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From the 11/19/2021 release of VAERS data:

Found 19,249 cases where Vaccine is COVID19 and Patient Died

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Case Details

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VAERS ID: 1690828 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-08-29
   Days after vaccination:59
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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: 2021-08-29
   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: Medical History/Concurrent Conditions: Cardiac failure; Dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101134072

Write-up: Cardiac arrest; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21125305. The patient was an 83-year-old female. Body temperature before vaccination was unknown. The family history was not provided. The patient had medical histories of cardiac failure and dementia. On an unspecified date in 2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# not reported, Expiration date not reported) for COVID-19 immunisation. On an unspecified date in Jul2021 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration as a single dose for COVID-19 immunization.Age at vaccination 83 years. On 29Aug2021 (unknown days after vaccination), at 04:00, the patient''s breathing was abnormal. At 05:00, no response was obtained. An ambulance was requested. At 05:26, the patient was confirmed to have cardiac arrest. At 05:45, the patient was transferred to the reporting hospital. At 07:11, the patient was confirmed to die and discharged from the hospital. It was unknown if autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. It was not reported that there was other possible cause of the event such as any other diseases. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1690829 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Decreased appetite
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: Lung cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101134118

Write-up: Death after appetite impaired; This is a spontaneous report from a contactable physician via a Pfizer company representative. An 80-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 number unknown, single for COVID-19 immunisation. Age at vaccination :80 years.Medical history included prior lung cancer. The patient''s concomitant medications were not reported. On an unknown date (unknown day(s) after the vaccination), the patient experienced appetite impaired. On an unknown date (unknown day(s) after the vaccination), the patient died after appetite impaired. The reporting physician classified the event as serious (death) and assessment for causality was not reported. It was not reported if an autopsy was performed. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender''s Comments: As there is limited information in the case provided, the causal association between the event appetite impaired 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: Appetite impaired


VAERS ID: 1690830 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Decreased appetite
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: Pancreatic carcinoma
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101134142

Write-up: Death after appetite impaired; This is a spontaneous report from a contactable physician . An 80-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 number unknown, single for covid-19 immunisation. Medical history included pancreatic carcinoma . The patient''s concomitant medications were not reported. On an unknown date (unknown day(s) after the vaccination), the patient experienced appetite impaired. On an unknown date (unknown day(s) after the vaccination), the patient died after appetite impaired. The outcome of the event was death. The reporting physician classified the event as serious (death) and assessed that the event was definitely related to BNT162b2. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of appetite impaired.. 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: Appetite impaired


VAERS ID: 1690831 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Herpes zoster
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101134153

Write-up: Herpes zoster; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. The patient was a male. The patient''s age was not provided. The family history was not provided. The medical history was unknown. On unknown date in 2021 (the day of vaccination), the patient received a dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration as a unknown, single for COVID-19 immunization. On unknown date in 2021 (unknown days/hours/minutes after the vaccination), the patient experienced herpes zoster. On unknown date in 2021 (unknown days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: After the vaccination, the patient experienced herpes zoster, and then, he died. Lot number was unknown. The causality between the event and BNT162b2 was not provided. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: herpes zoster


VAERS ID: 1690833 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-29
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3622 / 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: 2021-08-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TEGRETOL; HYPEN [ETODOLAC]; CERCINE; LOXONIN; MAGNESIUM OXIDE; ARTANE [TRIHEXYPHENIDYL HYDROCHLORIDE]; TOKISHAKUYAKUSAN [ALISMA ORIENTALE TUBER;ANGELICA ACUTILOBA ROOT;ATRACTYLODES LANCEA RHIZOME;CNIDIUM
Current Illness: Living in residential institution
Preexisting Conditions: Medical History/Concurrent Conditions: Brain tumour; Cerebral palsy (The patient was born with cerebral palsy); Coronavirus infection; Dystonia
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101146117

Write-up: Myocardial infarction; This is a spontaneous case from a contactable pharmacist received via a Pfizer sales representative. A 63-year-old female patient received the second dose of BNT162B2 (COMIRNATY; lot number FF3622, Expiration date 30Nov2021) on 25Aug2021, at 0.3 ml single, for COVID-19 immunisation. The patient had medical histories of cerebral palsy, brain tumour, generalized dystonia, and coronavirus infection in Jan2021. Concomitant medications included carbamazepine (TEGRETOL, Tablet) oral, etodolac (HYPEN, Tablet) oral, diazepam (CERCINE, Tablet) oral, loxoprofen sodium hydrate (LOXONIN, Tablet) oral, magnesium oxide oral, trihexyphenidyl hydrochloride (ARTANE, Tablet) oral, and alisma orientale tuber, angelica acutiloba root, atractylodes lancea rhizome, cnidium officinale rhizome, paeonia lactiflora root, poria cocos sclerotium (TOKISHAKUYAKUSAN [ALISMA ORIENTALE TUBER;ANGELICA ACUTILOBA ROOT;ATRACTYLODES LANCEA RHIZOME;CNIDIUM OFFICINALE RHIZOME;PAEONIA LACTIFLORA ROOT;PORIA COCOS SCLEROTIUM], Granules) oral. On 04Aug2021, the patient previously received the first dose of COMIRNATY (Lot# FC8736, Expiration date 30Sep2021), at 0.3 ml. On 25Aug2021 (the day of vaccination), the patient received the second dose of COMIRNATY (Lot number FF3622, Expiration date 30Nov2021) at 0.3 ml single, for COVID-19 immunization. On 29Aug2021 (4 days after the vaccination), the patient experienced myocardial infarction. On 29Aug2021 (4 days after the vaccination), the outcome of the event was fatal. Cause of death was myocardial infarction. It was not reported if an autopsy was performed. The course of the event was as follows: The patient was born with cerebral palsy and was residing in a facility. In the morning at the facility, her caregiver noticed that she was wrong and called an ambulance, but it was too late when the ambulance arrived. In Jan2021, the patient had medical history of Coronavirus infection. The causality between the event and BNT162b2 was not provided.; Sender''s Comments: Based on available information and the close drug event temporal association, a possible contributory role of suspect product BNT162B2 to the development of event myocardial infarction cannot be totally excluded. Preexisting patient medical history also considered as possible contributors. 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 RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Myocardial infarction


VAERS ID: 1690914 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-05-25
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3599 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Acute kidney injury, Alanine aminotransferase, Altered state of consciousness, Ammonia, Blood alkaline phosphatase, Blood bilirubin, Blood calcium, Blood chloride, Blood creatinine, Blood culture, Blood magnesium, Blood osmolarity, Blood phosphorus, Blood potassium, Blood pressure measurement, Blood sodium, Blood urea, C-reactive protein, COVID-19, Carcinoembryonic antigen, Cardiac failure, Chest X-ray, Computerised tomogram, Culture urine, Dyspnoea, Gamma-glutamyltransferase, Glomerular filtration rate, Granulocyte count, Haematocrit, Haemoglobin, Hepatorenal syndrome, Hypoxia, International normalised ratio, Investigation, Jaundice, Lymphocyte count, Malignant neoplasm progression, Mean cell haemoglobin, Mean cell volume, Metastases to liver, Neutrophil count, Oxygen saturation, Platelet count, Prothrombin time, Red blood cell count, Red cell distribution width, Renal failure, Respiratory failure, Reticulocyte count, SARS-CoV-2 test, Sepsis, Tachypnoea, Urine output, Vaccination failure, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Cholestasis and jaundice of hepatic origin (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Malignancy related conditions (narrow), Acute central respiratory depression (narrow), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Non-haematological malignant tumours (narrow), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-23
   Days after onset: 59
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: LEVOTHYROXINE; ATENOLOL; NEXIUM [ESOMEPRAZOLE MAGNESIUM]; AMIROL; ATORVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breast ductal carcinoma; Depression; Dyslipidaemia; Hypertension; Hypothyroidism; Metastasis; Non-smoker; Total knee replacement
Allergies:
Diagnostic Lab Data: Test Date: 20210722; Test Name: APTT; Test Result: 124.1 s; Test Date: 20210722; Test Name: APTT ratio; Result Unstructured Data: Test Result:4.98; Test Date: 20210706; Test Name: ALT; Result Unstructured Data: Test Result:74 IU/l; Test Date: 20210714; Test Name: ALT; Result Unstructured Data: Test Result:82 IU/l; Test Date: 20210722; Test Name: ALT; Result Unstructured Data: Test Result:109 IU/l; Test Date: 20210722; Test Name: ammonia; Result Unstructured Data: Test Result:82 IU/l; Test Date: 20210706; Test Name: alkaline phosphatase; Result Unstructured Data: Test Result:837 IU/l; Test Date: 20210714; Test Name: alkaline phosphatase; Result Unstructured Data: Test Result:831 IU/l; Test Date: 20210722; Test Name: alkaline phosphatase; Result Unstructured Data: Test Result:1041 IU/l; Test Date: 20210706; Test Name: bilirubin; Result Unstructured Data: Test Result:27.9 umol/l; Test Date: 20210714; Test Name: bilirubin; Result Unstructured Data: Test Result:40.8 umol/l; Test Date: 20210722; Test Name: bilirubin; Result Unstructured Data: Test Result:65.8 umol/l; Test Date: 20210706; Test Name: calcium serum; Result Unstructured Data: Test Result:2.62 mmol/L; Test Date: 20210706; Test Name: chloride (serum); Result Unstructured Data: Test Result:108.5 mmol/L; Test Date: 20210706; Test Name: creatinine; Result Unstructured Data: Test Result:114 umol/l; Test Date: 20210714; Test Name: creatinine; Result Unstructured Data: Test Result:191 umol/l; Test Date: 20210722; Test Name: creatinine; Result Unstructured Data: Test Result:913 umol/l; Test Date: 20210722; Test Name: Blood cultures; Result Unstructured Data: Test Result:No bacteria cultivated; Test Date: 20210722; Test Name: serum magnesium; Result Unstructured Data: Test Result:1.22 mmol/L; Test Date: 20210722; Test Name: osmolality calculated; Result Unstructured Data: Test Result:306 mosm/kg; Test Date: 20210722; Test Name: serum phosphate; Result Unstructured Data: Test Result:2.14 mmol/L; Test Date: 20210722; Test Name: serum potassium; Result Unstructured Data: Test Result:7.25 mmol/L; Test Date: 20210722; Test Name: blood pressure; Result Unstructured Data: Test Result:85/40; Test Date: 20210722; Test Name: blood pressure; Result Unstructured Data: Test Result:79/60; Test Date: 20210722; Test Name: serum sodium; Result Unstructured Data: Test Result:133 mmol/L; Test Date: 20210714; Test Name: urea serum; Result Unstructured Data: Test Result:10.1 mmol/L; Test Date: 20210722; Test Name: urea serum; Result Unstructured Data: Test Result:35.6 mmol/L; Test Date: 20210706; Test Name: CEA; Result Unstructured Data: Test Result:40.7 ng/ml; Test Date: 20210714; Test Name: CEA; Result Unstructured Data: Test Result:46.3 ng/ml; Test Date: 20210722; Test Name: chest X-Ray; Result Unstructured Data: Test Result:Lungs are mildly congested; Test Date: 20210525; Test Name: CT scan; Result Unstructured Data: Test Result:mild progression of liver metastasis; Test Date: 20210722; Test Name: C-reactive protein; Result Unstructured Data: Test Result:316.3 mg/l; Test Date: 20210722; Test Name: urine culture; Result Unstructured Data: Test Result:No bacteria cultivated; Test Date: 20210706; Test Name: gamma glutamyl transferase; Result Unstructured Data: Test Result:1073 IU/l; Test Date: 20210714; Test Name: gamma glutamyl transferase; Result Unstructured Data: Test Result:898 IU/l; Test Date: 20210722; Test Name: gamma glutamyl transferase; Result Unstructured Data: Test Result:470 IU/l; Test Date: 20210706; Test Name: EGFR; Result Unstructured Data: Test Result:43; Test Date: 20210714; Test Name: EGFR; Result Unstructured Data: Test Result:24; Test Date: 20210722; Test Name: EGFR; Result Unstructured Data: Test Result:4; Test Date: 20210706; Test Name: immature granulocytes; Result Unstructured Data: Test Result:0.25 x10 9/l; Test Date: 20210714; Test Name: immature granulocytes; Result Unstructured Data: Test Result:0.27 x10 9/l; Test Date: 20210722; Test Name: immature granulocytes; Result Unstructured Data: Test Result:0.34 x10 9/l; Test Date: 20210706; Test Name: haematocrit; Test Result: 26.2 %; Test Date: 20210714; Test Name: haematocrit; Test Result: 25.9 %; Test Date: 20210722; Test Name: haematocrit; Test Result: 26.1 %; Test Date: 20210706; Test Name: haemoglobin; Result Unstructured Data: Test Result:8.7 g/dl; Test Date: 20210714; Test Name: haemoglobin; Result Unstructured Data: Test Result:8.4 g/dl; Test Date: 20210722; Test Name: haemoglobin; Result Unstructured Data: Test Result:8.5 g/dl; Test Date: 20210722; Test Name: INR; Result Unstructured Data: Test Result:1.54; Test Date: 20210706; Test Name: nucleated red blood cells; Result Unstructured Data: Test Result:0.07 x10 9/l; Test Date: 20210714; Test Name: nucleated red blood cells; Result Unstructured Data: Test Result:0.13 x10 9/l; Test Date: 20210722; Test Name: nucleated red blood cells; Result Unstructured Data: Test Result:0.46 x10 9/l; Test Date: 20210706; Test Name: lymphocytes; Result Unstructured Data: Test Result:0.57 x10 9/l; Test Date: 20210714; Test Name: lymphocytes; Result Unstructured Data: Test Result:0.96 x10 9/l; Test Date: 20210722; Test Name: lymphocytes; Result Unstructured Data: Test Result:0.76 x10 9/l; Test Date: 20210706; Test Name: mean cell haemoglobin; Test Result: 36.6 pg; Test Date: 20210714; Test Name: mean cell haemoglobin; Test Result: 35.3 pg; Test Date: 20210722; Test Name: mean cell haemoglobin; Test Result: 34.4 pg; Test Date: 20210706; Test Name: mean cell volume; Result Unstructured Data: Test Result:110.1; Test Date: 20210714; Test Name: mean cell volume; Result Unstructured Data: Test Result:108.8; Test Date: 20210722; Test Name: mean cell volume; Result Unstructured Data: Test Result:105.7; Test Date: 20210722; Test Name: neutrophils; Result Unstructured Data: Test Result:8.32 x10 9/l; Test Date: 20210722; Test Name: SpO2; Test Result: 96 %; Comments: on RA improved to 99% on NFM; Test Date: 20210722; Test Name: SpO2; Result Unstructured Data: Test Result:less than 90 on RA %; Test Date: 20210706; Test Name: platelets; Result Unstructured Data: Test Result:138 x10 9/l; Test Date: 20210722; Test Name: platelets; Result Unstructured Data: Test Result:105 x10 9/l; Test Date: 20210722; Test Name: PT; Test Result: 15.6 s; Test Date: 20210706; Test Name: red cell count; Result Unstructured Data: Test Result:2.38 x10 12/l; Test Date: 20210714; Test Name: red cell count; Result Unstructured Data: Test Result:2.38 x10 12/l; Test Date: 20210722; Test Name: red cell count; Result Unstructured Data: Test Result:2.47 x10 12/l; Test Date: 20210706; Test Name: red cell distribution width; Test Result: 18.1 %; Test Date: 20210714; Test Name: red cell distribution width; Test Result: 18.7 %; Test Date: 20210722; Test Name: red cell distribution width; Test Result: 19.7 %; Test Date: 20210706; Test Name: reticulocytes; Result Unstructured Data: Test Result:79.70 x10 9/l; Test Date: 20210722; Test Name: reticulocytes; Result Unstructured Data: Test Result:73.40 x10 9/l; Test Date: 20210706; Test Name: reticulocytes; Test Result: 29.7 pg; Test Date: 20210722; Test Name: reticulocytes; Test Result: 73.4 pg; Test Date: 20210708; Test Name: sars-cov-2 test; Result Unstructured Data: Test Result:not detected; Test Date: 20210717; Test Name: sars-cov-2 test; Test Result: Positive ; Comments: new infection, CT 30 detected; Test Date: 20210722; Test Name: sars-cov-2 test; Test Result: Negative ; Comments: not detected; Test Date: 20210722; Test Name: urine output; Result Unstructured Data: Test Result:low; Test Date: 20210706; Test Name: WBC; Result Unstructured Data: Test Result:4.01 x10 9/l; Test Date: 20210722; Test Name: WBC; Result Unstructured Data: Test Result:9.99 x10 9/l
CDC Split Type: MTPFIZER INC202101158854

Write-up: Jaundice (Bilirubin 65.8); Acute kidney injury (Creatinine 191 to 913); covid-19; covid-19; mild progression of liver metastasis; mild progression of liver metastasis; Respiratory failure; Heart failure; Renal failure; Altered consciousness; Hepatorenal syndrome; sepsis; dyspnea; tachypnea; hypoxemia; This is a spontaneous report from a contactable physician. A 73-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 04May2021 (Lot Number: EX3599) as single dose, dose 1 intramuscular on 05Apr2021 (Lot Number: ET7205) as single dose for covid-19 immunisation. Medical history included hypertension, invasive Rt breast ductal carcinoma with bone and liver metastasis from 2016, dyslipidaemia, hypothyroid, depression, left total knee replacement from 2017 to an unknown date, non-smoker. Concomitant medications included levothyroxine; atenolol; esomeprazole magnesium (NEXIUM); amitriptyline hydrochloride (AMIROL); atorvastatin. The patient experienced covid-19 in Jul2021, dyspnea in 2021, tachypnea in 2021, hypoxemia in 2021, respiratory failure in 2021, heart failure in 2021, jaundice (bilirubin 65.8) on 22Jul2021, acute kidney injury (creatinine 191 to 913) on 22Jul2021, renal failure in 2021, altered consciousness in 2021, hepatorenal syndrome in 2021, sepsis in 2021, mild progression of liver metastasis on 25May2021. The patient was hospitalized for all events from 22Jul2021 to an unknown date. The patient did not have SARS-CoV2 antibodies at diagnosis. Patient admitted on the 22Jul2021 and died in hospital on the 23Jul2021 (1 day hospitalization). The patient was not admitted to an Intensive Care Unit. No autopsy was performed. The patient required supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation: Non rebreather 15L/min. The events required the initiation of new medication or other treatment or procedure that included Morphine pump with metoclopramide. It took 5 days from the SARS-CoV2 diagnosis before the SARS-CoV2 antigen test became negative (Covid test - positive on 17/07/2021; Covid test - negative on 22/07/2021). The patient has not been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. The patient died on 23Jul2021. No autopsy was performed. Primary cause of death: Hepatorenal syndrome as a consequence of sepsis as a consequence of metastatic invasive ductal carcinoma of the breast. Other significant contributory causes: COVID-19 infection. The patient underwent lab tests and procedures which included: 25May2021: CT Scan showed mild progression of liver metastasis; 06Jul2021: WBC 4.01 [4.30 - 11.40x10^9/L], Immature granulocytes 0.25 [0.0-0.09x10^9/L], lymphocytes 0.57 [1.30 - 3.60x10^9/L], red cell count 2.38 [3.90 - 5.40x10^12/L], nucleated red blood cells 0.07 [0.0-0.01x10^9/L], haemoglobin 8.7 [12-15.5 g/dl], haematocrit 26.2 [35.6 - 46%], mean cell volume 110.1 [79-97 fL], mean cell haemoglobin 36.6 [27-32 pg], red cell distribution width 18.1 [11.9-14.6%], platelets 138 [142-349x10^9/L], reticulocytes 29.7 [27.1-35.2 pg], CEA 40.7 [0-2.5 ng/ml], creatinine (serum) 114 [45-84 umol/l], chloride (serum) 108.5 [98-107 mmol/l], bilirubin (serum) 27.9 [0-21 micromole/l], alkaline phosphatase (serum) 837 [40-104 Iu/L], gamma glutamyl transferase (serum) 1073 [5-36 IU/l], ALT (serum) 74 [5-33IU/l], calcium (serum) 2.62 [2.15-2.55 mmol/l], EGFR: 43, reticulocytes 79.70 [20 - 65x10^9/L]; 08Jul2021: sars-cov-2 test: not detected; 14Jul2021: Immature granulocytes 0.27 [0.0-0.09x10^9/L], lymphocytes 0.96 [1.30 - 3.60x10^9/L], red cell count 2.38 [3.90 - 5.40x10^12/L], nucleated red blood cells 0.13 [0.0-0.01x10^9/L], haemoglobin 8.4 [12-15.5 g/dl], haematocrit 25.9 [35.6 - 46%], mean cell volume 108.8 [79-97 fL], mean cell haemoglobin 35.3 [27-32 pg], red cell distribution width 18.7 [11.9-14.6%], CEA 46.3 [0-2.5 ng/ml], creatinine (serum) 191 [45-84 umol/l], urea (serum) 10.1 [1.7-8.3 mmol/l], bilirubin (serum) 40.8 [0-21 micromole/l], alkaline phosphatase (serum) 831 [40-104 IU/L], gamma glutamyl transferase (serum) 898 [5-36 IU/l], ALT (serum) 82 [5-33IU/l], EGFR:24; 17Jul2021: sars-cov-2 test: positive new infection, CT 30 detected; 22Jul2021: BP on admission 85/40, later 79/60. On admission, SpO2 96% RA improved to 99% on NFM. Later SpO2 fell to less than 90% on RA. Low urine output, sars-cov-2 test: negative (not detected), chest x-ray: lungs are mildly congested, Immature granulocytes 0.34 [0.0-0.09x10^9/L], lymphocytes 0.76 [1.30 - 3.60x10^9/L], red cell count 2.47 [3.90 - 5.40x10^12/L], nucleated red blood cells 0.46 [0.0-0.01x10^9/L], haemoglobin 8.5 [12-15.5 g/dl], haematocrit 26.1 [35.6 - 46%], mean cell volume 105.7 [79-97 fL], mean cell haemoglobin 34.4 [27-32 pg], neutrophils 8.32 [1.90-7.70x10^9/L], red cell distribution width 19.7 [11.9-14.6%], platelets 105 [142-349x10^9/L], reticulocytes 73.40 [27.1-35.2 pg], APTT (Sec) 124.1 [23.1-27.7 sec], APTT ratio 4.98 [0.91-1.09 ratio], prothrombin time 15.6 [9.96-11.24 sec], INR 1.54 [0.94-1.06 ratio], creatinine (serum) 913 [45-84 umol/l], urea (serum) 35.6 [1.7-8.3 mmol/l], sodium (serum) 133 [136-145 mmol/l], potassium (serum) 7.25 [3.5-5.1 mmol/l], c-reactive protein 316.3 [0-5 mg/l], phosphate (serum) 2.14 [0.87-1.45 mmol/l], magnesium 1.22 [0.65-1.05 mmol/l], bilirubin (serum) 65.8 [0-21 micromole/l], alkaline phosphatase (serum) 1041 [40-104 IU/L], gamma glutamyl transferase (serum) 470 [5-36 IU/l], ALT (serum) 109 [5-33IU/l], osmolality calculated 306 [275 - 299 mOsm/kg], ammonia 82 [7-55 IU/l], Blood cultures and urine culture: No bacteria cultivated, EGFR:4, reticulocytes 79.40 [20 - 65x10^9/L], WBC 9.99 [4.30 - 11.40x10^9/L]. Outcome of all events was fatal. No follow-up attempts are possible; No further information is expected.; Sender''s Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to vaccination failure cannot be ruled out. The fatal events of dyspnoea, tachypnoea, hypoxemia, respiratory failure, heart failure, jaundice, acute kidney injury, renal failure, altered state of consciousness, hepatorenal syndrome, sepsis, liver metastasis and malignant neoplasm progression are a consequence of underlying metastatic invasive ductal carcinoma of breast. 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: mild progression of liver metastasis; Altered consciousness; Renal failure; Acute kidney injury (Creatinine 191 to 913); Jaundice (Bilirubin 65.8); Heart failure; Respiratory failure; hypoxemia; tachypnea; dyspnea; covid-19; covid-19; Hepatorenal syn


