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From the 10/15/2021 release of VAERS data:

Found 17,128 cases where Vaccine targets COVID-19 (COVID19) and Patient Died



Case Details

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VAERS ID: 1500070 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-24
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: 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 INC2021872368

Write-up: Death; This is a spontaneous report from a contactable physician received via Regulatory Authority. A male in his 60s patient received BNT162B2 (COVID-19 Vaccine - Manufacturer Unknown), on Jun2021, at DOSE 1, SINGLE for covid-19 immunisation. It was unknown whether he had any disease. The patient had no history of hospital visits. Concomitant medications were not reported. At the end of June (the day of vaccination), the patient received the first dose of BNT162b2 (COVID-19 Vaccine - Manufacturer Unknown, Solution for injection, Lot number not reported, Expiration date not reported) via an unspecified route of administration as a single dose for COVID-19 immunization at his workplace. The product name was unknown. It might be MODERNA if given in other places. The vaccination was not given by the reporting physician. It was unknown who performed the vaccination. On an unknown date (3 days after the vaccination), the patient experienced death. The reporting physician performed autopsy. Cause of death was not reported. The outcome of the event was fatal. The physician commented that the event could be due to the effect of the vaccine. Information on the lot/batch number has been requested. Sender''s Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event of death cannot be totally excluded/assessed. The case will be reassessed if additional information becomes available. Reported Cause(s) of Death: Death


VAERS ID: 1500075 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Blood test, Body temperature, Electrocardiogram, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-09
   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: TAKELDA; FORXIGA; NORVASC; URIEF; MAGMITT; BASEN [VOGLIBOSE]; FERROMIA; LENDORMIN
Current Illness: Aortic valve stenosis (candidate for surgery but surgery was not performed, patient was followed-up as an outpatient)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210708; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:no abnormality; Test Date: 20210708; Test Name: Blood collection; Result Unstructured Data: Test Result:no abnormality; Comments: no marked difference compared to the previous results; Test Date: 20210708; Test Name: Body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: before vaccination; Test Date: 20210708; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:no abnormality
CDC Split Type: JPPFIZER INC2021872408

Write-up: Sudden death; This is a spontaneous report from a contactable physician received via a Pfizer sales representative and from the Regulatory authority. Regulatory authority report number is v21118761. The patient''s age was 91-year and 0-month old. Body temperature before vaccination was 36.1 degrees centigrade. Medical history included aortic valve stenosis (the patient was a candidate for surgery but surgery was not performed). Aortic valve stenosis was ongoing and severe, for which the patient was followed-up as an outpatient. The patient lived alone and the patient''s daughter lived nearby. Concomitant medications included acetylsalicylic acid, lansoprazole (TAKELDA combination tablets) 1 tablet once daily in the morning, dapagliflozin propanediol monohydrate (FORXIGA 10 MG) 1 tablet once daily in the morning, amlodipine besilate (NORVASC 5 MG) 1 tablet once daily in the morning, silodosin (URIEF 4 MG) 1 tablet twice daily, magnesium oxide (MAGMITT 330 MG) 1 tablet 3 times daily, voglibose (BASEN 0.3 MG) 3 tablets before meals, ferrous sodium citrate (FERROMIA50 MG) 1 tablet twice daily, and brotizolam (LENDORMIN 0.25 MG) 1 tablet once daily before go to bed, all taken for unspecified indications, start dates were not reported and ongoing. On 17Jun2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number: FA2453 and expiration date: 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 08Jul2021 at 09:52 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: FA5765 and expiration date: 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On an unspecified date (1 day after the vaccination), the patient experienced sudden death. The outcome of the event was fatal. The course of the event was as follows: On 17Jun2021 (Thursday), the patient received the first vaccination. On 08Jul2021 at 10:00, the patient received the second vaccination. On the same day, clinical examination, blood collection, and electrocardiogram were performed. There was no abnormality in weight, blood pressure, electrocardiogram, and results of blood collection. On 09Jul2021 at 19:20, family member called the hospital and told that the patient fell and was unconscious, for which ambulance was requested. The patient experienced severe aortic valve stenosis at 19:20 on 09Jul2021. At around 21:00, death was confirmed. 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 aortic valve stenosis. The reporting physician commented as follows: Results of blood collection on 08Jul2021 showed no marked difference compared to the previous results. The reporting physician assessed that the causality between the event and BNT162b2 as unknown.; Reported Cause(s) of Death: severe aortic valve stenosis


VAERS ID: 1500077 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-07-08
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7338 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Interstitial lung disease
SMQs:, Interstitial lung disease (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-08
   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: Diabetes mellitus; Interstitial pneumonia
Preexisting Conditions: Medical History/Concurrent Conditions: Myocardial infarction
Allergies:
Diagnostic Lab Data: Test Date: 20210705; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021872412

Write-up: aggravation of interstitial pneumonia; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21118736. A 73-year and 3-month-old male patient received BNT162B2 (COMIRNATY), 2nd dose via an unspecified route of administration on 05Jul2021 16:30 (Lot Number: FA7338; Expiration Date: 30Sep2021) at age of 73 years old as a single dose for covid-19 immunisation. Medical history included ongoing interstitial pneumonia, myocardial infarction, ongoing diabetes mellitus. The patient''s concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# FA7338, Expiration date 30Sep2021) at age of 73 years old on 14Jun2021. The patient died of aggravation of Interstitial pneumonia on 08Jul2021 06:30. The patient underwent lab tests and procedures which included body temperature: 36.4 centigrade before vaccination on 05Jul2021.The patient died on 08Jul2021. It was not reported if an autopsy was performed. The course of the event was as follows: On 08Jul2021 at around 06:30, family member noticed something unusual and the patient was transferred to a hospital by ambulance. However, it was confirmed that the patient was already dead. 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 not provided. The reporting physician commented as follows: The patient was receiving visited medical care of another hospital. According to the primary care physician, symptom of interstitial pneumonia was considerably progressed and the condition could have changed suddenly at any time. Thus, it was considered that the patient died of aggravation of present illness.; Reported Cause(s) of Death: aggravation of interstitial pneumonia


VAERS ID: 1500174 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 2 GM / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Product administered at inappropriate site
SMQs:, Drug abuse and dependence (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bleeding spot subcutaneous; Extremity contracture (flexion contracture of four limbs, postural change required full assistance); Hypoalbuminaemia; Oedema; Progressive supranuclear palsy (receiving treatment for 15 years); Speech loss; Swallowing difficult (assistance was needed with oral intake)
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021885408

Write-up: Death; Intramuscular in the gluteus medius left; This is a spontaneous report from a contactable nurse received via COVID-19 Adverse Event Self-Reporting Solution. An 85-year-old female patient (not pregnant) received the second dose of BNT162B2 (COMIRNATY, solution for injection, Lot number FC5947 with Expiration Date 30Sep2021), via intramuscular administered in the gluteus medius left, on 13Jul2021 10:45 (at the age 85-year-old) at single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (COMIRNATY, solution for injection, Lot number FC5947 with Expiration Date 30Sep2021), via intramuscular administered in the gluteus medius left, on 22Jun2021 11:00 (at the age of 85-year-old) at single dose for COVID-19 immunisation. No other vaccine was received in four weeks. Relevant medical history included progressive supranuclear palsy (receiving treatment for 15 years), flexion contracture of four limbs (postural change required full assistance), not able to speak, swallowing difficult (assistance was needed with oral intake), low albumin, oedema and bleeding spot subcutaneous. Relevant concomitant medications included antiparkinsonian drug, laxative, and antihypertensive. Prior to vaccination, the patient was not diagnosed with COVID-19. On 13Jul2021 at 14:30 (3 hours 45 minutes after the vaccination), the patient experienced death. The cause of death was unknown. Since the vaccination, the patient has not been tested for COVID-19. No autopsy was performed.; Sender''s Comments: Based on the current limited available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event cannot be totally excluded/assessed. The medical history of patient are also considered as possible contributors.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 RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1500175 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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: Bedridden; Dementia; Malignant lymphoma
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021887980

Write-up: Death; This is a spontaneous report from a contactable physician via the Regulatory Authority. A 95-year-old female received the second dose of BNT162B2 (COMIRNATY, solution for injection, Lot number not provided), via intramuscular, on unknown date at single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (COMIRNATY) administered on unknown date for COVID-19 immunisation. Relevant medical history included malignant lymphoma, dementia, and bedridden. No relevant concomitant medications were provided. The patient died 5 days after the second BNT162b2 vaccination. The cause of death was not provided. It was not reported if an autopsy was performed. Sender''s Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. This case will be reassessed when additional information, particularly the clinical course before death, complete medical history, concomitant medication and autopsy report, becomes available. The impact of this report on the benefit/risk profile of the product is evaluated as part of 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, as appropriate. Reported Cause(s) of Death: death


VAERS ID: 1500237 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Encephalitis, Fall, Haemorrhage, Multiple fractures, Spondylitis
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (narrow), Accidents and injuries (narrow), Cardiomyopathy (broad), Osteoporosis/osteopenia (broad), Arthritis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
   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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: KRJNJFOC20210738794

Write-up: IDIOPATHIC ENCEPHALITIS; SPONDYLITIS; FELL DOWN FROM THE THIRD FLOOR OF THE HOSPITAL PARKING LOT; DIFFICULTY BREATHING; MULTIPLE FRACTURES; EXCESSIVE BLEEDING; This spontaneous report received from a consumer via a company representative via social media (news article) concerned a 31 year old male of unknown race and ethnicity. 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 admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 14-JUN-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 03-JUL-2021, the patient who was resting at home experienced faint from 11 pm with symptoms such as convulsion, difficulty breathing and high fever above 38 degree Celsius. After receiving a report of the patient 119 paramedics were dispatched and breathing returned. On 04-JUL-2021, the patient experienced loss of consciousness as he collapsed again while going out to meet his acquaintance, and then he recovered his sense again. Patient visited hospital on 06-JUL-2021 and fell down from the third floor of the hospital parking lot. The patient was transferred to the tertiary general hospital on 06-JUL-2021. According to the medical records of the general hospital the patient was showing idiopathic encephalitis, spondylitis and cognitive disturbances since sudden fainting three days ago. The patient also experienced delirium, walking helplessly, cognitive disturbance, and body aches after inoculation. On JUL-2021, the patient died from multiple fractures, excessive bleeding. The autopsy of the patient was conducted on 08-JUL-2021 and autopsy result are to be expected around 22-JUL-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the difficulty breathing, fell down from the third floor of the hospital parking lot, idiopathic encephalitis and spondylitis was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender''s Comments: V0-20210738794-covid-19 vaccine ad26.cov2.s-Multiple Fractures, Excessive bleeding, Idiopathic encephalitis, Fell down from the third floor of hospital parking lot. 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: MULTIPLE FRACTURES; EXCESSIVE BLEEDING; Autopsy-determined Cause(s) of Death: MULTIPLE FRACTURES; EXCESSIVE BLEEDING


VAERS ID: 1500240 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-06-20
   Days after vaccination:53
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NEXIUM [ESOMEPRAZOLE SODIUM]; COVERSYL [PERINDOPRIL ARGININE]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210511; Test Name: PCR; Result Unstructured Data: Test Result: Negative; Comments: Nasal Swab.
CDC Split Type: LBPFIZER INC2021870578

Write-up: cardiac crisis or stroke; cardiac crisis or stroke; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Apr2021 (at 78 years old) as for COVID-19 immunization. Medical history was not reported. Concomitant medications included esomeprazole sodium (NEXIUM) taken for an unspecified indication from 28Apr2021 and perindopril arginine (COVERSYL) taken for an unspecified indication, start and stop date were not reported. The patient did not have COVID-19 prior to vaccination. The patient was tested for COVID-19 post vaccination. The patient experienced cardiac crisis or stroke followed by death, on 20Jun2021 09:45, resulted in hospitalization. The patient underwent lab tests and procedures which included polymerase chain reaction: negative on 11May2021 (nasal swab). The patient died on an unspecified date. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: cardiac crisis or stroke; cardiac crisis or stroke


VAERS ID: 1500251 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-06-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0579 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Arthralgia, Asthenia, Cardio-respiratory arrest, Chest pain, Decreased appetite, Depressed level of consciousness, Dizziness, Fatigue, Headache, Myalgia, Pain
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021862278

Write-up: cardiorespiratory arrest; chest pain; loss of alertness; acute myocardial infarction; headache; ASTHENIA/adynamia; ASTHENIA / FATIGUE; pain/sensitivity; dizziness; hyporexia; myalgia; arthralgia; This is a spontaneous report from a non-contactable other health professional (HCP) via the Regulatory Authority. The Regulatory authority report number 16439-7. A 53-year-old non-pregnant female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EY0579; Expiration Date: 01Oct2021), intramuscular, administered in arm left on 16Jun2021 (at the age of 53-years-old) as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced headache, asthenia/adynamia, asthenia/ fatigue, pain/sensitivity, dizziness, hyporexia, myalgia, arthralgia, and acute myocardial infarction on 18Jun2021. Chest pain, loss of alertness, and cardiorespiratory arrest on an unspecified date. Patient presented to the general emergency department for chest pain, presenting with loss of alertness, and cardiorespiratory arrest. The outcome of the events was fatal. The patient died on an unspecified date. It was unknown if an autopsy was performed. The events were assessed as serious, hospitalization and death by the regulatory authority. No follow-up attempts are possible. No further information is expected. Information on lot number already obtained.; Reported Cause(s) of Death: headache, asthenia/adynamia, asthenia/ fatigue, pain/sensitivity, dizziness, hyporexia, myalgia, arthralgia, acute myocardial infarction, chest pain, loss of alertness, and cardiorespiratory arrest.


VAERS ID: 1500329 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-06-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-03
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021857711

Write-up: He died three days after vaccination. Cause of death unknown.; watery runny nose; This is a spontaneous report from a contactable Physician downloaded from the Regulatory Authority-WEB NL-LRB-00608666. A 56-year-old male patient received second dose of BNT162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number and Expiration Date: was not reported) via an unspecified route of administration on 29Jun2021 (age at the time of vaccination 56-year-old), as a 0.3 mL single dose for COVID-19 immunization. The patient previously received the first dose of BNT162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number and Expiration Date: was not reported), on an unspecified date (age at the time of vaccination 56-year-old), as a 0.3 mL single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported.On 29Jun2021, the patient had watery runny nose. On 03Jul2021, the patient died three days after vaccination. Cause of death was reported as unknown. No further complaints. Patient passed away unexpectedly in his sleep on 03Jul2021. Diagnostic procedures: An autopsy will take place if the family wants it. They arrange this with the doctor. The outcome of event death was fatal and the outcome of runny nose was unknown. No follow-up attempts possible. No further information expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: cause of death unknown


VAERS ID: 1500341 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-10
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

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

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


VAERS ID: 1500352 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-07-05
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2083 / 1 RA / OT

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: 2021-07-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARALGIN FORTE; PARACET
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pain; Smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021864972

Write-up: CARDIAC ARREST; This is a spontaneous report from a contactable physician from the Regulatory Authority. The regulatory authority number NO-NOMAADVRE-FHI-2021-U43rxa. Additional case identifier: NO-NOMAADVRE-E2B_00036153. A 61-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in arm right on 23Jun2021 (Batch/Lot Number: FE2083) as dose 1, single for COVID-19 immunisation. Medical history included tobacco user and pain. Concomitant medications included PARALGIN FORTE taken for pain from 01Jun2021 to an unspecified stop date and PARACET taken for pain from 01Jun2021 to an unspecified stop date. The patient experienced cardiac arrest on 05Jul2021. On 05Jul2021, the patient developed cardiac arrest at home. The patient had no known cardiovascular or pulmonary disease, or symptoms prior to the event. No relevant laboratory findings or investigations was included in the report. The patient''s outcome was Fatal, at the time of the report. The case was considered to be serious. The cause of death was cardiac arrest. The patient died on 05Jul2021. It was not reported if an autopsy was performed. The Regulatory Authority assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as Possible. No follow-up attempts are possible. No further information is expected. Reported Cause(s) of Death: CARDIAC ARREST


VAERS ID: 1500359 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-27
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC2336 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021865130

Write-up: DEATH; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB NO-NOMAADVRE-FHI-2021-Un2yp4. A 64-year-old female patient received BNT162B2 (COMIRNATY), 2nd dose intramuscularly on 02Jun2021 (Batch/Lot Number: FC2336, expiration date not provided) as a single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient died on 27Jun2021. The patient was hospitalized for 2 days. It was not reported if an autopsy was performed. Clinical course: A 64 Years old female patient received Comirnaty (second dose) on 02Jun2021 for vaccination. The patient died after two days of intensive care in hospital. No obvious cause of multi organ failure was found, but the patient had probably been weak for a long time. As of now, the vaccine is not suspected to be specifically connected to the death of the patient, but this is reported because of the timing and lack of diagnosis. Autopsy will be performed. The patients outcome was fatal, at the time of the report. The case was considered to be serious. This case was received from a physician. The Regulatory Authority assessed the causal relationship between BNT162B2 (COMIRNATY) and all the reported events as Possible. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


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

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

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

Write-up: Bl?dning; This regulatory authority case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Bl?dning) in a 72-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No medical history was provided by reporter. Concomitant products included PARACETAMOL for an unknown indication. On 21-Jun-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (Bl?dning) (seriousness criteria death and medically significant). The cause of death was not reported. It is unknown if an autopsy was performed. Treatment medication use information was not provided by reporter. Action taken with mRNA-1273 in response to the events was not applicable. The reporter did not provide causality assessment between mRNA-1273 and the events. This is a case of death in a 72-year-old female subject, who died after receiving first dose of vaccine. Very limited information has been provided at this time.; Sender''s Comments: This is a case of death in a 72-year-old female subject, who died after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1500371 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Decreased appetite, Gait disturbance, Haematoma, Pulmonary embolism, Weight, Weight decreased
SMQs:, Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cough; Smoker
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Weight; Result Unstructured Data: lost normal weight
CDC Split Type: PLJNJFOC20210735024

Write-up: PULMONARY EMBOLISM; WALKING PROBLEMS; LOST NORMAL WEIGHT; LOST APPETITE; HEMATOMA (SHAPE OF THE MOUSE) ON PROBABLY LEFT CALF; FELT VERY WEAK; This spontaneous report received from a consumer concerned a 66 year old male. Initial information was processed along with additional information on 20-JUL-2021. The patient''s height, and weight were not reported. The patient''s concurrent conditions included smoker, and coughs a lot. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, 1 total administered on 09-JUN-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient felt very weak after the vaccine. He actually looked very weak, but he did not want to talk about that. The patient got very calm, he was just sitting or laying on the couch. He developed walking problems. He lost his appetite and he lost his normal weight. On an unspecified date in 2021, Laboratory data included: Weight (not provided) lost normal weight. It was reported that the patient experienced some chest pain. The problems with breathing occurred, the patient was coughing a lot. In general, the patient coughed a lot, but the cough changed, the patient''s wife could hear that. The patient''s wife once spotted hematoma (shape of the mouse) on probably left calf which appeared quite big in shape as a mouse, it had beetroot-cyanosed color (not sure appeared before or after vaccination). The patient was hiding the signs. The patient went to the medically recommended physiotherapy, he was acting very strange at the day of the trip, he was in a big hurry, he was lugging heavy suitcases, and he really wanted to reach the place. On 14-JUL-2021, the patient got attack of dyspnoea, they carried out resuscitation, but it did not help. The doctor said that it was pulmonary embolism. In hospital they collected all documents. On an unspecified date in JUL/2021, the patient died from pulmonary embolism. It was unknown if autopsy was performed. The action taken with covid-19 vaccine was not applicable. The outcome of the felt very weak, walking problems, lost normal weight, lost appetite, and hematoma (shape of the mouse) on probably left calf was not reported. This report was serious (Death). Sender''s Comments: V0:20210735024-JANSSEN COVID-19 VACCINE. Pulmonary embolism with fatal outcome. 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: PULMONARY EMBOLISM


VAERS ID: 1500378 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-02
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021865245

Write-up: Sudden cardiac death; This is a spontaneous report from a contactable physician from the Regulatory Authority. The regulatory authority number PL-URPL-DML-MLP.4401.1.369.2021. A 72-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sudden cardiac death (death) on 02Apr2021. The patient died on 02Apr2021. An autopsy was not performed. Sender''s comment: Sudden cardiac death is an unexpected side effect for the vaccine. The doctor did not specify the date of vaccination, the medical history of the patient is unknown, there is no contact with the doctor, so the relationship between the vaccine and the occurrence of side effects cannot be assessed. No follow-up attempts are possible. No further information is expected. Reported Cause(s) of Death: Sudden cardiac death.


VAERS ID: 1500379 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-03-31
   Days after vaccination:64
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Embolism, Haemorrhage subcutaneous
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), 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), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021857861

Write-up: heart arrest; Haemorrhage subcutaneous; Embolism; This is a spontaneous report from a contactable consumer from the Regulatory Authority. The regulatory authority number PL-URPL-DML-MLP.4401.2.423.2021. A male patient of an unspecified age received bnt162b2 (COMIRNATY), intramuscular on 26Jan2021 (Batch/Lot Number: EP9598) (at age 81-years-old), as dose 2, single for covid-19 immunisation. The first dose was received on 06Jan2021 (lot number: EJ6136), intramuscular. The patient''s medical history and concomitant medications were not reported. The patient experienced embolism on 31Mar2021, heart arrest, and haemorrhage subcutaneous on an unspecified date. The patient died on 31Mar2021. It was not reported if an autopsy was performed. Clinical course were as follows: a haemorrhage on his hand a few days before his death. Not at the injection site. 43 days after the second dose of vaccination. Health result: death (date: 31Mar2021, reason: embolism, cessation of blood circulation). The reporting person did not classify its severity. Sender Comment: Comirnaty is an mRNA vaccine against COVID-19. Pulmonary embolism is not an expected side effect following administration of this vaccine. Until 28Jun2021, 5 cases of fatal embolism after Comirnaty administration were reported in the EudraVigilance database. The reporting person did not classify its severity. Due to the nature of the side effects and the patient''s death, the Office for Registration of Medicinal Products qualified the application as "severe". Due to the insufficient amount of data, the Regulatory Authority established an unclassifiable causal relationship between vaccination and death. The reporting person did not provide any contact details. The Office for Registration of Medicinal Products is not able to obtain additional data. Reported Cause(s) of Death: Embolism; Heart arrest.


