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From the 9/10/2021 release of VAERS data:

Found 14,925 cases where Vaccine is COVID19 and Patient Died



Case Details

This is page 87 out of 150

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VAERS ID: 1137187 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-16
Onset:2021-02-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042698 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Gastrointestinal haemorrhage, Haematemesis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (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: No adverse event (No reported medical history)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20210

Write-up: Gastrointestinal bleeding; Coffee ground emesis; A regulatory authority report was received from a physician concerning a 82-year-old female patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced coffee ground emesis/haematemesis and gastrointestinal bleeding/gastrointestinal haemorrhage and died. The patient''s medical history was not provided. Concomitant product use was not provided. On 16 Feb 2021, prior to the onset of events , the patient received a dose of mRNA-1273(Lot/batch:300042698) for prophylaxis of COVID-19 infection. On 17 Feb 2021, the patient experienced coffee ground emesis and gastrointestinal bleeding. Treatment information were not provided. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on an unspecified date. The events of gastrointestinal bleeding and coffee ground emesis were considered fatal. Plans for an autopsy was not provided.; Reporter''s Comments: Very limited information regarding these events have been provided at this time. No further follow up information is expected.; Reported Cause(s) of Death: gastrointestinal bleeding; coffee ground emesis


VAERS ID: 1137667 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-12
Onset:2021-02-16
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-03-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA INCONNU / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-16
   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: INLYTA; KEYTRUDA
Current Illness: Kidney cancer
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20210

Write-up: Sudden death; A Regulatory authority report was received from a physician concerning a 76-year-old, male patient, who received Moderna''s COVID-19 vaccine (mRNA-1273) and died. The patient''s medical history, as provided by the reporter, included kidney cancer. Other suspected medications included axitinib and pembrolizumab for kidney cancer. No relevant concomitant medications were reported. On 15 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: INCONNU ) intramuscularly for prophylaxis of COVID-19 infection. On 16 Feb 2021 the patient died. Cause of death is unknown. Autopsy report was unknown. Treatment for the event was unknown. Action taken with mRNA-1273 in response to the event was not applicable. The outcome of the event death was considered fatal on 16 Feb 2021.; Reporter''s Comments: Very limited information regarding the event of sudden death has been provided at this time. However, patient''s underlying malignancy may have been contributory. Concurrent medications axitinib and pembrolizumab were considered suspect. No further information has been requested.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1140477 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-15
Submitted: 0000-00-00
Entered: 2021-03-28
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: 2021-03-15
   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: THYROXINE; ALLOPURINOL; FERROUS SULFATE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021320783

Write-up: Adverse event following immunisation; This is a spontaneous report.. Regulatory authority report number is 523387. A contactable other health professional reported that an 88-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications included levothyroxine sodium (THYROXINE), allopurinol, ferrous sulfate. The patient experienced Adverse event following immunization on 15Mar2021. The outcome of the event was fatal. It was unknown if autopsy was done. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Adverse event following immunisation


VAERS ID: 1140478 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-13
Submitted: 0000-00-00
Entered: 2021-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021320785

Write-up: Pneumonia viral; This is a spontaneous report from a contactable other hcp. This is a report received from the Regulatory Authority. Regulatory authority report number 524247. A male patient of an unspecified age (reported as 96, unknown unit) received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced pneumonia viral on 13Mar2021, which resulted in death. The patient died on an unspecified date. It was not reported if an autopsy was performed. Information about lot/batch number cannot be obtained. No further information expected. ; Reported Cause(s) of Death: Pneumonia viral


VAERS ID: 1140479 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-15
Submitted: 0000-00-00
Entered: 2021-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021320906

Write-up: Malaise; This is a spontaneous report from a contactable other health professional received from a regulatory authority. Regulatory authority report number is 524473. A male patient of an unspecified age (reported as 91 unknown units) received BNT162B2 (COMIRNATY; batch/lot number was not reported) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Three days, the patient experienced malaise (with seriousness criteria of death) on 15Mar2021. The patient died on an unspecified date. It was not reported if an autopsy was performed. Follow up attempts not needed, information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Malaise


VAERS ID: 1140488 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-09
Onset:2021-03-13
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC2021310208

Write-up: sudden death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (CZ-CZSUKL-21002651). An 86-year-old female patient received the second dose of BNT162B2 (COMIRNATY; lot number: ET1831), via intramuscular route of administration on 09Mar2021 (at the age of 86 years, as reported) at 0.3 mL, single for COVID-19 immunization. The patient''s medical history was not reported. There were no concomitant medications. The patient previously took the first dose of COMIRNATY on an unspecified date for COVID-19 immunization. The patient had no reaction but had sudden death on 13Mar2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: sudden death


VAERS ID: 1140489 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-11
Onset:2021-03-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PANTOMYL; HUMULIN M3; ANOPYRIN; FURORESE [FUROSEMIDE]; METAMIZOLE SODIUM MONOHYDRATE; DETRALEX; LAGOSA; SORTIS; RIVOTRIL; VEROSPIRON
Current Illness: Carcinoma of liver; Chronic venous insufficiency; Diabetes mellitus (treated with insulin therapy); Hypertension; Multimorbidity
Preexisting Conditions: Medical History/Concurrent Conditions: Pain; Subdural haematoma (after fall)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC2021310236

Write-up: sudden death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB (CZ-CZSUKL-21002685). A 73-year-old male patient received the first dose of BNT162B2 (COMIRNATY; lot number: ET3620), via intramuscular route of administration on 11Mar2021 (at the age of 73 years, as reported) at a single dose for COVID-19 immunization. Medical history included ongoing hypertension, ongoing diabetes mellitus treated with insulin therapy, ongoing carcinoma of liver, subdural haematoma from Sep2020 to an unknown date (not ongoing) after fall, ongoing chronic venous insufficiency, ongoing multimorbidity, and pain. Concomitant medications included pantoprazole sodium sesquihydrate (PANTOMYL; strength: 40 mg); insulin human, insulin human injection, isophane (HUMULIN M3); acetylsalicylic acid (ANOPYRIN; strength: 100 mg); furosemide (FURORESE [FUROSEMIDE]; strength: 125 mg); metamizole sodium monohydrate (strength: 500 mg) taken for pain; diosmin, hesperidin (DETRALEX); silybum marianum (LAGOSA; strength: 150 mg); atorvastatin calcium (SORTIS; strength: 40 mg); clonazepam (RIVOTRIL); spironolactone (VEROSPIRON; strength: 50 mg). On 12Mar2021, the patient experienced a sudden death in the night at home. An autopsy was not performed. The reporter is unable to assess the causality between death and vaccination. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: sudden death


VAERS ID: 1140491 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Bronchitis, Hypertension, Oral fungal infection, Oxygen saturation, Pneumonia, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal infections (narrow), Hypertension (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-09
   Days after onset: 39
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DEKRISTOL; RIVASTIGMINE; TORASEMID; LEVODOPA-CARBIDOPA; XARELTO; MACROGOL; QUETIAPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia; Atrial fibrillation paroxysmal; Benign prostatic hyperplasia; Biliary stones; Dementia; Goiter; Hypertension; Osteoporosis; Parkinson''s disease; Polyneuropathy; Splenomegaly
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:190/110 mmHg; Test Name: oxygen saturation; Test Result: 97 %
CDC Split Type: DEPFIZER INC2021311612

Write-up: Pneumonia; Fever; Hypertension; oral mycosis; Bronchitis; This is a spontaneous report from a non-contactable physician downloaded from regulatory authorty. Regulatory authority number DE-DCGMA-21188443. This report was forwarded via regulatory authority (PEI), however no regulatory authority number was provided. A 79-year-old male patient received bnt162b2 (COMIRNATY) via an unspecified route of administration on 13Jan2021 (Lot Number: Unknown) as single dose for covid-19 immunization at age 79 years old. Medical history included dementia, parkinson''s disease, atrial fibrillation paroxysmal, goiter, biliary stones, splenomegaly, osteoporosis, benign prostatic hyperplasia, anaemia, hypertension, polyneuropathy, all from unknown dates and unknown if ongoing. Concomitant medications included colecalciferol (DEKRISTOL); rivastigmine; torasemide (TORASEMID); carbidopa, levodopa; rivaroxaban (XARELTO); macrogol; quetiapine; all taken for unspecified indications, start and stop date were not reported. On an unspecified date in Jan2021, the patient experienced fever, hypertension, bronchitis, and oral mycosis. On 08Feb2021, the patient experienced pneumonia. The events were reported as serious (fatal). Clinical course was reported as follows. Twelve days after vaccination the patient developed bronchitis and mycosis and hypertension and pneumonia and fever, lasting for unknown. The patient died on 08Feb2021. Unknown if autopsy was done. Death cause was reported as pneumonia. Outcome of the events was fatal. Reporter Comment: By himself, a lively Parkinson''s retirement home patient developed a fever 12 days after Covid vaccination, initially with oral mycosis Ther. with moronal suspension, then 4 days later for bronchitis prescription of azithromycin, 1 day later recurrence of resolved hypertension (RR 190/110 mmHg), PO2 97%, re-prescription of ramipril and metoprolol; subsequently increasing physical decline, died on 08Feb2021 prefinally with the diagnosis of pneumonia, 09Feb2021. Causality assessment for all events according to PEI: Inconsistent causal association. No follow-up attempts are possible, information about batch number cannot be obtained.; Reporter''s Comments: By himself, a lively Parkinson''s retirement home patient developed a fever 12 days after Covid vaccination, initially with oral mycosis Ther. with moronal suspension, then 4 days later for bronchitis prescription of azithromycin, 1 day later recurrence of resolved hypertension (RR 190/110 mmHg), PO2 97%, re-prescription of ramipril and metoprolol; subsequently increasing physical decline, died on 08Feb2021 prefinally with the diagnosis of pneumonia, 09Feb2021.; Reported Cause(s) of Death: bronchitis; Pneumonia; fever; hypertension; oral mycosis


VAERS ID: 1140492 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-06
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   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: Cardiac failure; COPD; Peripheral arterial occlusive disease; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Hyperkalemia; Non-Hodgkin''s lymphoma; Renal insufficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021311583

Write-up: Found dead; This is a spontaneous report from a non-contactable physician downloaded from a regulatory authority-WEB DE-DCGMA-21188508. This report was forwarded via RA, however no RA number was provided. An 82-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration at the age of 82-years-old on 06Mar2021 (Lot Number: EP2163) as single dose for COVID-19 immunization. Medical history included non-Hodgkin''s lymphoma from an unknown date and not ongoing, ongoing type 2 diabetes mellitus, ongoing chronic obstructive pulmonary disease, ongoing cardiac failure, ongoing peripheral arterial occlusive disease. On 05Mar2021 presentation to the nephrologist due to Renal insufficiency and hyperkalemia (according to relatives). Current laboratory values were not available. In the days before the vaccination, according to relatives, in good general condition. The patient''s concomitant medications were not reported. Three (3) days after vaccination (as reported) the patient was found dead, lasting for unknown. The patient is dead. The patient died on Mar2021. It was not reported if an autopsy was performed. Reporters comment: ADR course: vaccination on 06Mar2021. Found dead in the apartment on 08Mar2021. Unclear when exactly died. Last contact with relatives on 06Mar2021. Classified as an unexplained cause of death and notified the [PRIVACY] Criminal Police. Deceased seen as part of the medical on-call service. No follow-up attempts possible. No further information expected.; Reporter''s Comments: ADR course: vaccination on 06Mar2021. Found dead in the apartment on 08Mar2021. Unclear when exactly died. Last contact with relatives on 06Mar2021. Classified as an unexplained cause of death and notified the [PRIVACY] Criminal Police. Deceased seen as part of the medical on-call service.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1140536 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-02-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-11
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: histology; Result Unstructured Data: Test Result:no results provided
CDC Split Type: DEPFIZER INC2021311556

Write-up: Cerebral parenchymal hemorrhage; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority [DE-PEI-PEI2021003496]. A 69-year-old male patient received the first dose of bnt162b2 (COMIRNATY) via an unspecified route of administration on 05Feb2021 (Lot Number: Unknown) as single dose for covid-19 immunisation at age 69 years old. The patient''s medical history and concomitant medications were not reported. The patient experienced cerebral parenchymal hemorrhage on 06Feb2021. The event was reported as serious (fatal). Clinical course was reported as follows. On 06Feb2021, after vaccination the patient developed haemorrhage intracerebral, lasting for unknown. The patient died on 11Feb2021. Autopsy was done however results are not available. Further information awaited. Outcome of the event was fatal. Reporters comment: Autopsy as part of request - macroscopic and histological confirmation. No follow-up attempts possible, batch/lot number cannot be obtained. No further information expected; Reporter''s Comments: Autopsy as part of request - macroscopic and histological confirmation; Reported Cause(s) of Death: Cerebral parenchymal hemorrhage


VAERS ID: 1140538 (history)  
Form: Version 2.0  
Age: 97.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-15
Onset:2021-03-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Hypertension
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Hypertension (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: Palliative care
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021311663

Write-up: Intracerebral mass hemorrhage; Hypertensive; This is a spontaneous report from a non-contactable physician downloaded from the -WEB DE-PEI-PEI2021003570. This is a report received from the Regulatory Authority. A 97-year-old female patient received the first dose of bnt162b2 (COMIRNATY; batch/lot number and expiration date unknown), intramuscular on 15Mar2021 at a single dose for covid-19 immunisation. Medical history included hypertension and ongoing palliative situation. The patient''s concomitant medications were not reported. The patient experienced intracerebral mass hemorrhage and hypertensive on 16Mar2021. On 16Mar2021 after vaccination, the patient developed haemorrhage intracerebral and hypertensive. The patient is dead. The patient died on an unspecified date. It was unknown if an autopsy was performed. The attending physician assessed Comirnaty and all the events as having inconsistent causal association. No follow-up attempts are possible, information about lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Intracerebral mass hemorrhage; Hypertensive


VAERS ID: 1140539 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-12
Onset:2021-03-15
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021317744

Write-up: Death; This is a spontaneous report received from a non-contactable physician downloaded from the DE-PEI-PEI2021003601. This is a report received from the Regulatory Authority An 85-years-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 12Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient previously took the first dose bnt162b2 on 19Feb2021for covid-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced death on 15Mar2021. It was not reported if an autopsy was performed. No Follow-Up attempts are possible, information about batch number cannot be obtained.; Reported Cause(s) of Death: Death


VAERS ID: 1140540 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-13
Onset:2021-02-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Blood culture, Pneumonia, Sepsis, Staphylococcal sepsis
SMQs:, Interstitial lung disease (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-27
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood culture; Result Unstructured Data: Test Result:positive Staph. aureus
CDC Split Type: DEPFIZER INC2021317268

Write-up: Acute respiratory distress syndrome; Pneumonia; Sepsis; Staphylococcal sepsis; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB DE-PEI-PEI2021003605. This is a report received from the Regulatory Authority An 85-years-old female patient received second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 13Feb2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 14Feb2021 after vaccination the patient developed Pneumonia and Sepsis and ARDS. The patient is dead. Diagnosis was confirmed by Blood culture (result: positiv/positive, unit: Staph. aureus). The patient was treated with manual: therapy, e.g. antiphlogistic drugs. The patient died on 27Feb2021. An autopsy was not performed. Death cause was reported as Staphylococcal sepsis. Event assessment provided was Comirnaty for all events / Regulatory Authority/ B. Indeterminate. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Acute respiratory distress syndrome; Pneumonia; Sepsis; Staphylococcal sepsis


VAERS ID: 1140541 (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: 2021-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac disorder (in the past decades, but currently in good health at the time of vaccination)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021311105

Write-up: Mild stroke / another severe stroke which caused a thalamus infarction and Basilaris occlusion; another severe stroke which caused a thalamus infarction and Basilaris occlusion; another severe stroke which caused a thalamus infarction and Basilaris occlusion; This is a spontaneous report from a contactable consumer. This is a report based on information received by Pfizer a regulatory authority for COMIRNATY. An 87-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) solution for injection, via an unspecified route of administration in Jan2021 (Batch/Lot number was not reported) as a single dose for Covid-19 immunisation. Medical history included cardiac problems in the past decades, but currently in good health at the time of vaccination. The patient''s concomitant medications were not reported. The patient had a mild stroke at the end of Jan2021 two days after his vaccination, admitted himself to the hospital and a few days later died on the stroke unit of another severe stroke which caused a thalamus infarction and Basilaris occlusion. In the past decades, he had had some cardiac problems, however, he had been in good health prior to the vaccination and had not been on any blood thinners, which could have caused any problems, as far as the reporter had known. Since the patient had been fit for his 87 years, the reporter thought this case should be reported and maybe a consultation with his treating physicians at the hospital should take place. The patient was hospitalized due to the events. Outcome of the events was fatal. The patient died on an unspecified date in 2021 due to severe stroke, thalamus infarction, and Basilaris occlusion. It was not reported if an autopsy was performed. Information about lot/batch number has been requested.; Reported Cause(s) of Death: Mild stroke / another severe stroke which caused a thalamus infarction and Basilaris occlusion; another severe stroke which caused a thalamus infarction and Basilaris occlusion; another severe stroke which caused a thalamus infarction and Basilaris o


VAERS ID: 1140544 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-07
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac disorder, 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: 2021-03-07
   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: MESTINON; COROPRES [CANDESARTAN CILEXETIL]; SIMVASTATIN; OMEPRAZOLE; RAMIPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cataracts; Chronic kidney disease; Dyslipidaemia; Hypertension (HBP); Obesity ((BMI$g=30)); Ocular myasthenia; Type II diabetes mellitus (Type II diabetes)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021311640

Write-up: Sudden death; Sudden death with a basic cause of cardiopathy; This is a spontaneous report received from a contactable physician, downloaded from the Regulatory Authority (RA) ES-AEMPS-790867. An 86-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in arm left on 04Mar2021 (Batch/Lot Number: ET1831) as a single dose for COVID-19 immunization. Medical history included type II diabetes, dyslipidemia, obesity (BMI$g=30), chronic kidney disease, hypertension (HBP), ocular myasthenia from Dec2019, cataracts in both eyes. Patient under follow-up in neurology consultations due to a chronic course (since Dec2019) and slowly progressive worsening of established left ptosis, presents self-limited episodes of worsening (although without predominance in the evening), as well as self-limited episodes of binocular and horizontal diplopia, without clear hourly predominance or data suggestive of fatigability. No symptoms suggestive of proximal or distal bulbar, axial, or appendicular weakness. Blood tests were performed in Aug2020 showing positivity of antibodies against Acetylcholine Receptor 4.98 nmol / L [= 0.70] and cranial MRI and angioMRI in Sep2020 without alterations. EMG/ENG has also been performed and with the diagnosis of ocular myasthenia, MESTINON 60 mg half a tablet every 8 hours was started at that consultation in January. She reported good tolerance to the drug (no gastrointestinal symptoms or hypotension) and since the beginning of treatment, she refers to an improvement in ptosis (both she and her relatives have noted it), as well as complete resolution of binocular diplopia episodes. Clinical judgment: Established ptosis in the left eye and fluctuating binocular diplopia in relation to ocular myasthenia with positive anti-AchR antibodies. Plan: Maintain the same dose of MESTINON 60 mg half a tablet every 8 hours. Patient requested a chest CT to rule out alterations in the thymus. Maintained follow-up in the neurology. Neuromuscular consultation (appointment on 05Mar2021 at 11am): if will associate new neurological symptoms such as dysphagia, respiratory distress, asked to go to the emergency department. Main diagnosis: Ocular myasthenia with positive anti-AchR antibodies. Concomitant medications included pyridostigmine bromide (MESTINON) taken for ocular myasthenia from 22Jan2021; candesartan cilexetil (COROPRES); simvastatin; omeprazole; and ramipril. On 15Feb2021, patient had neurology phone consultation. The patient died suddenly at home on the night of 07Mar2021 (to 08Mar2021). Although it is true that considering the age of the patient and her history (hypertension, dyslipidemia, type II DM, obesity, chronic kidney disease), it is possible that the cause of death is related to these risk factors. Physician reported this fact due to temporal proximity to the vaccination. Until yesterday night, patient was asymptomatic. The only incident of interest is: vaccinated against COVID-19 with the Pfizer vaccine on 04Mar2021 (96 hours ago; as reported). It was reported that on 08Mar2021, there is no suspicion to proceed to a judicial autopsy and that they must proceed to a clinical autopsy. The coroner signed the death of the patient with a basic cause of cardiopathy. Unknown if autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cardiopathy


VAERS ID: 1140546 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Alzheimer''s disease; Bilateral pneumonia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021318133

Write-up: death; This is a spontaneous report from a Pfizer sponsored program. A contactable physician reported that a 82-year-old female patient received first dose bnt162b2 (COMIRNATY, solution for injection), via unspecified route of administration, On an unspecified date at single dose for COVID-19 immunisation patient Medical history included ongoing dementia Alzheimer''s type, and ongoing pneumonia. The patient''s concomitant medications were not reported. The patient experienced death on an unspecified date. The patient died on Mar2021. It was not reported if an autopsy was performed. They had taken samples to analyze and have informed the Drug Agency about it.; Sender''s Comments: As there is limited information in the case provided, the causal association between the event of death and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: death


VAERS ID: 1140552 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-25
Onset:2021-01-30
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Pulmonary embolism, Respiratory distress
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   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: PARACETAMOL; BACLOFENE; GUTRON; INEXIUM [ESOMEPRAZOLE MAGNESIUM]; LYRICA; KEPPRA; THERALENE; XANAX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiodepressive syndrome; Appendectomy; Breast cancer; Carpal tunnel decompression (right carpal tunnel surgery); Convulsive seizure (seizure and episodes of disturbed vigilance probably of psychogenic origin); Elbow fracture (left); Embolism pulmonary (postpartum); Fracture of metatarsal bone(s), closed (fracture of the right metatarsals); Gastric ulcer (Gastric ulcer on non-steroidal anti-inflammatory drugs); Hernia hiatal; Hip prosthesis user; Hysterectomy; Miscarriage (3 spontaneous miscarriages); Osteoporosis with fracture; Thrombosis venous deep (postpartum)
Allergies:
Diagnostic Lab Data: Test Date: 20210128; Test Name: blood test; Result Unstructured Data: Test Result:without any particularity
CDC Split Type: FRPFIZER INC2021311859

Write-up: Distress respiratory; significant cyanosis, and an oedematous face, leading to suspect a possible pulmonary embolism; This is a spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-DJ20210542. A 70-year-old female patient received the first dose of bnt162b2 (COMIRNATY, Lot number was not reported), intramuscular on 25Jan2021 as single dose for COVID-19 immunization; dihydrocodeine bitartrate (DICODIN), oral from an unspecified date, at an unspecified dose, 2x/day for pain; perampanel (FYCOMPA), via an unspecified route of administration from an unspecified date, at 6 mg, at bedtime for an unspecified indication. Medical history included breast cancer and hysterectomy from an unknown date, joint prosthesis user from 1998, also had carpal tunnel decompression right, 3 spontaneous miscarriages, foot fracture (right metatarsals), deep vein thrombosis (postpartum), mixed anxiety and depressive disorder, hiatus hernia, appendicectomy, osteoporosis with fracture, gastric ulcer on non-steroidal anti-inflammatory drugs, convulsive seizure, elbow fracture, and embolism pulmonary all from an unknown date and unknown if ongoing. Concomitant medications included paracetamol; baclofen (BACLOFENE); midodrine hydrochloride (GUTRON); esomeprazole magnesium (INEXIUM); pregabalin (LYRICA); levetiracetam (KEPPRA); alimemazine tartrate (THERALENE); and alprazolam (XANAX) all taken for an unspecified indication, start and stop date were not reported. The patient previously took Xylocaine hcl and experienced drug hypersensitivity, iodine and experienced giant hives. On 30Jan2021, the patient was found dead. Emergency service physician concluded to a natural death. Suspicion of respiratory distress on opiates given the presence at home of several opened boxes of Dicodin. The reporter specified that he himself had seen the deceased patient with blue eye cavities, significant cyanosis, and an oedematous face, leading him to suspect a possible pulmonary embolism. The death appeared sudden as the patient had had her children on the phone 1 or 2 hours before the unresponsiveness that had triggered the home visit. There did not seem to be any unusual complaints (in particular no mention of calf pain) in a patient who nevertheless had many medical problems, consulted many doctors and had a strong tendency to self-medicate, in particular for the management of pain. No suicidal intent according to the reporter. No autopsy, no other examinations carried out. A biological blood test carried out on 28Jan2021 without any particularity. The reporter mentions that he had no information on the tolerance of the vaccination. No information on a particular reactogenicity but no notion of complaints on this subject either. The reporter mentions that he is reporting this adverse event so that it can be recorded, without linking this death to the vaccination in a certain way. The report was made in the media context of pulmonary embolism under the Covid19 Astra Zeneca vaccine, which the patient had understood as pulmonary embolism problems under Comirnaty. The cause of death "respiratory distress" is that established by the emergency service doctor who signed the death certificate. The action taken for dihydrocodeine bitartrate and perampanel was not applicable. The patient died on 30Jan2021. An autopsy was not performed. No follow-up attempts are possible. Information on lot and batch numbers cannot be obtained. No further information is expected.; Reported Cause(s) of Death: significant cyanosis, and an oedematous face, leading to suspect a possible pulmonary embolism; Distress respiratory


VAERS ID: 1140553 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-02-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Ammonia, Angiogram, Blood creatine, Blood pressure measurement, Blood sodium, Blood urea, Body temperature normal, Cardio-respiratory arrest, Electrocardiogram, Exercise test, HIV test negative, Haemoglobin, Heart rate decreased, Hepatitis A virus test, Hepatitis B test negative, Hepatitis C virus test, Hepatitis E virus test, Hypothermia, Oxygen saturation, SARS-CoV-2 test negative, Somnolence, Tachycardia, Tachypnoea
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-19
   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: HYDROXYZINE; SPIRONOLACTONE; CYAMEMAZINE; PERMIXON; ALFUZOSIN; ULTIBRO BREEZHALER; LAMALINE; FUROSEMIDE; DIFFU K; ALLOPURINOL; OMEPRAZOLE; PROPRANOLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Benign prostatic hypertrophy; Cirrhosis alcoholic (Alcoholic cirrhosis Child A5 weaned); Combined pulmonary fibrosis and emphysema (emphysema fibrosis syndrome stable since 2015); COPD (chronic obstructive pulmonary disease stage 2); Gout; Ligation of esophageal varices; Sleep apnea syndrome (obstructive sleep apnoea syndrome supported by apparatus); Ulcer peptic
Allergies:
Diagnostic Lab Data: Test Date: 20210219; Test Name: normal ammonia; Result Unstructured Data: Test Result:normal; Test Name: Thoracic CT angio; Result Unstructured Data: Test Result:no pulmonary embolism; Test Date: 20210219; Test Name: creatine; Result Unstructured Data: Test Result:233; Comments: increased renal insufficiency; Test Date: 20210124; Test Name: blood pressure; Result Unstructured Data: Test Result:120/55 mmHg; Test Name: natriemia; Result Unstructured Data: Test Result:145 mM; Comments: two days before 19Feb2021; Test Date: 20210219; Test Name: natriemia; Result Unstructured Data: Test Result:135 mM; Test Date: 20210219; Test Name: urea; Result Unstructured Data: Test Result:30; Comments: increased renal insufficiency; Test Date: 20210124; Test Name: apyretic; Result Unstructured Data: Test Result:apyretic; Test Date: 20210124; Test Name: ECG; Result Unstructured Data: Test Result:no repolarisation or SQT segment disorder, incompl; Comments: no repolarisation or SQT segment disorder, incomplete block; Test Date: 20210218; Test Name: ECG; Result Unstructured Data: Test Result:ECG without abnormality, still in flutter; Comments: During the night of 18Feb2021 to 19Feb2021, ECG without abnormality, still in flutter; Test Date: 20210127; Test Name: exercise tolerance test; Result Unstructured Data: Test Result:right heart decompensation with pulmonary arterial; Comments: right heart decompensation with pulmonary arterial hypertension.; Test Name: haemoglobin; Result Unstructured Data: Test Result:stable; Comments: During hospitalisation; Test Date: 20210219; Test Name: heart rate decrease; Result Unstructured Data: Test Result:87/min; Test Name: hepatitis A virus negative; Test Result: Negative ; Test Name: hepatitis B virus negative; Test Result: Negative ; Test Name: hepatitis C virus negative; Test Result: Negative ; Test Name: hepatitis E virus negative; Test Result: Negative ; Test Name: HIV serologies negative; Test Result: Negative ; Test Date: 20210219; Test Name: hypothermia; Result Unstructured Data: Test Result:35.7 Centigrade; Test Date: 20210124; Test Name: saturation; Test Result: 90 %; Comments: on 3L O2; Test Date: 20210121; Test Name: COVID test; Test Result: Negative ; Test Date: 20210124; Test Name: tachycardia; Result Unstructured Data: Test Result:150 bpm; Comments: junctional tachycardia; Test Date: 20210124; Test Name: polypnoea; Result Unstructured Data: Test Result:28 bpm
CDC Split Type: FRPFIZER INC2021311890