VAERS ID: 1690915 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-08
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW9127 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Blood alkaline phosphatase, Blood chloride, Blood creatinine, Blood sodium, Blood urea, Body temperature, C-reactive protein, COVID-19, COVID-19 pneumonia, Cardiac failure, Cardiac failure congestive, Chest X-ray, Condition aggravated, Dyspnoea, Fibrin D dimer, Gamma-glutamyltransferase, Glomerular filtration rate, Granulocyte count, Haematocrit, Haemoglobin, Hypoxia, Investigation, Lymphocyte count, Monocyte count, Neutrophil count, Oxygen saturation, Procalcitonin, Red blood cell count, Red cell distribution width, Renal failure, Respiratory failure, Respiratory rate, SARS-CoV-2 test, Tachypnoea, Troponin T, Vaccination failure, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-08
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: BURINEX; ONE ALPHA; FOLIC ACID; ATORVASTATIN; ATROVENT; BUDESONIDE; ELTROXIN; MIXTARD [INSULIN;ISOPHANE INSULIN]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic heart failure; Chronic kidney disease; Chronic obstructive pulmonary disease (on Long-term oxygen therapy); Diabetes; Ex-smoker (Up to 100 cigarettes daily for many years); Hypertension; Hypothyroidism; Obesity; Obstructive sleep apnea syndrome (on Long-term oxygen therapy)
Allergies:
Diagnostic Lab Data: Test Date: 20210804; Test Name: alkaline phosphatase; Result Unstructured Data: Test Result:108 IU/l; Test Date: 20210804; Test Name: serum chloride; Result Unstructured Data: Test Result:97.9 mmol/L; Test Date: 20210807; Test Name: serum chloride; Result Unstructured Data: Test Result:91.1 mmol/L; Test Date: 20210808; Test Name: serum chloride; Result Unstructured Data: Test Result:87.5 mmol/L; Test Date: 20210804; Test Name: Creatinine; Result Unstructured Data: Test Result:316 umol/l; Test Date: 20210807; Test Name: Creatinine; Result Unstructured Data: Test Result:390 umol/l; Test Date: 20210808; Test Name: Creatinine; Result Unstructured Data: Test Result:446 umol/l; Test Date: 20210807; Test Name: serum sodium; Result Unstructured Data: Test Result:130 mmol/L; Test Date: 20210808; Test Name: serum sodium; Result Unstructured Data: Test Result:128 mmol/L; Test Date: 20210804; Test Name: serum urea; Result Unstructured Data: Test Result:15 mmol/L; Test Date: 20210807; Test Name: serum urea; Result Unstructured Data: Test Result:18 mmol/L; Test Date: 20210808; Test Name: serum urea; Result Unstructured Data: Test Result:20.7 mmol/L; Test Date: 20210804; Test Name: body temperature; Result Unstructured Data: Test Result:37.7; Test Date: 20210804; Test Name: Chest X-Ray; Result Unstructured Data: Test Result:abnormal; Test Date: 20210806; Test Name: Chest X-Ray; Result Unstructured Data: Test Result:suggestive of COVID-19 pneumonia; Comments: suggestive of COVID-19 pneumonia on a background of lung congestion; Test Date: 20210804; Test Name: C-reactive protein; Result Unstructured Data: Test Result:69.2 mg/l; Test Date: 20210807; Test Name: C-reactive protein; Result Unstructured Data: Test Result:221 mg/l; Test Date: 20210808; Test Name: C-reactive protein; Result Unstructured Data: Test Result:273.1 mg/l; Test Date: 20210804; Test Name: D-Dimer; Result Unstructured Data: Test Result:891 ng/ml; Test Date: 20210807; Test Name: D-Dimer; Result Unstructured Data: Test Result:1731 ng/ml; Test Date: 20210808; Test Name: serum gamma glutamyl transferase; Result Unstructured Data: Test Result:39 IU/l; Test Date: 20210804; Test Name: EGFR; Result Unstructured Data: Test Result:13; Test Date: 20210807; Test Name: EGFR; Result Unstructured Data: Test Result:10; Test Date: 20210808; Test Name: EGFR; Result Unstructured Data: Test Result:9; Test Date: 20210804; Test Name: immature granulocytes; Result Unstructured Data: Test Result:0.21 x10 9/l; Test Date: 20210807; Test Name: immature granulocytes; Result Unstructured Data: Test Result:0.42 x10 9/l; Test Date: 20210808; Test Name: immature granulocytes; Result Unstructured Data: Test Result:0.87 x10 9/l; Test Date: 20210804; Test Name: haematocrit; Test Result: 31.6 %; Test Date: 20210807; Test Name: haematocrit; Test Result: 28 %; Test Date: 20210808; Test Name: haematocrit; Test Result: 30.7 %; Test Date: 20210804; Test Name: haemoglobin; Result Unstructured Data: Test Result:10.2 g/dl; Test Date: 20210807; Test Name: haemoglobin; Result Unstructured Data: Test Result:9.3 g/dl; Test Date: 20210808; Test Name: haemoglobin; Result Unstructured Data: Test Result:10 g/dl; Test Date: 20210805; Test Name: MSU for C/S; Result Unstructured Data: Test Result:No bacteria cultivated; Test Date: 20210804; Test Name: lymphocytes; Result Unstructured Data: Test Result:1.13 x10 9/l; Test Date: 20210807; Test Name: lymphocytes; Result Unstructured Data: Test Result:0.36 x10 9/l; Test Date: 20210808; Test Name: lymphocytes; Result Unstructured Data: Test Result:0.66 x10 9/l; Test Date: 20210807; Test Name: monocytes; Result Unstructured Data: Test Result:0.34 x10 9/l; Test Date: 20210804; Test Name: neutrophils; Result Unstructured Data: Test Result:6.93 x10 9/l; Test Date: 20210807; Test Name: neutrophils; Result Unstructured Data: Test Result:9.17 x10 9/l; Test Date: 20210808; Test Name: neutrophils; Result Unstructured Data: Test Result:14.68 x10 9/l; Test Date: 20210804; Test Name: SpO2; Test Result: 80 %; Comments: on RA; Test Date: 20210804; Test Name: Procalcitonin; Result Unstructured Data: Test Result:0.279 ng/ml; Test Date: 20210804; Test Name: red cell count; Result Unstructured Data: Test Result:3.67 x10 12/l; Test Date: 20210807; Test Name: red cell count; Result Unstructured Data: Test Result:3.42 x10 12/l; Test Date: 20210808; Test Name: red cell count; Result Unstructured Data: Test Result:3.65 x10 12/l; Test Date: 20210804; Test Name: red cell distribution width; Test Result: 15 %; Test Date: 20210807; Test Name: red cell distribution width; Test Result: 14.9 %; Test Date: 20210808; Test Name: red cell distribution width; Test Result: 14.9 %; Test Date: 20210804; Test Name: respiratory rate; Result Unstructured Data: Test Result:36; Test Date: 20210804; Test Name: Sars cov-2 RT-PCR; Result Unstructured Data: Test Result:positive; Comments: nasal swab, new infection, CT 23 detected; Test Date: 20210804; Test Name: troponin T; Result Unstructured Data: Test Result:45 ng/L; Test Date: 20210804; Test Name: WBC; Result Unstructured Data: Test Result:8.89 x10 9/l; Test Date: 20210807; Test Name: WBC; Result Unstructured Data: Test Result:10.31 x10 9/l; Test Date: 20210808; Test Name: WBC; Result Unstructured Data: Test Result:17.13 x10 9/l
CDC Split Type: MTPFIZER INC202101158879

Write-up: covid-19; covid-19; dyspnea; tachypnea; hypoxemia; COVID-pneumonia; Respiratory failure; Heart failure; Acute kidney injury; renal failure; Infective exacerbation of congestive heart failure; Heart failure/renal failure/Chronic Kidney Disease and Chronic Heart Failure worsened during the SARS-CoV2 infection; This is a spontaneous report from a contactable physician. A 71-year-old female patient received bnt162b2 (COMIRNATY), dose 2 (Lot Number: EW9127) intramuscular, administered in arm Left on 08Apr2021, dose 1 (Lot Number: ER7812) intramuscular on 18Mar2021, both as single dose for covid-19 immunisation. Relevant medical history included hypertension, diabetes, chronic heart failure, obstructive sleep apnea (on Long-term oxygen therapy), chronic obstructive pulmonary disease (on Long-term oxygen therapy), chronic kidney disease, obesity, hypothyroid, ex-smoker (up to 100 cigarettes daily for many years). Concomitant medications included bumetanide (BURINEX); alfacalcidol (ONE ALPHA); folic acid; atorvastatin; ipratropium bromide (ATROVENT); budesonide (BUDESONIDE); levothyroxine sodium (ELTROXIN); and insulin, isophane insulin (MIXTARD). The patient experienced covid-19, dyspnea, tachypnea, hypoxemia, covid-pneumonia, respiratory failure, heart failure, acute kidney injury, and renal failure on an unspecified date. The patient was hospitalized from 04Aug2021. The patient died on 08Aug2021. Died at hospital (Hospitalised for 4 days). It was unkown if an autopsy was performed. Primary cause of death: Infective exacerbation of congestive heart failure as a consequence of COVID pneumonia Contributory causes: Chronic obstructive pulmonary disease, Diabetes Mellitus, Chronic Kidney Disease, Hypothyroid, hypertension, obstructive sleep apnoea. The patient was not admitted to the ICU. The patient required supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation. Therapeutic interventions included treatment with corticosteroids on 08Aug2021. Chronic Kidney Disease and Chronic Heart Failure worsened during the SARS-CoV2 infection. The patient has not been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. The patient underwent lab tests and procedures which included: 04Aug2021: On admission, temp 37.7, RR 36, SpO2 80% on RA, Sars cov-2 RT-PCR: positive nasal swab, new infection, CT 23 detected, chest x-ray: abnormal, WBC 8.89 [4.30 - 11.40x10^9/L], neutrophils 6.93 [1.90 - 7.70x10^9/L], lymphocytes 1.13 [1.30 - 3.60x10^9/L], immature granulocytes 0.21 [0.00 - 0.09x10^9/L], red cell count 3.67 [3.90 - 5.40 x10^12/L], haemoglobin 10.2 [12-15.5 g/dl], haematocrit 31.6 [35.6 - 46.0 %], red cell distribution width 15 [11.9 - 14.6%], D-Dimer 891 [0-500 ng/ml], Procalcitonin 0.279 [0.02 - 0.046 ng/ml], serum urea 15 [1.7 - 8.3 mmol/l], serum creatinine 316 [45-84 umol/l], serum chloride 97.9 [98-107 mmol/l], c-reactive protein 69.2 [0-5 mg/l], alkaline phosphatase 108 [40-104 U/L], Troponin T 45 [3-14ng/L], EGFR: 13. 05Aug2021: MSU for C/S: no bacteria cultivated. 06Aug2021: chest x-ray: suggestive of COVID-19 pneumonia on a background of lung congestion. 07Aug2021: WBC 10.31 [4.30 - 11.40x10^9/L], neutrophils 9.17 [1.90 - 7.70x10^9/L], lymphocytes 0.36 [1.30 - 3.60x10^9/L], immature granulocytes 0.42 [0.00 - 0.09x10^9/L], red cell count 3.42 [3.90 - 5.40 x10^12/L], haemoglobin 9.3 [12-15.5 g/dl], haematocrit 28 [35.6 - 46.0 %], red cell distribution width 14.9 [11.9 - 14.6%], D-Dimer 1731 [0-500 ng/ml], monocytes 0.34 [0.40 - 1.10x10^9/L], serum urea 18 [1.7 - 8.3 mmol/l], serum creatinine 390 [45-84 umol/l], serum chloride 91.1 [98-107 mmol/l], c-reactive protein 221 [0-5 mg/l], serum sodium 130 [136-145 mmol/l], EGFR: 10. 08Aug2021: WBC 17.13 [4.30 - 11.40x10^9/L], , neutrophils 14.68 [1.90 - 7.70x10^9/L], lymphocytes 0.66 [1.30 - 3.60x10^9/L], immature granulocytes 0.87 [0.00 - 0.09x10^9/L], red cell count 3.65 [3.90 - 5.40 x10^12/L], haemoglobin 10 [12-15.5 g/dl], haematocrit 30.7 [35.6 - 46.0 %], red cell distribution width 14.9 [11.9 - 14.6%], serum urea 20.7 [1.7 - 8.3 mmol/l], serum creatinine 446 [45-84 umol/l], serum chloride 87.5 [98-107 mmol/l], c-reactive protein 273.1 [0-5 mg/l], serum sodium 128 [136-145 mmol/l], gamma glutamyl transferase (serum) 39 [5-36 IU/L], EGFR: 9. The outcome of events was fatal. Follow-up activities are completed. No further information is requested.; Sender''s Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to vaccination failure cannot be ruled out. The fatal events of dyspnoea, tachypnoea, hypoxemia, respiratory failure, heart failure, acute kidney injury, renal failure, congestive heart failure and condition aggravated are due to exacerbation of underlying chronic heart failure as a consequence of COVID pneumonia with COPD, Diabetes, chronic kidney disease, hypertension, hypothyroidism and obstructive sleep apnoea as contributory factors 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: Respiratory failure; Heart failure; Acute kidney injury; renal failure; Heart failure/renal failure/Chronic Kidney Disease and Chronic Heart Failure worsened during the SARS-CoV2 infection; covid-19; covid-19; dyspnea; tachypnea; hypoxemia; Infective


VAERS ID: 1690959 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002338 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Chills, Death, Fatigue, Headache, Injection site inflammation, Injection site reaction, Injection site swelling, Malaise, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: PROPYLTHIOURACIL
Current Illness: Immunosuppression
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210710; Test Name: Body temperature; Result Unstructured Data: 38.0 to 40.4 degrees Celsius
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: Death; This case was initially received via the Regulatory Authority (Reference number: NL-LRB-COVID-00578763) on 18-Jun-2021. The most recent information was received on 03-Sep-2021 and was forwarded to Moderna on 03-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death), MYALGIA and the first episode of PYREXIA in a 47-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 3003652 and 3002338) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Immunosuppression. Concomitant products included PROPYLTHIOURACIL from 01-Jan-2006 to an unknown date for an unknown indication. On 02-Jun-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 ml. On 09-Jul-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to .5 ml. On 03-Jun-2021, the patient experienced INJECTION SITE REACTION. On 09-Jul-2021, the patient experienced MYALGIA (seriousness criterion medically significant), MALAISE, the first episode of FATIGUE, HEADACHE and INJECTION SITE SWELLING. 09-Jul-2021, the patient experienced the first episode of PYREXIA (seriousness criterion medically significant) and the second episode of PYREXIA. 09-Jul-2021, the patient experienced INJECTION SITE INFLAMMATION. 09-Jul-2021, the patient experienced CHILLS. On 10-Jul-2021, the patient experienced ARTHRALGIA and the second episode of FATIGUE. On 05-Jun-2021, INJECTION SITE REACTION had resolved. On 10-Jul-2021, CHILLS had resolved. On 11-Jul-2021, ARTHRALGIA and the last episode of PYREXIA had resolved. On 12-Jul-2021, last episode of FATIGUE had resolved. The patient died on an unknown date. The cause of death was not reported. At the time of death, MYALGIA outcome was unknown and INJECTION SITE INFLAMMATION, MALAISE, HEADACHE and INJECTION SITE SWELLING had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jul-2021, Body temperature: 38-40.4 (High) 38.0 to 40.4 degrees Celsius. No treatment information was provided. Company comments: This case concerns a 47 year-old female patient with reported fatal event of Myalgia after receiving the second dose of the mRNA-1273 vaccine. Very limited information has been provided at this time. Myalgia was reported by the Regulatory authority with a fatal outcome, although based on SD it is unclear if this occurred. Outcome of Myalgia was updated as Unknown, and conservatively Death was captured as an event. For the rest of the events: 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. Pyrexia seriousness captured as per Regulatory Authority assessment in the Source Document. Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Follow-up received and case upgraded as serious and new events (Myalgia, Fatigue, Malaise, Headache, Injection site swelling and Pyrexia) added.; Sender''s Comments: This case concerns a 47 year-old female patient with reported fatal event of Myalgia after receiving the second dose of the mRNA-1273 vaccine. Very limited information has been provided at this time. Myalgia was reported by the Regulatory authority with a fatal outcome, although based on SD it is unclear if this occurred. Outcome of Myalgia was updated as Unknown, and conservatively Death was captured as an event. For the rest of the events: 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. Pyrexia seriousness captured as per Regulatory Authority assessment in the Source Document.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1690963 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-13
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal cardiac arrest, Foetal growth restriction, Maternal exposure during pregnancy, Ultrasound foetal
SMQs:, Congenital and neonatal arrhythmias (broad), 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: 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: Test Date: 202108; Test Name: Ultrasound; Result Unstructured Data: Test Result:the embryo appeared too small and; Comments: there was no heart beat
CDC Split Type: NLPFIZER INC202101182270

Write-up: Maternal Exposure During Pregnancy, first trimester; Heart stopped beating; Embryo too small; This is as spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB. The regulatory authority report number is NL-LRB-00672339. The consumer reported events for both mother and fetus. This is the fetus case. A fetus patient of an unspecified gender received BNT162B2 (COMIRNATY), via transplacental route on 13Aug2021 (Batch/Lot Number: Unknown) as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient''s mother previously received BNT162B2 (COMIRNATY) on 28Jun2021 (Lot# unknown) for COVID-19 immunisation. The patient experienced heart stopped beating (cardiac arrest) (death) in Aug2021, maternal exposure during pregnancy, first trimester on 13Aug2021. On an unspecified date in Aug2021, during the first vitality ultrasound around 7-8 weeks, the embryo appeared too small and there was no heart beat; classified as a missed abortion. The patient died on an unspecified date in Aug2021. It was unknown if autopsy was done. No follow-up attempts are possible. No further information is expected. Information on lot and batch numbers cannot be obtained.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101182271 Maternal case;NL-PFIZER INC-202101125600 Maternal master case; Reported Cause(s) of Death: Heart stopped beating


VAERS ID: 1690964 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal cardiac arrest, Maternal exposure during pregnancy, Ultrasound foetal
SMQs:, Congenital and neonatal arrhythmias (broad), 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: 2021-08-13
   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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210812; Test Name: Ultrasound; Result Unstructured Data: Test Result:Heartbeat visible
CDC Split Type: NLPFIZER INC202101182998

Write-up: Heart of the embryo stopped beating; First vaccination took place at a pregnancy duration of about 1 week; second vaccination on sixth week of pregnancy; This is a spontaneous report from a contactable consumer (patient''s mother). This is the third of three reports. The first report downloaded from the Regulatory Authority. Regulatory Authority Report Number: NL-LRB-00672883. This consumer reported events for the mother and the fetus. This is the fetus report. A 24-year-old mother received BNT162B2 (COMIRNATY; Strength: 0.3 mL, Lot Numbers were not reported), via unspecified routes of administration, on 06Jul2021, as dose 1, 0.3 mL, single, and then on 10Aug2021, as dose 2, 0.3 mL, single, for COVID-19 immunization. The mother''s medical history and concomitant medications were not reported. On 06Jul2021, the fetus of an unspecified gender experienced maternal exposure during pregnancy via transplacental route of administration. The first vaccination took place at a pregnancy duration of about 1 week. On 10Aug2021, the mother had her second vaccination (sixth week of pregnancy) and now two weeks later unfortunately the baby has no heartbeat and she ended up having a miscarriage. 2 days after the second vaccination (12Aug2021), there was a heartbeat visible at the ultrasound. The day after the ultrasound (13Aug2021), the mother started bleeding, which was still present at the moment of the report. On Friday (13Aug2021), the mother started losing blood after seeing a heartbeat on 12Aug2021. So far blood loss. On 13Aug2021, the heart of the embryo stopped beating and a miscarriage has occurred. The miscarriage occurred at a pregnancy duration of about 6 weeks. The outcome of the events was fatal. The patient died on 13Aug2021. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot or batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101125594 Maternal report; Reported Cause(s) of Death: Heart of the embryo stopped beating; First vaccination took place at a pregnancy duration of about 1 week; second vaccination on sixth week of pregnancy


VAERS ID: 1690980 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-19
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 212CZ1A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, 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: PHJNJFOC20210916180

Write-up: DIFFICULTY OF BREATHING; FEVER; COUGH; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300103687] concerned a 58 year old male. 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: 212CZ1A, expiry: UNKNOWN) dose was not reported, 1 total administered on 12-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-AUG-2021, at 22:00, the patient experienced fever and cough. On 25-AUG-2021, at 02:00, the patient experienced difficulty of breathing prior to admission. On an unspecified date, the patient died from fever, cough, and difficulty of 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: 20210916180-covid-19 vaccine ad26.cov2.s-fever, cough, 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; COUGH; DIFFICULTY OF BREATHING


VAERS ID: 1690981 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-19
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Malaise, 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: PHJNJFOC20210916283

Write-up: BODY MALAISE; DYSPNEA; UNDOCUMENTED FEVER; This spontaneous report received from a physician via a Regulatory Authority [PHIFDA, PH-PHFDA-300103664] concerned a 66 year old female 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, frequency time 1 total was administered on 10-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-AUG-2021 at 07:00 , the patient experienced body malaise, dyspnea, undocumented fever and died from the same on an unspecified date. 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: 20210916283-COVID-19 VACCINE AD26.COV2.S- Body malaise, Dyspnea, Undocumented fever. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.; Reported Cause(s) of Death: BODY MALAISE; DYSPNEA; UNDOCUMENTED FEVER


VAERS ID: 1690982 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-15
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 212C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210916324

Write-up: COUGH, COLDS, FEVER, COVID-19; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300103947] concerned a 38 year old female with 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 11-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-AUG-2021, the patient experienced cough, colds, fever, covid-19. On an unknown date in 2021, the patient died due to cough, colds, fever, covid-19. 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: V0:20210916324-covid-19 vaccine ad26.cov2.s- cough, colds, fever, covid-19. 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: COUGH, COLDS, FEVER, COVID-19


VAERS ID: 1690983 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-09
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain
SMQs:, Retroperitoneal fibrosis (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: PHJNJFOC20210916379

Write-up: LUMBAR PAIN; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300104275] concerned a 79 year old male of unspecified race and ethnicity. The patient''s weight, height, and medical history were not reported. No concurrent diseases were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose was not reported, 1 total, administered on 03-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 09-AUG-2021 at 18:00, the patient experienced lumbar pain. On an unspecified date and month in 2021, the patient died from lumbar pain. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lumbar pain was fatal. This report was serious (Death).; Sender''s Comments: V0:20210916379- covid-19 vaccine ad26.cov2.s-Lumbar Pain. 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: LUMBAR PAIN


VAERS ID: 1690984 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-09
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Body temperature, Eye inflammation, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Corneal disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-12
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210809; Test Name: Body temperature; Result Unstructured Data: 38 C
CDC Split Type: PHJNJFOC20210916404

Write-up: FEVER; INFLAMMATION OF THE EYES; BODY WEAKNESS; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA PH-PHFDA-300103493] concerned a 77 year old male 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, with frequency time 1 total administered on 30-JUL-2021 09:04 for prophylactic vaccination. No concomitant medications were reported. On 09-AUG-2021, the patient experienced fever at 14:00, and the temperature was 38 C. The patient took paracetamol for fever. On the same day at 14:00, patient also experienced inflammation of the eyes and body weakness. On 10-AUG-2021, there was negative fever, however had body weakness. On 12-AUG-2021, the patient died from probable cerebrovascular accident, fever, inflammation of the eyes, and body weakness. 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 fever, inflammation of the eyes and body weakness on 12-AUG-2021. This report was serious (Death).; Sender''s Comments: V0: 20210916404-Covid-19 vaccine ad26.cov2.s-Fever, inflammation of the eyes, and body weakness.. 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: PROBABLE CEREBROVASCULAR ACCIDENT; FEVER; INFLAMMATION OF THE EYES; BODY WEAKNESS


VAERS ID: 1690985 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / 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: PHJNJFOC20210916406

Write-up: DEATH; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300104050] concerned a 59 year old male, with unspecified race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: Unknown and expiry: unknown) dose was not reported, 1 total administered on 28-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case . No concomitant medications were reported. On an unspecified date, the patient died due to unknown cause. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine was not applicable. This report was serious (Death).; Sender''s Comments: V0:20210916406-JANSSEN COVID-19 VACCINE - Death-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: UNKNOWN CAUSE OF DEATH


VAERS ID: 1690986 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Sexual dysfunction (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: PHJNJFOC20210916524

Write-up: DIZZINESS; NUMBNESS OF RIGHT EXTREMITIES; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA PH-PHFDA-300103383] concerned a 61 year old male. 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, and expiry: UNKNOWN) dose was not reported, 1 total administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, at 10:00 hours the patient experienced dizziness, and numbness of right extremities. On an unspecified date, the patient died from dizziness, and numbness of right extremities.es. It was unspecified if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210916524-COVID-19 VACCINE AD26.COV2.S -Dizziness, Numbness of right extremities. This event(s) is considered unassessable. The event(s) has an unknown/unclear 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: DIZZINESS; NUMBNESS OF RIGHT EXTREMITIES


VAERS ID: 1690989 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-21
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Malaise, Pyrexia, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210822; Test Name: COVID-19 virus test positive; Result Unstructured Data: Positive
CDC Split Type: PHJNJFOC20210916542

Write-up: COVID-19 POSITIVE; BODY MALAISE; COUGH; FEVER; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300103291] concerned an 85 year old male. 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 05-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-AUG-2021, at 6:00, the patient experienced body malaise, cough, fever. On 22-AUG-2021, at 6:00, the patient had covid-19 test which resulted as positive. On an unspecified date, the patient died from body malaise, cough, fever and covid-19 positive. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of covid-19 positive, body malaise, cough, fever on an unspecified date. This report was serious (Death).; Sender''s Comments: V0: 20210916542- Covid-19 vaccine ad26.cov2.s- Covid-19 positive, body malaise, cough, fever. 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: BODY MALAISE; COUGH; FEVER; COVID POSITIVE


VAERS ID: 1690994 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-18
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose increased, Dyspnoea, Malaise
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), 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:
Allergies:
Diagnostic Lab Data: Test Date: 20210818; Test Name: Blood sugar increased; Result Unstructured Data: increased
CDC Split Type: PHJNJFOC20210917053

Write-up: INCREASED BLOOD SUGAR; DIFFICULTY OF BREATING; BODY MALAISE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300104200] concerned a 72 year old male with unspecified race and ethnicity. 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 18-AUG-2021, patient experienced body malaise, increased blood sugar and difficulty of breathing as verbalized by patient''s daughter. It was unspecified if an autopsy was performed. On an unspecified date in 2021, the patient died from increased blood sugar, difficulty of breathing, and body malaise. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210917053 -covid-19 vaccine ad26.cov2.s- increased blood sugar, difficulty of breathing, and body malaise. 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: INCREASED BLOOD SUGAR; DIFFICULTY OF BREATING; BODY MALAISE


VAERS ID: 1690996 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-14
Onset:2021-08-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939900 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Chills, Dizziness
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHMODERNATX, INC.MOD20212