VAERS ID: 1500709 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-09
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Headache, Pain, Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-24
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension (defaulted on treatment due to side effects)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC2021871990

Write-up: Died; Pain; Mild headache; Left arm pain; This is a spontaneous report from a contactable physician. An 80-years-old female patient received BNT162b2 (BNT162B2) administration on an unspecified date (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. Medical history included hypertension - defaulted on treatment due to side effects. The patient''s concomitant medications were not reported. The patient experienced pain, mild headache and left arm pain on 09Jun2021 with outcome of unknown. The patient was reported to have died on 24Jun2021. It was unknown if autopsy was performed. Information on the lot/batch number has been requested.; Sender''s Comments: Death of unknown cause is assessed related as a cautionary measure and for reporting purposes. The underlying disease may provide an alternative cause. 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: Died


VAERS ID: 1501462 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: BRJNJFOC20210742007

Write-up: THROMBOSIS; This spontaneous report received from a consumer concerned a patient of unspecified age, sex, 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, and batch number were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced thrombosis and died. 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). This case, from the same reporter is linked to 20210723538.; Sender''s Comments: V0: 20210742007-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Thrombosis. 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: THROMBOSIS


VAERS ID: 1501694 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-26
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: CAPFIZER INC2021887750

Write-up: passed away in his sleep and didn''t wake up Monday morning; This is a spontaneous report from a contactable physician for a 24-year old-male consumer (patient), communicated to a sales representative regarding product BNT162B2. A 24-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 Vaccine, Formulation: solution for injection, Lot number and expiration date was not reported), via unspecified route of administration on unknown date as dose number unknown, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The reporter stated that a healthy and active 24 year old patient who received the Pfizer vaccine on a Sunday passed away in his sleep and didn''t wake up Monday morning. Event took place after use of product. It was unknown if autopsy was performed. No follow-up attempts are not possible. No further information expected.; Sender''s Comments: The information on the circumstances of the patient''s death is too limited to perform a meaningful company causality assessment: this event is handled as related to the suspect product BNT162B2 as a cautionary measure and for reporting purposes. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: passed away in his sleep and didn''t wake up Monday morning


VAERS ID: 1502606 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-18
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Death, Dyspnoea, Fatigue, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-20
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac disorder NOS (on therapy)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC2021874323

Write-up: Chest pain; Worsened breathing; Legs oedema; Unknown cause of death; Fatigue of whole body; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB CZ-CZSUKL-21007807. This consumer reported different events for the different doses of the same vaccine to the same patient. This is the first of two reports (report for second dose). A 74-years-old male patient received bnt162b2 (COMIRNATY, solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 31May2021 as dose 2, single for covid-19 immunisation. Medical history included cardiac disorder NOS (not otherwise specified) and patient was on therapy from an unknown date and unknown if ongoing, and ongoing diabetes mellitus. The patient''s concomitant medications included patient was taking medication for heart disease. The patient received the first dose of Comirnaty on an unspecified date in 2021 for covid-19 immunisation and experienced light leg oedema from knees down, chest pain, and severe fatigue of the whole body. On 18Jun2021, the patient had chest pain, worsened breathing, legs oedema and fatigue of whole body. It was also reported as two days later the 2nd dose of Comirnaty was applied he experienced legs oedema much more, severe chest pain, severe fatigue from every movement. The events chest pain and worsened breathing were reported as life-threatening. The fatigue was reported as non-serious. The patient was hospitalized from 18Jun2021 to an unknown date due to the events which were also reported as medically significant: chest pain, worsened breathing, and legs oedema. He was transferred to the hospital 18 days after the vaccination, he died 2 days later (on 20Jun2021). The patient experienced unknown cause of death on 20Jun2021. The outcome of the events chest pain, worsened breathing, legs oedema and fatigue of whole body was unknown. The patient died on 20Jun2021 with unknown cause of death. An autopsy was not performed. No follow-up attempts are possible; information on batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : CZ-PFIZER INC-2021899298 same patient/vaccine, different dose/events; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1502633 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-18
Submitted: 0000-00-00
Entered: 2021-07-26
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: 2021-06-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021874721

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-202100128975. This is first of two reports. An 84-year-old female patient received bnt162b2 (COMIRNATY, strength: 0.3 ml), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as single dose for covid-19 immunization. Age at vaccination was 84 years old. The patient''s medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on 23Mar2021 at 84 years old at single dose for covid-19 immunization and suffered an apoplexy. On 18Jun2021 the patient experienced Unknown cause of death after the second vaccination. The patient''s outcome was: fatal for Unknown cause of death. This report was serious - death, hospitalization. It was not reported if an autopsy was performed. Result of Assessment: Comirnaty/ event: Unknown cause of death/ PEI: D. Unclassifiable No follow-up attempts possible. No further information expected. Information about Lot/Batch number can not be obtained.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-2021899742 same patient, different dose, different event; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1502635 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6975 / 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: 2021-07-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021874965

Write-up: Sudden death unexplained; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB DE-PEI-202100128981. A 69-years-old female patient received second dose of BNT162B2 (COMIRNATY, formulation: solution for injection, lot number: FE6975, expiration date: unknown) (at the age of 69 years) via an unspecified route of administration on 30Jun2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient received first dose of BNT162B2 (COMIRNATY, formulation: solution for injection, lot number: unknown, expiration date: unknown) via an unspecified route of administration on 19May2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 01Jul2021, the patient experienced sudden death unexplained. The patient died on 01Jul2021. It was not reported if an autopsy was performed. Relatedness of drug to reaction(s)/event(s) D. Unclassifiable No follow-up attempts are possible. No further information was expected.; Reported Cause(s) of Death: Sudden death unexplained


VAERS ID: 1502636 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-09
Submitted: 0000-00-00
Entered: 2021-07-26
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: 2021-05-09
   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: Coronary disease
Preexisting Conditions: Medical History/Concurrent Conditions: Old myocardial infarction
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021874728

Write-up: Sudden death, cause unknown; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100128982. A 72-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history included old myocardial infarction from an unknown date and not ongoing; ongoing coronary disease. The patient''s concomitant medications were not reported. The patient experienced also sudden death, cause unknown on 09May2021. The patient''s outcome was: fatal for Sudden death, cause unknown. An autopsy was not performed. This report was serious - death. Relatedness of drug to event: D. Unclassifiable. No follow-up attempts are possible. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: sudden death, cause unknown


VAERS ID: 1502640 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-04
Submitted: 0000-00-00
Entered: 2021-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1440 / 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: 2021-06-04
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021874864

Write-up: Cardiac arrest; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB DE-PEI-202100129258. A 58-year-old male patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot Number: FC1440), via an unspecified route of administration on an unspecified date (at unknown age) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (COMIRNATY) on 15May2021 (at 58 years old) as single dose for COVID-19 immunisation. This report is serious-death. On 04Jun2021 the patient experienced Cardiac arrest. The patient''s outcome was fatal for Cardiac arrest. Relatedness of drug to reaction(s)/event(s) D. Unclassifiable. The patient died on 04Jun2021. It was unknown if an autopsy was performed.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1502641 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-11
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8889 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Hepatic failure, Ocular icterus, Pyrexia, Sepsis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cholestasis and jaundice of hepatic origin (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Conjunctival disorders (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-22
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Coronary disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021874927

Write-up: Pyrexia; Hepatic failure; Scleral icterus; Acute kidney failure; Sepsis; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100129260. A 72-years-old male patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, batch/lot number: FC8889), via an unspecified route of administration on 03Jun2021 as dose 2, single for covid-19 immunization. The patient''s medical history and concurrent conditions included arterial hypertension and coronary disease from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Patient previously received first dose of BNT162B2 (COMIRNATY, Solution for injection, batch/lot number: UNKNOWN), via an unspecified route of administration on 29Apr2021 as dose 1, single for covid-19 immunization and patient not had any adverse event. On 11Jun2021, the patient experienced pyrexia, hepatic failure, scleral icterus (ocular icterus), acute kidney failure (acute kidney injury) and sepsis. The adverse events considered as life threatening and led to hospitalization. On 22Jun2021, the patient was died due to Multiple organ failure. It was not reported if an autopsy was performed. Result of Assessment: Comirnaty/ all event(s):/ PEI: B. Indeterminate No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Multiple organ failure


VAERS ID: 1502654 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-06-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6975 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Brain death, 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: 2021-07-03
   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: Medical History/Concurrent Conditions: Anal cancer; COPD
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021874959

Write-up: Brain death; Cardiac death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100130499. A 53-year-old Female patient received BNT162B2 (COMIRNATY; formulation: solution for injection; Batch/lot number: FE6975 and Expiration date were not reported) via an unspecified route of administration on 30Jun2021 (at the age of 53-year-old), as an unknown, single dose for COVID-19 immunization. Patient medical history and concurrent conditions included anal cancer and chronic obstructive pulmonary disease. The concomitant medications were not reported. On 30Jun2021 (same day of vaccination), the patient experienced a Cardiac death, Brain death. Patient died on 03Jul2021. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Brain death; Cardiac death


VAERS ID: 1502917 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-12
Onset:2021-06-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC2336 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Headache, Muscle spasms
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dystonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-17
   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: PANODIL; MORFIN DAK; ELIQUIS; SIMVASTATIN KRKA; MULTIVITAMIN [VITAMINS NOS]; CALCIUM D [CALCIUM;COLECALCIFEROL]; ELTROXIN; DULCOLAX [BISACODYL]; FRUSAMIL [AMILORIDE HYDROCHLORIDE;FUROSEMIDE]; GANGIDEN; KALEORID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Constipation; Hypercholesterolaemia; Hypometabolism; Pain
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC2021873970

Write-up: Cerebral hemorrhage; Headache; Cramps; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DK-DKMA-WBS-0075608. A 73-years-old female patient received second dose of bnt162b2 (COMIRNATY, tozinameran, Formulation: Solution for injection, Lot Number: FC2336; Expiration Date: 30Sep2021) via an intramuscularly administered on 12Jun2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included constipation, pain, hypometabolism and hypercholesterolaemia from an unknown date and unknown if ongoing. The patient concomitant medications included paracetamol (PANODIL), 4000 mg, 1x/day (once per day), oral taken for pain from 06Apr2021 to an unspecified stop date; morphine hydrochloride (MORFIN DAK), 10 mg, as needed, maximum 4 times a day, oral taken for pain from 06Apr2021 to an unspecified stop date; apixaban (ELIQUIS), 5 mg, 1x/day (once per day), oral taken for thrombosis prophylaxis from 27May2020 to an unspecified stop date; simvastatin (SIMVASTATIN KRKA), 80 mg, 1x/day (once per day), oral taken for hypercholesterolaemia from 05Mar2014 to an unspecified stop date; vitamins nos (MULTIVITAMIN [VITAMINS NOS]), 1 DF, 1x/day (once per day), oral taken for vitamin supplementation from 26May2020 to an unspecified stop date; calcium, colecalciferol (CALCIUM D [CALCIUM;COLECALCIFEROL]), 2 DF, 1x/day (once per day), oral taken for mineral supplementation from 25May2020 to an unspecified stop date; levothyroxine sodium (ELTROXIN), 50 ug, 1x/day (once per day), oral taken for hypometabolism from 26May2020 to an unspecified stop date; bisacodyl (DULCOLAX [BISACODYL]) 5 mg, as needed, oral taken for constipation from 03May2021 to an unspecified stop date; amiloride hydrochloride, furosemide (FRUSAMIL [AMILORIDE HYDROCHLORIDE; FUROSEMIDE]) 2 DF, 1x/day (once per day), oral taken for diuretic therapy from 01Oct2020 to an unspecified stop date; macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (GANGIDEN) maximum 3 times a day, oral taken for constipation from 06Apr2021 to an unspecified stop date; potassium chloride (KALEORID) 1500 mg, 1x/day (once per day), oral taken for mineral supplementation from 29May2020 to an unspecified stop date. Historical vaccine included first dose of COMIRNATY (Lot Number: EW6126) via an intramuscularly administered on 07May2021 for COVID-19 immunisation. On 14Jun2021, two days after the second vaccination, the patient experienced headache, cerebral hemorrhage and cramps. The ADR Cerebral hemorrhage was fatal. The ADRs Cramps and Headache have an unknown outcome. Reported cause of death was cerebral hemorrhage. It is unknown if postmortem was performed. There is no information regarding test results. No treatment due to the ADRs was reported. The ADRs were by the reporter reported as being Fatal on 17Jun2021. The patient died on 17Jun2021. It was not reported if an autopsy was performed. The outcome events were Fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cerebral hemorrhage


VAERS ID: 1502972 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-05-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4598 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiocardiogram, Blood creatine phosphokinase, Chest pain, Electrocardiogram, Hyperhidrosis, Malaise, Myocardial rupture, Pyrexia, SARS-CoV-2 test, Syncope, Troponin I, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-17
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CARDYL; BISOPROLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic ischaemic heart disease, unspecified; COVID-19 (Covid-19 the first half of January did not require hospital admission.); Ex-smoker; Hypercholesterolaemia; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Date: 20210516; Test Name: Arteriogram coronary; Result Unstructured Data: Test Result:VI coronary angiography showing an image...; Comments: ...suggestive of wide INTERVENTRICULAR COMMUNICATION.; Test Date: 20210516; Test Name: Creatine kinase; Result Unstructured Data: Test Result:cardiac markers CK 836; Test Date: 20210514; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Normal; Test Date: 20210516; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:EKG rs showing Q lower elevation ST lower...; Comments: ...descent ST anterior; Test Date: 202101; Test Name: Covid-19 test PCR; Test Result: Positive ; Test Date: 20210516; Test Name: Troponin I; Result Unstructured Data: Test Result:Tn I 16 (micgr/l).
CDC Split Type: ESPFIZER INC2021874017

Write-up: Syncope; Cardiac rupture; Chest pain; Fever; General malaise; Vomited; Sweating increased; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number ES-AEMPS-931923. A 74-years-old male patient received second dose of BNT162B2 (COMIRNATY, formulation: Solution for injection, Batch/lot number: FA4598) via an unspecified route of administration on 14May2021 as single dose for covid-19 immunisation. Medical history included myocardial ischaemia from 2014 to an unknown date, covid-19 from Jan2021 to an unknown date Covid-19 the first half of January did not require hospital admission, hypertension from an unknown date and unknown if ongoing, hyper cholesterolaemia from an unknown date and unknown if ongoing, ex-tobacco user from an unknown date and unknown if ongoing. Concomitant medication(s) included atorvastatin calcium (CARDYL) taken for an unspecified indication, start and stop date were not reported; bisoprolol (BI-SOPROLOL) taken for an unspecified indication, start and stop date were not reported. The patient had historical vaccine of BNT162B2 (COMIRNATY, formulation: Solution for injection, Batch/lot number: EW9127) via an unspecified route of administration on 23APR2021 as single dose for covid-19 immunisation. On 15May2021 the patient experienced general malaise, vomited, sweating increased, fever, cardiac rupture. on 16May2021 syncope, cardiac rupture, chest pain. Clinical course reported as Just before receiving the second dose of the Comirnaty vaccine (14May2021), he had attended his annual checkup with the cardiologist. He received the vaccination in the afternoon and that same morning they had performed an echocardiogram that gave normal results, nothing alarming. On 15May he presented fever, malaise and vomiting. On 16May2021 in the morning he reported chest pain with syncope accompanied by profuse sweating and general malaise. Given the persistence of the pain, he decided to consult (he believed that the pain was related to the syncope and the fall). On arrival at the Clinic, pain persisted, hemodynamic stability, an rs EKG was performed, showing q lower st elevation, lower st anterior descent, 1st cardiac markers CK 836 and Tn I 16 (micgr / l). A VI coronary angiography was performed, showing an image suggestive of wide INTERVENTRICULAR COMMUNICATION. Clinical judg-ment: posteroinferiolateral AMI complicated with ventricular septal defect (VSD). Urgent Surgical intervention was decided on 17May2021 due to the BREAKAGE OF SEPTEMBER IV. REPAIR BY DACRON PATCH, VENTRICULOTOMY CLOSURE. Presents FORRESTER GRADE IV IN-TRAOPERATIVE CARDIOGENIC SHOCK. SUCCESSFUL IN THE FIRST HOUR AFTER SURGERY. The patient underwent lab tests and procedures which included angiocardiogram: vi coronary angiography showing an image on 16May2021. suggestive of wide IN-TERVENTRICULAR COMMUNICATION, blood creatine phosphokinase: cardiac markers ck 836 on 16May2021, electrocardiogram: normal on 14May2021, electrocardiogram: ekg rs showing q lower elevation st lower on 16May2021. descent ST anterior, sars-cov-2 test: positive on Jan2021, troponin i: tn i 16 (micgr/l) on 16May2021. The patient died on 17May2021. An autopsy was not performed. Root causes: ACUTE COMPLICATED CORONARY SYNDROME (16May21) Intermediate causes: FORRESTER GRADE IV INTRAOPERATIVE CARDIOGENIC SHOCK Immediate causes: ASYSTOLIA No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Root causes: COMPLICATED ACUTE CORONARY SYNDROME (16May21) Intermediate causes: FORRESTER GRADE IV INTRAOPERATIVE CARDIOGENIC SHOCK Immediate causes: ASYSTOLIA


VAERS ID: 1502990 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-06-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4632 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: EPLERENONE; ISOSORBIDE DINITRATE; BISOPROLOL; JANUMET [METFORMIN HYDROCHLORIDE;SITAGLIPTIN]; AMLODIPINE; ATORVASTATIN; DOXAZOSIN; HIDROSALURETIL; AAS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute myocardial infarction, subendocardial infarction; Diabetes mellitus; Dyslipidemia; Hypertension; Ischemic heart disease; Progressive renal failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021874025

Write-up: Sudden death; fell; bruising his head; This is a spontaneous report from a contactable other healthcare professional downloaded from the Regulatory Authority-WEB, regulatory authority number ES-AEMPS-937265. A 71-years-old male patient received first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot Number: FA4632, Expiration date: unknown) via an intramuscularly administered on 11Jun2021 as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. The patient''s medical history included hypertension, dyslipidaemia, diabetes mellitus, ischemic heart disease and progressive renal failure from an unknown date and unknown if ongoing and acute subendocardial infarction on LBBB from 11Dec2012 to an unknown date. Concomitant medication included eplerenone, isosorbide dinitrate, bisoprolol, metformin hydrochloride, sitagliptin (JANUMET), amlodipine, atorvastatin, doxazosin, hydrochlorothiazide (hydrosalurethyl) and acetylsalicylic acid (AAS) were taken for an unspecified indication, start and stop date were not reported. The patient experienced sudden death on 12Jun2021. She went to the emergency service at her place of residence 12Jun2021 because found the death patient at home hours of development, 24 hours after the vaccine. She impressed that in the civic center he fell, bruising his head and lying face down. No further information could be obtained. It was not reported if an autopsy was performed. The outcome of the event sudden death was fatal and other events was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1503175 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA NC / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-13
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma; Drug hypersensitivity; Fibromyalgia; Hypothyroidism; Obesity; Seasonal allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Bilateral cataracts
Allergies:
Diagnostic Lab Data: Test Date: 20210709; Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: FRMODERNATX, INC.MOD20212

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


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Obesity (Ob?sit?)
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20201201; Test Name: SARS-CoV-2 test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: FRMODERNATX, INC.MOD20212

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


VAERS ID: 1503266 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-07-03
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003181 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: TIA
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

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


VAERS ID: 1503393 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-05-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-13
   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: RAMIPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Blood pH high
Allergies:
Diagnostic Lab Data: Test Date: 20201119; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021870529

Write-up: brain stem hemorrhage; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202107081901426350-KX8NL, and Safety Report Unique Identifier is GB-MHRA-ADR 25622533. A 60-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12May2021 (batch/lot number: not known), as dose 2, single for COVID-19 immunisation. Medical history included atrial fibrillation and blood pH high. It was unsure if patient has had symptoms associated with COVID-19. Concomitant medication included ramipril taken for blood pH high. On 13May2021, patient experienced brain stem hemorrhage. It was reported that patient died alone within 24 hours of his 2nd Pfizer vaccination. Cause of death was a brain stem hemorrhage. The event was considered serious (fatal). The patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. The patient underwent lab test which included COVID-19 virus test: yes - positive COVID-19 test on 19Nov2020. The patient died on 13May2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: brain stem hemorrhage


VAERS ID: 1503573 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-10
Onset:2021-05-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Inappropriate schedule of product administration
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-15
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021871612

Write-up: Pain chest; First dose on 26Feb2021, second dose on 10May2021; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202107091749171530-EGFM9, Safety Report Unique Identifier GB-MHRA-ADR 25628521. A 55-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 10May2021 (at age of 55-year-old) as single dose via an unspecified route of administration for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Historical vaccine included first dose of BNT162B2 on 26Feb2021 for covid-19 immunisation. On 14May2021 patient experienced pain chest. Patient has not tested positive for COVID-19 since having the vaccine and it was unsure if patient was enrolled in clinical trial. The event was considered serious (fatal). The patient died on 15May2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: pain chest


VAERS ID: 1503758 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-15
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocarditis, SARS-CoV-2 test
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Myocarditis
Allergies:
Diagnostic Lab Data: Test Date: 20210218; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021871647

Write-up: Myocarditis; This is a spontaneous report from a contactable consumer reported for uncle. This is a report received from the Regulatory Agency. Regulatory authority report number {GB-MHRA-GB-MHRA-WEBCOVID-202107101104284390-0JPBJ} Safety Report Unique Identifier {GB-MHRA-ADR 25631666}. A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1, via an unspecified route of administration on an unspecified date in Feb2021 (Batch/lot number: Not Known, Expiration Date: not reported), as single dose for COVID-19 immunisation. Medical history included myocarditis. Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. On 15Feb2021 patient experienced myocarditis. The patient died on 15Feb2021 of myocarditis within two weeks of receiving first dose of Pfizer vaccine, which we only just now know had myocarditis listed as a side effect as of today. Pfizer vaccine killed the patient. The patient underwent lab tests and procedures which included COVID-19 virus test negative on 18Feb2021. The patient has not tested positive for COVID-19 since having the vaccine. Coroners autopsy report was conducted. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Myocarditis


VAERS ID: 1504255 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-27
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: GBPFIZER INC202100921064

Write-up: friend had passed away post-vaccination; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (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 friend had passed away post-vaccination (death) on an unspecified date. A member of the general public wanted to know whether the vaccine was still going through clinical trials or whether it had received full authorisation for use. She also mentioned that her friend had passed away post-vaccination but no further details were asked or provided. The death of the enquirer''s friend is being reported but no further details have been provided. The patient died on an unspecified date. It was not reported if an autopsy was 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: friend had passed away post-vaccination


VAERS ID: 1504291 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-06
Onset:2021-06-25
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Brain stem 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: 2021-06-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HKPFIZER INC2021906184

Write-up: BRAINSTEM HAEMORRHAGE; This is a spontaneous report from a non-contactable healthcare professional via the regulatory authority. (Regulatory authority report number: not provided), based on information received by Pfizer from BioNTech SE (manufacturer control number: HK-Fosun-2021FOS002664), license party for BNT162B2 (COMIRNATY). A 48-years-old male patient received an unknown dose of BNT162B2 (COMIRNATY, Tozinameran, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unknown route of administration at unspecified dosing frequency, administered at an unspecified anatomical location on 06Jun2021 (19 days prior to his death) (age at vaccination was unknown) as dose number unknown, single for COVID-19 immunization. The patient''s medical history, concomitant medications and past product were not reported. The patient experienced unknown adverse event and was hospitalized on an unknown date. The patient died on 25Jun2021 due to brainstem haemorrhage, 19 days after vaccination. Whether an autopsy was performed was unknown and the reported cause of death was brainstem haemorrhage. I was reported that the case would be included in the regulatory authority for analysis. There was no clinical evidence to indicate the event of brainstem haemorrhage was caused by vaccine. Unknown adverse event met the seriousness criterion of hospitalization and Brainstem haemorrhage met the seriousness criterion of death. Causality Assessment: Brain stem haemorrhage Per Reporter= Not Related Per Company (BioNTech) = Not Related Follow-up closed, no further information is possible.; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-2021905778 Same reporter/drug, different patient.;HK-PFIZER INC-2021905773 Same reporter/drug, different patient.;HK-PFIZER INC-202100910523 Same reporter/drug, different patient.; Reported Cause(s) of Death: BRAINSTEM HAEMORRHAGE


