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From the 9/17/2021 release of VAERS data:

Found 15,386 cases where Vaccine is COVID19 and Patient Died



Case Details

This is page 72 out of 154

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VAERS ID: 960122 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-19
Onset:2021-01-06
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH BNT162B2 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, SARS-CoV-2 test negative
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Unsure if patient is enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021031502

Write-up: Death; This is a spontaneous report from a contactable physician. This is a report received from the Medicines and Healthcare products Regulatory Agency (MHRA). Regulatory authority report number GB-MHRA-WEBCOVID-20210108135934, Sender''s (Case) Safety Report Unique Identifier GB-MHRA-ADR 24573149. An 80-year-old male patient received dCOVID-19 MRNA VACCINE BIONTECH (BNT162B2) on 19Dec2020 at single dose for Covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. It is unsure if patient is enrolled in clinical trial. The patient experienced death on 06Jan2021. No reports of any reaction after having the vaccine. The patient underwent lab tests and procedures which included Sars-cov-2 test: negative on an unspecified date. Patient likely died from Coronary event. Death was reported to the Coroner. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 960173 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-29
Onset:2020-12-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Cardiac arrest, Cardiac failure congestive, Condition aggravated, General physical health deterioration, Myocardial ischaemia, Oxygen saturation, Oxygen saturation decreased, SARS-CoV-2 test
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), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Respiratory failure (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-30
   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: ; ; ; ; ; ; COSMOCOL; ; ;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Congestive cardiac failure; Constipation; Epilepsy; Frailty; Indigestion; Ischaemic heart disease; LVH; Pain; TIA
Allergies:
Diagnostic Lab Data: Test Date: 20201230; Test Name: o2 sats; Result Unstructured Data: Test Result:falling; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No
CDC Split Type: GBPFIZER INC2021024664

Write-up: Cause of death was unknown but was probably due to frailty/known IHD/CCF; Cause of death was unknown but was probably due to frailty/known IHD/CCF; Cause of death was unknown but was probably due to frailty/known IHD/CCF; Cause of death was unknown but was probably due to frailty/known IHD/CCF; General physical health deterioration; falling 02 sats; subsequent arrest; This is a spontaneous report from a contactable physician. This is a report received from the MHRA. Regulatory authority report number: GB-MHRA-WEBCOVID-20210112154920, and safety report unique identifier: GB-MHRA-ADR 24584672. A 90-year-old female patient received single dose of BNT162B2 (Solution for injection), via an unspecified route of administration on 29Dec2020 for COVID-19 immunization. Medical history included frailty of old age, congestive cardiac failure, atrial fibrillation (AF), left ventricular hypertrophy (LVH), transient ischaemic attack (TIA), ischaemic heart disease, epilepsy, indigestion, pain, and constipation. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Concomitant medication included apixaban from 31Oct2019 for persistent atrial fibrillation, atorvastatin from 10Sep2019 for ischaemic heart disease, bisoprolol from 05Dec2017 for ischaemic heart disease, carbamazepine from 21Jan2002 for epilepsy, cimetidine from 03Apr2020 for indigestion, codeine from 22May2015 for pain, macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (COSMOCOL) from 16Dec2019 for constipation, digoxin from 31Oct2019 for atrial fibrillation, furosemide from 05Mar2020 for heart failure, congestive; and perindopril from 11Jul2020 for heart failure, congestive. The patient experienced general physical health deterioration on 30Dec2020 next day after vaccination. Rapid deterioration in health: falling 02 sats and subsequent arrest. The events were considered serious: medically significant. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative covid-19 test on an unspecified date. The outcome of general physical health deterioration, falling O2 sats, and subsequent arrest was unknown.The patient died on 30Dec2020. Cause of death was unknown but was probably due to frailty/known IHD/CCF. Cannot say if vaccination was causer of this but patient died within 24 hrs of the vaccination. 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: Death


VAERS ID: 960200 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1688 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Lower respiratory tract infection, SARS-CoV-2 test
SMQs:, Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Frailty; Comments: Known frailty and advanced dementia in care home. Had vaccine on 31/12/20 developed chest infection on 02/01/2021. Rapidly deteriorated and passed away on 02/01/2021 Unsure if patient has had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20201127; Test Name: COVID-19 test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021033456

Write-up: Chest infection; This is a spontaneous report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202101141121469160 and Safety Report Unique Identifier GB-MHRA-ADR 24594625. A contactable physician reported a 90-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1688) via an unspecified route on 31Dec2020 single dose for COVID-19 vaccination. The patient medical history included known frailty and advanced dementia in care home. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced chest infection on 02Jan2021. The patient had rapidly deterioration 48 hours after vaccine, developed chest infection and died. Patient had not tested positive for COVID-19 since having the vaccine. Reporter was unsure if patient had had symptoms associated with COVID-19. The patient underwent lab tests and procedures which included ''no - negative'' COVID-19 test on 27Nov2020. The patient died on 02Jan2021. It was unknown if an autopsy was performed. The cause of death was reported as chest infection. The action taken in response to the event(s) for BNT162B2 was not applicable. Outcome of the event was fatal. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: Chest infection


VAERS ID: 960201 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-08
Onset:2021-01-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0141 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-10
   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: ; ; ASPIRIN [ACETYLSALICYLIC ACID]; ; ;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cognitive impairment (mild); CVA; Myocardial infarction; Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021040949

Write-up: Death; This is a spontaneous report received from a contactable physician by Pfizer from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202101141345001560. An 84-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL0141, via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunization. Medical history included cerebrovascular accident from 2018 to an unknown date, myocardial infarction from 2018 to an unknown date and cognitive disorder (mild). Concomitant medication included atorvastatin (MANUFACTURER UNKNOWN), bisoprolol (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN), tamsulosin (MANUFACTURER UNKNOWN), clopidogrel (MANUFACTURER UNKNOWN) and esomeprazole (MANUFACTURER UNKNOWN). The patient has not had symptoms associated with COVID-19 and is not enrolled in a clinical trial. On 10Jan2021, the patient experienced death. It was reported that the patient was found dead at home 2 days after vaccination. It was discussed by the coroner that they felt it was likely due to myocardial infarction (MI) and likely unrelated to vaccination. The patient died on 10Jan2021. The cause of death was myocardial infarction. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Myocardial infarction


VAERS ID: 960202 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-12
Onset:2021-01-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK1768 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Steroid therapy (For exacerbation of COPD, not taking at time of vaccination); Comments: For exacerbation of COPD, not taking at time of vaccination. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021040991

Write-up: Death; This is a spontaneous report received from a contactable consumer by Pfizer from the Medicines and Healthcare products Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-ADR 24600276. An 85-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK1768), via an unspecified route of administration on 12Jan2021 at a single dose for COVID-19 immunization. Medical history included steroid therapy from an unknown date and unknown if ongoing (For exacerbation of COPD, not taking at time of vaccination), chronic obstructive pulmonary disease (COPD) from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient experienced death on 13Jan2021; within 24 hours of receiving the vaccination. The patient had not had symptoms associated with COVID-19; and did not have a COVID-19 test. The patient had not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in a clinical trial. The clinical outcome of the event was fatal. The patient died on 13Jan2021 due to unknown cause of death. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 960203 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-15
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1688 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021041094

Write-up: Death; 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-ADR 24600508 and Safety Report Unique Identifier of GB-MHRA-WEBCOVID-202101151324539460. An 88-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EJ1688), via an unspecified route of administration on 06Jan2021 as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced death on 15Jan2021; this was reported as an unexpected death. The patient died on 15Jan2021. It was not reported if an autopsy was performed. The cause of death was not reported. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 960204 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-09
Onset:2021-01-15
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cold sweat, Death, Pallor
SMQs:, Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease (Been in care since 201 (as reported)); Frailty; Comments: Severe Alzheimers Dementia Been in care since 201 Died suddenly on 15th November unexpected Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021040992

Write-up: Death; clammy and pale; clammy and pale; This is a spontaneous report received from a contactable physician by Pfizer from the Medicines and Healthcare products Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-ADR 24601997. A 90-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 09Jan2021 at a single dose for COVID-19 immunization. The patient''s medical history included Severe Alzheimer''s disease from an unknown date and unknown if ongoing (Been in care since 201 (as reported)), frail from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient experienced death (medically significant) on 15Jan2021, and clammy and pale (medically significant). The clinical course was reported as follows: the patient died suddenly on 15th November unexpected (as reported). The patient had been frail as normal; and became clammy and pale in the morning and then just died. The patient had not had symptoms associated with COVID-19; and did not have a COVID-19 test. The patient was not enrolled in a clinical trial. The patient had not tested positive for COVID-19 since having the vaccine. There was no relevant investigations or tests conducted. The clinical outcome of the event, death, was fatal. The clinical outcome of the events, clammy and pale, was unknown. The patient died on 15Jan2021 due to unknown cause of death. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: Death


VAERS ID: 960207 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-09
Onset:2021-01-18
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Cardiac arrest, Dizziness, Fall
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angioplasty; Anticoagulant therapy; Bone marrow transplant; Cardiac disorder NOS; Hepatic disorder NOS (caused by the anticoagulants he was receiving); Leukemia (unknown whether currently being treated); Myocardial infarction (second); Myocardial infarction (first); Osteonecrosis; Stent insertion NOS (2 of 2 stents that they were worn out); Stent insertion NOS (1 of 2 stents that they were worn out)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC2021045879

Write-up: cardiac arrest; felt dizzy; falling down; acute myocardial infarction; This is a spontaneous report from two contactable physicians (one was the hospital director and the other was the coordinator of the hospital vaccination program). A 63-year-old male patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: UNKNOWN), intramuscular on 09Jan2021 as a single dose for COVID-19 vaccination. Medical history included leukemia (unknown whether currently being treated), bone marrow transplant on an unknown date, cardiac disorder, two myocardial infarctions on an unknown dates, 2 stent placements on unknown dates (that they were worn out), heart balloon insertion on an unknown date, hepatic problems caused by the anticoagulants, and aseptic hip necrosis. The patient''s concomitant medications were not reported. On 18Jan2021, the patient experienced acute myocardial infarction, felt dizzy, falling down, and cardiac arrest. The clinical course was as follows: On 18Jan2021, the patient went for a walk, he felt dizzy and fell down to the ground. The patient suffered a cardiac arrest. He was admitted to the hospital where an attempt was made to resuscitate him, but the patient died on 18Jan2021. The reason of death was recorded as an acute myocardial infarction. An autopsy was not performed and would not be performed. The clinical outcomes of felt dizzy, fall, and cardiac arrest were unknown at the time of death. One of the reporting physicians (coordinator of the hospital vaccination program who vaccinated the patient) mentioned that there was no possibility the adverse events and the death could be attributed to the vaccine and they were unrelated. No follow-up attempts are possible; information about lot number cannot be obtained.; Sender''s Comments: Based on the information available and on the pathophysiology of the event company does not reasonably attribute the reported event sas related to study vaccine, concomitant drugs, or clinical trial procedure. The event was likely due to subject underlying contributory factors. Case will be reevaluated based on further information during follow-up; Reported Cause(s) of Death: acute myocardial infarction


VAERS ID: 960208 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Illness
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021035780

Write-up: cardiac arrest; This is a spontaneous report from a contactable consumer. A 90-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included a background illness. The patient''s concomitant medications were not reported. The patient passed away from a cardiac arrest on an unspecified date, less than 24 hours after the second vaccination. The patient has a background illness but in good condition and functioning. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 960210 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021031629

Write-up: Death; This is a spontaneous report from a contactable physician via a sales representative. A 64-years-old male patient who was a physician received bnt162b2 (COMIRNATY, Lot number: EL1484, Expiration Date: Apr2021), via an unspecified route of administration on 13Jan2021 13:58 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient was reported as multipathological subject. The reporter learned the news from the local press, front page of the newspaper. The patient experienced died following vaccination on an unspecified date in Jan2021. The patient was found death at home from his son on 14Jan2021. An autopsy would be performed.; Sender''s Comments: The event death is assessed as related to BNT162b2 vaccine and documented as such in the global safety database until sufficient information is available to allow an unrelated causality assessment. 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: 960215 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Concomitant disease aggravated, Feeling hot
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-07
   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: ; BRONKYL; SPIRONOLACTONE ORION; HALDOL; PARACET [PARACETAMOL]; KALEORID; FURIX [FUROSEMIDE]; ATROVENT; PRADAXA; ZOPICLONE ACTAVIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; COPD; Cor pulmonale; Dementia (Due to hyponatremia); Heart failure; Hypertension; Hypertonia; Hypokalemia; Hyponatremia (Due to medication use); Oedema; Pain NOS; Sleep disorder NOS; Terminal state; Unrest
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021035345

Write-up: CONCOMITANT DISEASE AGGRAVATED; Sensation of warmth; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB NO-NOMAADVRE-FHI-2021-U33d1, with Safety Report Unique Identifier NO-NOMAADVRE-E2B_00013799. A 94-year-old female patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, batch/lot number not provided), intramuscularly in left arm on 05Jan2021 at 11:00 at single dose (1st dose in left arm) for Covid-19 vaccination. The patient''s medical history included terminal state, hyponatremia (due to medication use), dementia (due to hyponatremia), cor pulmonale, chronic obstructive pulmonary disease (COPD), heart failure, hypertonia, hypertension, oedema, unrest, pain NOS, hypokalemia, atrial fibrillation, and sleep disorder NOS. The patient''s concomitant medications were metoprolol (strength: 50 mg) for hypertension, acetylcysteine (BRONKYL, strength: 200 mg), for COPD, spironolactone (SPIRONOLACTONE ORION, strength: 25 mg), for oedema and cardiac failure, haloperidol (HALDOL, strength: 1 mg) for unrest, paracetamol (PARACET, strength: 500 mg) for pain NOS, potassium chloride (KALEORID, strength: 750 mg) for hypokalemia, furosemide (FURIX, strength: 40 mg) for heart failure, ipratropium bromide (ATROVENT, strength: 0.25 mg) for COPD, dabigatran etexilate mesilate (PRADAXA, strength: 110 mg) for atrial fibrillation, and zopiclone (ZOPICLONE ACTAVIS, strength: 5 mg) for sleep disorder NOS. The patient experienced sensation of warmth on 05Jan2021, and concomitant disease aggravated on 06Jan2021. The patient died on 07Jan2021. It was not reported if an autopsy was performed but with unknown results. The Regional Pharmacovigilance Center assessed the causality between BNT162B2 and the events Sensation of warmth and Concomitant disease aggravated as Possible. According to reporter, death was caused by known concomitant disease (as reported). There is no clinical suspicion of a link between the vaccine and death. Information on the batch/lot number has been requested.; Reported Cause(s) of Death: Sensation of warmth; CONCOMITANT DISEASE AGGRAVATED


VAERS ID: 960216 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, General physical health deterioration, Weight
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-11
   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: Dementia (gradual deterioration since start of year 2020.); Reduced general condition; Underweight
Preexisting Conditions: Medical History/Concurrent Conditions: Fall; UTI
Allergies:
Diagnostic Lab Data: Test Date: 20210107; Test Name: Weight; Test Result: 38.6 kg; Comments: with clothes and shoes
CDC Split Type: NOPFIZER INC2021035332

Write-up: REDUCED GENERAL CONDITION; REDUCED GENERAL CONDITION; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority WEB NO-NOMAADVRE-FHI-2021-Ugy5d, Sender Safety Report Unique Identifier: NO-NOMAADVRE-E2B_00013860. An 89-years-old female patient received bnt162b2 (COMIRNATY) batch EJ6795, first dose intramuscular in left arm at single dose on 06Jan2021 at 17:30 for covid-19 vaccination. Medical history included fall from 05Jan2021, ongoing underweight, urinary tract infection from 31Dec2020, ongoing dementia since an unknown date, and gradual deterioration since start of year 2020; ongoing signs of reduced general condition since 05Jan2021. The patient''s concomitant medication was not reported. The past drug included pivmecillinam (SELEXID, 400mg) at 400mg taken 3x/day for urinary tract infection from 31Dec2020 to 06Jan2021. The patient experienced reduced general condition since 07Jan2021. The patient underwent lab tests and procedures which included weight: 38.6 kg on 07Jan2021 with clothes and shoes. The patient died on 11Jan2021 at 09:10. It was not reported if an autopsy was performed. The Center assessed the causality between bnt162b2 and the event death as Possible. Narrative verbatim: The patient has dementia, gradually declined from the beginning of the year 2020. First cognitive impact after the measures that came in connection with COVID-19. The patient has shown less interest, isolated himself and had reduced appetite. Weight loss despite measures to prevent malnutrition. Last weight check taken 07Jan2021 - 38.6kg (with clothes and shoes). The last 14 days before her death, the patient has had a urinary tract infection. Selexid 400mg 1x3 was started 31Dec2020 in consultation with the emergency ward, and stopped 06Jan2021. The patient received Comirnaty on 06Jan2021 at 17:30, and the last Selexid tablet was given around that time. According to the medical record, the patient had signs of reduced general condition 24 hours before the vaccine was given. On 05Jan2021 the patient fell after visit. After the vaccine was given, the patient has been conscious and was active despite reduced general condition (called the staff for help, move with a walker, among other things). On 07Jan2021 the patient was confused, did not remember where she was and what time of day it was. This persisted until her death. Her general condition progressed last 24 hours and the patient was considered as a terminal. The patient died 11Jan2021 at 09:10. A 89 Years old Female patient received Comirnaty 06Jan2021 for VACCINATION. The medical history included DEMENTIA, FALL (05Jan2021), UTI (31Dec2020), UNDERWEIGHT. The patient was treated in the past with Selexid. On 07Jan2021, the patient developed GENERAL PHYSICAL CONDITION DECREASED. Relevant laboratory findings and investigations included in the report (WEIGHT, 07Jan2021, 38.6kg (with clothes and shoes)). Action taken was: Not Applicable. The patient''s outcome was Fatal, at the time of the report. The case was considered to be Serious. This case was received from a Physician. Sender''s comment as reported: Background: An 89-year-old woman with known dementia, who has gradually declined since the beginning of 2020, decreased appetite and weight loss, was vaccinated with Comirnaty 06Jan2021 at 17:30. Urinary tract infection in the last 14 days, treated with Selexid (pivmecillinam) which was terminated on 06Jan2021. The patient had had signs of impaired general condition (AT) in the last 24 hours before vaccination. Further reduction in general condition until the patient died 11Jan2021. Comment: It was reported that the patient had several underlying diseases before the vaccination. Based on the information in the report it is likely that the underlying diseases is the cause of the death. However, there is a temporal correlation and it cannot be entirely ruled out that the vaccine could have contributed to the worsening of the patient''s underlying diseases. It can also be that the event had a completely different cause which coincidentally developed after the vaccination. Based on the criteria from WHO we assess the causal relationship between Comirnaty and death as Possible. Meaning, a reaction, including pathological lab samples, that happens in a temporal correlation to the use of a pharmaceutical but which could also be caused by underlying disease, other pharmaceuticals or chemicals. Based on the given criteria the report is assessed as serious.; Reporter''s Comments: Reporter''s qualification: physician; Reported Cause(s) of Death: REDUCED GENERAL CONDITION; REDUCED GENERAL CONDITION


VAERS ID: 960217 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-09
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Fatigue, Heart rate, Heart rate increased, Loss of consciousness, Pallor, Pupil fixed, Pupillary light reflex tests, Pyrexia, Respiratory rate, Respiratory rate increased, Somnolence, Tremor
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), Dementia (broad), Parkinson-like events (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), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-10
   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: ELIQUIS; ; NORSPAN [BUPRENORPHINE]; PARACET [PARACETAMOL]
Current Illness: Aphasia (Lost the ability to verbally communicate. Care givers have to evaluate the patient''s condition...); Dementia (Do not resuscitate order in agreement with relatives/next of kin.); Living in nursing home; Polymyalgia rheumatica
Preexisting Conditions: Medical History/Concurrent Conditions: Deep vein thrombosis (Twice.); Pain; Pulmonary embolism; Recurrent UTI (Since admission to nursing home.)
Allergies:
Diagnostic Lab Data: Test Date: 20210110; Test Name: Body temperature; Result Unstructured Data: Test Result:Subfebrile; Test Date: 20210110; Test Name: Pulse rate; Result Unstructured Data: Test Result:140; Comments: Units:{beats}/min; Test Date: 20210110; Test Name: Light reflex tests pupillary; Result Unstructured Data: Test Result:Fixed pupils, 2 mm, not reactive to light; Test Date: 20210110; Test Name: Respiratory rate; Result Unstructured Data: Test Result:40; Comments: Units:/min
CDC Split Type: NOPFIZER INC2021035333

Write-up: fixed pupils; Lost consciousness, elevated respiratory rate and pulse, resulting in death; Lost consciousness, elevated respiratory rate and pulse, resulting in death; Lost consciousness, elevated respiratory rate and pulse, resulting in death; subfebrile; tired; pallor skin; sleeps heavily; tremors; This is a spontaneous report downloaded from the Medicines Agency (MA) Regulatory Authority -WEB NO-NOMAADVRE-FHI-2021-Uj4x1, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00013871. A contactable other hcp reported that an 86-year-old female patient had received bnt162b2 (COMIRNATY, batch/lot number ej6795), via intramuscular route on 05Jan2021 at single dose (first dose, administered into left arm) for covid-19 immunisation. Medical history included ongoing aphasia (lost the ability to verbally communicate, care givers have to evaluate the patient''s condition from her facial expression), pulmonary embolism, ongoing dementia (do not resuscitate order in agreement with relatives/next of kin), deep vein thrombosis (twice), urinary tract infection from 2019 (since admission to nursing home), ongoing polymyalgia rheumatica, living in residential institution from 2019 and ongoing, and pain. Concomitant medications included apixaban (ELIQUIS, 2.5 mg) taken orally as anticoagulant therapy from 14Dec2017 at a dose of 2.5 mg every 12 hours, prednisolone (PREDNISOLONE, 5 mg) taken orally for polymyalgia rheumatica from 25Mar2015 at a dose of 10 mg every 24 hours, buprenorphine (NORSPAN [BUPRENORPHINE]) via transdermal route (patch), first started on an unspecified date in 2018, then from 13Mar2020 at a dose of 15 microgram/hour for pain, and paracetamol (PARACET [PARACETAMOL], 1 g) taken for pain from 25Mar2015 at a dose of 1 g every 8 hours. The patient lost consciousness, got elevated respiratory rate and pulse, all on 09Jan2021, eventually resulting in death. The patient died on 10Jan2021. On 09Jan2021, the patient experienced subfebrile, tired, pallor skin, slept heavily, tremors; and on 10Jan2021, Fixed pupils, outcome was these events were unknown. The patient underwent lab tests and procedures which included body temperature on 10Jan2021 with the subfebrile result, heart rate: 140 {beats}/min on 10Jan2021, pupillary light reflex tests on 10Jan2021 - fixed pupils, 2 mm, not reactive to light, and respiratory rate: 40/min on 10Jan2021. It was not reported if an autopsy was performed. The Regional Pharmacovigilance Center has assessed the causal relationship between the suspect product and the reported events as possible. Case narrative (from the Health Authority) including clinical course, therapeutic measures, outcome and additional relevant information: "A 86 Years old Female patient received Comirnaty on 05/Jan/2021 for VACCINATION. As concomitant medication the patient was given Eliquis, Prednisolone, Paracet, Norspan. The medical history included DEEP VEIN THROMBOSIS (twice), PULMONARY EMBOLISM, POLYMYALGIA RHEUMATICA, DEMENTIA with APHASIA, RECURRENT UTI (2019). Due to her dementia and aphasia she has had a pronounced need for assistance, and in agreement with her relatives/next of kin, she has a standing do not resuscitate (DNR) order. The patient has been a long-term resident at a nursing home since 2019, and has had a stable condition except for recurrent UTI. Her life expectancy was above 3 months at the time of the vaccination. On 09Jan2021, the patient was in her habitual state until the afternoon, when she became subfebrile, tired, and with pallor skin. She would not eat or drink the rest of the day and sleeps heavily, but reacts and awakens upon light shaking. On the morning of 10Jan2021 she seemed tired, would not open her eyes. When being rolled over for a change of diaper, the patient experienced sudden tremors, and developed LOSS OF CONSCIOUSNESS. Upon examination, she also has RESPIRATORY RATE INCREASED, HEART RATE INCREASED. Relevant laboratory findings and investigations included in the report (RESPIRATORY RATE, 10Jan2021, 40/min)( PULSE RATE, 10Jan2021, 140 bpm)( LIGHT REFLEX TESTS PUPILLARY, 10Jan2021, Fixed pupils, 2 mm, not reactive to light.)( BODY TEMPERATURE, 10Jan2021, Subfebrile). A palliative regime was started and the patient died the same day. The patient''s outcome was Fatal, at the time of the report. The case was considered to be Serious. This case was received from a Other health professional. Sender''s comments (Health Authority comments): "The report concerns loss of consciousness, increased respiratory rate and heart rate, which resulted in the death of a nursing home patient in her 80s, a few days after receiving the first dose of the Covid-19 vaccine Comirnaty. Reporter states that the patient is a resident of a long-term ward, does not speak, and otherwise had a great need for assistance, due to dementia. The patient also had polymyalgia rheumatica and recurrent urinary tract infections, but has otherwise been stable during her stay in the ward. Life expectancy was estimated to be over 3 months, when the vaccine was administered. When vaccinating marginal patients who are ill with many underlying diseases, some serious events, including death, may occur shortly after vaccination without any connection to vaccination. It cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease. In each case, it is difficult to know whether the death is due to the vaccine, the patient''s underlying disease or other accidental, concurrent cause that has nothing to do with the vaccination in question. On the basis of the information in the report and in accordance with international criteria, the causal link with vaccination is assessed as possible". No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Lost consciousness, elevated respiratory rate and pulse, resulting in death; Lost consciousness, elevated respiratory rate and pulse, resulting in death; Lost consciousness, elevated respiratory rate and pulse, resulting in death