Write-up: Cardio-respiratory arrest; drowsiness; This is a spontaneous report from a contactable pharmacist downloaded from a regulatory authority- WEB FR-AFSSAPS-GR20210749. A 67-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 18Feb2021 (Batch/Lot Number: Unknown) as 30 ug for covid-19 immunisation. Medical history included Alcoholic cirrhosis Child A5 weaned with ligation of esophageal varices; chronic obstructive pulmonary disease stage 2; obstructive sleep apnoea syndrome supported by apparatus; benign prostatic hypertrophy; ulcer peptic; emphysema fibrosis syndrome stable since 2015; gout. Concomitant medications included hydroxyzine 25 mg 0-0-1; spironolactone 50 mg 0-1-0; cyamemazine 25 mg 0-0-1; serenoa repens extract (PERMIXON) 160 1-0-1; alfuzosin 10mg 0-0-1; glycopyrronium bromide, indacaterol maleate (ULTIBRO BREEZHALER) 85/43 ug , 1 inhalation in the morning; caffeine, papaver somniferum tincture, paracetamol (LAMALINE (FRANCE) 2 capsules 1-3 times daily; furosemide 20 mg 0-1-0; potassium chloride (DIFFU K) 600 1-1-1; allopurinol 200 mg 1-0-0; omeprazole 20 mg 1-0-0; propranolol 40 mg 1-0-0, all were taken for an unspecified indication, start and stop date were not reported. History of the disease: On 21Jan2021, patient admitted to hospital for management of respiratory decompensation and assessment of altered general condition. The patient presented with a pneumopathy treated with Augmentin 1g 3 times a day per os, which was resolved and was followed by a fever with no symptoms, so he was put on tazocillin for 5 days. On 24Jan2021, episode of tachycardia at 150 bpm, blood pressure maintained 120/55 mmHg, apyretic, saturation 90% on 3L O2, polypnoea at 28 bpm. ECG performed: junctional tachycardia at 150 bpm, no repolarisation or SQT segment disorder, incomplete block. Reduction with carotid massage. 2 recurrences of this pattern in one day. On 26Jan2021, appearance of a flutter unmasked on a functional tachycardia, following the cardio advice, anticoagulation for 3 weeks then consultation in rhythmology for attempted ablation. On 27Jan2021, a realization of an exercise tolerance test, right heart decompensation with pulmonary arterial hypertension. On 30Jan2021, hepatic encephalopathy on progression of his alcoholic cirrhosis with Child C10, Wilson negative, a workup for overload disease (Gaucher and Fabri) had been initiated. During hospitalisation, discovery of pancytopenia with poor marrow and B9 deficiency, diagnosis of autoimmune haemolytic anaemia with warm IgG antibodies with negative work-up, persistence of haemolysis but stable haemoglobin, so decision not to go as far as the osteomedullary biopsy, no steroid therapy. On 18Feb2021, first injection (D1) of the Covid-19 vaccine Comirnaty. During the night of 18Feb2021 to 19Feb2021, episode of drowsiness without any focal sign apart from dysarthria, no sensory-motor deficit, no abnormality of the cranial pairs. ECG without abnormality, still in flutter. Differential diagnosis: COVID test on 21Jan2021, negative. Hepatitis A virus (HAV), hepatitis B virus (HBV), hepatitis C virus (HCV), hepatitis E virus (HEV) and HIV serologies negative. Thoracic CT angio: no pulmonary embolism. On 19Feb2021: natraemia at 135 mM (against 145 mM 2 days before, too fast correction?), stable liver balance, normal ammonia, increased renal insufficiency (urea 30, creatinine 233 uM). Development: On 19Feb2021, death of the patient on cardiorespiratory arrest due to hyperkalaemia at 5.1 mmol/L, acute renal failure with creatinine at 230 and urea at 30, cardiac decompensation. Heart rate decreased to 87/min and hypothermia to 35.7 Centigrade. The patient died on 19Feb2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected. Batch/lot number cannot be obtained. ; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1140554 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-03-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-04
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic incompetence (heart valve); Arthrosis; Hypercholesterolemia; Hypertension arterial
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021311883

Write-up: Myocardial Infarction; Death unexplained; Pain in arm/pain in the injected arm; tingling; This is as spontaneous report received from a contactable consumer downloaded from the Regulatory authority-WEB. The regulatory authority report number is FR-AFSSAPS-LM20210503. An 88-year-old female patient received the first dose of bnt162b2 (COMIRNATY, Batch/Lot Number: EP2166), intramuscular, administered in arm left on 02Mar2021 as a single dose for COVID-19 immunisation. Medical history included arthrosis, hypercholesterolemia and hypertension arterial from an unknown date and unknown if ongoing, aortic incompetence from 2007 to an unknown date. The patient''s concomitant medications were not reported. Clinical course was as follows: On 02Mar2021, the patient had the first injection of the pfizer vaccine in the afternoon. On 03Mar2021, complained of pain in the injected arm, tingling described to her daughter over the phone, took paracetamol. No tachycardia (palpitations) described by the patient to her daughter. On 04Mar2021, called her daughter at 7:00 a.m., still complained of pain in the arm without other complaints, prepared to go to her cardiac ultrasound appointment, around 9:45 a.m. activation of the Presence system, phone call for verification but no response, the taxi driver who came to pick her up entered the home and found the patient on the ground, called the fire brigade, patient in cardiopulmonary arrest. Doctor noting death talked to family with myocardial infarction. The patient experienced death unexplained on 04Mar2021, pain in arm/pain in the injected arm and tingling on 03Mar2021. Therapeutic measures were taken as a result of pain in arm/pain in the injected arm and tingling. The outcome of the events was fatal. The patient died on 04Mar2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: tingling; Pain in arm/pain in the injected arm; death unexplained; Infarct myocardial


VAERS ID: 1140557 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Investigation, 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: 2021-02-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZYMAD; SPASFON [PHLOROGLUCINOL]; PARACETAMOL; MOVICOL [MACROGOL 4000;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; GLUCOSE 5% BRAUN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Bed sore; Bedridden; Cholangitis; Cholelithiasis (Biliary lithiasis with cholangitis leading to hospitalization in Sep2020); COVID-19 (COVID19 + in September 2020); Dizziness; Hospitalization; Hypertension; Living in nursing home (Patient in residence of nursing home)
Allergies:
Diagnostic Lab Data: Test Date: 2019; Test Name: GIR2 score; Result Unstructured Data: Test Result:unknown; Test Name: RDT (rapid diagnostic test); Result Unstructured Data: Test Result:unknown; Comments: (fr TDR); Test Date: 202009; Test Name: COVID19; Test Result: Positive
CDC Split Type: FRPFIZER INC2021312031

Write-up: Sudden death; This is a spontaneous report from a contactable physician downloaded from the regulatory authority WEB FR-AFSSAPS-NC20210837. A 100-year-old female patient received BNT162B2 (COMIRNATY), second dose intramuscular, administered in the right arm on 11Feb2021 (batch/lot number: EJ6789) as a single dose for COVID-19 immunisation. Medical history included COVID-19 from Sep2020 (COVID19 + in September 2020), living in residential institution (patient in residence of nursing home), bedridden patient, Alzheimer''s disease, hypertension, RDT (rapid diagnostic test) (fr TDR), dizziness, bedsores, biliary lithiasis with cholangitis leading to hospitalization in Sep2020. Concomitant medications included colecalciferol (ZYMAD), phloroglucinol (SPASFON), paracetamol, macrogol 4000, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL) and glucose (GLUCOSE 5% BRAUN). The patient previously took BNT162B2 on an unspecified date (batch/lot number unknown) for COVID-19 immunisation, first vaccination (D1) performed without adverse effects. The patient experienced sudden death on 12Feb2021. It was also reported that on 12Feb2021, 11 p.m. after the second injection, the patient does not complain of any symptoms, her behavior was usual. She ate lunch in the dining room at the same time as the other residents. She was found dead at the end of the meal in her chair. Death the day after a second vaccine injection. Sudden or unexplained death following vaccination in a patient who had no new manifestation between vaccine and death. The patient underwent lab tests and procedures which included GIR2 score since 2019 (unknown). The patient died on 12Feb2021. 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: 1140558 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-02-11
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-11
   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: ATORVASTATIN KRKA; COVERSYL [PERINDOPRIL ARGININE]; KARDEGIC; CELIPROLOL ZYDUS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ejection fraction; Ischemic heart disease (stented (3 stents)); Myocardial infarction; Stent placement
Allergies:
Diagnostic Lab Data: Test Name: LVEF; Test Result: 45 %
CDC Split Type: FRPFIZER INC2021311876

Write-up: Sudden death/ventricular fibrillation having resulted in death; sudden cardiac arrest/asystole; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority FR-AFSSAPS-NC20210870. A 75-years-old male patient received first dose of BNT162b2 (COMIRNATY, solution for injection, lot number and expiry date not reported), intramuscular, administered in left arm on 19Jan2021 COVID-19 immunisationas single dose for COVID-19 immunisation; and started to receive celiprolol hydrochloride (CELIPROLOL ZYDUS, 200 mg), oral from an unspecified date to 11Feb2021 (reported as treated long term), at an unknown dose and frequency for ischaemic heart disease. Medical history included myocardial infarction from 1997 to an unknown date, myocardial infarction from 2004 to an unknown date, ischemic heart disease, where patient was stented (3 stents), and LVEF 45% (date unknown). Concomitant medications included atorvastatin calcium (ATORVASTATIN KRKA, 20 mg) taken for an unspecified indication, start and stop date were not reported; perindopril arginine (COVERSYL, 5mg) taken for an unspecified indication, start and stop date were not reported; and acetylsalicylate lysine (KARDEGIC, 75 mg) taken for an unspecified indication, start and stop date were not reported. On 11Feb2021, the declarant reported ventricular fibrillation having resulted in death of the patient. It was reported that during a hike in an isolated place the patient presented a sudden cardiac arrest. When the emergency services arrived, the patient was in asystole and could not be recovered. Evolution was reported as death due to the effect with conclusion reported as died of sudden death during treatment with celiprolol and 23 days after vaccination with Comirnaty (COVID-19 vaccine). The action taken in response to the events for bnt162b2 and celiprolol hydrochloride was not applicable. The patient died on 11Feb2021. The causes of death were ventricular fibrillation and sudden cardiac arrest/asystole. It was unknown if an autopsy was performed. Information on the batch number has been requested.; Reported Cause(s) of Death: Sudden death/ventricular fibrillation having resulted in death; sudden cardiac arrest/asystole


VAERS ID: 1140560 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-09
Onset:2021-03-11
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Blood glucose, Blood pressure measurement, Blood test, Body temperature, Cardiac failure, Depressed level of consciousness, Heart rate, Hypotension, Hypotonia, Investigation, Mini mental status examination, Oxygen saturation, Oxygen saturation decreased, Pain, Respiratory failure, SARS-CoV-2 test, Scan, Tachycardia
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (narrow), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: SKENAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Activities of daily living impaired; Antibiotic therapy; Bladder calculus; Blood pressure increased; Cholestasis; Cognitive impairment ((Mini-Mental State Exam (MMSE) =23/30); COVID-19 PCR test negative; Fever; Fractured sacrum; Gallbladder stone; GI haemorrhage (Recent upper GI haemorrhage/bleeding in the last month:); Hematoma NOS; Horton''s disease (treated with corticosteroids); Hypertension; Kyphoscoliosis; Memory impairment; Oxygen therapy; Pain; Pleural effusion; Respiratory insufficiency; Steroid therapy; Subfebrile; Superinfection; Unable to walk; Vertebral injury
Allergies:
Diagnostic Lab Data: Test Date: 20210311; Test Name: blood sugar; Result Unstructured Data: Test Result:normal; Test Date: 20210208; Test Name: blood pressure; Result Unstructured Data: Test Result:surge mmHg; Comments: blood pressure surge; Test Date: 20210311; Test Name: blood pressure; Result Unstructured Data: Test Result:80/50 mmHg; Comments: hypotension; Test Date: 20210208; Test Name: BLOOD TEST; Result Unstructured Data: Test Result:cholestasis; Test Date: 20210222; Test Name: Body Temperature; Result Unstructured Data: Test Result:38.6 Centigrade; Test Date: 20210306; Test Name: Body Temperature; Result Unstructured Data: Test Result:37.8 Centigrade; Comments: isolated subfebrile episode; Test Date: 20210311; Test Name: heart rate; Result Unstructured Data: Test Result:120; Comments: tachycardia; Test Date: 20210311; Test Name: lung examination; Result Unstructured Data: Test Result:She had no acute pulmonary oedema or crepitus focu; Comments: She had no acute pulmonary oedema or crepitus focus, only a few ronchi.; Test Name: MMSE; Result Unstructured Data: Test Result:23/30; Test Date: 20210311; Test Name: oxygen saturation; Test Result: 60 %; Test Date: 20210311; Test Name: oxygen saturation; Test Result: 75 %; Test Date: 20210222; Test Name: COVID PCR; Test Result: Negative ; Test Date: 20210306; Test Name: COVID PCR; Test Result: Negative ; Test Date: 20210311; Test Name: COVID PCR; Result Unstructured Data: Test Result:unknown; Test Date: 20210222; Test Name: pelvic scan; Result Unstructured Data: Test Result:pelvic scan which revealed fractures of the branc; Comments: pelvic scan which revealed fractures of the branches and sacral fin; Test Date: 20210208; Test Name: thoraco-abdominal scan; Result Unstructured Data: Test Result:A thoraco-abdominal scan was requested and showed; Comments: A thoraco-abdominal scan was requested and showed vesicular stones and on the respiratory level a left base parenchymal focus and a pleural effusion.
CDC Split Type: FRPFIZER INC2021311835

Write-up: Depressed level of consciousness/consciousness disorders; respiratory distress/Acute respiratory distress syndrome; Hypotension; Tachycardia; saturation of 60%; pain; hypotonia of all 4 limbs; decompensation; respiratory failure on oxygen; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB [FR-AFSSAPS-NC20210927]. A 93-years-old female patient received first dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number: EP9605, expiry date not reported), intramuscular on 09Mar2021 11:54 at a single dose for COVID-19 immunisation. Medical history included Horton''s disease (treated for many years with corticosteroids); numerous vertebral compressions (T5,T6,T7,T8,L1,L2,L4,L5) leading to kyphoscoliosis; Restrictive respiratory insufficiency requiring O2 which she refused to use outside of acute episodes (superinfection); moderate cognitive impairment (mini-Mental State Exam (MMSE) =23/30); recently discovered hypertension; 1 episode of febrile cholestasis on 08Feb2021 (to an unknown date) with discovery of a stone in the gallbladder, treated with antibiotics (dates unspecified); and recent upper GI haemorrhage/bleeding in the last month. The patient was on an assisted living residence since 18Nov2020. The patient was relatively independent for walking, eating, she needed help with washing and transfers, the speech was coherent with memory problems. On 08Feb2021, she had a blood pressure surge and a blood test was done showing cholestasis; and a thoraco-abdominal scan was requested and showed vesicular stones and on the respiratory level a left base parenchymal focus and a pleural effusion. A course of antibiotic treatment adapted to the 2 foci was started. On 22Feb2021 she had a fever at 38.6 degree centigrate (body temperature) with a urinary call point. In light of the loss of independence, the pain and not being able to walk since unspecified dates, she had a pelvic scan (22Feb2021) which revealed fractures of the branches and sacral fin. A COVID PCR (polymerase chain reaction) test came back negative on 22Feb2021. On the whole, her general condition improved well with the disappearance of fracture pain and a resumption of walking and transfers. On 06Mar2021, she had another isolated subfebrile episode at 37.8 degree Centigrade; a COVID PCR (polymerase chain reaction) test was carried out and was negative. She has major haematomas, the Lovenox used for fractures has been stopped. The patient previously took levofloxacin (LOVENOX) for fractures and experienced major haematomas. Concomitant medication included morphine sulfate (SKENAN) taken for years (dates unspecified) for numerous vertebral compressions (T5,T6,T7,T8,L1,L2,L4,L5) leading to kyphoscoliosis. Patient had decided to be vaccinated and the first injection was given on 09Mar2021 with the PFIZER vaccine lot No. EP9605 at 11:54 am. It was reported that, 21 people were vaccinated that day with the same lot. On 11Mar2021, she presented at the time of breakfast (8am) with respiratory distress/acute respiratory distress syndrome with depressed level of consciousness/consciousness disorders. The night had gone well, the carers had seen her 3 times during the night, the last between 5 and 6am. She had a saturation of 60%, polypnoea, intercostal traction, hypotension (80/50), tachycardia 120 (heart rate), she was apyretic and her blood sugar was normal, she was reactive even to pain, hypotonia of all 4 limbs. The nurse sets up oxygen at 9l/min with a high concentration mask and a venous line. On the arrival of the physician, the examination was identical, she had no mottling or cyanosis of the extremities, the tachycardia was regular, the ventilation was on the 2 pulmonary ranges (she had not eaten or taken any treatment so there was no risk of a false route). She had no acute pulmonary oedema or crepitus focus, only a few ronchi. With the increase of oxygen to 15l/min after about ten minutes, she opened her eyes and directed her gaze without any recovery of tone or improvement in her breathing. Seemingly improving, she was transferred to the emergency room for NIV (non-invasive ventilation) without any real aggressive resuscitation. She died in the emergency room at around noon. She did not have a blood and urine check-up, only a COVID PCR (polymerase chain reaction; unknown result). Physician have no idea what caused this decompensation. She was in respiratory failure on oxygen which she refused to put on. She had already had small warning signs with only one finding on routine examination of a 75% saturation in the morning on waking and was accepting oxygen temporarily. The patient was treated in response to the events reported. Patient died of respiratory distress/acute respiratory distress syndrome, depressed level of consciousness/consciousness disorders, hypotension, tachycardia, saturation of 60%, pain, decompensation, hypotonia of all 4 limbs, and respiratory failure on oxygen, 48 hours after a first dose of PFIZER anticovid vaccination (11Mar2021). It was unknown if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: respiratory distress/Acute respiratory distress syndrome; Depressed level of consciousness/consciousness disorders; hypotension; Tachycardia; saturation of 60%; pain; hypotonia of all 4 limbs; decompensation; respiratory failure on oxygen


VAERS ID: 1140561 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-12
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Stroke (recent)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021312091

Write-up: tired; Death unexplained; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA), regulatory authority number FR-AFSSAPS-NT20210647. A 87-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 04Mar2021 (Batch/Lot Number: EP2166) as single dose on left arm for covid-19 immunisation. Medical history included recent stroke. The patient''s concomitant medications were not reported. The patient experienced death unexplained on 12Mar2021. According to his wife, the patient had been tired in recent days. At around 6 a.m., the patient woke up screaming and died immediately. Intervention of the firefighters who ascertain the death. No COVID disease and no test performed. The patient died on 12Mar2021. 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 unexplained


VAERS ID: 1140564 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-03-07
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve disease mixed; Breast cancer; Diverticulitis; Hernia hiatal; Mitral insufficiency; Senile dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021312132

Write-up: Respiratory distress; Cardio-respiratory arrest; This is a spontaneous report from a contactable physician downloaded from the regulatory authority FR-AFSSAPS-PO20211203. An 88-year-old female patient received the second dose of BNT162B2 (COMIRNATY, lot number: EP9598) intramuscular in left arm on 18Feb2021 at 0.3 mL, single for COVID-19 immunisation. Medical history included senile dementia, mitral insufficiency, aortic valve disease mixed, breast cancer, diverticulitis, and hernia hiatal, all from an unknown date and unknown if ongoing. The patient had no history of COVID-19. The patient''s concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (COMIRNATY, lot number unknown) intramuscular in left arm on 27Jan2021 at 0.3 mL, single for COVID-19 immunisation with no adverse effects in progress. On 07Mar2021 around 11:30 p.m., sudden onset of acute respiratory distress, requiring the initiation of oxygen therapy. On 07Mar2021 around midnight (also reported as 08Mar2021, pending clarification), cardio-respiratory arrest not recovered despite appropriate treatment. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of the events was fatal (the stop date of the events also provided as 08Mar2021, pending clarification).; Reported Cause(s) of Death: Cardio-respiratory arrest; Respiratory distress


VAERS ID: 1140565 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-03-04
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Azotaemia, Blood creatinine, Blood sodium, Dehydration, Dementia, Eating disorder, Hypernatraemia, Livedo reticularis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Hyperglycaemia/new onset diabetes mellitus (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), Dementia (narrow), Noninfectious encephalopathy/delirium (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-11
   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: Medical History/Concurrent Conditions: Dementia Alzheimer''s type; Hypothyroidism
Allergies:
Diagnostic Lab Data: Test Date: 20210305; Test Name: uremia; Result Unstructured Data: Test Result:29 mmol/L; Test Date: 20210305; Test Name: serum creatinine; Result Unstructured Data: Test Result:190 umol/l; Test Date: 20210305; Test Name: Natremia; Result Unstructured Data: Test Result:166 mmol/L; Test Date: 20210305; Test Name: Natremia; Result Unstructured Data: Test Result:170 mmol/L
CDC Split Type: FRPFIZER INC2021311872

Write-up: Eating disorder; acute renal failure; dehydration; natremia at 166 mmol/L; worsening of dementia; notion of mottling; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB FR-AFSSAPS-PO20211322. An 83-years-old female patient received second dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number: EP2166, expiry date not reported), intramuscular, administered in left arm on 02Mar2021 as 0.3 mL, single dose for covid-19 immunisation. Medical history included Dementia Alzheimer''s type (Alzheimer-type dementia) history (in nursing home) and hypothyroidism, both from an unknown date and unknown if ongoing at the time of the events. The patient''s concomitant medications were not reported. The patient had the first IM injection (0.3mL, left arm) of the Comirnaty vaccine (lot EJ6795) on 09Feb2021 for COVID-19 immunisation. Patient had hospitalization on 05Mar2021 to an unknown date in 2021, for acute renal failure, and dehydration (natremia at 166 mmol/L) in a patient with eating disorder, reported as refusing to eat; all on 05Mar2021. On entry, patient G15, opponent, clinical examination impossible (notion of mottling since 04Mar2021). Biological assessment at entry (05Mar2021): serum creatinine at 190 umol/l, uremia at 29 mmol/L, and natremia at 170 mmol/L. Establishment of SC hydration, introduction of treatment with morphine electric syringe pump 0.5 mg / h, and collective decision to limit acute care before death on 11Mar2021. As conclusion, the reporter mentioned a worsening of dementia in the post-vaccination context. Therapeutic measures were taken as a result of the events reported. The outcome of the event notion of mottling was unknown. The patient died on 11Mar2021. The causes of death were reported as eating disorder, acute renal failure, dehydration, natremia at 166 mmol/L, and worsening of dementia. It was unknown if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Eating disorder; acute renal failure; natremia at 166 mmol/L; dehydration; worsening of dementia


VAERS ID: 1140566 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-03-14
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021311850

Write-up: asthenia; Sudden death; This is a spontaneous report from a contactable physician downloaded from the Regulatory authority -WEB, regulatory authority number FR-AFSSAPS-PO20211348. A 77-year-old female patient received the second dose of BNT162B2 (COMIRNATY, lot number: EK9788), intramuscular, administered in the left arm on 02Mar2021 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. She received a first IM injection of COMIRNATY (lot EP2166) in her left arm on 03Feb2021 for Covid-19 immunisation; and was administered second IM injection on 02Mar2021. A few days after vaccination, concept of asthenia. On 14Mar2021, death of the patient who was found in her bathtub (also reported as sudden death). Sudden death was considered serious (fatal) by the regulatory authority. The outcome of asthenia was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: sudden death


VAERS ID: 1140571 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-02-25
Submitted: 0000-00-00
Entered: 2021-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cardiac failure, Chronic obstructive pulmonary disease, Computerised tomogram thorax, Drug ineffective, Dyspnoea exertional, Investigation, Procalcitonin, Productive cough, Renal failure, Respiratory failure, SARS-CoV-2 antibody test, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-06
   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: RAMIPRIL; SYMBICORT
Current Illness: Asbestosis; Hypertension arterial; Prostatectomy
Preexisting Conditions: Medical History/Concurrent Conditions: Adenocarcinoma of prostate; COPD; Drug allergy (allergy to beta lactams)
Allergies:
Diagnostic Lab Data: Test Date: 20210302; Test Name: thoracic CT scan; Result Unstructured Data: Test Result:pulmonary emphysema. Bilateral pleural abnormaliti; Comments: pulmonary emphysema. Bilateral pleural abnormalities more marked on the left, with retractive parenchymal changes in the form of crow''s feet and probable left basal coil atelectasis. No pulmonary embolism.; Test Date: 202103; Test Name: infectious samples (multiplex PCR PAVM (Pulmonary Arteriovenous Malformations); Result Unstructured Data: Test Result:negativity; Test Date: 202103; Test Name: procalcitonin test; Result Unstructured Data: Test Result:negativity; Test Name: Anti-SARS -CoV- 2 serology; Result Unstructured Data: Test Result:COVID 19 IgM equivocal; Test Name: Anti-SARS -CoV- 2 serology; Result Unstructured Data: Test Result:IgG Spike positive; Test Name: Anti-SARS -CoV- 2 serology; Result Unstructured Data: Test Result:IgG capsid negative; Test Date: 20210301; Test Name: PCR COVID-19 on nasopharyngeal swab; Result Unstructured Data: Test Result:positive for variant
CDC Split Type: FRPFIZER INC2021312123

Write-up: COVID-19 aggravated; COVID-19 aggravated; renal failure; Increased oxygen dependence; probable cardiac decompensation; Dyspnoea/dyspnea on exertion; Cough/cough with purulent sputum; COPD exacerbation; This is a spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-RN20210757. A 92-year-old male patient received bnt162b2 (COMIRNATY, lot number unknown), dose 1 via an unspecified route of administration on an unspecified date as single dose and dose 2 intramuscular (vaccinated limb unknown) on 23Feb2021 as single dose for covid-19 immunisation. Medical history included ongoing hypertension arterial, prostate adenocarcinoma resected in 2019, adenocarcinoma of prostate from 2019 and unknown if ongoing, drug allergy (allergy to beta lactams) from an unspecified date and unknown if ongoing, ongoing asbestosis, chronic obstructive pulmonary disease (COPD) ) from an unspecified date and unknown if ongoing. The patient has no history of COVID-19. Concomitant medications included long-term with ramipril; budesonide, formoterol fumarate (SYMBICORT) and monthly homeopathy. The patient experienced dyspnoe and cough on 25Feb2021, COVID-19 aggravated on 01Mar202, COPD exacerbation in 2021, renal failure, increased oxygen dependence and probable cardiac decompensation in Mar2021. Clinical course: The patient presented on 25Feb2021 with cough with purulent sputum and dyspnea on exertion. Faced with an increase in symptoms, emergency consultation was on 01Mar2021. PCR (Polymerase Chain Reaction) COVID-19 on 01Mar2021 on nasopharyngeal swab: positive for variant. Anti-SARS -CoV- 2 serology on an unspecified date: COVID 19 IgM equivocal; IgG Spike positive; IgG capsid negative. In view of the underlying asbestos terrain with chronic obstructive pulmonary disease (COPD) and allergy to beta-lactam antibiotics, introduction of antibiotic therapy with pristinamycin (PYOSTACIN) 1g 3/d for 5 days in view of a possible bacterial superinfection and COPD exacerbation. Progressive increase in oxygen dependence leading to a thoracic CT scan (injected on 02Mar2021) with 46% of the patient affected. Underlying pathological lung: pulmonary emphysema. Bilateral pleural abnormalities more marked on the left, with retractive parenchymal changes in the form of crow''s feet and probable left basal coil atelectasis. No pulmonary embolism. Introduction of dexamethasone 10 mg/d IV on 03Mar2021 following an infectious disease opinion in view of the low probability of bacterial superinfection given the absence of a radiological focus and the negativity of infectious samples (multiplex PCR PAVM (Pulmonary Arteriovenous Malformations), antigenuries, PCT (procalcitonin test)) in Mar2021. Maintenance of moderate hydration in the presence of renal failure and the cardiac impact of pneumopathy. At D3 of dexamethasone, introduction of tocilizumab on 05Mar2021 in the presence of oxygen dependence at 6L/min. Increased oxygen dependence and probable cardiac decompensation without response to diuretic therapy leading to the patient''s death on 06Mar2021 at 5:20 am. CONCLUSION: Death from documented SARS Cov 2 (variant) infection in a setting of asbestos pathology and chronic obstructive pulmonary disease. The patient died on 06Mar2021. It was not reported if an autopsy was performed. Outcome of all events were fatal. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Increased oxygen dependence; probable cardiac decompensation; COVID-19 aggravated; renal failure; COVID-19 aggravated; Cough/cough with purulent sputum; Dyspnoea/dyspnea on exertion; chronic obstructive pulmonary disease/COPD exacerbation


VAERS ID: 1140572 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-15
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Blood pressure systolic, Brain scan normal, Dizziness, Electrocardiogram, Full blood count, Hypertensive crisis, Neurological examination, Physical examination, Sudden death, Tremor, Vertigo, Visual impairment
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), Hypertension (narrow), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: AMLODIPINE; VALSARTAN; BETAXOLOL; ESOMEPRAZOLE; ELIQUIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac arrhythmia; Dyslipidaemia; Ex-smoker (for 10 years); Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Date: 20210215; Test Name: Blood Pressure; Result Unstructured Data: Test Result:around 210/120; Test Date: 20210215; Test Name: Blood Pressure; Result Unstructured Data: Test Result:217/119; Comments: on clinical examination; Test Date: 20210215; Test Name: systolic blood pressure; Result Unstructured Data: Test Result:150-160; Comments: usually; Test Date: 20210215; Test Name: brain scan; Result Unstructured Data: Test Result:No intracranial hemorrhage; Test Date: 20210215; Test Name: ecg; Result Unstructured Data: Test Result:Atrial fibrillation, normo-focused, no; Comments: repolarization disorder; Test Date: 20210215; Test Name: complete blood count; Result Unstructured Data: Test Result:normal; Comments: no inflammatory syndrome. No ionic disorder, no kidney failure.; Test Date: 20210215; Test Name: Neurological examination; Result Unstructured Data: Test Result:G15 conscious oriented, no headache, no neck pain; Comments: supple neck no photo-phonophobia, no nausea. No sensory or motor deficit of upper limb or lower limb. No vestibular syndrome, no cerebellar syndrome. Walking possible, no balance disorders.; Test Date: 20210215; Test Name: Physical examination; Result Unstructured Data: Test Result:hemodynamic stable, no mottling, peripheral pulses; Comments: perceived. No chest pain, no palpitations, irregular cardiac auscultation without breath, no sign of heart failure, soft and painless calves. No cough, Ascending aorta eupneic, vesicular murmur + / + without added noise. Painless depressible plethoric abdomen, no mass, free and painless lumbar pits.
CDC Split Type: FRPFIZER INC2021311898

Write-up: Visual disturbances; Vertigo; Shakiness; Dizziness; Hypertensive crisis; Death unexplained/sudden death; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. The regulatory authority report number is FR-AFSSAPS-RS20210416. A 78-year-old male patient received the first dose of bnt162b2 (COMIRNATY, lot number was not reported), intramuscular on 03Feb2021 as single dose for COVID-19 immunization. Medical history included ex-tobacco user for 10 years from an unknown date to an unknown date, dyslipidaemia, arrhythmia, hypertension, and atrial fibrillation all from an unknown date and unknown if ongoing. Concomitant medication included amlodipine; valsartan; betaxolol; esomeprazole; and apixaban (ELIQUIS) all taken for an unspecified indication, start and stop date were not reported. On 15Feb2021 at 15:30 (3:30 pm) the patient complains of visual disturbances, tremors, dizziness, vertigo. On the same date, 15Feb2021, the patient had blood pressure taking at home which returns to around 210/120 versus systolic blood pressure at 150-160 usually according to the patient. Persistence of symptoms prompting an emergency call, which sends the patient to the hospital on 15Feb2021. On clinical examination, BP 217/119, hemodynamic stable, no mottling, peripheral pulses perceived. No chest pain, no palpitations, irregular cardiac auscultation without breath, no sign of heart failure, soft and painless calves. No cough, Ascending aorta eupneic, vesicular murmur + / + without added noise. Painless depressible plethoric abdomen, no mass, free and painless lumbar pits. Neurological examination, G15 conscious oriented, no headache, no neck pain, supple neck no photo-phonophobia, no nausea. No sensory or motor deficit of upper limb or lower limb. No vestibular syndrome, no cerebellar syndrome. Walking possible, no balance disorders. Normal complete blood count, no inflammatory syndrome. No ionic disorder, no kidney failure. ECG: Atrial fibrillation, normo-focused, no repolarization disorder. Brain scan: No intracranial hemorrhage. Symptoms not suggestive of a vascular cause (TIA or stroke) but rather of an acute hypertensive outbreak. No triggering factor found. Emergency care for hypertension was done prompting treatment with Loxen. patient was discharged and retuned home on 16Feb2021. On 01Mar2021, the patient experienced sudden death/unexplained death, reported as found dead in the morning. The outcome of the events visual disturbances, tremors, vertigo, hypertensive crisis was recovering for the event dizziness was not reported. The patient suddenly died on 01Mar2021. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: sudden death