VAERS ID: 1504310 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-22
Onset:2021-06-18
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3558 / 1 LA / OT

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: 2021-06-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021879948

Write-up: sudden death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB HU-OGYI-551321. This is a spontaneous report reported by a physician on 25/06/2021, A 61 years old male patient received BNT162B2 (Comirnaty, COVID-19 mRNA Vaccine (nucleoside modified)/ Tozinameran, Formulation was Solution for injection, Lot Number: FC3558), dose 1 via intramuscular in left arm on 22May2021, DOSE 1, 0.3 ML SINGLE, as single dose for COVID-19 immunization. The patient medical history and concomitant medication were not reported. On 18Jun2021 the patient died in his home. Autopsy was requested, further information is expected. The outcome of event was Fatal. Sender Comment: The patient died 25 days after Comirnaty vaccination. Autopsy was requested, further information is expected. The causal relationship between the reported death and Comirnaty is unassessable. The case is serious due to fatal outcome. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: sudden death


VAERS ID: 1504311 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Cardiac failure, Dyspnoea, Illness
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (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: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021899902

Write-up: heart failure; can not breathe; sick; body was weaker; This is a spontaneous report received from a contactable consumer or other non- health care professional (hcp) received via Regulatory authority. This consumer or other non-hcp reported about his mother and one of his colleague''s mother, this is the second of the two cases, of the reporter''s colleague''s mother. A 99-year-old female patient received bnt162b2 (COMIRNATY), 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. Medical history included ongoing high blood pressure. The patient''s concomitant medications were not reported. The reporter had a computer scientist colleague whose mother also received Pfizer COVID vaccination and his mother, aged 99 also died within two weeks after vaccination due to heart failure. Also there were recent news about vaccination and heart problems. So the reporter thought that reported this event. The patient had never had any problems with her heart other than high blood pressure. And 3 days after the second vaccination first she became sick during the night that she couldn''t breathe. Well, at the age of 99 the body was weaker. The patient died due to heart failure on an unspecified date. It was not reported if an autopsy was performed. The outcome of heart failure was fatal, while other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : HU-PFIZER INC-2021870291 same reporter, suspect product and event, different patient (reporter''s mother''s case); Reported Cause(s) of Death: heart failure


VAERS ID: 1504349 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-24
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: No medical history was provided.
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

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


VAERS ID: 1504360 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-17
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0201 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral haemorrhage; Cerebral infarction; Hypertension; Vascular dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100920497

Write-up: Death; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. An 87-year-old male patient received BNT162b2 (COMIRNATY, Solution for injection), second dose (Lot number EW0201, Expiration date 30Sep2021) intramuscular in the left arm on 13Jul2021 at 14:30 (the day of vaccination) as single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included cerebral infarction, cerebral haemorrhage, hypertension, and vascular dementia. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously took BNT162b2 (COMIRNATY, Solution for injection), first dose (Lot number FC3661, Expiration date 30Sep2021) intramuscular in the left arm on 22Jun2021 at 14:30 as single dose for COVID-19 immunization. On 17Jul2021 at an unknown time (4 days after the vaccination), the patient experienced death. The reporting physician assessed the event as serious (death). Since the vaccination, the patient has not been tested for COVID-19. It was unknown if Autopsy Done. The outcome of the event was fatal without treatment.; Sender''s Comments: Death of unknown cause is assessed related as a cautionary measure and for reporting purposes. The underlying disease may provide an alternative cause. 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: Unknown cause of death


VAERS ID: 1504383 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-06-25
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5295 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Aortic valve stenosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021870633

Write-up: Cardiovascular disease, unspecified; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. The patient was a non-pregnant 87-year-old female.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received therapeutic medicine for cardiac failure and others within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included severe aortic valve stenosis.On 15Jun2021 (the day of vaccination), the patient received the first single dose of COVID-19 vaccine (Trade name not reported, Solution for injection, Lot number FA5295, Expiration date 30Sep2021) via an unspecified route of administration in the unknown site for COVID-19 immunization.On 25Jun2021 (10 days after the vaccination), the patient experienced cardiovascular disease, unspecified. The event resulted in death. The outcome of the event was fatal without treatment. The reporting physician assessed the event as serious (death).Since the vaccination, the patient has not been tested for COVID-19. The reported event was as follows: The patient was visiting the hospital for severe aortic valve stenosis (the prognosis was considered as approximately 1 year). On 25Jun2021 (10 days after vaccination), the patient was found dead at her home.; Sender''s Comments: As there is limited information in the case provided, the causal association between the event Cardiovascular disease, unspecified and the suspect drug cannot be excluded, but consider also possible contributory effects from patient''s medical history of aortic valve stenosis. 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: Cardiovascular disease, unspecified


VAERS ID: 1504390 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-07-10
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3860 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LIXIANA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure chronic; Chronic atrial fibrillation; COPD
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021872457

Write-up: sudden cardiac death; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution and via a Pfizer sales representative. An 86-years-old female patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection) intramuscular, administered in Arm Left on 25Jun2021 15:00 (Lot Number: EY3860; Expiration Date: 31Aug2021) as dose 1, single (at age of 86-years-old) for covid-19 immunisation. No pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included chronic atrial fibrillation, cardiac failure chronic, chronic obstructive pulmonary disease (COPD). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included edoxaban tosilate (LIXIANA), unspecified prescription drugs within 2 weeks of vaccination. On 10Jul2021 at 18:00 (15 days 3 hours after the vaccination), the patient experienced sudden cardiac death. The outcome of the event was fatal without treatment. The course of the event was as follows: On 25Jun2021, the patient received the first dose of COMIRNATY. On 10Jul2021 at around 18:00, the patient died. Autopsy was conducted and it was assessed as sudden cardiac death. Since the vaccination, the patient has not been tested for COVID-19. The patient died on 10Jul2021. An autopsy was performed that revealed sudden cardiac death. The reporting physician classified the event as serious (death). The reporting physician assessed that the event was unrelated to BNT162b2.; Sender''s Comments: Based on known drug safety profile, the event of Sudden cardiac death is assessed as not related to the suspect product BNT162B2, and more likely due to underlying medical condition of chronic atrial fibrillation, cardiac failure chronic, chronic obstructive pulmonary disease (COPD) and elderly age (86) of patient. 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. ; Autopsy-determined Cause(s) of Death: sudden cardiac death


VAERS ID: 1504396 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-07-12
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3860 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Drug eruption; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021872857

Write-up: Death; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. The patient was a non-pregnant 90-year-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had allergic history of drug eruption, but the details were unknown. Other medical history included hypertension. The patient''s concomitant medications were not reported. On 08Jun2021 at 10:00, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# EX3617, Expiration date 31Aug2021) intramuscularly from left arm. On 29Jun2021 at 10:00 (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY3860, Expiration date 31Aug2021) via intramuscular route of administration in the arm left for COVID-19 immunization. On 12Jul2021 (12 days after the vaccination), the patient experienced death. The outcome of the event was fatal, it was unknown if the treatment was provided. The reporting physician assessed the event as serious (death). Since the vaccination, the patient has not been tested for COVID-19: Unknown. The reported event was described as follows: On 29Jun2021 (the day of vaccination), the patient received the second dose of BNT162b2 vaccination. On 12Jul2021 (12 days after vaccination), the patient was found dead at her home. Death cause was reported as unknown, it was also unknown if the autopsy was performed.; Sender''s Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the event "death" and 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: Unknown cause of death


VAERS ID: 1504400 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-27
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: Medical History/Concurrent Conditions: End stage cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021873123

Write-up: This is a spontaneous report from a contactable physician received from Medical Information Center. This case refers to a patient of unknown age and gender. Medical history included end stage cancer. Concomitant medications were not reported. On an unknown date at unknown time (the day of vaccination), the patient received a single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number not reported, Expiration date not reported) via an unspecified route of administration as a single dose for COVID-19 immunization. On an unknown date at unknown time (the next day of vaccination), the patient experienced death. The outcome of the event was fatal. It was not reported whether autopsy was done. The course of the event was as follows: The reporter heard of information on an adverse event that occurred after the BNT162b2 vaccination and therefore reported this case. The patient with end stage cancer was vaccinated. The next day, the patient died. The seriousness and causality of the event were not reported. Information on the lot/batch number has been requested.; Sender''s Comments: Based on current convention, the reported death is assessed as related to BNT162b2 until sufficient information is available to confirm an unrelated cause of death. This case will be re-evaluated 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 RAs, Ethics Committees, and investigators, as appropriate.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1504406 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac death, Decreased appetite
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: 2021-07-08
   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: Dementia
Allergies:
Diagnostic Lab Data: Test Date: 20210707; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021873287

Write-up: Death (sudden death)/ sudden cardiac death; no appetite; This is a spontaneous report from a contactable physician via COVID-19 Adverse Event Self-Reporting Solution and from the Regulatory authority. Regulatory authority report number is v21118886. The patient was an 86-year-old male. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was none. Relevant past drug history was unknown. Allergy was unknown. Other medical history was dementia. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 16Jun2021 at unknown time (at the age of 86-years-old), the patient previously received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: unknown, Expiration date not reported) intramuscularly for COVID-19 immunisation. Reason why batch/lot is unknown: not available/provided to reporter at the time of report completion. On 07Jul2021 in the afternoon (at the age of 86-years-old), the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: FC5947, Expiration date: 30Sep2021) intramuscularly for COVID-19 immunisation. Body temperature before vaccination was 36.5 degrees centigrade on 07Jul2021. On 07Jul2021 (the day of vaccination), the patient was vaccinated, and at dinner on the same day, he had no appetite. On 08Jul2021 around in the evening (1 day after the vaccination), the patient experienced death (sudden death). The course of the event was as follows: On 09Jul2021 at 05:40 (2 days after the vaccination), the patient was found dead in the room by the staff of the facility he was staying in. On the same day around 08:00, post-mortem examination was performed, and the estimated death time was around in the evening of 08Jul2021. The family did not request judicial autopsy. Sudden cardiac death was suspected, and a post-mortem certificate was prepared. The reporter stated that the adverse event resulted in death. The cause of death was unknown. No autopsy was performed. Treatment was not given for the adverse event. Outcome of event ''no appetite'' was unknown while ''death (sudden death)/sudden cardiac death'' was fatal. The patient died on 08Jul2021. The reporting physician assessed the event as serious (death). The reporting physician assessed the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases: No underlying condition was present, but because of the advanced age, there could be a disease that would cause sudden death. The reporting physician commented as follows: Report this case because the vaccination that was given on the day before death might have some effect.; Reported Cause(s) of Death: Death (sudden death)/ sudden cardiac death


VAERS ID: 1504415 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9909 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Death, Physical deconditioning, Respiratory disorder
SMQs:, Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-11
   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: Cardiac failure
Allergies:
Diagnostic Lab Data: Test Date: 20210708; Test Name: body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021873583

Write-up: Death; physical deconditioning; slight respiratory discomfort; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21118843. A 96-year-old female patient received bnt162b2 (COMIRNATY, Lot Number: FC9909; Expiration Date: 30Sep2021), via an unspecified route of administration on 08Jul2021 13:35 (the day of vaccination, at the age of 96-year-old) as dose 1, single for COVID-19 immunization. Medical history included cardiac failure. The patient''s concomitant medications were not reported. On 11Jul2021 at 05:00 (2 days/15 hours/25 minutes after the vaccination), the patient experienced death. On 11Jul2021 (3 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 08Jul2021 (the day of vaccination), at 13:35, the patient received the first dose of BNT162b2 vaccination. After the patient was followed up for 30 minutes in the hospital, no abnormalities were observed, and she went home. On 09Jul2021 (10 hours and 25 minutes after vaccination), no particular abnormalities were observed. On 10Jul2021 (one day, 10 hours, and 25 minutes after vaccination), the patient complained of physical deconditioning. The patient seemed to have slight respiratory discomfort by the family. At around 24:00 (2 days, 10 hours, and 25 minutes after vaccination), the patient was confirmed to sleep by the family. On 11Jul2021, at 06:50 (2 days, 17 hours, and 15 minutes after vaccination), the patient was found to collapse in the kitchen by her family. Postmortem rigidity was observed. The patient was assumed to have died at 05:00 (2 days, 15 hours, and 25 minutes after vaccination) according to the rectal temperature. The patient underwent lab tests and procedures which included Body temperature before vaccination on 08Jul2021 was 36.1 degrees centigrade. The patient died on 11Jul2021. Cause of death was unknown. It was unknown if an autopsy was performed. The outcome of the events physical deconditioning and slight respiratory discomfort was unknown. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases were as follows: The patient was an elderly, and she had medical history of cardiac failure. The reporting physician commented as follows: The causality between the event and BNT162b2 vaccination could not be ruled out completely.; Reported Cause(s) of Death: Death


VAERS ID: 1504435 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-11
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Schizophrenia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210707; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021874036

Write-up: Cardiac failure acute; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21118858. A 76-year-old female patient received BNT162B2 (COMIRNATY), 2nd dose via an unspecified route of administration on 07Jul2021 14:30 (Lot Number: FC5947; Expiration Date: 30Sep2021) at age of 76 years old as a single dose for covid-19 immunisation. Medical history included ongoing schizophrenia. The patient''s concomitant medications were not reported. The patient received 1st dose of BNT162b2 (COMIRNATY, Lot# FC5947, Expiration date 30Sep2021) on 16Jun2021 for covid-19 immunisation and the body temperature before vaccination 36.1 Centigrade. The patient experienced cardiac failure acute with fatal outcome on 11Jul2021 18:40. The patient underwent lab tests and procedures which included body temperature: 36.4 centigrade Before vaccination on 07Jul2021. The patient died on 11Jul2021. It was not reported if an autopsy was performed. On 11Jul2021 (4 days, 4 hours, and 10 minutes after vaccination), the patient''s condition suddenly changed after supper. 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 not provided. The reporting physician commented as follows: The causality between the event and BNT162b2 vaccination was unknown. However, on Day 4 after the patient received the second dose of BNT162b2 vaccination, the patient died.; Reporter''s Comments: Reporter comment: The causality between the event and BNT162b2 vaccination was unknown. However, on Day 4 after the patient received the second dose of BNT162b2 vaccination, the patient died.; Reported Cause(s) of Death: Cardiac failure acute


VAERS ID: 1504436 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-06-27
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021874141

Write-up: Unconscious; Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21119379. An 82-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 25Jun2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Body temperature before vaccination and family history were not reported. It was unknown whether there were points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status).On 08Jun2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number not reported, Expiration date not reported). On 27Jun2021 at 17:00 (2 days after the vaccination), the patient experienced death. On 27Jun2021 (2 days after the vaccination), the outcome of the events was fatal. The course of the events was as follows: On 27Jun2021 around 13:55 (2 days after the vaccination), the family saw the patient alive. In the late afternoon, the patient was found with her abdomen leaning on the handrail mounted on the side of the bed. The patient was unconscious. At 18:15, an ambulance was called. At the time of the ambulance arrived, the patient was in cardio-respiratory arrest. Rigidity was present. Autopsy imaging (AI) and post-mortem examination were performed at the request of the police. The reporting physician classified the events as serious (death) and assessed the causality between the events and BNT162b2 as un-assessable. Other possible cause of the events such as any other diseases was reported as: Details including underlying condition and allergy were unknown since the vaccination was done at a different hospital. The patient died on 27Jun2021. Autopsy was performed. The outcome of the events was fatal. The reporting physician commented as follows: Details including underlying condition were unknown since the vaccination was done at a different hospital (on 08Jun2021, 25Jun2021). In addition, the causal relationship with the vaccine was unknown. Information on the lot/batch number has been requested; Reported Cause(s) of Death: Cardio-respiratory arrest; Unconscious


VAERS ID: 1504442 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-07-06
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Death, Troponin T, Urine analysis
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE; PRAVASTATIN; ALLOPURINOL; BROTIZOLAM
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: cardiac blood test; Result Unstructured Data: Test Result: no obvious drug reactions; Test Name: peripheral blood test; Result Unstructured Data: Test Result: no obvious drug reactions; Test Name: Troponin T; Test Result: Negative ; Test Name: urine test; Result Unstructured Data: Test Result: no obvious drug reactions
CDC Split Type: JPPFIZER INC2021879500

Write-up: Death; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. An 86-year-old male received COVID-19 vaccine (Manufacturer not specified, Solution for injection, Dose number, Lot number, and Expiration date were not reported) via an unspecified route of administration on 18Jun2021, at patient age of 86-year-old, as a single dose for COVID-19 immunisation. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. It was unknown if the patient had allergies to medications, food, or other products. It was unknown if the patient had other medical history. The patient concomitant medications included amlodipine, pravastatin, allopurinol and brotizolam within 2 weeks of vaccination. It was unknown if the patient received other vaccines within 4 weeks prior to the COVID vaccine. Until the evening of 05Jul2021 (17 days after the vaccination), there was no complaint of obvious conditions. On 07Jul2021 at around 23:30 (19 days after the vaccination), the patient was found dead in the left lateral decubitus position and a postmortem examination was performed. On 06Jul2021 at around 18:30, the patient was found in the same position as when the patient died, so it was highly possible that the patient had already died at that time. Estimated time of death was around the evening of 06Jul2021. The testimony of the patient''s wife (who was living with him) with memory impairment was unreliable although the wife found him dead, and the testimony of the patient''s grandchild counted (the grandchild regularly visited the patient). A cardiac blood test, a peripheral blood test and a urine test did not show obvious drug reactions. Troponin T was negative. Neither an autopsy nor an autopsy imaging was conducted with the family''s wishes. From the above-mentioned background, onset date/time of the adverse event (unspecified) was unknown. There was a possibility that the patient did not have any subjective symptoms shortly before he died. The reporting facility was not the vaccination site where he received the vaccine, there was no detailed information relating the vaccine he received. The event resulted in death. The cause of death was assumed to be intrinsic disease. The outcome of the event was fatal without treatment. The autopsy was not performed. It was unknown if the patient has been tested for COVID-19 since the vaccination. The causality assessment was not reported.; Sender''s Comments: Based on limited available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported event of "Death" due to temporal relationship and current known drug safety profile; Reported Cause(s) of Death: Death


VAERS ID: 1504446 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MIRTAZAPIN; FLUNITRAZEPAM; HIRNAMIN [LEVOMEPROMAZINE]; MYSLEE; ARIPIPRAZOLE; AMLODIPINE; TELMISARTAN; AMITIZA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Hypertension; Schizophrenia
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021879562

Write-up: unnatural death; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. A 79-year-old male received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA5765, Expiration date 30Sep2021) intramuscular in the left arm on 08Jul2021 at 13:30, at patient age of 79-year-old, for COVID-19 immunization. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. According to the questionnaire, the patient had no allergies to medications, food, or other products. Other medical history included schizophrenia, hypertension and diabetes mellitus. Concomitant medications included mirtazapine (MIRTAZAPIN), flunitrazepam, levomepromazine (HIRNAMIN), zolpidem tartrate (MYSLEE), aripiprazole, amlodipine, telmisartan and lubiprostone (AMITIZA) within 2 weeks of vaccination. It was unknown if the patient received other vaccines within 4 weeks prior to the COVID vaccine. On 08Jul2021 at 13:30 (the day of vaccination), the patient received the first single dose of BNT162b2. On 09Jul2021 at around 08:00 (1 days after the vaccination), the patient experienced unnatural death. The event resulted in fatal. It was unknown if an autopsy was performed. It was unknown if the patient received the treatment for the event. It was unknown if the patient has not been tested for COVID-19 since the vaccination. The causality assessment was not provided.; Sender''s Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event cannot be totally excluded/assessed.The preexisting hypertension, diabetes mellitus,schizophrenia and advance age of patient are also considered as possible contributors.This case will be reassessed when additional information,particularly the clinical course before death and autopsy report 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: unnatural death


VAERS ID: 1504449 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-08
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dyslipidaemia; Hyperlipidaemia; Hypertension; Osteoporosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021879692

Write-up: Cardio-respiratory arrest; Death; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. The follow-up was received from the Regulatory Authority report number is V21118865. A non-pregnant 91-year-old female patient received 1st dose of BNT162B2 (COMIRNATY) at single dose on 01Jul2021 via an unknown route at 91-year-old for COVID-19 immunisation. Medical history included hypertension, hyperlipidaemia, osteoporosis, dyslipidaemia. The patient was in a private nursing home. Concomitant drug was not provided. It was unknown if the patient received other vaccines within 4 weeks prior to the COVID vaccine; unknown if the patient received other medications within 2 weeks of vaccination; unknown if the patient was diagnosed with COVID-19 prior to vaccination; unknown if the patient had allergies to medications, food, or other products. The patient experienced Cardio-respiratory arrest on 08Jul2021 09:50. The clinical course was reported as follows: On 01Jul2021 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date were not reported) via an unspecified route of administration for COVID-19 immunization. On 08Jul2021 at 09:35 (7 days after the vaccination), the patient took a bath at the nursing home. At 09:50, as the patient seemed to be sinking in the bathtub in front of the facility staff, they pulled up the patient from the bathtub. She was transferred to the reporter''s hospital by an ambulance. At 10:40, the ambulance arrived at the hospital. Cardiopulmonary resuscitation was performed. On arrival, the patient was in a state of cardio-respiratory arrest. After talking to her family, cardiopulmonary resuscitation was stopped. At 11:41, the patient''s death was confirmed. The reporter asked police to perform a postmortem examination. It was unknown if the patient has been tested for COVID-19 since the vaccination. Outcome of the event Cardio-respiratory arrest was fatal. Patient died on 08Jul2021 09:50. The event resulted in emergency room visit/urgent care. The reporting physician classified the events as serious (fatal outcome). The causality assessment was not reported. It was not reported if there was a possible cause of the events.; Reported Cause(s) of Death: Death; Cardio-respiratory arrest


VAERS ID: 1504450 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-07
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0203 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Death, Platelet count
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia; Hyperlipidaemia; Hypertension; Thrombocythaemia
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:anaemia; Comments: platelet level was fairy low; Test Name: platelet; Result Unstructured Data: Test Result:around 10000
CDC Split Type: JPPFIZER INC2021880226

Write-up: Death; This is a spontaneous report from a contactable other health professional and physician received via Medical information group. The patient was an 80-year-old male. Medical history included hypertension, hyperlipidaemia and thrombocythaemia. Concomitant medications were not reported. The patient started visiting a hospital (different from the reporter''s) regularly from this spring. He had thrombocythaemia (his platelet was around 10,000). The patient had not been referred to a special hematology department, but he took a blood test every month at the hospital (different from the reporter''s). It was pointed out that the platelet level was fairy low and he had anaemia at the hospital. On 10Jun2021 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# FA5715, Expiration date 31Aug2021) via an unspecified route of administration as single dose for COVID-19 immunization at the reporter''s hospital. On 01Jul2021 (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# EW0203, Expiration date 30Sep2021) via an unspecified route of administration as single dose for COVID-19 immunization at the reporter''s hospital. On 07Jul2021 (6 days after the vaccination), the patient died. (The reporter was informed by police). It was not reported if an autopsy was performed. The cause of death was not reported. The assessment of causality between the event and BNT162b2 and seriousness of the event were not provided.; Sender''s Comments: The information on the circumstances of the patient''s death is too limited to perform a meaningful company causality assessment: this event is handled as related to the suspect product BNT162B2 as a cautionary measure and for reporting purposes. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Death


