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

Found 22,193 cases where Vaccine targets COVID-19 (COVID19) and Patient Died

Government Disclaimer on use of this data



Case Details

This is page 183 out of 222

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VAERS ID: 1672222 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-18
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939599-CDC / 1 - / OT

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

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

Write-up: death; This regulatory authority case was reported by a pharmacist and describes the occurrence of DEATH (death) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939599-CDC) 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) (unknown route) .5 milliliter. Death occurred on 18-Jul-2021 The patient died on 18-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment medication was not provided by the reporter. The patient passed away at home on July 18. Company Comment: This is a case of death in a 75-year-old male patient, 13 days after receiving first dose of vaccine (Lot number 939599-CDC). Very limited information regarding underlying medical history, concomitant medications and autopsy report was not provided at this time. No further information is expected.; Sender''s Comments: This is a case of death in a 75-year-old male patient, 13 days after receiving first dose of vaccine (Lot number 939599-CDC). Very limited information regarding underlying medical history, concomitant medications and autopsy report was not provided at this time. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1672223 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-16
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939600-CDC / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiovascular disorder, Polymerase chain reaction
SMQs:, Cardiomyopathy (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: Test Name: PCR Test; Test Result: Negative ; Result Unstructured Data: negative
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Cardiovascular disease; This regulatory authority case was reported by an other health care professional and describes the occurrence of CARDIOVASCULAR DISORDER (Cardiovascular disease) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939600-CDC) for COVID-19 vaccination. No Medical History information was reported. On 12-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jul-2021, the patient experienced CARDIOVASCULAR DISORDER (Cardiovascular disease) (seriousness criterion death). The patient died on 16-Jul-2021. The reported cause of death was cardiovascular disease. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Polymerase chain reaction: negative (Negative) negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication information not provided. Treatment information not provided. On 16-Jul-2021, the patient''s family sent the patient to Hospital due to physical discomforts and the patient was pronounced dead before arriving at the hospital. The physician diagnosed it as cardiovascular disease. The family did not agree to an autopsy. PCR test result was negative. The patient''s family was told about the vaccine injury remedies, and the patient''s family did not apply for it. Very limited information regarding this event has been provided at this time. Further information will not be received as it is a Regulatory Authority report.; Sender''s Comments: Very limited information regarding this event has been provided at this time. Further information will not be received as it is a Regulatory Authority report.; Reported Cause(s) of Death: Cardiovascular disease


VAERS ID: 1672224 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-06
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: School       Purchased by: ?
Symptoms: Acute myocardial infarction, Fatigue, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, arterial (narrow), 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: 2021-07-06
   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:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiovascular disease, unspecified; Hyperglycemia (Symptoms of hyperglycemia)
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Fatigue; acute myocardial infarction; Unconsciousness; This regulatory authority case was reported by an other health care professional and describes the occurrence of ACUTE MYOCARDIAL INFARCTION (acute myocardial infarction), LOSS OF CONSCIOUSNESS (Unconsciousness) and FATIGUE (Fatigue) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Cardiovascular disease, unspecified and Hyperglycemia (Symptoms of hyperglycemia). On 03-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jul-2021, the patient experienced ACUTE MYOCARDIAL INFARCTION (acute myocardial infarction) (seriousness criterion death) and LOSS OF CONSCIOUSNESS (Unconsciousness) (seriousness criterion death). On an unknown date, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant). The patient died on 06-Jul-2021. The reported cause of death was Acute myocardial infarction. An autopsy was performed. At the time of death, FATIGUE (Fatigue) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant products used by the patient was not provided. Treatment information was not provided. The physician of the public health center completed the administrative postmortem and issued a death certificate. Cause of death: acute myocardial infarction. The death certificate has been uploaded on 07/23/2021. On 07/23/2021, the family did not agree to an autopsy. Company comment: This is a case of sudden death in an 85-year-old female subject with underlying medical history of cardiovascular disease and hyperglycemia, who died 4 days after receiving unknown dose of vaccine (Lot number unknown). Very limited information has been provided at this time. No further information is expected. Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2021: Translation received on 02-Sep-2021 included: added reporter details, added medical history, added events and updated narrative.; Sender''s Comments: This is a case of sudden death in an 85-year-old female subject with underlying medical history of cardiovascular disease and hyperglycemia, who died 4 days after receiving unknown dose of vaccine (Lot number unknown). Very limited information has been provided at this time. No further information is expected.; Reported Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1672225 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-19
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-04
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: 2021-07-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Death; This regulatory authority case was reported by a pharmacist and describes the occurrence of DEATH (Death) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Asthma. On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 19-Jul-2021 The patient died on 19-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product usage was not provided. Treatment details were not provided. The patient did not have any adverse reactions after the vaccination. The patient passed away in her sleep on July 18. Therefore, the adverse reaction was reported. Very limited information regarding this event has been provided at this time. Further information will not be received as it in a Regulatory Authority report.; Sender''s Comments: Very limited information regarding this event has been provided at this time. Further information will not be received as it in a Regulatory Authority report.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1672226 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Altered state of consciousness, Cardiac arrest, Choking, Electrocardiogram, Nausea, SARS-CoV-2 test, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant 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), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-16
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes mellitus; Ischemic cardiomyopathy (Ischemic cardiomyopathy (LVEF 25%, Simpson''s method (4-chamber view): 37%)
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiopulmonary resuscitation (CPCR for 30 mins); Infarction NOS (Old left occipital lobe infarction; Old infarct over bilateral basal ganglion); Retrosternal infection (History of Sternal wound infection status post Debridement of deep sternal wound infection)
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: EKG; Result Unstructured Data: EKG still revealed asystole; Test Date: 20210716; Test Name: SARS-CoV-2 RNA test; Test Result: Negative ; Result Unstructured Data: SARS-CoV-2 RNA test was negative
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Choking episode after eating; Cardiac arrest; Altered state of consciousness; Vomiting; Nausea; This regulatory authority case was reported by a pharmacist and describes the occurrence of CHOKING (Choking episode after eating), CARDIAC ARREST (Cardiac arrest), ALTERED STATE OF CONSCIOUSNESS (Altered state of consciousness), VOMITING (Vomiting) and NAUSEA (Nausea) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Retrosternal infection (History of Sternal wound infection status post Debridement of deep sternal wound infection), Infarction NOS (Old left occipital lobe infarction; Old infarct over bilateral basal ganglion) and Cardiopulmonary resuscitation (CPCR for 30 mins) on 16-Jul-2021. Concurrent medical conditions included Ischemic cardiomyopathy (Ischemic cardiomyopathy (LVEF 25%, Simpson''s method (4-chamber view): 37%) and Diabetes mellitus. On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion death) and NAUSEA (Nausea) (seriousness criterion death). On 16-Jul-2021, the patient experienced CHOKING (Choking episode after eating) (seriousness criteria death and medically significant), CARDIAC ARREST (Cardiac arrest) (seriousness criteria death and medically significant) and ALTERED STATE OF CONSCIOUSNESS (Altered state of consciousness) (seriousness criteria death and medically significant). The patient died on 16-Jul-2021. The reported cause of death was choking episode after eating and Cardiac arrest. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jul-2021, Electrocardiogram: abnormal (abnormal) EKG still revealed asystole. On 16-Jul-2021, SARS-CoV-2 test: negative (Negative) SARS-CoV-2 RNA test was negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered VOMITING (Vomiting) and NAUSEA (Nausea) to be possibly related. No further causality assessments were provided for CHOKING (Choking episode after eating), CARDIAC ARREST (Cardiac arrest) and ALTERED STATE OF CONSCIOUSNESS (Altered state of consciousness). Concomitant product use was not provided by the reporter. Treatment information was not provided. Patient experienced a choking episode after eating breakfast in the morning of 16-Jul-2021. The patient''s family found him unconscious and called 119. The patient was transferred to the emergency department of this hospital for emergency treatment. CPCR for 30 mins and EKG still revealed asystole. Explain current condition to patient''s family, they understood and asked to stop CPCR, and he died at 10:35 am. The physician diagnosed as cardiac arrest, with the unknown cause. On 23-Jul-2021, patient''s family expressed they do not want an autopsy test. Very limited information regarding these events have been provided at this time. No further information is expected at this time.; 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: Choking episode after eating; Cardiac arrest


VAERS ID: 1672232 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Fatigue
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-18
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pulmonary fibrosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: felt tired; gasped for breath; This regulatory authority case was reported by an other health care professional and describes the occurrence of FATIGUE (felt tired) and DYSPNOEA (gasped for breath) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Pulmonary fibrosis. On 10-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jul-2021, the patient experienced FATIGUE (felt tired) (seriousness criterion death) and DYSPNOEA (gasped for breath) (seriousness criterion death). The patient died on 18-Jul-2021. The reported cause of death was felt tired and gasped for breath. 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 medication was reported. No treatment was reported. Patient has previous medical history of heart stent, took anticoagulant and pulmonary fibrosis. 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. Patient''s age (72) and medical history of heart stent, taking anticoagulant and pulmonary fibrosis may be a contributory for the occurrence of fatigue and dyspnea.; 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. Patient''s age (72) and medical history of heart stent, taking anticoagulant and pulmonary fibrosis may be a contributory for the occurrence of fatigue and dyspnea.; Reported Cause(s) of Death: felt tired; gasped for breath


VAERS ID: 1672233 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-22
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: Death; This regulatory authority case was reported by a pharmacist and describes the occurrence of DEATH (Death) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Hypertension. On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milligram. Death occurred on 22-Jul-2021 The patient died on 22-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product was not provided by the reporter. Treatment product was not provided by the reporter. Company comment: This is a case of sudden death in a 69-year-old male subject with hx of Hypertension, who died 10 days after receiving first dose of vaccine. Very limited information has been provided at this time. Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2021: Translation document received on 02-SEP-2021 contained significant information Primary source information, Seriousness criteria, Event details was updated; Sender''s Comments: This is a case of sudden death in a 69-year-old male subject with hx of Hypertension, who died 10 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: 1672234 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-12
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939600-CDC / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Vaccination site pain
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: Medical History/Concurrent Conditions: Cardiovascular disease, unspecified; Diabetes
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: soreness and pain in his arm; Death; This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death) and VACCINATION SITE PAIN (soreness and pain in his arm) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939600-CDC) for COVID-19 vaccination. The patient''s past medical history included Diabetes and Cardiovascular disease, unspecified. On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (soreness and pain in his arm) (seriousness criterion death). The patient died on 12-Jul-2021. The cause of death was not reported. An autopsy was performed, but no results were provided. No concomitant medication details were reported. No treatment medication details was reported. On July 28, the patient''s daughter said that the patient has a medical history of diabetes, and took drugs for treatment on a regular basis. Patient passed away at home on July 12. Company comment: Very limited information regarding this event has been provided at this time. Further information is not expected. Patient�s history of cardiovascular risk factors are confounders for the event death.; Sender''s Comments: Very limited information regarding this event has been provided at this time. Further information is not expected. Patient�s history of cardiovascular risk factors are confounders for the event death.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1672237 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cold sweat, Death, Fatigue, Heart rate, Heart rate increased, Respiration abnormal
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Respiratory failure (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-19
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Lung adenocarcinoma
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia
Allergies:
Diagnostic Lab Data: Test Name: heart rate; Result Unstructured Data: more than 100 b/m; Test Name: heart rate; Result Unstructured Data: about 80-90 b/m
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: the case was dead; cold sweat after going to toilet; breathing loudly; case felt very tired; patient''s heart beat was a little faster after taking the targeted drugs; This regulatory authority case was reported by an other and describes the occurrence of DEATH (the case was dead) in a 72-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. The patient''s past medical history included Arrhythmia. Concurrent medical conditions included Lung adenocarcinoma. On 10-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jul-2021, the patient experienced FATIGUE (case felt very tired). In July 2021, the patient experienced HEART RATE INCREASED (patient''s heart beat was a little faster after taking the targeted drugs). On 19-Jul-2021, the patient experienced COLD SWEAT (cold sweat after going to toilet) and RESPIRATION ABNORMAL (breathing loudly). The patient died on 19-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, HEART RATE INCREASED (patient''s heart beat was a little faster after taking the targeted drugs), COLD SWEAT (cold sweat after going to toilet), RESPIRATION ABNORMAL (breathing loudly) and FATIGUE (case felt very tired) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 100 (High) more than 100 b/m and 80-90 (normal) about 80-90 b/m. Patient was taking targeted drug in Hospital now. No treatment medication details was reported. Company Comment: This case concerns the death of a 72-year-old female patient 8 days after receiving first dose of mRNA-1273. The patient experienced additional events of fatigue, increased heart rate, cold sweat and abnormal respiration after vaccination won an unspecified dates prior to the fatal outcome. These events are assessed as temporally associated with the vaccine use and thus causal relationship cannot be excluded. The cause of death is unknown, hence unable to assess the event of death. All events are confounded by the underlying Lung adenocarcinoma. and arrhythmia.; Sender''s Comments: This case concerns the death of a 72-year-old female patient 8 days after receiving first dose of mRNA-1273. The patient experienced additional events of fatigue, increased heart rate, cold sweat and abnormal respiration after vaccination won an unspecified dates prior to the fatal outcome. These events are assessed as temporally associated with the vaccine use and thus causal relationship cannot be excluded. The cause of death is unknown, hence unable to assess the event of death. All events are confounded by the underlying Lung adenocarcinoma. and arrhythmia.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1672238 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-20
Onset:2021-07-26
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939600-CDC / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Decreased appetite, Fatigue
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: Medical History/Concurrent Conditions: Osteoporosis; Parkinson''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Fatigue; Loss of appetite; This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and DECREASED APPETITE (Loss of appetite) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939600-CDC) for COVID-19 vaccination. The patient''s past medical history included Parkinson''s disease and Osteoporosis. On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 26-Jul-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion death) and DECREASED APPETITE (Loss of appetite) (seriousness criterion death). The reported cause of death was Fatigue and loss of appetite. It is unknown if an autopsy was performed. No concomitant medications were provided. No treatment information was provided. Doctor came to the home of the case for the first dose of Moderna vaccine, but the case felt tired and poor in appetite after vaccine inoculation. Daughter of patient was found that all the water was flowing out, and could not feel her pulse. Company Comment: Very limited information regarding this events has been provided at this time.; Sender''s Comments: Very limited information regarding this events has been provided at this time.; Reported Cause(s) of Death: Fatigue; Loss of appetite


VAERS ID: 1672244 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-23
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue
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: Medical History/Concurrent Conditions: Alcoholic hepatitis; Esophageal cancer; Tongue neoplasm (Tongue cancer)
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Fatigue; This regulatory authority case was reported by an other health care professional and describes the occurrence of FATIGUE (Fatigue) 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 Tongue neoplasm (Tongue cancer), Esophageal cancer and Alcoholic hepatitis. On 12-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jul-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion death). 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. Patient son found the patient was lying in the room with blood at the corners of the mouth and nose and has reported death. No relevant concomitant medications were reported No treatment information was provided. Company Comment: The case concern the death of a 67-year-old male patient which was confirmed 11 days after receiving mRNA-1273 . Although a temporal association exist, there is still insufficient information as the actual caused / date of death of death was not provided. In addition, the event is confounded by the patient;''s underlying history of oral cancer stage unspecified (Tongue cancer), esophageal cancer and Alcoholic hepatitis. No further information is expected Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2021: Translation received on 21-Aug-2021; narrative was updated.; Sender''s Comments: The case concern the death of a 67-year-old male patient which was confirmed 11 days after receiving mRNA-1273 . Although a temporal association exist, there is still insufficient information as the actual caused / date of death of death was not provided. In addition, the event is confounded by the patient;''s underlying history of oral cancer stage unspecified (Tongue cancer), esophageal cancer and Alcoholic hepatitis. No further information is expected; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1672245 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-16
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Brain death, Cerebral haemorrhage, Syncope, Vaccination complication
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-21
   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:
Current Illness: Diabetes
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Brain dead; Cerebral hemorrhage; Collapsed during exercise; Others; This regulatory authority case was reported by a consumer and describes the occurrence of BRAIN DEATH (Brain dead), CEREBRAL HAEMORRHAGE (Cerebral hemorrhage), SYNCOPE (Collapsed during exercise) and VACCINATION COMPLICATION (Others) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Diabetes. On 12-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, the patient experienced SYNCOPE (Collapsed during exercise) (seriousness criteria hospitalization, medically significant and life threatening). On 19-Jul-2021, the patient experienced VACCINATION COMPLICATION (Others) (seriousness criterion life threatening). On an unknown date, the patient experienced BRAIN DEATH (Brain dead) (seriousness criteria hospitalization, medically significant and life threatening) and CEREBRAL HAEMORRHAGE (Cerebral hemorrhage) (seriousness criteria hospitalization, medically significant and life threatening). At the time of the report, BRAIN DEATH (Brain dead), CEREBRAL HAEMORRHAGE (Cerebral hemorrhage), SYNCOPE (Collapsed during exercise) and VACCINATION COMPLICATION (Others) outcome was unknown. The patient died on 21-Jul-2021. The cause of death was not reported. An autopsy was not performed. No relevant concomitant medications were provided. No treatment information was provided. It was reported that patient had no discomfort on the day of vaccination. Patient was taken to the hospital and was in the respiratory intensive care unit. Very limited information regarding these events have been provided at this time. No further information is expected at this time; Sender''s Comments: Very limited information regarding these events have been provided at this time. No further information is expected at this time; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1672247 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-24
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute myocardial infarction, Arrhythmia, Choking, Fall, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, arterial (narrow), Accidents and injuries (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Syncope; acute myocardial choking; arrhythmia; Fell; Choking; This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE (Syncope), ACUTE MYOCARDIAL INFARCTION (acute myocardial choking), ARRHYTHMIA (arrhythmia), FALL (Fell) and CHOKING (Choking) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Hypertension and Diabetes. On 02-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jul-2021, the patient experienced SYNCOPE (Syncope) (seriousness criteria death and medically significant), ACUTE MYOCARDIAL INFARCTION (acute myocardial choking) (seriousness criteria death and medically significant), ARRHYTHMIA (arrhythmia) (seriousness criteria death and medically significant), FALL (Fell) (seriousness criterion death) and CHOKING (Choking) (seriousness criteria death and medically significant). The patient died on 24-Jul-2021. The reported cause of death was Syncope, Arrhythmia, Acute myocardial infarction and Fall. It is unknown if an autopsy was performed. Concomitant products were not provided. Treatment medication were not reported. The reporter considered events to be possibly related (suspected). Company Comment: This is a case of sudden death in a 71 -year-old male subject with a hx of Hypertension and Diabetes, who died 22 days after receiving first dose of vaccine. Very limited information has been provided at this time. Further information is not expected.; Sender''s Comments: This is a case of sudden death in a 71 -year-old male subject with a hx of Hypertension and Diabetes, who died 22 days after receiving first dose of vaccine. Very limited information has been provided at this time. Further information is not expected.; Reported Cause(s) of Death: Syncope; arrhythmia; Acute myocardial infarction; Fall


VAERS ID: 1672280 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Malaise, Multiple organ dysfunction syndrome
SMQs:, 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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-09
   Days after onset: 37
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: multiple organ failure; Malaise, multiple organ failure; This regulatory authority case was reported by a consumer and describes the occurrence of MULTIPLE ORGAN DYSFUNCTION SYNDROME (multiple organ failure) and MALAISE (Malaise, multiple organ failure) in a 74-year-old female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 03-Jul-2021, the patient experienced MULTIPLE ORGAN DYSFUNCTION SYNDROME (multiple organ failure) (seriousness criteria death, hospitalization and medically significant) and MALAISE (Malaise, multiple organ failure) (seriousness criteria death and hospitalization). The patient died on 09-Aug-2021. The cause of death was not reported. It is unknown if an autopsy was performed. No concomitant product information were provided by the reporter. No treatment information was provided by the reporter. This is a case of death of a 74-year-old female patient one month 10 days post vaccination. Although a strong temporal association exit as the onset is reported to have been the same day of vaccine administration. Yet Critical details such as the patient''s medical history, concomitant medication are lacking. However, due to temporality with onset, a causal association cannot be completely excluded. No further information is expected.; Sender''s Comments: This is a case of death of a 74-year-old female patient one month 10 days post vaccination. Although a strong temporal association exit as the onset is reported to have been the same day of vaccine administration. Yet Critical details such as the patient''s medical history, concomitant medication are lacking. However, due to temporality with onset, a causal association cannot be completely excluded. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1673465 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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: USPFIZER INC202101129948

Write-up: lost 7 friends; This is a spontaneous report from a non-contactable consumer. This consumer reporting same event under the same suspect product for 12 patients. This case for one of the 12 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified routed of administration on unspecified date as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The reporter had lost a friend. The cause of death was unknown. It was unknown if autopsy was done. The outcome of the event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : US-PFIZER INC-202101100059 Same reporter/event/drug, different patient; Reported Cause(s) of Death: lost 7 friends


VAERS ID: 1673466 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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: USPFIZER INC202101130471

Write-up: I have lost 7 friends; This is a spontaneous report from a non-contactable consumer reporting same event under the same suspect product for 12 patients. This is one of 12 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified routed of administration on unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter had lost a friend. The cause of death was unknown. It was unknown if autopsy was done. The outcome of the event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : US-PFIZER INC-202101100059 Same reporter/event/drug, different patient; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1673467 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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: USPFIZER INC202101130472

Write-up: lost a friend; This is a spontaneous report from a non-contactable consumer reporting same event under the same suspect product for 12 patients. This is one of 12 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified routed of administration on unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter had lost a friend. The cause of death was unknown. It was unknown if autopsy was done. The outcome of the event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : US-PFIZER INC-202101100059 Same reporter/event/drug, different patient; Reported Cause(s) of Death: lost a friend


VAERS ID: 1673468 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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: USPFIZER INC202101130473

Write-up: I have lost 7 friends; This is a spontaneous report from a non-contactable consumer reporting same event under the same suspect product for 12 patients. This is one of 12 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified routed of administration on unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter had lost a friend. The cause of death was unknown. It was unknown if autopsy was done. The outcome of the event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : US-PFIZER INC-202101100059 Same reporter/event/drug, different patient; Reported Cause(s) of Death: I have lost 7 friends


VAERS ID: 1673469 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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: USPFIZER INC202101130474

Write-up: lost a friend; This is a spontaneous report from a non-contactable consumer reporting same event under the same suspect product for 12 patients. This is one of 12 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified routed of administration on unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter had lost a friend. The cause of death was unknown. It was unknown if autopsy was done. The outcome of the event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : US-PFIZER INC-202101100059 Same reporter/event/drug, different patient; Reported Cause(s) of Death: lost a friend


VAERS ID: 1673470 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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: USPFIZER INC202101130475

Write-up: lost a friend; This is a spontaneous report from a non-contactable consumer reporting same event under the same suspect product for 12 patients. This is one of 12 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided) via an unspecified routed of administration on unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter had lost a friend. The cause of death was unknown. It was unknown if autopsy was done. The outcome of the event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Sender''s Comments: Linked Report(s) : US-PFIZER INC-202101100059 Same reporter/event/drug, different patient; Reported Cause(s) of Death: lost a friend


VAERS ID: 1673474 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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: USPFIZER INC202101134476

Write-up: lost a friend; This is a spontaneous report from a non-contactable consumer. This consumer reporting same event under the same suspect product for 12 patients. This case for one of the 12 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified routed of administration on unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter had lost a friend. The cause of death was unknown. It was unknown if autopsy was done. The outcome of the event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : US-PFIZER INC-202101100059 same reporter/drug/event, different patient; Reported Cause(s) of Death: lost a friend


VAERS ID: 1674444 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Platelet factor 4
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: Unknown
Allergies:
Diagnostic Lab Data: Test Name: Platelet factor 4; Result Unstructured Data: 2.543
CDC Split Type: ZAJNJFOC20210902000

Write-up: DEATH; This spontaneous report received via a company representative concerned a 50 year old female of unspecified race and ethnic origin. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) with frequency as 1 total, dose and start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient died from an unknown cause of death. It was unknown if autopsy was performed. Laboratory data (dates unspecified) included: Platelet factor 4 (NR: not provided) 2.543. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0-20210902000-Covid-19 vaccine ad26.cov2.S- Death. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1674453 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-30
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0927 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-08
   Days after onset: 9
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: ZAPFIZER INC202101121980

Write-up: Patient admitted to hospital on 30Jul2021 with dyspnea.; passed away; This is a spontaneous report from a contactable other hcp. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 administration on 02Jul2021 08:59 (Lot Number: FD0927; Expiration Date: 30Sep2021) at single dose for covid-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient was admitted in hospital on 30Jul2021 with dyspnea. On 08Aug2021, the patient passed away. It was not reported if an autopsy was performed. The outcome of dyspnea was unknown.; Sender''s Comments: The causal relationship between bnt162b2 and the events of death and dysponea cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: passed away


VAERS ID: 1675953 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Malaise, Pyrexia, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (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: 2021-08-28
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension; Nicotine dependence
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210907577

Write-up: SUDDEN DEATH, CAUSE UNKNOWN; PYREXIA; DIARRHEA; MALAISE; This spontaneous report received from a physician via Regulatory Authority (EVHUMAN Vaccines, DE-PEI-202100180239) on 03-SEP-2021 and concerned a 57 year old male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: nicotine dependence, and arterial hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE389) dose was not reported,1 total, administered on 19-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-AUG-2021, the patient experienced malaise, pyrexia, and diarrhea. On 28-AUG-2021, the patient had sudden death, and the cause of death was unknown. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of malaise, sudden death, cause unknown, pyrexia and diarrhea on 28-AUG-2021. This report was serious (Death).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1676028 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-04-06
   Days after vaccination:54
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood bicarbonate, Blood culture, Body temperature, COVID-19, Death, Escherichia pyelonephritis, Oxygen saturation, PCO2, PO2, SARS-CoV-2 test, Urine analysis, Vaccination failure, pH body fluid
SMQs:, Lack of efficacy/effect (narrow), Guillain-Barre syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-02
   Days after onset: 26
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ZOPICLONE; NOVORAPID; RAMIPRIL; FUROSEMIDE; BISOPROLOL HEMIFUMARATE; MEMANTINE HYDROCHLORIDE; TINZAPARIN; CHOLECALCIFEROL; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Alzheimer''s disease; Appendectomy; Cardiac failure; Chronic renal failure; Dyslipidaemia; Hypertension arterial; Insulin-requiring type 2 diabetes mellitus; Knee prosthesis user; Laparotomy; Peripheral arterial occlusive disease
Allergies:
Diagnostic Lab Data: Test Date: 20210406; Test Name: alkaline reserve; Result Unstructured Data: Test Result:28 mmol/L; Test Date: 20210406; Test Name: Alkaline reserve; Result Unstructured Data: Test Result:22 mmol/L; Test Date: 20210406; Test Name: blood cultures; Result Unstructured Data: Test Result:sterile; Test Date: 20210406; Test Name: body temperature; Result Unstructured Data: Test Result:hyperthermia; Test Date: 20210406; Test Name: Saturation oxygen; Test Result: 88 %; Test Date: 20210406; Test Name: Saturation oxygen; Test Result: 95 %; Test Date: 20210423; Test Name: Saturation oxygen; Test Result: 87 %; Test Date: 20210406; Test Name: partial pressure of carbon dioxide; Result Unstructured Data: Test Result:35 mmHg; Test Date: 20210406; Test Name: pH; Result Unstructured Data: Test Result:7.51; Test Date: 20210406; Test Name: partial pressure of oxygen; Result Unstructured Data: Test Result:67 mmHg; Test Date: 20210406; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210416; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: English variant; Test Date: 20210406; Test Name: examination of the urine; Result Unstructured Data: Test Result:wild E. coli pyelonephritis
CDC Split Type: FRPFIZER INC202101125279