VAERS ID: 960218 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-13
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / UNK LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dementia; Reduced general condition
Preexisting Conditions: Medical History/Concurrent Conditions: Fall (A few month ago); Femoral neck fracture (A few month ago); Living in nursing home
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021038913

Write-up: gradually lost himself to falling asleep quietly; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB, the regulatory authority report number is NO-NOMAADVRE-FHI-2021-Unrn7. A 87-year-old male patient received bnt162b2 (COMIRNATY, lot number: EJ6795), intramuscular in Left Arm on 07Jan2021 10:20 at single dose for covid-19 immunisation. Medical history included living in nursing home, fall with femoral neck fracture a few months ago in 2020, ongoing reduced general condition, and ongoing dementia. The patient''s concomitant medications were not reported. The patient had advanced dementia and with gradual deterioration recently. Had, among other things, had a fall with a fracture of the femoral neck a few months ago and had in that connection had a place in the nursing home. Lately in the vaccine he had no signs of infection but he had gradually lost weight. Ate and drank less. This gradual reduction in "AT" and "ET" continued after vaccination was given. He did not get any allergic reactions, did not fail but gradually lost himself to falling asleep quietly in 13Jan2021. Clinically, this appears more like a natural last time and not a side effect of the vaccine, but as it was completely new, this case was reported. With the strengthened recommendations according to the elderly who came after the vaccination, the patient should not have had the vaccine when he had a short time left in the beginning and physician did not think that the vaccine made the difference here and the patient had expected a short lifespan but as physician said it was a death so it was reported. The patient died on 13Jan2021. It was unknown if an autopsy was performed. Reporter''s assessment of relatedness of the events to the suspect drug: possible. Case comment: The information is registered in the national adverse reaction register (the Medicines Agency), and then forwarded to international adverse reaction databases. In this way, your message becomes part of an important international collaboration that is continuously ongoing to monitor and maintain safe vaccination worldwide. Based on the information in the report, it is likely that the underlying diseases are the cause of death. However, there is a temporal connection, and it cannot be completely ruled out that the vaccine may have contributed to the aggravation of the patient''s underlying disease. Based on WHO criteria, we consider the causal link between Comirnaty and death to be possible. That is, reaction, including pathological laboratory tests, which occurs in temporal relation to the use of a drug, but which may also be due to an underlying disease, other drugs or chemicals. Based on given criteria, the report is considered serious.; Reported Cause(s) of Death: gradually lost himself to falling asleep quietly


VAERS ID: 960219 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute coronary syndrome, Blood pressure measurement, Intracardiac thrombus, Nausea, Oxygen saturation, Respiratory rate increased, Vomiting
SMQs:, Acute pancreatitis (broad), Myocardial infarction (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALBYL-E; LEVAXIN; LITHIONIT; CIPRAMIL [CITALOPRAM HYDROBROMIDE]; TRIOBE [CYANOCOBALAMIN;FOLIC ACID;PYRIDOXINE]; SIMVASTATIN SANDOZ
Current Illness: Hypercholesteremia; Living in nursing home; Psychiatric disorder NOS
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210106; Test Name: Blood pressure; Result Unstructured Data: Test Result:drop in blood pressure; Test Date: 20210106; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:drop in oxygen saturation
CDC Split Type: NOPFIZER INC2021038848

Write-up: RESPIRATORY RATE HIGH; VOMITING; NAUSEA; ACUTE CORONARY SYNDROME; Cardiac thrombosis; This is a spontaneous report downloaded from the Agency Regulatory Authority-WEB NO-NOMAADVRE-FHI-2021-Uq8ag, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00013788. A contactable physician reported that an 82-year-old female patient received bnt162b2 (COMIRNATY, lot number: EJ6795), via intramuscular route on 05Jan2021 at a single dose (first dose, administered into left arm) for covid-19 immunisation. Medical history included ongoing mental disorder, ongoing living in residential institution and ongoing hypercholesteremia. Concomitant medications included acetylsalicylic acid, magnesium oxide (ALBYL-E, 75 mg) administered via oral route, levothyroxine sodium (LEVAXIN, 100 ug), lithium sulfate (LITHIONIT, 83 mg) administered via oral route, citalopram hydrobromide (CIPRAMIL [CITALOPRAM HYDROBROMIDE], 10 mg) administered via oral route, cyanocobalamin, folic acid, pyridoxine (TRIOBE [CYANOCOBALAMIN;FOLIC ACID;PYRIDOXINE], 0.5 mg/0.8 mg/3 mg), and simvastatin (SIMVASTATIN SANDOZ, 40 mg), all from an unspecified date in 2019 to an unspecified date in 2021 for unknown indication. The patient experienced respiratory rate high, vomiting, nausea and acute coronary syndrome (ACS), all on 06Jan2021 with fatal outcome. The patient underwent lab tests on 06Jan2021 which included blood pressure measurement: drop in blood pressure and oxygen saturation: drop in oxygen saturation. The patient died on 06Jan2021. An autopsy was performed that revealed cardiac thrombosis (intracardiac thrombus) as the cause of death. The Regional Pharmacovigilance Center has assessed the causal relationship between the suspect product and respiratory rate high, vomiting and nausea as Possible, and causal relationship between the suspect product and acute coronary syndrome as Unlikely. Reporter''s comment: The patient developed nausea and vomiting 24 hours later. Subsequent frequent superficial respiration with BT (blood pressure) and SAT (oxygen saturation) fall. Clinical suspicion of "ACS syndrome (reported as AKS)". 15-Jan-2021 RELIS: additional information received by telephone: Patient with comorbidity psychiatric disorder, hypercholestrolemia, reduced functional level. No known heart failure at time of vaccination. Residence at nursing home not considered as terminal, hard to say but expected lifetime about 1.5 years. Preliminary autopsy report concludes: CARDIAC THROMBOSIS cause of death. Sender''s comments (Health Authority comments): "The report concerns a nursing home resident with several underlying diseases who, within 24 hours after vaccination, developed nausea, vomiting and hyperventilation, interpreted as a possible ACS. Information has been obtained from a temporary autopsy report where a blood clot in the heart has been detected. When vaccinating marginal patients who are ill with many underlying diseases, some serious events, including death, may occur shortly after vaccination without any connection to vaccination. It is difficult to imagine how the vaccine can cause a blood clot in the heart within a day. The patient had several underlying risk factors for ischemic heart disease, and it is considered that these are more likely to have caused the reported symptoms. However, it cannot be ruled out that the vaccine has contributed to some of the symptoms, as nausea and vomiting are known side effects of the vaccine. Nor can it be ruled out that side effects of the vaccine have led to a worsening of the patient''s underlying diseases". No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: respiratory rate high; vomiting; nausea; acute coronary syndrome; CARDIAC THROMBOSIS; Autopsy-determined Cause(s) of Death: CARDIAC THROMBOSIS


VAERS ID: 960220 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-08
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021038893

Write-up: PNEUMONIA; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority NO-NOMAADVRE-FHI-2021-Uwje5. Safety Report Unique Identifier NO-NOMAADVRE-E2B_00013917. A 74-year-old male patient received first dose bnt162b2 (COMIRNATY) (Add info: J07BX - Other virus vaccines), intramuscular on 05Jan2021 at single dose (Dose no. in series: 1 ) for covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient experienced pneumonia on 08Jan2021, which les to death, with fatal outcome. The patient died in Jan2021. It was not reported if an autopsy was performed. Relatedness of suspect drug to AE assessed by Regional Pharmacovigilance Center as Possible. Sender''s comments : A man in his 70s, a nursing home resident, received the Covid-19 vaccine Comirnaty. He was evaluated at the hospital three days after vaccination to have clinical, biochemical, radiologically safe pneumonia with fatal outcome. There is no information in the report about any comorbidity, drugs in use or the status of the Covid-19 test. Uncertain causal relationship. The current incident is currently no known side effect of this vaccine. The incident most likely had another cause that occurred with a random coincidence in time, close to the time of vaccination. However, it cannot be ruled out that the vaccine may have contributed to some of the symptoms at the beginning of the course of the disease, or may have contributed to the worsening of any relevant underlying disease in the patient. Your message is important to increase knowledge about side effects that have not been discovered in the studies so far. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: PNEUMONIA


VAERS ID: 960221 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-08
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALBYL-E; IMOVANE; PINEX FORTE; LEVAXIN; LISINOPRIL/HYDROKLORTIAZID; TRESIBA; AMLODIPIN ACCORD
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Palliative care; Terminal state
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021035341

Write-up: DEATH; This is a spontaneous report downloaded from the Medicines Agency (MA) Regulatory authority WEB. Regulatory authority report number is NO-NOMAADVRE-FHI-2021-Uzd7p, safety report unique identifier: NO-NOMAADVRE-E2B_00013904. A contactable physician reported that a 90-year-old female patient received first dose BNT162B2 (COMIRNATY, Solution for injection; lot number: EJ6795; expiry date: not known), intramuscular in the left arm on 05Jan2021 12:00 at single dose for Covid-19 vaccination. Medical history included terminal state and palliative care. Concomitant medications included acetylsalicylic acid, magnesium oxide (ALBYL-E), zopiclone (IMOVANE), codeine phosphate, paracetamol (PINEX FORTE), levothyroxine sodium (LEVAXIN), hydrochlorothiazide, lisinopril (LISINOPRIL/HYDROKLORTIAZID), insulin degludec (TRESIBA), and amlodipine besilate (AMLODIPIN ACCORD). The patient experienced death on 08Jan2021 (three days after the vaccination). It was unknown if an autopsy was performed. The Regional Pharmacovigilance Center assessed the causality between BNT162B2 and the event death as "possible". Sender''s comment: In the report it was stated that it clinically didn''t appear to be a connection between the vaccination and death. When vaccinating marginal patients who have underlying diseases, some serious events may arise shortly after vaccination without there being a correlation to the vaccination. However, it cannot be completely ruled out that the vaccination has contributed to the worsening of the patient''s underlying diseases. In the individual case, it is hard to know whether the event was caused by the vaccine, the patient''s underlying disease or some other random, coinciding cause which does not have anything to do with the current vaccination.; Reported Cause(s) of Death: Death


VAERS ID: 960225 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC2021034241

Write-up: Death; This is a spontaneous report from a contactable healthcare professional (HCP). This is a report received from the agency, I.P., National Authority of Medicine and Health Products, I.P. The Regulatory authority report number was not provided. An 81-year-old male patient received one dose of the BNT162B2 (COMIRNATY) via unspecified route 0.3 mL single for COVID-19 immunisation on an unspecified date. The patient medical history and concomitant medications were not reported. The patient death was reported. The patient died on an unspecified date. It was not reported if an autopsy was performed. The reported cause of death was unknown. The action taken in response to the event for BNT162B2 was not applicable. Outcome of the event was fatal. No follow-up attempts are possible. Information on batch number cannot be obtained. No further Information is expected.; Reported Cause(s) of Death: death


VAERS ID: 961897 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-08
Onset:2021-01-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ELIQUIS; ENTRESTO; OXYCODON; ; MCP; ; DIGIMERCK; NOVAMINSULFON;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Breast cancer metastatic (With bone and liver metastases); Carcinoma of rectum; Cardiomyopathy; Coronary heart disease; Mitral valve insufficiency; Pulmonary embolism; Renal insufficiency; Type II diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: negative rapid test
CDC Split Type: DEPFIZER INC2021039352

Write-up: Sudden death, cause unknown; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB DE-PEI-PEI2021000426. A 80-year-old female patient received first dose of bnt162b2 (COMIRNATY) (lot/batch number EJ6796), intramuscular on 08Jan2021 at single dose for covid-19 immunization. Medical history included renal failure from an unknown date and unknown if ongoing, breast cancer female from an unknown date and unknown if ongoing, with bone and liver metastases, coronary artery disease from an unknown date and unknown if ongoing, mitral valve incompetence from an unknown date and unknown if ongoing, type 2 diabetes mellitus from an unknown date and unknown if ongoing, rectal cancer from an unknown date and unknown if ongoing, atrial fibrillation from an unknown date and unknown if ongoing, pulmonary embolism from an unknown date and unknown if ongoing, cardiomyopathy from an unknown date and unknown if ongoing. Concomitant medication included apixaban (ELIQUIS), sacubitril valsartan sodium hydrate (ENTRESTO), oxycodone hydrochloride (OXYCODON), metoprolol, metoclopramide (MCP), citalopram, digitoxin (DIGIMERCK), novaminsulfon, tamoxifen. 155 minutes after vaccination (08Jan2021) the patient developed death sudden, lasting for unknown. The patient was in satisfactory condition prior to vaccination. The vaccination was expressly requested. The patient is dead. Death cause was reported as Sudden death, cause unknown. COVID-Test rapid test post mortem negative in Jan2021. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Sudden death, cause unknown


VAERS ID: 961898 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Blood pressure measurement, Body temperature, Cardiac fibrillation, Heart rate, Malaise, Oxygen saturation, Syncope, Ventricular fibrillation, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Tachyarrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypotension; COPD; Diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:100/55 mmHg; Test Name: Body temperature; Result Unstructured Data: Test Result:36 Centigrade; Test Name: Heart rate; Result Unstructured Data: Test Result:60; Comments: BPM; Test Name: O2 saturation; Test Result: 90 %
CDC Split Type: DEPFIZER INC2021039286

Write-up: Syncope; Malaise; Vomiting; Cardiac fibrillation NOS; ventricular fibrillation; malignant arrhythmia/rhythmic disturbance; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB regulatory authority DE-PEI-PEI2021000508. A 91-year-old male patient was vaccinated with the first dose of bnt162b2 (COMIRNATY, batch/lot no.: EJ6796), via an unspecified route of administration on 07Jan2021 at single dose for prophylactic vaccination. Medical history included ongoing COPD (chronic obstructive pulmonary disease), ongoing arterial hypotension and ongoing diabetes mellitus. Concomitant medication was not reported. After vaccination, on 08Jan2021, the patient developed malaise, syncope, vomiting and cardiac fibrillation NOS. The patient was dead. Patient had rhythmic disturbance and ventricular fibrillation after resuscitation (defibrillation). The patient was intubated and ventilated 4 ml of suprarenin, 300 mg of amiodarone and 1000 ml of sterofundin were administered. The patient underwent lab tests and procedures which included blood pressure: 100/55 mmHg; body temperature: 36 Centigrade; heart rate: 60 BPM; O2 saturation: 90 %, all on unspecified date. The patient died on 08Jan2021 at 12:33. The death of the patient was caused by malignant arrhythmia and ventricular fibrillation. It was not reported if an autopsy had been performed. Outcome of events were fatal. Result of Assessment C was inconsistent causal association for Cardiac fibrillation NOS and Result of Assessment was unclassifiable for syncope / malaise / vomiting. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: malaise; syncope; vomiting; cardiac fibrillation NOS; malignant arrhythmia/rhythmic disturbance; ventricular fibrillation


VAERS ID: 961900 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Malaise, 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: 2021-01-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LANTUS; ACTRAPID; SPIRONOLACTON; ; ; NEUROTRAT [CYANOCOBALAMIN;PYRIDOXINE HYDROCHLORIDE;THIAMINE MONONITRATE]; FOLSAN; ;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute allergic urticaria; Allergic contact dermatitis; Cerebral artery stenosis; Cerebral infarction; Consciousness clouding; Diabetes mellitus; Epilepsy; Hip prosthesis user; Korsakov''s syndrome; Psoriasis; Stroke; Traumatic brain injury
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021039353

Write-up: Sudden death, cause unknown; Malaise; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB DE-PEI-PEI2021000638 and received via Regulatory Authority. A 79-year-old female patient received first dose of bnt162b2 (COMIRNATY, lot/batch number: EJ6796), via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 prophylaxis. The patient medical history included Stroke, Cerebral artery stenosis, Diabetes mellitus from 05Nov2012, Allergic contact dermatitis, Consciousness clouding from 04Mar2014, Psoriasis, Epilepsy from 04Mar2014, Traumatic brain injury, Korsakov''s syndrome from 05Nov2012, Cerebral infarction from 04Mar2014, Acute allergic urticaria from 04Nov2019, Hip prosthesis user, all unknown if ongoing. Concomitant medications included Bisoprolol; folic acid (FOLSAN); Levetiracetam; cyanocobalamin, pyridoxine hydrochloride, thiamine mononitrate (NEUROTRAT); Oxazepam; rupatadine (reported as Rupatadin); spironolactone (SPIRONOLACTON); insulin glargine (LANTUS, reported as Lantus Insulinpen); insulin (ACTRAPID). The patient experienced on the same day after vaccination (13Jan2021) the patient developed Sudden death, cause unknown and Malaise, lasting for unknown. The patient was dead on 13Jan2021. Death cause was reported as sudden death, cause unknown and Malaise. The outcome of the events was fatal. It was unknown whether an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Malaise; Sudden death, cause unknown


VAERS ID: 961901 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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: 2021-01-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: Covid tested; Test Result: Positive
CDC Split Type: DEPFIZER INC2021039029

Write-up: sick with Covid 19 and died after the vaccination. Covid positive after the first vaccination; sick with Covid 19 and died after the vaccination. Covid positive after the first vaccination; This is a spontaneous report from a contactable physician, based on information received by Pfizer from Biontech (manufacturer control number: not provided), license party for BNT162B2. The physician reported similar events for 2 patients. This is the case for the first of 2 patients. An elderly patient of an unspecified gender received the first dose of BNT162b2 (COMIRNATY,Lot/Batch Number and Expiration Date unknown), via an unspecified route of administration on 06Jan2021 at 1 dose form (DF) single dose for covid-19 prophylaxis. The patient''s medical history and concomitant medications were not reported. It was reported that the physician was a vaccinator of a vaccination center and on 06Jan2021, 07Jan2021 and 08Jan2021 he had vaccinated 3 elderly residents in a nursing home with the vaccine Corminaty. It turned out that 2 of the elderly residents were sick with Covid 19 and died after the vaccination in Jan2021. Covid tested positive after the first vaccination in Jan2021. This patient was vaccinated on 06Jan2021. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information,Linked Report(s) : DE-PFIZER INC-2021043240 same Reporter, same events, different patient; Reported Cause(s) of Death: Covid-19; Covid-19


VAERS ID: 961902 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-06
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID; Result Unstructured Data: Test Result:positive after the first vaccination
CDC Split Type: DEPFIZER INC2021043240

Write-up: sick with Covid 19 and died after the vaccination. Covid positive after the first vaccination; sick with Covid 19 and died after the vaccination. Covid positive after the first vaccination; This is a spontaneous report from a contactable physician, based on information received by Pfizer from Biontech (manufacturer control number: not provided), license party for BNT162B2. The physician reported similar events for 2 patients. This is the case for the 2nd of 2 patients. An elderly patient of an unspecified gender received the first dose of BNT162b2 (COMIRNATY), via an unspecified route of administration on 06Jan2021 at single dose for covid-19 prophylaxis. The patient''s medical history and concomitant medications were not reported. It was reported that the physician was a vaccinator of a vaccination center and on 06Jan2021, 07Jan2021 and 08Jan2021 he had vaccinated 3 elderly residents in a nursing home with the vaccine Corminaty. It turned out that 2 of the elderly residents were sick with Covid 19 and died after the vaccination. Covid tested positive after the first vaccination. This patient was vaccinated on 06Jan2021. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information,Linked Report(s) : DE-PFIZER INC-2021039029 same Reporter, same events, different patient; Reported Cause(s) of Death: Covid-19; Covid-19


VAERS ID: 961905 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-02
Onset:2021-01-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Bacterial test, Blood creatinine, Blood pressure systolic, Blood pressure systolic increased, Blood sodium, C-reactive protein, Chest X-ray, Coma, Coma scale, Computerised tomogram, Depressed level of consciousness, Fatigue, Flushing, Hemiparesis, Magnetic resonance imaging brain, Mobility decreased, Respiratory arrest, Vomiting, White blood cell count
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-05
   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: ; VOLTAREN [DICLOFENAC]; ELTROXIN; ; VITAMIN D [COLECALCIFEROL]; PANODIL; MAREVAN; SOLU-CORTEF; KALIUMKLORID; MAGNESIA [MAGNESIUM HYDROXIDE]
Current Illness: Cardiac pacemaker insertion (Due to bifascular block,); Constipation (concurrent conditions); Deep vein thrombosis (Multiple DVT); Gastric ulcer (concurrent conditions); Hypothyroidism; Monoclonal gammopathy; Pain (concurrent conditions); Panhypopituitarism; Pneumonia aspiration (OBS); Renal cell carcinoma (sequelae after cerebral radiation therapy due to metastases from renal cell carcinoma); Secondary adrenal insufficiency; Vitamin D deficiency (concurrent conditions)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: Bacteria urine; Test Result: Positive ; Test Date: 202101; Test Name: Creatinine; Result Unstructured Data: Test Result:31.6; Comments: Unit not specified; Test Date: 20210103; Test Name: systolic blood pressure; Result Unstructured Data: Test Result:persistently high systolic blood pressure; Test Date: 202101; Test Name: Sodium; Result Unstructured Data: Test Result:131; Comments: unit not specified; Test Date: 202101; Test Name: Thorax X-ray; Result Unstructured Data: Test Result:nothing abnormal; Test Date: 20210102; Test Name: Glasgow coma scale; Result Unstructured Data: Test Result:11; Test Date: 202101; Test Name: Glasgow coma scale; Result Unstructured Data: Test Result:descends gradually under admission; Test Date: 202101; Test Name: CT scan; Result Unstructured Data: Test Result:without acute bleeding or ischemia; Test Date: 202101; Test Name: C-reactive protein; Result Unstructured Data: Test Result:195; Comments: unit not specified; Test Date: 202101; Test Name: C-reactive protein; Result Unstructured Data: Test Result:103; Comments: unit not specified; Test Date: 202101; Test Name: C-reactive protein; Result Unstructured Data: Test Result:15; Comments: unit not specified; Test Date: 202010; Test Name: MRI brain; Result Unstructured Data: Test Result:Of pituitary gland; Test Date: 202101; Test Name: Leukocyte count; Result Unstructured Data: Test Result:13.6; Comments: unit not specified
CDC Split Type: DKPFIZER INC2021043434