VAERS ID: 1504451 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (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: JPPFIZER INC2021880231

Write-up: anaphylaxis; This is a spontaneous report from a contactable consumer (the patient''s colleague) received via Medical information group. Medical history and concomitant medications were not reported. On an unspecified date (the day of vaccination), the patient of unknown age and gender received BNT162b2 (COMIRNATY, Solution for injection, Dose number, Lot number and Expiration date not reported) via an unspecified route of administration as single dose for COVID-19 immunization. On an unspecified date, the patient died of anaphylaxis. The patient developed urticaria. It was not reported if an autopsy was performed. The assessment of causality between the event and BNT162b2 and seriousness of the event were not provided (uncertain). No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: anaphylaxis


VAERS ID: 1504453 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-07
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0889 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Mitral valve incompetence; Ventricular septal defect
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021881417

Write-up: cardiac failure; arrhythmia; Cardiac arrest; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21119383. The patient was a 23-year-old female. The patient had medical histories of after radical surgery for ventricular septal defect and mitral valve incompetence. Concomitant medications were not reported. On 30Jun2021 at 11:00 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FD0889, Expiration date 30Sep2021) via an unspecified route of administration as dose 1, single at the age of 23-year-old for COVID-19 immunisation. On 07Jul2021 at 03:00 (7 days after the vaccination), the patient experienced cardiac arrest. The outcome of the event was fatal. The course of the event was as follows: The patient was found dead on the bed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and bnt162b2 as unassessable. Other possible causes of the event such as any other diseases includes after radical surgery for ventricular septal defect and mitral valve incompetence. The reporting physician commented as follows: Since the patient suddenly died with poor findings of cardiac failure left, she was suspected to have arrhythmia. Although the causality between the event and bnt162b2 vaccination was unknown, this case was reported just in case. The event cardiac arrest resulted in death. The patient died on 07Jul2021. It was not reported if an autopsy was performed. The cause of death was cardiac arrest. The outcome of cardiac arrest was fatal. The outcome of other events was unknown.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1504454 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-10
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Progressive supranuclear palsy
Allergies:
Diagnostic Lab Data: Test Date: 20210708; Test Name: body temperature; Result Unstructured Data: Test Result:35.8 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021881418

Write-up: Cardio-respiratory arrest; activity of daily living (ADL) decreased; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21118887. The patient was an 87-year and 8-month-old male. Body temperature before vaccination was 35.8 degrees centigrade on 08Jul2021. The family history was not provided. The patient had medical history of progressive supranuclear palsy from an unknown date. Concomitant medications were not reported. On 08Jul2021 (the day of vaccination), the patient received the first dose of COVID-19 vaccine bnt162b2 (COMIRNATY, Solution for injection, Lot number EY4834, Expiration date 31Aug2021) via an unspecified route of administration as dose 1, single at the age of 87-year-old for COVID-19 immunisation. On unknown date in Jul2021 (unknown days after the vaccination), the patient was admitted to the hospital. On 10Jul2021 at 10:22 (2 days after the vaccination), the patient experienced (illegible) symptom and developed cardio-respiratory arrest. The seriousness of cardio-respiratory arrest was death and hospitalization. On 10Jul2021 (2 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On unknown date in Jul2021, the vital signs were stable; however, the activity of daily living (ADL) decreased, and the patient was admitted to the hospital. The seriousness of activity of daily living (ADL) decreased was hospitalization. On 10Jul2021 (2 days after vaccination), the patient died. The patient had cardio-respiratory arrest without particular signs. 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 progressive supranuclear palsy. The reporting physician commented as follows: The causality between the event and bnt162b2 vaccination was unlikely; however, it could not be ruled out. The event cardio-respiratory arrest resulted in death. The patient died on 10Jul2021. It was not reported if an autopsy was performed. The cause of death was cardio-respiratory arrest. The outcome of cardio-respiratory arrest was fatal. The outcome of activity of daily living (ADL) decreased was unknown.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1504456 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Basophil count, Blood albumin, Blood alkaline phosphatase, Blood bilirubin, Blood calcium, Blood chloride, Blood creatinine, Blood glucose, Blood lactate dehydrogenase, Blood potassium, Blood sodium, Blood thyroid stimulating hormone, Blood triglycerides, Blood urea, Blood uric acid, Body temperature, C-reactive protein, C-reactive protein increased, Cachexia, Cardiac disorder, Cardiac failure, Cardio-respiratory arrest, Eosinophil count, Gamma-glutamyltransferase, Glycosylated haemoglobin, Haematocrit, Haemoglobin, Infection, Investigation, Low density lipoprotein, Lymphocyte count, Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean cell volume, Monocyte count, N-terminal prohormone brain natriuretic peptide, N-terminal prohormone brain natriuretic peptide increased, Neutrophil count, Oxygen saturation, Oxygen saturation decreased, Platelet count, Pleural effusion, Pyrexia, Red blood cell count, Thyroxine free, Tri-iodothyronine free, White blood cell count
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
   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: Heart disorder; Renal disease
Allergies:
Diagnostic Lab Data: Test Date: 20210128; Test Name: ALT (GPT); Result Unstructured Data: Test Result:37; Comments: U/L; Test Date: 20210204; Test Name: ALT (GPT); Result Unstructured Data: Test Result:27; Comments: U/L; Test Date: 20210315; Test Name: ALT (GPT); Result Unstructured Data: Test Result:12; Comments: U/L; Test Date: 20210412; Test Name: ALT (GPT); Result Unstructured Data: Test Result:10; Comments: U/L; Test Date: 20210426; Test Name: ALT (GPT); Result Unstructured Data: Test Result:18; Comments: U/L; Test Date: 20210625; Test Name: ALT (GPT); Result Unstructured Data: Test Result:11; Comments: U/L; Test Date: 20210128; Test Name: AST (GOT); Result Unstructured Data: Test Result:52; Comments: (H) U/L; Test Date: 20210204; Test Name: AST (GOT); Result Unstructured Data: Test Result:35; Comments: U/L; Test Date: 20210315; Test Name: AST (GOT); Result Unstructured Data: Test Result:17; Comments: U/L; Test Date: 20210412; Test Name: AST (GOT); Result Unstructured Data: Test Result:17; Comments: U/L; Test Date: 20210426; Test Name: AST (GOT); Result Unstructured Data: Test Result:26; Comments: U/L; Test Date: 20210625; Test Name: AST (GOT); Result Unstructured Data: Test Result:24; Comments: U/L; Test Date: 20210625; Test Name: Basophils; Test Result: 0.2 %; Test Date: 20210128; Test Name: Albumin; Result Unstructured Data: Test Result:2.5 g/dl; Comments: (L); Test Date: 20210315; Test Name: Albumin; Result Unstructured Data: Test Result:2.8 g/dl; Comments: (L); Test Date: 20210412; Test Name: Albumin; Result Unstructured Data: Test Result:2.2 g/dl; Comments: (L); Test Date: 20210625; Test Name: Albumin; Result Unstructured Data: Test Result:2.2 g/dl; Comments: (L); Test Date: 20210128; Test Name: ALP (IFCC); Result Unstructured Data: Test Result:103; Comments: U/L; Test Date: 20210204; Test Name: ALP (IFCC); Result Unstructured Data: Test Result:94; Comments: U/L; Test Date: 20210315; Test Name: ALP (IFCC); Result Unstructured Data: Test Result:96; Comments: U/L; Test Date: 20210412; Test Name: ALP (IFCC); Result Unstructured Data: Test Result:70; Comments: U/L; Test Date: 20210426; Test Name: ALP (IFCC); Result Unstructured Data: Test Result:87; Comments: U/L; Test Date: 20210625; Test Name: ALP (IFCC); Result Unstructured Data: Test Result:97; Comments: U/L; Test Date: 20210128; Test Name: Bilirubin total; Test Result: 0.5 mg/dl; Test Date: 20210204; Test Name: Bilirubin total; Test Result: 0.2 mg/dl; Test Date: 20210315; Test Name: Bilirubin total; Test Result: 0.2 mg/dl; Test Date: 20210412; Test Name: Bilirubin total; Test Result: 0.3 mg/dl; Test Date: 20210128; Test Name: Calcium; Test Result: 8.6 mg/dl; Test Date: 20210204; Test Name: Calcium; Test Result: 7.9 mg/dl; Comments: (L); Test Date: 20210315; Test Name: Calcium; Test Result: 8.7 mg/dl; Test Date: 20210412; Test Name: Calcium; Test Result: 7.8 mg/dl; Comments: (L); Test Date: 20210128; Test Name: Chloride; Result Unstructured Data: Test Result:104 mEq/l; Test Date: 20210204; Test Name: Chloride; Result Unstructured Data: Test Result:101 mEq/l; Test Date: 20210315; Test Name: Chloride; Result Unstructured Data: Test Result:106 mEq/l; Test Date: 20210412; Test Name: Chloride; Result Unstructured Data: Test Result:104 mEq/l; Test Date: 20210426; Test Name: Chloride; Result Unstructured Data: Test Result:105 mEq/l; Test Date: 20210625; Test Name: Chloride; Result Unstructured Data: Test Result:103 mEq/l; Test Date: 20210128; Test Name: Creatinine; Test Result: 1.18 mg/dl; Comments: (H); Test Date: 20210204; Test Name: Creatinine; Test Result: 1.25 mg/dl; Comments: (H); Test Date: 20210315; Test Name: Creatinine; Test Result: 1.25 mg/dl; Comments: (H); Test Date: 20210412; Test Name: Creatinine; Test Result: 1.85 mg/dl; Comments: (H); Test Date: 20210426; Test Name: Creatinine; Test Result: 1.34 mg/dl; Comments: (H); Test Date: 20210625; Test Name: Creatinine; Test Result: 1.20 mg/dl; Comments: (H); Test Date: 20210128; Test Name: Blood glucose; Test Result: 84 mg/dl; Test Date: 20210204; Test Name: Blood glucose; Test Result: 132 mg/dl; Comments: (H); Test Date: 20210315; Test Name: Blood glucose; Test Result: 128 mg/dl; Comments: (H); Test Date: 20210412; Test Name: Blood glucose; Test Result: 134 mg/dl; Comments: (H); Test Date: 20210625; Test Name: Blood glucose; Test Result: 60 mg/dl; Test Date: 20210128; Test Name: LD (IFCC); Result Unstructured Data: Test Result:289; Comments: (H) U/L; Test Date: 20210204; Test Name: LD (IFCC); Result Unstructured Data: Test Result:189; Comments: U/L; Test Date: 20210315; Test Name: LD (IFCC); Result Unstructured Data: Test Result:135; Comments: U/L; Test Date: 20210412; Test Name: LD (IFCC); Result Unstructured Data: Test Result:150; Comments: U/L; Test Date: 20210426; Test Name: LD (IFCC); Result Unstructured Data: Test Result:184; Comments: U/L; Test Date: 20210625; Test Name: LD (IFCC); Result Unstructured Data: Test Result:163; Comments: U/L; Test Date: 20210128; Test Name: Potassium; Result Unstructured Data: Test Result:5.6 mEq/l; Comments: (H); Test Date: 20210204; Test Name: Potassium; Result Unstructured Data: Test Result:4.7 mEq/l; Test Date: 20210315; Test Name: Potassium; Result Unstructured Data: Test Result:4.2 mEq/l; Test Date: 20210412; Test Name: Potassium; Result Unstructured Data: Test Result:4.4 mEq/l; Test Date: 20210426; Test Name: Potassium; Result Unstructured Data: Test Result:4.5 mEq/l; Test Date: 20210625; Test Name: Potassium; Result Unstructured Data: Test Result:4.7 mEq/l; Test Date: 20210128; Test Name: Sodium; Result Unstructured Data: Test Result:141 mEq/l; Test Date: 20210204; Test Name: Sodium; Result Unstructured Data: Test Result:139 mEq/l; Test Date: 20210315; Test Name: Sodium; Result Unstructured Data: Test Result:140 mEq/l; Test Date: 20210412; Test Name: Sodium; Result Unstructured Data: Test Result:139 mEq/l; Test Date: 20210426; Test Name: Sodium; Result Unstructured Data: Test Result:144 mEq/l; Test Date: 20210625; Test Name: Sodium; Result Unstructured Data: Test Result:139 mEq/l; Test Date: 20210128; Test Name: TSH; Result Unstructured Data: Test Result:13.30 uiU/mL; Comments: (H); Test Date: 20210315; Test Name: TSH; Result Unstructured Data: Test Result:2.33 uiU/mL; Test Date: 20210412; Test Name: TSH; Result Unstructured Data: Test Result:5.65 uiU/mL; Comments: (H); Test Date: 20210128; Test Name: Triglycerides (TG); Test Result: 90 mg/dl; Test Date: 20210128; Test Name: Urea nitrogen; Test Result: 21.5 mg/dl; Comments: (H); Test Date: 20210204; Test Name: Urea nitrogen; Test Result: 17.7 mg/dl; Test Date: 20210315; Test Name: Urea nitrogen; Test Result: 31.9 mg/dl; Comments: (H); Test Date: 20210412; Test Name: Urea nitrogen; Test Result: 36.4 mg/dl; Comments: (H); Test Date: 20210426; Test Name: Urea nitrogen; Test Result: 20.5 mg/dl; Comments: (H); Test Date: 20210625; Test Name: Urea nitrogen; Test Result: 12.4 mg/dl; Test Date: 20210128; Test Name: Uric acid; Test Result: 6.8 mg/dl; Test Date: 20210204; Test Name: Uric acid; Test Result: 6.7 mg/dl; Test Date: 20210315; Test Name: Uric acid; Test Result: 6.3 mg/dl; Test Date: 20210412; Test Name: Uric acid; Test Result: 10.5 mg/dl; Comments: (H); Test Date: 20210426; Test Name: Uric acid; Test Result: 8.5 mg/dl; Comments: (H); Test Date: 20210624; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination; Test Date: 20210625; Test Name: Body temperature; Result Unstructured Data: Test Result:38.3 Centigrade; Test Date: 20210625; Test Name: Body temperature; Result Unstructured Data: Test Result:37.5 Centigrade; Comments: after oral administration of acetaminophen; Test Date: 20210625; Test Name: Body temperature; Result Unstructured Data: Test Result:39.0 Centigrade; Comments: at night; Test Date: 20210128; Test Name: CRP quantitative; Test Result: 19.54 mg/dl; Comments: (H), 6+; Test Date: 20210204; Test Name: CRP quantitative; Test Result: 3.66 mg/dl; Comments: (H), 2+; Test Date: 20210315; Test Name: CRP quantitative; Test Result: 4.64 mg/dl; Comments: (H), 3+; Test Date: 20210412; Test Name: CRP quantitative; Test Result: 9.99 mg/dl; Comments: (H), 5+; Test Date: 20210426; Test Name: CRP quantitative; Test Result: 2.53 mg/dl; Comments: (H), 2+; Test Date: 20210625; Test Name: CRP quantitative; Test Result: 2.63 mg/dl; Comments: (H), 2+; Test Date: 20210625; Test Name: Eosinophils; Test Result: 0.0 %; Test Date: 20210128; Test Name: gamma-GT (gammaGTP); Result Unstructured Data: Test Result:25; Comments: U/L; Test Date: 20210204; Test Name: gamma-GT (gammaGTP); Result Unstructured Data: Test Result:20; Comments: U/L; Test Date: 20210315; Test Name: gamma-GT (gammaGTP); Result Unstructured Data: Test Result:19; Comments: U/L; Test Date: 20210412; Test Name: gamma-GT (gammaGTP); Result Unstructured Data: Test Result:12; Comments: U/L; Test Date: 20210426; Test Name: gamma-GT (gammaGTP); Result Unstructured Data: Test Result:17; Comments: U/L; Test Date: 20210625; Test Name: gamma-GT (gammaGTP); Result Unstructured Data: Test Result:25; Comments: U/L; Test Date: 20210315; Test Name: HbA1cNGSP; Test Result: 5.0 %; Test Date: 20210412; Test Name: HbA1cNGSP; Test Result: 5.1 %; Test Date: 20210128; Test Name: Haematocrit value; Test Result: 39.4 %; Comments: (L); Test Date: 20210204; Test Name: Haematocrit value; Test Result: 37.4 %; Comments: (L); Test Date: 20210315; Test Name: Haematocrit value; Test Result: 36.1 %; Comments: (L); Test Date: 20210412; Test Name: Haematocrit value; Test Result: 34.0 %; Comments: (L); Test Date: 20210426; Test Name: Haematocrit value; Test Result: 35.9 %; Comments: (L); Test Date: 20210625; Test Name: Haematocrit value; Test Result: 36.5 %; Comments: (L); Test Date: 20210128; Test Name: Haemoglobin volume; Result Unstructured Data: Test Result:12.2 g/dl; Comments: (L); Test Date: 20210204; Test Name: Haemoglobin volume; Result Unstructured Data: Test Result:11.6 g/dl; Comments: (L); Test Date: 20210315; Test Name: Haemoglobin volume; Result Unstructured Data: Test Result:11.4 g/dl; Comments: (L); Test Date: 20210412; Test Name: Haemoglobin volume; Result Unstructured Data: Test Result:10.6 g/dl; Comments: (L); Test Date: 20210426; Test Name: Haemoglobin volume; Result Unstructured Data: Test Result:11.0 g/dl; Comments: (L); Test Date: 20210625; Test Name: Haemoglobin volume; Result Unstructured Data: Test Result:11.2 g/dl; Comments: (L); Test Date: 20210128; Test Name: Theophylline; Result Unstructured Data: Test Result:7.5 ug/ml; Comments: (L); Test Date: 20210128; Test Name: LDL cholesterol; Test Result: 37 mg/dl; Comments: (L); Test Date: 20210625; Test Name: Lymphocyte count; Test Result: 14.7 %; Comments: (L); Test Date: 20210128; Test Name: MCH; Test Result: 30.0 pg; Test Date: 20210204; Test Name: MCH; Test Result: 30.5 pg; Test Date: 20210315; Test Name: MCH; Test Result: 29.0 pg; Test Date: 20210412; Test Name: MCH; Test Result: 28.0 pg; Test Date: 20210426; Test Name: MCH; Test Result: 28.0 pg; Test Date: 20210625; Test Name: MCH; Test Result: 27.6 pg; Comments: (L); Test Date: 20210128; Test Name: MCHC; Test Result: 31.0 %; Comments: (L); Test Date: 20210204; Test Name: MCHC; Test Result: 31.0 %; Comments: (L); Test Date: 20210315; Test Name: MCHC; Test Result: 31.6 %; Test Date: 20210412; Test Name: MCHC; Test Result: 31.2 %; Comments: (L); Test Date: 20210426; Test Name: MCHC; Test Result: 30.6 %; Comments: (L); Test Date: 20210625; Test Name: MCHC; Test Result: 30.7 %; Comments: (L); Test Date: 20210128; Test Name: MCV; Result Unstructured Data: Test Result:97.0; Comments: fL; Test Date: 20210204; Test Name: MCV; Result Unstructured Data: Test Result:98.4; Comments: fL; Test Date: 20210315; Test Name: MCV; Result Unstructured Data: Test Result:91.9; Comments: fL; Test Date: 20210412; Test Name: MCV; Result Unstructured Data: Test Result:89.9; Comments: fL; Test Date: 20210426; Test Name: MCV; Result Unstructured Data: Test Result:91.3; Comments: fL; Test Date: 20210625; Test Name: MCV; Result Unstructured Data: Test Result:89.9; Comments: fL; Test Date: 20210625; Test Name: Monocytes; Test Result: 6.2 %; Test Date: 20210625; Test Name: Neutrophils; Test Result: 78.9 %; Comments: (H); Test Date: 20210128; Test Name: NTproBNP; Result Unstructured Data: Test Result:2022 pg/mL; Comments: (H); Test Date: 20210315; Test Name: NTproBNP; Result Unstructured Data: Test Result:2681 pg/mL; Comments: (H); Test Date: 20210412; Test Name: NTproBNP; Result Unstructured Data: Test Result:3505 pg/mL; Comments: (H); Test Date: 20210625; Test Name: NTproBNP; Result Unstructured Data: Test Result:30077 pg/mL; Comments: (H); Test Name: oxygen saturation; Test Result: 93 %; Comments: Until the day before; Test Date: 20210621; Test Name: oxygen saturation; Test Result: 95 %; Test Date: 20210625; Test Name: oxygen saturation; Test Result: 86 %; Test Date: 20210128; Test Name: Platelet count; Result Unstructured Data: Test Result:31.2; Comments: x10^4/uL; Test Date: 20210204; Test Name: Platelet count; Result Unstructured Data: Test Result:34.0; Comments: x10^4/uL; Test Date: 20210315; Test Name: Platelet count; Result Unstructured Data: Test Result:27.0; Comments: x10^4/uL; Test Date: 20210412; Test Name: Platelet count; Result Unstructured Data: Test Result:28.9; Comments: x10^4/uL; Test Date: 20210426; Test Name: Platelet count; Result Unstructured Data: Test Result:23.1; Comments: x10^4/uL; Test Date: 20210625; Test Name: Platelet count; Result Unstructured Data: Test Result:19.4; Comments: x10^4/uL; Test Date: 20210128; Test Name: Red blood cell count; Result Unstructured Data: Test Result:406; Comments: (L) x10^4/uL; Test Date: 20210204; Test Name: Red blood cell count; Result Unstructured Data: Test Result:380; Comments: (L) x10^4/uL; Test Date: 20210315; Test Name: Red blood cell count; Result Unstructured Data: Test Result:393; Comments: (L) x10^4/uL; Test Date: 20210412; Test Name: Red blood cell count; Result Unstructured Data: Test Result:378; Comments: (L) x10^4/uL; Test Date: 20210426; Test Name: Red blood cell count; Result Unstructured Data: Test Result:393; Comments: (L) x10^4/uL; Test Date: 20210625; Test Name: Red blood cell count; Result Unstructured Data: Test Result:406; Comments: (L) x10^4/uL; Test Date: 20210128; Test Name: Free T4; Result Unstructured Data: Test Result:1.43 ng/dL; Test Date: 20210315; Test Name: Free T4; Result Unstructured Data: Test Result:1.87 ng/dL; Comments: (H); Test Date: 20210412; Test Name: Free T4; Result Unstructured Data: Test Result:1.59 ng/dL; Test Date: 20210128; Test Name: Free T3; Result Unstructured Data: Test Result:1.3 pg/mL; Comments: (L); Test Date: 20210315; Test Name: Free T3; Result Unstructured Data: Test Result:2.4 pg/mL; Test Date: 20210412; Test Name: Free T3; Result Unstructured Data: Test Result:1.2 pg/mL; Comments: (L); Test Date: 20210128; Test Name: White blood cell count; Result Unstructured Data: Test Result:104; Comments: (H) x10^2/uL; Test Date: 20210204; Test Name: White blood cell count; Result Unstructured Data: Test Result:89; Comments: x10^2/uL; Test Date: 20210315; Test Name: White blood cell count; Result Unstructured Data: Test Result:81; Comments: x10^2/uL; Test Date: 20210412; Test Name: White blood cell count; Result Unstructured Data: Test Result:124; Comments: (H) x10^2/uL; Test Date: 20210426; Test Name: White blood cell count; Result Unstructured Data: Test Result:65; Comments: x10^2/uL; Test Date: 20210625; Test Name: White blood cell count; Result Unstructured Data: Test Result:42; Comments: x10^2/uL
CDC Split Type: JPPFIZER INC2021881431