Write-up: chills; dizziness; stomach pain; This regulatory authority case was reported by an other health care professional and describes the occurrence of CHILLS (chills), DIZZINESS (dizziness) and ABDOMINAL PAIN UPPER (stomach pain) in a 51-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 939900) for COVID-19 vaccination. No Medical History information was reported. On 14-Aug-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 15-Aug-2021, the patient experienced CHILLS (chills) (seriousness criterion death), DIZZINESS (dizziness) (seriousness criterion death) and ABDOMINAL PAIN UPPER (stomach pain) (seriousness criterion death). The patient died on 15-Aug-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications was not reported. Patient was dead on arrival to hospital. Company comments: Very limited information regarding this event/s has been provided at this time. Further information is not expected.; Sender''s Comments: Very limited information regarding this event/s has been provided at this time. Further information is not expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1691013 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-15
Onset:2021-02-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA G26761A / UNK - / OT

Administered by: Unknown       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: 2021-02-19
   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: PLMODERNATX, INC.MOD20213

Write-up: Subarachnoid haemorrhage; This case was received via Regulatory Authority (Reference number: PL-URPL-DML-MLP.4401.2.534.2021) on 03-Sep-2021 and was forwarded to Moderna on 03-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SUBARACHNOID HAEMORRHAGE (Subarachnoid haemorrhage) in a 72-year-old female patient who received mRNA-1273 (batch no. G26761A) for COVID-19 vaccination. No Medical History information was reported. On 15-Feb-2021, the patient received dose of mRNA-1273 (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced SUBARACHNOID HAEMORRHAGE (Subarachnoid haemorrhage) (seriousness criteria death, hospitalization and medically significant). The patient died on 19-Feb-2021. The reported cause of death was Haemorrhage brain. An autopsy was not performed. Concomitant medication information not provided. Treatment information not provided. Company comment This report refers to a case of a fatal subarachnoid haemorrhage in a 72-year-old female patient following administration of mRNA-1273. Latency was one day. The patient passed away three days after the event onset. Very limited information was provided and no further information is expected at this time. Based on the current available information and plausible temporal relationship, causal role cannot be fully excluded. Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Translation document received on 07-SEP-2021 contains translated verbatim.; Reporter''s Comments: The subarachnoid hemorrhage is an unexpected adverse reaction following the administration of COVID-19 Vaccine Moderna. As of August 10, 2021, 52 reports for PT subarachnoid hemorrhage have been registered in the Regulatory Authority database. There is a temporal relationship between administration of the vaccine and occurrence of the adverse reaction. Due to the patient''s death and the nature of the adverse reactions, Regulatory Authority has qualified the reported case as "severe".; Sender''s Comments: This report refers to a case of a fatal subarachnoid haemorrhage in a 72-year-old female patient following administration of mRNA-1273. Latency was one day. The patient passed away three days after the event onset. Very limited information was provided and no further information is expected at this time. Based on the current available information and plausible temporal relationship, causal role cannot be fully excluded.; Reported Cause(s) of Death: Haemorrhage brain


VAERS ID: 1692844 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-26
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Diarrhoea, Guillain-Barre syndrome, Headache
SMQs:, Peripheral neuropathy (narrow), Pseudomembranous colitis (broad), Guillain-Barre syndrome (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Demyelination (narrow), Noninfectious diarrhoea (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 13 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAJNJFOC20210906467

Write-up: GUILLAIN BARRE SYNDROME; DIARRHEA; HEADACHE; DEATH; This spontaneous report received from a consumer via a company representative via Social media concerned a male of unspecified age, 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 was not reported, batch number: Unknown) dose was not reported, frequency one total, administered on 25-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-JUN-2021, the patient started to get side effects, diarrhea, headache. On 29-JUN-2021, he started feeling numbness on his mouth. On 30-JUN-2021, he got numbed from his legs. He could no longer walk and was not able to hold a cup in his hand. His wife had to bath him and feed him with a straw and on evening of same day, he was hospitalized. On 02-JUL-2021, he went to ICU (Intensive care unit) confirmed by his physician to have GBS (Guillain Barre Syndrome). He was hospitalized for 13 days. On 12-JUL-2021, he died from an unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, guillain barre syndrome, and diarrhea. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210906467-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. 20210906467-COVID-19 VACCINE AD26.COV2.S-Guillain barre syndrome, diarrhea, headache. This event(s) is labeled per RSI and is therefore considered potentially related.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1695183 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-29
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-05
   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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210914370

Write-up: DEATH; HEART ATTACK; This spontaneous report received from a consumer concerned a male of unspecified age, race and ethnicity. 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, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on 27-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 29-JUL-2021, two days after vaccination, the patient started experiencing chest pains and difficulty in breathing, then had a heart attack on 05-AUG-2021 and tragically died on same day. It was reported that reporter was not saying the vaccine killed patient, but the vaccine might had triggered something that caused these symptoms and his heart attack. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heart attack. The patient died from unknown cause of death on 05-AUG-2021. This report was serious (Death and Other Medically Important Condition).; Sender''s Comments: V0: 20210914370- COVID-19 VACCINE AD26.COV2.S- Death, heart attack. 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: UNKNOWN CAUSE OF DEATH


VAERS ID: 1695185 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-08
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 209C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Decreased appetite, Depressed level of consciousness, Pain, Pyrexia
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-08-08
   Days after onset: 0
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: did not have any illness or ailments before she was vaccinated.
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210916019

Write-up: BODY PAIN; FEVER; SENSORIUM DECREASED; COVID-19 PROBABLE; LOSS OF APPETITE; This spontaneous report received from a consumer via a Regulatory Authority [PHIFDA: PH-PHFDA-300103346] concerned a 72-year-old female. The patient''s height, and weight were not reported. The patient did not have any illness or ailments before she was vaccinated. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 209C21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 03-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-AUG-2021, the patient experienced sensorium decreased, covid-19 probable, loss of appetite, patient became weak, had fever for two days, lost her appetite, had body aches for which she was hospitalized (date unspecified), her vaccinated arm was painful, had difficulty breathing properly, she lost her body oxygen and she eventually passed away on 08-AUG-2021, Patient was not taking any medications because she was active and strong and died from fever, covid-19 probable, body pain, loss of appetite, and sensorium decreased. Number of days hospitalized was unspecified. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sensorium decreased, covid-19 probable, loss of appetite, body pain and fever was fatal. This report was serious (Death, Hospitalization Caused / Prolonged, Life Threatening, and Disability Or Permanent Damage; Sender''s Comments: V0: 20210916019-covid-19 vaccine ad26.cov2.s-sensorium decreased, covid-19 probable, loss of appetite, body pain and fever. 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; COVID-19 PROBABLE; BODY PAIN; LOSS OF APPETITE; SENSORIUM DECREASED


VAERS ID: 1695187 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213CIA / 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210916503

Write-up: DIFFICULTY OF BREATHING; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300103585] concerned a 37 year old female 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: 213CIA and expiry: unknown) dose was not reported, frequency time 1 total was administered on 31-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-AUG-2021 at 9.00, the patient experienced difficulty of breathing. On an unspecified date, the patient died from difficulty of breathing. No autopsy details were reported. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210916503-Covid-19 vaccine ad26.cov2.s -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: DIFFICULTY OF BREATHING


VAERS ID: 1695191 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-01
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Cerebrovascular accident, Chills, Diarrhoea, Feeling abnormal, Feeling cold, Vomiting
SMQs:, Acute pancreatitis (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-06
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes; Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLJNJFOC20210917558

Write-up: HEAD STROKE; FEELING BAD; VOMITING; DIARRHEA; WEAKNESS; FEELING COLD; SHIVERS; This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnic origin. The patient''s height, and weight were not reported. The patient''s past medical history included diabetes, and stroke. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 29-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On the Wednesday 01-SEP-2021, she got shivers and was feeling cold, on the Thursday and Friday she had the same cold feeling on the Saturday 04-SEP-2021, she was lying down in bed very weak on Sunday 05-SEP-2021, she was vomiting and got the diarrhea. Her son called ambulance and they took her to hospital. In the hospital they did not diagnose anything serious and they discharged her to home. After 10 hours after discharge she started feeling very bad and was asking son for help, she died on the 06-SEP-2021. The son was asking in hospital about the reason of death and they said that was head stroke. It was unknown whether the autopsy was done or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shivers, weakness, feeling cold, vomiting, diarrhea and feeling bad was not reported. This report was serious (Death).; Sender''s Comments: V0; 20210917558; Covid-19 vaccine ad26.cov2.s- Head stroke.. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY.; Reported Cause(s) of Death: HEAD STROKE


VAERS ID: 1695212 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001659 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebral haemorrhage, Chills, Fatigue, Malaise, Vaccination site swelling, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: SELOKEN [METOPROLOL TARTRATE]
Current Illness: Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20213

Write-up: Cerebral bleeding; This case was received via Regulatory Authority (Reference number: SE-MPA-2021-048550) on 04-Sep-2021 and was forwarded to Moderna on 04-Sep-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of FATIGUE, VACCINATION SITE SWELLING, MALAISE, VOMITING, and CHILLS in a 65-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3001659) for COVID-19 vaccination. The patient''s past medical history included Stroke in 2015. Concurrent medical conditions included Hypertension since 2003. Concomitant products included METOPROLOL TARTRATE (SELOKEN [METOPROLOL TARTRATE]) for an unknown indication. In May 2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In May 2021, the patient experienced FATIGUE (seriousness criterion death), VACCINATION SITE SWELLING (seriousness criterion death), MALAISE (seriousness criterion death), VOMITING (seriousness criterion death), and CHILLS (seriousness criterion death). The reported cause of death was Cerebral bleeding. It is unknown if an autopsy was performed. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. There was no treatment medication reported.; Sender''s Comments: This is a case with a fatal outcome in a 65-year-old female patient with medical history of stroke and hypertension with AEs reported as cerebral hemorrhage, fatigue, vaccination site swelling, malaise, vomiting and chills. Cause of death was reported as cerebral haemorrhage. Latency was not specified. Very limited information was provided and no further information is expected.. Although there is plausible temporal relationship, considering patient''s medical history of hypertension and stroke as plausible confounders, the event of cerebral bleeding is unlikely related to mRNA-1273. Based on the current available information and plausible temporal relationship between product use and onset date of the events fatigue, malaise, vaccination site swelling, vomiting and chills, causal role cannot be excluded and therefore, the events are assessed as possibly related. Per RA SD, the events of fatigue, malaise, vomiting, and chills were reported with fatal outcome however, cause of death was reported as cerebral bleeding.; Reported Cause(s) of Death: Cerebral bleeding


VAERS ID: 1695215 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Acute kidney injury, Basophil count, Basophil percentage, Blood albumin, Blood bilirubin, Blood chloride, Blood creatinine, Blood fibrinogen, Blood osmolarity, Blood potassium, Blood sodium, Blood urea, Blood uric acid, Eosinophil count, Eosinophil percentage, Fibrin D dimer, Haematocrit, Haemoglobin, Lymphocyte percentage, Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean cell volume, Monocyte count, Monocyte percentage, Neutrophil count, Neutrophil percentage, Platelet count, Procalcitonin, Red blood cell count, Red cell distribution width, Sepsis, Thrombosis, Urosepsis, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (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), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-19
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; Paroxysmal atrial fibrillation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: APTT; Result Unstructured Data: ratio: 1:28 s; Test Date: 2021; Test Name: APTT; Result Unstructured Data: ratio: 1:28 s; Test Date: 2021; Test Name: APTT; Result Unstructured Data: 42.1 s; Test Date: 2021; Test Name: APTT; Result Unstructured Data: 45.5 s; Test Date: 2021; Test Name: BASO; Result Unstructured Data: 0.13 x10^9/l; Test Date: 2021; Test Name: BASO; Result Unstructured Data: 0.08 x10^9/l; Test Date: 2021; Test Name: BASO%; Result Unstructured Data: 0.8 %; Test Date: 2021; Test Name: BASO%; Result Unstructured Data: 0.4 %; Test Date: 2021; Test Name: Albumin; Result Unstructured Data: 24.7; Test Date: 2021; Test Name: Albumin; Result Unstructured Data: 27.7; Test Date: 2021; Test Name: Bilirubin total; Result Unstructured Data: 18.1 umol/l; Test Date: 2021; Test Name: Chlorids; Result Unstructured Data: 96 mmol/l; Test Date: 2021; Test Name: Creatinine; Result Unstructured Data: 324 umol/l; Test Date: 2021; Test Name: Creatinine; Result Unstructured Data: 351 umol/l; Test Date: 2021; Test Name: Fibrinogen; Result Unstructured Data: 5.4 g/l; Test Date: 2021; Test Name: Fibrinogen; Result Unstructured Data: 4.5 g/l; Test Date: 2021; Test Name: Osmolality serum; Result Unstructured Data: 302 mmol/kg; Test Date: 2021; Test Name: K; Result Unstructured Data: 5.38 mmol/l; Test Date: 2021; Test Name: Na; Result Unstructured Data: 131 mmol/l; Test Date: 2021; Test Name: Urea; Result Unstructured Data: 26.2mmol/l; Test Date: 2021; Test Name: Urea; Result Unstructured Data: 27.4mmol/l; Test Date: 2021; Test Name: Uric acid; Result Unstructured Data: 5.60 mmol/l; Test Date: 2021; Test Name: Uric acid; Result Unstructured Data: 5.76 mmol/l; Test Date: 2021; Test Name: EO; Result Unstructured Data: 0.04; Test Date: 2021; Test Name: EO%; Result Unstructured Data: 0.1%; Test Date: 2021; Test Name: EO%; Result Unstructured Data: 0.2%; Test Date: 2021; Test Name: Fibrin D dimer; Result Unstructured Data: 4.13 g/l; Test Date: 2021; Test Name: Fibrin D dimer; Result Unstructured Data: 3.97 g/l; Test Date: 2021; Test Name: HCT; Result Unstructured Data: 0.278; Test Date: 2021; Test Name: HCT; Result Unstructured Data: 0.312; Test Date: 2021; Test Name: HGB; Result Unstructured Data: 92 g/l; Test Date: 2021; Test Name: HGB; Result Unstructured Data: 101 g/l; Test Date: 2021; Test Name: LYMPH; Result Unstructured Data: 12.5 %; Test Date: 2021; Test Name: LYMPH; Result Unstructured Data: 12.5 %; Test Date: 2021; Test Name: MCH; Result Unstructured Data: 31.7 pg; Test Date: 2021; Test Name: MCH; Result Unstructured Data: 31.2 pg; Test Date: 2021; Test Name: MCHC; Result Unstructured Data: 331 g/l; Test Date: 2021; Test Name: MCHC; Result Unstructured Data: 324 g/l; Test Date: 2021; Test Name: MCV; Result Unstructured Data: 95.9 fl; Test Date: 2021; Test Name: MCV; Result Unstructured Data: 96.3 fl; Test Date: 2021; Test Name: MONO; Result Unstructured Data: 0.69 x10^9/l; Test Date: 2021; Test Name: MONO; Result Unstructured Data: 0.89 x10^9/l; Test Date: 2021; Test Name: MONO%; Result Unstructured Data: 4.1%; Test Date: 2021; Test Name: MONO%; Result Unstructured Data: 5.0%; Test Date: 2021; Test Name: NEUT; Result Unstructured Data: 1.47 x10^9/l; Test Date: 2021; Test Name: NEUT; Result Unstructured Data: 2.24 x10^9/l; Test Date: 2021; Test Name: NEUT; Result Unstructured Data: 86.2%; Test Date: 2021; Test Name: NEUT; Result Unstructured Data: 82.0%; Test Date: 2021; Test Name: PLT; Result Unstructured Data: 217 x10^9/l; Test Date: 2021; Test Name: PLT; Result Unstructured Data: 267 x10^9/l; Test Date: 2021; Test Name: Procalcitonin; Result Unstructured Data: 6.61 ng/ml; Test Date: 2021; Test Name: Procalcitonin; Result Unstructured Data: 6.39 ng/ml; Test Date: 2021; Test Name: RBC; Result Unstructured Data: 2.90 x10^12/l; Test Date: 2021; Test Name: RBC; Result Unstructured Data: 3.24 x10^12/l; Test Date: 2021; Test Name: RDW; Result Unstructured Data: 15.4%; Test Date: 2021; Test Name: RDW; Result Unstructured Data: 15.7%; Test Date: 2021; Test Name: RDW-SD; Result Unstructured Data: 54.3 fl; Test Date: 2021; Test Name: RDW-SD; Result Unstructured Data: 55.7 fl; Test Date: 2021; Test Name: thrombus; Test Result: Inconclusive ; Result Unstructured Data: 4.13; Test Date: 2021; Test Name: thrombus; Test Result: Inconclusive ; Result Unstructured Data: 3.97; Test Date: 2021; Test Name: wbc; Result Unstructured Data: 16,89 x10^9/l; Test Date: 2021; Test Name: wbc; Result Unstructured Data: 17,88 x10^9/l
CDC Split Type: SKMODERNATX, INC.MOD20213

Write-up: This case was received via Regulatory Authority (Reference number: SK-SUKLSK-20218467) on 03-Sep-2021 and was forwarded to Moderna on 03-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of UROSEPSIS, SEPSIS and ACUTE KIDNEY INJURY in an 85-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 immunisation. Concurrent medical conditions included Paroxysmal atrial fibrillation and Hypertension. In May 2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In May 2021, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced UROSEPSIS (seriousness criteria death and medically significant), SEPSIS (seriousness criteria death and medically significant) and ACUTE KIDNEY INJURY (seriousness criteria death and medically significant). The patient died on 19-Jun-2021. The reported cause of death was Urosepsis, Sepsis and Acute kidney failure. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Activated partial thromboplastin time: 1:28 (High) ratio: 1:28 s, 1.42 (High) ratio: 1:28 s, 42.1 (High) 42.1 s and 45.5 (High) 45.5 s. In 2021, Basophil count: normal (normal) 0.13 x10^9/l and normal (normal) 0.08 x10^9/l. In 2021, Basophil percentage: 0.8% (normal) 0.8 % and 0.4 (normal) 0.4 %. In 2021, Blood albumin: 24.7 (High) 24.7 and 27.7 (High) 27.7. In 2021, Blood bilirubin: 18.1 (normal) 18.1 umol/l. In 2021, Blood chloride: 96 (normal) 96 mmol/l. In 2021, Blood creatinine: 324 (High) 324 umol/l and 351 (High) 351 umol/l. In 2021, Blood fibrinogen: 5.4 (High) 5.4 g/l and 4.5 (High) 4.5 g/l. In 2021, Blood osmolarity: 302 (High) 302 mmol/kg. In 2021, Blood potassium: 5.38 (High) 5.38 mmol/l. In 2021, Blood sodium: 131 (Low) 131 mmol/l. In 2021, Blood urea: 26.2 (High) 26.2mmol/l and 27.4 (High) 27.4mmol/l. In 2021, Blood uric acid: 5.60 (High) 5.60 mmol/l and 5.76 (High) 5.76 mmol/l. In 2021, Eosinophil count: 0.04 (normal) 0.04. In 2021, Eosinophil percentage: 0.1 (normal) 0.1% and 0.2 (normal) 0.2%. In 2021, Fibrin D dimer: 4.13 (normal) 4.13 g/l and 3.97 (normal) 3.97 g/l. In 2021, Haematocrit: 0.278 (Low) 0.278 and 0.312 (Low) 0.312. In 2021, Haemoglobin: 92 (Low) 92 g/l and 101 (Low) 101 g/l. In 2021, Lymphocyte percentage: 8.6 (Low) 12.5 % and 12.5 (Low) 12.5 %. In 2021, Mean cell haemoglobin: 31.7 (normal) 31.7 pg and 31.2 (normal) 31.2 pg. In 2021, Mean cell haemoglobin concentration: 331 (normal) 331 g/l and 324 (normal) 324 g/l. In 2021, Mean cell volume: 95.9 (normal) 95.9 fl and 96.3 (normal) 96.3 fl. In 2021, Monocyte count: normal (normal) 0.69 x10^9/l and normal (normal) 0.89 x10^9/l. In 2021, Monocyte percentage: 4.1 (normal) 4.1% and 5.0 (normal) 5.0%. In 2021, Neutrophil count: low (Low) 1.47 x10^9/l and normal (normal) 2.24 x10^9/l. In 2021, Neutrophil percentage: 86.2 (High) 86.2% and 82.0 (High) 82.0%. In 2021, Platelet count: normal (normal) 217 x10^9/l and normal (normal) 267 x10^9/l. In 2021, Procalcitonin: 6.61 (normal) 6.61 ng/ml and 6.39 (normal) 6.39 ng/ml. In 2021, Red blood cell count: low (Low) 2.90 x10^12/l and low (Low) 3.24 x10^12/l. In 2021, Red cell distribution width: 15.4 (normal) 15.4%, 15.7 (normal) 15.7%, 54.3 (normal) 54.3 fl and 55.7 (normal) 55.7 fl. In 2021, Thrombosis: 4.13 (Inconclusive) 4.13 and 3.97 (Inconclusive) 3.97. In 2021, White blood cell count: high (High) 16,89 x10^9/l and high (High) 17,88 x10^9/l. For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered UROSEPSIS, SEPSIS and ACUTE KIDNEY INJURY to be related. Concomitant product use was not provided. Treatment information was not reported. Company Comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per SD Authority reporting. Events seriousness per assessment by Authority and per IME list. The physician was contacted by the SIDC and the physician suggested that death is related to vaccination. The conclusion from the pathologist is not available. Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Translation received on 08 Sep 2021 contains no new information.; Sender''s Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per SD Authority reporting. Events seriousness per assessment by Authority and per IME list.; Reported Cause(s) of Death: Urosepsis; Sepsis; Acute kidney failure


VAERS ID: 1697284 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-05
Submitted: 0000-00-00
Entered: 2021-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Renal disorder
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Antibiotic
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEJNJFOC20210916734

Write-up: RENAL DISORDER; DEATH; This spontaneous report received from a patient via a Regulatory Authority (EVHUMAN Vaccines) was received on 08-SEP-2021 and concerned a female of unspecified age and unknow race and ethnic origin. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included: Antibiotic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XE393 expiry: UNKNOWN) dose was not reported, frequency 1 total, start therapy date were not reported for covid-19 immunisation. No concomitant medications were reported. On 05-AUG-2021, the patient experienced renal disorder. On 05-AUG-2021, the patient died from renal disorder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on 05-AUG-2021. This report was serious (Death).; Reporter''s Comments: Treatment - No Evolution of the ADR - Gotten worse; Reported Cause(s) of Death: RENAL DISORDER


VAERS ID: 1697412 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Cardiac failure acute, SARS-CoV-2 test
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CO-AMOXICILLIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic back pain; Dementia Alzheimer''s type; Lung embolism; Urinary tract infection (Treated with Co-Amoxicillin from 05Jan2021-10Jan2021)
Allergies:
Diagnostic Lab Data: Test Date: 20210119; Test Name: Autopsy; Result Unstructured Data: Test Result:From a forensic medical point of view, the cause o; Comments: From a forensic medical point of view, the cause of death was a natural, internal event.; Test Date: 20210119; Test Name: PCR Sars-Cov-2 test; Test Result: Negative
CDC Split Type: CHPFIZER INC202101144498

Write-up: Acute heart failure of previously damaged heart; This is a spontaneous report received from a contactable consumer, the regulatory authority. Regulatory authority report number CH-SM-2021-21264. A 90-year-old male patient received BNT162B2 (COMIRANTY; Formulation: Solution for injection; Lot number: not reported, Expiration date: not reported, Age at vaccination: 90-year-old) via Intramuscular on 15Jan2021 as dose 1, single for COVID-19 immunization. The patient medical history included Dementia Alzheimer''s type, Chronic back pain, Lung embolism from 2005, anticoagulant treatment Marcoumar till 31Aug2021 taken for pulmonary embolism, Urinary tract infection from Jan2021 to Jan2021, which was treated with antibiotic therapy (Co-amoxicillin 1g 2xdie) from 05Jan2021 to 10Jan2021. Concomitant medications included CO-AMOXICILLIN taken for urinary tract infection. On 17Jan2021, patient experienced acute on chronic heart failure. Reporter also stated on 17Jan2021 at 07:55 the patient was found dead in bed. At around 05:00h, the patient was last seen alive on the occasion of an accompanied visit to the toilet. From the forensic report morphological and imaging examination results included: Cardiac muscle enlargement (own weight 430 g; 33% relative cardiac overweight with borderline widening of the ventricular walls, widening of the heart cavities and moderate calcification of the aortic valve. Long-range, high-grade calcifications of all three coronary arteries. Scarring measuring about 2x3 cm in the area of the left anterior ventricular wall and the anterior valvular muscles as well as several small scarring in the left posterior ventricular wall. Extensive callosity of the anterior and posterior valvular muscles of the left ventricle. Hyperhydration and blood stasis of the lungs. Acute blood stasis of the internal organs. Upper influence congestion in the form of discrete livid discolouration of the face and neckline and marked jugular venous congestion. Pinpoint-sized haemorrhages of the gastric mucosa (so-called stress haemorrhages) in the area of the entrance to the stomach. Moderate calcification of the aorta. Slight fatty deposits in the carotid arteries. Slight fatty deposits of the cerebral basal arteries. Fatty deposits of the pancreas. Multiple fluid-filled cavities of the liver (liver cysts). Multiple fluid-filled cavities of the kidneys (renal cysts). Nodular changes in the prostate gland and condition after transurethral prostate resection. Small, roundish bruise on the right forearm extensor side. The post-mortem examination of the corpse of the patient heart weighed 430 g, which was too large and too heavy, with thickening of both ventricular walls and widening of the heart cavities, and a severe narrowing of all three main branches of the coronary arteries due to calcification of the walls. Such a severely damaged heart can fail acutely at any time. Indirect signs of the acute cardiac failure causing death were discrete upper influence congestion, hyperhydration of the lungs and acute blood stasis of the internal organs. There was no evidence of mechanical force, either by the patient'''' own hand or by another person, which was relevant for the cause of death. With regard to the vaccination with Comirnaty, which had taken place a few days before the patient''s death, no indications of an inflammatory reaction or other changes in the organs could be found as an indication of a possible vaccination reaction. There were also no signs of a current infection which would have been a contraindication for vaccination. Thus, no autopsy evidence for a connection between the vaccination and the death could be found. From a forensic medical point of view, the cause of death was a natural, internal event. Lab test included PCR test for SARS-CoV-2: negative. The outcome of event was fatal. A causal relationship between Comirnaty and Acute on chronic heart failure was assessed as unlikely. RA medic assessed this case as serious with fatal outcome. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Reporter''s Comments: Death case; Sender''s Comments: Based on the available information there is not a reasonable possibility of a causal relation between the reported event "Acute on chronic heart failure"and suspect drug BNT162B2; Reported Cause(s) of Death: Acute on chronic heart failure; Autopsy-determined Cause(s) of Death: Acute on chronic heart failure