Write-up: Respiratory arrest; Coma. newly emerged level of consciousness. At arrival weak in contact. Gradual deterioration in level of consciousness under admission; had persistently high systolic blood pressure; Mobility decreased on the right site; Hemiparesis (right) with hanging mouth; flushing; vomiting; Newly emerged level of consciousness. At arrival weak in contact. Gradual deterioration in level of consciousness under admission; Aggravated tiredness; This is a spontaneous report downloaded from the Medicines Agency (MA) Regulatory Authority -WEB DK-DKMA-WBS-0028419. The report was received from a contactable physician via the Medicines Agency. An 80-year-old male patient received first dose of bnt162b2 (COMIRNATY, lot number: EJ6797, expiration date: 30Apr2021), via intramuscular on 02Jan2021 at single dose for covid-19 immunisation. Medical history included ongoing monoclonal gammopathy, ongoing cardiac pacemaker insertion (Due to bifascular block), ongoing deep vein thrombosis (Multiple DVT), ongoing pneumonia aspiration (OBS), ongoing hypothyroidism, ongoing secondary adrenocortical insufficiency, ongoing renal cell carcinoma (sequelae after cerebral radiation therapy due to metastases from renal cell carcinoma), ongoing panhypopituitarism, ongoing constipation (concurrent conditions), ongoing pain (concurrent conditions), ongoing gastric ulcer (concurrent conditions), ongoing vitamin D deficiency (concurrent conditions). Concomitant medication included lactulose from 11Mar2020 for constipation, diclofenac (VOLTAREN) from 08Jun2020 for pain localised, levothyroxine sodium (ELTROXIN) from 26May2017 for hypothyroidism, pantoprazole from 02Feb2016 for gastric ulcer, colecalciferol (VITAMIN D) from 19Jan2017 for vitamin D deficiency, paracetamol (PANODIL) from 28Jun2019 for pain, warfarin sodium (MAREVAN) from 02Feb2016 for anticoagulant therapy, hydrocortisone sodium succinate (SOLU-CORTEF) from 09Nov2020 for adrenal insufficiency, kaliumklorid from 20Apr2018 for potassium supplementation, magnesium hydroxide (MAGNESIA) from 27Nov2019 for constipation, and nutritional preparation. The patient experienced flushing on 02Jan2021, vomiting on 02Jan2021, newly emerged level of consciousness at arrival weak in contact gradual deterioration in level of consciousness under admission on 02Jan2021, aggravated tiredness on 02Jan2021, coma newly emerged level of consciousness at arrival weak in contact gradual deterioration in level of consciousness under admission on 03Jan2021, respiratory arrest on 04Jan2021, mobility decreased on the right site on 02Jan2021, hemiparesis (right) with hanging mouth on 02Jan2021. On 02Jan2021, the same days as the vaccination, the patient developed tiredness, flushing, mobility decreased, vomiting, decreased level of consciousness and hemiparesis (right). He was already weak in contact when he arrived to the hospital on 03Jan2021. Gradually aggravation in his consciousness under admission (Coma). On 04Jan201 the patient developed respiratory arrest and died on 05Jan2021 at 13:57. The patient was treated with oxygen demanding at high flow apparatus. Not a candidate for intensive care or heart-lung rescue. On 04Jan2021 the patient received a safety box. Conversation with relatives several times during the course, on the 05Jan2021 morning final decision to stop all treatment. On 03Jan2021, due to the patient''s pacemaker status, it was not possible to have an acute MRI scan to clarify the patient cerebral status and possibly cerebral stem infarction, which could also be explained in the situation where the patient had persistently high systolic blood pressure. The reported cause of death was respiratory arrest. The patient underwent lab tests and procedures which included bacteria urine: positive on Jan2021; creatinine: 31.6 unit not specified on Jan2021; sodium: 131 unit not specified on Jan2021; Thorax x-ray: nothing abnormal on Jan2021; Glasgow coma scale: showed 11 on 02Jan2021 and descends gradually under admission on Jan2021; computerised tomogram (CT scan): without acute bleeding or ischemia on Jan2021; c-reactive protein: 195 unit not specified on Jan2021, 103 unit not specified on Jan2021, 15 unit not specified on Jan2021; magnetic resonance imaging brain (MRI brain): of pituitary gland on Oct2020, Leukocyte count: 13.6 unit not specified on Jan2021; systolic blood pressure: persistently high systolic blood pressure on 03Jan2021. The patient died on 05Jan2021. An autopsy was not performed. The outcome of the event respiratory arrest was fatal, while other events was unknown. Causality reported as Consciousness is suspected to be due to normal pressure hydrocephalus, exacerbation of radiation sequelae in the brain due to infection or addison. However, it cannot be ruled out that the covid vaccine has had an impact on the course of the disease.; Reported Cause(s) of Death: Respiratory arrest


VAERS ID: 961906 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2020-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Dyspnoea, Hypersensitivity, Oxygen saturation, Respiratory distress
SMQs:, Anaphylactic reaction (broad), Angioedema (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), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Chronic kidney disease; Psychiatric disorder NOS
Allergies:
Diagnostic Lab Data: Test Date: 20201231; Test Name: Arterial oxygen saturation; Test Result: 64 %
CDC Split Type: ESPFIZER INC2021043530

Write-up: Acute dyspnea; respiratory distress; acute respiratory insufficiency; suspected severe allergic reaction; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority -WEB (ES-AEMPS-711273). A 75-year-old female patient received the first dose of BNT162B2 (COMIRNATY; Lot number: EJ6796), intramuscularly, on 31Dec2020 at a single dose for COVID-19 vaccination. Medical history included chronic kidney disease, arterial hypertension, and neuropsychiatric disorders. The patient had no allergy history. The patient''s concomitant medications were not reported. The patient experienced acute dyspnea, respiratory distress, acute respiratory insufficiency, and suspected severe allergic reaction on 31Dec2021, which were all reported as fatal. The clinical course was reported as: The patient had acute dyspnea and respiratory distress with arterial oxygen saturation of 64% two hours after vaccination, on 31Dec2020, and died three hours after vaccination. The emergency coordinating physician suspected severe allergic reaction. The clinical outcome of all of the events was fatal. The patient died on 31Dec2020 (reported as three hours after vaccination). The cause of death was reported as acute dyspnea, respiratory distress, acute respiratory insufficiency, and suspected severe allergic reaction. An autopsy was not performed. No follow-up attempts are possible. No information is expected.; Reported Cause(s) of Death: suspected severe allergic reaction; respiratory distress; acute dyspnea; Acute respiratory insufficiency


VAERS ID: 961907 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2012-03-26
Onset:2020-12-29
   Days after vaccination:3200
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: International normalised ratio increased, Rectal haemorrhage
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-05
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ; VALSARTAN KERN PHARMA; AMLODIPINO MYLAN PHARMACEUTICALS; XALACOM; FUROSEMIDA KERN PHARMA; ACTRAPID; SINTROM ; METAMIZOL NORMON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia; Arthrosis; Brain infarction; Cognitive deterioration; Confusion; CVA; Depressive disorder; Ejection fraction normal; Fibrillation atrial; Hypertension arterial; Hypertensive heart disease; Instability gait; Intestinal ischemia; Ischaemic cardiomyopathy; Osteoporosis; Right bundle branch block; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20201231; Test Name: INR increased; Result Unstructured Data: Test Result:5.5
CDC Split Type: ESPFIZER INC2021043468

Write-up: Rectorrhagia; This is a spontaneous report from a contactable healthcare professional downloaded from the Medicines Agency (MA) Regulatory Authority (ES-AEMPS-712082). A 96-year-old female patient received the first dose of BNT162B2 (COMIRNATY; Lot number: EJ6796), intramuscularly, on 27Dec2020 at a single dose (reported as 0.3 mL) for COVID-19 vaccination and acenocoumarol (SINTROM), orally, from 26Mar2012 at an unspecified dose for fibrillation atrial. Medical history included anaemia, ischaemic cardiomyopathy, type 2 diabetes mellitus, hypertension arterial, fibrillation atrial, osteoporosis, cognitive deterioration/cognitive impairment, non-ongoing cerebrovascular accident (CVA) from Jul2001 to Jul2001, arthrosis/osteoarthritis, intestinal ischemia, brain infarction, residual persistent instability, hypertensive heart disease with conserved left ventricular ejection fraction (LVEF), flutter headset, right bundle branch block, and depressive syndrome. Concomitant medications included trazodone (MANUFACTURER UNKNOWN) from 01Dec2020, valsartan (MANUFACTURED BY: KERN PHARMA) from 26Nov2019, amlodipine besilate (AMLODIPINO; MANUFACTURED BY: MYLAN PHARMACEUTICALS) from 16Jan2020, latanoprost, timolol maleate (XALACOM) from 28Mar2012, furosemide (FUROSEMIDA; MANUFACTURED BY: KERN PHARMA) from 07Apr2012, insulin (ACTRAPID) from 14Jun2017, metformin (MANUFACTURER UNKNOWN) taken for type 2 diabetes mellitus from 27Jan2020, metamizole sodium (METAMIZOL; MANUFACTURED BY: NORMON) from 14Sep2017, and captopril (MANUFACTURER UNKNOWN). The patient experienced rectorrhagia on 29Dec2020, which caused hospitalization and was reported as fatal. The clinical course was reported as follows: On 31Dec2020, the patient was taken to a hospital because for the previous three days small clots were observed in diapers. The international normalised ratio (INR) increased at 5.5 on 31Dec2020. There was a suspicion of ischemic colitis. On 03Jan2021, the patient presented with an abundant rectorrhagia. On 04Jan2021, the patient evolved unfavorably despite unspecified serum therapy and transfusion of unspecified concentrates. Treatment with sedoanalgesia was decided, but patient passed away. The action taken in response to the event for acenocoumarol was permanently withdrawn on 31Dec2020. The clinical outcome of rectorrhagia was fatal. The patient died on 05Jan2021. The cause of death was assessed as rectorrhagia (no cause of death reported). It was not reported if an autopsy was performed. Sender''s Comment: This is AA not known for the vaccine. Given the patient''s history (anticoagulated patient) and clinical suspicion, there is an alternative explanation to the vaccine. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Rectorrhagia


VAERS ID: 961910 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthmatic
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021043473

Write-up: Death; This is a spontaneous report received from a contactable reporting consumer via Pfizer sales representative. An 88-year-old male patient (uncle of the reporter) received bnt162b2 (COMIRNATY), via an unspecified route of administration on unspecified date at single dose for covid-19 immunisation. Medical history included asthmatic from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced death a few days after vaccinated on an unspecified date. It was not reported if an autopsy was performed. Patient with asthma, without knowledge of any other pathology according to the reporter. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: death


VAERS ID: 961936 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-31
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1688 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20201230; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021038637

Write-up: Death; This is a spontaneous report received by Pfizer from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-20210108181603 and Safety Report Unique Identifier is GB-MHRA-ADR 24574563. A contactable physician reported that an 89-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EJ1688) via an unspecified route of administration on 31Dec2020 at single dose for covid-19 vaccination. The patient medical history was not reported. Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced death on an unspecified date. The patient was a frail elderly lady at a nursing home and was a palliative patient and was reported as expected death. The patient was not on end of life medications at the time and reported stated that they did not feel this had contributed to cause of death. Patient had not tested positive for COVID-19 since having the vaccine. The patient underwent lab test which included COVID-19 virus test: negative on 30Dec2020. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: death


VAERS ID: 962006 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-23
Onset:2020-12-28
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Confusional state, Cough, Drug ineffective, Hypoxia, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-11
   Days after onset: 14
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: Clinical trial participant (recovery trial); Diabetes; Comments: Diabetes Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC2021040990

Write-up: breathing difficuties; SARS-CoV-2 infection; SARS-CoV-2 infection; Confusional state; Cough; Pyrexia; This is a spontaneous report received by Pfizer from the Medicines and Healthcare products Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202101141012341090 and Safety Report Unique Identifier GB-MHRA-ADR 24594185. A contactable healthcare professional reported that an 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunisation. Medical history included clinical trial participant (recovery trial), and diabetes mellitus. The patient''s concomitant medications were not reported. The patient became unwell experienced breathing difficuties (death) on 28Dec2020, sars-cov-2 infection on 30Dec2020, confusional state on 30Dec2020, cough on 30Dec2020, pyrexia on 30Dec2020. It was explained that the patient had deteriorated on 30Dec2020 with fever, cough, confusion. Admitted to hospital - hypoxic. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on unspecified date (on admission to hospital). Outcome of event breathing difficulties was fatal, of event sars-cov-2 infection was unknown, and of other events was not resolved. The patient died on 11Jan2021. An autopsy was not performed. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Hypoxia


VAERS ID: 962017 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-29
Onset:2020-12-31
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac failure, Cough, Disease progression, Malaise, Pneumonia, Pyrexia
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-04
   Days after onset: 4
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: Alzheimer''s disease; Hypertension; Ischemic cardiomyopathy; Pneumonia
Allergies:
Diagnostic Lab Data: Test Date: 20201231; Test Name: Body temperature; Result Unstructured Data: Test Result:37.8
CDC Split Type: ISPFIZER INC2021005287

Write-up: pneumonia; Three individuals had died after vaccination against corona/ Heart failiure; Disease progression; Cough; felt ill; Fever; The initial case was missing the following minimum criteria: (no first-hand knowledge). Upon receipt of follow-up information on (19Jan2021), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer and additional reporter: physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB. This is a report received from the Medicines Agency. The regulatory authority report number is IS-IMA-1502. A 94-year-old female patient received the bnt162b2 (COMIRNATY; Lot Number: EJ6796 and Expiration Date: 30Apr2021), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. The patient''s medical history included hypertension, Alzheimer''s disease, pneumonia, Ischemic cardiomyopathy; all from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient experienced the following events and outcomes: three individuals had died after vaccination against corona/ heart failure (death, hospitalization, medically significant, life threatening) on 04Jan2021, disease progression (death, hospitalization, life threatening) on 31Dec2020, pneumonia (death, hospitalization, medically significant, life threatening) on an unspecified date, cough (death, hospitalization, life threatening) on 31Dec2020, felt ill (death, hospitalization, life threatening) on 31Dec2020, fever (death, life threatening) on 31Dec2020 (also reported :30Dec2020); all of which had a fatal outcome. Narrative as received: "This case was received via e-reporting system by IMA from a physician. A 94-year old female with Alzheimer''s disease, HTN and ischaemic cardiomyopathy was vaccinated with COMIRNATY on 29Dec2020. No concomitant medications were reported. On 31Dec2020 the patient experienced fever (37.8), coughing and felt ill. Two days later the patient experienced heart failure and passed away on 04Jan2021. The patient was also diagnosed with pneumonia but not treated for pneumonia after consultation with the patient''s family due to the patient''s condition." The patient died on 04Jan2021 due to heart failure and pneumonia. It was unknown if an autopsy was performed. Reporter''s comments: "Cause of death was declared as pneumonia and heart failure. Causal association with COVID-19 vaccine is due to time relationship, uncertain causality."; Reported Cause(s) of Death: Heart failure; Pneumonia


VAERS ID: 962018 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-30
Onset:2021-01-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-03
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ischemic heart disease; Kidney failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: ISPFIZER INC2021005288

Write-up: Heart failure; heart attack; The initial case was missing the following minimum criteria: (no first-hand knowledge). Upon receipt of follow-up information on (19Jan2021), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer or other non-health professional and a contactable healthcare professional. This is a spontaneous report downloaded from the regulatory authority IS-IMA-1500. The report was received from a contactable physician via the e-reporting system by the regulatory authority. An 88-year-old male patient received bnt162b2 (COMIRNATY; lot number EJ6796, expiration date 30Apr2021), via an unspecified route of administration on 30Dec2020 as single dose for covid-19 immunization. Medical history included kidney failure and ischemic heart disease. No concomitant medication was reported. No direct adverse events were reported after injection. The patient was transferred to the hospital and diagnosed with a heart attack and heart failure on 02Jan2021. The patient died one day later. The patient died on 03Jan2021. It was not reported if an autopsy was performed. Outcome of events were fatal. Reporter''s comment: The only indication of the relationship between the events and the injection is the timing of the vaccination. The patient''s daughter thought it was an adverse event, but the reporter considered it unlikely but theoretically possible. Sender''s comment: This case is being further investigated locally. Follow-up information will be provided if available. No follow-up attempts possible. No further information expected.; Reporter''s Comments: The only indication of the relationship between the events and the injection is the timing of the vaccination. The patient''s daughter thought it was an adverse event, but the reporter considered it unlikely but theoretically possible; Reported Cause(s) of Death: heart attack; heart failure


VAERS ID: 965441 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0739 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Not registered at this practice, During vaccination screening Pt was asked to confirm; Pregnancy - Not Pregnant Pre existing medical conditions - None Any Allergies - None History of anaphylaxis - None Bleeding disorders / blood thinning medication - None Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021033366

Write-up: Death unexplained; This is a spontaneous report received from a contactable pharmacist via regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202101140831416270. Sender''s (Case) Safety Report Unique Identifier: GB-MHRA-ADR 24595177. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0739, expiry date not reported) via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 vaccination. The patient had not had symptoms associated with COVID-19, not had a COVID-19 test. She was not enrolled in clinical trial. She was not pregnant. She had no pre-existing medical conditions, no allergies, no history of anaphylaxis, no bleeding disorders / blood thinning medication. The concomitant medications, if any, were not reported. The patient was not registered at the practice. The patient did not experience direct or immediate reaction at the time of the vaccine. The practice was informed that approximately 6 hours post vaccine the patient had passed away. The patient died on 13Jan2021. An autopsy was not performed. The cause of death was unknown, death unexplained. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 965457 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-11
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-01-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-11
   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: NORSPAN [BUPRENORPHINE]; LAXOBERAL; DULCOLAX [BISACODYL]
Current Illness: Cognitive deterioration (advanced/severe cognitive impairment.); General physical condition decreased; Living in nursing home; Reduced general condition
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021035335

Write-up: DEATH; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authorityy -WEB NO-NOMAADVRE-FHI-2021-Urpw8, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00013915. An 82-years-old female patient received first dose of bnt162b2 (COMIRNATY), intramuscular on 05Jan2021 11:30 at single dose for Covid-19 immunisation. Medical history included cognitive deterioration (advanced/severe cognitive impairment), general physical condition decreased, reduced general condition and living in nursing home, all ongoing. The patient''s concomitant medications included buprenorphine (NORSPAN) from 07Dec2020 for pain, sodium picosulfate (LAXOBERAL) from 10Dec2020 for constipation, bisacodyl (DULCOLAX) from 26Nov2020 for constipation. Patient had gradually declining functional level and general condition/AT over several months. Vaccinated with bnt162b2 on 05Jan2021 and died on 11Jan2021. It was not reported if an autopsy was performed. The Regulatory Authority assessed the causality between bnt162b2 and the event death as Possible. Comment: Based on the information in the report it is likely that the underlying diseases is the cause of the death. However, there is a temporal correlation and it cannot be entirely ruled out that the vaccine could have contributed to the worsening of the patient''s underlying diseases. It can also be that the event had a completely different cause which coincidentally developed after the vaccination. Based on the criteria from WHO we assess the causal relationship between Comirnaty and death as Possible. Meaning, a reaction, including pathological lab samples, that happens in a temporal correlation to the use of a pharmaceutical but which could also be caused by underlying disease, other pharmaceuticals or chemicals. Based on the given criteria the report is assessed as serious. Reported Cause(s) of Death: Death.


VAERS ID: 969504 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-05
   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: Medical History/Concurrent Conditions: Stroke; Vascular encephalopathy
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021049780

Write-up: Cerebral seizures in the context of drug administration; This is a spontaneous report from a non-contactable physician received from the Medicines Agency (MA) Regulatory Authority-WEB DE-PEI-PEI2021000714. A 90-year-old female patient received first dose of bnt162b2 (COMIRNATY) (Lot/batch number EJ6796), intramuscular on 05Jan2021 at single dose for COVID-19 prophylaxis. Medical history included vascular encephalopathy from an unknown date and unknown if ongoing, last stroke from Oct2016. The patient''s concomitant medications were not reported. Patient before vaccination was inconspicuous, normal food ingestion. The patient experienced cerebral seizures in the context of drug administration on 05Jan2021. 5 hours after vaccination the patient developed seizure cerebral, lasting for unknown. The patient died on 05Jan2021. Death cause was reported as seizure cerebral. It was not reported if an autopsy was performed. The PEI assessed the causality between the event and the vaccine as unclassifiable. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Seizure cerebral


VAERS ID: 969506 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-03
Onset:2021-01-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Aggression, Aspiration, Malaise, Pneumonia aspiration, Rales, Vomiting
SMQs:, Acute pancreatitis (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-04
   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: SIMVASTATIN HEXAL; DICILLIN [DICLOXACILLIN SODIUM MONOHYDRATE]; GALANTAMIN KRKA; BETOLVEX [CYANOCOBALAMIN]; FINASTERID AUROBINDO; ENALAPRIL KRKA; ; PANODIL
Current Illness: Alzheimer''s disease; Hypertension; Vomiting
Preexisting Conditions: Medical History/Concurrent Conditions: Enlarged prostate; Hypercholesterolaemia; Pain; Peptic ulcer; Soft tissue infection; Vitamin B12 deficiency; Weight loss
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC2021043862

Write-up: In the evening the patient got unwell, respiratory rattling and aggressive behavior; In the evening the patient got unwell, respiratory rattling and aggressive behavior; In the evening the patient got unwell, respiratory rattling and aggressive behavior; aspiration as a consequence of vomiting; aspiration pneumonia; Same day vomiting, got better, but the day after he vomitted again; This is a spontaneous report downloaded from the Agency Regulatory Authority-WEB DK-DKMA-WBS-0028354. This report was received from two contactable Physicians via the Agency. A 89-year-old male patient received first dose bnt162b2 (COMIRNATY) (Lot/batch no: EJ6797, exp: 30Apr2021), intramuscular on 03Jan2021 at single dose for covid-19 immunisation. Medical history included ongoing alzheimer''s disease, weight loss from an unknown date and unknown if ongoing (the man has been ailing and lost weight in recent months), ongoing hypertension, vomiting from Dec2020 and ongoing (The patient had vomited since mid-December and no later than two days before vaccination he had vomit), Vitamin B12 deficiency, Soft tissue infection, enlarged prostate, pain, hypercholesterolaemia, peptic ulcer. Concomitant medication included simvastatin (SIMVASTATIN HEXAL) from 01Dec2014 for hypercholesterolaemia, dicloxacillin sodium monohydrate (DICILLIN) from 30Dec2020 for Soft tissue infection, galantamine hydrobromide (GALANTAMIN KRKA) from 09Jul2014 for dementia, cyanocobalamin (BETOLVEX) from 14Feb2017 for Vitamin B12 deficiency, finasteride (FINASTERID AUROBINDO) from 30Sep2014 for Enlarged prostate, enalapril maleate (ENALAPRIL KRKA) from 04Jul2017 for Hypertension, pantoprazole from 26Jan2015 for Peptic ulcer, paracetamol (PANODIL) from 25Apr2017 for Pain. He had not previous given the vaccine. There is no information regarding past medication. On 03Jan2021 patient experienced same day vomiting, got better, but the day after he vomitted again on the 04Jan2021. At 18:35 on the 04Jan2021, In the evening the patient got unwell, respiratory rattling and aggressive behavior. The vomiting causes aspiration (aspiration as a consequence of vomiting) and the patient develops aspiration pneumonia on 04Jan2021. Cause of death was vomiting, aspiration, aspiration pneumonia. An emergency doctor is called who assesses that no further treatment or resuscitation should be performed in case of cardiac arrest. The patient died 2 hours later on 04Jan2021. It was not reported if an autopsy was performed. The outcome of Vomiting, aspiration and aspiration pneumonia was reported as fatal. Outcome of respiratory rattling(rales), got unwell and aggressive behaviour were unknown. Reporter causality: Initial reporter: The vaccine has caused the vomiting and the man has then aspirated and developed an aspiration pneumonia. This has led to his death. The physician who performed the inquest questioned whether the vomiting was caused by the vaccine. An autopsy will be performed. FOLLOW-UP (version 002): Agency has by telephone requested follow-up from the Physician who has performed the initial inquest: The patient had vomited since mid-December and no later than two days before vaccination he had vomited. The physician therefore questioned whether the vomiting was caused by the vaccine. Despite the fact that the physician who performed the inquest does not immediately suspect the vaccine, she and the police have decided to perform an autopsy. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Vomiting; aspiration as a consequence of vomiting; Aspiration pneumonia