Write-up: wasting; increased cardiac load; cardio-respiratory arrest; Cardiac failure aggravated; Pyrexia; oxygen saturation decreased to 86%; C-reactive protein (CRP) 2.63; right pleural effusion; aggravation of infection; sharp increase in N-terminal prohormone brain natriuretic peptide (NTproBNP); This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is V21118863. The patient was an 82-year and 4-month-old male. Body temperature before vaccination was 36.3 degrees centigrade on 24Jun2021. The patient had no family history. Medical history included heart disorder and renal disease from an unknown date. Concomitant medications were not reported. On 03Jun2021, the patient previously received the first dose of bnt162b2 (COMIRNATY, Lot# FA2453, Expiration date 31Aug2021) via an unspecified route of administration as dose 1, single for COVID-19 immunisation. On 24Jun2021 (the day of vaccination), the patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FC3661, Expiration date 30Sep2021) via an unspecified route of administration as dose 2, single at the age of 82-year-old for COVID-19 immunisation. On 25Jun2021 at around 07:00 (1 day after the vaccination), the patient experienced cardiac failure aggravated and pyrexia. On 06Jul2021 (11 days after the vaccination, as reported), the outcome of the event was fatal. The course of the event was as follows: On the following morning of the second vaccination of bnt162b2, the patient developed pyrexia of 38.3 degrees centigrade on 25Jun2021 07:00. At the same time, oxygen saturation decreased to 86% (previously on 21Jun2021, it was 95%). Body temperature decreased to 37.5 degrees centigrade with oral administration of paracetamol (ACETAMINOPHEN); however, home oxygen therapy was required. There was marked right pleural effusion. At night, the patient developed pyrexia of 39.0 degrees centigrade. On the same day, blood collection revealed white blood cell (WBC) 4200 and C-reactive protein (CRP) 2.63; thus, aggravation of infection was considered mild. There were sharp increase in N-terminal prohormone brain natriuretic peptide (NTproBNP) from 3505 on 12Apr2021 to 30077. Until the day before, oxygen saturation was 93% with 2 L/minute of oxygen and oral intake of meals was possible in a small amount. On 06Jul2021 at around 08:00, the patient was found to have cardio-respiratory arrest. At 10:02, death diagnosis was made. Results of blood collection was as follows: Total bilirubin (0.2-1.2 mg/dL) was 0.5 on 28Jan2021, 0.2 on 04Feb2021, 0.2 on 15Mar2021, and 0.3 on 12Apr2021. Albumin (3.8-5.3 g/dL) was 2.5 (L) on 28Jan2021, 2.8 (L) on 15Mar2021, 2.2 (L) on 12Apr2021, and 2.2 (L) on 25Jun2021. Aspartate aminotransferase (AST [GOT]) (8-38 U/L) was 52 (H) on 28Jan2021, 35 on 04Feb2021, 17 on 15Mar2021, 17 on 12Apr2021, 26 on 26Apr2021, and 24 on 25Jun2021. Alanine aminotransferase (ALT [GPT]) (4-43 U/L) was 37 on 28Jan2021, 27 on 04Feb2021, 12 on 15Mar2021, 10 on 12Apr2021, 18 on 26Apr2021, and 11 on 25Jun2021. Gamma-glutamyltransferase (gamma-GT [gammaGTP]) (0-86 U/L) was 25 on 28Jan2021, 20 on 04Feb2021, 19 on 15Mar2021, 12 on 12Apr2021, 17 on 26Apr2021, and 25 on 25Jun2021. Lactate dehydrogenase (LD [IFCC]) (124-222 U/L) was 289 (H) on 28Jan2021, 189 on 04Feb2021, 135 on 15Mar2021, 150 on 12Apr2021, 184 on 26Apr2021, and 163 on 25Jun2021. Alkaline phosphatase (ALP [IFCC]) (38-113 U/L) was 103 on 28Jan2021, 94 on 04Feb2021, 96 on 15Mar2021, 70 on 12Apr2021, 87 on 26Apr2021, and 97 on 25Jun2021. Urea nitrogen (8.0-20.0 mg/dL) was 21.5 (H) on 28Jan2021, 17.7 on 04Feb2021, 31.9 (H) on 15Mar2021, 36.4 (H) on 12Apr2021, 20.5 (H) on 26Apr2021, and 12.4 on 25Jun2021. Creatinine (0.61-1.04 mg/dL) was 1.18 (H) on 28Jan2021, 1.25 (H) on 04Feb2021, 1.25 (H) on 15Mar2021, 1.85 (H) on 12Apr2021, 1.34 (H) on 26Apr2021, and 1.20 (H) on 25Jun2021. Uric acid (3.6-7.0 mg/dL) was 6.8 on 28Jan2021, 6.7 on 04Feb2021, 6.3 on 15Mar2021, 10.5 (H) on 12Apr2021, and 8.5 (H) on 26Apr2021. Blood glucose (60-109 mg/dL) was 84 on 28Jan2021, 132 (H) on 04Feb2021, 128 (H) on 15Mar2021, 134 (H) on 12Apr2021, and 60 on 25Jun2021. Haemoglobin A1C (HbA1cNGSP) (4.6-6.2%) was 5.0 on 15Mar2021 and 5.1 on 12Apr2021. LDL cholesterol (70-139 mg/dL) was 37 (L) on 28Jan2021. Triglycerides (TG) (30-149 mg/dL) was 90 on 28Jan2021. Sodium (135-150 mEq/L) was 141 on 28Jan2021, 139 on 04Feb2021, 140 on 15Mar2021, 139 on 12Apr2021, 144 on 26Apr2021, and 139 on 25Jun2021. Chloride (98-110 mEq/L) was 104 on 28Jan2021, 101 on 04Feb2021, 106 on 15Mar2021, 104 on 12Apr2021, 105 on 26Apr2021, and 103 on 25Jun2021. Potassium (3.5-5.3 mEq/L) was 5.6 (H) on 28Jan2021, 4.7 on 04Feb2021, 4.2 on 15Mar2021, 4.4 on 12Apr2021, 4.5 on 26Apr2021, and 4.7 on 25Jun2021. Calcium (8.6-10.1 mg/dL) was 8.6 on 28Jan2021, 7.9 (L) on 04Feb2021, 8.7 on 15Mar2021, and 7.8 (L) on 12Apr2021. Theophylline (10.0-20.0 ug/mL) was 7.5 (L) on 28Jan2021. Thyroid stimulating hormone (TSH) (0.54-4.54 uIU/mL) was 13.30 (H) on 28Jan2021, 2.33 on 15Mar2021, and 5.65 (H) on 12Apr2021. Tri-iodothyronine free (free T3) (2.1-4.2 pg/mL) was 1.3 (L) on 28Jan2021, 2.4 on 15Mar2021, and 1.2 (L) on 12Apr2021. Thyroxine free (free T4) (0.97-1.72 ng/dL) was 1.43 on 28Jan2021, 1.87 (H) on 15Mar2021, and 1.59 on 12Apr2021. N-terminal prohormone brain natriuretic peptide (NT-proBNP) (0-125 pg/mL) was 2022 (H) on 28Jan2021, 2681 (H) on 15Mar2021, 3505 (H) on 12Apr2021, and 30077 (H) on 25Jun2021. C-reactive protein (CRP quantitative) (0.00-0.30 mg/dL) was 19.54 (H) on 28Jan2021, 3.66(H) on 04Feb2021, 4.64 (H) on 15Mar2021, 9.99 (H) on 12Apr2021, 2.53 (H) on 26Apr2021, and 2.63 (H) on 25Jun2021. Qualitative test was 6+ on 28Jan2021, 2+ on 04Feb2021, 3+ on 15Mar2021, 5+ on 12Apr2021, 2+ on 26Apr2021, and 2+ on 25Jun2021. Red blood cell count (427-570 x10^4/uL) was 406 x10^4 (L) on 28Jan2021, 380 x10^4 (L) on 04Feb2021, 393 x10^4 (L) on 15Mar2021, 378 x10^4 (L) on 12Apr2021, 393 x10^4 (L) on 26Apr2021, and 406 x10^4 (L) on 25Jun2021. White blood cell count (39-98 x10^2/uL) was 104 x10^2 (H) on 28Jan2021, 89 x10^2 on 04Feb2021, 81 x10^2 on 15Mar2021, 124 x10^2 (H) on 12Apr2021, 65 x10^2 on 26Apr2021, and 42 x10^2 on 25Jun2021. Haemoglobin volume (13.5-17.6 g/dL) was 12.2 (L) on 28Jan2021, 11.6 (L) on 04Feb2021, 11.4 (L) on 15Mar2021, 10.6 (L) on 12Apr2021, 11.0 (L) on 26Apr2021, and 11.2 (L) on 25Jun2021. Haematocrit value (39.8-51.8%) was 39.4 (L) on 28Jan2021, 37.4 (L) on 04Feb2021, 36.1 (L) on 15Mar2021, 34.0 (L) on 12Apr2021, 35.9 (L) on 26Apr2021, and 36.5 (L) on 25Jun2021. Mean cell volume (MCV) (82.7-101.6 fL) was 97.0 on 28Jan2021, 98.4 on 04Feb2021, 91.9 on 15Mar2021, 89.9 on 12Apr2021, 91.3 on 26Apr2021, and 89.9 on 25Jun2021. Mean cell haemoglobin (MCH) (28.0-34.6 pg) was 30.0 on 28Jan2021, 30.5 on 04Feb2021, 29.0 on 15Mar2021, 28.0 on 12Apr2021, 28.0 on 26Apr2021, and 27.6 (L) on 25Jun2021. Mean cell haemoglobin concentration (MCHC) (31.6-36.6%) was 31.0 (L) on 28Jan2021, 31.0 (L) on 04Feb2021, 31.6 on 15Mar2021, 31.2 (L) on 12Apr2021, 30.6 (L) on 26Apr2021, and 30.7 (L) on 25Jun2021. Platelet count (13.1-36.2 x10^4/uL) was 31.2 x10^4 on 28Jan2021, 34.0 x10^4 on 04Feb2021, 27.0 x10^4 on 15Mar2021, 28.9 x10^4 on 12Apr2021, 23.1 x10^4 on 26Apr2021, and 19.4 x10^4 on 25Jun2021. Neutrophils (44.0-72.0%) was 78.9 (H) on 25Jun2021. Eosinophils (0.0-10.0%) was 0.0 on 25Jun2021. Basophils (0.0-3.0%) was 0.2 on 25Jun2021. Lymphocyte count (18.0-59.0%) was 14.7 (L) on 25Jun2021. Monocyte (0.0-12.0%) was 6.2 on 25Jun2021. The reporting physician classified the event as serious (death) and assessed that the event was related to bnt162b2. Other possible cause of the event such as any other diseases was wasting which was already remarkable. The reporting physician commented as follows: Reasonable course was that pyrexia resulted in increased cardiac load and aggravation of cardiac failure. Refer to the data of blood collection. Therapeutic measures were taken as a result of cardiac failure aggravated, pyrexia, oxygen saturation decreased to 86%. The event cardiac failure aggravated and pyrexia resulted in death. The patient died on 06Jul2021 10:02. It was not reported if an autopsy was performed. The cause of death were cardiac failure aggravated and pyrexia. The outcome of cardiac failure aggravated and pyrexia was fatal. The outcome of other events was unknown.; Reported Cause(s) of Death: Cardiac failure aggravated; Pyrexia


VAERS ID: 1504472 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0573 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Body temperature, Cardiac failure acute, Cardio-respiratory arrest, Computerised tomogram head, Computerised tomogram thorax, Loss of consciousness, Mobility decreased, Myocardial ischaemia, Pain in extremity
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Other ischaemic heart disease (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: IRTRA; ADALAT CR 20; MINNEBRO 1.25; PLAVIX 75; BEOVA 50; FLIVAS 50; MAGLAX 330; MUCODYNE-DS; MUCOSAL [ACETYLCYSTEINE]; MOHRUS L; MYSER [CYCLOSERINE]; PROPETO
Current Illness: Bronchitis chronic; Constipation; Hypertension; Language disorder; Late effects of cerebral infarction; Overactive bladder; Prostatic hyperplasia; Right sided paralysis
Preexisting Conditions: Medical History/Concurrent Conditions: Fall; Malnutrition; Thrombotic cerebral infarction (historical condition)
Allergies:
Diagnostic Lab Data: Test Date: 20210710; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7; Comments: before vaccination; Test Date: 20210712; Test Name: head CT; Result Unstructured Data: Test Result:no abnormal findings; Comments: Postmortem CT revealed no abnormal findings that identified the cause of death; Test Date: 20210712; Test Name: CHEST CT; Result Unstructured Data: Test Result:no abnormal findings; Comments: Postmortem CT revealed no abnormal findings that identified the cause of death
CDC Split Type: JPPFIZER INC2021881590

Write-up: cardiac failure acute; The patient was lying prone; Cardio-respiratory arrest; arrhythmia; ischaemic heart disease; The patient said that he could not raise his arm because of the side effect; difficulty raising his arm because of a mild arm pain; This is a spontaneous report from a contactable physician received from a company representative (dated 12Jul2021), from via COVID-19 Adverse Event Self-Reporting Solution (COVAES) (dated 13Jul2021), from Pharmaceuticals and Medical Devices Agency (PMDA). Regulatory authority report (dated 15Jul2021) and from PMDA. Regulatory authority report (dated 16Jul2021). A 69-years-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left at age of 69 years on 10Jul2021 12:00 (Lot Number: EY0573; Expiration Date: 30Sep2021) as single dose for covid-19 immunisation. Medical history included regularly visiting hospitals because of hypertension, late effects of cerebral infarction, prostatic hyperplasia, overactive bladder, bronchitis chronic, and constipation, all ongoing. Historical condition included cerebral infarction (not ongoing). Left atherothrombotic cerebral infarction caused late effects of ongoing mild language disorder and ongoing right sided paralysis both since Jul2020. The patient was living alone and was undernourished with a weight of about 41 kg. The patient had no family history. Patient falling off from the bicycle at 07Jul2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included medications the patient received within 2 weeks of vaccination irbesartan, trichlormethiazide (IRTRA Tablets LD), nifedipine (ADALAT CR 20), esaxerenone (MINNEBRO 1.25), clopidogrel bisulfate (PLAVIX 75), vibegron (BEOVA 50), naftopidil (FLIVAS 50), magnesium oxide (MAGLAX 330), carbocisteine (MUCODYNE-DS), acetylcysteine (MUCOSAL), ketoprofen (MOHRUS L), cycloserine (MYSER), and white soft paraffin (PROPETO), patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Jun2021 at 12:00, the patient previously received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA7338, Expiration date 30Sep2021) intramuscularly in the left arm at age of 68 years for COVID-19 immunisation. The most recent COVID-19 vaccine was administered at the doctor''s office/urgent care. On 10Jul2021 at 12:00, the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0573, Expiration date 30Sep2021) intramuscularly in the left arm for COVID-19 immunisation. On 11Jul2021 in the morning (1 day after the vaccination), the patient said that he could not raise his arm because of the side effect; the outcome of this event was not reported. On 12Jul2021 in the morning (2 days after the vaccination), the patient was lying prone and experienced cardio-respiratory arrest and death; the outcome of these events was fatal. It was not reported whether autopsy was done. The course of the events was as follows: On 10Jul2021 (the day of vaccination), the patient received the second BNT162b2 vaccination at the reporting clinic. On 11Jul2021 in the morning (1 day after the vaccination), the relative visited the patient''s house and saw him fine. The patient said that he could not raise his arm because of the side effect. On 12Jul2021 in the morning (2 days after the vaccination), there was no response or answer at visit of the relative. The patient was lying prone. An ambulance was called and transported him to Hospital. Cardio-respiratory arrest was noted at that time. Death was confirmed later. The head and chest were examined by computerised tomography (CT), but no abnormal findings were revealed. The reporting physician classified the event death as serious (death) and assessed that the event death was possibly related to BNT162b2. The seriousness and causality of the other events were not reported. The reporting physician commented that falling off from the bicycle at 07Jul2021 might have a relation to this case. The course of the events (as of 13Jul2021) was as follows: On the next day of the second vaccination, the patient only had difficulty raising his arm and was otherwise well as usual. On the following day in the morning, the relative living nearby greeted the patient but there was no answer. The patient was found lying prone. He was transported by ambulance; he underwent resuscitation in a state of cardio-respiratory arrest but was unresponsive and was confirmed dead. Post-mortem CT test was performed but revealed no obvious abnormal findings. As of 15Jul2021, Body temperature before vaccination was 36.7 degrees centigrade. The course of the events was as follows: On the next day of the second vaccination, the relative came to greet, and the patient said that he had difficulty raising his arm because of a mild arm pain, and he seemed the same as usual. On 12Jul2021 in the morning, the relative living nearby came to greet but there was no answer. The relative entered the room, and the patient was lying prone. The patient was transported by ambulance to the hospital nearby, but he was in a state of cardio-respiratory arrest. Resuscitation was performed but was not effective, and his death was confirmed. Postmortem CT revealed no abnormal findings that identified the cause of death. In the death certification, cardiac failure acute was written as cause of death. The reporting physician classified the event as serious (Death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible causes of the events such as any other diseases included ischaemic heart disease and fatal arrhythmia. No treatment received for could not raise his arm and mild arm pain. The patient died on 12Jul2021. The outcome of events could not raise his arm and mild arm pain was unknown, other events was fatal. Autopsy was not performed.; Reported Cause(s) of Death: Cardio-respiratory arrest; The patient was lying prone; arrhythmia; ischaemic heart disease; cardiac failure acute


VAERS ID: 1504474 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-06-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3860 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac arrest, Computerised tomogram, Electrocardiogram, Respiratory arrest, SARS-CoV-2 test
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), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hepatitis C virus test positive; Osteoporosis; Parkinson''s syndrome; Pneumococcal infection (this was cured later); Seizure
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Test Date: 20210629; Test Name: Post-mortem CT findings; Result Unstructured Data: Test Result:included accumulated endotracheal fluid and pulmon; Comments: included accumulated endotracheal fluid and pulmonary oedema, but these could be changes after death, and the direct cause was concluded as unknown; Test Date: 20210629; Test Name: Initial waveform; Result Unstructured Data: Test Result:Asys; Test Date: 20210629; Test Name: Post-mortem coronavirus antigen test; Test Result: Negative
CDC Split Type: JPPFIZER INC2021881621

Write-up: Respiratory and cardiac arrest; Respiratory and cardiac arrest; This is a spontaneous report from a contactable pharmacist received from the regulatory authority. Regulatory authority report number is v21118894. The patient was an 84-year-old female. Body temperature before vaccination was 36.3 degrees centigrade on an unspecified date. Family history was unknown. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). Historical conditions described in the narrative: Parkinson''s syndrome (06Oct2015), hepatitis C virus (HCV) antibody positive ''blood disease'' (06Oct2015), osteoporosis (23Jun2016), invasive pneumococcal infection (10Oct2018) which was cured later, and seizure (09Nov2020), all stopped on unknown date. There were no conditions that needed regular hospital visits. The patient''s concomitant medications were not reported. On an unknown date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number not reported, Expiration date not reported). On 28Jun2021 at 13:30 (the day of vaccination, at an unspecified age), the patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EY3860, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 29Jun2021 around 16:20 (1 day after the vaccination), the patient experienced respiratory and cardiac arrest, and a death case with unknown details occurred. On 29Jun2021 (1 day after the vaccination), the outcome of the events was fatal. No autopsy was performed. The course of the events was as follows: On 29Jun2021 around 06:30 (1 day after the vaccination), the patient was last seen fine. On the same day around 16:20, the family found the patient in a state of respiratory and cardiac arrest and called an ambulance. At 16:35, the emergency crews arrived. They started cardiopulmonary resuscitation (CPR) and transported the patient to the hospital. At 16:50, the ambulance arrived at the hospital. On arrival, the patient had rigid mandibular joint and had difficulty in mouth opening; intubation was impossible, and ventilation with a bag valve mask was performed. The initial waveform was asystole (Asys). While having CPR, the patient entered the emergency room (ER), and the wave form was checked every 2 minutes but was constantly Asys. At 17:01, administration of ACETATED RINGER''S SOLUTION was initiated. ADRENALINE was given at 1 mg per dose for 3 times (at 17:02/17:06/17:10). The heartbeat did not resume, and CPR was discontinued after a consultation with the family. At 17:13, death was confirmed. The results of the blood collection done during CPR were in another attachment. Post-mortem coronavirus antigen test was negative. Post-mortem computerised tomography (CT) findings included accumulated endotracheal fluid and pulmonary oedema, but these could be changes after death, and the direct cause was concluded as unknown. After a discussion, autopsy was decided not to be performed. The reporting pharmacist classified the event a death case with unknown details as serious (death) and assessed the causality between the event a death case with unknown details and BNT162b2 as unassessable. The seriousness and causality of the other events were not reported. It was not reported whether there were other possible causes of the events such as any other diseases. The reporting pharmacist commented as follows: Rigid mandibular joint was noted on arrival at the hospital. About 3 hours may have passed after death. Some of the test levels were consistent with post-mortem changes, while others were significantly abnormal. As there were no regular hospital visits, the test values at baseline were unknown, and it was difficult to make an assessment. They considered that this case had to be reported because of the death that occurred in close proximity to the vaccination time and the time when the patient was seen fine.; Reported Cause(s) of Death: Respiratory and cardiac arrest; Respiratory and cardiac arrest


VAERS ID: 1504499 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure congestive, Constipation, Dyspnoea, Pain in extremity, Respiratory arrest
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   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: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac failure chronic; Coronary artery disease; Renal failure chronic
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021887971

Write-up: At 08:50, he developed respiratory arrest; Cardiac failure congestive; Constipated; Shortness of breath; Arm pain; This is a spontaneous report from a contactable physician. A 93-year-old male patient received BNT162B2 (COMIRNATY, solution for injection, Lot number not provided), via intramuscular, on 01Jun2021 (at the age of 93-year-old) at 0.3 mL single dose for COVID-19 immunisation. Relevant medical history included coronary artery disease, renal failure chronic, cardiac failure chronic and atrial fibrillation. No relevant concomitant medications were provided (the patient was not receiving anticoagulant agents). On 01Jun2021, after the vaccination, the patient complained of the arm pain. On 03Jun2021, he was constipated. He went to the bathroom frequently and he had shortness of breath. On 04Jun2021 at 08:00, he was alive. At 08:50, he developed respiratory arrest. The clinic was informed of that. A different physician examined him, and his death was confirmed. The family refused to perform pathological autopsy. The cause of death was determined to be cardiac failure congestive, but it was uncertain because pathological autopsy was not conducted. The causal relationship with BNT162B2 was uncertain. No follow-up attempts are possible. Information about Batch/Lot number cannot be obtained.; Sender''s Comments: Based on the available data , the causal relationship between BNT162B2 and the cardiac failure and respiratory failure cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees; Reported Cause(s) of Death: Cardiac failure congestive


VAERS ID: 1504500 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-07-02
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5422 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiogenic shock, Myocarditis
SMQs:, Cardiac failure (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: TAKELDA; OLMETEC; CRESTOR; CALONAL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction; Hyperlipidaemia; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021887987

