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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: 1517311 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-07-15
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0201 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Brain natriuretic peptide, Cerebral haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-17
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MEMARY; TAKELDA; DIGOXIN; FUROSEMIDE; FUROSEMIDE; SPIRONOLACTONE; NEUQUINON; JUVELA N; AMITIZA; ELIQUIS; FERROMIA; METOANA; FEBURIC; SENNOSIDE A+B CALCIUM; BROTIZOLAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac failure chronic; Diabetes mellitus; Mitral valve insufficiency; Oedema lower limb; Tricuspid valve disease
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:The usual systolic blood pressure was 100 to 120,; Comments: and the usual diastolic blood pressure was 50 to 70; Test Name: BNP level; Result Unstructured Data: Test Result:had improved with adjustment of medications
CDC Split Type: JPPFIZER INC202100911349

Write-up: Intra-cerebral haemorrhage; This is a spontaneous report from a contactable other healthcare professional received via COVID-19 Adverse Event Self-Reporting Solution. A non-pregnant 91-year-old female patient received bnt162b2 (COMIRNATY), intramuscular administered in left arm on 29Jun2021 13:30 (Batch/Lot Number: EW0201; Expiration Date: 30Sep2021) (at the age of 91-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Medical history included cardiac failure chronic, oedema both lower limbs, diabetes mellitus, mitral valve insufficiency, tricuspid insufficiency, and atrial fibrillation. Concomitant medications included memantine hydrochloride (MEMARY); acetylsalicylic acid, lansoprazole (TAKELDA); digoxin; furosemide 40 mg; furosemide 20 mg; spironolactone; ubidecarenone (NEUQUINON); tocopheryl nicotinate (JUVELA N); lubiprostone (AMITIZA); apixaban (ELIQUIS); ferrous sodium citrate (FERROMIA); anagliptin, metformin hydrochloride (METOANA); febuxostat (FEBURIC); and sennoside a+b calcium; brotizolam. Historical vaccine includes first dose of bnt162b2 (COMIRNATY, Lot# EY0779, Expiration date 31Aug2021) (at the age of 91-year-old) via intramuscular route of administration in the arm right for COVID-19 immunization. On 15Jul2021 (16 days after the vaccination), the patient experienced intra-cerebral haemorrhage. The event resulted in hospitalization (duration of hospitalization was 3 days). The outcome of the event was fatal. The reporter classified the event as serious (hospitalization and death). The patient died on 17Jul2021. The cause of death was reported as cerebral haemorrhage. It was unknown if an autopsy was performed. Since the vaccination, the patient has not been tested for COVID-19. The course of the event was reported as follows: The patient had been receiving treatment for cardiac failure chronic and oedema both lower limbs. The BNP level, wheezing on exertion, and oedema lower limbs had improved with adjustment of medications, and course was stable. The usual systolic blood pressure was 100 to 120, and the usual diastolic blood pressure was 50 to 70, and the patient did not use an antihypertensive drug. On 15Jul2021 (16 days after the vaccination), in the afternoon, the patient started to have headache, and she took oral acetaminophen (CALONAL). The patient had supper and was active. However, before dawn, the patient had depressed level of consciousness from delirium-like movement, and did not respond to a call. The patient was emergently transferred to the hospital. The patient was diagnosed with intra-cerebral haemorrhage. On 17Jul2021 (18 days after vaccination), the patient died at the hospital where she was transferred to.; Reported Cause(s) of Death: Intra-cerebral haemorrhage


VAERS ID: 1517312 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-16
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ECARD LD; CADUET
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Osteoarthritis
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100911430

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 84-year-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received candesartan cilexetil hydrochlorothiazide and amlodipine besilate, atorvastatin calcium hydrate (CADUET 3) within 2 weeks of vaccination and still ongoing. 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 osteoarthritis and hypertension. On 22Jun2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# FA5765, Expiration date 30Sep2021) at the age of 84 years old. On 13Jul2021 at 10:30 (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA5765, Expiration date 30Sep2021) (at the age of 84 years old) via intramuscular route of administration in the arm left for COVID-19 immunization. On 16Jul2021 (2 days/13 hours/30 minutes after the vaccination), the patient experienced death. The event resulted in emergency room/department or urgent care, and 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: Unknown. The reported event was as follows: On 16Jul2021 (2 days/13 hours/30 minutes after the second dose of the vaccination), in the morning, the patient was confirmed to have died. An autopsy was performed by the police but results were not available.; Sender''s Comments: The reported event of death with unknown cause is considered as related due to lack of information. The company processes "death cause unknown" cases as possibly related and documents them as related in the global safety database unless information is provided that allows the Company to exclude that there is a reasonable possibility of relatedness to the suspect product. The case will be reassessed once more information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Death


VAERS ID: 1517314 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Shock
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)

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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100911620

Write-up: Shock; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21120701. A 70-year-old male patient (70-year and 5-month-old male) received the second dose of bnt162b2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration on 17Jul2021 (received at the age of 70-years-old) as DOSE 2, SINGLE for COVID-19 immunisation. The family history was not provided. 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). Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (COMIRNATY, Batch/Lot number was not reported) on an unknown date in 2021 for COVID-19 immunisation. On 17Jul2021 at 13:00, the patient experienced shock. The course of the event was as follows: On 17Jul2021 (the day of vaccination), the patient was found to collapse in the garden of his home by his neighbor, and an ambulance was called. When the ambulance service arrived, the neighbor was performing chest compression. The patient had skin warm. At 14:02, the patient was emergently transferred to the reporting hospital. Although resuscitation was tried, no response was obtained, and the patient was confirmed to die at 14:17. The patient died on 17Jul2021 14:17. The family wished the investigation of the cause of death. On 18Jul2021 (one day after vaccination), an autopsy was performed. An inquest was performed by the police, and the postmortem certificate was made. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: The autopsy showed that macroscopic organic disease which led to death was unknown. The death due to shock was definite. It was concluded that the causality between the event and BNT162b2 vaccination could not be ruled out. Information on batch number has been requested.; Reported Cause(s) of Death: Shock


VAERS ID: 1517316 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-12
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic dissection, Body temperature, Fall, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

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: SELECTOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Glomerulonephritis chronic; Hypertension; Pollinosis
Allergies:
Diagnostic Lab Data: Test Date: 20210709; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202100911744

Write-up: Acute aortic dissection; lost consciousness and fell down; lost consciousness and fell down; This is a spontaneous report from a contactable physician received from the regulatory authority. The Regulatory authority report number is v21120220.?? A 70-year-old and 4-months female patient received bnt162b2 (COMIRNATY, Solution for injection, Lot number FC3661, Expiration date 30Sep2021), via an unspecified route of administration in the left arm (also reported as left shoulder) on 09Jul2021 10:10 (the day of vaccination, at the age of 70-year-old) as dose 2, single for COVID-19 immunization. Medical history included chronic glomerulonephritis, hypertension, and pollinosis. Concomitant medication included celiprolol hydrochloride (SELECTOL) taken for an unspecified indication from 09Jul2021 10:10 and ongoing. On 18Jun2021 at 10:05, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot no.: FA2453, Expiration date: 31Aug2021) at single dose for COVID-19 immunization. On 12Jul2021 at 10:10 (3 days after the vaccination), the patient experienced acute aortic dissection. On 12Jul2021 (3 days after the vaccination), the outcome of the event was death. The course of the event was as follows: On 09Jul2021, the patient received BNT162b2 on the left shoulder. No particular problem was seen during 30-minute observation period, and the patient went back home. On 10Jul2021 and 11Jul2021, no change was noted in the patient''s physical conditions, and she spent time as usual. On 12Jul2021, since the patient''s mother had to be seen by a doctor, the patient drove their car to hospital A. While the patient was present in the medical examination, she suddenly lost consciousness and fell down. Cardiopulmonary resuscitation was immediately performed, but the heart beat did not reappear and the patient died. Information was obtained from the patient''s oldest daughter about the patient''s conditions after going back home on 09Jul2021. Information was also obtained from the document prepared by hospital A about the patient''s conditions after developing the event. The patient underwent lab tests and procedures which included Body temperature before vaccination on 09Jul2021 was 36.6 degrees centigrade. Therapeutic measure was taken as a result of the events. The patient died on 12Jul2021. Cause of death included acute aortic dissection, lost consciousness and fell down. It was unknown if an autopsy was performed. The reporting physician classified the event as serious (death) and considered that the causality of the event to BNT162b2 was unassessable. The reporting physician did not mention other possible cause of the event such as any other diseases.; Reported Cause(s) of Death: Acute aortic dissection; lost consciousness and fell down; lost consciousness and fell down


VAERS ID: 1517325 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-07-14
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 1 LA / OT

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction; Diabetes mellitus; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100916260

Write-up: Acute myocardial infarction; This is a spontaneous report from a contactable physician received via COVID-19 Self-Reporting. The patient was a non-pregnant 83-year-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient received any other 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. Other medical history included cerebral infarction, hypertension, and diabetes mellitus. On 29Jun2021 at 14:15 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC5947, Expiration date 30Sep2021) intramuscular in the arm left for COVID-19 immunization. On 14Jul2021 at 01:00 (14 days 10 hours 45 minutes after the vaccination), the patient experienced acute myocardial infarction. The event resulted in life-threatening and death. The outcome of the event was fatal with treatment including coronary angiography and catheter intervention. Since the vaccination, the patient has not been tested for COVID-19. The reporting physician classified the event as serious (death and life-threatening). Sender''s Comments: The event acute myocardial infarction is considered not related to BNT162B2. The event is more likely an intercurrent medical condition for this elderly patient with underlying cerebral infarction, hypertension, and diabetes. 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, Ethics Committees and Investigators, as appropriate. Reported Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1517326 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0207 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Cardiac failure acute, Decreased appetite, Malaise, Vomiting
SMQs:, Cardiac failure (narrow), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Hypertension; Interstitial pneumonia; Pneumonia
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100916884

Write-up: Cardiac failure acute; general malaise; low back pain; inappetence; vomiting; This is a spontaneous report from a contactable physician received via COVID-19 Self-Reporting. The patient was a 95-year-old male. On 13Jul2021 at 13:45 (at the age of 95 years old) (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EW0207, Expiration date 30Sep2021) via intramuscular route of administration in the arm left as single dose for COVID-19 immunisation. Medical history included interstitial pneumonia, pneumonia, hypertension, and dementia. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received prescription drugs (details unknown) 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. The patient historical vaccine included, on 08Jun2021 at 13:45, the patient received the first dose of BNT162b2 (COMIRNATY, Lot# FA7338, Expiration date 30Sep2021) via intramuscular route of administration in the arm left for COVID-19 immunisation. On 14Jul2021 at 08:00 (18 hours/15 minutes after the vaccination), the patient experienced cardiac failure acute. The event resulted in death. The reported event was as follows: On 14Jul2021, the following day of the vaccination, the patient had low back pain, inappetence, vomiting, and general malaise, and house visit by a physician was requested. At the house visit by a physician, a drip infusion of fluid replacement was performed. Shortly after the completion of the drip infusion, the condition was aggravated, and the patient died. Therapeutic measures were taken as a result of events with treatment including a drip infusion of fluid replacement. Since the vaccination, the patient has not been tested for COVID-19. The physician office visit included for the events low back pain, inappetence, vomiting, and general malaise. The reporting physician assessed the events as serious (death). Autopsy was not performed. The outcome of the events was fatal. No follow-up attempts are possible. No further information is expected. Sender''s Comments: Based on available information, a possible contributory role of the subject product, Comirnaty vaccine, cannot be excluded for the reported events of Cardiac failure acute, low back pain, inappetence, vomiting, and general malaise. 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: Cardiac failure acute


VAERS ID: 1517328 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Bronchitis, Shock haemorrhagic
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hypovolaemic shock conditions (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-14
   Days after onset: 20
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:unknown; Comments: before vaccination; Test Date: 20210624; Test Name: fever/pyrexia; Result Unstructured Data: Test Result:low grade fever; Test Date: 20210714; Test Name: fever/pyrexia; Result Unstructured Data: Test Result:38; Comments: degrees
CDC Split Type: JPPFIZER INC202100917998

Write-up: Shock haemorrhagic; Bronchitis; This is a spontaneous report from a contactable postmortem physician received from the regulatory authority. Regulatory authority report number is v21120365. A 76-year and 8-month-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number FC3661, Expiration date 30Sep2021), via an unspecified route of administration on 24Jun2021 15:30 at the age of 76 years old as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient family history was unknown. It was unknown if there were any 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). Body temperature before vaccination was unknown. On 24Jun2021, the patient experienced bronchitis. On 14Jul2021 (twenty days after the vaccination), the patient experienced shock haemorrhagic; around at night, death. The course of the event was as follows: On 24Jun2021 (the day of the vaccination), after the vaccination, the patient started to have low grade fever. On 14Jul2021, the patient visited a local internal medicine doctor, was found pyrexia of 38 degrees, and was diagnosed as Bronchitis. After that, the patient died on 14Jul2021. On 16Jul2021, a postmortem was performed, and it was diagnosed as Shock haemorrhagic based on Pleural haemorrhage due to Aortic aneurysm rupture. Outcome of event bronchitis was unknown. The patient died on 14Jul2021. The reporting physician classified the event as serious (fatal) and assessed that the event was unrelated to BNT162b2. Other possible cause(s) of the event such as any other diseases was unknown. The reporting physician did not provide any further comment.; Sender''s Comments: Based on the available information there is not a reasonable possibility of a causal relation between the reported event" Shock haemorrhagic" and suspect drug BNT162B2.; Reported Cause(s) of Death: Shock haemorrhagic; Autopsy-determined Cause(s) of Death: Shock haemorrhagic; Pleural haemorrhage; Aortic aneurysm rupture


VAERS ID: 1517329 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-04
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0207 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, C-reactive protein, C-reactive protein increased, Cardiac arrest, Coma scale, Computerised tomogram, Foaming at mouth, Hypopnoea, Loss of consciousness, Osteomyelitis, Oxygen saturation, Pneumonia, Pyrexia, Unresponsive to stimuli
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), Convulsions (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Osteonecrosis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiac failure chronic; Renal failure (being treated with Dialysis at the time of vaccination)
Preexisting Conditions: Medical History/Concurrent Conditions: Dialysis
Allergies:
Diagnostic Lab Data: Test Date: 20210704; Test Name: BP; Result Unstructured Data: Test Result: 97/43 mmHg; Test Date: 20210702; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination; Test Date: 20210704; Test Name: body temperature; Result Unstructured Data: Test Result: 38.6 Centigrade; Test Date: 20210704; Test Name: JCS; Result Unstructured Data: Test Result: 3-300; Test Date: 20210704; Test Name: CT; Result Unstructured Data: Test Result: showed pneumonia image on the right lower lung; Test Date: 20210704; Test Name: CRP; Result Unstructured Data: Test Result: 472; Comments: unit illegible; Test Date: 20210704; Test Name: SpO2; Test Result: 93%; Comments: 8 L/m RM.
CDC Split Type: JPPFIZER INC202100918002

Write-up: Osteomyelitis of toes; foaming at the mouth; unconscious; pneumonia image on the right lower lung; no reaction to pain stimulation; body temperature was 38.6 degrees Celsius; blood pressure was 97/43 mmHg; shallow spontaneous respiration was observed.; mild increase of C-reactive protein to 472; Cardiac arrest; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The Regulatory authority report number is v21120290. The report was also received from a healthcare professional via a representative. An 86-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 02Jul2021 (Lot Number: EW0207; Expiration Date: 30Sep2021) as dose 2, single for COVID-19 immunisation. Medical history included ongoing cardiac failure chronic and ongoing renal failure (being treated with dialysis at the time of vaccination). Body temperature before vaccination was 36.6 degrees centigrade (02Jul2021). The patient family history was not provided. Heart disorder, renal disease, Dialysis at the time of vaccination, antithrombogenic drug were reported on the vaccine screening questionnaire. On an unknown date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# and Expiration date were not provided) for COVID-19 immunisation. On 02Jul2021 (the day of vaccination) at unspecified time in the afternoon, the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EW0207, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 04Jul2021 at 04:00 (two days after the vaccination), the patient experienced Other Reactions. On 04Jul2021 (two days after the vaccination), the patient was admitted to the hospital. On 04Jul2021 (two days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The patient was under the treatment for Cardiac failure chronic and Renal failure (Dialysis). On 04Jul2021 (two days after the vaccination) at 04:00, the family of the patient found the patient foaming at the mouth and being unconscious and called an ambulance. At 05:45, the patient was transferred to the hospital. On arrival, Scale was 3-300 (no reaction to pain stimulation), body temperature was 38.6 degrees Celsius, blood pressure was 97/43 mmHg, oxygen saturation (SpO2) was 93% (8 L/m RM), shallow spontaneous respiration was observed. Blood test showed mild increase of C-reactive protein to 472 (unit illegible), Computerised tomogram showed pneumonia image on the right lower lung. The patient was admitted to the hospital and received the respiratory treatment with BiBAP. After that, Cardiac arrest was observed. The reporting physician classified the event as serious (fatal) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause(s) of the event such as any other diseases were Cardiac failure chronic, Renal failure, Osteomyelitis of toes and Pneumonia. The reporting physician did not provide any further comment. On 04Jul2021, the patient died due to cardiac arrest, while unknown outcome for the remaining events. It was unknown if an autopsy was performed. Reported Cause(s) of Death: Cardiac arrest.


VAERS ID: 1517330 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-15
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7338 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory arrest, Computerised tomogram, Pneumonia, SARS-CoV-2 test
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), Eosinophilic pneumonia (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: 2021-07-18
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lung cancer (surgery on the right lung, radiotherapy to the left lung); Lung operation; Radiotherapy to lung
Allergies:
Diagnostic Lab Data: Test Date: 20210708; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: Before vaccination; Test Date: 20210715; Test Name: CT; Result Unstructured Data: Test Result:right pneumonia; Test Name: coronavirus antigen test; Test Result: Negative
CDC Split Type: JPPFIZER INC202100918012

Write-up: Sudden death after pneumonia/right pneumonia; Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21120366. An 85-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 08Jul2021 09:30 (at the age of 85 years) (Batch/Lot Number: FA7338; Expiration Date: 30Sep2021) as single dose for COVID-19 immunization. Medical history included lung cancer, for which the patient had undergone surgery on the right lung and radiotherapy to the left lung. The patient''s concomitant medications were not reported. The patient was an 85-year and 10-month-old male. Body temperature before vaccination was 36.2 degrees Centigrade. On 18Jul2021 (10 days after the vaccination) at around 02:00, the patient experienced sudden death after pneumonia. The outcome of the event was fatal. The clinical course was reported as follows: On 15Jul2021 (8 days after the vaccination, as reported) in the morning, the patient presented to the reporting hospital with chief complaint of hyperthermia and dyspnoea. The patient was diagnosed with right pneumonia by computerised tomogram (CT), and he was admitted to the reporting hospital for treatment. The result of coronavirus antigen test was negative. On 17Jul2021 (9 days after the vaccination), the symptoms that the patient had had at the time of admission were resolving. However, on 18Jul2021 (10 days after the vaccination), in the early hours, sudden cardio-respiratory arrest developed. The patient died on 18Jul2021. It was unknown if autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was acute pneumonia.; Reported Cause(s) of Death: Sudden death after pneumonia; Cardio-respiratory arrest


VAERS ID: 1517331 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-07-10
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic rupture, Body temperature, Cardio-respiratory arrest, Computerised tomogram, Fall
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), Acute central respiratory depression (broad), Accidents and injuries (narrow), Respiratory failure (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: THYRADIN S; CALBLOCK; TAMSULOSIN; BENZBROMARONE; CANDESARTAN; URALYT [POTASSIUM CITRATE;SODIUM CITRATE DIHYDRATE]; FLUTIDE [FLUTICASONE PROPIONATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic aneurysm (father); Bronchial asthma; Hypertension; Neoplasm malignant (mother); Papillary thyroid cancer
Allergies:
Diagnostic Lab Data: Test Date: 20210616; Test Name: Body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: before vaccination; Test Name: CT scans; Result Unstructured Data: Test Result:no significant changes; Test Name: CT scans; Result Unstructured Data: Test Result:aortic rupture
CDC Split Type: JPPFIZER INC202100918014

Write-up: Cardio-respiratory arrest; aortic rupture; fell down; This is a spontaneous report from a contactable physician (specialized in respiratory medicine) received from the Medical Devices Agency. A 69-year-old male patient received BNT162B2 (COMIRNATY) at the age of 69-years-old, via an unspecified route of administration on 16Jun2021 15:30 (Batch/Lot Number: EY0779; Expiration Date: 31Aug2021) as dose 1, single for COVID-19 immunization. The patient was a 69-year-old male. Body temperature before vaccination was 36.1 degrees centigrade. The patient had family histories of aortic aneurysm (father) and neoplasm malignant (mother). The patient must not use alcohol and iodine. Medical history included bronchial asthma, hypertension, and papillary thyroid cancer. Concomitant medications included levothyroxine sodium (THYRADIN S), azelnidipine (CALBLOCK), tamsulosin (manufacture name not reported), benzbromarone (manufacture name not reported), candesartan (manufacture name not reported), potassium citrate/sodium citrate dihydrate (URALYT), and fluticasone propionate (FLUTIDE 100). On 08Jul2021, the patient made regular visit the outpatient otolaryngology department of the reporting hospital. CT scans including the chest showed no significant changes. On 10Jul2021, the patient was with his wife and his condition did not change. At 16:30 on the same date (24 days and 1 hour after the vaccination), the patient suddenly fell down and was taken to another hospital by ambulance. The patient was already in the condition of cardio-respiratory arrest when an emergency medical team arrived. Afterwards, resuscitation was continued; however, the heartbeat did not resume, and the patient''s death was confirmed on the same date, 10Jul2021. It was reported that a CT was performed after the patient''s death and revealed aortic rupture, which might be due to a cardiac massage. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: The patient regularly visited the otolaryngology department of the reporting hospital for pharyngeal cancer, the respiratory medicine department of the hospital for bronchial asthma, and the nephrology department of the hospital for hypertension; however, all the courses were favorable and stable. Although many days had passed since the vaccination, no other findings corresponding to the cause of death were found. Therefore, the reporting physician considered that a causal relationship could not be ruled out, and this case was reported.; Reported Cause(s) of Death: Cardio-respiratory arrest; Autopsy-determined Cause(s) of Death: aortic rupture, which might be due to a cardiac massage


VAERS ID: 1517332 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-07-01
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aspartate aminotransferase, Asthma, Body temperature, C-reactive protein, Cardiac failure, Dyspnoea, Pyrexia, SARS-CoV-2 antibody test, Vomiting, White blood cell count
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-07
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE; LANSOPRAZOLE; EBRANTIL [URAPIDIL]; UBRETID; URSO [URSODEOXYCHOLIC ACID]; BELSOMRA; ROZEREM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bedridden; Dementia; Diabetes mellitus; Hepatitis C; Osteoporosis
Allergies:
Diagnostic Lab Data: Test Date: 20210705; Test Name: GOT; Result Unstructured Data: Test Result:37; Test Date: 20210701; Test Name: Body temperature; Result Unstructured Data: Test Result:pyrexia Centigrade; Test Date: 20210705; Test Name: Body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210701; Test Name: CRP; Result Unstructured Data: Test Result:0; Test Date: 20210705; Test Name: CRP; Result Unstructured Data: Test Result:0.5; Test Date: 20210701; Test Name: SARS-CoV-2 antibody test; Result Unstructured Data: Test Result:negative; Test Date: 20210701; Test Name: WBC; Result Unstructured Data: Test Result:4000; Test Date: 20210705; Test Name: WBC; Result Unstructured Data: Test Result:6000
CDC Split Type: JPPFIZER INC202100918020

Write-up: suspected cardiac failure; shortness of breath; asthma; small amount of vomiting; pyrexia; This is a spontaneous report from a contactable physician via a Pfizer sales representative. The patient was 95-year-old female. The patient age at vaccination was 95-year-old. Medical history included dementia, diabetes mellitus (DM), hepatitis C, and osteoporosis. The patient was bedridden. Concomitant medications included amlodipine (manufacture name not reported), lansoprazole (manufacture name not reported), urapidil (EBRANTIL), distigmine bromide (UBRETID), ursodeoxycholic acid (URSO), suvorexant (BELSOMRA), and ramelteon (ROZEREM). On 22Jun2021, the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date were not reported) via an unspecified route of administration as DOSE 1, SINGLE for COVID-19 immunization. On 01Jul2021 (9 days after the vaccination), the patient developed pyrexia. WBC was 4000, and CRP was 0. SARS-CoV-2 antibody test showed negative. Cooling was performed in response to the event. On 05Jul2021 (13 days after the vaccination), as pyrexia of 38 degrees Centigrade persisted, acetaminophen (CALONAL) was prescribed. WBC was 6000, CRP was 0.5 and GOT was 37. On 06Jul2021 (14 days after the vaccination), while she was having conversation, she developed shortness of breath, symptoms of asthma, and she had small amount of vomiting. Given those symptoms, cardiac failure was suspected. On 07Jul2021 at 04:00 (15 days after the vaccination), the patient died. It was unknown whether autopsy was performed. The outcome of the event Cardiac failure was fatal and unknown for the other events. The reporting physician''s opinion was as follows: Eight days passed after the vaccination from pyrexia, it was considered that there was no causal relationship between the patient''s death and BNT162b2. Information on the lot/batch number has been requested.; Sender''s Comments: The patient was an 95-year-old female with multiple underlying diseases and was bedridden. Based on the temporal association, the reported events more likely represented intercurrent illnesses, but not related to BNT162b2.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate. ; Reported Cause(s) of Death: suspected cardiac failure


