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

Found 19,249 cases where Vaccine targets COVID-19 (COVID19) and Patient Died

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Case Details

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VAERS ID: 1339302 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-08
Onset:2021-05-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA 5831 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood bicarbonate, Blood creatinine, Blood gases, Blood lactic acid, Blood pressure measurement, Body temperature, Computerised tomogram head, Electrocardiogram, Hyperpyrexia, Hypotension, Nausea, Oxygen saturation, PCO2, PO2, Sopor, pH body fluid
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-10
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DOPAMINE; SYMBICORT; EMAGEL; CARDICOR; PLASIL [METOCLOPRAMIDE]; TRITTICO; LASIX [FUROSEMIDE]; OXYGENE LIQUID AIR LIQUID MEDICAL; CRESTOR; MYCOSTATIN; LANTUS; XARELTO; NOVORAPID; LANSOPRAZOLE; PERFALGAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute renal failure (the patient was hospitalized for acute renal failure on chronic dehydration; creatinine 4.1 all); Bradycardia-tachycardia syndrome; Candida of mouth; Chronic obstructive bronchopneumopathy; Decompensation cardiac; Dehydration; Dyslipidaemia; Hospitalization; Hypertensive heart disease; Insomnia; Permanent atrial fibrillation; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: HCO3; Result Unstructured Data: Test Result:25 mmol/L; Test Name: creatinine; Result Unstructured Data: Test Result:4.1; Test Date: 20210510; Test Name: Blood gases; Result Unstructured Data: Test Result:unknown results; Test Name: lactates; Result Unstructured Data: Test Result:7.7; Test Date: 20210509; Test Name: blood pressure; Result Unstructured Data: Test Result:90/50 mmHg; Test Date: 20210509; Test Name: blood pressure; Result Unstructured Data: Test Result:65/45 mmHg; Test Date: 20210509; Test Name: blood pressure; Result Unstructured Data: Test Result:100/60 mmHg; Test Date: 20210510; Test Name: blood pressure; Result Unstructured Data: Test Result:90/50 mmHg; Test Date: 20210510; Test Name: blood pressure; Result Unstructured Data: Test Result:80/40 mmHg; Comments: at 6:40; Test Date: 20210509; Test Name: body temperature; Result Unstructured Data: Test Result:38.7 Centigrade; Test Date: 20210509; Test Name: body temperature; Result Unstructured Data: Test Result:37.5 Centigrade; Test Date: 20210510; Test Name: body temperature; Result Unstructured Data: Test Result:37.8 Centigrade; Test Date: 20210510; Test Name: brain computed tomography; Result Unstructured Data: Test Result:negative for acute events; Test Date: 20210510; Test Name: electrocardiography; Result Unstructured Data: Test Result:unknown results; Test Name: saturation; Test Result: 90 %; Test Name: pCO2; Result Unstructured Data: Test Result:32 mmHg; Test Name: ph; Result Unstructured Data: Test Result:7.47; Test Name: pO2; Result Unstructured Data: Test Result:52 mmHg
CDC Split Type: ITPFIZER INC2021560645

