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

Found 17,128 cases where Vaccine is COVID19 and Patient Died



Case Details

This is page 111 out of 172

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VAERS ID: 1279427 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Kidney transplant (20 years ago)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021465681

Write-up: Passed away; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. Medical history included kidney transplant (20 years ago). The patient''s concomitant medications were not reported. The patient passed away on an unspecified date. The patient died on an unspecified date. Cause of death was unknown. It was not reported if an autopsy was performed. The event occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Passed away


VAERS ID: 1281036 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210455217

Write-up: Arrhythmia; This spontaneous report received from a patient via regulatory authority concerned a 77 year old of unspecified sex. The patients weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, on an unspecified anatomical site for prophylactic vaccination. Batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced arrhythmia. On an unspecified date, the patient died from arrhythmia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of arrhythmia on an unspecified date. This report was serious (Death).; Sender''s Comments: V0: 20210455217-COVID-19 VACCINE AD26.COV2.S-Arrythmia. This event is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: ARRHYTHMIA


VAERS ID: 1281131 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-03-04
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042723 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Death, Haemodynamic test, Neurological examination, Oxygen saturation, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-03-09
   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: ATOZET; ASPIRIN CARDIO; ENTRESTO; CARVEDILOLUM
Current Illness: Heart attack; Heart insufficiency; Hypercholesterolaemia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: Cardiac values; Result Unstructured Data: normal; Test Date: 202103; Test Name: Neurological tests; Test Result: Negative ; Result Unstructured Data: After 24 hours of sedation; Test Date: 202103; Test Name: Saturation values; Result Unstructured Data: Low saturation % levels
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Death; Ventricular fibrillation; Cardio-respiratory arrest; This regulatory authority case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEATH (Death), VENTRICULAR FIBRILLATION (Ventricular fibrillation) and CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) in an 84-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 300042723) for COVID-19 vaccination. The patient''s past medical history included Heart attack since 1998, Hypercholesterolaemia since 1998 and Heart insufficiency since an unknown date. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN CARDIO) for Acute myocardial infarction, SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO) and CARVEDILOLUM for Cardiac insufficiency, ATORVASTATIN CALCIUM, EZETIMIBE (ATOZET) for Hypercholesteraemia. On 02-Mar-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VENTRICULAR FIBRILLATION (Ventricular fibrillation) (seriousness criteria medically significant and life threatening) and CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) (seriousness criteria medically significant and life threatening). On 09-Mar-2021, VENTRICULAR FIBRILLATION (Ventricular fibrillation) and CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) had not resolved. The patient died on 09-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Haemodynamic test: normal (normal) normal. In March 2021, Neurological examination: negative (Negative) After 24 hours of sedation. In March 2021, Oxygen saturation (95-100): low% (Low) Low saturation % levels. Treatment of the events included resuscitation which was successful. It was reported that following ventricular fibrillation and cardio-respiratory arrest, the patient suffered cerebral anoxia with brain damage and neurological deficits. Although cardiac values were good per the reporter, low saturation levels were observed and the patient died after 5 days. This is a case of sudden death in a 84-year-old male patient with a history of Heart attack, Hypercholesterolaemia and Heart insufficiency, who died 7 days after receiving first dose of vaccine. Very limited information has been provided at this time. Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Translation received, diagnostic information was added as well as details pertaining to the fatal events.; Sender''s Comments: This is a case of sudden death in a 84-year-old male patient with a history of Heart attack, Hypercholesterolaemia and Heart insufficiency, who died 7 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1281136 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Diabetes mellitus; Obesity
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 test; Result Unstructured Data: Test Result:Positive
CDC Split Type: CRPFIZER INC2021402097

Write-up: After receiving both doses of the vaccine, he was positive for COVID; After receiving both doses of the vaccine, he was positive for COVID; doctor dies; This is a spontaneous report from a non-contactable physician (patient) via a Pfizer colleague. A 65-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Lot number and Expiry date was not reported) as single dose, dose 2 via an unspecified route of administration on an unspecified date (Lot number and Expiry date was not reported) as single dose for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing, diabetes mellitus from an unknown date and unknown if ongoing, obesity from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On an unspecified date, the patient experienced after receiving both doses of the vaccine, he was positive for COVID (vaccination failure), (covid-19). Today, through a television media it was reported that an employee from the Hospital was transferred to the ICU (Intensive care unit) of after receiving both doses of the vaccine was positive by COVID. They indicate that it can be related to variants of the virus circulating in the country. Physician indicated: HTA, DM, Obesity, had all 2 doses, the last 25 days ago, immunity is supposed to be reached within 21 days of the second dose. A worker from health center got COVID-19 after having the complete vaccination scheme, he was on Intensive care unit of Hospital. information was received form lay media via a Pfizer colleague: Started an investigation due to the case of a worker from hospital who is on a delicate health state due to COVID-19 despite of having his complete vaccination scheme against the virus (concluded 18 days after presenting symptoms). The epidemiology service of hospital started an investigation and analysis due to the physician case, from 65 years old who suffered a COVID-19 infection after completing his vaccination scheme with 2 doses (close to 3 weeks ago). As part of the process a sample was taken to be sent to corresponding analysis. When the investigation reveals more details they will be published. Patient is on a delicate health state and he is hospitalized on intensive care unit. On 27Apr2021, the patient died who was infected with Covid19 despite having received the complete vaccination scheme against respiratory disease. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of the events were unknown. Follow Up (12APR2021): The initial report was missing the criteria for a valid case. After the information received on 12APR2021, case contains all the information to be considered a valid case. Follow up (12APR2021): The following information was received from a non-contactable physician via a Pfizer colleague included patient age. Follow up (13APR2021): The following information was received form lay media via a Pfizer colleague stated that Patient is on a delicate health state and he is hospitalized on a intensive care unit on PRIVACY Hospital. No follow up attempts are possible, no further information is expected. Follow-up (27Apr2021): New information was received from lay media via a Pfizer colleague includes: new event (death) and course of events. No follow up attempts are possible, no further information is expected.; Sender''s Comments: Based on available information, there is not a reasonable possibility that the reported event Death is related to the suspect product BNT162B2, in this patient who, after receiving both doses of the vaccine, was positive for COVID. Medical history included hypertension, diabetes mellitus, and obesity.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1283558 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-14
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021470405

Write-up: Adverse event following immunization/ Outcome: Fatal; This is a spontaneous report from a contactable healthcare professional received from the regulatory authority. Regulatory authority report number is 542230. A 95-years-old female patient received the first and second doses of bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced adverse event following immunisation with fatal outcome on 14Apr2021. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Adverse event following immunization/ Outcome: Fatal


VAERS ID: 1283559 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-31
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Decreased appetite, Dysphagia
SMQs:, Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021470416

Write-up: Decreased appetite; Dysphagia; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 541389. A female patient of an unspecified age received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 31Mar2021, the patient experienced decreased appetite and dysphagia. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Decreased appetite; Dysphagia


VAERS ID: 1283560 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021470417

Write-up: Fatal adverse event; This is a spontaneous report from a contactable healthcare professional through the regulatory authority (Regulatory Authority report number: 541534. An 82-year-old female patient received BNT162B2 (COMIRNATY, Lot number and expiration date were not reported) as a single dose, with route of administration and therapy date unspecified, for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On an unspecified date, the patient had a fatal adverse event. The patient had died on an unspecified date, and the cause of death was unknown. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Reported Cause(s) of Death: Fatal adverse event.


VAERS ID: 1283561 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVERAM; DIABEX
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021470418

Write-up: Adverse event following immunisation/Outcome: Fatal; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 541883. A 88-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included amlodipine besilate, perindopril arginine (COVERAM); metformin hydrochloride (DIABEX) both taken for an unspecified indication, start and stop date were not reported. The patient experienced adverse event following immunization, outcome was fatal on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about batch number cannot be obtained.; Reported Cause(s) of Death: Adverse event following immunisation/Outcome: Fatal


VAERS ID: 1283562 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021470419

Write-up: Death; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 542190. An 88-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient''s medical and concomitant medications were not reported. It was unknown if the patient was pregnant at the time of vaccination. The patient experienced death on an unspecified date. It was unknown if an autopsy was performed. No follow-up attempts are possible, information about batch number cannot be obtained. ; Reported Cause(s) of Death: Death


VAERS ID: 1283563 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-10
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021470420

Write-up: Cerebral haemorrhage; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 542194. A 79-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for Covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced cerebral haemorrhage on 10Apr2021. The patient died on an unspecified date with cerebral haemorrhage as the cause of death. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Cerebral haemorrhage


VAERS ID: 1283564 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-02
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Adverse event following immunisation
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021470421

Write-up: Adverse event following immunisation; This is a spontaneous report from a contactable other health professional via a regulatory authority. Regulatory authority report number is 542196. A 97-year-old female patient received the second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced adverse event following immunization on 02Apr2021. The event reported as serious with seriousness criteria fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Adverse event following immunisation


VAERS ID: 1283565 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-03
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Intestinal obstruction
SMQs:, Gastrointestinal obstruction (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021470422

Write-up: Intestinal obstruction; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 542206. An 83-year-old male patient received bnt162b2 (COMIRNATY) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced intestinal obstruction (death) on 03Apr2021. The patient died on an unspecified date. It was unknown if an autopsy was performed. Outcome of the event was fatal. No follow-up attempts possible; information about lot/batch number cannot be obtained. ; Reported Cause(s) of Death: Intestinal obstruction


VAERS ID: 1283574 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cardiac disorder, Lung disorder, Renal disorder, SARS-CoV-2 test
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: COPFIZER INC2021479394

Write-up: renal, pulmonary and cardiac complications; renal, pulmonary and cardiac complications; renal, pulmonary and cardiac complications; COVID-19 PCR test positive; This is a spontaneous report from a non-contactable consumer (patient''s niece) received through a Pfizer colleague (Medical Manager). A 70-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as SINGLE DOSE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The reporter informed that after the patient received the Pfizer COVID-19 vaccine, two days later had COVID-19 PCR test positive and after 15 days died with renal, pulmonary and cardiac complications. The outcome of the event "COVID-19 PCR test positive" was unknown. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: renal, pulmonary and cardiac complications; renal, pulmonary and cardiac complications; renal, pulmonary and cardiac complications


VAERS ID: 1283575 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CRPFIZER INC2021464774

Write-up: after being vaccinated he died; This is a spontaneous report from a non-contactable nurse by regulatory authority. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient died after being vaccinated, it is not clear if it was the Pfizer vaccine, at the time there was not much information about it. The patient died on an unspecified date. 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 reported event of death with unknown cause is considered as related due to lack of information. The company processes "death cause unknown" cases as possibly related and documents them as related in the global safety database unless information is provided that allows the Company to exclude that there is a reasonable possibility of relatedness to the suspect product. The case will be reassessed once more information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: after being vaccinated he died


VAERS ID: 1283579 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-19
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Feeling abnormal, Pain in extremity
SMQs:, Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-20
   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: Arterial hypertension; Dyslipidemia; Smoker
Preexisting Conditions: Medical History/Concurrent Conditions: Arthrosis; Cholecystectomy; Hip prosthesis insertion (left side, due to arthrosis); Hysterectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC2021473878

Write-up: upper limbs pain; chest pain; she felt bad; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is CZ-CZSUKL-21004538. A 76-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 14Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Relevant medical history includes ongoing smoker, ongoing dyslipidemia, ongoing arterial hypertension, hysterectomy, hip prosthesis insertion left side, due to arthrosis, ang cholecystectomy; all on unspecified dates. Patient had no thromboembolic or COVID-19 history. The patient''s concomitant medications were not reported. Patient had COMIRNATY vaccination on 14Apr2021 and was complicated by bad feeling, chest pain, upper limbs pain on 19Apr2021. Immediately after vaccination she was without symptoms, when she was visiting her physician the last time. She died the next day, 20Apr2021.It was recommended to do autopsy, however was not reported if an autopsy was performed. No follow-up attempts are possible. Information on lot and batch numbers cannot be obtained. No further information is expected.; Reported Cause(s) of Death: upper limbs pain; chest pain; she felt bad


VAERS ID: 1283580 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-11
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9480 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021473675

Write-up: Haemorrhage intracerebral; This is a spontaneous report downloaded from the regulatory authority. number DE-DCGMA-21189504 and RA number DE-PEI-202100042016. A non-contactable physician reported that a 93-year-old male patient received bnt162b2 (COMIRNATY, lot number: ER9480), via an unspecified route of administration on an unspecified date as SINGLE DOSE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 11Apr2021, the patient experienced haemorrhage intracerebral. The patient died on 11Apr2021. It was not reported if an autopsy was performed. Causality was unclassifiable. Sender''s comment: Further information can be obtained from the Public Prosecutor''s Office after the case has been processed. No follow-up attempts needed, follow-up automatically provided regulatory authority.; Reported Cause(s) of Death: Haemorrhage intracerebral


VAERS ID: 1283581 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-14
Onset:2021-04-17
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, Cerebral haemorrhage, Cerebral venous sinus thrombosis, Computerised tomogram, Epilepsy, Fibrin D dimer, Magnetic resonance imaging, Platelet count
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Haemorrhagic central nervous system vascular conditions (narrow), Convulsions (narrow), Embolic and thrombotic events, venous (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Generalised convulsive seizures following immunisation (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-20
   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: CITALOPRAM; CANDESARTAN HCT; SIMVASTATIN; AMLODIPINE; VIANI forte
Current Illness: Arterial hypertension; Asthma bronchial
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Haemorrhage subarachnoid
Allergies:
Diagnostic Lab Data: Test Name: CCT; Result Unstructured Data: Test Result:intracerebral congestive bleeding with evidence of; Comments: intracerebral congestive bleeding with evidence of SVT; Test Date: 20210418; Test Name: Ct; Result Unstructured Data: Test Result:congestive bleeding and SVT visible; Comments: congestive bleeding and SVT visible; Test Date: 20210417; Test Name: CRP; Result Unstructured Data: Test Result:23.8 mg/l; Test Date: 20210420; Test Name: D-Dim; Result Unstructured Data: Test Result:95.9 mg/l; Test Date: 20210419; Test Name: MRI; Result Unstructured Data: Test Result:SVT confirmed, bleeding increase; Comments: SVT confirmed, bleeding increase; Test Date: 20210418; Test Name: PLT; Result Unstructured Data: Test Result:82; Comments: / nl
CDC Split Type: DEPFIZER INC2021473554

Write-up: Thrombosis of venous sinuses; Intracerebral hemorrhage; Epileptic seizure; This is a spontaneous report from a non-contactable physician downloaded from a regulatory authority-WEB [regulatory authority number:DE-PEI-202100040821]. A 85-years-old male patient received bnt162b2 (COMIRNATY, Batch/Lot Number: ER2659), via an unspecified route of administration on 14Mar2021 as single dose for COVID-19 immunization. Medical history included ongoing Arterial hypertension, ongoing Asthma bronchial, COVID-19 from 16Mar2021 to an unknown date, Haemorrhage subarachnoid from 2018 to an unknown date. Concomitant medications included citalopram; candesartan cilexetil, hydrochlorothiazide (CANDESARTAN HCT); simvastatin; amlodipine; fluticasone propionate, salmeterol xinafoate (VIANI FORTE). On 17Apr2021, the patient experienced Thrombosis of venous sinuses, Intracerebral hemorrhage, and Epileptic seizure. PLT: (18Apr2021): 82 / nl; D-Dim: 95.9 mg / L in the morning of (20Apr2021); CRP: (17Apr2021): 23.8 mg / L, CCT: intracerebral congestive bleeding with evidence of SVT (Sinus venous thrombosis), a CT done on (18Apr2021): congestive bleeding and SVT visible, on (19Apr2021) MRI done in the morning: SVT confirmed, bleeding increase until death on 20Apr2021. The patient died on 20Apr2021. It was not reported if an autopsy was performed. Causality assessment reported as D. Unclassifiable by PEI. Case Summary and Reporter''s Comments Text: PLT: (18Apr2021): 82 / nl; D-Dim: 95.9 mg / L in the morning of (20Apr2021); CRP: (17Apr2021): 23.8 mg / L, CCT: intracerebral congestive bleeding with evidence of SVT (Sinus venous thrombosis), a CT done on (18Apr2021): congestive bleeding and SVT visible, on (19Apr2021) MRI done in the morning: SVT confirmed, bleeding increase until death on 20Apr2021. No follow-up attempts are possible. No further information expected.; Reporter''s Comments: PLT: (18Apr2021): 82 / nl; D-Dim: 95.9 mg / L in the morning of (20Apr2021); CRP: (17Apr2021): 23.8 mg / L, CCT: intracerebral congestive bleeding with evidence of SVT (Sinus venous thrombosis), a CT done on (18Apr2021): congestive bleeding and SVT visible, on (19Apr2021) MRI done in the morning: SVT confirmed, bleeding increase until death on 20Apr2021.; Reported Cause(s) of Death: Thrombosis of venous sinuses; Intracerebral hemorrhage; Epileptic seizure


VAERS ID: 1283583 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-14
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021463092

Write-up: Death; This is a spontaneous report from a non-contactable healthcare professional (HCP) downloaded from the regulatory authority-WEB DE-PEI-202100040908. An 87-year-old female patient received bnt162b2 (COMIRNATY, solution for injection), first dose on an unspecified date (Batch/Lot number was not reported) and second dose on 20Feb2021 (Batch/Lot number was not reported); both via an unspecified route of administration (at the age of 87-years-old) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 14Mar2021, the patient experienced death. The report was considered serious by the HCP due to death. The patient died of an unknown cause. It was unknown if autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Death


VAERS ID: 1283584 (history)  
Form: Version 2.0  
Age: 100.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-19
   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: NOVAMINSULFON
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021463076

Write-up: sudden death; Severe tiredness 2 days after vaccination; This is a spontaneous report from a non-contactable other healthcare professional downloaded from the regulatory authority-WEB, regulatory authority report number DE-PEI-202100041844. This other healthcare professional reported different events for both doses of Comirnaty for the same patient. This is the first of two reports. A 100-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration (at the age of 100-years-old) on 15Apr2021 (Batch/Lot Number: Unknown) as single dose for COVID-19 immunization. The patient medical history was not reported. The patient''s weight was not reported, and height was not reported. Concomitant medication included novaminsulfon taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (COMIRNATY) dose 1 via an unspecified route of administration on 18Mar2021 (Batch/Lot Number: Unknown, strength: 0.3 ml) as single dose for COVID-19 immunization and experienced Thrombopenia. The patient experienced sudden death on 19Apr2021, and severe tiredness 2 days after vaccination on 17Apr2021. The outcome of the event severe tiredness was unknown. The patient died on 19Apr2021. It was not reported if an autopsy was performed. This report is serious - death. "English summary (full translation available upon request)". Sender Comment: after the 1st vaccination in Blood count Thrombopenia 126000 on 13Apr2021 The causality assessment for suspect drug Comirnaty to all events was reported as follows: Source of assessment PEI Result of Assessment D. Unclassifiable No follow-up attempts are possible, information on lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1283585 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-08
Onset:2021-01-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular disorder
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: 2021-01-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Adrenal insufficiency; Arterial hypertension; Coronary heart disease; Dementia; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Apoplexy; Deep vein thrombosis leg; Lung embolism
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021473669