Write-up: COVID-19; COVID-19; Diagnosis of wild E. Coli pyelonephritis at lab; death; asthenia; This is a spontaneous report from a contactable other HCP downloaded from the Regulatory Authority. Regulatory Authority Report Number: FR-AFSSAPS-AM20212326. A 87-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 11Feb2021 (Lot Number: Unknown) as DOSE 2, SINGLE, dose 1 intramuscular on 21Jan2021 (Lot Number: Unknown) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Alzheimer''s disease, Cardiac failure, Laparotomy, Dyslipidaemia, Appendectomy, Insulin-requiring type 2 diabetes mellitus, AFib, Peripheral arterial occlusive disease, Knee prosthesis user, Hypertension arterial, Chronic renal failure. Concomitant medications included zopiclone; insulin aspart (NOVORAPID); ramipril; furosemide; bisoprolol hemifumarate; memantine hydrochloride; tinzaparin; cholecalciferol; macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL), all taken for an unspecified indication, start and stop date were not reported. The patient was death on 02May2021, covid-19 (death, hospitalization) on 16Apr2021, diagnosis of wild e. coli pyelonephritis at lab (hospitalization) on 06Apr2021 with outcome of unknown, asthenia (non-serious) on 23Apr2021 with outcome of unknown. Clinical course reported on 06Apr2021, appearance of hyperthermia and unusual ideomotor slowing, 88% ambient air saturation, arrhythmia (known AFib), for which she was hospitalized the same day. Sars-CoV-2 PCR negative on admission. Diagnosis of wild E. Coli pyelonephritis at lab, sterile blood cultures. Furthermore, the arterial gas measurement in ambient air shows a saturation at 95%, pH 7.51, partial pressure of carbon dioxide (pCO2) 35 mmHg, partial pressure of oxygen (pO2) 67 mmHg, alkaline reserve at 28 mmol / L. Favorable evolution under amoxicillin. Discharge from hospital and return to nursing home on 09Apr2021. Implementation of preventive isolation according to the service protocol and performance of a PCR test on Day 7, that is 16Apr2021. The Sars-CoV-2 PCR test is positive for the different variant. The samples could not be sent to the Reference Center. 16Apr2021: amoxicillin is replaced by Augmentin, addition of Solupred. 23Apr2021: afebrile patient, 87% ambient air saturation, marked asthenia. Installation of an infusion of 0.9% NaCL + 4g of NaCl + 2g of KCl. Addition of Zithromax. 30Apr2021: administration of Durogesic 25ug / 72h and Hypnovel intravenous syringe driver. 02May2021: death of the patient. The patient died on 02May2021. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: COVID-19; death; COVID-19


VAERS ID: 1676072 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-11
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Drug ineffective, Respiratory distress, Suspected COVID-19
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-19
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia; Arterial insufficiency coronary; Hypertension arterial
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101131091

Write-up: respiratory distress; Covid-19 infection; Covid-19 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-BX20217875. A 74-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscularly on 31Mar2021 (Lot Number: EP2166) as dose 2, single; dose 1 on an unknown date (lot number unknown) as dose 1, single, both for COVID-19 immunisation. Medical history included hypertension arterial, arrhythmia, arterial insufficiency coronary. No history of Covid (no test). Concomitant medications were not reported. Confirmed Covid-19 infection. Signs start date 11Aug2021. Admitted to the emergency room on 18Aug2021 for respiratory distress. The patient died on 19Aug2021. It was unknown if an autopsy was performed. The outcome of events was fatal. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: infection COVID-19; respiratory distress; infection COVID-19


VAERS ID: 1676126 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-26
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Biopsy muscle, Blood creatine phosphokinase, Blood creatine phosphokinase increased, Blood phosphorus, Body temperature, C-reactive protein, COVID-19, Clinical dementia rating scale, Drug ineffective, Electromyogram, Fall, Fibrin D dimer, Head injury, Hypophosphataemia, Hypoxia, Liver function test, Lymphocyte count, Lymphopenia, Magnetic resonance imaging head, Oxygen saturation, PCO2, PO2, Renal function test, SARS-CoV-2 test, Specialist consultation, Tachypnoea
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Haematopoietic leukopenia (narrow), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Accidents and injuries (narrow), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-02
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma (Asthma with multiple hospitalizations for severe attacks); Cataract operation; Chronic sinusitis (nasosinus polyposis); Colon dysplasia; Delusional disorder, unspecified type (hospitalized for 1 month); Diverticulosis; Essential hypertension; Glaucoma; Hypothyroidism; Mitral valve disease (stable in 2014); Myalgia (with suspicion of iatrogenia (ELISOR discontinuation), normal muscle biopsy in 2003); Operation NOS; Orthostatic hypotension; Spinal operation; Type 2 diabetes mellitus (Output Factor Jul2021 normal); Vascular dementia (mini-mental state 17/30 in 2019, last brain MRI in 2015)
Allergies:
Diagnostic Lab Data: Test Date: 20210729; Test Name: thoracic angioscanner; Result Unstructured Data: Test Result:a typical COVID involvement estimated at 25%; Comments: a typical COVID involvement estimated at 25%, without pulmonary embolism.; Test Date: 2003; Test Name: Muscle biopsy; Result Unstructured Data: Test Result:normal; Test Date: 2004; Test Name: Muscle biopsy; Result Unstructured Data: Test Result:normal; Test Date: 20210729; Test Name: CPK; Result Unstructured Data: Test Result:1557; Comments: 9N (1557 ui/L); Test Date: 20210729; Test Name: hypophosphatemia; Result Unstructured Data: Test Result:0.7 mmol/L; Test Date: 20210728; Test Name: Body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210729; Test Name: Body temperature; Result Unstructured Data: Test Result:40 Centigrade; Test Date: 20210729; Test Name: Body temperature; Result Unstructured Data: Test Result:41 Centigrade; Test Date: 2019; Test Name: mini-mental state; Result Unstructured Data: Test Result:17/30; Test Date: 20210729; Test Name: CRP; Result Unstructured Data: Test Result:156.2 mg/l; Test Date: 2004; Test Name: EMG; Result Unstructured Data: Test Result:normal; Test Date: 20210729; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:1893 ng/L; Test Date: 20210729; Test Name: liver function; Result Unstructured Data: Test Result:normal; Test Date: 20210729; Test Name: Lymphopenia; Result Unstructured Data: Test Result:0.74 g/l; Test Date: 2004; Test Name: MRI brain; Result Unstructured Data: Test Result:normal; Test Date: 2015; Test Name: MRI brain; Result Unstructured Data: Test Result:Unknown Results; Test Date: 20210729; Test Name: SpO2; Test Result: 92 %; Test Date: 20210731; Test Name: SpO2; Result Unstructured Data: Test Result:85-90 %; Test Date: 20210729; Test Name: PCO2; Result Unstructured Data: Test Result:29 mmHg; Test Date: 20210729; Test Name: hypoxemia; Result Unstructured Data: Test Result:64 mmHg; Test Date: 20210729; Test Name: renal function; Result Unstructured Data: Test Result:normal; Test Date: 20210729; Test Name: SARS-CoV-2 PCR test; Test Result: Positive ; Comments: Ct (threshold cycle) 19.1 Delta variant; Test Date: 2014; Test Name: neurological consultation; Result Unstructured Data: Test Result:not in favor of myopathy
CDC Split Type: FRPFIZER INC202101125590

Write-up: Blood creatine phosphokinase increased to 9N (1557 ui/L); hypoxemia; lymphopenia; hypophosphatemia; falls; head trauma; COVID-19 respiratory infection/respiratory status deteriorated/COVID PCR was positive; COVID-19 respiratory infection/respiratory status deteriorated/COVID PCR was positive; slight polypnea; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-MP20216860. A 78-year-old male patient received BNT162B2 (COMIRNATY), second dose via intramuscular on 14Apr2021 as single dose, first dose via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history included essential hypertension arterial, orthostatic hypotension, non-insulin-dependent type 2 diabetes mellitus (Output Factor Jul2021 normal), glaucoma, sigmoid diverticulosis and colic from 2014, frontal vascular dementia from 2008 (mini-mental state 17/30 in 2019, last brain MRI in 2015), paranoid-type delusional disorder from 2008 (hospitalized for 1 month), mitral microleak from 2007 (stable in 2014), low grade dysplasia of the left colon from 2004, myalgia with rhabdomyolysis from 1999 [with suspicion of iatrogenia (ELISOR discontinuation), normal muscle biopsy in 2003, new internal medicine assessment in 2004 [magnetic resonance imaging (MRI), electromyogram (EMG) and biopsy normal], neuro consultation in 2014 not in favor of myopathy], Chronic sinusitis from 1978 (nasosinus polyposis), Asthma from 1965 (Asthma with multiple hospitalizations for severe attacks), hypothyroidism from 1999, cataract left eye operated on and cataract right eye from 2010, narrow lumbar canal operated from 2001, L5S1 herniated disc repair from 1983. The concomitant product included unspecified medication. On 26Jul2021, the patient experienced COVID-19 respiratory infection. The clinical course was as follows: On 26Jul2021, the symptoms begin, with a productive cough. On 28Jul2021, the patient falls with head trauma, without loss of consciousness. The family called the firemen who put him to bed. Appearance of a fever of 38�C in the evening. On 29Jul2021, the patient was febrile at 40�C, asthenic, and fell again in the morning. He went to the emergency room in the context. Clinically, he was febrile at 41�C with no sign of poor hemodynamic tolerance. Bilateral crepitus and an SpO2 of 92% on room air requiring 4L/min of oxygen were noted. Blood gases showed hypoxemia at 64 mmHg and PCO2 at 29 mmHg. The COVID polymerase chain reaction (PCR) was positive (threshold cycle 19, delta variant). The biological workup showed lymphopenia at 0.74 G/L, C-reactive protein (CRP) at 156.2 mg/L, hypophosphatemia at 0.7 mmol/L, normal renal function, normal liver function, Blood creatine phosphokinase (CPK) increased to 9N (1557 ui/L), D-Dimer at 1893 ng/L. The thoracic angioscanner showed a typical COVID involvement estimated at 25%, without pulmonary embolism. The patient received bricanyl/atrovent aerosols and a first dose of DEXAMETHASONE 6mg was administered. Hydration with NaCl was also started. During the night of 31Jul2021 to 01Aug2021, high flow oxygen therapy was started. Despite an oxygen flow rate of 60L/min and a FiO2 of 100%, no clinical improvement was observed, with SpO2 hardly remaining at 85-90%. The patient was comfortable, without signs of struggle, with a slight polypnea that was well tolerated. During the night of 01 to 02Aug2021, the patient was febrile and the respiratory status deteriorated with the need to introduce morphine and midazolam to the electric syringe pump in order to relieve the patient''s discomfort. The death was noted on 02Aug2021 at 8 am. The outcome of the events "COVID-19 respiratory infection/respiratory status deteriorated/COVID PCR was positive" was fatal, for other events was unknown. The patient died on 02Aug2021 at 8 am. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: COVID-19 respiratory infection/respiratory status deteriorated/COVID PCR was positive; COVID-19 respiratory infection/respiratory status deteriorated/COVID PCR was positive


VAERS ID: 1676132 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-16
Onset:2021-07-01
   Days after vaccination:107
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cerebrovascular accident, Coma, Disease recurrence, SARS-CoV-2 test, Sensory loss, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-06
   Days after onset: 36
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: Alzheimer''s disease; Arterial hypertension; Epilepsy; Hypothyroidism; Stroke
Allergies:
Diagnostic Lab Data: Test Date: 20210805; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101124842

Write-up: areactive coma; COVID-19 PCR test positive; Vaccination failure; Stroke; Stroke; complete right-sided deficit; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-NC20213719. A 97-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscularly on 16Mar2021 (Lot number: ET1831) as dose 2, single for COVID-19 immunisation. Historic vaccine was bnt162b2 received intramuscularly on 04Feb2021 (Lot Number: EJ6789) as dose 1, single for COVID-19 immunisation. Medical history included hypothyroidism, arterial hypertension, stroke, vascular epilepsy, advanced Alzheimer. Concomitant medications were not reported. Patient residing in a residential facility for dependent elderly people, at the end of her life in a context of recent stroke. Additional information from the regional pharmacovigilance centre: Vaccination of the patient in February and March very well tolerated. Patient in areactive coma following a brutal stroke (15Jul2021) with complete right-sided deficit since mid-July with cessation of treatment. PCR test came back positive on 05Aug2021, i.e. 5 months after complete vaccination, during a general test for all the residents of the home for dependent elderly people. Patient not febrile. Patient admitted to a nursing home since her coma, death expected. Evolution: could have led to death. Conclusion: 97 years old covid 19 positive patient died in the context of a recent positive PCR test and following an areactive coma after a stroke. Died on 06Aug2021 with no general or respiratory signs of Covid19 but positive PCR test on 05Aug2021 was end of life post stroke (coma). Other treatments: All treatments stopped in the face of coma. No treatment received. It was unknown if an autopsy was performed. The outcome of events was fatal. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Stroke; Stroke; areactive coma; complete right-sided deficit; COVID-19 PCR test positive; Vaccination failure


VAERS ID: 1676133 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-03
Onset:2021-08-04
   Days after vaccination:123
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Fall, General physical health deterioration, Lower respiratory tract congestion, SARS-CoV-2 test, Specialist consultation, Vaccination failure
SMQs:, Cardiac failure (broad), Lack of efficacy/effect (narrow), Accidents and injuries (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-05
   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: Chronic renal failure (moderate chronic renal failure); Depression; Glaucoma; Hypertension arterial; Hypothyroidism
Allergies:
Diagnostic Lab Data: Test Date: 20210805; Test Name: SARS-CoV-2 RT-PCR test; Test Result: Positive ; Test Date: 20210404; Test Name: Physician consultation; Result Unstructured Data: Test Result:bronchial congestion
CDC Split Type: FRPFIZER INC202101125327

Write-up: Vaccination failure; COVID-19 confirmed by positive COVID-19 test; deterioration of the patient''s general condition; Fall; bronchial congestion; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number FR-AFSSAPS-NC20213720. A 97-years-old female patient received second dose of bnt162b2 (COMIRNATY, formulation: Solution for injection, Batch/Lot Number: ET7205) via intramuscular on 03Apr2021 as dose 2, single and dose 1 for covid-19 immunisation bnt162b2 (COMIRNATY, formulation: Solution for injection, Batch/Lot Number: EP9605) via unspecified rout of administration on 06Mar2021 as dose 1, single. Medical history included hypothyroidism, glaucoma, hypertension arterial, moderate chronic renal failure, depression all from an unknown date and unknown if ongoing. Patient was residing in accommodation facility for dependent elderly people, good general condition, stabilized pathologies. The patient concomitant medications were not reported. On 04Aug2021, the patient experienced fall, bronchial congestion; It was reported that the patient was relatively well, fell from her height on 04Aug2021 leading to a consultation with the doctor who discovered a bronchial congestion and put the patient on antibiotic therapy. Vaccination of the patient in March and April very well tolerated. On 05Aug2021, the patient experienced vaccination failure and COVID-19 confirmed by positive covid-19 test. A general PCR test was performed for all residents on 05Aug2021, which came back positive the same day. The caregivers noticed a deterioration of the patient''s general condition the same day (05Aug2021). On 05Aug2021: death of the patient in her room. No complaint the previous hours. No information on a variant analysis performed. Summary of treatment was none. Course was death. Conclusion reported patient died of symptomatic covid by bronchial congestion discovered by the physician during a consultation + PCR test, without complaint from the patient, 4 months after full vaccination with Comirnaty. The patient underwent lab tests and procedures which included sars-cov-2 test (SARS-CoV-2 RT-PCR test): positive on 05Aug2021, specialist consultation (Physician consultation): bronchial congestion on 04Apr2021. The patient died on 05Aug2021. It was not reported (unknown) if an autopsy was performed. Other treatments reported as antibiotics. Outcome of the events fall, and deterioration of the patient''s general condition was unknown; the outcome of the events COVID-19 confirmed by positive COVID-19 test, vaccination failure and bronchial congestion was fatal. The pharmacovigilant notes: Imputability score(s) established without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable compensation procedures. no. 84/50, 24Jan1985. Published in Therapie 2011; 66(6): 517-525); Reported Cause(s) of Death: COVID-19 confirmed by positive COVID-19 test; Vaccination failure; symptomatic covid by bronchial congestion


VAERS ID: 1676138 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-06
Onset:2021-08-18
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8235 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Investigation, Nausea, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-20
   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: TERBINAFINE; ZYMAD; DOLIPRANE; NEBIVOLOL; PAROXETINE; IRBESARTAN; MOVICOL [MACROGOL 4000;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia; Anxiodepressive syndrome; Bladder prolapse; Constipation chronic; Femoral neck fracture; Hypertension arterial; Hypotension orthostatic; Living in residential institution; Osteoporosis; Sciatica; Senile macular degeneration
Allergies:
Diagnostic Lab Data: Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Test Name: TA; Result Unstructured Data: Test Result:17/8
CDC Split Type: FRPFIZER INC202101131059

Write-up: sudden death; Nausea; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number FR-AFSSAPS-NT20213464. A 92-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscularly, administered in left arm on 06Aug2021 (Lot Number: FE8235) as dose 1, single for COVID-19 immunisation. Medical history included anaemia, osteoporosis, hypotension orthostatic treated by venous retention, anxiodepressive syndrome, femoral neck fracture in 2020, hypertension arterial, senile macular degeneration, living in resident home, sciatica, bladder prolapse, chronic constipation. The patient was residing in nursing home, good general condition, GIR 3, consistent with recurrent persecution syndrome. Concomitant medications included terbinafine; colecalciferol (ZYMAD); paracetamol (DOLIPRANE); nebivolol; paroxetine; irbesartan; macrogol 4000, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL). Treatment (no recent changes): terbinafine 250 (1 / d), colecalciferol (1 / trim), paracetamol 500 (6 / d), nebivolol 5 (0.5 / d), paroxetine 20 (1 / d), irbesartan 300 (1 / d), Movicol (1 / d). Clinical history: Constants in immediate pre-vaccination: T o 36.3, TA 17/8. The patient had always refused all vaccines since entering the nursing home (DTP, pneumococcus, etc.). She refused the covid vaccination since Jan2021 but ended up being convinced by the epidemiological context. Vaccination with a 1st dose of bnt162b2 on 06Aug2021, without any problem that can be assessed until 19Aug2021. Visit of the attending physician on 13Aug2021 who did not note anything in particular and re-prescribed the same treatment. Circumstances of death: During the night of 18Aug2021 to 19Aug2021 the patient complained of nausea. Persistence during the day of 19Aug2021 of nausea without other symptoms. Eat little but no signs of seriousness. Said to feel better in the afternoon. Seen by the night staff during the night of 19Aug2021 to 20Aug2021 to remove rings that bothered her. No complaint reported. Systematic passage of the night staff 2 hours later: Death noted. In total, sudden death without prodrome on Day 14 + from a 1st dose of bnt162b2 in a 92-year-old patient with polymorbid. The patient died on 20Aug2021. An autopsy was not performed. The outcome of sudden death was fatal. The outcome of nausea was unknown. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : FR-AFSSAPS-NT20213464 AFSSAPS; Reported Cause(s) of Death: sudden death


VAERS ID: 1676147 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-16
Onset:2021-02-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Brain natriuretic peptide, Cardiac failure, Culture stool, Diarrhoea, Dysentery, Pruritus
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-27
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COUMADINE; LERCAN; BICARBONATE SODIUM; RESIKALI; VITAMINE D3; FUROSEMIDE TEVA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Atrial fibrillation; End stage renal disease (ESRD); Haemodialysis; Nephrectomy; Parathyroid adenoma; Septicaemia streptococcal
Allergies:
Diagnostic Lab Data: Test Date: 20210216; Test Name: cardiac markers; Result Unstructured Data: Test Result:Significantly increasing; Test Date: 20210223; Test Name: BNP; Result Unstructured Data: Test Result:546 ng/L; Test Date: 20210216; Test Name: Stool culture; Result Unstructured Data: Test Result:without any trace of food poisoning
CDC Split Type: FRPFIZER INC202101125555

Write-up: heart failure; Generalized itching all over the body; Extremely strong diarrhea; Extremely strong diarrhea akin to dysentery; This is a spontaneous report from a contactable consumer and an other health professional downloaded from the Regulatory authority. Regulatory Authority Report Number: FR-AFSSAPS-NY20213904. A 75-year-old male patient received second dose of BNT162B2 (COMIRNATY), intramuscularly on 16Feb2021 (lot number EJ6789) at the age of 75 years old as single dose for COVID-19 immunization. Medical history included End stage renal disease (ESRD), Arterial hypertension, Atrial fibrillation, Parathyroid adenoma, Septicaemia streptococcal, Nephrectomy, Haemodialysis from 17May2017. Concomitant medications included warfarin sodium (COUMADINE) for Atrial fibrillation, lercanidipine hydrochloride (LERCAN) for Hypertension arterial, sodium bicarbonate (BICARBONATE SODIUM), calcium polystyrene sulfonate (RESIKALI) for Hyperkalaemia, colecalciferol (VITAMINE D3) for Vitamin D supplementation, furosemide (FUROSEMIDE TEVA) for Chronic renal failure. On 16Feb2021, the patient experienced generalized itching all over the body, treated with antihistamines prescribed by the attending physician; extremely strong diarrhea akin to dysentery for 3 days, treated with antidiarrheals prescribed by the attending physician. Stool culture carried out without any trace of food poisoning. Significantly increasing cardiac markers. Death from heart failure (23Feb2021) it seemed. Found lifeless outside his home. Intervention of firefighters and SAMU without success. On 23Feb2021, BNP (brain natriuretic peptide) was 546 ng/L. The patient died on 27Feb2021. It was unknown if autopsy was done. The outcome of event heart failure was fatal, outcome of events "Extremely strong diarrhea akin to dysentery" was resolved on 19Feb2021, outcome of other event was resolved in 2021.; Reported Cause(s) of Death: heart failure


VAERS ID: 1676189 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-14
Onset:2021-08-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Coma, Malignant hypertension, Posterior reversible encephalopathy syndrome, SARS-CoV-2 test, Status epilepticus
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Hypertension (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   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:
Current Illness: Hypertension arterial; Metrorrhagia; Uterine fibroid
Preexisting Conditions: Medical History/Concurrent Conditions: Acute renal failure; COVID-19; Monoclonal gammopathy (IgG kappa); Polyneuropathy (Length-dependent sensory-motor axonal)
Allergies:
Diagnostic Lab Data: Test Date: 202010; Test Name: covid-19 test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101125204

Write-up: coma; Convulsive status epilepticus; Posterior reversible encephalopathy syndrome; Hypertension malignant; This is a spontaneous report from a contactable physician downloaded from the RA [FR-AFSSAPS-RN20212622]. A 50-year-old female patient received first dose of BNT162B2 (COMIRNATY) intramuscular single dose for COVID-19 immunisation on 14Aug2021 at 50-year-old. Medical history included COVID-19 from Oct2020, length-dependent sensory-motor axonal polyneuropathy, ongoing chronic metrorrhagia in, ongoing hypertension arterial, monoclonal gammopathy IgG kappa, ongoing uterine fibroid, acute renal failure system disease under review (unspecified). The patient''s concomitant medications were not reported. The patient experienced convulsive status epilepticus, posterior reversible encephalopathy syndrome, hypertension malignant, all death on 14Aug2021; coma with outcome of unknown. On 14Aug2021, 5 hours after vaccination, the patient had a state of convulsive harm on posterior reversible encephalopathy syndrome, secondary malignant hypertension. The patient experienced Ill state with coma requiring mechanical ventilation. It should be noted that in the month preceding the vaccination, several consultations had taken place with high tensions, uncontrolled despite the treatment of the female patient, all in a context of worsening renal failure and manifestations integrated into a system disease (neuro, renal impairment, hypertension) being assessed. Lab test included positive COVID-19 in Oct2020. The patient died in Aug2021. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: posterior reversible encephalopathy syndrome; Hypertension malignant; Convulsive status epilepticus


VAERS ID: 1676192 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-13
Onset:2021-08-18
   Days after vaccination:158
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, 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: 2021-08-24
   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: ATENOLOL; FUROSEMIDE; HALDOL; LEVOTHYROX; MIANSERINE [MIANSERIN]; RAMIPRIL; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; ZYMAD
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease (very advanced Alzheimer''s disease); Arthritis rheumatoid; Cholecystectomy; Chronic renal failure (IRC (Clearance around 30 ml / min)); COVID-19; Hypercholesterolaemia; Hyperthyroidism; Non-obstructive cardiomyopathy; Psoriasis
Allergies:
Diagnostic Lab Data: Test Date: 20210818; Test Name: Sars-cov-2 PCR test; Test Result: Positive ; Comments: variant
CDC Split Type: FRPFIZER INC202101124797

Write-up: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable pharmacist downloaded from the RA, regulatory authority number FR-AFSSAPS-SE20212255. A 94-years-old female patient (resident in a residential facility for dependent elderly people) received second dose of bnt162b2 (COMIRNATY, formulation: Solution for injection, Lot number: ET3620), via intramuscular route, at an unspecified injection site on 13Mar2021 as dose 2, single and first dose of bnt162b2 (COMIRNATY, formulation: Solution for injection, Lot number: EJ6789), via intramuscular route, at an unspecified injection site on 23Feb2021 as dose 1, single for covid-19 immunization. Medical history included Alzheimer''s disease (very advanced Alzheimer''s disease), non-obstructive cardiomyopathy, hypercholesterolaemia, psoriasis, hyperthyroidism, Arthritis rheumatoid, chronic renal failure (IRC: Clearance around 30 ml / min) and Covid-19, all from unknown dates and unknown if ongoing and the patient also had cholecystectomy on an unknown date. The patient was at risk of developing a severe form of COVID-19. Concomitant medications included atenolol; furosemide; haloperidol (HALDOL); levothyroxine sodium (LEVOTHYROX); mianserine (MIANSERIN); ramipril; macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL) and colecalciferol (ZYMAD), all taken for unspecified indications and start and stop dates were not reported. It was stated that, the patient experienced covid-19 confirmed by positive covid-19 test on 18Aug2021 (as reported in notes: 177 days after first dose and 159 days after second dose) and the event was considered as serious as the patient died on 24Aug2021 and the cause of death was reported as COVID-19 respiratory infection. As per the description of the effect, Vaccine failure confirmed with positive PCR, then death. Symptoms presented were decline in general condition, asthenia, dehydration, anorexia (no fever, no respiratory signs, no digestive signs) and as per the evolution Death occurred. As per the conclusion, there was a confirmed vaccine failure (COMIRNATY vaccine), with death of the patient. The patient underwent lab tests and procedures which included Sars-cov-2 PCR test (sars-cov-2 test) with positive results (variant), on 18Aug2021. The outcome for the event was reported as Fatal. Note: Accountability without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable compensation procedures. Time Interval between Beginning of Drug Administration and Start of all Reaction / Event 177days Time Interval between Last Dose of Drug and Start of all Reaction / Event 159 days.; Reported Cause(s) of Death: COVID-19 respiratory infection


VAERS ID: 1676200 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-26
Onset:2021-04-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX0893 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal hypokinesia, Hypoxic-ischaemic encephalopathy, Investigation, Maternal exposure during pregnancy, Neonatal anoxia, Neonatal multi-organ failure
SMQs:, Ischaemic central nervous system vascular conditions (narrow), 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 (broad), Noninfectious encephalopathy/delirium (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Neonatal disorders (narrow), Respiratory failure (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-18
   Days after onset: 83
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: 20210716; Test Name: cardiofetal monitoring; Result Unstructured Data: Test Result:flat rhythm; Comments: the cardiofetal monitoring showed a flat rhythm
CDC Split Type: FRPFIZER INC202101124822

Write-up: Neonatal multi-organ failure; severe anoxic-ischemic encephalopathy; Decreased fetal movement; Anoxia neonatal; maternal exposure during pregnancy, second trimester; This is a spontaneous report from a contactable other hcp downloaded from the RA, regulatory authority number FR-AFSSAPS-TO20217217. This other hcp reported information for both mother and baby. This is a baby report. A neonate female patient received bnt162b2 (COMIRNATY), transplacentally on 26Apr2021 (lot number: EX0893) as dose 1, single; dose 2 transplacentally on 07Jun2021 (Lot Number: FC3143) as dose 2, single, both for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 16Jul2021 the mother presented to the hospital because of a decrease in active fetal movements since 24 hours. The 42 years old mother was 37 weeks amenorrhea + 4 days pregnant. On admission, the cardiofetal monitoring showed a flat rhythm. Delivery by emergency caesarean section on 16Jul2021. The patient experienced anoxia neonatal on 16Jul2021. The patient, a girl, was born in a state of death on 18Jul2021 (as reported). Medical conclusion: severe anoxic-ischemic encephalopathy (on 16Jul2021) on feto-maternal transfusion and triple circular. Neonatal multi-organ failure on 18Jul2021. An autopsy was not performed. The outcome of events was fatal.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101143334 mother/baby case; Reported Cause(s) of Death: Neonatal multiorgan failure; Anoxia neonatal; severe anoxic-ischemic encephalopathy; maternal exposure during pregnancy, second trimester; Decreased fetal movement


