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

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



Case Details

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VAERS ID: 1104878 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Hyporesponsive to stimuli, Malaise, Pyrexia, Urosepsis
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

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: ALPRIM [TRIMETHOPRIM]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: UTI (Alprim 300mg daily from 26Feb2021 for a UTI)
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021245649

Write-up: urosepsis; He was also noted to be less responsive; Felt unwell; high temperature; This is a spontaneous report from a non-contactable other HCP via agency. A 96-year-old male patient received bnt162b2 (COMIRNATY) at single dose on 04Mar2021 just before lunch (around midday) for covid-19 immunisation. Medical history included had a medical history of a number of medical conditions but the only provided was urinary tract infection treated with Alprim 300mg daily from 26Feb2021 for a UTI, was an aged care resident. No known allergies. Concomitant medication included trimethoprim (ALPRIM) 300mg daily from 26Feb2021 and ongoing for UTI, prescribed by the patient''s regular GP to be taken until 05Mar2021. The patient experienced high temperature on 05Mar2021 10:00, felt unwell on 05Mar2021 10:30, urosepsis on 05Mar2021 18:30. The patient died on 05Mar2021 18:30. It was not reported if an autopsy was performed. Clinical course was as follows: No adverse events were noted following the injection. On 05Mar2021 around 10am he began to feel unwell (high temperature), he was assessed by the RN on duty and an ambulance was called at around 11am and tansported to the Emergency Centre of hospital. He was also noted to be less responsive at this time. He went to hospital via ambulance on 05Mar2021 and passed away at 18:30 on 05Mar2021. The consumer passed away in the EC and was not admitted to Hospital at the time. Hospital advised cause of death to be urosepsis. At the time of his death the patient was on a syringe driver of unspecified medication and had a NFR (Not for resuscitation) order in place. No death certificate has been issued at this time and the coroner has been notified in line with PRIVACY Health policies on deaths following COVID vaccination. It was unclear if an autopsy and coroner''s investigation will be performed or if the GP/Hospital will issue the death certificate. It is noted that the family had provided consent to the vaccination prior to the commencement of antibiotics. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Urosepsis


VAERS ID: 1104926 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-12
Onset:2021-01-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Apathy, Death
SMQs:, Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-23
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dementia; Heart disease, unspecified
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021266975

Write-up: Unknown cause of death; mouth wide open, apathy; This is a spontaneous report from a non-contactable consumer or other non-HCP downloaded from the Agency Regulatory Authority-WEB, regulatory authority number: DE-PEI-CADR2021014885, DE-CADRPEI-2021014885, DE-PEI-2021005337. A 92-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunisation. Medical history included ongoing dementia and ongoing heart disease. Concomitant medications were not reported. The patient''s weight was not reported, and height was not reported. On 14Jan2021, the patient experienced mouth wide open, apathy. On 23Jan2021, the patient experienced unknown cause of death. It was unknown if an autopsy was performed. Outcome of mouth wide open, apathy was unknown, of unknown cause of death was fatal. Sender Comment: dementia, medical therapy of heart. Reported causality assessment for both events: source of assessment was Regulatory Authority, result of assessment was inconsistent causal association to immunization. No follow-up attempts are possible. No further information is expected. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1104927 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-28
Onset:2021-01-05
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021266914

Write-up: Unknown cause of death; This is a spontaneous report received from a consumer or other non-health professional downloaded from the Regulatory Authority, regulatory authority number DE-PEI-CADR2021015068, and other manufacturer number DE-CADRPEI-2021015068, DE-PEI-2021005565. A 96-year-old female patient received BNT162B2 (COMIRNATY, LOT#: unknown), intramuscularly on 28Dec2020 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced unknown cause of death on 05Jan2021. The patient died on 05Jan2021. An autopsy was performed but results were not provided. Reported causality assessment: Source of assessment: Regulatory Authority; Result of Assessment: Inconsistent causal association to immunization. No follow-up attempts are possible. No further information is expected. information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1104928 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-25
Onset:2021-01-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, Dyspnoea, Incorrect route of product administration, Nasopharyngitis, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Drug abuse and dependence (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Medication errors (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-03
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Artificial cardiac pacemaker wearer; Hypertension; Overweight (light); Renal function disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Covid Test; Result Unstructured Data: Test Result:Positive
CDC Split Type: DEPFIZER INC2021266942

Write-up: pneumonia with covid infektion; slight cold symptoms; Breathing difficult; Vaccine given IV; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Regulatory Agency-WEB DE-PEI-CADR2021015198. A 89-years-old female patient received bnt162b2 (COMIRNATY) vaccine, intravenous on 25Jan2021 (Batch/Lot number was not reported) as 0.3 mL, single for covid-19 immunisation . Medical history included ongoing renal impairment , ongoing cardiac assistance device user , ongoing hypertension , ongoing overweight light. The patient''s concomitant medications were not reported. The patient experienced pneumonia with covid infection on 26Jan2021 , slight cold symptoms on 26Jan2021 with outcome of unknown , breathing difficult on 26Jan2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive. The patient died on 03Feb2021 from Covid-19 pneumonia. It was not reported if an autopsy was performed. The patient received the vaccine Intravenously and this is an Inappropriate route of vaccination. Course of event: Mild cold symptoms from the first day after vaccination, increased daily with cough and heavy breathing, no fever, admission to hospital on 5th day after vaccination in very weak condition, Corona rapid test positive, Diagnosis in hospital severe pneumonia, died 3 days after admission. According to PEI there is a consistent causal association to immunization for the event cold symptoms, but inconsistent causal association to immunization for the events pneumonia and breathing difficult. No follow-up attempts needed. Follow-up provided automatically by Agency.; Reported Cause(s) of Death: pneumonia with covid infektion


VAERS ID: 1104929 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-01-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, C-reactive protein, C-reactive protein increased, Chronic kidney disease, Death, Fall, Incorrect route of product administration, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug abuse and dependence (broad), Accidents and injuries (narrow), Chronic kidney disease (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-31
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute cardiac insufficiency; Renal impairment NOS
Allergies:
Diagnostic Lab Data: Test Date: 20210128; Test Name: fever 38.5 degrees; Result Unstructured Data: Test Result:38.5 Centigrade; Test Date: 20210128; Test Name: C-reactive protein; Result Unstructured Data: Test Result:increased
CDC Split Type: DEPFIZER INC2021266986

Write-up: Chronic renal insufficiency; Fall; C-reactive protein increased; Unknown cause of death; Fever 38.5 degrees; BNT162B2 via subcutaneous; This is a spontaneous report from a non-contactable consumer, received from the regulatory authority, downloaded from the Regulatory Authority-WEB. The regulatory authority report number is DE-PEI-CADR2021016113. An 88-year-old female patient received the second dose of BNT162B2 (COMIRNATY, batch/lot number and expiration date unknown) via subcutaneous on 27Jan2021 (88-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient''s medical history included acute cardiac insufficiency and renal impairment NOS, both from an unspecified date and unknown if ongoing. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (COMIRNATY, batch/lot number and expiration date unknown) via an unspecified route of administration on 06Jan2021, at single dose, for COVID-19 immunization. On 28Jan2021 the patient experienced chronic renal insufficiency (also reported as chronic renal failure), C-reactive protein increased, fever 38.5 degrees, and fall. Chronic renal insufficiency, C-reactive protein increased, and fall were reported as serious due to hospitalization. On 31Jan2021 the patient experienced unknown cause of death. The patient died on 31Jan2021. The patient''s weight was 72 kg, and height was 158 cm. Sender Comment: "Heart failure. Renal insufficiency / passed away 4 days after the 2nd vaccination against corona. Previously felt the home. Reanimated in the hospital. nd been artificially ventilated." The outcome of unknown cause of death was fatal; the outcome of other events was unknown. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1104930 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-07
Onset:2021-02-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Incorrect route of product administration
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Drug abuse and dependence (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021267015

Write-up: BNT162B2 (COMIRNATY), intravenous; Acute myocardial infarction; This is a spontaneous report received from a non-contactable consumer via regulatory authority (PEI) and downloaded from the Medicines Agency (EMA) EudraVigilance-WEB DE-PEI-CADR2021016955. A 47-year-old female patient received BNT162B2 (COMIRNATY, lot number unknown), intravenous on 07Feb2021 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 08Feb2021 the patient experienced acute myocardial infarction reported as serious death. The patient died on 08Feb2021. It was unknown if autopsy was performed and the reported cause of death was acute myocardial infarction. The outcome of the event was fatal. Causality from PEI: Inconsistent causal association to immunization. Sender Comment: death No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1104931 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-07
Onset:2021-02-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8723 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Incorrect route of product administration
SMQs:, Drug abuse and dependence (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-13
   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: Atrial fibrillation; Dyspnoea exertional; Primary hyperthyroidism
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021266972

Write-up: Unknown cause of death; intravenous; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority-WEB DE-PEI-CADR2021017125. An 82-year-old female patient received second dose of BNT162B2 (COMIRNATY), intravenous on 07Feb2021 (Lot Number: EL8723) at single dose for COVID-19 immunisation. Medical history included ongoing primary hyperthyroidism, ongoing atrial fibrillation and ongoing dyspnoea exertional. The patient''s concomitant medications were not reported. The patient previously received first dose of BNT162B2 (COMIRNATY) on 17Jan2021 for COVID-19 immunization. The patient death occurred on 13Feb2021, unknown cause of death. 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: Unknown cause of death


VAERS ID: 1104932 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-09
Onset:2021-01-22
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-02
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiac failure chronic
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 Test porsitiv; Result Unstructured Data: Test Result:Positive; Comments: tests in the old people''s home was negative. After the hospitalisation was the COVID-.PCR-Test positive
CDC Split Type: DEPFIZER INC2021266944

Write-up: shortness of breath; PCR test was then made and turned out positive; Death; This is a spontaneous report downloaded from the Regulatory Authority-WEB regulatory authority number DE-PEI-CADR2021017328. A non-contactable consumer reported that a 95-year-old female patient received BNT162b2 (COMIRNATY, solution for injection, batch/lot: unknown), via an intramuscular route of administration on 09Jan2021 at single dose for COVID-19 immunization. Medical history included ongoing cardiac failure chronic. Concomitant medications was not reported. Heart failure / the person complained 10 days after vaccination about shortness of breath and thus directed to the city hospital. The person was from the beginning of December in quarantine since there was a positive case in the home. All PCR tests were negative. In the hospital a PCR test was then made and turned out positive. On 02Feb2021 the person died. The cause of death was unknown. Outcome of death was fatal and outcome of both events was not recovered. Causality from regulatory authority: Inconsistent causal association to immunization No follow-up attempts are needed, follow-up automatically provided by regulatory authority.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1104933 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-02-01
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / UNK - / OT

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

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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021267522

Write-up: Patient died; This is a spontaneous report downloaded from the Regulatory Authority-WEB [DE-PEI- CADR2021019125]. A non-contactable consumer reported that an 84-year-old male patient received BNT162B2 (COMIRNATY/ mRNA TOZINAMERAN; solution for injection, Lot Number: EJ6796), intramuscular on 22Jan2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, the patient died on 01Feb2021. It was not reported if an autopsy was performed. The outcome of the event was reported as fatal. No follow-up attempts needed. Follow-up automatically provided by regulatory authority.; Reported Cause(s) of Death: patient died


VAERS ID: 1104934 (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: 2021-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Electrolyte depletion, Vomiting
SMQs:, Cardiac failure (narrow), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021267021

Write-up: Cardiac failure; Electrolyte depletion; Vomiting; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB DE-PEI-CADR2021020747. A 99-year-old female patient received second dose of BNT162B2 (COMIRNATY), intramuscular on 01Feb2021 (Lot Number: EK9788) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (COMIRNATY) on 04Jan2021 at single dose for COVID-19 immunisation. On 01Feb2021, the patient experienced electrolyte depletion and vomiting, both with outcome of not recovered; cardiac failure with fatal outcome. The patient died on 01Feb2021. 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 failure


VAERS ID: 1104935 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-15
Onset:2021-02-20
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

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: Arterial hypertension (treated with ramipril); Hypothyreosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021267505

Write-up: died with unknown cause; This is a spontaneous report downloaded from the Agency; Regulatory Authority-WEB [DE-PEI-CADR2021021478]. A non-contactable consumer reported that an 81-year-old female patient received BNT162B2 (COMIRNATY/ mRNA TOZINAMERAN; solution for injection; Lot number: unknown), intramuscular on 15Feb2021 at single dose for COVID-19 immunisation. The patient''s medical history included ongoing arterial hypertension (treated with ramipril) and ongoing hypothyreosis (treated). Concomitant medications were not reported. It was reported that, on 20Feb2021, the patient died with unknown cause. It was unknown if an autopsy was performed or not. The event was assessed as serious (death). The outcome of the event was reported as fatal. Health Authority Comment: Information on risk factors or previous illnesses: Arterial hypertension treated with ramipril treated hypothyroidism / unclear cause of death". No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: died with unknown cause


VAERS ID: 1104942 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-13
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021250313

Write-up: Death; This is a spontaneous report from a non-contactable physician downloaded from the Agency, [DE-PEI-PEI2021003113]. An 85-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection, lot number: EJ6789), via an unspecified route of administration on 13-Feb-2021 at a single dose for COVID-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced death on an unspecified date in 2021. The patient died on an unspecified date. The outcome of the event was fatal. It was unknown if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death


VAERS ID: 1104945 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 - / -

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: DEPFIZER INC2021267057

Write-up: Exitus letalis; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority. Regulatory authority number: DE-PEI-PEI2021003213. A 70-year-old male patient received second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 04Mar2021 as a single dose (at age of 70-year-old) for covid-19 immunisation, lot number: EP9598. Medical history and concomitant medications were not provided. First vaccine dose of BNT162B2 (COMIRNATY) was administered on 11Feb2021 (at age of 70-year-old) for COVID-19 immunisation, had been tolerated. On 05Mar2021, one day after vaccination, the patient developed death (exitus letalis), lasting for unknown (as reported). The cause of death was unknown. It was unknown if an autopsy was performed. Causality provided by Regulatory Authority was Unclassifiable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Exitus letalis


VAERS ID: 1104946 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-17
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021267055

Write-up: Exitus letalis; This is a spontaneous report downloaded from the Agency Regulatory Authority -WEB. The Regulatory Authority Number is DE-PEI-PEI2021003214. A non- contactable physician reported that an 82-year-old female patient received first dose of bnt162b2 (COMIRNATY; Lot Number: EM0477) via an unspecified route of administration on 17Jan2021 (at the age of 82-year-old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. It was reported that three days after vaccination that was on unknown date in Jan2021, the patient condition was life threatening and had exitus letalis. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Exitus letalis


VAERS ID: 1104947 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-06
Onset:2021-03-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Encephalitis, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-08
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021267042

Write-up: Meningoencephalitis; acute pulmonary failure; This is a spontaneous report downloaded from the Regulatory Authority-WEB, regulatory authority number: DE-PEI-PEI2021003222. A 54-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration from 06Mar2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 06Mar2021 patient experienced meningoencephalitis (death), acute pulmonary failure (death) on 06Mar2021. Seriousness of the case was death. Outcome of the both events was fatal. The patient died on 08Mar2021. It was not reported if an autopsy was performed. No follow-up attempts needed, follow-up automatically provided by regulatory authority.; Reported Cause(s) of Death: acute pulmonary failure; Meningoencephalitis


VAERS ID: 1104948 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-22
Onset:2021-02-25
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pain, Pyrexia, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   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: Carcinoma of rectum
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021272202

Write-up: General body pain; Unresponsive to verbal stimuli; Fever; This is a spontaneous report downloaded from the Regulatory Authority-WEB regulatory authority number DE-PEI-PEI2021003238. A contactable physician reported that a 60-year-old male patient received first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch number and Expiration date was not reported), via an unspecified route of administration on 22Feb2021 at single dose for COVID-19 immunisation. The patient''s medical history included carcinoma of rectum from an unspecified date in Sep2017 and ongoing. Concomitant medications were not reported. On 25Feb2021, after vaccination the patient developed fever, general body pain and unresponsive to verbal stimuli, lasting for unknown. The outcome of the events was fatal. The patient died on 01Mar2021. Cause of death was general body pain, unresponsive to verbal stimuli, fever. It was unknown if an autopsy was performed or not. Company causality assessment: Events, general body pain, unresponsive to verbal stimuli, fever was assessed to be unclassifiable to bnt162b2. Follow-up activities not applicable, Follow-up provided automatically by Regulatory Authority.; Reported Cause(s) of Death: Fever; General body pain; Unresponsive to verbal stimuli


VAERS ID: 1104949 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-07
Onset:2021-03-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 1 - / -

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

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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dilated cardiomyopathy
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021272210

Write-up: Exitus letalis/ patient is dead; This is a spontaneous report downloaded from the Agency-WEB DE-PEI-PEI2021003244. A non-contactable physician reported for an 85-year-old male patient received first dose of BNT162B2 (COMIRNATY; Solution for injection; Lot Number: EP2163), via an unspecified route of administration on 07Mar2021 at single dose for COVID-19 immunisation. Medical history included dilated cardiomyopathy. The patient''s concomitant medications were not reported. On 08Mar2021, after vaccination the patient was Exitus Letalis/ patient is dead, lasting for unknown. The patient died on 08Mar2021. An autopsy was performed, and results were not provided. No follow-up attempts needed. Follow-up automatically provided by Health Authority.; Reported Cause(s) of Death: Exitus letalis/ patient is dead


VAERS ID: 1104950 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-19
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Acute kidney injury, Back pain, Blood test, Colonoscopy, Ileus paralytic, Mobility decreased, Pain, Septic shock
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Acute pancreatitis (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 (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Parkinson-like events (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tumour lysis syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-07
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Heart valve disorders (weak valve); Hemoglobin low (well treated medically); Ogilvie''s syndrome (Suspected concurrent condition by the physician)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202011; Test Name: Blood test; Result Unstructured Data: Test Result:Bad kidney values; Test Date: 2021; Test Name: Blood test; Result Unstructured Data: Test Result:Very high infection count; Test Date: 2021; Test Name: Colonoscopy; Result Unstructured Data: Test Result:Dilated but no sign of colitis. No bacteria.; Comments: Might be Ogilvie''s syndrome
CDC Split Type: DKPFIZER INC2021254835

Write-up: Acute kidney failure; Stomach pain; General body pain; Paralysis of colon; back pain; Septic shock; couldn''t move for a few days; This is a spontaneous report from a contactable consumer (patient relative) and physician via The Agency and downloaded from the Regulatory Authority-WEB (Regulatory Authority number DK-DKMA-ADR 24774341). An 81-year-old male patient received BNT162B2 (COMIRNATY; lot EJ6134, expiry date 30Apr2021) on 14Jan2021, at single dose, for COVID-19 immunisation. Medical history included ongoing hemoglobin low (well treated medically), ongoing Ogilvie''s syndrome (suspected concurrent condition by the physician), ongoing heart valve disorders (weak valve). The patient''s concomitant medications were not reported. Before vaccination the patient was "well-functioning in his own home with dog, car and summerhouse". On 19Jan2021 the patient experienced acute kidney failure, stomach pain, general body pain, paralysis of colon, back pain, septic shock. As a consequence of general body pain, stomach pain and back pain, the patient couldn''t move for a few days. All the events were reported as serious as involved hospitalization from 15Jan2021. Kidney failure was reported with a fatal outcome. The other events outcome was unknown. The patient died on 07Feb2021. No autopsy was performed. The patient underwent lab tests and procedures which included blood test in Nov2020: bad kidney values (but this was not treated by the physician), blood test in 2021: very high infection count, colonoscopy in 2021: dilated but no sign of colitis. No bacteria. Might be Ogilvie''s syndrome. The physician (reporter of requested follow-up) suspected, that the patient had Ogilvie''s syndrome. The ADRs were reported by the (unspecified) reporter as resulting in hospitalisation on 15Jan2021 and fatal and on 07Feb2021. No treatment due to the ADRs was specified. The ADR Acute kidney failure was fatal. Outcome of Septic shock, Stomach pain, Back pain, Paralysis of colon, General body pain was unknown. Reported cause of death: Acute kidney failure. No obduction will be performed. Causality: The relative to the patient noted that the patient kidney values were bad in Nov2020 and he therefore might have been pre-disposed to kidney failure. However this most likely could have been handled medically if not for the vaccination. The vaccination could have caused the acute failure. The physician confirmed the described reactions, but did not suspect the vaccination to be the cause of them or the patient death. This case was therefore not medically confirmed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Acute kidney failure


VAERS ID: 1104953 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-30
Onset:2021-02-20
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood gases, Blood test, C-reactive protein, Chest X-ray, Dyspnoea, PCO2, PO2, Pain, Pneumonia, Restlessness, SARS-CoV-2 test, Sputum culture, pH body fluid
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-23
   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: GLYCERYLNITRAT; PREDNISOLONE; FUROSEMIDE; BISACODYL; OXAZEPAM; PANTOPRAZOLE; CLINDAMYCIN; ZOPICLONE; PRADAXA; NYSTATIN; SERETIDE; VENLAFAXINE; FENTANYL; MORPHINE; TIOTROPIUM; ATENOLOL
Current Illness: Atrial fibrillation; Cardiac insufficiency (EF of 40-45% (not heart failure)); Chronic obstructive airways disease (with FEV1 on 56%); Lymphangitis carcinomatosis; Pulmonary carcinoid tumor (Terminal lung cancer (palliative phase), of right inferior lobe metastasized to lymphnodes and lungs); Vancomycin-resistant enterococcal infection
Preexisting Conditions: Medical History/Concurrent Conditions: Pneumonia; Radiation therapy (Received radiation therapy 5 Gy 5 times in 2016)
Allergies:
Diagnostic Lab Data: Test Date: 20210223; Test Name: Blood gases (BE); Result Unstructured Data: Test Result:11.6; Test Date: 20210223; Test Name: blood gases: lactate; Result Unstructured Data: Test Result:4.4; Test Date: 20210223; Test Name: Blood test; Result Unstructured Data: Test Result:Renal values normal; Test Date: 20210223; Test Name: Thorax X-ray; Result Unstructured Data: Test Result:Infiltrates bilaterally; Test Date: 20210223; Test Name: C-reactive protein; Result Unstructured Data: Test Result:180; Test Date: 20210223; Test Name: Blood gases (po2); Result Unstructured Data: Test Result:8.0; Test Date: 20210223; Test Name: blood gases: ph; Result Unstructured Data: Test Result:7.4; Test Date: 20210223; Test Name: Blood gases (po2); Result Unstructured Data: Test Result:6.7; Test Date: 202102; Test Name: COVID-19 virus test; Test Result: Negative ; Test Date: 20210203; Test Name: Sputum culture; Result Unstructured Data: Test Result:Serratia marcesens, pos. for pip/tazo; Test Date: 20210209; Test Name: Sputum culture; Result Unstructured Data: Test Result:Severe growth of candida albican and krusei
CDC Split Type: DKPFIZER INC2021254839