VAERS ID: 1697539 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-09
Onset:2021-08-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCKX7 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Interchange of vaccine products, Off label use
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-20
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101124974

Write-up: Unknown cause of death; Interchange of vaccine products; Off-Label use; This is a spontaneous report from a non contactable physician downloaded from the Regulatory Agency (RA)-WEB:DE-PEI-202100175543. A 66-year-old male patient received bnt162b2 (COMIRNATY, mRNA TOZINAMERAN), dose 2 via an unspecified route of administration, at age 66 years, on 09Aug2021 (Batch/Lot Number: SCKX7) as DOSE 2, 0.3 ML SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient historically received the first dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (VAXZEVRIA) on 17May2021 for COVID-19 vaccination. On 09Aug2021, patient had interchange of vaccine products and off label use. On 20Aug2021, the patient experienced unknown cause of death. The patient''s outcome was fatal for unknown cause of death on 20Aug2021. An autopsy was performed and results were not provided. This report is serious - death. Relatedness of drug to reaction(s)/event(s), Agency D. Unclassifiable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1697728 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-27
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D012A / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Fall, Gait inability, Personality change, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Hostility/aggression (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: Medical History/Concurrent Conditions: Breast cancer female
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101155487

Write-up: Pyrexia; Unable to walk; Fall; General debility; Character change in; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB [DE-PEI-202100180543]. A 54-years-old female patient received second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration at the age of 53-years-old on 27May2021 (Lot Number: 1D012A) as single dose for covid-19 immunisation. Medical history included breast cancer female. The patient''s concomitant medications were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration at the age of 53-years-old on 20Apr2021 (Batch/Lot Number: unknown) as single dose for covid-19 immunisation. The patient experienced pyrexia, unable to walk, fall, general debility and character change in on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of the events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Pyrexia; General debility; Character change in; Unable to walk; Fall


VAERS ID: 1697733 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-19
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-14
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: 2021-07-19
   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: COVID-19 (Since then, significantly reduced general condition); Dementia; General physical condition decreased; Renal insufficiency; Weight loss
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101155282

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100181963. A 94-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection, strength: 0.3 ml), via an unspecified route of administration on 14Jul2021 (Batch/Lot number was not reported) as 0.3ml single for COVID-19 immunisation. Medical history included Renal insufficiency, weight loss, dementia, General physical condition decreased, COVID-19 from Jan2021 (Since then, significantly reduced general condition). The patient''s concomitant medications were not reported. The patient experienced unknown cause of death (death, medically significant) on 19Jul2021. The patient died on 19Jul2021. An autopsy was not performed. The outcome of event was fatal. Result of Assessment: Comirnaty/ event(s): Unknown cause of death/: 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: Unknown cause of death


VAERS ID: 1697734 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-05-22
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 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: Medical History/Concurrent Conditions: Epilepsy
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101155272

Write-up: Unknown cause of death; This is a spontaneous report received from a non-contactable physician downloaded from Regulatory Authority-WEB. The regulatory authority report number is DE-PEI-202100181966. A male patient of unknown age (adult) received the unknown number of dose of bnt162b2 (COMIRNATY) on 13May2021 (lot: unknown) as 0.3 ml single dose for COVID-19 immunisation. Medical history included Epilepsy. Concomitant medications were not reported. The patient experienced also Unknown cause of death. Time Interval between Beginning of Drug Administration and Start of Events was 9 days. This report is serious due to death. Relatedness of drug to events was assessed as Unclassifiable from RA. It was unknown if Autopsy Done. The outcome of the event was fatal. No follow-up attempts possible. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1697886 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-17
Onset:2021-08-10
   Days after vaccination:115
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Chills, Drug ineffective, Influenza, Pyrexia
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiovascular disorder NOS; Renal disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101142601

Write-up: COVID-19; COVID-19; Pyrexia; Chills; Cough, shortness of breath; This is a spontaneous report downloaded from non-contactable consumer via the regulatory authority DE-PEI-CADR2021170622, Safety Report Unique Identifier is DE-PEI-202100177681. An 85-year-old male patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, lot number was not reported), via an unspecified route of administration on 17Apr2021 as dose 2, 0.3 ml, single for COVID-19 immunisation. The patient medical history and concurrent conditions included ongoing renal disorder, ongoing Cardiovascular disorder nos. The patient''s concomitant medications were not reported. The patient previously took first dose of bnt162b2 (COMIRNATY, Solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient experienced pyrexia, chills, cough, shortness of breath and COVID-19 on 10Aug2021. The adverse events resulted into hospitalization from 15Aug2021 to 20Aug2021 and died on 20Aug2021. The autopsy was unknown. The outcome of events pyrexia, chills, cough, shortness of breath was unknown and outcome of COVID-19 was fatal. Event assessment: Comirnaty/ all events /PEI /Result of Assessment: Reasonable possibility. Health authority comment: Information on risk factors or previous illnesses Cardiovascular disease Kidney disease / inpatient stay v.15Aug- 20Aug2021, died on 20Aug2021 because of Covid-19. No follow-up attempts were needed. Information about lot/batch number could not be obtained. No further information was expected.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1697887 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-12
Onset:2021-08-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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: 2021-08-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101160638

Write-up: Infarct myocardial; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority number DE-PEI-CADR2021172602, safety Report Unique Identifier DE-PEI-202100181192. A 49-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 12Aug2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 13Aug2021 the patient experienced Infarct myocardial. This report is serious with death. The patient died on 13Aug2021. 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: Infarct myocardial


VAERS ID: 1697909 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2 test positive; Test Result: Positive
CDC Split Type: DEPFIZER INC202101167875

Write-up: SARS-CoV-2 test positive; SARS-CoV-2 test positive; This is a spontaneous report received from a contactable physician based on information received by Pfizer from Biontech [manufacturer control number: 84605], license party for Comirnaty. An 84-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection) via an unspecified route of administration, 1st single dose on an unspecified date (LOT/Batch number and expiration date unknown) and 2nd single dose on an unspecified date (LOT/Batch number and expiration date unknown) for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was vaccinated twice and vaccination has been administered over 6 months ago. Patient was tested positive for Corona and died in nursery home during quarantine about 10 to 14 days (also reported as within 10 days) after positive PCR test. There was a corona outbreak on a ward in the nursing home. It was not reported if an autopsy was performed. Outcome of the event was fatal. Lot/batch number has been requested.; Sender''s Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events drug ineffective and covid-19 and the suspect drug BNT162B2.; Reported Cause(s) of Death: SARS-CoV-2 test positive


VAERS ID: 1697910 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2 test positive; Test Result: Positive
CDC Split Type: DEPFIZER INC202101174291

Write-up: SARS-CoV-2 test positive; SARS-CoV-2 test positive; This is a spontaneous report from a contactable physician based on information received by Pfizer from Biontech [manufacturer control number: 84607], license party for Comirnaty. A 64-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration, 1st single dose on an unspecified date (LOT/Batch number and expiration date unknown) and 2nd single dose on an unspecified date (LOT/Batch number and expiration date unknown) for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient was vaccinated twice, vaccination was already over 6 months ago. Patient was tested positive for Corona and died in quarantine in the nursing home. Patient died approximately 10-14 days (also reported as within 10 days) after the positive PCR test. There was a corona outbreak on a ward in the nursing home. It was not reported if an autopsy was performed. Outcome of the event was fatal. Lot/batch number has been requested.; Sender''s Comments: Based on available information a contributory role of BNT162B2 to the reported Covid-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and drug ineffective is : expected. The case will be reassessed further upon receipt of additional information. 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: SARS-CoV-2 test positive


VAERS ID: 1697978 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8889 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, Computerised tomogram thorax, Dyspnoea, Inappropriate schedule of product administration, Respiratory failure, White blood cell count
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Medication errors (narrow), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-08-07
   Days after onset: 67
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: ESTRADIOL; PANTOPRAZOLE; INSULIN ASPART; SALBUTAMOL; METOPROLOL; LINAGLIPTIN; INSULIN GLARGINE; SIMVASTATIN; POTASSIUM CHLORIDE; AMLODIPINE; JERN C; APIXABAN; FUROSEMIDE; DIGOXIN; INNOVAIR; CALCIUM + VIT D; PARACETAMOL
Current Illness: Cardiomegaly; Insufficiency renal; Ischemic heart disease; Oxygen therapy (at home, due to COPD); Pulmonary hypertension aggravated
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210804; Test Name: Computerised tomogram thorax; Result Unstructured Data: Test Result:no sign of embolism with bilal infil; Test Date: 20210804; Test Name: C-reactive protein; Result Unstructured Data: Test Result:150; Comments: Unit not specified; Test Date: 20210804; Test Name: Leucocyte count; Result Unstructured Data: Test Result:12.7; Comments: Unit not specfied
CDC Split Type: DKPFIZER INC202101155429

Write-up: Respiratory insufficiency; hospitalized once more with dyspnoea in between vaccination and current hospitalization; Comirnaty 1st dose 26Feb2021, 2nd dose 01Jun2021; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number DK-DKMA-WBS-0084597. A 74-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 01Jun2021 (Lot Number: FC8889; Expiration Date: 30Sep2021) as single dose for covid-19 immunisation. Medical history included ongoing cardiomegaly, ongoing renal failure, ongoing pulmonary hypertension, ongoing myocardial ischaemia, ongoing oxygen therapy at home, due to COPD. Historical vaccine includes 1st dose of bnt162b2 (COMIRNATY, lot: ER2659, expiry: 30Jun2021), received on 26Feb2021. Concomitant medications included estradiol taken for hormone therapy from 28Aug2015 to an unspecified stop date; pantoprazole taken for gastrooesophageal reflux disease from 23Jan2014 to an unspecified stop date; insulin aspart taken for diabetes mellitus from 15Mar2021 to an unspecified stop date; salbutamol taken for chronic obstructive pulmonary disease from 11Jan2018 to an unspecified stop date; metoprolol taken for heart rate irregular from 23May2018 to an unspecified stop date; linagliptin taken for diabetes mellitus from 24Mar2021 to an unspecified stop date; insulin glargine taken for diabetes mellitus from 11May2021 to an unspecified stop date; simvastatin taken for hypercholesterolaemia from 29Mar2019 to an unspecified stop date; potassium chloride taken for mineral supplementation from 22Mar2021 to an unspecified stop date; amlodipine taken for hypertension from 21Dec2020 to an unspecified stop date; ascorbic acid, ferrous fumarate (JERN C) taken for mineral supplementation from 21Jun2021 to an unspecified stop date; apixaban taken for thrombosis prophylaxis from 10Sep2014 to an unspecified stop date; furosemide taken for diuretic therapy from 11Jan2018 to an unspecified stop date; digoxin taken for atrial fibrillation from 29Dec2017 to an unspecified stop date; beclometasone dipropionate, formoterol fumarate (INNOVAIR) taken for chronic obstructive pulmonary disease from 29Mar2021 to an unspecified stop date; calcium carbonate, vitamin d nos (CALCIUM + VIT D) taken for calcium deficiency from 06May2021 to an unspecified stop date; paracetamol taken for pain from 19Mar2021 to an unspecified stop date. The patient experienced respiratory insufficiency (death, hospitalization, life threatening) in Jun2021, hospitalized once more with dyspnoea in between vaccination and current hospitalization (hospitalization) in Jun2021, and inappropriate schedule of vaccine administered (non-serious) on 01Jun2021, as the vaccine was administered outside the 19-42 day range. On 04Aug2021, the patient underwent lab tests and procedures which included computerised tomogram thorax: no sign of embolism with bilal infil; c-reactive protein: 150 (Unit not specified); white blood cell count: 12.7 (Unit not specified). Therapeutic measures were taken as a result of respiratory insufficiency and dyspnoea: The patient was treated with unknown antibiotics, diuretics and supporting treatment, without effect. The patient died on 07Aug2021. Reported cause of death: Respiratory insufficiency. An autopsy was not performed. The outcome of event Respiratory insufficiency was fatal. The outcome of other events was unknown. Additional information. Causality: The reporter comments, the patient has been suffering from increasing lung symptoms and have been hospitalized once more with dyspnoea in between vaccination and current hospitalization. The C-reactive protein level did not improve after treatment with antibiotics. The patient''s Respiratory insufficiency was progressing until death. No follow up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Respiratory insufficiency


VAERS ID: 1698015 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-05-26
   Days after vaccination:103
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Bronchial aspiration procedure, C-reactive protein, COVID-19, Computerised tomogram, Culture urine, Femoral neck fracture, Glomerular filtration rate, Pneumonia bacterial, SARS-CoV-2 test, Sepsis, Vaccination failure, White blood cell count, X-ray
SMQs:, Lack of efficacy/effect (narrow), Accidents and injuries (narrow), Osteoporosis/osteopenia (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-18
   Days after onset: 23
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: Chronic renal failure; Dementia; Hypertension; Type 2 diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: bronchial aspirate; Result Unstructured Data: Test Result:Kleibsella aerogenes isolated; Test Date: 20210611; Test Name: CT; Result Unstructured Data: Test Result:frosted glass-type areas and sharp condensations; Comments: in both lungs. In addition, in both lungs have areas of consolidation, mostly in the lower lobes.; Test Name: CRP; Result Unstructured Data: Test Result:significant increase; Test Name: urine culture; Result Unstructured Data: Test Result:E. coli and Enterococcus faecium isolated; Test Name: eGFR; Result Unstructured Data: Test Result:45; Test Date: 20210529; Test Name: eGFR; Result Unstructured Data: Test Result:9; Test Date: 20210526; Test Name: SARS-CoV-2 PCR test; Test Result: Positive ; Test Name: White blood cell count; Result Unstructured Data: Test Result:leukocytosis; Test Name: X-ray; Result Unstructured Data: Test Result:perthrochanteric fragment of the right femur with; Comments: fragmented displacement. In addition, on the right VII and VIII ribs with low displacement fractions on the axillary line.
CDC Split Type: EEPFIZER INC202101155468

Write-up: This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number EE-SAM-48632108191. A 88-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 12Feb2021 (Batch/Lot Number: EJ6789; Expiration Date: 31May2021) as 0.3 ML SINGLE, dose 1 intramuscular on 22Jan2021 (Batch/Lot Number: EL1491; Expiration Date: 30Apr2021) as 0.3 ML SINGLE for covid-19 immunisation. Medical history included ongoing dementia, ongoing chronic kidney disease, ongoing type 2 diabetes, ongoing hypertension. The patient''s concomitant medications were not reported. The patient experienced vaccination failure and COVID-19 (death, hospitalization, medically significant) on 26May2021, sepsis and bacterial pneumonia (death, hospitalization, medically significant) on an unspecified date, fracture of the femoral neck (hospitalization) on an unspecified date. The clinical course as following: The patient was vaccinated with the first and second dose of Comirnaty vaccine on 22Jan2021 and 12Feb2021 respectively. The patient was hospitalized as an emergency due to a fracture of the femoral neck. X-ray perthrochanteric fragment of the right femur with fragmented displacement. In addition, on the right VII and VIII ribs with low displacement fractions on the axillary line. In the emergency department, the patient is also consulted by an orthopedist: indicated for surgical treatment, which is possible when there are no other problems. There were no focal-infiltrative changes in the lungs on arrival at the hospital. eGFR was 45; 29May2021: eGFR was 9. In addition, leukocytosis and a significant increase in CRP occurred. Antibacterial therapy was initiated with an adjusted renal dose of cefuroxime i/v. As the SARS-CoV-2 test was positive on 26May2021, the patient was initially hospitalized in the Infectious Diseases Department. At the end of the isolation, she was transferred to the pulmonology department on 08Jun. In the CT examination performed on 11Jun2021, frosted glass-type areas and sharp condensations in both lungs. In addition, in both lungs have areas of consolidation, mostly in the lower lobes. Clinically, this was considered to be bacterial pneumonia in the setting of post-SARS-2 lung injury. In consideration of age, concomitant dementia and other chronic diseases, the patient was not included in stage III intensive care with deterioration. The patient''s concomitant conditions: hypertension, chronic renal failure, type 2 diabetes, dementia. E. coli and Enterococcus faecium were isolated from urine, and Kleibsella aerogenes was isolated from bronchial aspirate. From 02Jun2021 she received antibacterial treatment with piperacillin/tazobactam and from 12Jun, with imipenem i/v. Against this background, clinically negative dynamics. The course of the disease was severe and the patient died on 18Jun2021 due to sepsis and bacterial pneumonia. The outcome of the events vaccination failure and COVID-19, sepsis and bacterial pneumonia was fatal and the outcome of the event fracture of the femoral neck was unknown. Investigation results received on 06Sep2021: Lot-#: EL1491; Batch-Expiry Year: 2021; Batch-Expiry Month: 04; Batch-Expiry Day: 30. The investigation included reviewing the involved batch records, deviation investigation and 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 EL1491. 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. concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. Lot-#: EJ6789; Batch-Expiry Year: 2021; Batch-Expiry Month: 05; Batch-Expiry Day: 31. Conclusion: The investigation included reviewing the involved batch records, deviation investigation and 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 EJ6789. 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. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. Sender Comment: Serious vaccine ineffectiveness report with fatal outcome. However, the patient was hospitalized due to fracture of the femoral neck instead. COVID, which was complicated by bacterial pneumonia and sepsis, was reported to be concomitant. As a result, the patient died. The course of the disease was assessed as severe. Thus, the causal relationship cannot be assessed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Vaccination failure; COVID-19; Sepsis; Bacterial pneumonia, unspecified


VAERS ID: 1698104 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-09
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101135890

Write-up: Sudden death unexplained; Cardiorespiratory arrest; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. Report number ES-AEMPS-985191. A 15-year-old male patient received unknown dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number: unknown), via an unspecified route on 02Aug2021 as a single dose for covid-19 immunization. The patient has no prior history medical history. The patient concomitant medications were not reported. On 09Aug2021 at 09:02, with no prior pathology family found the patient without a pulse. Upon arrival of the emergency team, he has no pulse. Some stiffness of limbs. There is no prior Cardiorespiratory arrest. Time of evolution of Cardiorespiratory arrest is unknown. Judicial protocol is activated. Sudden death unexplained on 09Aug2021 00:00. It was unknown if autopsy has been done. The outcome of the events was fatal. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1698139 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-03-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Cardiac failure congestive; Cardiac valvulopathy (Degenerative aortic valve disease); Diabetes mellitus; Parkinsonism
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101142614

Write-up: Cadiorespiratory arrest with EXITUS outcome; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority, regulatory authority number ES-AEMPS-986865. A 82-years-old female patient received second dose of bnt162b2 (COMIRNATY, Formulation: solution for injection, Lot Number: ET3620), via unknown route of administration, administered in Arm on 18Mar2021 (at the age of 82-years-old) as dose 2, single for covid-19 immunisation. Medical history included diabetes mellitus, cardiac valvulopathy (Degenerative aortic valve disease), cardiac failure congestive, and parkinsonism from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. It was unknown that the patient had passed COVID-19. It was reported that after receiving second dose of Pfizer vaccine on 18Mar2021, the patient died at dawn on 19Mar2021. She received the same vaccine. The doctor on duty certified the death as Cardiorespiratory Arrest. It was unknown if any autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cadiorespiratory arrest with EXITUS outcome


VAERS ID: 1698170 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-09
Onset:2021-01-18
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Dyspnoea, Gastrointestinal disorder, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), 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: Arterial hypertension (systemic arterial hypertension); Chronic venous insufficiency; Dementia; Prostate carcinoma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: negative; Test Name: SARS-CoV-2 test; Test Result: Positive ; Result Unstructured Data: positive
CDC Split Type: ESMODERNATX, INC.MOD20213

Write-up: severe gastrointestinal problems; breathing difficulties; COVID-19 infection 24 days after mRNA vaccine; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL DISORDER (severe gastrointestinal problems), DYSPNOEA (breathing difficulties) and COVID-19 (COVID-19 infection 24 days after mRNA vaccine) in an 86-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Concurrent medical conditions included Arterial hypertension (systemic arterial hypertension), Chronic venous insufficiency, Dementia and Prostate carcinoma. On 09-Jan-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced GASTROINTESTINAL DISORDER (severe gastrointestinal problems) (seriousness criteria death and hospitalization) and DYSPNOEA (breathing difficulties) (seriousness criteria death and hospitalization). On an unknown date, the patient experienced COVID-19 (COVID-19 infection 24 days after mRNA vaccine) (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 an unknown date, SARS-CoV-2 test: negative (Negative) negative and positive (Positive) positive. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. Patient was infected with COVID-19 after 24 days of vaccination, as he was sharing a room with COVID-19 infected patient and died after 4 days. The reporter reported that the vaccine does not work at all. No concomitant medications reported. No treatment medications provided. Company comment: This is a case of COVID-19 infection with fatal outcome in a 86-year-old male who died about 28 days after receiving the first dose of vaccine. For the event COVID-19, based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. For the rest of the events (dyspnoea and gastrointestinal disorders)), very limited information regarding these events has been provided at this time. However, patient''s age and previous history of arterial hypertension, prostate carcinoma and dementia could be confounding factors. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: Translation received on 07-sep-2021 and does not contain any new information.; Sender''s Comments: This is a case of COVID-19 infection with fatal outcome in a 86-year-old male who died about 28 days after receiving the first dose of vaccine. For the event COVID-19, based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. For the rest of the events (dyspnoea and gastrointestinal disorders)), very limited information regarding these events has been provided at this time. However, patient''s age and previous history of arterial hypertension, prostate carcinoma and dementia could be confounding factors. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1698197 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, General physical health deterioration, Inappropriate schedule of product administration
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-19
   Days after onset: 48
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: FIPFIZER INC202101131213

Write-up: Found dead; Inappropriate schedule of vaccine administered; Reduced general condition; This is a spontaneous report from a contactable consumer downloaded from Regulatory Authority, regulatory authority number FI-FIMEA-20214219. A 74-year-old female patient received the second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 15Jun2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received the first dose of BNT162B2 on 24Mar2021 at single dose for COVID-19 immunisation and no adverse event experienced. The patient experienced reduced general condition in Jun2021. After the vaccine, she felt worse. On 19Jul2021, she was found dead at her home. The cause of death was unknown. Reporter did not know if the vaccine had anything to do with it. The patient died on 19Jul2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected. Batch/Lot number cannot be obtained.; Reported Cause(s) of Death: Found dead; Reduced general condition


VAERS ID: 1698238 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Death, Pain
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-09
   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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Death Nos; Pain; Belly ache; This case was received via regulatory authority (Reference number: FR-AFSSAPS-BX20217434) on 03-Sep-2021 and was forwarded to Moderna on 03-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death Nos) in a 64-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 04-Jun-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In June 2021, the patient experienced ABDOMINAL PAIN (Belly ache). On 06-Jul-2021, the patient experienced PAIN (Pain). The patient died on 09-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, ABDOMINAL PAIN (Belly ache) outcome was unknown and PAIN (Pain) had not resolved. No concomitant medications are reported. No treatment medications are reported. Follow-up received on 03-SEP-2021 included no new information Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Translation received on 08 Sep 2021 contains no new information.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1698385 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-15
Onset:2021-08-04
   Days after vaccination:170
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 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? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Arterial hypertension; COPD; COVID-19; Multiple myeloma (without information on a possible current treatment); Pancreatitis; Stroke
Allergies:
Diagnostic Lab Data: Test Date: 20210804; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101160422

Write-up: Vaccination failure; COVID-19; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority [FR-AFSSAPS-MP20217025]. A 89-years-old male patient received bnt162b2 (COMIRNATY, Formulation: Solution for Injection, Batch/Lot number: EJ6788) intramuscularly on 15Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included covid-19, cerebrovascular accident, plasma cell myeloma, angina pectoris, chronic obstructive pulmonary disease, pancreatitis, hypertension. The patient''s concomitant medications were not reported. On 04Aug2021 patient experienced delta variant COVID infection who has been fully vaccinated since 15Feb2021. Cardiorespiratory decompensation requiring HAD (home hospitalization) treatment. Time interval between beginning of drug administration and start of reaction / event (number) was 171 days. Time interval between last dose of drug and start of reaction / event (number) was 171 days. The patient died on an unspecified date. An autopsy was not performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1698406 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-08-10
   Days after vaccination:187
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19, Cardio-respiratory arrest, Lower respiratory tract congestion, PO2, SARS-CoV-2 test, Vaccination failure
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (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), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-21
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Arterial hypertension; Dependence; Pulmonary embolism
Allergies:
Diagnostic Lab Data: Test Date: 20210810; Test Name: body temperature; Result Unstructured Data: Test Result:afebrile; Test Date: 20210810; Test Name: PO2; Test Result: 92 %; Comments: 92% under O2; Test Date: 20210811; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: identified Delta Variant; Test Date: 20210810; Test Name: COVID-19 test antigen; Test Result: Positive
CDC Split Type: FRPFIZER INC202101166381