Write-up: Sopor; Hyperpyrexia; Nausea; Hypotension; This is a spontaneous report received from a contactable physician downloaded from a regulatory authority-WEB. The regulatory authority report number is IT-MINISAL02-728650. A 90-year-old female patient received second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 08May2021 19:20 (lot number FA 5831) at single dose for COVID-19 immunization. Medical history included Decompensation cardiac, Type 2 diabetes mellitus, the patient was hospitalized for acute renal failure on chronic dehydration; creatinine 4.1 all, Permanent atrial fibrillation, Bradycardia-tachycardia syndrome, Chronic obstructive bronchopneumopathy, Hypertensive heart disease, Insomnia, Dyslipidaemia, Candida of mouth. Concomitant medications included dopamine, budesonide, formoterol fumarate (SYMBICORT) for Chronic obstructive bronchopneumopathy, polygeline (EMAGEL), bisoprolol fumarate (CARDICOR) for Hypertensive heart disease, metoclopramide (PLASIL), trazodone hydrochloride (TRITTICO) from 08May2021 to 09May2021 for Insomnia, furosemide (LASIX), oxygen (OXYGENE LIQUID AIR LIQUID MEDICAL), rosuvastatin calcium (CRESTOR) for Dyslipidaemia, nystatin (MYCOSTATIN) for Candida of mouth, insulin glargine (LANTUS) for Diabetes mellitus non-insulin-dependent, rivaroxaban (XARELTO) from 03May2021 to 09May2021 for Permanent atrial fibrillation, insulin aspart (NOVORAPID) for Diabetes mellitus non-insulin-dependent, lansoprazole, paracetamol (PERFALGAN). Historical Vaccine included first dose of Comirnaty on 16Apr2021 for COVID-19 immunization. The patient experienced Hyperpyrexia with nausea from 18:00 on 09May2021, subsequent hypotension: Temperature 38.7 Centigrade arterial tension 90/50 mmHg; after 1 vial Perfalgan Temperature 37.5 Centigrade arterial tension 65/45 mmHg; after 1 vial iv of Emagel arterial tension 100/60 mmHg; at 00:15 of 10May2021 sopor patient with blood pressure 90/50 mmHg, electrocardiography, blood gas analysis performed and oxygen therapy started; 1:24 hours marbled, not awakened, brain computed tomography performed (negative for acute events), Central venous catheter positioned for infusions, pumped Lasix and Dopamine; 6:40 blood pressure 80/40 mmHg body temperature 37.8 Centigrade, repositioned ice locally. Died at 7:50. It was unknown if autopsy was done. Measures Taken: Prescribed and administered: Perfalgan 1 vial intravenous, Emagel 1 vial intravenous, Plasil 1 vial in saline. 100 ml intravenous, Dopamina 1 vial in saline. 45cc in syringe pump at 1.8cc / hour then increased to 2cc / h, oxygen therapy 35% 8 liters / min, Lasix 250ml in syringe pump at 0.5cc / hour. Blood gas analysis result: pH 7.47; pCO2 32 mmHg; pO2 52 mmHg; HCO3 25 mmol / L; lactates 7.7; sO2 90%. The outcome of the events were fatal.; Reported Cause(s) of Death: Hyperpyrexia; Nausea; Hypotension; Sopor


VAERS ID: 1339303 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-10
Onset:2021-05-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5831 / 1 LA / OT

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: 2021-05-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVETIRACETAM; PHENOBARBITAL; LANSOPRAZOLE
Current Illness: Paralytic disability
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021560707

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB IT-MINISAL02-728694 A 65-year-old female patient received the first dose of BNT162B2 (COMIRNATY, lot number: FA5831 and expiration date: 31Aug2021), via intramuscular, in arm left, on 10May2021 12:10, at 0.3 mL single dose, for COVID-19 immunization. Medical history included paralytic disability from 14Nov2014 to 11May2021. Concomitant medications included levetiracetam, phenobarbital and lansoprazole. The patient experienced cardio-respiratory arrest (fatal) on 11May2021. The outcome of the event was fatal. Patient died on 11May2021. It was not reported if an autopsy was performed. Reporter comment: From the administration of the drug to the patient''s exit, there is no evidence of specific symptoms (patient in a vegetative state); Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1339304 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-07
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortocoronary bypass (chronic ischemic heart disease (two aortocoronary bypasses about 25 years ago)); Arterial hypertension; Atrial fibrillation; Chronic ischemic heart disease, unspecified
Allergies:
Diagnostic Lab Data: Test Date: 20210427; Test Name: Sars-cov-2 molecular test; Test Result: Positive
CDC Split Type: ITPFIZER INC2021560678