Write-up: Cerebral vascular disturbance; This is a Spontaneous report downloaded from the regulatory authority-WEB regulatory authority number DE-PEI-202100042982. This spontaneous report was received from a Lawyer reported that a 71-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 08Jan2021 (Batch/Lot Number: EJ6796) as single dose for covid-19 immunisation. Medical history included arterial hypertension, type 2 diabetes mellitus, apoplexy, adrenal insufficiency, dementia, coronary heart disease, lung embolism and deep vein thrombosis leg. The patient''s concomitant medications were not reported. On 09Jan2021 the patient experienced Cerebral vascular disturbance. The patient died on 09Jan2021. An autopsy was performed and results were not provided. The outcome of the event was fatal. No follow-up attempts needed, follow-up automatically provided by EMA.; Reported Cause(s) of Death: Cerebral vascular disturbance


VAERS ID: 1283586 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-16
Onset:2021-04-04
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Stroke
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021474556

Write-up: Cerebral haemorrhage; died, 19 days after vaccination; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Regulatory Authority. An 80-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection, strength: 0.3 mL), first dose via an unspecified route of administration on 16Mar2021 (lot number was unknown) as 0.3 mL, single dose for COVID-19 immunisation and prophylactic vaccination. Medical history included stroke from 2017 and ongoing. Concomitant medications were not reported. The patient experienced cerebral haemorrhage and died, 19 days after vaccination on 04Apr2021. The patient experienced unknown cause of death. An autopsy was not performed. Causality assessment reported as D. Unclassifiable. Sender Comment: "Information on risk factors or pre-existing disease Stroke 2017 / Sudden collapse, severe cerebral haemorrhage, died 7 hours later." 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: 1283587 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-20
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-09
   Days after onset: 20
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 INC2021478249

Write-up: Death; Dyspnoea; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority. regulatory authority number DE-PEI-CADR2021053412. An 83-year-old male patient received BNT162B2 (COMIRNATY, Batch/Lot Number: ER7812), via an unspecified route of administration on 17Mar2021 as single dose for covid-19 immunization. Medical history and concomitant medications were not reported. The patient experienced dyspnoea on 20Mar2021. The outcome of the event dyspnoea was not recovered. The patient died on 09Apr2021. The cause of death was not reported. It was not reported if an autopsy was performed. Sender Comment: Do you or the person concerned have any known allergies? If yes, which ones? No Information on risk factors or previous illnesses: none / hospitalization, death Event assessment: Comirnaty for both events was assessed by the reporter as unclassifiable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1283602 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DACORTIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Polymyalgia
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021473491

Write-up: Cardio-respiratory arrest; Aortic dissection; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority-WEB, regulatory authority number ES-AEMPS-830520. A 74-year-old female patient received bnt162b2 (COMIRNATY), first dose at the age of 74-years-old via an unspecified route of administration on 15Apr2021 (Batch/Lot Number: EW4815; Expiration Date: 31Jul2021) as single dose for covid-19 immunisation. Medical history included polymyalgia from an unknown date and unknown if ongoing. Concomitant medication included prednisone (DACORTIN) taken for polymyalgia from 09Apr2021 to an unspecified stop date. The patient experienced cardio-respiratory arrest on 15Apr2021. The patient was vaccinated on 15Apr2021 and she died on the same day. A judicial autopsy is carried out and the family members inform the notifier that the reason for death is an acute process, with hemopericardium, being an aortic dissection not related to the administration of the vaccine. The patient died on 15Apr2021 due to the events. An autopsy was performed that revealed aortic dissection. The outcome of the events was fatal. Case Summary and Reporter Comments Text: Reasons for vaccination of the patient: Over 65 years old 74-year-old woman vaccinated with Comirnaty on 15Apr2021, she died the same day. A judicial autopsy is carried out and the family members inform the notifier that the reason for death is an acute process, with hemopericardium, being an aortic dissection not related to the administration of the vaccine. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Reasons for vaccination of the patient: Over 65 years old 74-year-old woman vaccinated with Comirnaty on 15Apr2021, she died the same day. A judicial autopsy is carried out and the family members inform the notifier that the reason for death is an acute process, with hemopericardium, being an aortic dissection not related to the administration of the vaccine.; Sender''s Comments: The fatal aortic dissection was unrelated to bnt162b2. This was an intercurrent medical condition. Case will be reassessed if additional information is received; Reported Cause(s) of Death: cardio-respiratory arrest; Autopsy-determined Cause(s) of Death: Aortic dissection


VAERS ID: 1283603 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-22
Onset:2021-03-11
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal exploration, Activated partial thromboplastin time, Anion gap, Auscultation, Base excess, Basophil count, Bilirubin urine, Blood bicarbonate, Blood bilirubin, Blood chloride, Blood creatinine, Blood fibrinogen, Blood glucose, Blood lactic acid, Blood methaemoglobin, Blood potassium, Blood pressure measurement, Blood sodium, Blood urea, Blood urine, Body temperature, Calcium ionised, Carboxyhaemoglobin, Computerised tomogram, Electrocardiogram, Eosinophil count, Glomerular filtration rate, Glucose urine, Haematocrit, Haemoglobin, Heart rate, International normalised ratio, Investigation, Lymphocyte count, Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean cell volume, Mean platelet volume, Mesenteric artery thrombosis, Monocyte count, Neutrophil count, Nitrite urine, Oxygen saturation, PCO2, PO2, Physical examination, Platelet count, Protein C, Protein urine, Prothrombin time, Prothrombin time ratio, Rectal examination, Red blood cell count, Red blood cell sedimentation rate increased, Red cell distribution width increased, Specific gravity urine, Urine ketone body, Urobilinogen urine, White blood cell count, White blood cells urine, X-ray, pH body fluid, pH urine
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Embolic and thrombotic events, arterial (narrow), Ischaemic colitis (broad), Proteinuria (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-26
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: FUROSEMIDA [FUROSEMIDE]; GELOCATIL; ADIRO; OMEPRAZOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic sclerosis; Chronic renal failure; Cognitive deterioration; Fibrillation atrial; Hypertension arterial; Ischemic stroke; Left atrial dilatation; Mitral insufficiency; Tricuspid insufficiency
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: Abdominal exploration; Result Unstructured Data: Test Result:distended, soft, depressible; Comments: Several skin lesions compatible with seborrhoeic keratosis.Dull percussion. No pain on palpation. No defence. Murphy- Blumberg- Rovsing- Peristalsis positive no murmur; Test Date: 202103; Test Name: aPTT ratio; Result Unstructured Data: Test Result:0.73; Test Date: 202103; Test Name: aPTTm; Test Result: 23.2 s; Test Date: 202103; Test Name: Anion gap; Result Unstructured Data: Test Result:11.2 mmol/L; Test Date: 202103; Test Name: Cardiac auscultation; Result Unstructured Data: Test Result:RsCsRs without murmurs or friction rubs; Comments: No carotid murmurs; Test Date: 202103; Test Name: Pulmonary auscultation; Result Unstructured Data: Test Result:Global decrease in vesicular murmur; Test Date: 202103; Test Name: real base excess; Result Unstructured Data: Test Result:2.6 mmol/L; Test Date: 202103; Test Name: Basophils; Result Unstructured Data: Test Result:0.03 /mm3; Test Date: 202103; Test Name: Basophils; Test Result: 0.3 %; Test Date: 202103; Test Name: Urine bilirubin; Test Result: Negative ; Test Date: 202103; Test Name: bicarbonate; Result Unstructured Data: Test Result:28.6 mmol/L; Test Date: 202103; Test Name: bicarbonate; Result Unstructured Data: Test Result:24.9 mmol/L; Test Date: 202103; Test Name: total co2 concentration; Result Unstructured Data: Test Result:26.2 mmol/L; Test Date: 202103; Test Name: Bilirubin; Test Result: 0.5 mg/dl; Test Date: 202103; Test Name: Chloride; Result Unstructured Data: Test Result:103 mmol/L; Test Date: 202103; Test Name: Creatinine; Test Result: 1.17 mg/dl; Test Date: 202103; Test Name: Fibrinogeno; Test Result: 462 mg/dl; Test Date: 202103; Test Name: Glucose; Test Result: 151 mg/dl; Test Date: 202103; Test Name: Glucose; Test Result: 157 mg/dl; Test Date: 202103; Test Name: L-lactate; Result Unstructured Data: Test Result:2.0 mmol/L; Test Date: 202103; Test Name: Methemoglobin fraction; Test Result: 0.3 %; Test Date: 202103; Test Name: Potassium; Result Unstructured Data: Test Result:4.2 mmol/L; Test Date: 202103; Test Name: Potassium; Result Unstructured Data: Test Result:4.0 mEq/l; Test Date: 202103; Test Name: Blood pressure; Result Unstructured Data: Test Result:150/70 mmHg; Test Date: 202103; Test Name: Sodium; Result Unstructured Data: Test Result:143 mmol/L; Test Date: 202103; Test Name: Sodium; Result Unstructured Data: Test Result:138 mEq/l; Test Date: 202103; Test Name: Urea; Test Result: 52 mg/dl; Test Date: 202103; Test Name: Urine blood; Test Result: Positive ; Test Date: 202103; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Test Date: 202103; Test Name: Calcium ionium; Test Result: 4.57 mg/dl; Test Date: 202103; Test Name: Carboxyhaemoglobin fraction; Test Result: 1.3 %; Test Date: 20210311; Test Name: CT scan; Result Unstructured Data: Test Result:Thromboembolism of the superior mesenteric artery; Comments: with signs of intestinal distress in ileal loops; Test Date: 202103; Test Name: ECG; Result Unstructured Data: Test Result:Atrial fibrillation; Comments: at 70 bpm Axis deviated to the left at -45 to - 60 PR not assessable. Wide QRS, right bundle branch block. No other depolarisation alterations; Test Date: 202103; Test Name: Eosinophils; Result Unstructured Data: Test Result:0.0 /mm3; Test Date: 202103; Test Name: Eosinophils; Test Result: 0.0 %; Test Date: 202103; Test Name: Glomerular filtrate; Result Unstructured Data: Test Result:51; Comments: mL/min/1.73 m 2; Test Date: 202103; Test Name: Glucose; Test Result: Negative ; Test Date: 202103; Test Name: Hematocrit; Test Result: 43.9 %; Test Date: 202103; Test Name: Hemoglobin; Result Unstructured Data: Test Result:14.1 g/dl; Test Date: 202103; Test Name: Hemoglobin concentration; Result Unstructured Data: Test Result:14.5 g/dl; Test Date: 202103; Test Name: Heart rate; Result Unstructured Data: Test Result:82; Comments: beats per minute; Test Date: 202103; Test Name: INR; Result Unstructured Data: Test Result:1.22; Test Date: 202103; Test Name: Complementary tests; Result Unstructured Data: Test Result:no alarming signs or pathology; Test Date: 202103; Test Name: Lymphocytes; Result Unstructured Data: Test Result:0.56 /mm3; Test Date: 202103; Test Name: Lymphocytes; Test Result: 4.8 %; Test Date: 202103; Test Name: MCH; Test Result: 31.0 pg; Test Date: 202103; Test Name: MCHC; Result Unstructured Data: Test Result:32.1 g/dl; Test Date: 202103; Test Name: MCV; Result Unstructured Data: Test Result:96.5; Comments: fl; Test Date: 202103; Test Name: MPV; Result Unstructured Data: Test Result:8.6; Comments: fl; Test Date: 202103; Test Name: Monocytes; Result Unstructured Data: Test Result:0.46 /mm3; Test Date: 202103; Test Name: Monocytes; Test Result: 3.9 %; Test Date: 202103; Test Name: Neutrophils; Result Unstructured Data: Test Result:10.66 /mm3; Test Date: 202103; Test Name: Neutrophils; Test Result: 91.0 %; Test Date: 202103; Test Name: Nitrites; Test Result: Negative ; Test Date: 202103; Test Name: O2 saturation; Test Result: 96 %; Test Date: 202103; Test Name: O2 SATURATION; Test Result: 25.1 %; Test Date: 202103; Test Name: pCO2; Result Unstructured Data: Test Result:48.5 mmHg; Test Date: 202103; Test Name: pH; Result Unstructured Data: Test Result:7.379; Test Date: 202103; Test Name: pH; Result Unstructured Data: Test Result:6.0; Test Date: 202103; Test Name: Physical examination; Result Unstructured Data: Test Result:good general condition; Comments: Orientation in space and person, but not in time. No language alterations. Eupneic at rest. Normal colour, normohydrated and normoperfused; Test Date: 202103; Test Name: Physical examination; Result Unstructured Data: Test Result:bilateral malleolar oedema in calf and feet; Comments: slightly more marked on the right. No signs of DVT or superficial thrombophlebitis. Mobility preserved. Pedial pulses present; Test Date: 202103; Test Name: Platelets; Result Unstructured Data: Test Result:220.0; Test Date: 202103; Test Name: pO2; Result Unstructured Data: Test Result:16.9 mmHg; Test Date: 202103; Test Name: Reactive protein C; Test Result: 6.8 mg/dl; Test Date: 202103; Test Name: Protein; Test Result: Positive ; Test Date: 202103; Test Name: quick time; Result Unstructured Data: Test Result:13.6; Comments: m; Test Date: 202103; Test Name: Prothrombonin rate; Test Result: 73 %; Test Date: 202103; Test Name: Rectal examination; Result Unstructured Data: Test Result:No masses or megaliths palpable; Comments: Normal tone. No visualisation or palpation of haemorrhoids. Prostate, grade II/IV petrosal, not mobile or painful on palpation. Empty ampulla with scanty remains of faeces, no melena. melena.; Test Date: 202103; Test Name: erythrocytes; Result Unstructured Data: Test Result:4.55; Test Date: 202103; Test Name: Sediment; Result Unstructured Data: Test Result:10-20; Comments: haematies/field; Test Date: 202103; Test Name: RDW; Test Result: 13.6 %; Test Date: 202103; Test Name: Density; Result Unstructured Data: Test Result:1.030; Test Date: 202103; Test Name: Ketone bodies; Test Result: Positive ; Test Date: 202103; Test Name: Urobilinogen; Test Result: Negative ; Test Date: 202103; Test Name: Leukocytes; Result Unstructured Data: Test Result:11.71; Test Date: 202103; Test Name: Leucocytes urine; Test Result: Negative ; Test Date: 202103; Test Name: Abdomen RX; Result Unstructured Data: Test Result:Non-specific gaseous pattern.; Comments: No signs of osbtruction.; Test Date: 202103; Test Name: Thoracic X-ray anteroposterior and lateral views; Result Unstructured Data: Test Result:Increased density of the right lung base; Comments: with right costophrenic sinus impingement in relation to a certain amount of pleural effusion, already present in the previous study
CDC Split Type: ESPFIZER INC2021463100