Write-up: Cardio-respiratory arrest; COVID-19; bronchial congestion; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority; FR-AFSSAPS-NC20213970. A 91-year-old female patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: EJ6789), intramuscular, administered in arm left on 04Feb2021 as dose 2, single and first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: EM0477), intramuscular, administered in arm right on 03Jan2021 as dose 1, single for covid-19 immunisation. The patient''s medical history included pulmonary embolism from Mar2019, advanced old alzheimer''s, total dependence (GIR1) and arterial hypertension. The patient''s concomitant medications were not reported. The patient experienced bronchial congestion, afebrile, SAT 92% under O2 on 10Aug2021, cluster of COVID-19 in progress and positive test on 11Aug2021. Patient was living in home. The patient underwent lab tests and procedures on 10Aug2021 included body temperature resulted into afebrile, PO2 and resulted into 92% under O2, antigen test for COVID-19 and resulted into positive and on 11Aug2021, COVID-19 PCR test resulted into positive and identified Delta Variant. She received treatments included oxygen therapy at 5L / min, lovenox, ceftriaxone 1g, anticoagulant. The patient seemed to be doing better with regression of the bronchial congestion. However, on 21Aug2021, she died suddenly from cardiopulmonary arrest without any other symptoms prior to the end of nursing care, that was 11 days after the onset of the COVID-19 infection. No resuscitation or additional investigation. Death by cardiopulmonary arrest in a context of COVID-19 despite a vaccination schedule completed with a 2nd dose of Comirnaty 6 months previously. The autopsy was not performed. The outcome of events covid-19 and bronchial congestion was unknown and outcome of events vaccination failure and cardio-respiratory arrest was fatal on 21Aug2021. No follow-up attempts were possible. No further information was expected.; Reported Cause(s) of Death: cardiopulmonary arrest


VAERS ID: 1698479 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-14
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003610 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes mellitus inadequate control; Hypertension arterial
Preexisting Conditions: Medical History/Concurrent Conditions: Triple vessel bypass graft
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Arrest cardiac; This case was received via Regulatory Authority (Reference number: FR-AFSSAPS-PS20211985) on 06-Sep-2021 and was forwarded to Moderna on 06-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of CARDIAC ARREST (Arrest cardiac) in a 66-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3003610) for COVID-19 immunisation. The patient''s past medical history included Triple vessel bypass graft. Concurrent medical conditions included Diabetes mellitus inadequate control and Hypertension arterial. On 30-Jun-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced CARDIAC ARREST (Arrest cardiac) (seriousness criteria death and medically significant). The patient died on 14-Jul-2021. The reported cause of death was Arrest cardiac. It is unknown if an autopsy was performed. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Treatment information was not reported. Very limited information regarding this event has been provided at this time. Further information has been requested. However, this patient''s multiple underlying medical conditions (Diabetes mellitus inadequately control, arterial hypertension, triple vessels bypass) remains a contributory factor.; Sender''s Comments: Very limited information regarding this event has been provided at this time. Further information has been requested. However, this patient''s multiple underlying medical conditions (Diabetes mellitus inadequately control, arterial hypertension, triple vessels bypass) remains a contributory factor.; Reported Cause(s) of Death: Arrest cardiac


VAERS ID: 1698527 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-08-15
   Days after vaccination:165
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, COVID-19, General physical health deterioration, Oxygen saturation, Pneumonitis, Respiratory disorder, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Interstitial lung disease (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (narrow), Hypersensitivity (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: 2021-08-28
   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: ALLOPURINOL; ESCITALOPRAM; FUROSEMIDE; KARDEGIC; MIRTAZAPINE; SERESTA; FINASTERIDE; MACROGOL; PARACETAMOL; ZYMAD
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Basal cell carcinoma (basal cell carcinoma of the nose); Benign prostatic hypertrophy; Conduction disorders (Cardiac conductive disorders); Depression (depressive syndrome); Diffuse Lewy body disease (Lewy body disease); Glaucoma both eyes (bilateral glaucoma); Hypertension arterial; Hyperuricaemia; Obstructive sleep apnea syndrome (Obstructive sleep apnea syndrome with a machine)
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: saturation; Test Result: 88 %; Comments: SAT 88; Test Date: 20210818; Test Name: PCR positive; Test Result: Positive ; Comments: positive nucleocapsid RNA strong CT value 20.4, positive polymerase RNA strong CT value 20.8
CDC Split Type: FRPFIZER INC202101155535

Write-up: asthenic; respiratory deterioration; Vaccination failure; covid-19; Alteration of general condition; pneumonitis without signs of severity; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority. The regulatory authority report number is FR-AFSSAPS-SE20212328. A 92-year-old male patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Injection site: unspecified, Lot Number: EP2166), intramuscularly on 03Mar2021 as dose 2, single and first dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Injection site: unspecified, Lot Number: EJ6789), intramuscularly on 10Feb2021 as dose 1, single for covid-19 immunisation. The patient''s medical history included Hyperuricaemia, basal cell carcinoma of the nose, benign prostatic hypertrophy, Lewy body disease, Hypertension arterial, Obstructive sleep apnea syndrome with a machine, depressive syndrome, bilateral glaucoma and Cardiac conductive disorders from unspecified date. COVID-19 ANTECEDENTS: person at risk of developing a severe form of COVID-19: Yes, person who had COVID-19: Yes (vaccine failure), person who has been tested: 18Aug2021 (PCR positive, Delta variant). Concomitant medications included allopurinol (ALLOPURINOL) taken for an unspecified indication, escitalopram (ESCITALOPRAM) taken for an unspecified indication, furosemide (FUROSEMIDE) taken for an unspecified indication, acetylsalicylate lysine (KARDEGIC), 75mg taken for an unspecified indication, mirtazapine (MIRTAZAPINE) taken for an unspecified indication, oxazepam (SERESTA) taken for an unspecified indication, finasteride (FINASTERIDE) taken for an unspecified indication, macrogol (MACROGOL) taken for an unspecified indication, paracetamol (PARACETAMOL) taken for an unspecified indication and colecalciferol (ZYMAD) taken for an unspecified indication from unspecified date. It was reported that 1st signs of infection on 15Aug21 with cough, fever, Alteration of general condition, pneumonitis without signs of severity. Vaccine failure attested by PCR on 18Aug21 (positive nucleocapsid RNA strong CT value 20.4, positive polymerase RNA strong CT value 20.8). Treatment included ROCEPHINE 1g/d, LOVENOX 4000UI/d, SOLUMEDROL 40mg/d, Oxygen therapy 2l/min, hydration was started. On an unspecified date, the patient remained asthenic for 2 weeks with good vitals and no signs of respiratory distress. On 26Aug2021, a respiratory deterioration was noted with SAT 88, improved by corrective measures, but sudden death on 28Aug2021. The patient underwent lab tests and procedures which included saturation (oxygen saturation): 88 % (SAT 88) on 26Aug2021, PCR positive (sars-cov-2 test): positive on 18Aug2021 (positive nucleocapsid RNA strong CT value 20.4, positive polymerase RNA strong CT value 20.8.). The case was medically confirmed. Evolution: death. Conclusion was reported as confirmed vaccine failure (COMIRNATY vaccine), leading to the patient''s death. It was not reported if an autopsy was performed. The outcome of event, respiratory deterioration was recovered, vaccination failure and covid-19 resulting in death and other events was unknown. No follow-up attempts possible. No further information expected. Information on lot number already obtained.; Reported Cause(s) of Death: covid-19 infection


VAERS ID: 1698619 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA8016 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Death, Faecaloma, Fatigue, Haematoma, International normalised ratio, International normalised ratio increased, Myocardial infarction, Skin ulcer, Ultrasound scan
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-24
   Days after onset: 84
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: Medical History/Concurrent Conditions: Lung cancer; Renal cancer
Allergies:
Diagnostic Lab Data: Test Date: 202106; Test Name: body temperature; Result Unstructured Data: Test Result:No fever; Test Date: 20210601; Test Name: INR; Result Unstructured Data: Test Result:3; Test Date: 20210604; Test Name: INR; Result Unstructured Data: Test Result:6.8; Test Date: 202106; Test Name: INR; Result Unstructured Data: Test Result:normal; Test Date: 202106; Test Name: abdominal echography; Result Unstructured Data: Test Result:normal
CDC Split Type: FRPFIZER INC2021701505

Write-up: fecal impaction; heart attack; Patient died on 24Aug2021 from an outbreak of his kidney cancer, which metastasized to his lungs.; Giant hematoma on the half of torso and back; INR Increased; extreme fatigue; Small spot of few millimeters, like an ulceration, of greenish color, in the back; This is a spontaneous report from a contactable consumer or other non-health care professional (patient''s wife) on behalf of her husband who is a physician. A 74-year-old male patient received first dose of BNT162B2 (COMIRNATY; Solution for injection, Lot Number: FA8016/Batch number was not reported) via an unspecified route of administration on 02Jun2021 (at the age of 74 years old) as single dose for COVID-19 immunisation. The patient''s medical history included renal cancer and lung cancer. The patient''s concomitant medications were not reported. The patient experienced INR increased (international normalised ratio increased) on 04Jun2021, giant hematoma on the half of torso and back on 05Jun2021, Patient died on 24Aug2021 from an outbreak of his kidney cancer, which metastasized to his lungs, extreme fatigue (2-3 days after injection), small spot of fewmillimeters, like an ulceration, of greenish color, in the back on an unspecified date in Jun2021, fecal impaction and heart attack on an unspecified date in 2021. The case assessed as serios death (death, medically significant) and fecal impaction, heart attack (hospitalized, medically significant). The patient went to emergencies. The patient underwent lab tests and procedures which included body temperature: no fever in Jun2021, international normalised ratio: normal in Jun2021, international normalised ratio: 3 on 01Jun2021 (the day before injection), international normalised ratio: 6.8 on 04Jun2021, abdominal ultrasound scan: normal on an unspecified date in Jun2021. The outcome of the event Patient died on 24Aug2021 from an outbreak of his kidney cancer, which metastasized to his lungs was fatal, hematoma on the half of torso and back was resolving, not resolved for extreme fatigue, unknown for small spot of fewmillimeters, like an ulceration, of greenish color, in the back, and for INR increased (international normalised ratio increased) resolved on an unspecified date in Jun2021 and other events was unknown. It was not reported if an autopsy was performed. Follow up (07Sep2021): This is a follow up report received from the wife of the deceased patient. New information included: Added new events Fecal impaction and Heart attack. Cause of death (Metastasized to lungs) was added. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: kidney cancer; metastasized to lungs


VAERS ID: 1698647 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Fatigue, Feeling cold, Gait inability, Headache, Hypersensitivity, Muscular weakness, Myocardial infarction, Pain, Pain in jaw, Palpitations, Pharyngeal swelling, Swelling face
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Peripheral neuropathy (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, arterial (narrow), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Osteonecrosis (broad), Hypersensitivity (narrow), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101138068

Write-up: Heart palpitations, swollen throat, headache, chest pain, jaw pain, tiredness, unable to walk, weak legs, stabbing pains; Heart palpitations, swollen throat, headache, chest pain, jaw pain, tiredness, unable to walk, weak legs, stabbing pains; Heart palpitations, swollen throat, headache, chest pain, jaw pain, tiredness, unable to walk, weak legs, stabbing pains; Heart palpitations, swollen throat, headache, chest pain, jaw pain, tiredness, unable to walk, weak legs, stabbing pains; Heart palpitations, swollen throat, headache, chest pain, jaw pain, tiredness, unable to walk, weak legs, stabbing pains; Heart palpitations, swollen throat, headache, chest pain, jaw pain, tiredness, unable to walk, weak legs, stabbing pains; Heart palpitations, swollen throat, headache, chest pain, jaw pain, tiredness, unable to walk, weak legs, stabbing pains; Heart palpitations, swollen throat, headache, chest pain, jaw pain, tiredness, unable to walk, weak legs, stabbing pains; Heart palpitations, swollen throat, headache, chest pain, jaw pain, tiredness, unable to walk, weak legs, stabbing pains; Feeling cold; Swelling face; Hypersensitivity; suspected heart attack; .This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority. The regulatory authority report number is GB-MHRA-EYC 00259479, Safety Report Unique Identifier GB-MHRA-ADR 25865853. A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FE3380), parenterally on 24Aug2021 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 24Aug2021, the patient experienced heart palpitations, swollen throat, headache, chest pain, jaw pain, tiredness, unable to walk, weak legs, stabbing pains, feeling cold, swelling face and hypersensitivity. On receipt of the first vaccine the patient had a cold feeling in body and stabbing pains all over. After 4 hours the patient was unsteady on feet, headache, chest pains, face swelling, throat swelling, heart palpitations and unable to walk. Symptoms improved after 2 hours. After 24 hours symptoms came back worse, admitted to hospital with suspected heart attack. After 5 days symptoms still present but starting to subside. Advised by health care workers and doctor that the patient had an allergic reaction to the vaccination and not to take second dose. The event palpitations caused death, hospitalization and considered medically significant and all other events caused hospitalization and considered medically significant. At the time of the death, the outcome of all the events was recovering except for the event heart attack it was unknown. The patient died on an unspecified date due to heart palpitations. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Heart Palpitations


VAERS ID: 1699123 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, SARS-CoV-2 test
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-19
   Days after onset: 8
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210214; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101152208

Write-up: Stroke; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109021900415440-ZXL2Y, Safety Report Unique Identifier GB-MHRA-ADR 25888589. A 70-year-old male patient (age at vaccination: 70-year-old) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot unknown), via an unspecified route of administration on 11Feb2021 11:00 as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced stroke on 11Feb2021. It was further reported that the patient had dose 1 of the vaccine and the same night he had stroke and was hospitalized the following Sunday (14Feb2021) and died the following Friday, 19Feb2021. The event was reported as serious, hospitalization and disability. The patient underwent laboratory test which included Sars-cov-2 test: negative on 14Feb2021. It was not reported 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: Stroke


VAERS ID: 1699162 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-17
Onset:2021-04-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER1749 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-21
   Days after onset: 34
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: REGORAFENIB
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hepatic cancer; Sepsis
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101161098

Write-up: Sepsis; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109042228180330-2PBXF. Safety Report Unique Identifier GB-MHRA-ADR 25896866. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 17Apr2021 (Batch/Lot Number: ER1749) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included sepsis, hepatic cancer from an unknown date. Patient had not had symptoms associated with COVID-19. Concomitant medication included regorafenib taken for hepatic cancer, start and stop date were not reported. The patient experienced sepsis on 17Apr2021. The patient was admitted to hospital 8 days after vaccination. He was discharged after 9 days. He was still very poorly. He was readmitted 2 weeks later. He died of sepsis after two nights in hospital. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: negative, No - Negative COVID-19 test on an unspecified date. The patient died on 21May2021. It was not reported if an autopsy was performed. The outcome of event sepsis was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sepsis


VAERS ID: 1699204 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-27
Onset:2021-08-31
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, COVID-19, Fibrin D dimer, Heparin-induced thrombocytopenia test, Platelet count, SARS-CoV-2 test
SMQs:, Guillain-Barre syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-01
   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: Malignant breast neoplasm; Non-smoker; Transplant (Recently had a bone marrow transplant or taking medicines following a transplant (e.g. kidney, l...)
Allergies:
Diagnostic Lab Data: Test Name: D-dimer; Result Unstructured Data: Test Result:Unknown Result; Test Name: Anti-PF4 antibodies; Result Unstructured Data: Test Result:Unknown Result; Test Name: Platelet count; Result Unstructured Data: Test Result:Unknown Result; Comments: <150 A- 109/L; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Date: 20210831; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC202101168194

Write-up: Slightly debilitating; SARS-CoV-2 infection; This is a spontaneous report from a contactable other healthcare professional received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109062226036260-XM9XT, Safety Report Unique Identifier is GB-MHRA-ADR 25903681. A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 27Aug2021 (Lot number was not reported) as dose 2, single for COVID-19 immunisation. Medical history included malignant breast neoplasm, transplant (recently had a bone marrow transplant or taking medicines following a transplant (e.g. kidney, l), non-smoker all from an unknown date. Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. Patient is not enrolled in clinical trial. The patient experienced SARS-COV-2 infection on 31Aug2021 and slightly debilitating on an unspecified date. The patient underwent lab tests and procedures which included D-dimer $g4000 with unknown result, anti-PF4 antibodies identified with unknown result, platelet count <150 A- 109/L with unknown result, SARS-COV-2 test with negative result all on an unspecified date; positive on 31Aug2021. The patient died on 01Sep2021. It was not reported 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: SARS-CoV-2 infection; Slightly debilitating


VAERS ID: 1699287 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-27
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute disseminated encephalomyelitis, Acute myocardial infarction, Angiocardiogram, Angiogram, Anti-GAD antibody, Anti-neuronal antibody, Antibody test, Aphasia, Blood immunoglobulin G, Blood pressure increased, Blood pressure measurement, Brain death, Brain oedema, Carbohydrate antigen 125, Carbohydrate antigen 15-3, Carbohydrate antigen 19-9, Cerebral artery thrombosis, Cerebral haemorrhage, Cerebrovascular accident, Chest pain, Coma, Computerised tomogram abdomen, Computerised tomogram head, Computerised tomogram thorax, Demyelination, Depressed level of consciousness, Fibrin D dimer, Haematoma, Hypertensive crisis, Hyperventilation, Hypoaesthesia, Intracranial pressure increased, Lumbar puncture, Magnetic resonance imaging head, Methylenetetrahydrofolate reductase gene mutation, Muscular weakness, Platelet count, Prothrombin time, Pulmonary thrombosis, Pyramidal tract syndrome, Stress cardiomyopathy, Subarachnoid haemorrhage, Troponin increased, Ultrasound Doppler, Weight
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Congenital, familial and genetic disorders (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Optic nerve disorders (broad), Cardiomyopathy (narrow), Demyelination (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Other ischaemic heart disease (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad), Sexual dysfunction (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-08-25
   Days after onset: 29
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Non-smoker; SARS-CoV-2 infection
Allergies:
Diagnostic Lab Data: Test Date: 20210727; Test Name: coronary angiography; Test Result: Negative ; Comments: normal; Test Date: 20210816; Test Name: Angiography; Result Unstructured Data: Test Result:ABNORMAL: Showed thrombosis; Comments: ABNORMAL: Showed thrombosis of the left middle cerebral artery and a segmental branch of the right upper lobe of the lung. Computed tomography angiography; Test Date: 20210816; Test Name: brain CTA; Result Unstructured Data: Test Result:1 cm thrombus in the M1 branch of the left MCA; Comments: 1 cm thrombus in the M1 branch of the left middle cerebral artery and a small contrast deficit in a segmental branch of the right upper lobe of the lung, respectively.; Test Name: antibodies against membrane neuronic antigens; Result Unstructured Data: Test Result:Unknown results; Test Name: antibodies IgG against NMDA-R; Result Unstructured Data: Test Result:Unknown results; Test Name: detection of antibodies against anti-glutamic acid decarboxylase; Result Unstructured Data: Test Result:Unknown results; Test Name: antibodies (IgG) against neuronal antigens; Test Result: Negative ; Test Name: detection of immunoglobulin oligoclonal bands igg of cerebrospinal fluid/anososphere and albumines IgG determination of cerebrospinal fluid and serum; Result Unstructured Data: Test Result:Unknown results; Test Name: Blood pressure; Result Unstructured Data: Test Result:180/10 mmHg; Comments: increased: systolic 180 mmHg and diastolic 10 mmHg; Test Date: 20210816; Test Name: Cancer antigen 125; Result Unstructured Data: Test Result:5995 IU/ml; Test Date: 20210819; Test Name: Cancer antigen 125; Result Unstructured Data: Test Result:2916 IU/ml; Test Date: 20210816; Test Name: Cancer antigen 15-3; Result Unstructured Data: Test Result:800 IU/ml; Test Date: 20210819; Test Name: Cancer antigen 15-3; Result Unstructured Data: Test Result:460.10 IU/ml; Test Date: 20210816; Test Name: Cancer antigen 19-9; Result Unstructured Data: Test Result:449 IU/ml; Test Date: 20210819; Test Name: Cancer antigen 19-9; Result Unstructured Data: Test Result:403.57 IU/ml; Test Name: CT upper-lower abdomen; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210816; Test Name: brain CT; Result Unstructured Data: Test Result:1 cm thrombus in the M1 branch of the left MCA; Comments: 1 cm thrombus in the M1 branch of the left middle cerebral artery and a small contrast deficit in a segmental branch of the right upper lobe of the lung, respectively.; Test Date: 20210816; Test Name: brain CT; Result Unstructured Data: Test Result:subarachnoid hemorrhage, intracerebral hematomas; Comments: revealed subarachnoid hemorrhage, mainly on the left, and large intracerebral hematomas on the right frontobrachial, left frontobrachial and left basal ganglia, as well as edema.; Test Date: 20210817; Test Name: brain CT; Result Unstructured Data: Test Result:slightly hyponuclear imaging; Comments: a new brain CT was performed which revealed slightly hyponuclear imaging of the cerebral parenchyma right temporal occipitally, improvement in terms of hyponuclear imaging of the brainstem and no differentiation of the hemorrhagic elements.; Test Name: CT chest; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210816; Test Name: CT pulmonary angiogram; Result Unstructured Data: Test Result:1 cm thrombus in the M1 branch of the left MCA; Comments: 1 cm thrombus in the M1 branch of the left middle cerebral artery and a small contrast deficit in a segmental branch of the right upper lobe of the lung, respectively.; Test Date: 20210814; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:7.87 mg/l; Test Date: 20210814; Test Name: Lumbar puncture/spinal tap; Result Unstructured Data: Test Result:Unknown results; Test Name: MRI brain; Result Unstructured Data: Test Result:localized demyelination (mainly on the right); Test Date: 20210810; Test Name: MRI brain; Result Unstructured Data: Test Result:indicated acute diffused encephalomyelitis; Comments: showed scattered foci of abnormal signal intensity in both cerebral hemispheres, especially on the right side with lesions affecting both the ciliary cortex and the semicircular centers, as well as the subcortical white matter with an enhancement pattern more indicative of subcortical enrichment, without clear subarachnoid dispersion. The lesions are characterized by increased signal intensity in the DWI sequence, and a nodular focus of enhancement in the right ethusocochlear nerve is highlighted. The whole picture is suspicious of active demyelination, possibly in the context of acute diffuse encephalomyelitis (ADEM); Test Date: 202108; Test Name: MTHFR gene mutation; Result Unstructured Data: Test Result:HETEROZYGOUS (A1298C); Test Name: count of platelets; Result Unstructured Data: Test Result:normal; Test Date: 20210814; Test Name: Prothrombin time; Test Result: 13.8 s; Test Date: 20210727; Test Name: carotid TRIPLEX; Result Unstructured Data: Test Result:without findings; Test Name: weight; Test Result: 78 kg
CDC Split Type: GRPFIZER INC202101155998