VAERS ID: 1140573 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-10
Onset:2021-03-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Auscultation, Blood bicarbonate, Blood electrolytes, Blood pH, Body temperature, Bronchitis, C-reactive protein, COVID-19, Cardiovascular examination, Coma scale, Computerised tomogram thorax, Decreased appetite, Dyspnoea, Gastrointestinal examination, Hyperleukocytosis, Investigation, Ischaemic stroke, Neutrophil count, Neutrophil count increased, Oxygen saturation, Oxygen saturation decreased, PCO2, PO2, Platelet count, Pneumonitis, Pyrexia, Renal function test, Respiratory rate, SARS-CoV-2 test, Scan brain, Thrombocytopenia, White blood cell count
SMQs:, Anaphylactic reaction (broad), Haematopoietic thrombocytopenia (narrow), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Malignancy related conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (narrow), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-12
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PARACETAMOL; NEBIVOLOL; AMLODIPINE BESILATE; CLOPIDOGREL; LEVOTHYROX; PRAVASTATIN; CALCIDOSE VITAMINE D; LORAZEPAM; PAROXETINE
Current Illness: Speech disorder
Preexisting Conditions: Medical History/Concurrent Conditions: Appendectomy; C-section; Carcinoma of tongue; Coronary bypass; CVA; Hyperlipidemia; Penicillin allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210311; Test Name: pulmonary auscultation; Result Unstructured Data: Test Result:some crackles; Comments: some crackles in the right base, decrease in vesicular murmur on the left. Supra-clavicular pull, thoraco-abdominal swing; Test Date: 20210312; Test Name: pulmonary auscultation; Result Unstructured Data: Test Result:bilateral crackles; Test Date: 20210311; Test Name: bicarbonates; Result Unstructured Data: Test Result:21.7 mmol/L; Test Date: 20210312; Test Name: blood ionogram; Result Unstructured Data: Test Result:Normal; Test Date: 20210311; Test Name: blood pH; Result Unstructured Data: Test Result:7.44; Test Date: 20210311; Test Name: body temperature; Result Unstructured Data: Test Result:39.5 Centigrade; Test Date: 20210311; Test Name: Cardiovascular; Result Unstructured Data: Test Result:regular heart sounds, no murmur; no IMO; Comments: regular heart sounds, no murmur; no IMO, no jugular turgor; soft, painless calves; Test Date: 20210312; Test Name: Glasgow; Result Unstructured Data: Test Result:3; Test Date: 20210311; Test Name: CHEST CT; Result Unstructured Data: Test Result:no detectable acute proximal pulmonary embolism; Comments: Atypical bilateral pneumonitis, potentially suggestive of COVID involvement (moderate relaxation), with probable superinfection of bronchial origin within the left upper lobe; Test Date: 20210311; Test Name: C-reaktive protein; Result Unstructured Data: Test Result:2.5 mg/l; Test Date: 20210311; Test Name: Abdomen; Result Unstructured Data: Test Result:soft, depressible, tender in the epigastric region; Test Date: 20210311; Test Name: fractional shortening; Result Unstructured Data: Test Result:56; Comments: /min; Test Date: 20210311; Test Name: neutrophils; Result Unstructured Data: Test Result:10.42; Comments: G/L; Test Date: 20210311; Test Name: oxygen saturation; Test Result: 95 %; Test Date: 20210312; Test Name: oxygen saturation; Test Result: 82 %; Test Date: 20210311; Test Name: PCO2; Result Unstructured Data: Test Result:32 mmHg; Test Date: 20210311; Test Name: thrombocytes; Result Unstructured Data: Test Result:90; Comments: G/L; Test Date: 20210311; Test Name: PO2; Result Unstructured Data: Test Result:66 mmHg; Test Date: 20210312; Test Name: renal function; Result Unstructured Data: Test Result:normal; Test Date: 20210311; Test Name: respiratory rate; Result Unstructured Data: Test Result:40; Comments: /min; Test Date: 20210311; Test Name: SARS-CoV-2 PCR test; Test Result: Negative ; Test Date: 20210311; Test Name: brain scan; Result Unstructured Data: Test Result:acute constituted ischemic focus; Comments: systematized left frontal hypodensity suggesting an acute constituted ischemic focus; Test Date: 20210312; Test Name: brain scan; Result Unstructured Data: Test Result:systematized left frontal hypodensity; Test Date: 20210311; Test Name: wbc; Result Unstructured Data: Test Result:11.29; Comments: G/L
CDC Split Type: FRPFIZER INC2021311863

Write-up: Dyspnoea; Fever; Ischemic stroke; Saturation at 82%; Atypical bilateral pneumonitis; probable superinfection of bronchial origin within the left upper lobe; COVID-19; 10.42 G/L of PNN (neutrophils); did not eat all day; hyperleukocytosis 11.29 G/L; thrombocytopenia 90 G/L; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority (RA). The regulatory authority report number is FR-AFSSAPS-RS20210427. An 86-year-old female patient received the first dose of bnt162b2 (COMIRNATY; Lot Number: EP9605) intramuscular, administered in Arm Right, on 10Mar2021, as SINGLE DOSE for covid-19 immunisation. Medical history included cerebrovascular accident from 2020 to an unknown date, coronary artery bypass from an unknown date and unknown if ongoing, Penicillin allergy from an unknown date and unknown if ongoing, hyperlipidaemia from an unknown date and unknown if ongoing, caesarean section, Appendectomy, Carcinoma of tongue from an unknown date and unknown if ongoing, and ongoing significant speech problems. Concomitant medications included paracetamol, nebivolol, amlodipine besilate, clopidogrel, levothyroxine sodium (LEVOTHYROX), pravastatin, calcium carbonate, colecalciferol (CALCIDOSE VITAMINE D), lorazepam, and paroxetine. On 11Mar2021, emergency services was alerted by neighbours who have not seen the patient during the day. Patient found lying in bed, dyspneic, febrile, did not eat all day. On arrival of the emergency services, the patient was congested, saturated 95% AA (Amino Acids), febrile 39.5 C, FR (fractional shortening) 56/min. She was hospitalised. Questioning was not very helpful, significant speech problems since an operation for tongue cancer. According to her daughter-in-law, patient is usually comprehensible. Emergency examination: pulmonary auscultation: some crackles in the right base, decrease in vesicular murmur on the left. Supra-clavicular pull, thoraco-abdominal swing. Polypneic 40/min. Cardiovascular: regular heart sounds, no murmur; no IMO, no jugular turgor; soft, painless calves. Abdomen soft, depressible, tender in the epigastric region. Biology: hyperleukocytosis 11.29 G/L including 10.42 G/L of PNN (neutrophils); thrombocytopenia 90 G/L. Normal blood ionogram, normal renal function. CRP (C-reactive protein) (< 342.0mg/l) = 2.5, ABG (arterial blood gases): pH 7.44; PO2 (partial pressure of oxygen) 66 mmHg, PCO2 (partial pressure of carbon dioxide) 32 mmHg, bicarbonates 21.7 mmol/l; COVID PCR (Polymerase chain reaction) negative. Chest CT: no detectable acute proximal pulmonary embolism within the limits of the examination. Atypical bilateral pneumonitis, potentially suggestive of COVID involvement (moderate relaxation), with probable superinfection of bronchial origin within the left upper lobe. Introduction of levofloxacin. On 12Mar2021: clinical examination: patient is reactive Glasgow 3 with pupils in a reactive mydriasis, eye rolling; generalized mottling; grazing. Saturation at 82% AA (Amino Acids) increased to 95% on 15l oxygen. Lung auscultation: bilateral crackles. Emergency brain scan: systematized left frontal hypodensity suggesting an acute constituted ischemic focus. In view of the patient''s neurological condition and the severe cardiovascular terrain, it was decided to start palliative care. Dyspnoea, fever and ischaemic stroke the day after a D1 of COMIRNATY in a frail patient with a long cardiovascular history; COVID PCR (Polymerase chain reaction) negative but atypical lung lesions suggestive of moderate COVID involvement with probable bronchial superinfection. Outcome of dyspnoea, fever and ischaemic stroke was fatal while it was unknown for the other events. The patient died on 12Mar2021 at 14:30. Causes of death were reported as dyspnoea, fever and ischaemic stroke. It was unknown if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Dyspnoea; fever; ischaemic stroke


VAERS ID: 1140575 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-13
Onset:2021-03-16
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-16
   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: Medical History/Concurrent Conditions: Acute coronary syndrome; Acute oedema of lung, unspecified; Adult failure to thrive; Anaemia; Fall; Vascular dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021317486

Write-up: dies 15 minutes after help arrives; Feeling sick; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB FR-AFSSAPS-TO20211719. A 90-year-old male patient received second dose of bnt162b2 (COMIRNATY, lot number: EP9605), via intramuscular on the left arm on 13Mar2021 at single dose for COVID-19 immunisation. Medical history included Acute oedema of lung, unspecified, Anaemia, Vascular dementia, acute coronary syndrome, Adult failure to thrive, slip syndrome. The patient had presented for a month in a fragile, altered state of health. On 16Mar2021, 3 days after vaccination, patient was unwell at home, call for EMS by home help, patient dies 15 minutes after help arrives. It is unknown if autopsy was done. Action taken with unwell was unknown. Outcome of die was fatal. No follow-up attempts possible. No further information expected.; Sender''s Comments: Information provided was so limited to prevent a meaningful and definite medical assessment for this demise. A causal relationship cannot be completely excluded between death and BNT162B2 injection to COVID-19 immunization only due to close chronological sequence. Malaise was preceding the fatal outcome. Other evidence or argument suggesting that patient died of vaccination cannot be established, so far. Otherwise, advanced age and multi-morbid medical history (anemia, dementia, acute coronary syndrome), may be likely ongoing as current conditions, considered as contributory factors to fatal outcome. 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: dies 15 minutes after help arrives


VAERS ID: 1140619 (history)  
Form: Version 2.0  
Age: 98.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-02-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood gases, Blood pressure diastolic, Blood pressure systolic, Cardiac failure, Communication disorder, Cyanosis, Death, Decreased appetite, Disorientation, Dyspnoea, Electrocardiogram, Fatigue, Gait disturbance, Heart rate, Heart rate increased, Hypertension, Hyporesponsive to stimuli, Hypotension, Oedema peripheral, Oxygen saturation, Oxygen saturation decreased, Physical examination, SARS-CoV-2 antibody test, SARS-CoV-2 test, Snoring, Wheezing, X-ray
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-22
   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: PRAXITEN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210219; Test Name: ABG; Result Unstructured Data: Test Result:pH 7.46, pCO2: 5.3, pO2 7.9, K 3.3, GUK 14; Comments: Lac 1.3, spO2 92%; Test Date: 20210219; Test Name: Blood pressure diastolic; Result Unstructured Data: Test Result:90 mmHg; Test Date: 20210219; Test Name: Blood pressure diastolic; Result Unstructured Data: Test Result:65 mmHg; Test Date: 20210222; Test Name: Blood pressure diastolic; Result Unstructured Data: Test Result:50 mmHg; Test Date: 20210219; Test Name: Blood pressure systolic; Result Unstructured Data: Test Result:220 mmHg; Test Date: 20210219; Test Name: Blood pressure systolic; Result Unstructured Data: Test Result:115 mmHg; Test Date: 20210222; Test Name: Blood pressure systolic; Result Unstructured Data: Test Result:90 mmHg; Test Date: 20210219; Test Name: ECG; Result Unstructured Data: Test Result:SR 84/min; Test Date: 20210219; Test Name: pulse; Result Unstructured Data: Test Result:109/min; Test Date: 20210219; Test Name: Oxygen saturation; Test Result: 90 %; Test Date: 20210220; Test Name: Oxygen saturation; Test Result: 78 %; Test Date: 20210222; Test Name: Oxygen saturation; Test Result: 87 %; Test Date: 20210219; Test Name: examination; Result Unstructured Data: Test Result:Conscious, inadequate verbal contact, immobile,; Comments: sitting in bed, eupneic at rest. Skin neat. Lungs: basal crepitation. Heart: action rhythmic, tones clear, no noises. Abdomen: Level, soft, sensitive to diffuse palpation, audible peristalsis. Limbs: symmetrical, mobile, edema-free, AP symmetrical palpable.; Test Date: 20210219; Test Name: SARS-CoV-2 antibody test; Test Result: Negative ; Test Date: 20210219; Test Name: SARS-CoV-2 PCR test; Test Result: Negative ; Test Date: 20210219; Test Name: Xray; Result Unstructured Data: Test Result:On the summary AP image of the thoracic organs; Comments: lying down, no inflammatory infiltrates formed are seen in the analysis of the available parenchyma. There are no signs of acute stasis or pleural effusion. Ventilation disturbances pericardially left. The shadow of the heart corresponds to the lying position. Aortosclerosis. On the native abdominal image taken lying down (due to the general condition of the patient it was not possible to take an image on the left side) no evident pneumoperitoneum or distension of the intestinal convolutions is seen. The gas is monitored up to the rectum
CDC Split Type: HRPFIZER INC2021312058

Write-up: Unknown cause of death; Blood pressure low/90/50 mm Hg; Cyanosis; Weakness; Fatigue; pulse 109 / min; snores; Decompensation cardiac; Appetite lost/refusing meals; Shortness of breath/Breathing difficult; Wheezing; Blood pressure high/very high blood pressure of 220/90 mmHg; Oxygen saturation low/SPO2 90%, 78%, 87%; Edema hands; Gait instability/could no longer go to the toilet alone, he was not stable on his feet; Disorientated/disoriented in time and space; Communication disorder/did not understand what was being said to him/communication difficult; Hyporesponsive to stimuli/reacted only to a stronger stimulus; This is a spontaneous report from a contactable physician downloaded from the Regulatory authority-WEB with regulatory authority number HR-HALMED-300044911. A 98-year-old male patient received bnt162b2 (COMIRNATY; unknown lot number and expiration date), at 98-year-old vaccination age via an unspecified route of administration on 18Feb2021 as 30 ug single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included oxazepam (PRAXITEN) and Aramed. Until the day of vaccination (18Feb2021), the male patient performed the basic physiological needs independently, oriented in time and space without difficulties until the aforementioned date. On the day of vaccination (18Feb2021), the patient was in an unaltered state. On the same night, the patient''s condition worsened, he could no longer go to the toilet alone, he was not stable on his feet (gait instability), disoriented in time and space (disorientated), did not understand what was being said to him (communication disorder) and reacted only to a stronger stimulus (hyporesponsive to stimuli). On 19Feb2021 in the morning, the patient is disoriented in time and space, communication difficult, refusing meals (appetite lost) received NaCl 500 ml IV. After that, the user''s health condition deteriorates sharply (difficulty breathing, wheezing and has a very high blood pressure of 220/90 mmHg [range: 90/60 mmHg to 139/89 mmHg], SPO2 [Oxygen saturation] was 90% [range: 90% to 100%], both hands are edematous) and so emergency services called. The patient was examined by emergency services and was taken to hospital. On 20Feb2021, the patient returned home in very poor condition (same symptoms as above) received NaCl + Furosemide amp 40 mg I.V and he was given oxygen therapy 4 liters (SPO2: 78%). On 21Feb2021, the patient still in very bad condition and got NaCl again and reduced the oxygen from 4 liters to 3.5 liters. On 22Feb2021, the patient''s condition worsened. AT. 90/50 mm Hg, SPO2 87%, cyanosis on hands and lower legs. Received Glucose 5% 500 ml IV, and furosemide 40 mg IV, Klavocin 1gr 2x daily, Sumamed 500mg 1x1, Oxygen 3-4 l pp. The patient passed away at 4 p.m. Medical documentation reported referral diagnosis were weakness and fatigue on 19Feb2021. On 19Feb2021, the patient was brought in by emergency services as a cor decomp [coronary decompensation, atherosclerosis common]. As of today (19Feb2021), the deterioration of the general condition, yesterday received Comirnaty vaccine. As of today, he breathes heavily, snores, high blood pressure in the morning, then drank his therapy. At home, rapid antigen test was negative. Previous diseases were unknown. FIN were unknown. Medications: Praxiten pp, Aramed 25 mg (?); No allergies. The patient''s BP 115/65 mmHg, pulse 109/min, sp02 90%, Conscious, inadequate verbal contact, immobile, sitting in bed, eupneic at rest. Skin neat. Lungs: basal crepitation. Heart: action rhythmic, tones clear, no noises. Abdomen: Level, soft, sensitive to diffuse palpation, audible peristalsis. Limbs: symmetrical, mobile, edema-free, AP symmetrical palpable. Finding included ECG: SR 84 / min; X-ray: On the summary AP image of the thoracic organs lying down, no inflammatory infiltrates formed are seen in the analysis of the available parenchyma. There are no signs of acute stasis or pleural effusion. Ventilation disturbances pericardially left. The shadow of the heart corresponds to the lying position. Aortosclerosis. On the native abdominal image taken lying down (due to the general condition of the patient it was not possible to take an image on the left side) no evident pneumoperitoneum or distension of the intestinal convolutions is seen. The gas is monitored up to the rectum; sars-cov-2 on 19Feb2021 nasopharynx / throat sweet sars-cov-2 was negative Real-time PCR; and Art. ABS: pH 7.46, pCO2: 5.3, pO2 7.9, K 3.3, GUK 14, Lac 1.3, spO2 92%. Diagnosis were Shortness of breath and Cor decomp vrs. Therapy was reported that was given by the emergency services: furosemide 40 mg iv, oxygen 2 L/min; in hospital: oxygen 2 L/min; Urinary catheter (note: the patient urinated in the diaper both before catheter placement and after diuretic administration, so that the collected urine in the bag does not correspond to the actual diuresis during the night!) Opinion provided was the patient, a ward of the home, was examined and observed in HS for dyspnea. Here during the stay eupneic in the supine position, satisfactory values of gases in the arterial blood, without significant acute elements on the X-ray of the thorax. A diuretic is prescribed, which results in satisfactory diuresis. All the time of stay in HS hemodynamically and respiratory stable. Currently no evidence acute internal events. We advise to introduce Furosemide 40 mg in the morning with Kalinor 1 tablet with lunch, in case of absence of respiratory problems, the dosage can be diluted every other day - please check the clinical status by the competent family doctor. Pay attention to adequate hydration. Go to hospital if necessary. Additional information on drug provided in product notes: ADR is adequately labeled: no. The outcome of the events snore and pulse rate increased were unknown while the outcome of the other events was fatal. The patient died on 22Feb2021. It was unknown if an autopsy was performed. Sender Comment: 17Mar2021: Additional documentation was requested several times, however, not yet received.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1140620 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-02-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNK / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Blood pressure diastolic, Blood pressure systolic, Body temperature, Cyanosis, Heart rate, Hypopnoea, Oxygen saturation
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210219; Test Name: Blood pressure diastolic; Result Unstructured Data: Test Result:86 mmHg; Test Date: 20210220; Test Name: Blood pressure diastolic; Result Unstructured Data: Test Result:79 mmHg; Test Date: 20210219; Test Name: Blood pressure systolic; Result Unstructured Data: Test Result:140 mmHg; Test Date: 20210220; Test Name: Blood pressure systolic; Result Unstructured Data: Test Result:132 mmHg; Test Date: 20210219; Test Name: Body temperature; Result Unstructured Data: Test Result:37.1 Centigrade; Test Date: 20210220; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Test Date: 20210219; Test Name: Heart rate; Result Unstructured Data: Test Result:79; Comments: Units:{beats}/min; Test Date: 20210220; Test Name: Heart rate; Result Unstructured Data: Test Result:71; Comments: Units:{beats}/min; Test Date: 20210219; Test Name: Oxygen saturation; Test Result: 97 %; Test Date: 20210220; Test Name: Oxygen saturation; Test Result: 98 %
CDC Split Type: HRPFIZER INC2021312053

Write-up: cyanotic lips; Shallow breathing; Abdominal pain; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB. The regulatory authority report number is HR-HALMED-300044913. A 92-year-old female patient received her first dose of BNT162B2 (COMIRNATY lot number and expiry date were not reported) via intramuscular route on 18Feb2021 as a single dose for COID-19 immunisation. The patient''s medical history and concomitant medications were not reported. After vaccination, she felt well. As of Friday, 19Feb2021, the signs were normal (SPO2 97%, pulse 79, RR 140/86, Temp. 37.1). On the morning of 20Feb2021, she complained of abdominal pain, vital signs (RR 132/79, temp 36.8, SPO2 98%, pulse 71 rhythmic). After 20 minutes, the patient began to breathe shallowly/ shallow breathing and her lips were cyanotic/ cyanotic lips. An ambulance was called which soon came. After 10 min the patient was dead. Events were fatal. Patient died on 20Feb2021. It was unknown if an autopsy was performed. Sender''s comments: 16Mar2021: Additional data were requested, however no response was received until this day. All events Causality / Unassessable/Unclassifiable; Reported Cause(s) of Death: shallow breathing; abdominal pain; cyanotic lips


VAERS ID: 1140625 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-03-13
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: General physical health deterioration
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-14
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021311694

Write-up: Deterioration in general condition, worsening of general physical condition; This is a spontaneous report from a contactable healthcare professional downloaded from the Regulatory Authority-WEB, IT-MINISAL02-700476. A 95-year-old female patient received the first dose of bnt162b2 (COMIRNATY, solution for injection), via an unspecified route of administration, administered in left arm on 05Mar2021 (batch/lot number: EP2166; expiration date: 31May2021) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient had deterioration in general condition, worsening of general physical condition on 13Mar2021. The patient died on 14Mar2021. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Administration site: Left arm Sent from Agency; Reported Cause(s) of Death: Deterioration in general condition, worsening of general physical condition


VAERS ID: 1140640 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2019-02-25
Onset:2021-03-11
   Days after vaccination:745
Submitted: 0000-00-00
Entered: 2021-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Gastrointestinal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Paroxysmal atrial fibrillation
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021311611

Write-up: Gastrointestinal haemorrhage; This is a spontaneous report received from a contactable physician downloaded from the European Medicines Agency (EMA) EudraVigilance NL-LRB-00474090. An 80-year-old female patient received bnt162b2 (COMIRNATY; lot number/expiry date was not reported), via an unspecified route of administration on 06Mar2021 as single dose for COVID-19 immunization and acenocoumarol (ACENOCOUMAROL), via an unspecified route of administration from 25Feb2019 at unspecified dose for paroxysmal atrial fibrillation. Medical history included paroxysmal atrial fibrillation from 2019 and hypertension. The patient''s concomitant medications were not reported. The patient experienced gastrointestinal haemorrhage and died on 11Mar2021. It was not reported if an autopsy was performed. The action taken in response to the event for acenocoumarol was not applicable. No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: gastrointestinal haemorrhage


VAERS ID: 1140641 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-24
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Malaise, Myalgia, SARS-CoV-2 test positive
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20201202; Test Name: corona, confirmed with test; Test Result: Positive
CDC Split Type: NLPFIZER INC2021311605

Write-up: Not feeling well; Fatigue; Muscle pain; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Agency regulatory Authority-WEB, regulatory authority number NL-LRB-00478387. An elderly female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 24Feb2021 (Batch/Lot Number: Unknown) as SINGLE DOSE for covid-19 immunisation. Medical history included covid-19 from 02Dec2020 to an unknown date. The patient received first dose of COMIRNATY on 27Jan2021 for COVID-19 immunization. The patient''s concomitant medications were not reported. On an unspecified date, it was reported that the patient experienced malaise/ Not feeling well, fatigue, and myalgia/muscle pain; reported as 1 hour after start. The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive on 02Dec2020. Treatment: Malaise is treated with Eventually with oxygen and morphine on a palliative basis. The patient died on an unspecified date. The outcome of the events was fatal. It was not reported if an autopsy was performed. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Not feeling well; fatigue; muscle pain


VAERS ID: 1140642 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-11
Onset:2021-03-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FUROSEMIDE; PERINDOPRIL ERBUMINE; EPLERENONE; COLECALCIFEROL; METOPROLOL [METOPROLOL SUCCINATE]; PANTOPRAZOL [PANTOPRAZOLE]; ATORVASTATINE [ATORVASTATIN]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021311650

Write-up: died suddenly the night after the 2nd Pfizer dose; This is a spontaneous report from a contactable physician downloaded from the Regulatory authority-WEB, regulatory authority number NL-LRB-00478418. An 87-year-old female patient received the second dose of BNT162B2 (COMIRNATY; lot/batch number and expiration date not reported) via an unspecified route of administration on 11Mar2021 at a single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included furosemide, perindopril erbumine, eplerenone, colecalciferol, metoprolol succinate (METOPROLOL [METOPROLOL SUCCINATE]), pantoprazol [pantoprazole] (PANTOPRAZOL [PANTOPRAZOLE]) and atorvastatine [atorvastatin] (ATORVASTATINE [ATORVASTATIN]). The patient previously received first dose of Comirnaty on an unknown date for COVID-19 immunisation. The patient died suddenly the night after the 2nd Pfizer dose. The patient had no previous COVID-19 infection. The patient died on 12Mar2021. 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: died suddenly the night after the 2nd Pfizer dose


VAERS ID: 1140643 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-12
Onset:2021-03-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Bilirubin conjugated, Blood albumin, Blood alkaline phosphatase, Blood bilirubin, Blood calcium, Blood creatinine, Blood creatinine increased, Blood glucose, Blood glucose increased, Blood lactate dehydrogenase, Blood phosphorus, Blood potassium, Blood sodium, Blood test, Blood urea, Blood urea increased, Blood uric acid, Blood uric acid increased, C-reactive protein, Carbon dioxide, Catheterisation cardiac, Electrocardiogram, Gamma-glutamyltransferase, Gamma-glutamyltransferase increased, Glomerular filtration rate, Glomerular filtration rate decreased, Haematocrit, Haemoglobin, Mean cell haemoglobin, Mean cell volume, Myocardial infarction, Platelet count, Red blood cell scan, Red blood cell sedimentation rate, Reticulocyte count, Reticulocyte haemoglobin equivalent, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Liver related investigations, signs and symptoms (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Myocardial infarction (narrow), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, arterial (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-14
   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: CETOMACROGOL; DEXAMETHASONE; TOBRADEX
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210314; Test Name: ALAT; Result Unstructured Data: Test Result:32 U / L; Test Date: 20210314; Test Name: ASAT; Result Unstructured Data: Test Result:21 U / L; Test Date: 20210314; Test Name: Bilirubin Direct; Result Unstructured Data: Test Result:N n / a umol / L <5.0; Test Date: 20210314; Test Name: Albumin; Result Unstructured Data: Test Result:44 g/l; Test Date: 20210314; Test Name: Alkaline Phosphatase; Result Unstructured Data: Test Result:73 U / L; Test Date: 20210314; Test Name: Bilirubin Total; Result Unstructured Data: Test Result:5.4 umol/l; Test Date: 20210314; Test Name: Calcium; Result Unstructured Data: Test Result:2.52 mmol/L; Test Date: 20210314; Test Name: Creatinine; Result Unstructured Data: Test Result:128 umol/l; Test Date: 20210314; Test Name: Glucose; Result Unstructured Data: Test Result:12.5 mmol/L; Test Date: 20210314; Test Name: Lactate Dehydrogenase; Result Unstructured Data: Test Result:196 U / L; Test Date: 20210314; Test Name: Phosphate; Result Unstructured Data: Test Result:1 mmol/L; Test Date: 20210314; Test Name: Potassium; Result Unstructured Data: Test Result:4.8 mmol/L; Test Date: 20210314; Test Name: Sodium; Result Unstructured Data: Test Result:143 mmol/L; Test Date: 20210314; Test Name: BLOOD TEST; Result Unstructured Data: Test Result:everything normal, except: increased glucose,; Comments: GGT, urea, creatinine and uric acid, eGFR significantly reduced.; Test Date: 20210314; Test Name: Urea; Result Unstructured Data: Test Result:14 mmol/L; Test Date: 20210314; Test Name: Uric acid; Result Unstructured Data: Test Result:0.41 mmol/L; Test Date: 20210314; Test Name: Total CO2; Result Unstructured Data: Test Result:24 mmol/L; Test Date: 20210314; Test Name: Catheterisation cardiac; Result Unstructured Data: Test Result:Cardiac catheterization: STEMI IPL; Comments: based on occlusion ostial RCA for which drug management. Etiology mgl plaque erosion / rupture. DD cardiac embolism source, increased coagulation tendency).; Test Date: 20210314; Test Name: CRP; Result Unstructured Data: Test Result:<6.0 mg mg/l; Test Date: 20210314; Test Name: ECG; Result Unstructured Data: Test Result:Electrocardiogram: TAVB with AVN; Comments: escape rhythm 50 / min, elevation II, III, aVF, V3-6, ST depression V2, I and aVL; Test Date: 20210314; Test Name: Gamma-Glutamyl Transferase; Result Unstructured Data: Test Result:44 U / L; Test Date: 20210314; Test Name: eGFR (CKD-EPI); Result Unstructured Data: Test Result:33 ml/min; Test Date: 20210314; Test Name: Hematocrit; Result Unstructured Data: Test Result:0.45; Test Date: 20210314; Test Name: Hemoglobin; Result Unstructured Data: Test Result:8.8 mmol/L; Test Date: 20210314; Test Name: MCH; Result Unstructured Data: Test Result:1.90 fmol; Test Date: 20210314; Test Name: MCV; Result Unstructured Data: Test Result:98 fL; Test Date: 20210314; Test Name: Platelets; Result Unstructured Data: Test Result:230 x10 ^ 9 / L; Test Date: 20210314; Test Name: Erythrocytes; Result Unstructured Data: Test Result:4.6 x10 ^ 12 / L; Test Date: 20210314; Test Name: SEDIMENTATION; Result Unstructured Data: Test Result:5 mm / hour; Test Date: 20210314; Test Name: Reticulocytes; Result Unstructured Data: Test Result:75 x10 ^ 9 / L; Test Date: 20210314; Test Name: RET-HE N; Result Unstructured Data: Test Result:2.107; Test Date: 20210314; Test Name: Leucocytes; Result Unstructured Data: Test Result:5.8 x10 ^ 9 / L
CDC Split Type: NLPFIZER INC2021311659