Write-up: Thrombosis mesenteric artery; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (EMA) -WEB. Regulatory authority number is ES-AEMPS-835426. A 98--old male patient received bnt162b2 (Pfizer vaccine; Lot Number: EP9598), intramuscularly on 22Feb2021 at a single dose for covid-19 immunisation. Medical history included ischemic stroke from Dec2020 to an unknown date, tricuspid insufficiency, mitral insufficiency, aortic sclerosis, chronic renal failure, left atrial dilatation, cognitive deterioration, fibrillation atrial, and hypertension atrial. Concomitant medications included furosemida [furosemide] (FUROSEMIDA [FUROSEMIDE]); paracetamol (GELOCATIL); acetylsalicylic acid (ADIRO); omeprazole (OMEPRAZOL). The patient previously received amoxicillin/clavulanic acid (AUGMENTINE) and experienced diarrhoea. On 11Mar2021, the patient experienced thrombosis mesenteric artery, which was serious for death. The clinical course was as follows: the patient was referred to the emergency department after telephone assessment by 112 for bloody stools and abdominal pain. He talked to one of the daughters on the phone: at midday, he had generalised abdominal pain with vomiting and oral intolerance. Therapeutic measures were taken as a result of thrombosis mesenteric artery. Treatment recommendations included: bland diet and abundant hydration; watch for alarm symptoms to be consulted again (uncontrollable vomiting, uncontrollable pain or fever). After an initial telephone contact, it was recommended to monitor the symptoms and to take a paracetamol (1g/8h if needed for pain). The patient continued with the same symptoms and at around 18:00 he started to have liquid stools and the daughters observed red blood mixed with the stools, which was the reason for which he attended the clinic. He denied fever, cough, increased baseline dyspnoea, urinary discomfort. Not known covid contact. Previous days, he was asymptomatic, did not relate it to any trigger. On speaking to the patient, he denied any clinical manifestations and reported not knowing the reason for which he was in the emergency department. Lab data in Mar2021 included T: 36.5 degrees Centigrade; BP: 150/70 mmHg; HR: 82 bpm; O2 saturation: 96%. Physical examination included: good general condition. Orientation in space and person, but not in time. No language alterations. Eupneic at rest. Normal colour, normohydrated and normoperfused. Cardiac auscultation: Rhythmic cardiac sounds without murmurs or friction rubs. No carotid murmurs. Pulmonary auscultation: Global decrease in vesicular murmur. Abdominal exploration: distended, soft, depressible. Several skin lesions compatible with seborrhoeic keratosis. Dull percussion. No pain on palpation. No defence. Murphy- Blumberg- Rovsing- Peristalsis positive no murmur. Rectal examination: no masses or megaliths palpable. Normal tone. No visualisation or palpation of haemorrhoids. Prostate, grade II/IV petrea, not mobile or painful on palpation. Empty ampulla with scanty remains of faeces, no melena. Lower limbs: bilateral malleolar oedema in the calf and feet, slightly more marked on the right. No signs of DVT or superficial thrombophlebitis. Mobility preserved. Pedial pulses present. Main diagnosis was general malaise with no alarm signs. The patient remained clinically and haemodynamically stable at the present time. Complementary tests showed no alarming signs or pathology at the present time and discharge home was decided. Other recommendations included: control and review by your primary care physician (and of the results of the PCR performed). In case of worsening, return to the Emergency Department. Blood count: erythrocytes 4.55 (normal range 4.00 - 6.00); hemoglobin 14.1 g/dl (normal range 13.0 - 17.0 g/dl); hematocrit 43.9% (normal range 39.0 - 51.0%); MCV 96.5 fl (normal range 80.0 - 100.0 fl); MCH 31.0 pg (normal range 26.0 - 32.0 pg); MCHC 32.1 g/dl (normal range 32.0 - 37.0 g/dl); RDW 13.6 % (normal range 10.0 - 18.0 %); platelets 220.0 (normal range 150.0 - 450.0); MPV 8.6 fl (normal range 6.0 - 15.0 fl). Blood leucocytes: leukocytes 11.71 (normal range 3.70 - 11.00 ); neutrophils 91.0 % (normal range 40.0 - 80.0%); neutrophiles 10.66/mm3 (normal range 1.80 - 9.80/mm3); lymphocytes 4.8% (normal range 15.0 - 50.0%); lymphocytes 0.56/mm3 (normal range 0.50 - 4.80/mm3); monocytes 3.9 % (normal range 2.0 - 12.0%); monocytes 0.46/mm3 (normal range 0.80/mm3); eosinophils 0.0 % (normal range less than 7.0%); eosinophiles 0.00/mm3 (normal range less than 0.60/mm3); basophils 0.3% (normal range 1.8%); basophiles 0.03/mm3 (normal range 0.20/mm3). Basic coagulation: prothrombin rate 73 %; quick time 13.6m; INR 1.22 (normal range 0.60 - 1.20); fibrinogen 462 mg/dl (normal range 150 - 550mg/dl). APTT: aPTTm 23.2 seconds; aPTT RATIO 0.73 (normal range 0.70 - 1.35). Biochemistry: glucose 151 mg/dl (normal range 65 - 100mg/dl); urea 52 mg/dl (normal range 10 - 60mg/dl): creatinine 1.17 mg/dl (normal range 0.70 - 1.40 mg/dl): glomerular filtrate (ckd - epi) 51 ml/min/1.73 m 2 (les than 60 ml/min/1.73 m 2); sodium 138 meq/l (normal range 136 - 145 meq/l); potassium 4.0 meq/l (normal range 3.5 - 5.0 meq/l); reactive protein c (pcr) 6.8 mg/l (less than 5.0mg/l). Elemental and sediment: density 1.030; ph 6.0; protein positive; glucose negative; ketone bodies positive; urine bilirubin negative; urine blood positive; nitrites negative; urobilinogen negative; leucocytes urine negative; sediment : 10 - 20 haematites/field. Vein Gases: pH 7.379 (normal range 7.350 - 7.450); pCO2 48.5mmHg (normal range 35.0 - 48.0mmHg); pO2 16.9mmHg (normal range 83.0 - 108.0mmHg). Oximetry values: oxygen saturation 25.1 % ; hemoglobin concentration 14.5 g/dl (normal range 12.0 - 17.0g/dl): carboxyhaemoglobin fraction 1.3 % (less than 1.5%): methemoglobin fraction 0.3 % (less than 1.5%). Acid-base status: bicarbonate 28.6 mmol/l (normal range 22.0 - 26.0 mmol/l); standard bicarbonate 24.9 mmol/l (normal range 22.0 - 26.0mmol/l); real base excess 2.6 mmol/l (normal range -3.0 - 3.0 mmol/l); total co2 concentration 26.2 mmol/l (normal range 19.0 - 24.0 mmol/l). Electrolyte values: sodium 143 mmol/l (normal range 135 - 145 mmol/l); potassium 4.2 mmol/l (normal range 3.5 - 5.0 mmol/l); chloride 103 mmol/l (normal range 98 - 106 mmol/l); calcium ionium 4.57 mg/dl (normal range 4.61 - 5.17 mg/dl); anion gap 11.2 mmol/l (normal range 8.0 - 16.0 mmol/l). Metabolite values: glucose 157 mg/dl (normal range 65 - 110 mg/dl); l-lactate 2.0 mmol/l (normal range 0.5 - 1.6 mmol/l); bilirubin 0.5 mg/dl. Thoracic x-ray anteroposterior and lateral views: increased density of the right lung base with right costophrenic sinus impingement in relation to a certain amount of pleural effusion, already present in the previous study. Abdomen RX: non-specific gaseous pattern. no signs of osbtruction. ECG: atrial fibrillation at 70 bpm Axis deviated to the left at -45 to -60 PR not assessable. Wide QRS, right bundle branch block. No other depolarisation alterations. On 11Mar2021, CT scan: thromboembolism of the superior mesenteric artery with signs of intestinal distress in ileal loops. Urgent surgical intervention: thrombectomy and intestinal loop resection. The patient died on 26Mar2021 due to thrombosis mesenteric artery. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Thrombosis mesenteric artery


VAERS ID: 1283605 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-14
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 1 LA / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dyslipidaemia; Ex-smoker (2-3 packs / day ex-smoker (IPA100).); Flutter atrial (flutter with a high degree of blockage, cardiogenic edema, permanent pacemaker implantation.); Heavy drinker (previously daily consumption of 1 liter of wine and 1 liter of beer); Hypertension arterial; Ischaemic stroke; Lymph node dissection; Pacemaker insertion (cardiac); Respiratory therapy; Rosacea (with ocular involvement and rhinophyma.); Tumor resection (+ lymph node dissection + RT(respiratory therapist))
Allergies:
Diagnostic Lab Data: Test Date: 20210414; Test Name: EKG; Result Unstructured Data: Test Result:flat
CDC Split Type: ESPFIZER INC2021473595

Write-up: Sudden death; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB ES-AEMPS-836548. A 76-years-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration, administered in Arm Left on 06Apr2021 (Batch/Lot Number: EW2246) as single dose for covid-19 immunisation, at 76 years old. Medical history included atrial flutter from 2019 (flutter with a high degree of blockage, cardiogenic edema, permanent pacemaker implantation); ischaemic stroke from Nov2018, dyslipidaemia from an unknown date, Hypertension arterial from an unknown, rosacea from an unknown date (with ocular involvement and rhinophyma), submaxillary tumor operated from 2000, + lymph node dissection + RT(respiratory therapist), lymph node dissection from 2000, respiratory therapy from 2000, ex-drinker from unspecified date to Aug2020 (previously daily consumption of 1 liter of wine and 1 liter of beer); ex-smoker from an unspecified date, 2-3 packs / day ex-smoker (IPA100). The patient''s concomitant medications were not reported. The patient previously took adiro, omeprazol, and atorvastatin from an unspecified date. The patient experienced sudden death on 14Apr2021, 10:00. Clinical course was as follows: Exitus was at 10:00. It was warned because they have found the patient lying on the ground. Last seen at 09:15. Cold patient with mydriatic pupils, dry mucosa, does not respond, does not breathe, there is no pulse. EKG(electrocardiogram) was flat. He had been vaccinated a week ago with COMIRNATY. He was ok. The patient died on 14Apr2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. Information about batch number has been obtained.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1283607 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-04-12
   Days after vaccination:59
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2243 / 2 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-12
   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: QUETIAPINE; DEPRAX [FLUOXETINE HYDROCHLORIDE]; SINEMET PLUS; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adenocarcinoma; COVID-19 (COVID19 PCR+, with very mild respiratory symptoms for which he received bronchodilator treatment); Dementia with Lewy bodies (moderate dementia due to Lewy bodies associated with advanced Parkinson disease); General physical condition decreased; Parkinson''s disease (moderate dementia due to Lewy bodies associated with advanced Parkinson disease); Urinary incontinence
Allergies:
Diagnostic Lab Data: Test Date: 20200409; Test Name: COVID-19 PCR test; Test Result: Positive ; Test Date: 20210428; Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: ESPFIZER INC2021473498

Write-up: Death sudden; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number ES-AEMPS-838783. A 74-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unknown route of administration on 11Apr2021 (Lot Number: EW2243) as 0.3 mL, single for COVID-19 immunisation; paliperidone (INVEGA, strength: 3 mg), oral from 12Feb2021 (Lot Number: Unknown) to an unspecified date, at 3 mg, once a day for an unspecified indication. Medical history included moderate dementia due to Lewy bodies associated with advanced Parkinson''s disease, prostate adenocarcinoma and urinary incontinence. On 09Apr2020 COVID19 PCR+, with very mild respiratory symptoms for which he received bronchodilator treatment. Dependent for the basic activities of daily life with functional decline since February 2021. The patient was previously vaccinated with the first dose of bnt162b2 (Lot number: ET3620) intramuscular on an unspecified date for COVID-19 immunisation. Concomitant medications included quetiapine from 12Feb2021 to an unspecified stop date; fluoxetine hydrochloride (DEPRAX, 100 mg); carbidopa monohydrate, levodopa (SINEMET PLUS, 25 mg/100 mg); and paracetamol. On 12Apr2021, he returns home after notice of sudden death, less than 24 hours after receiving the second dose of Comirnaty. Upon arrival he does not respond, was not breathing and was declared deceased. The patient underwent lab tests and procedures which included COVID-19 PCR test: negative on 28Apr2021. The action taken in response to the event for paliperidone was permanently withdrawn on an unspecified date. The patient died on 12Apr2021. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected. Information about batch number already obtained.; Reported Cause(s) of Death: Death sudden


VAERS ID: 1283608 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4811 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021473598

Write-up: Sudden death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number ES-AEMPS-840176. A 74-year-old male patient received bnt162b2 (COMIRNATY) (at 74 years of age), dose 2 intramuscular on 14Apr2021 (Batch/Lot Number: EW4811) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included COMIRNATY, dose 1 via intramuscular route on 24Mar2021 (lot number: ET3674) for COVID-19 immunisation. It was reported that the 74 year-old male patient that suffered sudden death 48 hours after the second dose of COMIRNATY. The patient died on 16Apr2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. Information about batch number already obtained.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1283609 (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: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Acute respiratory failure, Alanine aminotransferase, Angiogram, Aspartate aminotransferase, Blood albumin, Blood alkaline phosphatase, Blood bicarbonate, Blood calcium, Blood creatinine, Blood folate, Blood glucose, Blood lactate dehydrogenase, Blood potassium, Blood sodium, Brain natriuretic peptide, C-reactive protein, Echocardiogram, Fibrin D dimer, Gamma-glutamyltransferase, Haemoglobin, Mean cell volume, Neutrophil count, Oxygen saturation, PCO2, PO2, Platelet count, Prothrombin level, Pulmonary embolism, SARS-CoV-2 test, Serum ferritin, Transferrin saturation, Troponin T, Vitamin B12, White blood cell count, pH body fluid
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), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (narrow), Hypersensitivity (broad), Respiratory failure (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-14
   Days after onset: 41
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: OMEPRAZOLE; EUTIROX; TARDYFERON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Arthropathy; Fall; Hypothyroidism; Iron deficiency anemia; Unsteadiness; Weakness
Allergies:
Diagnostic Lab Data: Test Date: 20210222; Test Name: APTT; Test Result: 26 s; Test Date: 20210222; Test Name: ALT; Result Unstructured Data: Test Result:7 IU/l; Test Date: 2021; Test Name: CT angiography; Result Unstructured Data: Test Result:Pulmonary thromboembolism; Test Date: 20210222; Test Name: AST; Result Unstructured Data: Test Result:19 IU/l; Test Date: 20210222; Test Name: albumin; Result Unstructured Data: Test Result:38 g/l; Test Date: 20210222; Test Name: ALP; Result Unstructured Data: Test Result:74 IU/l; Test Date: 20210222; Test Name: bicarbonate; Result Unstructured Data: Test Result:23 mmol/L; Test Date: 20210222; Test Name: Ca; Test Result: 8.9 mg/dl; Test Date: 20210222; Test Name: Creatinine; Test Result: 0.85 mg/dl; Test Date: 20210223; Test Name: Creatinine; Test Result: 1.12 mg/dl; Test Date: 20210303; Test Name: Creatinine; Test Result: 0.78 mg/dl; Test Date: 20210223; Test Name: folic; Result Unstructured Data: Test Result:5.24 ng/ml; Test Date: 20210222; Test Name: glycemia; Test Result: 124 mg/dl; Test Date: 20210222; Test Name: LDH; Result Unstructured Data: Test Result:281 IU/l; Test Date: 20210222; Test Name: K; Result Unstructured Data: Test Result:5 mmol/L; Test Date: 20210223; Test Name: K; Result Unstructured Data: Test Result:4 mmol/L; Test Date: 20210303; Test Name: K; Result Unstructured Data: Test Result:3.4 mmol/L; Test Date: 20210222; Test Name: Na; Result Unstructured Data: Test Result:140 mmol/L; Test Date: 20210223; Test Name: Na; Result Unstructured Data: Test Result:147 mmol/L; Test Date: 20210303; Test Name: Na; Result Unstructured Data: Test Result:148 mmol/L; Test Date: 20210222; Test Name: proBNP; Result Unstructured Data: Test Result:21813 pg/mL; Test Date: 20210223; Test Name: proBNP; Result Unstructured Data: Test Result:33825 pg/mL; Test Date: 20210303; Test Name: proBNP; Result Unstructured Data: Test Result:11381 pg/mL; Test Date: 20210222; Test Name: CRP; Result Unstructured Data: Test Result:2.7 mg/l; Test Date: 2021; Test Name: Echodoppler of lower limbs; Result Unstructured Data: Test Result:Deep venous thrombosis ruled out; Test Date: 20210222; Test Name: D-dimer; Result Unstructured Data: Test Result:1043 ug/L; Test Date: 20210303; Test Name: D-dimer; Result Unstructured Data: Test Result:612 ug/L; Test Date: 20210222; Test Name: GGT; Result Unstructured Data: Test Result:29 IU/l; Test Date: 20210222; Test Name: Hemoglobin; Result Unstructured Data: Test Result:10.3 g/dl; Test Date: 20210223; Test Name: Hemoglobin; Result Unstructured Data: Test Result:10.6 g/dl; Test Date: 20210303; Test Name: Hemoglobin; Result Unstructured Data: Test Result:10.4 g/dl; Test Date: 20210222; Test Name: MCV; Result Unstructured Data: Test Result:91; Comments: fL; Test Date: 20210223; Test Name: MCV; Result Unstructured Data: Test Result:93; Comments: fL; Test Date: 20210303; Test Name: MCV; Result Unstructured Data: Test Result:93; Comments: fL; Test Date: 20210222; Test Name: Neutrophils; Test Result: 82 %; Test Date: 20210223; Test Name: Neutrophils; Test Result: 68 %; Test Date: 2021; Test Name: SaO2; Test Result: 88 %; Test Date: 20210222; Test Name: pCO2; Result Unstructured Data: Test Result:47 mmHg; Test Date: 20210222; Test Name: pH; Result Unstructured Data: Test Result:7.32; Test Date: 20210222; Test Name: Platelet; Result Unstructured Data: Test Result:355000; Comments: /uL; Test Date: 20210223; Test Name: Platelet; Result Unstructured Data: Test Result:433000; Comments: /ul; Test Date: 20210303; Test Name: Platelet; Result Unstructured Data: Test Result:349000; Comments: /ul; Test Date: 20210222; Test Name: pO2; Result Unstructured Data: Test Result:56 mmHg; Test Date: 20210222; Test Name: Prothrombin; Test Result: 68 %; Test Date: 20210127; Test Name: SARS-COV-2 PCR; Test Result: Negative ; Test Date: 20210222; Test Name: SARS-COV-2 PCR; Test Result: Negative ; Test Date: 20210304; Test Name: SARS-COV-2 PCR; Test Result: Negative ; Test Date: 20210222; Test Name: ferritin; Result Unstructured Data: Test Result:69 ng/dL; Test Date: 20210223; Test Name: ferritin; Result Unstructured Data: Test Result:62 ng/dL; Test Date: 20210223; Test Name: transferrin saturation; Test Result: 4.5 %; Test Date: 20210223; Test Name: Troponin T; Result Unstructured Data: Test Result:116 ng/L; Test Date: 20210303; Test Name: Troponin T; Result Unstructured Data: Test Result:64 ng/L; Test Date: 20210223; Test Name: vit b12; Result Unstructured Data: Test Result:759 pg/ml; Test Date: 20210222; Test Name: Leukocyte; Result Unstructured Data: Test Result:11900; Comments: /uL; Test Date: 20210223; Test Name: Leukocyte; Result Unstructured Data: Test Result:9500; Comments: /ul; Test Date: 20210303; Test Name: Leukocyte; Result Unstructured Data: Test Result:8200; Comments: /ul
CDC Split Type: ESPFIZER INC2021473601

Write-up: Pulmonary embolism; acute respiratory failure; This is a spontaneous report from a contactable healthcare professional downloaded from the regulatory authority-WEB ES-AEMPS-840533. A 98-year-old female patient received first dose of bnt162b2 (COMIRNATY), intramuscular on 01Feb2021 (Lot Number: EK9788) at 0.3 mL, single; and second dose via an unspecified route of administration on 12Mar2021 (Lot Number: ET1831) at a single dose for covid-19 immunisation. Medical history included arterial hypertension, hypothyroidism, iron deficiency anaemia, degenerative arthropathy with frequent falls due to instability and weakness. The patient had no drug allergies or toxic habits. Concomitant medications included omeprazole; levothyroxine sodium (EUTIROX) for hypothyroidism; ferrous sulfate (TARDYFERON) for iron deficiency anemia. The patient experienced pulmonary embolism on 22Feb2021. The patient also experienced acute respiratory failure on an unspecified date in Feb2021. The patient was hospitalized for the events from 22Feb2021 to 04Mar2021. Pulmonary thromboembolism confirmed by CT angiography (2021). Deep venous thrombosis ruled out by Echodoppler of lower limbs. Analytics (22Feb2021): hemoglobin (Hb) 10.3 g/dL; mean corpuscular volume (MCV) 91 fL; Platelets: 355000/uL; Leukocytes: 11900/uL (Neutrophils 82%); Prothrombin 68%; activated partial thromboplastin time (APTT) 26 seconds (sec); D-dimer 1043 ug/L; glycemia 124 mg/dl; Creatinine 0.85 mg/dL; sodium (Na) 140 mmol/L; potassium (K) 5 mmol/L; calcium (Ca) 8.9 mg/dl; aspartate aminotransferase (AST) 19 U/L; alanine aminotransferase (ALT) 7 U/L; Gamma-glutamyl transferase (GGT) 29 U/ L; alkaline phosphatase (ALP) 74 U/L; Lactate dehydrogenase (LDH) 281 U/L; albumin 38 G/L; ferritin 69 ng/dl; proBNP 21813 pg/ml; c-reactive protein (CRP) 2.7 mg/L - Arterial blood gas: pH 7.32; Partial pressure of carbon dioxide (pCO2) 47 mmHg; Partial pressure of oxygen (pO2) 56 mmHg; bicarbonate 23 mmol/L - SARS-COV-2 PCR negative on admission (22Feb2021) and discharge (04Mar2021) (prior 27Jan2021 negative). Analytics (23Feb2021): Hb 10.6 g/dL; MCV 93 fL; Platelets: 433000/uL; Leukocytes: 9500/uL (Neutrophils 68%); Creatinine 1.12 mg/dL; Na 147 mmol/L; K 4 mmol/L; proBNP 33825 pg/ml; Troponin T 116 ng/L; transferrin saturation 4.5%; ferritin 62 ng/dl; folic 5.24 ng/ml; vit B12 759 pg/ml. Analytics (03Mar2021): Hb 10.4 g/dL; MCV 93 fL; Platelets: 349000/uL; Leukocytes: 8200/uL; D-dimer 612 ug/L; Creatinine 0.78 mg/dL; Na 148 mmol/L; K 3.4 mmol/L; Troponin T 64 ng/L; proBNP 11381 pg/ml. Evolution: due to baseline situation further study was rejected. Stable, without dyspnoea or tachycardia (Bisoprolol 2.5mg/d was started on admission), she maintained respiratory failure, oxygen saturation (SaO2) 88% (2021) and home O2 was indicated. It was reported that eight days after discharge, the patient experienced sudden onset of dyspnea after ingestion, respiratory insufficiency with desaturation. Upon arrival in the emergency room, carrier of high concentration O2, tachypneic, diaphoretic and unconscious. Faced with the terminal situation, agreed with the family comfort measures were started and she died on 14Mar2021. Therapeutic measures were taken as a result of the events. The patient died on 14Mar2021 due to pulmonary embolism and acute respiratory failure. It was unknown whether an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Acute respiratory failure; pulmonary embolism