Write-up: Dyspnea; unrest; Pain; Pneumonia; This is a spontaneous report from a contactable physician downloaded from the Agency, DK-DKMA-WBS-0042026 and DK-DKMA-ADR 24823579. Report received from the Agency. An 87-years-old male patient received the second dose of BNT162B2 (COMIRNATY, Lot. EK9788, Expiration date: 31-May-2021) intramuscularly, at single dose, on 30-Jan-2021, for COVID-19 immunisation. Relevant medical history included ongoing chronic obstructive pulmonary disease (with FEV1 on 56%), ongoing cardiac failure (EF of 40-45% (not heart failure)), ongoing vancomycin-resistant enterococcal infection, radiotherapy from 2016 to 2016 (received radiation therapy 5 Gy 5 times in 2016), ongoing lymphangitis carcinomatosis, ongoing carcinoid tumour pulmonary (terminal lung cancer (palliative phase), of right inferior lobe metastasized to lymphnodes and lungs), pneumonia from an unknown date and unknown if ongoing (hospitalized several times due to pneumonia), ongoing atrial fibrillation. Concomitant medication included glyceryl trinitrate (GLYCERYLNITRAT) from 18-Apr-2019, for angina pectoris; prednisolone from 12-Feb-2021, as glucocorticoid therapy; furosemide from 15-Feb-2021, as diuretic therapy; bisacodyl from 18-Dec-2020, for constipation; oxazepam from 19-Aug-2020 as sedative therapy; pantoprazole from 12-Feb-2021, as gastric ulcer prophylaxis; clindamycin from 15Feb2021 to 19-Feb-2021, for pneumonia; zopiclone from 04Feb2020, for insomnia; dabigatran etexilate mesilate (PRADAXA) from 17-Jan-2020, for thrombosis prophylaxis; nystatin from 09-Feb-2021, for oral fungal infection; fluticasone propionate, salmeterol xinafoate (SERETIDE) from 11-Dec-2020, for chronic obstructive airways disease; venlafaxine from 20-Aug-2020, for anxiety; fentanyl from 08-May-2019, for pain; morphine from 05-Sep-2019, for pain; tiotropium from 10-Sep-2019, for chronic obstructive airways disease and atenolol from 09-Jan-2020, for heart rate irregular. The patient previously, on 06-Jan-2021, received the first dose of BNT162B2 (COMIRNATY, Lot.EM0477, expiration date: 30-Apr-2021) intramuscularly, at single dose, for COVID-19 immunisation. On 20-Feb-2021 the patient developed pneumonia and on 23-Feb-2021 dyspnea, pain and unrest. The patient was treated with oxapam, midazolam, morphine and BERODUAL (Ipratropium Bromide and fenoterol hydrobromide). The patient underwent lab tests and procedures which included blood gases: BE: 11.6 (unit not provided) on 23-Feb-2021, blood gases: po2: 6.7 (unit not provided) on 23-Feb-2021, blood gases: ph: 7.4 (unit not provided) on 23-Feb-2021, blood gases: pco2: 8.0 (unit not provided) on 23-Feb-2021, blood gases: lactate: 4.4 (unit not provided) on 23-Feb-2021, blood test: renal values normal on 23-Feb-2021, chest x-ray: infiltrates bilaterally on 23-Feb-2021, C-reactive protein: 180 (unit not provided) on 23-Feb-2021, sars-cov-2 test: negative in Feb-2021, sputum culture: serratia marcesens, pos. for pip/tazo on 03-Feb-2021, sputum culture: severe growth of candida albican and krusei on 09-Feb-2021. The patient died on 23-Feb-2021. An autopsy was not performed. Clinical outcome of pneumonia and dyspnea was fatal, while clinical outcome of the other events was unknown. Causality: Reporting physician does not suspect any other pharmacological reason for cause of death. The physician who declares the patient dead assessed that it was a natural death. It is the reporting physician that suspects the vaccine as a causal connection to the death due to the time death. If the Agency receives supplemental significant information regarding this case the case will be re-submitted. No Follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Dyspnoea; Pneumonia


VAERS ID: 1104978 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Feeling cold, Malaise, Oral disorder
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Benign prostatic hyperplasia; Cardiac valvulopathy; Chronic obstructive lung disease; Colon neoplasia; Hypertension arterial; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021256515

Write-up: Malaise; initiation with cold feeling, deviation of oral commissure and later exitus; initiation with cold feeling, deviation of oral commissure and later exitus; initiation with cold feeling, deviation of oral commissure and later exitus; This is a spontaneous report downloaded from the Regulatory Authority-WEB (ES-AEMPS-776492). This is a spontaneous report from a physician. This is a report received from the Drug Agency, with the Regulatory authority report number ES-AEMPS-776492. A 97-year-old male patient received bnt162b2 (COMIRNATY, lot # EP9598), intramuscular at single dose on 19Feb2021 for COVID-19 immunization. Medical history included hypertension, benign prostatic hyperplasia, chronic obstructive pulmonary disease, type 2 diabetes mellitus, colon neoplasm, and cardiac valve disease. The patient''s concomitant medications were not reported. The patient experienced "initiation with cold feeling, deviation of oral commissure and later exitus" on 21Feb2021. The patient died in Feb2021. An autopsy was not performed but the initial or fundamental cause was colon neoplasia. End-stage disease. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Colon neoplasia. End-stage dsease


VAERS ID: 1104987 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Bedridden, Depressed level of consciousness, General physical health deterioration
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: PAMOL F; SELOKEN ZOC; XARELTO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebrovascular disorder; Disorder circulatory system (grave); Hypertension arterial; Intracerebral haemorrhage (years ago); Pressure ulcer
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021256392

Write-up: General physical health deterioration; alertness state of the patient decreased episode-like; the patient was bedridden; This is a spontaneous report from a contactable healthcare professional downloaded from The Regulatory Authority-WEB (Regulatory Authority number FI-FIMEA-20211071). An 88-year-old female patient received the first single dose of BNT162B2 (COMIRNATY; lot number EJ6795) intramuscular, on 15Jan2021, for COVID-19 immunisation. Medical history included hypertension arterial, intracerebral haemorrhage years ago, disorder of the cerebral circulation from 2020, grave blood circulatory diseases, pressure ulcer of heal. Concomitant medications included oral paracetamol (PAMOL F; Orodispersible tablet) 500 mg, daily, oral metoprolol succinate (SELOKEN ZOC; Prolonged-release tablet) 95 mg, daily and oral rivaroxaban (XARELTO; Film-coated tablet) 15 mg, daily. The patient experienced general physical health deterioration on 16Jan2021. After vaccination the patient''s condition deteriorated. The alertness state of the patient decreased episode-like and the patient was bedridden. The patient died on an unspecified date in 2021. It was not reported if an autopsy was performed. Follow-up attempts not possible. No further information expected.; Reported Cause(s) of Death: General physical health deterioration


VAERS ID: 1104989 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-16
Onset:2021-02-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM6950 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Blood pressure measurement, Body temperature, C-reactive protein, Cardio-respiratory arrest, Coma, Diarrhoea, Electrocardiogram, Heart rate, Hypertension, Investigation, Lung disorder, Oxygen saturation, SARS-CoV-2 test, Septic shock
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Toxic-septic shock conditions (narrow), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-18
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ALPRAZOLAM; CALCIDOSE [CALCIUM CARBONATE;COLECALCIFEROL]; DIFFU K; GUTRON; TERCIAN [CYAMEMAZINE TARTRATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiodepressive syndrome; Drug-induced parkinsonism (Iatrogenic parkinsonian syndrome with neuroleptics (2014)); Encephalopathy (post-meningitis at the age of 9); Fall; Home care; Meningitis; Mental deficiency (sequelae); Psychomotor skills impaired
Allergies:
Diagnostic Lab Data: Test Date: 20210218; Test Name: blood pressure; Result Unstructured Data: Test Result:14 / 8 cmHg; Comments: 14 / 8 cmHg (as reported); Test Date: 20210217; Test Name: blood pressure; Result Unstructured Data: Test Result:140 / 53 mmHg; Test Date: 20210218; Test Name: blood pressure; Result Unstructured Data: Test Result:90 / 60 mmHg; Test Date: 20210217; Test Name: body temperature; Result Unstructured Data: Test Result:39.8 Centigrade; Test Date: 20210218; Test Name: C reactive protein; Result Unstructured Data: Test Result:126; Test Date: 20210218; Test Name: ecg; Result Unstructured Data: Test Result:no repolarization disorder; Test Date: 20210217; Test Name: heart rate; Result Unstructured Data: Test Result:107bpm; Test Date: 20210218; Test Name: heart rate; Result Unstructured Data: Test Result:126bpm; Test Date: 20210218; Test Name: heart rate; Result Unstructured Data: Test Result:98; Test Date: 20210218; Test Name: examination; Result Unstructured Data: Test Result:crackling in the two fields; Comments: crackling in the two fields; Test Date: 20210217; Test Name: saturation Air Ambiant; Test Result: 95 %; Test Date: 20210218; Test Name: saturation Air Ambiant; Test Result: 93 %; Test Date: 20210218; Test Name: saturation Air Ambiant; Test Result: 40 %; Test Date: 20210218; Test Name: saturation Air Ambiant; Test Result: 75 %; Comments: under 15L O2; Test Name: COVID PCR; Test Result: Negative
CDC Split Type: FRPFIZER INC2021250333

Write-up: Cardio-respiratory arrest; A.R.D.S.; Coma; septic shock; diarrhea; blood pressure at 140/53mmHg; Pneumopathy; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-AM20210432. A 68-years-old female patient received second dose of bnt162b2 (COMIRNATY, solution for injection, lot number EM6950, expiry date not reported), intramuscular on 16Feb2021 at a single dose in the left deltoid for COVID-19 vaccination. Medical history included anxiodepressive syndrome, post-meningitis at the age of 9, encephalopathy, mental deficiency (sequelae), all from an unknown date and unknown if ongoing; and Parkinson''s syndrome (iatrogenic parkinsonian syndrome with neuroleptics) from 2014 to an unknown date and unknown if ongoing. The patient was in long-term care home and had numerous falls for a few weeks on possible parkinsonian syndrome, psychomotor slowdown. Concomitant medications included alprazolam, calcium carbonate, colecalciferol (CALCIDOSE), potassium chloride (DIFFU K), midodrine hydrochloride (GUTRON), and cyamemazine tartrate (TERCIAN). The first dose of Comirnaty was received on an unknown date as COVID-19 immunisation. On 17Feb2021, patient experienced pneumopathy described as onset of diarrhea, hyperthermia at 39.8 Celsius degrees, blood pressure at 140/53mmHg, heart rate at 107bpm and 95 percent saturation air ambiant (AA). Patient started IV paracetamol. On 18Feb2021, patient was still feverish, blood pressure at 90/60mmHg, heart rate at 126bpm and saturation at 93 percent Ambient Air (AA), presence of stiffness, fatigue, some cracklings on the left base. Biology found an inflammatory syndrome with C reactive protein (CRP) at 126. Isolation and introduction of antibiotic therapy. In the evening, had worsening of the condition with altered consciousness, bilateral mydriasis, mottling and cold extremities. Blood pressure at 14 / 8cmHg (as reported), heart rate at 98 bpm and saturation at 40 percent Ambient Air then 75 percent under 15L O2. Call for urgent medical aid. In the emergency room, reactive patient in A.R.D.S. On examination, crackling in the two fields. Electrocardiogram (ECG) showing no repolarization disorder. At 7:30 p.m., cardiopulmonary arrest, coma and death of the patient. Retained diagnosis of cardiorespiratory arrest on septic shock starting from the lungs. The COVID PCR was negative on an unknown date. Therapeutic measures were taken as a result of the events pneumopathy, cardiorespiratory arrest, A.R.D.S., coma and septic shock. The outcome of the events blood pressure at 140/53mmHg and diarrhea was unknown. The patient died on 18Feb2021 due to pneumopathy, cardiorespiratory arrest, A.R.D.S., coma and septic shock. It was unknown if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Septic shock; cardiorespiratory arrest; Coma; pneumopathy; A.R.D.S


VAERS ID: 1104992 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-02-08
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Hypoxia, Polymerase chain reaction, SARS-CoV-2 test, Vaccination failure
SMQs:, Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-14
   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: Chronic bronchitis; Dementia; Embolism pulmonary; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Date: 20210202; Test Name: PCR; Test Result: Negative ; Test Date: 20210208; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021250309

Write-up: Hypoxia; Vaccination Failure; COVID-19; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is FR-AFSSAPS-CF20210232. A 91-year-old female patient received BNT162B2 (COMIRNATY), intramuscular with the first dose on 08Jan2021 (Lot number unknown) and the second dose in the left arm on 29Jan2021 (Lot number EJ6788) and second dose (Lot number EJ6788) for covid-19 immunization. Medical history included hypertension arterial, dementia, pulmonary embolism, chronic bronchitis, each from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced covid-19 and vaccination failure on 08Feb2021; the patient also experienced hypoxia on 14Feb2021. The events were serious as they lead to death. The patient underwent lab tests and procedures which included polymerase chain reaction (PCR), which was negative on 02Feb2021; SARS-CoV-2 test which was positive on 08Feb2021. The clinical course was as follows: the first injection was given on 08Jan2021. The patient tested positive for COVID-19 on 08Feb2021 (about 10 days after the second injection), but tested negative for PCR on 02Feb2021. As of 08Feb2021, this patient presented fatigue without clinical signs (absence of oedema, urticaria, respiratory and cardiocirculatory failure). On 14Feb2021, the patient''s condition deteriorated. A rapidly settling hypoxia was observed requiring the intervention of the doctor on duty in emergency. Death occurred within 15-20 minutes after the hypoxia was detected. Death of the patient occurred before she could be hospitalised. No search for a viral variant was performed. Hypoxia stop date was reported as 14Feb2021, with fatal outcome. The patient died on 14Feb2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1104995 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-02-24
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Cardiac stress test, Cardio-respiratory arrest, Chest pain, Death, Dizziness, Echocardiogram, Electrocardiogram, Heart rate, Hypertension, Musculoskeletal stiffness, Oxygen saturation, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Arthritis (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PERINDOPRIL; AMLODIPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension arterial (Hypertension arterial treated with perindopril and amlodipine); Tabaquism (Active smoking 20 AP.)
Allergies:
Diagnostic Lab Data: Test Date: 20210224; Test Name: BP; Result Unstructured Data: Test Result:185/105; Comments: at 9:05 p.m,; Test Date: 20210224; Test Name: BP; Result Unstructured Data: Test Result:150/80; Comments: at 9:29 p.m.; Test Date: 202007; Test Name: stress test; Result Unstructured Data: Test Result:Negative; Test Date: 20210209; Test Name: Cardiac ultrasound; Result Unstructured Data: Test Result:normal; Test Date: 20210224; Test Name: ECG; Result Unstructured Data: Test Result:Unknown result; Comments: at 9:10 p.m.; Test Date: 20210224; Test Name: pulse; Result Unstructured Data: Test Result:80 bpm; Comments: at 9:05 p.m,; Test Date: 20210224; Test Name: Saturation; Test Result: 99 %; Comments: at 9:05 p.m,
CDC Split Type: FRPFIZER INC2021242196

Write-up: stiffens; Death unexplained; vomited; cardio-respiratory arrest; Chest pain; Hypertension worsened; felt leaving; This is a spontaneous report from a contactable physician. This is a report received from the Agency Regulatory Agency-WEB. Regulatory authority or other manufacturer number FR-AFSSAPS-MA20210660. A 54-year-old male patient received the 2nd dose of bnt162b2 (COMIRNATY, lot # EJ6788) intramuscular at single dose at left deltoid on 19Feb2021 for COVID-19 immunisation. Medical history included hypertension treated with perindopril and amlodipine, active smoking 20 packets. Covid-19 history was not specified. Concomitant medication included perindopril (manufacturer unknown) 2.5 mg from Sep2020 and increased to 5 mg in Nov2020 for arterial hypertension, amlodipine (manufacturer unknown) 10 mg from 07Jan2021 arterial hypertension. The patient experienced chest pain, hypertension worsened, felt leaving, stiffens, vomited and cardio-respiratory arrest on 24Feb2021, death unexplained on 25Feb2021. Clinical course as follows: On 24Feb2021 at 9 p.m. he experienced all for mid-sternal chest pain. At 9:05 p.m, medical team noted BP at 185/105, saturation at 99% and pulse at 80 bpm. At 9:10 p.m. the patient was lying down and an ECG was performed (unknown result). At 9:20 p.m. he was administered an ISOCARD spray which immediately relieves the patient. Three minutes later he presented a TA of 165/88. Six minutes later he presented a BP of 150/80. At 9.45 p.m.: the patient felt leaving, stiffens, vomited on the side then cardio-respiratory arrest. Cardiac massage was started immediately, oxygen in BAVU 15 L. After two failed VVP (peripheral venous route) placement, a right tibial bone catheter was placed. At 10 p.m.: the patient was intubated, he received adrenaline 1 mg/ml at 10:04 p.m., 10:07 p.m., 10:10 p.m., 10:17 p.m., 2:20 p.m., 10:25 p.m., 10:30 p.m., 10:36 p.m., 10:39 p.m., 10:45 p.m. and also received 11 shocks by automatic defibrillator. At 10:42 p.m.: arrival of the resuscitation team (thrombolysis, fibrillation, CEE and administration of Cordarone). At 11:48 p.m.: Departure of the patient with the resuscitation team to the hospital center. On 25Feb2021 at 12:20 am: Death on the coronary angiography table. Awaiting further ECG and coronary angiography information. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: chest pain; hypertension worsened; felt leaving; stiffens; vomited; cardio-respiratory arrest; death unexplained


VAERS ID: 1104996 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-02-07
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood culture, Body temperature, Chronic obstructive pulmonary disease, Dyspnoea, Erysipelas, Pyrexia, Scan, Sepsis
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-08
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210208; Test Name: blood culture; Result Unstructured Data: Test Result:Blood cultures positive for Pseudomonas aeruginos; Comments: Blood cultures positive for Pseudomonas aeruginosa. Death 08Feb2021 in a context of sepsis.; Test Date: 20210208; Test Name: Body temperature; Result Unstructured Data: Test Result:40 Centigrade; Test Date: 20210207; Test Name: scanner; Result Unstructured Data: Test Result:Normal
CDC Split Type: FRPFIZER INC2021233068

Write-up: Fever at 40 degree C; Breath shortness; Chronic obstructive pulmonary disease; erysipelas; sepsis; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-MP20210291. An 83-year-old male patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, lot/batch number not provided), intramuscular on 29Jan2021 (at unspecified age) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. No History of COVID-19. Patient considered to be at risk of developing a severe form of COVID-19 disease. Patient vaccinated as part of the COVID-19 vaccination campaign. Patient was hospitalized on unknown date for decompensation of COPD (Chronic obstructive pulmonary disease) and erysipelas, both events occurred on 07Feb2021 and were treated with Augmentin (amoxicillin/clavulanic acid) on a probabilistic basis. Patient was hospitalized on unknown date for Breath shortness (07Feb2021). Death 08Feb2021 in a context of sepsis (08Feb2021). Patient was hospitalized on unknown date for Fever at 40 degree C (08Feb2021). The patient underwent lab tests and procedures which included 07Feb2021: Normal scanner. 08Feb2021: Fever at 40 degree C motivating the carrying out of blood cultures in front of a probable sepsis in the context of erysipelas. 08Feb2021: Blood cultures positive for Pseudomonas aeruginosa. Death 08Feb2021 in a context of sepsis (08Feb2021). The patient died on 08Feb2021. It was unknown if an autopsy was performed. The outcome of the event sepsis was fatal, for other events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: sepsis


VAERS ID: 1105012 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-30
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

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: BISOPROLOL FUMARATE; FULTIUM-D3; RIVAROXABAN; SIMVASTATIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021245858

Write-up: Death; This is a spontaneous report from a contactable pharmacist. This is a report received from the Regulatory Agency. Regulatory authority report number GB-MHRA-EYC 00242663, Safety Report Unique Identifier GB-MHRA-ADR 24875322. An 89-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 14Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included bisoprolol fumarate, colecalciferol (FULTIUM-D3), rivaroxaban and simvastatin. The patient''s death occurred on 30Jan2021, unknown cause of death. 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: unknown cause of death


VAERS ID: 1105685 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-02-12
Submitted: 0000-00-00
Entered: 2021-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram head, Delirium, Platelet count, Platelet count decreased, SARS-CoV-2 test, Traumatic intracranial haemorrhage
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Accidents and injuries (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-27
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19 (Unsure when symptoms started)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Head CT; Result Unstructured Data: Test Result:unknown results; Test Date: 20210212; Test Name: platelets; Result Unstructured Data: Test Result:low; Test Date: 20210227; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021262559

Write-up: delirium; Traumatic intracranial bleeding; Low platelets; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory authority and Healthcare products Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202103011732171790, Safety Report Unique Identifier GB-MHRA-ADR 24882675. A 91-years-old male patient received BNT162B2 (PFIZER-BIONTECH, COVID-19 MRNA VACCINE; Lot number: Not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history included ongoing suspected COVID-19, and it was not sure when symptoms started. The patient was not enrolled in clinical trial. Patient had not tested positive for COVID-19 since having the vaccine. The patient''s concomitant medications were not reported. The patient experienced low platelets on 12Feb2021, likely to have triggered by COVID-19 vaccine. The patient was non-responsive to IV immunoglobulins (IVIg) and steroids, which were stopped after 2 doses since the patient experienced delirium on an unspecified date. The patient was given platelet transfusion for traumatic intracranial bleeding on 24Feb2021. The seriousness criteria for all the events is death, hospitalization and medically significant. The outcome of all the events is reported to be fatal. The patient underwent lab tests and procedures which included Head CT on an unspecified date with unknown results, COVID-19 virus test negative on 27Feb2021. The patient deteriorated and passed away on 27Feb2021. 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: Traumatic intracranial bleeding; Low platelets; delirium


VAERS ID: 1105793 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER1741 / 2 - / -

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: 2021-03-05
   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: BUNOV; MEMANTINE; SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia (significant dementia. Living in a dementia care home)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021263200

Write-up: Death; This is a spontaneous report from a contactable physician. This is a report received from the Medicines and Healthcare products Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202103091343388300, Safety Report Unique Identifier GB-MHRA-ADR 24905509. A 96-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: ER1741), on 04Mar2021 15:00 at single dose for covid-19 immunisation. Medical history included dementia, significant dementia. Living in a dementia care home. Patient has not had symptoms associated with COVID-19. Concomitant medication included buprenorphine (BUNOV) from 17Sep2019 for Pain, memantine from 09Dec2020 for Dementia, sertraline from 05Feb2020 for Depression. Patient was deteriorating in the days prior to her care homes date for second dose of Pfizer vaccine. End of Life discussions had been had and she was felt to be very likely to die within the next week or two. It was not an unexpected death but it was not felt by the staff at the home to be inappropriate to vaccinate her as the whole care home were receiving their second dose of the vaccine. She was very frail and bed bound and had just in case medications prepared for her. She had her vaccine at about 15.00 on 4Mar2021, and died peacefully at 13:30 the next afternoon on 5Mar2021. The patient experienced death on 05Mar2021 13:30. The lab tests included no - negative covid-19 test on unknown date. The patient died on 05Mar2021. An autopsy was not performed. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1106038 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-25
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK 9788 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Ischaemic stroke
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-03
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021261285

Write-up: Left cerebral ischemic stroke; This is a spontaneous report downloaded from the Regulatory Authority -WEB IT-MINISAL02-691146. A contactable physician reported that a 63-year-old male patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, lot EK 9788, expiration date: 31May2021), intramuscular at right arm (also reported as right shoulder) on 03Feb2021 13:15 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced Left cerebral ischemic stroke on 25Feb2021 and had Urgent hospitalization on 25Feb2021 at Stroke Unit, transfer to Neurosurgery and then to ICU. The patient had Emergency Room Visit. The patient died on 03Mar2021. It was unknown if an autopsy was performed. Sender Comment: The fact that the stroke occurred approximately 3 weeks after vaccination does not imply a cause-and-effect relationship. The link between vaccines and suspected deaths is disproved by epidemiological data. It is necessary to investigate the patient''s medical history and pre-vaccine health conditions.; Reported Cause(s) of Death: Left cerebral ischemic stroke


VAERS ID: 1106039 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-26
Onset:2021-02-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Computerised tomogram
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: 2021-03-04
   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: LASIX [FUROSEMIDE SODIUM]
Current Illness: Cardiac disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210227; Test Name: CT; Result Unstructured Data: Test Result:stroke
CDC Split Type: ITPFIZER INC2021272638