Write-up: Myocardial infarction; Glucose H 12.5 mmol/ L; GGT H 44 U / L; Urea H 14 mmol / L; Creatinine H 128 umol / L; eGFR (CKD-EPI) L 33 mL / min; Uric acid H 0.41 mmol / L; This is a spontaneous report from contactable physician downloaded from the regulatory authority NL-LRB-00478833. An 85-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 12Mar2021 (Batch/Lot Number: Unknown) as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included cetomacrogol (CETOMACROGOL); dexamethasone (DEXAMETHASONE); dexamethasone, tobramycin (TOBRADEX); all taken for an unspecified indication, start and stop date were not reported. This serious spontaneous report from a physician concerns a female aged 85 years, with myocardial infarction (death) following administration of covid-19 vaccine pfizer injvlst (action taken: not applicable) for COVID 19 immunization. Myocardial infarction was experienced by patient 2 days after start. Treatment: Myocardial infarction is treated with Drug policy (Cangrelor and Ticagrelor). Laboratory results on 14Mar2021 included BLOOD TEST everything normal, except: increased glucose, GGT, urea, creatinine and uric acid, eGFR significantly reduced (as reported), Catheterisation cardiac: STEMI IPL based on occlusion ostial RCA for which drug management. Etiology mgl plaque erosion / rupture. DD cardiac embolism source, increased coagulation tendency), Electrocardiogram: TAVB with AVN escape rhythm 50 / min, elevation II, III, aVF, V3-6, ST depression V2, I and aVL, Sedimentation 5 mm / hour <30, Hemoglobin 8.8 mmol / L 7.5-10.0, Hematocrit H 0.45 L / L 0.35-0.45, Erythrocytes 4.6 x10 ^ 12 / L 4.0-5.0, MCV 98 fL 80-100, MCH 1.90 fmol 1.70-2.10, Reticulocytes 75 x10 ^ 9 / L 25-120, RET-HE N 2.107$g 1.77, Platelets 230 x10 ^ 9 / L 150-400, Leucocytes 5.8 x10 ^ 9 / L 4.0- 0.0, Glucose H 12.5 mmol / L <7.8, Bilirubin Total 5.4 umol / L <17, Bilirubin Direct N n / a umol / L <5.0, ASAT 21 U / L <30,ALAT 32 U / L <35, LD 196 U / L <250, Alkaline Phosphatase (AF) 73 U / L 40-120, GGT H 44 U / L <40, Urea H 14 mmol / L 2.5-6.4, Creatinine H 128 umol / L 50-100, eGFR (CKD-EPI) L 33 mL / min$g 90, Uric acid H 0.41 mmol / L 0.14-0.34, Potassium 4.8 mmol / L 3.5-5.0, Sodium 143 mmol / L 135-145, Total CO2 24 mmol / L 23-29, Calcium 2.52 mmol / L 2.10-2.55, Phosphate 1.00 mmol / L 0.80-1.50, Albumin 44 g / L 35-50, CRP <6.0 mg / L <6.0. The outcome of myocardial infarction is fatal, for other events was unknown. The patient died on 14Mar2021. It was not reported if an autopsy was performed. Case Summary and Reporter''s Comments Text: BioNTech/Pfizer vaccin (Comirnaty) -Past drug therapy BioNTech/Pfizer vaccin (Comirnaty): unknown - Myocardinfarct -Additional information ADR: Single myocardial infarction - BSN available: yes - COVID19 - Previous COVID-19 infection: No - Other - diagnostic procedures: Electrocardiogram: TAVB with AVN escape rhythm 50 / min, elevation II, III, aVF, V3-6, ST depression V2, I and aVL No follow-up attempts are possible, information on batch/ lot number cannot be obtained.; Reporter''s Comments: BioNTech/Pfizer vaccin (Comirnaty) -Past drug therapy BioNTech/Pfizer vaccin (Comirnaty): unknown - Myocardinfarct -Additional information ADR: Single myocardial infarction - BSN available: yes - COVID19 - Previous COVID-19 infection: No - Other - diagnostic procedures: Electrocardiogram: TAVB with AVN escape rhythm 50 / min, elevation II, III, aVF, V3-6, ST depression V2, I and aVL; Reported Cause(s) of Death: Myocardial infarction


VAERS ID: 1140644 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-09
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood pressure decreased, Blood pressure measurement, Fatigue, Malaise, Oxygen saturation, Oxygen saturation decreased, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Respiratory failure (broad), Infective pneumonia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-16
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: XARELTO; COLECALCIFEROL; METOPROLOL; TOLBUTAMIDE; AMOXICILLIN; ATORVASTATIN; FUROSEMIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bypass surgery; Cardiac valve prosthesis user (10 years ago); Dementia; Mitral valve repair (cardiac burden)
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: blood pressure; Result Unstructured Data: Test Result:low; Test Date: 202103; Test Name: oxygen saturation; Result Unstructured Data: Test Result:low; Test Name: covid test negative; Test Result: Negative
CDC Split Type: NLPFIZER INC2021311607

Write-up: Malaise; tired, without energy; tired, without energy; low saturation; low bloodpressure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB NL-LRB-00479037, received from Regulatory Authority. A 91-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 09Mar2021 (Batch/Lot Number: Unknown) as single dose for COVID-19 immunization. Medical history included dementia, cardiac burden mitral valve repair, cardiac valve prosthesis user (aortic valve bioprosthesis 10 years ago) from 2011, bypass surgery. Concomitant medication included amoxicillin (AMOXICILLIN) taken for an unspecified indication from 15Mar2021 to an unspecified stop date; then rivaroxaban (XARELTO); colecalciferol (COLECALCIFEROL); metoprolol (METOPROLOL); tolbutamide (TOLBUTAMIDE); atorvastatin (ATORVASTATIN); furosemide (FUROSEMIDE), all taken for an unspecified indication, start and stop date were not reported. Complaints started 3 days after vaccination (malaise and fatigue: 3 days after start). Blood pressure decreased and oxygen saturation decreased: latency unknown (Mar2021). Six days later the physician was called: measured low blood pressure, low saturation, but no fever. A COVID 19 test was done and came back negative. Patient had no cough, no chest pain, but due to her age and medical history she did not want a hospital admission: palliative care was started and amoxicillin was started (Pragmatically still amoxicillin started at 15Mar2021). No previous COVID-19 infection. No diagnostic procedures (as reported). Only a Covid test: negative. Patient died a day later, on 16Mar2021. The outcome of the events was fatal. It was not reported if an autopsy was performed. Case Summary and Reporter''s Comments Text: Death. Not sure if this is because of the vaccine. Additional information ADR: 3 days after pfizer vaccination complaints of malaise, tired, no energy. Called doctor 3 days later. Low blood pressure, low saturation, no fever. Covid test taken: negative. No coughing, no chest pain. Previously discussed not to be sent in anymore In connection with history and age. Died on 16Mar. history: dementia, cardiac burden with mirtal valve replacement and aortic valve bioprosthesis 10 years ago. Also underwent bypass surgery. It is therefore not certain whether her symptoms are the result of a side effect of the vaccination or whether it is related to her comorbidity / age / history Patient number available: yes. Confounding factors: cardiac history (see previous description). Not sure if death is due to vaccination. No follow-up attempts are possible, information on batch number cannot be obtained.; Reporter''s Comments: Summary of Reporter Comment: Death Not sure if because of vaccine ADR 3 days after vaccination malaise,tired,no energy 3 days later Low blood pressure low saturation no fever Covid test negative No coughing, chest pain Previously discussed not to be sent in anymore in connection w/ history, age Died on 16Mar Hx dementia, cardiac burden w/ mirtalvalvereplacement and aorticvalvebioprosthesis 10 yrs ago Bypass surgery Notcertainwhethersymptomsareresultofvaccination/relatedtocomorbidity/age/history; Reported Cause(s) of Death: tired, without energy; tired, without energy; low saturation; low bloodpressure; malaise


VAERS ID: 1140645 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-26
Onset:2021-02-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Pain in extremity
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), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   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: SIMVASTATINE; THYRAX DUO; ACETYLSALICYLIC ACID; ENALAPRIL; METFORMIN; OMEPRAZOL; BUMETANIDE; METOPROLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetic; Dyspnoea; Flank pain; Heart failure; Hypertension; Orthopnea; Pacemaker insertion (cardiac); Renal function abnormal
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021311615

Write-up: cardiac arrest; died acutely; sat in chair, sighed twice and died; so very possible cardiac arrest; pain in arm; This is as spontaneous report received from a contactable physician downloaded from the European Medicine Agency (EMA) EudraVigilance-WEB. The regulatory authority report number is NL-LRB-00479149. An 81-year-old male patient received BNT162B2 (Comirnaty, Lot Number and expiry dates are not reported) via an unspecified route of administration on 26Feb2021 as single dose for covid-19 immunisation. Medical history included diabetes mellitus, orthopnoea, cardiac failure from, cardiac pacemaker insertion, dyspnoea, hypertension, flank pain, renal impairment. Concomitant medication(s) included acetylsalicylic acid tablet 80mg, bumetanide tablet 1mg, enalapril tablet 10mg, metformine tablet 500mg, metoprolol tablet gastro-resistant 100mg (succinaat), omeprazol capsule gastro-resistant 20mg, simvastatine tablet 40mg and levothyroxine tablet 150ug (acid). The patient experienced pain from the vaccinated arm 1 day on 26Feb2021. On 01Mar2021 (3 days after start), the patient had experienced cardiac arrest and died acutely; sat in chair, sighed twice and died. The patient recovered from pain in arm with a duration of 1 day and the outcome of cardiac arrest is fatal. Additional information was reported as patient died acutely; sat in chair, sighed twice and died; so very possible cardiac arrest confounding factors included known with heart failure, had a pacemaker; diabetes, hypertension, decreased kidney function, Lately dyspnoea complaints, also orthopnoea and pain complaints left flank when asked a widow (had not been to a doctor for this), Reporter think that the vaccination has no direct relationship with the death, after vaccination actually only had some problems with the lancing arm for 1 day. In Reporter opinion, death can be explained on the basis of his medical history; but reporter wanted to report it anyway. No any previous COVID-19 infection and diagnostic procedures reported. The comments reporting form: reporter missed a block of free text, so just wrote it down somewhere, because actually reporter don''t think it is an adverse reaction, but given the current events so thought that it might be necessary to report this death. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no death, cardiac arrest Additional information ADR: patient died acutely; sat in chair, sighed twice and died; so very possible cardiac arrest confounding factors: known with heart failure, had a pacemaker; diabetes, hypertension, decreased kidney function; Lately dyspnoea complaints, also orthopnoea and pain complaints left flank when asked a widow (had not been to a doctor for this); I myself think that the vaccination has no direct relationship with the death, after vaccination actually only had some problems with the lancing arm for 1 day. In my opinion, death can be explained on the basis of his medical history; but I wanted to report it anyway COVID-19 Previous COVID-19 infection: No. Other diagnostic procedures: no comments reporting form: I missed a block of free text, so I just wrote it down somewhere, because I actually don''t think it is an adverse reaction, but given the current events I thought that it might be necessary to report this death.; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 1140646 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-03-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-04
   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: MACROGOL; PARACETAMOL; PRAMIPEXOLE; LYRICA; LOSEC MUPS; COLECALCIFEROL; ZOLPIDEM
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021311700

Write-up: health practitioner suspects cardiac arrest; This is a spontaneous report received from a contactable other health professional downloaded from the Regulatory authority -WEB. The regulatory authority report number is NL-LRB-00479759. An 89-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 03Mar2021 (Lot Number: EK9788) as single dose for COVID-19 immunization. The patient''s medical history was not reported. Concomitant medications included macrogol (MACROGOL), paracetamol (PARACETAMOL), pramipexole (PRAMIPEXOLE), pregabalin (LYRICA), omeprazole magnesium (LOSEC MUPS), colecalciferol (COLECALCIFEROL), zolpidem (ZOLPIDEM); all taken for an unspecified indication, start and stop date were not reported. This serious spontaneous report from a other health professional concerns a female aged 89 years, with sudden death (death) 1 day after start, following administration of covid-19 vaccin pfizer (action taken: not applicable) for covid 19 immunisation. The outcome of sudden death is fatal. The health practitioner suspects cardiac arrest (death) on 04Mar2021. The patient died on 04Mar2021. It was not reported if an autopsy was performed. Reporter''s comments: BioNTech/Pfizer vaccin (Comirnaty) Past drug therapy BioNTech/Pfizer vaccin (Comirnaty): no died suddenly the day after the vaccination Additional information ADR: health practitioner suspects cardiac arrest. Previous COVID-19 infection: No Other: diagnostic procedures: no No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: BioNTech/Pfizer vaccin (Comirnaty) Past drug therapy BioNTech/Pfizer vaccin (Comirnaty): no died suddenly the day after the vaccination Additional information ADR: health practitioner suspects cardiac arrest Previous COVID-19 infection: No Other: diagnostic procedures: no; Reported Cause(s) of Death: health practitioner suspects cardiac arrest


VAERS ID: 1140647 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2016-12-30
Onset:2021-02-25
   Days after vaccination:1518
Submitted: 0000-00-00
Entered: 2021-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Depressed level of consciousness, Fatigue, Heart rate, Heart rate increased, Malaise, Pyrexia
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Methotrexate Sodium
Current Illness: Dementia; Psoriasis; Rheumatoid arthritis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210225; Test Name: pyrexia; Result Unstructured Data: Test Result:38 to 40.5 Centigrade; Comments: Fever: 38 to 40.5 centigrade; Test Date: 20210225; Test Name: pulse rate; Result Unstructured Data: Test Result:increased
CDC Split Type: NLPFIZER INC2021317704

Write-up: Depressed level of consciousness; Fever: 38 to 40.5 centigrade; Pulse rate increased; Fatigue; Not feeling well; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB NL-LRB-00480399, received from Regulatory Authority. This first of two reports, regarding the second dose. An 83 years female patient received 2nd dose of BNT162B2 (COMIRNATY) on 24Feb2021 for COVID-19 immunisation, methotrexate sodium tablet from 30Dec2016 to 01Mar2021 at 2.5mg daily for rheumatoid arthritis and psoriasis palm & soles. Medical history was dementia, rheumatoid arthritis, psoriasis, all ongoing. Concomitant drug was not reported. Historical Vaccine was 1st dose of COMIRNATY on 27Jan2021 but experienced flare-up of herpes zoster. Patient experienced Depressed level of consciousness (death, life threatening), Not feeling well/Doesn''t seem comfortable. (death, life threatening), fatigue (death, life threatening), pyrexia 38 to 40.5 centigrade (death, life threatening) and pulse rate increased/high pulse (death, life threatening) all from 25Feb2021 (Approximately 24 hours after vaccination). Also reported reduced approachability. Treated with symptomatic treatment: painkillers and something against the fever. No diagnostic procedures. Patient has been admitted to a nursing home because of dementia. Seemed to be able to cope with the second vaccination, but after probably her own immune response, she just got the push that she could no longer take. Therefore, I started on symptomatic treatment and no more studies were performed. Action taken in response to the event for Methotrexate Sodium was permanently withdrawn. No Previous COVID-19 infection. The outcome of events was fatal. No follow-up attempts are possible, information on batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-2021323439 the same patient/product/different event, a different dose; Reported Cause(s) of Death: Depressed level of consciousness; Fever: 38 to 40.5 centigrade; Pulse rate increased; Fatigue; Not feeling well


VAERS ID: 1140648 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-12
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute abdomen, Thrombosis mesenteric vessel
SMQs:, Acute pancreatitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Ischaemic colitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PANTOPRAZOLE; RISPERDAL; ASCAL [CARBASALATE CALCIUM]; TAMSULOSINE [TAMSULOSIN HYDROCHLORIDE]; CITALOPRAM; FENTANYL
Current Illness: Actinic keratosis; Amblyopia; Ankle osteoarthritis; Arthritis multiple joint; Arthrosis; Cataract; Chronic venous insufficiency; Defaecation disorder; Gonarthrosis; Leukemia; Mixed dementia; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Haemolytic anaemia direct Coombs positive; Hernia inguinal (also from 20Sep2017); Jaundice; Knee prosthesis insertion; Psychosis (After withdrawal of risperidone (RISPERDAL)); Splenectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021317722

Write-up: acute abdomen on 12Mar2021, not excluding acute mesenteric thrombosis; acute abdomen on 12Mar2021, not excluding acute mesenteric thrombosis; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB NL-LRB-00480453. An 85-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 04Mar2021 (Batch/Lot Number: EP9598) as single dose for covid-19 immunisation. Medical history included chronic venous insufficiency from 21Aug2019 and ongoing, hernia inguinal from 19Feb2010 (also from 20Sep2017), cataract OD from 2018 and ongoing, haemolytic anaemia direct Coombs positive from 01Jan2005, psychosis from 21Aug2020 (After withdrawal of risperidone (RISPERDAL)), mixed dementia from 30Apr2017 and ongoing, neglected jaundice from 1970 to an unknown date, splenectomy from 1953, amblyopia OS from 2018 and ongoing, leukaemia from 16Mar2009 and ongoing, arthritis multiple joint from 28Sep2015 and ongoing, actinic keratosis from 21Jul2019 and ongoing, other athrosis/related disorders from 14Jan2015 and ongoing, type 2 diabetes mellitus from 26May2009 and ongoing, change in defaecetion/defaecetion pattern from 06Jun2017 and ongoing, gonarthrosis from 16Mar2007 and ongoing, ankle arthrosis from 2007 and ongoing, total knee prosthesis left from 13Nov2017. Concomitant medications included pantoprazole; risperidone (RISPERDAL); carbasalate calcium (ASCAL); tamsulosin hydrochloride (TAMSULOSINE); citalopram; fentanyl pleister. The patient previously took risperidone. The patient experienced acute abdomen on 12Mar2021, not excluding acute mesenteric thrombosis, and patient died quickly in Mar2021. Outcome of both events was fatal. Reported cause of death was acute abdomen and acute mesenteric thrombosis. No autopsy was performed. Case summary and reporter''s comment: No past drug therapy BioNTech / Pfizer vaccine (Comirnaty). No dissection was performed and the cause of acute abdomen cannot be determined with certainty. It is absolutely not certain that there is a connection between the reported event and vaccination, however, in this case the report is nevertheless given if it occurs more often (a connection is also not excluded). No previous COVID-19 infection, no diagnostic procedures.; Reporter''s Comments: No past drug therapy BioNTech / Pfizer vaccine (Comirnaty). No dissection was performed and the cause of acute abdomen cannot be determined with certainty. It is absolutely not certain that there is a connection between the reported event and vaccination, however, in this case the report is nevertheless given if it occurs more often (a connection is also not excluded). No previous COVID-19 infection, no diagnostic procedures.; Reported Cause(s) of Death: acute abdomen on 12Mar2021, not excluding acute mesenteric thrombosis; acute abdomen on 12Mar2021, not excluding acute mesenteric thrombosis


VAERS ID: 1140649 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-13
Onset:2021-03-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aphonia, Bronchitis, Dysphonia, Fatigue, Malaise
SMQs:, Parkinson-like events (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-17
   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: COLECALCIFEROL; AMOXICILLINE/CLAVULAANZUUR; DICLOFENACUM NATRICUM; CALCI CHEW D3; PREGABALINE; PARACETAMOL; ETANERCEPT; OMEPRAZOL
Current Illness: Bronchitis; Rheumatoid arthritis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021317724

Write-up: loss of voice/hoarseness; mucus on the lungs resembling Bronchitis; General malaise; Fatigue; hoarseness; This is a spontaneous report received from a contactable consumer downloaded from the regulatory authority. The regulatory authority report number is NL-LRB-00480512. A 88-year-old female patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 13Mar2021 (Lot Number: EP9605) as 0.3 mL, single for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis, bronchitis from Jan2021 and ongoing. There was no previous COVID-19 infection. Concomitant medication(s) included colecalciferol; amoxicillin trihydrate, clavulanate potassium (AMOXICILLINE/CLAVULAANZUUR); diclofenacum natricum; calcium carbonate, colecalciferol (CALCI CHEW D3); pregabaline; paracetamol; etanercept; omeprazole (OMEPRAZOL). The patient experienced loss of voice/hoarseness, mucus on the lungs resembling bronchitis, general malaise, fatigue on 14Mar2021, all treated with antibiotics started on 16Mar2021. The outcome of the events was fatal. The patient died on 17Mar2021. It was not reported if an autopsy was performed. Reporter''s comments: BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no phlegm on the lungs resembling Bronchitis, loss of voice/hoarseness, general malaise, fatigue Additional information ADR: first complaints start on Sunday with a clear worsening every day until her death on Wednesday morning. The mucus was clearly audible with her breathing, she had less and less strength to cough it up. Started on Tuesday with antibiotics, but to no avail. patient did not want to be included confounding factors confounding factors: rheumatoid arthritis COVID-19 Previous COVID-19 infection: No. Other diagnostic procedures: General practitioner prescribed antibiotics via telephone consultation on Tuesday because the resembled that patient had in January when Bronchitis was diagnosed. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Summary of Reporter Comment first complaints start on Sunday with a clear worsening every day until her death on Wednesday morning. The mucus was clearly audible with her breathing, she had less and less strength to cough it up. Started on Tuesday with antibiotics, but to no avail. patient did not want to be included confounding factors; Reported Cause(s) of Death: loss of voice/hoarseness; loss of voice/hoarseness; mucus on the lungs resembling bronchitis; general malaise; fatigue


VAERS ID: 1140650 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-03-02
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral infarction, Computerised tomogram, Investigation
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-05
   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: ATACAND; ALBYL-E; FURIX [FUROSEMIDE]; ZANIDIP; TRAJENTA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart failure; Hypertension; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: CT scan; Result Unstructured Data: Test Result:CT caput (after hospitalization):; Comments: - Large cerebral infarction. Central, right hemisphere, including basal ganglia. CT angio (after hospitalization): - Significant stenosis of the carotid bifurcation bilaterally. And lack of contrast filling throughout the course of the external carotid artery.; Test Date: 202103; Test Name: examination; Result Unstructured Data: Test Result:neglect, left-sided hemiparesis, eye paresis, and; Comments: At hospitalization: neglect, left-sided hemiparesis, eye paresis, and clearly drooping corners of the mouth and dysarthria.
CDC Split Type: NOPFIZER INC2021311677

Write-up: CEREBRAL INFARCTION; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. An 88-year-old female patient received bnt162b2 (COMIRNATY), second dose intramuscular, administered in Arm Left on 24Feb2021 15:20 (Batch/Lot Number: EP2166) as single dose for covid-19 immunisation. The patient previously took the first dose of bnt162b2 (COMIRNATY) on an unspecified date for covid-19 immunisation. Medical history included (reported as Multimorbid patient) type 2 diabetes mellitus, hypertension and heart failure, all from an unknown date and unknown if ongoing. Concomitant medication included candesartan cilexetil (ATACAND) taken for hypertension from 2016 to an unspecified stop date oral at 8 mg, 1x/day; acetylsalicylic acid, magnesium oxide (ALBYL-E) taken for type 2 diabetes mellitus from 2010 to an unspecified stop date oral at 75 mg, 1x/day; furosemide (FURIX [FUROSEMIDE]) taken for cardiac failure from 2018 to an unspecified stop date oral at 20 mg, 1x/day; lercanidipine hydrochloride (ZANIDIP) taken for hypertension from 2015 to an unspecified stop date oral at 10 mg, 1x/day; linagliptin (TRAJENTA) taken for type 2 diabetes mellitus from 2019 to an unspecified stop date oral at 5 mg, 1x/day. It was reported that the patient was admitted after being found by her son at 12:30 am on the day of admission, lying next to the bed. The son last observed her at 23:00 pm the night before, then she was in a habitual state. At hospitalization: neglect, left-sided hemiparesis, eye paresis, and clearly drooping corners of the mouth and dysarthria. No public assistance at home. It was reported that the patient with a large cerebral infarction six days (02Mar2021) after vaccination with covid-19 vaccine (Comirnaty). Rapid deterioration after hospitalization, and palliative treatment was started due to major irreversible brain damage, carotid stenoses bilaterally and age. She died nine days after the vaccination. The patient underwent lab tests and procedures which included computerised tomogram: ct caput (after hospitalization): on Mar2021 Large cerebral infarction. Central, right hemisphere, including basal ganglia. CT angio (after hospitalization): - Significant stenosis of the carotid bifurcation bilaterally. And lack of contrast filling throughout the course of the external carotid artery. The patient died on 05Mar2021. It was not reported if an autopsy was performed. No follow-up attempts are needed. No further information is expected.; Reporter''s Comments: A 88 years old woman with a large cerebral infarction six days after vaccination with covid-19 vaccine (Comirnaty). Rapid deterioration after hospitalization, and palliative treatment was started due to major irreversible brain damage, carotid stenoses bilaterally and age. She died nine days after the vaccination. Multimorbid patient with hypertension, heart failure and type 2 diabetes mellitus.; Reported Cause(s) of Death: cerebral infarction


VAERS ID: 1140653 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-26
Onset:2021-02-28
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Angiocardiogram, Asthenia, Blood pressure decreased, Blood pressure measurement, Cardiac arrest, Cardiogenic shock, Chest pain, Heart rate, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (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), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Respiratory failure (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-04
   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: Hypertension; Hypothyroidism
Preexisting Conditions: Medical History/Concurrent Conditions: Coronary artery disease; STEMI
Allergies:
Diagnostic Lab Data: Test Date: 20210304; Test Name: coronography; Result Unstructured Data: Test Result:result unknown; Test Date: 20210302; Test Name: Blood pressure; Result Unstructured Data: Test Result:90/60; Test Date: 20210301; Test Name: Pulse; Result Unstructured Data: Test Result:normal
CDC Split Type: PLPFIZER INC2021311686

Write-up: Vomiting; Chest pain; Cardiac arrest; Cardiogenic shock; Acute myocardial infarction; Weakness; Blood pressure decreased/blood pressure 90/60; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. A 69-year-old female patient received bnt162b2 (COMIRNATY) at the age of 69-year-old, via an unspecified route of administration on 26Feb2021 08:29 (Lot Number: EP2166; Expiration Date: 31May2021) as single dose for COVID-19 immunisation. Medical history included STEMI from an unknown date and unknown if ongoing, ongoing hypothyroidism, ongoing hypertension, and coronary artery disease from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. It was reported that the patient was hospitalized in the cardiology department from 28Feb2021, admitted with chest pain and vomiting. On 01Mar2021, the patient''s condition was stable, and her pulse was normal. On 02Mar2021 there was weakness, blood pressure decreased/blood pressure 90/60. On 04Mar2021, the patient''s health deteriorated, resuscitation was performed, then the patient was intubated and coronography (unknown results) was performed. On the same day (04Mar2021) at 05:50 there was a cardiac arrest, at 06:12 the patient died. The patient also experienced acute myocardial infarction, the secondary cause was cardiogenic shock on 04Mar2021. According to the death certificate, the initial cause was acute myocardial infarction, the secondary cause was cardiogenic shock, and the direct cardiac arrest. Chest pain and vomiting, weakness, blood pressure 90/60 were also reported as cause of death. It was unknown if an autopsy was performed. The reporting person classified them as serious. URPL (RA) also classified the application as a serious. Sender comment: Taking into account the entire clinical picture, it should be concluded that the symptoms were related to coronary artery disease, which had been diagnosed earlier. It is difficult to say whether exacerbation of coronary heart disease, MI and death were related to vaccination. In the database, 2 cases of unstable angina and 35 cases of acute myocardial infarction after COMIRNATY vaccine have been reported. There is a time relationship between the administration of the vaccine and the occurrence of the reaction. The reporting person classified it as serious, URPL also classified the report as serious. Relatedness of drug to all events assessed by Regulatory Authority as Unclassifiable (WHO method of assessment). No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Vomiting; Chest pain; Weakness; Blood pressure decreased/blood pressure 90/60; Acute myocardial infarction; Cardiac arrest; Cardiogenic shock.