VAERS ID: 1676206 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-06
Onset:2021-08-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3318 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Body mass index, Chest pain, Computerised tomogram, Headache, Inappropriate schedule of product administration, Pain in extremity, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-07
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OXYCODONE; GAVISCON ADVANCED; METOCLOPRAMIDE; RACECADOTRIL; ENOXAPARIN; FOLIC ACID; FUROSEMIDE; OXICONAZOLE; CYCLOPHOSPHAMIDE; ZINC GLUCONATE; GABAPENTIN
Current Illness: Liposarcoma metastatic; Morbid obesity
Preexisting Conditions: Medical History/Concurrent Conditions: Cholecystectomy; Deafness; Erysipelas; Hospitalization; Liposarcoma (metastatic to the lungs); Lymphedema; Obesity hypoventilation syndrome (fitted with non-invasive nocturnal ventilation); Pulmonary metastases; Rheumatic fever (in childhood)
Allergies:
Diagnostic Lab Data: Test Name: Body mass index; Result Unstructured Data: Test Result:94; Test Date: 202106; Test Name: CT; Result Unstructured Data: Test Result:finding a clear increase in metastatic lesions in; Comments: finding a clear increase in metastatic lesions in the lungs with in particular a lesion of the right lower lobe of 7 x 11 cm (versus 2 cm at the last CT(computed tomogram) scan) and a nodule measuring 20 x 25 mm (versus 13 x 10 mm during the last evaluation)
CDC Split Type: FRPFIZER INC202101124900

Write-up: Sudden death; pain in the upper limb; pain in the right lung; Asthenia; Headache; Inappropiate schedule of vaccine administered; A 39-year-old female patient received bnt162b2 (COMIRNATY, Lot Number: FF3318), dose 2 intramuscular on 06Aug2021 at the age of 39-year-old as single dose for covid-19 immunisation. Medical history included morbid obesity, ongoing liposarcoma metastatic, deafness post recurrent bacterial meningiti, obesity hypoventilation syndrome (fitted with non-invasive nocturnal ventilation), erysipelas of the lower limbs, lymphedema of the lower limbs, rheumatic fever in childhood, giant liposarcoma from Jul2019 and metastatic to the lungs from Nov2020, cholecystectomy from Jul2019 to an unknown date. Concomitant medications included oxycodone; potassium bicarbonate, sodium alginate (GAVISCON ADVANCED); metoclopramide; racecadotril; enoxaparin; ferrous sulfate (TARDYFERON); folic acid; furosemide; oxiconazole; cyclophosphamide; zinc gluconate; gabapentin. It was reported that the 39-year-old patient with obesity: last known weight: 260 kg for 166 cm, BMI (body mass index) 94, deafness post recurrent bacterial meningitis (context of meningocele of the left riddled blade operated in 2013), obesity hypoventilation syndrome fitted with non-invasive nocturnal ventilation, repeated erysipelas and lymphedema of the lower limbs, rheumatic fever in childhood, giant liposarcoma diagnosed in Jul2019, initially treated surgically then metastatic to the lungs from November 2020 with initial refusal of treatment. Increase in pulmonary metastases with treatment agreement on 24Jun2021, cholecystectomy in Jul2019. Treatment in progress on 06Aug2021: oxycodone, Gaviscon, metoclopramide, racecadotril, enoxaparin, Tardyferon, folic acid, furosemide, oxiconazole cream, cyclophosphamide, gabapentin and zinc gluconate. From 18May to 16Jun2021, hospitalized for hypercapnic exacerbation of her obesity hypoventilation syndrome with favorable outcome under optimization of non-invasive ventilation. Episode of exudative pleurisy without documentation on probable neoplastic progression of giant metastatic liposarcoma in the lungs. On 22Jun2021, first dose of Comirnaty vaccine (batch number FC3143). In Jun2021: Reassessment finding a clear increase in metastatic lesions in the lungs with in particular a lesion of the right lower lobe of 7 x 11 cm (versus 2 cm at the last CT(computed tomogram) scan) and a nodule measuring 20 x 25 mm (versus 13 x 10 mm during the last evaluation). Consultation of announcement and implementation of treatment with Endoxan on 24Jun2021. 20Jul2021: Consult the emergency room for acute respiratory failure in a context of dyspnea that has gradually appeared for a few days. Management by non-invasive ventilation +/- oxygen therapy. Right chest pains related to the larger pulmonary metastasis of giant liposarcoma. Introduction of Oxynorm and gabapentin in increasing doses, well tolerated. Continuation of endoxan. On 06Aug2021 in the afternoon, second dose of Comirnaty vaccine (batch number FF3318). At 4 p.m .: headache, pain in the upper limb and in the right lung, asthenia. 07Aug2021 at 2:30 am: found deceased with non-invasive ventilation partially removed and oxygen therapy mismatched. Death certificate at 2:45 a.m. In total, sudden hospital death (acute hypoxia?) At H12 of D(dose)2 from COMIRNATY, in a 39-year-old patient hospitalized for acute respiratory failure in a context of morbid obesity and pulmonary metastases from liposarcoma during treatment with Endoxan, to whom an opioid treatment had just been added. The outcome for events headache, pain in the upper limb and in the right lung, asthenia was unknown, the rest of event was fatal. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101144086 same patient/drug, different dose and event.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1676210 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: FRPFIZER INC202101138029

Write-up: Massive myocardial infarction; This is a spontaneous report from a contactable physician via a sales representative. A 25-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single; then via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced massive myocardial infarction on an unspecified date with fatal outcome. The patient died on an unspecified date. It was not reported if an autopsy was performed.; Reporter''s Comments: A young man of 25 died 4 days after his 2nd dose of Pfizer from a massive myocardial infarction. You understand my revolt in the face of so much hypocrisy. You are of course for nothing and I do not blame you. Attached is the funeral notice. I was a doctor to his grandparents. For me, the score is 2 to 1 except that at 25, he had no risk of dying from Covid.; Sender''s Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Myocardial infarction (Fatal) and BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. ; Reported Cause(s) of Death: Massive myocardial infarction


VAERS ID: 1676213 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       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: FRPFIZER INC202101144381

Write-up: death from unknown cause; This is a spontaneous report from a non-contactable physician via a sales representative. A 31-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient''s medical history was not reported. She was described to be in good health. Concomitant medications were not reported. The patient experienced death from unknown cause on an unspecified date, 2 weeks after vaccination. The patient died on an unspecified date. It was unknown if an autopsy was performed. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: As there is limited information in the case provided, the causal association between the event "Unknown cause of death" and the suspect drug "BNT162B2" cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: death from unknown cause


VAERS ID: 1676232 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-06-06
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-07
   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: BUTTERCUP BRONCHOSTOP [THYMUS VULGARIS;THYMUS ZYGIS]
Current Illness: Dysautonomia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210808; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Overgrowth fungal; This case was received via RA (Reference number: GB-MHRA-ADR 25816392) on 26-Aug-2021 and was forwarded to Moderna on 26-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of OVERGROWTH FUNGAL (Overgrowth fungal) in a 44-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Dysautonomia. Concomitant products included THYMUS VULGARIS, THYMUS ZYGIS (BUTTERCUP BRONCHOSTOP [THYMUS VULGARIS;THYMUS ZYGIS]) for Dysautonomia. On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 06-Jun-2021, the patient experienced OVERGROWTH FUNGAL (Overgrowth fungal) (seriousness criteria death and medically significant). The patient died on 07-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment medication was not provided by the reporter. Limited information regarding the event / patient''s death has been provided at this time and a causal relationship cannot be excluded. Event term, onset date and outcome captured per SD Authority reporting. Cause of death not specifically reported, though fungal overgrowth can cause fatality so no additional event of "death" added. Event seriousness per assessment by Authority.; Sender''s Comments: Limited information regarding the event / patient''s death has been provided at this time and a causal relationship cannot be excluded. Event term, onset date and outcome captured per SD Authority reporting. Cause of death not specifically reported, though fungal overgrowth can cause fatality so no additional event of "death" added. Event seriousness per assessment by Authority; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1676623 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4493 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101131835

Write-up: cardiac arrest; The initial case had the missing following minimum criteria: Invalid for unidentifiable patient. Upon receipt of follow-up information on (31Aug2021), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable physician downloaded from Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-777109. A 51-year-old male patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot Number: FG4493) via an unspecified route of administration on an unspecified date as a Dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On an unknown date in Aug2021, the experienced cardiac arrest and died. It was not reported if an autopsy was performed or not.; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 1676626 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Product contamination
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: JPMODERNATX, INC.MOD20213

Write-up: Death; product contamination; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other and describes the occurrence of DEATH (Death) in a patient of an unknown age and gender who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEATH (Death) (seriousness criteria death and medically significant) and PRODUCT CONTAMINATION (product contamination). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PRODUCT CONTAMINATION (product contamination) had resolved. No concomitant medication was provided. No treatment information was provided. Company Comment: This is a case of Product contamination with associated AEs. Very limited information regarding these events have been provided at this time. No further information is expected.; Sender''s Comments: This is a case of Product contamination with associated AEs. 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: 1676729 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-01
Onset:2021-07-01
   Days after vaccination:212
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0573 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood creatine phosphokinase, Blood pressure decreased, Body temperature, Cerebral infarction, Computerised tomogram, Decreased appetite, Electrocardiogram abnormal, Oxygen saturation, Oxygen saturation decreased, Pneumonia, Pulmonary alveolar haemorrhage, Pulmonary congestion, Pyrexia, SARS-CoV-2 test, Troponin T, Troponin T increased
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-08
   Days after onset: 38
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Cancer (NOS); Gout
Allergies:
Diagnostic Lab Data: Test Date: 20210808; Test Name: CT; Result Unstructured Data: Test Result:bilateral diffuse ground-glass opacities and infil; Comments: bilateral diffuse ground-glass opacities and infiltrative shadows; Test Date: 20210808; Test Name: ECG; Result Unstructured Data: Test Result:Q wave abnormal and ST depressed; Comments: suspected of having an old cerebral infarction at the septum; Test Date: 20210806; Test Name: SpO2; Result Unstructured Data: Test Result:87 to 92 %; Comments: room air When the patient visited the reporting department for the first time; Test Date: 20210808; Test Name: SpO2; Result Unstructured Data: Test Result:60 or lower %; Comments: at 10:30; Test Date: 20210808; Test Name: SpO2; Test Result: 85 %; Comments: reservoir mask 10 L; Test Date: 20210808; Test Name: SARS-CoV-2 PCR test; Test Result: Negative ; Test Date: 20210808; Test Name: troponin T; Test Result: Positive ; Comments: mild positive; Test Date: 20210808; Test Name: CK; Test Result: Negative ; Test Date: 20210805; Test Name: body temperature; Result Unstructured Data: Test Result:37.1 Centigrade; Comments: Before vaccination; Test Date: 20210805; Test Name: body temperature; Result Unstructured Data: Test Result:around 38 Centigrade; Test Date: 202107; Test Name: CT; Result Unstructured Data: Test Result:ground-glass opacities in the both lung fields; Comments: in mid-Jul2021
CDC Split Type: JPPFIZER INC202101121375

Write-up: suspected old cerebral infarction; Troponin T mild positive; pulmonary congestion; Pulmonary alveolar haemorrhage suspected; blood pressure suddenly decreased; SpO2 was slightly low as 87 to 92%/decreased to 60% or lower; inappetence; pyrexia of around 38 degrees Celsius; drug-induced pneumonia; This is a spontaneous report from a contactable physician received from the Regulatory Agency. Regulatory authority report number is v21125436. A 67-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 05Aug2021 (Batch/Lot Number: EY0573; Expiration Date: 30Sep2021) as DOSE 1, SINGLE for covid-19 immunisation at the age of 67-year-old; oxaliplatin (OXALIPLATIN) and gimeracil, oteracil potassium, tegafur (TS-1), via an unspecified route of administration from Dec2020 (Batch/Lot number was not reported) to Jul2021, at unspecified dose for cancer. The patient was a 67-year-old male. Body temperature before vaccination was 37.1 degrees Centigrade. The family history was not provided. The patient had medical histories of cancer, ongoing hypertension, and gout, for which he was given drugs. On 05Aug2021 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0573, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 08Aug2021 (3 days after the vaccination), the patient experienced pulmonary congestion and pulmonary alveolar haemorrhage suspected. On 08Aug2021 (3 days after the vaccination), the outcome of the event was fatal. Oxaliplatin and TS-1 were captured as co-suspect drugs based on the information of Other possible cause of the event. The course of the event was as follows: From Dec2020 to early Jul2021, the patient was undergoing chemotherapy with oxaliplatin (OXALIPLATIN) and TS-1. CT in mid-Jul2021 showed ground-glass opacities on the both lung fields. CT in mid-Jul2021 showed ground-glass opacities in the both lung fields as above described. Thus, the patient was suspected to have drug-induced pneumonia, and he was referred to and visited the reporting department for the first time on 06Aug2021 (one day after vaccination). After the patient received the first dose of BNT162b2 vaccination on 05Aug2021 (the day of vaccination), the patient had pyrexia of around 38 degrees Celsius. When the patient visited the reporting department for the first time on 06Aug2021, the SpO2 was slightly low as 87 to 92% (room air)(there were no images on the same day). Thereafter, the patient had pyrexia and inappetence. On 08Aug2021 (3 days after vaccination), at 03:00, the patient woke up with dyspnoea, and on the same day, at 09:30, the patient contacted that he wished to be examined. At 10:30, when the patient was examined, the SpO2 decreased to 60% or lower. The patient also had pyrexia. While oxygen was administered, COVID-19 PCR test was performed. The result of the PCR showed negative. The SpO2 was maintained at around 85% with a reservoir mask 10 L, and the consciousness was alert. CT showed bilateral diffuse ground-glass opacities and infiltrative shadows. ECG showed Q wave abnormal and ST depressed suspected of having an old cerebral infarction at the septum . CK was negative, and the troponin T was mild positive. After CT was performed, the blood pressure suddenly decreased. Although cardiopulmonary resuscitation (CPR) was performed, the patient''s life could not be saved. The time between the hospital visit and confirmation of death was approximately 3 and a half hours. After the death was confirmed, a pathological autopsy was performed. The detailed results were still waited. However, at the time of the autopsy, the causes of death were severe pulmonary congestion on the both lungs and pulmonary alveolar haemorrhage suspected. No obvious pulmonary embolism was observed. The reporting physician classified the event as serious (death) and assessed that the causality between the events and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was as follows: From Dec2020 to early Jul2021, the patient was undergoing chemotherapy with oxaliplatin and TS-1. CT in mid-Jul2021 showed ground-glass opacities on the both lung fields. It was also possible that it was drug-induced. The reporting physician commented as follows: Since the patient had pyrexia after the vaccination, and the patient died within several days after the vaccination, although the causality between the events and the vaccination was unknown, this case was reported. As of this date, the reason for sudden change was not clear. Since a pathological autopsy was being performed, this case was to be reported as the second report. The outcome of pulmonary congestion and pulmonary alveolar haemorrhage was fatal, outcome of other events was unknown. Pfizer is a marketing authorization holder of oxaliplatin in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of oxaliplatin has submitted the same report to the regulatory authorities.; Reported Cause(s) of Death: Pulmonary congestion; Pulmonary alveolar haemorrhage suspected


VAERS ID: 1676730 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3860 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac dysfunction, Nausea, Pneumonia aspiration, Productive cough, Pyrexia, Respiratory failure, Vomiting
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-03
   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: Chronic kidney disease; Disuse syndrome; Haemodialysis; Occupational therapy; Physiotherapy; Strangulation ileus (surgery was performed); Surgery; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: body temperature; Result Unstructured Data: Test Result:37.6 Centigrade; Comments: Before vaccination; Test Date: 20210802; Test Name: body temperature; Result Unstructured Data: Test Result:39.0-39.9 Centigrade; Comments: After vaccination
CDC Split Type: JPPFIZER INC202101121499

Write-up: Pneumonia aspiration; Vomiting; sputum; queasy; respiratory failure; cardiac function decreased; pyrexia of 39.0-39.9 degrees Celsius; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21125208. A 76-year and 11-month-old male patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number EY3860, Expiration date 31Aug2021) via an unspecified route of administration, on 02Aug2021 at 14:20, at the age of 76-year-old, as dose 2, single, for COVID-19 immunization. Medical history included hemodialysis since 2011 for chronic kidney disease due to type 2 diabetes mellitus. On 26May2021, the patient had strangulation ileus, for which surgery was performed at another hospital. On 07Jun2021, the patient was diagnosed with disuse syndrome. The patient had no family history. Concomitant medications were not reported. Historical vaccine included BNT162B2 (COMIRNATY, Solution for injection, Lot number and expiration date unknown) via an unspecified route of administration, on 12Jul2021 at 14:20, at the age of 76-year-old, as dose 1, single, for COVID-19 immunization. On 28Jun2021, the patient was transferred to the reporting hospital for rehabilitation. Physiotherapy and occupational therapy were performed. Body temperature before vaccination on 02Aug2021 was 37.6 degrees centigrade. On 02Aug2021 (the day of vaccination), the patient had pyrexia of 39.0-39.9 degrees Celsius, and an antipyretic was used. On 03Aug2021 at 17:00 (one day/2 hours/40 minutes after the vaccination), the patient experienced pneumonia aspiration and vomiting; the patient had sputum, queasy, and vomiting. Thereafter, the patient had respiratory failure and cardiac function decreased. The reporting physician classified the events pneumonia aspiration and vomiting as serious (death) and assessed the causality between the events pneumonia aspiration and vomiting and BNT162B2 as unassessable. Other possible causes of the event such as any other diseases included strangulated ileus and chronic kidney disease. The reporting physician commented as follows: Since admission to the reporting hospital, the patient had never had queasy nor vomiting. However, approximately 15 hours after the second dose of BNT162B2 vaccination, the patient had vomiting, and he also had pneumonia aspiration. On 03Aug2021 at 21:48 (one day/7 hours/28 minutes after vaccination), the patient was confirmed dead. The outcome of the events pneumonia aspiration and vomiting was fatal while it was unknown for the other events. Causes of death were reported as pneumonia aspiration and vomiting. It was unknown if an autopsy was performed.; Reported Cause(s) of Death: Pneumonia aspiration; Vomiting


VAERS ID: 1676731 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8162 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory arrest, Electrocardiogram, Pupillary reflex impaired, Pyrexia, Ventricular tachycardia
SMQs:, Torsade de pointes/QT prolongation (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-26
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: E KEPPRA; RIVOTRIL; DEPAKENE [VALPROATE SODIUM]; CILOSTAZOL; MAINTATE; THYRADIN S; TAKEPRON; CALONAL; ALDACTONE-A; MAGNESIUM OXIDE; CLEANAL; MUCOSOLVAN; MUCODYNE; ALFAROL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral palsy; Epilepsy; Hypertrophic cardiomyopathy; Neuronal ceroid lipofuscinosis; Psychosomatic disease
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: body temperature; Result Unstructured Data: Test Result:37.4 Centigrade; Comments: at around 14:30; Test Date: 20210825; Test Name: body temperature; Result Unstructured Data: Test Result:38.5 Centigrade; Comments: at midnight; treatment with acetaminophen (ACETAMINOPHEN) 300 mg (suppository); Test Date: 20210825; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: in the morning; Test Name: ECG; Result Unstructured Data: Test Result:ventricular tachycardia
CDC Split Type: JPPFIZER INC202101125987

Write-up: ventricular tachycardia; cardio-respiratory arrest; light reflex lost; pyrexia of 37.4 degrees Centigrade/ the pyrexia rose to 38.5 degrees Centigrade; This is a spontaneous report from a contactable physician received via COVID-19 adverse event self-reporting method. A 41-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Lot number FE8162, Expiration date 30Nov2021), via intramuscular, administered in left arm on 23Aug2021 11:00 (the day of vaccination; at the age of 41-year-old) as dose 2, single for COVID-19 immunisation. The patient had no allergies to medications, food, or other products, but alcohol disinfection was prohibited. Other medical history included ceroid lipofuscinosis, severe psychosomatic disease, epilepsy, cerebral palsy, and hypertrophic cardiomyopathy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included levetiracetam (E KEPPRA), clonazepam (RIVOTRIL), valproate sodium (DEPAKENE), cilostazol, bisoprolol fumarate (MAINTATE), levothyroxine sodium (THYRADIN S), lansoprazole (TAKEPRON), paracetamol (CALONAL), spironolactone (ALDACTONE-A), magnesium oxide, fudosteine (CLEANAL), ambroxol hydrochloride (MUCOSOLVAN), carbocisteine (MUCODYNE), and alfacalcidol (ALFAROL); all taken for an unspecified indication, start and stop date were not reported (all received within 2 weeks of vaccination). The patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC9880, Expiration date 30Sep2021) intramuscular in the left arm on 26Jul2021 (at the age of 41-year-old) for COVID-19 immunization. The patient experienced ventricular tachycardia, cardio-respiratory arrest, light reflex lost, pyrexia of 37.4 degrees centigrade/ the pyrexia rose to 38.5 degrees centigrade. On 24Aug2021 at around 14:30 (1 day after the vaccination), the patient experienced pyrexia of 37.4 degrees Centigrade. On 26Aug2021 at 00:40 (3 day after the vaccination), the patient experienced cardio-respiratory arrest and light reflex lost. The event, cardio-respiratory arrest, resulted in urgent care with cardiac massage. The course of the event was as follows: On 23Aug2021 (the day of vaccination), the patient received the second dose of Comirnaty intramuscular injection. On 24Aug2021 at around 14:30 (1 day after the vaccination), the patient began to have pyrexia of 37.4 degrees Centigrade. On 25Aug2021 at midnight (2 days after the vaccination), the pyrexia rose to 38.5 degrees Centigrade, so the patient was treated with acetaminophen at 300 mg (suppository). The pyrexia fell to 36.5 degrees Centigrade in the morning. On 26Aug2021 at 00:40 (3 days after the vaccination), a call was made by a nurse due to cardio-respiratory arrest and light reflex lost. In a state of cardio-respiratory arrest, cardiac massage was attempted. As the patient was in hospitalization with ventricular tachycardia shown by electrocardiography (ECG) and severe psychosomatic disease, life-saving procedures at the time of a sudden change was not requested. After his family''s request was reaffirmed, cardiopulmonary resuscitation was stopped. At 01:04, the death was confirmed. The patient passed away on 26Aug2021. The reporting physician assessed the event as serious (death). On 25Aug2021 (2 day after the vaccination), The outcome of the event, pyrexia, was recovered with treatment including acetaminophen (ACETAMINOPHEN) at 300 mg (suppository); for other events outcome was fatal with treatment including cardiac massage. An autopsy was not performed. The reporting physician reported that the cause of death was ventricular tachycardia, cardio-respiratory arrest and light reflex lost. No Follow-up attempts are needed. No further information is expected.; Sender''s Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnaty in triggering the onset of fatal event ventricular tachycardia, cardio-respiratory arrest and light reflex lost cannot be excluded.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: ventricular tachycardia; light reflex lost; cardio-respiratory arrest


VAERS ID: 1676857 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-11
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 212C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough
SMQs:, Anaphylactic reaction (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-11
   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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210904003

Write-up: Cough; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300101736] concerned a 66 year old male of an unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 212C21A, expiry: unknown) dose was not reported. frequency time 1 total administered on 04-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-AUG-2021 at 11:28, the patient experienced cough (Shortness of breathing, slurring of speech ) and resulted in death. It was unspecified if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210904003-COVID-19 VACCINE AD26.COV2.S.- Cough. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: COUGH


VAERS ID: 1676858 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-11
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210904060

Write-up: DIFFICULTY BREATHING; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA,PH-PHFDA-300102526] concerned a 60 year old male with an unspecified race and ethnic origin.. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 27-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-Aug-2021 patient experienced fever, cough and colds. On 11-AUG-2021, the patient experienced difficulty breathing. On an unspecified date, the patient died from difficulty breathing. It was unknown, if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210904060- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Difficulty breathing. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: DIFFICULTY BREATHING


VAERS ID: 1676859 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-17
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210904070

Write-up: DIFFICULTY OF BREATHING; FEVER; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300102248] concerned a 49 year old male of unspecified race and ethnic origin. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A expiry: UNKNOWN) dose was not reported, frequency one total, administered on 24-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-AUG-2021, the patient experienced fever. On 21-AUG-2021, the patient experienced difficulty of breathing. On an unspecified date, the patient died from fever, and difficulty of breathing. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210904070-COVID-19 VACCINE AD26.COV2.S-fever, difficulty of breathing. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: FEVER; DIFFICULTY OF BREATHING


VAERS ID: 1676861 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-07
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Hypertension, Myocardial infarction
SMQs:, Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210807; Test Name: Blood pressure; Result Unstructured Data: Elevated
CDC Split Type: PHJNJFOC20210904733

Write-up: MI; ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300102827] concerned a 74-year-old male of an unspecified race and ethnic origin. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 212C21A expiry: unknown) dose was not reported, 1 total administered on 04-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-AUG-2021 at 12:00 hours, the patient experienced myocardial infarction (MI) and elevated blood pressure. Laboratory data included: Blood pressure (NR: not provided) elevated. On an unspecified date, the patient died from myocardial infarction and elevated blood pressure. It was unspecified if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of myocardial infarction and elevated blood pressure was fatal. This report was serious (Death).; Sender''s Comments: V0: 20210904733-covid-19 vaccine ad26.cov2.s- Myocardial Infarction, Elevated blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: ELEVATED BLOOD PRESSURE; MI.