VAERS ID: 1517333 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-07-06
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3860 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Death, Incontinence, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
   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: Angina pectoris; Atrioventricular block; Bypass surgery; Dyslipidaemia; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210625; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202100918021

Write-up: Loss of consciousness; Incontinence; dead; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21120289. A 74-year-old male patient received bnt162b2 (COMIRNATY, Batch/Lot Number: EY3860; Expiration Date: 31Aug2021), dose 1 via an unspecified route of administration on 25Jun2021 17:00 (at the age of 74years) as dose 1, single for Covid-19 immunization. Medical history included atrioventricular block, angina pectoris, bypass surgery, hypertension, and dyslipidaemia from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Body temperature before vaccination was 36.5 degrees centigrade. On 06Jul2021 at 18:24 (11 days after the vaccination), in the evening, around 30 minutes after the patient started to take a bath, the patient''s family member found him incontinent and unconsciousness in the bath. However, the patient did not seem to be drown. He was urgently transferred to Emergency Room and then confirmed dead. The patient''s family member stated that when the patient took a bath, decrease in his level of consciousness had often been seen, and that he preferred to take a long bath with hot water. The outcome of event incontinent was unknown. The patient died on 06Jul2021. It was unknown whether an autopsy was performed. The reporting physician classified the events as serious (death) and assessed causality to be unassessable to BNT162b2. The reporting physician did not mention other possible cause of the event such as any other diseases. The reporting physician commented as follows: It had been 12 days since the vaccination, and the causality was therefore not considered as explicit.; Reporter''s Comments: It had been 12 days since the vaccination, and the causality was therefore not considered as explicit.; Reported Cause(s) of Death: Loss of consciousness; dead


VAERS ID: 1517335 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-13
Onset:2021-06-19
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5422 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Body temperature, C-reactive protein increased, Investigation, KL-6, SARS-CoV-2 test, Serum ferritin
SMQs:, Interstitial lung disease (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-27
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210613; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination; Test Date: 20210621; Test Name: Body temperature; Result Unstructured Data: Test Result:38.4 Centigrade; Test Date: 20210622; Test Name: Body temperature; Result Unstructured Data: Test Result:39.5 Centigrade; Comments: at 22:00; Test Date: 20210622; Test Name: Body temperature; Result Unstructured Data: Test Result:over 39 Centigrade; Test Date: 202106; Test Name: CRP; Result Unstructured Data: Test Result:above 36; Test Date: 202106; Test Name: KL6; Result Unstructured Data: Test Result:above 800; Test Date: 20210621; Test Name: SARS-CoV2 ID-NOW COVID-19 (PCR) test; Test Result: Negative ; Test Date: 202106; Test Name: Ferritin; Result Unstructured Data: Test Result:1800; Test Date: 20210622; Test Name: A-DROP score; Result Unstructured Data: Test Result:3
CDC Split Type: JPPFIZER INC202100918040

Write-up: Acute respiratory distress syndrome; This is a spontaneous report from a contactable physician received from the Agency. The regulatory authority report number is v21120244. An 89-year and 8-month-old male patient received BNT162B2 (COMIRNATY; solution for injection; lot number: EY5422; expiration date: 31Aug2021), via an unspecified route of administration on 13Jun2021 (at the age of 89-years-old) as dose 1, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The family history was not provided. The patient''s body temperature on 13Jun2021 before vaccination was 36.5 degrees Centigrade. On 13Jun2021 (the day of vaccination), the patient received the first dose of BNT162B2. The clinical course of the event was as follows: On 19Jun2021 at 06:00 (6 days after the vaccination), the patient experienced acute respiratory distress syndrome (ARDS). On 21Jun2021 (8 days after vaccination), SARS-CoV2 ID-NOW COVID-19 (PCR) test were negative. On 21Jun2021 (8 days after vaccination), in the morning, the patient''s body temperature was 38.4 degrees Celsius. On 22Jun2021 (9 days after vaccination), the patient''s the body temperature was 39 degrees Celsius or higher. At 22:00 (9 days and 22 hours after vaccination), since the body temperature was 39.5 degrees Celsius, the patient visited the reporting hospital. Organizing pneumonia (OP) was observed in the left lower lobe. The A-DROP score was 3. After the hospitalization, in spite of the treatment, inflammation, cellular destruction, and respiratory failure rapidly progressed. On 27Jun2021 (14 days after vaccination), the patient died due to acute respiratory distress syndrome (ARDS). It was not reported if an autopsy was performed or not. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: The course of acute interstitial pneumonia (AIP) was especially rapid. No aspiration or chronic diseases were pointed out. The ferritin was 1800, the KL6 was above 800, and the CRP was above 36.; Reported Cause(s) of Death: Acute respiratory distress syndrome


VAERS ID: 1517336 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-18
   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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: CT; Result Unstructured Data: Test Result:could not identify the cause of death.
CDC Split Type: JPPFIZER INC202100918049

Write-up: Cardio-respiratory arrest; feeling unwell; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21120702. The 90-year and 11-month-old female patient received on 16Jul2021 at unknown time (the day of vaccination), the second dose of BNT162b2 (COVID-19 Vaccine - Manufacturer Unknown, Solution for injection, Lot number unknown, Expiration date not reported) via an unspecified route of administration as dose 2, single (at the age of 90 years) for COVID-19 immunisation. Body temperature before vaccination and family history were not reported. The patient''s concomitant medications 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 an unknown date at unknown time, the patient previously received the first dose of BNT162B2 (Manufacturer Unknown, Solution for injection, Lot number not reported, Expiration date not reported). On 17Jul2021 at 23:00 (1 day after the vaccination), the patient experienced cardio-respiratory arrest. The course of the event was as follows: The patient had been visiting another hospital regularly since before, but the disease was unknown. On 16Jul2021 (the day of vaccination), the patient received the second coronavirus vaccination. On 17Jul2021 (1 day after the vaccination), the patient was sleeping because of feeling unwell since this morning (things like body temperature measurement were not done). Around 22:30, the family saw the patient going to the toilet. At that time, a retching sound was heard. Around 23:00, as the patient became silent, the family went to see his condition; he was found lying next to the toilet, and an ambulance was called. The patient was in a state of cardio-respiratory arrest when the emergency crews arrived. He was transported to the reporting hospital. Return of spontaneous was not obtained even with resuscitation, and death was confirmed. Postmortem computerised tomography (CT) could not identify the cause of death. On 18Jul2021 (2 days after the vaccination), the outcome of the event cardio-respiratory arrest was fatal and unknown outcome for the event feeling unwell. The patient died on 18Jul2021. It was not reported whether autopsy was done. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases: The patient was in a state of cardio-respiratory arrest on arrival at the reporting hospital. The postmortem examination determined the cause of death as endogenous death of unknown cause. The reporting physician commented as follows: The cause of death was unidentified. Because the patient was at a very old age of 90, it was unknown to what level there was a causal relationship with the vaccination. However, the physician reported this case because also the causal relationship with the vaccine-induced side effects could not be denied considering the complaint of physical deconditioning in the morning on the next day of the second vaccination.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1517337 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-07-04
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Death, Magnetic resonance imaging
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diffuse large B-cell lymphoma (Five years ago)
Allergies:
Diagnostic Lab Data: Test Date: 20210618; Test Name: CT; Result Unstructured Data: Test Result: No abnormality for brain tumour; Test Date: 20210621; Test Name: MRI; Result Unstructured Data: Test Result: No abnormality for brain tumour
CDC Split Type: JPPFIZER INC202100918086

Write-up: Death; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. An 80-year-old male patient received bnt162b2 (COMIRNATY), intramuscular administered in left arm on 29Jun2021 14:30 (Batch/Lot Number: FA5765; Expiration Date: 30Sep2021) (at the age of 80-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient received any other 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 diffuse large b-cell lymphoma from 2016 (Five years ago). The patient''s concomitant medications were not reported. Historical vaccine includes first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number EY5420, Expiration date 31Aug2021), via intramuscular in the left arm for COVID-19 immunization and seven days after the vaccination, the patient could not stand up because of pain of lower extremities. On 04Jul2021 at 21:00 (5 days after the vaccination), the patient died. The cause of death was reported as "Unknown." The course of the event was reported as follows: Seven days after the first dose of the vaccination, the patient could not stand up because of pain of lower extremities. The patient received computerised tomography on 18Jun2021 and magnetic resonance imaging on 21Jun2021 at another hospital, where the patient''s primary care physician saw his brain tumour (diffuse large B-cell lymphoma). The results of examinations revealed no abnormality for brain tumour. The patient died 5 days after the second vaccination. It was unknown if the patient received treatments for the event. The reporting physician assessed the event as serious (Death). Autopsy was not performed. Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: The event of death is assessed as possibly related to the suspect drug BNT162B2 based on strong temporal association, but consider also possible contributory effects from patient''s medical history, elderly age, and/or concomitant medications. 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: 1517338 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-05-24
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Decreased activity, Urinary tract infection
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
   Days after onset: 43
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 INC202100918174

Write-up: urinary tract infection; decreased activities of daily living (ADL); This is a spontaneous report from a contactable physician received from Medical Devices Agency.The patient was an 81-year-old male. Body temperature before vaccination was not reported. Family history was not reported. 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) were unknown since the patient was not vaccinated at the reporting hospital. On 18May2021 (the day of vaccination), the patient received the first dose of BNT162b2 (COVID-19 Vaccine - Manufacturer Unknown, Solution for injection, Lot number and expiration date were not reported), via an unspecified route of administration as a single dose for COVID-19 immunization. On 24May2021 (6 days after the vaccination), the patient experienced decreased activities of daily living (ADL). On 06Jul2021 (49 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: Before the vaccination, the patient was able to walk normally. On 18May2021, the patient received the first dose of COVID-19 vaccine at another hospital. 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 urinary tract infection. The reporting physician commented as follows: The patient received the vaccine at another hospital. Outcome of the event urinary tract infection was unknown, and decreased activities of daily living (ADL) was fatal. The patient died on 06Jul2021. It was unknown if autopsy was done. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: decreased activities of daily living (ADL)


VAERS ID: 1517339 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5422 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-05
   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: Arteriosclerosis obliterans; Diabetes mellitus; Hyperlipidaemia; Late effects of cerebral infarction
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210704; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccinaiton
CDC Split Type: JPPFIZER INC202100918339

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the regulatory authority. The regulatory authority report number is v21120243. A 65-year-old (also reported as 65-year and 6-month-old) male patient received BNT162B2 (COMIRNATY, solution for injection, lot number: EY5422, expiration date: 31Aug2021), via an unspecified route of administration on 04Jul2021 (at the age of 65-years-old -as reported) at dose 1, single for COVID-19 immunization. Body temperature before vaccination on 04Jul2021 was 36.7 degrees Centigrade. Medical history included late effects of cerebral infarction, diabetes mellitus, hyperlipidaemia, arteriosclerosis obliterans, which were all ongoing. He was receiving drugs at his nearby hospital for late effects of cerebral infarction, diabetes mellitus, hyperlipidaemia, arteriosclerosis obliterans, and others. The patient''s family history was not provided. On 04Jul2021 (the day of vaccination), the patient received the first dose of BNT162B2 (COMIRNATY). On 05Jul2021 at 10:25 (reported as one day after the vaccination), the patient experienced cardio-respiratory arrest. When the home-visiting nurse visited the patient''s home, he experienced cardio-respiratory arrest. On 05Jul2021 (reported as one day after the vaccination), the outcome of the event was fatal. The patient died on 05Jul2021 due to cardio-respiratory arrest. An autopsy was performed with the intervention of the local police. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162B2 as unassessable. There was no other possible cause of the event such as any other diseases.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1517340 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Fall, Nausea, Oxygen saturation, Oxygen saturation decreased, Pyrexia, Somnolence, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (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? No
Previous Vaccinations:
Other Medications: ELIQUIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic stent insertion (5 years ago); Arrhythmia; Atrial fibrillation paroxysmal; Deep vein thrombosis; Parkinson''s syndrome; Thoracic aortic aneurysm
Allergies:
Diagnostic Lab Data: Test Date: 20210705; Test Name: Body temperature; Result Unstructured Data: Test Result:35.1 Centigrade; Comments: before vaccination; Test Date: 20210706; Test Name: Body temperature; Result Unstructured Data: Test Result:37.3 Centigrade; Test Date: 20210707; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Test Date: 20210706; Test Name: SpO2; Test Result: 87 %; Test Date: 20210707; Test Name: SpO2; Test Result: 96 %
CDC Split Type: JPPFIZER INC202100918354

Write-up: Sudden death; queasy; tendency for somnolence; pyrexia of 37.3 degrees centigrade / low grade fever; SpO2 87%; the patient fell in a toilet; This is a spontaneous report from a contactable physician received from the Pharmaceuticals and Medical Devices Agency (PMDA). Regulatory authority report number is v21120376. The patient was a 94-year and 2-month-old female. Body temperature before vaccination was 35.1 degrees Centigrade. Family history was not reported. Medical history included deep vein thrombosis, Parkinson''s syndrome, thoracic aortic aneurysm, stent-graft insertion for thoracic aortic aneurysm, arrhythmia, and paroxysmal atrial fibrillation (Paf). On 07Jun2021, the patient previously received the first dose of BNT162b2 (COMIRNATY; Lot number: EY5420, Expiration date: 31Aug2021) intramuscular, single, for COVID-19 immunization. Concomitant medication included apixaban (ELIQUIS) taken orally for deep vein thrombosis, start date was not reported and ongoing. On 05Jul2021 at 11:10 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection; at the age of 94-years-old; Lot number FA5765, Expiration date 30Sep2021) intramuscular as a single dose for COVID-19 immunization. On 10Jul2021 at 19:53 (5 days 8 hours 43 minutes after the vaccination), the patient experienced sudden death. On 10Jul2021 (5 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The patient had medical history of Parkinson''s syndrome, deep vein thrombosis, thoracic aortic aneurysm, etc., for which visited medical care has been provided. On 07Jun2021, the patient received the first dose of BNT162b2 intramuscularly and developed no pyrexia, etc. On 05Jul2021, the patient received the second dose of BNT162b2 intramuscularly. On 06Jul2021, a helper confirmed that the patient had pyrexia of 37.3 degrees centigrade and SpO2 87%. Home visiting nurse received a contact and on 07Jul2021, the nurse visited the patient. Body temperature was 36.6 degrees centigrade and SpO2 was 96%. The patient had tendency for somnolence to some extent. On 10Jul2021 at around noon, the patient called the eldest daughter and told that the patient had queasy. When the patient was visited, the patient fell in a toilet and the reporting clinic was contacted. On 10Jul2021 at 19:53, death was confirmed. The patient died a sudden death on 10Jul2021. An autopsy was not performed. Outcome of the other events 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 cause of the event such as any other diseases was as follows: Five years have passed since the patient had stent-graft insertion for thoracic aortic aneurysm. The patient had a history of Paf; thus, there was a possibility that the patient had lethal arrhythmia. The reporting physician also commented as follows: Since the patient had surgery for thoracic aortic aneurysm, arrhythmia, and deep vein thrombosis, it was considered that the patient died due to cardiovascular factor. Family member did not wish to have anatomy, etc.; however, family member requested to report the adverse reactions.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1517344 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-06-25
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 1 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Endocarditis, Myocarditis, Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Cardiomyopathy (broad), Chronic kidney disease (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: 2021-07-03
   Days after onset: 8
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: Chronic leukaemia in remission
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100918787

Write-up: Acute myocarditis; pericarditis; endocarditis; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The Regulatory authority report number is v21120912. The patient was a 71-year and 7-month-old male. Body temperature before vaccination was not provided. The family history was not provided. The underlying disease: The patient was receiving chemotherapy for chronic neutrophilic leukemia, treating with VIDAZA, the last dose was performed on the 6th cycle between 25May2021 and 02Jun2021. The chronic neutrophilic leukemia was assessed as almost remission. Concomitant drugs included unspecified oral antihypertensive drug. On 16Jun2021 at 12:30 (the day of vaccination), at age of 71-year-old, the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0779, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 25Jun2021 (8 days after the vaccination), the patient experienced acute myocarditis, pericarditis, and endocarditis. On 30Jun2021 (14 days after the vaccination), the patient was admitted to the hospital. On 03Jul2021 (16 days after the vaccination), the outcome of the events was fatal. The action taken for VIDAZA was post-therapy. The course of the event was as follows: In Aug2020, the patient visited the department of hematology of the hospital. The patient was diagnosed with chronic neutrophilic leukemia, and chemotherapy with VIDAZA was performed. The condition in almost remission was maintained. On 16Jun2021 (the day of vaccination), at 12:30, the patient received the first dose of BNT162b2 vaccination (Pfizer product, Lot#EY0779) at hospital. On 25Jun2021 (8 days after vaccination), the patient had pyrexia. On 30Jun2021 (13 days after vaccination), the patient was admitted to the department of hematology. An antibiotic was being administered. On 03Jul2021 (16 days after vaccination), in the morning, the patient suddenly had cardiac arrest in the ward, and he died. Since the cause of death was unknown, after an autopsy imaging was performed, no particular abnormalities were observed, and an autopsy was performed. The pericardia fluid increased to 250 mL or more, and the cardiac weight increased to 580 g. An image of significant eosinophilic inflammatory cell infiltration was histologically observed in the both ventricles of the heart. Thus, acute myocarditis was diagnosed on the autopsy. The inflammation extended to the epicardium and endocardium. It was assumed that myocarditis progressed to pump failure or lethal arrhythmia. 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 as follows: Recently, the patient was administered VIDAZA. However, it was the 6th cycle. No particular abnormalities were observed until the 5th cycle. Other oral medications such as an antihypertensive drug were not changed. The reporting physician commented as follows: Although the causality between myocarditis and BNT162b2 vaccination was unknown, the timing was close, and thus, this case was reported. Of note, in this case, in the future, consultation would be made with the specialists of pathology or infectious pathology via the Regulatory Authority. It was to be consulted how far additional investigation could be made from paraffin block or formalin-soaked specimens. Reported Cause(s) of Death: Acute myocarditis; pericarditis; endocarditis; Autopsy-determined Cause(s) of Death: Acute myocarditis.


VAERS ID: 1517345 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0889 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac death, Imaging procedure, Troponin T
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: 2021-07-12
   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: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210710; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination; Test Date: 20210713; Test Name: autopsy imaging; Result Unstructured Data: Test Result:no abnormalities; Comments: The AI showed no abnormalities which led to the direct cause of death.; Test Date: 20210713; Test Name: Troponin T; Test Result: Positive ; Comments: the cardiac blood showed that troponin T positive
CDC Split Type: JPPFIZER INC202100918789

Write-up: Cardiac death; This is a spontaneous report from a contactable physician received from Medical Devices Agency. The patient was a 65-year and 5-month-old (at vaccination) male. Body temperature before vaccination was 36.5 degrees centigrade. The patient had medical history of hypertension. The patient had no allergic history. There was no history of vaccination within 2 weeks. Concomitant medication was unknown. On 10Jul2021 at 18:30 (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 a single dose for COVID-19 immunization. On 12Jul2021 at 13:00 (2 days after the vaccination), the patient experienced cardiac death. The outcome of the event was fatal. The course of the event was as follows: On 10Jul2021 (the day of vaccination), the patient received the first dose of BNT162b2 vaccination. On 12Jul2021 (2 days after vaccination), the patient was found to collapse in the factory of his working place. On 13Jul2021, at 11:50, an autopsy imaging (AI) and an autopsy were performed at the reporting hospital. The AI showed no abnormalities which led to the direct cause of death. Since the cardiac blood showed that troponin T positive, the cause of death was determined as cardiac death. The estimated time of death was around 13:00 on 12Jul2021. 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 unknown. The reporting physician commented as follows: The causality between the death and BNT162b2 vaccination was unknown.; Reported Cause(s) of Death: Cardiac death; Autopsy-determined Cause(s) of Death: cardiac death


VAERS ID: 1517359 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-09
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Myocardial infarction, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, arterial (narrow), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: PLAVIX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Obstructive arteriosclerosis of lower extremities; Parkinson''s syndrome
Allergies:
Diagnostic Lab Data: Test Name: whole body CT after the death; Result Unstructured Data: Test Result:no haemorrhagic lesions in the brain; Comments: The whole body CT after the death (AI) showed no haemorrhagic lesions in the brain nor fracture . No abnormalities were observed in the major blood vessels.
CDC Split Type: JPPFIZER INC202100918919

Write-up: Sudden death; myocardial infarction was suspected; This is a spontaneous report from a contactable physician received from Medical Devices Agency. The patient was an 83-year and 4-month-old (at vaccination) female. The patient had medical histories of Parkinson''s syndrome, obstructive arteriosclerosis of lower extremities and hypertension. The patient''s activity of daily living (ADL) was reported as able to move with a walker. The concomitant medication included ongoing clopidogrel bisulfate (PLAVIX) taken orally. On 06Jul2021 at 13:30 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration as a single dose for COVID-19 immunization. On 09Jul2021 at 19:30 (3 days after the vaccination), the patient experienced sudden death. The outcome of the event was fatal. It was unknown if autopsy was performed. The course of the event was as follows: On 09Jul2021, at 19:30 (3 days after vaccination), the patient was found to collapse at her room, and an ambulance was called. When the patient was transferred to the emergency hospital, she was in cardio-respiratory arrest. Although resuscitation was performed, no return of spontaneous circulation was obtained, and the patient died. The whole body CT after the death (AI) showed no haemorrhagic lesions in the brain nor fracture. No abnormalities were observed in the major blood vessels. Cardiogenic disease such as myocardial infarction was suspected. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: The causality between the event and BNT162b2 vaccination was unknown; however, the patient experienced sudden death on Day 3 after the vaccination, and this case was reported. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: Sudden death; myocardial infarction was suspected