VAERS ID: 1140654 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-25
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Endoscopy upper gastrointestinal tract, Haematemesis, Melaena
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-31
   Days after onset: 30
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient treated with anticoagulants
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: Gastroscopy; Result Unstructured Data: Test Result:blood clots
CDC Split Type: PLPFIZER INC2021311683

Write-up: coffee-grounds vomiting/dusty vomit; Tarry stool; This is as spontaneous report downloaded from the Regulatory Authority.A contactable physician reported that an 87-year-old male patient received the first dose of bnt162b2 (COMIRNATY, lot number: EL1491; expiration date: 25Jan2021 ), intramuscular, administered in the left arm on 25Jan2021 at 14:18 as a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. It was reported that the patient was admitted to the hospital on 29Jan2021 due to coffee-grounds vomiting/dusty vomit and tarry stools which started on an unspecified date in Jan2021. The patient was treated with anti-clotting drugs. Gastroscopy showed blood clots. The patient received blood. The patient died on 31Jan2021 at 09:20 due to coffee-grounds vomiting/dusty vomit and tarry stools. It was not reported if an autopsy was performed. The relatedness of the drug reactions/events to the suspected drug (Source of assessment: NCA, Method of assessment: WHO scale) was possible. Sender comment: Comirnaty- vaccine against COVID-19 (mRNA). Fusky vomiting and tarry stools are unexpected side effects for the vaccine. So far, the EVDAS database has reported 4 cases of upper gastrointestinal haemorrhage, 6 cases of gastrointestinal haemorrhage. There is a warning in Comirnaty SPC that caution should be exercised in people receiving anticoagulant therapy as such people may bleed or bruise after intramuscular administration. There is a time relationship between vaccination and the occurrence of side effects. The person reporting post-vaccinal reaction qualified it as serious. Polish HA assessed the post-vaccinal reaction as serious. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Coffee-grounds vomiting; Tarry stool


VAERS ID: 1143780 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-02-09
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-03-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Death, Drug ineffective, Pyrexia, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210209; Test Name: COVID-19 test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021283040

Write-up: Death; Positive COVID-19 test; Positive COVID-19 test; Fever; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB (FR-AFSSAPS-MA20210672). A 90-year-old female patient received the first dose of BNT162B2 (COMIRNATY; lot number: EJ6788), via intramuscular route of administration on 19Jan2021 (at the age of 90 years) at a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 09Feb2021, the patient presented with fever and a COVID-19 test performed which found to be positive. The events were considered serious (medically significant). Evolution: Death (NOS - not otherwise specified). The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of the events positive COVID-19 test and fever was unknown. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Death


VAERS ID: 1146506 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-27
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: General physical health deterioration, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: MTX [METHOTREXATE]; LEFLUNOMID; CORTISONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Autoimmune disorder NOS; Multimorbidity; Rheumatoid arthritis
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021317264

Write-up: Fever; Deterioration in general condition; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority DE-PEI-PEI2021003606. An 85-year-old male patient received BNT162B2 (COMIRNATY), intramuscularly on 27Feb2021 (at age of 85-year-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included multimorbid, autoimmune disorder, and rheumatoid arthritis. Concomitant medications included methotrexate (MTX), leflunomide (LEFLUNOMID), and cortisone. The patient experienced fever, and deterioration in general condition on an unspecified date. The events were reported as serious with seriousness criteria death. The patient died on an unspecified date. It was not reported if an autopsy was performed. The Relatedness of suspect drug BNT162B2 to the events fever and deterioration in general condition was reported as ''Indeterminate'' per regulatory authority No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Deterioration in general condition; Fever


VAERS ID: 1146519 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-03-08
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 1 LA / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-08
   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: EUTIROX; PENTOXIFILLINE; OSVICAL D
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiodepressive syndrome; Chronic venous insufficiency; Coxarthrosis; Degenerative adult scoliosis; Hypothyroidism; Low back pain; Osteoporosis; Spondyloarthrosis; Trochanteric syndrome; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021317348

Write-up: fall with bleeding at the cranial and nasal level; fall with bleeding at the cranial and nasal level; fall with bleeding at the cranial and nasal level; fall; This is a spontaneous report from a contactable other healthcare professional downloaded from a regulatory authority-WEB ES-AEMPS-795102. An 86-years-old female patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration, administered in left arm on 03Mar2021 (Lot Number: EP2166) at single dose for COVID-19 immunisation. Medical history included hypothyroidism, Type 2 diabetes, Anxiodepressive syndrome, osteoporosis, chronic venous insufficiency. Independent for basic activities of daily living. She was seen in the Rehabilitation Service on 01Feb2021. Clinical judgement: Low back pain, spondyloarthrosis, degenerative scoliosis. Right greater trochanter syndrome. Right coxarthrosis. Treatment: alternate paracetamol with metamizole magnesium (NOLOTIL) every 8h if pain. No hypertension, no dyslipidemia. No known heart disease or bronchopathy. Concomitant medications included levothyroxine sodium (EUTIROX); pentoxifylline (PENTOXIFILLINE); calcium pidolate, colecalciferol (OSVICAL D). The patient previously took calcium pidolate;colecalciferol (OSVICAL D), levothyroxine sodium (EUTIROX). It was reported that the first dose was administered and after 4 days, patient appeared deceased at her home without signs of violence. Four days after bnt162b2 administration, she was found dead on the bathroom floor. She showed signs of a fall with bleeding at the cranial and nasal level. The patient died on 08Mar2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1146520 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: General physical health deterioration
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-22
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021317421

Write-up: General physical health deterioration; This is a spontaneous report from contactable consumer downloaded from the Regulatory authority-WEB, regulatory authority report number is FI-FIMEA-20211397. An 85-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced general physical health deterioration on 14Jan2021. It was reported the patient''s condition deteriorated after vaccination and ended in death about a week after vaccination on 22Jan2021. The cause of death was unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about lot number cannot be obtained. ; Reported Cause(s) of Death: Unknown cause of death; General physical health deterioration


VAERS ID: 1146521 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Hemiparesis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-18
   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: BISOPROLOL SANDOZ; ELIQUIS; MEMANTIN ORION; COHEMIN; NIMVASTID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia Alzheimer''s type; Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: Atrial fibrillation
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021317426

Write-up: Cerebral haemorrhage/massive brain haemorrhage; right side went weak; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is FI-FIMEA-20211414. A 91-year-old male patient received bnt162b2 (COMIRNATY, Batch/Lot Number: UNKNOWN), intramuscular on 11Feb2021 as a single dose for covid-19 immunization. The patient''s medical history included atrial fibrillation and Dementia Alzheimer''s type. Concomitant medications included bisoprolol fumarate (BISOPROLOL SANDOZ) taken for atrial fibrillation; apixaban (ELIQUIS) taken for atrial fibrillation; memantine hydrochloride (MEMANTIN ORION) taken for dementia alzheimer''s type; hydroxocobalamin acetate (COHEMIN) taken for an unspecified indication; and rivastigmine hydrogen tartrate (NIMVASTID) taken for dementia alzheimer''s type. The patient experienced cerebral haemorrhage/massive brain haemorrhage on 11Feb2021. It was also reported that less than 2 hours after vaccination right side went weak and level of consciousness (not further specified). The patient died on 18Feb2021 due to cerebral haemorrhage/massive brain haemorrhage. The outcome of the event right side went weak was unknown. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: massive brain haemorrhage


VAERS ID: 1146543 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-02-18
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood culture, Body mass index, Body temperature, Bronchitis, C-reactive protein, COVID-19, Computerised tomogram thorax, Fall, Fibrin D dimer, Lymphocyte count, Lymphopenia, Oxygen saturation, Platelet count, SARS-CoV-2 test, Thrombocytopenia, Vaccination failure
SMQs:, Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Lack of efficacy/effect (narrow), Systemic lupus erythematosus (broad), Accidents and injuries (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ATORVASTATINE ARROW; NATISPRAY; XELEVIA; ELIQUIS; UVEDOSE; CATAPRESSAN [CLONIDINE HYDROCHLORIDE]; STAGID; ESCITALOPRAM ARROW; ESOMEPRAZOLE; LEVOTHYROX; KARDEGIC; AMIODARONE; ATACAND; ACEBUTOLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cecity; Coronary arterial stent insertion; Fibrillation atrial; Hypertension arterial; Hypothyroidism; Ischaemic heart disease; Type II diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210223; Test Name: Blood cultures; Result Unstructured Data: Test Result:no -negative; Test Name: BMI; Result Unstructured Data: Test Result:27.4; Comments: BMI 27,4 kg/m2; Test Name: body temperature; Result Unstructured Data: Test Result:38.2 Centigrade; Test Date: 20210223; Test Name: body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210301; Test Name: Chest CT scan; Result Unstructured Data: Test Result:multiple endobronchial secretions; Comments: Chest CT compatible with Covid-19 lung infection, moderate involvement (25-50%). Signs of associated bronchial superinfection.; Test Name: CRP; Result Unstructured Data: Test Result:39.6 mg/l; Test Date: 20210222; Test Name: CRP; Result Unstructured Data: Test Result:26.7 mg/l; Test Date: 20210223; Test Name: D-dimer; Result Unstructured Data: Test Result:1462 ng/ml; Test Date: 20210225; Test Name: D-dimer; Result Unstructured Data: Test Result:502 ng/ml; Test Date: 20210301; Test Name: D-dimer; Result Unstructured Data: Test Result:1462 ng/ml; Test Date: 20210303; Test Name: D-dimer; Result Unstructured Data: Test Result:1966 ng/ml; Test Date: 20210305; Test Name: D-dimer; Result Unstructured Data: Test Result:1095 ng/ml; Test Date: 20210222; Test Name: Lymphocytes; Result Unstructured Data: Test Result:0.74 g/l; Test Date: 20210301; Test Name: Lymphocytes; Result Unstructured Data: Test Result:0.57 g/l; Test Date: 20210303; Test Name: Lymphocytes; Result Unstructured Data: Test Result:0.82 g/l; Test Date: 20210305; Test Name: Lymphocytes; Result Unstructured Data: Test Result:0.93 g/l; Test Date: 20210223; Test Name: lymphopenia; Result Unstructured Data: Test Result:350 /mm3; Test Date: 20210223; Test Name: saturation; Test Result: 90 %; Comments: saturation room air 90%; Test Date: 20210222; Test Name: Platelets; Result Unstructured Data: Test Result:108 g/l; Test Date: 20210301; Test Name: Platelets; Result Unstructured Data: Test Result:198 g/l; Test Date: 20210303; Test Name: Platelets; Result Unstructured Data: Test Result:219 g/l; Test Date: 20210305; Test Name: Platelets; Result Unstructured Data: Test Result:188 g/l; Test Date: 20210211; Test Name: COVID-19 PCR; Result Unstructured Data: Test Result:no-negative; Test Date: 20210223; Test Name: COVID-19 PCR; Result Unstructured Data: Test Result:yes - positive; Test Date: 20210223; Test Name: thrombocytopenia; Result Unstructured Data: Test Result:100 g/l
CDC Split Type: FRPFIZER INC2021311882

Write-up: bronchial superinfection; Vaccination failure; Covid-19 infection confirmed by positive PCR; lymphopenia; thrombocytopenia; falls; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number FR-AFSSAPS-BX20211500. A 93-year-old male patient received his second dose of bnt162b2 (COMIRNATY; Lot Number: EJ6795), intramuscular on 10Feb2021 as single dose, and his first dose of bnt162b2 (COMIRNATY; Lot Number: EJ6795) intramuscular on 20Jan2021 as single dose for covid-19 immunisation, and acebutolol, via an unspecified route of administration from an unspecified date, at an unspecified dose and for an unspecified indication. The patient received the first dose of bnt162b2 (COMIRNATY; Lot Number: EJ6795) intramuscular on 20Jan2021 as single dose for covid-19 immunisationm. Medical history included type II diabetes mellitus, coronary arterial stent insertion, Ischaemic heart disease, cecity, hypertension arterial, fibrillation atrial and hypothyroidism. The patient was at high risk of severe COVID with fatal outcome. Patient resided in nursing home since Nov2020. BMI was 27,4 kg/m2. Concomitant medications included atorvastatin calcium (ATORVASTATINE ARROW), glyceryl trinitrate (NATISPRAY), sitagliptin phosphate (XELEVIA), apixaban (ELIQUIS), colecalciferol (UVEDOSE), clonidine hydrochloride (CATAPRESSAN), metformin embonate (STAGID), escitalopram oxalate (ESCITALOPRAM ARROW), esomeprazole, levothyroxine sodium (LEVOTHYROX), acetylsalicylate lysine (KARDEGIC), amiodarone (AMIODARONE) and candesartan cilexetil (ATACAND). The patient experienced vaccination failure with severe COVID-19 on 23Feb2021. No mention in the medical record of immediate post-vaccination effects. The patient had negative Polymerase Chain Reaction (PCR) on 11Feb2021. Repeated falls from 18Feb2021, with 2 emergency room visits (on 18Feb2021 and 22Feb2021), with hospitalization from 23Feb2021. After return to nursing home, new fall with presence of fever (38.2 Centigrade), bilateral crackles (present from 22Feb2021 with cough), desaturation with room air and inflammatory syndrome with CRP 39.6 mg/L (against 26.7 mg/L on 22Feb2021). On 23Feb2021 suspected vaccine failure with Covid-19 infection confirmed by positive PCR the same day, absence of specified variants. On admission, the patient had fever (38 Centigrade), saturation room air 90%, without alteration of consciousness, absence of painful complaints, bilateral and symmetrical vesicular murmur, bilateral crepitants of the bases with light predominance on the right, absence of dyspnea, signs of peripheral hypoxemia and mottles. Biological investigation on admission on 23Feb2021 showed lymphopenia (350/mm3) and thrombocytopenia (100 G/l), D-dimer 1462 ng/ml (reference value < 550 ng/ml). Initial management with amoxicillin/clavulanic acid then piperacillin/tazobactam from 01Mar2021, prednisone from 25Feb2021, worsening neurological condition with hypovigilance, diabetes de-equilibrium, hyperosmolar coma. Chest CT scan performed on 01Mar2021 showed presence of multiple endobronchial secretions, especially in the left basal pyramid, left stem bronchus. Thickening of the bronchial walls, diffuse bronchiectasis images, especially in the middle lobe, apical and dorsal segments of the right upper lobe. Mixed ground-glass infiltrate, peribroncho-vascular and subpleural, predominantly in the upper lobes, moderate involvement 25-50%. Chest CT was compatible with Covid-19 lung infection, moderate involvement (25-50%). Signs of associated bronchial superinfection. Blood cultures of 23Feb2021 was negative. The patient had unfavorable evolution with worsening of the neurological state, in spite of a control of glycemia, increase of pulmonary lesions of the COVID with death. The patient performed lab tests which included also lymphocytes (VN: 1.24-3.62 G/L): 0.74 (22Feb2021), 0.57 (01Mar2021), 0.82 (03Mar2021), 0.93 (05Mar2021); platelets (VN : 150-393 G/L): 108 (22Feb2021), 198 (01Mar2021), 219 (03Mar2021), 188 (05Mar2021); D-dimer (VN: 0-500 ng/mL): 1462 (25Feb2021), 1966 (01Mar2021), 1095 (03Mar2021), 502 (05Mar2021). The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of events falls, lymphopenia, thrombocytopenia and bronchial superinfection was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Vaccination failure; Covid-19 infection confirmed by positive PCR


VAERS ID: 1146545 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-15
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021317482

Write-up: Attack heart (NOS); This is a spontaneous report from a contactable consumer, received from the regulatory authority, downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-BX20212082. A 75-year-old male patient received the first dose of BNT162B2 (COMIRNATY, batch/lot number and expiration date unknown) via intramuscular on 03Feb2021 (unknown age at time of vaccination), at single dose, for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On Day 12 of the vaccination (15Feb2021), heart attack (NOS) with support by the firefighters and SAMU (Emergency Medical Assistance Service) for attempted resuscitation. Evolution: Death on 15Feb2021. The outcome of the event was fatal. It was unknown if an autopsy was performed. The cause of death was heart attack (NOS). No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Attack heart (NOS)


VAERS ID: 1146549 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-18
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaemia, Asthenia, Blood pressure increased, Blood pressure measurement, Blood test, Body temperature, Death, Fall, General physical health deterioration, Heart rate, Joint injury, Oxygen saturation, SARS-CoV-2 test, X-ray
SMQs:, Haematopoietic erythropenia (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Hypertension (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-12
   Days after onset: 25
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: DIGOXINE NATIVELLE; BUMETANIDE; ELIQUIS; DIFFU K
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Age-related macular degeneration; Asymptomatic COVID-19; Chronic venous insufficiency; Coxarthrosis; Decompensation cardiac; Disorder gait (history of walking disorders); Erysipelas (Erysipelas in chronic venous insufficiency); Fall; Gammopathy; High weight; Hypercalcaemia; Hypertension arterial; Hypotension orthostatic
Allergies:
Diagnostic Lab Data: Test Date: 20210118; Test Name: blood pressure; Result Unstructured Data: Test Result:12/7 mmHg; Comments: usual blood pressure 13/7; Test Date: 20210203; Test Name: blood pressure; Result Unstructured Data: Test Result:202/96 mmHg; Test Date: 20210203; Test Name: blood test; Result Unstructured Data: Test Result:8.2 g/dl; Comments: anemia; Test Date: 20210203; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Test Date: 20210203; Test Name: Heart rate; Result Unstructured Data: Test Result:83; Comments: bpm; Test Date: 20210203; Test Name: oxygen saturation; Test Result: 99 %; Test Date: 20210203; Test Name: x-ray; Result Unstructured Data: Test Result:pelvic x-ray shows a fracture; Comments: pelvic x-ray shows a fracture in the upper third of the displaced left femoral shaft that has been engrained.; Test Name: corona virus test; Test Result: Negative
CDC Split Type: FRPFIZER INC2021272543

Write-up: knee injury; Fall; Asthenia; very altered general condition; anemia; patient was found dead; Blood pressure is 202/96; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA), regulatory authority number FR-AFSSAPS-DJ20210468. A 95-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 14Jan2021 (Batch/Lot Number: EM0477) as single dose for COVID-19 immunisation. Medical history included AFib, asymptomatic COVID-19 in Apr2020, high weight, coxarthrosis, disorder gait (history of walking disorders), repeated falls, several episodes of cardiac decompensation, hypercalcaemia, hypotension orthostatic, age-related macular degeneration, gammopathy, hypertension arterial, and erysipelas in chronic venous insufficiency. Concomitant medication included digoxin (DIGOXINE NATIVELLE), bumetanide (BUMETANIDE), apixaban (ELIQUIS), and potassium chloride (DIFFU K), all taken for an unspecified indication, start and stop date were not reported. The patient experienced fall and asthenia, both on 18Jan2021. Further ADR description stated that the patient received a first dose of the COMIRNATY vaccine on 14Jan2021. On 18Jan2021, the patient presented with a fall. Her blood pressure was 12/7 (usual blood pressure 13/7). Nothing in particular was reported to the ED where the patient had been referred according to the information provided. On 03Feb2021, the patient presented 2 new falls at 1 hour interval, one of which with a knee injury prompting her transfer to the hospital. It should be noted that between 18Jan2021 and 03Feb2021, nothing specific to the patient had been reported. The observation of the Emergencies mentioned a very altered general condition. Blood pressure is 202/96 with a pulse of 83 bpm, the temperature is 36.8 and the oxygen saturation is 99% in ambient air. The pelvic x-ray shows a fracture in the upper third of the displaced left femoral shaft that has been engrained. The search for coronavirus was negative. The patient was operated on 05Feb2021 and no postoperative complications were observed. On 12Feb2021, the patient was found dead by nurses overnight. On the semiological level, this patient has a history of walking disorders with repeated falls in a context of venous insufficiency with edema of the lower limbs and difficulty in moving. In addition, the coordinating nurse reported that in general the vaccinated patients presented with fatigue following the 1st injection. Additional information on the hospital stay indicated that patient''s hospital report from 03Feb2021 to 12Feb2021 mentioned biologically the existence of an anemia at 8.2 g / dl and that it was planned to administer a transfusion of 2 red blood cells. However, the attempt to set up a peripheral venous line by the department and the anesthetists was unsuccessful. As the patient tolerated her anemia well, vitamin-martial supplementation was continued as well as biological monitoring. Therapeutic measures were taken as a result of asthenia (asthenia) and knee injury. The patient died on 12Feb2021. It was unknown if an autopsy was done. The outcome of events fall and asthenia was not recovered while fatal for ''patient was found dead''; the outcome of other events was unknown. No follow-up attempts possible. No further information expected. Information on lot# already obtained.; Reported Cause(s) of Death: patient was found dead


VAERS ID: 1146550 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-02-14
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Hypertension arterial; Infarct myocardial; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021312007

Write-up: Death unexplained; This is a spontaneous report from a contactable physician (patient) downloaded from Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-GR20210789. A 50-year-old male patient received the first dose of bnt162b2 (COMIRNATY, lot number: EJ6796), intramuscular, administered in the right arm on 26Jan2021 at 0.3 mL, single dose for COVID-19 immunisation. Medical history included atrial fibrillation (Afib), type 2 diabetes mellitus, myocardial infarction from 1996 and arterial hypertension; all unknown if ongoing. Concomitant medications were not reported. On 14Feb2021, the patient experienced death unexplained. The patient had no symptoms between the 2 dates (vaccination date and death date). Differential diagnosis was death was unrelated to the vaccine. No autopsy has been performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Event unexplained death is assessed as related until sufficient information is available to confirm an unrelated cause of death. 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 unexplained


VAERS ID: 1146552 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-03-01
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, COVID-19, Confusional state, Fall, Oxygen saturation, Oxygen saturation abnormal, SARS-CoV-2 test, Tachypnoea
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Eosinophilic pneumonia (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-07
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: GLIMEPIRIDE; INDAPAMIDE;PERINDOPRIL; KARDEGIC; NEBIVOLOL; FOLIC ACID; ANASTROZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer; Diabetes; Essential thrombocythemia; Gastrointestinal stromal tumor; Heartburn; Osteoporosis; Partial gastrectomy; Vertebral collapse
Allergies:
Diagnostic Lab Data: Test Date: 20210304; Test Name: desaturation; Test Result: 89 %; Test Date: 20210304; Test Name: COVID-19 antigen test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021311852

Write-up: COVID-19 RESPIRATORY INFECTION; ABNORMAL OXYGEN SATURATION; POLYPNOEA; MENTAL CONFUSION; FALL; ASTHENIA; This is a spontaneous report from contactable pharmacist downloaded from the regulatory authority-WEB. The regulatory authority report number is FR-AFSSAPS-LL20211120. An 86-year-old female patient received BNT162B2 (COMIRNATY, lot number and expiry date were unknown, unknown if 1st or 2nd dose), via intramuscular route on 25Feb2021 as a single dose for COVID-19 immunisation. Medical history included heartburn, GIST with partial gastrectomy, essential thrombocythemia, diabetes, breast cancer, osteoporosis with vertebral collapse. Concomitant medications included glimepiride 1 mg, indapamide/perindopril 2/0.625 mg, acetylsalicylate lysine (KARDEGIC 75 mg), nebivolol 2.5 mg/ day; folic acid 5 mg, anastrozole 1 mg/day. On 04Mar2021 7:00 p.m., the patient referred to the emergency department by her attending physician for polypnea, 89% desaturation in ambient air and confusion. According to the patient, asthenia and falls for about 3 days and diarrhea for 2 days (therefore date of onset of symptoms on 01Mar2021). COVID + Antigen test in the emergency room. On 05Mar2021, the patient was hospitalized in a COVID unit for COVID +. Medical treatment included O2 8L / min, lovenox 0.4 x 2 / day, Dexamethasone 6mg IV per day, antibiotic therapy for extensive pulmonary involvement: Cefotaxime and Rovamycin. On 06Mar2021, rapid deterioration of the patient''s state of health was reported. At 3h O2 15L / min, at 4 p.m. O2 30L / min. At 7 p.m., the patient''s vital prognosis was engaged, she received comfort care. On 07Mar2021 at 2 a.m., death of the patient was reported. Events were fatal. The cause of death was COVID19. NB: imputability without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable compensation procedures. No follow-up attempts are possible, information on batch/ lot number cannot be obtained.; Reported Cause(s) of Death: COVID19


VAERS ID: 1146566 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-09
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body mass index, Body temperature, Hyperthermia, Multiple organ dysfunction syndrome, Oxygen saturation, Oxygen saturation decreased
SMQs:, Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Accidents and injuries (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Alzheimer''s disease; Bedridden (wasting stage, BMI at 16.7) but whose condition had been stable since Aug2020); Starvation (very undernourished, wasting stage, BMI at 16.7) but whose condition had been stable since Aug2020)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: BMI; Result Unstructured Data: Test Result:16.7; Test Date: 20210309; Test Name: body temperature; Result Unstructured Data: Test Result:38 Centigrade; Comments: in the morning; Test Date: 20210309; Test Name: body temperature; Result Unstructured Data: Test Result:39 Centigrade; Comments: in the afternoon 15:00; Test Date: 20210309; Test Name: oxygen saturation; Test Result: 80 %; Comments: in the afternoon 15:00
CDC Split Type: FRPFIZER INC2021311880

Write-up: Multi-organ failure; Oxygen saturation decreased; Hyperthermia; This is a spontaneous report received from a contactable pharmacist downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-MP20210493. A 96-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 04Mar2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history included bedridden, starvation (reported as very undernourished) (wasting stage, BMI at 16.7) but whose condition had been stable since Aug2020, Alzheimer''s disease (very advanced) all ongoing. The patient''s concomitant medications were not reported. It was reported from a declaration made by a healthcare professional from 09Mar2021, 5 days after a vaccination by Comirnaty (04Mar2021) fever (38 C in the morning) without respiratory signs, was no point to call for examination (suspecting infection ), later fever increased to 39 C in the afternoon (15:00) with desaturation (sat 80%) (reported as Hyperthermia and Oxygen saturation decreased) which did not improve under oxygen. The patient was referred to the emergency room at 17:00. where she died in the evening. The patient underwent lab tests and procedures which included body mass index: 16.7 on unspecified date, body temperature: 38 centigrade on 09Mar2021 in the morning , body temperature: 39 centigrade on 09Mar2021 in the afternoon 15:00, oxygen saturation: 80 % on 09Mar2021 in the afternoon 15:00. The patient died on 09Mar2021. An autopsy was not performed. It was noted that the cause of death was multi organ failure. Lot number not specified. Immunization dose no not specified. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Multi-organ failure


VAERS ID: 1146567 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-16
Onset:2021-02-19
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Diabetes mellitus management, Diabetic coma
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LEVEMIR; NOVORAPID; REPAGLINIDE; APIXABAN; ATENOLOL; SERTRALINE; MACROGOL; VITAMIN D [VITAMIN D NOS]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Diabetes mellitus (relatively balanced diabetes); Ischemic heart disease
Allergies:
Diagnostic Lab Data: Test Date: 20210126; Test Name: blood sugar; Result Unstructured Data: Test Result:4.85 g/l; Comments: Evening blood sugar; Test Date: 20210126; Test Name: blood sugar; Result Unstructured Data: Test Result:1.41 g/l; Comments: morning blood sugar; Test Date: 20210127; Test Name: blood sugar; Result Unstructured Data: Test Result:1.52 g/l; Comments: in the morning; Test Date: 20210127; Test Name: blood sugar; Result Unstructured Data: Test Result:2.07 g/l; Comments: in the evening; Test Date: 20210128; Test Name: blood sugar; Result Unstructured Data: Test Result:1.02 g/l; Comments: in the morning; Test Date: 20210128; Test Name: blood sugar; Result Unstructured Data: Test Result:3.67 g/l; Comments: in the evening; Test Date: 20210129; Test Name: blood sugar; Result Unstructured Data: Test Result:1.58 g/l; Comments: in the morning; Test Date: 20210130; Test Name: blood sugar; Result Unstructured Data: Test Result:1.68 g/l; Comments: in the morning; Test Date: 20210130; Test Name: blood sugar; Result Unstructured Data: Test Result:2.96 g/l; Comments: in the evening; Test Date: 20210131; Test Name: blood sugar; Result Unstructured Data: Test Result:0.92 g/l; Comments: in the morning; Test Date: 20210131; Test Name: blood sugar; Result Unstructured Data: Test Result:3.4 g/l; Comments: in the evening; Test Date: 20210201; Test Name: blood sugar; Result Unstructured Data: Test Result:1.36 g/l; Comments: in the morning; Test Date: 20210201; Test Name: blood sugar; Result Unstructured Data: Test Result:2.05 g/l; Comments: in the evening; Test Date: 20210202; Test Name: blood sugar; Result Unstructured Data: Test Result:1.09 g/l; Comments: in the morning; Test Date: 20210202; Test Name: blood sugar; Result Unstructured Data: Test Result:3.3 g/l; Comments: in the evening; Test Date: 20210216; Test Name: blood sugar; Result Unstructured Data: Test Result:0.99 g/l; Comments: in the morning; Test Date: 20210217; Test Name: blood sugar; Result Unstructured Data: Test Result:2.38 g/l; Comments: in the morning; Test Date: 20210217; Test Name: blood sugar; Result Unstructured Data: Test Result:3.49 g/l; Comments: in the evening; Test Date: 20210218; Test Name: blood sugar; Result Unstructured Data: Test Result:1.16 g/l; Comments: in the morning; Test Date: 20210218; Test Name: blood sugar; Result Unstructured Data: Test Result:3.94 g/l; Comments: in the evening; Test Date: 20210219; Test Name: blood sugar; Result Unstructured Data: Test Result:2.28 g/l; Comments: in the morning
CDC Split Type: FRPFIZER INC2021312038

Write-up: Coma diabetic; This is a spontaneous report from a contactable physician downloaded from the Regulatory authority -WEB. The regulatory authority report number is FR-AFSSAPS-NC20210868. A 92-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, the second dose on 16Feb2021 (Lot Number: EJ6788) on the right arm and the first dose on 26Jan2021 (Lot number was not reported), both as single dose for COVID-19 immunization. Medical history included dementia, ischemic heart disease, diabetes (relatively balanced and treatment given by registered nurse therefore good compliance) all from an unknown date. Concomitant medications included insulin detemir (LEVEMIR); insulin aspart (NOVORAPID); repaglinide (REPAGLINIDE); apixaban; atenolol; sertraline; macrogol; and vitamin D all taken for an unspecified indication, start and stop date were not reported. The patient experienced diabetic coma on 19Feb2021 15:00 (3 pm) and died thereafter despite hospitalization. The patient underwent lab tests and procedures which included blood sugar - 26Jan2021: morning blood sugar 1.41 g / l, evening blood sugar 4.85 g / L. 27Jan2021: blood sugar 1.52 g / L in the morning and 2.07 g / L in the evening. 28Jan2021: blood sugar 1.02 g / L in the morning and 3.67 g / L in the evening. 29Jan2021: blood sugar 1.58 g / L in the morning. 30Jan2021: blood sugar 1.68 g / L in the morning and 2.96 g / L in the evening. 31Jan2021: glycemia 0.92 g / L in the morning and 3.4 g / L in the evening. 01Feb2021: blood sugar 1.36 g / L in the morning and 2.05 g / L in the evening. 02Feb2021: blood sugar 1.09 g / L in the morning and 3.3 g / L in the evening. 16Feb2021: morning blood sugar 0.99 g / L. 17Feb2021: blood sugar 2.38 g / L in the morning and 3.49 g / L in the evening. 18Feb2021: blood sugar 1.16 g / L in the morning and 3.94 g / L in the evening. 19Feb2021: blood sugar 2.28 g / L in the morning. The patient died on 19Feb2021. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about lot/batch number of the first dose cannot be obtained. No further information is expected.; Reported Cause(s) of Death: diabetic coma


VAERS ID: 1146572 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-03-08
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM6950 / 2 LA / OT

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-03-08
   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: METHOTREXATE; SPECIAFOLDINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anemia iron deficiency; Arthritis rheumatoid; Asthma; Breast calcifications (microcalcifications next to the upper outer quadrant of the right breast); Bronchial hyperreactivity; Calculus kidney (left renal calcium lithiasis (calcium and magnesium oxalate)); Cervical tumor excision; Chronic sinusitis (chronic allergic sinusitis); COPD; Cyst of kidney (Bosniak 2); Inflammatory rheumatism; Jaundice; Left ventricular hypertrophy; Migraine (tendency to migraines); Pulmonary arterial hypertension; Rhizomelic pseudopolyarthritis; Widal syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021317407

Write-up: Cardio-respiratory arrest; Hypotension; Arrhythmia NOS; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB FR-AFSSAPS-NY20210568. An 82-year old male patient received second dose of BNT162B2 (COMIRNATY), batch number EM6950, intramuscular on the left arm on 05Mar2021 at single dose for COVID-19 immunization. Relevant medical history included viral jaundice, chronic allergic sinusitis, tendency to migraines, left renal calcium lithiasis from Sep1967 (calcium and magnesium oxalate), without argument for progressive acute arthritis of the joints with diagnosis of rhizomelic pseudopolyarthritis, microcalcifications next to the upper outer quadrant of the right breast (Aug2007), ventilatory constants at the limit of normal, possibly reflecting bronchial hyperreactivity (Dec2009), iron deficiency anemia (Jun2010), strong suspicion of Fernand Widal with significant obstructive disorders requiring the establishment of a basic treatment, chronic inflammatory rheumatism and initiation of treatment with methotrexate (10 mg per week) combined with folic acid (SPECIAFOLDINE), cystic formation of the upper pole of the right kidney, labeled Bosniak 2, suspected of malignancy (May2012).,Ii Jan2015 (renal ultrasound), Bosniak 2, without suspicious character, hypertension with moderate concentric left ventricular hypertrophy, contractile left ventricle, no dilation of left atrium, moderate pulmonary arterial hypertension (Nov2017), asthma, chronic obstructive pulmonary disease (COPD), excision of a cervical carcinoma (without further details) in Jan2020. Concomitant medications included methotrexate and folic acid. On 08Mar2021, the patient felt a rhythm disturbance and hypotension. Intervention of the medical services and death of the patient. Report from the emergency department who visited the patient: Cardio-respiratory arrest around 19:25 (no flow 3 minutes), witness massage. 30 min Semi-automatic defibrillator, 11 mg of adrenaline. Suspected cause: cardiac. Imputability (according to the French method): I1 (dubious). NB: Accountability without prejudice to the elements of investigations which could be carried out within the framework of legal or amicable compensation procedures. No follow-up attempts are possible, no information is expected.; Reported Cause(s) of Death: Cardio-respiratory arrest; Arrhythmia NOS; Hypertension