Write-up: stroke; This is a spontaneous report downloaded from the Regulatory Authority-WEB: IT-MINISAL02- 692495. A contactable other healthcare professional (patient family member) reported that an 89-year-old female patient received first dose of BNT162B2 (COMIRNATY; Formulation: Solution for injection; Lot number: EP9598) via an unspecified route of administration on 26Feb2021 as a single dose for COVID-19 immunisation. Medical history included ongoing cardiac disorder. Concomitant medication included furosemide sodium (LASIX) and anticoagulant therapy (unspecified). On 27Feb2021, the patient experienced stroke. In the morning following the date of administration of the 1st dose (performed on 26Feb2021) the patient was found in a confessional state and motor alteration (left side of the body), hospitalized in the emergency room with a diagnosis of stroke by CT, subsequent aggravation and death in the afternoon of 04Mar2021. It was not reported if an autopsy was performed. The outcome of the event was reported as fatal. Health Authority Comment: Patient in apparent good health, currently do not have other details (case occurred to family member in another Region).; Reported Cause(s) of Death: stroke


VAERS ID: 1106049 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Hypertension; Overweight
Preexisting Conditions: Medical History/Concurrent Conditions: Pacemaker insertion (cardiac)
Allergies:
Diagnostic Lab Data:
CDC Split Type: LTPFIZER INC2021258004

Write-up: anaphylaxis; This is a spontaneous report from a contactable physician received via a Company sales representative. An elderly female patient of unspecified age received the first single dose of BNT162B2 (COMIRNATY) on an unspecified date in Mar2021, for COVID-19 immunisation. Medical history included ongoing hypertensive disease, she had pacemaker and was currently overweight. The patient''s concomitant medications were not reported. The patient experienced anaphylaxis on an unspecified date in Mar2021. This event had a fatal outcome. The patient in 5-10 minutes after the first dose of Comirnaty felt unwell, complained of lack of air and dyspnoea. She was provided with anti-anaphylactic treatment. As the condition was worsening, the patient was reanimated. After 15-20 minutes the death was declared. The patient died on an unspecified date in Mar2021. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Sender''s Comments: Based on temporal association and known drug profile, a contributory role of the suspect drug cannot be excluded in the development of event fatal anaphylaxis. 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. This case will be reassessed upon receipt of additional information.; Reported Cause(s) of Death: anaphylaxis


VAERS ID: 1106062 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-02-23
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Chills, Death, Discomfort, Dyspnoea, Fatigue, Feeling cold, Hyperhidrosis, Loss of consciousness, Malaise, Respiratory distress
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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: Arterial hypertension; Diabetes mellitus; Illness
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021253670

Write-up: arrives at this unit without vital signs; Respiratory distress/acute respiratory difficulty; loss of consciousness; discomfort; poor condition; sweating; cold; asthenia/fatigue/adynamia; asthenia/fatigue/adynamia; chills; dyspnea / respiratory distress; This is a Spontaneous report from a non-contactable healthcare professional. This is a report received from The Regulatory Authority via email. Regulatory authority report number is 9174. A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number not reported), via an unspecified route of administration on 17Feb2021 at a single dose for covid-19 immunisation. Medical history included illness, diabetes mellitus (DM) and arterial hypertension (AH) from an unknown date. There were no allergies reported. Concomitant medications were not reported. The patient had COVID-19 vaccine application on 17Feb2021. On 23Feb2021, the patient experienced asthenia/fatigue/adynamia, chills, dyspnea / respiratory distress. A family member reported that after the application, she presented discomfort on an unspecified date that improved in the following days. On an unspecified date, it was reported that the patient had a normal breakfast and in the afternoon they noticed her in poor condition, sweating, cold, loss of consciousness and acute respiratory difficulty, she was treated by a private doctor and later arrived at the unit without vital signs. The family member administered a treatment or remedy prior to medical care (unspecified treatment). The patient died on an unspecified date. It was not reported if an autopsy was performed. Timeframe between vaccination and starting of symptoms was 23 days (as reported, discrepancy cannot be clarified). The outcome of the events was unknown. No follow-up attempts are possible. Information about batch/lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: arrives at this unit without vital signs


VAERS ID: 1106068 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-02-04
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute coronary syndrome, Circulatory collapse, Heart rate increased, Hypotension, Shock
SMQs:, Anaphylactic reaction (narrow), 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), 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), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-05
   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: D-CURA; BISACODYL; CALCI CHEW; ACETYLCYSTEINE; AZITROMYCINE; FOSTER [BECLOMETASONE DIPROPIONATE;FORMOTEROL FUMARATE]; VENTOLINE [SALBUTAMOL]; ATROVENT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021256604

Write-up: Hypotension; Collapse vascular, the first days after corona vaccination nothing unusual, collapse after day 9; Heart rate increased; hypotensive shock after an acute coronary syndrome; hypotensive shock after an acute coronary syndrome; This is a spontaneous report downloaded from the regulatory authority-WEB NL-LRB-00455939. The report was received from a contactable Physician via the Netherlands regulatory authority. A 78-year-old female patient received BNT162b2 (COMIRNATY, Solution for injection, Lot number EM0477), via an unspecified route of administration on 26Jan2021 at single dose for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease. Concomitant medication included colecalciferol (D-CURA) 25.000ie capsule, bisacodyl tablet gastro-resistant 5mg, calcium carbonate (CALCI CHEW) 500 mg , acetylcysteine 600mg, azithromycin tablet 250mg, beclometasone dipropionate/ formoterol fumarate (FOSTER) aerosol 100/6ug/dosis, salbutamol (VENTOLINE) aerosol 100ug/dosis, ipratropium bromide (ATROVENT) aerosol 20ug/dosis. First days after vaccination nothing unusual. On 04Feb2021, nine days after vaccination patient had a collapse vascular, most suitable for a hypotensive shock after an acute coronary syndrome. Patient died a day later on 05Feb2021. The reported fatal events were collapse vascular, hypotension and heart rate increased. Patient had no medical history of cardiac risk factors although COPD was 2-3 years old. It is questionable whether it is related to the corona vaccination, but given the seriousness and the fact that this was so unexpected, a report was made. Confounding factors: Advanced COPD which also increases cardiovascular risk. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: hypotensive shock matching with acute coronary syndrome


VAERS ID: 1106069 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-02-01
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0447 / 1 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Fluid intake reduced, Hypotension, Malaise, Nausea, Pyrexia
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (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 (broad), Hypokalaemia (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: APIXABAN; SPIRONOLACTON; FUROSEMIDE; PROPRANOLOL; OMEPRAZOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Electrolyte imbalance; Heart failure
Allergies:
Diagnostic Lab Data: Test Date: 20210201; Test Name: pyrexia; Result Unstructured Data: Test Result:Fever: 38 to 40.5 Centigrade
CDC Split Type: NLPFIZER INC2021256597

Write-up: Fluid intake decreased; Not feeling well; Hypotension; Chills; Fever: 38 to 40.5 Centigrade; Nausea; This is a spontaneous report from a contactable physician downloaded from the Agency-WEB, regulatory authority number NL-LRB-00456304. A 96-year-old female patient received her first dose of bnt162b2 (COMIRNATY) (Batch/Lot number EM0447), via an unspecified route of administration on 31Jan2021 at single dose for covid-19 immunisation and bumetanide, via an unspecified route of administration from 28Jan2021 to 02Feb2021 Tablet at 0,5 mg for cardiac failure. Medical history included electrolyte imbalance and cardiac failure from an unknown date and unknown if ongoing. Concomitant medications included apixaban, spironolactone, furosemide, propranolol, omeprazole. On 01Feb2021 the patient was not feeling well, experienced hypotension, chills, fever: 38 to 40.5 centigrade and nausea. The patient was treated with paracetamol for chills, pyrexia and malaise. The action taken in response to the events for bumetanide was permanently withdrawn on 02Feb2021. The patient died on an unspecified date. It was not reported if an autopsy was performed. Physician mentions that the hypotension could be caused by the adding of bumetanide to the already existing therapy with furosemide. Because of the malaise patient''s fluid intake decreased. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Fluid intake decreased; nausea; pyrexia; chills; hypotension; malaise; Unknown cause of death


VAERS ID: 1106070 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-02-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-26
   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; ENTRESTO; FENPROCOUMON; EPLERENONE; ALLOPURINOL; FUROSEMIDE; JANUVIA [SITAGLIPTIN]; BISOPROLOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021256649

Write-up: Death; This is a spontaneous report downloaded from the regulatory authority-WEB NL-LRB-00459695. The report was received from a contactable physician via the regulatory authority. An 84-year-old male patient received the first dose of bnt162b2 (COMIRNATY; lot number: EJ6790) on 25Feb2021 at single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included atorvastatin tablet 40mg, sacubitril valsartan sodium hydrate (ENTRESTO tablet 97/103mg), phenprocoumon (FENPROCOUMON tablet 3mg), eplerenone tablet 25mg, allopurinol tablet 100mg, furosemide tablet 40mg, sitagliptin (JANUVIA tablet 50mg), bisoprolol tablet 5mg. The patient experienced death following administration of covid-19 vaccine Pfizer on 26Feb2021. The patient had not previous COVID-19 infection. The patient died on 26Feb2021. The outcome of the event was fatal. 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: Unknown cause of death


VAERS ID: 1106071 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-02-28
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-28
   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: NLPFIZER INC2021256519

Write-up: Death; This is a spontaneous report received from a contactable physician via regulatory authority downloaded from the regulatory authority-WEB NL-LRB-00459988. An 88-year-old male patient received the second dose of BNT162B2 (COMIRNATY, lot number EJ6790), on 24Feb2021 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (COMIRNATY, lot number unknown), on 27Jan2021 at single dose for COVID-19 immunisation. It was reported that patient died on 28Feb2021. The event seriousness criteria was reported as death. It was not reported if an autopsy was performed and the reported cause of death was pre-existing co-morbidity. The outcome of the event was fatal. Reporter''s comments: There is no suspicion of a causal relationship between the corona vaccination and death, however, after telephone consultation with COVID line, it was decided to report it, as the death occurred relatively unexpectedly four days after the second corona vaccination was administered. Death is thought to have occurred as a result of pre-existing co-morbidity. No previous Covid-19 infection. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: There is no suspicion of a causal relationship between the corona vaccination and death, however, after telephone consultation with COVID line, it was decided to report it, as the death occurred relatively unexpectedly four days after the second corona vaccination was administered. Death is thought to have occurred as a result of pre-existing co-morbidity. No previous Covid-19 infection.; Reported Cause(s) of Death: pre-existing comorbidity


VAERS ID: 1106072 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-02-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SINEMET; OMEPRAZOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021256570

Write-up: Death; Malaise; This is a spontaneous report from a contactable other healthcare professional via Regulatory Authority, downloaded from the Agency Regulatory Authority-WEB (NL-LRB-00463055). A 92-year-old female patient received BNT162B2 (COMIRNATY) via an unspecified route of administration on 24Feb2021 at single dose for COVID-19 immunisation. Relevant medical history was not reported. Concomitant medications included carbidopa/levodopa (SINEMET) 100mg/25mg and omeprazole (OMEPRAZOL) 20 mg. On 25Feb2021, the patient experienced malaise and died on the same date. The cause of death was unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot and or batch number cannot be obtained.; Reported Cause(s) of Death: death


VAERS ID: 1106073 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-03
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-16
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: 2021-03-04
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MOVICOLON; PARACETAMOL; SIMVASTATIN; METFORMIN; PANTOPRAZOLE; NIFEDIPINE; NOVORAPID; HYDROCHLOORTHIAZIDE; COLEXKLYSMA; TRESIBA FLEXTOUCH; FOSINOPRIL; CLOPIDOGREL; FERROUS FUMARATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anemia; Cerebrovascular accident; Diabetes mellitus; TURP
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021267122

Write-up: Mr. died 1 day after vaccination, acutely and unexpectedly; This is a spontaneous report from a contactable physician downloaded from The Regulatory Authority-WEB NL-LRB-00464284. A 82-years-old male patient received bnt162b2 (COMIRNATY) vaccine, dose 2 via an unspecified route of administration on 03Mar2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunisation . Medical history included anaemia , cerebrovascular accident, transurethral prostatectomy, diabetes mellitus. Concomitant medication included macrogol, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOLON) taken for an unspecified indication from 20Nov2020 to an unspecified stop date; paracetamol (PARACETAMOL) taken for an unspecified indication from 20Nov2020 to an unspecified stop date; simvastatin (SIMVASTATIN) taken for an unspecified indication from 20Nov2020 to an unspecified stop date; metformin (METFORMIN) taken for an unspecified indication ; pantoprazole (PANTOPRAZOLE) taken for an unspecified indication from 20Nov2020 to an unspecified stop date; nifedipine (NIFEDIPINE) taken for an unspecified indication from 20Nov2020 to an unspecified stop date; insulin aspart (NOVORAPID) taken for an unspecified indication from 30Dec2020 to an unspecified stop date; hydrochloorthiazide (HYDROCHLOORTHIAZIDE) taken for an unspecified indication from 20Nov2020 to an unspecified stop date; phosphoric acid sodium, sodium phosphate dibasic (COLEXKLYSMA) taken for an unspecified indication from 20Nov2020 to an unspecified stop date; insulin degludec (TRESIBA FLEXTOUCH) taken for an unspecified indication from 10Feb2021 to an unspecified stop date; fosinopril (FOSINOPRIL) taken for an unspecified indication from 20Nov2020 to an unspecified stop date; clopidogrel (CLOPIDOGREL) taken for an unspecified indication from 20Nov2020 to an unspecified stop date; ferrous fumarate (FERROUS FUMARATE) taken for an unspecified indication from 23Feb2021 to an unspecified stop date. The patient received the first dose of COMIRNATY on 03Feb2021. In principle, man had no complaints of corona vaccination. Man died a day later, acutely and unexpectedly on 04Mar2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. Information about lot/batch# cannot be obtain.; Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): yes ADRs: No Date: 03Feb2021 Man passed away Additional information ADR: In principle, man had no complaints of corona vaccination. Man died a day later, acutely and unexpectedly. confounding factors: CVA, Anemia, DMII, TURP Previous COVID-19 infection: No.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1106074 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-26
Onset:2021-02-28
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-16
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: 2021-02-28
   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: NLPFIZER INC2021250865

Write-up: patient died; This is a spontaneous report from a contactable nurse . A 80-years-old male patient received bnt162b2 (COMIRNATY), via an on 26Feb2021 at single dose for covid-19 immunisation.Age at vaccination 80 years. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient died on 28Feb2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Sender''s Comments: Based on available information, a possible contributory role of the subject vaccine cannot be excluded for the reported even of death NOS due to temporal relationship. However, the reported event may possibly be associated with intercurrent medical conditions in this elderly patient. There is limited information provided in this report. Incomplete information does not permit a meaningful causality assessment. 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: 1106076 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Biopsy pharynx, Blood creatine phosphokinase, Blood creatinine, Blood lactate dehydrogenase, Blood lactic acid, Blood pressure measurement, Blood pressure systolic, Body temperature, C-reactive protein, Computerised tomogram head, Depressed mood, General physical health deterioration, Oxygen saturation, Respiratory rate, Sepsis, Skeletal survey, Troponin, White blood cell count
SMQs:, Depression (excl suicide and self injury) (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-24
   Days after onset: 23
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: RISPERDAL; FENTANYL SANDOZ
Current Illness: Dementia; Living in nursing home
Preexisting Conditions: Medical History/Concurrent Conditions: Pain
Allergies:
Diagnostic Lab Data: Test Date: 20210223; Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result:400 IU/l; Test Date: 20210223; Test Name: ASAT; Result Unstructured Data: Test Result:400 IU/l; Test Date: 20210223; Test Name: Biopsy nasopharynx; Test Result: Negative ; Test Date: 20210223; Test Name: Creatine kinase; Result Unstructured Data: Test Result:5000 IU/l; Test Date: 20210223; Test Name: Creatinine; Result Unstructured Data: Test Result:124 umol/l; Test Date: 20210223; Test Name: Lactate dehydrogenase; Result Unstructured Data: Test Result:1000 IU/l; Test Date: 20210223; Test Name: Lactate; Result Unstructured Data: Test Result:7.1 mmol/L; Test Date: 20210223; Test Name: Lactate; Result Unstructured Data: Test Result:3.3 mmol/L; Test Date: 20210223; Test Name: Blood pressure; Result Unstructured Data: Test Result:108/72 mmHg; Test Date: 20210223; Test Name: Blood pressure systolic; Result Unstructured Data: Test Result:70 mmHg; Test Date: 20210223; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Test Date: 20210223; Test Name: Computerised tomography head; Result Unstructured Data: Test Result:No stroke; Test Date: 20210223; Test Name: CRP; Result Unstructured Data: Test Result:27; Test Date: 20210223; Test Name: O2 saturation; Test Result: 88 %; Test Date: 20210223; Test Name: O2 saturation; Test Result: 100 %; Test Date: 20210223; Test Name: Respiration rate; Result Unstructured Data: Test Result:30-40 per minute; Test Date: 20210223; Test Name: Respiration rate; Result Unstructured Data: Test Result:40 per minute; Comments: increased; Test Date: 20210223; Test Name: X-ray skeleton; Result Unstructured Data: Test Result:No bone broken; Test Date: 20210223; Test Name: Troponin; Result Unstructured Data: Test Result:99; Test Date: 20210223; Test Name: Leucocyte count; Result Unstructured Data: Test Result:21 mol/L
CDC Split Type: NOPFIZER INC2021261286

Write-up: SEPSIS; Reduced condition in the period before admission/ general condition reduced; Depressed mood in the period before admission; This is a spontaneous report downloaded from the Regulatory Authority-WEB NO-NOMAADVRE-FHI-2021-U8n9n, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00017057. A contactable physician reported that an 86-year-old female patient received the second dose of bnt162b2 (COMIRNATY, batch/lot number EK9788), via intramuscular route on 03Feb2021, at single dose for covid-19 immunisation. Medical history included ongoing living in nursing home and ongoing dementia, and pain. Concomitant medications included risperidone (RISPERDAL), and fentanyl (FENTANYL SANDOZ) for pain. The patient previously received the first dose of BNT162B2 (COMIRNATY) on 13Jan2021 for covid-19 immunisation. The patient experienced sepsis (hospitalization, death) on 23Feb2021 with fatal outcome, and reduced condition in the period before admission and depressed mood in the period before admission, both on an unspecified date in Feb2021 with outcome of not recovered. The patient was hospitalized from 23Feb2021. Clinical course: On the 23Feb2021 she was found hanging on the walking aid with systolic BP 70 mm Hg, increased respiration and an O2 saturation of 88 %. Initially suspected as an adverse reaction to opioids (naloxone was administered), but she was on 23Feb2021 at 13:00 PM admitted to hospital where sepsis was suspected. Before admittance general condition reduced, depressed mood during the last couple of weeks. Found hanging on the walking aid. The patient was administered naloxone to suspected overdose analgetics, slight improvement. Qsofa 2/3, treatment with antibiotics started. At 20:30 the patients mostly unchanged. The patient died during the night. The patient underwent lab tests and procedures on 23Feb2021 which included alanine aminotransferase: 400 IU/l, aspartate aminotransferase: 400 IU/l, Biopsy nasopharynx: negative, Creatine kinase: 5000 IU/l, blood creatinine: 124 umol/l, blood lactate dehydrogenase: 1000 IU/l, blood lactic acid: 7.1 mmol/l, blood lactic acid: 3.3 mmol/l, blood pressure measurement: 108/72 mmHg, blood pressure systolic: 70 mmHg, body temperature: 36.4 centigrade, computerised tomogram head: no stroke, C-reactive protein: 27, oxygen saturation: 88 %, oxygen saturation: 100 %, respiratory rate: 30-40 per minute, respiratory rate: 40 per minute, X-ray skeleton: no bone broken, troponin: 99 (units not specified), and Leucocyte count: 21 mol/l. Therapeutic measures were taken as a result of sepsis in form of naloxone and unspecified antibiotics. The patient died on 24Feb2021. An autopsy was not performed. The reporting physician stated that the sepsis was most probably unrelated to the vaccination. The reporter stated that the causal relationship between the suspect product and the sepsis was Unlikely, and the Pharmacovigilance Center has assessed the causal relationship between the suspect product and the general physical health deterioration and depressed mood as Possible. Case Summary and Reporter''s Comments: The undersigned has no real suspicion that the COVID vaccine was the cause of the patient''s death, but the report is submitted as the death occurred as consequence of a sepsis condition without known focus one week after the second dose (to be clarified). Sender''s Comments: causality assessment: Short-term malaise and fatigue are among the known side effects of the vaccine. A large proportion of those vaccinated reported fatigue, joint and muscle pain, and a small proportion developed fever and chills after this vaccine. Sepsis is not among the known side effects of this vaccine. Data from use in frail patients with comorbidity is also limited, and such lack of information will be obtained in post-marketing studies. In the individual case, however, it is difficult to know whether the events are due to the vaccine or another, random simultaneous cause that has nothing to do with the vaccine in question. On the basis of the information in the report and in accordance with international criteria, the causal relationship with vaccination and the worsening of patient''s condition after 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. Sepsis is considered a serious medical event, and although the cause is probably not related to vaccination, it is important that such events are also reported. Since the patient died, the report is classified as serious, although a causal link between the vaccine and sepsis and the death has not been established. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: SEPSIS


VAERS ID: 1106932 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-16
Onset:2021-02-23
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ 6790 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad), 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: Geromarasmus (Old age)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID; Result Unstructured Data: Test Result:nagative
CDC Split Type: ATPFIZER INC2021250321

Write-up: Cardiac arrest; This is a spontaneous report from contactable consumers and physician downloaded from the regulatory authority-WEB -2021-07029. A 93-year-old female patient received bnt162b2 (COMIRNATY; lot number EJ 6790), intramuscular on 16Feb2021 at a single dose for covid-19 immunisation. Medical history included ongoing geromarasmus due to old age. The patient''s concomitant medications were not reported. On 23Feb2021, the patient experienced cardiac arrest (fatal). The patient died on unknown date from geromarasmus and cardiac arrest. It was reported that patient died because of old age, she had no other signs, the heart just stopped. She had been tested for Covid - negative result. The treating physician did not provide any information either by telephone or in writing, except that he sees no connection to the vaccination and that he has never encountered a connection between a death and a vaccination in 30 years of practice. Sender Comment: Follow-up information has been requested. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: The 93-year-old female patient had pre-existing geromarasmus. The reported fatal cardiac arrest was considered as natural death and unlikely causally related to the vaccine of bnt162b2 (COMIRNATY).; Reported Cause(s) of Death: Cardiac arrest; Geromarasmus


VAERS ID: 1106949 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-02-12
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Fall, Gait inability, Pneumonia, SARS-CoV-2 test positive
SMQs:, Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-19
   Days after onset: 7
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LORADUR; TRITACE; WARFARIN; RIVOCOR
Current Illness: Atrial fibrillation; Hypertension arterial
Preexisting Conditions: Medical History/Concurrent Conditions: Pulmonary embolism (st. post pulmonary embolism)
Allergies:
Diagnostic Lab Data: Test Date: 20210218; Test Name: Covid-19 positive; Result Unstructured Data: Test Result:positive
CDC Split Type: CZPFIZER INC2021250168