VAERS ID: 969508 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-01-25
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: Chronic disease (heavy treatments)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021049620

Write-up: death; This is a spontaneous report received from a contactable health minister(physician) via media source forwarded by a Pfizer colleague via media source, then from other health professional was from Regulatory Authority reported same event for five patients. This is the first of five reports. An elderly patient of an unspecified gender received bnt162b2 (COMIRNATY) , via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Patient was leaving in nursing home, with chronic diseases and heavy treatments. Concomitant medications were not reported. The patient experienced death after having received vaccination with Pfizer-BioNTech vaccine. It was unknown if an autopsy was performed. The health minister reported 5 patients dead after having received vaccination with Pfizer-BioNTech vaccine (BNT162B2, COMIRNATY) in 3 different nursing homes. The dead patients were all aged more than 75 years and were suffering co-morbidities. These are patients that died within the days following vaccination without presenting signs of allergic reaction after vaccination. In nursing homes, patients were fragile, elderly with less autonomy, often with lot of diseases and drugs. Cause of death can be totally unrelated. Pharmacovigilance studies are being conducted by health authorities in association with physicians to determine whether there is a relatedness to vaccination or if this is a sad concomitance. As soon as there is an alert there is an enquiry and if strong suspicion, additional analysis can be performed. The other health professional from agency reported the 5 dead patients were elderly patients leaving in nursing home, all with chronic diseases and heavy treatments. At this time, considering the available data, there is nothing allowing to conclude that deaths were related to vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-2021049621 same reporter/drug/event, different patient;FR-PFIZER INC-2021049622 same reporter/drug/event, different patient;FR-PFIZER INC-2021049623 same reporter/drug/event, different patient;FR-PFIZER INC-2021049624 same reporter/drug/event, different patient; Reported Cause(s) of Death: death


VAERS ID: 969509 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-01-25
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: Chronic disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021049621

Write-up: death; This is a spontaneous report received from a contactable health minister(physician) via media source forwarded by a Pfizer colleague via media source, then from other health professional was (Regulatory Authority number was not provided) reported same event for five patients. This is the second of five reports. An elderly patient of an unspecified gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date at single dose for COVID -19 immunization. Patient was leaving in nursing home, with chronic diseases and heavy treatments. Concomitant medications were not reported. The patient experienced death after having received vaccination with Pfizer-BioNTech vaccine. It was unknown if an autopsy was performed. The health minister reported 5 patients dead after having received vaccination with Pfizer-BioNTech vaccine (BNT162B2, COMIRNATY) in 3 different nursing homes. The dead patients were all aged more than 75 years and were suffering co-morbidities. These are patients that died within the days following vaccination without presenting signs of allergic reaction after vaccination. In nursing homes, patients were fragile, elderly with less autonomy, often with lot of diseases and drugs. Cause of death can be totally unrelated. Pharmacovigilance studies are being conducted by health authorities in association with physicians to determine whether there is a relatedness to vaccination or if this is a sad concomitance. As soon as there is an alert there is an enquiry and if strong suspicion, additional analysis can be performed. The other health professional reported the 5 dead patients were elderly patients leaving in nursing home, all with chronic diseases and heavy treatments. At this time, considering the available data, there is nothing allowing to conclude that deaths were related to vaccination. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Death with unknown cause is assessed related to BNT162B2 for reporting purpose. Current information is limited and does not allow a full medical assessment.,Linked Report(s) : FR-PFIZER INC-2021049620 same reporter/drug/event, different patient; Reported Cause(s) of Death: death


VAERS ID: 969510 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-01-25
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: Chronic disease (heavy treatments)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021049622

Write-up: death; This is a spontaneous report received from a contactable health minister(physician) via media source forwarded by a Pfizer colleague via media source, then from other health professional was from RA ANS (Regulatory Authority was not provided) reported same event for five patients. This is the third of five reports. An elderly patient of an unspecified gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Patient was leaving in nursing home, with chronic diseases (ongoing) and heavy treatments. Concomitant medications were not reported. The patient experienced death after having received vaccination with Pfizer-BioNTech vaccine. It was unknown if an autopsy was performed. The health minister reported 5 patients dead after having received vaccination with Pfizer-BioNTech vaccine (BNT162B2, COMIRNATY) in 3 different nursing homes. The dead patients were all aged more than 75 years and were suffering co-morbidities. These are patients that died within the days following vaccination without presenting signs of allergic reaction after vaccination. In nursing homes, patients were fragile, elderly with less autonomy, often with lot of diseases and drugs. Cause of death can be totally unrelated. Pharmacovigilance studies are being conducted by health authorities in association with physicians to determine whether there is a relatedness to vaccination or if this is a sad concomitance. As soon as there is an alert there is an enquiry and if strong suspicion, additional analysis can be performed. The other health professional from French RA ANSM reported the 5 dead patients were elderly patients leaving in nursing home, all with chronic diseases and heavy treatments. At this time, considering the available data, there is nothing allowing to conclude that deaths were related to vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: It was reported that the 5 dead patients were elderly patients leaving in nursing home, all with chronic diseases and heavy treatments. At this time, considering the available data, there is nothing allowing to conclude that deaths were related to vaccination. The case will be reassessed should additional 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.,Linked Report(s) : FR-PFIZER INC-2021049620 same reporter/drug/event, different patient; Reported Cause(s) of Death: death


VAERS ID: 969511 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-01-25
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: Chronic disease (heavy treatments)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021049623

Write-up: death; This is a spontaneous report received from health minister via media source forwarded by a Pfizer colleague via media source and a healthcare professional from regulatory authority ANSM. Regulatory Authority number was not provided. The health minister reported 5 patients dead after having received vaccination with Pfizer-BioNTech vaccine (BNT162B2 COMIRNATY) in 3 different nursing homes (this is the fourth of five reports). An elderly patient of an unspecified gender received bnt162b2 (COMIRNATY) via an unspecified route of administration on an unspecified date at a single dose for COVID -19 immunization. Patient was leaving in nursing home, with chronic diseases and heavy treatments. Concomitant medications were not reported. The patient experienced death after having received vaccination with Pfizer-BioNTech vaccine. The cause of death was unknown. It was not reported if an autopsy was performed. The health minister reported 5 patients dead after having received vaccination with Pfizer-BioNTech vaccine (BNT162B2, COMIRNATY) in 3 different nursing homes. The dead patients were all aged more than 75 years and were suffering co-morbidities. These are patients that died within the days following vaccination without presenting signs of allergic reaction after vaccination. In nursing homes, patients were fragile, elderly with less autonomy, often with lot of diseases and drugs. Cause of death can be totally unrelated. Pharmacovigilance studies are being conducted by health authorities in association with physicians to determine whether there is a relatedness to vaccination or if this is a sad concomitance. As soon as there is an alert there is an enquiry and if strong suspicion, additional analysis can be performed. The health professional stated that the 5 dead patients were elderly patients leaving in nursing home, all with chronic diseases and heavy treatments. At this time, considering the available data, there is nothing allowing to conclude that deaths were related to vaccination. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Lacking detailed information on the cause of patient''s demise, the Company cannot completely exclude a causal relationship between the COVID 19 Vaccine, BNT162B2 and patient''s death of unknown cause, as a cautionary measure and for reporting purposes. However, reportedly, the patient was aged more than 75 years with chronic diseases and heavy treatments, which might have provided alternative explanations towards the patient''s death. The impacts of this report on the benefit/risk profile of the 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.,Linked Report(s) : FR-PFIZER INC-2021049620 same reporter/drug/event, different patient; Reported Cause(s) of Death: death


VAERS ID: 969512 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-01-25
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: Chronic disease (heavy treatments)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021049624

Write-up: death; This is a spontaneous report received from health minister via media source forwarded by a Pfizer colleague, then from other health professional was from Regulatory authority (RA), Regulatory Authority was not provided. This is the fifth of five reports An elderly patient of an unspecified gender received bnt162b2, via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. Patient was leaving in nursing home, with chronic diseases and heavy treatments. The patient''s concomitant medications were not reported. The patient experienced death after having received vaccination with Pfizer-BioNTech vaccine on an unknown date. It was unknown if an autopsy was performed. The health minister reported 5 patients dead after having received vaccination with Pfizer-BioNTech vaccine (BNT162B2, COMIRNATY) in 3 different nursing homes. The dead patients were all aged more than 75 years and were suffering co-morbidities. These are patients that died within the days following vaccination without presenting signs of allergic reaction after vaccination. In nursing homes, patients were fragile, elderly with less autonomy, often with lot of diseases and drugs. Cause of death can be totally unrelated. Pharmacovigilance studies are being conducted by health authorities in association with physicians to determine whether there is a relatedness to vaccination or if this is a sad concomitance. As soon as there is an alert there is an enquiry and if strong suspicion, additional analysis can be performed. The other health professional from regulatory authority reported the 5 dead patients were elderly patients leaving in nursing home, all with chronic diseases and heavy treatments. At this time, considering the available data, there is nothing allowing to conclude that deaths were related to vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Lacking detailed information on the cause of patient''s demise, the Company cannot completely exclude a causal relationship between the COVID 19 Vaccine, BNT162B2 and patient''s death of unknown cause, as a cautionary measure and for reporting purposes. However, reportedly, the patient was aged more than 75 years with chronic diseases and heavy treatments, which might have provided alternative explanations towards the patient''s death. The impacts of this report on the benefit/risk profile of the 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.,Linked Report(s) : FR-PFIZER INC-2021049620 same reporter/drug/event, different patient.; Reported Cause(s) of Death: death


VAERS ID: 969519 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-21
Onset:2020-12-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ0724 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-21
   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: ADCAL [CALCIUM CARBONATE]; ; ; ; ;
Current Illness: Atrial fibrillation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20201221; Test Name: Blood glucose; Result Unstructured Data: Test Result:8.8
CDC Split Type: GBPFIZER INC2021049031

Write-up: not sure pt had a cardiac arest about 25 mins after the vaccine in car park on his way home unobserved; This is a spontaneous report downloaded from the Agency Regulatory Authority-WEB, regulatory authority report number GB-MHRA-EYC 00236088, GB-MHRA-ADR 24546158, reported by a contactable physician. A 96-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number ej0724, expiry date not reported) intramuscular on 21Dec2020 at 0.3 mL single dose for COVID-19 vaccination. Medical history included ongoing atrial fibrillation. Concomitant medication included calcium carbonate (ADCAL), lansoprazole, alendronic acid, edoxaban, bisoprolol fumarate, furosemide. The patient experienced a cardiac arrest ("not sure" as stated by reporter) about 25 minutes after the vaccine in car park on his way home unobserved. He had had 15 minutes observation already and was absolutely fine. He was found collapsed and cardiopulmonary resuscitation performed. After 40 minutes of cardiopulmonary resuscitation ambulance came performed more cardiopulmonary resuscitation etc and had an output and took the patient to hospital. He subsequently died later that night (21Dec2020). Seriousness criteria of event cardiac arrest included medically significant and death. The reporter stated the patient was not suffering from any intercurrent acute illness at the time of vaccination. During resus a blood glucose was performed which was 8.8. The reporter didn''t what happened after he was taken away in the ambulance. Cardiac arrest was reported as cause of death. Further details on the certified cause of death, including a copy of the Post Mortem report was not yet available. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 969523 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-23
Onset:2021-01-11
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Chest X-ray, Hypersensitivity pneumonitis, Pneumonia
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Interstitial lung disease (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), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Respiratory failure (narrow), 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: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ; ; ; ;
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: chest x-ray; Result Unstructured Data: Test Result:bilateral interstitial changes; Comments: chest X ray showed bilateral interstitial changes. Most likely infection with underlying fibrotic changes, but reaction to vaccine such as hypersensitivity pneumonitis is suspected
CDC Split Type: GBPFIZER INC2021047343

Write-up: Acute respiratory decompensation; Most likely infection with underlying fibrotic changes; reaction to vaccine such as hypersensitivity pneumonitis suspected; This is a spontaneous report from a contactable physician. This is a report received from the regulatory authority. Regulatory authority report number GB-MHRA-EYC 00238009, Safety Report Unique Identifier GB-MHRA-ADR 24607748. An 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiry date not reported) on 23Dec2020 intramuscularly at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included amlodipine, amoxicillin, atorvastatin, bendroflumethiazide and perindopril. On 11Jan2021 the patient experienced acute respiratory decompensation. He was admitted to hospital 11Jan2021 with shortness of breath and was treated for chest infection and discharged with antibiotic on 12Jan2021. He was readmitted on 13Jan2021 with worsening respiratory failure and passed away on 14Jan2021 despite treatment with further intravenous antibiotic. On both admission, chest X ray showed bilateral interstitial changes. Most likely infection with underlying fibrotic changes, but reaction to vaccine such as hypersensitivity pneumonitis was suspected. The patient died on 14Jan2021. It was not reported if an autopsy was performed. No follow-up attempts possible; information regarding batch/lot cannot be obtained; No further information expected.; Reported Cause(s) of Death: Acute respiratory decompensation


VAERS ID: 969530 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-05
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-05
   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: Medical History/Concurrent Conditions: Appearance personal neglect of; CVA; Fall; Frailty; Home care; Low weight
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:no - negative covid-19 test
CDC Split Type: GBPFIZER INC2021044787

Write-up: Death; This is a spontaneous report received from a contactable physician by Pfizer from the Medicines and Healthcare products Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-20210111112742. An 81-year-old male patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 31Dec2020 at a single dose for COVID-19 immunization. Medical history included living with frailty, cerebrovascular accident (CVA), self-neglect, falls, admitted to care home, very low weight; all from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), lansoprazole (MANUFACTURER UNKNOWN), rivaroxaban (MANUFACTURER UNKNOWN), tamsulosin (MANUFACTURER UNKNOWN), folic acid (MANUFACTURER UNKNOWN); all taken for an unspecified indication from an unspecified date to an unspecified date. The patient experienced death (death, medically significant) on 05Jan2021. The clinical course was reported as follows: The patient was living with frailty following a CVA; there were concerns about self-neglect and falls. The patient was admitted to care home on a temporary basis. The patient had very low weight and the case was in the process of investigation and referral to mental health and adult safeguarding due to self-neglect. The case had been referred to the coroner. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative covid-19 test on an unspecified date. The clinical outcome of the event was fatal. The patient died on 05Jan2021 due to "unexpected death in the context of severe frailty." It was unknown if an autopsy was performed. The patient had not had symptoms associated with COVID-19. The patient was not enrolled in a clinical trial. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unexpected death in the context of severe frailty


VAERS ID: 969531 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-30
Onset:2021-01-05
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1688 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocardial infarction, SARS-CoV-2 test, 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), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-05
   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: ; ; ; COSMOCOL; ; EVACAL D3; ; ; SENNA [SENNA ALEXANDRINA LEAF]; ; VENTOLINE [SALBUTAMOL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Agitation; Asthma; Chronic kidney disease; Constipation; Depression; Dyspepsia; Ischemic heart disease; Myocardial infarction; Peripheral oedema; Stroke; Vascular dementia
Allergies:
Diagnostic Lab Data: Test Date: 20210101; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021048744

Write-up: presumed/ suspected further MI; Death/ Sudden death; This is a spontaneous report from a contactable Physician. This is a report received from the MHRA. Regulatory authority report number GB-MHRA-WEBCOVID-20210111153208. Safety Report Unique Identifier GB-MHRA-ADR 24580919. A 93-year-old female patient received her fist single dose of BNT162B2 (Pfizer/ BioNTech Covid-19 vaccine, lot number EJ1688) on 30Dec2020 for covid19 immunisation. The patient had a history of chronic kidney disease (CKD), ischemic heart disease (IHD), strokes and vascular dementia. The patient was in elderly mentally infirm (EMI) residential homes care and had a myocardial infarction (MI) in Oct2020. Other relevant medical history included constipation, agitation in dementia, peripheral oedema, dyspepsia, depression and asthma. Concomitant medications included aripiprazole for dementia, bisoprolol for IHD, clopidogrel for IHD, macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (COSMOCOL) for constipation, diazepam for agitation in dementia, calcium carbonate, colecalciferol (EVACAL D3) for bone protection, furosemide for peripheral oedema, omeprazole for dyspepsia, senna alexandrina leaf (SENNA) for constipation, sertraline for depression, salbutamol (VENTOLINE) for asthma. The patient was feeling fine after Covid vaccination. Day 6 post immunization, on 05Jan2021, she was found dead at side of bed, sat leaning against wall with hand on chest. It was also reported as sudden death and presumed/ suspected further MI. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient had Covid-19 virus test on 01Jan2021 and result was negative. It was unknown if an autopsy was performed. It was reported that the death unlikely caused by vaccination as she was feeling well in the week leading up to death and suspected further MI, but best to report given time proximity and black triangle drug.; Reported Cause(s) of Death: presumed/ suspected further MI


VAERS ID: 969559 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-01-06
Submitted: 0000-00-00
Entered: 2021-01-25
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: 2021-01-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021041415

Write-up: Died; This is a spontaneous report from a contactable consumer. An 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot/batch number: unknown), via an unspecified route of administration on an unknown date at a single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to bnt162b2. Prior to vaccination, the patient was not diagnosed with COVID-19. On 06Jan2021, the patient was hospitalized and died. The cause of death was not available at the time of the report. It was unknown if an autopsy was performed. No further information was available at the time of the report.; Reported Cause(s) of Death: died


VAERS ID: 969562 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-12
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure inadequately controlled, Sudden death, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-20
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hyperlipidemia (under oral treatment NOS (ongoing)); Hypertension (under oral treatment NOS (ongoing)); Prostatic hypertrophy (under oral treatment NOS (ongoing))
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC2021059633

Write-up: sudden death; Vomiting; blood pressure unncotrolled; This is a spontaneous report from a contactable physician. An 87-year-old male patient received the first dose of BNT162B2 (COMIRNATY), intramuscular on 19Jan2021 as a single dose for COVID-19 immunisation. The patient also received FOLIFI which included irinotecan hcl (CAMPTO), calcium folinate (LEUCOVORIN), fluorouracil sodium (5 FLUROURACIL), aflibercept (MANUFACTURER UNKNOWN); all intravenous from 12Jan2021 to 13Jan2021 (at the hospital) at unknown doses cyclic for metastatic colorectal cancer. Medical history included hypertension, hyperlipidaemia, and prostatic hypertrophy. The patient''s concomitant medications included unspecified ongoing oral treatment for hypertension, hyperlipidaemia, and benign prostatic hyperplasia. In Jan2021, patient''s blood pressure was deregulated due to his chemotherapy the week prior and his hypertension treatment regimen was increased. The patient completed his chemotherapy regimen and returned home on 14Jan2021. On 19Jan2021, he was vaccinated with BNT162B2. In the morning of 20Jan2021, the patient experienced vomiting and recovered the same day. Then the patient got dressed. However, when he was going down the stairs, he experienced sudden death. He was transferred to the hospital, but he was already dead on 20Jan2021. No autopsy was performed as his family refused to permit it. The clinical outcome of blood pressure deregulated was unknown at the time of death. The actions taken in response to the events for irinotecan hcl, calcium folinate, fluorouracil sodium, and aflibercept were not applicable. The reporting physician considered that the chemotherapy and the vaccine were possibly related to the event of sudden death. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the information available, high age of the patient, and on the pathophysiology of the event company does not reasonably attribute the reported event as related to vaccine. The event was likely due to subject underlying contributory factors. Autopsy details would have been helpful for further medically meaningful causality assessment The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.; Reported Cause(s) of Death: sudden death


VAERS ID: 969563 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-15
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Auscultation, Cardiac arrest, Dyspnoea, Oxygen saturation, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), 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), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-18
   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: ABASAGLAR
Current Illness: Living in nursing home
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210118; Test Name: saturation; Result Unstructured Data: Test Result:dropped; Test Date: 202101; Test Name: covid-19 PCR; Test Result: Negative
CDC Split Type: GRPFIZER INC2021061279

Write-up: cardiac arrest; acute respiratory failure; dyspnoea; auscultation findings; This is a spontaneous report from a contactable physician, who was responsible for the geriatric facility. This physician reported similar events for two patients. This is the first of two reports. A 90-year-old female patient received BNT162B2 (COMIRNATY), intramuscular on 13Jan2021 as a single dose for COVID-19 vaccination. Medical history included diabetes mellitus. Concomitant medications included insulin glargine (ABASAGLAR) for diabetes mellitus. The patient experienced dyspnoea and auscultation findings on 15Jan2021 and cardiac arrest and acute respiratory failure on 18Jan2021. The clinical course was as follows: During her admission to the nursing home (Jan2021), the patient underwent a Covid-19 PCR test that was negative. The patient had been in a nursing home for a week (Jan2021). On 15Jan2021, the patient experienced dyspnea and had auscultation findings. Her condition deteriorated soon. Her saturation dropped and on 18Jan2021 the patient died. The clinical outcome of the dyspnea and auscultation findings were unknown at the time of death. The cause of death was cardiac arrest and acute respiratory failure as a result of lower system respiratory infection. No autopsy was performed. The reporting physician could not exclude a causality of the vaccine to the events. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the information available in old patient of 90 year age and on the pathophysiology of the event company does not reasonably attribute the reported events to the vaccine. The event was likely due to subject underlying contributory factors. Autopsy and relevant past medical history details would be helpful for a medically meaningful causality assessment. 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.,Linked Report(s) : GR-PFIZER INC-2021061457 same reporter/facility, same vaccine, reporting the similar events in different patients; Reported Cause(s) of Death: cardiac arrest; acute respiratory failure


VAERS ID: 969564 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-17
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OLARTAN; ZANIDIP; MANTOMED; SALOSPIR; SEROXAT; DELTIUS
Current Illness: Living in nursing home
Preexisting Conditions: Medical History/Concurrent Conditions: Colon cancer (non treated); Dementia; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC2021061457

Write-up: Cardiac arrest; This is a spontaneous report from a contactable physician, who was responsible for the geriatric facility the patient resided in. This physician reported similar events for two patients. This is the second of two reports. An 86-year-old female patient received the first dose of BNT162B2 (COMIRNATY), intramuscular on 13Jan2021 as a single dose for COVID-19 immunisation. Medical history included hypertension, dementia, and colon cancer (not treated). The patient was a current nursing home resident. Concomitant medications included olmesartan medoxomil (OLARTAN) for hypertension, lercanidipine hydrochloride (ZANIDIP) for hypertension, memantine hydrochloride (MANTOMED) for dementia, acetylsalicylic acid (SALOSPIR) for an unknown indication, paroxetine hydrochloride (SEROXAT) for an unknown indication, and colecalciferol (DELTIUS) for an unknown indication. On 17Jan2021, the patient experienced cardiac arrest and the patient died the same day. The cause of death was reported as cardiac arrest, colon cancer and end stage dementia. An autopsy was not performed. The patient''s condition was very aggravated, and the reporting physician did not consider that the event was related to the vaccine. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the information available in a old patient of age 86 years and on the pathophysiology of the event company does not reasonably attribute the reported event as related to vaccine. The event was likely due to subject underlying contributory factors. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.,Linked Report(s) : GR-PFIZER INC-2021061279 same reporter/facility, same vaccine, reporting the similar events in different patients; Reported Cause(s) of Death: colon cancer; end stage dementia; Cardiac arrest


VAERS ID: 969580 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-01
Onset:2020-12-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chronic obstructive pulmonary disease, Diarrhoea, Infection, Oxygen saturation, Oxygen saturation decreased, Pyrexia, Respiratory distress
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DUROFERON; ; ; SPIRIVA; ; ; ; ELIQUIS; IMPUGAN [FUROSEMIDE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac failure; Chronic obstructive pulmonary disease; Hypertension; Tobacco user
Allergies:
Diagnostic Lab Data: Test Date: 202012; Test Name: fever; Result Unstructured Data: Test Result:38; Comments: degrees Celcius; Test Date: 202012; Test Name: fever; Result Unstructured Data: Test Result:39; Comments: degrees Celcius; Test Date: 202012; Test Name: fever; Result Unstructured Data: Test Result:39; Comments: degrees Celcius; Test Date: 202012; Test Name: saturation; Test Result: 97 %; Test Date: 202012; Test Name: saturation; Test Result: 88 %
CDC Split Type: SEPFIZER INC2021043501