VAERS ID: 1283610 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-03-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Cardio-respiratory arrest, Dysarthria, Dysphagia, Hyperhidrosis, Hypotension, Physical examination, Pyrexia, Speech disorder
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: HIDROSALURETIL; JANUVIA [SITAGLIPTIN]; GLICLAZIDA MYLAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Amnestic disorder; Anemia; Arthrosis multiple; Dementia; Diarrhea; Dyslipidemia; Hypertension; Infection urinary tract; Type 2 diabetes mellitus; Ulcer; Wheelchair user (Dependent on someone during Daily Basic Life Activities)
Allergies:
Diagnostic Lab Data: Test Date: 20210319; Test Name: blood pressure; Result Unstructured Data: Test Result:hypotensive; Test Date: 20210319; Test Name: examination; Result Unstructured Data: Test Result:sweaty
CDC Split Type: ESPFIZER INC2021473604

Write-up: hypotensive; Dysphagia; cardiorespiratory arrest; Dysarthria; speech disturbance; fever; sweaty; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority- WEB, regulatory authority number ES-AEMPS-840573. A 90-year-old female patient received bnt162b2 (COMIRNATY, dose 2) intramuscularly on 18Mar2021 (lot number: ER7812) as 0.3 mL, single for COVID-19 immunization. Medical history included type 2 diabetes mellitus, ulcer complications, anemia, hypertension arterial/hypertension, dyslipidemia, amnestic deterioration, dementia, polyarthrosis, wheelchair bound (dependent on someone during daily basic life activities), acute urinary tract infection, and diarrhea. Concomitant medications included hydrochlorothiazide (HIDROSALURETIL, strength: 50 mg) for hypertension; sitagliptin (JANUVIA [SITAGLIPTIN], strength: 50 mg); and gliclazide (GLICLAZIDA MYLAN, strength: 30 mg) for type 2 diabetes mellitus. The patient previously took dose 1 of COMIRNATY (lot number: EP9598), intramuscularly on 25Feb2021 for COVID-19 immunization. Patient received the second dose of COVID vaccine on 18Mar2021. The following day (19Mar2021), the patient began to have fever and speech disturbance. No evidence of hypoglycemia. On 19Mar2021, during examination, patient was hypotensive and sweaty, in borderline condition. Patient also had dysphagia and dysarthria on 19Mar2021. The patient was brought to the emergency department due to the events. Upon arrival at the emergency department, the patient was in cardiorespiratory arrest. The patient underwent lab tests and procedures which included blood pressure: hypotensive and examination: sweaty on 19Mar2021. The patient died on 19Mar2021 due to hypotensive, dysphagia, cardiorespiratory arrest, dysarthria. It was not reported if an autopsy was performed. The outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cardiorespiratory arrest; hypotensive; Dysphagia; Dysarthria


VAERS ID: 1283612 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-18
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Functional residual capacity decreased; Memory disturbance
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021473697

Write-up: Death; Vomited; Chest pain; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FI-FIMEA-20212010. A 97-year-old female patient received second dose of bnt162b2 (COMIRNATY; Lot Number: EW2246), intramuscular on 15Apr2021 as single dose for COVID-19 immunisation. Medical history included memory disorder and functional capacity decreased. The patient eats independently occasionally but is otherwise completely dependent. The patient''s concomitant medications were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY; Lot number and expiry date were unknown), via unspecified route of administration on unspecified date as single dose for COVID-19 immunisation. The patient received the Comirnaty booster dose on 15Apr2021, after which the patient did not have any significant symptoms. On 18Apr2021, the patient vomited and had chest pain. The symptoms calmed down, but the patient was found dead in her own room the same day. No clear indications of adverse reaction to the vaccine, but the death happened soon after the patient received the vaccine. 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: Vomited; Chest pain; Death


VAERS ID: 1283616 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-18
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Asthenia, Cardiac arrest, Constipation, Death, Decreased appetite, Nausea, SARS-CoV-2 test, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Respiratory failure (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-20
   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: ATORVASTATINE [ATORVASTATIN]; LYSANXIA; ASPEGIC [ACETYLSALICYLIC ACID]; PAROXETINE; PROPRANOLOL; STRESAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Dyslipidaemia; General physical health deterioration (for about two months (prior to vaccination)); TIA; Type 2 diabetes mellitus; Weight loss (for about two months (prior to vaccination))
Allergies:
Diagnostic Lab Data: Test Date: 20210330; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:negative
CDC Split Type: FRPFIZER INC2021473667

Write-up: Death unexplained; cardiac arrest; abdominal pain/epigastric pain; vomited; constipation; asthenia; nausea; loss of appetite; This is a spontaneous report received from a contactable Physician, downloaded from the regulatory authority. Regulatory Authority Report Number: FR-AFSSAPS-DJ20210954, Safety Report Unique Identifier: FR-AFSSAPS-2021041803. A 76-years-old female patient received bnt162b2 (COMIRNATY), (dose 2) intramuscular on 14Apr2021 (Batch/Lot Number: Unknown) as a single dose for COVID-19 immunization. Medical history included Transient Ischemic Attack (TIA) in 2017, arterial hypertension, dyslipidemia, Type 2 Diabetes Mellitus with diet alone, weight loss, and general deterioration. Concomitant medications included atorvastatine [atorvastatin] (ATORVASTATINE [ATORVASTATIN]) taken for an unspecified indication, start and stop date were not reported; prazepam (LYSANXIA) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (ASPEGIC [ACETYLSALICYLIC ACID]) taken for an unspecified indication, start and stop date were not reported; paroxetine (PAROXETINE) taken for an unspecified indication, start and stop date were not reported; propranolol (PROPRANOLOL) taken for an unspecified indication, start and stop date were not reported; etifoxine hydrochloride (STRESAM) taken for an unspecified indication, start and stop date were not reported. The patient received the first dose of bnt162b2 (COMIRNATY), on an unknown date for COVID-19 immunization with no adverse reaction. After the first dose of vaccine, no adverse effects were reported. The patient received the vaccine (second dose) of COMIRNATY (lot number: unknown) on 14Apr2021. On 14Apr2021, she received the second dose of COMIRNATY vaccine. On 18Apr2021, she reported asthenia, nausea, and loss of appetite. On 19Apr2021, she consulted her physician without an appointment because she is worried, she has abdominal pain, has vomited, no fever, auscultation is normal, has constipation, epigastric pain, and loss of appetite. The doctor prescribed treatment for constipation: TRANSULOSE to be taken in the morning and SPASFON LYOC. On 19Apr2021, in the evening, she ate a little before going to bed. She vomited during the night and had a cardiac arrest in her bed at home around 3am on 20Apr2021, which the doctor could not recover. The paramedics were unable to resuscitate her following a call from her husband. The attending physician reported that the patient was active until about two months ago. She had been experiencing weight loss and mild general deterioration for about two months (prior to vaccination). He assumes death from inhalation following the vomiting but is not sure of the diagnosis, so death, 7 days after the second dose of COMIRNATY vaccine, with no definite cause: may be vomiting in bed and inhalation then cardiac arrest. The patient underwent lab tests and procedures which included COVID-19 PCR test: negative, on 30Mar2021. The patient died on 20Apr2021 at 3AM. Autopsy was not performed. The outcome of the events ''cardiac arrest'' was fatal while the outcome of the rest of the events was unknown. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: Death unexplained; cardiac arrest


VAERS ID: 1283617 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-11
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVOTHYROX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Dysfunction thyroid; Stroke
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:120/70; Test Date: 20210410; Test Name: fever; Result Unstructured Data: Test Result:38.6 Centigrade
CDC Split Type: FRPFIZER INC2021473672

Write-up: cause of death unknown; Fever; This is a spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-LL20212056. An 82-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 09Apr2021 13:15 (Batch/Lot Number: EW2239) as single dose for covid-19 immunisation. Medical history included Stroke (reported as 10 years ago), arterial hypertension, and dysfunction thyroid from an unknown date. Patient did not have COVID prior vaccination and has not been tested for COVID. The patient had suffered an ischemic stroke 10 years ago. She was taking her medication regularly and her blood pressure was 120/70. She was on calcium channel blocker, antiplatelet agent, beta blocker, statin and LEVOTHYROX. Coronary artery disease was suspected several years ago but the coronary workup at that time was normal. The last cardiology workup was in Dec2018 was normal. Concomitant medication included levothyroxine sodium (LEVOTHYROX) taken for an unspecified indication, start and stop date were not reported. The patient experienced fever (38.6 centigrade) the next morning without any associated signs as seen by the attending physician. The patient died on 11Apr2021 between 9:00 and 10:00 (cause of death unknown). The patient underwent lab tests and procedures which included blood pressure measurement: 120/70 on an unspecified date, body temperature: 38.6 centigrade on 10Apr2021. Outcome of the events was fatal. The patient died on 11Apr2021. It was not reported if an autopsy was performed. NB: Imputability without prejudice to the investigative elements that could be carried out in the context of legal or amicable compensation procedures. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: cause of death unknown; pyrexia; pyrexia


VAERS ID: 1283618 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-03-22
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-02
   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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210322; Test Name: Covid-19 PCR test; Test Result: Positive ; Comments: PCR test positive for variant V1
CDC Split Type: FRPFIZER INC2021473597

Write-up: Vaccination failure/COVID-19 PCR test was positive for variant V1/of respiratory problems; Vaccination failure/COVID-19 PCR test was positive for variant V1/of respiratory problems; This is a spontaneous report from a contactable consumer, downloaded from the regulatory authority. Regulatory Authority Report Number: FR-AFSSAPS-LL20212111, Safety Report Unique Identifier FR-AFSSAPS-2021041026. A 92-years-old male patient received bnt162b2 (COMIRNATY), (dose 2) intramuscular on 19Feb2021 (Batch/Lot Number: Unknown) as a single dose, and (dose 1) intramuscular on 29Jan2021 (Batch/Lot Number: Unknown) as a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. It was reported that the patient experienced vaccination failure; a PCR test was done on 22Mar2021, and the COVID-19 PCR test was positive for variant V1. On 26Mar2021, appearance of respiratory problems occurred. The patient was hospitalized and died on 02Apr2021. It was not reported if autopsy was performed. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reporter''s Comments: COVID Vaccine declaration 92 year old patient vaccinated with COMIRNATY IM Lot not specified 1st injection on 29Jan2021 2nd injection on 19Feb2021 On 26Mar2021 appearance of respiratory problems PCR test done on 22Mar2021 PCR test positive for variant V1 The patient is hospitalised and dies on 02Apr2021 NB: Imputability without prejudice to the elements of investigation which could be carried out in the context of legal or amicable compensation procedures.; Reported Cause(s) of Death: Vaccination failure/COVID-19 PCR test was positive for variant V1; Vaccination failure/COVID-19 PCR test was positive for variant V1


VAERS ID: 1283619 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-15
Onset:2021-04-05
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 1 LA / OT

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Benign prostatic hyperplasia; Dyslipidaemia (well-balanced treated dyslipidemia); Tabaquism
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic stenosis; Atheromatosis
Allergies:
Diagnostic Lab Data: Test Date: 20210324; Test Name: Coronary angiography; Result Unstructured Data: Test Result:normal left common trunk; Comments: normal left common trunk; well-developed diagonal IVA axis, normal; normal left marginal circumflex network; a dominant right coronary discreetly atheromatous in sector III, without stenosing lesion.
CDC Split Type: FRPFIZER INC2021473600

Write-up: Cardio-respiratory arrest; chest pain, with discomfort (coming back from a usual walk); chest pain, with discomfort (coming back from a usual walk); This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-LL20212114, Safety Report Unique Identifier FR-AFSSAPS-2021041047. A 75-year-old male patient received first dose of BNT162B2 (COMIRNATY, solution for injection, lot number: EP9605), intramuscularly administered in the left arm on 15Mar2021 at a single dose for COVID-19 immunization. Medical history included ongoing dyslipidaemia (well-balanced treated dyslipidemia), ongoing active smoking, ongoing benign prostatic hyperplasia; and arteriosclerosis and severe aortic stenosis (SAS), both from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced cardio-respiratory arrest, chest pain, with discomfort (coming back from a usual walk) on 05Apr2021. It was reported that on 05Apr20201 sudden onset of chest pain, with discomfort (coming back from a usual walk), cardiopulmonary arrest then death noted by the Emergency medical and resuscitation service around 6 PM to 6.30 PM. The reporter assessed the event cardio-respiratory arrest as serious (life-threatening and death). The patient was not considered at risk, has not had COVID and was not tested. The patient underwent lab tests and procedures which included coronary angiography: normal left common trunk; well-developed diagonal IVA axis, normal; normal left marginal circumflex network; a dominant right coronary discreetly atheromatous in sector III, without stenosing lesion on 24Mar2021. The outcome of the event cardio-respiratory arrest was fatal while the outcome of the events chest pain, with discomfort (coming back from a usual walk) was unknown. The patient died on 05Apr2021 due to cardio-respiratory arrest. An autopsy was not performed. NB: Accountability without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable compensation procedures. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1283622 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001650 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pyrexia, Sudden death, Tonic clonic movements
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Epilepsy
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20210

Write-up: Sudden death; Tonic clonic jerking; Pyrexia; This regulatory authority case was reported by a physician and describes the occurrence of SUDDEN DEATH (Sudden death), TONIC CLONIC MOVEMENTS (Tonic clonic jerking) and PYREXIA (Pyrexia) in a 50-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001650) for COVID-19 vaccination. The patient''s past medical history included Epilepsy. On 09-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced SUDDEN DEATH (Sudden death) (seriousness criterion death), TONIC CLONIC MOVEMENTS (Tonic clonic jerking) (seriousness criterion medically significant) and PYREXIA (Pyrexia) (seriousness criterion medically significant). The patient died on 10-Apr-2021. The reported cause of death was Sudden death. It is unknown if an autopsy was performed. At the time of death, TONIC CLONIC MOVEMENTS (Tonic clonic jerking) and PYREXIA (Pyrexia) had resolved. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided Company comment:Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Cause of death not provided. Pyrexia retained as serious / MS per assessment included in Authority report. It is not clear if the vaccine dose administered prior to the events was the first or second dose.; Reported Cause(s) of Death: sudden death


VAERS ID: 1283801 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-03-01
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER1741 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Large intestine perforation, Perforation, SARS-CoV-2 test, Septic shock, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Toxic-septic shock conditions (narrow), Gastrointestinal perforation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (narrow), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-16
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CITALOPRAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021469266

Write-up: septic shock; Perforation; Perforation; Abdominal pain; vomiting; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202104231625408450-WA667, Safety Report Unique Identifier GB-MHRA-ADR 25188832. A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER1741) via unspecified route of administration on 24Feb2021 at 60 years old as single dose for covid-19 immunisation. Medical history included anxiety. The patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Concomitant medications included citalopram for anxiety. The patient experienced septic shock on an unspecified date, vomiting on Mar2021, perforation on 15Mar2021 and abdominal pain on Mar2021. The patient was hospitalized for septic shock, vomiting, perforation from 15Mar2021 to an unknown date. The patient was admitted to hospital on 15Mar2021 with abdominal pain and vomiting and diagnosed with septic shock secondary to perforated sigmoid colon. She sadly died on 16Mar2021. Patient was generally in good health for age. Her death was completely unexpected and the reporter thought it would be important to mention she had the vaccination recently though they could not see how it was related to her death. Patient had not tested positive for COVID-19 since having the vaccine. This report did not relate to possible blood clots or low platelet counts. The patient underwent lab tests and procedures which included sars-cov-2 test: no-negative covid-19 test on unspecified date. It was not reported if an autopsy was performed. Septic shock was reported as cause of death. Outcome of the event septic shock was fatal, of the events vomiting and abdominal pain was unknown, of the event perforation was not recovered. This is a serious report with seriousness criteria- results in death, caused/prolonged hospitalization and other medically important condition. No follow-up attempts are possible. No further information is expected; Reported Cause(s) of Death: Septic shock


VAERS ID: 1283803 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-10
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 test, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-11
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210210; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021464285

Write-up: Clot blood; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202104252205256800-QJHM5. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in Feb2021 (Batch/Lot Number: not known) as single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient experienced clot blood on 10Feb2021. The patient underwent lab test which included Covid-19 virus test: no - negative covid-19 test on 10Feb2021. Patient has not tested positive for COVID-19 since having the vaccine. The patient died on 11Feb2021. Cause of death was clot blood. It was not reported if an autopsy was performed. Follow-up attempts are completed; Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: clot blood


VAERS ID: 1283834 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-03-30
   Days after vaccination:41
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BERODUAL; QUAMATEL; DOXAZOSIN; MATRIFEN; TALLITON; COVERCARD; VEROSPIRON; MILURIT; KONAKION; SOLU-MEDROL; TENAXUM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia; Atrial fibrillation; Chronic renal failure; Clostridium difficile infection; Exsiccosis; Haematuria; Hypertension; Hypokalaemia; Nephrectomy; Obesity
Allergies:
Diagnostic Lab Data: Test Name: Creatinine; Result Unstructured Data: Test Result:300 ?m/l; Test Date: 20210330; Test Name: COVID-19 antigen test; Result Unstructured Data: Test Result:positive
CDC Split Type: HUPFIZER INC2021464151