Write-up: Pneumonia; COVID-19: positive; fell down; Weakness generalised; Unable to walk; This is a spontaneous report from a contactable Consumer or other non HCP downloaded from the regulatory authority-WEB CZ-CZSUKL-21001234 A 91-year-old male patient received the 1st dose of bnt162b2 (COMIRNATY, Lot # EL0725) at single dose on 09Feb2021 for COVID-19 immunisation. Medical history included ongoing arterial hypertension, st. post pulmonary embolism, ongoing atrial fibrillation. Concomitant medication included amiloride hydrochloride, hydrochlorothiazide (LORADUR), ramipril (TRITACE) at 1.25 mg, warfarin (manufacturer unknown) oral at 5 mg (1x za 24hodin) (as reported) for lung embolism, bisoprolol fumarate (RIVOCOR) At 5 mg. The patient experienced pneumonia and COVID-19 positive (serious as fatal, hospitalization, medically significant, life threatening) on 18Feb2021, weakness generalised (serious as hospitalization, disability, medically significant, life threatening) on 12Feb2021 with outcome of not recovered, fell down (serious as hospitalization) on 15Feb2021 with outcome of unknown, unable to walk on 12Feb2021 with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19: positive on 18Feb2021. Course of events was as follows: after the 1st dose vaccination the patient experienced following adverse reaction: generalised weakness after the vaccination, lost his overall energy, started to walk badly, could not sit on bed by himself or to stand up. On 15Feb2021 afternoon the patient fell down and was transferred to the hospital. He was released home the same day, still not self-sufficient. On 18Feb2021 the patient was Covid-19 positive and hospitalised with pneumonia. On 19Feb2021 the patient died in the evening hours. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1106958 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-02-13
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Ascites, Atrial fibrillation, Cardiac failure, Oedema peripheral, Pleural effusion, SARS-CoV-2 test, Tachycardia induced cardiomyopathy
SMQs:, Cardiac failure (narrow), Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Angioedema (broad), Systemic lupus erythematosus (broad), Supraventricular tachyarrhythmias (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (narrow), Cardiac arrhythmia terms, nonspecific (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), COVID-19 (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:negative
CDC Split Type: DEPFIZER INC2021250325

Write-up: Cardiac arrhythmia; TAA/Tachyarrhythmia absoluta; Tachycardia induced cardiomyopathy; atrial fibrillation; pleural effusion; myocardial decompensation; Ascites; edema of legs; This is a spontaneous report from a non-contactable physician. This is a report received from the regulatory authority-WEB. Regulatory authority or other manufacturer number DE-PEI-PEI2021003141. A 38-year-old female patient received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ6788), via an unspecified route of administration on 10Feb2021 at a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 13Feb2021 after vaccination, the patient developed myocardial decompensation, edema of legs, ascites, pleural effusion. On 21Feb2021, the patient experienced cardiac arrhythmia, tachyarrhythmia absoluta, atrial fibrillation and tachycardia induced cardiomyopathy, lasting for unknown. The patient is dead, was hospitalized and condition was life threatening. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on an unspecified date. The patient was treated with manual: therapy, e.g. antiphlogistic drugs. The patient died on an unspecified date. It was not reported if an autopsy was performed. The patient died due to the reported events. The outcome of the events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: myocardial decompensation; edema of legs; ascites; pleural effusion; cardiac arrhythmia; tachyarrhythmia absoluta; atrial fibrillation; tachycardia induced cardiomyopathy


VAERS ID: 1106959 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-02-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Vaccination complication
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-25
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021250328

Write-up: Vaccination adverse reaction; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (EMA) EudraVigilance-WEB DE-PEI-PEI2021003143. An 89-year-old male patient received the first dose of bnt162b2 (COMIRNATY, lot number: EJ6789), via an unspecified route of administration on 18Feb2021 at SINGLE DOSE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On the same day after vaccination on 18Feb2021, the patient developed vaccination adverse reaction from which the patient died on 25Feb2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Vaccination adverse reaction


VAERS ID: 1106961 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-04
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021263397

Write-up: death; This is a spontaneous report received from a contactable physician based on information received by Pfizer. A female patient of an unspecified age received bnt162b2 (lot number and expiry date not reported), via an unspecified route of administration on Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The physician reported the death of a female doctor on 04Jan2021, who was apparently otherwise completely healthy and had been vaccinated with the vaccine days earlier. It was not reported if an autopsy was performed. Event occurred in a country different from that of the reporter. This may be a duplicate if the reporter also submitted directly to his/her local agency. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender''s Comments: The information in this report is limited, and does not allow a medically meaningful assessment of the case. In particular, the following information is not available: clinical course, concomitant medications, medical history, and autopsy results. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to committees and Investigators, as appropriate.; Reported Cause(s) of Death: death


VAERS ID: 1106970 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-02-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Cerebral haematoma, Chest X-ray, Computerised tomogram head, Heart rate, Oedema, Oxygen saturation
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-25
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anesthesia; Basal ganglia hematoma; Dysphasia; Facial paralysis; Hemianopia homonymous (RHH); Hemiplegia (right); Hospitalization; Thalamus hemorrhage
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:165/110; Test Name: boody temperature; Result Unstructured Data: Test Result:36 Centigrade; Test Date: 20210219; Test Name: thorax RX; Result Unstructured Data: Test Result:thorax RX showed free costophrenic sinuses; Comments: no masses or infiltrates, right jugular central venous route, NGS and orotracheal intubation tube normalized.; Test Date: 20210108; Test Name: non-contrasted brain CT; Result Unstructured Data: Test Result:unknown results; Comments: previous scan; Test Date: 20210219; Test Name: non-contrasted brain CT; Result Unstructured Data: Test Result:Hyperdense intraaxial collection; Comments: measuring 3.5 x 2.7 cm right capsular thalamus compatible with acute intraparenchymal hematoma, which IT is open to the right LV, with blood content occupying the III and IV ventricles. Surrounding the hematoma, a small halo of vasogenic edema is observed. All of this conditions an expansive effect with effacement of the right hemispheric sulci and deviation of the midline structures towards the left by 4 mm. ASH focus in right frontal furrows. Sequelae of hematoma in the region of the left basal ganglia and ipsilateral cerebral peduncle. Rest unchanged from previous CT. Impression: Acute intraparenchymal hematoma in the right capsular thalamus region with an intraventricular component.; Test Name: Heart rate; Result Unstructured Data: Test Result:90; Test Name: oxygen saturation; Test Result: 99 %
CDC Split Type: ESPFIZER INC2021250316

Write-up: Hematoma cerebral/acute intraparenchymal hematoma in the right capsular thalamus region with an intraventricular component; Lower limbs with pitting edema in right lower limb; This is a spontaneous report from a contactable physician downloaded from The Regulatory Authority-WEB. Regulatory authority report number is ES-AEMPS-771065. A 74-year-old male patient received first dose of BNT162B2 (COMIRNATY; Solution for injection, unknown lot number and expiration), intramuscular on 18Feb2021 at 0.3 mL, single for COVID-19 immunisation. Medical history included admission/hospitalization on 25Dec2019 due to hematoma in the left basal ganglia with opening to the ventricles of hypertensive origin, dismissed at admission surgical attitude. He remained admitted until 14Feb2020. Upon discharge, the patient was evaluated with neurology which showed predominantly motor mixed dysphasia (emits sounds and some isolated monosyllables, repeats monosyllables, does not nominate, performs 1-2 simple orders and becomes intoxicated with the following and with semi-complexes), right homonymous hemianopia (RHH), mild-moderate right facial paralysis, right hemiplegia with RES spastic component, right anesthesia, thalamus hemorrhage on 25Dec2019, and right extensor CRP, left flexor. The patient previously received Citalopram, Deprax, losartan, and Zolpidem as treatments. The patient received first dose of COMIRNATY vaccine on 18Feb2021. The following day on 19Feb2021, the patient was found with altered/deterioration in level of consciousness without response to painful stimuli, for which he was transferred and admitted to hospital. This was caused by acute intraparenchymal hematoma in the right thalamocapsular region with an intraventricular component. The patient previously was independent for basic activities of daily living (ERM 0, unknown CVRF). Upon arrival, a CT scan was performed, the right jugular central venous line was channeled without immediate complications, and the orotracheal intubation tube was changed due to continuous leakage for tube n8. The neurologist was notified for evaluation and in consensus with the family it was decided not to place a ventricular drain. The patient remained sedated pending neurological evolution due to the poor prognosis, dying on 25Feb2021. Physical examination revealed TA (blood pressure) 165/110, heart rate 90, oxygen saturation 99%, and body temperature 36 degree C. Low effect of sedoanalgesia. Right pupil discoric, not reactive to light. Decerebrate position to painful stimulus. AC: impresses rhythmic AP: good bilateral ventilation without added noise. Abdomen soft, not painful. Lower limbs with pitting edema in right lower limb. On 19Feb2021, non-contrasted brain CT findings (compared with previous CT on 08Jan2021 with unknown result): Hyperdense intraaxial collection measuring 3.5 x 2.7 cm right capsular thalamus compatible with acute intraparenchymal hematoma, which IT is open to the right LV, with blood content occupying the III and IV ventricles. Surrounding the hematoma, a small halo of vasogenic edema is observed. All of this conditions an expansive effect with effacement of the right hemispheric sulci and deviation of the midline structures towards the left by 4 mm. ASH focus in right frontal furrows. Sequelae of hematoma in the region of the left basal ganglia and ipsilateral cerebral peduncle. Rest unchanged from previous CT. Impression: Acute intraparenchymal hematoma in the right capsular thalamus region with an intraventricular component. On the same day, thorax RX showed free costophrenic sinuses, no masses or infiltrates, right jugular central venous route, NGS and orotracheal intubation tube normalized. Diagnosis is acute intraparenchymal hematoma in the right capsular thalamus region with an intraventricular component. Outcome of lower limbs with pitting edema in right lower limb was unknown. Hematoma cerebral stop date on 25Feb2021 reported with fatal outcome. The patient died on 25Feb2021. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Hematoma cerebral/acute intraparenchymal hematoma in the right capsular thalamus region with an intraventricular component


VAERS ID: 1107032 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-28
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK1768 / UNK - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   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: BISOPROLOL; FULTIUM-D3; RIVAROXABAN; SIMVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021245948

Write-up: SARS-CoV-2 infection; SARS-CoV-2 infection; This is a spontaneous report from a contactable pharmacist. This is a report received from The Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202103041356454850, Safety Report Unique Identifier GB-MHRA-ADR 24875375. An 89-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, lot # EK1768), via an unspecified route of administration oat single dose on 14Jan2021 for COVID-19 immunisation. Medical history included suspected COVID-19 from 28Jan2021 to 30Jan2021. Patient was not enrolled in clinical trial. Concomitant medication included bisoprolol (BISOPROLOL) for Hypertension, colecalciferol (FULTIUM-D3) for Vitamin D deficiency, rivaroxaban (RIVAROXABAN) for Anticoagulant therapy, simvastatin (SIMVASTATIN) for cholesterol. The patient experienced Sars-cov-2 infection (suspected covid-19) on 28Jan2021. The patient underwent lab tests and procedures which included Sars-cov-2 test: yes - positive covid-19 test. The patient died on 30Jan2021 due to suspected COVID, not sure link between vaccine and death. 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: Suspected COVID-19


VAERS ID: 1107054 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-02-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790-66008 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Coma, Coma scale, Dyspnoea, Loss of consciousness, Malaise, Prothrombin time, Pulmonary oedema, Pyrexia, Rales
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-26
   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: AMIODARONE; COUMADIN; BISOPROLOL FUMARATE; TRITTICO; OLANZAPINE; TAVOR [LORAZEPAM]; ENAPREN
Current Illness: Anxiety depression; Arterial hypotension
Preexisting Conditions: Medical History/Concurrent Conditions: Agitated depression; Anxiety neurosis; Aortic valve replacement; Atrial flutter; Hypertension arterial; Tachycardia; Thromboangiitis obliterans
Allergies:
Diagnostic Lab Data: Test Date: 20210225; Test Name: body temperature; Result Unstructured Data: Test Result:37.2 Centigrade; Comments: in the evening; Test Date: 20210226; Test Name: glasgow; Result Unstructured Data: Test Result:3; Test Date: 20201126; Test Name: Pro-thrombin time; Result Unstructured Data: Test Result:results unknown; Test Date: 20210128; Test Name: Pro-thrombin time; Result Unstructured Data: Test Result:results unknown
CDC Split Type: ITPFIZER INC2021250927

Write-up: unconsciousness; Dyspnea/dyspnoicity; comatose Glasgow 3; Edema lung; coarse rales; mild pyrexia 37.2 C; general malaise not well; arthralgia; This is a spontaneous report downloaded from The Regulatory Authority-WEB IT-MINISAL02-689131. A contactable physician reported that an 86-year-old male patient received the first dose of bnt162b2 (COMIRNATY, lot number: EJ6790-66008), intramuscular in the right arm on 25Feb2021 12:00 at 0.3 mL, single for COVID-19 immunisation. The patient''s medical history included ongoing anxiety depression, ongoing arterial hypotension, thromboangiitis obliterans, aortic valve replacement, tachycardia, atrial flutter, agitated depression, anxiety neurosis, and hypertension arterial. Concomitant medications included amiodarone (tablet) from 16Oct2014 for tachycardia, warfarin sodium (COUMADIN, tablet) for aortic valve replacement, bisoprolol fumarate (tablet) from 19Jun2012 for atrial flutter, trazodone hydrochloride (TRITTICO, 60 mg/ml oral drops, solution) from 10Feb2020 for anxiety depression, olanzapine from 10Oct2020 to 30Nov2020 for agitated depression, lorazepam (TAVOR, tablet) from 10Apr2015 for anxiety neurosis, and enalapril maleate (ENAPREN, 20 mg tablet) from 15Jun2018 for hypertension arterial. The patient previously took influenza vaccine on Dec2020 for immunization. On 25Feb2021, in the evening, the patient showed a state of general malaise not well defined with arthralgia and mild pyrexia 37.2 Centigrade. On the morning of 26Feb2021 (also reported as 25Feb2021, pending clarification), the patient was found by his wife in a state of unconsciousness and dyspnea/dyspnoicity. Upon the reporter''s arrival at 8:00, the patient was in a comatose Glasgow 3 and edema lung with coarse rales and orotracheal died. The patient underwent other lab tests and procedures which included prothrombin time on 26Nov2020 and on 28Jan2021 with unknown results. The patient died on 26Feb2021. It was not reported if an autopsy was performed. The events were reported as serious with seriousness criteria of death from HA. Sender comment: batch and expiration Sol. Physiological not available; vaccine reconstitution time 11.30; Reporter comment: The clinical worsening occurred at night and the wife did not notice her husband''s condition, so it is difficult to establish the exact dynamics of the facts.; Reported Cause(s) of Death: mild pyrexia 37.2 C; general malaise not well; arthralgia; Edema lung; Dyspnea/dyspnoicity; coarse rales; comatose Glasgow 3; unconsciousness


VAERS ID: 1107055 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-23
Onset:2021-02-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-26
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac failure; Hypertensive cardiomyopathy; IHD; Myocardial infarction acute
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021256504

Write-up: Fever < 39.5; This is a spontaneous report from a contactable physician/pharmacist downloaded from The Regulatory Authority-WEB IT-MINISAL02-690154. A 79-year-old male patient receivedthe 1st dose of bnt162b2 (COMIRNATY; lot # EJ6790, exp date 31May2021), intramuscular at single dose at left deltoid on 23Feb2021 13:21 for COVID-19 immunisation. Medical history included cardiovascular pathology as: atrial fibrillation, acute myocardial infarction in 1993, myocardial ischaemia (IHD), hypertensive ischemic cardiopathy, cardiac decompensation. The patient''s concomitant medications were not reported. The patient experienced fever < 39.5 on 24Feb2021. On 24Feb2021 2 ER admission for fever.. The patient died on 26Feb2021 at home, present the general practioner. It was not reported if an autopsy was performed. Reporter''s comment: Inoculation site: left deltoid. Other information: on 26feb2021 at home, present the general practitioner DR x, Died. Sender''s comment: 04Mar2021 CRFV: requests for follow-up information from the reporter regarding the medical documentation of the case and dose. Waiting for an answer. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Inoculation site: LEFT DELTOID Other information: ON 26Feb2021 AT HOME, PRESENT THE GENERAL PRACTITIONER DR x, DIED; Reported Cause(s) of Death: Fever < 39.5


VAERS ID: 1107064 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-08
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Cardiac failure, Dyspnoea, Nausea, Vomiting
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-17
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CITALOPRAM; PANTOPRAZOL [PANTOPRAZOLE]; LERCANIDIPINE; CANDESARTAN
Current Illness: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210210; Test Name: Blood pressure; Result Unstructured Data: Test Result:blood pressure was fine
CDC Split Type: NLPFIZER INC2021256580

Write-up: Dyspnea; Nausea; vomited mucus; Doctor says weakened heart muscle. Her heart suffered a lot after the vaccination. She had also never had fluid behind her lungs.; This is a spontaneous report from a contactable consumer received from Regulatory Authority, downloaded from the Regulatory Authority-WEB (NL-LRB-00455123). An 84-year-old female patient (reporter''s mother) received BNT162B2 (COMIRNATY) via an unspecified route of administration on 08Feb2021 at single dose for COVID-19 immunization. Relevant medical history included ongoing hypertension. Concomitant medications included citalopram strength 10 mg, pantoprazole (PANTOPRAZOL) strength 20 mg, lercanidipine strength 20 mg and candesartan strength 8 mg. On 09Feb2021, the patient experienced dyspnea and nausea and in Feb2021 she experienced vomiting mucus and doctor said weakened heart muscle; her heart suffered a lot after the vaccination; she had also never had fluid behind her lungs (cardiac failure). The patient underwent lab tests and procedures which included blood pressure measurement on 10Feb2021 which showed that blood pressure was fine. The patient was treated with furosemide for dyspnea and with primperan for nausea. The patient died on 17Feb2021. It was unknown if an autopsy was performed. The outcome of the events dyspnea and cardiac failure was fatal; the outcome of nausea and vomited mucus was unknown. No confounding factor, regular check-up of blood and blood pressure by elderly care in the doctors practice. Additionally: ''initially the patient was recovering from dyspnea after receiving treatment, no fluid in the legs. At that moment there was no reason for a COVID-19 PCR test (no known contaminations in the environment). In the night of 10Feb2021 to 11Feb2021, the patient had again dyspnea and there was a respiratory sound (fluid), the patient also vomited mucus. She took paracetamol and fell asleep almost sitting. These complaints came on very unexpectedly and suddenly. There were no infections in her area, as far as the reporter knows. During the day she was pretty good. The nights were hard, she regularly sat on the chair. They did not dare to call a doctor and during the day it went reasonably well. She had a strange feeling but could not describe it well. She did the laundry, cooked and had other activities. Until the morning of 17Feb2021. Then she became very short of breath again. She was so scared that she called the reporter again but could not say anything on the phone. The reporter called back and was told she was very short of breath. The father of the reporter then called the emergency line and then again. In the meantime, she passed away. The days before the vaccination there were no complaints. During the events the patient took all her prescribed medications. The general practitioner told that they underestimated the situation. The cause of death was reported as cardiac failure: doctor said weakened heart muscle; her heart suffered a lot after the vaccination; she had also never had fluid behind her lungs. No follow-up attempts are possible; information about lot and or batch number cannot be obtained.; Reported Cause(s) of Death: Doctor says weakened heart muscle. Her heart suffered a lot after the vaccination. She had also never had fluid behind her lungs.


VAERS ID: 1107065 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-25
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021256645

Write-up: patient received the secondo dose of bnt162b2 (COMIRNATY), on 04Feb2021; patient received the secondo dose of bnt162b2 (COMIRNATY), on 04Feb2021; Death, grandmother dies (did not have any underlying diseases); This is a spontaneous report downloaded from the regulatory authority-WEB NL-LRB-00457876. The report was received from a contactable consumer via the regulatory authority. A 86-years-old female patient received the second dose of bnt162b2 (COMIRNATY), on 04Feb2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No previous Covid-19 infection. The patient took comirnaty 1st dose on 28Jan2021. The patient experienced death, grandmother died (did not have any underlying diseases) on 25Feb2021.. The patient died on 25Feb2021. It was not reported if an autopsy was performed.Outcome of the other events was unknown. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: death


VAERS ID: 1107066 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-02-27
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / UNK - / -

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

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: COLECALCIFEROL; EZETIMIBE; ROSUVASTATIN; LAMOTRIGINE; DEPAKINE ENTERIC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral damage; Epilepsy; Familial hypercholesterolaemia; Fetal distress; Mental disability; Premature birth
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021256566

Write-up: The gentleman died approximately 38 hours after vaccination. He suffered from mental retardation and epilepsy; This is a spontaneous report from a contactable physician via Regulatory Authority, downloaded from the regulatory authority-WEB (NL-LRB-00460038). A 39-year-old male patient received BNT162B2 (COMIRNATY; lot number EK9788) via an unspecified route of administration on 25Feb2021 at single dose for COVID-19 immunisation. Relevant medical history included mental disability, familial hypercholesterolaemia, epilepsy, pre-term birth, cortical damage and fetal distress. The patient suffered from mental retardation and nocturnal epilepsy, based on cortical damage and pre-term birth (8 weeks)/fetal distress. Another cause for mental retardation was never confirmed. Nocturnal epilepsy was treated by the neurologist. Patient was residing in an institution. The patient had an alarm system for nocturnal epilepsy that worked well. Concomitant medications included colecalciferol 5600 IU, ezetimibe strength 10 mg, rosuvastatin strength 10 mg, lamotrigine 50 mg twice daily and valproate sodium (DEPAKINE ENTERIC) at 1000 mg twice daily. The patient died on 27Feb2021, approximately 38 hours after vaccination. He suffered from mental retardation and epilepsy. An autopsy was not performed. Prior to his death, the patient had no other complaints and no fever. No obduction was done. LDL values were under control and there was no sign of any cardiovascular issues due to his familial hypercholesterolaemia. The patient was in a good state the days prior to the vaccination. The vaccination was decided after consultation with the neurologist. After vaccination, there was nothing out of the ordinary, no complaints or symptoms. The evening before death the patient was in a good state, was happy and extensively called with the parents through video call. Because the patient had not woken up at 7.30, at 8.00 one had a look and one found the patient dead in bed. Was still warm, but rigor mortis already started. A bit of foam was visible on the mouth. There were no other things out of ordinary. Unclear if there is a relationship with the vaccination. The patient suffered from mental retardation and epilepsy after an extremely pre-term birth. Additionally, there was familiar hypercholesterolemia. He was treated by the neurologist. Using lamotrigine and depakine he had persistent nocturnal attacks which were stable. The patient was found on 27Feb2021 dead in bed. The patient did not have complaints the day before, no fever. There has been discussion with the neurologist. There was no strict contra-indication for vaccination. The relationship with the vaccination and passing away has not been confirmed and it is not possible confirm afterwards. It has been decided to not choose to have an obduction. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1107067 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-03-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Glomerular filtration rate, Haemoglobin
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-02
   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: ACETYLSALICYLZUUR; METFORMINE [METFORMIN]; OMEPRAZOL; LORAZEPAM; TOLTERODINE
Current Illness: Anemia; Chronic renal insufficiency; Vascular dementia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: eGFR; Result Unstructured Data: Test Result:22; Test Name: Hb; Result Unstructured Data: Test Result:6.8
CDC Split Type: NLPFIZER INC2021256560

Write-up: Death; This is a spontaneous report from a contactable physician via Regulatory Authority, downloaded from the Agency Regulatory Authority-WEB (NL-LRB-00462109). A 91-year-old male patient received the second dose of BNT162B2 (COMIRNATY; Lot number EP9598) via an unspecified route of administration on 02Mar2021 at single dose for COVID-19 immunisation. Relevant medical history included ongoing chronic kidney disease, ongoing vascular dementia and ongoing anaemia. Concomitant medications included acetylsalicylic acid (ACETYLSALICYLZUUR) 80 mg, metformin (METFORMINE) 250 mg, omeprazole (OMEPRAZOL) 20 mg, lorazepam 1 mg and tolterodine 2 mg. The patient previously took the first dose of BNT162B2 (COMIRNATY) for COVID-19 immunization on an unspecified date and risperidone on an unspecified date and experienced malaise, fluid intake reduced and consciousness decreased. The patient died on 02Mar2021, 3 hours after vaccination. The patient underwent lab tests and procedures on an unspecified date which included glomerular filtration rate 22 and haemoglobin 6.8. The cause of death was unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-2021261550 same patient, same vaccine, different events after different doses; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1107068 (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: 2021-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Malaise, Pyrexia, Transient ischaemic attack
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Disease risk factor
Allergies:
Diagnostic Lab Data: Test Date: 20210212; Test Name: Body temperature; Result Unstructured Data: Test Result:38 to 40.5 Centigrade
CDC Split Type: NLPFIZER INC2021256568