Write-up: Blood pressure increased: systolic 180 mmHg and diastolic 10 mmHg.; Localized demyelination (mainly on the right); Intraparenchymal hematomas; Possible acute disseminated encephalomyelitis; Cerebral hemorrhage; Subarachnoid hemorrhage; Cerebral edema; increased intracranial pressure; drop in level of consciousness; hyperpnea; Coma; Takotsubo cardiomyopathy; Precordial pain; Cerebrovascular event; non-STEMI infarction; Numbness of extremities; Serum troponin increased; Brain death; Difficulty in holding items; Hypertensive crisis; Aphasic disorders; Thrombosis of the left middle cerebral artery and a segmental branch of the right upper lobe of the lung.; Thrombosis of the left middle cerebral artery and a segmental branch of the right upper lobe of the lung.; Pyramidal tract syndrome; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority number GR-GREOF-20217168. A 48-years-old female patient received first dose of bnt162b2 (COMIRNATY), intramuscular on 17Jul2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history included SARS-CoV-2 infection and she had been infected with COVID-19 in Nov2020 (mild hospitalization) and Non-smoker. She had not used Alcohol and no allergies. Brother passed away at age 26 from seminoma (testicular cancer). The patient''s concomitant medications were not reported. The patient experienced brain death on an unspecified date (considered as serious with death, medically significant and life-threatening). The patient experienced thrombosis of the left middle cerebral artery and a segmental branch of the right upper lobe of the lung on 16Aug2021 with outcome of unknown, blood pressure increased: systolic 180 mmhg and diastolic 10 mmhg on an unspecified date with outcome of unknown, localized demyelination (mainly on the right) on an unspecified date with outcome of unknown, numbness of extremities on 27Jul2021 with outcome of unknown, serum troponin increased on 27Jul2021 with outcome of unknown, intraparenchymal hematomas on an unspecified date with outcome of unknown, possible acute disseminated encephalomyelitis on an unspecified date with outcome of unknown, pyramidal tract syndrome on 16Aug2021 with outcome of unknown, difficulty in holding items on an unspecified date with outcome of unknown, aphasic disorders on 16Aug2021 with outcome of unknown, cerebral hemorrhage on an unspecified date with outcome of unknown, cerebrovascular event on 27Jul2021 with outcome of unknown, non-stemi infarction on 27Jul2021 with outcome of unknown, subarachnoid hemorrhage on an unspecified date with outcome of unknown, cerebral edema on an unspecified date with outcome of unknown, precordial pain on 27Jul2021 with outcome of unknown, hypertensive crisis on an unspecified date with outcome of unknown, coma on 16Aug2021 with outcome of unknown, considered as serious with medically significant and life-threatening. The patient also experienced Takotsubo cardiomyopathy on 27Jul2021, increased intracranial pressure, drop in level of consciousness and hyperpnea. The patient underwent lab tests and procedures which included: Angiography on 16Aug2021 ABNORMAL: Showed thrombosis of the left middle cerebral artery and a segmental branch of the right upper lobe of the lung; Computed tomography angiography: brain CTA on 16Aug2021: 1 cm thrombus in the M1 branch of the left middle cerebral artery and a small contrast deficit in a segmental branch of the right upper lobe of the lung, respectively; carbohydrate antigen 125: 5995 iu/ml on 16Aug2021; carbohydrate antigen 125: 2916 iu/ml on 19Aug2021; carbohydrate antigen 15-3: 800 iu/ml on 16Aug2021; carbohydrate antigen 15-3: 460.10 iu/ml on 19Aug2021; carbohydrate antigen 19-9: 449 iu/ml on 16Aug2021; carbohydrate antigen 19-9: 403.57 iu/ml on 19Aug2021; brain computerised tomogram on 16Aug2021: 1 cm thrombus in the M1 branch of the left middle cerebral artery and a small contrast deficit in a segmental branch of the right upper lobe of the lung, respectively, brain computerised tomogram on 16Aug2021: subarachnoid hemorrhage, intracerebral hematomas revealed subarachnoid hemorrhage, mainly on the left, and large intracerebral hematomas on the right frontobrachial, left frontobrachial and left basal ganglia, as well as edema; brain computerised tomogram on 17Aug2021: a new brain CT was performed which revealed slightly hyponuclear imaging of the cerebral parenchyma right temporal occipitally, improvement in terms of hyponuclear imaging of the brainstem and no differentiation of the hemorrhagic elements; CT pulmonary angiogram on 16Aug2021: 1 cm thrombus in the M1 branch of the left middle cerebral artery and a small contrast deficit in a segmental branch of the right upper lobe of the lung, respectively, fibrin d dimer: 7.87 mg/l on 14Aug2021, lumbar puncture on 14Aug2021; methylenetetrahydrofolate reductase gene mutation: heterozygous (a1298c) on Aug2021. On 27Jul2021, Ten days after the vaccination, the patient developed increased serum troponin (she was hospitalized and there she underwent coronary angiography which was negative). Also, she underwent carotid TRIPLEX which was also without findings. She also developed numbness of left upper limb with difficulty in holding items. Blood pressure increased (180/10) and furthermore she underwent MRI of brain with image of localized demyelination (mainly on the right). She was transferred to another hospital, where she underwent a complete check (spinal tap). She subsequently suffered from a cerebrovascular event, ending up in brain death. During her hospitalization she suffered from a cerebrovascular event, diagnosed also with thrombosis (normal count of platelets), despite the fact that she was on anticoagulation medication and she underwent thrombolysis. She was then transferred to another hospital for a thrombectomy and after the onset of a cerebral haemorrhage she was admitted to an intensive care unit. On 27Jul2021 hospitalization in a cardiology clinic with diagnosis non-STEMI infarction. On 10Aug2021 she underwent MRI due to the appearance of signs of left pyramidal tract syndrome. The findings were suspicious for active demyelination, possibly in the context of acute diffuse encephalomyelitis. On 13Aug2021 admission to the Hospital for further examination. On 16Aug2021 the female patient suffered from pyramidal tract syndrome (right) with aphasic disorders. The CTA showed thrombosis of the left middle cerebral artery (M1) and a segmental branch of the right upper lobe of the lung. On the same day the patient underwent thrombolysis with alteplase and due to therapeutic failure she was admitted to a General Hospital. Immediately after thrombectomy, the patient fell into coma (GCSQ 7/15) and was transferred intubated to a hospital where she had been hospitalized during the previous days. Brain CT showed subarachnoid hemorrhage mainly on the left and scattered extensive intraparenchymal hematomas and cerebral edema. On 17Aug2021 she underwent a left decompressive craniotomy and immediately postoperatively admitted in the intensive care unit. They had sent via email, results from, CT-CTA-BRAIN, CT angiography of pulmonary artery, CT brain, CT chest, CT upper-lower abdomen, hemostasis control, detection of antibodies against anti-glutamic acid decarboxylase, detection of immunoglobulin oligoclonal bands igg of cerebrospinal fluid, antibodies (IgG) against neuronal antigens was negative, antibodies IgG against NMDA-R, antibodies against membrane neuronic antigens, MRI of brain (10Aug2021) indicated acute diffused encephalomyelitis, molecular control, cancer indicators and anososphere and albumines IgG determination of cerebrospinal fluid and serum. Every imaging examination or laboratory test and etc general examinations, are in our disposal in order to be assessed from The National Pharmacovigilance Committee. The patient was hospitalized at the Neurology Clinic from 13Aug2021 to 17Aug2021, when she was transferred intubated to the ICU of our hospital, after having undergone a decompressive craniectomy of the left hemisphere, due to increased intracranial pressure, by the Doctors of the Neurosurgery Clinic. On 27Jul2021, ten days after vaccination, the patient first developed hypertensive spike and was transferred a General Hospital, where a high troponin value was found, so she underwent coronary angiography which was normal. It is reported that a diagnosis of Takotsubo cardiomyopathy was made. A few days later, and after being discharged from the hospital with the recommendation to continue taking specific medication (Duoplavin 1x1, Lopresor 100 mg 1/2x3, Atrost 20 mg 1x1, Nitrong 6 mg 1x2, Copalia 5/160 mg 1x1), the patient developed persistent dysfunction of the left hand limb, which after three days was also accompanied by a drop in the angle of the mouth on the left side. A brain MRI was performed on 10Aug2021 at the Diagnostic Center, which showed scattered foci of abnormal signal intensity in both cerebral hemispheres, especially on the right side with lesions affecting both the ciliary cortex and the semicircular centers, as well as the subcortical white matter with an enhancement pattern more indicative of subcortical enrichment, without clear subarachnoid dispersion. The lesions are characterized by increased signal intensity in the DWI sequence, and a nodular focus of enhancement in the right ethusocochlear nerve is highlighted. The whole picture is suspicious of active demyelination, possibly in the context of acute diffuse encephalomyelitis (ADEM). In the differential diagnoses the possibilities of ischemic lesions or secondary localizations due to neoplasia are mentioned as more remote. The patient was admitted to the Neurology Clinic, on a general duty day, on 13Aug2021, for further investigation and treatment of the pathological findings of the brain imaging. Clinically, she presented with left pyramidal syndrome (weakness of the left upper limb and drooping of the mouth angle on the left, with plantar reflexes in flexion bilaterally). On 14Aug2021, being haemodynamically stable and unresponsive, the patient underwent lumbar puncture and subsequently started Solu-medrol 1 g/day as part of ADEM therapy. On 15Aug2021 the patient remained hemodynamically stable, unresponsive, and clinically stable. On 16Aug2021 07:40 the patient presented with right limb hemiplegia (right limb paralysis), emission aphasia (mute), gaze shift to the left, right mouth angle drop with Babinski''s sign (+) intact (NIHSS = 20/42). Emergency brain CT, brain CTA and chest CTPA were performed, which revealed the presence of a ca. 1 cm thrombus in the M1 branch of the left middle cerebral artery and a small contrast deficit in a segmental branch of the right upper lobe of the lung, respectively. Therefore, considering the patient''s clinical picture and history, thrombolysis with 70 mg alteplase (patient weight: 78 kg) was performed with a starting time of 10:15. Upon completion of thrombolysis, the patient remained haemodynamically stable with NIHSS = 19/42 (no improvement in her clinical status). Subsequently, after consultation, she was transferred to the General Hospital for mechanical thrombectomy. During the thrombectomy the patient remained alert and haemodynamically stable. However, upon completion of the procedure, and after the thrombus was removed, the patient presented a drop in level of consciousness and hyperpnea, and was intubated with GCS = 7/15. She was then returned by ambulance to our hospital, where she underwent a brain CT scan, which revealed subarachnoid hemorrhage, mainly on the left, and large intracerebral hematomas on the right frontobrachial, left frontobrachial and left basal ganglia, as well as edema. On 17Aug2021, and while the patient remained isocaloric with a positive photomotor reflex, a new brain CT was performed which revealed slightly hyponuclear imaging of the cerebral parenchyma right temporal occipitally, improvement in terms of hyponuclear imaging of the brainstem and no differentiation of the hemorrhagic elements. Subsequently, the patient underwent decompressive craniectomy by the physicians of the Department of Neurosurgery and then transferred to the ICU. During her hospitalization, her neurological situation worsened and led to brain death. She died on 25Aug2021. It was not reported if an autopsy was performed. Sender''s comments: Initial report with follow-up information. Amendment: Has been added the reaction ADEM. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Brain death


VAERS ID: 1699309 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Metastases to lung, Pulmonary imaging procedure
SMQs:, Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-27
   Days after onset: 117
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: Lung lobectomy; Lung neoplasm NOS
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: Pulmonary imaging procedure; Result Unstructured Data: Test Result:clean lung image; Test Date: 202104; Test Name: Pulmonary imaging procedure; Result Unstructured Data: Test Result:metastases in the right lobe of the lung; Comments: metastases in the right lobe of the lung, about 1/3 of the respiratory surface remained
CDC Split Type: HUPFIZER INC202101158299

Write-up: Metastasis in lung/dyspnoea; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Agency-WEB, regulatory authority number HU-OGYI-719221. This spontaneous, serious case was reported by a patient''s relative on 23/08/2021, concerning the occurrence of metastasis in lung after the administration of Comirnaty concentrate for dispersion for injection (30 micrograms of COVID-19 mRNA Vaccine, MAH: BioNTech Manufacturing GmbH/ Pfizer). On 01/04/2021 (at the vaccination age of 60 years old), the 60-year-old female patient received the first dose of Comirnaty (COVID-19 mRNA Vaccine (nucleoside modified)/ Tozinameran) concentrate for dispersion for injection (strength: 1 dose (0.3 mL) contains 30 micrograms of COVID-19 mRNA Vaccine, intramuscularly, batch number: unknown) for COVID-19 immunisation. On 01/04/2021, the patient experienced dyspnoea, and in the end of 04/2021, metastases were found in the right lobe of the lung by unspecified pulmonary imaging procedure, approximately 1/3 of the lung surface remained clean. The patient died on 27/07/2021 among the symptoms of respiratory arrest. There is no information about whether autopsy was done. Medical history included lung lobectomy in 03/2021 due to a tumor. Clean image of the lung was seen in 01/2021.Concomitant medications were unspecified antihipertensive and antidiabetic medication. No further information is expected. Sender''s comments: Metastases occurred in lung within a month, and the patient died 3 months after Comirnaty vaccination. There is no information about whether autopsy was done. The causal relationship between the reported event and Comirnaty is unassessable. The case is serious due to fatal outcome. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Metastasis in lung/dyspnoea; Respiratory arrest


VAERS ID: 1699310 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-02-17
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, Chest X-ray, Disorientation, Drug ineffective, Dyspnoea, Pyrexia, SARS-CoV-2 test, Sepsis, Somnolence
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-24
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ELIQUIS; DIGOXIN; TANYDON HCT; MEDROL [METHYLPREDNISOLONE]; HUMA-FOLACID; CONCOR; SORBIFER DURULES [ASCORBIC ACID;FERROUS SULFATE]; TREXAN [METHOTREXATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atherosclerosis generalised; Chronic atrial fibrillation; Dilated cardiomyopathy; Hypertension; Seronegative rheumatoid arthritis
Allergies:
Diagnostic Lab Data: Test Date: 20210219; Test Name: Chest X-ray; Result Unstructured Data: Test Result:multifocal pneumonia, right side; Test Date: 20210217; Test Name: COVID-19 antigen test; Test Result: Positive
CDC Split Type: HUPFIZER INC202101158514

Write-up: On 17Feb2021, the patient experienced dyspnoea; COVID-19 pneumonia; The patient became septic, and died; The patient was somnolent and disoriented, feverish.; The patient was somnolent and disoriented, feverish.; The patient was somnolent and disoriented, feverish.; COVID-19 pneumonia; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number HU-OGYI-729221. An 82-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Lot Number: EJ6134), intramuscular on 27Jan2021 as dose 1, 0.3 ml, single for covid-19 immunisation. Medical history included arteriosclerosis generalised, chronic atrial fibrillation, hypertension, seronegative rheumatoid arthritis and dilated cardiomyopathy. Concomitant medications included apixaban (ELIQUIS); digoxin (MANUFACTURER UNKNOWN); hydrochlorothiazide/telmisartan (TANYDON HCT); methylprednisolone (MEDROL); folic acid (HUMA-FOLACID); bisoprolol fumarate (CONCOR); ascorbic acid/ferrous sulfate (SORBIFER DURULES); methotrexate (TREXAN). The patient experienced COVID-19 pneumonia, dyspnoea on 17Feb2021. The patient had somnolence, disorientation, fever, drug ineffective and became septic in 2021. The patient was hospitalized from 19Feb2021. It was reported that COVID-19 pneumonia occurred after 21 days, and the patient died 28 days after the first dose of Comirnaty. Autopsy was not done. Immunity might has not developed after the first dose of the vaccine. The case was serious due to hospitalization. The patient underwent lab tests and procedures which included chest x-ray: multifocal pneumonia, right side on 19Feb2021; sars-cov-2 test: positive on 17Feb2021. Therapeutic measures were taken antibiotic and antiviral therapy. The outcome of events somnolent, dyspnoea and disoriented, feverish was unknown. The patient died on 24Feb2021. The cause of death was reported as COVID-19 pneumonia and septic. An autopsy was not performed. No follow-up attempts possible. No further information expected. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: sepsis; COVID-19 pneumonia; COVID-19 pneumonia


VAERS ID: 1699311 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-02-15
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Computerised tomogram thorax, Hepatic function abnormal, Hepatic lesion, Inflammation, Multiple organ dysfunction syndrome, Pancreatic enzymes, Pericardial effusion, Procalcitonin, Renal cyst, Renal mass, Sepsis
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Systemic lupus erythematosus (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), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-20
   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: CO VALSACOR; MEZITAN; TANYDON; CARDURA; CAVINTON FORTE; BETALOC [METOPROLOL SUCCINATE]
Current Illness: Cardiac insufficiency; Diabetes mellitus; Hypertension; Liver abscess; Renal insufficiency; Right bundle branch block
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210215; Test Name: abdominal CT; Result Unstructured Data: Test Result:multiple hepatic lesions, pericardial liquid; Comments: multiple hepatic lesions, pericardial liquid, renal cysts on the right side and renal mass on the left side; Test Date: 20210215; Test Name: Chest CT; Result Unstructured Data: Test Result:multiple hepatic lesions, pericardial liquid; Comments: multiple hepatic lesions, pericardial liquid, renal cysts on the right side and renal mass on the left side; Test Date: 20210215; Test Name: Hepatic function; Result Unstructured Data: Test Result:abnormal; Test Date: 20210215; Test Name: inflammatory parameters; Result Unstructured Data: Test Result:high; Test Date: 20210215; Test Name: pancreatic enzymes; Result Unstructured Data: Test Result:elevated; Test Date: 20210215; Test Name: procalcitonin; Result Unstructured Data: Test Result:high
CDC Split Type: HUPFIZER INC202101158512

Write-up: sepsis; renal mass on the left side; multi organ failure; multiple hepatic lesions; renal cysts on the right side; pericardial liquid; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority number HU-OGYI-729321. On 12/02/2021 at 13:41, the 81 years old male patient received the first dose of COMIRNATY (concentrate for dispersion injection; active substance: tozinameran - 1 dose (0.3 mL) contains 30 micrograms of COVID-19 mRNA vaccine; lot number: EL0725, expiry date: 31/03/2021, MAH: BioNTech Manufacturing GmbH) intramuscularly to the left upper arm for COVID-19 immunisation. On 15/02/2021, the patient was submitted to hospital because of abdominal pain. He was disoriented. Upon examination, his procalcitonin and inflammatory parameters were high. Hepatic function was abnormal, pancreatic enzymes were elevated. Chest and abdominal CT has found multiple hepatic lesions, pericardial liquid, renal cysts on the right side and renal mass on the left side. The patient''s condition was worsening, therefore he was submitted to ICU from gastroenterology. Sepsis and multi organ failure has occurred and he died on 20/02/2021. The outcome of sepsis and Renal mass were fatal and for other events are unknown. The patient''s medical history included hypertension, right bundle branch block, diabetes mellitus, renal insufficiency, hepatic abscess, and cardiac insufficiency.Concomitant medications included BETALOC (metoprolol), CARDURA (doxazosin), CAVINTON FORTE (vinpocetin), CO-VALSACOR (hydrochlorothiazide, valsartan), MEZITAN (trimetazidine) and TANYDON (telmisartan). The case was investigated by the national competent authority for vaccines. The investigator did not find any irregularities regarding the transportation and storage of the vaccine. No relationship was found between vaccination and death, it is contributed to the patient''s underlying diseases.; Sender''s Comments: Based on known temporal relationship the possibility of causal association between the reported events sepsis, renal mass, Renal cyst, hepatic lesion, pericardial effusion, multi organ failure, and the suspect drug BNT162B2 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: Sepsis; renal mass on the left side


VAERS ID: 1699466 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-10
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Haematoma, Peripheral circulatory failure
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

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

Write-up: This case was received via regulatory authority (Reference number: IT-MINISAL02-775005) 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 PERIPHERAL CIRCULATORY FAILURE in an 85-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-May-2021, the patient experienced PERIPHERAL CIRCULATORY FAILURE (seriousness criterion death) and HAEMATOMA (seriousness criterion death). The cause of death was not reported. It is unknown if an autopsy was performed. No concomitant medications were reported. No treatment information was provided. Company Comment: Very limited information regarding these events have been provided at this time. No further follow up information is expected. Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Follow up included no new information.; Sender''s Comments: Very limited information regarding these events have been provided at this time. No further follow up information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1699517 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-05-18
   Days after vaccination:61
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: CSF test, Creutzfeldt-Jakob disease, Magnetic resonance imaging
SMQs:, Dementia (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-12
   Days after onset: 86
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ISOPTINE; ACETYLSALICYLIC ACID; ATORVASTATIN; TIMOLOL; STILNOX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Glaucoma; Non-Hodgkin''s lymphoma (large cell non-Hodgkin''s lymphoma, 8 cycles of CT, complete remission since 2004 (follow up annu); Paroxysmal supraventricular tachycardia (two remote episodes of paroxysmal supraventricular tachycardia); Radical prostatectomy (Robotic radical prostatectomy for carcinoma in 2016: T1 N0 Gleason 6. annual follow-up, always)
Allergies:
Diagnostic Lab Data: Test Date: 20210827; Test Name: CSF; Result Unstructured Data: Test Result:Waiting for the results of the CSF tests; Test Date: 20210531; Test Name: MRI; Result Unstructured Data: Test Result:MRI abnormal; Comments: Signal changes in the right parietal cortex diffusion-weighted imaging / FLAIR of non-univocal iteration
CDC Split Type: ITPFIZER INC202101135850

Write-up: Jakob-Creutzfeldt disease; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority number IT-MINISAL02-775458. A 79-years-old male patient received bnt162b2 (COMIRNATY,Formulation:Solution for injection,Batch/Lot Number: ET1831), via intramuscularly administered in Arm Left on 18Mar2021 as Dose 2, 0.3mL, Single for covid-19 immunization. Medical history included supraventricular tachycardia from an unknown date and unknown if ongoing, two remote episodes of paroxysmal supraventricular tachycardia, radical prostatectomy from 01Jan2016 to an unknown date Robotic radical prostatectomy for carcinoma in 2016, T1 N0 Gleason 6. annual follow-up, always, glaucoma from an unknown date and unknown if ongoing, non-hodgkin''s lymphoma from an unknown date and unknown if ongoing, large cell non-Hodgkin''s lymphoma, 8 cycles of CT, complete remission since 2004 (follow up annual). Historical vaccination included the patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: EJ6790) via unspecified route on 25Feb2021 as Dose 1, Single for covid-19 immunization.Concomitant medication(s) included verapamil hydrochloride (ISOPTINE) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (ACETYLSALICYLIC ACID) taken for an unspecified indication, start and stop date were not reported; atorvastatin (ATORVASTATIN) taken for an unspecified indication, start and stop date were not reported; timolol (TIMOLOL) taken for an unspecified indication, start and stop date were not reported; zolpidem tartrate (STILNOX) taken for an unspecified indication, start and stop date were not reported. The patient experienced jakob-creutzfeldt disease (creutzfeldt-jakob disease) (death, hospitalization) on 18May2021. The patient was hospitalized for jakob-creutzfeldt disease (creutzfeldt-jakob disease) from 03Jun2021 to 09Jun2021. The patient underwent lab tests and procedures which included CSF test: waiting for the results of the csf tests on 27Aug2021, magnetic resonance imaging: mri abnormal on 31May2021. Signal changes in the right parietal cortex diffusion-weighted imaging / FLAIR of non-univocal iteration. Therapeutic measures were taken as a result of jakob-creutzfeldt disease (creutzfeldt-jakob disease). The patient died on 12Aug2021. An autopsy was not performed. Reporter''s comment: probable Creutzfeldt Jakob disease detection from mRNA vaccines - Actions taken (hydration-morphine-anticholinergic-anticonvulsants) - Ethnic origin (PRIVACY) - COVID 19 COMIRNATY VACCINE (PFIZER): Administration site (left shoulder) Booster dose number (2) second dose Pfizer 18Mar2021 (Lot ET1831) from April 2021. general malaise and dyspraxia, from May: ataxia. hallucinations. taste alterations, dysarthria, akinetic mutism, total dysphagia. First dose performed on 25Feb202 Sender''s comment: Regional Pharmacovigilance: Pending Lot Number. 25Aug2021 Regional Center for Pharmacovigilance : requests for follow-up information from the reporter regarding doc. medical case. 26Aug2021 hospital of PRIVACY: Pending final discharge letter, including the results of the CSF tests made 27Aug2021 Regional Center for Pharmacovigilance: the form is updated with the additional information provided by the reporter and the clinical report is attached. The autopsy was not done. LOT: ET1831 No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: probable Creutzfeldt Jakob disease detection from mRNA vaccines - Actions taken (hydration-morphine-anticholinergic-anticonvulsants) - Ethnic origin (PRIVACY) - COVID 19 COMIRNATY VACCINE (PFIZER): Administration site (left shoulder) Booster dose number (2) second dose Pfizer 18Mar2021 (Lot ET1831) from April 2021. general malaise and dyspraxia, from May: ataxia. hallucinations. taste alterations, dysarthria, akinetic mutism, total dysphagia. First dose performed on 25Feb202; Reported Cause(s) of Death: Jakob-Creutzfeldt disease


VAERS ID: 1699655 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-24
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Coma, Death
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-24
   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: COUMADIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101135998

Write-up: Death; Coma; Cerebral haemorrhage; This is a spontaneous report from a contactable consumer or other non-HCP from the regulatory authority, regulatory authority number IT-MINISAL02-777111. A 54-year-old male patient received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot number was not reported), intramuscular on an unspecified date as dose number unknwon single for COVID-19 immunization. The patient''s medical history was not reported. Concomitant medication included warfarin sodium (COUMADIN) taken for an unspecified indication, start and stop date were not reported. On 24Apr2021, the patient experienced death, coma, cerebral haemorrhage. The patient died on 24Apr2021. It was reported that the cause of death was coma, cerebral haemorrhage, death. It was not reported if an autopsy was performed. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Cerebral haemorrhage; Coma; Death


VAERS ID: 1699661 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-05-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-14
   Days after onset: 74
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 (was naturally immunized in Jan2021)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101135900

Write-up: Dad was naturally immunized in Jan2021, he was given a double dose of PFIZER (Feb and Mar), and died on 14Jul2021; Bilateral pneumonia; This is a spontaneous report from a contactable consumer or other non-healthcare professional downloaded from the Regulatory Authority. . An 86-year-old male patient received the second dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: ET7205, Expiration date not reported) via an unspecified route of administration on 31Mar2021 as single dose for COVID-19 immunisation. Medical history included COVID-19 from Jan2021 to an unknown date and was naturally immunized in Jan2021. The patient''s concomitant medications were not reported. Historical vaccine given to patient previously was first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: unknown, Expiration date not reported) via an unspecified route of administration on Feb2021 as single dose for COVID-19 immunisation. It was reported that reporter''s dad was naturally immunized in jan2021, he was given a double dose of Pfizer (In Feb2021 and Mar2021) on 01May2021, general physical health deterioration and experienced bilateral pneumonia, no swab and of course no correlation. The patient died on 14Jul2021. It was not reported if an autopsy was performed. Reporter''s comment: I am thrilled they authorize the use of this serum on kids over 12 years old, after a trial on 80 kids and I, nearby, know an 85-year-old diabetic who has been successfully cured twice by COVID, my father who was practically asymptomatic, had immunized in Jan2021, without problems, was then vaccinated in Feb2021 and Mar2021 with Pfizer, got progressively worse with hospitalization due to the absence of potassium (same symptom as another grandfather, who died this summer after. Sender''s comments: 23Aug2021 Local Centre of Pharmacovigilance contacted reporting after vaccination reports progressive deterioration of the state of health with the onset of pneumonia and death on 14Jul2021 requested clinical documentation. Waiting.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1699694 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-11
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Dermatitis bullous, Investigation, Limb injury, Septic shock, Skin lesion
SMQs:, Severe cutaneous adverse reactions (narrow), Toxic-septic shock conditions (narrow), Accidents and injuries (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-24
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LASIX [FUROSEMIDE]; INHIXA; DIBASE; INSULIN LISPRO; LANSOPRAZOLE; TOUJEO; RAMIPRIL; DEXAMETHASONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Brain injury; Diabetes; Lung adenocarcinoma (undergoing atypical resection of the upper left lung lobe in lateral thoracotomy in Oct 2020); Thoracotomy
Allergies:
Diagnostic Lab Data: Test Name: Impact on quality of life; Result Unstructured Data: Test Result:4/10
CDC Split Type: ITPFIZER INC202101155412

Write-up: lower limb injury; septic shock; fluid-filled blisters in the feet, from the knees down; fluid-filled blisters in the feet, from the knees down; This is a spontaneous report from a contactable consumer downloaded from the Agency. Regulatory authority number IT-MINISAL02-779310. A 67-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in right shoulder on 08Apr2021 (Lot Number: EW2246) as dose 1, 0.3 mL, single for covid-19 immunisation. Medical history included diabetes, lung adenocarcinoma (undergoing atypical resection of the upper left lung lobe in lateral thoracotomy in Oct 2020), single brain injury. Concomitant medications included furosemide (LASIX); enoxaparin sodium (INHIXA); colecalciferol (DIBASE); insulin lispro; lansoprazole; insulin glargine (TOUJEO); ramipril; dexamethasone. The patient experienced fluid-filled blisters in the feet, from the knees down, on 11Apr2021. On 18Apr2021, he had a septic shock, on 24Apr2021, he died. It was also reported that "Access to hospital for lower limb injury". Events resulted in "Physician Office Visit". The patient underwent lab tests and procedures which included Impact on quality of life (4/10). The outcome of event lower limb injury was unknown. The patient died from "fluid-filled blisters in the feet, from the knees down" and "septic shock" on 24Apr2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Dermatitis bullous; Skin lesion; septic shock