Write-up: Infection; fever/fever was 38 degrees Celcius/fever was 39 degrees Celcius; Loose stools; respiratory distress; an exacerbation of the chronic obstructive pulmonary disease; saturation was 88%/before vaccination saturation was 97%; This is a spontaneous report received from a contactable physician downloaded from the Medicine Agency (MA) regulatory authority -WEB. The regulatory authority report number is SE-MPA-1609848284297. Safety report unique identifier SE-MPA-2021-000086. A 93-year-old male patient received BNT162B2 (COMIRNATY, tozinameran, COVID-19 mRNA Vaccine (nucleoside modified), lot: EJ6795), via an unspecified route of administration in Dec2020 at single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease, cardiac failure, hypertension and atrial fibrillation, the man was smoking (tobacco user). There were no earlier known drug reactions. Concomitant medications included ferrous sulfate (DUROFERON), zolpidem, mirtazapine, tiotropium bromide (SPIRIVA), simvastatin, omeprazole, metoprolol, apixaban (ELIQUIS), and furosemide (IMPUGAN). In Dec2020, adverse drug reaction was signs of infection. The man experienced fever, loose stools and respiratory distress that started 12 hours after the vaccination in Dec2020. According to the reporter the fever was 38 degrees Celcius in the morning the day after vaccination and saturation was 88% (before vaccination saturation was 97%), later that day the fever was 39 degrees Celcius and the man''s general condition was reduced. Day 2 after the vaccination the fever was still 39 degrees Celcius and the man was given antibiotics and steroids. The man died 3 days after vaccination. According to the reporter, it was difficult to know if it was the vaccine or an exacerbation of the chronic obstructive pulmonary disease that caused the man''s reduced general condition. Outcome of event saturation was 88%/before vaccination saturation was 97% was unknown and of other events was fatal.; Reported Cause(s) of Death: Infection; fever/fever was 38 degrees Celcius/fever was 39 degrees Celcius; Loose stools; respiratory distress; an exacerbation of the chronic obstructive pulmonary disease


VAERS ID: 969581 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-30
Onset:2021-01-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   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: ; ; IMPUGAN [FUROSEMIDE]; CANODERM; KALCIPOS-D; LEVAXIN; WARAN;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adverse reaction to antibiotics; Atrial fibrillation; Cardiac failure; Ischemic heart disease; Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021043475

Write-up: Death; This is a spontaneous report from a contactable other healthcare professional downloaded from the Medicines Agency (MA) Regulatory Authority-WEB SE-MPA-2021-000089, Safety Report Unique Identifier SE-MPA-1609851420494. A 86-years-old female patient received bnt162b2 (COMIRNATY, batch/lot number: EJ6795), intramuscular on 30Dec2020 at single dose for covid-19 immunization. Medical history included cardiac failure, atrial fibrillation, stroke, ischemic heart disease, all from an unknown date and unknown if ongoing. Concomitant medications included carvedilol, paracetamol, furosemide (IMPUGAN), urea (CANODERM), calcium carbonate, colecalciferol (KALCIPOS-D), levothyroxine sodium (LEVAXIN), warfarin sodium (WARAN), citalopram. Previous drug reactions included beta-lactamase-sensitive penicillins, cefalosporiner third generation and tetracyclines, unknown what kind of reactions. The patient experienced death in Jan2021 with outcome of fatal. The woman did not have any reactions at that time for the vaccination. Four days after the vaccination the woman was found dead. It was not reported if an autopsy was performed. The cause of death was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 971251 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-30
Onset:2021-01-06
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Respiration abnormal, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ISPFIZER INC2021016581

Write-up: Sudden death; changes to breathing; The initial case was missing the following minimum criteria: no first-hand knowledge. Upon receipt of follow-up information on 20Jan2021, this case now contains all required information to be considered valid. This case was received via e-reporting system by Program and received from a contactable other healthcare profession (HCP, a healthcare worker) downloaded from the Medicines Agency (MA) Regulatory Authority IS-IMA-1540. A 90-year-old male patient received bnt162b2 (COMIRNATY, lot number: EJ6796, expiration date: 30Apr2021) on 30Dec2020 at 0.3ml single for Covid-19 immunisation. Medical history and concomitant medication were not reported. On 06Jan2021 the patient was sleeping in his wheelchair when the staff at the nursing home noticed sudden changes to his breathing. The patient took few breaths with a long interval before he passed away. Sudden death reported as cause of death. It was unknown if autopsy was done. Reporter comment: The patients family considers whether the immunisation had a role in the patients death.; Sender''s Comments: Based on the available information, the Company considers a possible contributory role ofBNT162B2 vaccination in the development of sudden death and respiration abnormal in this elderly patient cannot be excluded. Additional information regarding relevant medical history, underlying conditions and concomitant medications will aid in comprehensive assessment of the case. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Sudden death


VAERS ID: 971333 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-28
Onset:2020-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary embolism, SARS-CoV-2 test, Urinary retention, Vaginal discharge
SMQs:, Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-31
   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: CANDESARTAN; ITERIUM; RISPERIDON SANDOZ; NOVALGIN [METAMIZOLE SODIUM]; LAXOGOL; PASPERTIN [METOCLOPRAMIDE HYDROCHLORIDE]; DULCOLAX [SODIUM PICOSULFATE]; THYREX; MEMANTINE; DOXAZOSIN HEXAL; DUROTIV; LAEVOLAC; TRAJENTA; DOMINAL [ACETYLSALICYL
Current Illness: Arteriosclerosis (severe general atherosclerosis); Decompensation cardiac (Cardiac decompensation); Deep vein thrombosis (deep vein thrombosis on both sides); Dementia; Diabetes mellitus (Diabetes mellitus - treated with medication, values were in the normal range); Emphysema pulmonary (highly chronic obstructive pulmonary emphysema); Hypertension (Hypertension values were checked once a day for the last few days. controlled, and were also in the normal range - 130/80 Heart rate 74 / min); Retention cyst
Preexisting Conditions: Medical History/Concurrent Conditions: Adnexectomy (Status post adnexectomy); Appendectomy (Status post appendectomy); Cholecystectomy (Status post cholecystectomy); COVID-19 PCR test positive (The patient was tested positive for Corona by means of PCR on November 25, 2020 and was officially segregated until December 10, 2020. PCR from December 7th, 2020 negative.); Hysterectomy (Status post hysterectomy); Pneumonia (Condition after pneumonia right subfield in July 2020 - the oxygen saturation was checked daily and was 93%); Strumectomy (Condition after strumectomy with substitution)
Allergies:
Diagnostic Lab Data: Test Date: 20201125; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:POSITIVE; Test Date: 20201207; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:NEGATIVE
CDC Split Type: ATPFIZER INC2021054438

Write-up: massive central pulmonary embolism of the A. pulmonaris dexter and sinister; brownish vaginal discharge; no urine; This is a spontaneous report from a contactable healthcare professional/ physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB. The regulatory authority report number AT-BASGAGES-2021-00009. An 87-year-old female patient BNT162B2 (COMIRNATY; Lot number EJ6796), via an unspecified route of administration on 28Dec2020 as single dose for COVID-19 immunization. The patient''s medical history and concurrent conditions included: COVID-19 PCR test positive on 25NOV2020, diabetes mellitus (continuing; treated with medication, values were in the normal range), hypertension (continuing; hypertension values were checked once a day for the last few days, controlled, and were also in the normal range - 130/80, Heart rate 74 / min), decompensation cardiac (continuing), pneumonia (Condition after pneumonia right subfield in Jul2020 - the oxygen saturation was checked daily and was 93%), dementia (continuing), Arteriosclerosis (continuing; severe general atherosclerosis), Strumectomy (Condition after strumectomy with substitution), Deep vein thrombosis (continuing; deep vein thrombosis on both sides), Emphysema pulmonary (continuing; highly chronic obstructive pulmonary emphysema), Cholecystectomy (Status post cholecystectomy), Appendectomy (Status post appendectomy), Hysterectomy (Status post hysterectomy), Adnexectomy (Status post adnexectomy), retention cyst (continuing). Concomitant medication included candesartan (MANUFACTURER UNKNOWN) from 21JUL2020, rilmenidine (ITERIUM) for 10JUN2020, risperidone (RISPERIDON SANDOZ), metamizole sodium (NOVALGIN [METAMIZOLE SODIUM]) for musculoskeletal pain from 05APR2019 and 27JUL2020 and , macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (LAXOGOL) from 13DEC2019, metoclopramide hydrochloride (PASPERTIN) from 15JUL2020, sodium picosulfate (DULCOLAX) from 06AUG2019, levothyroxine sodium (THYREX) from 23JUN2019, memantine (MANUFACTURER UNKNOWN) from 16JUL2020, doxazosin mesilate (DOXAZOSIN HEXAL) from 09JUN2020, esomeprazole (DUROTIV) from 03FEB2020, lactulose (LAEVOLAC), linagliptin (TRAJENTA) from 05APR2019, acetylsalicylic acid (DOMINAL) from 18NOV2019, sertraline hydrochloride (SERTRALIN BLUEFISH) from 05JUN2020, colecalciferol (OLEOVIT D3) from 15JUL2019, magnesium carbonate, magnesium oxide (MAGNOSOLV) from 05APR2019, calcium chloride, potassium chloride, sodium chloride (RINGER FRESENIUS) from 17DEC2019, ambroxol hydrochloride (AMBROBENE) for coughing from 09JUN2020, levothyroxine sodium (THYREX) for coughing from 22JUN2019. The patient experienced massive central pulmonary embolism of the a. pulmonaris dexter and sinister on 23Jan2020 which was serious as it had fatal outcome; she also experienced brownish vaginal discharge on 30Dec2020 with outcome of unknown; Patient had no urine on 29Dec2020 with outcome of recovered on 29Dec2020. The patient underwent lab tests and procedures which included history COVID-19 PCR test that was positive on 25Nov2020 and COVID-19 PCR test again on 07Dec2020 was negative. Clinical course was as follows: the patient received BNT162B2 on 28Dec2020, then on 30Dec2020, the patient experienced vaginal discharge abnormality. On 29Dec2020, the patient experienced urinary retention. On 31Dec2020, at 03:45 the patient experienced recurrent pulmonary embolism death. The patient died from recurrent pulmonary embolism. BASGAGES follow up autopsy findings from reported the cause of death as massive central pulmonary embolism of A. pulmonalis dext et sin. The patient died on 31Dec2020. Sender''s comments: BASGAGES comment from 7.1.2020: Data capture aid form of Pfizer taken into consideration for further request of FU. Cause of death and Autopsy findings requested. Confounding factors: elderly age, underlying diabetes mellitus, hypertension, decompensation cardiac, deep vein thrombosis, etc The causal relationship between the product Comirnaty and pulmonary embolism is assessed as unlikely. The information provided in this individual case does not warrant a change in the product information or other measures. The case will be closed at this time. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Recurrent pulmonary embolism


VAERS ID: 971346 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-18
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021050519

Write-up: second dose vaccination the patient died; This is a spontaneous report based on information received by Pfizer, license party for COMIRNATY. A contactable physician reported similar events for two patients. This is the second of two reports. A patient of unspecified age and gender received second dose of bnt162b2 (COMIRNATY) on 18Jan2021 at single dose for COVID-19 immunisation. The patient medical history and the concomitant medications were not reported. The patient previously received first dose of bnt162b2 on 28Dec2020 at single dose for COVID-19 immunisation. Several hours after second dose vaccination the patient died. The patient died on an unspecified date in Jan2021. It was unknown if an autopsy was performed. Information on the batch number has been requested.; Sender''s Comments: Death with unknown cause is considered related to BNT162B2 for reporting purpose. Case will be reassessed once receiving additional information, including cause of death and clinical course. 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. ,Linked Report(s) : DE-PFIZER INC-2021050589 same reporter/drug/event, different patient; Reported Cause(s) of Death: died


VAERS ID: 971347 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-18
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021050589

Write-up: after second dose vaccination the patient died; This is a spontaneous report based on information received by Pfizer from LLP- BioNtech, license party for COMIRNATY. A contactable physician reported similar events for two patients. This is the first of two reports. A patient of unspecified age and gender received second dose of bnt162b2 (COMIRNATY), on 18Jan2021 at single dose for COVID-19 immunisation. The patient medical history and the concomitant medications were not reported. The patient previously received first dose of bnt162b2 on 28Dec2020 at single dose for COVID-19 immunisation. Several hours after second dose vaccination the patient died. The patient died on an unspecified date in Jan2021. It was unknown if an autopsy was performed. Information on the batch number has been requested; Sender''s Comments: Lacking information on the cause of patient''s demise, the Company cannot completely exclude a causal relationship between the COVID 19 vaccine, BNT162B2, and patient''s death of unknown cause, as a cautionary measure and for reporting purposes. More information (patient age group, underlying medication conditions, relevant lab tests, autopsy results) is required for the Company to make a more meaningful causality assessment. The impacts of this report on the benefit/risk profile of the 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.,Linked Report(s) : DE-PFIZER INC-2021050519 same reporter/drug/event, different patient; Reported Cause(s) of Death: after second dose vaccination the patient died


VAERS ID: 971349 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SERTRALIN KRKA [SERTRALINE HYDROCHLORIDE]; ELIQUIS; RISPERDAL; ATORVASTATIN ACCORD; TAMSULOSIN TEVA; DONEPEZIL JUBILANT; METOPROLOLSUCCINAT HEXAL
Current Illness: Alzheimer''s disease; Artificial cardiac pacemaker user (dual chamber pacemaker); Conduction disorder; Ischemic heart disease (3-vessel disease); Vascular dementia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC2021054517

Write-up: Was found dead in bed in the morning; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) WEB (DK-DKMA-WBS-0028478). An 89-year-old male patient received the first dose of bnt162b2 (COMIRNATY: lot number: EM0477), intramuscularly on 06Jan2021 15:00 at a single dose for COVID-19 immunization. Medical history included ongoing vascular dementia, ongoing myocardial ischaemia (3-vessel disease), ongoing conduction disorder, ongoing artificial cardiac pacemaker user (dual chamber pacemaker), ongoing Alzheimer''s disease; all from an unknown date. Concomitant medication included sertraline hydrochloride (SERTRALIN KRKA), taken for depression from 2020 to an unspecified date, apixaban (ELIQUIS), taken for thrombosis prophylaxis from 2020 to an unspecified date, risperidone (RISPERDAL), taken for aggression from 2019 to an unspecified date, atorvastatin calcium trihydrate (ATORVASTATIN ACCORD), taken for cardiac disorder prophylaxis from 2000 to an unspecified date, tamsulosin hydrochloride (TAMSULOSIN TEVA), taken for urination difficulty from 2016 to an unspecified date, donepezil hydrochloride (DONEPEZIL JUBILANT), taken for dementia from 2018 to an unspecified date, metoprolol succinate (METOPROLOLSUCCINAT HEXAL) taken for heart rate irregular from 2018 to an unspecified date. The patient was in a habitual state when vaccinated. The patient was found dead in bed in the morning on 07Jan2021. The event was reported as life threatening and fatal. The patient died on 07Jan2021. The cause of death was unknown. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Was found dead in bed in the morning


VAERS ID: 971350 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Pyrexia, Somnolence
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METFORMIN AUROBINDO; GLIMEPIRID SANDOZ; LOSARTAN MEDIC VALLEY
Current Illness: COPD; Dementia; Ischaemic heart disease; Type 2 diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC2021048665

Write-up: somnolence in the morning; febrilia in the morning; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority -WEB [DK-DKMA-WBS-0028530], Safety Report Unique Identifier: DK-DKMA-ADR 24569858. A 90-year-old male patient received bnt162b2 (COMIRNATY) lot # EM0477, intramuscular on 06Jan2021 at single dose for covid-19 immunisation. Medical history included ongoing type 2 diabetes mellitus, ongoing chronic obstructive pulmonary disease, ongoing Ischaemic heart disease, ongoing dementia. Concomitant medication included metformin hydrochloride (METFORMIN AUROBINDO) for Type 2 diabetes mellitus, glimepiride (GLIMEPIRID SANDOZ) for Type 2 diabetes mellitus, losartan potassium (LOSARTAN MEDIC VALLEY) for Renal disorder. On 06Jan2021 the patient was vaccinated with the first dose Comirnaty (Batch number: EM0477) for COVID-19 immunisation. The patient was healty at the time of vaccination, no newly sickness. In the morning of 07Jan2021 the patient had developed fever and somnolence. The patient did not experience any immediate reaction to the vaccine. The ADRs were by the physician reported as Fatal. The patient died on 07Jan2021 23:45. No treatment due to the ADRs was reported except loving care. There is no information regarding test results. The outcome of the events was fatal. An autopsy was not performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Fever; somnolence in the morning


VAERS ID: 971351 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood bicarbonate, Blood glucose, Blood lactate dehydrogenase, Blood pH, Cardiac arrest, Oxygen saturation, PCO2, PO2
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RILUTEK
Current Illness: ALS (had worsening of ALS in stages over the last year); Chronic respiratory failure (NIV-demanding); Contrast media allergy; Lymphoma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210108; Test Name: blood bicarbonate (st-HCO3); Result Unstructured Data: Test Result:15.6; Test Date: 20210108; Test Name: Blood glucose; Result Unstructured Data: Test Result:17.5; Test Date: 20210108; Test Name: blood lactate dehydrogenase (laktat); Result Unstructured Data: Test Result:5.1; Test Date: 20210108; Test Name: Arterial blood pH; Result Unstructured Data: Test Result:6.81; Test Date: 20210108; Test Name: Arterial oxygen saturation; Test Result: 96 %; Test Date: 20210108; Test Name: PCO2; Result Unstructured Data: Test Result:29.9; Test Date: 20210108; Test Name: PO2; Result Unstructured Data: Test Result:23.5
CDC Split Type: DKPFIZER INC2021054445

Write-up: Cardiac arrest; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory authority -WEB. This is a report received from the regulatory authority . The regulatory authority report number is DK-DKMA-WBS-0028595. A 75-year-old male patient received the first dose of the bnt162b2 (COMIRNATY; Lot Number: EM0477), intramuscularly on 07Jan2021 at a single dose for COVID-19 immunization. Medical history included ongoing lymphoma from an unspecified date, ongoing amyotrophic lateral sclerosis (ALS) from an unspecified date (had worsening of ALS in stages over the last year), ongoing chronic respiratory failure (NIV-demanding) from an unspecified date, ongoing contrast media allergy from an unspecified date. Concomitant medications included riluzole (RILUTEK) taken for ALS from 27Feb2020 to an unspecified date. On 08Jan2021, the patient experienced: cardiac arrest (death, medically significant, life threatening). No treatment due to the event was reported and/or Medical procedure was performed. The relatives of the patient did not describe that the patient had had any side effects associated with the vaccination. The patient underwent lab tests and procedures which included blood bicarbonate (st-HCO3): 15.6, blood glucose: 17.5, blood lactate dehydrogenase (laktat): 5.1, Arterial blood pH (pH): 6.81, Arterial oxygen saturation: 96 %, pco2: 29.9, po2: 23.5; all on 08Jan2021. The clinical outcome of the event, cardiac arrest, was fatal. The patient died on 08Jan2021 due to cardiac arrest. An autopsy was not performed. Causality: The patient may, however, have developed cardiac arrest due to its co-morbidities and not the vaccine. The hospital doctor believed that cardiac arrest was due to hypoxia and not the vaccine but cannot rule it out. If the Medicines Agency receives supplemental significant information regarding this case the case will be re-submitted.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 971353 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-27
Onset:2020-12-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, COVID-19, Drug ineffective, Respiratory failure, SARS-CoV-2 test, Severe acute respiratory syndrome
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2020-12-29
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20201228; Test Name: Blood test; Result Unstructured Data: Test Result:No results reported; Test Date: 20201228; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: DKPFIZER INC2021054421

Write-up: Respiratory insufficiency / severe acute respiratory syndrome; Respiratory insufficiency / severe acute respiratory syndrome; Respiratory insufficiency / severe acute respiratory syndrome; Respiratory insufficiency / severe acute respiratory syndrome; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (EMA) EudraVigilance-WEB. This is a report received from the regulatory authority (DKMA). The regulatory authority report number is DK-DKMA-WBS-0028707; Safety Report Unique Identifier DK-DKMA-ADR 24576087. A 91-year-old female patient received the bnt162b2 (COMIRNATY; Lot Number: EJ6796), intramuscularly on 27Dec2020 at a single dose for COVID-19 immunization. The patient''s medical history included COVID-19 from an unknown date and unknown if ongoing. Concomitant medications were not reported. On 28Dec2020, the patient experienced: respiratory insufficiency / severe acute respiratory syndrome; which was assessed as medically significant, life threatening, and resulted in hospitalization and death. The patient was hospitalized for respiratory insufficiency / severe acute respiratory syndrome from 28Dec2020 to an unknown date. The patient underwent lab tests and procedures which included blood test: no results reported on 28Dec2020, COVID-19 virus test: positive on 28Dec2020. The clinical outcome of the event was fatal. The patient died on 29Dec2020 due to respiratory insufficiency / severe acute respiratory syndrome. An autopsy was not performed. Causality: Reporter stated that it cannot be ruled out that the vaccine was a contributing cause, why the death was reported as presumed adverse drug reaction of the vaccine. If the Medicines Agency receives supplemental significant information regarding this case the case will be re-submitted. ADDITIONAL INFORMATION ON DRUG PROVIDED IN PRODUCT NOTES: Previous given: No; Reported Cause(s) of Death: Respiratory insufficiency; severe acute respiratory syndrome


VAERS ID: 971354 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-30
Onset:2020-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-30
   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: LEVOFLOXACIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: CVA (approximately one month ago)
Allergies:
Diagnostic Lab Data: Test Date: 202012; Test Name: Coronavirus antigen test; Test Result: Negative
CDC Split Type: ESPFIZER INC2021054774

Write-up: it seemed like a sudden death; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB (ES-AEMPS-711321). An 88-year-old female patient received the first dose of bnt162b2 (COMIRNATY; Lot number: EJ6796), intramuscularly on 30Dec2020 at a single dose for COVID-19 immunization. Medical history included cerebrovascular accident (CVA) from Nov2020 to an unknown date (approximately one month ago). Concomitant medication included levofloxacin (MANUFACTURER UNKNOWN) taken for infection respiratory from Dec2020 to an unspecified date. It was reported that it seemed like a sudden death on 30Dec2020. She was administered the coronavirus vaccine on 30Dec2020 and 12 hours later she died. The staff of the institution reported that she was fine and that it seemed like a sudden death. The patient underwent lab tests and procedures which included: coronavirus antigen test: negative in Dec2020. The patient died on 30Dec2020. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 971355 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Hypotension, PO2
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant 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), Hypersensitivity (broad), Respiratory failure (narrow), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   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:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthrosis; Cerebral small vessel ischaemic disease; Haemorrhagic stroke (basal ganglia); Hearing loss; Hiatus hernia; Hypoacusis; Knee prosthesis user; Living in care; Nasogastric tube feeding
Allergies:
Diagnostic Lab Data: Test Date: 20210107; Test Name: Arterial oxygen partial pressure; Result Unstructured Data: Test Result:87
CDC Split Type: ESPFIZER INC2021054536