VAERS ID: 1676895 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-05
Onset:2021-05-04
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Drug ineffective, Off label use, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-18
   Days after onset: 75
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RAMIPRIL; TRAZODONE; TAMSULOSIN; CARBAMAZEPINE
Current Illness: Anxiety; Benign prostatic hyperplasia; Dementia; Depression; Epilepsy; Hypertension
Preexisting Conditions: Comments: No medical history was provided by the reporter.
Allergies:
Diagnostic Lab Data: Test Date: 20210713; Test Name: SARS-CoV-2 PCR test; Test Result: Positive ; Result Unstructured Data: Positive Iu international unit(s)
CDC Split Type: PTMODERNATX, INC.MOD20213

Write-up: Death; Vaccination failure; Patient tested positive for SARS-CoV-2 PCR test after both the doses of vaccine; 1 ml; This case was received via Regulatory Agency (Reference number: PT-INFARMED-F202108-1032) on 30-Aug-2021 and was forwarded to Moderna on 30-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death) in an 82-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concurrent medical conditions included Anxiety, Depression, Hypertension, Dementia, Epilepsy and Benign prostatic hyperplasia. Concomitant products included RAMIPRIL, TRAZODONE, TAMSULOSIN and CARBAMAZEPINE for an unknown indication. On 05-Apr-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 milliliter. On 03-May-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 milliliter. On 04-May-2021, the patient experienced OFF LABEL USE (1 ml). On 13-Jul-2021, the patient experienced VACCINATION FAILURE (Vaccination failure) and DRUG INEFFECTIVE (Patient tested positive for SARS-CoV-2 PCR test after both the doses of vaccine). The patient died on 18-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, VACCINATION FAILURE (Vaccination failure) and OFF LABEL USE (1 ml) outcome was unknown and DRUG INEFFECTIVE (Patient tested positive for SARS-CoV-2 PCR test after both the doses of vaccine) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was reported. The action taken with mRNA-1273 (Spikevax) was Not applicable. Company comment: This is a fatal case of vaccine failure and drug ineffective in which COVID 19 is not reported as such. Very limited information regarding this events has been provided at this time. Patient�s age and comorbidities are confounders for the outcome of the case. Translation has been requested. Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Follow up received on 30-Aug-2021 and included No new information.; Sender''s Comments: This is a fatal case of vaccine failure and drug ineffective in which COVID 19 is not reported as such. Very limited information regarding this events has been provided at this time. Patient�s age and comorbidities are confounders for the outcome of the case. Translation has been requested.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1676958 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-06
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939600-CDC / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, 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: 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: Parkinson''s disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210706; Test Name: body temperature; Result Unstructured Data: Degree Celsius. The fever was relieved in the evening.
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Fever; This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939600-CDC) for COVID-19 vaccination. Concurrent medical conditions included Parkinson''s disease. On 06-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) (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): On 06-Jul-2021, Body temperature: 39.5�c degree Celsius (High) The fever was relieved in the evening.. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication information was mentioned by reporter No treatment medication information was mentioned by reporter; Sender''s Comments: This is a case of death in a 90-year-old male subject with hx of Parkinson''s Disease, who died 2ays after receiving the vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: unknown couse of death


VAERS ID: 1676959 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939599-CDC / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Body temperature, Mental status changes, Pyrexia, Sepsis
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-17
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210703; Test Name: body temp.; Result Unstructured Data: 37.3 �C
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Poor mental status; General weakness; Sepsis; Fever; This regulatory authority case was reported by an other and describes the occurrence of SEPSIS (Sepsis), MENTAL STATUS CHANGES (Poor mental status) and ASTHENIA (General weakness) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939599-CDC) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. 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. On 03-Jul-2021, the patient experienced PYREXIA (Fever). On 08-Jul-2021, the patient experienced MENTAL STATUS CHANGES (Poor mental status) (seriousness criterion hospitalization) and ASTHENIA (General weakness) (seriousness criterion hospitalization). On an unknown date, the patient experienced SEPSIS (Sepsis) (seriousness criteria death and medically significant). On 04-Jul-2021, PYREXIA (Fever) had resolved. The patient died on 17-Jul-2021. The reported cause of death was Sepsis. It is unknown if an autopsy was performed. At the time of death, MENTAL STATUS CHANGES (Poor mental status) and ASTHENIA (General weakness) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2021, Body temperature: 37.3 �c degree Celsius (normal) 37.3 �C. No concomitant medication information was mentioned by reporter No treatment medication information was mentioned by reporter On July 14, 2021, due to persisting symptoms, the patient was accompanied by the family members to the Emergency Department, and upon diagnosis by the physician, the patient was hospitalized (in a general ward). On July 15, 2021, the patient was hospitalized (in a general ward). Company Comment: This case concerns an 94-year old female who had adverse events of fever, asthenia, mental status changes and sepsis and died 14 days after receiving mRNA-1273 (Moderna COVID-19 Vaccine). The reported cause of death was Sepsis. It is unknown if an autopsy was performed. Very limited information regarding this event/s has been provided at this time.; Sender''s Comments: This case concerns an 94-year old female who had adverse events of fever, asthenia, mental status changes and sepsis and died 14 days after receiving mRNA-1273 (Moderna COVID-19 Vaccine). The reported cause of death was Sepsis. It is unknown if an autopsy was performed. Very limited information regarding this event/s has been provided at this time.; Reported Cause(s) of Death: sepsis


VAERS ID: 1676963 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-07-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939599-CDC / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Death, Myalgia, Vaccination site pain, Vaccination site swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-07
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Death; abdominal bloating; Muscle pains; Swelling at the injection site; Pain at the injection site; This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939599-CDC) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Hypertension. On 05-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jul-2021, the patient experienced ABDOMINAL DISTENSION (abdominal bloating), MYALGIA (Muscle pains), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE PAIN (Pain at the injection site). The patient died on 07-Jul-2021. The cause of death was not reported. An autopsy was not performed. At the time of death, ABDOMINAL DISTENSION (abdominal bloating), MYALGIA (Muscle pains), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown. Concomitant medications was not reported. No treatment medication were reported. The patient''s son reported that the patient did not develop any discomfort after receiving the vaccine on 7/5. The patient''s wife objected to an autopsy and the patient''s body has been cremated. The patient''s son reported that the patient had a history of high blood pressure and would regularly fill his prescription in a nearby clinic. Very limited information regarding this event has been provided at this time. Further information is not expected. Patient�s age and history of hypertension are confounders for the event death.; Sender''s Comments: Very limited information regarding this event has been provided at this time. Further information is not expected. Patient�s age and history of hypertension are confounders for the event death.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1676966 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-21
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Cold sweat, Myocardial infarction, Shock
SMQs:, Anaphylactic reaction (narrow), Myocardial infarction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (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, arterial (narrow), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-22
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: diagnosed with myocardial infarction; cold sweat; shock symptoms; developed generalized weakness; This regulatory authority case was reported by an other health care professional and describes the occurrence of MYOCARDIAL INFARCTION (diagnosed with myocardial infarction), COLD SWEAT (cold sweat), SHOCK (shock symptoms) and ASTHENIA (developed generalized weakness) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, the patient experienced COLD SWEAT (cold sweat) (seriousness criteria death and hospitalization), SHOCK (shock symptoms) (seriousness criteria death, hospitalization and medically significant) and ASTHENIA (developed generalized weakness) (seriousness criteria death and hospitalization). On 22-Jul-2021, the patient experienced MYOCARDIAL INFARCTION (diagnosed with myocardial infarction) (seriousness criteria death, hospitalization and medically significant). The patient died on 22-Jul-2021. The reported cause of death was Cold sweat, developed generalized weakness, Myocardial infarction and Shock. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. patient received the Moderna vaccine at Arena administered by Hospital Concomitant medication were not provided. Treatment information was not 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: cold sweat; developed generalized weakness; myocardial infarction; Shock


VAERS ID: 1676968 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-18
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Coronary artery disease, Myocardial ischaemia, Physical examination, SARS-CoV-2 test
SMQs:, Other ischaemic heart disease (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 PCR test; Test Result: Negative ; Result Unstructured Data: Negative; Test Name: Examination; Result Unstructured Data: No external trauma
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Ischemic heart disease; Coronary heart disease with severe obstruction; This regulatory authority case was reported by an other health care professional and describes the occurrence of MYOCARDIAL ISCHAEMIA (Ischemic heart disease) and CORONARY ARTERY DISEASE (Coronary heart disease with severe obstruction) in a 51-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jul-2021, the patient experienced MYOCARDIAL ISCHAEMIA (Ischemic heart disease) (seriousness criteria death and medically significant) and CORONARY ARTERY DISEASE (Coronary heart disease with severe obstruction) (seriousness criterion death). The patient died on 18-Jul-2021. An autopsy was performed. The autopsy-determined cause of death was Ischemic heart disease and coronary heart disease with severe obstruction. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Physical examination: no external trauma (normal) No external trauma. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDIAL ISCHAEMIA (Ischemic heart disease) and CORONARY ARTERY DISEASE (Coronary heart disease with severe obstruction) to be possibly related. It was reported that on 18-Jul-2021, patient was driving a commercial vehicle and lost consciousness suddenly at a red light and was found unresponsive and sent to hospital for emergency treatment. Patient was Out-of-hospital cardiac arrest (OHCA) before reaching hospital and was dead. No concomitant medication information was reported. No treatment information was reported. Company comment: This is a serious RA case from CDC. The reaction / event as reported by the primary source is �other� . As per autopsy result described in narrative of SD, the events Myocardial ischemia and Coronary artery disease, with fatal outcome are captured. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: This is a serious RA case from CDC. The reaction / event as reported by the primary source is �other� . As per autopsy result described in narrative of SD, the events Myocardial ischemia and Coronary artery disease, with fatal outcome are captured. 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.; Autopsy-determined Cause(s) of Death: Ischemic heart disease; Coronary heart disease with severe obstruction


VAERS ID: 1678062 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-18
Onset:2021-08-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004731 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-20
   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: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Death unexplained; This case was received via RA (Reference number: FR-AFSSAPS-CF20212480 ) on 30-Aug-2021 and was forwarded to Moderna on 30-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death unexplained) in a 40-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004731) for COVID-19 vaccination. The patient''s past medical history included COVID-19. On 18-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. Death occurred on 20-Aug-2021 The patient died on 20-Aug-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. Company comment: Very limited information regarding this event/s has been provided at this time.; Sender''s Comments: Very limited information regarding this event/s has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1678226 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-20
Onset:2021-07-27
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Subarachnoid haemorrhage, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Haemorrhagic central nervous system vascular conditions (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-27
   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: JPMODERNATX, INC.MOD20213

Write-up: Thrombosis accompanied by thrombocytopenia; Subarachnoid haemorrhage; This case was received via Takeda Pharmaceuticals (Reference number: JP-TAKEDA-2021TJP083959) on 01-Sep-2021 and was forwarded to Moderna on 02-Sep-2021. This case, initially reported to the Regulatory authority by a staff member of emergency department, was received via the RA (Ref, v21125853). On 20-Jul-2021, the patient received the vaccine (unknown number of doses). After the vaccination, the patient had symptoms such as malaise. On 27-Jul-2021, the patient suffered cardiopulmonary arrest at home and was transported to the reporting hospital. Although cardiopulmonary resuscitation was performed, spontaneous circulation did not return. The results of blood test showed decreased platelet (Plt) (130,000) and increased D-dimer (1,422). The decrease in platelet count and the increase in D-dimer were improbable under normal condition. There was a possibility that the patient experienced thrombosis accompanied by thrombocytopenia and subarachnoid hemorrhage which was not associated with this vaccine. Theo outcome of thrombosis accompanied by thrombocytopenia and subarachnoid hemorrhage was reported as fatal. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: Low platelets of the value which was improbable under normal condition and coagulation abnormality of increased D-dimer were noted. The patient was transported to the emergency department in a state of cardiopulmonary arrest. The details of the situation at the time of vaccination were unknown, and the patient received the vaccine 1 week before; thus, causality of the vaccine is unclear, but it cannot be ruled out.; Sender''s Comments: Very limited information regarding these events has been provided at this time. Additional information required.; Reported Cause(s) of Death: Thrombosis accompanied by thrombocytopenia; Subarachnoid haemorrhage


VAERS ID: 1678227 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-08-11
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002619 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Coma scale, Computerised tomogram, Computerised tomogram head, 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: 2021-08-23
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210811; Test Name: GCS; Result Unstructured Data: diagnosed with subarachnoid haemorrhage based on GCS 3/3/6; Test Date: 20210811; Test Name: CT; Result Unstructured Data: diagnosed with subarachnoid haemorrhage; Test Date: 20210811; Test Name: Head contrast CT; Result Unstructured Data: erebral aneurysm of about 3.7 mm in the bifurcation of the left basilar artery and superior cerebellar artery
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Subarachnoid hemorrhage; This case was received via Regulatory Authority (Reference number: JP-TAKEDA-2021TJP083999) on 01-Sep-2021 and was forwarded to Moderna on 03-Sep-2021. This case, initially reported to the Regulatory Authority (RA) by a physician, was received via the PMDA (Ref, v21125512). On 08-Jul-2021, the patient received the 1st dose of this vaccine. On 04-Aug-2021, the patient received the 2nd dose of this vaccine. Transient headache and difficulty breathing developed in 12 hours after the vaccination. On 11-Aug-2021, at 18:45, sudden headache, difficulty breathing, and convulsion developed, and the patient was transported to the hospital. On arrival, the patient was diagnosed with subarachnoid haemorrhage based on GCS 3/3/6 and the result of CT. Head contrast CT revealed cerebral aneurysm of about 3.7 mm in the bifurcation of the left basilar artery and superior cerebellar artery. On 23-Aug-2021, the patient was confirmed dead. The outcome of subarachnoid hemorrhage was reported as fetal. Follow-up investigation will be made. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: Spontaneous rapture of cerebral aneurysm may be another contributing factor. Whether the cerebral aneurysm was caused by natural history or by the administration of this vaccine cannot be determined. The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This is a case of death in a 43-year-old female subject, who died 8 days after receiving second dose of vaccine due to Subarachnoid haemorrhage. Very limited information has been provided at this time.; Reported Cause(s) of Death: Subarachnoid haemorrhage


VAERS ID: 1678333 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-08-14
   Days after vaccination:184
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Interchange of vaccine products, Pulmonary embolism
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), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Medication errors (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: SILDENAFIL CITRATE
Current Illness: Interstitial lung disease; Interstitial pneumonia; Pulmonary fibrosis; Pulmonary hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Resuscitation
Allergies:
Diagnostic Lab Data:
CDC Split Type: ARMODERNATX, INC.MOD20213

Write-up: First dose Sputnic V and second dose of Moderna vaccine; Pulmonary thromboembolism; Cardio-respiratory arrest / respiratory deterioration; This spontaneous case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM (Pulmonary thromboembolism) and CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest / respiratory deterioration) in a 56-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. Co-suspect product included non-company product TREPROSTINIL SODIUM for Pulmonary hypertension. The patient''s past medical history included Resuscitation on 14-Aug-2021. Previously administered products included for COVID-19 immunisation: Sputnik V in May 2021. Concurrent medical conditions included Pulmonary hypertension, Pulmonary fibrosis, Interstitial lung disease and Interstitial pneumonia. Concomitant products included SILDENAFIL CITRATE for an unknown indication. On 11-Feb-2021, the patient started TREPROSTINIL SODIUM (Nasal) at an unspecified dose. On 13-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Aug-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary thromboembolism) (seriousness criteria death and medically significant) and CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest / respiratory deterioration) (seriousness criteria death and medically significant). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (First dose Sputnic V and second dose of Moderna vaccine). The patient died on an unknown date. The reported cause of death was Pulmonary thromboembolism. It is unknown if an autopsy was performed. At the time of death, INTERCHANGE OF VACCINE PRODUCTS (First dose Sputnic V and second dose of Moderna vaccine) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information was mentioned by reporter No treatment medication information was mentioned by reporter Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, history of pulmonary hypertension, pulmonary fibrosis, and interstitial lung disease may have contributed to the events and the fatal outcome.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, history of pulmonary hypertension, pulmonary fibrosis, and interstitial lung disease may have contributed to the events and the fatal outcome.; Reported Cause(s) of Death: pulmonary thromboembolism


VAERS ID: 1678403 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-28
Onset:2021-04-03
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       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: 2021-04-03
   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: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101124413

Write-up: Cerebral hemorrhage (parenchymal hemorrhage in the midbrain); This is a spontaneous report from a contactable physician downloaded from the Agency EudraVigilance-WEB, regulatory authority number AT-BASGAGES-2021-042401. A 56-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection; lot number: unknown and expiration date: not reported), via an unspecified route of administration on 28Mar2021 (at the age of 56-Year-old) as DOSE 2, SINGLE for covid-19 immunization. The patient had no medical history and concomitant medication. The patient previously received the BNT162B2 (COMIRNATY) via an unspecified route of administration on an unspecified route of administration as DOSE 1, SINGLE for covid-19 immunization. In the course of the judicial autopsy of a woman who died on 03Apr2021, the patient was found died from cerebral hemorrhage (parenchymal hemorrhage in the midbrain). The patient did the autopsy and result was cerebral hemorrhage (parenchymal hemorrhage in the midbrain). From a forensic medical angle, a connection cannot be ruled out with certainty. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Cerebral hemorrhage (parenchymal hemorrhage in the midbrain); Autopsy-determined Cause(s) of Death: Cerebral hemorrhage (parenchymal hemorrhage in the midbrain)


VAERS ID: 1679472 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-11
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral venous sinus thrombosis, Coma, Confusional state, Headache, Immune thrombocytopenia, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-17
   Days after onset: 6
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: Electronic cigarette user
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210902066

Write-up: VACCINE INDUCED IMMUNE THROMBOTIC THROMBOCYTOPENIA; HEADACHE; CONFUSION; SINUS VEIN THROMBOSIS; COMA; FEVER; VOMITING; This spontaneous report was received from a consumer following publication of a newspaper article and concerned a 34 year-old male patient. The patient''s height and weight were not reported. The patient''s concurrent conditions included being an electronic cigarette user, but was otherwise healthy. The patient''s wife and mother had experienced no vaccine-related reactions. The patient received COVID-19 vaccine Ad26.CoV2.S (suspension for injection, intramuscular, batch number unknown) dose and vaccination date not reported, for prophylactic vaccination. The batch number was not reported and the company is unable to perform follow-up. No concomitant medications were reported. On an unspecified date following vaccination, the patient experienced a headache, vomited and developed a fever. A doctor prescribed unspecified antibiotics for a suspected infected mosquito bite, which was ineffective. A day prior to a planned vacation, the patient''s wife telephoned for an ambulance as his headache was bad and he was walking around confused. The patient was hospitalised on an unspecified date and was in a coma in the intensive care unit of the hospital from 11-JUN-2021 (reported as 2 weeks post-vaccination) with sinus vein thrombosis. The patient underwent several unspecified operations in the hospital, together with unspecified medications. The doctor''s report from the hospital reported that the findings were typical of a SARS-CoV2 vaccine-induced immune thrombotic thrombocytopenia. On 17-JUN-2021, the patient died from the vaccine-induced immune thrombotic thrombocytopenia and sinus vein thrombosis. An autopsy was ordered by the public prosecutor and was performed on an unspecified date, with the report confirming the family and doctor''s suspicions and ended ''this is a serious (fatal) vaccination reaction''. The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. The outcomes of the fever, headache, vomiting and confusion were not reported. This report was serious (death, caused/prolonged hospitalization and other medically important condition). This case, from the same reporter, is linked to case 20210902067.; Sender''s Comments: V0: This spontaneous report received from a consumer following publication of a newspaper article concerns a 34-year-old male patient who was hospitalized 2 weeks after vaccination and subsequently died from vaccine-induced immune thrombocytopenic thrombocytopenia and sinus vein thrombosis. Patient''s height, weight and concomitant medications were not reported. The patient''s concurrent conditions included being an electronic cigarette user but was otherwise healthy. The patient''s wife and mother had experienced no vaccine-related reactions. Unspecified time after vaccination patient experienced headache, vomiting and fever. He was prescribed unspecified antibiotics for a suspected infected mosquito bite, which was ineffective. A day prior to a planned vacation, the patient''s wife telephoned for an ambulance as his headache was bad and he was walking around confused. The patient died after 6 days being hospitalized in the intensive care unit in coma with sinus vein thrombosis. He has undergone several unspecified operations in the hospital, he has been treated with unspecified medications and the doctor''s report from the hospital stated that the findings were typical of a SARS-CoV2 vaccine-induced immune thrombotic thrombocytopenia. Autopsy report confirmed the family and doctor''s suspicions and ended ''this is a serious (fatal) vaccination reaction''. Based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS, per definition), the low platelet count and temporal relationship to vaccination, the events are assessed to have a plausible relationship with vaccination.; Reported Cause(s) of Death: VACCINE INDUCED IMMUNE THROMBOTIC THROMBOCYTOPENIA; SINUS VEIN THROMBOSIS


VAERS ID: 1679801 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-13
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, COVID-19, Fibrin D dimer, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Interstitial lung disease (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-22
   Days after onset: 9
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: MODOPAR; PARACETAMOL; LEVOTHYROXINE; PRAVASTATIN; AMIODARONE; ACETYLSALICYLIC ACID; PANTOPRAZOLE
Current Illness: Choked on food (inhalation lung disease); Deafness; Oropharyngeal squamous cell carcinoma (squamous cell carcinoma of the oropharynx resulting in numerous false routes); Osteoporosis with fracture; Parkinsonian gait (parkinsonian syndrome)
Preexisting Conditions: Medical History/Concurrent Conditions: Auricular fibrillation (reduced atrial fibrillation); Breast cancer (right breast cancer); Lung disease; Pyelonephritis; Sinus operation
Allergies:
Diagnostic Lab Data: Test Name: Age-corrected D-dimer; Test Result: Negative ; Test Date: 20210813; Test Name: SARS-CoV-2 PCR test; Test Result: Positive ; Comments: delta variant A0B0C1
CDC Split Type: FRPFIZER INC202101142798

Write-up: Acute respiratory distress syndrome; positive Covid-19 PCR (delta variant A0B0C1)/COVID-19 respiratory infection; positive Covid-19 PCR (delta variant A0B0C1)/COVID-19 respiratory infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-BR20213302. A 91-year-old female patient received BNT162B2 (COMIRNATY, lot number: FE1248) dose 2 intramuscular on 21Jun2021 at single dose, first dose on unspecified date at single dose for COVID-19 immunisation. Medical history included ongoing Oropharyngeal squamous cell carcinoma (squamous cell carcinoma of the oropharynx resulting in numerous false routes), Pyelonephritis from Jul2021 to Aug2021, Auricular fibrillation/ reduced atrial fibrillation (not ongoing), Choked on food from Jul2021 and ongoing, ongoing Parkinsonian gait, ongoing Osteoporosis with fracture, right breast cancer not ongoing, ongoing Deafness, right middle meatotomy, inhalation lung disease from Jul2021. Concomitant medications included benserazide hydrochloride, levodopa (MODOPAR), paracetamol, levothyroxine, pravastatin, amiodarone, acetylsalicylic acid, pantoprazole. Hospitalization on 13Aug2021 for the onset of dyspnea and fever 2 days after discharge from geriatric medicine, with a positive Covid-19 PCR (delta variant A0B0C1). Probable nosocomial infection. Hospitalization due to oxygen dependence. Abrupt degradation of respiratory status on 21Aug2021, at Day 8 of the onset of symptoms, despite high concentration face mask oxygen therapy, prednisone 40 mg, preventive LOVENOX and 6 days of ROCEPHINE from 13Aug2021 to 18Aug2021. Optiflow recusal given age and recent history. Died on 22Aug2021 at 8pm secondary to Covid-19 respiratory infection. Acute respiratory distress syndrome. Age-corrected D-dimer was negative. No follow-up attempts are possible, no further information is expected. Batch/lot number cannot be obtained.; Reported Cause(s) of Death: positive Covid-19 PCR (delta variant A0B0C1)/COVID-19 respiratory infection; positive Covid-19 PCR (delta variant A0B0C1)/COVID-19 respiratory infection; Acute respiratory distress syndrome


VAERS ID: 1679838 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-08-06
   Days after vaccination:169
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM6950 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Computerised tomogram thorax, Mini mental status examination, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute rheumatism (acute articular rheumatism on scarlet fever at the age of 20); Ankylosing spondylitis; Anxiodepressive syndrome; Bipolar disorder; Cognitive impairment (MMSE 27/30 / Mattis 127/144 in 2011 vascular etiology); Collapsed vertebra (Multiple vertebral compression D11, D10, D9, L5); COVID-19; Dyslipidaemia; Fracture of pelvis (Fracture left acetabular base with ascent /depression total hip replacement, orthopaedic treatment); Fracture treatment; Hypertension arterial; Osteosynthesis (Fracture distal end of the left radius treated by osteosynthesis in 2021); Radius fracture (Fracture distal end of the left radius treated by osteosynthesis in 2021); Rectocele; Scarlatina (at the age of 20); Total hip replacement (Right); Total hip replacement (Left); Total knee replacement (Right); Wrist fracture (Left wrist fracture orthopedic treatment in 1998)
Allergies:
Diagnostic Lab Data: Test Name: Chest CT; Result Unstructured Data: Test Result:Absence of pulmonary embolism up to the sub-segmen; Comments: Moderate pulmonary involvement of SARS-CoV-2 infection (approximately 25%).; Test Name: MMSE; Result Unstructured Data: Test Result:27/30; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101142987

Write-up: Vaccination failure; Covid-19; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-LL20215881. A 101-year-old female patient received BNT162B2 (COMIRNATY), 1st dose on 28Jan2021 (lot number EM0477, expiration date 30Apr2021), 2nd dose on 18Feb2021 (lot number EM6950, expiration date 31May2021), both at single dose intramuscular in left arm for COVID-19 immunisation. Medical history included rectocele, Collapsed vertebra /multiple vertebral compression d11, d10, d9, l5 on the surgical level, ankylosing spondylitis, anxiety and depression syndrome, dyslipidemia, hypertension arterial, COVID-19 (had been tested for COVID-19), acute articular rheumatism on scarlatina / scarlet fever at the age of 20, bipolar syndrome, MCI (mild cognitive impairment) with MMSE (Mini-Mental State Examination) 27/30 / Mattis 127/144 in 2011 vascular etiology, left total hip replacement in 1997 + right in 1988, right total knee replacement in 1998, left wrist fracture treatment, orthopedic treatment in 1998, fracture distal end of the left radius treated by osteosynthesis in 2021, fracture of the left acetabular base with ascent and depression of the total hip replacement, orthopaedic treatment in Jul2021. Concomitant drug was not provided. On 06Aug2021, patient experienced appearance of a SARS COV2 infection, despite double vaccination. SARS-CoV-2 test was positive. Chest CT (computed tomogram): Absence of pulmonary embolism up to the sub-segmental level. Moderate pulmonary involvement of SARS-CoV-2 infection (approximately 25%). Outcome of the event was fatal. Conclusion of investigation results for lots EM0477 and EM6950 provided by Product Quality group was as follows: A sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EM0477 and lot EM6950. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. It was concluded that the reported defect is not representative of the quality of the batch and the batch remains acceptable. It was determined that a regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. The report was assessed as serious with seriousness criteria of death and hospitalization.; Reported Cause(s) of Death: Vaccination failure; Covid-19


VAERS ID: 1679872 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-08
Onset:2021-08-04
   Days after vaccination:177
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Drug ineffective, Suspected COVID-19
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: 2021-08-04
   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: Parkinson''s disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101131327

Write-up: COVID-19 respiratory infection; Drug ineffective; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-MP20216790. A 78-years-old male patient received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: EK9788) dose 2 via an intramuscular route of administration, on 08Feb2021 as dose 2, single for covid-19 immunisation. Medical history included ongoing parkinson''s disease from unknown start date. The patient''s concomitant medications were not reported. On 04Aug2021 the patient experienced covid-19 respiratory infection, drug ineffective and on an unspecified date, vaccination failure. Patient was hospitalized on an unspecified date. The patient was died on 04Aug2021. The outcome of the event covid-19 respiratory infection and drug ineffective was fatal. The outcome of the event vaccination failure was unknown. Autopsy performed was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: infection covid


VAERS ID: 1679909 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-05
Onset:2021-08-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004233 / UNK - / 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: 2021-08-06
   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: Cardiac failure; Dementia Alzheimer''s type; Hypertensive heart disease, unspecified; Infarct myocardial; Smoker
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Stroke
Allergies:
Diagnostic Lab Data: Test Date: 20210125; Test Name: SARS-CoV-2 test; Test Result: Positive ; Result Unstructured Data: SARS-CoV-2 test Positive
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Death unexplained; This case was received via Regulatory Authority (Reference number: FR-AFSSAPS-PV20212455) on 30-Aug-2021 and was forwarded to Moderna on 30-Aug-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (Death unexplained) in a 90-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004233) for COVID-19 vaccination. The patient''s past medical history included COVID-19 on 25-Jan-2021 and Stroke. Concurrent medical conditions included Infarct myocardial, Dementia Alzheimer''s type, Hypertensive heart disease, unspecified, Cardiac failure and Smoker. On 05-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. Death occurred on 06-Aug-2021 The patient died on 06-Aug-2021. The cause of death was not reported. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, SARS-CoV-2 test: positive (Positive) SARS-CoV-2 test Positive. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Treatment information was not provided. Company comment: Very Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded. However elderly age and patient�s medical history of cardiac failure, myocardial infraction , hypertensive heart disease and stroke could be a confounder. Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Translation received on 02-sep-2021 includes information on medical condition (Smoker).; Sender''s Comments: Very Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded. However elderly age and patient�s medical history of cardiac failure, myocardial infraction , hypertensive heart disease and stroke could be a confounder.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1680558 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? 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: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Lactation decreased; Miscarriage; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Date: 20210820; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative; Comments: No - Negative COVID-19 test; Test Name: scan; Result Unstructured Data: Test Result:no heart beat; Comments: Went to the scan and told there was no heart beat. Vaccine taken at 11+1 baby died at 11+3
CDC Split Type: GBPFIZER INC202101133106

Write-up: Miscarriage; Maternal exposure during pregnancy; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202108301639126920-YL2YN, Safety Report Unique Identifier GB-MHRA-ADR 25869929. This consumer or other non hcp reported information for both mother and fetus/baby. This is a maternal report. A 35-year-old pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: FC9001, Expiry date was not reported), via an unspecified route of administration on 21Aug2021 as single dose for COVID-19 immunization. The patient''s medical history included abortion spontaneous from an unknown date and unknown if ongoing, suppressed lactation from an unknown date and unknown if ongoing, pregnancy from an unknown date and unknown if ongoing (patient no longer pregnant at the time of reporting), Folic acid supplementation from an unknown date and unknown if ongoing. The patient''s concomitant medication(s) included folic acid was taken for Folic acid supplementation, start and stop date were not reported. Previously, the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number, Expiry date was not reported) via an unspecified route of administration on unknown date for COVID-19 immunization. The patient experienced maternal exposure during pregnancy on 21Aug2021, miscarriage on 23Aug2021. The mother reported she became pregnant while taking bnt162b2. The vaccine was taken at 11+1 weeks and baby died at 11+3 week. An autopsy was not performed. The patient went for a routine 12 weeks scan and told the baby died around the time of having the 2nd vaccine. Patient was not tested COVID-19 positive since having the vaccine. One previous miscarriage caused by detached placenta at 20 weeks. Patient was exposed to the medicine first-trimester. The event caused death, medically significant. The patient had 3 healthy pregnancies. The patient underwent lab tests and procedures which included sars-cov-2 test was negative on 20Aug2021 No - Negative COVID-19 test, scan was no heartbeat (Went to the scan and told there was no heartbeat. Vaccine taken at 11+1 baby died at 11+3). The outcome of the event was maternal exposure during pregnancy was unknown, miscarriage was Fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Miscarriage