Write-up: Died; Vaccination failure; COVID-19 antigen test positive; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. Regulatory authority number is HU-OGYI-208121. An 83-year-old male patient received first dose of bnt162b2 (COMIRNATY), intramuscular at the left arm on 17Feb2021 (Lot Number: EL0725, Expiry date not reported) as 0.3 mL, single, and second dose (lot number: ET1831, expiry date not reported), intramuscular on 14Mar2021 (Lot Number: ET1831, expiry date not reported) as 0.3 mL, single at the left arm for COVID-19 immunization. Medical history included atrial fibrillation, clostridium difficile infection, nephrectomy, hypokalaemia, haematuria, chronic kidney disease, obesity, hypertension, anaemia and dehydration (exsiccosis), all from an unknown date to an unknown date. Concomitant medications included fenoterol hydrobromide, ipratropium bromide (BERODUAL) taken for an unspecified indication from 31Mar2021 to 04Apr2021; famotidine (QUAMATEL) taken for an unspecified indication, start and stop date were not reported; doxazosin taken for an unspecified indication, start and stop date were not reported; fentanyl (MATRIFEN) taken for an unspecified indication from 04Apr2021 to 04Apr2021; carvedilol (TALLITON) taken for an unspecified indication, start and stop date were not reported; amlodipine besilate, perindopril arginine (COVERCARD) taken for an unspecified indication, start and stop date were not reported; spironolactone (VEROSPIRON) taken for an unspecified indication from 01Apr2021 to 04Apr2021; allopurinol (MILURIT) taken for an unspecified indication, start and stop date were not reported; phytomenadione (KONAKION) taken for an unspecified indication from 01Apr2021 to 04Apr2021; methylprednisolone sodium succinate (SOLU-MEDROL) taken for an unspecified indication from 30Mar2021 to 04Apr2021; and rilmenidine phosphate (TENAXUM) taken for an unspecified indication, start and stop date were not reported. The patient experienced covid-19 antigen test positive and vaccination failure on 30Mar2021, with outcome of unknown. The patient underwent lab tests and procedures which included blood creatinine: 300 on um/l on an unspecified date, and sars-cov-2 test: positive on 30Mar2021. The patient died on 04Apr2021. It was not reported if an autopsy was performed. Verbatim narrative: This spontaneous, serious case was reported by a physician on 06Apr2021, concerning the occurrence of positive COVID-19 antigen test and lack of drug effect after the administration of Comirnaty concentrate for dispersion for injection (30 micrograms of COVID-19 mRNA Vaccine, MAH: BioNTech Manufacturing GmbH/ Pfizer).On 17Feb2021, the 83-year-old male patient received the first dose of Comirnaty (COVID-19 mRNA Vaccine (nucleoside modified)/ Tozinameran) concentrate for dispersion for injection (strength: 1 dose (0.3 mL) contains 30 micrograms of COVID-19 mRNA Vaccine, intramuscularly, left arm, batch number: EL 0725) and on 14Mar2021 he received the second dose (intramuscularly, left arm, batch number: ET 1831). On 30Mar2021, the patient''s COVID-19 antigen test became positive, got transfusion on 02Apr2021, and died on 04Apr2021. There is no information about the cause of death or whether autopsy was done.Medical history included severe anaemia, atrial fibrillation, chronic renal failure, haematuria, hypertension, severe hypokalaemia, left side nephrectomy, obesity, exsiccosis, and Clostridium difficile enteritis. His serum creratinin was 300 um/l on unknown date. Concomitant medication included TALLITON (carvedilol), BERODUAL (fenoterol, ipratropium bromide) between 31Mar20212021 and 04Apr2021, COVERCARD (amlodipine, perindopril), unknown doxazosin, KONAKION (Phytomenadione), between 01Apr2021 and 04Apr2021, MATRIFEN (fentanyl) on 04Apr2021,MILURIT (allopurinol), QUAMATEL (famotidine), SOLU-MEDROL (methylprednisolone), between 30Mar2021 and 04Apr2021, TENAXUM (rilmenidine), VEROSPIRON (spironolactone) between 01Apr2021 and 04Apr2021. No further information is expected. Sender Comment: The patient''s COVID-19 antigen test became positive 16 days, and died 21 days after the second dose of Comirnaty vaccine. There is no information about the cause of death or whether autopsy was done. Vaccination failure is considered possible with Comirnaty. The case is serious due to fatal outcome. Follow-up activities closed. No routine follow-up is possible for EV-WEB ICSRs.; Reported Cause(s) of Death: Died


VAERS ID: 1283835 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-02-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-20
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210216; Test Name: COVID-19 test; Test Result: Positive
CDC Split Type: HUPFIZER INC2021464111

Write-up: COVID-19/COVID-19 test was positive; patient died, cause of death was not reported; febrile; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number HU-OGYI-219821. An 86-year-old male patient received first dose bnt162b2 (COMIRNATY; Lot Number: EL0725) intramuscularly administered into left arm on 12Feb2021 14:20 as 0.3 mL, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient started to have symptoms of COVID-19 two days after vaccination, patient became febrile on 14Feb2021. The patient was diagnosed to have COVID-19 4 days after vaccination on 16Feb2021 and was admitted to the hospital on an unspecified date. The patient died on 20Feb2021, cause of death was not reported. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 16Feb2021. It was not reported if an autopsy was performed. Outcome of events COVID-19 and pyrexia was unknown. Sender Comment: The patient started to have symptoms of COVID-19 two days after vaccination and diagnosed to have COVID-19 4 days after vaccination. Immunity may have not developed within 4 days after the first dose of vaccine. The case is serious because the patient died. No further information is expected. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: patient died, cause of death was not reported


VAERS ID: 1283836 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Death
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-22
   Days after onset: 21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Angina pectoris; Diabetes; Myocardial infarction
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021464095

Write-up: died; COVID-19; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number HU-OGYI-220021. An 85-year-old female patient received first dose of bnt162b2 (COMIRNATY, solution for injection, lot: EL0725), intramuscular in left arm on 12Feb2021 as 0.3 mL, single for covid-19 immunisation. Medical history included ongoing diabetes, ongoing angina pectoris and ongoing myocardial infarction. Before vaccination the patient''s chronic diseases were in balance. The patient''s concomitant medications were not reported. The patient experienced occurrence of covid-19 after vaccination with bnt162b2 (non-serious) in Feb2021. The outcome of covid-19 was unknown. The patient died of an unknown cause on 22Feb2021. An autopsy was not performed. The physician considered the report as serious. In the opinion of the patient''s physician, the death was not related to the vaccination. Sender Comment: The patient died ten days after vaccination. Death is not expected adverse event of COMIRNATY. It might be related to the patient''s chronic cardiovascular diseases. Based on the above, and in lack of detailed medical information, relationship between death and COMIRNATY is not assessable. The case is serious because the patient died. No further information is expected. Follow-up attempts are completed. No further information is expected.; Sender''s Comments: The information provided is very limited and does not allow for a complete medical assessment. Based on current convention, the case of death is assessed as related to bnt162b2 until sufficient information is available to confirm an unrelated cause of death. The patient''s angina pectoris, myocardial infarction and diabetes may have contributed to the patient''s death. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: died


VAERS ID: 1283837 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-01-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Circulatory collapse, Computerised tomogram, Cough, General physical health deterioration, Pneumonia, Pneumonitis, Pyrexia, SARS-CoV-2 test negative
SMQs:, Anaphylactic reaction (narrow), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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), Eosinophilic pneumonia (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-05
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: GERODORM; RILEX [LORAZEPAM]; MIRZATEN; KEMADRIN; PARNASSAN; PAROGEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Bipolar affective disorder; COPD; Multiple myeloma; Secondary parkinsonism; Sleep disorder
Allergies:
Diagnostic Lab Data: Test Date: 20210131; Test Name: CT; Result Unstructured Data: Test Result:bronchopneumonia confirmed; Test Date: 20210201; Test Name: COVID-19 PCR; Test Result: Negative ; Test Date: 20210203; Test Name: COVID-19 PCR; Test Result: Negative
CDC Split Type: HUPFIZER INC2021464184

Write-up: Bronchopneumonia; Coughing; Fever; deteriorating state of health; inflammation of the lung; collapse of the patient''s circulation; This is a spontaneous report from a contactable healthcare professional downloaded from the Agency Regulatory Autority-WEB, regulatory authority number HU-OGYI-240621. A 75-year-old male patient received the first dose of bnt162b2 (COMIRNATY), intramuscular on 29Jan2021 (Batch/Lot Number was not reported) as 0.3 mL, single for covid-19 immunisation. Medical history included Alzheimer''s disease, bipolar affective disorder, COPD (Chronic obstructive pulmonary disease), multiple myeloma, secondary Parkinsonism and sleep disorder; all unknown if ongoing. Concomitant medications included cinolazepam (GERODORM); lorazepam (RILEX [LORAZEPAM]); mirtazapine (MIRZATEN); procyclidine hydrochloride (KEMADRIN); olanzapine (PARNASSAN); and paroxetine hydrochloride (PAROGEN). The patient experienced fever, bronchopneumonia, and coughing on 29Jan2021. On 31Jan2021, the patient was admitted in the hospital where bronchopneumonia was confirmed through a CT. On 05Feb2021, the patient passed away due to the events. The patient underwent lab tests and procedures which included Covid PCR results were negative: negative on 01Feb2021 and on 03Feb2021. Based on the autopsy report, the cause of death was bronchopneumonia. The patient''s deteriorating state of health and inflammation of the lung attributed and led to the collapse of the patient''s circulation. Health authority comment: As immunity may have not developed yet as the patient received the first dose of Comirnaty on 29Jan2021 and also bronchoneumonia was confirmed on 31Jan2021, the causal relationship is unlikely between the suspected drug and the cause of death. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Bronchopneumonia; fever; coughing; inflammation of the lung; collapse of the patient''s circulation; deteriorating state of health; Autopsy-determined Cause(s) of Death: Bronchopneumonia


VAERS ID: 1283838 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-30
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / UNK LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021464161

Write-up: COVID-19; Drug Ineffective; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number: HU-OGYI-243821. An 83-year-old female patient received first dose of bnt162b2 (COMIRNATY), intramuscular, administered on left arm on 04Mar2021 (lot number: EP2163) at 0.3 mL, single for COVID-19 immunisation. Medical history included COVID-19 from an unknown date and unknown if ongoing. Concomitant medications were not reported. On 30Mar2021, the patient experienced COVID-19 and drug ineffective with fatal outcome. It was reported as occurrence of COVID-19 infection resulting in death after COMIRNATY injection for active immunization to prevent COVID-19. The patient was hospitalized on an unknown date because of COVID-19, and on 30Mar2021 at 21:15, the patient passed away. It was not reported if an autopsy was performed. Sender''s Comment: According to the SmPC of Comirnaty, immunity usually develops 14 days after the second dose of the vaccine. The patient received the first dose of Comirnaty on 04Mar2021 and passed away on 30Mar2021 after getting infected with the virus, therefore immunity may have not developed yet. Based on the above, the causal relationship is unlikely between the suspected drug and the adverse event. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: COVID-19; drug ineffective


VAERS ID: 1283839 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-03-11
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021464118

Write-up: COVID-19; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number HU-OGYI-244621. An 83-year-old male patient received bnt162b2 (COMIRNATY), intramuscular in the left arm on 03Mar2021 (Lot Number: EP2163) as 0.3 mL, single, 1st dose for COVID-19 immunisation. Medical history included COVID-19 from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced COVID-19 on 11Mar2021. Outcome of event COVID-19 was fatal. The patient died on 11Mar2021. It was unknown if an autopsy was performed. It was also reported as follows: occurrence of Covid-19 infection resulting in death after COMIRNATY injection for active immunization to prevent COVID-19. The patient was hospitalized on an unknown date because of Covid-19, and on 11Mar2021 at 06:15 the patient passed away. Senders comment: According to the HA of Comirnaty, immunity usually develops 14 days after the second dose of the vaccine. The patient received the first dose of Comirnaty on 03Mar2021 and passed away on 11Mar2021 after getting infected with the virus, therefore immunity may have not developed yet. Based on the above, the causal relationship is unlikely between the suspected drug and the adverse event. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: COVID 19


VAERS ID: 1283842 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-13
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-22
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic renal insufficiency (chronic renal insufficiency); COPD (COPD)
Preexisting Conditions: Comments: COPD, CNI,
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021473390

Write-up: manifest COVID infection with exitus letalis; protective effect did not occur; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number AT-BASGAGES-2021-23736. An 84-year-old male patient received second dose of BNT162B2 (COMIRNATY) intramuscular on 31Mar2021 (Batch/Lot Number: ET1831; Expiration Date: 30Jun2021) as single dose for covid-19 immunization. Medical history included ongoing chronic obstructive pulmonary disease COPD and ongoing Chronic renal insufficiency. The patient''s concomitant medications were not reported. The patient manifest symptomatic Covid infection (pneumonia on both sides) since 13Apr and lack of protective effect. Therapy included fluid substitution, oxygen, inhalation, antibiotic therapy, dexamethasone parenterally, however further worsening. Exitus letalis on 22Apr2021. Therapeutic measures were taken as a result of manifest covid infection. The patient''s outcome was unknown for Vaccination failure, fatal for COVID-19 pneumonia. The patient died on 22Apr2021. It was not reported if an autopsy was performed. No follow-up attempts needed. No further information is expected, batch/lot.no. has already been reported.; Reported Cause(s) of Death: manifest COVID infection with exitus letalis on 22Apr2021


VAERS ID: 1283843 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 2 - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-16
   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: Anaemia (erythrocyte concentrate 3x1 intravenously 8-11Apr2021 Indication anaemia); Atrial fibrillation; Chronic renal insufficiency; Coronary artery disease NOS (Coronary artery disease); Diabetes mellitus insulin-dependent (insulin-dependent diabetes); Dilated cardiomyopathy; Gastric antral vascular ectasia (GAVE Syndrome); Myelodysplastic syndrome (Myelodysplastic syndrome)
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial appendage closure (atrial appendage occlusion); Diseases of mitral valve (heart valve repair); Mitral valve repair (heart valve repair)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021473394

Write-up: Septal myocardial infarction; cardiac decompensation by known dilated cardiomyopathy; This is a spontaneous report downloaded from the regulatory authority-WEB local regulatory authority number AT-BASGAGES-2021-23759. A 78-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 15Apr2021 (Batch/Lot Number: EW2246; Expiration Date: 31Jul2021) as single dose, for COVID-19 immunisation. Relevant medical history includes ongoing anemia treated with erythrocyte concentrate 3x1 intravenously from 8-11Apr2021 for anemia, ongoing atrial fibrillation, mitral valve repair/heart valve operation NOS, diseases of mitral valve, atrial appendage closure/occlusion, ongoing chronic renal insufficiency, ongoing dilated cardiomyopathy, ongoing coronary artery disease, ongoing diabetes mellitus insulin-dependent, ongoing gastric antral vascular ectasia (GAVE Syndrome) and ongoing myelodysplastic syndrome. The patient''s concomitant medications were not reported. Patient historically took first dose of COMIRNATY (lot number: ET1831) on 17Mar2021 for COVID-19 vaccination. Patient had stationary admission for cardiac decompensation with known dilated cardiomyopathy and atrial fibrillation. At the station, forced diuresis, erythrocyte concentrate administration in myelodysplastic syndrome and GAVE syndrome was done to patient. Patient was also reported to have been treated with erythrocyte concentrate 3x1 intravenous 08Apr2021 to 11Apr2021 for the indication of anemia and furosemide received orally and intravenously intermittently from 07Apr2021 to 16Apr2021, for the indication of cardiac decompensation. After stabilization, observance after vaccination on 15Apr2021. On 16Apr2021, the patient experienced septal myocardial infarction death and decompensation cardiac. Patient died of septal myocardial infarction on 16Apr2021. The patient''s outcome was fatal for septal myocardial infarction and decompensation cardiac. No evidence of thrombosis. It was not reported if an autopsy was performed. This serious spontaneous report was received from a physician and concerns a male patient of 78 years. Sender Comment: BASGAGES-comment: Follow-up information requested. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Septal myocardial infarction; cardiac decompensation by known dilated cardiomyopathy


VAERS ID: 1283894 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2017-06-08
Onset:2021-04-09
   Days after vaccination:1401
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 1 LA / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Cancer of prostate (Prostate cancer treated with radiation therapy.); Dyslipidaemia; Intermittent claudication (Claudication in the lower limbs operated on in the lower right limb.)
Allergies:
Diagnostic Lab Data: Test Date: 20210115; Test Name: COVID-19 PCR test positive; Test Result: Positive
CDC Split Type: ESPFIZER INC2021473589

Write-up: Sudden death; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB ES-AEMPS-836605. A 76-year-old male patient received the first dose of bnt162b2 (COMIRNATY, lot number: EW2246), via an unspecified route of administration administered in left arm on 06Apr2021 as SINGLE DOSE for COVID-19 immunisation and leuprorelin acetate (ELIGARD; strength: 45 mg), via an unspecified route of administration from 08Jun2017 to 18Jun2020 at unknown dose every 3 months for cancer of prostate. Medical history included dyslipidaemia, intermittent claudication (Claudication in the lower limbs operated on in the lower right limb), arterial hypertension, prostate cancer (Prostate cancer treated with radiation therapy and quarterly Eligard. He was fine and had gone to work in a garage that he owned). The patient''s concomitant medications were not reported. The patient previously took losartan and acetylsalicylic acid (ADIRO). On 09Apr2021, the patient experienced sudden death. It was further reported that they went to home where they found the patient, deceased probably since 1 hour. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on 15Jan2021. The action taken in response to the event for leuprorelin acetate was not applicable. The patient died on 09Apr2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1283895 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-19
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4813 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cognitive disorder, Condition aggravated, Respiratory distress, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Dementia (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-20
   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: ESOMEPRAZOLE; METFORMIN; APIXABAN; FUROSEMIDE; SPIRONOLACTONE; ENALAPRIL; ALLOPURINOL; TRAZODONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Bedridden; Cholestasis; Chronic kidney disease stage 3; Cognitive deterioration; Dyslipidemia; Gastric cancer (gastrointestinal neoplasm in 2009); Hypertension arterial; Ischaemic stroke (lacunar ischemic stroke in June 2019); Senile osteoporosis; Type II diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210419; Test Name: SARS-CoV-2 PCR test; Test Result: Negative
CDC Split Type: ESPFIZER INC2021473486

Write-up: Cognitive deterioration; Condition worsened; Distress respiratory; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number ES-AEMPS-838684. A 88-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 14Apr2021 (Batch/Lot Number: EW4813) as 0.3 mL, single for covid-19 immunisation. Medical history included chronic kidney disease stage 3, gastric cancer (gastrointestinal neoplasm) in 2009, Cognitive deterioration from Apr2021, senile osteoporosis, atrial fibrillation, type 2 diabetes mellitus, ischaemic stroke from Jun2019, hypertension arterial, dissociated cholestasis, dyslipidaemia and was bedridden. Concomitant medication(s) included esomeprazole, metformin, apixaban, furosemide, spironolactone, enalapril, allopurinol, and trazodone; all from unknown dates and unknown if ongoing. The patient experienced cognitive deterioration, condition worsened and distress respiratory on 19Apr2021 which resulted in death. In the two weeks prior to vaccination, he had deteriorated, asleep all day, did not speak, could not swallow solid food. On 19Apr2021 he deteriorated with great progression in the last week. PCR Covid-19 negative. On 20Apr2021, externally audible secretional noises, pale coloration and tachypneic. The patient takes a deep breath and was not breathing. He passed away. The doctor reported that the patient has shown galloping deterioration after the 1st dose of the Pfizer vaccine. Causation assessment: Taking into account the age, the history of the patient and the pre-vaccination situation of the patient, it is considered that an alternative causal explanation to the vaccine cannot be ruled out. The patient died on 20Apr2021. An autopsy was not performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: cognitive deterioration; condition worsened; distress respiratory