Write-up: THE PATIENT DIED AT HOME ON 05.07.2021, ASYMPTOMATIC BUT POSITIVE TO COVID-19, MOLECULAR SWAB OF 04.27.2021, VACCINATED WITH PFIZER BIONTECH 2 DOSES; THE PATIENT DIED AT HOME ON 05.07.2021, ASYMPTOMATIC BUT POSITIVE TO COVID-19, MOLECULAR SWAB OF 04.27.2021, VACCINATED WITH PFIZER BIONTECH 2 DOSES; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-728833. A 95-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 18Mar2021 09:46 (Batch/Lot Number: EP9598) as 2ND DOSE, SINGLE, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included chronic ischemic heart disease (two aortocoronary bypasses about 25 years ago), atrial fibrillation, arterial hypertension, all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced the patient died at home on 07May2021, asymptomatic but positive to covid-19, molecular swab of 27Apr2021, vaccinated with pfizer biontech 2 doses on 07May2021. The patient underwent lab tests which included sars-cov-2 test positive: positive on 27Apr2021. The patient died on 07May2021. It was not reported if an autopsy was performed. Reporter''s comment: The patient died on 07May2021, tested positive for Covid-19 with a molecular swab on 27APR21. Vaccinated with two administrations of PFIZER COMIRNATY; in anamnesis: chronic ischemic heart disease (two aortocoronary bypasses about 25 years ago), atrial fibrillation, arterial hypertension. No follow up attempts needed, no further information is expected; Reported Cause(s) of Death: THE PATIENT DIED AT HOME ON 05.07.2021, ASYMPTOMATIC BUT POSITIVE TO COVID-19, MOLECULAR SWAB OF 04.27.2021, VACCINATED WITH PFIZER BIONTECH 2 DOSES; THE PATIENT DIED AT HOME ON 05.07.2021, ASYMPTOMATIC BUT POSITIVE TO COVID-19, MOLECULAR SWAB OF 04.


VAERS ID: 1339321 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-09
Onset:2021-05-11
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021566360

Write-up: Unknown cause of death; This is a spontaneous report received from contactable consumer (patient''s brother-in-law). A 59-years-old female patient received BNT162B2 (COMIRNATY), dose 1 via an unspecified route of administration on 09May2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history was none (patient was fine, she did not suffer from any pathology, she did not take drugs). There were no concomitant medications. The patient experienced unknown cause of death on 11May2021. The patient had been subjected to the Pfizer vaccine on 09May2021, without having complained of uncomfortable situations. The morning of 11May2021 (at 7), the patient was found died in bed. The alarm to Emergency medical service was immediately gave, but on the arrival of the health workers there was nothing more to be done. A Healthcare worker collaborator told that probably it was a cardiovascular short circuit. An autopsy was requested to clarify the cause (results were not provided) and if there was a connection with vaccination but a declaration of death has been issued with specified that it was an inexplicable cause. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1339519 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-10
Onset:2021-05-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4811 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Body temperature, Brain herniation, Cerebral haemorrhage
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), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-13
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hepatic disease
Allergies:
Diagnostic Lab Data: Test Date: 20210510; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021550660

Write-up: Extensive cerebral haemorrhage/Hypertensive cerebral haemorrhage; Brain herniation; Consciousness disturbed; This is a spontaneous report from a contactable pharmacist. This is a report received from the Regulatory Authority (RA). Regulatory authority report number is v21106552. A 95-year-old female patient received the first dose of the bnt162b2 (COMIRNATY; Lot Number: EW4811; Expiration Date: 31Jul2021), via an unspecified route of administration on 10May2021 at 14:30 at a single dose for covid-19 immunisation. Medical history included hepatic disease. The patient''s concomitant medications were not reported. On 12May2021 at 19:00, the patient experienced extensive cerebral haemorrhage/hypertensive cerebral haemorrhage, brain herniation, and consciousness disturbed, which required emergency room visit and hospitalization from 12May2021 to 13May2021. The clinical course was as follows: on 10May2021 around 14:30 (the day of vaccination), the patient received the first dose of BNT162b2. On 12May2021 at 19:00 (2 days after the vaccination), the patient experienced consciousness disturbed. On 12May2021 at 22:00 (2 days after the vaccination), the patient was groaning on the floor in her room and was unresponsive to calls; an ambulance was called and transported the patient to the reporting hospital. On 12May2021 (2 days after the vaccination), the patient was admitted to the hospital. Extensive cerebral haemorrhage mainly manifesting from the left thalamus over the left putamen was noted with a condition of brain herniation. The patient would only be attended on her deathbed as it was difficult to save her. On 13May2021 (3 days after the vaccination), the patient died and was discharged. The patient underwent lab tests and procedures which included body temperature: 36.8 degrees Centigrade on 10May2021 before vaccination. Therapeutic measures were taken as a result of extensive cerebral haemorrhage/hypertensive cerebral haemorrhage, brain herniation, and consciousness disturbed. The clinical outcome of the event was fatal. The patient died on 13May2021 due to extensive cerebral haemorrhage/hypertensive cerebral haemorrhage, brain herniation, and consciousness disturbed. It was not reported if an autopsy was performed. The reporting physician classified the events as serious (hospitalization) and assessed the causality between the events and BNT162b2 as unassessable. Other possible cause of the events such as any other diseases was hypertensive cerebral haemorrhage. No follow-up attempts needed. No further information expected, batch number/ lot number cannot be obtained.; Reported Cause(s) of Death: Consciousness disturbed; Brain herniation; Extensive cerebral haemorrhage/Hypertensive cerebral haemorrhage