VAERS ID: 1699695 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-04
Onset:2021-01-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Renal failure, Respiratory failure, Underdose, Vasculitis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Vasculitis (narrow), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-29
   Days after onset: 236
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: ITPFIZER INC202101155364

Write-up: initial asthenia and respiratory insufficiency; initial asthenia and respiratory insufficiency/vasculitis diagnosis; initial asthenia and respiratory insufficiency; renal and respiratory failure; as 0.03 mL, single dose; This is a spontaneous report from a contactable physician downloaded from the Agency. Regulatory authority number IT-MINISAL02-779342. A 48-years-old male patient received first dose of bnt162b2 (COMIRNATY), via intramuscular, administered in Arm Right on 04Jan2021 (Batch/Lot Number: EL1484; Expiration Date: 01Apr2021) as 0.03 mL, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced failure respiratory, vasculitis and asthenia, on 12Jul2021. Seriousness provided as death. It was reported patient experienced initial asthenia and respiratory insufficiency. Therapeutic measures were taken as a result of failure respiratory, vasculitis, Renal failure and asthenia. Patient was hospitalized at resuscitation from 23Jul2021 and immunoglobulins dialysis treatment plasma exchange were administered. The outcome of events was fatal. The patient died on 29Aug2021. It was not reported if an autopsy was performed. Reporter Comment: renal and respiratory failure, vasculitis diagnosis.; Reporter''s Comments: renal and respiratory failure, vasculitis diagnosis; Reported Cause(s) of Death: Unknown cause of death; initial asthenia and respiratory insufficiency; initial asthenia and respiratory insufficiency/vasculitis diagnosis; initial asthenia and respiratory insufficiency


VAERS ID: 1699696 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-28
Onset:2021-06-29
   Days after vaccination:183
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral ischaemia, Renal failure, Respiratory failure, Vasculitis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Ischaemic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Vasculitis (narrow), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-05
   Days after onset: 37
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 INC202101157985

Write-up: cerebral ischemia; Renal failure; Vasculitis; respiratory failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority number IT-MINISAL02-779343. A 55-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Right on 28Dec2020 (lot number: EJ6796; expiration date: 28Dec2020) as dose 1, 0.03 mL, single (pending confirmation) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced renal and respiratory failure vasculitis diagnosis, kidney and respiratory insufficiency cerebral ischemia on 29Jun2021. The patient died on 05Aug2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: cerebral ischemia; Renal failure; Vasculitis; respiratory failure


VAERS ID: 1699911 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-07
Submitted: 0000-00-00
Entered: 2021-09-15
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: AUPFIZER INC202101139112

Write-up: Adverse event following immunisation/Outcome: Fatal; This is a spontaneous report from a contactable healthcare professional via the Regulatory Authority (RA). Regulatory authority report number is 611939. A 49-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) dose number unknown, single, for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced an adverse event following immunisation/outcome: fatal on 07Aug2021. The patient died on an unspecified date. The cause of death was unknown. It was not reported 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: Adverse event following immunisation/Outcome: Fatal


VAERS ID: 1699912 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-09
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Concomitant disease aggravated, Sepsis
SMQs:, Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101139114

Write-up: Concomitant disease aggravated; Sepsis; This is a spontaneous report from a contactable healthcare professional via the Regulatory Authority (RA). The regulatory authority report number is 613030. A 67-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 09May2021, the patient experienced concomitant disease aggravated and sepsis. The patient died on an unspecified date due to concomitant disease aggravated and sepsis. It was not reported 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: Concomitant disease aggravated; Sepsis


VAERS ID: 1699913 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-15
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: AUPFIZER INC202101139115

Write-up: Adverse event following immunisation; outcome: Fatal; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 610581. A 70-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Unknown if patient was pregnant at the time of vaccination. The patient experienced adverse event following immunisation; outcome: fatal on an unspecified date. The patient died on an unspecified date. It was not reported 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: Adverse event following immunisation; outcome: Fatal


VAERS ID: 1700046 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-04
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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 INC202101169638

Write-up: Cardiac arrest; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 613371. A 44-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Patient received the first dose of bnt162b2 (COMIRNATY) on unknown date for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced cardiac arrest on 04Aug2021. The patient died on an unspecified date. It was not reported 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: 1700047 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-15
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 INC202101169737

Write-up: Subarachnoid haemorrhage; This is a spontaneous report from a contactable other health professional via the regulatory auhority. Regulatory authority report number is 613645. A 57-year-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 medical history and concomitant medications were not reported. The patient experienced subarachnoid haemorrhage (death) on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. 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: 1700048 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Headache, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (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 INC202101169738

Write-up: Arthralgia; Headache; Vomiting; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 615012. A 54-year-old male 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 medical history and concomitant medications were not reported. The patient experienced arthralgia (death) on an unspecified date, headache (death) on an unspecified date, vomiting (death) on an unspecified date. The patient died on an unspecified date. It was not reported 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: Arthralgia; Headache; Vomiting


VAERS ID: 1700049 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-15
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 INC202101169739

Write-up: Cardiac arrest; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 617068. A 41-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection), 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 and concomitant medications were not reported. The patient experienced cardiac arrest (death) on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of 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: Cardiac arrest


VAERS ID: 1700986 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocarditis
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101169740

Write-up: Myocarditis; This is a spontaneous report from a contactable other health professional via the Regulatory Authority (RA). Regulatory authority report number is 615875. A 50-year-old male patient received unknown dose number of bnt162b2 (COMIRNATY) via an unspecified route of administration on an unspecified date (Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced myocarditis (death) on an unspecified date. The patient died on an unspecified date. It was not reported 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: Myocarditis


VAERS ID: 1700987 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-01
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Adverse event following immunisation, Malaise
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: AUPFIZER INC202101169741

Write-up: Adverse event following immunisation; Outcome - Fatal; Malaise; This is a spontaneous report from a contactable other health professional via the Regulatory Authority (RA). Regulatory authority report number is 616124. A 17-years-old male 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 medical history and concomitant medications were not reported. The patient experienced adverse event following immunisation; malaise on 01Sep2021. The outcome was fatal. The patient died on an unspecified date. It was not reported 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: Adverse event following immunisation; Malaise


VAERS ID: 1700988 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-28
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache
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: AUPFIZER INC202101169742

Write-up: Headache; This is a spontaneous report from a contactable other health professional via the Regulatory Authority (RA). Regulatory authority report number is 615803. A 43-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced headache on 28Aug2021. The outcome of the event was fatal. The patient died on an unspecified date. It was not reported 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: Headache


VAERS ID: 1701080 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure acute, Pericarditis, SARS-CoV-2 test
SMQs:, Cardiac failure (narrow), Systemic lupus erythematosus (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-22
   Days after onset: 51
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Gout; Hypertension; Insufficiency renal; Panic disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: SARS-CoV-2 PCR test; Test Result: Negative
CDC Split Type: CZPFIZER INC202101142485

Write-up: cardiac failure acute; pericarditis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB CZ-CZSUKL-21010315. A 55-year-old male patient received BNT162B2 (COMIRNATY), intramuscular on 29Jun2021 (Batch/Lot Number: Unknown) as dose 2, single for COVID-19 immunization. Medical history included hypertension, panic disorder, renal insufficiency and gout; all ongoing. Historical vaccine included BNT162B2 (COMIRNATY), on an unspecified date (Batch/Lot Number: Unknown) as dose 1, single for COVID-19 immunization. The patient''s concomitant medications were not reported. The patient experienced cardiac failure acute and pericarditis on Jun2021 which were fatal, life-threatening and disability. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 2021. The patient died on 22Jul2021. An autopsy was performed that revealed pericarditis. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: cardiac failure acute; with pericarditis; Autopsy-determined Cause(s) of Death: Pericarditis


VAERS ID: 1701164 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-09
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D020A / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19, Deep vein thrombosis, Fibrin D dimer, Pulmonary embolism, Pyrexia, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (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: 2021-08-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Intervertebral disc prolapse
Allergies:
Diagnostic Lab Data: Test Date: 20210809; Test Name: 37.9; Result Unstructured Data: Test Result:37.9; Test Date: 20210809; Test Name: D-dimer; Result Unstructured Data: Test Result:10.97 mg/l; Test Date: 20210809; Test Name: COVID-19 PCR; Test Result: Positive
CDC Split Type: DEPFIZER INC202101142659

Write-up: Deep venous thrombosis groin; Pulmonary embolism; Vaccination failure; COVID-19 PCR positive; body temperature: 37.9; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100179157. A 70-year-old female patient received the second dose of BNT162B2 (COMIRNATY) at 70-year-old, via an unspecified route of administration on 02Aug2021 (Batch/Lot Number: 1D020A) at single dose, and the first dose via an unspecified route of administration on 24Jun2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. Medical history included intervertebral disc prolapse from Jun2021. The patient''s concomitant medications were not reported. The patient experienced deep venous thrombosis groin on an unspecified date, pulmonary embolism on 09Aug2021, vaccination failure on 09Aug2021, COVID-19 PCR positive on 09Aug2021, and body temperature: 37.9 on 09Aug2021. Patient notes: Alternative hypothesis on the pathogenesis of intervertebral disc protrusion and reduced mobility as well as possible lack of anticoagulation. DVT possibly already present before the second COVID-19 vaccination. This report was serious - death. The patient underwent lab tests and procedures which included body temperature: 37.9 on 09Aug2021, fibrin D dimer: 10.97 mg/l on 09Aug2021, COVID-19 PCR: Positive on 09Aug2021. Outcome of events vaccination failure, COVID-19 PCR positive, and body temperature: 37.9 was unknown. The patient died on 09Aug2021. It was not reported if an autopsy was performed. For events: Deep venous thrombosis groin and Pulmonary embolism: Relatedness of drug to reaction(s)/event(s): Source of assessment: RA; Result of Assessment: D. Unclassifiable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Deep venous thrombosis groin; Pulmonary embolism


VAERS ID: 1701170 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-12
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Embolism
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-12
   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: MARCUMAR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation (treatment with Marcumar); Cardiac insufficiency; Pulmonary embolism; Type II diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101142588

Write-up: Embolism; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100179187. A 74-year-old female patient received BNT162B2 (COMIRNATY, lot number EW8904) at single dose via an unknown route on 09Apr2021 at 74-year-old for COVID-19 immunisation. Medical history included cardiac insufficiency, pulmonary embolism, type II diabetes mellitus, atrial fibrillation (treatment with phenprocoumon (MARCUMAR). Concomitant drugs included phenprocoumon for atrial fibrillation. On 12Apr2021 the patient experienced embolism. Outcome of embolism was fatal. It was unknown if autopsy was performed. Result of assessment (source: RA) was unclassifiable. This report was serious with seriousness of death. No follow-up activities possible. No further information expected.; Reported Cause(s) of Death: Embolism


VAERS ID: 1701175 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-20
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3095 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101142598

Write-up: Death sudden; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100179218. A 78-year-old male patient received BNT162B2 (COMIRNATY), dose 2 via an unspecified route of administration on 10Jun2021 (Batch/Lot Number: FC3095) as single dose for covid-19 immunisation. Historical vaccine included 1st dose of BNT162B2 on 12May2021 (Strength: 0.3 ml) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced death sudden on 20Jun2021. It was not reported if an autopsy was performed. The RA assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as D. Unclassifiable. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death sudden


VAERS ID: 1701191 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-08-18
   Days after vaccination:62
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD9324 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body mass index, 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: 2021-08-18
   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: Adipositas per magna; Hypertension; Hypertensive heart disease; Lymphoedema
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: BMI; Result Unstructured Data: Test Result:53
CDC Split Type: DEPFIZER INC202101142606

Write-up: Cardiac death; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB DE-PEI-CADR2021170039, Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100177053. A 61-year-old female patient received the second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 17Jun2021 (Batch/Lot Number: FD9324) at single dose for COVID-19 immunisation. Medical history included adipositas per magna, hypertension, lymphoedema, hypertensive heart disease. The patient''s concomitant medications were not reported. Patient previously received the first dose of BNT162B2 for COVID-19 immunisation. The patient experienced cardiac death on 18Aug2021. Sudden death, resuscitation unsuccessful. This report is serious - death. The patient''s outcome was fatal for cardiac death. Information on risk factors or previous illnesses: Obesity permagna (BMI 53), hypertension, lymphedema, hypertensive heart disease/no more patient contact after the second vaccination on 17Jun2021. The patient died on 18Aug2021. An autopsy was not performed. Relatedness of drug to reaction(s)/event(s) assessed by RA as D. Unclassifiable. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cardiac death


VAERS ID: 1701192 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-08-09
   Days after vaccination:53
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD9234 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma; Attention deficit hyperactivity disorder; Hypertension; Obesity
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101142620

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority [DE-PEI-CADR2021170054], Safety Report Unique Identifier is DE-PEI-202100177058. A 50-year-old male patient received the second dose of BNT162B2 (COMIRNATY, strength: 0.3 mL, Lot#: FD9234) at single dose on 17Jun2021 for COVID-19 immunisation. Ongoing medical history included obesity; asthma; attention deficit hyperactivity disorder; hypertension. Concomitant medication was not reported. On 09Aug2021, the patient experienced unknown cause of death. The autopsy was not performed. The outcome of event was fatal. This report was serious - death. Sender Comment: Are you or the person concerned known of any allergies? If yes, which? No. Information on risk factors or previous illnesses: obesity, hypertension, asthma, ADHD. Found dead in the apartment on 09Aug2021. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1701193 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-05-21
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1C006A / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Atrial fibrillation, Blood sodium, Cardiac arrest, Fatigue, Malaise, Multiple organ dysfunction syndrome, Transient ischaemic attack
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Ischaemic 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, arterial (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-27
   Days after onset: 67
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: Hypertrophy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Sodium; Result Unstructured Data: Test Result:Drop
CDC Split Type: DEPFIZER INC202101143191

Write-up: Atrial fibrillation; Multiple organ failure; cardiac arrest; Transient ischemic attack; Malaise; Fatigue; Weakness; This is as spontaneous report received from a non contactable consumer downloaded from the Regulatory Authority-WEB. The regulatory authority report number is DE-PEI-CADR2021170609, Safety report unique identifier DE-PEI-202100178090. A 81-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 19May2021 (Lot Number: 1C006A) as DOSE 2, SINGLE for covid-19 immunisation . Medical history included ongoing hypertrophy. The patient''s concomitant medications were not reported. The patient experienced multiple organ failure on 27Jul2021 , atrial fibrillation on an unspecified date with outcome of unknown , transient ischemic attack, malaise, fatigue , weakness on 21May2021 with outcome of unknown. The patient died on 27Jul2021. It was not reported if an autopsy was performed. In mid-July, taken to hospital by ambulance (suspected of having a transitory ischaemic attack). inpatient for 4 days, then ever greater weakness, sodium drop. 21Jul2021 hospital again with suspected epileptic seizure (tongue bite). In hospital, multiple organ failure: Pleural effusion, ascitis, liver congestion, subileus, diabetes, heart failure, atrial fibrillation. In the night of 27Jul2021, after resuscitation, died of cardiac arrest. The outcome of event multiple organ failure, cardiac arrest was fatal. Seriousness criteria reported as hospitalization for multiple organ failure, atrial fibrillation, transient ischemic attack. Relatedness Assessment: Weakness: D. Unclassifiable. Multiple organ failure: D. Unclassifiable Atrial fibrillation: D. Unclassifiable Malaise: Transient ischemic attack: D. Unclassifiable Fatigue: D. Unclassifiable Source of assessment: RA No follow-up attempts possible. No further information expected. Information on lot# already obtained.; Reported Cause(s) of Death: Multiple organ failure


VAERS ID: 1701194 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCRM8 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-27
   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: Sarcoidosis
Preexisting Conditions: Medical History/Concurrent Conditions: Rheumatism
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101143192

Write-up: On the morning of 27Aug2021, the husband found her dead.; A few hours after the injection, the patient reported that she was unwell.; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021170614, Safety Report Unique Identifier DE-PEI-202100177600. A 74-year-old female patient received the first dose of BNT162B2 (COMIRNATY, Lot Number: SCRM8) via an unspecified route of administration on 26Aug2021 at age of 74-year-old at single dose for COVID-19 immunisation. Medical history included rheumatism without drug therapy and ongoing sarcoidosis. The patient''s concomitant medications were not reported. A few hours after the injection on 26Aug2021, the patient reported that she was unwell. Put to sleep in the evening, found dead by the husband in the morning of 27Aug2021. The outcome of event "a few hours after the injection, the patient reported that she was unwell" was not recovered, the outcome of event "on the morning of 27Aug2021, the husband found her dead" was fatal. The patient died on 27Aug2021. An autopsy was not performed. Relatedness of drug to reaction(s)/event(s) was Indeterminate for Malaise, and Unclassifiable for Unknown cause of death per RA. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: On the morning of 27Aug2021, the husband found her dead.


VAERS ID: 1701195 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Bronchitis; Smoker
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101142493

Write-up: Person found dead at home approx. 2 weeks after 2nd dose of Comirnaty; This is a spontaneous report from a consumer or other non hcp downloaded from the Regulatory Authority-WEB DE-PEI-CADR2021170666 Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100177688 . A 77-year-old female patient received bnt162b2 (COMIRNATY, mRNA TOZINAMERAN), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as dose 2, single for covid-19 immunisation. Medical history included ongoing bronchitis, ongoing tobacco user. The patient''s concomitant medications were not reported. The patient previously took first dose of bnt162b2 (COMIRNATY) for covid-19 immunization. The patient experienced person found dead at home approx. 2 weeks after 2nd dose of comirnaty on 01Jul2021. The patient died on 01Jul2021. The patient''s outcome was fatal. An autopsy was not performed. This report is serious - death. Sender Comment: Do you or the person concerned have any known allergies? If yes, which ones? No information Information on risk factors or previous illnesses According to police report, bronchitis and heavy nicotine consumption known / No information. Causal relationship between the event/s and the administration of CORMINATY was assessed as "Unclassifiable (D)" by the RA. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1701196 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-24
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101142625

Write-up: Unknown cause of death; This is a spontaneous report downloaded from the regulatory authority received from a non-contactable consumer. Regulatory Authority Report Number: DE-PEI-CADR2021170782. Other case identifier number DE-PEI-202100177998. An unknown age Male patient received 2nd dose of BNT162B2 (COMIRNATY, mRNA TOZINAMERAN), on 22Aug2021 at single dose for COVID-19 immunisation. No relevant medical history reported. No concomitant medication reported. The reporter is the sister of the male vaccine, who died post vaccination, but no further information regarding medical validation of the outcome is currently available. The reporter has been contacted to provide further information on the circumstances of the fatal outcome. On 24Aug2021 the patient experienced Unknown cause of death. No autopsy was done. The patient''s outcome was fatal. This report is serious - death. Relatedness of drug to reaction(s)/event(s): event Unknown cause of death, Source of assessment PEI, Result of Assessment: D. Unclassifiable. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1701197 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-06-01
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1C006A / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-25
   Days after onset: 54
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: Heart valve calcification
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101142613

Write-up: Brain death; cardiac arrest; Fatigue/exhaustion; This is a spontaneous report from a non-contactable consumer or other non HCP downloaded from the Regulatory Authority-WEB DE-PEI-CADR2021170878, Safety Report Unique Identifier DE-PEI-202100177729. A 76-year-old male patient received BNT162B2 (COMIRNATY), dose 2 via unspecified route of administration on 21May2021 (Batch/Lot Number: 1C006A) as single dose for COVID-19 immunisation. The patient medical history included slight calcification of the heart valve, but always assessed by cardiologists as not serious. The patient had none known allergy. No concomitant medication reported. On 01Jun2021 the patient experienced fatigue. On an unspecified date, the patient had inconspicuous visit to cardiologist (routine) 2 weeks before cardiac arrest / already after the 2nd vaccination, state of exhaustion in hitherto outstandingly good physical condition. On 16Jul2021, the patient collapsed during sport with cardiac arrest, resuscitation by wife. After switching off the equipment due to brain death, he was released on 25Jul2021. It was reported death from cardiac arrest. Autopsy was not performed. The outcome of the event fatigue was not recovered before death. The outcome of the other events was fatal. RA assessed the relatedness of drug to the event was D. Unclassifiable. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death from cardiac arrest


VAERS ID: 1701198 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-07-31
   Days after vaccination:43
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-14
   Days after onset: 14
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 INC202101142622

Write-up: Lung embolism; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB DE-PEI-CADR2021170993. Safety Report Unique Identifier: DE-PEI-202100178342. A 76 Years old male patient received BNT162B2 (COMIRNATY, Lot number unknown) at single dose for COVID-19 immunisation on 18Jun2021. The patient''s medical history and concurrent conditions were unknown. On 31Jul2021 the patient experienced Lung embolism. The patient''s outcome was fatal for Lung embolism. This report was serious - death. No autopsy was performed. Sender Comment: Do you or the person concerned have any known allergies? If yes, which ones? No / Deceased Relatedness: Comirnaty/Lung embolism/RA/D. Unclassifiable No follow-up attempts possible. No further information expected. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Lung embolism


VAERS ID: 1701201 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-24
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Arrhythmia, Body temperature, Breast pain, Computerised tomogram, Death, Decreased appetite, Dry mouth, Electrocardiogram, Fatigue, Lung disorder, Nausea, Pain, Pneumonia, Pyrexia, SARS-CoV-2 test negative
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Cardiac arrhythmia terms, nonspecific (narrow), Lipodystrophy (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: 2021-08-21
   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? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension; Overweight
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Hay fever
Allergies:
Diagnostic Lab Data: Test Name: Suddenly fever appeared (38.6); Result Unstructured Data: Test Result:38.6; Test Name: Computerised tomogram; Result Unstructured Data: Test Result:milky white spots on the lungs; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:showed irregularities/interruptions; Test Name: PCR; Test Result: Negative
CDC Split Type: DEPFIZER INC202101149632

Write-up: Unknown cause of death; cardiac arrhythmia; milky spots on the lungs; Lung infection NOS; stomach pain/Acute gastric pain; Breast pain; Fatigue/Tiredness; loss of appetite; constant nausea; Dry mouth; pain in the upper body; Suddenly fever appeared (38.6); This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021172075, Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100179922. A 74-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 10Jul2021 (Batch/Lot Number: Unknown) as DOSE 2, 0.3 ML SINGLE for COVID-19 immunisation. Medical history included asthma caused by hay fever from unknown date and unknown if ongoing, hay fever, ongoing hypertension and ongoing overweight. The patient''s concomitant medications were not reported. On 26Jul2021, the patient experienced arrhythmia, acute gastric pain, tiredness, breast pain, lung infection NOS, fatigue, stomach pain, chest pain, cardiac arrhythmia, milky spots on the lungs according to CT. 14 days after second vaccination on 24Jul2021, constant tiredness appeared. After about a week, there was a loss of appetite and constant nausea, dry mouth and pain in the upper body. On 15Aug2021, 112 was called. Electrocardiogram showed irregularities/interruptions. The patient was admitted to hospital. Computerised tomogram showed milky white spots on the lungs. PCR was negative (tested 2 days apart). Treatment with antibiotics for the events. After about 3 days there was an improvement. Suddenly fever appeared (38.6) and condition worsened. The patient died after 7 days in hospital. Result of Assessment: Comirnaty/ event(s): Arrhythmia, Lung infection NOS, Acute gastric pain, Tiredness Breast pain, Unknown cause of death/ RA: D. Unclassifiable. On 21Aug2021, the patient experienced unknown cause of death. It was unknown if an autopsy was performed. The outcome of loss of appetite, nausea, dry mouth, pain in the upper body and fever was unknown. The outcome of the rest of events was not recovered. Sender''s comments: Do you or the person concerned have any known allergies? If yes, which ones? Hay fever, asthma caused by hay fever. No follow-up attempts possible. No further information expected. Information about LOT/Batch number can not be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1701202 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral ischaemia, Cerebral venous sinus thrombosis, Immune thrombocytopenia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-02
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210919864

Write-up: IMMUNE THROMBOCYTOPENIA; CEREBRAL ISCHEMIA; THROMBOSIS OF VENOUS SINUSES; This spontaneous report received from a consumer by a Regulatory Authority (EVHUMAN Vaccines, DE-PEI-CADR2021174694) on 09-SEP-2021 concerned a 50 year old female. The patient''s weight was 65 kilograms, and height was 170 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 12-AUG-2021 for prophylactic vaccination.The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 24-AUG-2021, the patient experienced immune thrombocytopenia, cerebral ischemia, thrombosis of venous sinuses. On 02-SEP-2021, the patient died from thrombosis of venous sinuses. 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 immune thrombocytopenia and cerebral ischemia on 02-SEP-2021. This report was serious (Death).; Reported Cause(s) of Death: THROMBOSIS OF VENOUS SINUSES