VAERS ID: 1680604 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Death, Loss of consciousness, Shock
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), 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), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-25
   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: PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE]; SEROQUEL
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRJNJFOC20210910877

Write-up: DEATH; LOSS OF CONSCIOUSNESS; SHOCK CIRCULATORY; BLOOD PRESSURE DECREASED; This spontaneous report received from a physician via Regulatory Authority (EVHUMAN Vaccines, GR-GREOF-20217207) on 06-SEP-2021 concerned a 73 year old female of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown and expiry: unknown) dose was not reported, 1 total administered on 23-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included Plaquenil (hydroxychloroquine phosphate), and Seroquel (quetiapine fumarate) drugs used for unknown indication. On 24-AUG-2021, the patient experienced loss of consciousness, had shock circulatory and her blood pressure decreased. On 25-AUG-2021, the patient died from shock circulatory and an autopsy was not performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died of blood pressure decreased, death and loss of consciousness on 25-AUG-2021. This report was serious (Death, and Other Medically Important Condition).; Reported Cause(s) of Death: SHOCK CIRCULATORY


VAERS ID: 1680841 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-07-20
   Days after vaccination:89
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX0893 / 2 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute abdomen, Angiogram, Blood creatine phosphokinase MB, Blood lactate dehydrogenase, Blood lactate dehydrogenase increased, Body temperature, Computerised tomogram head, Computerised tomogram thorax, Disorientation, Dyspnoea, Fibrin D dimer, Fibrin D dimer increased, Myocardial necrosis, Pulmonary embolism, Pyrexia, Sopor, Troponin, Unresponsive to stimuli, Urine output, Urine output decreased
SMQs:, Acute renal failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-05
   Days after onset: 16
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: CARDIOASPIRIN; TORVAST
Current Illness: Cerebrovascular disorder (Current Condition); Diabetic polyneuropathy (Current Condition); Ischemic heart disease (Current Condition; previous lower necrosis); Type II diabetes mellitus with neurological manifestations (Current Condition; Type II diabetes mellitus with neurological manifestations)
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetic neuropathy; Unspecified cerebrovascular disease
Allergies:
Diagnostic Lab Data: Test Date: 20210626; Test Name: Angiogram; Result Unstructured Data: Test Result:evidenced pulmonary embolism; Test Date: 20210727; Test Name: Blood creatine phosphokinase MB; Test Result: 12.5 ng; Test Date: 20210727; Test Name: Blood lactate dehydrogenase; Result Unstructured Data: Test Result:922; Comments: (UNDER 1000) increased IU; Test Date: 20210720; Test Name: body temperature; Result Unstructured Data: Test Result:fever; Test Date: 20210727; Test Name: Computerised tomogram head; Result Unstructured Data: Test Result:unknown results; Test Date: 20210726; Test Name: Computerised tomogram thorax; Result Unstructured Data: Test Result:unknown results; Test Date: 20210726; Test Name: Fibrin D dimer; Test Result: 56.6 mg; Comments: increased; Test Date: 20210727; Test Name: Troponin; Test Result: 161.8 ng; Comments: increased; Test Date: 20210720; Test Name: Urine output; Result Unstructured Data: Test Result:decreased
CDC Split Type: ITPFIZER INC202101089258

Write-up: ever, diff. respiratory and temporal disorientation, high DDimer value, angiography evidenced pulmonary embolism acute abdomen picture with more than of LDH and ind of myocardial necrosis 27.06; ever, diff. respiratory and temporal disorientation, high DDimer value, angiography evidenced pulmonary embolism acute abdomen picture with more than of LDH and ind of myocardial necrosis 27.06; ever, diff. respiratory and temporal disorientation, high DDimer value, angiography evidenced pulmonary embolism acute abdomen picture with more than of LDH and ind of myocardial necrosis 27.06; ever, diff. respiratory and temporal disorientation, high DDimer value, angiography evidenced pulmonary embolism acute abdomen picture with more than of LDH and ind of myocardial necrosis 27.06; ever, diff. respiratory and temporal disorientation, high DDimer value, angiography evidenced pulmonary embolism acute abdomen picture with more than of LDH and ind of myocardial necrosis 27.06; ever, diff. respiratory and temporal disorientation, high DDimer value, angiography evidenced pulmonary embolism acute abdomen picture with more than of LDH and ind of myocardial necrosis 27.06; ever, diff. respiratory and temporal disorientation, high DDimer value, angiography evidenced pulmonary embolism acute abdomen picture with more than of LDH and ind of myocardial necrosis 27.06; ever, diff. respiratory and temporal disorientation, high DDimer value, angiography evidenced pulmonary embolism acute abdomen picture with more than of LDH and ind of myocardial necrosis 27.06; ever, diff. respiratory and temporal disorientation, high DDimer value, angiography evidenced pulmonary embolism acute abdomen picture with more than of LDH and ind of myocardial necrosis 27.06; ever, diff. respiratory and temporal disorientation, high DDimer value, angiography evidenced pulmonary embolism acute abdomen picture with more than of LDH and ind of myocardial necrosis 27.06; ever, diff. respiratory and temporal disorientation, high DDimer value, angiography evidenced pulmonary embolism acute abdomen picture with more than of LDH and ind of myocardial necrosis 27.06; This is a spontaneous report from a contactable physician from the Regulatory Authority-WEB, company number IT-SA-SAC20210817000841. This is a spontaneous serious case received by PRIVACY (license partner of other company regarding levofloxacin). (Reference Number: IT2021166199) on 04Aug2021 and received by PRIVACY on 10Aug2021. This case was reported by a physician via regulatory authority and described the occurrence of pulmonary embolism in an 83-year-old male patient who received levofloxacin (LEVOXACIN) tablet for dyspnea, oral started from an unknown date at 500 mg once daily (500 mg daily). Co-suspect products included bnt162b2 (COMIRNATY) dose 2 intramuscular on 22Apr2021 (Lot number EX0893 expiry date 31Jul2021) as 0.3 ML single for covid-19 vaccination. Concurrent medical conditions included ongoing diabetic polyneuropathy; ongoing ischemic heart disease (previous lower necrosis); ongoing cerebrovascular disorder; ongoing type II diabetes mellitus with neurological manifestations; Diabetic neuropathy; and Unspecified cerebrovascular disease. Concomitant products included acetylsalicylic acid (CARDIOASPIRIN) and atorvastatin calcium (TORVAST). Historical vaccine included bnt162b2 (COMIRNATY, formulation "0.45 ml concentrate for injectable dispersion, intramuscular route, vial (ve)") 1st dose on 01Apr2021 for covid-19 vaccination with no adverse event. On 20Jul2021 (as reported), unknown after starting levofloxacin, the patient experienced pulmonary embolism (serious criteria hospitalization, death, and PRIVACY company medically significant), unresponsive to verbal stimuli (serious criteria hospitalization, death, and PRIVACY company medically significant), acute abdomen (serious criteria hospitalization, death, and PRIVACY company medically significant), myocardial necrosis (serious criteria hospitalization, death, and PRIVACY company medically significant), lactate dehydrogenase increased (serious criteria hospitalization, death), temporal disorientation (serious criteria hospitalization, death), fibrin d dimer high (serious criteria hospitalization, death), dyspnea (serious criteria hospitalization, death), sopor (Abnormally deep sleep) (serious criteria hospitalization, death), fever (serious criteria hospitalization, death) and urine output decreased (serious criteria hospitalization, death), with description of "ever, diff. respiratory and temporal disorientation, high DDimer value, e.g. chest CT angiography evidenced pulmonary embolism on 26/06 / acute abdomen picture with more than of LDH and ind of myocardial necrosis 27.06.". On 05Aug2021, the outcome of the embolism pulmonary, unresponsive to verbal stimuli, acute abdomen, myocardial necrosis, LDH (Blood lactate dehydrogenase) increased, temporal disorientation, fibrin d dimer high, dyspnea, sopor (Abnormally deep sleep), fever and urinary output diminished were fatal. The patient died on 05Aug2021. The reported cause of death was urinary output diminished, dyspnea, fever, temporal disorientation, fibrin d dimer high, acute abdomen, sopor (Abnormally deep sleep), unresponsive to verbal stimuli, ldh increased, myocardial necrosis and embolism pulmonary. It was not reported if an autopsy was performed. It was unknown if the reporter considered the embolism pulmonary, unresponsive to verbal stimuli, acute abdomen, myocardial necrosis, LDH (Blood lactate dehydrogenase) increased, temporal disorientation, fibrin d dimer high, dyspnea, sopor (Abnormally deep sleep), fever and urinary output diminished to be related to Levofloxacin. The patient underwent lab tests and procedures which included angiogram: evidenced pulmonary embolism on 26Jun2021 (as reported); Blood creatine phosphokinase MB: 12.5 ng on 27Jul2021; Blood lactate dehydrogenase: 922 (UNDER 1000) increased IU on 27Jul2021; body temperature: fever on 20Jul2021; computerised tomogram head: unknown results on 27Jul2021; computerised tomogram thorax: unknown results on 26Jul2021; Fibrin D dimer: 56.6 mg increased on 26Jul2021; Troponin: 161.8 ng increased on 27Jul2021; urine output: decreased on 20Jul2021. The action taken in response to the events for levofloxacin was provided as not applicable. PRIVACY Reference number: 764592. Also reported that the Health Care professional considered the events Urine output decreased, Fibrin D dimer increased, Pyrexia, Disorientation, Acute abdomen, Sopor, Pulmonary embolism, Blood lactate dehydrogenase increased, Myocardial necrosis, Unresponsive to stimuli, Dyspnoea were as Related/Reasonable possibility with levofloxacin. PRIVACY (license partner of other company) Company Comment: Initial 10Aug2021 levofloxacin [levofloxacin]. Pulmonary embolism (Hospitalized) (IME), Unresponsive to stimuli (Hospitalized) (IME), Acute abdomen (Hospitalized) (IME) , Myocardial necrosis (Hospitalized) (IME) , Blood lactate dehydrogenase increased (Hospitalized) , Disorientation (Hospitalized) , Fibrin d dimer increased (Hospitalized) , Dyspnoea (Hospitalized) , SOPOR (Hospitalized) , Pyrexia (Hospitalized) , Urine output decreased (Hospitalized) , In summary, this case report does not change the known safety profile of levofloxacin[levofloxacin]: Reporter causality: Unknown, Company causality: Related. Initial information from Italy regarding an unsolicited valid serious case received from Physician via PRIVACY under reference: IT2021166199 on 10Aug2021 and transmitted to PRIVACY on 17Aug2021. Initial information was received from a physician via regulatory authority on 04Aug2021: fever, diff. respiratory and temporal disorientation, high D Dimer value, e.g. (exempli gratia) chest CT angiography evidenced pulmonary embolism on 26Jun2021 acute abdomen picture with greater than of LDH (Blood lactate dehydrogenase) and IND (Investigational New Drug) of myocardial necrosis 27Jun2021. Follow-up information was received from a physician via regulatory authority: Upon follow-up, Seriousness upgraded to Fatal for all events. Patient death details updated and cause of death was added. Follow-up 18Aug2021 levofloxacin [levofloxacin]. Pulmonary embolism (Death) (IME), Unresponsive to stimuli (Death) (IME), Acute abdomen (Death) (IME), Myocardial necrosis (Death) (IME), Blood lactate dehydrogenase increased (Death), Disorientation (Death), Fibrin d dimer increased (Death), Dyspnoea (Death), SOPOR (Death), Pyrexia (Death), Urine output decreased (Death): Reporter causality: Unknown, Company causality: Related. In summary, this case report does not change the known safety profile of levofloxacin [levofloxacin]. Initial information from Italy regarding an unsolicited valid serious case received from Physician via PRIVACY under reference: IT2021166199 on 18Aug2021 and transmitted to PRIVACY on 23Aug2021: Patient death details were added, Outcome was updated from not recovered/not resolved to Fatal for all events. Seriousness criteria was updated to Fatal. Sender (other company) assessed the events Urine output decreased, Fibrin D dimer increased, Pyrexia, Disorientation, Acute abdomen, Sopor, Pulmonary embolism, Blood lactate dehydrogenase increased, Myocardial necrosis, Unresponsive to stimuli, Dyspnoea were as Reportable with levofloxacin. Sender (other company) comments: PRIVACY company comment dated 18Aug2021: Based on the limited information provided, the causal role of company drug to cause the event cannot be excluded but lack of information regarding past medication, therapy details, any family history and any and indication of the drug precludes comprehensive case assessment. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: ever, diff. respiratory and temporal disorientation, high DDimer value, angiography evidenced pulmonary embolism acute abdomen picture with more than of LDH and ind of myocardial necrosis 27.06; ever, diff. respiratory and temporal disorientation, hi


VAERS ID: 1680842 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-25
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-27
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Familial hypercholesterolaemia
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Acute myocardial infarction; This case was received via Pharmaceutical Company (Reference number: JP-TAKEDA-2021TJP083998) on 01-Sep-2021 and was forwarded to Moderna on 03-Sep-2021. This case, initially reported to the regulatory authority by a (physician), was received via the regulatory authority (Ref, v21126070). The patient was under medication for depression. On 31-Jul-2021, the patient received the 1st dose of this vaccine. On 25-Aug-2021, 07:00, vomiting, and chest and back pain developed. At 09:00, the patient visited a nearby hospital. Electrocardiography revealed suspected acute myocardial infarction, and the patient was transported to the reporting hospital by ambulance. Emergency cardiac catheterization showed acute occlusion of two branches of the left anterior descending and right coronary arteries. The patient was in cardiogenic shock and underwent emergency percutaneous coronary intervention after IABP insertion. Recirculation was successful, and the patient was admitted to the hospital. The patient had postoperative CPK elevation to 11,059 and extensive myocardial damage. The patient experienced low cardiac output syndrome and severe cardiac failure. Although NPPV was used, the respiratory condition could not be maintained, and endotracheal intubation was performed. Although high-dose pressure-boosting drugs were used afterwards, the blood pressure could not be maintained, and acidosis progressed. On 27-Aug-2021, 19:28, the patient was confirmed dead. The outcome of Acute myocardial infarction was reported as fatal. Follow-up investigation will be made. Reporter comments continuation: Because of familial hypercholesterolemia, myocardial infarction can occur at an early age, but it is possible that the patient had simultaneous occlusion of two artery branches and was prone to thrombosis. A causal relationship with this vaccine could not be ruled out. The platelet count was normal. The autopsy was not performed by the intention of the family. Other factors may include familial hypercholesterolemia and depression. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: Very limited information regarding this event has been provided at this time. No further follow-up information is expected. However, the patients medical history of familial hypercholesterolemia is a confounder.; Reported Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1680975 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-08-23
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003657 / 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: 2021-08-25
   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: JPMODERNATX, INC.MOD20213

Write-up: Death; Pyrexia; This case was received via Pharmaceuticals (Reference number: JP-TAKEDA-2021TJP082397 ) on 30-Aug-2021 and was forwarded to Moderna on 30-Aug-2021. This case was reported to Pharmaceutical Company. On 18-Jul-2021, the patient received the 1st dose of this vaccine (lot number: 3003657). On 22-Aug-2021, the patient received the 2nd dose of this vaccine (lot number: 3004734). On 23-Aug-2021, pyrexia developed, and the patient was absent from work. On 24-Aug-2021, pyrexia resolved, and the patient went to work. After returning home, the patient went to bed. On 25-Aug-2021, in the morning, death was confirmed. Cause of death was unknown: information is being collected. The outcome of pyrexia was reported as resolved. No follow-up information was available due to non-cooperation of the reporter. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.No further information is available for this case; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1680984 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-07
Onset:2021-08-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003657 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-07
   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: Medical History/Concurrent Conditions: Multiple myeloma
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: 36.3 degree Celcius
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Cardio-respiratory arrest; Acute pulmonary oedema; This case was received via Pharmaceuticals (Reference number: 2021TJP083556) on 30-Aug-2021 and was forwarded to Moderna on 01-Sep-2021. This case, initially reported to the Pharmaceuticals and appropriate authorities by a physician, was received via the PMDA (Ref, v21125438). On 06-Aug-2021, the patient had no problems and was able to walk on his/her own. On an unknown date, body temperature before the vaccination: 36.3 degrees Celsius. On 07-Aug-2021, at 08:50, the patient received the 1st dose of this vaccine. The patient went to the vaccination venue alone. Around 10:00, in the adjacent parking lot, the patient contacted a friend to ask for help because the patient was not feeling well after the vaccination and was unable to find the location of the parked car. When the friend rushed to the scene, the patient was in a sitting position and appeared to be struggling to breathe. The friend temporarily left the patient to look for the car, but when the friend returned later, the patient had become limp and collapsed. Hence, after the friend called for help from the people around the place, an emergency call was made. The patient was judged to be in cardiopulmonary arrest, and cardiac massage was started. AED shock was not indicated for the patient''s symptoms, so the patient continued to be resuscitated, and then the ambulance team arrived. At that time, the patient was in cardiac arrest. Adrenaline administration was started, but there was no response, and the patient was transported to hospital. At 10:26, the patient was still in cardiopulmonary arrest on arrival at the hospital. At 11:24, The patient was confirmed dead at the hospital. The postmortem pathological diagnostic CT imaging showed findings that should not be surprising if there was acute pulmonary edema. The outcome of cardio-respiratory arrest and acute pulmonary oedema was reported as fatal. Follow-up investigation will be made. Reporter comments continuation: The patient had been in this condition for several days, so there is a possibility that some sort of new clinical conditions had appeared. However, on the day of the vaccination, the patient visited the venue by himself/herself, there were no problems during the interview for vaccination, and the patient was able to receive the vaccination. Since the patient subsequently went into cardio-respiratory arrest, the impact of the dose of this vaccine could not be denied on a time-series basis. With regard to the disease state that led to cardio-respiratory arrest, the differential diagnosis was difficult, and the causal relationship with this vaccine could not be evaluated. Company Comment: Although the events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273), it is also considered that the events are due to effects from past medical history and patient background, etc.; Reporter''s Comments: The patient had a past medical history of multiple myeloma, and according to the patient''s son, there was blood in the tissue every day for about 2 weeks, and the patient had complained of backache and sore throat for the last several days. Therefore, the possibility of an association with multiple myeloma cannot be denied because there was this recent change in the patient''s symptoms. See "narrative" section; Sender''s Comments: Very limited information regarding the events have been provided at this time. No further information will be received as it is a RA report.; Reported Cause(s) of Death: Cardio-respiratory arrest; Acute pulmonary oedema


VAERS ID: 1681002 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood culture, Blood pressure measurement, Capillary leak syndrome, Chills, Computerised tomogram, Computerised tomogram abdomen, Dizziness, Heart rate, Imaging procedure, Investigation, Pyrexia, SARS-CoV-2 test, Shock, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Smoldering myeloma (Diagnosed 1.5 years before)
Preexisting Conditions: Medical History/Concurrent Conditions: Capillary leak syndrome (Occurred 1.5 years earlier); Fever; Hospitalisation (the patient in our study had been admitted 1.5 years earlier for fever, vomiting, myalgia, generalized edema and hypotension (blood pressure 90/60 mm Hg). Laboratory results showed hemoconcentration (hematocrit 58.4%) and hypoalbuminemia (3.03 g/dL at nadir), but diagnosis was unclear, and the patient recovered spontaneously after fluid administration. He revisited hospital 5 months earlier and no laboratory abnormalities found.); Hypoalbuminemia; Vomiting
Allergies:
Diagnostic Lab Data: Test Name: Heart rate; Result Unstructured Data: 130 {beats}/min; Test Name: Blood pressure; Result Unstructured Data: 100/90 mmHg; Test Name: Imaging procedure; Result Unstructured Data: Not reported; Test Name: SARS-CoV-2 RT-PCR test; Result Unstructured Data: Negative; Test Name: Investigation; Result Unstructured Data: Showed marked hemoconcentration and hypoalbuminemia; Test Name: Computerised tomogram abdomen; Result Unstructured Data: Unremarkable; Test Name: Heart rate; Result Unstructured Data: 132 {beats}/min; Test Name: Blood pressure; Result Unstructured Data: 60/40 mmHg; Test Name: Blood culture; Result Unstructured Data: Negative; Test Name: Computerised tomography; Result Unstructured Data: Unremarkable
CDC Split Type: KRJNJFOC20210901548

Write-up: HYPOTENSIVE SHOCK WORSENING; SUSPECTED SYSTEMIC CAPILLARY LEAK SYNDROME; DIZZINESS; CHILLS; RECURRENT VOMITING; FEVER; GENERAL WEAKNESS; This spontaneous report was received from literature:, Fatal Systemic Capillary Leak Syndrome after SARS-CoV-2 Vaccination in Patient with Multiple Myeloma. 2021 Aug 30; 27. This report concerned a 38-year-old male. The patient''s height, and weight were not reported. The patient''s past medical history included: Hospitalization 1.5 years earlier for fever, vomiting, myalgia, generalized edema and hypotension (blood pressure 90/60 mm Hg). Laboratory results showed hemoconcentration (hematocrit 58.4%) and hypoalbuminemia (3.03 g/dL at nadir), but diagnosis was unclear, and the patient recovered spontaneously after fluid administration which was retrospectively assumed as flare episode of systemic capillary leak syndrome (SCLS), he revisited hospital 5 months earlier and no laboratory abnormalities found. Concurrent conditions included: smoldering multiple myeloma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number Unknown and expiry was unknown), 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date,12�24 hours post-vaccination, the patient experienced fever, chills, and myalgia and 24-48 hours post-vaccination the patient had nausea, recurrent vomiting and general weakness. The patient had emergency room visit and got treatment for vomiting and dizziness. At the time of admission, he was afebrile, his heart rate was 130 beats/min, and his blood pressure was 100/90 mm Hg, with no noticeable edema. Isotonic saline was administered and initiated diagnostic evaluation: Laboratory tests, Imaging. COVID-19 reverse transcription polymerase chain reaction (PCR) showed negative results. Test results showed marked hemoconcentration and hypoalbuminemia. Chest and abdominal computed tomography results were unremarkable. 6 hours after admission, the patient was hypotensive, blood pressure was 60/40 mm Hg, had a heart rate of 132 beats/min, and reported dyspnea. The blood culture was found negative. The patient was treated with broad-spectrum antimicrobials, intravenous fluids, and inotropes. Despite these measures, the patient''s hypotensive shock got worsened, and he died 10 hours after admission. Although at admission the patient showed neither peripheral edema nor severe hypoalbuminemia, SCLS was suspected as blood cultures and COVID-19 testing were negative. On an unspecified date, the patient died from hypotensive shock worsening. An autopsy was performed on an unspecified date showed no evidence of acute infection or cardiovascular disease in the internal organs. Pulmonary edema, pleural effusion, and pericardial effusion were identified. Although pulmonary edema was atypical in acute SCLS attacks (leak phase), prolonged cardiopulmonary resuscitation and fluid administration might have affected the autopsy findings. Histopathologic findings in both kidneys suggested autolysis or acute tubular necrosis, which helped exclude other possible etiologies of refractory hypotensive shock. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the recurrent vomiting, dizziness, fever, chills, general weakness and suspected systemic capillary leak syndrome was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender''s Comments: V0: This spontaneous report from literature concerned a 38-year old man who experienced worsening hypotensive shock with fatal progression 2 days after vaccination, and suspected systemic capillary leak syndrome (SCLS). Medical history included smoldering multiple myeloma and previous hospital admission (1.5 years prior) for suspected SCLS. Lab results showed hemoconcentration and hypoalbuminemia but diagnosis was unclear (flare episode of systemic capillary leak syndrome assumed by authors), and recovery was spontaneous after fluid administration. COVID-19 test was negative. Normal chest and abdominal CT. No concomitant medications reported. The patient experienced fever, chills, and myalgia 12�24 hours post vaccination; nausea, recurrent vomiting, and general weakness 24�48 later. The patient was admitted to the ED 2 days after vaccination with HR of130/min, BP of 100/90 mm Hg; no fever and noticeable edema, and received isotonic saline. Six hours after admission, BP was 60/40 mm Hg, HR was 132/min, and dyspnea was reported. Blood was cultured (negative) and broad-spectrum antimicrobials, intravenous fluids, and inotropes were given. Hypotensive shock worsened, and patient died 10 hours after admission. Autopsy: no evidence of acute infection or cardiovascular disease. Pulmonary edema, pleural effusion, and pericardial effusion due to prolonged cardiopulmonary resuscitation were noted. Kidney histopathology: autolysis or acute tubular necrosis. The patient''s previous history of suspected SCLS and concurrent multiple myeloma may have increased the risk for the event to occur. However, considering the temporal relationship with vaccination, a relationship with Janssen Covid-19 vaccine cannot be ruled out. Therefore, the relationship is considered indeterminate.; Reported Cause(s) of Death: HYPOTENSIVE SHOCK WORSENING


VAERS ID: 1681153 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-15
Onset:2021-08-10
   Days after vaccination:176
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM6950 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Oxygen saturation, SARS-CoV-2 test, 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: 2021-08-15
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LOSARTAN; SIMVASTATIN; CLOPIDOGREL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Appendectomy; Arterial hypertension; Benign prostatic hypertrophy; Constipation chronic; Dyslipidemia; Hemiparesis (left); Ischemic stroke; Typhoid fever
Allergies:
Diagnostic Lab Data: Test Date: 20210810; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:<90 %; Comments: <90 % percent; Test Date: 20210810; Test Name: SARS-CoV-2 PCR test; Test Result: Positive ; Comments: positive Iu international unit(s)
CDC Split Type: PTPFIZER INC202101125804

Write-up: Vaccination failure; SARS-CoV-2; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number PT-INFARMED-F202108-2044. An 89-year-old male patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection), second dose via intramuscular on 15Feb2021 (Batch/Lot Number: EM6950), as a 0.3 ml single, first dose via intramuscular on 25Jan2021 (Batch/Lot Number: EJ6134), as a 0.3 ml single for COVID-19 immunisation. Medical history included hypertension, dyslipidaemia, benign prostatic hyperplasia, constipation from an unknown date and unknown if ongoing, ischaemic stroke from 2011 to an unknown date, hemiparesis from 2011 to an unknown date, typhoid fever from 1947 to an unknown date, appendicectomy from 1952 to an unknown date. Concomitant medications included losartan (LOSARTAN); simvastatin (SIMVASTATIN); clopidogrel (CLOPIDOGREL) taken for an unspecified indication, start and stop date were not reported. On 10Aug2021, the patient experienced vaccination failure, Sars-Cov-2. The patient underwent lab tests and procedures which included oxygen saturation: <90 % on 10Aug2021 <90 % percent, Sars-Cov-2 test: positive on 10Aug2021 positive IU international units. The patient was institutionalized in a home, where an outbreak happened. Death occurred on 15Aug2021. No attributed cause of death, most likely due to SARS-CoV-2 pneumonia. Autopsy Evolution of adverse drug reaction: death is unknown. The patient died on 15Aug2021. It was not reported if an autopsy was performed. The reporter''s assessment of the causal relationship of the vaccination failure, COVID-19 with the suspect product was relatedness of drug to reactions/events: Source of assessment: reporter, method of assessment: Unknown, Result of Assessment: Definitive. Reporter''s comments: Concomitant Medication-Clopidogrel 75 mg once a day; Losartan 100mg twice a day; Simvastatin 40 mg once a day medication error occurred no further information attachment. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: Vaccination failure; SARS-CoV-2