VAERS ID: 1339521 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-05-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET9096 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-14
   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: Living in nursing home
Preexisting Conditions: Medical History/Concurrent Conditions: Hyperlipidaemia; Hypertension; Old cerebral infarction; Pleurisy
Allergies:
Diagnostic Lab Data: Test Date: 20210513; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination; Test Name: Abdomen CT; Result Unstructured Data: Test Result:no abnormalities; Test Name: Head CT; Result Unstructured Data: Test Result:no abnormalities; Test Name: Chest CT; Result Unstructured Data: Test Result:no abnormalities
CDC Split Type: JPPFIZER INC2021552247

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the regulatory authority and a contactable pharmacist. Regulatory authority report number is v21106665. A 75-year-old patient of unspecified gender received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: ET9096, Expiration date 31Jul2021), via intramuscular route of administration on 13May2021 13:30 (at the age of 75-year-old) as single dose for COVID-19 immunization. Medical history included old cerebral infarction, pleurisy, hypertension, hyperlipidaemia and ongoing living in nursing home. Concomitant medications included treatment drugs for hypertension and hyperlipidaemia within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. No information on family history was provided. Since the vaccination, the patient has not been tested for COVID-19. The patient previously received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# ET9096, Expiration date 31Jul2021) via Intramuscular route of administration on 21Apr2021 at around 13:30 as a single dose for COVID-19 immunization. On 14May2021 the patient died of cardio-respiratory arrest. The course of the event was described by the physician as follows: On 13May2021 at around 13:30 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# ET9096, Expiration date 31Jul2021) via an intramuscular route of administration as a single dose for COVID-19 immunization. On 14May2021 at 14:21 (1 day after the vaccination), the patient died of cardio-respiratory arrest. On 14May2021 at 14:20 (1 day after the vaccination), the patient was found lying on the stomach in the room by a staff and the staff called an ambulance. When the emergency team arrived, cardio-respiratory arrest was confirmed. While transporting to the reporter''s hospital, epinephrine (EPIQUICK) 7 ampules was administered and resuscitation was performed, however, the patient''s spontaneous circulation did not return. After arriving the reporter''s hospital, CPR (cardiopulmonary resuscitation) was performed for about 30 minutes, but the patient did not recover. Head CT (computerized tomography), chest CT and abdomen CT showed no abnormalities. The reporting physician classified the event cardio-respiratory arrest as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: The patient had underlying conditions of old cerebral infarction and pleurisy. It was reported that the patient was walking as usual on 14May2021 at around 14:00. The reporting pharmacist reported that the cause of death was provided as acute circulatory failure. Autopsy was not performed.; Reported Cause(s) of Death: Cardio-respiratory arrest; acute circulatory failure