VAERS ID: 1146575 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-17
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021312012

Write-up: Sudden death; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB FR-AFSSAPS-PA20210354. A 75-year-old male patient received the first dose of bnt162b2 (COMIRNATY; batch/lot number and expiration date unknown), intramuscular on 11Feb2021 at 0.3 mL, single for covid-19 immunisation. The patient has no medical history. The patient is athletic (100 km by bike per month). The patient''s concomitant medications were not reported. It was reported that the patient was doing very well and even said "I wonder if I have been injected with something because I don''t feel anything". On 17Feb2021, the patient suddenly died. It was reported that when leaving the bike, the patient was found near his bike, inanimate. The emergency services were unable to revive him. An autopsy was not performed. NB: Imputation made "without prejudice to the elements of investigations which could be carried out within the framework of legal or amicable compensation procedures". No follow-up attempts are possible. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1146576 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-02-15
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021311820

Write-up: Cerebrovascular accident/Stroke progressing to death; This is a spontaneous report from a contactable physician downloaded from the Regulatory authority-WEB FR-AFSSAPS-PA20210368. A 76-year-old male patient received first dose of bnt162b2 (COMIRNATY; Lot Number: EM0477), intramuscularly administered into the left arm on 26Jan2021 as 0.3 mL, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced cerebrovascular accident; further reported as a stroke progressing to death on 15Feb2021. The patient died on 15Feb2021 and it was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cerebrovascular accident/Stroke progressing to death


VAERS ID: 1146582 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-30
Onset:2021-02-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 LA / OT

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: 2021-02-02
   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: Triple vessel bypass graft
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 test; Test Result: Negative
CDC Split Type: FRPFIZER INC2021317502

Write-up: Death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB regulatory authority FR-AFSSAPS-RE20210740. An 86-year-old male patient received BNT162B2 (COMIRNATY, lot number: EJ6788) second dose on 30Jan2021 intramuscular on left arm at single dose for COVID-19 immunisation. Medical history included Triple vessel bypass graft from 2003 and unknown if ongoing. Concomitant medications were not reported. Patient considered to be at risk of developing a severe form of COVID-19 disease, not having contracted COVID-19. Completion of a COVID-19 virus test on unknown date with result of negative. On 02Feb2021, death of the patient at 6:00 p.m. (without further details). Unknown if autopsy was done or not. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: death


VAERS ID: 1146592 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-02-27
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021313500

Write-up: Pulmonary embolism; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number: GB-MHRA-WEBCOVID-202103211025417290, Safety Report Unique Identifier: GB-MHRA-ADR 24991463. A 64-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; batch/lot number: Not known, Expiration Date: not reported), via an unspecified route of administration on 10Feb2021 as single dose for COVID-19 immunisation. Patient''s medical history and concomitant medications were not reported. The patient has not had symptoms associated with COVID-19, not had a COVID-19 test and was not enrolled in clinical trial. The patient experienced pulmonary embolism on 27Feb2021. The patient has not tested positive for COVID-19 since having the vaccine. The event was assessed as fatal and medically significant. The patient died on 27Feb2021. Outcome of the event was fatal. It was unknown if an autopsy was performed. Reported cause of death was pulmonary embolism. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Pulmonary embolism


VAERS ID: 1146595 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Brain death, Cerebral haemorrhage, Haematoma, Magnetic resonance imaging, Memory impairment, Pyrexia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-15
   Days after onset: 41
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: Parkinson''s disease (under treatment)
Allergies:
Diagnostic Lab Data: Test Date: 202102; Test Name: Blood test; Result Unstructured Data: Test Result:no infection; Test Date: 2021; Test Name: MRI; Result Unstructured Data: Test Result:hematoma
CDC Split Type: GRPFIZER INC2021333091

Write-up: brain dead; memory "gaps"; hematoma; Cerebral hemorrhage; fever; This is a spontaneous report from a contactable consumer. An elderly male patient received BNT162b2 (COMIRNATY; Lot Number: UNKNOWN), intramuscular in Feb2021 (around 20Feb2021) as a single dose for COVID-19 immunisation. Medical history included Parkinson''s disease (under treatment) from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. In Feb2021, a day following the vaccination, the patient experienced fever that was not subsiding. A blood test did not reveal any infection. After 4-5 days (Feb2021), he experienced memory "gaps". He went to the hospital and underwent a magnetic resonance imaging (MRI) that revealed hematoma (2021). The neurologist considered that he would recover in 1 month and that he would not be impressed if the event was due to the vaccine. A day later the patient showed a significant aggravation and the patient was transferred to another hospital where he was pronounced brain dead on 14Mar2021. On 15Mar2021, the following day, he died due to cerebral hemorrhage. No autopsy was performed. The clinical outcomes of the fever, memory "gaps", hematoma, and brain death were unknown at the time of death. No follow-up attempts are possible; information about lot number cannot be obtained. ; Reported Cause(s) of Death: Cerebral hemorrhage


VAERS ID: 1146598 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-13
Onset:2021-03-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Blood gases, Chest X-ray, Electrocardiogram, Investigation, Pneumonia, SARS-CoV-2 test, Thrombocytopenia
SMQs:, Anaphylactic reaction (broad), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anticoagulant therapy; Chronic atrial fibrillation; Diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: Blood gas analysis; Result Unstructured Data: Test Result:unknown result; Test Name: high flows chest x-ray; Result Unstructured Data: Test Result:unknown result; Test Name: ECG; Result Unstructured Data: Test Result:unknown result; Test Name: Laboratory tests; Result Unstructured Data: Test Result:unknown result; Test Name: Resuscitation evaluation; Result Unstructured Data: Test Result:unknown result; Test Date: 20210314; Test Name: sars cov-2 test; Test Result: Negative ; Test Date: 20210314; Test Name: Thrombopenia; Result Unstructured Data: Test Result:positive;2000
CDC Split Type: ITPFIZER INC2021317720

Write-up: right lobar pneumonia; acute severe scc thrombocytopenia; serious respiratory failure; This is a spontaneous report from a contactable physician downloaded from the WEB IT-MINISAL02-699360. A 89-years-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 13Mar2021 15:16 (Lot Number: ET1831; Expiration Date: 30Jun2021) as 0.3 mL, single for covid-19 immunisation. Medical history included Chronic atrial fibrillation, diabetes mellitus, anticoagulant therapy. The patient''s concomitant medications were not reported. The patient experienced serious respiratory failure, acute severe scc thrombocytopenia with right lobar pneumonia, sars cov-2 test negative on 14Mar2021. The patient was on arrival in the emergency room oxygen therapy with high flows chest x-ray at the bed. Blood gas analysis. Resuscitation evaluation. Laboratory tests. ECG. Pharmacological and infusion therapy. The laboratory reports serious thrombocytopenia (positive; 2000) on 14Mar2021. The patient died on an unspecified date. It was not reported if an autopsy was performed. ; Reported Cause(s) of Death: serious respiratory failure, acute severe scc thrombocytopenia with right lobar pneumonia; serious respiratory failure, acute severe scc thrombocytopenia with right lobar pneumonia; serious respiratory failure, acute severe scc thrombocytopenia with


VAERS ID: 1146599 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-03-11
Onset:2021-03-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Disorientation, Oropharyngeal pain
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-15
   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: CRESTOR; LASIX LIQUIDUM; LANTUS; OLPRESS; PANTOPRAZOLE; APIDRA; NITRODERM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac disorder; Diabetes
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021312443

Write-up: appearance of pharyngodynia; covid vaccination with Pfizer vaccine performed on 11Mar2021, onset of symptoms on 12MAR2021 asthenia and disorientation, slight worsening on 13Mar2021, death in the night between; covid vaccination with Pfizer vaccine performed on 11Mar2021, onset of symptoms on 12Mar2021 asthenia and disorientation, slight worsening on 13Mar2021, death in the night between; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-700181. An 84-year-old patient of an unspecified gender received first dose of bnt162b2 (COMIRNATY), intramuscular, administered in Arm Right on 11Mar2021 (Lot Number: ET1831) as single dose for covid-19 immunisation. Medical history included diabetes and cardiopathy. Concomitant medications included rosuvastatin calcium (CRESTOR) taken for an unspecified indication, start and stop date were not reported; furosemide sodium (LASIX LIQUIDUM) taken for an unspecified indication, start and stop date were not reported; insulin glargine (LANTUS) taken for an unspecified indication, start and stop date were not reported; olmesartan medoxomil (OLPRESS) taken for an unspecified indication, start and stop date were not reported; pantoprazole (PANTOPRAZOLE) taken for an unspecified indication, start and stop date were not reported; insulin glulisine (APIDRA) taken for an unspecified indication, start and stop date were not reported; glyceryl trinitrate (NITRODERM) taken for an unspecified indication, start and stop date were not reported. It was reported covid vaccination with pfizer vaccine performed on 11Mar2021, onset of symptoms on 12Mar2021 asthenia and disorientation, slight worsening on 13Mar2021, death in the night between. The patient died on 15Mar2021 (as reported). It was not reported if an autopsy was performed. Reporter''s Comment: Pfizer covid vaccine 11Mar2021 onset of symptoms on 12Mar2021 asthenia and mild disorientation, slight worsening with the appearance of pharyngodynia the following day and death in the night between 14 and 15Mar2021. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Pfizer covid vaccine 11Mar2021 onset of symptoms on 12Mar2021 asthenia and mild disorientation, slight worsening with the appearance of pharyngodynia the following day and death in the night between 14 and 15Mar2021.; Reported Cause(s) of Death: Asthenia; disorientation; appearance of pharyngodynia


VAERS ID: 1146600 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-03-11
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021311729

Write-up: Sudden death (suspected cardiac); This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is IT-MINISAL02-700615. An 88-year-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: EP2166), Intramuscularly on Left arm on 03Mar2021 18:54, at single dose for covid-19 immunisation. The patients medical history and concomitant medications were not reported. The physician reported for temporal correlation but, death not related to vaccination. The clinical report will be sent. The outcome of event was Fatal. No follow-up attempts possible. No further information expected.; Reporter''s Comments: reported only for temporal correlation but in my opinion death not related to vaccination; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product to the event cannot be totally excluded. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1146602 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-03-15
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Computerised tomogram, Death, Pneumonia, Pulmonary embolism, Thrombosis, Ultrasound scan
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-15
   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: ACENOCOUMAROL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anemia normocytic; Sarcoidosis
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:unknown results; Test Name: CT scan; Result Unstructured Data: Test Result:unknown results; Test Name: ultrasound; Result Unstructured Data: Test Result:unknown results
CDC Split Type: NLPFIZER INC2021317680

Write-up: First pneumonia, soon after the vaccine. Treated with antibiotics.; Then thrombotic leg, pulmonary embolism was diagnosed in hospital. Probably died of this.; Then thrombotic leg, pulmonary embolisms diagnosed in hospital. Probably died of this.; Death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB NL-LRB-00476543, received from Regulatory Authority. An 87-years-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 17Feb2021 (Batch/Lot Number: Unknown) as SINGLE DOSE for covid-19 immunisation. Medical history included Anemia normocytic and sarcoidosis. There was no previous COVID-19 infection. Concomitant medication(s) included acenocoumarol. The patient experienced first pneumonia, soon after the vaccine. Treated with antibiotics. Then thrombotic leg, pulmonary embolisms diagnosed in hospital. Probably died of this. The patient was hospitalized for 4 days. Death was 26 days after start (15Mar2021). Death, lung embolism, thrombosis leg and pneumonia were all treated with Fraxiparine (as reported). The diagnostic procedures included: CT scan, ultrasound, blood tests. Confounding factors included sarcoidosis and possible lymphoma (unknown). The patient died on 15Mar2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reporter''s Comments: Comirnaty. Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no Death Hospitalization information: 4 days ADR info: First pneumonia, soon after the vaccine. Treated with antibiotics.Then thrombotic leg, pulmonary embolisms diagnosed in hospital. Probably died of this. Patient number available: yes Confounding factors: Sarcoidosis. Possible lymphoma (unknown). COVID-19 Previous COVID-19 infection: No. diagnostic procedures: CT scan, ultrasound, blood tests.; Reported Cause(s) of Death: thrombotic leg; pulmonary embolism; death; pneumonia


VAERS ID: 1146603 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-06
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-12
   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: Atrial fibrillation
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021317676

Write-up: on day 3 after vaccination (6/03/2021) stroke with right hemiplegia and then died on 12/03/21; This is a spontaneous report from a contactable Physician downloaded from the Agency Regulatory Authority-WEB NL-LRB-00479029. An 89-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 04Mar2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history included atrial fibrillation. The patient''s concomitant medications were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY, solution for injection) at 0.3 ml on 04Feb2021 for covid-19 immunisation with no adverse reactions. On day 3 after vaccination (06Mar2021), the patient experienced stroke with right hemiplegia and then died on 12Mar2021. Cause of death reported as Cerebrovascular accident(CVA). It was not reported if an autopsy was performed. Health Authority Comment: BioNTech / Pfizer vaccine (Comirnaty). Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): yes ADRs: none Date: 04Feb2021. Confounding factors: Atrial fibrillation. Previous COVID-19 infection: No. Other diagnostic procedures: no additional examinations. No follow-up attempts possible. No information expected. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: cva


VAERS ID: 1146604 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-10
Onset:2021-03-15
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BECLOMETASONE;FORMOTEROL;GLYCOPYRRONIUM; SIMVASTATINE; OMEPRAZOLE; CARBASALATE CALCIUM; ALENDRONIC ACID; PROPRANOLOL; CALCIUM CARBONATE W/VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021317715

Write-up: Cardiac arrest; Shortness of breath/ dyspnoea; This is a spontaneous report from a contactable consumer or other non-HCP downloaded from the Regulatory Authority NL-LRB-00479712. An 81-year-old female patient received first dose of BNT162B2 (COMIRNATY, Lot Number: EP2166), via an unspecified route of administration on 10Mar2021 at age of 81-year-old at single dose for COVID-19 immunisation. The patient''s medical history was not reported. Concomitant medications included beclomethasone/ formoterol/ glycopyrronium, simvastatine, omeprazole, carbasalate calcium, alendronic acid, propranolol, calcium carbonate/ colecalciferol (CALCIUM CARBONATE W/ VITAMIN D). No diagnostic procedures. No previous COVID-19 infection. On 15Mar2021, 5 days after BNT162B2, the patient experienced cardiac arrest and Shortness of breath/ dyspnoea. The outcome of events cardiac arrest and shortness of breath/ dyspnoea was fatal. The patient died on Mar2021. 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; Dyspnoea


VAERS ID: 1146605 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Petechiae
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-23
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SOBRIL; MORFIN [MORPHINE]; ZYPREXA; MIDAZOLAM PANPHARMA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; General physical health deterioration; Living in nursing home; Pain
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021317768

Write-up: FRAILTY; Expected death 12 days after vaccination. Had widespread petechia. Warns now in retrospect as it was not originally intended to be a side effect; This is a spontaneous report from a contactable physician downloaded from the Regulatory authority-WEB NO-NOMAADVRE-FHI-2021-Uj3gpm, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00022382. A 92-years-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 11Feb2021 10:00 (Batch/Lot Number: Unknown) as SINGLE DOSE for covid-19 immunisation. Medical history included Living in nursing home, poor general condition, pain and anxiety. Concomitant medication(s) included oxazepam (SOBRIL) taken for anxiety; morphine (MORFIN) taken for pain; olanzapine (ZYPREXA); and midazolam hydrochloride (MIDAZOLAM PANPHARMA) taken for anxiety. Expected death 12 days after vaccination. Had widespread petechia. Warns now in retrospect as it was not originally intended to be a side effect. When they started vaccinating at her nursing home, the patient was initially not considered for vaccination due to poor general condition. Then her condition improvement somewhat; she was up during the day, ate and showed improved function. As she stayed at the nursing home with a reasonably healthy spouse, the staff decided to let her get vaccinated. A while after the vaccination her condition deteriorated again, and she died 23Feb2021 (12 days after vaccination). The physician considered this to be an expected death. After death though, he noticed that she had widespread tightly packed small petechia on her body, to such an extent he hadn?t seen before. He considered that it was probably neither meningitis nor sepsis, and since the death was expected, he did not carry out any further tests/examinations. Start date for the petechia were reported to 11Feb2021, but this was not clear from the description of the event exactly when the petechia first appeared. The reporter emphasized that he still did not believe that the patient died due to the vaccination, but he chose to report this case retrospectively due to the latest reports of a similar picture with the AstraZeneca vaccine. The reaction was severe and fatal. Comirnaty to the petechia, reported as possible by Pharmacovigilance Center. The patient died on 23Feb2021. An autopsy was not performed. Reporter''s comment: The patient was frail and the death expected. The reporter noticed though (possibly after death, but start date is not clearly stated), that the patient had widespread tightly packed small petechia on her body, to such an extent he hadn?t seen before. He considered that it was probably neither meningitis nor sepsis, and since the death was expected, he did not carry out any further tests/examinations. Sender Comment: Thank you for reporting a suspected side effect after vaccination. The information is registered in the national adverse reaction register (at 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. When vaccinating patients with frailty who are ill with many underlying diseases, some serious events, including death, may occur shortly after vaccination without any connection to vaccination. However, it cannot be excluded 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 was caused by the vaccine, the patient''s underlying disease or something else coincidental that has nothing to do with the current vaccination. When it comes to increased bleeding tendency, this is something that the Medicines Agency authorities pay special attention to in covid-19 vaccines, and therefore it is important to report such reactions like this (1). Causal assessment: The patient, an elderly frail woman, died twelve days after the vaccination, and the death is stated to be expected. However, it was observed that the patient had stated pethecia, and there is no evidence that the patient used blood-thinning medication. On the basis of the information in the report and in accordance with international criteria, the causal relationship with vaccination is assessed as possible. A possible causal relationship is defined as a reaction, including pathological laboratory tests, which occurs in a temporal relation to the use of a drug, but which may also be due to an underlying disease, other drugs or chemicals. Since the patient''s death, the message is classified as serious, even though no causal relationship between the vaccine and the death has been established. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reporter''s Comments: The patient was frail and the death expected. The reporter noticed though (possibly after death, but start date is not clearly stated), that the patient had widespread tightly packed small petechia on her body, to such an extent he hadn?t seen before. He considered that it was probably neither meningitis nor sepsis, and since the death was expected, he did not carry out any further tests/examinations.; Reported Cause(s) of Death: FRAILTY; WIDESPREAD PETECHIA


VAERS ID: 1146606 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Cardio-respiratory arrest, General physical health deterioration, Hyperkalaemia, Investigation, Loss of consciousness, Malaise, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dialysis (for several years); Renal insufficiency; SARS-CoV-2 infection (declared cured)
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: analysis; Result Unstructured Data: Test Result:hyperkalemia
CDC Split Type: ROPFIZER INC2021323216

Write-up: his health condition worsened progressively; he felt ill, his condition deteriorating subsequently; his health condition worsened progressively; he felt ill, his condition deteriorating subsequently; fever; cardio-respiratory arrest; hyperkalemia which led to a rhythm disorder and subsequently to cardio respiratory arrest; hyperkalemia which led to a rhythm disorder and subsequently to cardio respiratory arrest; the patient was unconscious; This is a spontaneous report from a non-contactable consumer. This report was received via a sales representative. A 35-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 19Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history reported as follows: the patient had been doing regular, for several years, dialysis being diagnosed with renal insufficiency. He suffered from SARS-Cov2 infection, but was declared cured. The patient''s concomitant medications were not reported. The patient was vaccinated at the dialysis center with the second dose of bnt162b2 on 19Mar2021. After administration of the vaccine, he did not accuse any adverse reactions, and subsequently the patient followed the dialysis session. He left the dialysis center without any problems. His health condition worsened progressively starting with the evening of 19Mar2021, he felt ill, his condition deteriorating subsequently, when he accused the appearance of fever. During the evening from Saturday to Sunday, the patient''s family called the emergency phone number requesting medical assistance as the patient was unconscious. The patient made a cardio-respiratory arrest being resuscitated by the ambulance staff. Arriving at the emergency room, the patient again went into cardio-respiratory arrest without responding to resuscitation maneuvers. Agency declares that the death was not related to the vaccination, and the analyzes performed at the emergency reception unit showed a hyperkalemia which led to a rhythm disorder and subsequent to cardio respiratory arrest. The outcome of event cardio-respiratory arrest was fatal, of other events was unknown. The patient died about 48 hours after being immunized with the second dose of the COVID-19 vaccine. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected. The information about lot number cannot be obtained.; Reported Cause(s) of Death: cardio-respiratory arrest


VAERS ID: 1146608 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PAA164811 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   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: TROMBYL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Multimorbidity
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021317774

Write-up: Cerebral bleeding; This is a spontaneous report from a contactable physician downloaded from the Regulatory authority-WEB, regulatory authority number SE-MPA-2021-019617. Other case identifier number SE-MPA-1615821519629. An 83-year-old male patient received bnt162b2 (COMIRNATY) (Batch/lot number: PAA164811) in Mar2021 at single dose for COVID-19 immunisation. Medical history included multimorbidity. Concomitant medication included acetylsalicylic acid (TROMBYL). Patient experienced cerebral bleeding which occurred 10 days after vaccination (Mar2021). The outcome of the event was fatal. Report assessed as serious, death. Patient died in Mar2021 due to cerebral haemorrhage. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cerebral bleeding


VAERS ID: 1146624 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-11
Onset:2021-03-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Loss of consciousness, Malaise, Syncope, Wheezing
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SUPRARENIN [EPINEPHRINE]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SIPFIZER INC2021317270

Write-up: General malaise/felt unwell; Wheezed; Loss of consciousness; fainted; This is a spontaneous report from a contactable physician downloaded from the Regulatory authority-WEB SI-JAZMP-NCPHV-2021SI0321_0321. A 90-year-old female patient received the second dose of BNT162B2 (COMIRNATY, lot number ER7812, exp. d: 30Jun2021) via intramuscular on 11Mar2021 for COVID-19 prophylactic vaccination. The patient''s medical history was not reported. Concomitant therapy included suprarenin on 12Mar2021. On 12 Mar2021 the patient general malaise/felt unwell (lasted for 30 mins), wheezed, fainted, lost consciousness and died. Reported by the emergency physician, the patient was resuscitated. The outcome of event fainted was unknown, outcome of other events were fatal. Sender Comment: Follow up data ris expected along with the assessment. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: General malaise; Wheezed; Loss of consciousness


VAERS ID: 1146792 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-12
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Circulatory collapse
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: 2021-03-01
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021320723

Write-up: Circulatory collapse; This is a spontaneous report received from a contactable other Health Professional via the Regulatory Authority. Regulatory authority report number is 523503. An 83-year-old female patient received BNT162B2 (reported as "COVID-19 Vaccine (Type not specified)", Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Suspect (0 days) and experienced Circulatory collapse on set date 12Mar2021 with fatal outcome. The patient died on an unspecified date in Mar2021. It was not reported if an autopsy was performed. Follow up attempts not needed, no further information expected. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Circulatory collapse


VAERS ID: 1146793 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-03-11
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: General physical health deterioration
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021320784

Write-up: General physical health deterioration; This is a spontaneous report from a contactable other Health Professional. This is a spontaneous report received from the Regulatory Authority. Regulatory authority report number is 524083. A 77-year-old male patient received BNT162B2 (COMIRNATY, Lot number was not reported), via an unspecified route of administration on 03Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Suspect (8 days) and experienced general physical health deterioration onset date 11Mar2021 with a fatal outcome. The patient died on an unspecified date in Mar2021. It was not reported if an autopsy was performed. No follow up attempts are needed, no further information is expected. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: General physical health deterioration


VAERS ID: 1146810 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-14
Onset:2021-03-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic aneurysm, Aortic dissection, Cardiogenic shock, Computerised tomogram thorax, Echocardiogram, Electrocardiogram, Haemothorax
SMQs:, Cardiac failure (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Accidents and injuries (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: CT-Thorax; Result Unstructured Data: Test Result:Diagnosis confirmed; Comments: Cardiogenic shock and Hemothorax and Dissecting aortic aneurysm; Test Name: Echo; Result Unstructured Data: Test Result:Diagnosis confirmed; Comments: Cardiogenic shock and Hemothorax and Dissecting aortic aneurysm; Test Name: EKG; Result Unstructured Data: Test Result:Diagnosis confirmed; Comments: Cardiogenic shock and Hemothorax and Dissecting aortic aneurysm
CDC Split Type: DEPFIZER INC2021317739

Write-up: Aortic dissection; Aortic aneurysm; Cardiogenic shock; Hemothorax; This is a spontaneous report received from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is DE-PEI-PEI2021003600. An 80-year-old female patient received first dose of bnt162b2 (COMIRNATY, Lot Number: ER2659), via an unspecified route of administration on 14Mar2021 (at age of 80 years old) at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced aortic dissection/ Dissecting aortic aneurysm, aortic aneurysm, cardiogenic shock and hemothorax on 15Mar2021 (also reported as 2 day(s) after vaccination). Events were reported as fatal. The patient was dead. Diagnosis was confirmed by Echo (Echocardiogram), CT-Thorax (Computerised tomogram thorax), EKG (Electrocardiogram) on unknown date. Death cause was reported as Aortic aneurysm rupture. The patient died on 15Mar2021. It was unknown if an autopsy was performed. No follow-up attempts possible. No further information expected. Information on lot# already obtained.; Reported Cause(s) of Death: Aortic dissection/Dissecting aortic aneurysm; Aortic aneurysm; Cardiogenic shock; Hemothorax; Aortic aneurysm rupture


VAERS ID: 1146816 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-02-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Respiration abnormal
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiovascular disease, unspecified (Cardiovascular disease (excluding HTA)); Hypertension arterial (HTA)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021317342

Write-up: Respiration abnormal; This is a spontaneous report from a contactable other health care professional downloaded from the Agency Regulatory Authority-WEB ES-AEMPS-795075. A 92-years-old female patient received the first dose of bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP9598), via an unspecified route of administration on arm left on 18Feb2021 as SINGLE DOSE for covid-19 immunisation. Medical history included hypertension arterial (HTA), cardiovascular disease (excluding HTA). The patient''s concomitant medications were not reported. The patient experienced respiration abnormal on 19Feb2021 and caused death. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of the event was fatal. No follow-up attempts possible. No information expected.; Reported Cause(s) of Death: respiration abnormal


VAERS ID: 1146818 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-02-09
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Scan myocardial perfusion
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EXELON [RIVASTIGMINE]; MEMANTINE MERZ; TRIOBE [CYANOCOBALAMIN;FOLIC ACID;PYRIDOXINE HYDROCHLORIDE]; DIVISUN; AVODART; CALCICHEW D3 APPELSIINI
Current Illness: Alzheimer''s disease; Living in nursing home
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: heart film; Result Unstructured Data: Test Result:he was in good shape due to his athletic; Comments: background and he had a strong heart
CDC Split Type: FIPFIZER INC2021317416

Write-up: Death; This is a spontaneous report from a contactable consumer, downloaded from the Regulatory Authority-WEB FI-FIMEA-20211120. An 80-year-old male patient (reporter''s father) received BNT162B2 (COMIRNATY) via an unspecified route of administration on 29Jan2021 (Batch/Lot Number: UNKNOWN) at single dose for COVID-19 immunization. Medical history included ongoing advanced Alzheimers and ongoing living in nursing home. No allergies. No reactions to vaccines in the past. The patient had had a heart film taken maybe a year/ couple of years earlier and his own geriatrician said that despite the memory impairment, the father might well live up to ten years, because he was in good shape due to his athletic background and he had a strong heart. Concomitant medications included rivastigmine (EXELON) for dementia alzheimer''s type; memantine hydrochloride (MEMANTINE MERZ) for dementia alzheimer''s type; cyanocobalamin/ folic acid/ pyridoxine hydrochloride (TRIOBE) for an unspecified indication; colecalciferol (DIVISUN) for an unspecified indication; dutasteride (AVODART) for benign prostatic hyperplasia; calcium carbonate/ colecalciferol (CALCICHEW D3 APPELSIINI) for an unspecified indication; all start and stop date were not reported. According to the nurses, the patient had no symptoms after the vaccination and was doing well. On 09Feb2021 on the day of his death he ate well, went to pedicure and in the afternoon he passed away. The face looked calm, but the pictures showed that the face was sweating. The patient lived in a nursing home. There had been no downs in patient''s condition, and the situation was stable as it was for a long time. There were no warning signs of the upcoming and death came unexpectedly. Therefore, it came inevitably to the report''s mind that the vaccine could be the cause of the father''s death. It was not reported if an autopsy was performed. The cause of death was unknown. No follow-up attempts are possible. Information about lot/batch number could not be obtained.; Reported Cause(s) of Death: passed away


VAERS ID: 1146844 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-11
Onset:2021-03-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-14
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Asymptomatic COVID-19; Ischaemic heart disease; Osteoarthritis knee; Thrombosis venous deep (3 episodes in 2010)
Allergies:
Diagnostic Lab Data: Test Date: 202009; Test Name: covid-19 virus test; Test Result: Positive ; Comments: asymptomatic form
CDC Split Type: FRPFIZER INC2021317447

Write-up: Dyspnoea; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-CF20210307. A 92-year-old female patient received her second dose BNT162B2 (COMIRNATY, Lot Number: EP9598), intramuscular at arm left on 11Mar2021 at single dose for COVID-19 immunisation. Medical history included arterial hypertension, ischemic heart disease, thrombosis venous deep (3 episodes in 2010) and advanced knee osteoarthritis. This patient was diagnosed with Covid-19 Positive in Sep2020 (asymptomatic form). The patient''s concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (Comirnaty, Lot: EM 6950) injection, on 19Feb2021 for Covid-19 immunisation. On 12Mar2021, this patient presented with sudden onset dyspnea requiring emergency hospitalization. The patient underwent lab tests included covid-19 virus test: positive on Sep2020 (asymptomatic form). The patient died in hospital on 14Mar2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Dyspnoea


VAERS ID: 1146868 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-03-12
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac arrest, Electrocardiogram, Investigation, Pyrexia, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-13
   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: HALDOL; CLOZAPINE MYLAN; GUTRON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Deglutition disorder (swallowing disorder requiring a diet with adapted textures and a special chair for sleeping); Huntington''s chorea; Hypotension orthostatic (orthostatic hypotension treated with GUTRON); Schizophrenia
Allergies:
Diagnostic Lab Data: Test Name: body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210216; Test Name: Electrocardiographic monitoring; Result Unstructured Data: Test Result:regular; Test Date: 20210216; Test Name: counts; Result Unstructured Data: Test Result:regular; Test Name: antigen test; Test Result: Negative ; Test Name: Covid-19 PCR test; Test Result: Negative
CDC Split Type: FRPFIZER INC2021317566