VAERS ID: 1283902 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time ratio, Alanine aminotransferase, Aortic dissection, Aspartate aminotransferase, Blood alkaline phosphatase, Blood bilirubin, Blood creatinine, Blood lactic acid, Blood potassium, Blood sodium, Gamma-glutamyltransferase, Haemoglobin, Platelet count, Prothrombin level, Troponin, White blood cell count
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: APROVEL; EFFEXOR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Cessation of smoking; Depression; Pulmonary mass; Tuberculosis (tuberculosis treated 30 years ago)
Allergies:
Diagnostic Lab Data: Test Name: activated partial thromboplastin time rati; Result Unstructured Data: Test Result:3.7; Test Name: glutamo pyruvic transaminase; Result Unstructured Data: Test Result:26 IU/l; Test Name: glutamo oxaloacetic transaminase; Result Unstructured Data: Test Result:44 IU/l; Test Name: alkaline phosphatases; Result Unstructured Data: Test Result:60 IU/l; Test Name: Total bilirubin; Result Unstructured Data: Test Result:5.9 mg/l; Test Name: creatinine; Result Unstructured Data: Test Result:6.5 mg/l; Test Name: lactate; Result Unstructured Data: Test Result:3.6 mmol/L; Test Name: K; Result Unstructured Data: Test Result:3.8 mmol/L; Test Name: Na; Result Unstructured Data: Test Result:136 mmol/L; Test Name: gamma GT; Result Unstructured Data: Test Result:21 IU/l; Test Name: Hg; Result Unstructured Data: Test Result:12.6 g/dl; Test Name: platelets; Result Unstructured Data: Test Result:255 g/l; Test Name: prothrombin; Test Result: 73 %; Test Name: Troponin; Result Unstructured Data: Test Result:6 mg/l; Test Name: leukocytes; Result Unstructured Data: Test Result:15.08 g/l
CDC Split Type: FRPFIZER INC2021473677

Write-up: Aortic dissection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number [FR-AFSSAPS-LL20212096] and safety report unique identifier [FR-AFSSAPS-2021040799]. An 83-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on an unspecified date (Batch/Lot Number: Unknown) as a single dose for COVID-19 immunization. Medical history included pulmonary mass, arterial hypertension, depressive syndrome, tuberculosis treated 30 years ago, and smoking cessation. The patient had no known allergy. Concomitant medications included irbesartan (APROVEL) and venlafaxine hydrochloride (EFFEXOR). The patient experienced aortic dissection (death, hospitalization) on an unspecified date. On an unspecified date, patient underwent lab tests which included blood alkaline phosphatase: 60 iu/l, blood bilirubin: 5.9 mg/l, blood count: hg 12.6 g/dl, leukocytes at 15.08 g/l, and platelets at 255 g/l , blood creatinine: 6.5 mg/l, blood electrolytes: na 136 mmol/l, k 3.8 mmol / l, blood lactic acid: 3.6 mmol/l, gamma-glutamyltransferase: 21 iu/l, haemostasis: prothrombin 73%, activated partial thromboplastin time ratio 3.7, liver function test: glutamo oxaloacetic transaminase: 44 iu/l; glutamo pyruvic transaminase: 26 IU/L, troponin: 6 mg/l. The patient died on an unspecified date. It was unknown if an autopsy was performed. Case Summary and Reporter''s Comments Text:COVID vaccine declaration - UNDER INFORMATION. 83-year-old patient with a history of lung mass being assessed, depressive syndrome, tuberculosis treated 30 years ago, smoking cessation, high blood pressure and no known allergy. She is treated with APROVEL 150 and EFFEXOR 75. Vaccinated by COMIRNATY intramuscular batch not specified in second injection. Within 24 hours of the second injection, appearance of a type A aortic dissection. Biology report: Creatinine 6.5 mg/L, Na: 136 mmol/l, K: 3.8 mmol/l, lactate 3.6 mmol/L, liver function tests: glutamo oxaloacetic transaminase at 44 IU/l, glutamo pyruvic transaminase 26IU / l, Total bilirubin at 5.9mg / l, alkaline phosphatases 60IU / l, and gamma GT 21IU / l, Blood count: Hg 12.6g / dl, leukocytes at 15.08g / L and platelets at 255G / l, Hemostasis: prothrombin 73%, activated partial thromboplastin time ratio 3.7, Cardiovascular biomarkers = troponin at 6 mg / l. The patient died. No follow-up attempts are possible, information on batch number cannot be obtained.; Reporter''s Comments: COVID vaccine declaration - UNDER INFORMATION 83-year-old patient with a history of lung mass being assessed, depressive syndrome, tuberculosis treated 30 years ago, smoking cessation, high blood pressure and no known allergy She is treated with APROVEL 150 and EFFEXOR 75 Vaccinated by COMIRNATY intramuscular batch not specified in second injection. Within 24 hours of the second injection, appearance of a type A aortic dissection. Biology report : Creatinine 6.5mg / L, Na 136mmol / l, K 3.8mmol / l Lactate 3.6mmol / L Liver function tests: glutamo oxaloacetic transaminase at 44IU / l, glutamo pyruvic transaminase 26IU / l Total bilirubin at 5.9mg / l, alkaline phosphatases 60IU / l and gamma GT 21IU / l Blood count: Hg 12.6g / dl, leukocytes at 15.08g / L and platelets at 255G / l Hemostasis: prothrombin 73%, activated partial thromboplastin time ratio 3.7 Cardiovascular biomarkers = troponin at 6 mg / l. The patient died.; Reported Cause(s) of Death: Aortic dissection


VAERS ID: 1283905 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-05
Onset:2021-04-17
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary embolism, Sudden death, Thrombophlebitis, Ultrasound Doppler
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (narrow), Cardiomyopathy (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-19
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210418; Test Name: ultrasound doppler; Result Unstructured Data: Test Result:unknown results
CDC Split Type: FRPFIZER INC2021463084

Write-up: Sudden death; fatal pulmonary embolism; Phlebitis lower limb/sural phlebitis (thrombophlebitis); This is a spontaneous report downloaded from the regulatory authority. [Regulatory authority number FR-AFSSAPS-MP20211402 and Safety Report Unique Identifier FR-AFSSAPS-2021041249]. A contactable physician reported a 70-year-old male patient received the 1st dose of bnt162b2 (COMIRNATY), intramuscular administered on arm left on 05Apr2021 (Batch/Lot Number: EW2239) as SINGLE DOSE for COVID-19 immunization. Medical history was not reported. The patient had no particular history including thromboembolism and had no current treatment. On 18Apr2021 (Saturday), the patient presented to the doctor''s office for calf pain with swelling. The doctor diagnosed sural phlebitis/phlebitis of lower limb (thrombophlebitis) and prescribed anti-coagulation with tinzaparin sodium (INNOHEP) and ultrasound doppler (unknown result). The patient presented no dyspnea, no tachycardia, no neurological signs. On 19Apr2021 (Sunday), the patient was found unconscious in the garden of his house, the resuscitation measures were ineffective. The doctor mentioned a fatal pulmonary embolism and the family refuses the autopsy. CONCLUSION: Sudden death the day after a thrombophlebitis on D14 post-vaccination 1st dose in a 70-year-old patient with no previous history. Sural phlebitis/phlebitis of lower limb (thrombophlebitis) was also considered as serious (life threatening). No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden death the day after a thrombophlebitis; Sudden death the day after a thrombophlebitis; fatal pulmonary embolism


VAERS ID: 1283910 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-15
Onset:2021-02-28
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Body temperature, Bronchitis, COVID-19, Computerised tomogram, Oxygen saturation, Oxygen saturation decreased, Pharyngitis, Productive cough, Pulmonary congestion, Pyrexia, Respiratory distress, SARS-CoV-2 test, Vaccination failure
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Agranulocytosis (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal infections (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: 2021-04-11
   Days after onset: 41
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: DILTIAZEM LP; ESIDREX; LOSARTAN; SERTRALINE; VALACICLOVIR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Colopathy; Deep vein thrombosis leg; Diverticulosis; Extrinsic allergic alveolitis; Follicular lymphoma; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210324; Test Name: thoracic angioscan; Result Unstructured Data: Test Result:No pulmonary embolism on angioscan or signs of PAH; Comments: No pulmonary embolism on angioscan or signs of PAH (pulmonary arterial hypertension). Increased parenchymal abnormalities of Covid-19 compared to the CT scan of 18Mar21. Extensive involvement estimated to date at 50%.; Test Date: 20210402; Test Name: thoracic angioscan; Result Unstructured Data: Test Result:No sign of pulmonary embolism or PAH (pulmonary ar; Comments: No sign of pulmonary embolism or PAH (pulmonary arterial hypertension). Appearance of diffuse mediastinal and cervical emphysema (tracheal rupture?). Increase in ground-glass areas.; Test Date: 20210409; Test Name: thoracic angioscan; Result Unstructured Data: Test Result:Subtotal resorption of the subcutaneous emphysema.; Comments: Subtotal resorption of the subcutaneous emphysema. Clear regression of pneumomediastinum which persists in the pericardium and anterior mediastinum. Complete resorption of the right pneumothorax. Persistence of a thin blade of left apical pneumothorax. Increased parenchymal involvement at Covid-19 from 50% to 70%. Absence of adenopathy with a pejorative appearance. No pleuropericardial effusion. Respiratory distress due to severe SARS Cov2 lung disease leading to transfer to a continuing care unit.; Test Date: 20210228; Test Name: body temperature; Result Unstructured Data: Test Result:38-38.5 Centigrade; Test Date: 20210318; Test Name: CT scan; Result Unstructured Data: Test Result:unknown results; Test Date: 20210318; Test Name: O2 saturation; Test Result: 93 %; Test Date: 20210312; Test Name: SARS CoV2 PCR test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021473423

Write-up: O2 saturation at 93%; COVID-19/positive SARS-CoV-2 PCR test; COVID-19/positive SARS-CoV-2 PCR test; Respiratory distress due to severe hypoxemic SARS-Cov-2 infectious lung disease; onset of symptoms suggestive of bronchitis (pharyngitis, congestion, coughing up sputum, fever 38-38.5C); onset of symptoms suggestive of bronchitis (pharyngitis, congestion, coughing up sputum, fever 38-38.5C); onset of symptoms suggestive of bronchitis (pharyngitis, congestion, coughing up sputum, fever 38-38.5C); onset of symptoms suggestive of bronchitis (pharyngitis, congestion, coughing up sputum, fever 38-38.5C); onset of symptoms suggestive of bronchitis (pharyngitis, congestion, coughing up sputum, fever 38-38.5C); This is a spontaneous report from a contactable pharmacist downloaded from a regulatory authority-WEB FR-AFSSAPS-PS20210841. Safety Report Unique Identifier FR-AFSSAPS-2021042007. An 80-year-old female patient received second dose of bnt162b2 (COMIRNATY) intramuscularly on 15Feb2021 and first dose intramuscular on 19Jan2021; both as single dose for COVID-19 immunisation. Medical history included follicular lymphoma, deep vein thrombosis right leg from 2017, extrinsic allergic alveolitis, diverticulosis of the sigmoid and a 4 mm left colon polyp resected with forceps in 2013, hypertension and functional colopathy. Concomitant medications included diltiazem hydrochloride (DILTIAZEM LP), hydrochlorothiazide (ESIDREX), losartan (LOSARTAN), sertraline (SERTRALINE), valaciclovir (VALACICLOVIR). On 28Feb2021 patient experienced onset of symptoms suggestive of bronchitis (pharyngitis, congestion, coughing up sputum, fever 38-38.5C). The patient was treated with antibiotic therapy with amoxicillin. On 12Mar2021, patient had COVID-19 confirmed by a positive SARS-CoV-2 PCR test. On 18Mar2021 patient''s O2 saturation was at 93% leading to a visit to the emergency room and was then hospitalized. The patient underwent lab tests and procedures which included CT scan (18Mar2021): unknown results, thoracic angioscan (24Mar2021): No pulmonary embolism on angioscan or signs of PAH. Increased parenchymal abnormalities of Covid-19 compared to the CT scan of 18Mar2021. Extensive involvement estimated to date at 50%, thoracic angioscan (02Apr2021): No sign of pulmonary embolism or PAH. Appearance of diffuse mediastinal and cervical emphysema (tracheal rupture?). Increase in ground-glass areas and thoracic angioscan (09Apr2021): Subtotal resorption of the subcutaneous emphysema. Clear regression of pneumomediastinum which persists in the pericardium and anterior mediastinum. Complete resorption of the right pneumothorax. Persistence of a thin blade of left apical pneumothorax. Increased parenchymal involvement at Covid-19 from 50% to 70%. Absence of adenopathy with a pejorative appearance. No pleuropericardial effusion. Respiratory distress due to severe hypoxemic SARS-CoV-2 infectious lung disease leading to transfer to a continuing care unit. The patient was treated with Oxygen therapy, Optiflow under 100% FiO2, G 5 500 ml + PV 1 ampoule B1-B6 500 mg, piperacillin/tazobactam (TAZOCILLIN) 4 g IV (intravenous) every 8 hours, tocilizumab 600 mg IV, lansoprazole 15 mg/day, trimethoprim/sulfamethoxazole (BACTRIM) 800/160 mg, valaciclovir 500 mg, Novorapid subcutaneous protocol, tinzaparin (INNOHEP) 10,000 IU subcutaneous at night. The patient died on 11Apr2021 due to respiratory distress due to severe hypoxemic SARS-Cov-2 infectious lung disease. It was not reported if an autopsy was performed. Outcome of all other events was unknown. No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Respiratory distress due to severe hypoxemic SARS-Cov-2 infectious lung disease; COVID-19/positive SARS-CoV-2 PCR test; COVID-19/positive SARS-CoV-2 PCR test


VAERS ID: 1283913 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-17
Onset:2021-04-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW9127 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-17
   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: PANTOPRAZOLE; FUROSEMIDE; ATROVENT; BISOPROLOL; ALLOPURINOL; DIFFU-K; PREVISCAN [FLUINDIONE]; VENTOLINE [SALBUTAMOL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve insufficiency (moderate aortic valve insufficiency (discovered in March 2018)); Atrial fibrillation (permanent); Atrioventricular block second degree; Cardiac arrest; Chronic kidney disease stage 3 (stage G3B); COPD (GOLD stage II COPD); Coxarthrosis (on the left); Gout; Hypertensive heart disease NOS (Patient with a history of post-hypertensive heart disease with 45% LVEF in Jun2019); Permanent cardiac pacemaker insertion (Double chamber pacemaker placed in 2014.); Prostate surgery; Recurrent cardiac decompensation (passages in intensive care in 2014,2018 and 2019); Venous thrombosis (Superficial TV of the left upper limb in Jun2018.); Venous thrombosis superficial limb (Superficial TV of the left upper limb in Jun2018.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021473794

Write-up: Recurrent cardiac decompensation; This is a spontaneous report from a contactable other healthcare professional and physician downloaded from the regulatory authority. The regulatory authority report number is FR-AFSSAPS-ST20211622, Safety report unique identifier FR-AFSSAPS-2021042430. A 91-year-old male patient received BNT162B2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 17Apr2021 10:19 at the age of 91-years-old, (Batch/Lot Number: EW9127) as 0.3 mL, single dose for COVID-19 immunization. Medical history included gout, post-hypertensive heart disease with 45% LVEF in Jun2019: Mobitz 2 second degree atrioventricular block. Double chamber pacemaker placed in 2014; Permanent atrial fibrillation, moderate aortic valve insufficiency (discovered in Mar2018), multiple cardiac decompensations (passages in intensive care in 2014, 2018 and 2019; cardiac arrest resuscitated in 2019); Superficial venous thrombosis of the left upper limb in Jun2018; GOLD stage II COPD; drip; coxarthrosis on the left; prostate surgery in 1998; chronic kidney disease stage G3B. Hospitalized from 15 to 20Oct2021 for exacerbation of COPD added to cardiac decompensation. Concomitant medications included pantoprazole; furosemide; ipratropium bromide (ATROVENT); bisoprolol; allopurinol; potassium chloride (DIFFU-K); fluindione (PREVISCAN); salbutamol (VENTOLINE); all taken for an unspecified indication, start and stop date were not reported. The patient had no COVID-19 history. The patient was vaccinated on 17Apr2021 at 10:19 a.m. He did not present any adverse events for the day. On the night of 17-18Apr2021, he presented constriction in his chest with respiratory discomfort. He took his usual Ventolin + Atrovent treatments. As that was not enough, he called for help. When help arrived, the patient had died. The physician saw the patient on 09Apr2021, no symptoms of cardiac asthma but edema of the lower limbs ++. Has doubled the usual dose of furosemide to reduce edema. The patient''s daughter reported that the day of vaccination recurrence of edema in the legs despite the increase in furosemide. The patient has already presented several episodes of the same type (constriction in the chest with respiratory discomfort) requiring 2 emergency visits since 2021. Conclusion was the patient has recurrence of probable cardiac decompensation on old heart disease in an extremely fragile patient according to the attending physician. The patient died on 17Apr2021. An autopsy was not performed.; Reported Cause(s) of Death: cardiac decompensation


VAERS ID: 1283948 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-02
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Fibrin D dimer, Platelet count, Pulmonary embolism, SARS-CoV-2 test
SMQs:, Embolic and thrombotic events, venous (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-27
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BENDROFLUMETHIAZIDE; LERCANIDIPINE; LISINOPRIL; SIMVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Hypertension; Non-smoker; Pulmonary embolism
Allergies:
Diagnostic Lab Data: Test Date: 20210426; Test Name: CT Angiogram Pulmonary; Result Unstructured Data: Test Result:Bilateral pulmonary embolism; Test Date: 20210426; Test Name: D-dimer; Result Unstructured Data: Test Result:$g4000?: No; Test Name: Platelet count; Result Unstructured Data: Test Result:Lowest - 281; Comments: After vaccine (Normal range 150-450); Test Date: 20210426; Test Name: Platelet count; Result Unstructured Data: Test Result:<150 A - 109/L?: No; Test Name: Platelet count; Result Unstructured Data: Test Result:unknown results; Comments: platelet count before vaccination is unknown and it was unknown if anti-PF4 antibodies were identified; Test Date: 20210426; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021474953