VAERS ID: 1681283 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2020-07-21
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Private       Purchased by: ?
Symptoms: Carbon monoxide poisoning, Cervical vertebral fracture, Death, Rib fracture, Spinal cord haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Accidents and injuries (narrow), Osteoporosis/osteopenia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-21
   Days after onset: 365
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Unknown cause of Death; Fracture and bleeding in cervical spine at the level of C6/7; Fracture of left front 3rd~7th rib; Intraspinal haemorrhage; The skin of the limbs appeared cherry red, and carbon monoxide poisoning was suspected; This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (Unknown cause of Death), CARBON MONOXIDE POISONING (The skin of the limbs appeared cherry red, and carbon monoxide poisoning was suspected), CERVICAL VERTEBRAL FRACTURE (Fracture and bleeding in cervical spine at the level of C6/7), RIB FRACTURE (Fracture of left front 3rd~7th rib) and SPINAL CORD HAEMORRHAGE (Intraspinal haemorrhage) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2020, the patient experienced CARBON MONOXIDE POISONING (The skin of the limbs appeared cherry red, and carbon monoxide poisoning was suspected) (seriousness criterion death) and SPINAL CORD HAEMORRHAGE (Intraspinal haemorrhage) (seriousness criteria death and medically significant). On 21-Jul-2021, the patient experienced DEATH (Unknown cause of Death) (seriousness criteria death and medically significant), CERVICAL VERTEBRAL FRACTURE (Fracture and bleeding in cervical spine at the level of C6/7) (seriousness criteria death and medically significant) and RIB FRACTURE (Fracture of left front 3rd~7th rib) (seriousness criterion death). The patient died on 21-Jul-2021. The cause of death was not reported. An autopsy was performed. The autopsy-determined cause of death was the patient''s left chest rib was fractured left front 3rd~7th rib, the skin of the limbs appeared cherry red, and carbon monoxide poisoning was suspected and fractured cervical spine and intraspinal haemorrhage. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication not provided. Treatment medication not provided. On 21-Jul-2021, the patient was found dead in the driver''s seat of the passenger car, in a sitting position, with the gear shifted in N, and the front left portion of the car slightly collided with the flower bed in front of the temple. During the autopsy, it was found that the patient''s left chest rib was fractured and the police on the spot said that they had done CPR for the patient. The family members believed that the cause of death was related to the vaccine, so the autopsy was required to find out the cause of death. On 29-Jul-2021, the judicial autopsy was performed. After the autopsy, the forensic doctor initially judged that: 1. The skin of the limbs appeared cherry red, and carbon monoxide poisoning was suspected. 2. Fracture and bleeding in cervical spine at the level of C6/7. 3. Fracture of left front 3rd-7th rib. This is a case of a 67-year-old male patient who received first dose of mRNA-1273 and was found dead two weeks later in the driver''s seat of the passenger car. Autopsy was performed and revealed skin of the limbs appeared cherry red (carbon monoxide poisoning was suspected), fracture and bleeding in cervical spine at the level of C6/7 and fracture of left front 3rd-7th rib. The exact cause of death was not 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 a 67-year-old male patient who received first dose of mRNA-1273 and was found dead two weeks later in the driver''s seat of the passenger car. Autopsy was performed and revealed skin of the limbs appeared cherry red (carbon monoxide poisoning was suspected), fracture and bleeding in cervical spine at the level of C6/7 and fracture of left front 3rd-7th rib. The exact cause of death was not provided. Very limited information regarding these events has been provided at this time. No further information is expected.; Reported Cause(s) of Death: Unknown cause of Death; intraspinal hemerage; Autopsy-determined Cause(s) of Death: The patient''s left chest rib was fractured left front 3rd~7th rib; The skin of the limbs appeared cherry red, and carbon monoxide poisoning was suspected; Fractured cervical spine and Intraspinal haemorrhage


VAERS ID: 1681284 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939599-CDC / 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: 2021-07-19
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Heart failure; Psoriasis
Preexisting Conditions: Medical History/Concurrent Conditions: Motor vehicle accident (30 Jun)
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Death; Fever; This regulatory authority case was reported by an other and describes the occurrence of DEATH (Death) and PYREXIA (Fever) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939599-CDC) for COVID-19 vaccination. The patient''s past medical history included Motor vehicle accident (30 Jun). Concurrent medical conditions included Heart failure and Psoriasis. On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, the patient experienced PYREXIA (Fever) (seriousness criterion death). The patient died on 19-Jul-2021. The cause of death was not reported. An autopsy was performed, but no results were provided. No concomitant medication was provided. No treatment information was provided. Company Comment: Although a temporal association exist between the fatal outcome and the administration of mRNA-1273 vaccine, critical details such as the actual cause of death was not provided. No further information is expected. The patient had fever on the day of vaccination with o reported complications. Patient also had significant history of heart failure and recent motor accident for which there was frequent need to visit the hospital Symptoms; Sender''s Comments: Although a temporal association exist between the fatal outcome and the administration of mRNA-1273 vaccine, critical details such as the actual cause of death was not provided. No further information is expected. The patient had fever on the day of vaccination with o reported complications. Patient also had significant history of heart failure and recent motor accident for which there was frequent need to visit the hospital Symptoms; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1681288 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-26
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-29
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Discomfort; This regulatory authority case was reported by an other health care professional and describes the occurrence of DISCOMFORT (Discomfort) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 15-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jul-2021, the patient experienced DISCOMFORT (Discomfort) (seriousness criteria death and hospitalization). The patient was hospitalized on 26-Jul-2021 due to DISCOMFORT. The patient died on 29-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. Concomitant medication list was not provided. Treatment information was not provided. It was reported that t patient was hospitalized for medical treatment of discomfort on 26-Jul-2021 and was admitted to the intensive care unit. Company Comment: Very limited information regarding this event has been provided at this time. No further information is expected.; Sender''s Comments: Very limited information regarding this event has been provided at this time. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1681290 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Dizziness, Fatigue, Headache, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-27
   Days after onset: 20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210720; Test Name: COVID-19 nucleic acid test; Test Result: Negative ; Result Unstructured Data: COVID-19 nucleic acid test result was negative.
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Fatigue; Generalized weakness; Syncope; Dizziness; Headache; This regulatory authority case was reported by an other and describes the occurrence of SYNCOPE (Syncope), FATIGUE (Fatigue), DIZZINESS (Dizziness), HEADACHE (Headache) and ASTHENIA (Generalized weakness) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 07-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, the patient experienced SYNCOPE (Syncope) (seriousness criteria death, hospitalization and medically significant), DIZZINESS (Dizziness) (seriousness criteria death and hospitalization) and HEADACHE (Headache) (seriousness criteria death and hospitalization). On 08-Jul-2021, the patient experienced FATIGUE (Fatigue) (seriousness criteria death and hospitalization) and ASTHENIA (Generalized weakness) (seriousness criteria death and hospitalization). The patient died on 27-Jul-2021. The reported cause of death was Syncope, Fatigue, Dizziness, Headache and generalized weakness. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jul-2021, SARS-CoV-2 test: negative (Negative) COVID-19 nucleic acid test result was negative.. Patient was hospitalized for treatment after visiting the Emergency Department on 10 JUL 2021. Concomitant medication of the patient was not reported. 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: Syncope; Fatigue; Dizziness; Headache; Generalized weakness


VAERS ID: 1681291 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939599-CDC / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Decreased appetite, Dyspnoea, Pleural effusion, Pyrexia, Urinary tract infection
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-26
   Days after onset: 18
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; Hyperglycemia; Hyperlipidemia; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Breathing difficulty; urinary tract infection; pleural effusion; Fever; Loss of appetite; This regulatory authority case was reported by a physician and describes the occurrence of DYSPNOEA (Breathing difficulty), URINARY TRACT INFECTION (urinary tract infection ), PLEURAL EFFUSION (pleural effusion) and PYREXIA (Fever) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939599-CDC) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension, Hyperlipidemia, Hyperglycemia and Diabetes. On 07-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 08-Jul-2021, the patient experienced DECREASED APPETITE (Loss of appetite). On 11-Jul-2021, the patient experienced PYREXIA (Fever) (seriousness criterion death). On 12-Jul-2021, the patient experienced DYSPNOEA (Breathing difficulty) (seriousness criteria death and hospitalization), URINARY TRACT INFECTION (urinary tract infection ) (seriousness criteria death and hospitalization) and PLEURAL EFFUSION (pleural effusion) (seriousness criteria death and hospitalization). The patient was hospitalized on 12-Jul-2021 due to DYSPNOEA, PLEURAL EFFUSION and URINARY TRACT INFECTION. On 09-Jul-2021, DECREASED APPETITE (Loss of appetite) had resolved. The patient died on 26-Jul-2021. The reported cause of death was breathing difficulty, Urinary tract infection, Pleural effusion and Fever. 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 medication provided. No treatment information mentioned. The patient developed fever on 11Jul2021. The patient visited the Emergency Department of Hospital due to breathing difficulty on 12Jul2021, and she was hospitalized (suspected urinary tract infection and pleural effusion). The patient died on 26Jul2021. This is a case of death in a 85-year-old female subject, with a history of HTN, DM and Hyperlipidemia, who died 20 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 85-year-old female subject, with a history of HTN, DM and Hyperlipidemia, who died 20 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Fever; Breathing difficulty; urinary tract infection; pleural effusion


VAERS ID: 1685823 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Antibody test, Atelectasis, Blood fibrinogen, Brain contusion, Brain death, Brain oedema, Cardiac arrest, Central nervous system necrosis, Cerebral haemorrhage, Cerebral venous sinus thrombosis, Congestive hepatopathy, Deep vein thrombosis, Fibrin D dimer, Haematoma, Haemorrhage subcutaneous, Haemorrhagic ovarian cyst, Haemothorax, Heparin-induced thrombocytopenia test positive, Immune thrombocytopenia, Laryngeal haematoma, Magnetic resonance imaging, Platelet count, Pleural effusion, Pulmonary embolism, Pupils unequal, Right ventricular dilatation, Subarachnoid haemorrhage, Vena cava thrombosis
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (narrow), Accidents and injuries (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-14
   Days after onset: 13
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: Adiposity; Cardiovascular disease, unspecified; Chronic renal insufficiency (with suspected vascular neuropathy); Hirsutism (Hirsutism in the chin area. Tumorous pituitary enlargement (18:12:6 mm) - suspected pituitary adenoma.); Hypertension arterial (arterial hypertension); Left ventricular hypertrophy (left ventricular hypertrophy); Leukoencephalopathy (Leukoencephalopathy DD vasculitis. Cadasil genetic test negative.); Mitral valve prolapse (mitral valve prolapse, tricuspid insufficiency); Pituitary tumour (Tumorous pituitary enlargement (18:12:6 mm) - suspected putuitary adenoma.); Renal vascular disorder NOS (with suspected vascular neuropathy); Splenomegaly (Splenomegaly (14 cm MR 14.2.18)); Struma nodosa (Small-nodule goiter, both sides); Tricuspid valve incompetence (tricuspid insufficiency); Uterine myomatosis (Uterus myomatosus); Vasculitis (Leukoencephalopathy DD vasculitis. Cadasil genetic test negative.)
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20180214; Test Name: MRI; Result Unstructured Data: Splenomegaly (14 cm); Test Date: 20210811; Test Name: Fibrinogen; Result Unstructured Data: 118 mg/dL; Test Date: 20210811; Test Name: Platelet count; Result Unstructured Data: 29000 G/l; Test Date: 20210811; Test Name: Antibody test; Result Unstructured Data: 2.46; Test Date: 20210811; Test Name: Fibrin D dimer; Result Unstructured Data: less than 20
CDC Split Type: ATJNJFOC20210845391

Write-up: HEPARIN-PLATELET FACTOR 4 ANTIBODY COMPLEX TEST POSITIVE; CARDIAC ARREST; IMMUNE THROMBOCYTOPENIA; BRAIN DEATH; INTRACEREBRAL HEMORRHAGE (ICH); HAEMATOMA; INFERIOR VENACAVAL THROMBOSIS; BRAIN CONTUSION; RECURRENT PULMONARY EMBOLISM; EFFUSION PLEURAL; HEPATIC CONGESTION; BLEEDING SPOT SUBCUTANEOUS; DEEP VEIN THROMBOSIS LEG; RIGHT VENTRICULAR DILATATION; HAEMORRHAGE INTO OVARIAN CYST; PARTIAL ATELECTASIS; CEREBRAL VENOUS SINUS THROMBOSIS; PLEURAL HAEMORRHAGE; BRAIN EDEMA; CENTRAL NERVOUS SYSTEM NECROSIS; LARYNGEAL HAEMATOMA; HAEMORRHAGE SUBARACHNOID; RIGHT PUPIL CONSIDERABLY WIDER THAN LEFT ONE; This spontaneous report received from a physician by a Regulatory Authority (AT-EMA-DD-20210831-banala_s-154341) on 03-SEP-2021 and concerned a 35 year old female of unknown race and ethinicity. Initial information was processed with additional information received on 06-Sep-2021. The patient''s weight was 90 kilograms, and height was 160 centimeters. The patient''s concurrent conditions included: mitral valve prolapse, chronic renal insufficiency, vasculitis, splenomegaly, left ventricular hypertrophy, renal vascular disorder nos, hypertension arterial, leukoencephalopathy, tricuspid valve incompetence, pituitary tumour, hirsutism, adiposity, uterine myomatosis, struma nodosa, and cardiovascular disease, unspecified. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 0.5 ml, 1 dosage forms, 1 total administered on 31-JUL-2021 for covid-19 vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 14-FEB-2018, Laboratory data included: MRI (NR: not provided) Splenomegaly (14 cm). On AUG-2021, the patient experienced haematoma, inferior venacaval thrombosis, brain contusion, recurrent pulmonary embolism, effusion pleural, hepatic congestion, bleeding spot subcutaneous, deep vein thrombosis leg, right ventricular dilatation, haemorrhage into ovarian cyst, partial atelectasis, cerebral venous sinus thrombosis, pleural haemorrhage, brain edema, central nervous system necrosis, laryngeal haematoma, haemorrhage subarachnoid, immune thrombocytopenia. On 11-AUG-2021, the patient experienced brain death, intracerebral hemorrhage (ich), right pupil considerably wider than left one. The patient was hospitalized (date unspecified). Laboratory data included: Antibody test (NR: not provided) 2.46, Fibrin D dimer (NR: not provided) less than 20, Fibrinogen (NR: not provided) 118 mg/dL, and Platelet count (NR: not provided) 29000 G/l. On 14-AUG-2021, the patient experienced cardiac arrest. On an unspecified date, the patient experienced heparin-platelet factor 4 antibody complex test positive, and was hospitalized. On 14-AUG-2021, the patient died from intracerebral haemorrhage, and cardiac arrest. An autopsy was performed on an unspecified date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of immune thrombocytopenia, brain death, intracerebral hemorrhage (ICH), brain contusion, recurrent pulmonary embolism, right ventricular dilatation, brain edema and central nervous system necrosis on 14-AUG-2021, had not recovered from right pupil considerably wider than left one, haematoma, inferior venacaval thrombosis, effusion pleural, hepatic congestion, bleeding spot subcutaneous, deep vein thrombosis leg, haemorrhage into ovarian cyst, partial atelectasis, cerebral venous sinus thrombosis, pleural haemorrhage, laryngeal haematoma, and haemorrhage subarachnoid, and the outcome of heparin-platelet factor 4 antibody complex test positive was not reported. This report was serious (Death, Hospitalization Caused / Prolonged, and Other Medically Important Condition) Additional information was received from Physician on 03-Sep-2021. The following information was updated and incorporated into the case narrative: New reporter added (consumer), New patient medical history was added under disease which are pituitary tumour, hirsutism, adiposity, uterine myomatosis, struma nodosa, and cardiovascular disease, unspecified, in Event tab new events were added which are haematoma, inferior venacaval thrombosis, brain contusion, recurrent pulmonary embolism, effusion pleural, hepatic congestion, bleeding spot subcutaneous, deep vein thrombosis leg, right ventricular dilatation, haemorrhage into ovarian cyst, partial atelectasis, cerebral venous sinus thrombosis, pleural haemorrhage, brain edema, central nervous system necrosis, laryngeal haematoma, haemorrhage subarachnoid, right pupil considerably wider than left one, heparin-platelet factor 4 antibody complex test positive and cardiac arrest.; Reported Cause(s) of Death: INTRACEREBRAL HAEMORRHAGE; CARDIAC ARREST


VAERS ID: 1685872 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysphagia, Dyspnoea, Malaise, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

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: AUPFIZER INC202101134715

Write-up: Dysphagia; Dyspnoea; Malaise; Vomiting; This is a spontaneous report from a contactable other health professional via the Agency. Regulatory authority report number is 609817. A 56-year-old male patient received BNT162B2 (COMIRNATY) on unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced Dysphagia, Dyspnoea, Malaise, Vomiting on unknown date. The outcome of all events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Reported Cause(s) of Death: Dysphagia; Dyspnoea; Malaise; Vomiting


VAERS ID: 1685874 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-11
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Lethargy, Vaccination site pain
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101139110

Write-up: Headache; Injection site pain; Lethargy; This is a spontaneous report from a contactable other health professional via the Agency. Regulatory authority report number is 610431. A 44-year-old female patient received BNT162B2 (COMIRNATY) on unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced Headache, Injection site pain and Lethargy on 11Jul2021. The outcome of all events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Reported Cause(s) of Death: Headache; Injection site pain; Lethargy


VAERS ID: 1685875 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-14
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arteriosclerosis coronary artery, Myocardial fibrosis
SMQs:, Cardiomyopathy (narrow), Other ischaemic heart disease (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: AUPFIZER INC202101139111

Write-up: Arteriosclerosis coronary artery; Myocardial fibrosis; This is a spontaneous report from a contactable other health professional via the Agency. Regulatory authority report number is 611057. A 45-year-old male patient received BNT162B2 (COMIRNATY) on unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced Arteriosclerosis coronary artery and Myocardial fibrosis on 14Jun2021. The outcome of both events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Reported Cause(s) of Death: Arteriosclerosis coronary artery; Myocardial fibrosis


VAERS ID: 1685876 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-07
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral infarction, Decreased appetite, Lethargy, Oxygen saturation, Oxygen saturation decreased, Somnolence
SMQs:, Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Dementia (broad), 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), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Oxygen saturation; Result Unstructured Data: Test Result:decreased
CDC Split Type: AUPFIZER INC202101139113

Write-up: Cerebral infarction; Decreased appetite; Lethargy; Oxygen saturation decreased; Somnolence; This is a spontaneous report from a contactable other health professional via the Agency. Regulatory authority report number is 613011. A 89-year-old female patient received BNT162B2 (COMIRNATY) on unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced Cerebral infarction, Decreased appetite, Lethargy, Oxygen saturation decreased and Somnolence on 07Aug2021. The outcome of all events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Reported Cause(s) of Death: Cerebral infarction; Decreased appetite; Lethargy; Oxygen saturation decreased; Somnolence


VAERS ID: 1685877 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: 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: 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: AUPFIZER INC202101139116

Write-up: Subarachnoid haemorrhage; This is a spontaneous report from a contactable other health professional via the Agency. Regulatory authority report number is 613645. A 57-year-old female patient received BNT162B2 (COMIRNATY) on unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced Subarachnoid haemorrhage on unknown date. The outcome of the event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Reported Cause(s) of Death: Subarachnoid haemorrhage


VAERS ID: 1685878 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-04
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: AUPFIZER INC202101139117

Write-up: Cardiac arrest; This is a spontaneous report from a contactable other healthcare professional received via the agency. Regulatory authority number 613371. A 44 years old male patient received BNT162B2 (COMIRNATY) on an unspecified date, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced cardiac arrest on 04Aug2021, with fatal outcome. The patient died on an unspecified date in 2021. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1685899 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, COVID-19, COVID-19 pneumonia, Cachexia, Computerised tomogram, Death, Dementia, Drug ineffective, Urinary tract infection
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Lack of efficacy/effect (narrow), 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), Dementia (narrow), Noninfectious encephalopathy/delirium (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210822; Test Name: CT scan; Result Unstructured Data: Test Result:COVID-19 positive; Comments: COVID-19 positive
CDC Split Type: BEPFIZER INC202101124488

Write-up: covid 19 pneumonia complicated by superinfected pneumonia; COVID-19 infection after vaccination; Cachexia; COVID-19 infection after vaccination; Death; Urinary infection; Dementia; acute renal failure; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is BE-FAMHP-DHH-N2021-105736. A 98-years-old female patient received BNT162B2 (COMIRNATY, solution for injection; Batch/Lot Number: Unknown), dose 2 via an unspecified route of administration on 09Feb2021 as DOSE 2, SINGLE for covid-19 immunization and dose 1 via an unspecified route of administration on 19Jan2021 (Batch/Lot Number: Unknown) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced covid-19 pneumonia complicated by superinfected pneumonia, covid-19 infection after vaccination, which was considered as lack of efficacy, cachexia, death, urinary infection, dementia and acute renal failure. On 22Aug2021, the patient was hospitalized for covid-19 pneumonia complicated by superinfected pneumonia. The patient underwent lab tests and procedures which included computerised tomogram and covid-19 positive on 22Aug2021. Therapeutic measures were taken as a result of covid-19 pneumonia complicated by superinfected pneumonia, cachexia, covid-19 infection after vaccination, death, urinary infection, dementia, acute renal failure which included oxygen therapy, aerosol therapy, physiotherapy, antibiotic therapy. The patient died on 24Aug2021. It was not reported if an autopsy was performed. The outcome of all events was fatal. Health Authority''s comment: Treatment was given with oxygen therapy, aerosol therapy, physiotherapy, antibiotic therapy. Evolution of the ADR was Death. ADR description - hospitalized on 22Aug2021 for covid 19 pneumonia complicated by superinfected pneumonia despite complete vaccination (19Jan2021 and 09Feb2021). acute renal failure with associated urinary tract infection, dementia and cachexia No follow-up attempts possible, information about lot/batch numbers cannot be obtained. No further information expected.; Reported Cause(s) of Death: COVID-19 pneumonia; Drug ineffective; Cachexia; COVID-19; Urinary tract infection; Dementia; acute renal failure


VAERS ID: 1686124 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Cough, Fatigue, Intestinal haemorrhage, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-03
   Days after onset: 32
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiac arrhythmia NOS; Diabetes mellitus NOS
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210415; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: CZMODERNATX, INC.MOD20213

Write-up: Intestinal bleeding; �nava; COVID-19 infection; Ka�el; This case was received via regulatory authority (Reference number: CZ-CZSUKL-21009888) on 01-Sep-2021 and was forwarded to Moderna on 01-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of INTESTINAL HAEMORRHAGE (Intestinal bleeding) and COVID-19 (COVID-19 infection) in a 77-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes mellitus NOS and Cardiac arrhythmia NOS. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In April 2021, the patient experienced COVID-19 (COVID-19 infection) (seriousness criterion medically significant) and COUGH (Ka�el). On 02-May-2021, after starting mRNA-1273 (Spikevax), the patient experienced INTESTINAL HAEMORRHAGE (Intestinal bleeding) (seriousness criteria death, medically significant and life threatening) and FATIGUE (�nava). The patient died on 03-May-2021. The reported cause of death was Intestinal bleeding. An autopsy was performed, but no results were provided. At the time of death, COVID-19 (COVID-19 infection), COUGH (Ka�el) and FATIGUE (�nava) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive. Concomitant medications were not reported . Treatment information was not provided. Company Comment: Based on biological implausibility and mechanism of action of the product mRNA-1273, a causal relationship between the reported serious unexpected event of COVID-19 and the administration of mRNA-1273 assessed as unlikely. COVID-19 was more consistent with the increased risk of infections due to environmentally mediated pandemic for COVID-19 and confounded by increased risk of COVID-19 due to underlying comorbidities diabetes mellitus and cardiac arrhythmia complicated by advanced age. The serious unexpected event of Intestinal haemorrhage was more consistent with the possible complication of COVID-19. The non-serious events Cough and Fatigue were more consistent with the symptoms of COVID-19. This case was linked to CZ-CZSUKL-21010242 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: translation received contains no new information.; Sender''s Comments: Based on biological implausibility and mechanism of action of the product mRNA-1273, a causal relationship between the reported serious unexpected event of COVID-19 and the administration of mRNA-1273 assessed as unlikely. COVID-19 was more consistent with the increased risk of infections due to environmentally mediated pandemic for COVID-19 and confounded by increased risk of COVID-19 due to underlying comorbidities diabetes mellitus and cardiac arrhythmia complicated by advanced age. The serious unexpected event of Intestinal haemorrhage was more consistent with the possible complication of COVID-19. The non-serious events Cough and Fatigue were more consistent with the symptoms of COVID-19. CZ-CZSUKL-21010242:; Reported Cause(s) of Death: Intestinal bleeding


VAERS ID: 1686132 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-17
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time ratio, Alanine aminotransferase, Amylase, Aspartate aminotransferase, Blood alkaline phosphatase, Blood calcium, Blood chloride, Blood creatine phosphokinase MB, Blood creatinine, Blood glucose, Blood magnesium, Blood potassium, Blood pressure measurement, Blood sodium, Blood urea, Body temperature, C-reactive protein, Chest X-ray, Gamma-glutamyltransferase, General physical health deterioration, Glomerular filtration rate, Haemoglobin, International normalised ratio, Oxygen saturation, Platelet count, Protein total, Prothrombin time, Red blood cell count, Respiratory tract infection, SARS-CoV-2 test, White blood cell count
SMQs:, Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-18
   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: LUSOPRESS; QUETIAPIN; TIAPRIDAL
Current Illness: Aortic valve stenosis and insufficiency (combined aortic defect, mild stenosis with regurgitation 2/4); Arthrosis multiple; Atherosclerosis generalized; Cerebral atherosclerosis; Hypertension; Incontinence; Ischaemic heart disease (no angina pectoris); Mitral regurgitation (mild, 2/4 with mild to severe pulmonary hypertension); Pulmonary hypertension; Senile dementia (loss of personality and health condition and mobility); Walking difficulty
Preexisting Conditions: Medical History/Concurrent Conditions: General physical health deterioration (according to doctors the condition corresponds to age); Mobility decreased (due to senile dementia)
Allergies:
Diagnostic Lab Data: Test Date: 20210312; Test Name: Activated partial thromboplastin time ratio; Result Unstructured Data: Test Result:0.97; Test Date: 20210317; Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result:0.29; Comments: ukat/L; Test Date: 20210317; Test Name: Blood alpha amylase; Result Unstructured Data: Test Result:2; Comments: ukat/L; Test Date: 20210317; Test Name: ASAT; Result Unstructured Data: Test Result:0.48; Comments: ukat/L; Test Date: 20210317; Test Name: Alk phos; Result Unstructured Data: Test Result:1.66; Comments: ukat/L; Test Date: 20210317; Test Name: Calcium; Result Unstructured Data: Test Result:2.14 mmol/L; Test Date: 20210317; Test Name: Chloride; Result Unstructured Data: Test Result:105 mmol/L; Test Date: 20210312; Test Name: Creatine kinase MB; Result Unstructured Data: Test Result:4.2; Comments: ukat/L; Test Date: 20210312; Test Name: Creatinine; Result Unstructured Data: Test Result:114 umol/l; Test Date: 20210317; Test Name: Creatinine; Result Unstructured Data: Test Result:106 umol/l; Test Date: 20210317; Test Name: Blood glucose; Result Unstructured Data: Test Result:6.7 mmol/L; Test Date: 20210317; Test Name: Magnesium; Result Unstructured Data: Test Result:0.86 mmol/L; Test Date: 20210312; Test Name: Potassium; Result Unstructured Data: Test Result:5 mmol/L; Test Date: 20210317; Test Name: Potassium; Result Unstructured Data: Test Result:4.4 mmol/L; Test Date: 20210317; Test Name: Blood pressure; Result Unstructured Data: Test Result:166/79 mmHg; Test Date: 20210317; Test Name: Serum sodium; Result Unstructured Data: Test Result:139 mmol/L; Test Date: 20210312; Test Name: Sodium; Result Unstructured Data: Test Result:139 mmol/L; Test Date: 20210312; Test Name: Urea; Result Unstructured Data: Test Result:8 mmol/L; Test Date: 20210317; Test Name: Urea; Result Unstructured Data: Test Result:9.4 mmol/L; Test Date: 20210317; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Test Date: 202103; Test Name: CXR; Result Unstructured Data: Test Result:without signs of pneumonia; Test Date: 20210312; Test Name: C-reactive protein; Result Unstructured Data: Test Result:102 mg/l; Test Date: 20210317; Test Name: C-reactive protein; Result Unstructured Data: Test Result:231 mg/l; Test Date: 20210317; Test Name: GGT; Result Unstructured Data: Test Result:0.3; Comments: ukat/L; Test Date: 20210312; Test Name: Estimated glomerular filtration rate; Result Unstructured Data: Test Result:0.925; Test Date: 20210312; Test Name: Hemoglobin; Result Unstructured Data: Test Result:104 g/l; Test Date: 20210317; Test Name: Hemoglobin; Result Unstructured Data: Test Result:94 g/l; Test Date: 20210312; Test Name: International normalised ratio; Result Unstructured Data: Test Result:1.13; Test Date: 20210317; Test Name: Oxygen saturation; Test Result: 90 %; Comments: natively; Test Date: 20210312; Test Name: Platelet count; Result Unstructured Data: Test Result:208 x10 9/l; Test Date: 20210317; Test Name: Platelet count; Result Unstructured Data: Test Result:307 x10 9/l; Test Date: 20210317; Test Name: Protein total; Result Unstructured Data: Test Result:57 g/l; Test Date: 20210312; Test Name: Pro-thrombin time; Test Result: 12.1 s; Test Date: 20210312; Test Name: RBC count; Result Unstructured Data: Test Result:3.22 x10 12/l; Test Date: 20210317; Test Name: RBC count; Result Unstructured Data: Test Result:3.01 x10 12/l; Test Date: 20210316; Test Name: COVID-19 antigen test; Test Result: Negative ; Test Date: 20210312; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210312; Test Name: White blood cell count; Result Unstructured Data: Test Result:9.3 x10 9/l; Test Date: 20210317; Test Name: White blood cell count; Result Unstructured Data: Test Result:10.3 x10 9/l
CDC Split Type: CZPFIZER INC202101148328