Write-up: Fever 38 to 40.5 C; Death, first the patient got something that looked like suspected TIA; Not feeling well; This is a spontaneous report downloaded from the regulatory authority-WEB number NL-LRB-00462485] from a contactable other health professional. A 91-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration, on 11Feb2021, at single dose, for COVID-19 immunisation. Medical history included disease risk factor. Concomitant medications were not reported. The patient experienced fever 38 to 40.5 C (fatal) on 12Feb2021, death, first the patient got something that looked like suspected TIA (fatal) on 12Feb2021, malaise (fatal) on 12Feb2021. Pyrexia has been treated with morphine. The patient underwent lab tests and procedures which included pyrexia on 12Feb2021: fever: 38 to 40.5 C. The patient died on 12Feb2021. It was not reported if an autopsy was performed. Case Summary and Reporter Comment: Additional information ADR: First patient got something that looked like a suspected TIA. Previous COVID-19 infection: No. Other diagnostic procedures: No, it is being covered up. Comments report form: The exact data of the client can I do not pass on because of privacy. Seven clients died at this address in a short time. Possibly partly because of the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reporter''s Comments: First patient got something that looked like a suspected TIA. Previous COVID-19 infection: No. Other diagnostic procedures: No, it is being covered up. Comments report form: The exact data of the client can I do not pass on because of privacy. Seven clients died at this address in a short time. Possibly partly because of the vaccine.; Reported Cause(s) of Death: Death, first the patient got something that looked like suspected TIA; Not feeling well; Fever 38 to 40.5 C


VAERS ID: 1107094 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-02-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood alkaline phosphatase, Blood bilirubin, Jaundice
SMQs:, Cholestasis and jaundice of hepatic origin (narrow), Acute pancreatitis (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (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 stenosis; Dementia; Hypertension; Memory impairment; Obstipation; Stroke
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: ALAT; Result Unstructured Data: Test Result:3,9; Test Date: 2021; Test Name: ASAT; Result Unstructured Data: Test Result:5,31; Test Date: 2021; Test Name: ALP; Result Unstructured Data: Test Result:15; Test Date: 2021; Test Name: bilirubin; Result Unstructured Data: Test Result:97
CDC Split Type: SEPFIZER INC2021250724

Write-up: Icterus; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number SE-MPA-2021-006569. Other case identifier number SE-MPA-1613996929890. A 95-year-old male patient received second dose of bnt162b2 (COMIRNATY; lot/batch EJ6134), via an unspecified route of administration in Jan2021 at single dose for COVID-19 immunization. Medical history included hypertension, obstipation, dementia, stroke, memory impairment, and aortic valve stenosis. The patient received first dose of bnt162b2 on an unspecified date for COVID-19 immunization. The patient''s concomitant medications were not reported. In Feb2021, the patient experienced icterus. The reporter stated that four days after the second dose, they started to see signs of icterus. No abdominal pain, initially well-being but quickly deteriorated due to reduced food and fluid intake. The patient was planned for investigation with DT abdomen but could not carry out the examination and patient described as worsened quickly and died 2.5 weeks later. Autopsy will not be performed according to the reporter. Furthermore, the reporter stated that he cannot assess the cause of acute jaundice, even though it was probably not linked to the vaccination. The patient underwent lab tests and procedures in 2021 which included alanine aminotransferase (ALAT): 3.9, aspartate aminotransferase (ASAT): 5.31 and alkaline phosphatase (ALP) was 15 and bilirubin: 97. The patient died on an unspecified date due to icterus. An autopsy was not performed. No follow-up attempts possible. No further information expected.; Sender''s Comments: As an individual case report there is not enough evidence to establish a causal relationship with the suspect vaccine. Currently there is no clear biological plausibility between the vaccine use and the even icterus onset.; Reported Cause(s) of Death: Icterus


VAERS ID: 1107095 (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: 2021-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, General physical health deterioration, Livedo reticularis, Pyrexia, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Chronic obstructive pulmonary disease; Vascular dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021256608

Write-up: Death; uncontactable; impaired general condition; fever; mottled on the legs; This is a spontaneous report from a contactable nurse downloaded from the regulatory authority-WEB (Regulatory authority numbers SE-MPA-2021-009261 and SE-MPA-1614601604152). An 83-year-old female patient received BNT162B2 (COMIRNATY, lot number EJ6797) intramuscular, in Feb2021, at 0.3 ml single, for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease, vascular dementia and asthma, all from an unknown date and unknown if ongoing. The patient had 24 unspecified concomitant medications. The patient was vaccinated and rapidly deteriorated two days later with impaired general condition, fever, was uncontactable and became mottled on the legs. The patient died three days after Comirnaty was given, on an unspecified date in Feb2021. Report assessed as serious (fatal) for death. The other events outcome was unknown. It was unknown if an autopsy was done. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: Death


VAERS ID: 1107275 (history)  
Form: Version 2.0  
Age: 97.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-03-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Auscultation, Blood bicarbonate, Blood gases, Bronchial hyperreactivity, Cardiac monitoring, Chest X-ray, Chronic respiratory failure, Electrocardiogram, Heart rate, Lower respiratory tract infection, PCO2, PO2, Physical examination, Respiratory acidosis, SARS-CoV-2 test, pH body fluid
SMQs:, Asthma/bronchospasm (narrow), Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad), 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: BIRESP SPIROMAX; PECTOX LISINA; SIMVASTATINA; DELTIUS; METAMIZOLUM; CARVEDILOL; FUROSEMIDA [FUROSEMIDE]; AMLODIPINO [AMLODIPINE]; NITROGLYCERIN TRANSDERMAL SYSTEM; TRAZODONA [TRAZODONE]; EUTIROX; OMEPRAZOL; ADIRO; IRBESARTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure congestive (congestive heart failure); Chronic respiratory failure; COPD; COVID-19; Cyanosis of lip; Diabetes (Type II diabetes); Difficulty in walking; Feeling bad (felt strange); Fractured vertebra (compression); Hyperglycemia; Hypertension arterial (HTA); Hypertensive crisis; Pale; Paroxysmal atrial fibrillation; Pulmonary hypertension; Respiratory infection (treatment by her primary care doctor with bronchodilators and azithromycin); Stupor
Allergies:
Diagnostic Lab Data: Test Name: Lung auscultation; Result Unstructured Data: Test Result:expiratory wheezing in both lung fields, rales in; Comments: expiratory wheezing in both lung fields, rales in the left field; Test Name: HCO3; Result Unstructured Data: Test Result:32.3; Test Name: arterial blood gas test; Result Unstructured Data: Test Result:2 L/min; Comments: base excess 5.9; Test Name: Cardiac auscultation; Result Unstructured Data: Test Result:rscsrs; Test Name: Rx thorax; Result Unstructured Data: Test Result:increased density in right midfield; Comments: increased density in right midfield with bilateral redistribution; Test Name: ECG; Result Unstructured Data: Test Result:HB 78 bpm; Test Name: Heartbeat; Result Unstructured Data: Test Result:78 bpm; Test Name: pCO2; Result Unstructured Data: Test Result:69.3; Test Name: pH; Result Unstructured Data: Test Result:7.29; Test Name: physical exam; Result Unstructured Data: Test Result:conscious, oriented and collaborative; Comments: conscious, oriented and collaborative. Good hygiene and good presence. Tachypneic. Cardiac auscultation: rscsrs. Lung auscultation: expiratory wheezing in both lung fields, rales in the left field. Globular abdomen, soft, depressible, not painful, without defense or signs of peritonism. Lower extremities: bilateral pitting edema; Test Name: pO2; Result Unstructured Data: Test Result:84; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:negative
CDC Split Type: ESPFIZER INC2021250306

Write-up: low respiratory infection and chronic respiratory failure exacerbated with respiratory acidosis; low respiratory infection and chronic respiratory failure exacerbated with respiratory acidosis; low respiratory infection and chronic respiratory failure exacerbated with respiratory acidosis; Bronchial hyperreactivity/Bronchial hyperresponsiveness; This is a spontaneous report from a contactable physician downloaded from The Regulatory Authority-WEB ES-AEMPS-774329. A 97-year-old female patient received the first dose of bnt162b2 (COMIRNATY, lot number: EP2163), via an unspecified route of administration on 02Mar2021 at single dose for COVID-19 immunisation. Medical history included Type II diabetes; hypertension arterial (HTA); TVP years ago; COPD probably secondary to pulmonary HT with O2-home therapy at 1.5 bpm; lumbar vertebral compression fracture; admission in Mar2020 for hypertensive crisis, hyperglycemia, reversed paroxysmal atrial fibrillation after amiodarone infusion, secondary myocardial damage, cardiac failure congestive (congestive heart failure) and exacerbated chronic respiratory failure. Admitted to the hospital for COVID 19 pneumonia in April 2020. Concomitant medication included budesonide, formoterol fumarate (BIRESP SPIROMAX 160 ug/4.5 ug), carbocisteine lysine (PECTOX LISINA), simvastatina, colecalciferol (DELTIUS), metamizolum, carvedilol, furosemide (FUROSEMIDA), amlodipine (AMLODIPINO), glyceryl trinitrate (NITROGLYCERIN TRANSDERMAL SYSTEM), trazodone (TRAZODONA), levothyroxine sodium (EUTIROX, 25 ug), omeprazole (OMEPRAZOL), acetylsalicylic acid (ADIRO), and irbesartan. After administering the first dose of COVID-19 Pfizer-Bi vaccine, the patient presented a picture of discomfort, with paleness, labial cyanosis and doubtful loss of consciousness. Not accompanied by other clinical background. The relative comments that before the vaccination she had already "felt strange." They also refer to finding her stuporous with paleness and labial cyanosis. The daughter refers that before the injection she had been feeling bad and she walked worse. Focal deficits are not reported. No fever. She has been treated with methylprednisolone and high-flow O2. Last week treatment by her primary care doctor with bronchodilators and azithromycin for suspected respiratory infection. Evolution in the Emergency Department: A control arterial blood gas test was performed without evident improvement, persistent hypercapnia without hypoxemia. Neurologically, she remains awake without drowsiness. The patient suffers abrupt respiratory deterioration, while waiting for admission to the internal medicine ward, entering respiratory arrest finally ending death despite attempted ventilatory resuscitation. Diagnosis: Bronchial hyperresponsiveness/ bronchial hyperreactivity on 02Mar2021. Doubtful post-vaccination reaction: low respiratory infection and chronic respiratory failure exacerbated with respiratory acidosis. Physical examination: conscious, oriented and collaborative. Good hygiene and good presence. Tachypneic. Cardiac auscultation: rscsrs. Lung auscultation: expiratory wheezing in both lung fields, rales in the left field. Globular abdomen, soft, depressible, not painful, without defense or signs of peritonism. Lower extremities: bilateral pitting edema. Radiology: Chest X-ray: increased density in the middle right field with bilateral redistribution. Other tests: ECG: heartbeat at 78 bpm. Arterial blood gas test at 2 L / min: pH 7.29, pCO2 69.3, pO2 84, HCO3 32.3, base excess 5.9. PCR SARS-COV-2 Negative. The patient died on an unspecified date due to bronchial hyperreactivity/bronchial hyperresponsiveness. It was not reported if an autopsy was performed. The outcome of the event low respiratory infection and chronic respiratory failure exacerbated with respiratory acidosis was unknown. No follow-up attempts are possible, no information is expected.; Reported Cause(s) of Death: Bronchial hyperreactivity/Bronchial hyperresponsiveness


VAERS ID: 1107481 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-29
Onset:2020-12-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Respiratory failure, Vaccination complication
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-03
   Days after onset: 35
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Cystic fibrosis; Kidney transplant; Lung transplant
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC2021250674

Write-up: Pulmonary failure; serious health/medical complications (vaccination adverse reaction); This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB. Regulatory authority report number is CZ-CZSUKL-21001570. A 31-year-old female patient received first dose of BNT162B2 (COMIRNATY; Solution for injection, unknown lot number and expiration), intramuscular on 29Dec2020 at a single dose for COVID-19 immunisation. Medical history included cystic fibrosis, lung transplant in Dec2007, and kidney transplant in 2015, all ongoing. The patient''s concomitant medications were not reported. Few hours after the vaccination, the patient experienced serious health/medical complications (vaccination adverse reaction) on 30Dec2020 which needed immediate medical care, patient was hospitalized. Pulmonary failure developed later on unspecified date, and the patient was transferred to Department of Anesthesiology, Resuscitation and Intensive Medicine, where she died on 03Feb2021. The attending physician was contacted. No further information and are waiting for results from indicated tests and autopsy report. Whole report will be sent with complete information. Outcome of serious health/medical complications (vaccination adverse reaction) was unknown. The patient died of pulmonary failure on 03Feb2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Pulmonary failure


VAERS ID: 1107484 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-02-01
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH BNT03 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Fatigue, Lethargy, Nausea, Pulmonary embolism, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-20
   Days after onset: 19
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: Carcinoma of the prostate metastatic (Nauseated, vomiting, weightloss, backpain); General physical condition decreased (functional decline); Life expectancy shortened; Living in nursing home; Weight decreased (weightloss)
Preexisting Conditions: Medical History/Concurrent Conditions: Back pain; Nauseated; Vomiting
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021250337

Write-up: LUNG EMBOLISM; subsequent week worsening of nausea, vomiting and back pain; subsequent week worsening of nausea, vomiting and back pain; subsequent week worsening of nausea, vomiting and back pain; fatigue lethargy; fatigue lethargy; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency WEB Regulatory Authority number NO-NOMAADVRE-FHI-2021-Uywx5, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00017293. A 91-year-old male patient received the first dose of BNT162B2 (COMIRNATY; lot: BNT03, expiry: unknown) intramuscular in the right arm on 28Jan2021 at a single dose for COVID-19 immunisation. Medical history included carcinoma of the prostate metastatic, living in nursing home, functional decline (general physical condition decreased), life expectancy shortened, and weight decreased (weight loss), all ongoing; nauseated, vomiting, and back pain. The patient''s concomitant medications were not reported. During the period before vaccination the patient''s condition general condition improved some, and first dose of Comirnaty was given even though life expectancy was unsure. During the week after vaccination (Feb2021), the patient''s nausea, back pain and vomiting were aggravated. Due to the decline the patient was admitted to hospital for evaluation by the oncologist. A massive asymptomatic (no dyspnoea) lung embolism was diagnosed, and the patient was readmitted to the nursing home, the patient is bedridden and general condition further declines. The event lung embolism was also assessed as medically significant. Reporter commented: "Patient with prostate cancer with metastases. The last months before hospitalization and subsequent hospitalization, increasing disability, nausea, vomiting, weight loss, back pain. He recovers somewhat initially during a stay in the nursing home and receives coronary vaccine 1 dose 28Jan (life expectancy was uncertain) In the following week worsening of nausea, vomiting and back pain. He is admitted to hospital by appointment with an oncologist to be able to know more about disease progression. A massive pulmonary embolism is then detected, asymptomatic, ie no dyspnoea. He is returned to the nursing home, is reduced, bedridden, gradually increasing onset in the form of fatigue lethargy, back pain, no dyspnea. He dies 20Feb2021. My assessment that he will in all probability die of his long-term cancer, the pulmonary embolism can also be explained on this basis. But finds it correct with an assessment as to whether the vaccine may have contributed to the pulmonary embolism". The patient died on the 20Feb2021 due to lung embolism. The outcome of the event "fatigue lethargy" was unknown while the events nausea aggravated, vomiting aggravated and back pain aggravated was not recovered. It was unknown if an autopsy was performed. The reporting physician states that the lung embolism was most probably related to the cancer disease, which is also the probable the cause of death, but the report is sent as the vaccination might have contributed. Sender Comment: Causality assessment: Short-term malaise and lethargy are among the known side effects of the vaccine. A large proportion of those vaccinated reported fatigue, joint and muscle pain, and a small proportion developed fever and chills after this vaccine. Pulmonary embolism is not among the known side effects of this vaccine, but is among events that one wants to monitor specifically. Data from use in frail patients with comorbidity are also limited, and such lack of information among others will be obtained in post-marketing studies. In the individual case, however, it is difficult to know whether the symptoms are due to the vaccine or another, random simultaneous cause that has nothing to do with the vaccine in question. On the basis of the information in the report and in accordance with international criteria, the causal relationship with vaccination and the patient''s deterioration after vaccination is assessed as possible. A possible causal relationship is defined as a reaction, including pathological laboratory tests, which occurs in a temporal relationship to the use of a drug, but which may also be due to an underlying disease, other drugs or chemicals. Pulmonary embolism is considered a serious medical event, and although the cause is likely to be related to the patient''s underlying disease, it is important that such events are also reported. The reporter assessed the causal relationship between Comirnaty and event lung embolism as unlikely. The center assessed the causal relationship between Comirnaty and events vomiting aggravated, nausea aggravated, back pain aggravated as possible. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Summary of Reporter Comment: My assessment that he will in all probability die of his long-term cancer, the pulmonary embolism can also be explained on this basis. But finds it correct with an assessment as to whether the vaccine may have contributed to the pulmonary embolism.; Reported Cause(s) of Death: LUNG EMBOLISM


VAERS ID: 1107554 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-08
Onset:2021-02-17
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Body temperature, C-reactive protein, C-reactive protein increased, Chills, Glomerular filtration rate, Haematocrit, Haemoglobin, Neutrophil count, Pyrexia, Red blood cell count, Red blood cell sedimentation rate, Red blood cell sedimentation rate increased, Renal disorder, SARS-CoV-2 test, White blood cell count
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-18
   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: Confusion; Disease Parkinson''s; Wheelchair user; Comments: had beginnende parkinson maar was enkel op de benen (rolstoel) en verwardheid. Anders ok. At goed enzo...
Allergies:
Diagnostic Lab Data: Test Name: creatinine; Test Result: 0.95 mg/dl; Test Date: 20210217; Test Name: Fever; Result Unstructured Data: Test Result:40 Centigrade; Test Name: CRP; Result Unstructured Data: Test Result:15.2 mg/l; Test Name: eGFR; Result Unstructured Data: Test Result:56ml/min/1.73m(2); Test Name: hematocrit; Test Result: 47 %; Test Name: haemoglobin; Result Unstructured Data: Test Result:15.2 g/dl; Test Name: Neutrophils; Test Result: 7903 uL; Test Name: erythrocyte count; Result Unstructured Data: Test Result:5.24 10*9/uL; Test Name: blood sedimentation rate; Result Unstructured Data: Test Result:38mm; Test Name: PCR test cov2; Test Result: Negative ; Test Name: leucocytes; Test Result: 86 %
CDC Split Type: BEPFIZER INC2021250332

Write-up: c-reactive protein: 15.2 mg/l; blood cell sedimentation rate: 38mm; Fever (40 centigrade); Shivering; Renal disorder; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB BE-FAMHP-DHH-N2021-79632. This report originated from the Health Authority. An 82-year-old female patient received the second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 08Feb2021 at single dose for COVID-19 immunization. Medical history included early onset Parkinson''s but only on the legs (wheelchair) (Parkinson''s disease from an unknown date and unknown if ongoing) and confusion. Otherwise patient was ok, ate well and stuff. The patient''s concomitant medications were not reported. The patient experienced fever, shivering and renal disorder all on 17Feb2021 with fatal outcome. Lab data on an unspecified date included blood creatinine: 0.95 mg/dl, c-reactive protein: 15.2 mg/l, haematocrit: 47 %, haemoglobin: 15.2 g/dl, Glomerular filtration rate (eGFR) : 56ml/min/1.73m(2) ml/min, neutrophil count: 7903 ul, erythrocyte coun: 5.24 10*9/ul, blood cell sedimentation rate: 38mm, PCR test cov2: negative, and leukocytes (segment nuclei): 86 %, On 17Feb2021, patient''s temperature (pyrexia) was 40 centigrade. The outcome of the other events was unknown. The patient died on 18Feb2021. Events assessed as unclassifiable by Health Authority. It was unknown if an autopsy was performed. Reporter''s Comment: "Treatment-Nee/ Evolution of the ADR-Overleden/ Examinations: PCR test SARS-CoV-2 negatief, Bloedanalyse volgens labo:-verhoogde CRP(15,2mg/L)-bloedbezinking laag(38mm)-verhoogde erythrocyten(5,24miljoen/?l)-verhoogd hemoglobine(15,2g/dl)-verhoogd hematocriet(47%)-segmentkernigen leucocyten verhoogd(86%)-neutrofielen verhoogd(7903?L)-verminderde nierfunctie(creatinine 0,95mg/dl; verlaagd eGFR(MDRD)56 ml/min/1,73m2), 9 dagen na 2e dosis vaccin(toegediend op 8/2/21):hoge koorts tot 40 graden en in minder dan 20 uur overleden(op 18/2/21)zonder aantoonbare reden" No follow-up attempts are needed, information on lot number cannot be obtained. No further information is expected.; Reporter''s Comments: Treatment-Nee/Evolution of the ADR - Overleden Examinations: PCR test SARS-CoV-2 negatief Bloedanalyse volgens labo: - verhoogde CRP (15,2 mg/L) - bloedbezinking laag (38 mm) - verhoogde erythrocyten (5,24 miljoen/?l) - verhoogd hemoglobine (15,2 g/dl) - verhoogd hematocriet (47%) - segmentkernigen leucocyten verhoogd (86%) - neutrofielen verhoogd (7903 ?L) - verminderde nierfunctie (creatinine 0,95 mg/dl; verlaagd eGFR (MDRD) 56 ml/min/1,73 m2); Reported Cause(s) of Death: Fever; Shivering; Renal disorder


VAERS ID: 1107556 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-02-05
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Oxygen saturation decreased, Respiratory distress, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-13
   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: Test Date: 20210205; Test Name: oxygen saturation; Test Result: 90 %
CDC Split Type: DEPFIZER INC2021250320

Write-up: Vaccination failure; Covid-19; respiratory problems/distress respiratory; Oxygen saturation drop 90%; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority-WEB [DE-PEI-PEI2021003122]. An 81-year-old male patient received bnt162b2 (COMIRNATY, Lot # EM0477) at single dose 1st dose on 05Jan2021 and 2nd dose on 26Jan2021 for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced vaccination failure, COVID-19, respiratory problems/distress respiratory and, oxygen saturation drop 90% lasting for 9 day on 05Feb2021 (32 days after the first vaccination, as reported). The patient underwent lab tests and procedures which included oxygen saturation: 90% on 05Feb2021. The patient died on 13Feb2021. It was not reported if an autopsy was performed. Cause of death was reported as COVID-19. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1107557 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-02-18
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-03-17
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: 2021-02-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021250319

Write-up: died at home/Death; This is a spontaneous report from a contactable physician downloaded from the . An 82-year-old female patient received 1st dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 28Jan2021 at a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. An elderly with many underlying diseases received bnt162b2 (COMIRNATY) vaccine on 28Jan2021, on 18Feb2021 the patient died at home/death. 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 at home/Death


VAERS ID: 1107558 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-02-15
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Investigation, Oxygen saturation decreased
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-18
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Hypertension arterial; Peripheral arterial disease; Wound
Allergies:
Diagnostic Lab Data: Test Date: 20210215; Test Name: test; Result Unstructured Data: Test Result:awaiting the result
CDC Split Type: FRPFIZER INC2021250327