Write-up: Pulmonary embolus; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202104271839249790-HJA5A, Safety Report Unique Identifier GB-MHRA-ADR 25206933. A 79-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 02Apr2021 (Batch/Lot Number: Not known) at a single dose for COVID-19 immunisation. Medical history included hypertension, dementia, pulmonary embolism, all from an unknown date and unknown if ongoing. The patient was a non-smoker. The patient has not had symptoms associated with COVID-19, and is not enrolled in clinical trial. Concomitant medications included Bendroflumethiazide, lercanidipine, lisinopril, and simvastatin taken for an unspecified indication, start and stop date were not reported. The patient previously took heparin for an unknown indication, and was administered with first dose of BNT162B2 vaccine (lot number: unknown) on an unknown date for COVID-19 immunisation and experienced pulmonary embolism. The patient experienced pulmonary embolus on an unspecified date, which resulted in death on 27Apr2021. The patient reportedly had no previous reaction to heparin or anticoagulants. It was unknown if the patient has a history of, or has current malignancy, and has no concurrent or recent intracranial infections. The patient did not have a recent surgical or medical interventions to central nervous system or had a recent trauma/head injury. The patient underwent lab tests and procedures which included SARS-CoV-2 test: no - negative COVID-19 test on 26Apr2021, patient has not tested positive for COVID-19 since having the vaccine, CT angiogram pulmonary: bilateral pulmonary embolism on 26Apr2021, platelet count was not <150 A - 109/L on 26Apr2021, platelet count was lowest at 281 on an unspecified date after vaccination (Normal range 150-450), D-Dimer was not $g4000 on 26Apr2021. The platelet count before vaccination is unknown and it was unknown if anti-PF4 antibodies were identified on an unknown date. Therapeutic measures such as anticoagulation was taken as a result of pulmonary embolism. The patient died on 27Apr2021 due to the event. It was unknown if an autopsy was performed. No follow-up attempts are possible, information on the batch/lot number could not be obtained. No further information is expected.; Reported Cause(s) of Death: Pulmonary embolism


VAERS ID: 1283949 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-08
Onset:2021-01-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ16668 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular disorder, Condition aggravated, Dyspnoea, Malaise, Myocardial ischaemia, SARS-CoV-2 test, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebrovascular disorder; Ischaemic heart disease; Stroke
Allergies:
Diagnostic Lab Data: Test Date: 20210107; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021480126

Write-up: ischaemic heart disease; Cerebrovascular disorder; Condition aggravated; Dyspnoea; Malaise; vomiting; This is a spontaneous report from a contactable physician received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202104271926199810-NOHKU. Safety Report Unique Identifier GB-MHRA-ADR 25207191. A 96-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 08Jan2021, at the age of 96 years, (Batch/Lot Number: EJ16668) as single dose for covid-19 immunisation. Medical history included myocardial ischaemia from an unknown date and unknown if ongoing, cerebrovascular accident from an unknown date and unknown if ongoing, cerebrovascular disorder from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced ischaemic heart disease on an unspecified date, cerebrovascular disorder on an unspecified date, dyspnoea on an unspecified date, vomiting on 09Jan2021, malaise on 10Jan2021. The patient had been nonspecifically unwell on the morning of the vaccine, but no temperature and vaccine delivered. Remained well in the afternoon afterwards. Started vomiting the following day in the afternoon. Seen by General Practitioner. Was short of breath. Offered admission but patient declined. Died the following day. Discussed with coroner and cause of death were reported as old age, Ischaemic heart disease and cerebrovascular disease. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 07Jan2021. The patient died on Jan2021. An autopsy was not performed. Patient has not tested positive for COVID-19 since having the vaccine. the outcome of the events vomiting and dyspnoea was unknown while the outcome of the event malaise was recovered.; Reported Cause(s) of Death: Cerebrovascular disorder; Elderly; Ischaemic heart disease


VAERS ID: 1283962 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-03-15
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cardiopulmonary failure, Drug ineffective
SMQs:, Cardiac failure (narrow), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Colonic neoplasm NOS (received chemotherapy); Decompensation cardiac
Preexisting Conditions: Medical History/Concurrent Conditions: Chemotherapy; General physical health deterioration
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021464105

Write-up: Cardiorespiratory insufficiency; COVID-19; COVID-19; This is a spontaneous report downloaded from the regulatory authority (Regulatory Authority report number: HU-OGYI-219921). A contactable physician (contactable through Regulatory Authority only) reported that an 84-year-old male patient received the first dose of BNT162B2 (COMIRNATY) on 12Feb2021 (Lot Number: EL0725; Expiration date was not reported) and the second dose on 05Mar2021 (14:20) (Lot Number: EJ6790; Expiration date was not reported); both intramuscular as a single dose, for COVID-19 immunization. Medical history included ongoing colonic neoplasm (received chemotherapy); ongoing cardiac decompensation; and general condition was wrong. The patient''s concomitant medications were not reported. On an unspecified date in 2021, after the first and second doses of vaccination, the patient had COVID-19. On 15Mar2021, the patient had cardiorespiratory insufficiency. The outcome of the event, COVID-19, was unknown. The patient had died on 15Mar2021, and the reported cause of death was cardiorespiratory insufficiency. An autopsy was not performed. As reported, death was not an expected adverse event of BNT162B2. It might be related to the patient''s chronic diseases and bad general condition. Based on the above, and in the lack of detailed medical information, the relationship between death and COMIRNATY was not assessable. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Cardiorespiratory insufficiency


VAERS ID: 1283963 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-03-19
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cardio-respiratory arrest, Drug ineffective, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-21
   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: FOLIC ACID; KALDYUM; SORBIFER DURULES [FERROUS SULFATE]; FUROGAMMA; FRONTIN; TEGRETOL
Current Illness: Anaemia; Arteriosclerosis; Cerebral arteriosclerosis; Cerebral infarction; COVID-19; Dementia; Epilepsy; Heart failure; Hypertension; Hypertensive cardiomyopathy; Osteoporosis; Vertebrobasilar artery syndrome
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210319; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:positive
CDC Split Type: HUPFIZER INC2021464212

Write-up: Cardio-respiratory arrest; Drug Ineffective; COVID-19 pcr test positive; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number HU-OGYI-241121. An 88-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left on 02Mar2021 (Batch/Lot Number: EP2163) as 0.3 ml, single, left arm for covid-19 immunisation. Medical history included ongoing cerebral infarction, ongoing arteriosclerosis, ongoing cardiac failure, ongoing Vertebrobasilar artery syndrome, ongoing dementia , ongoing covid-19, ongoing cerebral arteriosclerosis , ongoing hypertension , ongoing hypertensive cardiomyopathy , ongoing anaemia, ongoing epilepsy, ongoing osteoporosis. Concomitant medications included folic acid (FOLIC ACID) taken for anaemia; potassium chloride (KALDYUM) taken for cardiac failure; ferrous sulfate (SORBIFER DURULES [FERROUS SULFATE]) taken for anaemia; furosemide (FUROGAMMA) taken for cardiac failure; alprazolam (FRONTIN) taken for dementia; carbamazepine (TEGRETOL) taken for epilepsy; start and stop dates were not reported. On 21Mar2021, occurrence of cardio-respiratory arrest after the use of Comirnaty was reported. The patient experienced cardio-respiratory arrest and died. The patient was hospitalized from an unknown date and received the vaccine in the hospital. On 19Mar2021, a COVID-19 PCR test was positive. Drug ineffective was reported. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 19Mar2021. The patient died on 21Mar2021. An autopsy was not performed. Sender Comment: According to the SmPC of Comirnaty concentrate for dispersion for injection, cardio-respiratory arrest is not listed and not expected. TTO is 19 days. Dechallenge and rechallenge were not applicable. The causal relationship between the suspected drug and the event is considered not relatable. According to the reporting physician, he does not consider a causal relationship between the death of the patient and the vaccine. The case is considered serious due to fatal outcome. Follow-up activities closed. No routine follow-up is possible for EV-WEB ICSRs.; Sender''s Comments: Reported cardio-respiratory arrest is considered intercurrent and unrelated to suspect BNT162B2. Consider patient underlying conditions and comorbidities as causative. ; Reported Cause(s) of Death: cardio-respiratory arrest


VAERS ID: 1284072 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-03
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
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021467415

Write-up: patient probably died of a background illness; patient who fell ill in Corona after being vaccinated; patient who fell ill in Corona after being vaccinated; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events for four patients. This is the first of four reports. An elderly male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and patient''s concomitant medications were not reported. It was reported (by the Pfizer colleague) that the patient who fell ill in Corona after being vaccinated (so I heard through a second source from a female acquittance that her husband is hospitalized there and not from a medical staff member: not a first source). The patient probably died of a background illness. As other vaccinated patients and a female staff member also fell in corona, the department is under quarantine for a few days. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of the other events was unknown.; Sender''s Comments: Limited information precludes a medically meaningful assessment of the case. A possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded. "Patient probably died of a background illness" is most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : IL-PFIZER INC-2021467416 same reporter / different patient;IL-PFIZER INC-2021467417 same reporter / different patient;IL-PFIZER INC-2021467418 same reporter / different patient; Reported Cause(s) of Death: patient probably died of a background illness


VAERS ID: 1284142 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: OXYGEN; DONEPEZIL; ISOPTIN [VERAPAMIL]; MIRTAZAPINE; SINEMET; ESOMEPRAZOLE; ENTACT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; COPD; Depression; Encephalopathy; Gastritis; Sleeplessness; Tachycardia
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021463088

Write-up: Cardiocirculatory arrest; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-718856. A 79-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 08Apr2021 (Batch/Lot Number: EW2246) as 0.3 mL, single for COVID-19 immunization. Medical history included alzheimer''s disease, tachycardia, sleeplessness, COPD, encephalopathy, depression, and gastritis. Concomitant medication included oxygen; donepezil; verapamil (ISOPTIN [VERAPAMIL]); mirtazapine; carbidopa, levodopa (SINEMET); esomeprazole; escitalopram oxalate (ENTACT) taken for an unspecified indication, start and stop date were not reported. On 10Apr2021, the patient experienced cardiocirculatory arrest. The patient died on an unspecified date. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Cardiocirculatory arrest


VAERS ID: 1284145 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-04-10
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Atrial fibrillation, Dyspnoea, Electrocardiogram
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Supraventricular tachyarrhythmias (narrow), 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: 2021-04-12
   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 HEMIFUMARATE; NORVASC; PRISMA [CITALOPRAM HYDROBROMIDE]; OSSIGENO AIR LIQUIDE SANITA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardio-respiratory failure; Hypertension arterial; Renal failure
Allergies:
Diagnostic Lab Data: Test Name: electrocardiogram; Result Unstructured Data: Test Result:Unknown result
CDC Split Type: ITPFIZER INC2021473611

Write-up: Epigastralgia, dyspnea, atrial fibrillation; Epigastralgia, dyspnea, atrial fibrillation; Epigastralgia, dyspnea, atrial fibrillation; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-719120. A 93-year-old female patient received bnt162b2 (COMIRNATY), intramuscular left deltoid on 07Apr2021 (Lot Number: ET7205) as single dose for covid-19 immunisation. Medical history included renal failure, cardio-respiratory failure, and hypertension arterial, all from an unknown date and unknown if ongoing. Concomitant medications included bisoprolol fumarate; amlodipine besilate (NORVASC); citalopram hydrobromide (PRISMA); oxygen (OSSIGENO AIR LIQUIDE SANITA); all taken for an unspecified indication, start and stop date were not reported. On 10Apr2021, the patient experienced epigastralgia, dyspnea, and atrial fibrillation. The seriousness criterion was death. The patient underwent lab tests and procedures which included electrocardiogram: unknown result on an unspecified date. The patient''s family was proposed the hospitalization of the patient, but they refused. The patient died at her home 13:30 on 12Apr2021. It was not reported if an autopsy was performed. Sender comment: all available information has been reported. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Atrial fibrillation; Dyspnea; Epigastralgia


VAERS ID: 1284150 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-02-26
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: 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), Hypersensitivity (broad), Respiratory failure (narrow), 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: LANSOPRAZOLE; ELIQUIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Senile dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021473484

Write-up: Experienced respiratory failure, the reporter indicates that the reaction lasted 8 days and oxygen therapy was performed and subsequently died; This is a spontaneous report from a contactable other healthcare professional downloaded from the European Medicines Agency (EMA) EudraVigilance-WEB. The regulatory authority report number is IT-MINISAL02-719507. An 87-year-old female patient received the first dose of bnt162b2 (COMIRNATY, Lot Number: EJ6790), intramuscular on 19Feb2021 as single dose for covid-19 immunization. Medical history included atrial fibrillation and senile dementia both from an unknown date. Concomitant medications included lansoprazole and apixaban (ELIQUIS) both taken for an unspecified indication, start and stop date were not reported. On 26Feb2021, the patient experienced respiratory failure, the reporter indicates that the reaction lasted 8 days and oxygen therapy was performed and patient subsequently died. Therapeutic measures were taken as a result of respiratory failure which includes treatment with oxygen therapy. The patient died on an unspecified date. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Experienced respiratory failure, the reporter indicates that the reaction lasted 8 days and oxygen therapy was performed and subsequently died


VAERS ID: 1284151 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-12
Onset:2021-03-19
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: 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), Hypersensitivity (broad), Respiratory failure (narrow), 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: LASIX [FUROSEMIDE]; OMEPRAZOLE; METFORMINA ACTAVIS; DEPONIT; CARDIOASPIRIN; ZYLORIC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021473833

Write-up: On 19Mar2021 she experienced respiratory failure for one day. Oxygen therapy administered. Death followed; This is a spontaneous report from a contactable healthcare professional downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-719569. A 99-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 12Mar2021 (Lot Number: EP2166) as single dose for covid-19 immunisation. The first dose was received in 19Feb2021. Medical history included diabetes mellitus. Concomitant medications included furosemide (LASIX), omeprazole; metformin hydrochloride (METFORMINA ACTAVIS), glyceryl trinitrate (DEPONIT), acetylsalicylic acid (CARDIOASPIRIN), allopurinol (ZYLORIC); all taken for an unspecified indication, start and stop date were not reported. On 19Mar2021 the patient experienced respiratory failure for one day. Oxygen therapy administered. Death followed. The patient died on an unspecified date. It was not reported if an autopsy was performed. Clinical course, therapeutic measures, outcome and additional relevant information: the patient was vaccinated with 1st dose of Pfizer vaccine on 19Feb2021 and with the 2nd dose of Pfizer vaccine on 13Mar2021. On 19Mar2021 she experienced respiratory failure for one day, she was treated with oxygen therapy, then she died. The reporter did not indicate the date of death, therefore further information has been requested in this regard.; Reported Cause(s) of Death: On 19Mar2021 she experienced respiratory failure for one day. Oxygen therapy administered. Death followed


VAERS ID: 1284155 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-04-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX0893 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Acute pulmonary oedema, Blood gases, Blood lactic acid, Blood pH, Blood pressure measurement, Body temperature, Electrocardiogram, Hypoxia, Lactic acidosis, Mediastinoscopy, Renal failure, Respiratory failure, Tachypnoea, Ultrasound scan
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Lactic acidosis (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Myocardial infarction (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: PREGABALIN; RAMIPRIL; PANTOPRAZOLE; PENTOXIFYLLINE; AMLODIPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anemia; Breast cancer; Breast neoplasm; Gastric irritation; Gastrointestinal dysplasia; Hypertension; Neuropathy; Peripheral vasodilatation; Thromboendarterectomy
Allergies:
Diagnostic Lab Data: Test Date: 20210422; Test Name: Arterial blood gases; Result Unstructured Data: Test Result:unknown result; Test Date: 20210422; Test Name: lactic; Result Unstructured Data: Test Result:5.6 mmol/L; Comments: likely kidney insufficiency; Test Date: 20210422; Test Name: ph; Result Unstructured Data: Test Result:7.13; Comments: severe acidosis; Test Date: 20210422; Test Name: Blood pressure; Result Unstructured Data: Test Result:115/48; Test Date: 20210422; Test Name: Body temperature; Result Unstructured Data: Test Result:35 Centigrade; Test Date: 20210422; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:unknown result; Test Date: 20210422; Test Name: Thoracoscopy; Result Unstructured Data: Test Result:unknown result; Test Date: 20210422; Test Name: Echography; Result Unstructured Data: Test Result:unknown result
CDC Split Type: ITPFIZER INC2021473624

Write-up: acute pulmonary edema/diffused rales in the chest, marbled skin reported as acute pulmonary edema in likely acute myocardial infarction; respiratory insufficiency; desaturation/ hypoxemia; tachypnea with use of accessory muscles; acute myocardial infarction; severe acidosis (ph 7.13)//lactic (5.6 mmol/l)likely kidney insufficiency; severe acidosis (ph 7.13)//lactic (5.6 mmol/l)likely kidney insufficiency; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-720362. An 81-year-old female patient received bnt162b2 (COMIRNATY, dose 2) intramuscularly on 22Apr2021 (lot number: EX0893; expiration date: 31Jul2021) as 0.3 mL, single for COVID-19 immunization. Medical history included hypertension arterial/ hypertension, thromboendarterectomy, neuropathy, all from an unknown date and unknown if ongoing; breast neoplasm, previous breast cancer and previous anemia due to duodenal dysplasia, gastric irritation, and peripheral vasodilatation. Concomitant medications included pregabalin for neuropathy; ramipril for hypertension; pantoprazole for gastric irritation; pentoxifylline for peripheral vasodilatation; and amlodipine for hypertension. On 22Apr2021, the patient arrived at the ER due to serious acute pulmonary edema, respiratory insufficiency, desaturation/ hypoxemia, tachypnea with use of accessory muscles. Upon arrival, noted diffused rales in the chest, marbled skin reported as acute pulmonary edema in likely acute myocardial infarction. The patient underwent lab tests and procedures which included arterial blood gases: unknown result, lactic: 5.6 mmol/l (likely kidney insufficiency), ph: 7.13 (severe acidosis), blood pressure of 115/48, body temperature of 35 centigrade; electrocardiogram, thoracoscopy, and echography with unknown results, all on 22Apr2021. Therapeutic measures were taken as the result of all the events which included non-invasive ventilation: PEEP 10 PS 6 FIO2 60%, bicarbonate IV slow infusion, saturation monitoring and vital parameters monitoring. The patient died on 22Apr2021 due to acute pulmonary edema/diffused rales in the chest, marbled skin reported as acute pulmonary edema in likely acute myocardial infarction, respiratory insufficiency, desaturation/ hypoxemia, tachypnea with use of accessory muscles, acute myocardial infarction. It was not reported if an autopsy was performed. The outcome of the other events was unknown. Reporter''s comment: previous breast cancer and previous anemia due to duodenal dysplasia.; Reporter''s Comments: previous breast cancer and previous anemia due to duodenal dysplasia.; Reported Cause(s) of Death: acute pulmonary edema/diffused rales in the chest, marbled skin reported as acute pulmonary edema in likely acute myocardial infarction; respiratory insufficiency; desaturation/ hypoxemia; tachypnea with use of accessory muscles; acute myocardial inf