Write-up: General physical health deterioration; respiratory infection; This is a spontaneous report from a contactable consumer. This is the 2nd of 2 reports. The first report was downloaded from the Regulatory Authority-WEB [Regulatory Authority number CZ-CZSUKL-21001231]. A 91-year-old male patient received the 2nd dose of bnt162b2 (COMIRNATY), intramuscular on 04Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing hypertension, ongoing senile dementia (loss of personality and health condition and mobility), general physical health deterioration (according to doctors the condition corresponds to age), mobility decreased (due to senile dementia), ongoing ischaemic heart disease (no angina pectoris), ongoing mitral regurgitation (mild, 2/4 with mild to severe pulmonary hypertension), ongoing pulmonary hypertension, ongoing arthrosis multiple, ongoing cerebral atherosclerosis, ongoing atherosclerosis generalized, ongoing incontinence, ongoing walking difficulty, ongoing aortic valve stenosis and insufficiency (combined aortic defect, mild stenosis with regurgitation 2/4). Concomitant medications included nitrendipine (LUSOPRESS), quetiapine fumarate (QUETIAPIN), tiapride hydrochloride (TIAPRIDAL). Previously the patient received the 1st dose of Comirnaty on 11Feb2021 for COVID-19 immunisation and experienced pain, dysstasia, pain in extremity, gait disturbance. The patient experienced general physical health deterioration (death) on 17Mar2021 with fatal outcome on 18Mar2021 at 14:10, respiratory infection (medically significant) on 17Mar2021 with outcome of unknown. It was reported that on 12Mar2021 the patient fell down on the straight and he was brought by ambulance to the hospital, he had pertrochanteric fracture of the right femur, conservative therapy. On 17Mar2021 afternoon (day of admission) there was maybe a mild aspiration, patient was put temporarily on the oxygen therapy with nasal cannula due to hyposaturation. On 17Mar2021 the patient was moved to the after-care department. On 18Mar2021 the patient died at 14:10. The patient underwent lab tests and procedures which included activated partial thromboplastin time ratio: 0.97 on 12Mar2021, alanine aminotransferase: 0.29 on 17Mar2021 ukat/L , amylase: 2 on 17Mar2021 ukat/L, aspartate aminotransferase: 0.48 on 17Mar2021 Units:ukat/L, blood alkaline phosphatase: 1.66 on 17Mar2021 ukat/L, blood calcium: 2.14 mmol/l on 17Mar2021, blood chloride: 105 mmol/l on 17Mar2021, blood creatine phosphokinase mb: 4.2 on 12Mar2021 ukat/L, blood creatinine: 114 umol/l on 12Mar2021, blood creatinine: 106 umol/l on 17Mar2021, blood glucose: 6.7 mmol/l on 17Mar2021, blood magnesium: 0.86 mmol/l on 17Mar2021, blood potassium: 5 mmol/l on 12Mar2021, blood potassium: 4.4 mmol/l on 17Mar2021, blood pressure measurement: 166/79 mmhg on 17Mar2021. PCR test for COVID-19 was negative on 12Mar2021, antigen test for COVID-19 was negative on 16Mar2021. Therapeutic measures were taken as a result of the events and included treatment with Augmentin and analgotherapy. An autopsy was not performed. The lot number for bnt162b2 was not provided and will be requested during follow-up.; Sender''s Comments: Linked Report(s) : CZ-PFIZER INC-2021250302 Same patient/drug, different dose/events; Reported Cause(s) of Death: General physical health deterioration


VAERS ID: 1686147 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

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: DEPFIZER INC202101125215

Write-up: Death; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority DE-PEI-202100137316. A 74-year-old male patient received bnt162b2 (COMIRNATY; Lot Number: Unknown), via an unspecified route of administration on 01May2021 (at 74 years) as single dose for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. The patient experienced death on an unspecified date in May2021.It was not reported if an autopsy was performed. Sender Comment: Report of the Police Directorate: on 15May2021 a male corpse was found; the corpse has not been conclusively identified due to an advanced corpse appearance. It is assumed that the person died a few days after the vaccination.Relatedness of drug to reaction/event (Source of assessment PEI) was Assessment B. Indeterminate. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Reported Cause(s) of Death: Death


VAERS ID: 1686595 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-23
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 055E21A / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest, Chest pain, Chills, Dyspnoea, Headache, Heart rate increased, Injection site pain, Pyrexia, Respiratory arrest
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Moderna Covid19 vaccine
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: Cardiac/respiratory arrest at home resulting to death on 08/23/2021 after receiving first dose of Moderna Covid19 vaccine last 08/21/2021. The next day, he also had suffered side effect of headache, fever, chill, and pain on injection side. And on the second day when he got the heart attack, he had difficulty breathing, chest pain, and fast heartbeats leading to cardiac arrest. His wife tried to contact an ambulance to bring him to the hospital but never made to the emergency room.


VAERS ID: 1686696 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-15
Onset:2021-03-01
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM6950 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Antineutrophil cytoplasmic antibody, Arthralgia, Atrial fibrillation, Auscultation, Biopsy, Bleeding time prolonged, Blood cortisol, Blood electrolytes, Blood pressure measurement, Blood sodium, Blood test, Body temperature, C-reactive protein, Cerebral atrophy, Clostridium test, Coma scale, Computerised tomogram, Computerised tomogram abdomen, Computerised tomogram head, Coxiella test, Culture stool, Death, Discomfort, Dysphonia, Fatigue, General physical health deterioration, Guillain-Barre syndrome, HIV test, Heart rate, Hepatitis B virus test, Hepatitis C virus test, Hypertension, Hyponatraemia, Inflammation, Inflammatory marker increased, Investigation, Lumbar puncture, Magnetic resonance imaging head, Mobility decreased, Nasopharyngoscopy, Neck pain, Neurological examination, Neutrophil count, Oxygen saturation, Pain, Physical examination, Serum ferritin, Spinal myelogram, Tachypnoea, Treponema test, Tularaemia, Urinary retention, Urine analysis, Vocal cord paralysis, Vomiting, Wheezing
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Supraventricular tachyarrhythmias (narrow), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Hypertension (narrow), Demyelination (narrow), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Arthritis (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-17
   Days after onset: 46
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: Basal cell carcinoma; Cognitive disturbance; Dyslipidaemia; Hypertension arterial; Hyperuricaemia; Periarthritis scapulohumeralis
Allergies:
Diagnostic Lab Data: Test Name: antineutrophil cytoplasmic antibodies; Result Unstructured Data: Test Result:not found; Test Date: 20210320; Test Name: Cardiovascular; Result Unstructured Data: Test Result:Nothing to report; Test Date: 20210320; Test Name: digestive; Result Unstructured Data: Test Result:Nothing to report.; Test Date: 20210320; Test Name: pulmonary; Result Unstructured Data: Test Result:Nothing to report; Test Name: temporal artery biopsy; Result Unstructured Data: Test Result:Negative; Test Name: haemostasis; Result Unstructured Data: Test Result:normal; Test Name: cortisol levels; Result Unstructured Data: Test Result:normal; Test Name: ionogram; Result Unstructured Data: Test Result:normal; Test Date: 20210320; Test Name: blood pressure; Result Unstructured Data: Test Result:180/80; Test Name: hyponatremia; Result Unstructured Data: Test Result:124; Test Name: Blood test; Result Unstructured Data: Test Result:Serum protein electrophoresis compatible with mode; Comments: Serum protein electrophoresis compatible with moderate inflammatory syndrome; Test Name: Blood test upon admission; Result Unstructured Data: Test Result:slight disturbance of liver function with cholesta; Comments: slight disturbance of liver function with cholestasis.; Test Date: 20210320; Test Name: patient referred; Result Unstructured Data: Test Result:Apyrexia; Test Date: 20210320; Test Name: investigation for clostridium; Result Unstructured Data: Test Result:Negative; Test Date: 20210320; Test Name: Glasgow; Result Unstructured Data: Test Result:15; Test Date: 20210320; Test Name: chest computed tomography; Result Unstructured Data: Test Result:Strictly normal; Test Name: Thoracic-abdominal-pelvic computed tomography; Result Unstructured Data: Test Result:no abnormal hypermetabolic lesion detectable in th; Comments: no abnormal hypermetabolic lesion detectable in the ear, nose throat region and at the cricoarytenoid level.; Test Date: 20210320; Test Name: pelvic abdominal computed tomography; Result Unstructured Data: Test Result:Normal; Test Date: 20210320; Test Name: Cerebral computed tomography; Result Unstructured Data: Test Result:cortico-subcortical atrophy only; Test Name: Coxiella; Result Unstructured Data: Test Result:negative.; Test Name: c-reactive protein; Result Unstructured Data: Test Result:123; Comments: Blood test upon admission; Test Date: 20210316; Test Name: c-reactive protein; Result Unstructured Data: Test Result:117; Test Date: 20210320; Test Name: stool cultures; Result Unstructured Data: Test Result:negative; Test Date: 20210320; Test Name: Pulse; Result Unstructured Data: Test Result:80; Comments: beats per minute; Test Name: Hepatitis B; Result Unstructured Data: Test Result:negative; Test Name: Hepatitis / C; Result Unstructured Data: Test Result:negative; Test Name: Human Immunodeficiency Virus; Result Unstructured Data: Test Result:negative; Test Name: bartonellosis; Result Unstructured Data: Test Result:negative; Test Name: Burnetli; Result Unstructured Data: Test Result:negative; Test Date: 20210320; Test Name: rheumatoid; Result Unstructured Data: Test Result:Nothing to report; Test Name: Wipple serologies; Result Unstructured Data: Test Result:negative; Test Name: lumbar puncture; Result Unstructured Data: Test Result:Normal; Test Date: 20210320; Test Name: Brain magnetic resonance imaging; Result Unstructured Data: Test Result:no haemorrhagic or ischemic lesion; Test Name: Nasofibroscopy; Result Unstructured Data: Test Result:complete diplegia of the vocal cords without local; Comments: complete diplegia of the vocal cords without local lesion. Guillain Barre syndrome or a viral cause is evoked.; Test Name: Nasofibroscopy; Result Unstructured Data: Test Result:same diplegia of the vocal cords; Comments: Performing a 2nd nasofibroscopy due to a new episode of dyspnea; Test Date: 20210320; Test Name: neurological; Result Unstructured Data: Test Result:Nothing to report; Test Date: 20210316; Test Name: neutrophil; Result Unstructured Data: Test Result:18.5 g/l; Test Name: neutrophils; Result Unstructured Data: Test Result:19.68 g/l; Comments: Blood test upon admission; Test Date: 20210320; Test Name: oxygen saturation; Test Result: 97 %; Test Date: 20210320; Test Name: dermatological; Result Unstructured Data: Test Result:Nothing to report; Test Date: 20210320; Test Name: Ear, nose, and throat examination; Result Unstructured Data: Test Result:dysphonia for 4-5 days; Test Name: serum ferritin; Result Unstructured Data: Test Result:1138; Comments: increased Blood test upon admission; Test Name: Myelogram; Result Unstructured Data: Test Result:normal; Test Name: syphilis; Result Unstructured Data: Test Result:not found; Test Name: tularemia; Result Unstructured Data: Test Result:negative; Test Date: 20210320; Test Name: urine examination; Result Unstructured Data: Test Result:Negative cytobacteriological
CDC Split Type: FRPFIZER INC202101107871

Write-up: Paralysis vocal cord; Inflammatory marker increased; Diffuse pain; deterioration of general state of health; arthralgia, knee pain; neck pain; fatigue; inflammatory syndrome; hyponatremia; Atrial fibrillation; surge in hypertension; motor paralysis; acute retention of urine and occlusion; Guillain Barre syndrome; patient died which remains unexplained; wheezing; discomfort with vomiting +++; discomfort with vomiting +++; polypnea; cortico-subcortical atrophy; dysphonia; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-BR20213265. An 81-year-old male patient received second dose of BNT162B2 (COMIRNATY) (Lot Number: EM6950) intramuscular single dose for COVID-19 immunisation on 15Feb2021. Medical history included hypertension arterial, cognitive disturbance, hyperuricaemia, basal cell carcinoma, dyslipidaemia, periarthritis scapulohumeralis. The patient''s concomitant medications were not reported. The patient experienced paralysis vocal cord on 22Mar2021 with outcome of not recovered, inflammatory marker increased on 16Mar2021 with outcome of recovering, atrial fibrillation in Mar2021 with outcome of recovered, diffuse pain on 01Mar2021 with outcome of recovering; all hospitalization from Mar2021 to 13Apr2021. In the following 2 weeks, the patient experienced deterioration of general state of health with onset of arthralgia, knee pain, neck pain, fatigue and inflammatory syndrome with polynucleosis (c-reactive protein at 117, neutrophils at 18.5 G/l on 16Mar) with hyponatremia at 124, prompting hospitalisation by the general practitioner. Male patient referred to the emergency room on 20Mar2021, pulse 80 beats per minute, blood pressure 180/80, apyrexia, oxygen saturation 97%, glasgow 15. Blood test upon admission: increased serum ferritin at 1138, neutrophils at 19.68 G/l, c-reactive protein at 123, slight disturbance of liver function with cholestasis. Transfer to Multipurpose Medicine on 20Mar2021. Cardiovascular, pulmonary, digestive, dermatological, rheumatoid, and neurological examinations: Nothing to report. Ear, nose, and throat examination: dysphonia for 4-5 days. Normal pelvic abdominal computed tomography. On 20Mar2021: discomfort with vomiting +++, polypnea. Strictly normal chest computed tomography. Cerebral computed tomography: cortico-subcortical atrophy only. Brain magnetic resonance imaging: no haemorrhagic or ischemic lesion. Negative cytobacteriological urine examination, investigation for clostridium, negative stool cultures. On 22Mar2021: episode of polypnea with wheezing and right neck pain associated with dyspnea. Nasofibroscopy: complete diplegia of the vocal cords without local lesion. Guillain Barre syndrome or a viral cause is evoked. A brain computed tomography enables phlegmon to be eliminated. Hypothesis of cricoarytenoid arthritis rejected after revaluation. Negative temporal artery biopsy. Performing a 2nd nasofibroscopy due to a new episode of dyspnea: same diplegia of the vocal cords. Thoracic-abdominal-pelvic computed tomography: no abnormal hypermetabolic lesion detectable in the ear, nose throat region and at the cricoarytenoid level. Normal lumbar puncture. Myelogram: normal. Blood test: Serum protein electrophoresis compatible with moderate inflammatory syndrome, normal ionogram, normal haemostasis, normal cortisol levels, antineutrophil cytoplasmic antibodies not found, syphilis not found. Hepatitis B, C, Human Immunodeficiency Virus, Coxiella, Burnetli, tularemia, bartonellosis, and Wipple serologies negative. After advice by a specialist in internal medicine, recommendation to continue the paraneoplastic assessment if we consider that the only persistent clinical point is atypical mononeuritis, with colonoscopy and fibroscopie gastro-duodenale to be performed externally. Transition to atrial fibrillation during the stay, introduction of XARELTO 20 mg/day + bisoprolol 5 mg/day. Faced with this negative aetiological assessment, introduction of corticosteroid therapy 1 mg/kg for 10 days allowing a decrease in asthenia and a resumption of walking as well as an improvement in blood test findings with decrease in white blood cells and c-reactive protein. Returned home on 13Apr2021 on a decreasing dose of corticosteroid. Ear, nose throat consultations, multipurpose medicine, hepatogastroenterologists, scheduled respectively on 15Apr, 29Apr, and 12May. Patient died at home on 17Apr2021 without explanation. It was unknown if an autopsy was performed. Conclusion was reported as: According to the reporting general practitioner, the surge in hypertension, diplegia of the vocal cords, the inflammatory syndrome, the transition to persistent atrial fibrillation, as well as a motor paralysis with acute retention of urine and occlusion would support a Guillain Barre syndrome. According to the head of the Polyvalent Medicine ward contacted on 19Aug2021, the Guillain Barre syndrome mentioned initially due to the diplegia of the vocal cords was not subsequently retained. Moreover, no motor or intestinal or bladder paralysis was found during the hospital stay. Outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: patient died which remains unexplained


VAERS ID: 1686778 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-22
Onset:2021-08-03
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3065 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Choking, Cough, Death
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-03
   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: HALOPERIDOL; SEROQUEL; LAMICTAL; TERCIAN [CYAMEMAZINE]; LOXAPAC [LOXAPINE]; SERESTA; ZOCOR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol dependence syndrome; Dyslipidaemia; Hospitalization (in June-July 2021/Regular hospitalization about once a year); Hypertension arterial; Overweight (overweight, not very active but still independent); Schizophrenia (since the age of 18)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101142794

Write-up: Death unexplained; The coroner ruled that the patient died of suffocation/by choking; cough; This is a spontaneous report from a contactable consumer (patient''s father) and a physician, downloaded from the Regulatory Authority. The regulatory authority report number FR-AFSSAPS-DJ20213347. A 44-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 22Jul2021 (Batch/Lot Number: FE3065) as dose 2, single for covid-19 immunisation. Medical history included schizophrenia (since the age of 18), alcohol dependence syndrome, Hypertension arterial, dyslipidaemia and hospitalization (in June-July 2021/Regular hospitalization about once a year), patient was overweight, not very active but still independent. Concomitant medication included haloperidol; quetiapine fumarate (SEROQUEL); lamotrigine (LAMICTAL); cyamemazine (TERCIAN [CYAMEMAZINE]); loxapine (LOXAPAC [LOXAPINE]); oxazepam (SERESTA); simvastatin (ZOCOR). The patient experienced death unexplained on 03Aug2021, choking on 03Aug2021, cough on an unspecified date. It was a medically confirmed case. additional documentation carried out the patient''s psychiatrist included background: Severe schizophrenia since the age of 18, alcohol dependence, high blood pressure, dyslipidemia. habitual treatment no recent modification, old treatment: Haloperidol 20 mg/day, Seroquel 800 mg/day, Lamictal 100 mg/day, Tercian 400 mg/day, Loxapac 100 mg/day, Seresta 150 mg/day, Zocor 10 mg/day. Triatec recently discontinued during a hospitalization in June-July 2021. History of illness: Patient with history of severe schizophrenia, difficult to balance therapeutically. In addition, chronic alcohol consumption with massive consumption episodes. Regular hospitalization about once a year for management of this problem. Patient who received a second injection of COMIRNATY on 22Jul2021 (lot FE3065). The father reported the death of his son on August 7 by a medical examiner. In the absence of news of his son, the call to the fire department was made and the patient was found dead in his bed on August 7. The doctor estimated the date of death in the night of August 3 to August 4, 2021. No other information in the initial statement. Call from the psychiatrist following the patient who stated that this patient was overweight, not very active but still independent. Not aware of whether or not an autopsy was performed. Had only learned of the patient''s death after a call from the father but without any details. He also specified that the patient had no particular cardiovascular history apart from a slight arterial hypertension which had not been found during the last hospitalization, hence the discontinuation of Triatec. He was discharged from his last hospitalization on 09Jul2021. No history of rhythm disorder. No diabetes. Additional information requested from the father, who stated that the firefighters had intervened through the balcony and found him in bed. The police made an investigation in the building. The neighbors said that for several days, the patient had strong coughing attacks. The coroner ruled that the patient died of suffocation. No answer on the question of the autopsy (notion of examination by a forensic doctor on 07Aug2021). In total, unexplained death (by choking?) in a schizophrenic patient with an important neuroleptic treatment, occurring at about Day 13 (as reported) of the 2nd injection of COMIRNATY. The patient died on 03Aug2021 (The doctor estimated the date of death in the night of 03Aug2021 to 04Aug2021). Outcome of cough was unknown. An autopsy was performed and results were not provided. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death unexplained; The coroner ruled that the patient died of suffocation/by choking


VAERS ID: 1686779 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-15
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Vaccination failure
SMQs:, Lack of efficacy/effect (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Automated external defibrillator user; Cardiac aneurysm (of the inferior wall of the left ventricle with thrombus and complicated by an ischemic stroke � resolved); Cardiac failure; Hip prosthesis insertion; Hypertension arterial; Ischaemic heart disease (Strictures at multiple levels Distally thrombosed right coronary artery); Ischaemic stroke NOS (sur FA); Renal disease (chronic stage 4); Smoker; Sternotomy (for VG aneurysm cure); Type II diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20210909320

Write-up: Vaccination failure; This spontaneous report received from a consumer via regulatory authority [FR-AFSSAPS-DJ20213409)] on 06-SEP-2021 and concerned an 83 year old male of unknown race and ethnicity. The patient''s height, and weight were not reported. The patient''s past medical history included automated external defibrillator user, cardiac failure, ischaemic heart disease, hypertension arterial, type 2 diabetes mellitus, hip prosthesis insertion, smoking, renal disease, sternotomy, cardiac aneurysm, and ischaemic stroke nos. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C10-02 expiry: unknown) 1 dosage forms, 1 total, administered on 29-MAY-2021 for covid-19 vaccination. The drug start period was 79 days. No concomitant medications were reported. On 15-AUG-2021, the patient died from vaccination failure. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Reported Cause(s) of Death: VACCINATION FAILURE


VAERS ID: 1686802 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-05-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Atrial fibrillation, Body temperature, Bronchopneumopathy, Cardiac flutter, Cardiopulmonary failure, Hypercapnia, Inflammation, Oxygen saturation, Pneumonia, Respiratory distress, Septic shock, Supraventricular tachycardia, Vomiting
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Interstitial lung disease (broad), Supraventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Toxic-septic shock conditions (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tachyarrhythmia terms, nonspecific (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-30
   Days after onset: 47
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: Arterial stent insertion; COPD (Post-smoking Chronic obstructive pulmonary disease with emphysema (last pulmonary follow-up in 2017)); Emphysema (last pulmonary follow-up in 2017); Ex-smoker (Former smoker 50 packs annually, cessation for 3 years); Myocardial infarction (Stented arteriopathy obliterating the myocardial infarction); Prostate cancer (Neoplasia of the prostate under surveillance)
Allergies:
Diagnostic Lab Data: Test Date: 20210516; Test Name: body temperature; Result Unstructured Data: Test Result:39 Centigrade; Test Date: 20210517; Test Name: Saturation; Test Result: 90 %; Comments: under 5L O2
CDC Split Type: FRPFIZER INC202101149715

Write-up: acute respiratory distress; supraventricular tachycardia; Cardiac flutter; Acute bronchopneumopathy; acute hypoxemic community-acquired pneumonia complicated by hypercapnic respiratory distress with signs of septic shock; acute hypoxemic community-acquired pneumonia complicated by hypercapnic respiratory distress with signs of septic shock; acute hypoxemic community-acquired pneumonia complicated by hypercapnic respiratory distress with signs of septic shock; Septic shock; complete arrhythmia due to atrial fibrillation in the aftermath of the sepsis; Persistent inflammatory syndrome; cardio-respiratory decompensation; vomiting; This is a spontaneous report from a contactable consumer and other health professional downloaded from the Regulatory Authority, regulatory authority number FR-AFSSAPS-LM20212449. An 81-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 13May2021 (Lot Number: Unknown) as single dose (at the age of unknown) for COVID-19 immunisation. Medical history included ex-tobacco user (Former smoker 50 packs annually, cessation for 3 years), post-smoking Chronic obstructive pulmonary disease with emphysema (last pulmonary follow-up in 2017), stented arteriopathy obliterating the myocardial infarction, neoplasia of the prostate under surveillance. The patient''s concomitant medications were not reported. The day after vaccination (14May2021): vomiting. Then appearance of a fever at 39 degree Celsius at Day 3 with still vomiting on 16May2021. Admission to pneumology (17May2021) for dyspnea, with mottling, labial cyanosis, Sat 90% under 5L O2, right crepitus, polypnea. Acute bronchopneumopathy on 17May2021. Then transfer to intensive care: acute hypoxemic community-acquired pneumonia complicated by hypercapnic respiratory distress with signs of septic shock (inhalation pneumopathy?) on 17May2021. Management with dual antibiotic therapy and non-invasive ventilation. Some passages in complete arrhythmia due to atrial fibrillation in the aftermath of the sepsis on 17May2021. Discharge from hospital on 15Jun2021 (after 1 month). Readmission to cardiology on 19Jun2021 for acute respiratory distress. On admission marbling with polypnea and signs of struggle, with evidence of supraventricular tachycardia on 19Jun2021. There is a strong suspicion of rapid atrial flutter with incomplete left bundle branch block initially becoming complete with acceleration of the rhythm on 19Jun2021. Persistent inflammatory syndrome, crackles on 19Jun2021. Regular transition to atrial fibrillation at the Telemonitoring. Oxygen therapy, furosemide. Death on 30Jun2021 due to cardio-respiratory decompensation, outcome of cardiac flutter was not resolved, Septic shock was resolved on 31May2021, acute bronchopneumopathy was resolving, the other events was unknown. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: cardio-respiratory decompensation


VAERS ID: 1686856 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-03-01
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Asphyxia, Asthenia, Blood test, Completed suicide, Computerised tomogram coronary artery, Dizziness, Fatigue, Feeling drunk, Insomnia, Magnetic resonance imaging head, Neurological examination, Paraesthesia, Scan brain, Somnolence, Tremor
SMQs:, Peripheral neuropathy (broad), Suicide/self-injury (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Vestibular disorders (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-19
   Days after onset: 139
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: blood test; Result Unstructured Data: Test Result:discrete inflammatory syndrome; Test Date: 20210707; Test Name: coronary scan; Result Unstructured Data: Test Result:within normal limits; Test Date: 20210624; Test Name: MRI cerebral; Result Unstructured Data: Test Result:No detectable signal abnormality; Comments: No detectable signal abnormality at the subtentorial level. At the supratentorial level: fairly marked periventricular leukopathy with numerous hyper signals in the white matter. Moderate cortical and subcortical atrophy without predominance in the medial temporal structures. Right hippocampal millimetric hypersignal. No significant dilatation of the ventricular system. No cerebral edema.; Test Date: 20210613; Test Name: neurological examination; Result Unstructured Data: Test Result:No visible signs of radicular or neuropathic damag; Comments: No visible signs of radicular or neuropathic damage in the lower limbs; Test Date: 20210701; Test Name: neurological examination; Result Unstructured Data: Test Result:global hypokinesia; Comments: global hypokinesia but no patent extrapyramidal syndrome, no systematized muscle weakness, no orthostatic hypotension. Describes a more important drowsiness with Xanax that she does not wish to decrease for fear of a reappearance of the anguish phenomena. Decision to decrease aprazolam and prazepam anyway.; Test Date: 20210613; Test Name: scan head; Result Unstructured Data: Test Result:atrophy; Comments: discrete bi-frontotemporal and mesencephalic atrophy
CDC Split Type: FRPFIZER INC202101142859