VAERS ID: 1517371 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-03-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Alanine aminotransferase, Amylase, Aspartate aminotransferase, Bilirubin conjugated, Blood albumin, Blood alkaline phosphatase, Blood bilirubin, Blood chloride, Blood cholesterol, Blood cholinesterase, Blood creatine phosphokinase, Blood creatinine, Blood glucose, Blood lactate dehydrogenase, Blood potassium, Blood pressure measurement, Blood sodium, Blood triglycerides, Blood urea, Blood uric acid, Body temperature, C-reactive protein, Cerebral haematoma, Cerebral haemorrhage, Cerebral ventricular rupture, Computerised tomogram, Dysarthria, Fibrin, Fibrin D dimer, Gamma-glutamyltransferase, Glycosylated haemoglobin, Haematocrit, Haemoglobin, Headache, Heart rate, Hepatitis B surface antigen, Hepatitis C RNA, Hepatitis C virus test, High density lipoprotein, Imaging procedure, Low density lipoprotein, N-terminal prohormone brain natriuretic peptide, Nausea, Oxygen saturation, Platelet count, Protein total, Prothrombin time, Red blood cell count, Respiratory rate, White blood cell count
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-29
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: URSODEOXYCHOLIC ACID; BEZAFIBRATE
Current Illness: Dyslipidaemia; Hepatitis C
Preexisting Conditions: Medical History/Concurrent Conditions: Appendicitis; Common cold (treated on 11Feb2018 in a hospital)
Allergies:
Diagnostic Lab Data: Test Date: 20210328; Test Name: APTT ratio; Result Unstructured Data: Test Result:1.03; Test Date: 20210328; Test Name: ALT; Result Unstructured Data: Test Result:15 IU/l; Test Date: 20210328; Test Name: Amylase; Result Unstructured Data: Test Result:95 IU/l; Test Date: 20210328; Test Name: AST; Result Unstructured Data: Test Result:45 IU/l; Test Date: 20210328; Test Name: bilirubin direct; Test Result: 0.06 mg/dl; Test Date: 20210328; Test Name: Alb; Result Unstructured Data: Test Result:5.3 g/dl; Test Date: 20210328; Test Name: ALP; Result Unstructured Data: Test Result:545 IU/l; Test Date: 20210328; Test Name: bilirubin total; Test Result: 0.43 mg/dl; Test Date: 20210328; Test Name: Chloride; Result Unstructured Data: Test Result:101 mEq/l; Test Date: 20210328; Test Name: Cholesterol total; Test Result: 229 mg/dl; Test Date: 20210328; Test Name: Cholinesterase; Result Unstructured Data: Test Result:399 IU/l; Test Date: 20210328; Test Name: CPK; Result Unstructured Data: Test Result:139 IU/l; Test Date: 20210328; Test Name: Creatinine; Test Result: 0.59 mg/dl; Test Date: 20210328; Test Name: blood glucose; Test Result: 240 mg/dl; Test Date: 20210328; Test Name: LDH; Result Unstructured Data: Test Result:409 IU/l; Test Date: 20210328; Test Name: K; Result Unstructured Data: Test Result:3.3 mEq/l; Test Date: 20210327; Test Name: BP; Result Unstructured Data: Test Result:185/116; Test Date: 20210328; Test Name: BP; Result Unstructured Data: Test Result:160/133; Test Date: 20210328; Test Name: Na; Result Unstructured Data: Test Result:140 mEq/l; Test Date: 20210328; Test Name: Triglycerides; Test Result: 118 mg/dl; Test Date: 20210328; Test Name: BUN; Test Result: 21.7 mg/dl; Test Date: 20210328; Test Name: Uric acid; Test Result: 4.5 mg/dl; Test Date: 20210324; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before the vaccination; Test Date: 20210328; Test Name: CT scan; Result Unstructured Data: Test Result:Cerebral hemorrhage (diffuse hemorrhage in the rig; Comments: Cerebral hemorrhage (diffuse hemorrhage in the right hemisphere, intraventricular perforation); Test Date: 20210328; Test Name: CRP; Test Result: 0.12 mg/dl; Test Date: 20210328; Test Name: Fibrin; Test Result: 358.7 mg/dl; Test Date: 20210328; Test Name: D-dimer; Result Unstructured Data: Test Result:1.2 ug/ml; Test Date: 20210328; Test Name: Gamma-GTP; Result Unstructured Data: Test Result:18 IU/l; Test Date: 20210328; Test Name: HbA1c; Test Result: 5.8 %; Test Date: 20210328; Test Name: Haematocrit; Test Result: 38.5 %; Test Date: 20210328; Test Name: Hb; Result Unstructured Data: Test Result:13.0 g/dl; Test Date: 20210327; Test Name: HR; Result Unstructured Data: Test Result:64; Comments: irregular; Test Date: 20210328; Test Name: HR; Result Unstructured Data: Test Result:55; Comments: irregular; Test Date: 20210328; Test Name: HBsAg; Result Unstructured Data: Test Result:negative; Test Date: 20210328; Test Name: HCV (quantitative); Result Unstructured Data: Test Result:5.14; Test Date: 20210328; Test Name: HCV (Qualitative); Test Result: Positive ; Test Date: 20210328; Test Name: HDL; Test Result: 67.8 mg/dl; Test Name: Brain imaging; Result Unstructured Data: Test Result:revealed a large hematoma with ventricular rupture; Comments: revealed a large hematoma with ventricular rupture; Test Date: 20210328; Test Name: LDL; Test Result: 119.3 mg/dl; Test Date: 20210328; Test Name: NT-proBNP; Result Unstructured Data: Test Result:155.8 pg/mL; Test Date: 20210327; Test Name: SPO2; Test Result: 97 %; Comments: Room air; Test Date: 20210328; Test Name: SPO2; Test Result: 95 %; Comments: Room air; Test Date: 20210328; Test Name: Platelet count; Result Unstructured Data: Test Result:216000 /mm3; Test Date: 20210328; Test Name: Protein total; Result Unstructured Data: Test Result:8.7 g/dl; Test Date: 20210328; Test Name: PT-INR; Result Unstructured Data: Test Result:0.88; Test Date: 20210328; Test Name: RBC; Result Unstructured Data: Test Result:4070000 /mm3; Test Date: 20210327; Test Name: RR; Result Unstructured Data: Test Result:20; Test Date: 20210328; Test Name: RR; Result Unstructured Data: Test Result:19; Test Date: 20210328; Test Name: WBC; Result Unstructured Data: Test Result:9700 /mm3
CDC Split Type: JPPFIZER INC202100968282

Write-up: Cerebral haemorrhage; Brain imaging revealed a large hematoma with ventricular rupture; Brain imaging revealed a large hematoma with ventricular rupture; developed dysarthria with complaints of headache and nausea; developed dysarthria with complaints of headache and nausea; developed dysarthria with complaints of headache and nausea; This case was initially received on 29MAR2021 and it was previously submitted under unique case identification number. However, due to human error, this master case was erroneously nullified. Therefore a new master has been created with the same information under manufacturer number. All subsequent follow-up will be reported under this manufacturer report number. This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution; and also via a Pfizer sales representative. A 72-year-old female patient received BNT162B2 (COMIRNATY, solution for injection, Lot number: EP9605; Expiration Date: 30Jun2021) at the age of 72 years, dose 1 intramuscular on 24Mar2021 15:30 as dose 1, single for COVID-19 immunization. The patient was a non-pregnant and it was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was also was unknown whether the patient received any other medications within 2 weeks of vaccination. It was unknown the patient had been diagnosed with COVID-19 or had tested positive for COVID-19 prior to vaccination. It was unknown whether the patient had side effect history or received other vaccines prior to the COVID vaccine. It was also unknown whether the patient had side effect history after receiving any vaccines. The degree of care which the patient needed was unknown. The degree of independence in activities of daily living (ADL) was unknown. Her swallowing function and whether she was able to take orally were unknown. Abnormalities noted before and after vaccination were unknown. Medical history included ongoing hepatitis C, ongoing dyslipidaemia, appendicitis, common cold (treated on 11Feb2018 in a hospital). The patient did not have any histories of allergy, smoking or alcohol intake. The patient''s concomitant medications included ursodeoxycholic acid and bezafibrate both taken orally from an unknown date to 28Mar2021. The patient body temperature before vaccination was 36.2 degrees Centigrade (24Mar2021). On 27Mar2021 at 21:00 (3 days after the vaccination), the patient has gone to bed. On 27Mar2021 23:30, the patient was found to have following abnormalities: headache, queasy and inarticulateness. The patient experienced cerebral hemorrhage and was in need of treatment in an emergency room/department or urgent care. Medical checkup conducted when members of an ambulance crew arrived showed that JCS II-20, RR 20, Spo2 97% (room air), BP 185/116 and HR 64 irregular. The event resulted in hospitalization. On the same day at 23:30, the patient complained of headache, nausea, Dysarthria. On 28Mar2021 (4 days after the vaccination), the patient was transported to the reporter''s institution at 00:42. Clinical course and therapeutic measures taken while she was transported were unknown. Physical examination conducted when the patient was arrived at the hospital showed that JCS III-100, BP 160/133, HR 55 irregular, RR 19, Spo2 95% (room air), MMT: rt-upper 5, rt-lower 5, It-upper 0, It-lower 1. The patient underwent lab test included computerized tomogram scan results on 28Mar2021 which showed that it was cerebral hemorrhage (diffuse hemorrhage in the right hemisphere, intraventricular perforation), and the patient has been diagnosed with cerebral hemorrhage. Surgery or life-prolonging treatment for the event was not desired, so the patient was followed up. On 28Mar2021, therapeutic measures were taken as a result of cerebral hemorrhage. Therapeutic measures for the event included transfusion (hemostatic agent, intracranial pressure-lowering agent and antihypertensive). On 28Mar2021, the patient visited the hospital and underwent lab tests and procedures which included APTT ratio (activated partial thromboplastin time ratio): 1.03, ALT: 15 iu/l, Amylase: 95 iu/l, AST: 45 iu/l, bilirubin direct: 0.06 mg/dl, blood albumin: 5.3 g/dl, ALP: 545 iu/l, bilirubin total: 0.43 mg/dl, Chloride: 101 meq/l, Cholesterol total: 229 mg/dl, Cholinesterase: 399 iu/l, Blood creatine phosphokinase (CPK): 139 iu/l, Creatinine: 0.59 mg/dl, blood glucose: 240 mg/dl, Blood lactate dehydrogenase (LDH): 409 iu/l, Blood potassium (K): 3.3 mEq/L, Blood sodium (Na): 140 mEq/L, Triglycerides: 118 mg/dl, blood urea nitrogen (BUN): 21.7 mg/dl, Uric acid: 4.5 mg/dl, CRP: 0.12 mg/dl, Fibrin: 358.7 mg/dl (150-350), D-dimer: 1.2 ug/ml (0-1.0), Gamma-GTP: 18 iu/l, HbA1c: 5.8 %, Haematocrit: 38.5%, Haemoglobin: 13.0 g/dl, Hepatitis B surface antigen (HBsAg): negative, HCV (quantitative): 5.14, HCV (Qualitative): positive, HDL: 67.8 mg/dl, LDL: 119.3 mg/dl, NT-proBNP: 155.8 pg/mL, Platelet count: 216000 /mm^3 (11.7-33.6), Protein total: 8.7 g/dl, PT-INR (Prothrombin time): 0.88, RBC: 4070000 /mm^3, WBC: 9700 /mm^3. On 29Mar2021 at 10:52 (5 days after the vaccination), the patient''s death has been confirmed in spite of the treatment with infusion of hemostatic agents, cerebral hypotensive agents, and antihypertensive agents. Surgery or life-prolonging treatment for the event was not desired, so the patient was followed up. An autopsy was not performed. The patient died due to cerebral haemorrhage. Diagnostic imaging at the time of her death or autopsy was not conducted. It was inferred that there was no direct relationship to vaccination. The reporting physician considered that the patient died of cerebral haemorrhage. The reporting physician''s considerations for the causal relationship between vaccination and death (including evidence of assessment) was reported as unknown. No follow-up attempts are possible, and no information is required. Follow-up (30Mar2021): This is a follow-up report from a same contactable physician received from Medical Devices Agency. New information included: added relevant medical history, added lab data. The reporter''s comment: base on the results of clinical lab test, no coagulation abnormal was observed. Follow-up attempts are completed. No further information is expected. Follow-up (01Apr2021): New information received from the same contactable physician via a Pfizer sales representative includes: causality assessment from the reporter, concomitant medication updated, therapeutic measures for the events updated, patient medical history was updated, laboratory information, clinical information details. A 72-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single for covid-19 immunization. Medical history included hepatitis c, dyslipidemia, both from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Three days after the first shot of tozinameran, she developed dysarthria with complaints of headache and nausea. Brain imaging revealed a large hematoma with ventricular rupture. Her platelet count was 216,000/mm3. She died 5 days after receiving tozinameran. The outcome of the events was


VAERS ID: 1517406 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-15
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0889 / 2 LA / 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: 2021-07-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PREDONINE [PREDNISOLONE]; DAIPHEN; BAYASPIRIN; TAKECAB; THYRADIN; DIOVAN; AMLODIPINE; DIART [AZOSEMIDE]; ALDACTONE [SPIRONOLACTONE]; LAGNOS; REFLEX [MIRTAZAPINE]; CONTOMIN [CHLORPROMAZINE HIBENZATE]; JARDIANCE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Dyslipidaemia; Hypothyroidism; Lung cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021902203

Write-up: Pulmonary embolism (dyspnoea and respiratory failure); This is a spontaneous follow-up report from a non-contactable pharmacist via COVID-19 Adverse Event Self-Reporting Solution. An 84-year-old female patient received BNT162B2 (COMIRNATY; Lot Number: FD0889; Expiration Date: 30Sep2021), intramuscular, in left arm on 07Jul2021 (at the age of 84-years-old) as dose 2, single for COVID-19 immunization. Medical history included lung cancer, hypothyroidism, diabetes mellitus, and dyslipidaemia. There was no relevant past drug history. There were no known allergies. Concomitant medication included prednisolone (PREDONINE), sulfamethoxazole, trimethoprim (DAIPHEN), acetylsalicylic acid (BAYASPIRIN), vonoprazan fumarate (TAKECAB), thyroid (THYRADIN), valsartan (DIOVAN), amlodipine, azosemide (DIART), spironolactone (ALDACTONE), lactulose (LAGNOS JELLY), mirtazapine (REFLEX), chlorpromazine hibenzate (CONTOMIN), and empagliflozin (JARDIANCE). The patient was not pregnant at the time of vaccination. The most recent COVID-19 vaccine was administered at the nursing home/senior living facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 16Jun2021 at unknown time, the patient previously received the BNT162b2 (COMIRNATY, Solution for injection, Lot number EY3860, Expiration date 31Aug2021) intramuscularly in the left arm as dose 1, single for COVID-19 immunization. On 07Jul2021 at unknown time (the day of vaccination), the patient received the second dose of vaccine. On 15Jul2021 at 17:00 (8 days after the vaccination), the patient experienced pulmonary embolism (dyspnoea and respiratory failure). After changing position at the time of diaper changing, the patient experienced dyspnoea and respiratory failure. The cause was diagnosed as pulmonary embolism. The reporter stated that the adverse events resulted in doctor or other healthcare professional office/clinic visit and death on 15Jul2021. The death cause was pulmonary embolism. No autopsy was performed. Treatment was not given for the adverse events. The reporting pharmacist assessed the event as serious (death). The causality of the events was not reported. The outcome of the event was fatal. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the temporal relation, the association between pulmonary embolism and suspect drug cannot be completely ruled out. The contribution of patient''s age cannot be completely ruled out in the occurrence of the events. 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: Pulmonary embolism


VAERS ID: 1517409 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-06-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac death, Pyrexia, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (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), 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: 2021-06-30
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DILTIAZEM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac valvulopathy
Allergies:
Diagnostic Lab Data: Test Date: 20210622; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021902546

Write-up: Acute cardiac death; The patient vomited several times; A high fever persisted; This is a spontaneous report from a physician via COVID-19 Adverse Event Self-Reporting Solution and also via Medical Devices Agency. The patient was a 72-year-old male. The most recent COVID-19 vaccine was administered at the hospital. It was unknown whether the patient received other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination included diltiazem (DILTIAZEM). There was no relevant past drug history. There were no known allergies. Other medical history included cardiac valvulopathy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 01Jun2021 at 14:30, the patient previously received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EX3617, Expiration date 31Aug2021) intramuscularly in the right arm for COVID-19 immunisation. On 22Jun2021 at 14:30 (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EX3617, Expiration date 31Aug2021) intramuscularly in the right arm for COVID-19 immunisation. On 30Jun2021 at 17:00 (8 days after the vaccination), the patient experienced acute cardiac death. The reporter stated that the adverse event resulted in death. The death cause was acute cardiac death. No autopsy was performed. Treatment was not given for the adverse event. The reporting physician assessed the event as serious (death). The causality of the event was not reported. Upon follow-up it was reported that patient''s body temperature before vaccination was 36.4 degrees centigrade. On 22Jun2021 at unknown time (the day of vaccination), a high fever persisted after the COVID-19 vaccination. On 29Jun2021 at night (7 days after the vaccination), the patient vomited several times. The course of the events was as follows: On 22Jun2021 (the day of vaccination), a high fever persisted after the COVID-19 vaccination. The patient could not eat from 28Jun2021, and on 29Jun2021 at night, the patient vomited several times. On 01Jul2021 at 20:40, postmortem examination was performed (details was not reported). The reporting physician assessed the causality between the event (acute cardiac death) and BNT162b2 as unassessable. The seriousness and causality of the other events were not reported. Other possible causes of the events such as any other diseases were unknown. The reporting physician commented as follows: On 01Jul2021 at 20:40, postmortem examination was performed.; Reported Cause(s) of Death: Acute cardiac death


VAERS ID: 1517411 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asphyxia, Body temperature
SMQs:, Acute central respiratory depression (broad), Hostility/aggression (broad), Respiratory failure (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: ATELEC; FUROSEMIDE; MEVALOTIN
Current Illness: Hypertension (receiving treatment)
Preexisting Conditions: Medical History/Concurrent Conditions: Subarachnoid haemorrhage
Allergies:
Diagnostic Lab Data: Test Date: 20210624; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021902813

Write-up: Asphyxia; This is a spontaneous report from a contactable physician received from the Regulatory Authority (Regulatory Authority report number: V21119846). The patient was a 74-year and 5-month-old female. Body temperature on 24Jun2021 (before vaccination) was 36.5 degrees Centigrade. The family history was not provided. The patient had medical history of ongoing hypertension, for which she was receiving treatment; and subarachnoid haemorrhage (not ongoing). The concomitant medications included oral cilnidipine (ATELEC), furosemide, pravastatin sodium (MEVALOTIN) and unspecified hypertension medication; all were ongoing. On 24Jun2021 at 10:00 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: EY0779; Expiration date: 31Aug2021) as dose 1, single, with route of administration unspecified, for COVID-19 immunization. On 27Jun2021 (3 days after the vaccination), the patient experienced asphyxia. On 27Jun2021 (3 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 24Jun2021 (the day of vaccination), at 10:00, the patient received the first dose of BNT162b2 vaccination. At the time of vaccination, no side reactions were observed. On 26Jun2021 (2 days after vaccination), it was confirmed that the patient was fine by her neighbor. On 30Jun2021 (6 days after vaccination), the patient was found dead leaning forward in the kitchen sink. It was specified that the patient died on 27Jun2021 (3 days after vaccination) on the inquest by the police. The cause of death was asphyxia. 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 as follows: The patient had medical history of subarachnoid haemorrhage (past history), a disease which could cause vomiting. The reporting physician commented as follows: A large amount of pieces of meats which the patient seemed to have eaten were removed from the oral cavity of the dead body. Since there was no incidence, no autopsy was performed. The causality between the event and BNT162b2 vaccination was unknown.; Reported Cause(s) of Death: Asphyxia


VAERS ID: 1517421 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-06-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Condition aggravated, Heart rate decreased, Loss of consciousness, Myelodysplastic syndrome, Septic shock
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haematopoietic cytopenias affecting more than one type of blood cell (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), Toxic-septic shock conditions (narrow), Blood premalignant disorders (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Myelodysplastic syndrome (narrow), Respiratory failure (broad), Hypoglycaemia (broad), Sepsis (narrow), Opportunistic infections (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? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ROMIPLATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic stenosis; Atrial fibrillation; Cancer of transverse colon; Cardiac failure; Colon adenoma (after polypectomy); ESBL producing bacteria test positive; Gastric cancer; Idiopathic thrombocytopenic purpura (ROMIPLATE was administrated); Lung cancer; Myelodysplastic syndrome; Polypectomy; Radiotherapy; Spondylosis; Tuberculosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021903086

Write-up: pulse rate decreased, and the patient had cardiac arrest; pulse rate decreased, and the patient had cardiac arrest; Loss of consciousness; Septic shock; Myelodysplastic syndrome aggravation; Myelodysplastic syndrome aggravation; This is a spontaneous report from a contactable pharmacist received from Medical Devices Agency. The patient was an 85-year and 1-month-old female. Body temperature before vaccination was not provided. The family history was not provided. The patient'' medical history included as follows: idiopathic thrombocytopenic purpura, for which she was administered romiplostim (ROMIPLATE) 250 ug/week, myelodysplastic syndrome, cardiac failure, atrial fibrillation, aortic stenosis, after radiotherapy for lung cancer, colon adenoma (after polypectomy), after surgery for gastric cancer, cancer of transverse colon, cervical spondylotic myelopathy, ESBL producing Escherichia carrier, and tuberculosis. On 02Jun2021, the patient previously received the first dose of COVID-19 Vaccine (manufacturer Unknown, Lot# not reported, Expiration date not reported) for COVID-19 immunization. On 23Jun2021 (the day of vaccination), the patient received the second dose of COVID-19 Vaccine (Manufacturer Unknown, Solution for injection, Lot number reported as unknown, Expiration date reported as unknown) via an unspecified route of administration as a single dose for COVID-19 immunization. On 25Jun2021 at 08:00 (2 days and 8 hours after the vaccination), when the patient got in a car, she suddenly lost consciousness. At 09:00 (2 days and 9 hours after vaccination), an ambulance was called, and the patient was transferred to the reporting hospital. The patient was admitted to the hospital. Since the patient was suspected to have septic shock, administration of meropenem hydrate (MEROPENEM) was initiated. Diltiazem hydrochloride 6 mg/hour and noradrenaline 0.5 mg/hour were continuously administered. At around 17:00 (2 days and 17 hours after vaccination), the pulse rate decreased, and the patient had cardiac arrest. On 25Jun2021 at 17:36 (2 days, 17 hours, and 36 minutes after vaccination), death was confirmed. The direct cause of death on the death certificate: Septic shock (the cause: myelodysplastic syndrome) (the blood culture on hospitalization showed no bacteria). The date of discharge from the hospital was reported as 25Jun2021. It was not reported if an autopsy was performed. The reporting pharmacist classified the events as serious (hospitalization and death) and assessed that the events were unrelated to COVID-19 Vaccine. Other possible cause of the events such as any other diseases was myelodysplastic syndrome. The reporting pharmacist commented as follows: The patient had septic shock after the second dose of COVID-19 vaccination. It was considered that the septic shock was caused by aggravation of myelodysplastic syndrome. It was considered that the events were unrelated to COVID-19 Vaccine; however, this case was reported as adverse events after the vaccination. Pfizer is a marketing authorization holder of COVID-19 Vaccine in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of COVID-19 Vaccine has submitted the same report to the regulatory authorities.; Sender''s Comments: Based on close temporal relationship the role of the usage of the COVID-19 vaccine in triggering/contributing to the events loss of consciousness, septic shock, cardiac arrest, pulse rate decreased, myelodysplastic syndrome aggravation 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 RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: pulse rate decreased, and the patient had cardiac arrest; Septic shock; Myelodysplastic syndrome aggravation; Myelodysplastic syndrome aggravation; pulse rate decreased, and the patient had cardiac arrest; Loss of consciousness


VAERS ID: 1517456 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-04
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Computerised tomogram, Intestinal obstruction, Peritonitis
SMQs:, Gastrointestinal obstruction (narrow), Gastrointestinal perforation (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210531; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination; Test Date: 20210604; Test Name: CT; Result Unstructured Data: Test Result:intestinal obstruction
CDC Split Type: JPPFIZER INC2021904404

Write-up: Intestinal obstruction; Peritonitis; This is a spontaneous report from a contactable physician received from Medical Devices Agency. A 91-year-old male patient received BNT162B2 (COMIRNATY) at the age of 91-years-old, via an unspecified route of administration on 31May2021 14:30 (Batch/Lot Number: EY0779; Expiration Date: 31Aug2021) as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient was a 91-year-old male. Body temperature before vaccination was 36.2 degrees centigrade. Family history was not reported. 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). On 04Jun2021 (4 days after the vaccination), the patient experienced intestinal obstruction and peritonitis, the patient was admitted to the hospital, the outcome of the events was fatal. The course of the event was as follows: After the vaccination, the patient had abdominal pain and diarrhoea. The symptoms tended to alleviate. On 03Jun2021, mild abdominal pain recurred, and the patient had bloating. Since there was no improvement, on 04Jun2021, the patient visited a hospital. As a result of CT, diagnosis of intestinal obstruction was made, for which the patient was hospitalized. Subsequently, on the same day, the patient developed peritonitis and died. The patient died on 04Jun2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Intestinal obstruction; Peritonitis


VAERS ID: 1517461 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-31
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: JPPFIZER INC2021905756

Write-up: Death; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date in 2021 (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. It was reported that on unknown date in 2021 (the day of vaccination), the patient received a single dose of BNT162b2. On unknown date in 2021 (unknown days after the vaccination), the patient experienced death. The course of the event was as follows: On unknown date in 2021, the patient died shortly after s/he went home. The outcome of event was fatal. It was not reported if an autopsy was performed.; Sender''s Comments: The reported event of death with unknown cause is considered as related due to lack of information. The company processes "death cause unknown" cases as possibly related and documents them as related in the global safety database unless information is provided that allows the Company to exclude that there is a reasonable possibility of relatedness to the suspect product. The case will be reassessed once more information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Different patient, different AE, same reporter, same drug; Reported Cause(s) of Death: death


VAERS ID: 1517474 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-06-30
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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: 2021-06-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021908099

Write-up: Sudden death; This is a spontaneous report from a contactable consumer received via Medical Information Team. An 83-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 22Jun2021 (the day of vaccination, Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 30Jun2021 (8 days after the vaccination), the patient experienced sudden death. The patient died on 30Jun2021. It was not reported if an autopsy was performed. The reported event was as follows: On 22Jun2021 (the day of vaccination), the patient received the first dose of BNT162b2 vaccination. On 30Jun2021 (8 days after vaccination), the patient experienced sudden death. The patient had no underlying diseases and he died suddenly. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1517607 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-12
Onset:2021-04-15
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Nasopharyngitis, 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: 2021-04-15
   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: HYDROCORTISONE; NIFEDIPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Left ventricular hypertrophy; Polymyalgia rheumatica; Subclinical hypothyroidism
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202100915914