Write-up: Acute respiratory insufficiency; Acute hypotension; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB. This is a report received from the Spanish Regulatory Authority (AEMPS). The regulatory authority report number is ES-AEMPS-713828. A 90-year-old female patient received the bnt162b2 (COMIRNATY; Lot Number: EJ6796), via an unspecified route of administration on 07Jan2021 at a single dose for COVID-19 immunization. The patient''s medical history included cerebral small vessel ischaemic disease from an unknown date and unknown if ongoing, haemorrhagic stroke from Oct2020 to an unknown date (basal ganglia), hypoacusis from an unknown date and unknown if ongoing, arthrosis from an unknown date and unknown if ongoing, hiatus hernia from an unknown date and unknown if ongoing, hearing loss from an unknown date and unknown if ongoing, prostheses for both knees from an unknown date and unknown if ongoing, institutionalized from an unknown date and unknown if ongoing, nasogastric tube carrier from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously took alprazolam (MANUFACTURER UNKNOWN), omeprazol (MANUFACTURER UNKNOWN), acetylsalicylic acid (ADIRO; 100 MG tablets GASTRORESISTANT), calcifediol (HIDROFEROL); all taken for an unspecified indication from an unspecified date to an unspecified date. On 07Jan2021, the patient experienced: acute respiratory insufficiency (death, medically significant), and acute hypotension (death). The clinical course was reported as follows: A 90-year-old woman with a history of hemorrhagic stroke in Oct2020, hearing loss, osteoarthritis, prostheses for both knees and ischemic small vessel disease. "Until she had the stroke, she lived alone and in October as a result of this event she was institutionalized and a nasogastric tube carrier until a month ago, she already ate alone." The health professional who attended her, reported that an hour and a half after the administration of COMIRNATY she presented a picture of sudden hypotension and desaturation that required oxygen therapy. The patient''s general condition deteriorated and the next morning she was admitted to the emergency room because she was "very stuporous." The patient died after ten minutes due to respiratory failure. The patient "had not passed COViD-19." The patient underwent lab tests and procedures which included arterial oxygen partial pressure: 87 on 07Jan2021. The clinical outcome of the event was fatal. The patient died on an unspecified date in Jan2021 due to acute respiratory insufficiency and acute hypotension. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Acute hypotension; Acute respiratory insufficiency


VAERS ID: 971356 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-09
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Headache, Malaise, Oxygen saturation, Presyncope, Pyrexia, Vaccination complication
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-10
   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: SINTROM; DIGOXINA KERN PHARMA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic atrial fibrillation (CONTROLLED ANTICOAGULANT TREATMENT); Fibrillation atrial (CONTROLLED ATRIAL FIBRILLATION)
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:120/70; Test Name: body temperature; Result Unstructured Data: Test Result:37.5 Centigrade; Comments: fever peak of 37.5 Centigrade; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:93-95 %
CDC Split Type: ESPFIZER INC2021054355

Write-up: Vaso vagal attack; Fever; Vaccination adverse reaction; General malaise; Headache; This is a spontaneous report from a contactable consumer downloaded from the European Medicines Agency (EMA) EudraVigilance-WEB. The regulatory authority report number is ES-AEMPS-714909. An 85-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration in the arm on 07Jan2021 as single dose for covid-19 immunization. Medical history included chronic atrial fibrillation from an unknown date reported with controlled anticoagulant treatment and (detailed as controlled atrial fibrillation), from unknown dates. Concomitant medication included acenocoumarol (SINTROM) for chronic atrial fibrillation from 21Jan2016, digoxin (DIGOXINA KERN PHARMA) also for chronic atrial fibrillation from 21Jan2016. The patient experienced the following fatal events: headache on 09Jan2021, fever on 09Jan2021, vaccination adverse reaction on 09Jan2021, general malaise on 09Jan2021, vaso vagal attack on 10Jan2021. The patient underwent lab tests and procedures which included blood pressure: 120/70 and oxygen saturation: 93-95 % on an unspecified date. The patient had not gone through a COVID-19. Details were as follows: On day 9 the male patient started to experience general malaise with mild headache and fever peak of 37.5 Centigrade. In the morning of day 10 the general malaise got worse and the normal values were maintained. The blood pressure was 120/70 and oxygen saturation of 93-95 %. On day 10 he ate breakfast and ate a lot, and after lunch, he had a cardiac arrest, which resulted in a vasovagal attack in which the blood pressure could not be taken nor the pulse be found. 061 Services were called and advanced Cardiopulmonary resuscitation was performed for 30 minutes, with no response, thus 2.30 p.m. death was declared. The patient died on 10Jan2021. 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: Cardiac arrest


VAERS ID: 971359 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021053615

Write-up: Death unexplained; felt unwell; This is a spontaneous report received from a contactable other health professional from the Medicines and Healthcare products Regulatory Agency (]MHRA). The regulatory authority report number is GB-MHRA-ADR 24608080. A 90-year-old female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 15Jan2021 at a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 16Jan2021, the patient experienced: felt unwell and death unexplained. On 21Jan2021, the Health Professional was informed of a death following the administration of the Pfizer vaccine to an elderly 90-year-old female patient. One day after the administration of the vaccine, the patient reportedly began to feel unwell later on in the day following administration, it was administered at lunch time (as reported). The clinical outcome of the event, felt unwell, was unknown. The clinical outcome of the event, death unexplained, was fatal. The patient died on 16Jan2021 due to death unexplained. An autopsy was not performed. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 971372 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-11
Onset:2021-01-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac pacemaker evaluation, Death, Investigation
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-11
   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: APIXABAN; ACETYLSALICYLIC ACID; BIMATOPROST; BRALTUS; BRIMONIDINE TARTRATE; BUMETANIDE; CETRABEN [LIGHT LIQUID PARAFFIN;WHITE SOFT PARAFFIN]; DERMOL [BENZALKONIUM CHLORIDE;CHLORHEXIDINE HYDROCHLORIDE;ISOPROPYL MYRISTATE;PARAFFIN, LIQUID]; D
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac pacemaker evaluation (Distant pacemaker test.); Comments: .
Allergies:
Diagnostic Lab Data: Test Name: Cardiac pacemaker evaluation; Result Unstructured Data: Test Result:unknown result; Test Name: Distant pacemaker test; Result Unstructured Data: Test Result:unknown result
CDC Split Type: GBPFIZER INC2021055139

Write-up: died; This is a spontaneous report from a contactable Physician. This is a report received from the MHRA. Regulatory authority report number GB-MHRA-TPP33625993C958413YC1610466869231, Safety Report Unique Identifier GB-MHRA-ADR 24602229. A 91-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: not reported) on 11Jan2021, at 0.3ml (30mcg), single dose for COVID-19 immunisation. The patient previously received first dose of BNT162B2 in Dec2020. Medical history included cardiac pacemaker evaluation: Distant pacemaker test. Concomitant medication included Apixaban from 27Sep2019, acetylsalicylic acid from 27Sep2019, bimatoprost from 15Jan2020, tiotropium bromide (BRALTUS) from 27Sep2019,brimonidine tartrate from 15Jan2020, bumetanide from 02Jul2020, light liquid paraffin, white soft paraffin (CETRABEN) from 01Jun2020, benzalkonium chloride, chlorhexidine hydrochloride, isopropyl myristate, paraffin, liquid (DERMOL) from 27Oct2020 to 24Nov2020, docusate sodium from 27Sep2019, mometasone furoate (ELCON) from 04Dec2020 to 18Dec2020, glyceryl trinitrate from 27Sep2019 to 25Nov2020, nicorandil from 27Sep2019, Olive oil from 03Nov2020 to 01Dec2020, omeprazole from 27Sep2019, salbutamol from 27Sep2019 to 27Nov2020, senna alexandrina from 27Sep2019 and simvastatin from 27Sep2019. On 11Jan2021 the patient died 24 days after first Covid vaccination. It was unknown if an autopsy was performed. No follow-up attempts possible; information regarding batch/lot cannot be obtained;; Reported Cause(s) of Death: died


VAERS ID: 971383 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-17
Onset:2020-12-01
Submitted: 0000-00-00
Entered: 2021-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Chest X-ray, Coma scale, Coma scale abnormal, Confusional state, Fall, Haemoglobin, Head injury, Hypotension, Hypothermia, Hypoxia, Investigation, Lung consolidation, Pneumonia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-30
   Days after onset: 29
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INFLUENZA VACCINE; AMLODIPINE; APIXABAN; FERINJECT; FUROSEMIDE; LANSOPRAZOLE
Current Illness: Iron deficiency anaemia
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Hiatus hernia; Macular degeneration; Memory impairment
Allergies:
Diagnostic Lab Data: Test Date: 202012; Test Name: low BP; Result Unstructured Data: Test Result:low; Test Date: 202012; Test Name: low BP; Result Unstructured Data: Test Result:hypotensive; Test Date: 202012; Test Name: hypothermic; Result Unstructured Data: Test Result:hypothermic; Test Date: 202012; Test Name: Chest X-ray; Result Unstructured Data: Test Result:Left consolidation; Test Date: 202012; Test Name: Glasgow coma scale; Result Unstructured Data: Test Result:low; Test Date: 202012; Test Name: Hb; Result Unstructured Data: Test Result:drop; Comments: diagnosed as iron deficiency anaemia; Test Date: 202012; Test Name: hypoxic; Result Unstructured Data: Test Result:hypoxic; Test Date: 20201229; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021055340

Write-up: Pneumonia; increased confusion; fall with head injury; fall with head injury; low BP/Hypotensive; hypoxic; hypothermic; low GCS; Left consolidation was seen on chest x-ray; This is a spontaneous report from a contactable pharmacist. This is a report received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-20201231163559, Safety Report Unique Identifier GB-Regulatory Authority-ADR 24549459. A 97-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not known), via an unspecified route of administration on 17Dec2020 at single dose for COVID-19 vaccination. Medical history included atrial fibrillation from an unknown date and unknown if ongoing, hiatus hernia from an unknown date and unknown if ongoing, Macular degeneration from an unknown date and unknown if ongoing, memory problems from an unknown date and unknown if ongoing, ongoing Iron deficiency anaemia. Concomitant medications included amlodipine, apixaban, ferric carboxymaltose (FERINJECT) from Dec2020 for Iron deficiency anaemia, furosemide, influenza vaccine, lansoprazole. The patient was involved in hospitalisation from 22Dec2020 to 28Dec2020 increased confusion, fall with head injury, low BP, drop in Hb, diagnosed as iron deficiency anaemia (Dec2020). Then again involved in hospitalisation from 29Dec2020 to 30Dec2020 Found to be hypoxic, hypothermic, hypotensive, low GCS (Dec2020). Left consolidation was seen on chest x-ray in Dec2020. Patient admitted twice to hospital after vaccine. Unknown cause. Patient had not tested positive for COVID-19 since having the vaccine. Unsure if patient had had symptoms associated with COVID-19. Unsure if patient was enrolled in clinical trial. Patient was COVID (COVID-19 virus test) negative on 29Dec2020. The patient died/ death on 30Dec2021 due to pneumonia from 29Dec2020. An autopsy was not performed. The outcome of the event Pneumonia was fatal, of the other events was unknown.; Reported Cause(s) of Death: pneumonia


VAERS ID: 971385 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-23
Onset:2021-01-02
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ0724-L456 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021049866

Write-up: Death; This is a spontaneous report received from a contactable physician from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-20210108063030. An 87-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EJ0724- L456) on 23Dec2020 at single dose via unknown route of administration for COVID-19 vaccination. Medical history and concomitant medications were not reported. Patient died at home within 2 weeks of COVID vaccination on 02Jan2021. Outcome of post-mortem awaited. Patient had not tested positive for COVID-19 since having the vaccine. Patient had not had symptoms associated with COVID-19. Patient had not been tested/or had had an inconclusive test for COVID-19. Patient was not enrolled in clinical trial. There was no clear reaction to the vaccine. Notification via Yellow Card relates to unexpected death of patient within 2 weeks of vaccination. The outcome of the event was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death


VAERS ID: 971396 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-04
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1688 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-04
   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: ADCAL-D3; ALENDRONIC ACID; AMIODARONE; ASPIRIN; ATORVASTATIN; BISOPROLOL; LEVOTHYROXINE SODIUM; PERINDOPRIL; SPIRONOLACTONE; TAMSULOSIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute myocardial infarction; Chronic kidney disease stage 3; Defibrillator/pacemaker insertion; Fall; Fragility fracture; Frailty; Hypothyroidism; Left ventricular systolic dysfunction; Neoplasm prostate; Osteoporosis; Peripheral vascular disease; Rib injury; Ventricular tachycardia
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021050530

Write-up: Death; This is a spontaneous report from a contactable Pharmacist. This is a report received from the Medicines and Healthcare products Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-20210111102556, Safety Report Unique Identifier GB-MHRA-ADR 24578125. An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EJ1688/expiration date) via an unspecified route of administration on 31Dec2020 at a single dose for COVID-19 immunization. Medical history included CKD3, LVSD, cardiac defibrillator, ventricular tachycardia, peripheral ischaemic vascular disease, osteoporosis, fragility fracture, malignant neoplasm prostate in 2015, hypothyroidism, and acute MI in 1999. The patient had not had symptoms associated with COVID-19. He had not been tested nor had an inconclusive test for COVID-19. He was not enrolled in clinical trial. The patient also had fall on Christmas day (25Dec2020) injuring his ribs. The patient had been frailer since then. Concomitant medication included calcium carbonate, colecalciferol (ADCAL-D3) from 14Nov2017 for calcium supplementation, alendronic acid from 14Nov2017 for bone fragile, amiodarone from 13Nov2019 for ventricular tachycardia, acetylsalicylic acid (ASPIRIN) from 22Jan1999 for secondary prevention, atorvastatin from 04Apr2019 for secondary prevention, bisoprolol from 22Oct2019 for recurrent ventricular tachycardia, levothyroxine sodium from 04Nov1999 for hypothyroidism, perindopril from 29Apr2004 for left ventricular systolic dysfunction, spironolactone from 29Dec2020 for left ventricular systolic dysfunction, and tamsulosin from 23Dec2014. The patient died on 04Jan2021. It was not reported if an autopsy was performed. The patient had not tested positive for COVID-19 since having the vaccine. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: death


VAERS ID: 971397 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-09
Onset:2021-01-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0141 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-10
   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: MEMANTINE; MIRTAZAPINE
Current Illness: Agitated depression (low mood); Dementia Alzheimer''s type (normally managed)
Preexisting Conditions: Medical History/Concurrent Conditions: Diverticular disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021055262

Write-up: Death; first on 22Dec2020 and second on 09Jan2021; This is a spontaneous report received by Pfizer from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-20210111130432 and Safety Report Unique Identifier GB-MHRA-ADR 24579835. An 81-year-old male patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number: EL0141 and Expiration Date unknown) via an unspecified route of administration on 09Jan2021, at single dose for COVID-19 vaccination. Medical history included ongoing dementia alzheimer''s type though normally managed and had not seen GP for any reason for 15months, ongoing agitated depression and diverticular disease. Patient did not have symptoms associated with COVID-19. Patient has not been tested/or has had an inconclusive test for COVID-19. Patient is not enrolled in clinical trial. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number: EJ0553 and Expiration Date unknown) via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 vaccination. Concomitant included mirtazapine from 22Aug2013 for low mood and memantine from 12May2016 for dementia alzheimer''s type. Patient had a history of demenita, his last saw his dementia specialist in Mar2020, 10 months prior to death. He had 2 doses COVID vaccine as listed above, first on 22Dec2020 and second on 09Jan2021. He was well immediately afterwards, then collapsed and died on night of 10Jan2021. Patient has not tested positive for COVID-19 since having the vaccine. It was unknown if Autopsy has been done. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 971398 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-09
Onset:2021-01-11
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-01-25
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: 2021-01-11
   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: AMITRIPTYLINE; PARACETAMOL; PRAMIPEXOLE; TRAMULIEF
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Osteoarthritis; Restless legs syndrome; Total knee replacement; Comments: Previously fit and well. Had total knee replacement December. Patient has not had symptoms associated with COVID-19 Patient has not been tested/or has had an inconclusive test for COVID-19. Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021054317

Write-up: Death; This is a spontaneous report from a contactable physician. This is a report received from the Medicines and Healthcare products Regulatory Agency (MHRA). Regulatory authority report number GB-MHRA-WEBCOVID-20210111133859, Safety Report Unique Identifier GB-MHRA-ADR 24579919. An 80-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunization. Medical history included Previously fit and well. Had total knee replacement December. Patient had not had symptoms associated with COVID-19 Patient had not been tested/or has had an inconclusive test for COVID-19. Patient was not enrolled in clinical trial. Concomitant medication included amitriptyline for restless legs syndrome, paracetamol for osteoarthritis, pramipexole for restless legs syndrome and tramadol hydrochloride (TRAMULIEF SR) for osteoarthritis. The patient experienced death on 11Jan2021. The patina had the vaccine on Saturday, no immediate ill effects and was observed for 15 mins as per protocol. According to patient''s wife, he was very well yesterday. This morning his wife went to wake him up and found him dead on 11Jan2021. Patient had not tested positive for COVID-19 since having the vaccine. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Death


VAERS ID: 971399 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-16
Onset:2020-12-21
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ0553 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Sudden unexpected death at home. Coroners case- no death certificate as yet. No COD at present. CKD 3 and hypertension. Patient has not had symptoms associated with COVID-19 Patient has not been tested/or has had an inconclusive test for COVID-19. Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021055298

Write-up: sudden unexpected death; This is a spontaneous report received from a contactable physician from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-20210111143134 and Safety Report Unique Identifier GB-MHRA-ADR 24580607. A 88-year-old female patient received BNT162B2 (lot number EJ0553) via an unspecified route of administration on16Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. Patient had not been tested/or has had an inconclusive test for COVID-19. Patient was not enrolled in clinical trial. It was reported as sudden unexpected death at home on 21Dec2020. CKD 3 and hypertension were reported but was not specified as medical history or events. Sudden death- within a week of covid vaccination. Causality was reported as unknown. Patient had not tested positive for COVID-19 since having the vaccine. An autopsy was not performed. The cause of death was unknown. The outcome of the event was fatal. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: sudden unexpected death


VAERS ID: 971478 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Circulatory collapse, Diarrhoea
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), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-17
   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: ALENDRONIC ACID; AMLODIPINE; CANDESARTAN; DIAZEPAM; EZETIMIBE; FULTIUM D3; LANSOPRAZOLE; LEVEMIR; LEVOTHYROXINE SODIUM; LIPITOR [ATORVASTATIN CALCIUM]; NOVORAPID; PARACETAMOL; PREDNISOLONE; ROPINIROLE; SUKKARTO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypothyroidism; Polymyalgia rheumatica (Polymyalgia rheumatica, opn reducing course of steroids); Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)); Comments: Polymyalgia rheumatica, opn reducing course of steroids Developed D+V 36 hours post-vaccine, sudden collapse and cardiac arrest 48 hours after onset of symptoms Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021046933

Write-up: Diarrhoea NOS; sudden collapse and cardiac arrest; sudden collapse and cardiac arrest; This is a spontaneous report from a contactable physician. This is a report received from the MHRA. Regulatory authority report number GB-MHRA-WEBCOVID-202101180828470250, Safety Report Unique Identifier GB-MHRA-ADR 24607247. A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 14Jan2021 at single dose for covid-19 immunization. Medical history included steroid therapy (Taking regular steroid treatment (e.g. orally or rectally), Polymyalgia rheumatica (opn reducing course of steroids), and hypothyroidism. Concomitant medication included alendronic acid, amlodipine, candesartan, diazepam, ezetimibe, colecalciferol (FULTIM D3), lansoprazole, insulin detemir (LEVEMIR), levothyroxine sodium for Hypothyroidism, atorvastatin calcium (LIPITOR), insulin aspart (NOVORAPID), paracetamol, prednisolone, ropinirole, metformin hydrochloride (SUKKARTO). On 15Jan2021 the patient experienced diarrhoea NOS (fatal outcome). It was reported: Patient had vaccine 14Jan. 36 hours later she started to developed D+V. The vomiting settled in the next 48 hours but she was very weak as a result. She suddenly collapsed in the bathroom and was in cardiac arrest, attempted prolonged CPR but unable to revivie her. Patient was not tested positive for COVID-19 since having the vaccine. Developed D+V 36 hours post-vaccine, sudden collapse and cardiac arrest 48 hours after onset of symptoms. Patient did not had symptoms associated with COVID-19 and not had a COVID-19 test. The patient died on 17Jan2021. It was not reported if an autopsy was performed. The outcome of diarrhea was fatal. The outcome of events sudden collapse and cardiac arrest was unknown. No follow-up attempts are possible; information regarding batch/lot cannot be obtained; No further information is expected.; Reported Cause(s) of Death: Diarrhoea NOS


VAERS ID: 971481 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK1768 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic aneurysm rupture, Malaise, Myocardial infarction
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-15
   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: ASPRIN; ATORVASTATIN; BISOPROLOL; FUROSEMIDE; ISOSORBIDE MONONITRATE; NICORANDIL; OMEPRAZOLE; ROPINIROLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal aortic aneurysm (Recent abdominal aortic aneurysm); Coronary heart disease; Ischaemic heart disease; Legs restless
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021047275

Write-up: Recent abdominal aortic aneurysm Looks like returned from covid clinic and collapsed; unwell; a suspected heart attack; This is a spontaneous report from a contactable pharmacist. This is a report received from the MHRA. Regulatory authority report number GB-MHRA-WEBCOVID-202101181156428650, Safety Report Unique Identifier GB-MHRA-ADR 24608600. A 91-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: Ek1768) on 15Jan2021 at single dose for Covid-19 immunization. Medical history included recent abdominal aortic aneurysm, legs restless, Ischaemic heart disease and Coronary heart disease. Concomitant medication included acetylsalicylic acid (Aspirin) for Ischaemic heart disease, atorvastatin for Ischaemic heart disease, bisoprolol for Coronary heart disease, furosemide for Coronary heart disease, isosorbide mononitrate for Ischaemic heart disease, nicorandil for Ischaemic heart disease, omeprazole for prophylaxis and ropinirole for legs restless. The patient died on 15Jan2021. It was reported: Patient attended covid clinic and was vaccinated. He returned home and within a few hours was unwell and subsequently died from a suspected heart attack. Patient has not tested positive for COVID-19 since having the vaccine. Recent abdominal aortic aneurysm looks like returned from covid clinic and collapsed with a heart attack and patient passed away. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. Patient is not enrolled in clinical trial. It was not reported if an autopsy was performed. No follow-up activities are possible. No further information is expected.; Reported Cause(s) of Death: Recent abdominal aortic aneurysm Looks like returned from covid clinic and collapsed; a suspected heart attack


VAERS ID: 971482 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-09
Onset:2021-01-16
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0739 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021046807

Write-up: Death; This is a spontaneous report from a contactable physician. This is a report received from the Medicines and Healthcare products Regulatory Agency (MHRA). Regulatory authority report number GB-MHRA-WEBCOVID-202101181222001950, Safety Report Unique Identifier GB-MHRA-ADR 24608694. A 95-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL0739), via an unspecified route of administration on 09Jan2021 as single dose for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced death on 16Jan2021; the patient was found dead at home. Patient had not had symptoms associated with COVID-19 and had not had a COVID-19 test. The patient was not enrolled in clinical trial. The patient died on 16Jan2021. The cause of death was not reported. An autopsy was not performed. No follow-up activities are possible. No further information is expected.; Reported Cause(s) of Death: DEATH


VAERS ID: 971483 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-18
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK1768 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-18
   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: CALCIUM, COLECALCIFEROL; FLUOXETINE; OMEPRAZOLE; PROPRANOLOL; SUMATRIPTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gastritis; Hypocalcaemia; Migraine; Mixed anxiety and depressive disorder; Comments: Mixed Anxiety and Depression Migraine. Not seen GP since 2017 Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021047164

Write-up: Death; This is a spontaneous report from a contactable physician. This is a report received from the MHRA. Regulatory authority report number GB-MHRA-WEBCOVID-202101181557540160, Safety Report Unique Identifier GB-MHRA-ADR 24609996. An 80-year-old female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK1768), via an unspecified route of administration on 15Jan2021 at a single dose for COVID-19 immunization. Medical history included mixed anxiety and depression, migraine, hypocalcaemia, gastritis; all from an unknown date and unknown if ongoing. It was reported that: "not seen GP since 2017." Concomitant medications included calcium, colecalciferol (MANUFACTURER UNKNOWN) taken for hypocalcaemia from 10Jan2017 to unknown if ongoing, fluoxetine (MANUFACTURER UNKNOWN) taken for mixed anxiety and depressive disorder from 03Jun2003 to unknown if ongoing, omeprazole (MANUFACTURER UNKNOWN) taken for gastritis from 07Mar2017 to unknown if ongoing, propranolol (MANUFACTURER UNKNOWN) taken for anxiety from 29May2003 to unknown if ongoing, sumatriptan (MANUFACTURER UNKNOWN) taken for migraine from 16May2014 to unknown if ongoing. The patient experienced death (death, medically significant) on 18Jan2021. It was reported that the patient was found dead by relatives and emergency services; Cardiopulmonary resuscitation (CPR) was unsuccessful. The clinical outcome of the event was fatal. The patient died on 18Jan2021 due to unknown cause of death. It was unknown if an autopsy was performed. The patient had not had symptoms associated with COVID-19. The patient had not had a COVID-19 test. The patient was not enrolled in a clinical trial. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 971484 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-22
Onset:2021-01-06
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021057388