VAERS ID: 1339529 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-02
Onset:2021-05-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Polymerase chain reaction, Pyrexia, Septic shock
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Toxic-septic shock conditions (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: 2021-05-15
   Days after onset: 12
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210515; Test Name: PCR; Result Unstructured Data: Test Result:Negative; Comments: Nasal Swab
CDC Split Type: JPPFIZER INC2021557661

Write-up: Pyrexia; Septic shock; This is a spontaneous report from a contactable physician. The patient was a 93-years-old (at the vaccination) female patient. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no other medical history. The patient''s concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. On 02May2021 (the day of vaccination), the patient received?the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: unknown, expiry date: unknown) via an unspecified route of administration for COVID-19 immunization in a hospital. On 03May2021 (one day after vaccination), the patient experienced pyrexia. On 15May2021 (13 days after vaccination), the patient died due to septic shock. An autopsy was not performed. The event pyrexia resulted in hospitalization (Emergency room/department or urgent care), disability and fatal. The duration of hospitalization was 2 days. The treatment received for the adverse event included antibacterial agents, infusions, vasopressors, oxygen administration, etc. On 15May2021, the patient has been tested for COVID-19 by polymerase chain reaction (PCR) test (Nasal Swab) and the test result was negative. An autopsy was not performed. The clinical outcome of septic shock and pyrexia was reported as fatal.; Sender''s Comments: Based on the available information and known product profile, the causal relationship between the reported events pyrexia and septic shock with a fatal outcome and the use of BNT162B2 seems unlikely. There is limited information available in this case to make a more meaningful assessment. The case will be assessed 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: pyrexia; Septic shock


VAERS ID: 1339530 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-17
Onset:2021-05-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Aortic dissection, Cardiac tamponade, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021557888

Write-up: Aortic dissection; pyrexia; cardiac tamponade; This is a spontaneous report from a contactable pharmacist received via a Company sales representative. The patient''s age and gender were not provided. Body temperature before vaccination was not provided. The patient family history and medical history were not provided.On 17May2021 at (the day of vaccination), the patient received a dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via intramuscular at a dose of 0.3 mL, single for COVID-19 immunization. On 17May2021 (the day of the vaccination), the patient experienced pyrexia and aortic dissection. On 17May2021 (the day of the vaccination), the outcome of the events was fatal. The course of the events was as follows: On 17May2021 (the day of vaccination), after the patient received BNT162b2 vaccination at the institution where she was admitted to, she experienced an adverse event of pyrexia, and she was emergently transferred to another hospital. While the patient was being treated in the hospital, she experienced an adverse event of aortic dissection and cardiac tamponade occurred. Thereafter, the patient died. Cause of death was reported as cardiac tamponade; aortic dissection, pyrexia also reported as fatal. Unknown whether autopsy was performed or not. The causality between the event and BNT162b2 was not provided. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event pyrexia cannot be excluded. However, the events of Aortic dissection and Cardiac tamponade are most likely related to an intercurrent or underlying condition which is unlikely related to the suspected drug. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Aortic dissection; pyrexia; cardiac tamponade


VAERS ID: 1339532 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-10
Onset:2021-05-16
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9480 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Apnoea, Blood test, Body temperature, Cardiac arrest, Computerised tomogram thorax, Cyanosis, Magnetic resonance imaging head, Oxygen saturation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-16
   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: Aortic dissection; Cerebral infarction; Gastrostomy; Hypertension; Obstruction lung disease; Prostatic hyperplasia
Allergies:
Diagnostic Lab Data: Test Date: 20210514; Test Name: Blood test; Result Unstructured Data: Test Result:no abnormalities; Test Date: 20210510; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination; Test Date: 20210514; Test Name: Chest CT; Result Unstructured Data: Test Result:no abnormalities; Test Date: 20210514; Test Name: Head MRI; Result Unstructured Data: Test Result:no abnormalities; Test Date: 20210514; Test Name: SpO2; Result Unstructured Data: Test Result:84-86 %; Comments: decreased
CDC Split Type: JPPFIZER INC2021558977