Write-up: Oxygen saturation decreased; This is a spontaneous report from a contactable physician from The Regulatory Authority-WEB, Regulatory Authority number is FR-AFSSAPS-RE20210558. An 83-year-old female patient received second dose of bnt162b2 (COMIRNATY, solution for injection, lot number: EJ6788, expiry date was not reported), intramuscular in the left arm on 12Feb2021 at a single dose for COVID-19 immunisation. Medical history included hypertension arterial, chronic leg wounds, Alzheimer''s disease, and arteriopathy of the lower limbs, all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Historical vaccine included COMIRNATY, first dose, intramuscular injection (batch number unknown) on an unknown date for COVID-19 immunisation. Patient was considered to be at risk of developing a severe form of COVID-19 disease, not having contracted COVID-19. The patient experienced oxygen saturation decreased on 15Feb2021 with fatal outcome. The patient died on 18Feb2021. It was not reported if an autopsy was performed. It was mentioned that on 15Feb2021 a test (unknown) was carried out, awaiting the result. It was mentioned that during the night of 15Feb2021 to 16Feb2021, the patient presented with desaturation requiring oxygenation. On 16Feb2021: Improvement of the patient''s condition allowing oxygen weaning. General condition deteriorating in a very inconstant way (Feb2021), unknown outcome. 18Feb2021 at 11:00 p.m .: Death of the patient. Evolution: Death. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Oxygen saturation decreased


VAERS ID: 1107693 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-23
Onset:2021-02-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / UNK RA / -

Administered by: Other       Purchased by: ?
Symptoms: Multiple organ dysfunction syndrome
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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-24
   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: Arterial hypertension; Chronic atrial fibrillation; Cognitive deterioration; Renal impairment
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021250311

Write-up: Multiple organ failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB ES-AEMPS-766497. A 88-year-old female patient received bnt162b2 (COMIRNATY, lot number: EL0725), via an unspecified route of administration (on right arm) on 23Feb2021 at SINGLE DOSE for covid-19 immunisation. Medical history included renal impairment, arterial hypertension, chronic atrial fibrillation and advanced cognitive deterioration, all on unknown dates. Concomitant medications were not reported. It was reported that the patient died within 24 hours after administration of the vaccine. The reporter believed the cause was multi-organ failure on 23Feb2021. The patient died on 24Feb2021. An autopsy was not performed.; Reported Cause(s) of Death: Multiple organ failure


VAERS ID: 1107696 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-02-19
Submitted: 0000-00-00
Entered: 2021-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Death, Fatigue, Lymphadenopathy, Myalgia, Tachycardia, Vaccination site reaction
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (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: MXPFIZER INC2021253660

Write-up: Actual status: Death; Asthenia, Fatigue, Adynamia; Asthenia, Fatigue, Adynamia; Local reaction, induration, nodule; Axillary adenopathy; Tachycardia; Myalgia; This is a spontaneous report from a non-contactable healthcare professional. This is a report received from Authority via email. Regulatory authority report number is 8457. A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number not reported), via an unspecified route of administration on an unspecified date at a single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. The patient has no reported allergies. On 19Feb2021, the patient experienced asthenia, fatigue, adynamia, local reaction, induration, nodule, axillary adenopathy, tachycardia, and myalgia. Treatment received for the events was diclofenac. The patient''s actual status: death (as reported), on an unknown date. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of the events was unknown. No follow-up attempts are possible. Information about batch/lot number cannot be obtained. No further information is expected.; Sender''s Comments: The information on the circumstances of the patient''s death is too limited to perform a meaningful company causality assessment: this event is handled as related to suspect drug BNT126b2 as a cautionary measure and for reporting purposes. The impacts 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: Actual status: Death


VAERS ID: 1107697 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-21
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abnormal faeces, Blood creatinine, Blood potassium, Blood sodium, Blood urea, C-reactive protein, General physical health deterioration, Glomerular filtration rate, Haemoglobin, Hand deformity, Influenza like illness, Livedo reticularis, Mean cell volume, Peripheral coldness
SMQs:, Biliary system related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-31
   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: MOVICOLON; COLECALCIFEROL; PARACETAMOL; LIPOSIC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Carcinoma breast; Cognitive disorder; Frailty; Underweight
Allergies:
Diagnostic Lab Data: Test Name: creatinine; Result Unstructured Data: Test Result:66; Test Name: Potassium; Result Unstructured Data: Test Result:3.6; Test Name: sodium; Result Unstructured Data: Test Result:141; Test Name: urea; Result Unstructured Data: Test Result:13.7; Test Name: CRP; Result Unstructured Data: Test Result:56; Test Name: eGFR; Result Unstructured Data: Test Result:70; Test Name: Hemoglobin; Result Unstructured Data: Test Result:6.7; Test Name: MCV; Result Unstructured Data: Test Result:102
CDC Split Type: NLPFIZER INC2021256637

Write-up: Claw hand left; Marbled skin; Two days after vaccination patient got: thin stools; suddenly rapid deterioration (indicated by CVA, or infectious image); Cold acra; Indicated a flu-like feeling; This is a spontaneous report from a contactable physician downloaded from The Regulatory Authority-WEB (Regulatory Authority number NL-LRB-00456208). A 91-years-old female patient received BNT162B2 (COMIRNATY; lot EJ6795) on 19Jan2021, at single dose, for COVID-19 immunisation. Medical history included cognitive disorder, underweight, frailty and carcinoma breast. Concomitant medications included macrogol, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOLON; powder for oral solution), colecalciferol (800 iU capsule), paracetamol (1000 mg tablet) if needed to a maximum of 2 tablets 3 times a day and carbomer (LIPOSIC; 2 mg/g eye gel). On 21Jan2021 the patient experienced claw hand left, marbled skin, thin stools, suddenly rapid deterioration (indicated by CVA, or infectious image), cold acra and indicated a flu-like feeling. Treatment consisted of comfort care only. All these events were reported with a fatal outcome. The patient died on 31Jan2021. Cause of death was unknown. It was not reported if an autopsy was performed. The patient underwent lab tests and procedures on an unknown date which included blood creatinine: 66, blood potassium: 3.6, blood sodium: 141, blood urea: 13.7, C-reactive protein: 56, glomerular filtration rate: 70, haemoglobin: 6.7, mean cell volume: 102. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Claw hand left; marbled skin; Two days after vaccination patient got: thin stools; suddenly rapid deterioration (indicated by CVA, or infectious image); Cold acra; Indicated a flu-like feeling; Unknown cause of death


VAERS ID: 1108480 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dehydration, Disturbance in attention, Dyspnoea, Pneumonia bacterial
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Renal insufficiency; Type II diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021256438

Write-up: Exsiccosis; suspected Pneumonia bacterial; Dyspnoea; Vigilance decreased; This is a spontaneous report downloaded from the Regulatory Authority-WEB DE-PEI-PEI2021003159. This is a report from a non-contactable physician received form Regulatory Authority. An 82-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. Medical history included renal insufficiency, dementia, type 2 diabetes mellitus, all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 01Feb2021 after vaccination the patient experienced exsiccosis, suspected pneumonia bacterial, dyspnoea, vigilance decreased. It was reported that there were no dyspnoea symptoms until vaccination. The patient was treated with antibiotic therapy. The events were serious as fatal and life threatening. The patient died on 04Feb2021. It was not reported if an autopsy was performed. Health Authority Relatedness of drug to all events: D. Unclassifiable. The information on the batch/lot number has been requested. ; Reported Cause(s) of Death: Exsiccosis; Pneumonia bacterial; Dyspnoea; Vigilance decreased


VAERS ID: 1108483 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 - / OT

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: 21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TARGINIQ; TENOX [TEMAZEPAM]; PEGORION; GASTERIX
Current Illness: Atherosclerosis; Cardiac insufficiency; Coronary artery disease; Dementia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021256383

Write-up: General physical health deterioration; This is a spontaneous report downloaded from the regulatory authority-WEB, regulatory authority number FI-FIMEA-20211070. A contactable Health Care Professional reported that a 97-year-old female patient received the first dose of BNT162B2 (COMIRNATY, lot number EJ6795) intramuscularly, at single dose, on 15Jan2021, for COVID-19 immunisation. Relevant medical history included arteriosclerosis, morbus cordis coronarius, cardiac insufficiency and severe degree dementia, all from an unspecified date and ongoing. Concomitant medication included oral naloxone hydrochloride, oxycodone hydrochloride (TARGINIQ, prolonged-release tablet) 2 DF, daily; oral temazepam (TENOX, tablet) 10 mg, daily; oral macrogol 4000 (PEGORION, powder and solvent for oral suspension) and oral lansoprazole (GASTERIX, gastro-resistant capsule, hard) 30 mg, daily. The patient experienced general physical health deterioration in Jan2021. After the vaccination the patient condition deteriorated and the patient was found dead in her bed. The patient died on 22Jan2021. It was not reported if an autopsy was performed. Clinical outcome of general physical health deterioration was reported as fatal. No Follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: General physical health deterioration


VAERS ID: 1108492 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-03-01
   Days after vaccination:40
Submitted: 0000-00-00
Entered: 2021-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Renal vasculitis, SARS-CoV-2 test
SMQs:, Vasculitis (narrow), Renovascular disorders (narrow), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021258797

Write-up: Renal vasculitis; 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-202103081226406770, Safety Report Unique Identifier GB-MHRA-ADR 24899397. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration, on 20Jan2021, at single dose for Covid-19 immunisation. Medical history included hypertension, Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial. The patient experienced renal vasculitis described as , painful joints 2 weeks after vaccine, 4 weeks after rash on legs swollen hands and feet all on an unspecified date. The patient died from renal vasculitis on 07Mar2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative covid-19 test on unknown date. It was not reported if an autopsy was performed. The clinical course was reported as: Painful joints 2 weeks after vaccine. 4 weeks after rash on legs swollen hands and feet Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Renal vasculitis


VAERS ID: 1108494 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-02-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IRBESARTAN; COLECALCIFEROL; MACROGOL EN ELEKTROLYTEN; DIPIPERON; ACETYLSALICYLZUUR; LORAZEPAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021256642

Write-up: Death; This is a spontaneous report downloaded from The Regulatory Agency-WEB NL-LRB-00457824. The report was received from a contactable Physician via the Regulatory Authority. A 76-years-old female patient received the second dose of bnt162b2 (COMIRNATY, batch: EJ6790), via an unspecified route of administration on 25Feb2021 at single dose for covid-19 immunisation. Medical history included dementia. Concomitant medication included irbesartan (IRBESARTAN), colecalciferol (COLECALCIFEROL), macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MACROGOL EN ELEKTROLYTEN), pipamperone hydrochloride (DIPIPERON), acetylsalicylzuur (ACETYLSALICYLZUUR), lorazepam (LORAZEPAM). The patient received the first dose of Comirnaty on 28Jan2021 and experienced no adverse event. The patient died on 25Feb2021 about 7 hours after being vaccinated. It was not reported if an autopsy was performed. Reporters comment: ADR: Concerns a 76-year-old woman with dementia. No evidence that death is related to vaccination. But also no other explanation for death except for dementia. Previous COVID-19 infection: No No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1108495 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-02-28
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-28
   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; ACETYLCYSTEINE; GANFORT; COMBIVENT; OXYCODON; CITALOPRAM; HALOPERIDOL; FLUTICASONE PROPIONATE; OXAZEPAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrioventricular block (2nd degree); Colon carcinoma (palliative policy); COPD; Living in nursing home (For 1 year)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021256578

Write-up: Death; This is a spontaneous report downloaded from the Agency regulatory authorities -WEB [Lareb (LRB) number NL-LRB-00459915] from a contactable physician. An 88-year-old male patient received the 2nd dose of bnt162b2 (COMIRNATY) (lot# EJ6790), via an unspecified route of administration, on 24Feb2021, at single dose, for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease, 2nd degree atrioventricular block, colon cancer (palliative policy), living in nursing home (for 1 year). Concomitant medications included paracetamol (unknown manufacturer), acetylcysteine (unknown manufacturer), bimatoprost, timolol maleate (GANFORT), ipratropium bromide, salbutamol sulfate (COMBIVENT), oxycodone hydrochloride (OXYCODON), citalopram (unknown manufacturer), haloperidol (unknown manufacturer), fluticasone propionate (unknown manufacturer), oxazepam (unknown manufacturer). The patient previously took the 1st dose of Comirnaty for COVID-19 immunisation and experienced no adverse event. The patient experienced death on 28Feb2021. It was not reported if an autopsy was performed.No clinical changes were seen between the vaccination and patient''s death. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: death


VAERS ID: 1109821 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-02-05
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-27
   Days after onset: 22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: VENTOLINE [SALBUTAMOL]; BISOPROLOL; XARELTO; RAMIPRIL; FURESIS
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021256364

Write-up: Cold symptoms; Dyspnoea; Cardiac insufficiency; This is a spontaneous report from a contactable physician downloaded from The Regulatory Authority-WEB FI-FIMEA-20211043. This is a report from Regulatory Authority. A 92-year-old male patient received bnt162b2 (COMIRNATY) (lot EJ6134) second dose intramuscular on 21Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included salbutamol (VENTOLINE), bisoprolol, rivaroxaban (XARELTO), ramipril, furosemide (FURESIS). The patient experienced cold symptoms, dyspnoea and cardiac insufficiency on 05Feb2021. The patient developed dyspnea which was seen as a symptom of a cold. The symptoms of a cold eased but the dyspnea still persisted. The patient''s functional capacity decreased and the patient was admitted to the hospital ward due to worsening of cardiac insufficiency. The correlation between the symptoms and the received vaccination is unclear, but the symptoms started after the patient received the vaccine and there was no clear reason for the dyspnea, so a suspicion was raised of a possible reaction caused by the vaccine. The patient died on 27Feb2021. It was not reported if an autopsy was performed. Follow-up attempts not possible. No further information expected.; Reported Cause(s) of Death: Cold symptoms; Dyspnoea; Cardiac insufficiency


VAERS ID: 1109864 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-06
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia
SMQs:, Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (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: FUROSEMIDE; METOPROLOL; NEULEPTIL [PERICIAZINE]; PERINDOPRIL ERBUMINE; AMIODARON [AMIODARONE]; ACENOCOUMAROL; ROSUVASTATINE [ROSUVASTATIN]; GLUCIENT SR
Current Illness: Arrhythmia; Implantable cardioverter defibrillator insertion
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021256558

Write-up: Arrhythmia; This is a spontaneous report from a contactable physician via the Agency (LRB), downloaded from the Agency Regulatory Agency-WEB (NL-LRB-00454760). A 70-year-old male patient received the first dose of BNT162B2 (COMIRNATY; Lot number EM0477) via an unspecified route of administration on 04Feb2021 at single dose for COVID-19 immunisation. Relevant medical history included ongoing implantable defibrillator insertion and ongoing arrhythmia. Concomitant medications included furosemide 40 mg, metoprolol 100 mg, periciazine (NEULEPTIL) 5 mg, perindopril erbumine 2 mg, amiodarone (AMIODARON) 200 mg, acenocoumarol 1 mg, rosuvastatin [ROSUVASTATINE] 10 mg and metformin hydrochloride (GLUCIENT SR) 500 mg. On 06Feb2021, the patient experienced arrhythmia for which he was hospitalized on the same day. The reporter specified that the patient had previous hospitalization''s due to this arrhythmia. After a hospitalization of 2 weeks, the patient deceased on an unspecified date in 2021. 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: Based on his known heart rhythm problem


VAERS ID: 1109877 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-26
Onset:2021-02-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-27
   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: SIPFIZER INC2021255501

Write-up: Sudden death; Feeling unwell; This is a spontaneous report from a contactable physician downloaded from WEB. This is a report received from the regulatory authority. Regulatory authority report number is [SI-JAZMP-NCPHV-2021SI0210_0210]. A 61-year-old male patient received the 2nd dose of bnt162b2 (COMIRNATY) intramuscular at singled dose on 26Feb2021 for COVID-19 immunisation The patient medical history and concomitant medications were not reported. The patient experienced feeling unwell and sudden death on 27Feb2021. Course of events was as follows. On the next day in the morning, on 27Feb2021, the patient began to feel unwell and in the afternoon the patient suddently died. Autopsy will be performed. It was not reported if an autopsy was performed. Sender Comment: Follow up is expected in due course.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1110746 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-02
Onset:2021-01-18
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Dyspnoea, General physical health deterioration, Oxygen saturation, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-19
   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: FUROSEMID; AMLODIPIN; RAMIPRIL AL; BERLINSULIN H BASAL; BISOPROLOL 1A PHARMA; KALINOR [POTASSIUM CHLORIDE]; ASS-RATIOPHARM; METHIZOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute myocardial infarction; Cerebral infarction; Diabetes mellitus; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210118; Test Name: Oxygen saturation; Test Result: 96 %; Test Date: 20210113; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:Negative; Test Date: 20210107; Test Name: COVID-19 rapid POC test; Result Unstructured Data: Test Result:Negative; Test Date: 20210109; Test Name: COVID-19 rapid POC test; Result Unstructured Data: Test Result:Negative; Test Date: 20210111; Test Name: COVID-19 rapid POC test; Result Unstructured Data: Test Result:Negative; Test Date: 20210112; Test Name: COVID-19 rapid POC test; Result Unstructured Data: Test Result:Negative; Test Date: 20210118; Test Name: COVID-19 rapid POC test; Result Unstructured Data: Test Result:Positive
CDC Split Type: DEPFIZER INC2021120239

Write-up: 4 am seething breathing, 7 am died; COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; Acute deterioration of general condition, no fever; This is a spontaneous report downloaded from The Regulatory Authority-WEB (DE-DCGMA-21187734). A non-contactable physician reported that an 88-years-old female patient received the first dose of BNT162B2 (COMIRNATY, Lot. EM0477) on 02Jan2021, at single dose, for COVID-19 immunisation. Relevant medical history included cerebral infarction from on an unspecified date in 2007, acute myocardial infarction on an unspecified date and unknown if ongoing, diabetes mellitus from an unspecified date and unknown if ongoing and hypertension from an unspecified date and unknown if ongoing. Concomitant medication included furosemide (FUROSEMID), amlodipine (AMLODIPIN), RAMIPRIL AL10 mg, insulin human injection, isophane (BERLINSULIN H BASAL), bisoprolol fumarate (BISOPROLOL 1A PHARMA), potassium chloride (KALINOR) 1,56 g, acetylsalicylic acid (ASS-RATIOPHARM) and thiamazole (METHIZOL). On 18Jan2021, the patient experienced acute deterioration of general condition, no fever. On 19Jan2021, the patient developed breathing difficult described as "at 4 AM seething breathing, at 7 AM the patient died". It was unknown if autopsy was done. COVID-19 rapid POC test performed on 07Jan2021, on 09Jan2021, on 11Jan2021, and on 12Jan2021, all with negative results. COVID-19 PCR test performed on 13Jan2021 with negative result. COVID-19 rapid POC test performed on 18Jan2021 with positive result. Oxygen saturation was at 96 % on 18Jan2021. Clinical outcome of the adverse event "COVID-19 confirmed by positive COVID-19 test" was unknown at time of the patient''s death. Relatedness of drug to reactions/events by Regulatory Authority: A. Consistent causal association to Follow-up attempts completed. No further information expected.; Reported Cause(s) of Death: General physical condition decreased; Breathing difficult


VAERS ID: 1110756 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-01-27
Submitted: 0000-00-00
Entered: 2021-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-27
   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: DEPFIZER INC2021120230

Write-up: Exitus letalis; This is a spontaneous report downloaded from The Regulatory Authority number: DE-PEI-PEI2021002011. A non-contactable physician reported that an 86 years old female patient received BNT162B2 (COMIRNATY) at single dose, on an unspecified date, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On 27Jan2021 after vaccination the patient died (death, exitus letalis was reported). It was unknown if autopsy was done. Death cause was reported as unknown cause of death. Reporter''s comment: another 3 patients died in the retirement home after the corona vaccination. Relatedness of drug to reaction/event Source of assessment: Regulatory Authority Result of Assessment: D. Unclassifiable No follow-up attempts are possible, information about lot number cannot be obtained.; Reporter''s Comments: Another 3 patients died in the retirement home after the corona vaccination.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1110757 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-16
Onset:2021-01-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Loss of consciousness, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-22
   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: Medical History/Concurrent Conditions: Dementia
Allergies:
Diagnostic Lab Data: Test Date: 20201226; Test Name: COVID-19 PCR test; Test Result: Positive ; Test Date: 2021; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20201224; Test Name: COVID-19 rapid POC test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021120226

Write-up: Exitus letalis; Unconsciousness; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-PEI2021002012. A 79-year-old female patient received BNT162B2 (COMIRNATY), via unspecified route on 16Jan2021 at single dose for COVID-19 immunization. Concomitant medications were not reported. The patient''s medical history included dementia, unknown if ongoing. On 17Jan2021 the patient experienced unconsciousness and died on 22Jan2021. The cause of death was unknown, and it was unknown if an autopsy was performed. Lab data included COVID-19 rapid POC test on 24Dec2021 with positive result and COVID-19 PCR test on 26Dec2021 with positive result and on unknown date in 2021 with negative result. Relatedness of drug to events by Regulatory authority: A. Consistent causal association to. No follow-up attempts possible. No further information expected. Lot/batch number was not provided and unable to obtain.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1110758 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-29
Onset:2021-01-03
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-03
   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 Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:Positive
CDC Split Type: DEPFIZER INC2021125922

Write-up: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; death; This is a spontaneous report from a contactable other hcp based on information received by Pfizer from Biontech (manufacturer control number unknwn), license partner for COMIRNATY. A 85-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 29Dec2020 at single dose for covid-19 vaccination. The patient medical history and the patient''s concomitant medications were not reported. The patient had a positive covid-test on an unspecified date, typical symptoms and died on 03Jan2021. It was not reported if an autopsy was performed. The patient was vaccinated prior to her death. According to the staff of the hospital, the patient received a positive COVID-Test on the day of her death, after she had developed typical symptoms 2 days prior and therefore was switched to the "Covid-Station" of the nursing home. Over the further cause the vaccination symptoms increased and the patient died. Information about batch number was not available and is going to be requested.; Sender''s Comments: Death of unknown cause is assessed related as a cautionary measure and for reporting purposes. Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported positive COVID-Test based on the known safety profile. 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: 1110772 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-22
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, C-reactive protein, C-reactive protein increased, Confusional state, Mini mental status examination, Pyelonephritis, Pyrexia, Urinary tract infection, Urine analysis, Vaccination site erythema
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-26
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arm fracture; Bedridden; Cataract extraction; Fall (Resulting in a fragmented mid-diaphyseal fracture of the right thigh, surgically treated); Femur fracture (Fracture ossified well, but rehabilitation did not progress.); Fracture treatment (The patient was in the hospital ward for further rehabilitation. Walking capacity was not restored.); Hearing aid user; Hospitalisation; Knee prosthesis insertion; Rehabilitation therapy (The patient was in the hospital ward for further rehabilitation. Walking capacity was not restored.); Subluxation shoulder; Surgery (Three times, most recently at C8 level.); Ulnar nerve injury; Walking difficulty
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: Body temperature; Result Unstructured Data: Test Result:37.5; Test Date: 20210122; Test Name: CRP; Result Unstructured Data: Test Result:increased; Test Date: 20210125; Test Name: CRP; Result Unstructured Data: Test Result:118; Test Date: 202002; Test Name: Mini-Mental State Exam; Result Unstructured Data: Test Result:27/30; Test Date: 202101; Test Name: urine sample; Result Unstructured Data: Test Result:E. Coli
CDC Split Type: FIPFIZER INC2021114127