Write-up: Heart arrest; Fever; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-MA20210872. A 51 years old female patient received BNT162B2 (COMIRNATY, Lot Number: EP9605) dose 1 intramuscular on 11Mar2021 as single dose for covid-19 immunisation; haloperidol (HALDOL) oral from 10Feb2021 and ongoing at 40 drop, daily for schizophrenia; clozapine (CLOZAPINE MYLAN) oral from 10Feb2021 at 200 mg, daily and via an unspecified route of administration from an unspecified date at 125 twice daily for schizophrenia; midodrine hydrochloride (GUTRON) oral from an unspecified date and ongoing at 2.5 mg, daily for orthostatic hypotension. The patient lives in a specialized accommodation center for Huntington disease with swallowing disorder requiring a diet with adapted textures and a special chair for sleeping and orthostatic hypotension treated with GUTRON. The patient is installed in her special chair for the night, she is monitored regularly and remains afebrile. She is also schizophrenic with a state of agitation having is subject to modification of treatment in Feb2021: reduction in dosage of CLOZAPINE from 125x 2 to 100x 2 (there is a plasma dosage of CLOZAPINE in the therapeutic values expected before the reduction in dosage) and replace Xenazine by HALDOL. The patient''s concomitant medications were not reported. The patient previously took xenazine. The patient presented a fever 36 hours after the first dose of COMIRNATY on 12Mar2021 19:00, feverish peak at 38 Centigrade and presence of foam around the mouth, antigen test and Covid-19 PCR negative. Cardiac arrest with death the next day on 13Mar2021 08:00, Adrenaline massage and return to sinus rhythm. Recurrence of cardiac arrest and death at 9:30 a.m. Electrocardiographic monitoring and counts are regular and within the standards, last count on 16Feb2021. No Covid-19 history. The action taken in response to events for haloperidol, clozapine and midodrine hydrochloride was dose not changed. The outcome of events fatal. The patient was died on 13Mar2021. Causes of death were reported as fever and cardiac arrest. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: fever; cardiac arrest


VAERS ID: 1146870 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-10
Onset:2021-03-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Haemorrhagic stroke
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HYDROCHLOROTHIAZIDE; TELMISARTAN
Current Illness: Hypertension arterial
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021317503

Write-up: HEMORRHAGIC STROKE; This is a spontaneous report from a contactable physician downloaded from the regulatory authority FR-AFSSAPS-MP20210545. This is a report received from the Regulatory Authority. An 86-years-old female patient received first dose of bnt162b2 (COMIRNATY), intramuscular administered in left arm on 10Mar2021 (Lot Number: EP9605) at single dose for COVID-19 immunisation. Medical history included ongoing hypertension arterial, did not have history of COVID-19. Concomitant medications included hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for hypertension arterial; telmisartan (TELMISARTAN) taken for hypertension arterial. The patient was died due to hemorrhagic stroke on 12Mar2021. The patient died on 12Mar2021 at 7 p.m. at the hospital. The clinical course was reported as follows: on 12Mar2021, 48 hours after vaccination, headache and dizziness. Call from emergency medical service (EMS) service. Supported by medical firefighter team at home for discomfort in front of witnesses with trusted person at 3:30 p.m. and rapidly coma, bilateral mydriasis reactive to support. Other contributive additional examinations: CTc: Fisher 4 subarachnoid hemorrhage associated with acute hydrocephalus. Lack of vascularization of the bilateral V3 V4 portions, the basilar trunk and the posterior arteries in connection with intracranial hypertension. Lack of individualized aneurysm formation. Tonsillus commitment. Evolution: Death on 12Mar2021 at 7 p.m. at the hospital. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Haemorrhagic stroke


VAERS ID: 1146877 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-02-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Anuria, Asthenia, Blood albumin, Blood calcium, Blood creatinine, Blood parathyroid hormone, Blood thyroid stimulating hormone, Death, Hyperthyroidism, International normalised ratio, International normalised ratio increased, Rectal haemorrhage, SARS-CoV-2 test, Thyroxine
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver-related coagulation and bleeding disturbances (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Gastrointestinal haemorrhage (narrow), Guillain-Barre syndrome (broad), Ischaemic colitis (broad), Hyperthyroidism (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-18
   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: COUMADINE; LEVOTHYROX; OROCAL [CALCIUM CARBONATE]; GRANIONS DE ZINC; ATROVENT; FUROSEMIDE; NEVIBOLOL DCI; DELURSAN; UVEDOSE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anorexia; Arterial hypertension; Atrial fibrillation; Cardiac failure; Cognitive impairment; Diabetes mellitus; Thyroidectomy
Allergies:
Diagnostic Lab Data: Test Date: 20210211; Test Name: blood serum; Result Unstructured Data: Test Result:149 mmol/L; Test Date: 20210211; Test Name: calcium; Result Unstructured Data: Test Result:2.07 mmol/L; Test Date: 20210211; Test Name: serum creatinine; Result Unstructured Data: Test Result:78 umol/l; Test Date: 20210211; Test Name: pth; Result Unstructured Data: Test Result:112 pg/mL; Test Date: 20210211; Test Name: blood tsh; Result Unstructured Data: Test Result:0.26 MiU/L; Test Date: 20210104; Test Name: international normalized ratio test; Result Unstructured Data: Test Result:2.51; Test Date: 20210202; Test Name: international normalized ratio test; Result Unstructured Data: Test Result:2.58; Test Date: 20210216; Test Name: international normalized ratio test; Result Unstructured Data: Test Result:above 10; Test Date: 20210217; Test Name: international normalized ratio test; Result Unstructured Data: Test Result:3.42; Test Date: 20201124; Test Name: SARS -CoV-2 test; Result Unstructured Data: Test Result:negative; Test Date: 20210211; Test Name: blood T4; Result Unstructured Data: Test Result:22.4 pmol/L
CDC Split Type: FRPFIZER INC2021272547

Write-up: Death; very weakened; anuria; International normalised ratio increased; Rectal bleeding; Hyperthyroidism; This is a spontaneous report from a contactable physician downloaded from the regulatory authority FR-AFSSAPS-PO20211018. A 96-year-old female patient received second dose of BNT162B2 (COMIRNATY), intramuscular, administered in arm left on 10Feb2021 (Lot Number: EJ6789) as single dose for COVID-19 immunisation. Medical history included diabetes mellitus, arterial hypertension, cardiac failure, atrial fibrillation, thyroidectomy, each from an unknown date and unknown if ongoing, cognitive impairment and anorexia, both from 09Feb2021. Concomitant medications included warfarin sodium (COUMADINE) at 3 mg daily; levothyroxine sodium (LEVOTHYROX) at 50 ug daily; calcium carbonate (OROCAL) at 2 dose form daily; zinc (GRANIONS DE ZINC, formulation: oral solution) one dose form daily; ipratropium bromide (ATROVENT, formulation: inhalation vapour, solution) at 3 dose form daily; furosemide at 40 mg daily; nebivolol hydrochloride (NEVIBOLOL DCI) at 2.5 mg daily; ursodeoxycholic acid (DELURSAN) at 3 dose form daily and colecalciferol (UVEDOSE, formulation: oral solution, strength: 10000 iU) one ampoule every two weeks, all taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162B2 (COMIRNATY) on 15Jan2021 and experienced no adverse effects. The patient experienced hyperthyroidism on 11Feb2021, rectal bleeding on 15Feb2021, international normalized ratio (INR) increased on 16Feb2021, anuria and very weakened, both on 17Feb2021. Therapeutic measures were taken as a result of the bleeding and included vitamin K on 15Feb2021. All events were serious (medically significant). The patient underwent lab tests and procedures which included blood albumin (136-145 mmol/L): 149 mmol/l on 11Feb2021, blood calcium: 2.07 mmol/l on 11Feb2021, blood creatinine: 78 umol/l on 11Feb2021, blood parathyroid hormone (PTH) (15-68): 112 pg/ml on 11Feb2021, blood thyroid stimulating hormone (THS): 0.26 miu/l on 11Feb2021, international normalized ratio (INR): 2.51 on 04Jan2021 , 2.58 on 02Feb2021, above 10 on 16Feb2021, 3.42 on 17Feb2021, SARS-COV-2 test: negative on 24Nov2020, thyroxine (T4) (6-19): 22.4 pmol/l on 11Feb2021. The patient outcome of the events was not recovered. The patient died on 18Feb2021. It was not reported if an autopsy was performed, the cause of death was unknown. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1146881 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-19
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 LA / OT

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: 2021-02-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210121; Test Name: Sars-cov-2 test; Result Unstructured Data: Test Result:negative
CDC Split Type: FRPFIZER INC2021317595

Write-up: Death unexplained/death during her sleep; This is a spontaneous report from a contactable consumer (the patient''s son) downloaded from the Regulatory Authority-WEB FR-AFSSAPS-PS20210528. An 86-years-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 11Feb2021 (Batch/Lot Number: UNKNOWN) at single dose (reported as 1 DF) for covid-19 immunisation. Medical history included arterial hypertension. The patient''s concomitant medications were not reported. The patient experienced death unexplained on 19Feb2021, 8 days after vaccination with bnt162b2, description of the effect: Occurrence on 19Feb2021 of a death during her sleep, while the patient had no serious pathology. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 21Jan2021. It was unknown if an autopsy was performed. Information about lot/batch number cannot be obtained. No further information expected.; Reported Cause(s) of Death: Death unexplained/death during her sleep


VAERS ID: 1146926 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-03-14
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 1 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: BICALUTAMIDE; ENALAPRIL; SIMVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021317709

Write-up: Massive brain haemorrhage; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number NL-LRB-00480280. A 88-year-old male patient received first dose of bnt162b2 (COMIRNATY) via an unspecified route of administration on 18Feb2021 (Lot Number: EJ6789, expiration date was unknown) as single dose for covid-19 immunisation; apixaban (ELIQUIS) via an unspecified route of administration from 2020 to an unspecified date at 5mg per 12 hours as blood thinner for cerebral infarction. Medical history included cerebral infarction from 2020. Patient did not have any past drug therapy with comirnaty. He did not have previous COVID-19 infection. Concomitant medications included bicalutamide, enalapril and simvastatin. The patient experienced massive brain haemorrhage on 14Mar2021. The patient died due to massive brain haemorrhage on an unspecified date in 2021. The action taken in response to the event for apixaban was not applicable. 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: massive brain haemorrhage


VAERS ID: 1146964 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-01-31
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain lower, Alanine aminotransferase, Alanine aminotransferase increased, Anuria, Arteriosclerosis, Aspartate aminotransferase, Aspartate aminotransferase increased, Base excess, Blood lactic acid, Cervical spinal stenosis, Contusion, Cyanosis, Cytomegalovirus test, Hepatitis B core antibody, Hypersensitivity, Hypotonia, Intervertebral disc protrusion, Magnetic resonance imaging neck, Metabolic acidosis, Oxygenation index, PCO2, PO2, Paralysis, Paraparesis, Prostatic specific antigen, Prostatic specific antigen increased, Respiratory failure, Spinal cord compression, Swelling, pH body fluid
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Lactic acidosis (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Tumour markers (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Prostate tumours of unspecified malignancy (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result:high; Test Name: Aspartate aminotransferase; Result Unstructured Data: Test Result:high; Test Name: Base excess; Result Unstructured Data: Test Result:22.7; Test Name: Lactates; Result Unstructured Data: Test Result:16.31; Test Name: CMV IgG antibody; Result Unstructured Data: Test Result:$g 250; Test Name: CMV IgM antibody; Result Unstructured Data: Test Result:0.13; Test Name: Anti-HBc antibody; Result Unstructured Data: Test Result:7.47; Test Name: Cervical MRI; Result Unstructured Data: Test Result:At the C5 / C6 level, herniated intervertebral; Comments: At the C5 / C6 level, herniated intervertebral disc with edge osteophytosis compresses the spinal cord with depletion of the perspinal fluid reserve. Features of large swelling to the back of the spine. The lesions are most visible on the right side at C2-C5 level, but extend to the level of the thoracic spine. Increased degenerative stenosis. It is most pronounced at the C5 / C6 level of the spinal cord with depletion of the fluid reserve with an increased signal dependent. features of compression at this level (a few illegible words); Test Name: Oxygenation index; Result Unstructured Data: Test Result:1.0; Test Name: Partial pressure CO2; Result Unstructured Data: Test Result:14.8; Test Name: pH; Result Unstructured Data: Test Result:7.108; Test Name: Partial pressure O2; Result Unstructured Data: Test Result:101; Test Name: PSA; Result Unstructured Data: Test Result:308.97
CDC Split Type: PLPFIZER INC2021323078

Write-up: AST (Aspartate aminotransferase) high; ALT (Alanine aminotransferase) high; total PSA (Prostatic specific antigen): 308.97; Respiratory failure requiring intubation and mechanical ventilation; Herniated intervertebral disc with edge osteophytosis compresses the spinal cord; Distal cyanosis of the extremities (generalized advanced atherosclerosis); Increased degenerative stenosis; most pronounced at the C5 / C6 level of the spinal cord; Herniated intervertebral disc with edge osteophytosis compresses the spinal cord with depletion of the peri spinal fluid reserve; Allergic reaction (erythema multiforme); Paralysis of the right upper limb; Paresis of both lower limbs; Anuria; Abdominal pain lower; Distal cyanosis of the extremities (generalized advanced atherosclerosis); Hypotonia; Metabolic acidosis; Features of large swelling to the back of the spine; Bruising of the limbs; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB PL-URPL-3-306-2021. A contactable physician reported that a 68-year-old male patient received second dose of BNT162B2 (COMIRNATY; Solution for injection; Lot Number: EJ6136; Expiration Date: 30Jan2021), intramuscular on arm left on an unspecified date at 0.3 ml, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 31Jan2021, the doctor indicated allergic reaction (erythema multiforme), bruising of the limbs. In the report, the doctor gave: AST (Aspartate aminotransferase) and ALT (Alanine aminotransferase) high, total PSA (Prostatic specific antigen): 308.97, anti-HBc antibodies: 7.47, CMV and IgG above 250, CMV (Cytomegalovirus test) and IgM: 0.13. paralysis of the right upper limb, paresis of both lower limbs, hypotonia, distal cyanosis of the limbs (generalized advanced atherosclerosis), respiratory failure requiring intubation and mechanical ventilation, FiO2 (oxygen content in the respiratory mixture): 1.0, anuria, metabolic acidosis, lactated: 16,31, BE (excess alkaline) in blood: 22.7, standard carbohydrate concentration: 4.6, pCO2 (carbon dioxide partial pressure): 14.8, pO2 (oxygen partial pressure): 101, Ph: 7.108, abdominal pain in the lower abdomen. MRI (Magnetic resonance imaging) of the cervical spine: at the C5 / C6 level, herniated intervertebral disc with edge osteophytosis compresses the spinal cord with depletion of the peri spinal fluid reserve. Features of large swelling to the back of the spine. The lesions are most visible on the right side at C2-C5 level but extend to the level of the thoracic spine. Increased degenerative stenosis. It is most pronounced at the C5 / C6 level of the spinal cord with depletion of the fluid reserve with an increased T2 signal features of compression at this level (a few illegible words). The reporting person classified them as severe. Due to the assessment of the reporting person, the nature of the side effects and the patient death, URPL qualified the report as severe. The patient died on 01Feb2021. It was unknown if an autopsy was performed or not. The outcome of the events ALT high, AST high and PSA increased was reported as unknown whereas for other events it was reported as fatal. Causality assessment: For the drug COMIRNATY, the events Metabolic acidosis, Paralysis, Paraparesis, Anuria, Respiratory failure, Hypotonia, Acrocyanosis, Erythema multiforme were possible as per NCA and WHO scale. The events Intervertebral disc herniation, Spinal stenosis in cervical region, Local swelling were Unlikely as per NCA and WHO scale. Health Authority Comments: COMIRNATY is an mRNA vaccine against COVID-19 (with modified nucleosides). All reported adverse reactions are not included in COMIRNATY Summary of Product Characteristics. It cannot be ruled out that the paralysis of the upper limb and the paresis of the lower limbs were caused by numerous diseases within the spine, which was detected by MRI (intervertebral disc hernia with edge osteophytosis, spine edema, degenerative stenosis). Due to the descendant of the aforementioned spine diseases (chronic diseases), it was decided to give an unlikely cause-and-effect relationship between their occurrence and the administration of COMIRNATY. Distal extremity cyanosis may be due to generalized advanced atherosclerosis, and metabolic acidosis may be due to respiratory failure. Until 07Mar2021 in the database, 21 cases of paralysis, 19 cases of paresis, 47 cases of respiratory failure, 5 cases of anuria (anuria) were reported. URPL has no information on any additional circumstances (medications used, allergies, etc.) that could have resulted in the described side effects. The temporal relationship speaks for a cause, effect and relationship. The reporting person classified them as severe. Due to the assessment of the reporting person, the nature of the side effects and the patient death, URPL qualified the report as severe. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Distal cyanosis of the extremities (generalized advanced atherosclerosis); Herniated intervertebral disc with edge osteophytosis compresses the spinal cord with depletion of the peri spinal fluid reserve; Bruising of the limbs; Metabolic acidosis; He


VAERS ID: 1148621 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-02-08
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Blood alkaline phosphatase, Blood bicarbonate, Blood lactate dehydrogenase, Blood potassium, Blood sodium, Blood test, C-reactive protein, Chest X-ray, Computerised tomogram, Cough, Cytomegalovirus test negative, Differential white blood cell count, Drug resistance, Dyspnoea, Haematocrit, Haemoglobin, Histology, Lymphocyte count, Lymphocyte count abnormal, Malaise, Monocyte count abnormal, Multiple organ dysfunction syndrome, Neutrophil count, Neutrophil count abnormal, Neutrophil/lymphocyte ratio increased, Oxygen saturation, Oxygen saturation decreased, Pneumocystis jirovecii infection, Pneumonia, Red blood cell count, Respiratory disorder, SARS-CoV-2 antibody test, Troponin, Urine analysis, Vitamin D deficiency, White blood cell count
SMQs:, Anaphylactic reaction (broad), Haematopoietic leukopenia (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), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (broad), Opportunistic infections (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-23
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: D-CURE; CARVEDILOL EG; TRIPLIXAM; CLEXANE; COVERSYL [PERINDOPRIL ERBUMINE]; DOMPERIDONE EG; ASAFLOW; ALGOSTASE MONO; ATORVASTATINE SANDOZ; ENTEROL [FURAZOLIDONE]; CLOPIDOGREL EG; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Cerebrovascular accident (ischemic, at right Middle cerebral artery area (thrombosis of right internal carotid and left internal carotid stenosis of 60%)); Contusion of knee (- restrictive lung disease second to morbid obesity - Right adrenal nodule with diameter up to 3.2 cm. - Cholesterol papules in the gallbladder have no signs of cholecystitis or bile duct dilation. - Prominent pancreatic head and proximal body, slightly inhomogeneous, which may be part of edematous pancreatitis. - Chronic lumbo-sciatica due to multilevel spinal canal stenosis.); Foot fracture (left foot fracture base MT 2-3, for which lower leg cast); Pelvic fracture; Smoking cessation therapy; Transient ischemic attack
Allergies:
Diagnostic Lab Data: Test Date: 20210215; Test Name: lung examination; Result Unstructured Data: Test Result:Compression zone infrailar to the right and diffus; Comments: Compression zone infrailar to the right and diffuse bronchial reinforcement lung drama drawing bilateral with slightly blurred areas of compaction: more probably infectious. No pleural effusions.; Test Date: 20210217; Test Name: lung examination; Result Unstructured Data: Test Result:Bilaterally extensive flaky compaction zones: righ; Comments: Bilaterally extensive flaky compaction zones: right more than left: increased compared to February 15th. Small amount of pleural fluid bibasal.; Test Date: 20210220; Test Name: lung examination; Result Unstructured Data: Test Result:Scattered blurred areas of compaction bilateral: v; Comments: Scattered blurred areas of compaction bilateral: virtually unchanged compared to February 19, 2021 study. No pleural effusions.; Test Date: 20210222; Test Name: lung examination; Result Unstructured Data: Test Result:clinical information: bilateral pneumonia. Mechani; Comments: clinical information: bilateral pneumonia. Mechanical ventilation. Spotty compaction zones spread over both lung fields: earlier similar picture; Test Date: 20210217; Test Name: chest CT scan; Result Unstructured Data: Test Result:clinical information: dyspnoea, increased D-dimers; Comments: clinical information: dyspnoea, increased D-dimers, pneumonia. No central pulmonary embolisms, no peripheral pulmonary embolisms. Very extensive confluent lung compactions in both lower lobes and multifocal in both upper lobes: most likely infectious, covid cannot be ruled out. Small amount of pleural fluid on the right. Nodule with diameters up to 3 cm in the adrenal gland on the right: most likely still adenoma.; Test Date: 20210215; Test Name: CRP; Result Unstructured Data: Test Result:213.2 mg/l; Test Date: 20210217; Test Name: CRP; Result Unstructured Data: Test Result:200.7 mg/l; Test Date: 20210218; Test Name: CRP; Result Unstructured Data: Test Result:203.6 mg/l; Test Name: CMV; Result Unstructured Data: Test Result:no CMV was detected; Test Date: 20210215; Test Name: Immature myeloid cells; Result Unstructured Data: Test Result:2.6; Test Date: 20210217; Test Name: Immature myeloid cells; Result Unstructured Data: Test Result:2.0; Test Date: 20210218; Test Name: Immature myeloid cells; Result Unstructured Data: Test Result:2.0; Test Date: 20210215; Test Name: hematocrit; Result Unstructured Data: Test Result:34; Test Date: 20210217; Test Name: hematocrit; Result Unstructured Data: Test Result:32; Test Date: 20210218; Test Name: hematocrit; Result Unstructured Data: Test Result:32; Test Date: 20210215; Test Name: haemoglobin; Result Unstructured Data: Test Result:10.6 g/dl; Test Date: 20210217; Test Name: haemoglobin; Result Unstructured Data: Test Result:10 g/dl; Test Date: 20210218; Test Name: haemoglobin; Result Unstructured Data: Test Result:9.9 g/dl; Test Name: histopathological examination; Result Unstructured Data: Test Result:post-mortem pre-evaluation of lung tissue for hist; Comments: post-mortem pre-evaluation of lung tissue for histopathological examination was performed: Extensive changes in the lung parenchyma appropriate in the context of diffuse alveolar damage with predominantly organizing component (ARDS spectrum); Test Date: 20210215; Test Name: lymphocyte; Test Result: 6 %; Test Date: 20210217; Test Name: lymphocyte; Test Result: 5.9 %; Test Date: 20210218; Test Name: lymphocyte; Test Result: 7.1 %; Test Date: 20210215; Test Name: Abs. lymphocyte count; Result Unstructured Data: Test Result:0.83 x10 9/l; Test Date: 20210217; Test Name: Abs. lymphocyte count; Result Unstructured Data: Test Result:0.92 x10 9/l; Test Date: 20210218; Test Name: Abs. lymphocyte count; Result Unstructured Data: Test Result:1.16 x10 9/l; Test Date: 20210215; Test Name: Abs. monocyte count; Result Unstructured Data: Test Result:1.13 x10 9/l; Test Date: 20210217; Test Name: Abs. monocyte count; Result Unstructured Data: Test Result:1.08 x10 9/l; Test Date: 20210218; Test Name: Abs. monocyte count; Result Unstructured Data: Test Result:1.13 x10 9/l; Test Date: 20210215; Test Name: Neutrophil segment nucleus; Test Result: 81.2 %; Test Date: 20210217; Test Name: Neutrophil segment nucleus; Test Result: 83.7 %; Test Date: 20210218; Test Name: Neutrophil segment nucleus; Test Result: 83.7 %; Test Date: 20210215; Test Name: Abs. neutrophil count; Result Unstructured Data: Test Result:11.23 x10 9/l; Test Date: 20210217; Test Name: Abs. neutrophil count; Result Unstructured Data: Test Result:13.07 x10 9/l; Test Date: 20210218; Test Name: Abs. neutrophil count; Result Unstructured Data: Test Result:13.66 x10 9/l; Test Date: 20210215; Test Name: Neutrophil / lymphocyte ratio; Result Unstructured Data: Test Result:13.53; Test Date: 20210217; Test Name: Neutrophil / lymphocyte ratio; Result Unstructured Data: Test Result:14.21; Test Date: 20210218; Test Name: Neutrophil / lymphocyte ratio; Result Unstructured Data: Test Result:11.78; Test Date: 20210212; Test Name: oxygen saturation; Test Result: 84 %; Comments: with 2l O2, few opportunities to give more.; Test Name: pneumocystis; Result Unstructured Data: Test Result:no pneumocystis detected.; Test Date: 20210215; Test Name: Red blood cells; Result Unstructured Data: Test Result:3.9 x10 12/l; Test Date: 20210217; Test Name: Red blood cells; Result Unstructured Data: Test Result:3.6 x10 12/l; Test Date: 20210218; Test Name: Red blood cells; Result Unstructured Data: Test Result:3.7 x10 12/l; Test Date: 20210208; Test Name: covid test; Result Unstructured Data: Test Result:negative; Test Date: 20210215; Test Name: hs-troponin; Result Unstructured Data: Test Result:23 ng/L; Test Date: 20210212; Test Name: urine test; Result Unstructured Data: Test Result:suspected contaminated sample. The patient has no; Comments: suspected contaminated sample. The patient has no urinary complaints; Test Date: 20210215; Test Name: white blood cell count; Result Unstructured Data: Test Result:13.8 x10 9/l; Test Date: 20210217; Test Name: white blood cell count; Result Unstructured Data: Test Result:15.6 x10 9/l; Test Date: 20210218; Test Name: white blood cell count; Result Unstructured Data: Test Result:16.3 x10 9/l; Test Date: 20210215; Test Name: Alkaline Phosphatase; Result Unstructured Data: Test Result:123 IU/l; Test Date: 20210215; Test Name: Sodium bicarbonate; Result Unstructured Data: Test Result:32; Test Date: 20210217; Test Name: Sodium bicarbonate; Result Unstructured Data: Test Result:30; Test Date: 20210218; Test Name: Sodium bicarbonate; Result Unstructured Data: Test Result:32; Test Date: 20210215; Test Name: LDH; Result Unstructured Data: Test Result:370 IU/l; Test Date: 20210215; Test Name: potassium; Result Unstructured Data: Test Result:3.32 mmol/L; Test Date: 20210217; Test Name: potassium; Result Unstructured Data: Test Result:3.08 mmol/L; Test Date: 20210218; Test Name: potassium; Result Unstructured Data: Test Result:2.93 mmol/L; Test Date: 20210215; Test Name: sodium; Result Unstructured Data: Test Result:144 mmol/L; Test Date: 20210217; Test Name: sodium; Result Unstructured Data: Test Result:148 mmol/L; Test Date: 20210218; Test Name: sodium; Result Unstructured Data: Test Result:149 mmol/L; Test Date: 20210212; Test Name: blood test; Result Unstructured Data: Test Result:inflammatory blood picture and vitamin D deficienc
CDC Split Type: BEPFIZER INC2021283111

