to exclude other underlying cause as the patient experienced fever prior to cardiac arrest. In addition, the exact temperature and other diagnostic findings were not provided. Hence, details provided is not sufficient to adequately assess causality. No further information is expected. Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow-up received included no new information; Sender''s Comments: Although, a temporal association exist, based on the available information, it is not possible to exclude other underlying cause as the patient experienced fever prior to cardiac arrest. in addition, the exact temperature and other diagnostic findings were not provided. Hence, details provided is not sufficient to adequately assess causality. No further information is expected. Reported Cause(s) of Death: Arrest cardiac; Fever.


VAERS ID: 1517217 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002917 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardio-respiratory 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), Respiratory failure (broad)

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:
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 CARDIO-RESPIRATORY ARREST in a 49-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002917) for COVID-19 vaccination. No Medical History information was reported. On 15-Jul-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular). On 16-Jul-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced CARDIO-RESPIRATORY ARREST (ECG); (seriousness criteria death and medically significant). The patient died on 16-Jul-2021. The reported cause of death was cardio-respiratory (ecg). 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 and treatment information provided. Action taken with mRNA-1273 in response to the event was Not Applicable Company Comment: Very limited information regarding the serious unexpected event of Cardio-respiratory arrest has been provided at this time insufficient for causality assessment. Further information (translation) has been requested. Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Additional information was received from regulatory authority and contains no new information; Sender''s Comments: Very limited information regarding the serious unexpected event of Cardio-respiratory arrest has been provided at this time insufficient for causality assessment. Further information (translation) has been requested.


VAERS ID: 1517218 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002543 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Coombs positive haemolytic anaemia, Dyspnoea, Thrombocytopenia
SMQs:, Haemolytic disorders (narrow), Anaphylactic reaction (broad), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-10
   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: ITMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of THROMBOCYTOPENIA, COOMBS POSITIVE HAEMOLYTIC ANAEMIA and DYSPNOEA in an 84-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002543) for COVID-19 vaccination. No Medical History information was reported. On 01-Jun-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter in total. On 01-Jun-2021, the patient experienced THROMBOCYTOPENIA (seriousness criteria death and medically significant), COOMBS POSITIVE HAEMOLYTIC ANAEMIA (seriousness criteria death and medically significant) and DYSPNOEA (seriousness criterion death). The patient died on 10-Jun-2021. The reported cause of death was Thrombocytopenia, Hemolytic autoimmune anemia DCP and Dyspnea. 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 No treatment information was provided. The patient developed Haemolytic autoimmune anaemia ICP and Haemolytic autoimmune anaemia DCP. 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: Thrombocytopenia; Hemolytic autoimmune anemia DCP; Dyspnea


VAERS ID: 1517812 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-09
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Myalgia, Pyrexia, Sepsis
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), Sepsis (narrow), Opportunistic infections (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:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: Sepsis (Sepsis); fatigue; headache; muscle ache; fever; This regulatory authority case was reported by a consumer and describes the occurrence of SEPSIS (Sepsis (Sepsis)), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle ache) and PYREXIA (fever) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jul-2021, the patient experienced SEPSIS (Sepsis (Sepsis)) (seriousness criteria death and medically significant), FATIGUE (fatigue) (seriousness criterion death), HEADACHE (headache) (seriousness criterion death), MYALGIA (muscle ache) (seriousness criterion death) and PYREXIA (fever) (seriousness criterion death). The reported cause of death was Fatigue, Sepsis, Fever, Muscle ache and Headache. It is unknown if an autopsy was performed. Concomitant medication was not provided by reporter. No treatment information was provided. Company Comment A 73-year-old male patient experienced sepsis, fatigue, headache, myalgia and pyrexia 6 days following vaccination with mRNA-1273 and subsequently died. Very limited information regarding these events has been provided at this time. No information regarding patient''s medical history nor concomitant medicatons was provided. It is also unknown if an autopsy was performed. Causality is confounded with patient''s advanced age.; Sender''s Comments: A 73-year-old male patient experienced sepsis, fatigue, headache, myalgia and pyrexia 6 days following vaccination with mRNA-1273 and subsequently died. Very limited information regarding these events has been provided at this time. No information regarding patient''s medical history nor concomitant medicatons was provided. It is also unknown if an autopsy was performed. Causality is confounded with patient''s advanced age.; Reported Cause(s) of Death: fatigue; sepsis; fever; muscle ache; headache


VAERS ID: 1519432 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-05-26
   Days after vaccination:46
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-25
   Days after onset: 30
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 Name: COVID-19 PCR test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: BEMODERNATX, INC.MOD20212

Write-up: COVID-19 infectie na vaccinatie; This regulatory authority case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID-19 infectie na vaccinatie) in a 59-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 10-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced COVID-19 (COVID-19 infectie na vaccinatie) (seriousness criteria death and hospitalization). The patient died on 25-Jun-2021. The reported cause of death was covid-19 infectie na vaccinatie. 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: positive (Positive) Positive. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication information was not reported. Treatment medication was not reported. Company comment: Based on biological implausibility, a causal relationship between the reported serious unexpected event COVID-19 developed 1 month 17 days after the administration of mRNA-1273 is assessed as unlikely. The event was more consistent with the increased risk of environmentally mediated COVID-19 infections (including fatal infections) due to ongoing COVID-19 pandemic. Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Additional information included patient''s death details, updated laboratory data, updated dosing details and updated event details.; Sender''s Comments: Based on biological implausibility, a causal relationship between the reported serious unexpected event COVID-19 developed 1 month 17 days after the administration of mRNA-1273 is assessed as unlikely. The event was more consistent with the increased risk of environmentally mediated COVID-19 infections (including fatal infections) due to ongoing COVID-19 pandemic.; Reported Cause(s) of Death: COVID-19 infectie na vaccinatie