Write-up: Urinary tract infection; Pyelonephritis; Confusion; C-reactive protein increased; Pyrexia; Vaccination site erythema; This is a spontaneous report from a non-contactable physician downloaded from The Regulatory Agency-WEB. This is a report received from the Regulatory Authority. Regulatory authority report number was FI-FIMEA-20210329. An 84-year-old female patient received BNT162B2 (COMIRNATY; Lot Number: UNKNOWN) intramuscular on 14Jan2021 as s single dose for COVID-19 vaccination. Medical history included cervical surgery three times on unknown dates (the most recent at C8 level), left knee prosthesis in 2014, cataracts cut in 2017, hearing aid in 2017, left upper arm fracture in 2011, delta paresis a subluxation of the shoulder joint from an unknown date, left ulnar nerve symptoms from an unknown date, collapse which resulted in fragmented mid-diaphyseal fracture of the right thigh (surgically treated-fracture ossified well) in May2020, further rehabilitation in hospital ward (walking capacity was not restored); ability to walk decreased after fracture and therefore patient was bedridden from an unknown date. The patient did not have an established memory disease and in Feb2020, Mini-Mental State Exam was 27/30. The patient''s concomitant medications were not reported. On 22Jan2021, the patient experienced urinary tract infection, pyelonephritis, confusion, C-reactive protein increased, pyrexia, and vaccination site erythema; all serious for being fatal. The clinical course was as follows: the patient was unresponsive in the morning and found to be more confused and a bit of temperature of 37.5. A urine sample was taken due to symptoms of infection. The patient was started on cephalexin (KEFEXIN) orally due to possible urinary tract infection. It was noted that the left upper arm from the elbow up and back extending also was red. The urine sample showed E.coli. A Do Not Resuscitate order was made. On 25Jan2021, c-reactive protein was 118. On 25Jan2021, the patient was switched from cephalexin to cefuroxime (ZINACEF) at 1.5 g three times a day and hydration of 1000 ml per day; both intravenous for suspected pyelonephritis. However, the level of consciousness did not improve and a calm exitus was observed from the morning. The patient died on 26Jan2021. It was not reported if an autopsy was performed. The reporting physician stated that a possible pyelonephritis infection took away the remaining strength from the patient. After the vaccine on 14Jan2021, the patient had a rise in temperature, severe reddening of the skin areas in the upper arm including back of vaccinated hand. After consultation with a forensic physician, a suspicion of an adverse reaction to COVID vaccine was noted on the death certificate. The clinical outcomes of urinary tract infection, pyelonephritis, confusion, c-reactive protein increased, pyrexia, and vaccination site erythema were reported as fatal. No follow-up attempts are possible; information about lot number cannot be obtained.; Reported Cause(s) of Death: suspicion of adverse reaction to COVID vaccine; urinary tract infection; pyelonephritis; C-reactive protein increased; pyrexia; vaccination site erythema; confusion


VAERS ID: 1110773 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-23
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK RA / OT

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, Foaming at mouth, Pallor, Pyrexia, Rash erythematous, Respiratory tract infection, SARS-CoV-2 test, White blood cell count
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-23
   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: Alcoholism; Bedridden (in need of full help); Bipolar disorder (with alcoholism in the background ; on disability pension); Brain injury; Disability (had a disability pension due to bipolar disorder); Fracture; Hemiparesis (left); Living in residential institution (since 2007); Respiratory infection (fall); Rib fracture; Subdural hematoma (resulting in left hemiparesis and weakness of the right lower limb); Traffic accident (with diffuse brain injury and right subdural hematoma); Weakness of limbs
Allergies:
Diagnostic Lab Data: Test Date: 20210123; Test Name: CRP; Result Unstructured Data: Test Result:114; Test Date: 20210123; Test Name: fever; Result Unstructured Data: Test Result:fever peaked at 38.6; Test Date: 2020; Test Name: COVID test; Result Unstructured Data: Test Result:negative; Test Date: 20210123; Test Name: leuk; Result Unstructured Data: Test Result:14.7
CDC Split Type: FIPFIZER INC2021114143

Write-up: Foaming at mouth; Respiratory tract infection; Pallor; Rash erythematous; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority. The regulatory authority report number is FI-FIMEA-20210330. A 58-year-old male patient received BNT162B2 (COMIRNATY; Lot number unknown), intramuscular in the right arm on 14Jan2021 as single dose for covid-19 immunization. The patient''s medical history included respiratory infection in fall 2020, being injured in a car crash in Jun2005 with diffuse brain injury and right subdural hematoma (resulting in left hemiparesis and weakness of the right lower limb), L1 fracture and multiple rib fractures on unspecified dates. Previously had a disability pension due to bipolar disorder, with alcoholism in the background. Has been in the long-term ward since 2007. Bed patient, in need of full help. Concomitant medications were not reported. The patient previously received influenza vaccine inactive split 4v (VAXIGRIPTETRA) on 03Nov2020 for immunization. The patient experienced foaming at mouth, respiratory tract infection, pallor, rash erythematous on 23Jan2021. The events were serious as they were fatal. Details were as follows: the vaccine was administered on 14Jan2021. Patient started fevering on 23Jan2021, fever peaked at 38.6, breathing with a rumbling and slimy cough. CRP 114, leucocytes (leuk) 14.7, COVID test was negative. On the day of 23Jan2021, while washing an fine-grained red skin eczema in the left armpit was noticed, the patient received the COVID vaccine basing on the records in the right upper arm 14Jan2021. 23Jan2021, in the evening, when going into the room the resident was pale and lifeless, was in a half-sitting position on the bed. White foam spilled from the mouth. The patient was set on his side and his back was patted. Another nurse brought suction, sucked plenty of foamy mucus from the mouth. The patient was still lifeless, EXITUS certified at 9:55 p.m. Police were notified of the death on 28Jan2021, as the primary cause of death was the aftermath of a brain injury caused by a traffic accident. As agreed, a fax copy of the death certificate was sent to the police. The patient had not had respiratory infections frequently, had a respiratory infection once last fall in 2020, and COVID test was negative at the time, date unspecified in 2020. No lung disease background was noted, though shortness of breath at night, for a long time in the ward was thought to have a sleep apnea. Fatal respiratory infection; it was unclear whether COVID vaccine could be a component of this. According to the forensic doctor''s instructions, this suspicion is mentioned on the death certificate. The patient died on 23Jan2021. 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: Respiratory tract infection; aftermath of a brain injury caused by a traffic accident


VAERS ID: 1110775 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-12
Onset:2021-01-25
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Oxygen saturation decreased
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-27
   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: LEVODOPA BENSERAZIDE; DIFFU K; PARACETAMOL; LACTULOSE; GLUCOSE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bedridden; Dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021120418

Write-up: Death unexplained; Oxygen saturation decreased; This is a spontaneous report from a contactable Pharmacist downloaded from the regulatory authority-WEB FR-AFSSAPS-AN20210159. A 86-years-old female patient received the first dose of bnt162b2 (COMIRNATY; Lot # EM0477) vaccine , intramuscular on 12Jan2021 at single dose for Covid-19 immunisation . Medical history included dementia, bedridden . Concomitant medication included benserazide hydrochloride, levodopa (LEVODOPA BENSERAZIDE), potassium chloride (DIFFU K), paracetamol (PARACETAMOL), lactulose (LACTULOSE), glucose (GLUCOSE). The patient experienced death unexplained on 27Jan2021 , oxygen saturation decreased from 25Jan2021 to death. The patient was vaccinated against COVID-19 by a first injection of COMIRNATY on 12Jan2021. No immediate reaction reported after vaccination. No hyperthermia episode. This was a bedridden patient living in a nursing home and who has been eating little since January. The patient''s condition has deteriorated since the end of November 2020. On 19Jan2021, the examination of the patient was very difficult, the patient was also non-dyspneic. On 25Jan2021, it presented a deterioration of the general condition and a desaturation. The patient died of unknown cause on 27Jan2021. An autopsy was not performed. No follow-up attempts are possible, batch number already obtained.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1110776 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-27
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatine, C-reactive protein, Death, Haemoglobin, SARS-CoV-2 test, White blood cell count
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-27
   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: Medical History/Concurrent Conditions: Cataract bilateral NOS; Prostate adenoma
Allergies:
Diagnostic Lab Data: Test Date: 20210113; Test Name: Leukocytes; Result Unstructured Data: Test Result:7.58 g/l; Test Date: 20201208; Test Name: Creatinine; Result Unstructured Data: Test Result:176 umol/l; Test Date: 20201214; Test Name: Creatinine; Result Unstructured Data: Test Result:153 umol/l; Test Date: 20201223; Test Name: Creatinine; Result Unstructured Data: Test Result:22 umol/l; Test Date: 20201230; Test Name: Creatinine; Result Unstructured Data: Test Result:255 umol/l; Test Date: 20210106; Test Name: Creatinine; Result Unstructured Data: Test Result:258 umol/l; Test Date: 20210113; Test Name: Creatinine; Result Unstructured Data: Test Result:343 umol/l; Test Date: 20210106; Test Name: CRP; Result Unstructured Data: Test Result:<4 mg/l; Test Date: 20201230; Test Name: hemoglobin; Result Unstructured Data: Test Result:10.7 g/dl; Test Date: 20210106; Test Name: hemoglobin; Result Unstructured Data: Test Result:9.6 g/dl; Test Date: 20210113; Test Name: hemoglobin; Result Unstructured Data: Test Result:3.04 g/dl; Test Date: 20201231; Test Name: PCR SARS-COV 2; Result Unstructured Data: Test Result:undetectable; Test Date: 20201230; Test Name: Leukocytes; Result Unstructured Data: Test Result:9.84 g/l; Test Date: 20210106; Test Name: Leukocytes; Result Unstructured Data: Test Result:6.11 g/l
CDC Split Type: FRPFIZER INC2021120401

Write-up: Death unexplained; This is a spontaneous report from a contactable physician from the Regulatory Authority-WEB FR-AFSSAPS-AN20210164. An 86-year-old male patient received bnt162b2 (COMIRNATY) , intramuscular at single dose on 06Jan2021 for Covid-19 immunisation (in comfort care for months). Medical history included cataract bilateral nos and prostate adenoma. Concomitant medications were not reported. The patient experienced death unexplained on 27Jan2021. Course of the event as follows: Around 20Jan2021, deterioration of the general condition. Rapidly progressing renal failure managed in a palliative manner. Patient died on 27Jan2021. An autopsy was not performed. Declaration of pharmacovigilance in principle, not related to the supposed vaccination because pre-existing severe condition. The patient underwent lab tests and procedures which included Creatinine (?mol / L): 153 (14Dec2020), 176 (08Dec2020), 22 (23Dec2020), 255 (30Dec2020), 258 (06Jan2021) 343 (13Jan2021); Leukocytes (G / L) 9.84 (30Dec2020), 6.11 (06Jan2021), 7.58 (13Jan2021); Hemoglobin (g / dL): 10.7 (30Dec2020), 9.6 (06Jan2021), 3.04 (13Jan2021); CRP: <4mg / L on 06Jan2021; PCR SARS-COV 2 undetectable on 31Dec2020. No follow-up attempts possible. No further information expected, information about lot/batch number cannot be obtained.; Sender''s Comments: Based on the current available information, the event Death unexplained is most likely related to an intercurrent or underlying condition which is not related to the suspect product BNT162B2. The case will be reassessed if additional information becomes available.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1110777 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-25
Onset:2021-01-27
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-27
   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: Living in care
Preexisting Conditions: Medical History/Concurrent Conditions: Aneurysm of abdominal aorta; Aortic stenosis (loose calcified aortic stenosis); Arterial hypertension; Atrial fibrillation; Duodenal ulcer (moderate intestinal gastritis / duodenal stump ulcer treated with proton-pump inhibitors); Dyslipidaemia; Gastritis (moderate intestinal gastritis / duodenal stump ulcer treated with proton-pump inhibitors); Gastroduodenal anastomosis (partial gastrectomy with gastro-jejunal anastomosis in 1995); Hyperuricaemia (Chronic renal failure with episode of hyperuricaemia); Hypothyroidism (Supplemented hypothyroidism); Ischaemic heart disease; Kidney failure chronic (Chronic renal failure with episode of hyperuricaemia); Livedo reticularis; Mixed dementia; Partial gastrectomy (partial gastrectomy with gastro-jejunal anastomosis in 1995); Peptic ulcer haemorrhage (hemorrhagic peptic ulcers repetitive since 1980); Peripheral arterial occlusive disease; Transient ischemic attack (notion of transient ischemic attack before 2010); Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021120456

Write-up: Death unexplained; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB (Regulatory Authority number: FR-AFSSAPS-CF20210115). An 81-year-old male patient received the first single dose of BNT162B2 (COMIRNATY; lot EJ6788) intramuscular, on 25Jan2021, in early afternoon, for COVID-19 immunisation. The patient was residing in long-term care unit. Medical history included supplemented hypothyroidism, peripheral arterial occlusive disease, kidney failure chronic (chronic renal failure with episode of hyperuricaemia), peptic ulcer haemorrhage (hemorrhagic peptic ulcers repetitive since 1980), atrial fibrillation, type 2 diabetes mellitus, dyslipidaemia, mixed dementia, ischaemic heart disease, arterial hypertension, livedo reticularis, infra-renal abdominal aortic aneurysm in 2007, loose calcified aortic stenosis, notion of transient ischemic attack before 2010, partial gastrectomy with gastro-jejunal anastomosis in 1995, moderate intestinal gastritis / duodenal stump ulcer treated with proton-pump inhibitors. Concomitant medications were not reported. Without any clinical warning sign (absence of oedema, urticaria, respiratory and cardiocirculatory failure), the patient''s death was observed on 27Jan2021 at 17:30 (death unexplained). It was unknown 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: 1110779 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-17
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 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: 2021-01-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Bedridden; Convulsive seizure; CVA; Hypertension arterial
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021120441

Write-up: Sudden death; This is a spontaneous report from a contactable physician from the regulatory authority-WEB FR-AFSSAPS-GR20210181. An 86-year-old female patient receive the first dose of bnt162b2 (COMIRNATY) (lot no. EJ6795), intramuscular at 30 ug, single in the left arm on 06Jan2021 for Covid-19 immunisation (good immediate tolerance). Medical history included hypertension arterial, convulsive seizure, cerebrovascular accident (CVA), bedridden, Alzheimer''s disease. Concomitant medications were not reported. The patient has been in supportive care since May2020. The patient experienced sudden death on 17Jan2021. Death, unrelated to the vaccination according to the doctor. An autopsy was not performed. No follow-up attempts possible. No further information expected.; Sender''s Comments: Based on the current available information, the event Sudden death is most likely related to an intercurrent or underlying condition which is not related to the suspect product BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1110782 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-29
   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: NORSET
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021118814

Write-up: was found dead in her bed; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. Regulatory Authority Report Number: FR-AFSSAPS-NC20210194. An 89-year-old female patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, lot number: EJ6788), intramuscularly on 28Jan2021 at single dose (1 dose form) for COVID-19 vaccination. The patient''s medical history included depressive syndrome. The patient''s concomitant medications included mirtazapine (NORSET). The patient received on 28Jan2021 an injection of bnt162b2. The patient did not show any symptoms immediately after injection. On 29Jan2021 the patient was found dead in her bed. It was unknown if an autopsy was performed. The outcome of the event was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: was found dead in her bed


VAERS ID: 1110784 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute pulmonary oedema
SMQs:, Cardiac failure (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation (anticoagulant); Decompensation cardiac; Embolism pulmonary; Hypertension arterial
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021120450

Write-up: Acute pulmonary edema; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-PO20210102. A 92-year-old female patient received the first dose of BNT162B2 (COMIRNATY), from lot # EJ6795, via intramuscular route at the left arm on 20Jan2021 1:30 p.m at 0,3ml single dose for COVID-19 immunization. Concomitant medications were not reported. The patient was at risk of developing COVID-19 due to age and high blood pressure. The patient has not had COVID-19 and has not been tested for COVID-19. She was treated with an anticoagulant as part of an atrial fibrillation (drug not specified). She presented an episode of minimal cardiac decompensation in Aug2020. Since that date her clinical condition has been stable. The patient''s medical history included hypertension arterial, embolism pulmonary, decompensation cardiac and atrial fibrillation, all unknown if ongoing. At 10:30 p.m. on 21Jan2021 (33 hours after the injection) the patient had malaise for 20 minutes, acute pulmonary edema occurred. Then quickly the death was noted. Post-mortem examination showed the presence of a significant amount of foam and was in favor of acute massive lung edema. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Acute pulmonary edema; Autopsy-determined Cause(s) of Death: presence of a significant amount of foam and was in favor of acute massive lung edema


VAERS ID: 1111113 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-22
Onset:2020-12-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1688 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Breath sounds abnormal, COVID-19, Drug ineffective, Hypopnoea, Illness, Lethargy, Pyrexia, Respiratory rate increased, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-19
   Days after onset: 28
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: AMLODIPINE; BISOPROLOL
Current Illness: Gastrointestinal carcinoma (In remission since 2018)
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Neoplasm (Recently treated (radiotherapy or chemotherapy)); Surgery; Comments: Patient has not had symptoms associated with COVID-19. Unsure if patient is enrolled in clinical trial.
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Test Date: 20201230; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC2021121224

Write-up: COVID-19 virus test positive; COVID-19 virus test positive; Breathing became progressively worse: fast, shallowand noisy.; Breathing became progressively worse: fast, shallowand noisy.; Breathing became progressively worse: fast, shallowand noisy.; Patient became very sick; Fever; lethargic; This is a spontaneous report from a contactable consumer (patient''s wife) received from the MHRA. The Agency Regulatory Authority report number is GB-MHRA-WEBCOVID-202102030931565490. Safety Report Unique Identifier GB-MHRA-ADR 24689483. A 53-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EJ1688), via an unspecified route of administration, on 22Dec2020, at single dose, for COVID-19 immunisation. Medical history included neoplasm (recently treated (radiotherapy or chemotherapy)), gastrointestinal carcinoma from 2017 and ongoing (in remission since 2018), surgery (not ongoing), atrial fibrillation from 2017 (unknown if ongoing). Patient has not had symptoms associated with COVID-19. Unsure if patient was enrolled in clinical trial. Concomitant medications included amlodipine (unknown manufacturer) and bisoprolol (unknown manufacturer). The patient experienced COVID-19 virus test positive (death, hospitalization, medically significant, life threatening) on 30Dec2020, patient became very sick (hospitalization, life threatening) on 22Dec2020 evening with outcome of unknown, fever (hospitalization, life threatening) on 22Dec2020 with outcome of unknown, lethargic (hospitalization, life threatening) on 22Dec2020 with outcome of unknown, breathing became progressively worse: fast, shallow and noisy (hospitalization, life threatening) on 24Dec2020 with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on unknown date, positive on 30Dec2020. The patient died on 19Jan2021 due to COVID-19 virus test positive. It was not reported if an autopsy was performed. Clinical course was as follow: from 22Dec2020 evening the patient became very sick. He had fever and was lethargic. Patient''s wife assumed it was the expected side effects. On 24Dec2020 the breathing became progressively worse: fast, shallow, and noisy. 4 or 5 days after vaccination, in Dec2020, in the middle of the night 999 was called, he was taken to hospital and was hospitalized due to the events. On 19Jan2021, about 3 weeks after, the patient died due to COVID-19 virus test positive (underwent on 30Dec2020). No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: COVID-19 virus test positive; COVID-19 virus test positive


VAERS ID: 1111117 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-24
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH H1G0L / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Lethargy, Mobility decreased
SMQs:, Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE; ATORVASTATIN; BISOPROLOL; LANSOPRAZOLE; ROPINIROLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Hypertension; Monoclonal gammopathy; Vascular dementia; Comments: vascular dementia, AF, hypertension, monoclonal gammopathy Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021121571

Write-up: lethargy; mobility worse/bedbound; Death; This is a spontaneous report from a contactable physician. This is a report received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202102041610358040 and Safety Report Unique Identifier of GB-MHRA-ADR 24700552. A 99-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 18Dec2020 and on 07Jan2021 each as a single dose for COVID-19 immunization. Medical history included vascular dementia, hypertension, atrial fibrillation and monoclonal gammopathy from an unknown dates. Concomitant medication included amlodipine (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), bisoprolol (MANUFACTURER UNKNOWN), lansoprazole (MANUFACTURER UNKNOWN), ropinirole (MANUFACTURER UNKNOWN). The patient experienced lethargy and mobility worse/bedbound on an unspecified date. The patient experienced death on 24Jan2021. The patient was vaccinated with both the first and second dose of the vaccine; since the 2nd vaccine, she gradually deteriorated, with lethargy and worse mobility, became bedbound and died peacefully on 24Jan2021. The family was wondering if the vaccine caused her death. Patient has not had symptoms associated with COVID-19 , nor had she had a COVID-19 test. The patient was not enrolled in a clinical trial. The patient experienced death on 24Jan2021. The patient died on 24Jan2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information regarding the first batch/lot cannot be obtained; No further information is expected; Reported Cause(s) of Death: death


VAERS ID: 1111232 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-16
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Frailty (Classified as level 8 on clinical frailty score.); Living in nursing home
Allergies:
Diagnostic Lab Data: Test Name: Investigation; Result Unstructured Data: Test Result:Score 8; Comments: CLINICAL FRAILTY SCALE: Score 8. (Date of assessment unknown).
CDC Split Type: NOPFIZER INC2021120225

Write-up: DEATH; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB manufacturer report number NO-NOMAADVRE-FHI-2021-U4ezd, Sender''s (Case) Safety Report Unique Identifier NO-NOMAADVRE-E2B_00014215. A 92-years-old female patient received the first dose of bnt162b2 (COMIRNATY; Lot #EJ6796 ) vaccine , via an unspecified route of administration on 06Jan2021 at single dose for covid-19 immunisation . Medical history included asthenia (Classified as level 8 on clinical frailty score) , living in residential institution The patient''s concomitant medications were not reported. The patient died from an unknown cause on 16Jan2021. The patient underwent lab tests and procedures which included investigation: score 8 on CLINICAL FRAILTY SCALE. It was not reported if an autopsy was performed. Sender Comment: Background: A woman in her 90s Clinical Frailty score of 8 received her first dose of the covid-19 vaccine Comirnaty. According to the doctor at the nursing home, she allegedly had no clear side effects, but died 10 days after vaccination. The doctor does not have access to more information about the patient with regard to any previous illnesses or drug use. Comment: The message does not contain sufficient information to be able to assess a possible causal link with the vaccination. We ask for more information to be able to assess the incident. If more information is not available, we would like advice from notifiers on who we can contact to obtain this information. On a general basis, we have the following comment: Normally between 300 and 400 people die per week in nursing homes and similar institutions. In a study of patients on long-term stays, a high degree of comorbidity, severe dementia and the need for assistance in daily activities, as well as lower BMI were among the factors associated with higher mortality. International, retrospective studies have similar findings and find, among other things, that the risk of death is increased in the first four months after hospitalization, and that patients who have recently been admitted to hospital have a particularly increased risk. Other diseases or factors that increase the risk of death, regardless of dementia or level of function, are cancer, cardiovascular disease (including heart failure and arrhythmia), kidney failure, chronic lung disease and weight loss. In general, the cause of death in nursing home patients is often multifactorial and difficult to establish with certainty. The cause of death is usually considered to be a chronic, underlying disease, which ultimately leads to a sequence of fatal complications. In a recently published cohort study that analyzed the causes of death in nursing home patients on long-term stays, cardio and cerebrovascular disease accounted for 1 in 4 registered deaths. Other common causes of death in the population were neurodegenerative disease (including dementia) (20%), respiratory and infectious diseases (including pneumonia and sepsis) (15%), and cancer (10%). When vaccinating marginal patients who are ill with many underlying diseases, some serious events, including death, may occur shortly after vaccination without any connection to vaccination. Since the patient''s death, the message is classified as serious, even though no causal link between the vaccine and the death has been established. Relatedness of drug to reaction/event Source of assessment Not assessable Reporter''s comment: Regulatory Authority have requested more information, but the reporting doctor at the nursing home does not have more information about the patient regarding the current course of events, any previous illnesses or whether she used any other drugs. No follow-up attempts possible. No further information expected; Reporter''s Comments: Regulatory Authority have requested more information, but the reporting doctor at the nursing home does not have more information about the patient regarding the current course of events, any previous illnesses or whether she used any other drugs.; Reported Cause(s) of Death: Death unknown cause