Write-up: mild cold/Common cold; Death, acute/Sudden death; This is a spontaneous report from a contactable consumer downloaded from the Medicines Agency. A 74-year-old male patient received bnt162b2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration on 12Apr2021 as dose 1, single for COVID-19 immunisation. Medical history included subclinical hypothyroidism, hypertension, left ventricular hypertrophy and polymyalgia rheumatica from an unknown date. Concomitant medications included hydrocortisone and nifedipine, both taken for an unspecified indication, start and stop dates were not reported. The patient experienced Death, acute/Sudden death on 15Apr2021 and mild cold/common cold on an unspecified date. The clinical course was as follows: Patient was found collapsed in a shower cabinet. He was alone and found a couple of minutes later. Resuscitation was unsuccessful. Cause of death remains unknown: possible arrhytmia, myocardial infarct, cerebral hemorrhage. No autopsy is done. As far as known patient had no side effects after vaccination. On the day of his death patient had symptoms of a common cold, no fever. The outcome of the event Death, acute/Sudden death was fatal, while of mild cold/common cold was unknown. The patient died on 15Apr2021. An autopsy was not performed. Reporter Comment: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no Additional information ADR: Acute death Previous COVID-19 infection: No 14Jul2021 Follow up received: 1. Natural death. I don''t know what is listed. differential diagnosis arrhythmia, myocardial infarction, massive brain haemorrhage (GP told me), 2. No known side effects, 3. I thought a mild cold, not a fever, 4. Collapsed in shower cubicle, tap was not on yet. He was alone, was found a few minutes later., 5. Polymyalgia rheumatica, subclinical hypothyroidism, hypertension, left ventricular hypertrophy, 6. 1x recording due to a torn knee ligament for which OK, 7. High Blood Pressure $g Nifedipine. polymyalgia rheumatica $g hydrocortisone, low dose, 8. Vital man, lived independently with wife, 9. No deteriorating health, except rheumatism complaints since 1 yr, which got better. No other complaints, vital., 10. No, not tested, 11. No autopsy done Assessor Lareb: FU received. No autopsy, cause of death remains unknown. Cold reaction added. Medical history added. Comedication added. Summary edited. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected; Reporter''s Comments: summary: BioNTech/Pfizer vaccine (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no Passing away Additional information ADR: Acute death COVID-19 Previous COVID-19 infection: No; Reported Cause(s) of Death: Death, acute


VAERS ID: 1517608 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-12
Onset:2021-04-26
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Oedema peripheral
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (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)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-12
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NOVORAPID
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202100915727

Write-up: cardiac arreststil; Fat ankles, death; Fat legs, death; This is a spontaneous report from a contactable consumer downloaded from the Medicines Agency. This serious spontaneous report from a consumer professional concerned a female aged 74 years. A 74-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 12Apr2021 (Batch/Lot Number: Unknown) as DOSE 1, SINGLE for COVID-19 immunisation. The patient''s medical history was not reported. Concomitant medication included insulin aspart (NOVORAPID). The patient had no previous COVID-19 infection. The patient experienced fat ankles, death and fat legs, death on 26Apr2021 with fatal outcome; and cardiac arreststil on 12May2021 with fatal outcome. The patient died on 12May2021. It was not reported if an autopsy was performed. Reporter''s comment: BioNTech/Pfizer vaccine (Comirnaty). Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no. Previous COVID-19 infection: No. No follow-up attempts are possible, information on batch number cannot be obtained.; Reporter''s Comments: BioNTech/Pfizer vaccine (Comirnaty). Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no. Previous COVID-19 infection: No.; Reported Cause(s) of Death: Fat ankles, death; Fat legs, death; cardiac arreststil


VAERS ID: 1517613 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-06-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Fatigue, Malaise, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ANTIGRIPPINE [ASCORBIC ACID;CAFFEINE;PARACETAMOL]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202100948822

Write-up: Myalgia; Not feeling well; Fatigue; Pain in the joints; Cold shivers; This is a spontaneous report received from a contactable consumer or other non hcp downloaded from the Medicines Agency. A 65-years-old male patient received a dose of bnt162b2 (COMIRNATY, Batch/Lot Number: Unknown), via an unspecified route of administration on 15Jun2021 as Dose number unknown, Single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included ascorbic acid, caffeine, paracetamol (ANTIGRIPPINE) taken for an unspecified indication, start and stop date were not reported. On 16Jun2021, the patient experienced myalgia, not feeling well, fatigue, pain in the joints, cold shivers. The patient died on an unspecified date. Therapeutic measures were taken as a result of myalgia, not feeling well, fatigue, pain in the joints, cold shivers. The patient died on an unspecified date. It was not reported if an autopsy was performed. The patient was treated with Ibuprofen. The clinical outcome of event was fatal. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccin (Comirnaty): unknown Previous COVID-19 infection: No; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1517647 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-31
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: NZPFIZER INC2021908105

Write-up: death; This is a spontaneous report from a contactable other health care professional via the Medsafe. Regulatory authority report number is unknown. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: death


VAERS ID: 1517648 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-31
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: NZPFIZER INC2021908116

Write-up: death; This is a spontaneous report from a contactable other health care professional via the Medsafe. Regulatory authority report number is unknown. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: death


VAERS ID: 1517649 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-31
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: NZPFIZER INC2021908122

Write-up: death; This is a spontaneous report from a contactable other health care professional via the Medsafe. Regulatory authority report number is unknown. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: death


VAERS ID: 1517650 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-31
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: NZPFIZER INC2021908123

Write-up: death; This is a spontaneous report from a contactable other health care professional via the Medsafe. Regulatory authority report number is unknown. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), 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 died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: death


VAERS ID: 1517651 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-31
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: NZPFIZER INC2021908124

Write-up: death; This is a spontaneous report from a contactable other health care professional via the Med safe. Regulatory authority report number is unknown. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: death


VAERS ID: 1517652 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-31
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: NZPFIZER INC2021908125

Write-up: death; This is a spontaneous report from a contactable other health care professional via the Med safe. Regulatory authority report number is unknown. A patient of unspecified age and gender received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced death on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about Lot/Batch number cannot be obtained.; Reported Cause(s) of Death: death


VAERS ID: 1517653 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-31
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: NZPFIZER INC2021908126

Write-up: death; This is a spontaneous report from a contactable other health care professional via the Medsafe. Regulatory authority report number is unknown. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), 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 died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: death


VAERS ID: 1517654 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-31
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: NZPFIZER INC2021908127

Write-up: death; This is a spontaneous report from a contactable other health care professional via the . Regulatory authority report number is unknown. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: death


VAERS ID: 1517694 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-03
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Embolism, Infarction, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-06
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension (Patient was taking medications for the treatment of hypertension.); Post-traumatic epilepsy (Patient was taking medications for the treatment of post-traumatic epilepsy)
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLJNJFOC20210758721

Write-up: FEVER 38.0 - 38.4 C LASTING UP TO 48 HOURS; SUSPICION OF INFARCTION/EMBOLISM; SUSPICION OF INFARCTION/EMBOLISM; This spontaneous report received from a physician via a Regulatory Authorityconcerned a 47 year old male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included hypertension, and post-traumatic epilepsy. The patient was on medication for treatment of hypertension, and post-traumatic epilepsy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD975 expiry: 27-OCT-2021) 0.5 dose (units unspecified), 1 total administered on 27-MAY-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 03-JUN-2021; 20:30, the patient experienced suspicion of infarction/embolism (coded as Infarction), suspicion of infarction/embolism (coded as embolism). On an unspecified date, the patient experienced fever 38.0 - 38.4 c lasting up to 48 hours. On 03-JUN-2021, the subject died from infarction, and embolism. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of suspicion of infarction/embolism (Infarction) and suspicion of infarction/embolism (embolism) on 03-JUN-2021, and the outcome of fever 38.0 - 38.4 c lasting up to 48 hours was not reported. This report was serious (Death, and Other Medically Important Condition).; Covid-19 vaccine ad26.cov2.s- Suspicion of infarction/embolism(Embolism), Suspicion of infarction/embolism(Infarction). 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: UNDERLYING DISEASE -Covid-19 vaccine ad26.cov2.s-Fever 38.0 - 38.4?C lasting up to 48 hours. This event(s) is labeled per RSI and is therefore considered potentially related.; Reported Cause(s) of Death: INFARCTION; EMBOLISM


VAERS ID: 1517701 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-07
Onset:2021-06-21
   Days after vaccination:45
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2172 / 2 - / OT

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: 2021-06-24
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC202100949261

Write-up: stroke; This is a spontaneous report from a contactable consumer downloaded from the Medicines Agency. A 69-years-old male patient received BNT162B2 (COMIRNATY; Solution for injection; Batch/Lot Number: EY2172; CAUL (Additional information on drug): 22021), dose 2 intramuscular on 07May2021 as dose 2, 0.3ml single for COVID-19 immunisation. The indication verbatim was reported as indicated for active immunization to prevent COVID-19 caused by the SARS-CoV-2 virus. The patient medical history and concomitant medications were not reported. The patient previously took BNT162B2 (COMIRNATY; Solution for injection; Batch/Lot Number: EW2243; (CAUL (Additional information on drug): 17621), dose 1 Intramuscular on 09Apr2021 as dose 1, 0.3 ml single for COVID-19 immunisation. On 21Jun2021, the patient experienced stroke. The adverse reaction (ADR) started 45 days after the administration of the 2nd dose of the suspected vaccine. The notifier was contacted in order to obtain additional information, but no response was obtained, so the clinical history, concomitant medication and results of complementary diagnostic tests are unknown. The patient was hospitalized and died 3 days later. The patient died due to Stroke on 24Jun2021. It is unknown whether an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Stroke


VAERS ID: 1517765 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 30
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: SEPFIZER INC202100915865

Write-up: HEAVY TO BREATHE; GENERAL FEELING OF ILLNESS; TIREDNESS; This is a spontaneous report from a contactable consumer professional downloaded from the Medicines Agency. This consumer reported different events for the same patient after different vaccine doses. This is the first of two reports. Both cases are serious. An 80-year-old female patient received the first dose of BNT162B2 (COMIRNATY, solution for injection) via an unspecified route of administration on Apr2021 (Lot Number: Unknown) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. A few days after the first vaccination in Apr2021, patient experienced general feeling of illness (general malaise), tiredness (fatigue) and heavy to breathe (difficulty breathing). The second dose was given in May2021 (as reported). The outcome of the events was fatal. The case was reported as serious, death. The patient died in May2021. An autopsy was performed and results were not provided. No follow-up attempts are possible. Information on batch number cannot be obtained.; Reported Cause(s) of Death: HEAVY TO BREATHE; GENERAL FEELING OF ILLNESS; TIREDNESS


VAERS ID: 1517801 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-03-12
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Aphasia, Cerebral ischaemia, Computerised tomogram head, Facial paralysis, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Ischaemic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   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:
Allergies:
Diagnostic Lab Data: Test Date: 20210312; Test Name: CT angiography; Result Unstructured Data: Test Result:without occlusion or stenosis of cerebral vessels.; Comments: without occlusion or stenosis of cerebral vessels.; Test Date: 20210312; Test Name: CT brain; Result Unstructured Data: Test Result:without early focal changes and sign of dense arte; Comments: without early focal changes and sign of dense artery, CT angiography without occlusion or stenosis of cerebral vessels.; Test Date: 20210313; Test Name: CT brain; Result Unstructured Data: Test Result:developed ischaemia on the right frontoparietal an; Comments: developed ischaemia on the right frontoparietal and frontotemporal and in the basal ganglia.
CDC Split Type: SKPFIZER INC2021904877

Write-up: Focal cerebral ischaemia; his right oral corner hung /expressive aphasia/right hemiparesis /left hemiplegia developed; right upper limb weakened; his right oral corner hung /expressive aphasia/right hemiparesis /left hemiplegia developed; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency. Case is a spontaneous serious case report sent by a physician. A 97-year-old male patient received bnt162b2 (COMIRNATY), via intramuscular on 24Feb2021 (Batch/Lot Number: Unknown) as DOSE 2, SINGLE for covid-19 immunisation. Concomitant therapy, medical history and additional details were not reported and have been requested. The patient experienced focal cerebral ischaemia on 12Mar2021. On 12Mar2021, the patient stopped talking, his right oral corner hung and his right upper limb weakened. Clinically on admission the patient had the expressive aphasia, he understood everything, but he had right hemiparesis with a central lesion of facial nerve (CN VII). Two hours later, left hemiplegia developed. The patient was transferred to the Geriatric Department, where he died shortly after. CT of the brain (12Mar2021): without early focal changes and sign of dense artery, CT angiography without occlusion or stenosis of cerebral vessels. CT of the brain (13Mar2021): developed ischaemia on the right frontoparietal and frontotemporal and in the basal ganglia. NUL - Focal cerebral ischemia right fronto-temporally and in the basal ganglia, clinically aphasia, right-sided hemiparesis. Causality assessment assessed by the pathologist was not yet available. The patient died in Mar2021. It was not reported if an autopsy was performed. The outcome of event focal cerebral ischaemia was reported as fatal, outcome of other event was unknown. No follow-up attempts possible. No further information expected. Information on batch number cannot be obtained.; Reported Cause(s) of Death: Focal cerebral ischaemia


VAERS ID: 1517802 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-05-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Guillain-Barre syndrome, Paraesthesia, Paraesthesia oral, Pneumonia
SMQs:, Peripheral neuropathy (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-07
   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: Medical History/Concurrent Conditions: Chronic obstructive pulmonary disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: SKPFIZER INC2021904912

Write-up: Paraesthesia of limbs; Paraesthesia tongue; Weakness; Pneumonia; Guillain-Barre syndrome; This is a spontaneous report from a contactable consumer downloaded from the- Medicines Agency. This is the first of two reports reporting different events for different vaccine doses for the same patient. A 71-year-old male patient received BNT162B2 (COMIRNATY) intramuscular on 28Apr2021 (Batch/Lot Number: Unknown) as dose 2, single for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease. The patient''s concomitant medications were not reported. The patient previously received first dose of COMIRNATY (lot number were not reported) and experienced weakness and pain in upper extremity. The patient experienced guillain-barre syndrome on 01May2021 with outcome of fatal, pneumonia on an unspecified date with outcome of fatal, paraesthesia of limbs and paraesthesia tongue on 02May2021 with outcome of unknown, weakness on an unspecified date with outcome of unknown. The patient was hospitalized for paraesthesia of limbs and paraesthesia tongue from 02May2021. The patient died on 07May2021. An autopsy was performed and results were not provided. After the second dose, the patient was weaker. On the fourth day the patient had paraesthesia of upper and lower extremities and tongue. Emergency services was called on 02May2021 in the morning. The patient was hospitalized on Department of Neurology. The patient experienced Guillain-Barre syndrome. He could not cough as usual. Mucus accumulated in his lungs and he got severe pneumonia. On the third day of the hospitalization, the patient was transferred to the Department of Anesthesiology and Intensive Medicine, where he was in artificial sleep. The patient died on 07May2021. Autopsy was done. Guillain-Barre syndrome and pneumonia were assessed as cause of death. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Guillain-Barre syndrome; pneumonia


VAERS ID: 1517803 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-04
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-04
   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: SKPFIZER INC2021904956

Write-up: Death; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Medicines Agency. An 89-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 01Apr2021 (Batch/Lot Number: Unknown), dose 1 on 03Mar2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported, after being vaccinated with the second dose of experimental gene therapy Comirnata from Pfizer / Biontech, in the 3rd and 4th phases of the clinical trial, the patient died within 72 hours (on 04Apr2021). It was the direct cause of her death. Her health was probably excellent, she could be part of the experiment. Ask for more information from the MD, who agreed and evaluated the health status of people in DSS. Cause of death and information about autopsy were not reported. Causality assessment assessed by the pathologist is not yet available. The primary source assessed death of the patient as a direct cause. No follow-up attempts are possible, information on batch number cannot be obtained.; Reporter''s Comments: The primary source assessed death of the patient as a direct cause.; Reported Cause(s) of Death: unknown cause of death


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

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Myalgia, Pyrexia, Sepsis
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

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

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


VAERS ID: 1518329 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-07-12
   Days after vaccination:41
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Dyspnoea
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 (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad)

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: Cardiac disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202100909570

Write-up: Cardiac arrest; Shortness of breath; This is a spontaneous report from a contactable other health care professional. A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 01Jun2021 (at the age of 69-years-old) as dose number unknown, single for covid-19 immunisation. Medical history included cardiac disorder. The patient concomitant medications were not reported. On 12Jul2021, the patient experienced cardiac arrest and shortness of breath. The event cardiac arrest assessed as serious (death, medically significant). On 12Jul2021, the patient died. An autopsy was not performed. The outcome for shortness of breath was unknown as reported. Case comment: Based on available information, a possible contributory role of bnt162b2 vaccine can not be excluded for the reported event of Cardiac arrest due to temporal relationship and current known drug safety profile. Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product was 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, would be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. No further information was available at the time of this report.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1518330 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-09
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FB0927 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Death, Fibrin D dimer, Fibrin D dimer increased, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage laboratory terms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210709; Test Name: Fibrin D-dimer; Result Unstructured Data: Test Result:$g20
CDC Split Type: ZAPFIZER INC202100909601

Write-up: Died; Chest pain; D-Dimer $g20; Vomiting; This is a spontaneous report from a contactable other healthcare professional. A 69-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection), dose 1 via an unspecified route of administration on 01Jul2021 (Batch/Lot Number: FB0927, Expiry date was not reported) (at the age of 69-years-old) as dose 1, single for covid-19 immunisation. Medical history included hypertension. The patient''s concomitant medications were not reported. On 09Jul2021, the patient experienced chest pain in the morning; vomiting and had a d-dimer $g20. On the same day, the patient died (cause: not reported). Laboratory test on 09Jul2021 included Fibrin D dimer was $g20. An autopsy was not performed. The outcome of the events chest pain, vomiting and d-dimer $g20 was unknown. No further details were provided at the time of this report. ; Sender''s Comments: Based on the limited information in the case report, a meaningful medical assessment is not possible and a causal relationship between event death and suspect product BNT162B2 cannot be completely ruled out. The case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: death


VAERS ID: 1518331 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-30
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaemia, Asthenia, Blood iron, Blood iron increased, Chest pain, Death, Dizziness, Dyspnoea, HIV test, Haematocrit decreased, Haemoglobin decreased, Mean cell haemoglobin concentration, Mean cell haemoglobin concentration decreased, Mean cell volume, Mean cell volume increased, Monocyte count, Monocyte count increased, Pain, Platelet count, Platelet count decreased, Productive cough, Red blood cell count, Red blood cell count decreased, Red blood cell sedimentation rate, Red blood cell sedimentation rate increased, Red cell distribution width, Red cell distribution width increased, Reticulocyte count, Reticulocyte count decreased, Serum ferritin, Serum ferritin increased, White blood cell count, White blood cell count decreased
SMQs:, Anaphylactic reaction (broad), Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-10
   Days after onset: 10
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: Renal impairment
Allergies:
Diagnostic Lab Data: Test Date: 20210630; Test Name: HIV; Result Unstructured Data: Test Result:negative; Test Date: 20210708; Test Name: red blood cell count low; Result Unstructured Data: Test Result:low; Test Date: 20210708; Test Name: hemoglobin low; Result Unstructured Data: Test Result:low; Test Date: 20210708; Test Name: haematocrit low; Result Unstructured Data: Test Result:low; Test Date: 20210708; Test Name: MCV high; Result Unstructured Data: Test Result:high; Test Date: 20210708; Test Name: red cell distribution width high; Result Unstructured Data: Test Result:high; Test Date: 20210708; Test Name: MCHC low; Result Unstructured Data: Test Result:low; Test Date: 20210708; Test Name: Platelet count low; Result Unstructured Data: Test Result:low; Test Date: 20210708; Test Name: monocytes high; Result Unstructured Data: Test Result:high; Test Date: 20210708; Test Name: iron high; Result Unstructured Data: Test Result:high; Test Date: 20210708; Test Name: ferritin high; Result Unstructured Data: Test Result:high; Test Date: 20210708; Test Name: white blood cell count low; Result Unstructured Data: Test Result:low; Test Date: 20210708; Test Name: reticulocyte count low; Result Unstructured Data: Test Result:low; Test Date: 20210708; Test Name: ESR high; Result Unstructured Data: Test Result:high
CDC Split Type: ZAPFIZER INC202100909620

Write-up: Death; Symptomatic anaemia; Red blood cell count low; Hemoglobin low; Haematocrit low; MCV high; Red cell distribution width high; MCHC low; Platelet count low; Monocytes high; Iron high; Ferritin high; White blood cell count low; Reticulocyte count low; ESR high; Chest pain; Difficulty breathing; Body pain; Weakness; Productive cough; Dizziness; This is a spontaneous report from a contactable physician. A 85-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: Not reported) via unspecified route of administration, administered on an unspecified date for covid-19 immunization. Medical history included renal impairment. The patient''s concomitant medications were not reported. On 30Jun2021, the patient experienced body pain, weakness, productive cough, dizziness, chest pain, difficulty breathing, had symptomatic anemia. On 08Jul2021, the lab results red blood cell count low, hemoglobin low, hematocrit low, MCV high, red cell distribution width high, MCHC low, Platelet count low, monocytes high, iron high, ferritin high, white blood cell count low, reticulocyte count low, ESR high. On 30Jun2021 patient underwent HIV test: negative. The patient died on 10Jul2021. An autopsy was not performed. Outcome of the events was unknown except death which is fatal. No further information was available in the time of this report. ; Sender''s Comments: As there is limited information in the case provided, the causal association between the event death and the suspect drug BNT162b2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1518337 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-07
Onset:2021-06-30
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7812 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-02
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202100942000

Write-up: Thrombocytopenia; Death; This is a spontaneous report from a contactable physician. An 81-year-old female patient received BNT162b2 (COMIRNATY) first single dose administration on 07Jun2021 at 12:29 (Batch/Lot Number: FA7812; Expiration Date: 30Sep2021) for covid-19 immunization at age of 81-year-old. The patient''s medical history and concomitant medications were not reported. The patient developed thrombocytopenia (hospitalization) on 30Jun2021. The patient is reported to have died on 02Jul2021. The cause of death was not reported. It was not reported if an autopsy was performed. Outcome of the event thrombocytopenia was unknown.; Sender''s Comments: The information available in this report is limited, and does not allow a medically meaningful assessment of the case. The event die is assessed as related to the suspect drug per company guidance. A contributory role of BNT162B2 to event thrombocytopenia cannot be excluded based on temporal association and available information. The case will be re-assessed when relevant information, particularly the cause of death, 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: Death


VAERS ID: 1519184 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-05
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Haemorrhagic stroke
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)

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, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Esophageal varices; Hepatic cirrhosis
Preexisting Conditions: Comments: The patient was in compromised health. It was reported that the patient was not pregnant
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESJNJFOC20210763703

Write-up: DEATH; NON-THROMBOCYTOPENIC HEMORRHAGIC STROKE; This spontaneous report received from a consumer via a company representative concerned a 7 decade old (reported in her 60''s) female of an unspecified race and ethnic origin. The patient''s height, and weight were not reported. The patient''s concurrent conditions included cirrhosis, and esophageal varices. The patient''s pre-existing medical condition included that she was in compromised health. It was reported that the patient was not pregnant. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, and expiry: unknown) dose, start therapy date were not reported, frequency time was 1 total administered on an unspecified date in JUN-2021 (reported as died about 15 days after receiving the vaccination) for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-JUL-2021, the patient was hospitalized for 1 day due to a stroke and she was died at 08:00 on unspecified date. The hospital did not link the death to the vaccine, they have diagnoses for stroke as a non-thrombocytopenic hemorrhagic stroke. It was unspecified if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died on an unspecified date, and the outcome of non-thrombocytopenic hemorrhagic stroke was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0 20210763703-COVID-19 VACCINE AD26.COV2.S-Death, non-thrombocytopenic hemorrhagic stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1519203 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Suspected COVID-19, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: ITJNJFOC20210763420

Write-up: SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer via a representative from a concerned a 78-year-old male. Initial information was processed along with the additional information received on 30-JUL-2021 The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, 1 in total administered on 04-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 an unspecified date, the patient deceased with COVID diagnosis (suspected covid-19 infection) one month after vaccination (suspected clinical vaccination failure). The patient was hospitalized. Number of days of hospitalization were not reported. The action taken with covid-19 vaccine was not applicable. The patient died of suspected covid-19 infection on an unspecified date in 2021, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210764741. Sender''s Comments: V0:20210763420 JANSSEN COVID-19 VACCINE. Suspected covid19 infection 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). V0:20210763420 JANSSEN COVID-19 VACCINE. Suspected clinical vaccination failure. 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: SPECIAL SITUATIONS; Reported Cause(s) of Death: COVID DIAGNOSIS


VAERS ID: 1519235 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-28
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210764217