Write-up: Myocarditis; cardiogenic shock; This is a spontaneous report from a contactable physician. An 80-year-old female patient (not pregnant) received the second dose of BNT162B2 (COMIRNATY, solution for injection, Lot number EY5422 with Expiration Date 31Aug2021), via intramuscular, on 14Jun2021 11:00 (at the age of 80-year-old) at single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (COMIRNATY, solution for injection, Lot number EY0779 with Expiration date 31Aug2021) administered on 19May2021 (at the age of 80-year-old) at single dose for COVID-19 immunisation. Relevant medical history included cerebral infarction from 2016, hyperlipidaemia and hypertension. Prior to vaccination, the patient was not diagnosed with COVID-19. Past drug history included acetylsalicylic acid (BUFFERIN) and developed shock. Relevant concomitant medications included aspirin lansoprazole (TAKELDA), olmesartan medoxomil (OLMETEC), rosuvastatin calcium (CRESTOR), and acetaminophen (CALONAL). On 02Jul2021 (18 days after vaccination), the patient was admitted to the hospital for cardiogenic shock, and she died due to myocarditis. Since the vaccination, the patient has not been tested for COVID-19. The events resulted in emergency room/department or urgent care, hospitalization, and death. The outcome of the events was fatal with treatment including intensive care in the catalytic cracking unit (CCU). The reporting physician assessed the events as serious (hospitalization and death). No autopsy was performed.; Sender''s Comments: Based on the information currently available, a causal association between the reported events myocarditis/cardiogenic shock and BNT162B2 cannot be fully excluded. Case will be reassessed when additional 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 RAs, Ethics Committees, and investigators, as appropriate. ; Reported Cause(s) of Death: Myocarditis; cardiogenic shock


VAERS ID: 1504634 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX7823 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Cerebral haemorrhage, Cerebral infarction, Electrocardiogram, Headache, Magnetic resonance imaging, Optical coherence tomography, Pneumonia, Ultrasound Doppler, Visual field tests, Visual impairment
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-15
   Days after onset: 45
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 15 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: XALMONO; PERINDOPRIL [PERINDOPRIL ERBUMINE]; TIMOLOL; METOPROLOL [METOPROLOL SUCCINATE]; ACETYLSALICYLIC ACID; SIMVASTATIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:unknown; Test Name: ECG; Result Unstructured Data: Test Result:unknown; Test Name: MRI; Result Unstructured Data: Test Result:no results were reported; Test Date: 20210523; Test Name: OCT; Result Unstructured Data: Test Result:unknown; Test Name: doppler; Result Unstructured Data: Test Result:unknown; Test Date: 20210523; Test Name: visual field examination; Result Unstructured Data: Test Result:unknown
CDC Split Type: NLPFIZER INC2021874793

Write-up: various additional cerebral infarctions; death due to brain haemorrhage; problems with his vision; persistent headache; Pneumonia; This is a spontaneous report from a contactable consumer based on information downloaded via the Regulatory Authority-WEB: NL-LRB-00612322. A 73-year-old elderly male received the second dose of BNT162b2 (COMIRNATY, solution for injection; Lot EX7823 expiry not provided) as a single dose via an unspecified route on 13May2021 for COVID-19 immunisation. There was no medical history reported. The patient had no history of previous COVID infection. Relevant medical history included Suspected COVID-19 (unknown when; with severe symptoms but no hospitalization; disease symptoms: quite). Concomitant medications included latanoprost (XALMONO) from an unspecified date for unspecified indication; perindopril erbumine (PERINDOPRIL) from an unspecified date for unspecified indication; timolol from an unspecified date for unspecified indication; metoprolol succinate (METOPROLOL) from an unspecified date for unspecified indication; acetylsalicylic acid from an unspecified date for unspecified indication; and simvastatin from an unspecified date for unspecified indication. The patient previously received COVID-19 immunisation with the first dose of BNT162b2 (COMIRNATY, solution for injection; batch/not and expiry information not provided) as a single dose on 08Apr2021 with no adverse effect. On an unspecified date the patient experienced various additional cerebral infarctions and death due to brain haemorrhage which were classified serious (death/hospitalization and life-threatening). On an unspecified date the patient experienced Pneumonia: which was classified serious (death). On an unspecified date the patient experienced problems with his vision and persistent headache; which were classified non-serious. The reporter indicated that about one to one and one-half weeks after vaccination, in May2021 patient started to get problems with his vision and a persistent headache. He went to an eye doctor on 23May2021, though they could not find a cause for the problems. The patient was sent to the hospital for visual field examination and Optical coherence tomography (OCT). On 27May2021 the patient was seen by the doctor. On 31May2021 the patient was admitted to hospital with cerebral bleeding and multiple cerebral infarctions. Several tests were done, but no cause was found. He also got a pneumonia (latency unknown) for which he was treated with multiple different antibiotics that were not effective. On 03Jun2021 the patient''s health declined fast and was then not responsive. The patient was then switched to palliative care, because of the poor prognosis of his brain and because the pneumonia treatment was not effective. The patient died as a result of the pneumonia. The reporter indicated that the first signs of the adverse reaction occurred approximately 1-1.5 weeks after receiving the second vaccine. It started with visual complaints and increasingly persistent headaches. On 23May2021 at the outpatient ophthalmologist for examination, who could not find anything immediately, referred to hospital for visual field examination and OCT (Optical coherence tomography). Only seen for the first time by ophthalmologist on Thursday 27May2021 and on 31May2021 at tia-poli. Since 1st complaints situation gradually deteriorated. From about 3-6 the situation deteriorated quickly and my father was soon unresponsive and passed away on 15Jun2021. Hospitalization information: cerebral hemorrhage and various cerebral infarctions. My father was in the hospital in the neurology department from 31May2021 until his death on 15Jun2021. Laboratory testing included ECG, doppler, blood test, MRI though no results were reported. It was unknown if an autopsy was performed. The reporter indicated In my opinion, the official reason given for the time being is that he died from the effects of pneumonia (after various antibiotics did not work, we decided in consultation with the doctors to have my father die palliatively. The outcome of the events various additional cerebral infarctions, death due to brain haemorrhage, and Pneumonia was fatal. The outcome of the events problems with his vision and persistent headache was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: In my opinion, the official reason given for the time being is that he died from the effects of pneumonia (after various antibiotics did not work, we decided in consultation with the doctors to have my father die palliatively.


VAERS ID: 1504635 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-14
Onset:2021-02-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Cardiac arrest, Cardiac failure, Chills, Diagnostic procedure, Feeling abnormal, Malaise, Vaccination site inflammation, Vaccination site pain, Vaccination site warmth
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Acute central respiratory depression (broad), Cardiomyopathy (broad), Arthritis (broad), Respiratory failure (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-25
   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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Diagnostic procedure; Result Unstructured Data: Test Result:serious heart problems; Comments: permanent damage to the heart muscle
CDC Split Type: NLPFIZER INC2021874182

Write-up: Heart failure; Cardiac arrest; Felt very strange; Not feeling well; Chills; Reaction at or around the injection site: pain; Pain in the joints; Inflammatory reaction at the reaction site: heat, pain; Reaction at or around the injection site: heat; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority Report. An 89-year-old female patient received first dose of BNT162b2 (COMIRNATY, solution for injection, lot and expiry date not reported), via unspecified route of administration on 14Feb2021 as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced chills, reaction at or around the injection site: pain, pain in the joints, inflammatory reaction at the reaction site: heat, pain, reaction at or around the injection site: heat on 15Feb2021; heart failure (start date also reported as one weeks start), cardiac arrest (start date also reported as one weeks start), not feeling well on 20Feb2021. Patient was treated with blood thinners and other unknown cardiac medication. Due to cardiac arrest the heart muscle was permanently damaged. Heart failure - hospitalized for 5 days and 6 nights. It was reported that the patient had no known heart complaints or heart failure. A week after the vaccination she felt very strange and was rushed by the ambulance. She had a heart attack that damaged the heart muscle. She was hospitalized for a few days, but eventually died. The doctors don''t know what caused her death, but they bet on heart failure. This problem only started a week after the vaccination. Patient had an unspecified diagnostic procedure which showed serious heart problems and permanent damage to the heart muscle on an unspecified date. The patient did not have a previous COVID-19 infection. Sender diagnosis: Injection site inflammation. Outcome of all the events was fatal. The patient died on 25Feb2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. Information on batch/lot number cannot be obtained.; Reporter''s Comments: Additional information ADR: The person had no known heart complaints or heart failure. A week after the vaccination she felt very strange and was rushed by the ambulance. She had a heart attack that damaged the heart muscle. She was hospitalized for a few days, but eventually died. The doctors don''t know what caused her death, but they bet on heart failure. This problem only started a week after the vaccination.; Reported Cause(s) of Death: Cardiac arrest; Chills; reaction at or around the injection site: pain; Pain in the joints; inflammatory reaction at the reaction site: heat, pain; Not feeling well; inflammatory reaction at the reaction site: heat, pain; Felt very strange; heart fai


VAERS ID: 1504641 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-03
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Dyspnoea, Fatigue, Feeding disorder, Gait inability, Magnetic resonance imaging, Malaise, Myalgia, Nausea, Pulmonary embolism
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-07
   Days after onset: 37
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart disorder
Allergies:
Diagnostic Lab Data: Test Date: 202105; Test Name: MRI; Result Unstructured Data: Test Result:No specific results reported
CDC Split Type: NLPFIZER INC2021874646

Write-up: Clogged pulmonary vein; unable to walk and eat; unable to walk and eat; short of breath; Pain in the joints; Nausea; Myalgia; Not feeling well, feeling bad; Fatigue; This is a spontaneous report from a contactable consumer or other non-healthcare professional (hcp) downloaded from the regulatory authority-WEB NL-LRB-00614866. This is a serious spontaneous report. A 68-year-old male patient received bnt162b2 (COMIRNATY, Batch/Lot Number: Unknown), via an unspecified route of administration on 03May2021 as dose 1, 0.3 ml, single for COVID-19 immunization. Medical history included heart disorder from an unknown date and unknown if ongoing. There was no past drug therapy BioNTech/Pfizer vaccine. The patient''s concomitant medications were not reported. The patient experienced malaise (felt ill/feeling bad) and fatigue happened on 2 days after start on 05May2021 following administration of COVID-19 vaccine Pfizer; nausea, pain in the joints (generalized joint pain) and myalgia happened on 3 days after start on 06May2021; clogged pulmonary vein/lung embolism happened on 14 days after start on 17May2021. Patient was not able to walk and eat and had dyspnoea in May2021. For these reasons, he was admitted to hospital where they diagnosed lung embolism. Additional information of adverse reaction was found at hospital admission. Confounding factors: Heart patient. There was no previous COVID-19 infection. Diagnostic procedures: MRI scan in May2021. Lab test included: MRI was done, no specific results reported. The outcome of events fatigue, generalized joint pain, lung embolism, malaise, myalgia, nausea were fatal, outcome of events not able to walk and eat and dyspnoea were unknown. The patient died on 07Jun2021. It was not reported if an autopsy was performed. Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no. Clogged pulmonary vein: Hospitalization information: Feeling bad, unable to walk and eat, short of breath. Additional information ADR: Found at hospital admission. Confounding factors: Heart patient. Previous COVID-19 infection: No. Other: diagnostic procedures: MRI scan. Sender Comment: Due to incompatibility between latency period and date of death, the latency time of side effects was corrected from starting in July to starting in May, right after the vaccination. Reported is asked for clarification. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.; Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no Clogged pulmonary vein: Hospitalization information: Feeling bad, unable to walk and eat, short of breath. Additional information ADR: Found at hospital admission confounding factors: Heart patient Previous COVID-19 infection: No Other: diagnostic procedures: MRI scan; Reported Cause(s) of Death: myalgia; pain in the joints (generalized joint pain); nausea; fatigue; malaise (felt ill/feeling bad); clogged pulmonary vein/lung embolism


VAERS ID: 1504710 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-05-23
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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: 2021-05-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021873963

Write-up: Pulmonary embolism/ Breathing difficult/problems with catching the breath as if a concrete slab had fallen on the chest; This is a spontaneous report received from a contactable consumer or other non professional downloaded from the Regulatory Authority report. Report was sent on 30Jun2021 by the patient''s wife. A 53-years-old male patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number and Expiration date was unknown), via an intramuscular route on 18May2021 (at the age of 53 years) as a dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 18May2021, approximately 3 hours after vaccination, patient had problems with catching the breath as if a concrete slab had fallen on the chest. On 19May2021, patient had a consultation by phone, he was supposed to lie down to rest and ingest vitamin D. On 23May2021, patient was hospitalized, 4 hours. The patient was hospitalized on 23May2021, for 4 hours. The patient died on 23May2021. An autopsy was performed that revealed pulmonary embolism (cause of death). Sender''s comments: Pulmonary embolism is an unexpected side effect for a vaccine. Numerous cases of pulmonary embolism following vaccine use have already been reported to the database. Due to the temporal relationship, an influence of the vaccine on the development of adverse drug reactions cannot be excluded. Assessed the application as severe (death). No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Pulmonary embolism; Autopsy-determined Cause(s) of Death: Pulmonary embolism


VAERS ID: 1504766 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-07-01
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA8016 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes; Hypertension; Rheumatism
Preexisting Conditions: Medical History/Concurrent Conditions: Back surgery
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021874648

Write-up: embolism; BLOOD CLOT; shortness of breath; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority. A 71-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on Jun2021 (Lot Number: FA8016) as single dose for COVID-19 immunization. Medical history included ongoing Rheumatism, ongoing hypertension, Back surgery from 2021 to an unknown date (not ongoing), ongoing diabetes. The patient''s concomitant medications were not reported. The patient previously received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on Apr2021 (Lot Number: EW4815) as single dose for COVID-19 immunization. The patient experienced embolism, blood clot, shortness of breath on Jul2021. Reported suspect adverse event was embolism. The date on which dose two was given is not stated in the report. The reporter states that the woman was healthy one week before she woke up with shortness of breath. An ambulance was called but the woman''s life could not be saved. Outcome: Fatal. Report assessed as serious, death. The patient died on an unspecified date. It was not reported if an autopsy was performed. Supplementary information from NVR (National Vaccination Register) has been received regarding the date of the vaccination. 29 days after vaccine dose 2, the woman gets a blood clot and dies the same day. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: BLOOD CLOT; shortness of breath; Embolism


VAERS ID: 1504945 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-06-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0927 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Aphasia, Asthenia, Blood chloride, Blood creatinine, Blood potassium, Blood sodium, Blood urea, Death, Diarrhoea, Dyspnoea, Gait inability, Haematocrit, Haemoglobin, Illness, Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean cell volume, Mean platelet volume, Platelet count, Red blood cell count, Red cell distribution width, White blood cell count
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Noninfectious diarrhoea (narrow), Respiratory failure (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: Medical History/Concurrent Conditions: Arthritis; Hypertension (on treatment)
Allergies:
Diagnostic Lab Data: Test Date: 20210703; Test Name: Chloride; Result Unstructured Data: Test Result:108 mmol/L; Comments: increased; Test Date: 20210703; Test Name: Creatinine; Result Unstructured Data: Test Result:439 umol/l; Comments: increased; Test Date: 20210703; Test Name: Potassium; Result Unstructured Data: Test Result:6.6 mmol/L; Comments: increased; Test Date: 20210703; Test Name: Sodium; Result Unstructured Data: Test Result:160 mmol/L; Comments: increased; Test Date: 20210703; Test Name: Urea; Result Unstructured Data: Test Result:greater than 40 mmol/L; Comments: increased; Test Date: 20210703; Test Name: eGFR (CKD-EPI); Result Unstructured Data: Test Result:8 ml/min; Test Date: 20210703; Test Name: Haematocrit; Result Unstructured Data: Test Result:0.456 L/L; Test Date: 20210703; Test Name: Hemoglobin; Result Unstructured Data: Test Result:14.4 g/dl; Test Date: 20210703; Test Name: MCH; Test Result: 13.4 pg; Test Date: 20210703; Test Name: MCHC; Result Unstructured Data: Test Result:31.6 g/dl; Test Date: 20210703; Test Name: MCV; Result Unstructured Data: Test Result:102.5 fL; Comments: increased; Test Date: 20210703; Test Name: mean platelet volume; Result Unstructured Data: Test Result:12; Test Date: 20210703; Test Name: Platelet count; Result Unstructured Data: Test Result:139; Comments: decreased; Test Date: 20210703; Test Name: Red blood cell count; Result Unstructured Data: Test Result:4.45 x10 12/l; Test Date: 20210703; Test Name: red cell distribution width; Test Result: 15.3 %; Test Date: 20210703; Test Name: White blood cell count; Result Unstructured Data: Test Result:13.73 x10 9/l; Comments: increased
CDC Split Type: ZAPFIZER INC2021877008

Write-up: Acute respiratory distress syndrome; Shortness of breath; Ill looking; Weak; Diarrhea; Unable to talk; Unable to walk; Died; This is a spontaneous report from a contactable other hcp. A 78-year-old female patient received BNT162B2 (COMIRNATY, formulation: solution for injection, Lot Number: FD0927, Expiration Date: Sep2021) via an unspecified route of administration on 25Jun2021 at 14:16 as dose 1, single for Covid-19 immunization. The patients medical history included hypertension; on treatment and arthritis. The patients concomitant medications were not reported. On 26Jun2021 patient experienced illness, weakness, diarrhoea, unable to talk, unable to walk, shortness of breath and acute respiratory distress syndrome. Patient was admitted to hospital on 03Jul2021. On 04Jul2021 at 02:40, patient died. An autopsy was not performed. The patient underwent lab tests and procedures on 03Jul2021 which included blood chloride: 108 mmol/l, increased; blood creatinine: 439 micromole/ litre (umol/l), increased; blood potassium: 6.6 millimoles/litre (mmol/l), increased; blood sodium: 160 mmol/l, increased; blood urea: greeter than 40 mmol/l, increased; glomerular filtration rate: 8 Millilitre/minute (ml/min), haematocrit: 0.456 litre/litre (l/l), haemoglobin: 14.4 grams/decilitre (g/dl), mean cell haemoglobin: 13.4 picograms (pg), mean cell haemoglobin concentration: 31.6 g/dl, mean cell volume: 102.5 femtoliters (fl), increased; mean platelet volume: 12, platelet count: 139, decreased; red blood cell count: 4.45 x10 12/l, White blood cell count: 3.90 x10 9/l, increased; red cell distribution width: 15.3 percent. The outcome of event was fatal and outcome of all other event was unknown. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: "Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events of ARDS, DEATH and 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: Died


VAERS ID: 1504948 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-05
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1436 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aphasia, Bilirubin conjugated increased, Blood albumin, Blood chloride, Blood creatinine, Blood sodium, Blood urea, COVID-19, Cerebrovascular accident, Death, Dizziness, Gait inability, Haematocrit, Haemoglobin, Hemiparesis, Hypoglycaemia, Hypotension, Protein total, Red blood cell count, Tachycardia, Thrombocytopenia, Urinary tract infection
SMQs:, Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Haematopoietic thrombocytopenia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (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), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Biliary system related investigations, signs and symptoms (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (narrow), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CLEXANE; PARACETAMOL; PREDNISONE; ZINC; VITAMIN C ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic renal failure (with abnormal renal functions); Hypertension (defaulted on treatment)
Allergies:
Diagnostic Lab Data: Test Date: 20210705; Test Name: conjugated bilirubin test; Result Unstructured Data: Test Result:increased; Comments: high; Test Date: 20210705; Test Name: albumin test; Result Unstructured Data: Test Result:decreased; Comments: Low; Test Date: 20210705; Test Name: chloride test; Result Unstructured Data: Test Result:increased; Comments: high; Test Date: 20210705; Test Name: creatinine test; Result Unstructured Data: Test Result:increased; Comments: high; Test Date: 20210705; Test Name: sodium test; Result Unstructured Data: Test Result:increased; Comments: high; Test Date: 20210705; Test Name: urea test; Result Unstructured Data: Test Result:increased; Comments: high; Test Date: 20210705; Test Name: hematocrit; Result Unstructured Data: Test Result:decreased; Comments: Low; Test Date: 20210705; Test Name: hemoglobin; Result Unstructured Data: Test Result:decreased; Comments: Low; Test Date: 20210705; Test Name: total protein test; Result Unstructured Data: Test Result:decreased; Comments: Low; Test Date: 20210705; Test Name: red blood cell count; Result Unstructured Data: Test Result:decreased; Comments: Low
CDC Split Type: ZAPFIZER INC2021884885

Write-up: Covid 19; Thrombocytopenia; CVA; UTI; Died; Unable to walk; Unable to talk; Dizziness; Hypotension (94/67); Tachycardia (122 bpm); Hypoglycaemia; Hemiparesis (right); This is a spontaneous report from a contactable physician. A 88-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FC1436; Expiration Date: 31Oct2021) via unspecified route of administration on 02Jul2021 11:21(Age at vaccination:88 years) at a dose 1 single for covid-19 immunization. The patient past Medical history included chronic kidney disease (with abnormal renal function), hypertension defaulted on treatment. Concomitant medications included enoxaparin sodium (CLEXANE); paracetamol (PARACETAMOL); prednisone (PREDNISONE); zinc (ZINC); ascorbic acid (VITAMIN C ACID). On 05Jul2021, the patient reported unable to walk, unable to talk, dizziness, hypotension (94/67), tachycardia (122 bpm), hypoglycemia, low oxygen saturation, bilateral lung crepitation (rales), hemiparesis (right), UTI (urinary tract infection). On 05Jul2021, patient had abnormal lab results, sodium high (blood sodium increased), chloride high (blood chloride increased), urea high (blood urea increased), creatinine high (blood creatinine increased), total protein low (protein total decreased), albumin low (blood albumin decreased), conjugated bilirubin high (bilirubin conjugated increased), red blood cell count low (red blood cell count decreased), hemoglobin low (hemoglobin decreased), hematocrit low (hematocrit decreased). The event outcome was Unknown. On 05Jul2021, the patient was Hospitalized and found to have Covid-19, thrombocytopenia, pneumonia, he had CVA (stroke), died on 06Jul2021. Outcome of all events was fatal. No further information was available at the time of this report; Sender''s Comments: As there is limited information in the case provided, the causal association between the events: Death, Covid 19, Gait Inability, aphasia, dizziness, Hypotension, Tachycardia, Hypoglycaemia, hemiparesis, Urinary tract infection, thrombocytopenia and cerebrovascular accident and the suspect drug 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 drug 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: CVA


VAERS ID: 1504950 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-06-26
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0927 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Death, Pyrexia, SARS-CoV-2 test
SMQs:, 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: 2021-07-02
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: ZAPFIZER INC2021893422

Write-up: High fever; Tested positive for COVID-19; Death; This is a spontaneous report from a contactable nurse. A 78-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, the diluent batch#: 59346; expiry date: May2023) dose 1 administration on 22Jun2021 (lot number: FD0927; Expiration Date: Sep2021) (At vaccination age of 78-year-old), single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The vaccine was reconstituted on 22Jun2021. The patient experienced high fever on 26Jun2021. The patient was hospitalized for high fever from 27Jun2021. The patient is reported to have tested positive for Covid-19 (COVID-19 virus test positive). Patient died on 02Jul2021. An autopsy was not performed. The outcome of the event fever and COVID-19 was unknown. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: As there is limited information in the case provided, the causal association between the events Death, Pyrexia and the suspect drug BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) 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: Death