VAERS ID: 1111236 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-27
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Diarrhoea, Pneumonia, Pulmonary oedema, Pyrexia, Vomiting
SMQs:, Cardiac failure (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-29
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210127; Test Name: Body temperature; Result Unstructured Data: Test Result:38.0 - 38.4 Centigrade
CDC Split Type: PLPFIZER INC2021120237

Write-up: Fever 38.0 - 38.4 centigrade persisting for 48 hours; Diarrhea; Vomiting; Lung oedema; Suspected pneumonia; This is a spontaneous report downloaded from the Agency Regulatory Authority -WEB, Regulatory Authority number PL-URPL-3-96-2021. A contactable physician reported that an 89 years old patient of an unspecified gender received the first dose of BNT162B2 (COMIRNATY, Lot. EL1491, expiration date: 22Jan2021) intramuscularly, at single dose, on 20Jan2021 at 15:53, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On 27Jan2021 at 17:15, the patient experienced fever at 38.0 - 38.4 Centigrade persisting for 48 hours, diarrhea and vomiting. Complications occurred: lung oedema and suspected pneumonia. The patient died on 29Jan2021. Clinical outcome of all events was reported as fatal. It was unknown if autopsy was done. Sender''s comments: fever is an expected side effect for the vaccine. The fever started one week after vaccination with diarrhea and vomiting, so the cause could not be vaccine-related. Pulmonary edema, suspected pneumonia in an elderly person, which led to death, most likely occurred in the time coincidence until vaccination, although the role of the vaccine cannot be completely ruled out. There is a time relationship between vaccination and the occurrence of side effects. The person reporting ADR qualified it as severe. Assessed the ADR as heavy. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Fever 38.0 - 38.4 centigrade persisting for 48 hours; Diarrhea; Vomiting; Lung oedema; Pneumonia


VAERS ID: 1111248 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-01
Onset:2020-12-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ 6795 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Death, Dyspnoea, Productive cough, Wheezing
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-01
   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: CITALOPRAM SANDOZ; MORFIN ABCUR; TROMBYL; MONOPROST; MIDAZOLAM ACCORD; CANODERM; FURIX [FUROSEMIDE]; BEHEPAN [CYANOCOBALAMIN]; GABAPENTIN ACCORD; FOLACIN [FOLIC ACID]; METOPROLOL ORION; AZOPT; FENTANYL MYLAN; OXYNORM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Hypertension; Mixed anxiety and depressive disorder; Senile cataract; Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021120419

Write-up: Dead 45 minutes after the vaccination; Wheeze; Phlegm; Heart insufficiency; Breathing difficult; This is a spontaneous report from a contactable pharmacist downloaded from the Agency Regulatory Authority-WEB , SE-MPA-1611739167214. Safety Report Unique Identifier SE-MPA-2021-001770. A 92-year-old female patient received bnt162b2 (COMIRNATY) (Lot # EJ 6795), intramuscular at 0.3 mL, single on an unspecified date in Dec2020 for Covid-19 immunisation. Medical history included hypertension, cerebrovascular accident, dementia, mixed anxiety and depressive disorder, cataract. Concomitant medication included citalopram hydrobromide (CITALOPRAM SANDOZ), morphine hydrochloride (MORFIN ABCUR), acetylsalicylic acid (TROMBYL), latanoprost (MONOPROST), midazolam hydrochloride (MIDAZOLAM ACCORD) , urea (CANODERM), furosemide (FURIX [FUROSEMIDE]), cyanocobalamin (BEHEPAN [CYANOCOBALAMIN]), gabapentin (GABAPENTIN ACCORD), folacin [folic acid] (FOLACIN [FOLIC ACID]) , metoprolol succinate (METOPROLOL ORION), brinzolamide (AZOPT), fentanyl (FENTANYL MYLAN), oxycodone hydrochloride (OXYNORM). On an unspecified date in Dec2020, the patient experienced wheeze, and dead 45 minutes after the vaccination. The patient died on an unspecified date Dec2020. An autopsy was not performed. Course of events: The patient developed thick phlegm in throat and mouth, she had difficult to swallow and wheezing which was discovered 45 minutes after the vaccination with Comirnaty. According to the reporter no signs of anaphylaxis but the patient received Jext 300 micrograms subcutaneously in her thigh and 10 tablets of Betapred dissolved in water, she also received Robinul 0,2 mg/ml injection 1 ml subcutaneously. The patient was put in prone side position with elevated head end but died within 5 minutes. According to the report was the ultimate cause of the woman''s death was probably heart insufficiency and breathing difficulties. Report assessed as serious, death.; Reported Cause(s) of Death: Heart insufficiency; Breathing difficult


VAERS ID: 1111249 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Upper gastrointestinal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BEHEPAN [CYANOCOBALAMIN]; ENALAPRIL; ESOMEPRAZOLE; KALCIPOS-D; FURIX [FUROSEMIDE]; XARELTO; DUROFERON; METOPROLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac failure; Cognitive impairment; Hypertension; Ulcer stomach (past ulcer x 2)
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021118996

Write-up: ACUTE Upper gastrointestinal bleeding; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number SE-MPA-1611914132186. A 95-year-old female patient received BNT162B2 (COMIRNATY), via unspecified route in Jan2021 at 0,3ml single dose for COVID-19 immunization. Concomitant medications were cyanocobalamin (BEHEPAN), ferrous sulfate (DUROFERON), furosemide (FURIX), calcium carbonate, colecalciferol (KALCIPOS-D), rivaroxaban (XARELTO), enalapril, esomeprazole, metoprolol. The patient''s medical history and concurrent conditions included: Cognitive impairment, Hypertension, Ulcer stomach, Cardiac failure, Atrial fibrillation. On unknown date in Jan2021 the patient experienced acute Upper gastrointestinal bleeding and died. The woman has been found lifeless in her bed in the morning the day after the vaccination. Fresh black blood in the oral cavity that had run out on the blanket. Death was confirmed during a home visit by the reporter. No follow-up attempts possible. No further information expected. Lot/batch number was not provided and unable to obtain ; Reported Cause(s) of Death: Upper gastrointestinal bleeding


VAERS ID: 1111252 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, General physical health deterioration, Myocardial infarction, SARS-CoV-2 test, Sepsis
SMQs:, Myocardial infarction (narrow), Pseudomembranous colitis (broad), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Sepsis (narrow), Opportunistic infections (broad), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ALVEDON; LEVETIRACETAM; BLOXAZOC; FURIX [FUROSEMIDE]; ENALAPRIL; ATORVASTATIN; KETOGAN NOVUM; ACETYLSALICYLIC ACID; FELODIPINE; BETOLVIDON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Hypertension; Ischemic heart disease; Type 2 diabetes mellitus; Watery diarrhea
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:unknown results
CDC Split Type: SEPFIZER INC2021120364

Write-up: Watery Diarrhea; REDUCED general condition; MYOCARDIAL INFARCTION; SEPSIS; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority WEB and received via Regulatory Authority SE-MPA-2021-001789. A 90-years-old female patient received bnt162b2 (COMIRNATY) vaccine , via an unspecified route of administration on Jan2021 at single dose for Covid-19 immunisation . Medical history included type 2 diabetes mellitus , dementia , hypertension, diarrhoea , myocardial ischaemia . Concomitant medication included paracetamol (ALVEDON), levetiracetam (LEVETIRACETAM), metoprolol succinate (BLOXAZOC), furosemide (FURIX [FUROSEMIDE]), enalapril (ENALAPRIL) , atorvastatin (ATORVASTATIN), ketobemidone hydrochloride (KETOGAN NOVUM), acetylsalicylic acid (ACETYLSALICYLIC ACID), felodipine (FELODIPINE), cyanocobalamin (BETOLVIDON). The patient experienced reduced general condition on Jan2021 , myocardial infarction on Jan2021 , sepsis on Jan2021. The patient died from the reported events. No autopsy will be performed. The woman had earlier in the week been admitted to the Emergency room due to diffuse rashes, interpreted as age-related rashes/hemangiomas, normal lab tests were taken, thereafter she got vaccinated with Comirnaty. The woman arrived at the emergency room 2 days after the vaccination with a deteriorating general condition since the day before and recurring periods of watery diarrhoea (unclear how long they have lasted) and she was admitted. The woman received Ringer''s Acetate to raise her blood pressure and albumin but got insufficient effect from this and was started on piperacillin / tazobactam, all hypertensive drugs were paused. No new Covid test was taken, but the woman was kept isolated as a Covid patient, the diarrhoea could be a sign of Covid. Lab values: white 20.4, Pk/INR 1.2, albumin 25, creatinine which has gone up to 278 and therefore gives an eGFR of 12, ASAT 3.5, ALAT 0.95, CRP 192, Troponin$g 10000, lactate 2.3 Palliative care is initiated due to pain and anxiety, which the patient may feel. The patient was found dead the next morning, assessment sepsis with unclear focus with dehydration and pronounced secondary infarction, given age and previous illnesses. No follow-up attempts possible. No further information expected.Lot/batch number was not provided and unable to obtain; Reported Cause(s) of Death: Reduced general condition; Myocardial infarct; Sepsis


VAERS ID: 1112855 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-17
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Haematemesis, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 16
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: 20210117; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: COVID pos in hospital
CDC Split Type: ATPFIZER INC2021250307

Write-up: SARS COVID 19; died within a week; Haematemesis; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB [regulatory authority number AT-BASGAGES-2021-09458]. A 76-year-old male patient received his first dose of BNT162b2 (COMIRNATY, lot number EP2163), intramuscular on 14Jan2021, at single dose for COVID-19 immunisation. The patient medical and concomitant medications were not reported. The patient experienced haematemesis and SARS COVID 19 on 17Jan2021. On 17Jan2021 the patient was hospitalized. On the same day, in hospital, the patient was found positive COVID-19 PCR test. The patient was vaccinated on Thursday and was positive on Sunday, so was probably vaccinated in the incubation period. Previously, he was never tested positive and tests were carried out very frequently in the affected nursing home. Patient was hospitalized on 17Jan2021 and died within a week due to SARS COVID 19 (on unspecified date in Jan2021). The outcome of event haematemesis was unknown. 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: SARS COVID 19; died within a week


VAERS ID: 1112860 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-02-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, Contusion, Dysphagia, Myalgia, Somnolence, Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Weight decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (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), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-04
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia (mixed Alzheimer''s and vascular dementia.); Drowsiness; Swallowing difficult; Weight loss
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021265131

Write-up: weight loss; increased drowsiness; swallowing; Condition declined post vaccination - weight loss, increased drowsiness, swallowing; Pain, redness, swelling on injection site; Pain, redness, swelling on injection site; Pain, redness, swelling on injection site; muscle/body aches; Bruising; This is a spontaneous report received from the Regulatory Authority (Regulatory authority number AU-TGA-0000521644). A contactable physician reported that a 78-year-old female patient received BNT162B2 (COMIRNATY) first dose on 25Feb2021 at single dose for COVID-19 immunisation. Medical history included patient had end-stage dementia mixed Alzheimer''s and vascular dementia, patient was on palliative care pathway. Patient declining over some months - increased drowsiness over a few weeks prior to vaccination and weight loss, swallowing. Concomitant medications were not reported. Patient died on 04Mar2021 after COVID vaccine on 25Feb2021 Pain, redness, swelling on injection site, muscle/body aches Bruising. Condition declined post vaccination - weight loss, increased drowsiness, swallowing and end of life care commenced. Physician was not concerned that this was a vaccine reaction. Causality was reported as Causality possible. No follow-up attempts are possible. Information about batch cannot be obtained.; Reported Cause(s) of Death: Pain, redness, swelling on injection site; Pain, redness, swelling on injection site; Pain, redness, swelling on injection site; muscle/body aches; Bruising; weight loss; increased drowsiness; swallowing; Condition declined post vaccination - weight


VAERS ID: 1112861 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-07
Onset:2021-03-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Confusional state, Hyperglycaemia, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-08
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: BGL; Result Unstructured Data: Test Result:27
CDC Split Type: AUPFIZER INC2021265262

Write-up: Vomited; confused; BGL 27; This is a spontaneous report received from the Therapeutic Goods Administration (TGA) (Regulatory authority number AU-TGA-0000522242). The reporter type to the TGA was reported as a Health Professional. A 95-year-old female patient received the first dose BNT162B2 (COMIRNATY; Lot number not provided), intramuscular on 07Mar2021 at 14:00, at single dose for covid-19 immunisation. Medical history was unknown. Relevant concomitant medications were unknown. The patient received the first dose of vaccine at 14:00, and did not experienced issues immediately following vaccination. On 07Mar2021 she was found confused at 02:00hrs with blood glucose 27. On 08Mar2021 at a 20:00hrs the patient experienced vomiting. The patient was transferred to hospital at 03.20hrs, 09Mar2021 (as reported). It was reported that the patient passed away in the evening of the 08Mar2021. Clinical outcome of the adverse events was fatal. No follow-up attempts are possible; information about lot number cannot be obtained.; Reported Cause(s) of Death: Vomited; confused; BGL 27


VAERS ID: 1112868 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-18
Onset:2021-01-29
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Haemorrhagic stroke, Nervous system disorder
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: 2021-02-01
   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: KEMADRIN; VITAMIN D NOS; HALDOL; LORMETAZEPAM; BEFACT [CYANOCOBALAMIN;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE MONONITRATE]; BISOPROLOL; TAMSULOSIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Benign prostatic hyperplasia; Mitral insufficiency (mild aortic and mitral insufficiency); Paranoid schizophrenia; Comments:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021250330

Write-up: Nervous system disorder; Hemorrhagic stroke; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB. The Regulatory Authority report number is BE-FAMHP-DHH-N2021-79017. This report originated from the Regulatory Authority. A 77-year-old male patient received the first dose of bnt162b2 (COMIRNATY, lot number: EM0477), via an unspecified route of administration on 18Jan2021 at single dose for Covid-19 immunization. Medical history included paranoid schizophrenia, benign prostatic hyperplasia, and mild aortic and mitral insufficiency. Concomitant medications included procyclidine hydrochloride (KEMADRIN), vitamin D, haloperidol (HALDOL), lormetazepam, cyanocobalamin, pyridoxine hydrochloride, riboflavin, thiamine mononitrate (BEFACT), bisoprolol, and tamsulosin; all taken from an unspecified date for an unspecified indication. Nutritional supplement included Easy-Transil. The patient experienced nervous system disorder and hemorrhagic stroke, both on 29Jan2021 with fatal outcome. There was no treatment received for the adverse events. The patient died on 01Feb2021. It was unknown if an autopsy was performed. Events were assessed by FAMHP as unclassifiable. Reporter comment: Patient was of a thin corpulence. He had a correct general condition before and after vaccination. On 29Jan2021, neurological problems appeared: agitation, mutism, swallowing disorders, falls,..linked with a cerebral haemorrhage. Follow-up attempts are not needed. No further information is expected.; Reported Cause(s) of Death: Nervous system disorder; Hemorrhagic stroke


VAERS ID: 1112870 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-02-23
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 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: 2021-02-23
   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: L-THYROXINE [LEVOTHYROXINE SODIUM]; NEUROBION [CYANOCOBALAMIN;PYRIDOXINE HYDROCHLORIDE;THIAMINE DISULFIDE]; EMCORETIC; PRAREDUCT; ROCALTROL; CO-BISOPROLOL; SERTRALINE EG; TRAZODONE EG; LYSANXIA; OZEMPIC; L-THYROXINE [LEVOTHYROXINE SODIUM];
Current Illness: Cerebral atrophy; Hyperparathyroidism; Hypocalcemia; Malabsorption; Osteopenia; Supraventricular extrasystoles; Ventricular extrasystoles
Preexisting Conditions: Medical History/Concurrent Conditions: Algoneurodystrophy (complex regional pain syndrome); Bypass surgery; Cataract (left); Depression; Eventration repair; Gastric banding; Radius fracture; Skull fracture; Thyroidectomy total; Total knee replacement
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021266825

Write-up: death in her sleep on day 5; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB BE-FAMHP-DHH-N2021-79852. A 73-year-old female patient received the second dose of BNT162B2 (COMIRNATY, lot number EK9788) via an unspecified route of administration on 18Feb2021 at single dose for COVID-19 immunisation. Medical history included fronto-parietal atrophy from 18Sep2020 and ongoing; isolated supraventricular extrasystoles from 21Sep2020 and ongoing; rare ventricular extrasystoles from 21Sep2020 and ongoing; hyperparathyroidism due to hypocalcemia (malabsorption phenomenon) from 01Jan2010 and ongoing; mixed osteopenia from 19Mar2020 and ongoing; algoneurodystrophy on right total knee replacement (complex regional pain syndrome) from 01Jan2014 to 01Jan2017; depression on 01Jan2000 (as reported); head fracture right radius on 04Dec2016; gastric banding on 01Jan2000; bypass on 01Jan2009; left eye cataract on 02Mar2016; eventration cure from an unspecified date to 17Dec2020; right total knee replacement on 01Jan2014, and total thyroidectomy on 01Jan2000. Concomitant medications included levothyroxine sodium (L-THYROXINE) from 21Dec2020; cyanocobalamin, pyridoxine hydrochloride, thiamine disulfide (NEUROBION) from 09Mar2020; bisoprolol fumarate, hydrochlorothiazide (EMCORETIC) from 09Mar2020; pravastatin sodium (PRAREDUCT) from 09Mar2020; calcitriol (ROCALTROL) from 09Mar2020; bisoprolol fumarate, hydrochlorothiazide (CO-BISOPROLOL) from 20Oct2020; sertraline hydrochloride (SERTRALINE EG) from 17Dec2020; trazodone hydrochloride (TRAZODONE EG) from 17Dec2020; prazepam (LYSANXIA) from 11Sep2020; semaglutide (OZEMPIC) from an unspecified date; levothyroxine sodium (L-THYROXINE) from 20Oct2020; ferrous sulfate (FERO-GRADUMET) from 09Mar2020, all for unspecified indication. The patient experienced death in her sleep on day 5 on 23Feb2021. An autopsy was not performed. The Regulatory Authority considered the causality of the sudden death with Comirnaty as unclassifiable. Reporter Comment: No particular fragility: completely autonomous patient, no mobility problem, no cognitive disorders. She had little medical history that could explain such a sudden death. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: No particular fragility: completely autonomous patient, no mobility problem, no cognitive disorders. She had little medical history that could explain such a sudden death.; Reported Cause(s) of Death: death in her sleep on day 5


VAERS ID: 1112871 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-02-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALPRAZOLAM; PARACETAMOL; XARELTO; COVALSAR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Artificial cardiac pacemaker user (pacemaker); Atrial fibrillation (consecrated atrial fibrillation); Mitral insufficiency; Weight normal (normal build)
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021266831

Write-up: Cardiovascular disorder; This is a spontaneous report received from a physician downloaded from the Regulatory Authority-WEB BE-FAMHP-DHH-N2021-80414. This report originated from the Regulatory Authority. A 92 year old female patient received 2nd dose of bnt162b2 (COMIRNATY- lot number EJ6789), via an unspecified route of administration on 24Feb2021 12:00 for covid-19 immunisation. Medical history included consecrated atrial fibrillation, mitral valve incompetence. The patient had a pacemaker and was from normal build. Concomitant medication included alprazolam, paracetamol, rivaroxaban (XARELTO), hydrochlorothiazide, valsartan (COVALSAR). The patient experienced cardiovascular disorder on 25Feb2021. The patient died on 25Feb2021. It was not reported if an autopsy was performed. Regulatory Authority considered the event as unclassifiable. Reporter comment: vaccination process totally normal on 24Feb2021 at 12h, no post-vaccination reaction. Patient was found deceased in bed on 25Feb2021 at 8 am. The death certificate concludes a natural death, probably stroke or fatal arrhythmia. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cardiovascular disorder


VAERS ID: 1112877 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Incorrect route of product administration, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Drug abuse and dependence (broad), Cardiomyopathy (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-13
   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: PANTOPRAZOL SPIRIG HC; CANSARTAN; CLOPIN ECO; CLOPIXOL [ZUCLOPENTHIXOL DECANOATE]; OXIS TURBOHALER; RIVOTRIL; SAYANA; AZICLAV
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acid reflux (esophageal); Alcohol use (Occasional); Atheromatosis; Bronchitis chronic; Folliculitis (Cheek area on the right.); Hypertension; Nicotine abuse (Smoking:14 - 18 cig/day for years); Obesity; Schizophrenia; Seizures
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC2021262161

Write-up: Unexpected and sudden death 30-36 hours after vaccination with Pfizer-BioNTech 1st dose.; Vaccination with Comirnaty on 11Feb2021, subcutaneously (not known why),; This is a spontaneous report received from a contactable physician, the regulatory authority. Regulatory authority report number CH-SM-2021-11636. A non-pregnant 35-year-old female patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, lot/batch number not provided), subcutaneous on 11Feb2021 (at age of 35-year-old) at 0.3 mL, single for COVID-19 immunisation. Medical history included eosophageal reflux, hypertension, Schizophrenia, chronic bonchitis, Nicotine abuse (Smoking: 14-18 cig/day for years), obesity, folliculitis in the cheek area on the right from 05Feb2021, Seizures from 07Sep2020, infected atheroma, Alcohol use (Occasional). Allergies was None. Kidney disease and Liver disease were Not known. Concomitant medications included: pantoprazole sodium sesquihydrate (PANTOPRAZOL SPIRIG HC) from May2018 for reflux, candesartan cilexetil (CANSARTAN) from 14Mar2017 for hypertension, clozapine (CLOPIN ECO) from 11Jan2011 for Schizophrenia, zuclopenthixol decanoate (CLOPIXOL) from 11Jan2011 for schizophrenia, formoterol fumarate (OXIS TURBOHALER), from 28May2018 for chronic bronchitis in nicotine abuse, clonazepam (RIVOTRIL) from 04Jul2017 for Seizures, medroxyprogesterone acetate (SAYANA) from 29Aug2017 for Contraception, amoxicillin, clavulanate potassium (AZICLAV) from 05Feb2021 to 12Feb2021 for infected atheroma/folliculitis in the cheek area on the right. Vaccination with COMIRNATY on 11Feb2021, subcutaneously (not known why), In the evening (13Feb2021), the patient was found dead in institution. Unexpected sudden death 30-36 hours after vaccination. Forensic medical examination at (privacy) ordered by prosecution. The outcome of the event was fatal. On 09Mar2021 the results of the autopsy were not yet available. As soon as we receive them we will evaluate the case and adjust the causality assessment. An autopsy was performed and results were not provided. A causal relationship between Comirnaty and Death is at the moment conditional/unclassified. This case was reported as serious (fatal outcome). Sender''s comment: Unexpected sudden death 30-36 hours after vaccine in a young patient known for several pathologies (schizophrenic, eosophageal reflux, hypertensive, chronic bonchitis, nictotin abuse, obese and recent folliculitis treated with antibiotic), and in chronic therapy with several drugs. From the first data of the autopsy a clear cause of death did not emerge but they are investigating further and will give us the details of the final report. At the moment (09Mar2021) we have therefore judged the causal correlation between the vaccine and the death of the patient as conditional/unclassified. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unexpected and sudden death 30-36 hours after vaccination with Pfizer-BioNTech 1st dose.


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