Write-up: Death; This is a spontaneous report from a contactable consumer. This is a report received from the MHRA. Regulatory authority report number GB-MHRA-WEBCOVID-202101182317499430 Safety Report Unique Identifier GB-MHRA-ADR 24612640. A male patient of unknown age received bnt162b2 (BNT162B2), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunisation. Medical history was unknown. Concomitant medications were unknown. The patient died on 06Jan2021. The outcome of the event was fatal. Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial. COVID-19 virus test: No - Negative COVID-19 test. It was unknown if autopsy was performed. No follow-up attempts possible; information regarding batch/lot cannot be obtained; No further information expected.; Reported Cause(s) of Death: Death


VAERS ID: 971486 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-08
Onset:2021-01-14
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MIDAZOLAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Brain metastases (lung cancer metastasis with stage 4 brain mets. No chemo or radiotherapy); Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...); Lung cancer metastatic (lung cancer metastasis with stage 4 brain mets. No chemo or radiotherapy); Comments: Pt had lung cancer metastasis with stage 4 brain mets. No chemo or radiotherapy. Patient has not had symptoms associated with COVID-19 Unsure if patient is enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021056828

Write-up: Death; This is a spontaneous report from a contactable Physician. This is a report received from the MHRA. Regulatory authority report number GB-MHRA-WEBCOVID-202101201100435240, Safety Report Unique Identifier GB-MHRA-ADR 24619845. A 72-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 08Jan2021 at single dose for COVID-19 immunisation. Medical history included immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodeficiency)), had lung cancer metastasis with stage 4 brain mets. No chemo or radiotherapy. Concomitant medication included midazolam from 11Jan2021 for Sedative therapy. The patient had Covid vaccination on 8Jan2021 and died on 14Jan2021. The patient experienced death on 14Jan2021. An autopsy was not performed. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Lab data included No - Negative COVID-19 test. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Death


VAERS ID: 971499 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high; Diabetes
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021057048

Write-up: suddenly her husband found her dead; This is a spontaneous report from a contactable consumer. An elderly female patient of unknown age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at single dose for COVID-19 immunisation. Medical history included high blood pressure and diabetes. Concomitant medication was not reported. The patient previously received first dose of BNT162B2 for COVID-19 immunisation. After receiving the first dose she suffered from shortness of breath, and had difficulty sleeping during the night. The patient died after receiving the second dose of the vaccine. She consulted with the physician about receiving the second dose and he told her that no problem was expected. She was vaccinated at 15:00, and died at 1:00. The cause of death was unknown, no post-mortem was performed. Suddenly her husband found her dead. No follow-up attempts are possible, information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: suddenly her husband found her dead


VAERS ID: 971500 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-18
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Cardiac arrest, Cerebellar haemorrhage, Echocardiogram, Malaise, Pain in extremity, Thrombosis
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), 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), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Respiratory failure (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   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: Overweight
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: cardiac echo; Result Unstructured Data: Test Result:large blood clots
CDC Split Type: ILPFIZER INC2021060959

Write-up: felt unwell in her home and was found lying on the floor with asystole; felt unwell in her home and was found lying on the floor with asystole; large blood clots; insignificant hand pain; Fatal cardiac arrhythmia; Cerebellar hemorrhage; This is a spontaneous report from a contactable healthcare professional received via the Health Authority. The regulatory authority report number was not reported. A 57-year-old female patient received second dose of bnt162b2, via an unspecified route of administration on 18Jan2021 at single dose for covid-19 immunization. Medical history included overweight from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced fatal cardiac arrhythmia, cerebellar hemorrhage, large blood clots, insignificant hand pain all in Jan2021, felt unwell in her home and was found lying on the floor with asystole on 20Jan2021. The female patient with overweight, no known background diseases. Received the second corona vaccine on 18Jan2021. After the vaccine she complained of insignificant hand pain. On 20Jan2021 she felt unwell in her home and was found lying on the floor with asystole at the arrival of MDA, after prolonged resuscitation, her death was determined in the trauma room in the emergency medical center, in a hospital in the north of the country. Emergency medical center diagnoses: Fatal cardiac arrhythmia; Cerebellar hemorrhage. It was further noted that a cardiac echo was performed by a cardiologist, diagnosed with large blood clots. The patient underwent lab tests and procedures which included cardiac echo: large blood clots in Jan2021. The outcome of events for fatal cardiac arrhythmia was death, for other events was unknown. The patient died in Jan2021. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: Fatal cardiac arrhythmia


VAERS ID: 971502 (history)  
Form: Version 2.0  
Age: 104.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LANSOPRAZOLE; TORASEMIDE; CLASTEON; DIBASE; MYLICON; DEURSIL; ACETYLSALICYLIC ACID; ZYLORIC; MACROGOL 4000; CYANOCOBALAMIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021048826

Write-up: guest of nursing home for elderly at 2 pm vaccination anticovid 19 (comirnaty), observed as per protocol until 17 (vigile, she was eating) at 19.45 died; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) WEB. The regulatory authority report number is IT-MINISAL02-651890. A 104-year-old female patient received BNT162B2 (COMIRNATY; Lot number EL1484), intramuscular on 07Jan2021 at 0.3 mL, single for covid-19 immunization. The patient medical history was not reported. Concomitant medication included lansoprazole (MANUFACTURER UNKNOWN), torasemide (MANUFACTURER UNKNOWN), clodronate disodium (CLASTEON), colecalciferol (DIBASE), simeticone (MYLICON) , ursodeoxycholic acid (DEURSIL), acetylsalicylic acid (MANUFACTURER UNKNOWN), allopurinol (ZYLORIC), macrogol 4000 (MANUFACTURER UNKNOWN), cyanocobalamin (MANUFACTURER UNKNOWN). On 07Jan2021, at 19:45, the patient, who was a guest of nursing home for elderly at 2 pm vaccination anticovid 19 (comirnaty), observed as per protocol until 17 (vigile, she was eating) at 19:45 died. The patient died on 07Jan2021. The reporter commented that about six hours after the administration of BNT162B2, the 104-year-old patient, who was suffering from multiple pathologies, who had not presented any disturbances in the three hours of observation following the injection, as per protocol, died. It was not reported if an autopsy was performed. The cause of death was reported as heart failure (in patient with known pathology).; Reporter''s Comments: It is reported that about 6 hours after the administration of Comirnaty a 104-year-old patient, suffering from multiple pathologies, who had not presented any disturbances in the three hours of observation following the injection, as per protocol, died.; Reported Cause(s) of Death: Heart failure


VAERS ID: 971503 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-04
Onset:2021-01-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arteriosclerosis, Condition aggravated, Dehydration, Dysphagia, General physical health deterioration, Weight decreased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-05
   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: TACHIPIRINA; BISOPROLOL FUMARATE; MINIAS; TAVOR [LORAZEPAM]; PROZIN [CHLORPROMAZINE HYDROCHLORIDE]; LEVOPRAID [LEVOSULPIRIDE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Artificial cardiac pacemaker user; Cerebral vascular disturbance; Dementia vascular; Femur fracture; Living in nursing home
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021054118

Write-up: bed rest syndrome; further weight loss; Dehydration; blood vessels sclerotic; Severe general conditions of dysphagic patient. Worsening of the general condition in the last 4/6 weeks; Severe general conditions of dysphagic patient. Worsening of the general condition in the last 4/6 weeks; This is a spontaneous report from a contactable physician downloaded from the Agency. This is a report received from the Regulatory authority. The regulatory authority report number is IT-MINISAL02-652640. A 100-year-old female patient received the second dose (reported as: Booster dose number: 1) of the bnt162b2 (COMIRNATY; Lot Number: EL1484 and Expiration Date: Apr2021), intramuscularly on 04Jan2021 at 15:00 at 0.3 mL, single for COVID-19 immunization. Medical history included dementia vascular from an unknown date and unknown if ongoing, admitted to a nursing facility from 16Nov2018 to an unknown date, chronic cerebral vasculopathy from an unknown date and unknown if ongoing, persottrocanteric fracture results left femur from an unknown date and unknown if ongoing, carrier of pacemaker from an unknown date and unknown if ongoing. The patient previously received the first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) for COVID-19 immunization on an unknown date. Concomitant medications included paracetamol (TACHIPIRINA), bisoprolol fumarate (MANUFACTURER UNKNOWN), lormetazepam (MINIAS), lorazepam (TAVOR [LORAZEPAM]), chlorpromazine hydrochloride (PROZIN [CHLORPROMAZINE HYDROCHLORIDE]) , levosulpiride (LEVOPRAID [LEVOSULPIRIDE]); all taken for an unspecified indication from an unspecified date to an unspecified date. On an unspecified date, the patient experienced: further weight loss, bed rest syndrome, dehydration, and blood vessels sclerotic. On 05Jan2021, the patient experienced: "severe general conditions of dysphagic patient. Worsening of the general condition in the last 4/6 weeks." The clinical course was reported as follows: The patient was admitted to a nursing facility on 16Nov2018 with diagnosis of chronic cerebral vasculopathy, persottrocanteric fracture results left femur, patient carrier of pacemaker. The patient died on 5Jan2021. The general condition of the patient had progressively worsened in the last 4/6 weeks, with dysphagia, further weight loss and bed rest syndrome, dehydrated patient, difficulty in administering rehydration therapy due to blood vessels sclerotic. The clinical outcome of the events: further weight loss, bed rest syndrome, dehydration, and blood vessels sclerotic, was unknown. The clinical outcome of the event, "severe general conditions of dysphagic patient. Worsening of the general condition in the last 4/6 week", was fatal. The patient died on 05Jan2021 due to "severe general conditions of dysphagic patient. Worsening of the general condition in the last 4/6 week". It was unknown if an autopsy was performed. Sender comment: "13Jan2021, the doctor present in the facility at the time of administration for clinical report contacted again." No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: .; Reported Cause(s) of Death: severe general conditions of dysphagic patient. Worsening of the general condition in the last 4/6 week; severe general conditions of dysphagic patient. Worsening of the general condition in the last 4/6 week


VAERS ID: 971508 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coronary artery disease; Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC2021058845

Write-up: Patient died 2 weeks after vaccine administration; This is a spontaneous report from a contactable physician via a sales representative. A 9-decade-old (around 80 years old) male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. Medical history included coronary artery disease (CAD) S/P stenting and mild stroke. The patient''s concomitant medications were not reported. It was reported that a male, around 80 years old, with co-morbidities, was given Pfizer''s Covid Vaccine in the US. Patient died 2 weeks after vaccine administration. The patient died on an unspecified date. It was unknown if an autopsy was performed. The event [Patient died 2 weeks after vaccine administration] occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Lacking information on the cause of patient''s demise, the Company cannot completely exclude a causal relationship between the recent administrated COVID 19 vaccine, BNT162B2, and patient''s death of unknown cause, as a cautionary measure and for reporting purposes. Of note, this was a patient around 80 years old, with co-morbidities, which might have provided alternative explanations. 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 RA, IEC, as appropriate.; Reported Cause(s) of Death: Patient died 2 weeks after vaccine administration


VAERS ID: 971512 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure abnormal, Death, Dehydration, Dyspnoea, General physical health deterioration, Infection, Respiratory rate increased, SARS-CoV-2 test negative
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hypertension (broad), Cardiomyopathy (broad), Dehydration (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   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: Alcohol induced persisting dementia; Chronic obstructive pulmonary disease; Stroke
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: Covid-19 test, PCR; Test Result: Negative
CDC Split Type: SEPFIZER INC2021048595

Write-up: Unknown cause of death; dyspnea; reduced general condition; blood pressure disorder; increased respiratory rate; signs of an infection (unspecified) and was dehydrated; signs of an infection (unspecified) and was dehydrated; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) WEB (SE-MPA-2021-000187 & SE-MPA-1610115916184). A 76-year-old female patient received BNT162B2 (COMIRNATY; Lot number: EJ6796), via an unspecified route of administration in Jan2021 at a single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease, stroke, alcohol induced persisting dementia. The patient''s concomitant medications were not reported. The patient experienced unknown cause of death in Jan2021. The patient experienced dyspnea, reduced general condition, blood pressure disorder and an increased respiratory rate in Jan2021. Clinical details were reported as follows: the patient died one day after the vaccination due to an unknown cause of death, according to the reporter. After the vaccination with BNT162B2 the woman arrived at the emergency room under diffuse circumstances. She had dyspnea, reduced general condition, blood pressure disorder and an increased respiratory rate. Due to dementia, it was difficult to collect a correct medical history. A Covid-19 test, PCR, was performed, with a negative result in Jan2021. The woman showed signs of an infection (unspecified) and was dehydrated and she died of unknown cause of death. The clinical outcome of dyspnea, reduced general condition, blood pressure disorder and an increased respiratory rate was unknown. The reporter confirmed that the probability of death caused by Comirnaty is weak. An autopsy will be performed. The Agency will demand the autopsy protocol. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 971513 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-25
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: 2021-01-01
   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: ALVEDON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cataract operation; Hip fracture; Hip surgery; Living in nursing home; Macular degeneration; Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021053743

Write-up: Death (after COVID-vaccination); This is a spontaneous report from a contactable consumer downloaded from the Medicines Agency (MA) WEB (SE-MPA-2021-000188 & SE-MPA-1610185526828). A 95-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration in Jan2021 at a single dose for COVID-19 immunization. Medical history included stroke from 2010 to an unknown date, hip surgery from Dec2020 to an unknown date, cataract operation, macular degeneration, hip fracture from Dec2020 to an unknown date and lives in a nursing home. Concomitant medication included paracetamol (ALVEDON), unspecified statins, unspecified eye drops, and additional medicines not specified. The patient experienced death (after COVID-vaccination) in Jan2021. In Dec2020 the patient had a hip fracture and hip surgery. After the hip surgery the patient had been weak. The patient was found dead in the nursing home the day after the vaccination. According to the reporter, an autopsy will be performed. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: Death (after COVID-vaccination)


VAERS ID: 971514 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-01
Onset:2021-01-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, C-reactive protein, Circulatory collapse, Urinary tract infection
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MADOPARK QUICK; CILAXORAL; MAGNESIUM CITRATE;MAGNESIUM LACTATE; TRAJENTA; KALCIPOS D; ALVEDON; FOLVIDON; BUVENTOL EASYHALER; BETOLVIDON; LAKTULOS MEDA; DIVIFARM; SCHERIPROCT [CINCHOCAINE HYDROCHLORIDE;PREDNISOLONE CAPROATE]; PROPYLESS; NITR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arteriosclerotic heart disease; Catheter placement; Chronic obstructive pulmonary disease; Diverticulosis; Hypertension; Parkinson''s disease; Type 2 diabetes mellitus; Wheelchair user
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: Body temperature; Result Unstructured Data: Test Result:did not have a fever; Test Date: 202101; Test Name: CRP; Result Unstructured Data: Test Result:97
CDC Split Type: SEPFIZER INC2021048832

Write-up: Urinary tract infection; Acute circulatory failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. This is a report received from the Regulatory Authority. The regulatory authority report number is SE-Regulatory Authority-2021-000216. An 83-year-old male patient received the bnt162b2 (COMIRNATY), intramuscularly in Dec2020 at 0.3 mL, single for COVID-19 immunization. Medical history included hypertension, Parkinson''s disease, chronic obstructive pulmonary disease, diverticulosis, type 2 diabetes mellitus, arteriosclerotic heart disease, wheelchair user, catheter; all from an unknown date and unknown if ongoing. Concomitant medications included benserazide hydrochloride, levodopa (MADOPARK QUICK), sodium picosulfate (CILAXORAL), magnesium citrate; magnesium lactate (MANUFACTURER UNKNOWN), linagliptin (TRAJENTA), calcium carbonate, colecalciferol (KALCIPOS D) , paracetamol (ALVEDON), folic acid (FOLVIDON), salbutamol sulfate (BUVENTOL EASYHALER), cyanocobalamin (BETOLVIDON), lactulose (LAKTULOS MEDA) , colecalciferol (DIVIFARM), cinchocaine hydrochloride, prednisolone caproate (SCHERIPROCT [CINCHOCAINE HYDROCHLORIDE;PREDNISOLONE CAPROATE]), propylene glycol (PROPYLESS), glyceryl trinitrate (NITROLINGUAL), omeprazole (OMEPRAZOL SANDOZ [OMEPRAZOLE]) , furosemide (IMPUGAN [FUROSEMIDE]), bisoprolol fumarate (BISOPROLOL SANDOZ), budesonide, formoterol fumarate (BUFOMIX EASYHALER), ferrous sulfate (DUROFERON), tiotropium bromide (SPIRIVA RESPIMAT); all taken for an unspecified indication from an unspecified date to an unspecified date. The patient experienced: patient that died in infection 5 days after the vaccination (death, hospitalization, medically significant), urinary tract infection (death, hospitalization, medically significant), acute circulatory failure (death, hospitalization, medically significant); all in Jan2021. The patient was hospitalized for the events from Jan2021 to Jan2021. The clinical course was reported as follows: The physician reported regarding an 83-year-old male who was using a wheelchair and catheter; who was vaccinated with COMIRNATY (also reported as: TOZINAMERAN), COVID-19 mRNA Vaccine (nucleoside modified), which was given at a special housing for the elderly. The physician became somnolent the same afternoon and sent to the hospital. A urinary tract infection was diagnosed in the hospital. The patient did not have a fever; however, the patient''s C-reactive protein (CRP) was 97. The patient was treated with an intravenous antibiotic in the hospital. The patient was then sent to a special housing with the tablet amoxicillin/clavulanic acid BB. The patient slowly improved but died in his sleep five days after the vaccination. The cause of death was acute circulatory failure due to urinary tract infection in combination with the underlying diseases atherosclerotic heart disease and Parkinson''s disease. Therapeutic measures were taken as a result of urinary tract infection. The clinical outcome of the events was fatal. The patient died on an unspecified date in Jan2021 due to acute circulatory failure, urinary tract infection, atherosclerotic heart disease, and Parkinson''s disease. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: atherosclerotic heart disease; Parkinson''s disease; Acute circulatory failure; Urinary tract infection


VAERS ID: 971515 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-27
Onset:2021-01-01
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abnormal behaviour, Fatigue, Insomnia, Nausea, Sudden death, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   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: FOLVIDON; DUPHALAC [LACTULOSE]; KLYX; IMPUGAN [FUROSEMIDE]; KETOCONAZOLE; OXASCAND; LEVOCAR [CARBIDOPA;LEVODOPA]; PARACETAMOL; PROPYLESS; PROLIA; HYPOTRON; RESOLOR; CLOZAPINE; DIVISUN; NORSPAN [BUPRENORPHINE]; KALEORID; LAXOBERAL; PEVARYL [
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia Alzheimer''s type; Parkinson''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021048720

Write-up: tired; more awake; more changed behavior; Nausea; vomiting; Sudden Death; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB, Regulatory Authority number SE-MPA-2021-000219, other case identifier number SE-MPA-1610351260971. A 70-year-old male patient received bnt162b2 (COMIRNATY, COVID-19 mRNA Vaccine (nucleoside modified)), lot number: EJ6796, intramuscularly on 27Dec2020 at 0.3 mL, single for Covid-19 immunisation. Medical history included Parkinson and Alzheimers dementia. Concomitant medications included folic acid (FOLVIDON), lactulose (DUPHALAC), docusate sodium, sorbitol (KLYX), furosemide (IMPUGAN), ketoconazole, oxazepam (OXASCAND), carbidopa, levodopa (LEVOCAR), paracetamol, propylene glycol (PROPYLESS), denosumab (PROLIA), midodrine hydrochloride (HYPOTRON), prucalopride succinate (RESOLOR), clozapine, colecalciferol (DIVISUN), buprenorphine (NORSPAN), potassium chloride (KALEORID), sodium picosulfate (LAXOBERAL), econazole nitrate (PEVARYL), benserazide hydrochloride, levodopa (MADOPARK), cyanocobalamin (BETOLVEX). Reported adverse event was unexpected death (Sudden Death) approximately two weeks after vaccination in Jan2021. The patient was very tired after vaccination, difficult to contact. Thereafter more awake and more changed behavior. No deviating in status, no signs of infection. Did not want to take his medicines. Nausea and vomiting, patient found death soon thereafter. Prolia injection was given the day before patient died. It was not reported if an autopsy was performed. Outcome of events tired, more awake and more changed behavior, Nausea and vomiting was unknown. Report was assessed as serious, death. According to reporter "connection between death and COVID vaccine was considered dubios but patient has nevertheless shown clear reaction to the vaccine". No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden Death


VAERS ID: 971516 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ 6796 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   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: TRESIBA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cancer surgery ((PAST) OPERATION COLON CANCER); Colon cancer; Dementia; Diabetes
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021053903

Write-up: Death; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory authority-WEB (SE-MPA-2021-000221 & SE-MPA-1610360166435). An 85-year-old female patient received bnt162b2 (COMIRNATY; Lot number: EJ 6796), intramuscularly in Jan2021 at a single dose for COVID-19 immunization. Medical history included colon cancer, dementia, cancer surgery ((past) operation colon cancer), diabetes. Concomitant medication included insulin degludec (TRESIBA) taken from Jan2021 to an unspecified date. The patient experienced death in Jan2021. The patient had progressive dementia since the autumn of 2020 and had in recent times increasingly more swinging diabetes. The patient was estimated to be palliative the same day that the vaccine was given but was surprisingly alert which was the reason why the vaccine was given. The patient was vaccinated in Jan2021 and died peacefully four days later. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: death


VAERS ID: 971517 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   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: Artificial cardiac pacemaker user; Atrial fibrillation; Bedridden (last months); Cardiac failure; Dementia; Detached; General physical condition decreased (since last one year); Stroke; Unspecified anemia
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021048583

Write-up: Death; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB (SE-MPA-2021-000234 and SE-MPA-1610378265907). A 95-year-old male patient received BNT162B2 (COMIRNATY; Lot number: EJ6796), via an unspecified route of administration, in Jan2021 at a single dose for COVID-19 immunisation. Medical history included dementia, stroke, unspecified anemia, cardiac failure, artificial cardiac pacemaker user, atrial fibrillation, slowly impaired general condition (since last one year), bedridden (last months), and some days difficult to contact. The patient''s concomitant medications were not reported. The patient died in Jan2021 due to an unknown cause of death. The cause of death was not reported. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death


VAERS ID: 971520 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-01
Onset:2021-01-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 6795 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CIPROFLOXACIN; OMNILAX; CANODERM; HEMINEVRIN [CLOMETHIAZOLE EDISILATE]; ORUDIS; ALVEDON; BUPRENORPHINE SANDOZ [BUPRENORPHINE]; EBIXA; RISPERIDON SANDOZ; MIRTAZAPIN "2CARE4"
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bacteriuria; Dementia Alzheimer''s type
Allergies:
Diagnostic Lab Data: Test Name: ECG; Result Unstructured Data: Test Result:ST elevation; Test Name: urine test; Result Unstructured Data: Test Result:positive nitrate test
CDC Split Type: SEPFIZER INC2021054019

Write-up: Myocardial infarct; Cardiac arrest; This is a spontaneous report from a contactable physician downloaded from the Agency -WEB. Regulatory authority report number is SE-MPA-2021-000309. An 84-year-old female patient received BNT162B2 (COMIRNATY; Lot number 6795), intramuscular in Dec2020 as single dose for covid-19 immunization. Medical history included dementia Alzheimer''s type and bacteriuria from an unknown date and unknown if ongoing. Concomitant medication included ciprofloxacin (MANUFACTURER UNKNOWN) from Jan2021, macrogol (OMNILAX), urea (CANODERM), clomethiazole edisilate (HEMINEVRIN [CLOMETHIAZOLE EDISILATE]), ketoprofen (ORUDIS) , paracetamol (ALVEDON), buprenorphine (BUPRENORPHINE SANDOZ [BUPRENORPHINE]), memantine hydrochloride (EBIXA) from 2019, risperidone (RISPERIDON SANDOZ) from Oct2020, mirtazapine (MIRTAZAPIN "2CARE4"). The patient experienced myocardial infarct and cardiac arrest in Jan2021, which were serious as they lead to death. The patient underwent lab tests and procedures which included electrocardiogram which noted ST elevation and a urine test showed positive nitrate test, both on an unknown date. Details were as follows: the patient was vaccinated at the end of Dec2020. Five days after the vaccination, positive nitrate test of urine after completed Selexid treatment and ciprofloxacin was prescribed. Witnessed cardiac arrest seven days after vaccination. Therapeutic measures included an external cardiac massage on site, continued emergency measures in ambulances and in hospital. ECG showed ST elevation. The diagnosis in the hospital was cardiac arrest and acute myocardial infarction. The patient died in the emergency room after 34 minutes of cardiopulmonary resuscitation. The reporter indicated that the patient for one to two weeks before this, had increased fatigue and confusion but no obvious pain. The reporter states in the medical records that "time connection, but not something that makes causality probable."; Reported Cause(s) of Death: Cardiac arrest; Myocardial infarct


VAERS ID: 972049 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-24
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 UN / UN

Administered by: Senior Living       Purchased by: ?
Symptoms: Oculogyric crisis, Stereotypy
SMQs:, Neuroleptic malignant syndrome (broad), Dyskinesia (narrow), Dystonia (narrow), Ocular motility disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-25
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PANTOPRAZOL, ASS, Actrapid, Torasmid, Amlodipine, Benazepril; Hydrochlorothiazid; Protaphane
Current Illness: --
Preexisting Conditions: Diabetes, Hypertension, Apoplect.- Insult 2019
Allergies: --
Diagnostic Lab Data: i have a 90 seconds video section on demand.
CDC Split Type:

Write-up: 5 days after application of second dose, patient developed oculogyric crisis with oropharyngeal automatisms (schmatzautomatismen) i.e. parkinsonoid at 9:00 a.m and was seen by me the following day at 01:00 a.m. patient was delivered to neurology unit of ameos klinikum bernburg (section 14 for follow-up). at nursing home, no vaccination documents could be retrieved. any other immunization status unknown. pantoprazole seems not to be attributable. once-in-a-lifetime entity. I think the report is valid. Poor data at nursing home. There is ZERO vaccination documentation on-site. Only the Pfizer/Biontec vaccine is available at time of vaccination.