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

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Death
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of DEATH and CHEST PAIN in an 18-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002916) for COVID-19 vaccination. No Medical History information was reported. On 12-Jul-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced DEATH and CHEST PAIN (seriousness criterion death). The patient died on 14-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment information was provided. Company Comment: This is a case of death in a 18-year-old male subject, who died after receiving second dose of vaccine. Very limited information has been provided at this time.; Sender''s Comments: This is a case of death in a 18-year-old male subject, who died after receiving second dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: UNKNOWN


VAERS ID: 1504985 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-21
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-22
   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: Asthma
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210747081

Write-up: DIED; DIFFICULTY OF BREATHING; FEVER; This spontaneous report received from a pharmacist concerned a 7 decade old female of unknown race and ethnicity. The patient''s height, and weight were not reported. The patient''s concurrent conditions included asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 21-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-JUL-2021, at night after the vaccination patient experienced fever. On 22-JUL-2021, day after the vaccination in the morning the patient had difficulty of breathing, then was rushed to the hospital. On 22-JUL-2021, the patient died in the hospital from unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on 22-JUL-2021, and the outcome of fever and difficulty of breathing was not reported. This report was serious (Death).; Sender''s Comments: V0-20210747081- covid-19 vaccine ad26.cov2.s -Death. 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(s) than the drug. Specifically: MEDICAL HISTORY; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1505096 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202100935881

Write-up: someone he knew close to him died 2 days after receiving the vaccine from a stroke.; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162b2 (COMIRNATY, Solution for injection), dose number unknown, 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. As reported, someone the reporter knew, close to him died 2 days after receiving the vaccine from a stroke. Medical personnel had concluded that it was unrelated but he (the reporter) knew it was because of the vaccine. The patient died on an unspecified date. 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: Based on the information currently available ,the fatal event stroke is unrelated to the suspect vaccine BNT162B2 or comirnaty.; Reported Cause(s) of Death: stroke


VAERS ID: 1505143 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-17
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX0904 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Deep vein thrombosis, Immune thrombocytopenia, Multiple organ dysfunction syndrome, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (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) (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), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-30
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 13 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Nasal Swab; Result Unstructured Data: Test Result:Negative
CDC Split Type: CAPFIZER INC2021901560

Write-up: Suspected VITT thrombocytopenia; DVT; CVA; multi system organ failure; This is a spontaneous report from a contactable pharmacist. A 69-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at age of 69-years-old on 06Apr2021 (Lot Number: EX0904) as single dose for covid-19 immunisation. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient''s concomitant medications were not reported. The patient experienced multi system organ failure on 30Apr2021, Suspected (VITT) Vaccine-induced Immune Thrombotic Thrombocytopenia, Deep vein thrombosis (DVT), Cerebrovascular accident (CVA) on 17Apr2021. The patient was hospitalized for Suspected Vaccine-induced Immune Thrombotic Thrombocytopenia (VITT), Deep vein thrombosis (DVT), Cerebrovascular accident (CVA) for 13 days. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included Nasal Swab: negative. Treatment received for the events included anticoagulation initially. Events resulted in Emergency room/department or urgent care. The patient died on 30Apr2021 due to multi system organ failure. It was not reported if an autopsy was performed. Outcome of other events was unknown.; Sender''s Comments: Based on the plausible temporal relation, the association between the events of Multi-organ failure, Immune-mediated thrombocytopenia, Deep Vein thrombosis and Cerebrovascular Accident and the suspect product of BNT162B2 cannot be completely ruled out. 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: multi system organ failure


VAERS ID: 1505220 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-03
Onset:2021-04-14
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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: 2021-04-14
   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: Dilated cardiomyopathy; Hypertonus; Left ventricular failure
Preexisting Conditions: Medical History/Concurrent Conditions: Penicillin allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021882763

Write-up: Infarct myocardial; This is as spontaneous report received from a non-contactable consumer downloaded from the regulatory authority. The regulatory authority report number DE-PEI-CADR2021130020. Sender''s (Case) Safety Report Unique Identifier: DE-PEI-202100126427. An 80-year-old male patient received bnt162b2 (COMIRNATY, Batch/Lot Number not reported), via an unspecified route of administration on 03Apr2021 as dose 1, 0.3ml single for COVID-19 immunisation. Medical history included ongoing dilated cardiomyopathy, ongoing hypertonus, ongoing left ventricular failure and amoxicillin allergy from an unknown date. The patient''s concomitant medications were not reported. On 14Apr2021, the patient experienced infarct myocardial. The outcome of the event was fatal. The patient died on 14Apr2021. An autopsy was not performed. Sender''s comments Are you or the person concerned known of any allergies? If yes, which? Amoxicillin Information on risk factors or previous illnesses Left heart failure, hypertension, dilated cardiomyopathy, / dropped dead on the street lifting a tire No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1505221 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-02-19
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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: 2021-02-19
   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: CLOZAPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Psychosis; Schizophrenia
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021882739

Write-up: lung embolism; This is as spontaneous report received from a non-contactable consumer downloaded from the regulatory authority. The regulatory authority report number DE-PEI-CADR2021130363. Sender''s (Case) Safety Report Unique Identifier: DE-PEI-202100128967. A 51-year-old male patient received bnt162b2 (COMIRNATY, solution for injection), via unspecified route of administration on 20Jan2021 (batch/lot number and expiry date unknown) as dose 2, 0.3 ml single for covid-19 immunization. Medical history included schizophrenic, psychosis. Concomitant medications included clozapine taken for an unspecified indication, start and stop date were not reported. On 19Feb2021, the patient experienced lung embolism. The event was reported serious (death). The outcome of the event was fatal. The patient died on 19Feb2021. An autopsy was not performed. Sender''s comments: Are you or the person concerned known of any allergies? If yes, which?: No. Information on risk factors or previous illnesses known: schizophrenic psychosis, taking clozapine. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: lung embolism


VAERS ID: 1505222 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-06-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-27
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: 2021-06-17
   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: DEPFIZER INC2021883163

Write-up: found dead in the apartment; This is a spontaneous report from a non-contactable consumer, downloaded from the Regulatory Authority-WEB number DE-PEI-CADR2021132117, Safety Report Unique Identifier DE-PEI-202100129409. A 69-year-old male patient received BNT162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 16Jun2021 (Batch/Lot Number: FD9234) at 0.3 ml single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. No known allergies. The patient was found dead in the apartment on 17Jun2021. The cause of death was unknown. Autopsy was performed and results were not provided. Event assessment : Comirnaty/ event/Regulatory Authority /Result of Assessment : D. Unclassifiable No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1506176 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-09
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Chest pain, Cyanosis, Tachypnoea, Vaginal haemorrhage
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: AFib; Alveolar hypoventilation; Arterial hypertension; Asthma; Bowen''s disease; Congenital aortic valve stenosis; Dyslipidemia; Mitral valve incompetence; Pulmonary arterial hypertension; Type II diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Bundle branch block right; Cesarean section; Coronaropathy; Hip prosthesis insertion; Sleep apnoea syndromes; Worry; Comments: Well-balanced type 2 diabetes, coronary artery disease, hypertension, PAH, alveolar hypoventilation, sleep apnea syndrome with device, asthma, continuous atrial fibrillation, right bundle branch block, low-grade mitral insufficiency, non-severe aortic stenosis, dyslipidemia, anxiety, Bowen''s disease (squamous cell carcinoma bowenoid in situ leg G 2016), bilateral THA, 3 cesarean sections.
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20210751966

Write-up: HEART ARREST; CYANOSIS; STETHALGIA; TACHYPNOEA; HAEMORRHAGE VAGINAL; This spontaneous report received from a physician via a Regulatory Authority [NLP, FR-AFSSAPS-NT20212652] concerned a 77 year old female ,unspecified race and ethnic origin. The patient''s weight was 100 kilograms, and height was 149 centimeters. The patient''s past medical history included worry, sleep apnoea syndromes, hip prosthesis insertion, coronaropathy, cesarean section, and bundle branch block right, and concurrent conditions included alveolar hypoventilation, congenital aortic valve stenosis, dyslipidemia, mitral valve incompetence, pulmonary arterial hypertension, bowen''s disease, afib, arterial hypertension, type 2 diabetes mellitus, and asthma, and other pre-existing medical conditions included well-balanced type 2 diabetes, coronary artery disease, hypertension, pah, alveolar hypoventilation, sleep apnea syndrome with device, asthma, continuous atrial fibrillation, right bundle branch block, low-grade mitral insufficiency, non-severe aortic stenosis, dyslipidemia, anxiety, bowen''s disease (squamous cell carcinoma bowenoid in situ leg g 2016), bilateral tha, 3 cesarean sections. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C11-02 expiry: UNKNOWN) 1 dosage forms, frequency one total , administered on 01-JUN-2021 for sars-cov-2 vaccination.No concomitant medications were reported. On 09-JUL-2021, the patient experienced heart arrest, cyanosis, stethalgia, tachypnoea and haemorrhage vaginal. drug start period was 39 days. On 09-JUL-2021, the patient died from heart arrest, cyanosis, stethalgia, tachypnoea, and haemorrhage vaginal. An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210751966-COVID-19 VACCINE AD26.COV2.S-Heart arrest, Cyanosis, Stethalgia, Tachypnoea, Haemorrhage vaginal. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE; Reported Cause(s) of Death: HEART ARREST; CYANOSIS; STETHALGIA; TACHYPNOEA; HAEMORRHAGE VAGINAL


VAERS ID: 1506608 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-12
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiomyopathy
SMQs:, Cardiomyopathy (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRPFIZER INC2021887840

Write-up: Patient passed away on Monday / the cause of death was myocardia; This is a spontaneous report from a contactable consumer (unspecified relation to the patient) from Pfizer medical information team. A 48-years-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 09Jul2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter said that the patient was 48 years old, healthy and out of nowhere, he took the vaccine on Friday (09Jul2021) and died on Monday (12Jul2021). The reporter informed that the father (patient) of a 16-year-old boy passed away on Monday (12Jul2021) and they are suspecting that the cause was because he took the Pfizer vaccine. The patient''s son wants the body to be exhumed for an autopsy to find out if it was really the vaccine. The reporter informed that the cause of death was myocardia and that the patient''s son was convinced that it was because of the vaccine. The reporter also informed that the medical examiner did not write in the report, but he said that the death had been caused by the vaccine. An autopsy was not performed. The outcome of the event myocardia was fatal.; Reported Cause(s) of Death: Patient passed away on Monday / the cause of death was myocardia


VAERS ID: 1506627 (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: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Cardiac failure, Chills, Dyspnoea, Ear pain, Hypotension, Myalgia, Oropharyngeal pain, Pyrexia, Rhinitis, Rhinorrhoea, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-20
   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:
Current Illness: Factor V Leiden mutation; Goiter; Hashimoto''s thyroiditis (with goiter); High cholesterol (mildly elevated cholesterol)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC2021882828

Write-up: Cardiac failure/heart failure; Breathlessness/shortness of breath; blood pressure decreased; vomiting; runny nose/sniffles; muscle pain/generalised muscle aches; rigoring/chills; joint pain/generalised joint pain; sore throat; ear pain; fever; rhinitis; This is a spontaneous report from a contactable consumer (patient, as reported) from the Regulatory Authority. The regulatory authority number is CZ-CZSUKL-21008120. A 79-year-old female patient received BNT162B2 (COMIRNATY Solution for injection), intramuscular, in Jun2021 (Batch/Lot number was not reported), as dose 1, single, for COVID-19 immunisation. Medical history included Hashimoto''s thyroiditis with goiter, high cholesterol (mildly elevated cholesterol), and factor V Leiden mutation, all from unknown dates and ongoing. Concomitant medications included unspecified thyroid hormones and common analgesics. In Jun2021 (reported as "approximately 14 days after the administration of the first dose of the COMIRNATY vaccine"), the patient experienced breathlessness/shortness of breath, blood pressure decreased, vomiting, runny nose/sniffles, muscle pain/generalised muscle aches, rigoring/chills, joint pain/generalised joint pain, sore throat, ear pain, fever and rhinitis. In Jun2021, the patient experienced cardiac failure/heart failure and died on 20Jun2021. The cause of death was cardiac failure/heart failure. The outcome of the events breathlessness/shortness of breath, blood pressure decreased, vomiting, runny nose/sniffles, muscle pain/generalised muscle aches, rigoring/chills, joint pain/generalised joint pain, sore throat, ear pain, fever and rhinitis was unknown (event stop date was also reported as Jun2021, pending clarification). The outcome of the event cardiac failure/heart failure was fatal. An autopsy was not performed. The health authority assessed the event cardiac failure/heart failure as serious (death, life-threatening, medically significant); and the events breathlessness/shortness of breath, blood pressure decreased, vomiting as serious (medically significant). No follow-up attempts are possible; information on batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Cardiac failure/heart failure


VAERS ID: 1506629 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-06-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7958 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021883244

Write-up: Pyrexia; Decompensation cardiac; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority, regulatory authority number DE-PEI-202100130820. A 60-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 23Jun2021 (Lot Number: FD7958) at age of 60-years-old as DOSE 2, 0.3 ML SINGLEfor covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient previously took the first dose bnt162b2 on 26May2021 for covid-19 immunization. The patient experienced pyrexia, decompensation cardiac on 24Jun2021. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of events was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Decompensation cardiac; Pyrexia


VAERS ID: 1506630 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7011 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021882865

Write-up: Unknown cause of death; This is a spontaneous report downloaded from the Regulatory Authority; number DE-PEI-202100130821. A non-contactable physician reported that an 83-year-old male patient received BNT162B2 (COMIRNATY; Lot Number: FE7011), via an unspecified route of administration on 07Jul2021 as 0.3 mL single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received COVID-19 vaccine (VAXZEVRIA) on 20Apr2021 for COVID-19 vaccination (COVID-19 Vaccine AstraZeneca). On 08Jun2021, the patient experienced unknown cause of death. It was not reported if an autopsy was performed. This report is serious - death. Event assessment: Comirnaty/ event/PEI /Result of Assessment: D. Unclassifiable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1506631 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-06-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7958 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Osteoporosis; Psoriatic arthritis
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021882870

Write-up: Dyspnoea; Immunization reaction; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number DE-PEI-202100130822. A 54-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 22Jun2021 (Batch/Lot Number: FD7958) as dose 2, 0.3 ml single (at the age of 54 years) for covid-19 immunisation. The patient''s medical history included osteoporosis and psoriatic arthritis from an unknown date and unknown if ongoing. There were no concomitant medications. The patient received the first dose of COMIRNATY on 11May2021 at dose 1, 0.3mL, single for Covid-19 vaccination. The patient experienced immunization reaction on 23Jun2021 with outcome of not recovered (at the time of patient''s death). On 06Jul2021, the patient experienced dyspnea. The outcome of the event dyspnea was fatal as the patient died on 06Jul2021. It was not reported if an autopsy was performed. Relatedness of drug to reaction(s)/event(s) (Dyspnoea) Source of assessment: RA Result of Assessment: D. Unclassifiable Drug-reaction(s) / Event(s) Matrix Relatedness of drug to reaction(s)/event(s) (Immunization reaction) Source of assessment: RA Result of Assessment: A. Consistent causal association to immunization No follow-up attempts are possible; information about batch number already obtained; Reported Cause(s) of Death: dyspnoea


VAERS ID: 1506701 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-20
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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: 2021-06-20
   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 INC2021882982

Write-up: Lung embolism; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority, regulatory authority number DE-PEI-CADR2021129665, Safety Report Unique Identifier DE-PEI-202100126981. A 57-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 10Jun2021 (Batch/Lot Number: Unknown) as DOSE 2, 0.3 ML SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced lung embolism (resulted in death) on 20Jun2021. The patient died on 20Jun2021. An autopsy was not performed. Sender comment: Are you or the person concerned known of any allergies? If yes, which? not known Information on risk factors or previous illnesses not known / pulmonary embolism, 10 days after vaccination. 90 minute resuscitation. Event assessment: Comirnaty/ event/PEI /Result of Assessment: D. Unclassifiable. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Lung embolism


VAERS ID: 1506711 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

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: DEPFIZER INC2021891174

Write-up: sudden cardiac death; This is a spontaneous report received from a contactable physician by Pfizer from Biontech (manufacturer control number: 73194), license party for bnt162b2 (COMIRNATY). A female patient of an unspecified age received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced sudden cardiac death, the event resulted in hospitalization, patient died 2 weeks after first bnt162b2 dose in a clinic. The patient died on an unspecified date. It was unknown if an autopsy was performed. According to the reporting physician, causality was unrelated. 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 and the suspect drug 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: sudden cardiac death


VAERS ID: 1506712 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-05
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal death, 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: 2021-06-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021892163

Write-up: exposure during pregnancy; baby died after 2nd vaccination; This is a spontaneous report from a contactable consumer (parent). This consumer reported information for both mother and fetus, this is the fetus report. The first dose of mother case is received by Pfizer from Biontech (manufacturer control number: 73312]), license party for Comirnaty. An unspecified age female mother received bnt162b2 (COMIRNATY), dose 1 on an unspecified date (Batch/Lot number was not reported) via an unspecified route of administration on an unknown date as DOSE 1, SINGLE, via an unspecified route of administration on 03Jun2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The Fetus experienced exposure during pregnancy on an unspecified date, baby died after 2nd vaccination on 05Jun2021. The Fetus died on 05Jun2021. 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: Linked Report(s) : DE-PFIZER INC-2021892004 mother case first dose;DE-PFIZER INC-2021890779 mother case second dose; Reported Cause(s) of Death: baby died after 2nd vaccination; exposure during pregnancy


VAERS ID: 1506713 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Interchange of vaccine products, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021892586

Write-up: Lung embolism; 1. Dose VAXZEVRIA followed by COMIRNATY as second vaccination; This is a spontaneous report received by Pfizer from Biontech (manufacturer control number: not provided), license party for bnt162b2 (COMIRNATY). A approximately 50-years-old female 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; covid-19 vaccine nrvv ad (chadox1 ncov-19) (VAXZEVRIA Astra Zeneca), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient received first dose of VAXZEVRIA and following dose of COMIRNATY, experienced Lung embolism and died due to it in hospital on an unknown date. The patient died on an unspecified date. It was not reported if an autopsy was performed. Information about Batch/Lot number has been requested.; Reported Cause(s) of Death: Lung embolism


VAERS ID: 1506787 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-09
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Drug level, Pulmonary embolism, Status epilepticus
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Embolic and thrombotic events, venous (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLOZAPINE
Current Illness: Psychotic disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210609; Test Name: drug level of clozapine; Result Unstructured Data: Test Result:3330 ug/L; Comments: increase in drug level of clozapine in tox. range (3330 ug / L)
CDC Split Type: DEPFIZER INC2021882749

Write-up: Status epilepticus, increase in drug level of clozapine in toxicology range (3330 ug / L); fulminant pulmonary embolism; This is a spontaneous report received from a non-contactable consumer downloaded from the Regulatory Authority, regulatory authority number DE-PEI-CADR2021130367 and Safety Report Unique Identifier DE-PEI-202100128971. A 59-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 31May2021 (Lot Number: Unknown) as dose 2, single for COVID-19 immunization. Medical history included ongoing psychotic disorder. Concomitant medication included clozapine taken for psychosis. On 09Jun2021 the patient experienced status epilepticus and fulminant pulmonary embolism. The patient underwent laboratory test which included: increase in drug level of clozapine in tox. range (3330 ug / L) on 09Jun2021. The patient''s outcome was fatal. The patient died on 09Jun2021. Cause of death were status epilepticus and fulminant pulmonary embolism. An autopsy was not performed. Senders comment: Do you or the person concerned have any known allergies? If yes, which? no, information about known risk factors or pre-existing conditions, psychosis, treatment with clozapine No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Status epilepticus; fulminant pulmonary embolism


VAERS ID: 1507120 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-16
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100923112

Write-up: DVT of legs; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107191138112760-HBQPF, GB-MHRA-ADR 25672169. A 46-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW3143) via an unspecified route of administration on 04Jun2021 as DOSE 1, SINGLE for COVID-19 immunisation. Unsure if patient has had symptoms associated with COVID-19. Not had a COVID-19 test. The patient''s medical history and concomitant medications were not reported. On 16Jun2021, the patient experienced dvt of legs. Additional information: Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Suspect Reactions- Details of any relevant investigations or tests conducted: Post mortem on an unspecified date. The patient died on 16Jun202. The outcome of he event dvt of legs was fatal. An autopsy was performed and results were not provided. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: DVT of legs


VAERS ID: 1507229 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-07-02
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0785 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Chest X-ray, Death, Dyspnoea, Inflammation scan, Inflammatory marker increased, Pneumonia, Pyrexia, Renal function test, Renal impairment, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-03
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: VALSACOR; SYNCUMAR; CONCOR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anemia; CLL; DVT; Dyslipidaemia; Hepatic cyst; Hypertension; Pneumonia
Allergies:
Diagnostic Lab Data: Test Date: 20210702; Test Name: Chest X-ray; Result Unstructured Data: Test Result:pneumonia; Test Date: 20210702; Test Name: inflammatory parameters; Result Unstructured Data: Test Result:elevated; Test Date: 20210702; Test Name: kidney function; Result Unstructured Data: Test Result:narrowed kidney function; Test Date: 20210702; Test Name: COVID-19 antigen test; Test Result: Negative
CDC Split Type: HUPFIZER INC2021887208

Write-up: fever; breathing difficulties; pneumonia; elevated inflammatory parameters; narrowed kidney function; Death; sudden asystole; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority HU-OGYI-609421. A 73-year-old female patient received BNT162B2 (COMIRNATY), 1st dose intramuscularly, administered in Arm Left on 10Jun2021 (Batch/Lot Number: FD0785, expiration date not provided) as 0.3ml, a single dose for covid-19 immunisation. Medical history included dyslipidaemia, hepatic cyst, hypertension, anaemia, chronic lymphocytic leukaemia (CLL), pneumonia, all from an unknown date and unknown if ongoing, deep vein thrombosis from 2002 to an unknown date. Concomitant medications included valsartan (VALSACOR); acenocoumarol (SYNCUMAR); bisoprolol fumarate (CONCOR). The patient experienced death on 03Jul2021 02:15, sudden asystole on 03Jul2021 with fatal outcome, fever on 02Jul2021 with outcome of unknown, breathing difficulties on 02Jul2021 with outcome of unknown, pneumonia on 02Jul2021 with outcome of unknown, elevated inflammatory parameters on 02Jul2021 with outcome of unknown, narrowed kidney function on 02Jul2021 with outcome of unknown. The patient was hospitalized for fever, breathing difficulties, pneumonia, elevated inflammatory parameters, narrowed kidney function, all from 02Jul2021 to an unknown date. The patient underwent lab tests and procedures which included chest x-ray: pneumonia, inflammatory parameters: elevated, kidney function: narrowed kidney function, COVID-19 antigen test: negative, all on 02Jul2021. Therapeutic measures were taken as a result of fever, breathing difficulties, pneumonia, elevated inflammatory parameters, narrowed kidney function. The patient died on 03Jul2021. An autopsy was performed and results were not provided. Clinical course: This spontaneous, serious, medically confirmed case was reported on 05Jul2021 by a physician and concerns the occurrence of death after COMIRNATY injection for active immunization to prevent COVID-19. On 10Jun2021 the 73-years-old female patient received the first dose of 0.3 ml COMIRNATY concentrate for dispersion for injection (tozinameran (COVID-19 mRNA Vaccine embedded in lipid nanoparticles), batch number: FD0785, expiry date: unknown, MAH: BioNTech Manufacturing GmbH/Pfizer) intramuscularly in the left arm to prevent Covid-19. The patient was hospitalized on 02Jul2021 because of fever and breathing difficulties. Covid-19 antigen test was negative. Chest X-ray showed pneumonia. Laboratory result showed elevated inflammatory parameters and narrowed kidney function. The patient received antibiotic therapy, but her condition progressed and had to be intubated. On 03Jul2021 sudden asystole occurred and after an unsuccessful reanimation, the patient passed away at 02:15. Medical history included chronic lymphocytic leukemia, DVT, hepatic cyst, hypertension and dyslipidemia. Concomitant drugs were Concor (bisoprolol), Valsacor (valsartan) and Syncumar (acenocumarol). Further information is not expected. Senders comment: The reporter physician assessed the event as related to the patient''s primary diseases (CLL), therefore the causal relationship is unlikely between the suspected rug and the adverse event. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: unknown cause of death; sudden asystole