Write-up: CHEST PAIN; This spontaneous report received from a health care professional via a representative concerned a 50 years above old male of an unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, frequency 1 total administered on 28-JUL-2021 for prophylactic vaccination at half past 09.00 (09:30). The batch number was not reported and has been requested. No concomitant medications were reported. On 28-JUL-2021, the patient complained of chest pain shortly. He was given Epinephrine within 15 mins. Patient was brought to hospital where he died within 30 mins from chest pains. The action taken with covid-19 vaccine was not applicable. This report was serious (Death). Sender''s Comments: V0:20210764217-Covid-19 vaccine. Chest pain. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Reported Cause(s) of Death: CHEST PAINS


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-25
   Days after onset: 30
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 PCR test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: BEMODERNATX, INC.MOD20212

Write-up: COVID-19 infectie na vaccinatie; This regulatory authority case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID-19 infectie na vaccinatie) in a 59-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 10-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced COVID-19 (COVID-19 infectie na vaccinatie) (seriousness criteria death and hospitalization). The patient died on 25-Jun-2021. The reported cause of death was covid-19 infectie na vaccinatie. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication information was not reported. Treatment medication was not reported. Company comment: Based on biological implausibility, a causal relationship between the reported serious unexpected event COVID-19 developed 1 month 17 days after the administration of mRNA-1273 is assessed as unlikely. The event was more consistent with the increased risk of environmentally mediated COVID-19 infections (including fatal infections) due to ongoing COVID-19 pandemic. Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Additional information included patient''s death details, updated laboratory data, updated dosing details and updated event details.; Sender''s Comments: Based on biological implausibility, a causal relationship between the reported serious unexpected event COVID-19 developed 1 month 17 days after the administration of mRNA-1273 is assessed as unlikely. The event was more consistent with the increased risk of environmentally mediated COVID-19 infections (including fatal infections) due to ongoing COVID-19 pandemic.; Reported Cause(s) of Death: COVID-19 infectie na vaccinatie


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic asthma; Left bundle branch block
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20212

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


VAERS ID: 1520533 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-26
Onset:2021-07-11
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8274 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-11
   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: PARACETAMOL; ENALAPRIL PENSA; SIMVASTATIN; CONDROSAN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202100920659

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency (RA)-WEB ES-AEMPS-945848. A 56-year-old male patient received BNT162b2 (COMIRNATY, Solution for injection, Lot number- FD8274) via intramuscularly on 26Jun2021 as dose 2 single for COVID-19 immunization. Medical history was not reported. Concomitant medications included oral paracetamol at 1000 mg from 21Jan2020 to an unknown date for traumatic arthropathy, oral enalapril maleate (ENALAPRIL PENSA) at 5 mg for hypertension from 22Jan2020 to an unknown date, oral simvastatina for hyperlipidaemia at 10 mg from 17Mar2017 to an unknown date, chondroitin sulfate (CONDROSAN) at 800 mg for Traumatic arthropathy from 10Jun2016 to an unknown date. Historical vaccine included BNT162b2 (COMIRNATY, Solution for injection, Lot number- FA5833) via an unspecified route of administration on 05Jun2021 as dose 1 single for COVID-19 immunization. It was reported that the second dose of Comirnaty had been administered 15 days before. It was reported that on 11Jul2021, the patient without serious illnesses is found death in cardiorespiratory arrest by his wife. The patient died on 11Jul2021. It was not reported if an autopsy was performed. The outcome of the event was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1520688 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-18
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Investigation, 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: 2021-07-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Smoker
Allergies:
Diagnostic Lab Data: Test Date: 202107; Test Name: post-mortem clinical examination; Result Unstructured Data: Test Result:Nothing particular
CDC Split Type: FRPFIZER INC202100948864

Write-up: Death sudden; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-PO20213715, Safety Report Unique Identifier FR-AFSSAPS-2021096363. A 54-year-old male patient received bnt162b2 (COMIRNATY, Batch/Lot Number: Unknown), dose 2 intramuscular on 01Jul2021 as 0.3 ml, single dose for covid-19 immunisation. Medical history included smoker. The patient''s concomitant medications were not reported. The patient experienced death sudden on 18Jul2021. The patient died on 18Jul2021. An autopsy was not performed. Case Summary and Reporter''s Comments: 01Jul2021: Second IM injection of Comirnaty (batch unknown). The 18Jul2021: Sudden death of the patient who is found in his bed. Nothing particular to the post-mortem clinical examination. No autopsy performed. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reporter''s Comments: 01Jul2021: Second IM injection of Comirnaty (batch unknown). The 18Jul2021: Sudden death of the patient who is found in his bed. Nothing particular to the post-mortem clinical examination. No autopsy performed.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1520797 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-13
Onset:2021-06-26
   Days after vaccination:133
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Endocarditis noninfective, Heart injury, Intracardiac thrombus, Myocarditis, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), 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: 2021-06-26
   Days after onset: 0
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Antiphospholipid syndrome; Systemic sclerosis (Clinically stable prior to the vaccination with improvement of her systemic sclerosis)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100922986

Write-up: Intracardiac thrombus, intra myocardial capillary thrombosis; breathless; mitral valve destruction; Nonbacterial thrombotic endocarditis; Acute myocarditis; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107161405463720-Z3IZH. Safety Report Unique Identifier is GB-MHRA-ADR 25664073. A 42-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Feb2021 as single dose for COVID-19 immunisation. The patient previously received the first dose on an unspecified date. Medical history included ongoing antiphospholipid syndrome and ongoing systemic scleroderma (clinically stable prior to the vaccination with improvement of her systemic sclerosis). She has not had symptoms associated with COVID-19 and was not enrolled in clinical trial. The patient''s concomitant medications included unspecified anticoagulant. The patient experienced nonbacterial thrombotic endocarditis and acute myocarditis on 26Jun2021, intracardiac thrombus and breathless on an unspecified date. Case narrative: Acute myocarditis, nonbacterial thrombotic endocarditis. This patient was a complex case. She had systemic sclerosis and antiphospholipid syndrome. She was on anticoagulants. She had been clinically stable prior to the vaccination with improvement of her systemic sclerosis. She became acutely breathless over 48 hours and was admitted but despite care in critical care unit (CCU) with inotropic support she passed away. She has subsequently had a post-mortem which was unable to exclude the vaccine as a cause for her death. The extent of her mitral valve destruction was noted as was intra myocardial capillary thrombosis. In physician''s opinion, the vaccine was a major contributory factor in her death. She has not tested positive for COVID-19 since having the vaccine. She underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on an unknown date. The patient died on 26Jun2021. Cause of death was nonbacterial thrombotic endocarditis. The outcome of acute myocarditis was not recovered, while outcome of other events was unknown. Case was reported as serious by health authority (resulted to death, hospitalization, and disability). No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Nonbacterial thrombotic endocarditis


VAERS ID: 1521259 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-03-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Apnoea, Biopsy heart, Biopsy kidney, Biopsy liver, Biopsy lung, Cardiac arrest, Cyanosis, Death, Fatigue, Myalgia, Mydriasis, Pulmonary embolism
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-05
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: COPD (Without medication); Hypercholesterolemia (Regulated with medication); Hypertension (Regulated with medication)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210407; Test Name: Biopsy of heart; Result Unstructured Data: PULMONARY EMBOLISM; Comments: .; Test Date: 20210407; Test Name: Biopsy of kidney; Result Unstructured Data: PULMONARY EMBOLISM- histological part of kidney.; Test Date: 20210407; Test Name: Biopsy of liver; Result Unstructured Data: PULMONARY EMBOLISM- histological part of liver; Test Date: 20210407; Test Name: Biopsy of lung; Result Unstructured Data: PULMONARY EMBOLISM- histological part of lungs
CDC Split Type: GRMODERNATX, INC.MOD20212

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


VAERS ID: 1521274 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-06-25
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Pneumonia, Pulmonary embolism, Pulmonary infarction
SMQs:, Embolic and thrombotic events, venous (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-07
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma; Hypertension; Non-insulin-dependent diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Cholelithiasis; COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: CT- angiography; Result Unstructured Data: Test Result:bilateral embolism of pulmonary arteries; Comments: bilateral embolism of pulmonary arteries and infarction with pneumonia. Slight cardiomegaly was detected
CDC Split Type: HUPFIZER INC202100922301

Write-up: Bilateral embolism in pulmonary arteries and pneumonia with infarcion; Bilateral embolism in pulmonary arteries and pneumonia with infarcion; Bilateral embolism in pulmonary arteries and pneumonia with infarcion; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number HU-OGYI-651121. A 54-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 21Jun2021 (Batch/Lot Number: Unknown) as 0.3 ml single for COVID-19 immunization. Medical history included ongoing asthma, cholelithiasis from an unknown date and unknown if ongoing, ongoing hypertension, ongoing non-insulin-dependent diabetes mellitus, COVID-19 from Mar2021 to an unknown date (not ongoing). He has not taken regularly his medicines. The patient''s concomitant medications were not reported. The patient previously received bnt162b2 (COMIRNATY), dose 1 intramuscular on an unspecified date (Batch/Lot Number: Unknown) as 0.3 ml single for COVID-19 immunization. This spontaneous, serious report from a physician describes the occurrence of lung embolism after vaccination with COMIRNATY (tozinameran). The patient experienced bilateral embolism in pulmonary arteries and pneumonia with infarcion on 25Jun2021. On 21Jun2021, the 54 years old male patient received the second dose of COMIRNATY (concentrate for dispersion injection; active substance: tozinameran - 1 dose (0.3 mL) contains 30 micrograms of COVID-19 mRNA vaccine; lot number: unknown, expiry date: unknown, MAH: BioNTech Manufacturing GmbH) intramuscularly for COVID-19 immunisation. On 25Jun2021, the patient had dyspnoea and collapsed after doing physical work. The patient was reanimated and was submitted to intensive care unit. CT- angiography (in 2021) has found bilateral embolism of pulmonary arteries and infarction with pneumonia. Slight cardiomegaly was detected. Invasive ventilation was necessary and thrombolysis was started. The patient''s condition was continuously worsening. The patient died on 07Jul2021. It was not reported if an autopsy was performed. Sender Comment: Lung embolism is not expected adverse event of COMIRNATY. It might have been related to the patient''s uncontrolled cardiovascular diseases and previous COVID-19. TTO was 4 days. Based on the above, causality between the lung embolism and COMIRNATY is unlikely. The case is serious because the patient died. No further information is expected. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Bilateral embolism in pulmonary arteries and pneumonia with infarcion; Bilateral embolism in pulmonary arteries and pneumonia with infarcion; Bilateral embolism in pulmonary arteries and pneumonia with infarcion


VAERS ID: 1521353 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-05-06
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

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


VAERS ID: 1521371 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-04-26
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6327 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Body temperature, Loss of consciousness, Peripheral swelling, Pyrexia, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-15
   Days after onset: 80
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: XATRAL; DIBASE; BLOPRESID; COUMADIN; BRIMICA GENUAIR; DELTACORTENE; CEDRAVIS; CARVEDILOL; LASIX [FUROSEMIDE]; PRODUXEN; APIDRA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma-COPD overlap syndrome; Atrial fibrillation; Diabetes mellitus; Heart valvular prosthesis wearer; Left hemicolectomy; Mixed cryoglobulinaemia; Prostate adenoma
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:38 Centigrade
CDC Split Type: ITPFIZER INC202100948930

Write-up: After Pfizer on the third day severe abdominal pain, fever 38, severe shaking, unconsciousness, swelling of the limbs with runny serum.; After Pfizer on the third day severe abdominal pain, fever 38, severe shaking, unconsciousness, swelling of the limbs with runny serum.; After Pfizer on the third day severe abdominal pain, fever 38, severe shaking, unconsciousness, swelling of the limbs with runny serum.; After Pfizer on the third day severe abdominal pain, fever 38, severe shaking, unconsciousness, swelling of the limbs with runny serum.; After Pfizer on the third day severe abdominal pain, fever 38, severe shaking, unconsciousness, swelling of the limbs with runny serum.; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority. Report number IT-MINISAL02-759694. A 83-year-old male patient received bnt162b2 (COMIRNATY; solution for injection; Lot Number: EW6327; Expiration Date: Jul2021), dose 2 intramuscular, administered in left arm on 23Apr2021 as dose 2, 0.3 ml single for covid-19 immunisation. Medical history included left hemicolectomy from 01Jan2004 and unknown if ongoing, mixed cryoglobulinaemia, heart valvular prosthesis wearer, asthma-COPD overlap syndrome from, diabetes mellitus, atrial fibrillation, prostatic adenoma; all from an unknown date and unknown if ongoing. Concomitant medications included alfuzosin hydrochloride (XATRAL); colecalciferol (DIBASE); candesartan cilexetil/ hydrochlorothiazide (BLOPRESID); warfarin sodium (COUMADIN; tablet; strength: 5 mg); aclidinium bromide/ formoterol fumarate (BRIMICA GENUAIR); prednisone (DELTACORTENE) orally; risedronate sodium (CEDRAVIS; coated tablet; strength: 35 mg); carvedilol orally; furosemide (LASIX [FUROSEMIDE]); dutasteride (PRODUXEN); insulin glulisine (APIDRA); all taken for an unspecified indication, start and stop date were not reported. Patient historical vaccine includes Comirnaty dose 1 (batch number: ET7205) on 31Mar2021 in the left deltoid as dose 1, single for covid-19 immunisation. It was reported that after pfizer vaccine on the third day patient experienced severe abdominal pain, fever 38, severe shaking, unconsciousness, swelling of the limbs with runny serum on 26Apr2021. Patient underwent lab test which included body temperature which was 38 centigrade. The patient died on 15Jul2021. It was unknown if an autopsy was performed. Therapeutic measures were taken as a result of events. The outcome of the events was fatal. Reporters comments: Mitral valve replaced, mild diabetes caused by drugs, vasculitis cured by cortisone weakening the bones. I breathe a little labored, sometimes help with oxygen. Regulatory authority comments: 31Mar2021 at 17:23 first dose of Comirnaty vaccine (batch ET7205) in the left deltoid. Attached is the email sent by the daughter who made the report, who was also requested the clinical documentation that will be attached as soon as we receive it. No follow-up attempts possible. No further information expected. ; Reporter''s Comments: Mitral valve replaced, mild diabetes caused by drugs, vasculitis cured by cortisone weakening the bones. I breathe a little labored, sometimes help with oxygen.; Reported Cause(s) of Death: After Pfizer on the third day severe abdominal pain, fever 38, severe shaking, unconsciousness, swelling of the limbs with runny serum.; After Pfizer on the third day severe abdominal pain, fever 38, severe shaking, unconsciousness, swelling of the l


VAERS ID: 1521381 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-04-26
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Blood pressure decreased, Blood test, Discomfort, Dyspnoea, General physical health deterioration, Injury, Loss of consciousness, Lymphadenopathy, Mouth haemorrhage, Oedema peripheral, Peripheral swelling, Platelet count decreased, Pruritus, Pyrexia, Seizure, Sepsis, Serum sickness, Somnolence, Speech disorder, Transfusion, Tremor, Wheezing
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (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), Retroperitoneal fibrosis (broad), Dementia (broad), Convulsions (narrow), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-15
   Days after onset: 80
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: blood test; Result Unstructured Data: Test Result:platelets decreased; Comments: a severe drop in platelets was noted from blood counts
CDC Split Type: ITPFIZER INC202100939369

Write-up: no physical recovery in hospital; severe drop in platelets; Blood transfusion bag; shortness of breath; Lymph nodes on the left arm, where the serum leaks out; arm is severely swollen; the serum comes out of the legs; hospital septicemia; lowering of blood pressure; bleeding from mouth; seizures; to relieve the patient''s soul is to give him a little morphine; swollen legs; drowsiness; wheezing; belly speech; unconsciousness with trauma; trauma; itching; fever; Abdominal pain; severe tremor; This is a spontaneous report based on information received by Pfizer from Biontech [manufacturer control number: 74904], license party for Comirnaty, A Contactable reporter for male patient of an unspecified age received bnt162b2 (Comirnaty solution for injection lot number: not reported), dose 2 via an unspecified route of administration on 23Apr2021 as dose 2, single for covid-19 immunization. The patient medical history was not reported. The patients concomitant medications were not reported. Patients historical vaccine included first dose of bnt162b2 (Comirnaty solution for injection lot number: not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. In an emergency, the doctors decide to give two blood transfusion bags, but the clinical picture is very well occupied, shortness of breath, lymph nodes on the left arm where the serum leaks, the arm is severely swollen and very painful, including the legs, the serum comes out. Without further immune defense, obviously hospital septicemia. Lowering blood pressure. Finally, bleeding from the mouth, inhuman seizures in the hospital bed, the only solution to relieve the patients soul is to give them a little morphine. On an unspecified date, the patient experienced no physical recovery in hospital, severe drop in platelets, blood transfusion bag, shortness of breath, lymph nodes on the left arm, where the serum leaks out, arm is severely swollen, the serum comes out of the legs, hospital septicemia, lowering of blood pressure, bleeding from mouth, and to relieve the patients soul is to give him a little morphine. On 26Apr2021, the patient experienced severe abdominal pain, fever, and severe tremor. On 27Apr2021, the patient experienced itching , unconsciousness with trauma and trauma. On an unspecified date, the patient experienced swollen legs, drowsiness, wheezing, belly speech. The patient underwent lab tests and procedures which included blood test: platelets decreased on a severe drop in platelets was noted from blood counts. The patient died on 15Jul2021 in an unrecognizable devastated body that exploded. It was not reported if an autopsy was performed. The outcome of the events abdominal pain, fever, itching, severe tremor, unconsciousness with trauma, trauma, swollen legs, drowsiness, wheezing, and belly speech was unknown. Information regarding lot/batch number has been requested.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1521472 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-14
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0572 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Brain stem haemorrhage, Computerised tomogram head, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (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), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-18
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Dyslipidaemia; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210708; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination; Test Date: 20210714; Test Name: Head CT; Result Unstructured Data: Test Result:pontine hemorrhage
CDC Split Type: JPPFIZER INC202100918936

Write-up: respiratory failure; Pontine haemorrhage; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21120429. An 87-years-old male patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot Number: EY0572; Expiration Date: 31Oct2021), dose 1 via an unspecified route of administration on 08Jul2021 as single dose for covid-19 immunisation. Medical history included hypertension, diabetes mellitus, and dyslipidaemia. The patient''s concomitant medications were not reported. The patient was an 87-year and 0-month-old male. Body temperature before vaccination was 36.3 degrees centigrade. 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). On 14Jul2021 at an unknown time (6 days after the vaccination), the patient experienced pontine haemorrhage. On 18Jul2021 (10 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 14Jul2021, the event occurred with consciousness disturbed. The patient was diagnosed with pontine hemorrhage with a head CT. On 18Jul2021, the patient died from respiratory failure caused by pontine haemorrhage. The patient had underlying diseases such as hypertension, diabetes mellitus, and dyslipidaemia at risk of developing cerebrovascular disorders. A blood test showed no platelets decreased or abnormal coagulation ability. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases were hypertension, diabetes mellitus, and dyslipidaemia. The reporting physician commented as follows: It was not clear whether COMIRNATY triggered cerebral haemorrhage, and the causal relationship between the vaccination and pontine hemorrhage was unknown. Patient died on 18Jul2021. It was unknown if an autopsy was performed.; Reported Cause(s) of Death: Respiratory failure caused by pontine haemorrhage; Respiratory failure caused by pontine haemorrhage


VAERS ID: 1521476 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0201 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Adrenal insufficiency, Blood creatine phosphokinase, Blood creatine phosphokinase increased, Body temperature, C-reactive protein, C-reactive protein increased, Cardiac failure chronic, Gait disturbance, Guillain-Barre syndrome, Muscular weakness, Oxygen saturation, Oxygen saturation decreased, Pneumonia aspiration, Polymyositis, Procalcitonin, Procalcitonin increased, Pyrexia, Rhabdomyolysis, Septic shock
SMQs:, Rhabdomyolysis/myopathy (narrow), Acute renal failure (narrow), Cardiac failure (narrow), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (narrow), Myocardial infarction (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 (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Demyelination (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-19
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210719; Test Name: CPK; Result Unstructured Data: Test Result:hyper-CPK-emia; Test Date: 20210713; Test Name: Body temperature; Result Unstructured Data: Test Result:35.9 Centigrade; Comments: before vaccination; Test Date: 20210718; Test Name: Body temperature; Result Unstructured Data: Test Result:37.2 Centigrade; Test Date: 20210719; Test Name: C-reactive protein; Test Result: 22.84 mg/dl; Test Date: 20210718; Test Name: Oxygen saturation; Test Result: 80 %; Comments: 22:00, Under Oxygen supplementation 7L/min via reservoir mask.; Test Date: 20210718; Test Name: Oxygen saturation; Test Result: 93 %; Comments: Under Oxygen supplementation 10L/min via reservoir mask.; Test Date: 20210719; Test Name: Procalcitonin; Result Unstructured Data: Test Result:50.00 ng/ml
CDC Split Type: JPPFIZER INC202100919009

Write-up: SpO2 decreased to 80%; a fever of 37.2 centigrade; adrenal hypofunction; polymyositis; Rhabdomyolysis; difficulty in walking; Weakness of both lower extremities; Guillain-Barre syndrome; septic shock; suspected pneumonia aspiration; acute kidney injury; Cardiac failure chronic; hyper-CPK-emia; CRP: 22.84 mg/dL; procalcitonin 50.00 ng/mL; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21120927. A 79-years-old male patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection) via an unspecified route of administration on 13Jul2021 15:00 (Lot Number: EW0201; Expiration Date: 30Sep2021) as dose 2, single (at age of 79-years-old) for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient''s family history was not reported. body temperature: 35.9 centigrade before vaccination on 13Jul2021. Historical Vaccine included the first dose of BNT162b2 (COMIRNATY, Lot number: FA5765, Expiration date 30Sep2021) on 22Jun2021 for covid-19 immunisation. On 14Jul2021 (1 day after the vaccination), the patient experienced rhabdomyolysis. On 19Jul2021 (6 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 13Jul2021, after the second vaccination of BNT162b2, the patient experienced weakness of both lower extremities (it had not been confirmed whether the event was Guillain-Barre syndrome). On 14Jul2021, the patient had difficulty in walking. On 15Jul2021, the weakness improved. On 16Jul2021, the weakness worsened again, and the patient was admitted to a nearby hospital (rhabdomyolysis, adrenal hypofunction, and polymyositis were suspected). On 18Jul2021, the patient had a fever of 37.2 centigrade. At around 22:00, the SpO2 decreased to 80% (oxygen 7 L/min reservoir mask) and then increased to 93% (oxygen 10 L/min reservoir mask). Dopamine hydrochloride (INOVAN) at 3 microgram/kg/min was used. On 19Jul2021, the patient was transferred to the reporting hospital (septic shock, suspected pneumonia aspiration, acute kidney injury, Cardiac failure chronic, hyper-CPK-emia, CRP: 22.84 mg/dL, procalcitonin 50.00 ng/mL). At 11:10 the patient died. All events resulted in physician office visit. Outcome of the events was fatal. The patient died on 19Jul2021. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and considered that the causality between the event and BNT162b2 was unassessable. The reporting physician did not mention other possible causes of the event such as any other diseases. The reporting physician commented as follows: Although the causality between the event and the vaccination was unclear, the patient died in a short period after the vaccination. Therefore, this case is reported. The patient might have developed Guillain-Barre syndrome because he had weakness of the lower extremities. However, no further examination was performed since he was transferred to the reporting hospital after the worsening of his general conditions.; Reported Cause(s) of Death: rhabdomyolysis; Weakness of both lower extremities; Guillain-Barre syndrome; difficulty in walking; adrenal hypofunction; polymyositis; a fever of 37.2 centigrade; SpO2 decreased to 80%; Septic shock; Pneumonia aspiration suspected; Acute renal failu


VAERS ID: 1521499 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-13
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0203 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Body temperature, Coma scale, Heart rate, PO2, Respiratory rate
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Hypersensitivity (broad), Respiratory failure (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210704; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: Before vaccination; Test Date: 20210713; Test Name: CS; Result Unstructured Data: Test Result:III-300; Test Date: 20210713; Test Name: pulse rate; Result Unstructured Data: Test Result:130/minute; Test Date: 20210713; Test Name: pulse rate; Result Unstructured Data: Test Result:decreased in the ambulance; Test Date: 20210713; Test Name: SpO2; Test Result: 82 %; Comments: SpO2 was 82% (10 L mask, 90%).; Test Date: 20210713; Test Name: Respiratory rate; Result Unstructured Data: Test Result:30/minute
CDC Split Type: JPPFIZER INC202100921032