VAERS ID: 973080 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-01-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac disorder
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   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: Hearing loss (for years now); Heart disorder (almost a 40 year old issue, regulated and not causing any issues); Tremor of hands (for years now)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC2021063911

Write-up: 2 days after the first dose of vaccine he died in his sleep-doctor said it was his heart. But he didn''t have any symptoms or other health issues, it was sudden and very close to the vaccine; This is a spontaneous report from a contactable consumer. An 84-year-old male patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: UNKNOWN), via an unspecified route of administration on 07Jan2021 as a single dose for COVID-19 immunization. Ongoing medical history included chronic heart disease (almost 40-year-old issue-regulated and not causing any issues), small loss of hearing (for years), and hand tremor (for years). Other than that, the patient was perfectly mobile and healthy. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient''s concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. In Jan2021 (also reported as 23Jan2021), 2 days after getting the first dose of the vaccine he died in his sleep. The doctor said it was his heart but he didn''t have any symptoms or other health issues, it was sudden and very close to the vaccine. The reported cause of death was heart malfunction. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Heart malfunction


VAERS ID: 976293 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Weakness
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC2021062708

Write-up: death after COVID-19 vaccination in frail elderly people; This is a spontaneous report received from a contactable consumer from Regulatory Authority which was received in the frame of a HA request. Regulatory Authority number was not reported. This reporter reported same event for four patients. This is the first of four reports. An elderly patient of an unspecified gender received BNT162B2, via an unspecified route of administration from an unspecified date to an unspecified date at single dose for covid-19 immunisation. The patient medical history included ongoing frail. Concomitant medications were not reported. The patient experienced death after COVID-19 vaccination in frail elderly people in the age group between 84 and 92 years. The patient died on an unspecified date. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : CH-PFIZER INC-2021063064 Same reporter, drug, event, different patient.;CH-PFIZER INC-2021063062 Same reporter, drug, event, different patient.;CH-PFIZER INC-2021063063 Same reporter, drug, event, different patient.; Reported Cause(s) of Death: death after COVID-19 vaccination in frail elderly people


VAERS ID: 976294 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Frailty
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC2021063062

Write-up: death after COVID-19 vaccination in frail elderly people; This is a spontaneous report received from a contactable consumer from Regulatory Authority medic which was received in the frame of a HA request. Regulatory Authority number was not reported. This reporter reported similar events for four patients. This is the second of four reports. An elderly patient of an unspecified gender received BNT162B2, via an unspecified route of administration from an unspecified date to an unspecified date at single dose for COVID-19 immunization. The patient medical history included ongoing frail. Concomitant medications were not reported. The patient experienced death after COVID-19 vaccination in frail elderly people in the age group between 84 and 92 years. The patient died on an unspecified date. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : CH-PFIZER INC-2021062708 Same reporter, drug, event, different patient.; Reported Cause(s) of Death: death after COVID-19 vaccination in frail elderly people


VAERS ID: 976295 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Frailty
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC2021063063

Write-up: death after COVID-19 vaccination in frail elderly people in the age group between 84 and 92 years have been also reported; This is a spontaneous report received from a contactable consumer from the regulatory authority which was received in the frame of a request. Regulatory Authority number was not reported. This reporter reported similar events for four patients. This is the third of four reports. An elderly patient of an unspecified gender received BNT162B2, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history included ongoing frail. Concomitant medications were not reported. The patient experienced death after COVID-19 vaccination in frail elderly people in the age group between 84 and 92 years. The patient died on an unspecified date. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : CH-PFIZER INC-2021062708 Same reporter, drug, event, different patient.; Reported Cause(s) of Death: death after COVID-19 vaccinatio


VAERS ID: 976296 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Frailty
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC2021063064

Write-up: death after COVID-19 vaccination in frail elderly people; This is a spontaneous report received from a contactable consumer from the regulatory authority which was received in the frame of a request. Regulatory Authority number was not reported. This reporter reported same event for four patients. This is the fourth of four reports. An elderly patient of an unspecified gender received BNT162B2, via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history included ongoing frail. Concomitant medications were not reported. The patient experienced death after COVID-19 vaccination in frail elderly people in the age group between 84 and 92 years. The patient died on an unspecified date. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : CH-PFIZER INC-2021062708 Same reporter, drug, event, different patient.; Reported Cause(s) of Death: death after COVID-19 vaccination in frail elderly people


VAERS ID: 976301 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-29
Onset:2020-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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: 2021-01-07
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Oxygen therapy; Respiratory insufficiency
Allergies:
Diagnostic Lab Data: Test Date: 20201229; Test Name: COVID-19 test; Result Unstructured Data: Test Result:positive
CDC Split Type: DEPFIZER INC2021061184

Write-up: This is a spontaneous report from a physician via the Health Authority. This case is being treated according to the Authorities Protection against Infection Act. Fatal adverse event, ambulatory treatment was required. A contactable physician reported that an 82-year-old male patient received his first dose of bnt162b2 (COMIRNATY, batch/lot number and expiry date: Unknown), via an unspecified route of administration on 29Dec2020 at single dose for Covid-19 immunisation. Medical history included chronic respiratory insufficiency on oxygen concentration therapy. The patient''s concomitant medications were not reported. The patient received the vaccination on 29Dec2020 in the morning. In the afternoon, the COVID-19 test took place. This had a positive result (29Dec2020). His condition continued to deteriorate. He died in the nursing home on 07Jan2021. The cause of death was Acute respiratory insufficiency. There was a questionable connection with the COVID-vaccination. It was not reported if an autopsy was performed. No follow up attempts are possible. Information on the batch number cannot be obtained.; Reported Cause(s) of Death: acute respiratory failure


VAERS ID: 976303 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-29
Onset:2020-12-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Body temperature increased, COVID-19, Crepitations, Drug ineffective, Food refusal, General physical health deterioration, Heart rate, Oxygen saturation, Oxygen saturation decreased, Pneumonia, SARS-CoV-2 test, Tachycardia
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-07
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Apoplexy; Bedridden; Cardiac insufficiency; Renal insufficiency; Vascular dementia
Allergies:
Diagnostic Lab Data: Test Date: 20210106; Test Name: Body temperature; Result Unstructured Data: Test Result:37.9 Centigrade; Test Date: 20210106; Test Name: Heart rate; Result Unstructured Data: Test Result:123 / min; Test Date: 20210106; Test Name: Heart rate; Result Unstructured Data: Test Result:in later measurements 102 -106 / min; Test Date: 20210106; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:76-86 %; Test Date: 20210107; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:74-78 %; Comments: dropped; Test Name: post-mortem smear test of SARS-CoV-2; Test Result: Positive ; Comments: Ct value 31
CDC Split Type: DEPFIZER INC2021061562

Write-up: Positive post-mortem smear test of SARS-CoV-2 (Ct value: 31); Positive post-mortem smear test of SARS-CoV-2 (Ct value: 31); crackles; suspicion of pneumonia; body temperature up to 37.9 centigrade; tachycardia (up to 123 /min); oxygen saturation was on 06Jan2021 at 76-80%; food refusal; general condition deteriorated; This is a spontaneous report from a contactable physician. An 83-year-old female patient received first dose of bnt162b2 (COMIRNATY, batch/lot number: EJ6796), via an unspecified route of administration on 29Dec2020 at single dose for covid-19 immunisation. The patient''s concomitant medications were not reported. Patient was a largely bedridden lady, resident of a nursing home with medical history of vascular dementia, renal insufficiency, cardiac insufficiency, and state after apoplexy in Apr2019. Vaccination performed on 29Dec2020. At the time there were already Covid-19 cases in the house, but not in the immediate living area. From 30Dec2020 the general condition deteriorated, she refused to eat more and more and indicated that she wanted to be left alone. On 06Jan2021 she developed body temperature up to 37.9 centigrade and tachycardia up to 123 / min (in later measurements 102-106 / min), the oxygen saturation was on 06Jan2021 at 76-80%. A hospitalization was waived after consultation with the relatives due to the presumed wishes of the patient. On 07Jan2021 patient developed crackles, the saturation dropped to 74-78% and she died at 8:48 a.m. It was suspicion of vaccination reactions. Diagnosis were food refusal from 30Dec2020 to end, and tachycardia and temperature increase, suspicion of pneumonia from 06Jan2021 to end. Diagnosis / suspected diagnosis was supported by the following investigations: positive post-mortem smear test of SARS-CoV-2 (Ct value: 31). Outcome of events general condition deteriorated and crackles was unknown, outcome of other events was fatal. The mentioned vaccines had not been used again after the symptoms subsided. The symptoms of a suspected vaccination complication didn''t recur in patients without a temporal connection. Life-threatening adverse events, ambulatory treatment required, hospitalization refused. The patient died on 07Jan2021. An autopsy was performed. Reported cause of death was positive post-mortem smear test of SARS-CoV-2 (Ct value: 31), suspicion of pneumonia, body temperature up to 37.9 centigrade, tachycardia (up to 123 /min), oxygen saturation was on 06Jan2021 at 76-80% and food refusal.; Sender''s Comments: There is not a reasonable possibility that reported events are related to BNT162B2. Symptoms started 1 day after vaccination. It''s likely that all reported symptoms are due to COVID-19. And it''s reported at the time of vaccination, there were already COVID-19 cases in the house patient lived. Therefore, all reported events are more likely intercurrent medical conditions. The elderly patient''s underlying diseases may also be contributory. 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: body temperature up to 37.9 centigrade; suspicion of pneumonia; tachycardia (up to 123 /min); food refusal; Positive post-mortem smear test of SARS-CoV-2 (Ct value: 31); Positive post-mortem smear test of SARS-CoV-2 (Ct value: 31); oxygen saturation ; Autopsy-determined Cause(s) of Death: Positive post-mortem smear test of SARS-CoV-2 (Ct value: 31); Positive post-mortem smear test of SARS-CoV-2 (Ct value: 31)


VAERS ID: 976305 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-29
Onset:2020-12-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Body temperature, COVID-19 pneumonia, Cardiac failure, Chest X-ray, Drug ineffective, Heart rate, Laboratory test, Oxygen saturation, SARS-CoV-2 test, Tachyarrhythmia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Lack of efficacy/effect (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-04
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension; Atrial fibrillation; Cardiac insufficiency; Dementia; Living in nursing home
Preexisting Conditions: Medical History/Concurrent Conditions: Bladder cancer (underwent surgery)
Allergies:
Diagnostic Lab Data: Test Date: 20201230; Test Name: body temperature; Result Unstructured Data: Test Result:37.4 Centigrade; Test Date: 20201231; Test Name: body temperature; Result Unstructured Data: Test Result:39.2 Centigrade; Test Name: chest X-ray; Result Unstructured Data: Test Result:diagnosis confirmed; Test Date: 20201231; Test Name: heart rate; Result Unstructured Data: Test Result:140; Test Name: lab test; Result Unstructured Data: Test Result:diagnosis confirmed; Test Name: oxygen saturation; Test Result: 87 %; Test Date: 20201230; Test Name: SARS CoV 2 PCR test; Test Result: Positive ; Test Date: 20201229; Test Name: SARS CoV 2 rapid test; Test Result: Negative
CDC Split Type: DEPFIZER INC2021061657

Write-up: cardiac decompensation with tachyarrhythmia; cardiac decompensation with tachyarrhythmia; acute on chronic renal failure; COVID pneumonia; COVID pneumonia; This is a spontaneous report from a contactable physician and a other healthcare professional (HCP). An 89-year-old male patient received first dose of BNT162B2 (COMIRNATY, lot number: EJ6796), via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunization. The relevant medical history included ongoing arterial hypertension, ongoing cardiac insufficiency, ongoing atrial fibrillation, bladder cancer (underwent surgery), ongoing dementia and ongoing living in nursing home. Concomitant medications were not reported. On day of vaccination a rapid test for SARS-CoV 2 was negative, but there were already cases in the nursing home. The next day the patient developed runny nose and temperature up to 37.4 degrees, a PCR test was positive. On 31Dec2020 he had fever of 39.2 degrees and a heart rate of 140. He was hospitalized on 31Dec2020. The oxygen saturation was 87%. The patient experienced cardiac decompensation with tachyarrhythmia and acute on chronic renal failure with onset date 31Dec2020. Symptoms were reported as fever, cough, respiratory insufficiency. Diagnosis was confirmed by lab tests and chest X-ray. Despite of treatment with antibiotics, oxygen, Remdesivir and dexamethasone the patient died due to cardiac decompensation on 04Jan2021. It was unknown if vaccination complications occurred after previous vaccinations. The outcome of the event cardiac decompensation was fatal, while other events were unknown.; Sender''s Comments: The 89-year-old patient had relevant medical history included ongoing arterial hypertension, cardiac insufficiency, atrial fibrillation, bladder cancer (underwent surgery), dementia and living in nursing home. He received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 29Dec2020, and COVID-19 test positive on 30Dec2020. No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the positive COVID likely represents a pre-existing infection prior to vaccine use. Diagnosis of COVID-19 pneumonia was confirmed by lab tests and chest X-ray. The fatal cardiac decompensation was likely triggered by the COVID infection, and all events including tachyarrhythmia and acute on chronic renal failure were unlikely causally related to the first dose of BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: cardiac decompensation


VAERS ID: 976306 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-29
Onset:2020-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Multimorbidity, SARS-CoV-2 test
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: 2021-01-02
   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: Multimorbidity
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20201229; Test Name: SARS-CoV-2 test PCR; Test Result: Positive
CDC Split Type: DEPFIZER INC2021061739

Write-up: The patient passed away on 02Jan2021 as a result of her multiple diseases and a very long life; SARS-CoV-2 test PCR positive/death in relation to Covid-19 vaccination; SARS-CoV-2 test PCR positive; This is a spontaneous report from a contactable physician received via Regional Authority for Health and Social Matters and LLP-Biontech. An 87-year-old female patient received her first dose bnt162b2 (COMIRNATY), via an unspecified route of administration on 29Dec2020 10:00 at single dose for COVID-19 immunisation. Vaccine has not been re-administered. Medical history included ongoing multimorbidity. The patient''s concomitant medications were not reported. She has been tested for Corona before (positive) but did not develop any symptom. Afterwards was reported that the patient has been vaccinated against Corona on 29Dec2020 around 10:00 by the vaccination team. Around 14:00 of the same day SARS-CoV-2 test PCR positive four hours after vaccination. The patient passed away on 02Jan2021 as a result of her multiple diseases and a very long life. death in relation to Covid-19 vaccination: Vaccination - test - death - there was a temporal relation. The symptoms recurred without temporal relation to the vaccination. About the causality can only be speculated.It was unknown if an autopsy was performed.The outcome of event SARS-CoV-2 test PCR positive/death in relation to Covid-19 vaccination was unknown. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: passed away on 02Jan2021 as a result of her multiple diseases and a very long life


VAERS ID: 976359 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-19
Onset:2020-12-01
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ0553 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Agitation, COVID-19, COVID-19 pneumonia, Chest X-ray, Cough, Drug ineffective, Dyspnoea, Fall, Investigation, Oxygen saturation, SARS-CoV-2 test, Viral test
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-25
   Days after onset: 24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ASPIRIN [ACETYLSALICYLIC ACID]; ATORVASTATIN; FERROUS FUMARATE; MEMANTINE; MIRTAZAPINE; OMEPRAZOLE; OXYTETRACYCLINE; RAMIPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia; Coronary artery disease; Dementia; Depression; Gastritis erosive; Head injury; Osteoarthritis; Rosacea; Comments: Patient has not had symptoms associated with COVID-19 Patient has not been tested/or has had an inconclusive test for COVID-19. Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20201223; Test Name: Chest X-ray; Result Unstructured Data: Test Result:reported that whilst appearances are most likely t; Comments: reported that whilst appearances are most likely to reflect oedema, acute respiratory distress syndrome (ARDS) and atypical infection cannot be excluded; Test Date: 20201223; Test Name: examination; Result Unstructured Data: Test Result:bilateral crepitus; Comments: No focal neurological deficit was found on examination, 4 limbs power 5/5; Test Date: 20201223; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:low; Test Date: 20201223; Test Name: COVID-19 PCR test; Test Result: Positive ; Test Date: 20201223; Test Name: swabs; Result Unstructured Data: Test Result:confirmed COVID infection
CDC Split Type: GBPFIZER INC2021059619

Write-up: swabs confirmed COVID infection; swabs confirmed COVID infection; Dyspnoea; cough; Fall; Agitation; COVID-19 pneumonia; This is a spontaneous report received from a contactable physician by Pfizer from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-20201231160257, Safety Report Unique Identifier GB-MHRA-ADR 24549450. A 90-year-old male patient received his first BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) Lot # EJ0553, via an unspecified route of administration on 19Dec2020 at single dose for covid-19 immunisation. Medical history included Coronary artery disease, dementia, osteoarthritis, head injury all from an unknown date and unknown if ongoing, additional medical history included Anaemia, Depression, Gastritis erosive and Rosacea. Concomitant medication included aspirin [acetylsalicylic acid] for Coronary artery disease, atorvastatin for Coronary artery disease, ferrous fumarate for Anaemia, memantine for Dementia, mirtazapine for Depression, omeprazole for Gastritis erosive, oxytetracycline for Rosacea, ramipril for Coronary artery disease. Patient has not had symptoms associated with COVID-19. Patient has not been tested/or has had an inconclusive test for COVID-19. Patient was not enrolled in clinical trial. Patient received COVID-19 (Coronavirus disease 2019) vaccination on 19Dec2020. Subsequently he had a fall on 23Dec2020. He was attended to by the paramedics at home who also noted that he had a cough and breathlessness. He was taken to hospital and swabs confirmed COVID infection on 23Dec2020. COVID-19 PCR test positive. He was admitted on 23Dec2020, although his condition deteriorated and he died on 25Dec2020. He had his first COVID immunisation on 19Dec2020, he had no preceding symptoms at this time. He subsequently had a fall on 23Dec2020 and was noted to be chesty/dyspnoeic by the paramedics and was taken to hospital, where he was admitted. His condition continued to deteriorate, the discharge summary states; ''presented with fall with head injury, shortness of breath (SOB) and cough, low O2 saturations. Tested positive for COVID-19. On examination he had bilateral crepitus. No focal neurological deficit was found on examination, 4 limbs power 5/5/. Patient rapidly deteriorated and required 15L O2. His chest x-ray reported that whilst appearances are most likely to reflect oedema, acute respiratory distress syndrome (ARDS) and atypical infection cannot be excluded. Clinically impression was that patient desaturated due to COVID pneumonia in Dec2020. Patient appeared very agitated in Dec2020 on medical review. As patient was very unwell, NOK was contacted - daughter who has Power Of Attorney (POA) was informed of patient''s poor prognosis and that he was unlikely to survive the illness. Next of kin (NOK) was aware of do-not-attempt-rescuscitation (DNAR) and that patient was forward based care. It was agreed that a trial of treatment would be continued. He was treated with antibiotics and dexamethasone. He unfortunately did not improve with treatment and passed away on 25Dec2020. A postmortem has not been performed. The certified cause of death was unknown at this point in time. The outcome of COVID-19 pneumonia was fatal and for all other events was not resolved. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: COVID-19 pneumonia


VAERS ID: 976481 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-09
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Death, Gastritis, SARS-CoV-2 test, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Acute pancreatitis (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), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-16
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210115; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021061766

Write-up: AKI; gastritis; unknown cause of death; Vomiting; This is a spontaneous report received from a contactable physician by Pfizer from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202101161909277840, Safety Report Unique Identifier GB-MHRA-ADR 24611872. An 87-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. This patient had Pfizer injection on Wednesday on 06Jan2021. The patient started vomiting on Saturday on 09Jan2021. He was admitted for AKI (Acute kidney injury) and gastritis on an unspecified date. Unfortunately kept deteriorating. The patient died due to unknown cause of death on 16Jan2021. The autopsy was unknown. The patient underwent lab test included COVID-19 virus test which showed No - Negative COVID-19 test on 15Jan2021. The outcome of the event unknown cause of death was fatal, while other events were not recovered. No follow up attempts are possible; information about batch number cannot be obtained.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 976485 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-08
Onset:2021-01-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Circulatory collapse, Dyspnoea, Myocardial infarction
SMQs:, Anaphylactic reaction (narrow), Myocardial infarction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-12
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Difficulty in walking; Feeling unwell (He felt unwell but could not identify a particular symptom); Ischaemic heart disease; Memory impairment (undiagnosed memory problems so agitation before events outside the home was not uncommon); Pallor (His pallor was grey); Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021051993

Write-up: Heart attack; Circulatory collapse; Breathlessness; This is a spontaneous report received from the MHRA. Regulatory authority report number is GB-MHRA-WEBCOVID-202101181221580420, Safety Report Unique Identifier is GB-MHRA-ADR 24608758. A contactable consumer reported that a 90-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date were unknown), via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 vaccination. Medical history included myocardial ischaemia, pallor from 08Jan2020 (reported that his pallor was grey), malaise from 08Jan2020 (he felt unwell but could not identify a particular symptom), memory impairment (undiagnosed memory problems so agitation before events outside the home was not uncommon), and gait disturbance. Patient had no symptoms associated with COVID-19. He had no COVID-19 test. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. On patient''s immediate return from the vaccination he appeared to be fine. However, the patient started to experience breathlessness 24 hours after vaccination (09Jan2021). This worsened over the following 2 days. He collapsed at home on the 12Jan2021 and died. Paramedics attended, and the coroner and GP determined a heart attack as the cause of death. He did not seek any medical attention over this time period. Coroner was involved but determined a post-mortem was not necessary. Patient has not tested positive for COVID-19 since having the vaccine. Outcome of circulatory prolapse was unknown, while not recovered from breathlessness. The patient died on 12Jan2021. An autopsy was not performed. No follow-up attempts are possible; information regarding batch/lot cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Myocardial infarction


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