Write-up: Apnoea; Acute cardiac arrest; Cyanosis; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21106877. The patient was an 89-year and 0-month-old male. Body temperature before vaccination was 36.3 degrees Centigrade. Medical history included hypertension, cerebral infarction, post-acute aortic dissection surgery, obstruction lung disease, post-gastrostomy and prostatic hyperplasia. No information on concomitant medications or family history was provided. On 19Apr2021, the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# ER9480, Expiration date 31Jul2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 10May2021 at 15:00 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# ER9480, Expiration date 31Jul2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 16May2021 at 04:50 (6 days after the vaccination), the patient died of apnoea. It was not reported if an autopsy was performed.The course of the event was as follows: On 19Apr2021, the patient received the first dose of the vaccination. On 04May2021, as the patient developed rash on the body trunk and four limbs, he visited a nearby hospital. Anti-histamine medication was administered and then the symptoms improved. During the first dose of the vaccination and the second one, neither dermatologic symptoms, cardiovascular symptoms, respiratory symptoms, nor gastrointestinal symptoms other than the above mentioned symptoms were noted, and pyrexia was not recognized either. On 10May2021 at 15:00, the patient received the second dose of the vaccination. On 14May2021, after the patient made a regular visit to a different hospital, he visited the reporter''s hospital. At that time, no abnormalities were noted in particular. At that night, since SpO2 (oxygen saturation percutaneous) decreased (to 84-86%), he visited an emergency hospital where chest CT, head MRI and blood test were performed. The result showed no abnormalities and the symptoms showed improvement. On 15May2021, his condition was good as usual. On 16May2021 at 04:50 (in the morning), the patient developed sudden respiratory arrest, and cyanosis appeared. Therefore, he was transferred to a hospital on emergency. Acute cardiac arrest and geromarasmus were diagnosed, and the patient''s death was confirmed. The reporting physician classified the event as serious (fatal outcome) and assessed that the event was not related to BNT162b2. It was not reported if there was other possible cause of the event such as any other diseases. The reporting physician commented as follows: It was considered that there was no causal relationship with BNT162b2.; Sender''s Comments: Based on information provided, the event apnoea was more likely related to underlying disease but unlikely related to BNT162b2 (COMIRNATY). The case will be reassessed once more information become 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: Acute cardiac arrest; apnea; cardiac arrest; geromarasmus


VAERS ID: 1339534 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-16
Onset:2021-05-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Body temperature, Computerised tomogram
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-18
   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: CILOSTAZOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210516; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination; Test Date: 20210518; Test Name: CT; Result Unstructured Data: Test Result:suspected myocardial infarction; Comments: (only findings of severe pulmonary congestion)
CDC Split Type: JPPFIZER INC2021563636

Write-up: Acute myocardial infarction; This is a spontaneous report from a contactable physician, medical examiner. This is a report received from the Regulatory Authority (RA). Regulatory authority report number is v21107059. An 89-year-old female patient received the first dose of the bnt162b2 (COMIRNATY; Lot Number: EX3617; Expiration Date: 31Aug2021), via an unspecified route of administration on 16May2021 at 09:15 at a single dose for covid-19 immunisation. The medical history included hypertension. Concomitant medication included cilostazol (CILOSTAZOL). On 18May2021 at 01:00, the patient experienced acute myocardial infarction, which was serious for death. On 16May2021 at 09:15 (the day of vaccination), the patient received the first dose of BNT162b2. On 17May2021 (one day after vaccination), until at night, the patient led a normal life. On 18May2021 around 01:00 (2 days after the vaccination), the patient experienced acute myocardial infarction. On 18May2021 at 06:30, the patient was found to collapse to the floor of the bedroom, and she was confirmed to be dead. The patient underwent lab tests and procedures which included body temperature: 36.7 degrees Centigrade on 16May2021 before vaccination, computerised tomogram: strongly suspected myocardial infarction (only findings of severe pulmonary congestion) on 18May2021. The patient died on 18May2021 due to acute myocardial infarction. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and bnt162b2 as unassessable. Other possible cause of the event such as any other diseases was hypertension. REPORTER COMMENT: The causal relationship between the event and BNT162b2 was unknown according to the patient''s age and underlying disease. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Acute myocardial infarction


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