Write-up: Respiratory disorder; Acute respiratory failure; Drug resistance; Multi organ failure; Bilateral pneumonia; Dyspnea; Oxygen saturation low; Vitamin D deficiency; Coughing; General malaise; This is a spontaneous report from a contactable physician downloaded from the Regulatory authority-WEB regulatory authority BE-FAMHP-DHH-N2021-80761. A 73-year-old female patient received her second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 02Feb2021 as single dose for covid-19 immunisation. The patient had recevied the first dose of vaccine on 12Jan2021. Medical history included smoking cessation therapy from 2019 to an unknown date (nicotine abuses, pack a day, started at age 17), cerebrovascular accident from 2003 to an unknown date, ischemic, at right Middle cerebral artery area (thrombosis of right internal carotid and left internal carotid stenosis of 60%), contusion right knee from 2019 to an unknown date, restrictive lung disease second to morbid obesity, Right adrenal nodule with diameter up to 3.2 cm. Cholesterol papules in the gallbladder have no signs of cholecystitis or bile duct dilation. Prominent pancreatic head and proximal body, slightly inhomogeneous, which may be part of edematous pancreatitis. Chronic lumbo-sciatica due to multilevel spinal canal stenosis, transient ischaemic attack from 2019 to an unknown date , foot fracture from 2020 to an unknown date (left foot fracture base MT 2-3, for which lower leg cast), pelvic fracture from 2020 to an unknown date , arterial hypertensionfrom an unknown date. Concomitant medications included amlodipine besilate, indapamide, perindopril arginine (TRIPLIXAM); enoxaparin sodium (CLEXANE) taken from 26Feb2021; perindopril erbumine (COVERSYL); domperidone taken for nausea; acetylsalicylic acid (ASAFLOW), paracetamol (ALGOSTASE MONO) taken for pain; atorvastatin calcium; furazolidone (ENTEROL) taken for diarrhoea; clopidogrel bisulfate; macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL) taken for constipation; colecalciferol (D-CURE); carvedilol. The patient experienced respiratory disorder on an unspecified date, acute respiratory failure on 17Feb2021, general malaise on 08Feb2021 , multi organ failure on 17Feb2021 , bilateral pneumonia on 17Feb2021 , dyspnea on 12Feb2021, oxygen saturation low on 12Feb2021, vitamin d deficiency on 12Feb2021, coughing on 12Feb2021, drug resistance on 17Feb2021. The events were assessed as serious for fatal outcome. The patient died on 23Feb2021. it was unknow if an autopsy was performed. Clinical course was the following since 08Feb2021 general malaise, since 12Feb2021 cough and dyspnoea. Covid tested negative and policy with Amoxiclav instituted. Blood test on 12Feb2021: inflammatory blood picture and vitamin D deficiency. Urine test on 12Feb2021 suspected contaminated sample. The patient has no urinary complaints. In a nursing home with difficulty up to 84% saturation with 2l O2, few opportunities to give more. Admission of lung disease on 15Feb2021 starting: Tazocin, Solu-Medrol, UtraK, Clexane, Combivent. Rx thorax at bed: Compression zone infrailar to the right and diffuse bronchial reinforcement lung drama drawing bilateral with slightly blurred areas of compaction: more probably infectious. No pleural effusions. On chest CT 17Feb2021: clinical information: dyspnoea, increased D-dimers, pneumonia. No central pulmonary embolisms, no peripheral pulmonary embolisms. Very extensive confluent lung compactions in both lower lobes and multifocal in both upper lobes: most likely infectious, covid cannot be ruled out. Small amount of pleural fluid on the right. Nodule with diameters up to 3 cm in the adrenal gland on the right: most likely still adenoma. Admitted to the intensive care unit on 18Feb2021 because of dyspnoea until death on 23Feb2021. Rx thorax at bed on 19feb2021: Bilaterally extensive flaky compaction zones: right more than left: increased compared to 15Feb2021. Small amount of pleural fluid bibasal. Chest x-ray at bed on 20Feb2021: Scattered blurred areas of compaction bilateral: virtually unchanged compared to 19Feb2021 study. No pleural effusions. Chest x-ray in bed on 22Feb2021: clinical information: bilateral pneumonia. Mechanical ventilation. Spotty compaction zones spread over both lung fields: earlier similar picture. Main diagnosis: bilateral pneumonia. Additional diagnosis: acute (on chronic?) respiratory insufficiency, hypotension, respiratory acidosis, hypercapnia, significantly decreased lung compliance (multifactorial), acute renal failure, oluguria, obesity, hypernatremia, increased troponins, tachycardia, hypokalaemia. Evolution: All therapy (hydromineral perfusion, stress ulcer and DVT prophylaxis, corticoids, bronchidilators, broad spectrum antibiotics (pip / tazo 15/2$g ...), respiratory support therapy (Optiflow and physiotherapy), intubation (19/02), mechanical ventilation (19/02$g ...), analgosis / curarisation, vasopressors, enteral nutrition), the evolution is unfavorable. Patient progressing to multi-organ failure with therapy-resistant respiratory failure up to her death. Post-mortem pre-evaluation of lung tissue for histopathological examination was performed: Extensive changes in the lung parenchyma appropriate in the context of diffuse alveolar damage with predominantly organizing component (ARDS spectrum). Cause of this cannot be determined histologically (infection? toxic?). No CMV was detected, no pneumocystis detected. The patient underwent lab tests and procedures which included blood alkaline phosphatase: 123 iu/l on 15Feb2021, blood bicarbonate: 32 on 15Feb2021, blood bicarbonate: 30 on 17Feb2021, blood bicarbonate: 32 on 18Feb2021, blood lactate dehydrogenase: 370 iu/l on 15Feb2021, blood potassium: 3.32 mmol/l on 15Feb2021, blood potassium: 3.08 mmol/l on 17Feb2021, blood potassium: 2.93 mmol/l on 18Feb2021, blood sodium: 144 mmol/l on 15Feb2021, blood sodium: 148 mmol/l on 17Feb2021, blood sodium: 149 mmol/l on 18Feb2021, blood test: inflammatory blood picture and vitamin d deficiency on 12Feb2021, chest x-ray: on 15Feb2021 Compression zone infrailar to the right and diffuse bronchial reinforcement lung drama drawing bilateral with slightly blurred areas of compaction: more probably infectious. No pleural effusions, chest x-ray: on 17Feb2021 Bilaterally extensive flaky compaction zones: right more than left: increased compared to February 15th. Small amount of pleural fluid bibasal; chest x-ray: on 20Feb2021 Scattered blurred areas of compaction bilateral: virtually unchanged compared to February 19, 2021 study. No pleural effusions; chest x-ray: on 22Feb2021: clinical information: bilateral pneumonia. Mechanical ventilation. Spotty compaction zones spread over both lung fields: earlier similar picture. Chest CT scan on 17Feb2021 : clinical information: dyspnoea, increased D-dimers, pneumonia. No central pulmonary embolisms, no peripheral pulmonary embolisms. Very extensive confluent lung compactions in both lower lobes and multifocal in both upper lobes: most likely infectious, covid cannot be ruled out. Small amount of pleural fluid on the right. Nodule with diameters up to 3 cm in the adrenal gland on the right: most likely still adenoma. Hemoglobin 18Feb2021: 9.9 g / dL - 17Feb2021: 10.0 - 15Feb2021: 10.6; Hematocrit 18Feb2021: 32 - 17Feb2021: 32 - 15Feb2021: 34; Red blood cells 18Feb2021: 3.7 x10 * 12 / L - 17Feb2021: 3.6 x10 * 12 / L - 15Feb2021: 3.9 x10 * 12 / L; White blood cells 18Feb2021: 16.3 x10 * 9 / L - 17Feb2021: 15.6 x10 * 9 / L - 15Feb2021: 13.8 x10 * 9 / L; Neutrophil segment nucleus 18Feb2021: 83.7%) - 17Feb2021: 83.7 - 15Feb2021: 81.2; Lymphocytes 18Feb2021: 7.1% - 17Feb2021: 5.9 - 15Feb2021: 6.0; Neutrophil / lymphocyte ratio 18Feb2021: 11.78 - 17Feb2021: 14.21 - 15Feb2021: 13.53; Abs. neutrophil count 18Feb2021: 13.66 x10 * 9 / L - 17Feb2021: 13.07 x10 * 9 / L - 15Feb2021: 11.23 x10 * 9 / L; Abs. lymphocyte count 18Feb2021: 1.16 x10 * 9 / L -17Feb2021: 0.92 x10 * 9 / L - 15Feb2021: 0.83 x10 * 9 / L; Abs. monocyte count 18Feb2021: 1.13 x10 * 9 / L - 17Feb2021: 1.08 x10 * 9 / L - 15Feb2021: 1.13 x10 * 9 / L; Immature myeloid cells 18Feb2021: 2.0 - 17Feb2021: 2.0 - 15Feb2021: 2.6; Platelets 18Feb2021: 493x10 * 9 / L - 17Feb2021: 480x10 * 9 / L - 15Feb2021 487x10 * 9 / L; hs-Troponin T 15Feb2021: 23 ng / L; CRP 18Feb2021: 203.6 mg / L - 17Feb2021: 200.7 - 15Feb2021 213.2. Comirnaty to all events reported as unclassifiable by Agency using WHO method of assessment. No follow-up attempts are possible. No further information is expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Respiratory disorder; Acute respiratory failure; General malaise; Multi organ failure; Bilateral pneumonia; Dyspnea; Oxygen saturation low; Vitamin D deficiency; Coughing; Drug resistance


VAERS ID: 1149544 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-26
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: General physical health deterioration
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-19
   Days after onset: 24
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cachexia (Cachexia); Down''s syndrome (Down''s Syndrome); Lung fibrosis (Pulmonary fibrosis); Renal insufficiency
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021283079

Write-up: General condition deteriorated for 3 days, then again relatively good general condition; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority- AT-BASGAGES-2021-13928. A 67-years-old male patient received the first dose of bnt162b2 (COMIRNATY, Batch/Lot Number: EJ6797), intramuscular on 20Jan2021 as SINGLE DOSE for covid-19 immunisation . Medical history included ongoing pulmonary fibrosis Pulmonary fibrosis , ongoing renal failure , ongoing cachexia, ongoing trisomy 21 Down''s Syndrome. The patient''s concomitant medications were not reported. Patient''s weight was not reported, and height was not reported. On 26Jan2021, The patient experienced general condition deteriorated for 3 days, then again relatively good general condition (medically significant) on 26Jan2021. Clinical course is as follows On 26Jan2021 the patient experienced Reduced general condition, other. The patient''s outcome was: recovered/resolved for Reduced general condition no concomitant medication reported with known cachexia, NINS and pulmonary fibrosis. 6 days after 1st vaccination (20Jan2021): General condition deterioration for 3 days, then again relatively good general condition. The male patient was already in a poor general condition. After the 1st vaccination (batch number EJ6796), the general condition was very poor, the doctor believed that the patient would not survive and after his recovery was not sure whether she should give the second vaccination The clinical outcome of the event reduced general condition was recovered. Source of assessment : BASGAGES, Result of Assessment : possible Senders comment : The report is for one patient. No mail was sent to reporters. Date of death: 19Feb2021 (Refer To Linked Report) No follow-up attempts possible. No further information expected. COMIRNATY batch already obtained.; Sender''s Comments: Linked Report(s) : 2021283085 same patient, different dose (first dose), different events


VAERS ID: 1149562 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-05
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC2021310296

Write-up: death; This is a spontaneous report from a contactable physician, downloaded from the WEB, regulatory authority number CZ-CZSUKL-21002656. A 91-year-old female patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection; lot number: EP2166, expiration date was unknown), intramuscularly on 01Mar2021 at 0.3 mL, single for COVID-19 immunization. The patient''s medical history was not reported. The patient did not take any concomitant medicinal products. The patient experienced death on 05Mar2021. The patient died on 05Mar2021 after the first vaccination with COMIRNATY. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: death/ patient died


VAERS ID: 1149583 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-15
Onset:2021-02-28
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM6950 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Thrombotic microangiopathy, Thrombotic thrombocytopenic purpura
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, arterial (narrow), Renovascular disorders (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-10
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CONDROSULF; BETAHISTINE; ENALAPRIL + HIDROCLOROTIAZIDA; METOCLOPRAMIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthrosis; Hypertension arterial; Vertigo
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021311735

Write-up: Thrombotic microangiopathy; Thrombotic thrombocytopenic purpura; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB with regulatory authority number ES-AEMPS-793023. A 92-year-old female patient received her first dose of bnt162b2 (COMIRNATY; lot number: EM6950; expiration date: unknown), at unknown vaccination age via an unspecified route of administration on 15Feb2021 as a single dose for covid-19 prophylaxis (covid-19 immunization). Medical history included hypertension arterial, vertigo and arthrosis. Concomitant medications included chondroitin sulfate sodium (CONDROSULF) for arthrosis; betahistine for vertigo from 25Feb2021 to an unspecified stop date; enalapril maleate, hydrochlorothiazide (ENALAPRIL + HIDROCLOROTIAZIDA) for hypertension arterial from 12Jul2018 to an unspecified stop date; and metoclopramide for vertigo from 25Feb2021 to an unspecified stop date. On 28Feb2021, the patient presented a thrombotic microangiopathy of the Thrombotic Thrombocytopenic Purpura type, ten days later she died (10Mar2021). Awaiting follow-up information for further clinical details. It was reported that the stop date for both events was 10Mar2021. The event''s seriousness criterion was death. The outcome of the events was fatal. The patient died on 10Mar2021. It was unknown if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Thrombotic microangiopathy; Thrombotic thrombocytopenic purpura


VAERS ID: 1149589 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-02-09
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaemia, Blood test, COVID-19, Drug ineffective, Lymphopenia, Renal failure, Renal function test, SARS-CoV-2 test, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Lack of efficacy/effect (narrow), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-22
   Days after onset: 13
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: CANDESARTAN CILEXETIL; PRAVASTATIN SODIUM; PANTOPRAZOLE; MOVICOL [MACROGOL 4000;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; DOLIPRANE; HYDROCHLOROTHIAZIDE; PREDNISONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic obstructive airways disease; Double inguinal hernia; Dupuytren''s contracture; Fracture, closed, colles'' (fracture Beam Glues left); Haemorrhoids; Hypercholesterolemia; Living in residential institution; Nasal polyps; Oesophagitis ulcerative (stage IV); Pleuritis; Pyelonephritis; Shoulder dislocation; Venous peripheral insufficiency (lower limbs)
Allergies:
Diagnostic Lab Data: Test Name: anemia; Result Unstructured Data: Test Result:11.6 g/dl; Test Name: clearance; Result Unstructured Data: Test Result:44.2 ml/min; Comments: stage 3 renal failure with a clearance of 44.2mL / min.; Test Date: 20210209; Test Name: PCR SarS-CoV-2; Test Result: Positive ; Test Name: lymphopenia; Result Unstructured Data: Test Result:0.93 g/l
CDC Split Type: FRPFIZER INC2021311770

Write-up: COVID-19 aggravated; COVID-19 aggravated; Anemia; Lymphopenia; Stage 3 renal failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-AM20210581. A 100-year-old male patient living in a retirement home received first dose of bnt162b2 (COMIRNATY) intramuscular, administered in Deltoid Left on 21Jan2021 (Lot Number: EM0477) as single dose for covid-19 immunisation. Medical history included double inguinal hernia, fracture, closed, colles'' (fracture beam glues left), nasal polyps, venous peripheral insufficiency (lower limbs), haemorrhoids, oesophagitis ulcerative (stage IV), chronic obstructive airways disease, hypercholesterolaemia, pyelonephritis, dupuytren''s contracture, shoulder dislocation and pleuritis. Concomitant medications included candesartan cilexetil (CANDESARTAN CILEXETIL), pravastatin sodium (PRAVASTATIN SODIUM), pantoprazole (PANTOPRAZOLE), macrogol 4000, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL), paracetamol (DOLIPRANE), hydrochlorothiazide (HYDROCHLOROTHIAZIDE), prednisone (PREDNISONE). On 21Jan2021, the patient received his first injection of COMIRNATY. Four weeks after his vaccination, on 09Feb2021, in front of a pulmonary symptomatology, realization of a PCR SarS-CoV-2 which returned positive. Support was as follows: amoxicillin, clavulanic acid (AUGMENTIN) and levofloxacin (LOVENOX). On 16Feb2021, faced with the development of a severe form of COVID-19, he was hospitalized. The management was as follows: bi antibiotic therapy with ceftriaxone sodium (ROCEPHIN) and erythromycin, high flow oxygen therapy (12L/ min). No intensive care. On unknown date, on the laboratory assessment, anemia at 11.6g/ dL, lymphopenia at 0.93G/ L, stage 3 renal failure with a clearance of 44.2mL/ min. From 17Feb2021 to 22Feb2021 degradation of the patient requiring sedation. Patient died on 22Feb2021 due to COVID-19. An autopsy was not performed. Outcome of the events renal failure, lymphopenia and anemia was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Drug ineffective; Drug ineffective; COVID-19


VAERS ID: 1149638 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: FRPFIZER INC2021311854

Write-up: Infarct myocardial; This is a spontaneous report from a contactable physician downloaded from the regulatory authority FR-AFSSAPS-TO20211616. An 85-year-old female patient received bnt162b2 (COMIRNATY, Injection: D2), dose 2 intramuscular on 04Mar2021 (Lot Number: EP2166) as single dose (in "left") for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient previously received bnt162b2 (COMIRNATY), dose 1 on an unspecified date (Lot Number: unknown) as single dose for COVID-19 immunization. The patient experienced infarct myocardial on 04Mar2021 (fatal). HISTORY OF THE CASE: Sudden death the night following the injection by myocardial infarction. The patient had no known cardiological history. EVOLUTION: Not reinstated on declaration date // 2021). The patient died on an unspecified date. It was not reported if an autopsy was performed. "Covid test: unknown" File in progress: request for additional information (atcd, other signs before death) No follow-up attempts are possible.; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1149874 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-03-14
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-16
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 molecular test; Result Unstructured Data: Test Result:positive; Test Name: rapid antigen swab; Result Unstructured Data: Test Result:positive
CDC Split Type: ITPFIZER INC2021323047

Write-up: After the 1st dose, the patient became ill with COVID-19.; After the 1st dose, the patient became ill with COVID-19.; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB IT-MINISAL02-703039. A 92-year-old male patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: EJ6790; Expiration Date: 31Mar2021), intramuscular, administered on the right arm on 24Feb2021 as 0.3 mL, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 14Mar2021, following serious asthenia, the other healthcare professional was contacted and performed a rapid positive antigenic swab and transported to the emergency room where positivity was confirmed with a molecular test. In ER, bilateral interstitial pneumonia was diagnosed and death occurs on 16Mar2021. Therapeutic measures were taken as a result of the event. The patient died on 16Mar2021. It was not reported if an autopsy was performed. Reporter''s comment: Onset of Covid 19 with bilateral interstitial pneumonitis about 2 weeks after 1st vaccination.; Reporter''s Comments: Onset of Covid 19 with bilateral interstitial pneumonitis about 2 weeks after 1st vaccination.; Reported Cause(s) of Death: bilateral interstitial pneumonia; Covid-19


VAERS ID: 1149875 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-06
Onset:2021-03-08
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210311; Test Name: histological examination of the lungs; Result Unstructured Data: Test Result:awaiting for the result
CDC Split Type: ITPFIZER INC2021323046

Write-up: suspected pulmonary embolism, during the diagnosis of a person who died in hospital, pending confirmation by histopathological examination; This is as spontaneous report received from a contactable physician downloaded from the WEB. The regulatory authority report number is IT-MINISAL02-703463. A 84-year-old female patient received the first dose of BNT162B2 (COMIRNATY, COVID 19 COMIRNATY VACCINE (PFIZER): Booster dose number 1, formulation: Solution for injection, lot number: EP2166; Expiration date: not reported), via intramuscular route on 06Mar2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 08Mar2021, The patient experienced suspected pulmonary embolism, during the diagnosis of a person who died in hospital, pending confirmation by histopathological examination. Reporter commented as, the patient died in hospital a few hours after admission two days after the first dose of the COMIRNATY vaccine. Diagnostic finding with suspicion of death due to pulmonary embolism (awaiting histological confirmation), Emergency department access documentation and autopsy report will be posted as soon as available. The patient underwent lab tests and procedures which included histological examination of the lungs: awaiting for the result on 11Mar2021. Outcome of the event was fatal. No follow-up attempts possible. No further information expected ad information on lot# already obtained.; Reporter''s Comments: Patient died in hospital a few hours after admission two days after the first dose of the Comirnaty vaccine . Diagnostic finding with suspicion of death due to pulmonary embolism (awaiting histological confirmation); Reported Cause(s) of Death: suspected pulmonary embolism, during the diagnosis of a person who died in hospital, pending confirmation by histopathological examination


VAERS ID: 1149892 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Death, Fall, Fatigue, Femoral neck fracture, Hypotension
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Accidents and injuries (narrow), Osteoporosis/osteopenia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   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: METFORMIN ACTAVIS; FOLVIDON; PANODIL; FELODIPINE; MEMANTINE SANDOZ; HALDOL; CANDEXETIL; INSUMAN BASAL; OXIS TURBOHALER; LEVAXIN; SIMVASTATIN SANDOZ; BISOPROLOL SANDOZ; ELIQUIS; RIVASTIGMINE ACTAVIS; MOXALOLE; SYMBICORT TURBOHALER; BETOLVIDO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Atrial fibrillation; Blood pressure low; Chronic ischemic heart disease, unspecified; Hallucinations; Hypothyroidism; Type 2 diabetes mellitus; Vascular dementia
Allergies:
Diagnostic Lab Data: Test Date: 20210108; Test Name: blood pressure; Result Unstructured Data: Test Result:110/70 mmHg; Test Date: 202102; Test Name: blood pressure; Result Unstructured Data: Test Result:130 mmHg
CDC Split Type: SEPFIZER INC2021282975

Write-up: low blood pressure; Tiredness; fall; broke her femoral neck; unknown cause of death; passed away; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is SE-MPA-2021-007695. An 83-year-old female patient received the second dose of bnt162b2 (COMIRNATY) via an unspecified route of administration on 04Feb2021 (Lot Number: unknown) as single dose for covid-19 immunisation. Medical history included asthma, atrial fibrillation, hallucination, hypothyroidism, myocardial ischaemia, type 2 diabetes mellitus, vascular dementia, all from unknown dates and unknown if ongoing. Previous low blood pressure during the fall of 2020, which improved after adjustment of medication. Concomitant medications included metformin hydrochloride (METFORMIN ACTAVIS) from 06May2020 to an unspecified stop date; folic acid (FOLVIDON) from 14May2020 to an unspecified stop date; paracetamol (PANODIL) from 06May2020 to an unspecified stop date; felodipine from an unspecified start date to Feb2021; memantine hydrochloride (MEMANTINE SANDOZ) from 06May2020 to an unspecified stop date; haloperidol (HALDOL) from 06May2020 to an unspecified stop date; candesartan cilexetil (CANDEXETIL) from 11Jun2020 to an unspecified stop date; insulin human injection, isophane (INSUMAN BASAL) from 06May2020 to an unspecified stop date; formoterol fumarate (OXIS TURBOHALER) from 06May2020 to an unspecified stop date; levothyroxine sodium (LEVAXIN) from 06May2020 to an unspecified stop date; simvastatin (SIMVASTATIN SANDOZ) from 06May2020 to an unspecified stop date; bisoprolol fumarate (BISOPROLOL SANDOZ) from 06May2020 to an unspecified stop date; apixaban (ELIQUIS) from 06May2020 to an unspecified stop date; rivastigmine hydrogen tartrate (RIVASTIGMINE ACTAVIS) from 17Sep2020 to an unspecified stop date; macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOXALOLE) from 06May2020 to an unspecified stop date; budesonide, formoterol fumarate (SYMBICORT TURBOHALER) from 06May2020 to an unspecified stop date; cyanocobalamin (BETOLVIDON) from 06May2020 to an unspecified stop date; furosemide (IMPUGAN [FUROSEMIDE]) from 06May2020 to an unspecified stop date; all taken for an unspecified indication. The patient previously received the first dose of COMIRNATY on 07Jan2021 for COVID-19 immunization. The patient experienced low blood pressure and tiredness on 06Feb2021. These events were reported as serious (medically significant). Clinical course was reported as follows. Reported suspect vaccine was COMIRNATY (covid-19 vaccine). Reported suspect adverse events were tiredness and low blood pressure. The patient was vaccinated with 1st dose on 07Jan2021 and 2nd dose on 04Feb2021. On 06-07Feb2021, the patient had low blood pressure and was tired. On 08Feb2021, her blood pressure was 110/70 mmHg. Treatment with felodipine 10 mg once daily was withdrawn and after that, the patient felt better. No blood pressure was taken after felodipine was withdrawn. In late Feb2021, the patient had a fall and broke her femoral neck. No blood pressure was taken in conjunction with the fall. Upon arrival at the hospital, systolic blood pressure was 130 mmHg, but according to the reporter, the patient was probably in pain at this point. During surgery, the patient passed away. The reporter writes that she has seen an unusual number of cases with low blood pressure and falls in blood pressure among her patients following vaccination with COMIRNATY. She also writes that each individual case can be explained by concomitant illness, medication and so on, but that the number of patients affected has been remarkable. The reporter has reported 11 valid cases alongside this letter, and two non-valid cases to showcase that low blood pressure can occur even without vaccination. Outcome of the events tiredness, low blood pressure, fall, and broke her femoral neck was unknown. The patient died with unknown cause of death on an unspecified date in Feb2021. Unknown if autopsy was done. No follow-up attempts are possible; information about LOT/batch number cannot be obtained.; Reported Cause(s) of Death: unknown cause of death; passed away


VAERS ID: 1149897 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Haematemesis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (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: Medical History/Concurrent Conditions: Anxiety; Depression; Diverticulitis; Hypertension; Lung sarcoid; Osteoporosis; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021311771

Write-up: the patient died 2 days after vaccination; The patient was found dead with coffee sump like vomiting; This is as spontaneous report received from a contactable consumer downloaded from the Regulatory Authority-WEB. The regulatory authority report number is SE-MPA-2021-017039, other case identifier is SE-MPA-1615556907316. A elderly male patient received bnt162b2 (COMIRNATY, lot number: EP2163, expiration date: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient''s medical history included hypertension, depression, lung sarcoid, type 2 diabetes mellitus, diverticulitis, osteoporosis, and anxiety. The patient''s concomitant medications were not reported. On an unspecified date, the patient died 2 days after vaccination. The patient was found dead with coffee sump like vomiting. 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: the patient died 2 days after vaccination


VAERS ID: 1149898 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Thrombosis
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bipolar disorder; Blood sugar increased
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021311754

Write-up: SEVERAL OF THROMBOSES; severe abdominal pain; This is a spontaneous report from a contactable nurse downloaded from the regulatory authority-WEB, regulatory authority numberSE-MPA-2021-018721. Other Case identifier number: SE-MPA-1615843203133. An 83-year-old female patient received first dose of bnt162b2 (COMIRNATY; Lot Number: EL0725) via an unspecified route of administration, on Feb2021, as SINGLE DOSE for covid-19 immunisation. Medical history included blood glucose increased and bipolar disorder. The patient''s concomitant medications were not reported. In Feb2021, 6 day after the vaccine, the patient developed severe abdominal pain and went to a hospital, where multiple thrombosis in her body was discovered. The woman died the following day. This was completely unexpected and sudden, is described as an alert woman who managed her life on her own. Outcome of abdominal pain was unknown while it was fatal for several thromboses. Cause of death was reported as several of thromboses. No autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: several of thromboses


VAERS ID: 1151734 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-10
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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: 2021-03-13
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021314531

Write-up: pneumonia; This is a spontaneous report from a contactable consumer (Administration spoke person) via Pfizer colleague. This consumer (Administration spoke person) reported same events for two patients. This is one of two reports. A male patient in his mid 80s received bnt162b2 (COMIRNATY), via an unspecified route of administration on 10Mar2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. A source close to the patient said the patient was previously well before the vaccine, and rapidly deteriorated the following day. The patient experienced pneumonia on an unspecified date in Mar2021. The outcome of the event was fatal. The patient died on 13Mar2021. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : AU-PFIZER INC-2021314530 same reporter, event, different patient; Reported Cause(s) of Death: pneumonia


VAERS ID: 1151746 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-02-20
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Ischemic cardiomyopathy
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021328256

Write-up: Sudden death; This is a spontaneous report from a contactable physician downloaded from the Regulatory authority-WEB. Health authority report number is BE-FAMHP-DHH-N2021-82433. A 90-year-old male patient received BNT162B2 (COMIRNATY; Unknown lot number and expiration), via an unspecified route of administration on 10Feb2021 at a single dose for COVID-19 immunisation. Medical history included ischemic cardiomyopathy and advanced Alzheimer''s. The patient''s concomitant medications were not reported. The patient experienced sudden death on 20Feb2021. It was unknown if an autopsy was performed. Reporter''s comments: Treatment - Unknown. Evolution of the ADR - ADR description - Died on 20Feb2021, probably not linked to vaccine due to ischemic cardiomyopathy and advanced Alzheimer''s disease. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : BE-FAMHP-DHH-N2021-82433 FAMHP; Reported Cause(s) of Death: Sudden death


VAERS ID: 1151755 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-02-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Death, Dehydration, Nausea, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-09
   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: Chronic kidney disease (Further information not known)
Preexisting Conditions: Medical History/Concurrent Conditions: Renal failure; SARS-CoV-2 infection (Further information not known); Upper gastrointestinal hemorrhage (Recent (further information not known))
Allergies:
Diagnostic Lab Data: Test Date: 20210207; Test Name: Fever; Result Unstructured Data: Test Result:39 Centigrade
CDC Split Type: CHPFIZER INC2021328075

Write-up: Death; Vomiting; Fever of 39 degree centigrade; Nausea; Dehydration; This is a spontaneous report from a contactable physician via the regulatory authority with regulatory authority report number CH-SM-2021-11463. An 89-year-old female patient received bnt162b2 (COMIRNATY; unknown lot number and expiration date), at vaccination age of 89-year-old intramuscular on 05Feb2021 as a single dose for covid-19 immunisation. Medical history included ongoing chronic kidney disease, advanced renal failure, covid-19 infection from 15Jan2021 to an unknown date and recent upper gastrointestinal haemorrhage, all had further information as not known. The patient''s concomitant medications were not reported. The patient experienced death on 09Feb2021, fever on 07Feb2021, nausea on 05Feb2021, dehydration on 05Feb2021 and vomiting on 08Feb2021. It was reported that the patient showed nausea on 05Feb2021 then pyrexia (39 degree Centigrade) on 07Feb2021 and vomiting on 08Feb2021 which exitus as a result of dehydration on 09Feb2021. The outcome of the events was fatal. The patient died on 09Feb2021. It was not reported if an autopsy was performed. A causal relationship between Comirnaty and death was assessed as being unlikely. A causal relationship between Comirnaty and all other events was assessed as being possible. regulatory authority assessed this case as serious, results in death. Reporter''s Comment: Vaccination on 05Feb2021; Fever 39 degree on 07Feb2021; From 08Feb2021 rec. vomiting; Death case 09Feb2021 Sender''s comment: Elderly patient following vaccination with Comirnaty (05Feb2021) manifested nausea, pyrexia (3 days of latency) and vomiting (4 days of latency) that led to a state of dehydration and, therefore, death. Notoriety, nausea (common) is reported under Gastrointestinal disorders and pyrexia (very common, 14.2%) under Systemic diseases and conditions related to the site of administration, whereas vomiting is not listed among the adverse events, as are death and dehydration. In contrast the, the FDA''s Comirnaty datasheet (1) includes a table indicating the "Frequency and percentage of participants with systemic adverse reactions elicited after each dose, by degree of severity, within 7 days of each dose-participants $g=56 years of age-population safety subgroup reactivity analysis" and vomiting is listed here, specifying various levels of severity ("any degree," "mild," "moderate","severe." ) From a literature search, Micromedex (3) reports vomiting (incidence: 0.5%-1.9%) among gastrointestinal adverse events. UpToDate (4), however, indicates that nausea and vomiting may also be symptoms attributable to advanced renal failure and (5) also highlights the increased morbidity in the case of advanced renal disease. Serious adverse reaction (death). According to current knowledge, the causal link - related to the adverse reactions nausea, fever, vomiting - is considered possible, given the close temporal correlation with the vaccination (chronological criterion) and the notoriety (1, 2, 3) of the adverse events manifested by the patient. These adverse events may have contributed to a state of dehydration that, however, is also attributable to and/or exacerbated by the patient''s underlying comorbidities (recent upper gastrointestinal bleeding and COVID-19 infection; advanced renal pathology: 4,5). In conclusion, it is plausible to assume that it was this state of dehydration to determine, in the final analysis, the death of the patient and - although we can not exclude that the vaccine, in a patient with such copatologies, may have contributed to dehydration - the death is not directly attributable to vaccination (causal link unlikely). (1): "Study 2 - Frequency and Percentages of Participants with Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Each Dose - Participants 56 Years of Age and Older - Reactogenicity Subset of the Safety Population: Vomiting (Any, Mild, Moderate, Severe)". (3): "Gastrointestinal Effects - Vomiting: Incidence: 0.5% to 1.9%". (4): "A wide range of disorders may develop as a consequence of the loss of kidney function. These include (...) nausea, vomiting". (5): "End-stage kidney disease - Compared with individuals who had an eGFR of 60 mL/min per 1.73 m2 or more, the relative risks for ESKD among those who had an eGFR between 45 and 59 mL/min per 1.73 m2 were 3.1 (95% CI, 1.1-8.3) in those younger than 65 years and 3.4 (95% CI, 1.6-7.2) in those older than 65 years. In contrast to cardiovascular mortality, absolute rates of ESKD were lower in those older than 65 years". No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.; Reporter''s Comments: Vaccination on 05Feb2021; Fever 39 degree on 07Feb2021; From 08Feb2021 rec. vomiting; Death case 09Feb2021; Sender''s Comments: The reported death is most likely the consequence of nausea, fever, vomiting, dehydration in the context of concurrent medical conditions of chronic kidney disease, advanced renal failure, covid-19 infection, unlikely directly related to the administration of the COVID19 vaccine, 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 RA, IEC, as appropriate.; Reported Cause(s) of Death: Dehydration


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