VAERS ID: 1507230 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-05
Onset:2021-04-22
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal neoplasm, Deep vein thrombosis, Imaging procedure, SARS-CoV-2 test
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Non-haematological tumours of unspecified malignancy (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atherosclerosis (coronary arteries); Chronic obstructive pulmonary disease; COVID-19; Endometrial adenocarcinoma; Hypertension; Metastases to liver; Myocardial fibrosis
Allergies:
Diagnostic Lab Data: Test Date: 20210422; Test Name: Imaging procedure; Result Unstructured Data: Test Result:spreading deep vein thrombosis, abdominal space-oc; Comments: spreading deep vein thrombosis, abdominal space-occupying lesion, associated with hepatic secunderity; Test Date: 20210422; Test Name: COVID-19 antigen test; Test Result: Negative
CDC Split Type: HUPFIZER INC202100927853

Write-up: deep vein thrombosis of left thigh; abdominal bulking process/abdominal space-occupying lesion; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number HU-OGYI-650321. An 82-year-old female patient received bnt162b2 (COMIRNATY), Solution for injection, Lot number: EW2239 and Expiry date: Unknown), via an dose 1 intramuscular, administered in Arm Left on 05Apr2021 as DOSE 1, 0.3 ML, SINGLE for Covid-19 immunization. Medical history included hypertension from 2015 to an unknown date, covid-19 from Nov2020 to an unknown date, endometrial adenocarcinoma, hepatic metastasis, chronic obstructive pulmonary disease, myocardial fibrosis from an unknown date and unknown if ongoing, atherosclerosis of coronary arteries. The patient''s concomitant medications were not reported. On 22Apr2021 the patient got hospitalized due to spreading deep vein thrombosis and abdominal space-occupying lesion associated with hepatic secondarity confirmed by unspecified imaging procedures. COVID-19 antigen test was negative. Swelling of the left leg was noticed by the patient 4 days before, she experienced bloody urine occasionally for 2 months, and pain in hypochondria and dorsal regions. Due to the initiated anticoagulant treatment, the circulatory conditions of the thrombotic lower limb improved, and its tension and swelling decreased. No further examinations were performed due to the general condition of the patient. The patients condition gradually progressed and she died on 01May2021 at 23:40. Autopsy was performed, the cause of death was pulmonary embolism from deep vein thrombosis of the left thigh. Underlying diseases were endometrial adenocarcinoma with hepatic metastasis, chronic obstructive pulmonary disease, atherosclerosis of coronary arteries and myocardial fibrosis. Outcome of events was fatal. Senders comment: Deep vein thrombosis of leg and abdominal neoplasm occurred after 17 days, and the patient died 26 days after the first dose of Comirnaty. Based on autopsy results, the causal relationship between the event and Comirnaty is considered unlikely. The case is serious due to hospitalization and fatal outcome. No follow-up attempts possible. No further information expected. Information about batch number has been obtained. ; Autopsy-determined Cause(s) of Death: Pulmonary embolism


VAERS ID: 1507247 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-16
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2243 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: General physical health deterioration, Hepatic failure, Vomiting
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-19
   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: HYLO-FORTE; RIVOTRIL; ZIMOVANE; TYLEX [PARACETAMOL]; SPIRIVA; ATORVASTATIN; ASPIRIN [ACETYLSALICYLIC ACID]; COMBIVENT; PROTIUM [PANTOPRAZOLE SODIUM SESQUIHYDRATE]; EFEXOR XL; BISOPROLOL; RELVAR ELLIPTA [FLUTICASONE FUROATE;VILANTEROL TRIFEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; IHD; Left ventricular dysfunction (Mildly impaired LV function)
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021883167

Write-up: DIED OF LIVER FAILURE; VOMITING; SUBSEQUENTLY DETERIORATED AND ADMITTED TO HOSPITAL; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. This is a report received from the Regulatory Authority, Regulatory authority report number IE-HPRA-2021-078272. A 72-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 09Apr2021 (Batch/Lot Number: EW2243) as single dose for covid-19 immunisation. Medical history included depression, left ventricular dysfunction (Mildly impaired LV function), IHD. Concomitant medications included hyaluronate sodium (HYLO-FORTE); clonazepam (RIVOTRIL); zopiclone (ZIMOVANE); paracetamol (TYLEX [PARACETAMOL]); tiotropium bromide (SPIRIVA); atorvastatin; aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); ipratropium bromide, salbutamol sulfate (COMBIVENT); pantoprazole sodium sesquihydrate (PROTIUM [PANTOPRAZOLE SODIUM SESQUIHYDRATE]); venlafaxine hydrochloride (EFEXOR XL) taken for depression; bisoprolol; fluticasone furoate, vilanterol trifenatate (RELVAR ELLIPTA [FLUTICASONE FUROATE;VILANTEROL TRIFENATATE]); mirtazapine. On 16Apr2021, the patient experienced vomiting. Subsequently, the patient''s health deteriorated and she was admitted to hospital, It was unknown if any treatment was administered. On 19Apr2021, the reporter was informed that the patient had died of liver failure in hospital. It was not reported if an autopsy was performed. The case was reported as serious with seriousness criteria of death, medically significant. No follow-up attempts are possible. No further information expected. ; Reported Cause(s) of Death: Vomiting; General physical health deterioration; Liver failure


VAERS ID: 1507258 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Illness, Road traffic accident
SMQs:, Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-24
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: ITJNJFOC20210754119

Write-up: SUDDEN ILLNESS; MOTOR VEHICLE ACCIDENT; This spontaneous report received from a patient via a company representative concerned a 33 year old male of unknown 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 admin not reported, batch number: Unknown expiry Unknown) frequency 1 total dose, for prophylactic vaccination on an unspecified date around one and half month ago prior reporting. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 24-JUL-2021 the patient died while driving a bus for a sudden illness. The driver had been vaccinated, causing an accident that resulted in the injury of several people and the death of the driver himself. Post-mortem examinations were underway to determine whether the accident occurred due to the driver being sick or for other reasons. 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: 20210754119--Sudden illness, motor vehicle accident. 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: SUDDEN ILLNESS; MOTOR VEHICLE ACCIDENT


VAERS ID: 1507272 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2625 / 1 LA / OT

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:
Preexisting Conditions: Medical History/Concurrent Conditions: Bullous dermatitis; Cardiac assistance device user; Chronic atrial fibrillation; Chronic obstructive pulmonary disease; Heart failure (medium-grade); Myocardial ischaemia; Obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202100926945

Write-up: After the first dose: death in a patient with severe heart failure chronic atrial fibrillation, carrier of pacemaker, pulmonary edema; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority. The regulatory authority report number is IT-MINISAL02-755525. A 82-years-old elderly male patient received first dose of BNT162b2 (COMIRNATY, Solution for Injection, Batch/Lot Number: FE2625) via intramuscular route of administration, administered in Deltoid Left on 30Jun2021 as Dose 1, 30 ug, Single for COVID-19 immunization. Medical history included chronic ischemic heart disease and a pacemaker carrier with medium-grade heart failure, chronic atrial fibrillation, bullous dermatitis, obesity, chronic obstructive pulmonary disease with oxygen use. The patient''s concomitant medications were not reported. The patient experienced after the first dose: death in a patient with severe heart failure chronic atrial fibrillation, carrier of pacemaker, pulmonary edema on 01Jul2021. The events assessed as serious (death). The patient died on 01Jul2021. It was not reported if an autopsy was performed. The outcome of the event was reported as fatal. No follow-up attempts possible. No further information expected. Information on lot number already obtained.; Reported Cause(s) of Death: Unknown


VAERS ID: 1507281 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2707 / 1 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Agitation, Body temperature, Death, Overdose, Pyrexia, SARS-CoV-2 test, Somnolence, Tachypnoea
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Drug abuse and dependence (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-14
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TRITTICO; FUROSEMIDE; TAMSULOSIN HYDROCHLORIDE; LISINOPRIL; ESCITALOPRAM OXALATE; BISOPROLOL FUMARATE; CARDIOASPIRIN; BROMAZEPAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure; COPD; COVID-19; Dementia
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: body temperature; Result Unstructured Data: Test Result:38.5 Centigrade; Test Date: 20210211; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:unknown results
CDC Split Type: ITPFIZER INC202100926754

Write-up: Agitated patient, 38.5 degree C, breathing with difficulty; drowsy; tachypnoea, not tachycardic; death in the morning;; Agitated patient, 38.5 degree C, breathing with difficulty; drowsy; tachypnoea, not tachycardic; death in the morning;; Agitated patient, 38.5 degree C, breathing with difficulty; drowsy; tachypnoea, not tachycardic; death in the morning;; Agitated patient, 38.5 degree C, breathing with difficulty; drowsy; tachypnoea, not tachycardic; death in the morning;; Agitated patient, 38.5 degree C, breathing with difficulty; drowsy; tachypnoea, not tachycardic; death in the morning;; VACCINE COVID 19 COMIRNATY (PFIZER) 195FL 0.45ML; This is a spontaneous report downloaded from the Regulatory Authority, regulatory authority number IT-MINISAL02-758106. A contactable physician reported that a 92-year-old male patient received first dose of BNT162b2 (COMIRNATY, solution for injection), via an unspecified route of administration in right arm on 13Jul2021 at 11:50 (Batch/Lot Number: FE2707; Expiration Date: 31Oct2021) at a dose of 0.45 ml as single dose for COVID-19 immunization. The patient''s medical history included dementia, chronic obstructive pulmonary disease, cardiac failure, the patient had COVID-19 infection earlier from an unknown date. The patient''s cause of death was reported as pulmonary embolism. The patient''s concomitant medications included trazodone hydrochloride (TRITTICO), furosemide, tamsulosin hydrochloride, lisinopril, escitalopram oxalate, bisoprolol fumarate, acetylsalicylic acid (CARDIOASPIRIN), bromazepam taken for an unspecified indication, start and stop date were not reported. On 13Jul2021, the patient received VACCINE COVID 19 COMIRNATY (PFIZER) 195FL 0.45ML which was an overdose, the next day, on 14Jul2021, the patient experienced initially agitated (patient was woken up by his son) patient said that he was dying, after temperature measurement 38.5 Celsius degrees, medical examination at about 9:30, drowsy (reacted if called loudly), tachypnoea, after perioral pallor, not tachycardic, fast and unexpected worsening, breathing with difficulty and death in morning at 10:15. The patient was treated with Paracetamol 500mg and 1/2 Aspirin 500mg for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown results on 11Feb2021, body temperature shown 38.5 centigrade on 14Jul2021. The outcome of the events was fatal, and the patient died on 14Jul2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: pulmonary embolism


VAERS ID: 1507329 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0201 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Loss of consciousness, Respiratory arrest
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus (stable); Dialysis (3 times/week performed (Monday, Wednesday and Friday).); Heart disorder (stable); Myocardial infarction; Pacemaker generated rhythm; Renal failure (stable)
Allergies:
Diagnostic Lab Data: Test Date: 20210709; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021882381

Write-up: Respiratory arrest; Loss of consciousness; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21118996. An 83-year-old (also reported as 83-year and 7-month-old) male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 09Jul2021 (Batch/Lot Number: EW0201; Expiration Date: 30Sep2021) as dose 2, single for covid-19 immunisation. Medical history included stable renal failure, pacemaker, stable diabetes mellitus, stable heart disorder, dialysis 3 times/week performed (Monday, Wednesday and Friday) and myocardial infarction. The family history was not provided. The patient''s concomitant medications were not reported. The patient received first dose of bnt162b2 for covid-19 immunisation in 2021. Body temperature before vaccination was 36.2 degrees centigrade. On 10Jul2021 at 14:30 (one day/14 hours/30 minutes after the vaccination), the patient experienced respiratory arrest and loss of consciousness. On 10Jul2021 (one day after the vaccination), the patient was admitted to the hospital. On 10Jul2021 (one day after the vaccination), the outcome of the events was fatal. The course of the event was as follows: On 09Jul2021 (the day of vaccination), the patient received the second dose of bnt162b2 vaccination. On 10Jul2021, at around 12:00 (one day and 12 hours after vaccination), the patient normally spoke. At 14:30 (one day, 14 hours, and 30 minutes after vaccination), the patient had respiratory arrest and loss of consciousness (reported by the family). At 16:15 (one day, 16 hours, and 15 minutes after vaccination), the patient was confirmed died at the reporting hospital. The reporting physician classified the event as serious (hospitalization and death) and assessed that the event was related to bnt162b2. Other possible causes of the event such as any other diseases were myocardial infarction and others. The reporting physician commented as follows: although the patient had underlying diseases such as renal failure, diabetes mellitus, and heart disorder, they were stable. It was considered highly likely that the events were caused by the vaccination. The patient died on 10Jul2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Respiratory arrest; Loss of consciousness


VAERS ID: 1507330 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac death, Cardio-respiratory arrest, Gastroenteritis
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), Noninfectious diarrhoea (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-03
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210701; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021882389

Write-up: Cardio-respiratory arrest; Cardiac death acute; Acute gastroenteritis; This is a spontaneous report from a contactable healthcare professional received from the Regulatory Authority (Regulatory Authority report number: V21119598). The patient was a 64-year and 5-month-old female. Body temperature on 01Jul2021 (before vaccination) was 36.3 degrees Centigrade. The family history was not provided. The patient had medical history of ongoing diabetes mellitus. On an unspecified date in 2021, the patient previously received the first dose of BNT162B2 (COMIRNATY, Lot number and expiration date were not reported). On 01Jul2021 (the day of vaccination), the patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: FC3661; Expiration date: 30Sep2021) as dose 2, single, with route of administration unspecified, for COVID-19 immunization. On 01Jul2021 (the day of the vaccination), the patient experienced acute gastroenteritis. On 03Jul2021 (2 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 01Jul2021 (the day of vaccination), the patient received the second dose of BNT162B2 vaccination at the prefectural hospital. On the same day, in the evening, the patient had vomiting and diarrhoea. The patient was unable to visit the hospital, and she was followed up at her home. On 03Jul2021 (2 days after vaccination), the patient was found to have cardio-respiratory arrest, and she was emergently transferred to the reporting hospital. Although emergency medical care was performed, the patient''s life could not be saved. The direct causes of death were as follows: I a. cardiac death acute, b. diabetes mellitus, and II acute gastroenteritis. The patient died at 11:17 (2 days, 11 hours, and 17 minutes after vaccination). The reporting other healthcare professional classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as un-assessable. Other possible cause of the event such as any other diseases was as follows: The patient received the treatment of diabetes mellitus several years ago. At present, the patient was not visiting the hospital, and the disease condition of diabetes mellitus was unknown. The acute gastroenteritis was possibly caused by metabolic disorder such as ketoacidosis due to diabetes mellitus. Thus, it was un-assessable whether the event was affected by the vaccination or not. The reporting other healthcare professional commented as follows: The causality between acute gastroenteritis and the vaccination was unknown. The patient had underlying disease of untreated diabetes mellitus. It was considered that the general condition was aggravated due to acute gastroenteritis or diabetes-related metabolic disorder, which led to death.; Reported Cause(s) of Death: Cardiac death acute; Cardio-respiratory arrest; diabetes mellitus; acute gastroenteritis


VAERS ID: 1507338 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-07-02
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 LA / OT

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: 2021-07-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Renal failure chronic
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021882545

Write-up: Myocardial infarction suspected; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. A 70-year-old non-pregnant female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 24Jun2021 (Batch/Lot Number: Unknown) (at the age of 70 years) as DOSE 1, SINGLE for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unknown medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Medical history included angina pectoris, renal failure chronic; both from an unknown date and unknown if ongoing. There were unspecified concomitant medications. The patient experienced myocardial infarction suspected (resulted in death) on 02Jul2021. The patient died on 02Jul2021. An autopsy was not performed. On 02Jul2021 (8 days after the vaccination), the patient experienced myocardial infarction suspected. The event resulted in death. The outcome of the event was fatal without treatment. No autopsy was performed. The reported event was as follows: On 02Jul2021 (8 days after vaccination), the patient died. Since the vaccination, the patient has not been tested for COVID-19. The reporting physician assessed the event as serious (death). The causality between the event and BNT162b2 vaccination was not provided. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the information currently available, a causal association between the reported event myocardial infarction and BNT162B2 cannot be fully excluded. Case will be reassessed when additional 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 RAs, Ethics Committees, and investigators, as appropriate. ; Reported Cause(s) of Death: Myocardial infarction suspected


VAERS ID: 1507351 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0572 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BAYASPIRIN; ADALAT CR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Late effects of cerebral infarction
Allergies:
Diagnostic Lab Data: Test Date: 20210709; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021883438

Write-up: Cardiac failure acute; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21119033. A 73-year-old male patient received second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 09Jul2021 11:00 (Lot Number: EY0572; Expiration Date: 31Oct2021) as single dose for covid-19 immunisation. Medical history included hypertension and late effects of cerebral infarction. Concomitant medications included acetylsalicylic acid (BAYASPIRIN) and nifedipine (ADALAT CR). The patient previously took first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on unspecified date as single dose for covid-19 immunisation. Body temperature before vaccination on 09Jul2021 was 36.4 degrees centigrade. On 10Jul2021 presumably around 02:00 (1 day after the vaccination), the patient experienced cardiac failure acute. The course of the events was as follows: The patient who was living alone experienced sudden death. On 09Jul2021 at 18:00 (7 hours after the vaccination), the patient was talking on the phone as usual. On 10Jul2021 at 08:00 (1 day after the vaccination), the caregiver found the patient lying on the bed. The patient was already in state of cardio-respiratory arrest. Cardiac failure acute was considered based on the autopsy results. On 10Jul2021 (1 day after the vaccination), the outcome of the event was fatal. The patient died. Autopsy was done. The reporting physician classified the events as serious (death) and assessed the causality between the events and BNT162b2 as unassessable. There was no other possible cause of the events such as any other diseases. The reporting physician commented as follows: There were regular hospital visits for hypertension and late effects of cerebral infarction. Although symptoms of stroke were absent and death due to cardiac failure was considered, it was unknown whether the event was attributable to the vaccine.; Autopsy-determined Cause(s) of Death: Cardiac failure acute


VAERS ID: 1507376 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-11
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0572 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Death, Feeling abnormal, Malaise
SMQs:, Dementia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetic nephropathy
Preexisting Conditions: Medical History/Concurrent Conditions: Haemodialysis (three times a week (Tuesday, Thursday, Saturday))
Allergies:
Diagnostic Lab Data: Test Date: 20210612; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before the first vaccination; Test Date: 20210703; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before the second vaccination
CDC Split Type: JPPFIZER INC2021887954

Write-up: The patient was lying down at home; not feeling well; The patient felt poorly while bathing at the large public bathhouse; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is V21119106. The patient was a 65-year-old female. Body temperature was 36.3 degrees centigrade before the first vaccination and 36.7 before the second vaccination. On 03Jul2021 at 12:00 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0572, Expiration date 31Oct2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. The patient had no family history. Medical history included haemodialysis three times a week (Tuesday, Thursday, Saturday) and diabetic renal failure. Concomitant medications were not reported. On 12Jun2021 at 12:00, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number FC3661, Expiration date 30Sep2021) for COVID-19 immunisation. On 11Jul2021 (8 days after the vaccination), the patient felt poorly while bathing at the large public bathhouse. On 12Jul2021 around 16:00 (9 days after the vaccination), the patient was lying down at home; the outcome of this event was fatal. The course of the events was as follows: No significant changes were noted at both vaccinations. The patient was on haemodialysis three times a week (Tuesday, Thursday, Saturday). On 10Jun2021 (7 days after the vaccination), no remarkable changes were noted. On 11Jul2021 (8 days after the vaccination), the patient felt poorly while bathing at the large public bathhouse and was transported by ambulance to a Medical Center. After an intravenous drip, the symptom slightly improved, and the patient went home. On 12Jul2021 in the morning (9 days after the vaccination), the patient was not feeling well. In the afternoon, she was found lying down at home. At 16:00, the patient was carried to another Emergency & Critical Care Medical Center and was confirmed dead. The death cause was reportedly unknown. The outcome of events feels poorly and feeling unwell was recovering. The patient died on 12Jul2021 with unknown cause. It was unknown if an autopsy was performed. The reporting physician classified the event (the patient was lying down at home) as serious (death) and assessed the causality between the event (the patient was lying down at home) and BNT162b2 as un-assessable. The seriousness and causality of the other event were not reported. Other possible causes of the events such as any other diseases were present (details was not reported). The reporting physician commented as follows: The patient was on maintenance dialysis for diabetic renal failure and the sudden change while bathing became the trigger, but detailed information was not available at the reporting clinic.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1507379 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-10
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Disease recurrence, Pneumonia aspiration
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-11
   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: Hospitalisation; Neurological disorder NOS (underling disease of intractable neurological disease)
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to antibiotic; Pneumonia aspiration; Progressive supranuclear palsy
Allergies:
Diagnostic Lab Data: Test Date: 20210702; Test Name: body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021887958

Write-up: Pneumonia aspiration; Pneumonia aspiration; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21119607. The patient was a 66-year-old male. Body temperature before vaccination was 36.1 degrees centigrade on 02Jul2021. The family history was unknown. The patient had medical histories of allergy to penicillin drug, pneumonia aspiration, and progressive supranuclear palsy. On 02Jul2021 at 14:10 (the day of vaccination, at an unspecified age), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5420, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 10Jul2021 (8 days/9 hours/50 minutes after the vaccination), the patient experienced pneumonia aspiration. On 07Aug2020 (before the vaccination), the patient was admitted to the hospital. On 11Jul2021 (9 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 02Jul2021 (the day of vaccination), at 14:10, when the patient received the first dose of BNT162b2 vaccination, the patient had no particular pyrexia, or no anaphylactic symptoms. On 10Jul2021 (8 days, 9 hours, and 50 minutes after vaccination), the patient experienced pneumonia aspiration, and an antibacterial drug and oxygen were used; however, no improvement was observed. On 11Jul2021 (9 days, 9 hours, and 50 minutes after vaccination), the patient was discharged dead. The reporting physician classified the event as serious (hospitalization and 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 as follows: The patient originally often had pneumonia aspiration due to progressive supranuclear palsy. The reporting physician commented as follows: The hospitalized patients who had an underling disease of intractable neurological disease inevitably had pneumonia aspiration. An accumulation of knowledge on the vaccination in those patients in the future was expected. It was unknown if the autopsy was performed.; Reported Cause(s) of Death: Pneumonia aspiration; Pneumonia aspiration


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