Write-up: suicide / asphyxia; asphyxia; morning tremors lasting 3/4 of an hour / legs shaking 45 min every morning / trembling of the lower limbs; physical and moral exhaustion; paresthesias of the lower legs and the back of the 2 feet; important asthenia; Dizziness; Anguish / anxiety; Insomnia; sensation of drunkenness; desire to sleep all the time; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB. The regulatory authority report number FR-AFSSAPS-NC20213788. An 81-year-old female patient received the second dose of BNT162B2 (COMIRNATY) via intramuscular on the left arm on 25Feb2021 (Lot Number: EP9598) as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on 28Jan2021 (Lot Number: EJ6788) as single dose for COVID-19 immunization. For 4 months, describes morning tremors lasting 3/4 of an hour, persisting when getting up, with sensation of drunkenness, trembling of the lower limbs, paresthesias of the lower legs and the back of the 2 feet. Recurrence at the end of the afternoon with important asthenia. This began suddenly after a dizziness that occurred on returning from the beach on 01Mar2021, 4 days after vaccination. On 01Mar2021, the patient also experienced physical and moral exhaustion, dizziness, insomnia. The patient''s legs shaking 45min every morning, desire to sleep all the time and anxiety. Phenomena of anguish 4 days after vaccination leading to moral and physical exhaustion resulting in suicide by VMI (voluntary drug intoxication) and asphyxia. On 19Jul2021, the patient died as asphyxia on suicide, intentionally took several sleeping pills before asphyxiating herself with a bag on the head. Biology / complementary examinations / etiological research: Neurological examination on 13Jun2021: No signs of radicular or neuropathic involvement visible in the lower extremities. Brain scan: discrete bi-frontotemporal and mesencephalic atrophy. Brain MRI on 24Jun2021: No detectable signal abnormality at the subtentorial level. At the supratentorial level: fairly marked periventricular leukopathy with numerous hyper signals in the white matter. No sign of recent ischemic or hemorrhagic lesion. Moderate cortical and subcortical atrophy without predominance in the medial temporal structures. Right hippocampal millimetric hypersignal. No significant dilatation of the ventricular system. No cerebral edema. Neurological examination on 01Jul2021: global hypokinesia but no patent extrapyramidal syndrome, no systematized muscle weakness, no orthostatic hypotension. Describes a more important drowsiness with Xanax that she does not wish to decrease for fear of a reappearance of the anguish phenomena. Decision to decrease aprazolam and prazepam anyway. Coronary scan on 07Jul2021: within normal limits. Biological check-up of 16Jul2021: discrete inflammatory syndrome. On 13Jun2021, the patient admission to the emergency room. Prescriptions: On 06Apr2021: Prazepam 10mg 1 tablet /d. On 16Apr2021 Seresta 10mg 1-0-1 stop prazepam. On 06May2021: Tanganil 200mg 2-2-2 for 3 days; prazepam 1/2 tablet morning; escitalopram 5mg 1 tablet evening. On 03Jun2021 : gabapentin 100. On13Jun2021: alprazolam 0.5mg 1-1-0. On 23Jun2021 : alprazolam 0.25 2 tablets/day.On 25Jun2021 : Brintellix 10mg 1 tablet / day. On 01Jul2021 : prazepam 1/2 tablet during 3 days then stop ; alprazolam 0.25 decrease from 4.5 tablets to 2 tablets / day in 3 weeks. On 13Jul2021: alprazolam 0.25mg 2cp/d. The cause of death included suicide and asphyxia. Autopsy was unknown. The outcome of suicide and asphyxia was fatal. The outcome of feeling drunk and drowsiness was unknown. The outcome of other events was not recovered.; Reported Cause(s) of Death: Asphyxia; suicide


VAERS ID: 1686883 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-08-13
   Days after vaccination:73
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Brain natriuretic peptide, C-reactive protein, COVID-19 pneumonia, Drug ineffective, Echocardiogram, Platelet count, SARS-CoV-2 test, Troponin
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-15
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LEVOTHYROX; MIANSERINE [MIANSERIN HYDROCHLORIDE]; TEMERIT; TRAMADOL [TRAMADOL HYDROCHLORIDE]; SILODOSINE; HYDREA; LASILIX [FUROSEMIDE]; XARELTO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Cardiac failure; Cardiomyopathy; Chronic renal failure; COVID-19 pneumonia (hospitalization); Kyphoscoliosis; Pulmonary arterial hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210813; Test Name: BNP; Result Unstructured Data: Test Result:695 ng/L; Test Date: 20210813; Test Name: C-reactive protein; Result Unstructured Data: Test Result:21.9 mg/l; Test Date: 20210813; Test Name: Transthoracic echocardiography; Result Unstructured Data: Test Result:right heart failure; Comments: Non-dilated left ventricle with preserved left ventricular ejection fraction in atrial fibrillation, grade 2 mitral insufficiency, dilated left atrium, preserved flow, very dilated right ventricle 2X the left ventricle without paradoxical septum, global hypokinesia of the right ventricle with Tricuspid annular plane systolic excursion at 11mm, inferior vena cava at 28mm non compliant, dry pericardium, no pleural effusion, moderate B line. Conclusion: right heart failure on probable chromic pulmonary heart on chronic respiratory failure, without left-sided failure explaining the hypoxemia.; Test Date: 20210813; Test Name: Platelet count; Result Unstructured Data: Test Result:89000 /mm3; Test Date: 20210813; Test Name: Test PCR covid-19; Test Result: Positive ; Comments: DELTA variant; Test Date: 20210813; Test Name: Troponin; Result Unstructured Data: Test Result:3344 ug/L
CDC Split Type: FRPFIZER INC202101142820

Write-up: Vaccination failure; Covid-19 pneumonia; This is a spontaneous report from a contactable other hcp downloaded from the Regulatory Agency-WEB, regulatory authority number FR-AFSSAPS-NY20213973. A 78-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on Jun2021 (Lot Number: ET6956) as DOSE 1, SINGLE for covid-19 immunisation . Medical history included chronic kidney disease, cardiomyopathy, COVID-19 pneumonia and hospitalization , kyphoscoliosis, cardiac failure, pulmonary arterial hypertension, atrial fibrillation. Concomitant medications included levothyroxine sodium (LEVOTHYROX) taken for hypothyroidism; mianserin hydrochloride (MIANSERINE [MIANSERIN HYDROCHLORIDE]) taken for depression; nebivolol hydrochloride (TEMERIT) taken for cardiac failure; tramadol hydrochloride (TRAMADOL [TRAMADOL HYDROCHLORIDE]) taken for pain; silodosine taken for benign prostatic hyperplasia; hydroxycarbamide (HYDREA); furosemide (LASILIX [FUROSEMIDE]) taken for chronic kidney disease; rivaroxaban (XARELTO) taken for atrial fibrillation. On 13Aug2021, Vaccination failure which led to death on 15Aug2021. Hospitalization on 13Aug2021 for pneumonia COVID-19 (VARIANT DELTA) complicating chronic respiratory failure and right heart failure. Unfavourable evolution with an increase in oxygen requirements up to 100% FiO2, unfavourable evolution on the hemodynamic level. Background of cardiopulmonary history, intubation with unreasonable mechanical ventilation. Comfort care reinforced by sedation. Died on 15Aug2021. On 13Aug2021, PCR covid-19 test: Positive; On 13Aug2021, Transthoracic echocardiography: Non-dilated left ventricle with preserved left ventricular ejection fraction in atrial fibrillation, grade 2 mitral insufficiency, dilated left atrium, preserved flow, very dilated right ventricle 2X the left ventricle without paradoxical septum, global hypokinesia of the right ventricle with Tricuspid annular plane systolic excursion at 11mm, inferior vena cava at 28mm non compliant, dry pericardium, no pleural effusion, moderate B line. Conclusion: right heart failure on probable chromic pulmonary heart on chronic respiratory failure, without left-sided failure explaining the hypoxemia.On 13Aug2021, Platelet count: 89000 per cubic millimetre; On 13Aug2021, Troponin: 3344 microgram per litre; 13Aug2021, BNP: 695 nanogram per litre; 13Aug2021, C-reactive protein: 21.9 milligram per litre. The patient died on 15Aug2021. It was not reported if an autopsy was performed. The outcome of events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Vaccination failure; Covid-19 pneumonia


VAERS ID: 1686990 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Alpha 1 globulin, Asthenia, Auscultation, Blood albumin, Blood gases, Bronchiectasis, C-reactive protein, Cardiac failure, Cardio-respiratory arrest, Cardiovascular examination, Chromaturia, Condition aggravated, Deep vein thrombosis, Ejection fraction, Electrocardiogram, Electrocardiogram repolarisation abnormality, Gait disturbance, General physical health deterioration, Haematoma muscle, Heart rate increased, Heart sounds, Heart sounds abnormal, Hepatitis A virus test, Hypocapnia, Hypoxia, Inappropriate schedule of product administration, Inflammation, Investigation, Malnutrition, Pallor, Respiratory disorder, Scan, Scan parathyroid, Spinal fracture, Superior vena cava syndrome, Ultrasound Doppler, Urine abnormality, Urine analysis, Weight
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (narrow), Conduction defects (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, venous (narrow), Malignancy related conditions (narrow), Parkinson-like events (broad), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Osteoporosis/osteopenia (broad), Hypotonic-hyporesponsive episode (broad), Proteinuria (broad), Respiratory failure (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-29
   Days after onset: 28
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: ELIQUIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute coronary syndrome; Adenomyosis; Adnexectomy; AFib; Algodystrophy; Alphaglobulin abnormal (hyperalphaglobulinemia); Cardiac failure; Cementoplasty (L2 in 2016, D12 and L1 in 2017, D1 L3 and L4 in 2017); Chronic renal failure; Chronic venous insufficiency; Dyslipidaemia; Essential hypertension; Foot fracture (and of the right and left 3rd metatarsals); Hepatitis A; Hypercalcaemia; Hyperparathyroidism; Hypoalbuminemia (appearance of hypoalbuminemia since the beginning of 2021 at 23 g/L); Hysterectomy; Inflammatory reaction (with low-noise biological inflammatory syndrome (CRP at 5 mg/L, hyperalphaglobulinemia)); Ischemic heart disease (ST- Tropo); Lymphoedema; Macroscopic haematuria; Malnutrition; Myocardial infarction (transseptal myocardial infarction on tight anterior interventricular stenosis); Nephroangiosclerosis (benign nephroangiosclerosis); Nephropathy tubular (probable chronic tubulointerstitial nephropathy); Omarthrosis; Orthopaedic procedure; Osteoporosis with fracture (on bisphosphonates); Parathyroid adenoma; Saphenectomy (in 1984, 1991, 2001 for chronic venous insufficiency with bilateral lymphoedema); Shoulder arthroplasty (right); Starvation; Ventricular aneurysm (extensive); Wrist fracture (orthopaedic treatment)
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: alphaglobulin; Result Unstructured Data: Test Result:hyperalphaglobulinemia; Test Date: 20210707; Test Name: Auscultation; Result Unstructured Data: Test Result:fine crackles in the left base; Test Date: 20210728; Test Name: Auscultation; Result Unstructured Data: Test Result:decreased vesicular murmur with adventitia,; Comments: crackles at the bases; Test Name: albumin; Result Unstructured Data: Test Result:18 g/l; Test Date: 2021; Test Name: albumin; Result Unstructured Data: Test Result:23 g/l; Comments: hypoalbuminemia; Test Date: 20210728; Test Name: Gasometry; Result Unstructured Data: Test Result:slight hypoxia PCO2 = 77.9 mmHg, clear hypocapnia; Comments: PCO2 = 31.4 mmHg; Test Date: 20210707; Test Name: Cardiovascular examination; Result Unstructured Data: Test Result:oedema of the lower limbs; Comments: known lymphoedema of the lower limbs with haematoma of the L +++ thigh, warm and tense. Mobilisation of the toes is sp, with no disturbance of sensitivity. The pedal pulses are not perceived (oedemas too significant); Test Date: 2021; Test Name: CRP; Result Unstructured Data: Test Result:5 mg/l; Test Date: 20210728; Test Name: CRP; Result Unstructured Data: Test Result:107.9 mg/l; Test Name: LVEF; Test Result: 54 %; Test Date: 20210707; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:regular sinus rhythm, 150 bpm, left axis, no; Comments: repolarisation or conduction disorder; Test Date: 20210728; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:atrial fibrillation with ventricular response at; Comments: 117 BPM. Non-specific diffuse repolarization abnormality. Sequela of inferior necrosis; Test Date: 20210728; Test Name: heart sound; Result Unstructured Data: Test Result:Irregular heart sounds; Test Name: Hepatitis A virus; Result Unstructured Data: Test Result:serology positive; Test Date: 20210707; Test Name: Pulmonary examination; Result Unstructured Data: Test Result:no dyspnoea, no cough; Test Name: vitamin; Result Unstructured Data: Test Result:The assessment did not reveal any vitamin B9 and; Comments: B12 deficiency; Test Date: 20210707; Test Name: Thorax, Abdomen and Pelvis scan; Result Unstructured Data: Test Result:left quadriceps muscle compressive haematoma; Comments: measuring 10 x 8.5 x 25 cm (length, width, height) with venolymphatic stasis with no arterial or venous supply detected. No Thorax, Abdomen and Pelvis pathological process detected. Ventilatory disorders with varicose bronchestasis of sequential appearance at both lung bases without infectious focus should be noted.; Test Name: parathyroid scan; Result Unstructured Data: Test Result:primary hyperparathyroidism with presence of a le; Test Date: 20210712; Test Name: Ultrasound of the upper limbs; Result Unstructured Data: Test Result:The humeral artery is well identified; Comments: normally permeable, no humeral vein in its vicinity, it is probably thrombosed. The whole picture suggests, at the very least, a superior vena cava syndrome. Suspicion of deep venous thrombosis in the right upper limb not visualised on ultrasound because of the significant upper limb oedema.; Test Date: 20210728; Test Name: Cytobacteriological examination of the urine; Result Unstructured Data: Test Result:very cloudy, brown coloured urine.; Comments: Leukocytes = 159 G/L; haematopoietic 97 G/L; polymorphic bacterial flora $g10^3 CFU/mL.; Test Date: 20210729; Test Name: Cytobacteriological examination of the urine; Result Unstructured Data: Test Result:polymorphic bacterial flora $g10^3 CFU/mL.; Test Name: weight; Result Unstructured Data: Test Result:10% weight loss in 6 months
CDC Split Type: FRPFIZER INC202101149789

Write-up: left thigh hematoma/left quadriceps muscle compressive haematoma measuring 10 x 8.5 x 25 cm (length, width, height) with venolymphatic stasis/Compressive muscle haematoma; Ventilatory disorders with varicose bronchestasis of sequential appearance at both lung bases without infectious focus; Suspicion of deep venous thrombosis in the right upper limb; dorsal fracture; cardiac decompensation (upper and lower limb oedema); Ventilatory disorders with varicose bronchestasis of sequential appearance at both lung bases without infectious focus; Protein-energy malnutrition with albumin at 18 g/L,; Loss of autonomy with difficulty in walking; Cardio-respiratory arrest; diffuse repolarization abnormality; hypoxia; poor general condition; pallor; asthenia; Irregular heart sounds; Inflammatory syndrome with CRP 107.9 mg/L; Inflammatory syndrome with CRP 107.9 mg/L; hypocapnia; urine with very cloudy; brown coloured urine; a superior vena cava syndrome; 150 bpm; dose 1 on 12May2021/dose 2 on 01Jul2021; This is a spontaneous report from a contactable consumer and other hcp downloaded from the Regulatory Authority, regulatory authority number FR-AFSSAPS-ST20213182. A 77-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 01Jul2021 (Batch/Lot number was not reported) as DOSE 2, 0.3 ML SINGLE at age of 77-year-old for covid-19 immunisation; paracetamol (PARACETAMOL), via an unspecified route of administration from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at unknown dose for dorsal fracture under biphosphonates antalgia; morphine sulfate (ACTISKENAN), via an unspecified route of administration from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at 5 mg/4h, as needed for unknown indication; furosemide (LASILIX), via an unspecified route of administration from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at unknown dose for unknown indication; bisoprolol fumarate (BISOCE), via an unspecified route of administration from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at unknown dose for Ischaemic and rhythmic heart disease, with complete arrhythmia; levofloxacin (LOVENOX), subcutaneous from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at unknown dose for Compressive muscle haematoma; atorvastatin calcium, ezetimibe (LIPTRUZET) and buspirone hydrochloride (BUSPIRONE), both via an unspecified route of administration from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at unknown dose for unknown indication; fentanyl (DUROGESIC), via an unspecified route of administration from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at 1 patch every 3 days for unknown indication; potassium chloride (DIFFU K); phloroglucinol, trimethylphloroglucinol (SPASFON); risedronate sodium (RISEDRONATE SODIUM); metoclopramide hydrochloride, pancreatin (PRIMPERAN COMPOSITUM); macrogol (MACROGOL), all via an unspecified route of administration from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at unknown dose for unknown indication; amiodarone hydrochloride (CORDARONE), via an unspecified route of administration from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at unknown dose for Ischaemic and rhythmic heart disease, with complete arrhythmia. No COVID-19. Medical history included Dyslipidaemia, Starvation, Essential hypertension all from unknown date, Nephrological: - Chronic renal failure (Severe chronic renal failure stage IV) secondary to probable chronic tubulointerstitial nephropathy +/- benign nephroangiosclerosis; - Chronic hypercalcaemia since at least 2019 secondary to primary hyperparathyroidism with presence of a left lower parathyroid adenoma on parathyroid scan; - Recurrent macroscopic haematuria since February 2021. Cardiovascular: - Heart failure with moderately preserved LVEF at 54% without LVH with moderate anterior wall hypokinesia and apical akinesia secondary to ischemic heart disease in this case ST- Tropo + acute coronary syndrome with transseptal myocardial infarction on tight anterior interventricular stenosis complicated by an extensive ventricular aneurysm (1985); - Complete arrhythmia with permanent atrial fibrillation on Eliquis and amiodarone, left atrial dilatation to 48mm/24cm2; - Saphenectomy for chronic venous insufficiency with bilateral lymphoedema in 1984, 1991, 2001. Rheumatology: - Severe fractured osteoporosis on bisphosphonates: Cimentoplasty L2 in 2016, D12 and L1 in 2017, D1 L3 and L4 in 2017; Fatigue fracture of the right foot complicated by algodystrophy (2012) and of the right and left 3rd metatarsals; Fracture of the right wrist in 2011: orthopaedic treatment; - Arhtroplasty right shoulder following eccentric omarthrosis. Other: - Severe malnutrition: 10% weight loss in 6 months, appearance of hypoalbuminemia since the beginning of 2021 at 23 g/L with low-noise biological inflammatory syndrome (CRP at 5 mg/L, hyperalphaglobulinemia) concomitant with an altered general state; - Hysterectomy with adnexectomy in 1997 for adenomyosis; - Hepatitis A virus serology positive. Concomitant medication(s) included apixaban (ELIQUIS) taken for Complete arrhythmia with permanent atrial fibrillation, start and stop date were not reported. Historical vaccine included dose 1 of bnt162b2 (COMIRNATY, lot EX7823) on 12May2021 and experienced deep vein thrombosis-pulmonary embolism (patient with recent pulmonary embolism following two DVT of the lower limbs). The patient experienced cardio-respiratory arrest on 29Jul2021, cardiac decompensation on an unspecified date. The events were reported as serious for death, hospitalization. Dose 2 COMIRNATY unknown lot on 01Jul2021. Hospitalized on 07Jul2021 for left thigh hematoma and deglobulation at 6 in the context of curative anticoagulation for pulmonary embolism and deep vein thrombosis < 3 months. On 07Jul2021, a Thorax, Abdomen and Pelvis scan showed a left quadriceps muscle compressive haematoma measuring 10 x 8.5 x 25 cm (length, width, height) with venolymphatic stasis with no arterial or venous supply detected. No Thorax, Abdomen and Pelvis pathological process detected. Ventilatory disorders with varicose bronchestasis of sequential appearance at both lung bases without infectious focus should be noted. On 07Jul2021, Cardiovascular examination: -oedema of the lower limbs: known lymphoedema of the lower limbs with haematoma of the L +++ thigh, warm and tense. Mobilisation of the toes is sp, with no disturbance of sensitivity. The pedal pulses are not perceived (oedemas too significant). Pulmonary examination: -Clinical: no dyspnoea, no cough. -Auscultation: fine crackles in the left base. On 07Jul2021, Electrocardiogram: regular sinus rhythm, 150 bpm, left axis, no repolarisation or conduction disorder. Ultrasound of the upper limbs on 12Jul2021 The humeral artery is well identified, normally permeable, no humeral vein in its vicinity, it is probably thrombosed. The whole picture suggests, at the very least, a superior vena cava syndrome. Suspicion of deep venous thrombosis in the right upper limb not visualised on ultrasound because of the significant upper limb oedema. Cardiovascular: The stay was complicated by an episode of cardiac decompensation (upper and lower limb oedema) of probably mixed aetiology between the 6 transfusions and the recent pulmonary embolism. Hydrosodic depletion was carried out by increasing doses of Lasilix, maintenance at 40mg/day and 2 Diffu-K per day. Nutritional: Protein-energy malnutrition with albumin at 18 g/L, introduction of a low-salt enriched diet with 2 oral nutritional supplements/day. The assessment did not reveal any vitamin B9 and B12 deficiency. Discharge data: Compressive muscle haematoma under Lovenox. Known macroscopic haematuria, stable without deglobulation, undergoing assessment: suspicion of underlying bladder neoplasia. Ischaemic and rhythmic heart disease, with complete arrhythmia due to atrial fibrillation known to be on BISOCE and AMIODARONE. Suspicion of deep vein thrombosis of the upper right limb (patient already anticoagulated, not visualised on ultrasound due to significant oedema/ patient with recent pulmonary embolism following two DVT of the lower limbs); Osteoporosis: dorsal fracture under biphosphonates antalgia by Paracetamol, Durogesic 50ug 1 patch every 3 days and Actiskenan 5mg/4h if needed; Severe chronic renal failure stage IV; Loss of autonomy with difficulty in walking. Transfer to follow-up and rehabilitation care on 28 July. On admission: poor general condition, asthenia, pallor. Oedema of the lower limbs, no signs of cardiac decompensation. Irregular heart sounds. Pulmonary auscultation: decreased vesicular murmur with adventitia, crackles at the bases. ECG; atrial fibrillation with ventricular response at 117 BPM. Non-specific diffuse repolarization abnormality. Sequela of inferior necrosis. Biology: Inflammatory syndrome with CRP 107.9 mg/L. Gasometry disturbed with slight hypoxia PCO2 = 77.9 mmHg, clear hypocapnia PCO2 = 31.4 mmHg. Cytobacteriological examination of the urine with very cloudy, brown coloured urine. Leukocytes = 159 G/L; haematopoietic 97 G/L; polymorphic bacterial flora $g10^3 CFU/mL. On 29Jul2021: irreversible cardiorespiratory arrest and death. The action taken in response to the events for all the suspect drugs was not applicable. The outcome of events cardiac decompensation and Cardio-respiratory arrest was fatal, of the other events was unknown. The patient died on 29Jul2021. It was not reported if an autopsy was performed. The lot number for BNT162b2 was not provided and will be requested during follow up; Reported Cause(s) of Death: Cardio-respiratory arrest; cardiac decompensation


VAERS ID: 1687011 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-08-13
   Days after vaccination:183
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19, Cardio-respiratory arrest, Drug ineffective, General physical health deterioration, Hyperthermia, Rhinitis, Rhonchi, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Accidents and injuries (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-20
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arteriopathy (of the lower limbs, obliterating); Arteritis (lower limb); Cognitive disorders; Deep vein thrombosis (chronic); Dementia; Dyslipidemia; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Date: 20210813; Test Name: body temperature; Result Unstructured Data: Test Result:38.5 Centigrade; Test Date: 20210813; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101156031

Write-up: cardio respiratory arrest leading to death; rhinitis; hyperthermia at 38.5; deterioration of general condition; rhonchi; Drug ineffective; COVID-19; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority, regulatory authority number FR-AFSSAPS-TO20217469. A 92-year-old female patient received second dose of bnt162b2 (COMIRNATY, Batch/Lot Number: EJ6788), Solution for injection, intramuscular, administered in Arm Left on 11Feb2021 as single dose for covid-19 immunisation. Medical history included obliterating arteriopathy of the lower limbs, lower limb arteritis, dementia, dyslipidemia, hypertension arterial, cognitive disorders and chronic deep vein thrombosis. The patient''s concomitant medications were not reported. On 13Aug2021, the patient experienced vaccination failure, covid-19, cardiorespiratory arrest leading to death, rhinitis, hyperthermia at 38.5, deterioration of general condition and rhonchi. The patient underwent lab tests and procedures which included body temperature: 38.5 centigrade on 13Aug2021, sars-cov-2 test: positive on 13Aug2021. The patient died on 20Aug2021. An autopsy was not performed. The outcome of drug ineffective, COVID-19 and cardio respiratory arrest leading to death was fatal and outcome of all other events was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19 pneumonitis


VAERS ID: 1687031 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-05-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA8016 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal growth restriction, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101152931

Write-up: Maternal exposure during pregnancy, first trimester; hypotrophic embryo; This is a spontaneous report from a contactable physician. This is the second of two reports. The first report is a report downloaded from the Regulatory Authority-WEB FR-AFSSAPS-PC20213053. This physician reported information for both mother and fetus. This is a fetus report. A fetus patient of an unspecified gender received bnt162b2 (COMIRNATY), dose 1 transplacental on 24May2021 (Lot Number: FA8016) as dose 1, single for covid-19 immunisation. The fetus medical history and concomitant medications were not reported. The fetus experienced hypotrophic embryo on an unspecified date , maternal exposure during pregnancy, first trimester on 24May2021. It was reported that a 36-year-old mother received first dose bnt162b2 (COMIRNATY) Intramuscular on 24May2021 at her 36-year-old in the left arm, her last period date was 25Apr2021. The mother is at 4 weeks of gestation when taking the vaccine. On 26Jun2021: Days + 34: spontaneous miscarriage without history, with hypotrophic embryo. The mother was taking medication for a voluntary termination of pregnancy. Evolution was healing without sequelae. In total: Spontaneous miscarriage at months + 1 of the Dose1 of the vaccine. Healing. The fetus died on an unspecified date. It was not reported if an autopsy was performed. Outcome of hypotrophic embryo was fatal.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101108010 mother; Reported Cause(s) of Death: hypotrophic embryo


VAERS ID: 1687045 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-10
Onset:2021-08-15
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (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: GBPFIZER INC202101118582

Write-up: Cardiac death; This is a spontaneous report from a contactable other Health care professional. This is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-APPCOVID-20210824094928. Safety Report Unique Identifier is GB-MHRA-ADR 25860276. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number & Expiry date not reported) via an unspecified route of administration on 10Aug2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. Patient is not enrolled in clinical trial.On 15Aug2021 (5days after vaccination) the patient experienced cardiac death. The Outcome of event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Cardiac death


VAERS ID: 1687740 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-18
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Medication errors (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-11
   Days after onset: 24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: COVID test; Test Result: Positive
CDC Split Type: GBPFIZER INC202101126141

Write-up: died from COVID/positive for COVID; died from COVID/positive for COVID; received BNT162B2 dose 1 on 14May2021 and dose 2 on 12Jul2021; This is a spontaneous report from a contactable consumer (parent) via Pfizer. A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jul2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Historical vaccine information included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14May2021 as dose 1, single for COVID-19 immunisation. The reporter stated, "Our son who was 39 years old, fit and healthy, died from COVID on 11Aug2021. He had his first pfizer vaccine on 14May2021 and his 2nd on the 12Jul2021. He tested positive for COVID on 18Jul2021, was admitted to hospital on 24Jul2021, but despite every effort he died. There appeared to be no protection whatsoever from his vaccines. We are devastated and we really need an answer to this - we hope you can help". The patient received BNT162B2 dose 1 on 14May2021 and dose 2 on 12Jul2021. The patient was hospitalized for COVID from 24Jul2021 to an unknown date. The patient underwent lab tests and procedures which included COVID test: positive on 18Jul2021. The patient died on 11Aug2021. It was unknown if an autopsy was performed. The lot number for [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: died from COVID; died from COVID


VAERS ID: 1687765 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-20
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Congenital anomaly
SMQs:, Congenital, familial and genetic disorders (narrow)

Life Threatening? No
Birth Defect? Yes
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: GBPFIZER INC202101152690

Write-up: Congenital anomaly; This is a spontaneous report from a contactable consumer (parent) received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108251046184020-KSCHI. Safety Report Unique Identifier GB-MHRA-ADR 25846459. This is the second of two reports (Baby). A patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FE3380) via an unspecified route of administration on 20Aug2021 as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced congenital anomaly (death, medically significant, congenital anomaly) on an unspecified date, It was not reported if an autopsy was performed. Clinical course: Patient'' mother found out she was around 6 weeks pregnant a couple of days after the vaccine, and then started to experience the symptoms of a miscarriage around 3 days later. She went to a&e yesterday and they confirmed it was a probable miscarriage and she has to return next week for a scan. She would not have had the vaccine if she had known she was pregnant. Patient''s mother has not tested positive for COVID-19 since having the vaccine. Patient''s mother is not enrolled in clinical trial. She had a miscarriage 3-4 days after. She did not take folic acid supplement during pregnancy. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101111379 Mother/baby case; Reported Cause(s) of Death: Congenital anomaly


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