Write-up: Acute respiratory failure; This is a spontaneous report from a contactable pharmacist received via a Pfizer sales representative, from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution, from a same contactable pharmacist received from the Regulatory Authority. Regulatory authority report number is v21120611. A 50-year and 6-month-old female patient received the 2nd dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EW0203, Expiration date 30Sep2021) via intramuscular in the arm left on 04Jul2021 at 11:30 at age of 50 years old as single dose for COVID-19 immunization. Medical history included ongoing hypertension and being treated. The patient had body temperature 36.6 Centigrade before vaccination. Concomitant medications were unknown. On 13Jun2021 at 11:15, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# FA2453, Expiration date 31Aug2021) intramuscular in the arm left for COVID-19 immunization. On 13Jul2021 (9 days after the vaccination), the patient experienced death. On 13Jul2021 (9 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The patient had underlying disease of hypertension only, and her primary physician judged that the patient was able to receive BNT162b2 vaccination. On 13Jun2021, the patient received the first dose of BNT162b2 vaccination, and no side reactions were observed. On 04Jul2021 (the day of vaccination), the patient received the second dose of BNT162b2 vaccination. On 11Jul2021 (7 days after vaccination), the patient had respiratory discomfort. On 12Jul2021 (8 days after vaccination), the patient visited a cardiovascular clinic. A Holter ECG was attached. On 13Jul2021, at 06:00 (9 days after vaccination), the patient felt difficulty in breathing while out for a walk, and she went home. The patient had loss of consciousness at her home. An ambulance was called. In the ambulance, the patient had cardio-respiratory arrest at 06:47 (9 days, 6 hours, and 47 minutes after vaccination). The patient was transferred to the reporting hospital. Although cardiopulmonary resuscitation and administration of adrenaline (EPINEPHRINE) were performed, the cardiopulmonary resuscitation was discontinued, and the patient was confirmed to die at 07:50 (9 days, 7 hours, and 50 minutes after vaccination). The causality between the event and BNT162b2 vaccination was un-assessable. The course of the event from the same contactable pharmacist was as follows: On 13Jul2021 at 06:00, the patient experienced respiratory failure acute. The additional clinical course of the event was as follows: On 12Jul2021 (7 days after vaccination), the patient visited the cardiovascular specialist clinic (nothing was pointed out). A Holter ECG was attached. The patient was to visit the clinic next week. On 13Jul2021, at 6:00 (8 days after vaccination), the patient had respiratory discomfort while out for a walk. The patient had loss of consciousness for several seconds at her home, and she was emergently transferred. When the ambulance service arrived, the patient had tachycardia (130/minute) and tachypnoea (30/minute), and the SpO2 was 82% (10 L mask, 90%). The pulse rate decreased in the ambulance. At 06:47 (8 days, 19 hours, and 17 minutes after vaccination), the patient had cardio-pulmonary arrest. At 06:55 (8 days, 19 hours, and 25 minutes after vaccination), the patient arrived at the emergency outpatient department of the reporting hospital. At the time of arrival, the consciousness level was III-300. The patient had respiratory arrest. Cardiopulmonary resuscitation was initiated, adrenaline (BOSMIN INJECTION) and atropine sulfate hydrate (ATROPINE SULFATE) were administered; however, no response was obtained. At 07:45 (8 days, 20 hours, and 15 minutes after vaccination), the patient''s death was pronounced to the husband. Approval for the completion of cardiopulmonary resuscitation was obtained. At 07:50 (8 days, 20 hours, and 30 minutes after vaccination), it was confirmed that vital reactions such as light reflex disappeared, and cardiopulmonary resuscitation was terminated. The reporting pharmacist classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting pharmacist commented as follows: Since one week had passed from the vaccination to the onset of the event, it was considered unlikely that the event was related to BNT162b2 vaccination. Under this situation, it was impossible to judge the presence or absence of the causality. The physician reported that the patient''s cause of death was reported as acute respiratory failure. Autopsy was not performed.; Reported Cause(s) of Death: Acute respiratory failure


VAERS ID: 1521517 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-20
Onset:2021-07-09
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aphasia, Body temperature, Cardio-respiratory arrest, Cerebral haemorrhage, Chronic kidney disease, Coma scale, Computerised tomogram, Echocardiogram, Incontinence, Magnetic resonance imaging, Seizure
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Convulsions (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-11
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: WARFARIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Blind left eye; Carotid endarterectomy; Cerebral infarction; Chronic kidney disease; Diabetes mellitus; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210620; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination; Test Date: 20210709; Test Name: CS; Result Unstructured Data: Test Result:10; Comments; Test Date: 20210709; Test Name: CT; Result Unstructured Data: Test Result:Cerebral haemorrhage; Test Date: 20210709; Test Name: CT; Result Unstructured Data: Test Result:No increased haemorrhage; Test Date: 20210709; Test Name: echocardiography; Result Unstructured Data: Test Result:EF 61 %; Comments: Left ventricular ejection fraction 61%; Test Date: 20210709; Test Name: MRI; Result Unstructured Data: Test Result:cerebral haemorrhage
CDC Split Type: JPPFIZER INC202100923738

Write-up: generalised convulsion; cardiopulmonary arrest; CKD aggravated; Cerebral haemorrhage; incontinence; aphasia; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21120564. A 72-year and 6-month-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Lot number FC3661, Expiration date 30Sep2021) via an unspecified route of administration on 20Jun2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient had past medical history of cerebral infarction in 2008, left carotid endarterectomy (CEA) in 2016, chronic kidney disease (CKD), diabetes mellitus (DM), angina pectoris (no assessment of coronary artery was performed because of CKD), blind left eye and hypertension. Concomitant medication included oral warfarin and no anti platelet agents was administered. Body temperature before vaccination was 36.3 degrees Centigrade on 20Jun2021. On 09Jul2021 (also reported as uncertain) (19 days after the vaccination), the patient experienced cerebral haemorrhage. On 09Jul2021 (same day of the vaccination), the patient was admitted to the hospital. On 11Jul2021 (21 days after the vaccination), the outcome of the event was Fatal. The course of the event was as follows: On 09Jul2021 (19 days after the vaccination), in the morning, the patient did not get up. When his wife tried to wake him up, the patient did not speak, and he had incontinence. The patient was urgently transported to the hospital by ambulance. Computerised tomogram (CT) and magnetic resonance imaging revealed cerebral haemorrhage, so the patient was admitted to the reporting hospital. The patient was under the following condition; coma scale, 10; 3/5 of right upper and lower limbs; and presence of aphasia motor possible to respond to command. On the same day (09Jul2021, 19 days after the vaccination), CT was performed again, without showing increased haemorrhage. Ejection fraction (EF) was 61% on echocardiography. On 10Jul2021 (20 days after the vaccination), CKD was aggravated. At 22:05, the patient had generalised convulsion, and went into cardiopulmonary arrest (CPA), for which cardiac massage was started. After that, bradycardia and cardiac arrest were repeated but no improvement was noted. On 11Jul2021 (21 days after the vaccination) at 0:05, after informed consent was obtained from his family, the patient was confirmed dead. The reporting physician classified the event as serious (Hospitalized) and assessed that the event was unrelated to BNT162b2. Other possible causes of the event such as any other diseases were cerebral infarction, CKD, DM, angina pectoris, hypertension, and administration of warfarin. The reporting physician commented as follows: It was thought that there was no causal relationship between BNT162b2 and the event, but this report was made based on strong request of the bereaved family.; Sender''s Comments: As there is limited information in the case provided, the causal association between the event Cerebral Haemorrhage, incontinence, Aphasia, Chronic kidney disease, Seizure and Cardo-Respiratory arrest 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: Cerebral haemorrhage


VAERS ID: 1521519 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-01-26
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5829 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Atrial flutter, Body temperature, Computerised tomogram, Multiple organ dysfunction syndrome, Thrombosis
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Supraventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-26
   Days after onset: 150
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210624; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination; Test Name: CT; Result Unstructured Data: Test Result:suspected thrombosis
CDC Split Type: JPPFIZER INC202100923752

Write-up: Multi-organ failure due to thrombosis; Multi-organ failure due to thrombosis; Atrial flutter; consciousness disturbed; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21120933. A 92-year and 5-month-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Lot number FA5829, Expiration date 31Aug2021) via an unspecified route of administration on 24Jun2021 at an unknown time as DOSE 2, SINGLE for covid-19 immunisation. Family history, medical history, and concomitant medications were not reported. 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). Body temperature before vaccination was 36.4 degrees centigrade on 24Jun2021. On an unknown date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# was not reported, Expiration date was not reported). On 26Jun2021 at 16:00 (2 days after the vaccination), the patient experienced multi-organ failure due to thrombosis. On 26Jun2021 (2 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 26Jun2021, the patient was transported by ambulance due to consciousness disturbed, and he had atrial flutter. Resuscitation was performed; however, the symptoms did not improve, and the patient died. A CT after the death revealed findings of suspected thrombosis. The reporting physician classified the event as serious (death) and assessed the event was related to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Multi-organ failure due to thrombosis was considered to be the cause of death.; Reported Cause(s) of Death: Atrial flutter; Multi-organ failure due to thrombosis; Multi-organ failure due to thrombosis


VAERS ID: 1521529 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood culture, Blood pressure measurement, Blood test, Body temperature, Computerised tomogram, Culture urine, Disseminated intravascular coagulation, Hepatic necrosis, Intestinal ischaemia, Myocardial infarction, Pyelonephritis acute, Renal function test, Renal graft infection, Septic shock, Splenic infection, Urinary tract infection, Urine analysis
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Myocardial infarction (narrow), Toxic-septic shock conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Ischaemic colitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-29
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunosuppressant drug therapy
Preexisting Conditions: Medical History/Concurrent Conditions: Living donor renal transplant
Allergies:
Diagnostic Lab Data: Test Date: 20210628; Test Name: blood culture; Result Unstructured Data: Test Result:gram-positive coccus was detected; Comments: gram-positive coccus was detected on the blood culture and the urine culture (later, it was revealed as methicillin-resistant Staphylococcus aureus [MRSA]); Test Date: 20210627; Test Name: blood pressure; Result Unstructured Data: Test Result:decreased; Test Date: 20210623; Test Name: blood examination; Result Unstructured Data: Test Result:no abnormalities; Test Date: 20210627; Test Name: blood examination; Result Unstructured Data: Test Result:significant inflammatory reaction; Test Date: 20210625; Test Name: Body temperature; Result Unstructured Data: Test Result:39s Centigrade; Comments: pyrexia of 39s degrees Celsius; Test Date: 20210627; Test Name: CT; Result Unstructured Data: Test Result:no obvious cause of fever; Test Date: 20210628; Test Name: urine culture; Result Unstructured Data: Test Result:gram-positive coccus was detected; Comments: gram-positive coccus was detected on the blood culture and the urine culture (later, it was revealed as methicillin-resistant Staphylococcus aureus [MRSA]); Test Date: 20210627; Test Name: renal function; Result Unstructured Data: Test Result:aggravation; Test Date: 20210623; Test Name: urine examinations; Result Unstructured Data: Test Result:no abnormalities; Test Date: 20210627; Test Name: urine examinations; Result Unstructured Data: Test Result:pyuria and bacteriuria
CDC Split Type: JPPFIZER INC202100923793

Write-up: Septic shock; urinary tract infection (pyelonephritis acute); urinary tract infection (pyelonephritis acute); haemorrhage and white shadows on the transplanted kidney, and infection was suspected, which was considered as primary lesion; map-like macula was observed in the liver, and necrosis was suspected; intestinal ischaemia; infectious spleen; myocardial infarction suspected; disseminated intravascular coagulation; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21120430. A 74-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 24Jun2021 at 74-year-old (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included renal transplant, ongoing immunosuppressant drug therapy. The patient was a 74-year-old (at vaccination) male. Since the patient was after living donor renal transplant, he was receiving immunosuppressant drug therapy. She had concomitant Therapy. The patient experienced septic shock on 27Jun2021 with fatal outcome, urinary tract infection (pyelonephritis acute) on 25Jun2021 with fatal outcome, disseminated intravascular coagulation on 27Jun2021 with outcome of unknown, haemorrhage and white shadows on the transplanted kidney, and infection was suspected, which was considered as primary lesion , map-like macula was observed in the liver, and necrosis was suspected, intestinal ischaemia, infectious spleen, and myocardial infarction suspected, all on unknown date with unknown outcome. The patient was hospitalized for septic shock, urinary tract infection (pyelonephritis acute) from 27Jun2021 to an unknown date. The patient died on 29Jun2021. Treatment received for all events. On 24Jun2021 (the day of vaccination), the patient received the first dose of BNT162b2. On 25Jun2021 (1 day after the vaccination), the patient experienced urinary tract infection (pyelonephritis acute). On 27Jun2021 (3 days after the vaccination), the patient experienced septic shock and was admitted to the hospital. On 29Jun2021 (5 days after the vaccination), the outcome of the events was fatal. The course of the event was as follows: On 23Jun2021, when the patient was usually examined at the outpatient department, the blood and urine examinations showed no abnormalities. On 24Jun2021 (the day of vaccination), the patient received the first dose of BNT162b2 vaccination. On 25Jun2021 (one day after vaccination), the patient had pyrexia of 39s degrees Celsius. On 27Jun2021 (3 days after vaccination), since the pyrexia persisted, the patient visited the reporting hospital. Diarrhoea and vomiting were noted as other symptoms. The blood examination showed significant inflammatory reaction. Since aggravation of renal function was observed, and pyuria and bacteriuria were noted, the patient was diagnosed with urinary tract infection (pyelonephritis acute). CT showed no obvious cause of fever. The patient was admitted to the hospital, and a drip infusion of an antibiotic and fluid replacement was performed; however, blood pressure decreased was noted. It was considered that the patient had septic shock, which required catecholamine support. The patient also had disseminated intravascular coagulation (DIC). On 28Jun2021 (4 days after vaccination), gram-positive coccus was detected on the blood culture and the urine culture (later, it was revealed as methicillin-resistant Staphylococcus aureus [MRSA]), and an antibiotic was added; however, the condition was aggravated. The patient was admitted to the cardiac care unit (CCU), and tracheal intubation was performed, and hemodialysis therapy was initiated. However, the condition did not improve. On 29Jun2021 (5 days after vaccination), the patient was confirmed to die. A pathologic autopsy (macroscopic) showed haemorrhage and white shadows on the transplanted kidney, and infection was suspected, which was considered as primary lesion. In addition, map-like macula was observed in the liver, and necrosis was suspected, and intestinal ischaemia was also noted. In addition, infectious spleen and myocardial infarction suspected were also noted. The reporting physician classified the septic shock 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 pyelonephritis acute. The reporting physician commented as follows: It was considered that the cause of death was septic shock, and cause of septic shock was pyelonephritis acute. It was impossible to judge whether the vaccination was involved or not; however, the timing of the event was immediately after the vaccination, and thus, this case was reported. The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: Septic shock; urinary tract infection (pyelonephritis acute); urinary tract infection (pyelonephritis acute); Autopsy-determined Cause(s) of Death: intestinal ischaemia; infectious spleen; myocardial infarction suspected; haemorrhage and white shadows on the transplanted kidney, and infection was suspected, which was considered as primary lesion; map-like macula was observed in the liver, and ne


VAERS ID: 1521542 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-07-01
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5295 / 2 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: Dyslipidaemia; Hypertension; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100923871

Write-up: Unknown cause of death; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. An 86-year-old female patient (non-pregnant) received bnt162b2 (COMIRNATY, Solution for injection, Lot number FC5295, Expiration date 30Sep2021) intramuscular, administered in Arm Left on 25Jun2021 09:00 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included type 2 diabetes mellitus, hypertension, and dyslipidaemia. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications (drugs name unspecified) within 2 weeks of vaccination. On 04Jun2021 at 9:00, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# FA7338, Expiration date 30Sep2021) via intramuscular route of administration in the arm left for COVID-19 immunization. On unknown date in Jul2021, the patient died. The cause of death was unknown. An autopsy was performed that revealed unknown cause of 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: On 04Jun2021 at 09:00, the patient received the first dose of BNT162b2 vaccination. On 25Jun2021 at 09:00 (the day of vaccination), the patient received the second dose of BNT162b2 vaccination. On 17Jul2021 (22 days after the 2nd dose of vaccination), the patient was confirmed dead in a rotten condition at her home. According to an autopsy result which was performed by the police, it was considered that one week or longer had passed since the patient had died; however, the decomposition was severe, and the cause of death was unknown.; Sender''s Comments: Based on the limited information given, a causal association between the event "death" and bnt162b2 (COMIRNATY) cannot be completely excluded. The case will be reassessed once more information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Unknown cause of death; Autopsy-determined Cause(s) of Death: Unknown cause of death


VAERS ID: 1521820 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8680 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATORVASTATIN; AERIUS [DESLORATADINE]; CLOPIDOGREL; GIONA; BETAPRED; NEXIUM [ESOMEPRAZOLE MAGNESIUM TRIHYDRATE]; CREON; ALVEDON; BRICANYL; FLUCONAZOLE; CITODON [CODEINE PHOSPHATE HEMIHYDRATE;PARACETAMOL]; JEXT; LOSARSTAD
Current Illness: Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Amaurosis fugax; Angioedema; Cerebrovascular accident NOS
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202100920830

Write-up: Shortness of breath; coughing during the week; Feeling unwell; Sudden cardiac death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number SE-MPA-2021-054978. A 67-year-old female patient received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: EX8680, Expiry date: unknown), via an unspecified route of administration on unspecified date in May2021 as dose 1, single for covid-19 immunization. Medical history included hypertension, amaurosis fugax, cerebral insult and angioedema of wasp sting. Concomitant medications included atorvastatin at 40 mg, once a day, desloratadine (AERIUS (DESLORATADINE)) as needed, clopidogrel at 75 mg, once a day, budesonide (GIONA), betamethasone sodium phosphate (BETAPRED) as needed, esomeprazole magnesium trihydrate (NEXIUM (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE)) as needed, pancreatin (CREON) as needed, paracetamol (ALVEDON) as needed, terbutaline sulfate (BRICANYL) as needed, fluconazole, codeine phosphate hemihydrate, paracetamol (CITODON) as needed, epinephrine bitartrate (JEXT) as needed, losartan potassium (LOSARSTAD, Film-coated tablet) at 100 mg, once a day. On an unspecified date one week after receiving the vaccine the patient had been feeling unwell with shortness of breath and coughing during the week as per her medical records, then the patient was found lying supine in the garden, CPR was started and ambulance was called, on arrival they took over, about 45 minutes later the resuscitation attempts were terminated, the ECG (Echocardiogram) showed no electrical activity during CPR and the patient''s skin already had blue mottled skin on her face and lower body parts at the start of CPR. There were also no corneal reactions, no breathing and no cardiac activity. The patient probably died three to five hours earlier in an unspecified date in May2021. The reporter assessed case as serious, fatal. The outcome of events was fatal. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. Information about batch number has been obtained. ; Reported Cause(s) of Death: Sudden cardiac death


VAERS ID: 1521829 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-07-01
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD6840 / 2 - / 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: 2021-07-01
   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: ALLOPURINOL; CARVEDILOL; ALFACALCIDOL; FUROSEMIDE; IMDUR; ESOMEPRAZOLE; CANDESARTAN; FELODIPINE
Current Illness: Aortic dissection
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202100916021

Write-up: SUDDEN DEATH; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number SE-MPA-2021-061025. A 53-year-old male patient (also reported as 62-years-old, pending clarification) received BNT162B2 (COMIRNATY), intramuscular on Jun2021 (Batch/Lot Number: FD6840) as dose 2, 0.3ml single for COVID-19 immunisation. Medical history included ongoing chronic aortic dissection. Concomitant medications included allopurinol; carvedilol; alfacalcidol; furosemide; isosorbide mononitrate (IMDUR); esomeprazole; candesartan and felodipine, all taken for an unspecified indications, start and stop dates were not reported. Historical vaccine included BNT162B2 (COMIRNATY), intramuscular on May2021 (Batch/Lot Number: FD6840) as dose 1, single for COVID-19 immunisation. The reported side effect was sudden death in Jul2021, 15 days after the introduction of Comirnaty. The person was found dead by a neighbor. The police were called in for a forensic autopsy due to a medical measure within 4 weeks. The case was considered serious, death. 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: Sudden death, cause unknown


VAERS ID: 1521868 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TNPFIZER INC202100927573

Write-up: I just lost my dad to covid despite having the first and second dose vaccinated.; I just lost my dad to covid despite having the first and second dose vaccinated.; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated that, just lost their dad to covid despite having the first and second dose vaccinated and also stated if the vaccine doesn''t protect them, then what are all these vaccine companies for. It was very shocked that it happened to his/her father. They stated they kept all their trust in our laboratory but finally they lost their father. The patient died on an unspecified date. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: covid


VAERS ID: 1522402 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLJNJFOC20210764863

Write-up: DEATH; This spontaneous report received from a consumer via social media concerned multiple patients. The patient''s weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: UNKNOWN) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, it was reported that in the middle age group people (healthy, active group people), there were no problem after vaccination but death (unknown cause of death) was recorded. 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 20210764876, 20210764838, 20210764866, 20210764885 and 20210764857.; Sender''s Comments: 20210764863-COVID-19 VACCINE AD26.COV2.S-Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1522498 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-05
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-05
   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: AUPFIZER INC202100924262

Write-up: Adverse event following immunisation; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 584822. An 85-year-old female patient received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, solution for injection, Lot number not provided), via an unspecified route of administration, on unknown date at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. On 05Jul2021, the patient had adverse event following immunization with fatal outcome. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Adverse event following immunisation


VAERS ID: 1522499 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202100924284

Write-up: adverse event following immunization with fatal outcome; This is a spontaneous report from a contactable health care professional via the Regulatory Authority. Regulatory authority report number is 584827. A 65-year-old female patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date (Lot number and Expiry date was not reported) as dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced adverse event following immunization with fatal outcome on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: adverse event following immunization with fatal outcome


VAERS ID: 1522500 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-06
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Adverse event following immunisation, Myalgia, Presyncope
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202100924285

Write-up: Adverse event following immunisation; Myalgia; Presyncope; Adverse event following immunisation; Myalgia; Presyncope; Adverse event following immunisation; Myalgia; Presyncope; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 584829. A 49-year-old male patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced adverse event following immunization, myalgia and presyncope, all on 06Jul2021. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Adverse event following immunisation; Myalgia; Presyncope


VAERS ID: 1522501 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-03
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Concomitant disease aggravated, Pneumonia
SMQs:, Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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 INC202100924287

Write-up: asthenia; concomitant disease aggravated; pneumonia; asthenia; concomitant disease aggravated; pneumonia; asthenia; concomitant disease aggravated; pneumonia; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 585806. A 90-year-old male patient received bnt162b2 (COMIRNATY, solution for injection), via unspecified route of administration on an unspecified date (batch/lot number and expiry date unknown) as dose number unknown, single for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. On 03Jul2021, the patient experienced asthenia; concomitant disease aggravated; pneumonia. The patient died on an unspecified date due to the events. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: asthenia; concomitant disease aggravated; pneumonia; asthenia; concomitant disease aggravated; pneumonia; asthenia; concomitant disease aggravated; pneumonia


VAERS ID: 1522593 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-04-13
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest, Cardiogenic shock, Myocardial fibrosis, Myocarditis
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 (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-04
   Days after onset: 21
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: Aldactone; ATENURIX; DIALVIT; Nexium; ROCALTROL; ARANESP; FERINJECT; FRAGMIN; VITAMIN B12 NOS; FRAGMIN
Current Illness: D-hypervitaminosis (Vitamin D)); Dialysis; Gastrooesophageal reflux; Gout; Hyperuricaemia; Renal necrosis NOS
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: Myocardial fibrosis; This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS, CARDIAC ARREST, CARDIOGENIC SHOCK and MYOCARDIAL FIBROSIS (Myocardial fibrosis) in a 67-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Renal necrosis NOS, Dialysis, Gastrooesophageal reflux, Hyperuricaemia, Gout and D-hypervitaminosis (Vitamin D)). Concomitant products included Spironolactone (Aldactone), FEBUXOSTAT (ATENURIX), ASCORBIC ACID, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, RIBOFLAVIN, THIAMINE MONONITRATE (DIALVIT), Esomeprazole magnesium (Nexium), CALCITRIOL (ROCALTROL), DARBEPOETIN ALFA (ARANESP), FERRIC CARBOXYMALTOSE (FERINJECT), DALTEPARIN SODIUM (FRAGMIN), VITAMIN B12 NOS and DALTEPARIN SODIUM (FRAGMIN) for an unknown indication. On 17-Mar-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 100 microgram. On 13-Apr-2021, the patient experienced MYOCARDITIS (seriousness criteria death, hospitalization, medically significant and life threatening) and CARDIAC ARREST (seriousness criteria death, hospitalization, medically significant and life threatening). In May 2021, the patient experienced CARDIOGENIC SHOCK (seriousness criteria death, hospitalization, medically significant and life threatening). On an unknown date, the patient experienced MYOCARDIAL FIBROSIS (Myocardial fibrosis) (seriousness criterion death). The patient died on 04-May-2021. The reported cause of death was Cardiogenic shock. An autopsy was performed. The autopsy-determined cause of death was Myocarditis and Myocardial fibrosis. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered MYOCARDITIS, CARDIAC ARREST and CARDIOGENIC SHOCK to be possibly related. No further causality assessment was provided for MYOCARDIAL FIBROSIS (Myocardial fibrosis). Company Comment: Very limited information regarding this events has been provided at this time.; Reporter''s Comments: Covid-19 Vaccine Moderna? mRNA Covid-19; Senders Comments: Very limited information regarding this events has been provided at this time.; Reported Cause(s) of Death: Cardiogenic shock; Autopsy-determined Cause(s) of Death: Myocarditis; Myocardial fibrosis