VAERS ID: 1519774 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-05
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Septic shock
SMQs:, Toxic-septic shock conditions (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-05
   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: Medical History/Concurrent Conditions: Allergic asthma; Left bundle branch block
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: Septic shock; This regulatory authority case was reported by a physician and describes the occurrence of SEPTIC SHOCK (Septic shock) in a 70-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Allergic asthma and Left bundle branch block in April 2019. On 02-Jun-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 05-Jun-2021, the patient experienced SEPTIC SHOCK (Septic shock) (seriousness criteria death, hospitalization and medically significant). The patient died on 05-Jun-2021. The reported cause of death was Septic shock. An autopsy was not performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were given by the reporter. No Treatment information were provided by the reporter. 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: Septic shock


VAERS ID: 1521259 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-03-30
   Days after vaccination:0
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: Apnoea, Biopsy heart, Biopsy kidney, Biopsy liver, Biopsy lung, Cardiac arrest, Cyanosis, Death, Fatigue, Myalgia, Mydriasis, Pulmonary embolism
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-05
   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: COPD (Without medication); Hypercholesterolemia (Regulated with medication); Hypertension (Regulated with medication)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210407; Test Name: Biopsy of heart; Result Unstructured Data: PULMONARY EMBOLISM; Comments: .; Test Date: 20210407; Test Name: Biopsy of kidney; Result Unstructured Data: PULMONARY EMBOLISM- histological part of kidney.; Test Date: 20210407; Test Name: Biopsy of liver; Result Unstructured Data: PULMONARY EMBOLISM- histological part of liver; Test Date: 20210407; Test Name: Biopsy of lung; Result Unstructured Data: PULMONARY EMBOLISM- histological part of lungs
CDC Split Type: GRMODERNATX, INC.MOD20212

Write-up: Death; Asystole; Cyanosis; Mydriasis in both eyes; Apnea; Fatigue; Pulmonary embolism; Intense muscle pain; This regulatory authority case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism), MYALGIA (Intense muscle pain), DEATH (Death), CARDIAC ARREST (Asystole), CYANOSIS (Cyanosis), MYDRIASIS (Mydriasis in both eyes), APNOEA (Apnea) and FATIGUE (Fatigue) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Hypercholesterolemia (Regulated with medication), Hypertension (Regulated with medication) and COPD (Without medication). On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria death and medically significant), MYALGIA (Intense muscle pain) (seriousness criteria death and medically significant) and FATIGUE (Fatigue) (seriousness criteria death and medically significant). On 05-Apr-2021, the patient experienced DEATH (Death) (seriousness criteria death and medically significant), CARDIAC ARREST (Asystole) (seriousness criteria death and medically significant), CYANOSIS (Cyanosis) (seriousness criteria death and medically significant), MYDRIASIS (Mydriasis in both eyes) (seriousness criteria death and medically significant) and APNOEA (Apnea) (seriousness criteria death and medically significant). The patient died on 05-Apr-2021. The reported cause of death was Pulmonary embolism. An autopsy was performed. The autopsy-determined cause of death was Pulmonary embolism. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, Biopsy heart: pulmonary embolism (abnormal) PULMONARY EMBOLISM. On 07-Apr-2021, Biopsy kidney: pulmonary embolism (abnormal) PULMONARY EMBOLISM- histological part of kidney.. On 07-Apr-2021, Biopsy liver: pulmonary embolism (abnormal) PULMONARY EMBOLISM- histological part of liver. On 07-Apr-2021, Biopsy lung: pulmonary embolism (abnormal) PULMONARY EMBOLISM- histological part of lungs. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment information was provided by the reporter. No Concomitant medication were provided by the reporter Company Comment: Very limited information regarding these events have been provided at this time. No further information is expected at this time.; Reporter''s Comments: .; 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: Pulmonary embolism; Autopsy-determined Cause(s) of Death: Pulmonary embolism


VAERS ID: 1521353 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-05-06
   Days after vaccination:2
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: Herpes zoster
SMQs:, Opportunistic infections (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:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of HERPES ZOSTER in an 89-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 04-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 06-May-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced HERPES ZOSTER (seriousness criterion death). The reported cause of death was Shingles. It is unknown if an autopsy was performed. No relevant concomitant medications were reported. Treatment information was not provided. The batch number of mRNA-1273 (COVID 19 Vaccine Moderna) was unknown. The reporter did not provide causal relationship between mRNA-1273 (COVID 19 Vaccine Moderna) and the events. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) in response to the events was not applicable. This is a case of a 89-year-old female patient who developed Herpes zoster two days after receiving mRNA-1273 (lot # unknown). The patient subsequently died. Very limited information regarding this event has been provided at this time. No information regarding the patient''s medical history nor concomitant medications was available at this moment. Furthermore, it is also unknown if an autopsy was performed. Causality is confounded with patient''s advanced age. The translation of the source document has been requested.; Sender''s Comments: This is a case of a 89-year-old female patient who developed Herpes zoster two days after receiving mRNA-1273 (lot # unknown). The patient subsequently died. Very limited information regarding this event has been provided at this time. No information regarding the patient''s medical history nor concomitant medications was available at this moment. Furthermore, it is also unknown if an autopsy was performed. Causality is confounded with patient''s advanced age. The translation of the source document has been requested.; Reported Cause(s) of Death: Shingles


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