VAERS ID: 1701227 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-03
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6126 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral thrombosis, Electrocardiogram, Office visit, Pain in extremity
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-20
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CORODIL [ENALAPRIL MALEATE]
Current Illness: Hypercholesterolaemia (well regulated by medical check in feb2021); Hypertension (well regulated by medical check in feb2021)
Preexisting Conditions: Comments: The patient does not have any other health problems. He was a very active pensioner who had just finished 6 hour guard. The day before he won a hill sprint with the gymnastics team, and 3 weeks before he finished renovating the utility room. He did gymnastics and yoga and lived healthy. He had recently been to a major annual medical check-up, with no signs of worry - everything was normal. No previous blood clots (reported by the GP)
Allergies:
Diagnostic Lab Data: Test Date: 202102; Test Name: EKG; Result Unstructured Data: Test Result:Normal; Test Date: 202102; Test Name: office visit; Result Unstructured Data: Test Result:with no signs of worry - everything was normal; Comments: He had recently been to a major annual medical check-up, with no signs of worry - everything was normal.
CDC Split Type: DKPFIZER INC202101149865

Write-up: Cerebral thrombosis. Suddenly had a died without warning 3 weeks after 2nd vaccine; Pain in arm after both vaccinations; This is a spontaneous report from a contactable consumer or other non-healthcare professional downloaded from the Regulatory Authority-WEB, regulatory authority number DK-DKMA-WBS-0081966. This is the first of two reports. A 74-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Lot Number: EW6126; Expiration Date: 31Jul2021), via an unspecified route of administration on 03May2021 as dose 2, single for COVID-19 immunization. The patient medical history included ongoing hypercholesterolaemia (well regulated by medical check in feb2021), ongoing hypertension (well regulated by medical check in feb2021). The patient concomitant medications included enalapril maleate (CORODIL [ENALAPRIL MALEATE]) was taken for hypertension from 08May2014 to an unspecified stop date. Historical vaccine included first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: EW4811; Expiration Date: 31Jul2021), via an unspecified route of administration on 12Apr2021 as dose 1, single for COVID-19 immunization. The patient experienced cerebral thrombosis. suddenly had a died without warning 3 weeks after 2nd vaccine on 20May2021 and pain in arm after both vaccinations on May2021. The reporter stated that patient does not have any other health problems. He was a very active pensioner who had just finished 6 hour guard. The day before he won a hill sprint with the gymnastics team, and 3 weeks before he finished renovating the utility room. He did gymnastics and yoga and lived healthy. He had recently been to a major annual medical check-up, with no signs of worry - everything was normal. No previous blood clots (reported by the GP). Causality was the GP considers the death to be surprising, however, there has been no suspicion of causality between the deaths and Comirnaty, and there still is not. The GP believes the death may be due to a blood clot in the brain, but this is not a confirmed diagnosis, but her best assessment, as the deceased was suddenly found dead at his volunteer work, and is found dead on arrival at the hospital. In addition, the Police reports state that relatives have stated that the deceased has not experienced any ADRs other than pain in the arm after neither the 1st nor the 2nd vaccination with Comirnaty. Therefore, the forensic pathologist has no suspicion of the vaccine, and no indication for autopsy. The case is not medically confirmed. The patient underwent lab tests and procedures which included electrocardiogram was normal on unspecified date Feb2021, office visit was with no signs of worry - everything was normal (He had recently been to a major annual medical check-up, with no signs of worry - everything was normal) on unspecified date Feb2021. Cause of Death was cerebral thrombosis. An autopsy was not performed. The outcome of the events was cerebral thrombosis. suddenly had a died without warning 3 weeks after 2nd vaccine was death on 20May2021 and pain in arm after both vaccinations was recovered on an unspecified date 2021. No follow up attempts possible. No further information is expected.; Sender''s Comments: Linked Report(s) : DK-PFIZER INC-202101159351 Same patient/ vaccine, different dose/ events; Reported Cause(s) of Death: Cerebral thrombosis


VAERS ID: 1701244 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-17
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW9127 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aneurysm, Blood pressure measurement, Cardio-respiratory arrest, Cerebrovascular accident, Coma scale, Computerised tomogram, Depressed level of consciousness, Headache, Hypertensive crisis, Malaise, Pyrexia, Subarachnoid haemorrhage, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Cataract (left); Cervical pain (worsening in the last week); COVID-19 (admission in Feb2021); Hospitalisation; Lumbar spondylosis; Scoliosis
Allergies:
Diagnostic Lab Data: Test Date: 20210424; Test Name: CT scan; Result Unstructured Data: Test Result:subarachnoid hemorrhage; Comments: showing subarachnoid hemorrhage and saccular aneurysm of 3 mm in the anterior communicant.; Test Date: 20210424; Test Name: Blood pressure; Result Unstructured Data: Test Result:186/97 mmHg; Test Date: 20210417; Test Name: BP; Result Unstructured Data: Test Result:elevated; Test Name: Glasgow; Result Unstructured Data: Test Result:3; Test Name: CT scan; Result Unstructured Data: Test Result:more cerebral edema; Comments: showing more cerebral edema and the rest without significant changes.; Test Name: CT scan; Result Unstructured Data: Test Result:subarachnoid hemorrhage in the cisterns; Comments: showing subarachnoid hemorrhage in the cisterns of the base, right sylvian and with interhemispheric component, without ventricular dilatation.
CDC Split Type: ESPFIZER INC202101174662

Write-up: Aneurysm; subarachnoid hemorrhage in the cisterns of the base; cardiorespiratory arrest; low level of consciousness; stroke; Frontal headache/Headache; General malaise; vomiting; Fever; Crisis hypertensive/elevated BP/blood pressure of 186/97 mmHg; This is a spontaneous report received from a contactable pharmacist downloaded from the regulatory authority. The regulatory authority report number is ES-AEMPS-973523. A non-pregnant 77-year-old female patient received 1st dose of BNT162B2 (COMIRNATY, Lot Number: EW9127), via an unspecified route of administration on 14Apr2021 as single dose for COVID-19 immunisation. Medical history included Lumbar spondylosis, patient had passed COVID-19 and admission in Feb2021, anxiety, Cataract (left), scoliosis, cervical pain (worsening in the last week). Concomitant medications were not reported. The patient previously took omeprazol (2141A) and pontalsic. Patient complained of frontal headache since this morning (17Apr2021) and cervical pain for several months, worsening in the last week (since Apr2021). Three days ago she received her first dose of Pfizer vaccine. This morning she was seen in the PAC for general malaise and headache, with elevated BP, two vomiting this morning, fever on arrival at the ER, discharge after treatment. FOLLOW-UP: Telephone call for patient evaluation from the Neurosurgery Department. The patient presented with low level of consciousness, activating the stroke code. A cranial CT scan was performed showing subarachnoid hemorrhage in the cisterns of the base, right sylvian and with interhemispheric component, without ventricular dilatation. Midline not displaced. According to what we were told, the patient presented GCS of 7-8p so we proceeded to IOT in the hospital. Transfer was accepted, contacting the ICU, which accepted the patient''s admission. FOLLOW-UP: Patient vaccinated 10 days ago with Covid with Pfizer who has been presenting headaches and cervical pain since that time. She went to her physician''s office on 24Apr2021 in the early hours of the morning and was found to have blood pressure of 186/97 mmHg and was transferred to the Hospital for code Ictus. In the emergency room comatose state with medium pupils with little reactivity and deviation of the gaze to the right. Urgent cranial CT was performed showing subarachnoid hemorrhage and saccular aneurysm of 3 mm in the anterior communicant. The rest of the patient had no significant findings. In the emergency room she suffered cardiorespiratory arrest and was resuscitated for 10 min, recovering heart rate. She was transferred to the hospital by helicopter and pupillary arreativity was referred by the transfer team. On admission to our unit, the patient was intubated with bilateral mydriasis arrecativa and no corneal reflexes. Glasgow 3 p. Repeat CT scan of the skull showing more cerebral edema and the rest without significant changes. The patient was admitted with GCS 3p with mydriatic mydriatic pupils arreactivas, being the first record of BIS 11 with TS 71. Subsequent evolution to encephalic death, confirmed by clinical examination and transcranial Doppler. A subarachnoid hemorrhage Anterior communicating saccular aneurysm. Encephalic death. The outcome of the event cardiorespiratory arrest was recovering, of other events depressed level of consciousness, stroke, headache, general malaise, vomiting and Fever were not recovered. The patient died on an unspecified date due to Crisis hypertensive, Aneurysm ad subarachnoid hemorrhage in the cisterns of the base. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Crisis hypertensive; Aneurysm; subarachnoid hemorrhage in the cisterns of the base


VAERS ID: 1701267 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-08-20
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-20
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC202101142875

Write-up: Sudden death; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority FI-FIMEA-20214257. A 36-year-old male patient received BNT162B2 (COMIRNATY) at single dose via an unknown route on 21Jul2021 for COVID-19 immunisation. Medical history and concomitant drug were not provided. Serious event was reported as sudden death with onset date of 20Aug2021. The patient died suddenly while sitting on the living room couch during the day at 2 p.m. The first aid which came after 10 minutes could not do anything. The situation came as a complete surprise. It was also reported as "24Aug2021 initial consumer: Death". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1701271 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-03
Onset:2021-06-04
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiomyopathy, Pulmonary embolism, Venous thrombosis limb
SMQs:, Embolic and thrombotic events, venous (narrow), Cardiomyopathy (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Antibiotic therapy (In March, he contracted a shingles infection, which led him to use an antibiotic for a long time.); Overweight; Shingles (In March, he contracted a shingles infection, which led him to use an antibiotic for a long time.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC202101149856

Write-up: Pulmonary embolism; Cardiomyopathy; venous thrombosis of the left calf; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority WEB-regulatory authority number FI-FIMEA-20214308. A 32-year-old male patient received unspecified dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: unknown), via an intramuscular route of administration on 03May2021 as dose number unknown, single for COVID-19 immunisation. Medical history included overweight from an unknown date and unknown if ongoing, the patient was otherwise of good health and did not have any known underlying diseases. In March, he contracted a shingles infection of his lower limb, which led him to use an antibiotic for a long time. The patient''s concomitant medications were not reported. On 04Jun2021 patient celebrated his engagement. In the evening began to breathe heavily and experienced malaise. His bride called the emergency centre. During the call, he lost consciousness. Upon the arrival of first aid, he went lifeless. Immediate resuscitation was ineffective. He died suddenly. An autopsy revealed abundant pulmonary embolism, venous thrombosis of the left calf, and cardiovascular disease. On 27Aug2021 follow-up doctor: death certificate Immediate cause of death Embolia pulmonis Pulmonary embolism basic cause of death cardiomyopathy causing heart dilatation. According to the information from the police investigation report (5530 / S / 5365/21) and the patient records of the health centre and the hospital. Outcome of the events were fatal. No follow-up attempts are possible. No further information is expected. Batch/Lot number cannot be obtained. ; Reported Cause(s) of Death: Cardiomyopathy; venous thrombosis of the left calf; Pulmonary embolism


VAERS ID: 1701291 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-02-08
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cholangiosarcoma, Drug ineffective, Oxygen saturation, Oxygen saturation decreased, Respiratory disorder
SMQs:, Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Biliary malignant tumours (narrow), Liver malignant tumours (narrow), Respiratory failure (broad), Non-haematological malignant tumours (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-09
   Days after onset: 181
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: 20210208; Test Name: oxygen; Test Result: 85 %
CDC Split Type: FRPFIZER INC202101149744

Write-up: cholangiosarcoma; drug ineffective; Coronavirus infection; Oxygen saturation decreased; acute respiratory syndrome; This is a spontaneous report from a contactable physician downloaded from the regulatory authority , regulatory authority number FR-AFSSAPS-MA20213309. An 89-year-old female patient received bnt162b2 (COMIRNATY), first single dose intramuscularly on 19Jan2021 (Batch/Lot Number: EM0477) for covid-19 immunisation at age of 89-year-old. The patient''s medical history and concomitant medications were not reported. The patient experienced severe acute respiratory syndrome coronavirus 2 (Sars-Cov-2) infection desaturation in Oxygen (85%) (Oxygen saturation decreased) on 08Feb2021, 20 days after the first injection of COMIRNATY vaccine. The Sars-Cov-2 infection was resolved, but patient died later on 09Aug2021 of a cholangiosarcoma. It was unknown if autopsy was performed. Outcome of the event cholangiosarcoma was fatal, while of other events was recovered. No follow-up attempts are possible. No further information expected. ; Reported Cause(s) of Death: cholangiosarcoma


VAERS ID: 1701360 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-08-11
   Days after vaccination:183
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Oxygen saturation, Respiratory rate, 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: 2021-08-22
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease (Advanced, bedridden); Chronic atrial fibrillation; COVID-19; Dependence (total dependence (GIR1)); Femoral neck fracture; Prostate adenoma
Allergies:
Diagnostic Lab Data: Test Date: 20210820; Test Name: saturation; Test Result: 88 %; Comments: desaturation; Test Date: 20210820; Test Name: respiratory rate; Result Unstructured Data: Test Result:increase; Test Date: 20210811; Test Name: COVID-19 PCR; Test Result: Positive ; Comments: Search for variant: Delta variant
CDC Split Type: FRPFIZER INC202101166350

Write-up: Vaccination failure; COVID-19; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-NC20213971. A 92-years-old male patient received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: EJ6789) dose 2 via an Intramuscular route of administration, administered in Arm Left on 09Feb2021 as dose 2, single and bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: EM0477) dose 1 via an Intramuscular route of administration, administered in Arm Left on 13Jan2021 as dose 1, single for covid-19 immunisation. Medical history included advanced Alzheimer''s disease bedridden, total dependence (GIR1), chronic atrial fibrillation and prostate adenoma from an unknown date and unknown if ongoing. On Mar2018 femoral neck fracture to an unknown date and covid-19 from 11Aug2021 to an unknown date. The patient''s concomitant medications were not reported. On 11Aug2021 the patient presented respiratory symptoms such as bronchitis and experienced vaccination failure and covid-19. on 11Aug2021 sars-cov-2 test with positive result Search for variant: Delta variant. On 20Aug2021 the patient underwent lab tests and procedures which included oxygen saturation: 88 % desaturation, respiratory rate: increase. Therapeutic measures were taken as a result of covid-19 (covid-19). subcutaneous perfusion, Lovenox 4000, ceftriaxone 1g, oxygen therapy was given to patient. On 20Aug2021 deterioration of the patient''s condition in the afternoon, supra-clavicular draught, the patient was apyretic. Decision not to hospitalize after calling for help. Oxygen therapy 5 L/min and scopolamine and Anticoagulant. On 21Aug2021 patient was stable. The patient died on 22Aug2021 11 days after confirmation of COVID-19 infection. It was not reported if an autopsy was performed. death from confirmed COVID-19 vaccine failure that occurred 6 months after completion of the vaccine regimen. The outcome of the event was fatal. The RA 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 follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: Died 11 days after confirmation of COVID-19 infection


VAERS ID: 1701374 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-05
Onset:2021-09-01
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Intestinal obstruction
SMQs:, Gastrointestinal obstruction (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-05
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac disorder; Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101181560

Write-up: intestinal obstruction; This is a spontaneous report received from a contactable consumer (patient''s friend) via Medical Information. An 88-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 05Aug2021 as dose number unknown, single for COVID-19 immunisation. Medical history included cardiac disorder from an unknown date and unknown if ongoing, stroke from Feb2021 to an unknown date. The patient''s concomitant medications were not reported. The patient experienced intestinal obstruction in Sep2021. It was given that she was a cardiac person (she had a stroke in Feb2021), the physicians only investigated if this problem could have a cardiac etiology and did not find the intestinal obstruction right away. Her pain appeared in early Sep2021. The patient died from an intestinal obstruction on 05Sep2021. 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: intestinal obstruction


VAERS ID: 1701375 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-10
Onset:2021-08-17
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7051 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal death, Karyotype analysis, Maternal exposure timing unspecified
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVOTHYROX; UVEDOSE; SPASFON [PHLOROGLUCINOL]; PARACETAMOL; HYDROCORTISONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Foetal macrosomia
Allergies:
Diagnostic Lab Data: Test Name: Cord blood sampling for foetal karyotype; Result Unstructured Data: Test Result:No results provided
CDC Split Type: FRPFIZER INC202101183106

Write-up: Maternal drug exposure during pregnancy; Foetal death in utero; This is a spontaneous report from a contactable physician downloaded . This is the second of two reports. The first report is a report downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-SE20212241. A fetus patient received bnt162b2 (COMIRNATY), dose 2 transplacental on 10Aug2021 (Batch/Lot Number: FE7051) as DOSE 2, SINGLE for covid-19 immunisation. Medical history and concomitant medications for the fetus were none. On 17Aug2021. the patient experienced foetal death in utero maternal drug exposure during pregnancy. with outcome of recovered with sequelae. This mother reported her last menstrual period was on 04Dec2020. The mother reported she became pregnant while taking bnt162b2. The mother was 36 Weeks pregnant at the onset of the event. On 17Aug2021 (Day 7 of the 2nd dose of COMIRNATY), the patient, at week 35 of amenorrhea + 5 days, consulted the Gynaecological Emergency Room for absence of active foetal movements for 3 days. On monitoring: no audible heart sounds. On ultrasound monitoring: No cardiac activity, no fetal movement, oligohydramnios, high anterior placenta, no image of haematoma. Labour induced on 20Aug2021. On 21Aug2021: A stillborn male child was delivered by vaginal delivery at 9:18 am. as due to deliver on 10Sep2021. The mother delivered the pregnancy on 21Aug2021 via vaginal delivery. The pregnancy resulted in still birth. The fetal outcome is intrauterine death. The patient underwent lab tests and procedures which included karyotype analysis: no results provided on unspecified date. The patient died on 17Aug2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101131236 same reporter, different patient( mother); Reported Cause(s) of Death: Foetal death in utero


VAERS ID: 1701380 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Fatigue, Inappropriate schedule of product administration
SMQs:, Medication errors (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 INC202101153260

Write-up: Death unexplained; Tiredness; Dose 1 on Nov2020 and Dose 2 on Feb2021; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-ADR 25887681. Safety Report Unique Identifier GB-MHRA-ADR 25887681. A 91-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Feb2021 (at the age of 91-year-old) as dose 2, single for COVID-19 vaccination. The patient''s medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 in Nov2020 for COVID-19 vaccination. The patient experienced tiredness in Feb2021 and death unexplained on an unspecified date. Clinical course was reported as follows: patient had the jab in Nov2020, she has no reaction to the jab and was as health as normal, 12 weeks later she got a call from her general practitioner (GP) saying it was time for the second dose, she went to the have the second jab and 2 days later her son noticed she was tired and called her GP for advice the GP said not to take her to hospital but to make her comfortable because she did not have long left and 4 days later patient passed away. Patient''s son is currently struggling with the loss of his mother and was looking for closure and wanted to know if there have been reports of deaths by the Pfizer vaccine and what background information is out there regarding deaths and Pfizer jab. The patient has not recovered from the event fatigue. The patient died on an unspecified date. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1701381 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pancreatitis acute
SMQs:, Acute pancreatitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101176114

Write-up: Acute pancreatitis; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-ADR 25901059. Safety Report Unique Identifier GB-MHRA-ADR 25901059. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 Immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced acute pancreatitis (death, hospitalization, life threatening) on an unspecified date. It was reported that: The patient had second dose Pfizer jab and immediately fell ill. Within 2 days he had severe acute Pancreatitis with complications which led to his death. He signed a waiver whilst in ITU for test to see if there was a conbection. The patient maintained the vaccine was cause. He was a very fit man who had never had a cold or illness previously. He worked up to his death. The patient died on an unspecified date. An autopsy was not performed. 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: Acute pancreatitis


VAERS ID: 1701560 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ankle brachial index, Asthenia, Biopsy, Blindness cortical, Computerised tomogram, Death, Disease recurrence, Exercise tolerance decreased, Giant cell arteritis, Hypoperfusion, Interstitial lung disease, Investigation, Red blood cell sedimentation rate, SARS-CoV-2 test, Tenderness, Ultrasound scan, Vasculitis, Visual impairment
SMQs:, Interstitial lung disease (narrow), 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), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Vasculitis (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (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: CLENIL MODULITE; RAMIPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Claudication; Cortical blindness (Admitted 14th August 2021); Dehydration; Giant cell arteritis; Headache; Hypertension; Hypoperfusion; Inflammatory arterial reaction; Interstitial lung disease; Leg pain (had seen vascular in 2017 for leg pain which was atypical for intermittent claudication); Non-smoker; Sciatica; Sexually transmitted infection; Stenosis; Tenderness; Vasculitis; Visual disturbance; Weakness
Allergies:
Diagnostic Lab Data: Test Name: Ankle brachial pressure index; Result Unstructured Data: Test Result:normal; Test Name: artery biopsy; Result Unstructured Data: Test Result:Unknown results; Comments: Pt was too unwell from admission for a temporal artery biopsy; Test Name: CT angiogram lower limb both; Result Unstructured Data: Test Result:imaging appearances are atypical; Comments: Clinical presentation and imaging appearances are atypical. There is diffuse circumferential vascular disease below the inguinal ligament with multifocal moderate to critical stenoses and short occlusions in both SFA, popliteal arteries and tibial vessels which raises the possibility of inflammatory pathology (medium sized vasculitis/Buerger''s disease; any history of smoking connective-tissue disease); Test Date: 202105; Test Name: investigation; Result Unstructured Data: Test Result:revealed bilateral inflammatory disease; Comments: investigation in May/June revealed bilateral inflammatory disease throughout his arterial extremities in lower limbs; Test Date: 202105; Test Name: ESR; Result Unstructured Data: Test Result:44; Test Date: 202105; Test Name: ESR; Result Unstructured Data: Test Result:37; Test Date: 20210329; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Name: temporal artery ultrasound; Result Unstructured Data: Test Result:giant cell arteritis; Comments: thickened temporal, frontal and axillary arteries in keeping with giant cell arteritis; Test Name: ultrasound; Result Unstructured Data: Test Result:suggestive for the presence of GCA; Comments: the common superficial temporal and frontal branch of the temporal artery exhibit positive halo and compression sign which would be suggestive for the presence of GCA. The parietal branch was unremarkable. The axillary artery was unremarkable at this time. Right Side The axillary artery exhibits evidence of wall thickening measuring 1.46mmAP which may indicate the presence of GCA in this vessel.
CDC Split Type: GBPFIZER INC202101174757

Write-up: cortical blindness; inflammatory disease; temporal tenderness; hypoperfusion; visual disturbance; weakness; giant cell arteritis; Vasculitis, Cortical blindness, hypoperfusion, visual disturbance, weakness and giant cell arteritis; symptoms persisted until his death; exercise tolerance; Vasculitis; This is a spontaneous report from two contactable physicians downloaded from the regulatory authority number GB-MHRA-WEBCOVID-202109021639158550-NTJET. Safety Report Unique Identifier GB-MHRA-ADR 25887817. A 66-year-old male patient received the first dose of BNT162B2 (PFIZER- BIOTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included giant cell arteritis, stenosis, interstitial lung disease, tenderness, vasculitis, dehydration, headache, Cortical blindness (Admitted 14Aug2021), Sciatica, Hypoperfusion, Visual disturbance, Claudication, Weakness, Asthma and Hypertension. Non-smoker and not diabetic. Patient had seen vascular in 2017 for leg pain which was atypical for intermittent claudication and diagnosed as sciatica. Interestingly normal Ankle brachial pressure index then, so no evidence of peripheral vascular disease in 2017. Patient had not symptoms associated with COVID-19. Further investigation in May/June revealed bilateral inflammatory disease throughout his arterial extremities in lower limbs. He was referred to Rheumatology, but unfortunately developed and V&D illness. Concomitant medications included beclometasone dipropionate (CLENIL MODULITE) taken for asthma from 20Feb2020 to an unspecified stop date; ramipril taken for hypertension from 01Aug2018 to an unspecified stop date. The patient experienced exercise tolerance on an unspecified date; vasculitis NOS on Feb2021; cortical blindness, inflammatory disease, temporal tenderness, hypoperfusion, visual disturbance, weakness and symptoms persisted until his death all on an unspecified date. Patient had not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on 29Mar2021. The outcome of event vasculitis was not recovered, while for remains events was unknown. The patient died on an unspecified date with unknown cause. It was not reported if an autopsy was performed. The clinical course was reported as follows: 2 weeks after 1st Pfizer vaccine developed symptoms of intermittent claudication and headaches, with no history of this before vaccine. Exercise tolerance was severely limited compared with christmas 2020. These symptoms persisted until his death. Further investigation in May/June revealed bilateral inflammatory disease throughout his arterial extremities in lower limbs. He was referred to Rheumatology, but unfortunately developed and V&D illness. Admitted on 14Aug2021 with cortical blindness, bilateral weakness and bilateral hemispheric MCA infarcts secondary to bilateral occluded internal carotid arteries. ESR in May was mildly elevated at 44 (37 when repeated). Described some temporal tenderness and visual disturbance around this time. Patent was too unwell from admission for a temporal artery biopsy, however temporal artery ultrasound revealed thickened temporal, frontal and axillary arteries in keeping with giant cell arteritis. Possible dehydration and prothrombotic state with D&V illness cause hypoperfusion and ICA occlusion on top of previous undiagnosed ICA stenosis, secondary to undiagnosed and untreated Vasculitis. Patient had no evidence of Atrial Fibrillation or Left ventricular thrombus and no known atherosclerotic disease previously. Any other relevant investigations or tests conducted: As above [US doppler temporal artery both] Bedside Assessment. Patient habitus prevented direct imaging of the right temporal arterial system. Left side On ultrasound the common superficial temporal and frontal branch of the temporal artery exhibit positive halo and compression sign which would be suggestive for the presence of GCA. The parietal branch was unremarkable. The axillary artery was unremarkable at this time. Right Side The axillary artery exhibits evidence of wall thickening measuring 1.46mmAP which may indicate the presence of GCA in this vessel. [CT angiogram lower limb both] Clinical presentation and imaging appearances are atypical. There is diffuse circumferential vascular disease below the inguinal ligament with multifocal moderate to critical stenoses and short occlusions in both SFA, popliteal arteries and tibial vessels which raises the possibility of inflammatory pathology (medium sized vasculitis/Buerger''s disease; any history of smoking connective-tissue disease). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: symptoms persisted until his death


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