VAERS ID: 1522606 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-06-10
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 30380777700688 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Acute renal failure; Dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: Respiratorische Verschlechterung; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Respiratorische Verschlechterung) in a 92-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch nos. 30380777700688 and 3001942) for COVID-19 vaccination. The patient''s past medical history included Acute renal failure and Dementia. Concurrent medical conditions included Arterial hypertension. On 04-May-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. Death occurred on 10-Jun-2021 The patient died on 10-Jun-2021. The cause of death was not reported. An autopsy was not performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered DEATH (Respiratorische Verschlechterung) to be unlikely related. Concomitant and treatment medications were not reported Company comments:Although a causal relationship cannot be excluded based on the current available information and temporal association between the use of the product and the start date of the event, it was considered unlikely per the treating physician.; Sender''s Comments: Although a causal relationship cannot be excluded based on the current available information and temporal association between the use of the product and the start date of the event, it was considered unlikely per the treating physician.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1522610 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-04-27
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-05
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASPIRIN CARDIO; BILOL; LISITRIL COMP.; CRESTOR
Current Illness: Arterial hypertension; Chronic renal insufficiency; Chronic venous insufficiency; Coronary disease; Dyslipidemia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: C-reactive protein; Result Unstructured Data: high; Test Date: 202104; Test Name: Echocardiography; Result Unstructured Data; Test Date: 202104; Test Name: Electrocardiogram; Result Unstructured Data:.
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: Cardiac arrest; Atrial fibrillation; This regulatory authority case was reported by a physician and describes the occurrence of CARDIAC ARREST (Cardiac arrest) and ATRIAL FIBRILLATION (Atrial fibrillation) in an 83-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for an unknown indication. Concurrent medical conditions included Coronary disease, Arterial hypertension, Dyslipidemia, Chronic renal insufficiency and Chronic venous insufficiency. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN CARDIO), BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISITRIL COMP) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication. On 22-Apr-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 27-Apr-2021, after starting mRNA-1273 (COVID-19 Vaccine Moderna), the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criteria death and medically significant). On 05-May-2021, the patient experienced CARDIAC ARREST (Cardiac arrest) (seriousness criteria death and medically significant). The patient died on 05-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, C-reactive protein: 32mg/l (High) high. In April 2021, Echocardiogram: abnormal (abnormal). In April 2021, Electrocardiogram: abnormal (abnormal). For mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown), the reporter considered CARDIAC ARREST (Cardiac arrest) and ATRIAL FIBRILLATION (Atrial fibrillation) to be unlikely related. No treatment information was provided. Company Comment: Very limited information regarding these events has been provided at this time. However, multiple underlying co-morbidities may remain as confounding factors. No follow up is possible.; Sender''s Comments: Very limited information regarding these events has been provided at this time. However, multiple underlying co-morbidities may remain as confounding factors.No follow up is possible.; Reported Cause(s) of Death: Unknown


VAERS ID: 1523535 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3065 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Platelet factor 4, Pulmonary embolism, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Respiratory failure (broad)

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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Migraine
Allergies:
Diagnostic Lab Data: Test Name: antiPF4 antibodies; Test Result: Negative
CDC Split Type: ESPFIZER INC202100920846

Write-up: Cardio-respiratory arrest; Pulmonary thromboembolism; Several vomiting episodes; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB ES-AEMPS-944658. A 48-year-old female patient received second dose of bnt162b2 (COMIRNATY, solution for injection; lot number FE3065; strength: 0.3mL), intramuscularly on 07Jul2021 (at the age of 48-year-old) as single dose for COVID-19 immunization. Medical history of the patient included migraine and no other notable history. Patient previously received first dose of bnt162b2 (COMIRNATY, solution for injection; lot number FC3098) on 15Jun2021 (at the age of 48-year-old) as single dose for COVID-19 immunization. On 07Jul2021 at night after second dose of vaccination, patient experienced several vomiting episodes. On 08Jul2021 when she woke up, her husband found her unconscious, and later realized that she was in respiratory arrest and requested a clinical necropsy, pending the result. The COVID 19 disease has not passed. Patient went to the hospital emergency room on 08Jun2021, transferred by the Emergency Medical Service in cardiorespiratory arrest, which she did not recover after 120 minutes, resulted in death. In the autopsy study, a hemorrhagic area was identified that occupies a large part of the lower lobe of the right lung, compatible with a pulmonary infarction of a few days of evolution secondary to pulmonary thromboembolism. On the other hand, possible causes of sudden death such as acute myocardial infarction, aortic dissection or acute intracranial bleeding have been ruled out. Cerebrospinal fluid study was pending to rule out a neuroinfectious process. The cause of death can be provisionally attributed to a pulmonary infarction. During the necropsy, serum was extracted and analyzed for antiPF4 antibodies result was negative. There was no analytical while the patient was alive. Analysis of fluid cytology and histopathology is pending. The outcome of event vomiting was unknown. No follow-up attempts possible. No further information expected. Information about batch number has been obtained.; Reported Cause(s) of Death: Cardiorespiratory arrest; Autopsy-determined Cause(s) of Death: Pulmonary infarction


VAERS ID: 1523641 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-07-11
   Days after vaccination:170
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH E56788 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202100973154

Write-up: Occurrence of COVID with patients death; Occurrence of COVID with patients death; This is a spontaneous report from a contactable other healthcare professional downloaded from the Regulatory Authority-WEB FR-AFSSAPS-MP20215662. An elderly male patient received second dose of bnt162b2 (COMIRNATY, Formulation: Solution for Injection, Batch/Lot Number: E56788, Expiration date not reported) via intramuscular route of administration in an unspecified anatomical location on 22Jan2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that occurrence of covid with patient''s death on 11Jul2021. The patient died on an unspecified date in Jul2021. It was reported as not specified whether the patient was tested. It was not reported if an autopsy was performed. The outcome of the events was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Covid 19


VAERS ID: 1523642 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-01-31
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Diarrhoea, Influenza like illness, Nausea, Pain, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-17
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LEVOTHYROX; ROSUVASTATIN; ANORO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Dyslipidemia; Hypothyroidism
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021140049

Write-up: COVID-19 aggravated; Diarrhea; Influenza like illness; Nausea; fever; body aches; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-NC20210263. An 85-year-old male patient received the 1st dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EK9788), intramuscular on 29Jan2021 as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included dyslipidaemia, Iatrogenic hypothyroidism and chronic obstructive pulmonary disease (COPD). Concomitant medications included levothyroxine sodium (LEVOTHYROX), rosuvastatin, umeclidinium bromide/vilanterol trifenatate (ANORO). On 31Jan2021, the patient experienced diarrhea, influenza like illness, nausea. The patient experienced covid-19 aggravated on 06Feb2021. The patient died on 17Feb2021. It was not reported if an autopsy was performed. On 29Jan2021, the patient received 1st vaccination of COMIRNATY. On 31Jan2021, the patient experienced fever, body aches, nausea and diarrhea. No local effect. Then a call to SOS doctor was done, which resulted in a prescription of paracetamol (manuafcturer unknown), metoclopramide hydrochloride (PRIMPERAN) and phloroglucinol, trimethylphloroglucinol (SPASFON). At the time of the report, the patient was not recovered from events stated above (fever, body aches, nausea and diarrhea). On 06Feb2021, the patient was hospitalized for worsening of symptoms. At the hospital, covid-19 was diagnosed to the patient. Despite the care given, fatal evolution on 17Feb2021. No variant search performed. Medical opinions diverged: some said the vaccine caused it all, some others said that the contamination dated from before the vaccination. In total, patient developed covid-19 in the days following his 1st vaccination. Doubt about an exacerbation of covid-19 by the vaccine. No follow-up attempts are possible. No further information is expected. Follow-up (27Jul2021): This is a follow-up report downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-NC20210263. New information includes: suspect vaccine details, medical history, concomitant medications, new events (fever, body aches), event details. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: COVID-19 aggravated; Influenza like illness; Diarrhea; Nausea; fever; body aches


VAERS ID: 1523766 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-07-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003610 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypercholesterolaemia; Infarct myocardial; Osteoporosis; Parkinsonism hyperpyrexia syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Death unexplained; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death unexplained) in an 86-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003610) for COVID-19 vaccination. The patient''s past medical history included Parkinsonism hyperpyrexia syndrome, Infarct myocardial in 2014, Hypercholesterolaemia and Osteoporosis. On 21-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 22-Jul-2021 The patient died on 22-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication reported. No Treatment medication reported. Sender''s (Case) Safety Report Unique Identifier: FR-AFSSAPS-SE20211893. Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded.; Sender''s Comments: Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded.; Reported Cause(s) of Death.


VAERS ID: 1523801 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-08
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0141 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Blood test, Chest X-ray, Dyspnoea, Hyperkalaemia, Pneumonia, Pulmonary oedema
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Tumour lysis syndrome (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-17
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: CAPASAL; TAMSULOSIN; WARFARIN; SERTRALINE; BISOPROLOL; PREGABALIN; LACTULOSE; FINASTERIDE; ALOGLIPTIN; RITUXIMAB; RAMIPRIL; PARACETAMOL; SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: CABG; Pain; Thoracic outlet surgery
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:renal function was reduced; Test Name: Chest X-ray; Result Unstructured Data: Test Result:pulmonary oedema; Test Date: 20201214; Test Name: Chest X-ray; Result Unstructured Data: Test Result:cardiomediastinal and hilar contours showed no; Comments: interval features, background of previous CABG and thoracic surgery noted. A new airspace opacification seen in the right mid zone has almost completely resolved when compared with the previous imaging. No new acute pulmonary features identified, very subtle inflammatory change persisting; Test Date: 20210106; Test Name: Chest X-ray; Result Unstructured Data: Test Result:1
CDC Split Type: GBPFIZER INC202100956788

Write-up: Pneumonia; Acute kidney injury; Hyperkalaemia; Pulmonary oedema; short of breath; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-ADR 25641800, Safety Report Unique Identifier is GB-MHRA-ADR 25641800. An 83-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL0141; Expiration Date: 11Jan2021) via intramuscular at single dose on 08Jan2021 for COVID-19 immunisation. Medical history included CABG, thoracic surgery, pain. 1 PA chest on 14Dec2020 compared with the previous imaging: cardiomediastinal and hilar contours showed no interval features, background of previous CABG and thoracic surgery noted. A new airspace opacification seen in the right mid zone has almost completely resolved when compared with the previous imaging. No new acute pulmonary features identified, very subtle inflammatory change persisting, followup chest x-ray in additional 6 weeks was advised to ensure complete resolution. Stable bony review. Concomitant medications included coal tar/cocos nucifera oil/salicylic acid (CAPASAL) from 01May2020; tamsulosin from 08Dec2020; warfarin from 16Nov2020; sertraline from 29Dec2020; bisoprolol; pregabalin from 31Dec2020; lactulose from 07Jun2019; finasteride from 31Dec2020; alogliptin from 16Nov2020; rituximab from 03Dec2020; ramipril from 31Dec2020; paracetamol for pain from 03Nov2020; sertraline from 31Dec2020. The patient experienced pneumonia, acute kidney injury, hyperkalaemia, pulmonary oedema and short of breath on an unspecified date. Patient was admitted on 11Jan2021 after patient was unable to get himself out of bed and had to lower himself to the floor. Pressed his care on call wrist buzzer and was attended to by paramedics. On admission it was noted that patient was more short of breath. Investigated with chest x-rays, blood tests and diagnosed with community acquired pneumonia. Patient was treated with oral antibiotics, intravenous fluids and oxygen therapy. It was noted on routine blood tests that renal function was reduced and diagnosed with an acute kidney injury and hyperkalaemia. For the hyperkalaemia, patient received intravenous fluids, calcium gluconate, sodium bicarbonate, insulin/dextrose infusions and salbutamol nebulisers. Despite appropriate medical therapy, patient continued to require increasing amounts of oxygen to maintain target saturations. It was also noted on 14Jan2021 that his renal function and inflammatory markers were worsening (although his hyperkalaemia improved). Due to this worsening of his clinical state, patient was catheterised and his antibiotics were escalated to intravenous antibiotics. Repeat chest x-rays noted that there was pulmonary oedema and patient was diuresed with intravenous furosemide. Patient continued to deteriorate and on 15Jan21 it was felt that he was approaching the end of his life and was placed on the end of life pathway. Patient subsequently died on 17Jan2021. Referral to Coroner No. An autopsy was not performed. The patient underwent lab tests and procedures which included blood test showed renal function was reduced; Chest X-ray was 1 on 06Jan2021. The outcome of events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Acute kidney injury; Pneumonia; Hyperkalaemia; Pulmonary oedema; short of breath


VAERS ID: 1523802 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1688 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood pressure increased, Blood pressure measurement, Cheyne-Stokes respiration, Dysarthria, Heart rate, Hemiparesis, Hypophagia, Transient ischaemic attack
SMQs:, Neuroleptic malignant syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hypertension (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-16
   Days after onset: 15
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: CONOTRANE [BENZALKONIUM CHLORIDE;DIMETICONE]; TIMOLOL MALEATE; MIRTAZAPINE; COLECALCIFEROL; DOCUSATE; SENNA ACUTIFOLIA; OMEPRAZOLE; LEVOTHYROXINE SODIUM; HYPROMELLOSE; PARACETAMOL; PROCHLORPERAZINE
Current Illness: Acquired hypothyroidism; Glaucoma; Hypertensive; Lipid metabolism disorder; Ocular hypertension; Osteoporosis; Pain in calf; Vitamin B12 deficiency; Vitamin D deficiency
Preexisting Conditions: Medical History/Concurrent Conditions: Angina unstable; Constipation; Depressive disorder; Dry eye; DVT; Fragility fracture; Frailty; Incontinence; Penicillin allergy (Adverse reaction to penicillins); Radius fracture
Allergies:
Diagnostic Lab Data: Test Date: 20210108; Test Name: Blood pressure; Result Unstructured Data: Test Result:150/90; Test Date: 20210108; Test Name: Pulse rate; Result Unstructured Data: Test Result:98
CDC Split Type: GBPFIZER INC202100956803

Write-up: Cheyne Stokes respiration pattern; blood pressure: 150/90; Transient ischaemic attack; Muscle weakness right-sided; Slurred speech; reduced oral intake; Asthenia/gradually deteriorated over week, becoming frailer/frailty of old age; This is a spontaneous report from a contactable Other Health Professional received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-ADR 25641803. Safety Report Unique Identifier GB-MHRA-ADR 25641803. An 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on 31Dec2020 (Lot Number: EJ1688) as 0.3ml single for COVID-19 immunisation. Medical history included asthenia from an unknown date and unknown if ongoing, adverse reaction to penicillins from an unknown date to 13May2015, angina unstable from 16Jan2001 to 30Jan2016, radius fracture from 10Dec2010 to 29Jan2016, pathological fracture from 10Jan2011 to 29Jun2016, depression from 30May2018 to 23Aug2018, depression from 28Nov2019 to 05Mar2020, deep vein thrombosis from 24Oct2018 to an unknown date, constipation from 27May2020 to 25Jun2020, hypothyroidism from 01Jan1960 and ongoing, lipid metabolism disorder from 16Jan2001 and ongoing, osteoporosis from 25Jan2007 and ongoing, ocular hypertension from 08Apr2008 and ongoing, glaucoma from 05Nov2013 and ongoing, Vitamin B12 deficiency from 21May2014 and ongoing, Vitamin D deficiency from 02Oct2017 and ongoing, pain in extremity from 08Jan2020 and ongoing, dry eye and incontinence, both from unknown date. Concomitant medications included benzalkonium chloride, dimeticone (CONOTRANE [BENZALKONIUM CHLORIDE;DIMETICONE]) taken for incontinence; timolol maleate, mirtazapine, colecalciferol, senna acutifolia, omeprazole, levothyroxine sodium, paracetamol, prochlorperazine, all taken for an unspecified indication; docusate taken for constipation; hypromellose taken for dry eye; all with start and stop date were not reported. The patient previously took citalopram from unknown date to 13May2015 and experienced adverse drug reaction, simvastatin from unknown date to 30Jan2008 and experienced adverse drug reaction, nifedipine from unknown date to 16Jan2001, vibramycine from unknown date to 16Mar1998. The patient experienced transient ischaemic attack on 08Jan2021 with outcome of fatal, muscle weakness right-sided and slurred speech, both on 07Jan2021 with outcome of recovered on 07Jan2021. The patient underwent lab tests and procedures which included blood pressure: 150/90 on 08Jan2021, heart rate: 98 on 08Jan2021. The patient died on 16Jan2021. It was not reported if an autopsy was performed. Clinical course was reported as background of increasing frailty. Nursing home resident. Presented with right sided weakness and slurred speech on 07Jan2021. Lasted several hours. Assessed by a colleague on 08Jan2021 no persistent neurological deficit. Started on clopidogrel. Gradually deteriorated over week, becoming frailer, reduced oral intake. Out of hours contacted early on 16Jan2021 as had Cheyne Stokes respiration pattern. Died later that day on 16Jan2021. Outcome of reduced oral intake, Cheyne Stokes respiration pattern and blood pressure: 150/90 was unknown. Reporter thought this was natural causes but felt obliged to report as within 1 month of new COVID vaccine. Cause of death 1a cerebrovascular disease and frailty of old age. This case was reported as serious with seriousness criteria-results in death, caused/prolonged hospitalization. No Follow-up attempts are needed. No further information is expected. ; Reported Cause(s) of Death: Transient ischaemic attack; Asthenia/gradually deteriorated over week, becoming frailer/frailty of old age


VAERS ID: 1523803 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-03
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ0274 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Bone contusion, Malaise, Monoplegia, Musculoskeletal chest pain, Oxygen saturation, Pneumonia, Pyrexia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Accidents and injuries (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-14
   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: MIDAZOLAM; GLYCOPYRRONIUM BROMIDE; CYCLIZINE; WATER FOR INJECTIONS; AMOXICILLIN; CODEINE; MORPHINE SULFATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Bed rest; Fall (banged chest); Nausea; Pain; Rib contusion
Allergies:
Diagnostic Lab Data: Test Date: 20210106; Test Name: Oxygen saturation; Test Result: 95 %
CDC Split Type: GBPFIZER INC202100956811

Write-up: off legs; Pneumonia; Pyrexia; Musculoskeletal chest pain; Malaise; rib contusion; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-ADR 25641805. An 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EJ0274) via intramuscular at 30 ug single on 31Dec2020 for covid-19 immunization. Medical history included fall from 03Jan2020, banged chest, bone contusion, gradually became bed bound; pain, nausea and anxiety all from 14Jan2021. The patient previously took lercanidipine from 20Aug2020 for blood pressure measurement; estriol from 20Aug2020; clopidogrel from 20Aug2020 for cerebrovascular accident; metformin from 20Aug2020 for diabetes mellitus; cinnarizine from 20Aug2020 for dizziness; labetalol from 23Jun2004 and experienced headache; felodipine from 12May2004 but caused oedema; moxonidine from 20Mar2002 and caused fatigue; doxazosin mesylate from 30Oct1998 and caused micturition urgency; nicardipine hydrochloride (CARDENE SR) from 05Jun1996 and caused oedema; amlodipine besilate from 29May1996 and caused oedema. Concomitant medications included midazolam for anxiety from 14Jan2021; glycopyrronium bromide from 14Jan2021 and from 13Jan2021; cyclizine taken for nausea from 14Jan2021; water for injection (WATER FOR INJECTIONS); amoxicillin from 13Jan2021; codeine for pain from 06Jan2021; morphine sulfate for pain from 14Jan2021. The patient experienced pneumonia on an unspecified date, pyrexia on 06Jan2021, musculoskeletal chest pain on 06Jan2021, malaise on 06Jan2021, rib contusion on 03Jan2021, off legs on an unspecified date. Oxygen saturation was 95% on 06Jan2021. The patient died on 14Jan2021. An autopsy was not performed. Physician stated patient died of pneumonia. Physician suspected unrelated to vaccine but obliged to report. It was a serious report - but not really PTO. Physician thought was a natural death. Went "off legs" progressively after fall. Seen 06Jan2021- oxygen saturation 95%, mild fever, right-sided chest wall tenderness. Family phoned 12Jan2021 requesting details of carers as needing more help. Family phoned 13Jan2021 - bed bound on 03Jan2021, they felt she was dying. Insited lunchtime 14Jan2021 - dismally had rt (right) basal pneumonia. It was unwell. Decision made to palliative rather than admit. Patient died peacefully the next day. Physician had only reported this as it was within a month of the new vaccine - but physician thought it was natural causes. The outcome of events was fatal. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the information available and a possible contributory role of the suspect BNT162B2 to the reported event pneumonia can be completely excluded/unrelated;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: Pneumonia; Pyrexia; Musculoskeletal chest pain; Malaise; rib contusion; off legs


VAERS ID: 1524362 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-05-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA8016 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Cerebral haemorrhage, Confusional state, Headache, Mobility decreased, Monoparesis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   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:
CDC Split Type: ITPFIZER INC202100927012

Write-up: Lumbosacral pain, lower limb hemiparesis. On 30/05 diffuse headache, which lead the subject to hospitalization the following day for confusion.; Lumbosacral pain, lower limb hemiparesis. On 30/05 diffuse headache, which lead the subject to hospitalization the following day for confusion.; Lumbosacral pain, lower limb hemiparesis. On 30/05 diffuse headache, which lead the subject to hospitalization the following day for confusion.; severe lumbosacral pains that prevent her from moving; Lumbosacral pain, lower limb hemiparesis. On 30/05 diffuse headache, which lead the subject to hospitalization the following day for confusion.; Lumbosacral pain, lower limb hemiparesis. On 30/05 diffuse headache, which lead the subject to hospitalization the following day for confusion.; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number IT-MINISAL02-757301. A 69-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Right on 26May2021 13:52 (Batch/Lot Number: FA8016) as dose 2, single (at the age of 69 years) for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient received the first dose of COMIRNATY on 05May2021 at 13:27 (batch/lot: EX7389) in the left deltoid for Covid-19 immunisation. The patient had lumbosacral pain, lower limb hemiparesis. On 30/05 diffuse headache, which lead the subject to hospitalization the following day for confusion. It was further reported that the patient accuses severe lumbosacral pains that prevent her from moving with symptoms of hemiparesis in both lower limbs on 26May2021. On 30May2021 she develops very strong headache which brought the patient to hospitalization in a confused state the following day (31May2021). The day after admission, death from cerebral haemorrhage which occurred on 01Jun2021. The outcome of the events was fatal as the patient died on 01Jun2021. It was not reported if an autopsy was performed. Senders comment: 05May2021 at 13:27 first dose of Comirnaty vaccine (batch EX7389) in the left deltoid. 14Jul2021 Request documentation and clinical report to the referring physician No follow up attempts needed, no further information is expected; Reporter''s Comments: 1st vaccine dose 05May2021 After the 2nd dose of vaccine 26May2021 the patient accuses severe lumbosacral pains that prevent her from moving with symptoms of hemiparesis in both lower limbs on 30May2021 she develops very strong headache which brought the patient to hospitalization in a confused state the following day (31May2021). The day after admission, death from cerebral haemorrhage occurred (01Jun2021).; Reported Cause(s) of Death: Lumbosacral pain, lower limb hemiparesis. On 30/05 diffuse headache, which lead the subject to hospitalization the following day for confusion.); Lumbosacral pain, lower limb hemiparesis. On 30/05 diffuse headache, which lead the subject to hospitali


VAERS ID: 1524371 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-18
Onset:2021-04-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Overdose, Pneumonia, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Drug abuse and dependence (broad), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-28
   Days after onset: 71
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: RETACRIT [EPOETIN ALFA EPBX]; PANTORC; LASIX [FUROSEMIDE]
Current Illness: Multiple myeloma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202100926903

Write-up: Bronchopneumonia; Pain chest; Thrombosis leg; overdose/dose 2, 45 ml single; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority, regulatory authority number IT-MINISAL02-757952. A 74-year-old male patient received bnt162b2 (COMIRNATY; Batch/Lot number was not reported) intramuscularly on 18Apr2021 as dose 2, 45 mL, single for COVID-19 immunisation. Medical history included multiple myeloma from 2011 and ongoing. Concomitant medications included epoetin alfa epbx (RETACRIT) taken for multiple myeloma; pantoprazole sodium sesquihydrate (PANTORC); furosemide (LASIX). Historical vaccine include first dose of bnt162b2 (COMIRNATY) on 28Mar2021 for COVID-19 immunization. On 18Apr2021 patient received the second dose as dose 2, 45 mL, single and was reported as overdose. On 23Apr2021 patient experienced bronchopneumonia, pain chest, thrombosis leg and was hospitalized from 23Apr2021 to 30Apr2021 treated with antibiotic therapies not yet known. In the days following discharge, the pulmonary symptoms worsened and the treating physician deemed it appropriate to prescribe a cortisone therapy associated with oxygen therapy (tank of 02+ Soldesam drops). The patient died on 28Jun2021. An autopsy was not performed. Reporter comment: 15Jul: not yet in possession of any documentation despite hospital record have been requested a month ago. Sender Comment: 16Jul: requested to the reporter for the 2nd dose, hospital medical record, clinical course and therapies performed in hospital. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Reporter''s Comments: 15Jul: not yet in possession of any documentation despite hospital record have been requested a month ago.; Reported Cause(s) of Death: thrombus in his right leg; Bronchopneumonia; Pain chest


VAERS ID: 1524396 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003601 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-18
   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: ITMODERNATX, INC.MOD20212

Write-up: DECESSO; DECESSO; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (DECESSO) and PYREXIA (DECESSO) in a 71-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003601) for COVID-19 vaccination. No Medical History information was reported. On 18-Jul-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 18-Jul-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced DEATH (DECESSO) (seriousness criteria death and medically significant) and PYREXIA (DECESSO) (seriousness criterion death). The patient was treated with PARACETAMOL 17-Jul-2021 for Fever, at an unspecified dose and frequency. The patient died on 18-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided. Very limited information regarding these events have been provided at this time. No further information is expected at this time. Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow up received on 29-Jul-2021, contains information about event pyrexia and concomitant drug paracetamol.; Sender''s Comments: Very limited information regarding these events have been provided at this time. No further information is expected at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1524420 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-14
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Endocarditis, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-16
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: POLARAMINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve replacement ((biological valve))
Allergies:
Diagnostic Lab Data: Test Date: 20210713; Test Name: COVID-19 antigen test; Test Result: Negative ; Comments: Nasopharyngeal swab
CDC Split Type: JPPFIZER INC202100922491

Write-up: multiple cerebral haemorrhage; Endocarditis infective; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. A 69-year-old male patient received first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC3661, Expiration date 30Sep2021) intramuscular in the left arm at the age of 69 years old for COVID-19 immunization. Medical history included postoperative status of aortic valve replacement (biological valve) from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included dexchlorpheniramine maleate (POLARAMINE) taken for an unspecified indication, start and stop date were not reported (within 2 weeks of vaccination). Since the vaccination, the patient has been tested for COVID-19. On 13Jul2021 (6 days after the vaccination), nasopharyngeal swab was performed, and the result of COVID-19 antigen test was negative. On 14Jul2021 (7 days after the vaccination), the patient experienced endocarditis infective. On 16Jul2021 (9 days after the vaccination), the outcome of the event was fatal despite treatment including antibiotic and thrombomodulin alfa (RECOMODULIN). Cause of death was multiple cerebral haemorrhage (unknown date). The patient died on 16Jul2021. An autopsy was not performed.; Sender''s Comments: A causal association cannot be completely excluded for the reported events and BNT162B2 based on temporal association. However, the patient''s history of aortic valve replacement might also have played a contributory role towards the fatal events. 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: Endocarditis infective; multiple cerebral haemorrhage


VAERS ID: 1524439 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Computerised tomogram, Dyspnoea, Interstitial lung disease, Pyrexia
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (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), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (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: 2021-07-19
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic interstitial pneumonia; Rheumatoid arthritis
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: CT scan; Result Unstructured Data: Test Result:Ground-glass-pattern shadow; Comments: in both lungs
CDC Split Type: JPPFIZER INC202100924551

Write-up: Acute respiratory failure; Breathing difficulty; Interstitial pneumonia aggravated; Pyrexia; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The regulatory authority report number is v21120641. A 90-year and 6-month-old female patient received BNT162B2 (COMIRNATY; solution for injection; lot number: FA2453; expiration date: 31Aug2021), via an unspecified route of administration on 12Jul2021 14:00 (at the age of 90-years-old) as dose 1, single for COVID-19 immunisation. Medical history included rheumatoid arthritis and chronic interstitial pneumonia. The patient''s concomitant medications were not reported. On 12Jul2021 at 14:00 (the day of vaccination), the patient received the first dose of BNT162B2. On 12Jul2021 at around 21:00 (7 hours after the vaccination), the patient experienced interstitial pneumonia aggravated (based on diagnosis). On 16Jul2021 (4 days after the vaccination), the patient was hospitalized. The clinical course of the events was as follows: The patient was regularly visiting a nearby hospital for the treatment of rheumatoid arthritis. On 12Jul2021 at night (the day of vaccination), the patient developed pyrexia. On 16Jul2021 (4 days after the vaccination), breathing difficulty appeared, and she visited the reporter''s hospital. Acute respiratory failure was noted. CT scan showed ground-glass-pattern shadow in both lungs. The patient was hospitalized to receive the treatment under diagnosis of interstitial pneumonia. On 19Jul2021 (7 days after the vaccination), the patient died due to interstitial pneumonia aggravated. It was not reported if an autopsy was performed. The outcome of the remaining events was unknown. The reporting physician classified the event as serious (fatal outcome) and assessed that the event was related to BNT162B2. Interstitial pneumonia aggravated associated with rheumatoid arthritis was considered as another possible cause of the event. The reporting physician commented as follows: It was considered that the patient had a background of chronic interstitial pneumonia caused by rheumatoid arthritis. Interstitial pneumonia aggravated occurred followed by pyrexia after the vaccination. The possibility that BNT162B2 triggered acute aggravation could not be denied.; Reported Cause(s) of Death: Interstitial pneumonia aggravated


VAERS ID: 1524458 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-06-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic dissection, Apnoea, Body temperature, C-reactive protein increased, Chest X-ray, Electrocardiogram, Malaise, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-08
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210630; Test Name: Body temperature; Result Unstructured Data: Test Result:35.8 Centigrade; Comments: before vaccination; Test Date: 20210630; Test Name: Body temperature; Result Unstructured Data: Test Result:about 37.5 Centigrade; Comments: at night; Test Date: 20210701; Test Name: Body temperature; Result Unstructured Data: Test Result:around 37.5 Centigrade; Test Date: 20210702; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: after taking antipyretic; Test Date: 20210702; Test Name: Body temperature; Result Unstructured Data: Test Result:37.6 Centigrade; Comments: during the night; Test Date: 20210703; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Test Date: 20210704; Test Name: Body temperature; Result Unstructured Data: Test Result:37.6 Centigrade; Test Date: 20210705; Test Name: Body temperature; Result Unstructured Data: Test Result:35.8 Centigrade; Test Date: 20210707; Test Name: Chest X-ray; Result Unstructured Data: Test Result:no abnormality; Test Date: 20210707; Test Name: CRP; Result Unstructured Data: Test Result:23.06; Comments: increased to 23.06; Test Date: 20210707; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:no abnormality
CDC Split Type: JPPFIZER INC202100925896

Write-up: Ascending aortic dissection; apnoea; pyrexia of approximately 37.5 degrees centigrade/low-grade fever; general malaise; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21120670. A 63-year and 9-month-old female patient received BNT162B2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 30Jun2021 at 13:30 (Batch/Lot Number: FA5765; Expiration Date: 30Sep2021) as dose 2, single for COVID-19 immunisation. Body temperature before vaccination was 35.8 degrees centigrade. The patient had no family history. Medical history and concomitant medications were not reported. 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). On 09Jun2021, the patient previously received the first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration (Lot# EY0779, Expiration date 31Aug2021) as dose 1, single for COVID-19 immunisation. On 08Jul2021 around 07:00 (approximately 7 days, 17 hours, and 30 minutes after the vaccination), the patient experienced ascending aortic dissection. On 08Jul2021 at 07:57 (7 days, 18 hours, and 27 minutes after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 09Jun2021, the patient received the first dose of the vaccine (no abnormalities were noted until the second dose). On 30Jun2021, the patient received the second dose of the vaccine. From after the vaccination to the night, the patient had a pyrexia of approximately 37.5 degrees centigrade. The patient had a general malaise. On 01Jul2021, the patient had a pyrexia of around 37.5 degrees centigrade (the patient took 1 tablet of acetaminophen (CALONAL)). On 02Jul2021, the body temperature was 36.5 degrees centigrade (after taking antipyretic). The body temperature was 37.6 degrees centigrade during the night. On 03Jul2021, the body temperature was 36.2 degrees centigrade. The fever went down. On 04Jul2021, pyrexia of 37.6 degrees centigrade recurred. On 05Jul2021, the patient had a general malaise (35.8 degrees centigrade). On 06Jul2021, the patient had a general malaise and low-grade fever. On 07Jul2021, since the general malaise and low-grade fever persisted, the patient visited the reporting clinic. Chest X-ray and ECG showed no abnormalities. The blood test results of the following day would be awaited. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. Other possible cause(s) of the event such as any other diseases was unknown. The patient died on 08Jul2021. It was not reported if an autopsy was performed. The reporting physician commented as follows: On 08Jul2021 around 07:00, the patient was taken to Hospital by ambulance because of apnoea. The patient was confirmed dead at 07:57 due to ascending aortic dissection at the hospital (on 07Jul2021, CRP increased to 23.06). No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: On 08Jul2021 around 07:00, the patient was taken to Hospital A by ambulance because of apnoea. The patient was confirmed dead at 07:57 due to ascending aortic dissection at the hospital (on 07Jul2021, CRP increased to 23.06).; Sender''s Comments: Medical Review completed. Regulatory authority case. Fatal event noted.; Reported Cause(s) of Death: Ascending aortic dissection


VAERS ID: 1524459 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-18
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0583 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 degrees Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202100925975

Write-up: Death; This is a spontaneous report from a contactable physician (forensic anatomist) received from the Regulatory Authority. Regulatory authority report number is v21120640. A 77-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 14Jul2021 (the day of vaccination; at the age of 77 years old) (hearsay) (Batch/Lot Number: EY0583; Expiration Date: 31Oct2021) as dose 2, single for COVID-19 immunization. The patient previously received BNT162b2 (COMIRNATY, Solution for injection) on an unspecified date (Batch/Lot number and Expiration date were unspecified) as dose 1, single for COVID-19 immunization. As for the patient''s family history, it was reported that the patient had lived alone (unknown details, hearsay). The 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) was reported as unknown. The patient''s medical history and concomitant medications were not reported. The patient experienced death on 18Jul2021 at 03:39. On 18Jul2021 (4 days after the second dose of the vaccination) at 03:39 (estimated time of death through the clinical diagnosis), the patient died. The reporting physician classified the event as serious (Death), and assessed the causality between the event and BNT162b2 as unassessable (because the investigation was in progress, details were unknown at the time of the reporting). Other possible causes of the event such as any other diseases were not reported. The reporting physician commented as follows: This was the case of autopsy which was requested by the police according to the law regarding investigation of the cause of death or the identity of corpse handled by police, etc. The patient underwent lab test and procedure, which included body temperature of 36.6 degrees Centigrade on 14Jul2021 before vaccination. The outcome of the event was fatal. The cause of death was not reported. The patient died on 18Jul2021. An autopsy was being performed and results were not provided.; Reported Cause(s) of Death: Death


VAERS ID: 1524460 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-30
Onset:2021-06-07
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7338 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Physical deconditioning
SMQs:, Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-22
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210620; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202100925982

Write-up: Physical deconditioning; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21120682. A 72-year and 3-month-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 30May2021 (Batch/Lot Number: FA7338; Expiration Date: 30Sep2021) as DOSE 1, SINGLE, and dose 2 via an unspecified route of administration on 20Jun2021 (Batch/Lot Number: EY5423; Expiration Date: 31Aug2021) as DOSE 2, SINGLE for COVID-19 immunisation. Body temperature before vaccination on 20Jun2021 was 36.5 degrees centigrade. Family history was not reported. The patient medical history and concomitant medications were not reported. The patient experienced physical deconditioning (resulting in death) on 07Jun2021. The patient died on 22Jun2021. It was not reported if an autopsy was performed. ''The patient had a symptom (feeling dull) at the time of second vaccination on 22Jun2021''. Physical deconditioning had continued after the previous vaccination. On 07Jun2021 (8 days after the first vaccination), the patient experienced physical deconditioning but made no hospital visit for it, and physical deconditioning still continued afterwards. On 20Jun2021 at unknown time, despite the persisting physical deconditioning, the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5423, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 22Jun2021 in the morning (2 days after the second vaccination), an ambulance was called because of physical deconditioning, but the patient was confirmed dead when transported to the hospital.(The reporting physician heard the above course from the patient''s wife after receiving a request from the physician on duty to prepare a death certificate). It was not reported whether autopsy was done. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. It was not reported whether there were other possible causes of the event such as any other diseases. The reporting physician commented as follows: Reported this case because the time between the vaccination and the physical deconditioning and death was close.; Reported Cause(s) of Death: Physical deconditioning


VAERS ID: 1524461 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure fluctuation, Blood pressure measurement, Body temperature, Cardiac arrest, Coma scale, Cyanosis, Feeling cold, Heart rate, Loss of consciousness, Mouth breathing, Nausea, Oxygen saturation, Oxygen saturation decreased, Pupillary reflex impaired, Pupils unequal, Pyelonephritis, Pyrexia, Respiratory distress, Respiratory rate, Sepsis, Skin discolouration, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (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), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-10
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypothyroidism; Spinocerebellar disease
Allergies:
Diagnostic Lab Data: Test Date: 20210609; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:118/85; Comments: at 22:00; Test Date: 20210610; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:111/81; Comments: at 00:00; Test Date: 20210610; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:fluctuated widely; Comments: at 02:30; Test Date: 20210608; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination; Test Date: 20210609; Test Name: Body temperature; Result Unstructured Data: Test Result:37.9 Centigrade; Comments: at 08:25; Test Date: 20210609; Test Name: Body temperature; Result Unstructured Data: Test Result:39.4 Centigrade; Comments: at 13:50; Test Date: 20210609; Test Name: Body temperature; Result Unstructured Data: Test Result:40.1 Centigrade; Comments: at 18:40; Test Date: 20210609; Test Name: Body temperature; Result Unstructured Data: Test Result:37.1 Centigrade; Comments: at 22:00; Test Date: 20210610; Test Name: Body temperature; Result Unstructured Data: Test Result:37.7 Centigrade; Comments: at 00:00; Test Date: 20210610; Test Name: Body temperature; Result Unstructured Data: Test Result:37.7 Centigrade; Comments: at 00:56; Test Date: 20210610; Test Name: Body temperature; Result Unstructured Data: Test Result:37.6 Centigrade; Comments: at 02:30; Test Date: 20210610; Test Name: Body temperature; Result Unstructured Data: Test Result:38.5 Centigrade; Comments: at 06:00; Test Date: 20210610; Test Name: Body temperature; Result Unstructured Data: Test Result:39.5 Centigrade; Comments: at 07:45; Test Date: 20210610; Test Name: Consciousness level; Result Unstructured Data: Test Result:III-300; Comments: at 07:45; Test Date: 20210610; Test Name: Pulse rate; Result Unstructured Data: Test Result:110s; Comments: at 06:00; Test Date: 20210609; Test Name: SpO2; Test Result: 93 %; Comments: at 18:40; Test Date: 20210609; Test Name: SpO2; Test Result: 96 %; Comments: at 22:00; Test Date: 20210610; Test Name: SpO2; Result Unstructured Data: Test Result:80s %; Comments: at 00:00; Test Date: 20210610; Test Name: SpO2; Test Result: 81 %; Comments: at 00:56; on room air, it became 99% with 5 L of oxygen; Test Date: 20210610; Test Name: SpO2; Test Result: 88 %; Comments: with 8 L of oxygen; Test Date: 20210610; Test Name: SpO2; Result Unstructured Data: Test Result:90-91 %; Comments: at 07:48; with 10 L of oxygen; Test Date: 20210610; Test Name: RR; Result Unstructured Data: Test Result:26; Comments: at 00:56
CDC Split Type: JPPFIZER INC202100926045

Write-up: cardiac arrest; jaw breathing; pupil laterality; loss of light reflex; did not respond to a call / consciousness level was III-300; respiratory distress; blood pressure fluctuated widely; feeling cold; ill color of fingers; cyanosis of the right toe(s); queasy; vomited; SpO2 93%; body temperature was 37.9 degrees centigrade; sepsis due to pyelonephritis; sepsis due to pyelonephritis; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21120723. A 68-year-old female patient received BNT162b2 (COMIRNATY, Solution for injection, Lot number FA4597, Expiration date 31Aug2021) via an unspecified route of administration on 08Jun2021 14:00 (at the age of 68-years-old) at dose 1, single for COVID-19 immunization. Medical history included spinocerebellar degeneration and hypothyroidism. Concomitant medication was not reported. Body temperature before vaccination was 36.7 degrees centigrade. On 08Jun2021 at 14:00 (the day of vaccination), the patient received the first dose of BNT162b2. On 09Jun2021 at 08:25 (18 hours 25 minutes after the vaccination), the patient experienced sepsis due to pyelonephritis. On 10Jun2021 (2 days after the vaccination), the outcome of the events was fatal. The course of the event was as follows: On 08Jun2021, the patient received BNT162b2. On 09Jun2021 at 08:25, body temperature was 37.9 degrees centigrade. At 13:50, body temperature was 39.4 degrees centigrade. At 18:40, the patient vomited. Body temperature was 40.1 degrees centigrade and SpO2 was 93%. At 22:00, body temperature was 37.1 degrees centigrade, blood pressure was 118/85, and SpO2 was 96%. The patient had queasy. On 10Jun2021 at 00:00, the patient vomited a small amount. Body temperature was 37.7 degrees centigrade, blood pressure was 111/81, and SpO2 was 80s. At 00:35, 2 L of oxygen was initiated. At 00:56, respiratory rate (RR) was 26, body temperature was 37.7 degrees centigrade, and SpO2 was 81% (on room air), which became 99% with 5 L of oxygen. At 02:30, SpO2 was not measurable, body temperature was 37.6 degrees centigrade, and blood pressure fluctuated widely. The patient had respiratory distress, feeling cold, ill color of fingers, and cyanosis of the right toes. At 06:00, body temperature was 38.5 degrees centigrade and pulse rate was 110s. The patient had respiratory distress, SpO2 was not measurable, feeling cold was present, and the patient did not respond to a call. At 07:45, the patient did not respond to a call. The patient had jaw breathing, pupil laterality and loss of light reflex. Consciousness level was III-300, body temperature was 39.5 degrees centigrade, and blood pressure and SpO2 were not measurable. Oxygen 8 L was initiated and SpO2 was 88%. At 07:48, oxygen 10 L was initiated and SpO2 was 90-91%. At 08:05, the patient was found to have cardiac arrest. At 08:09, chest compression was initiated, BOSMIN 1 ampoule was intravenously administered, and automated external defibrillator (AED) was placed. At 08:10, spontaneous circulation returned. At 08:23, Bosmin 1 ampoule was intravenously administered. At 08:25, the patient was transferred to a city hospital. At 10:27, the patient repeatedly had cardiac arrest. Family member was consulted and resuscitation was discontinued and then the patient died on 10Jun2021. Cause of death was sepsis due to pyelonephritis (information was received from the city hospital). It was unknown if autopsy was performed. Outcome of the other events 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 cause of the event such as any other diseases was pyelonephritis (as reported). Reporter comment: According to the information received from the city hospital, cause of death was pyelonephritis and sepsis. Thus, there was no clear relationship between the vaccination and the events; however, the case was reported since the patient died 2 days after the vaccination.; Reported Cause(s) of Death: sepsis due to pyelonephritis; sepsis due to pyelonephritis


VAERS ID: 1524481 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Chest X-ray
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: 2021-07-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210711; Test Name: Chest x-ray; Result Unstructured Data: Test Result:Pulmonary oedema
CDC Split Type: JPPFIZER INC202100927153

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21120742.??The patient was a 77-year (at vaccination) female. On 10Jul2021 (the day of vaccination), the patient received?the second dose of COVID-19 Vaccine (manufacturer unknown) via an unspecified route of administration as dose 2, single for COVID-19 immunization. On 11Jul2021 at 03:00 (1 day after the vaccination), the patient experienced cardio-respiratory arrest. On 11Jul2021 (1 day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 10Jul2021, the patient received the second dose of COVID-19 vaccine. After the vaccination, the patient experienced dyspnoea. As the symptom did not improved, she called an ambulance at 02:24 on 11Jul2021. When the ambulance arrived at her home, cardio-respiratory arrest was found. Resuscitation was performed while the patient was urgently transferred to the reporting hospital. Chest X-ray showed the findings of pulmonary oedema. The patient died at 03:50 on 11Jul2021. The reporting physician classified the event as serious (death) and assessed that the event was related to the vaccine. It was not reported if autopsy was performed. The reporting physician commented as follows: The causality between the event and the vaccine was considered to be present. Pfizer is a marketing authorization holder of COVID-19 Vaccine in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of COVID-19 Vaccine has submitted the same report to the regulatory authorities.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1524482 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0201 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac disorder, Oxygen saturation, Pyrexia, Respiratory failure, Tremor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-21
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LIXIANA; NORVASC; MAINTATE; NEXIUM [ESOMEPRAZOLE MAGNESIUM TRIHYDRATE]; MUCOSOLVAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Emphysema (surgery conducted in Mar2016); Lung cancer (surgery conducted in Mar2016); Obesity; Oxygen saturation decreased (on mild exertion); Oxygen therapy (SpO2 was 80 to 90% on mild exertion); Respiratory failure (respiratory failure was aggravated); Respiratory failure aggravated (underwent surgery in Mar2016. Thereafter); Surgery
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination; Test Date: 20210715; Test Name: body temperature; Result Unstructured Data: Test Result:37.0 Centigrade; Comments: On waking on the vaccination date; Test Date: 2021; Test Name: SpO2; Result Unstructured Data: Test Result:80 to 90 %; Test Date: 20210716; Test Name: SpO2; Result Unstructured Data: Test Result:50s %
CDC Split Type: JPPFIZER INC202100927180

Write-up: respiratory failure/SpO2 decreased to 50s%/respiratory condition were aggravated; cardiac function; were aggravated; pyrexia; tremor; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21120754. A 65-year-old male patient with a body temperature before vaccination (15Jul2021) of 36.5 degrees centigrade, received bnt162b2 (COMIRNATY, solution for injection), via unspecified route of administration on 15Jul2021 09:30 (batch/lot number EW0201 and expiry date 30Sep2021) as dose 1, single for covid-19 immunization. Medical history included emphysema, lung cancer (surgery conducted in Mar2016), respiratory failure, atrial fibrillation, obesity. The family history was not provided. The patient had a high risk of COVID-19 infection. In early Mar2021, the patient was receiving home oxygen therapy. Although the patient was receiving home oxygen therapy, the SpO2 was 80 to 90% on mild exertion, and respiratory failure was significant. Concomitant medications included edoxaban tosilate (LIXIANA), amlodipine besilate (NORVASC), bisoprolol fumarate (MAINTATE), esomeprazole magnesium trihydrate (NEXIUM [ESOMEPRAZOLE MAGNESIUM TRIHYDRATE]), ambroxol hydrochloride (MUCOSOLVAN); all taken for an unspecified indication from an unspecified start date. On 15Jul2021 (the day of vaccination) on awaking, the body temperature was 37 degrees Celsius; however, the body temperature before vaccination was 36.5 degrees Celsius. On 15Jul2021 at 09:30 (the day of vaccination), the patient received the first dose vaccine. On 16Jul2021 at around 13:00 (one day after the vaccination), the patient experienced tremor and pyrexia. The SpO2 decreased to 50s% reported by phone. On 16Jul2021 13:00, the patient experienced respiratory failure, pyrexia. An emergency hospitalization was asked to another hospital, and the patient was admitted to the hospital on 16Jul2021. On 21Jul2021 (5 days after the vaccination), the patient died due to events. It was unknown if an autopsy was performed. The reporting physician classified the events "respiratory failure aggravated", "heart disease aggravated", "pyrexia" as serious (hospitalization and death) and assessed that the events were related to BNT162b2. Other possible cause of the event such as any other diseases was aggravation of the underlying diseases due to pyrexia. The reporting physician commented as follows: It was considered that the patient died because the cardiac function and the respiratory condition were aggravated due to pyrexia caused by a side reaction to the vaccination.; Reported Cause(s) of Death: cardiac function; were aggravated; respiratory failure/SpO2 decreased to 50s%/respiratory condition were aggravated; Pyrexia


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