VAERS ID: 1284325 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-04-26
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-26
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210421; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021481525

Write-up: Death; This is a spontaneous report from a contactable physician. This is a report received from the Agency Regulatory Authority. Regulatory authority report number is v21103938. A 45-year-old female patient received the first dose of the bnt162b2 (COMIRNATY), via an unspecified route of administration on 21Apr2021 (Lot Number: ET3674; Expiration Date: 31Jul2021) at a single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient had no family history. The patient experienced death on 26Apr2021 at 04:00. The course of the event was as follows: on 21Apr2021 in the morning (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot Number: ET3674; Expiration Date: 31Jul2021) via an unspecified route of administration as a single dose for COVID-19 immunization. After the vaccine was administered, the patient was (eligible letter) for 30 minutes at the place where the vaccination was performed. No abnormality was observed. On 26Apr2021 at 04:00 presumed (5 days after the vaccination), the patient died. On 26Apr2021, the day of event onset, there was no change to complain from the patient. On 27Apr2021, the patient was day-off, and there was no symptomatic report until the event onset, for which no presumption was available. The patient underwent lab tests and procedures which included body temperature: 36.3 degrees Centigrade on 21Apr2021 before vaccination. The clinical outcome of the event, death, was fatal. The patient died on 26Apr2021 due to unknown cause of death. It was not reported if an autopsy was performed. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. The reporting physician commented that the patient was healthy without issue to concern on history taking before the vaccination.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1284328 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-03-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9480 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Anuria, Body temperature, Disease progression, Marasmus
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   Days after onset: 33
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pressure sore
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210326; Test Name: Body temperature; Result Unstructured Data: Test Result:36.9 Centigrade
CDC Split Type: JPPFIZER INC2021481920

Write-up: geromarasmus progression; geromarasmus progression; Anuria; Acute renal failure; This is a spontaneous report from a contactable physician. This is a report received from the regulatory authority. Regulatory authority report number is v21104257. A 92-year-old female patient received the first dose of the bnt162b2 (COMIRNATY; Lot Number: ER9480; Expiration Date: 31Jul2021), via an unspecified route of administration on 26Mar2021 at 10:00 as single dose for covid-19 immunisation. Medical history included ongoing sacral pressure sore. The patient''s concomitant medications were not reported. On 26Mar2021, the patient experienced acute renal failure and anuria. On an unspecified date, the patient experienced geromarasmus progression. The clinical course was as follows: on 26Mar2021 at 10:00, the patient received the first dose of bnt162b2. On 26Mar2021, the patient experienced acute renal failure with outcome of fatal. The course of the event was as follows: anuria (as reported). The patient underwent lab tests and procedures which included body temperature: 36.9 degrees Centigrade on 26Mar2021. The clinical outcome of the event, anuria, was unknown. The clinical outcome of the events, acute renal failure and geromarasmus progression, was fatal. The patient died on 28Apr2021 due to acute renal failure and geromarasmus progression. It was unknown if an autopsy was performed. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The reporting physician classified the event acute renal failure as fatal and the causality between acute renal failure and bnt162b2 as unassessable. Other possible cause of the event such as any other diseases was geromarasmus progression. The reporting physician commented as follows: since there was a medical history of sacral pressure sore and had a tendency of aggravated, it was considered that geromarasmus was aggravated. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Acute renal failure; Geromarasmus progression; Geromarasmus progression


VAERS ID: 1284329 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-04-27
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-27
   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: Ischaemic heart disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021482052

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician. A 73-year-old male patient received first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number ER2659, Expiration date 30Jun2021) via intramuscularly at left arm on 21Apr2021 at 11:30 as a single dose for COVID-19 immunization. Medical history included ischaemic heart disease. The patient had no allergies to medications, food, or other products. Concomitant medications included anticoagulant (name was not provided) (received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 27Apr2021 in the afternoon (6 days after the vaccination), the patient experienced cardio-respiratory arrest and died. An autopsy was not performed. The patient did not receive any treatment for the event. The reporting physician assessed the event as serious (death) and assessed cause of death as unknown, suspected heart disease (as reported). Causality assessment was not provided.; Sender''s Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Cardio-respiratory arrest with fatal outcome and the suspect vaccine BNT162B2. Consider also possible contributory effects from patient''s pre-existing risk factors like ischaemic heart disease and elderly age. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Unknown, suspected heart disease


VAERS ID: 1284330 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-27
Onset:2021-04-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET9096 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure chronic; Dementia Alzheimer''s type; Gallbladder drainage (post-therapy); Myocardial infarction old (more than 3 years ago)
Allergies:
Diagnostic Lab Data: Test Date: 20210427; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination; Test Date: 20210427; Test Name: HR; Result Unstructured Data: Test Result:100-110; Test Date: 20210427; Test Name: SpO2; Result Unstructured Data: Test Result:99-100 %
CDC Split Type: JPPFIZER INC2021484188

Write-up: Cardio-respiratory arrest; Apnoea; Anaphylaxis; This is a spontaneous report received from a contactable physician via the Agency Regulatory Authority. Regulatory authority number is v21104325. A 91-year-old female patient received first dose of BNT162B2 (COMIRNATY, formulation: Solution for injection, lot number: ET9096, expiry date: 31Jul2021), (age at the time of vaccination: 91-years-old) via unspecified route on 27Apr2021 at 9:45 at single dose for COVID-19 immunization. Body temperature before vaccination was 36.3 degrees Centigrade. The patient medical history included dementia Alzheimer''s type, cardiac failure chronic and myocardial infarction old (more than 3 years before) as past history and post-gallbladder drainage performed in Jan2021. Concomitant medical history not reported. The patient had no family history. No obvious change was found in the morning of the vaccination as the patient ate all the volume of breakfast. On 27Apr2021 at 12:00 (2 hours and 15 minutes after the vaccination), the patient experienced cardio-respiratory arrest and apnoea. The patient was seen in the emergency room. On 27Apr2021 at 14:10 (4 hours and 25 minutes after the vaccination), the patient died. The outcome of the event was fatal. The course of the event was as follows: On 27Apr2021 at 9:45, BNT162b2 vaccine was administered. Around 12:00, the patient had cardio-respiratory arrest and was seen in the emergency room. Intubation was immediately performed, and cardiac massage was started. Pupillary light reflex and spontaneous breathing did not return although heart rate (HR) returned with the defibrillator. Thereafter, manual artificial ventilation was continued. Spontaneous breathing did not return although SpO2 99-100% and HR 100-110 (sinus tachycardia). At 13:55, mechanical ventilation was stopped with agreement of the patient''s family. About 15 minutes later, cardiac arrest developed, and the patient was confirmed dead. The reporting physician classified the events as serious (Death) and assessed them as related to BNT162b2. Other possible causes of the event such as any other diseases were past history of cardiac failure chronic and myocardial infarction old. However, the patient''s condition was favorable until the morning of the vaccination date. The reporting physician commented as follows: 40 minutes of follow-up time was taken after the patient received the vaccine at the place where the vaccination was taken place. No obvious change was noted. Skin and mucosal manifestation of anaphylaxis were not confirmed. It was unknown if an autopsy was performed or not. However, it could not be found anything else but anaphylaxis as possible cause for the sudden cardiopulmonary arrest. The causal relationship between the events and BNT162b2 was therefore considered as related.; Reported Cause(s) of Death: Cardio-respiratory arrest; Apnoea; Anaphylaxis


VAERS ID: 1284387 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-02
Onset:2021-04-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Dyspnoea, Feeding disorder, Pneumonia
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-08
   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: Oesophageal carcinoma NOS (stable before vaccination)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021473953

Write-up: Severe breathlessness; moisture behind lungs, severe pneumonia; unable to drink and eat; severe tightness of the chest; This is a spontaneous report downloaded from the Agency Regulatory Authority-WEB [Regulatory authority number NL-LRB-00516949]. A contactable consumer reported an 84-year-old female patient received the 2nd dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 02Apr2021 (Batch/Lot Number: Unknown) as SINGLE DOSE for COVID-19 immunization. Medical history included ongoing oesophageal carcinoma that was stable before vaccination. Concomitant medications were not reported. She had no previous COVID-19 infection. The patient received the first dose of COMIRNATY on 26Feb2021 (lot/batch not provided) as COVID-19 immunization with no adverse reaction. Then, the 2nd dose on 02Apr2021. The night after vaccination severe tightness of the chest, in the early morning transported to hospital. On 03Apr2021, the patient was noted to have severe breathlessness; moisture behind lungs (severe pneumonia) which was unable to drink and eat. The patient was hospitalized in Apr2021. Patient was treated with antibiotics, but the antibiotics were withdrawn due to her physical health declining. The patient died on 08Apr2021 due to severe breathlessness and pneumonia. Outcome of the events of unable to drink and eat; and severe tightness of the chest was unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: moisture behind lungs, severe pneumonia; Severe breathlessness


VAERS ID: 1284388 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-15
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021473847

Write-up: My mother has had cardiac arrest and never had heart complaints/ cardiac arrest; heart attack; Myalgia; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority -WEB. The Regulatory Authority report number is NL-LRB-00517009. This is first of two reports. An 82-year-old female patient received the second dose of BNT162B2 (COMIRNATY, Lot Number: ET3674 and expiration date not reported), intramuscular on 07Apr2021 as a single dose for COVID-19 immunisation; oxycodone hydrochloride (OXYNORM), via an unspecified route of administration from 06Apr2021 to an unspecified date, at 10 mg, twice daily, then via an unspecified route of administration from an unspecified date at unspecified dose, twice daily (20 in the morning and 10 in the evening) for Hip pain complaints; oxycodone hydrochloride (OXYCONTIN), via an unspecified route of administration from 06Apr2021 to 08Apr2021, at 10 mg, once daily for Pain complaints in the hip. The patient''s medical history and concomitant medications were not reported. The patient has no previous COVID-19 infection. The patient previously took the first dose of BNT162B2 (COMIRNATY) on 02Mar2021 for COVID-19 immunization and experienced Injection site pain/ pain at the injection site, Fatigue and sleepiness. On 06Apr2021, a day prior to vaccination, the patient started using Oxynorm and Oxycontin for hip pain. The patient was very nauseous from the oxycontin and was stopped on 08Apr2021. On 07Apr2021, the vaccination. The oxynorm was then increased to 20 in the morning and 10 in the evening. Just before midnight, the patient died suddenly of a heart attack or cardiac arrest on 15Apr2021. It was also reported that the patient experienced myalgia on 15Apr2021. The patient''s daughter reported that the patient has been in cardiac arrest on 15Apr2021 and never had heart complaints. She does not know if it all has to do with it, that was what we were for. The action taken in response to the events for oxycodone hydrochloride (OXYNORM) was not applicable, and for oxycodone hydrochloride (OXYCONTIN) was post-therapy. The patient died on 15Apr2021 due to the events. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest or myocardial infarction; Cardiac arrest or myocardial infarction; Myalgia


VAERS ID: 1284389 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-11
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Dehydration, Dysphagia, Hypophagia, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-22
   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: ACENOCOUMAROL
Current Illness: Atrial fibrillation (Atrial fibrillation. Medication including acenocoumarol); Heart failure HA class II; Heart failure HA class IV
Preexisting Conditions: Medical History/Concurrent Conditions: CABG (Coronary artery bypass graft surgery); Ischaemic cerebral infarction (Recurrent Ischemic Cerebrovascular Accident); Percutaneous coronary intervention (left ventricle Percutaneous Coronary Intervention)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021473844

Write-up: On 17Apr, patient had a Cerebrovascular Accident (Unilateral View). This is obviously not a secondary event, but possibly a complication; swallowing disorder and no oral intake; swallowing disorder and no oral intake; dehydration; possibly renal failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number NL-LRB-00517195. An 84-year-old male patient received bnt162b2 (COMIRNATY, solution for injection, 0.3 mL), via an unspecified route of administration on 11Apr2021 (Batch/Lot Number: Unknown) at 0.3 mL, single (dose 2) for COVID-19 immunisation. Medical history included ongoing Heart failure NYHA class II - IV (Heart Association II-IV) at state after the left ventricle Percutaneous Coronary Intervention and Coronary artery bypass graft surgery, ongoing atrial fibrillation and ongoing ischaemic cerebral infarction (Recurrent Ischemic Cerebrovascular Accident). No previous COVID-19 infection. Concomitant medications included acenocoumarol (tablet 1mg) for atrial fibrillation. Past drug therapy included COVID-19 vaccine pfizer Injectable solution 0,3ml on 07Mar2021, no side effect was reported.. On 17Apr2021, the patient experienced cerebrovascular accident (CVA) (unilateral view). This is obviously not a secondary event, but possibly a complication. CVA led to a swallowing disorder and no oral intake, which caused dehydration (dehydration due to a swallowing disorder and no more intake after the Cerebrovascular Accident 17Apr) and possibly renal failure (and presumed renal failure). This caused the patient''s death. No diagnostics or obduction was done due to the wish of the patient. The patient died on 22Apr2021. An autopsy was not performed. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: and presumed renal failure/ possibly renal failure; dehydration due to a swallowing disorder and no more intake after the Cerebrovascular Accident 17Apr; swallowing disorder and no oral intake; swallowing disorder and no oral intake; dehydration


VAERS ID: 1284390 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-20
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-05-04
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: 2021-04-20
   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: LOSARTAN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021473853

Write-up: Patient passed away; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB NL-LRB-00517200. A 79-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 15Apr2021 as single dose for COVID-19 immunisation. The patient''s medical history was not reported. Concomitant medications included losartan (LOSARTAN). The patient patient passed away on 20Apr2021, the cause of death was unknown. It was also reported that it was not clear whether the patient died from the vaccine. An autopsy was not performed. No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: The information currently provided is too limited to make a meaningful medical assessment. However, per company causality assessment guidance, the event of death with unknown cause is assessed as related until the cause of death is clarified and assessed as unrelated. 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 appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Patient passed away


VAERS ID: 1284391 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-02-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Cerebral infarction, Computerised tomogram, Dysphagia, Muscular weakness, Pain in extremity, Product administered at inappropriate site, Urine analysis
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Drug abuse and dependence (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-09
   Days after onset: 48
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: TACAL D3; ASCORBIC ACID; LEVOTHYROXINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood values; Result Unstructured Data: Test Result:unknown result; Test Name: CTscan; Result Unstructured Data: Test Result:unknown result; Test Name: urine values; Result Unstructured Data: Test Result:unknown result
CDC Split Type: NLPFIZER INC2021473835

Write-up: later swallowing problem; 23Mar2021 a brain infarct, 24Mar2021 another brain infarct, loss of right leg and arm, half of the right face, could not speak a word anymore.; 23Mar2021 a brain infarct, 24Mar2021 another brain infarct, loss of right leg and arm, half of the right face, could not speak a word; 3.5 weeks after vaccination (19Feb2021) suffered from right arm strength loss; 3.5 weeks after the vaccination (19Feb2021) problems with right arm, pain; vaccination was put in left leg; This is a spontaneous report from a contactable Other Health Professional downloaded from the Regulatory Authority-WEB, regulatory authority number NL-LRB-00517311. A 95-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration in Leg Left on 19Feb2021 (Batch/Lot Number: Unknown) as a single dose for COVID-19 immunisation. The patient''s medical history was not reported. Concomitant medications included calcium carbonate, colecalciferol (TACAL D3), ascorbic acid (ASCORBIC ACID) and levothyroxine, all taken for an unspecified indication, start and stop date were not reported. The patient had no history of covid-19 infection. It was reported that 3.5 weeks after vaccination (19Feb2021), the patient suffered from right arm strength loss. Also, 3.5 weeks after the vaccination (19Feb2021) problems with right arm, pain. On 23Mar2021 the patient had a brain infarct, on 24Mar2021 another brain infarct, loss of right leg and arm, half of the right face, could not speak a word anymore. Later swallowing problem, on an unspecified date. The patient was hospitalized for these events. The outcome of these events was fatal. It was also reported that the patient had left cerebral infarction. His vaccination was put in left leg. Therapeutic measures were taken as a result of Pain in arm, patient was treated with Bloedverdunners and weakness in extremity which was treated with Bloedverdunners (as reported). Additional information: This remained until 23Mar21 a cerebral infarction, 24Mar21 another cerebral infarction, loss of right leg and arm, half of the face on the right, could not speak a word anymore, later swallowing problem. Diagnostic procedures: No link was made. They were doing it now. 2x CT scan; blood values and urine values (all with unknown results). The patient died on 09Apr2021. It was not reported if an autopsy was performed. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Left cerebral infarction. Vaccination was put in left leg.; later swallowing problem; 3.5 weeks after the vaccination (19Feb2021) problems with right arm, pain; 3.5 weeks after vaccination (19Feb2021) suffered from right arm strength loss


VAERS ID: 1284392 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute coronary syndrome, Arrhythmia, Body temperature, Fatigue, Pyrexia, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-11
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210410; Test Name: body temperature; Result Unstructured Data: Test Result:37.5 to 38 Centigrade
CDC Split Type: NLPFIZER INC2021473839

Write-up: Patient died suddenly on Sunday evening 11Apr/unclear what causes death; Possible acute coronary syndrome/fatal cardiac arrhythmia; Possible acute coronary syndrome/fatal cardiac arrhythmia; Fatigue; Fever: 37.5 to 38 degrees Celsius; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. The regulatory authority report number is NL-LRB-00517449. An 80-year-old male patient received the second dose of bnt162b2 (COMIRNATY, Lot number was not reported), via an unspecified route of administration on 09Apr2021 as 0.3 mL, single dose for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. No previous COVID-19 infection. The patient previously received the first dose of bnt162b2 (Lot number was not reported) on 11Mar2021 for covid-19 immunization. On 10Apr2021, the following day after the second dose vaccination, the patient experience fever: 37.5 to 38 degrees Celsius treated with paracetamol and fatigue, both recovered on 11Apr2021. On 11Apr2021, patient died suddenly on Sunday evening 11Apr and unclear what causes death. It is unclear what causes death. Patient died sitting in his chair in his room. There was no family or concern with this. Possible acute coronary syndrome/fatal cardiac arrhythmia. Given the Pfizer vaccine, thrombosis and pulmonary embolism are very unlikely as a cause of death. However, we cannot completely rule out a relationship between death and vaccination. The fever and fatigue may have triggered something that caused patient rapid deterioration. The patient died on 11Apr2021. It was not reported if an autopsy was performed. Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty). Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): yes. ADRs: Unknown. Date: 11Mar2021. Patient suddenly passed away on Sunday evening 11Apr. No follow-up attempts are possible, information on lot/batch number cannot be obtained.; Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty). Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): yes. ADRs: Unknown. Date: 11Mar2021. Patient suddenly passed away on Sunday evening 11Apr.; Reported Cause(s) of Death: Patient died suddenly on Sunday evening 11Apr/unclear what causes death; Possible acute coronary syndrome/fatal cardiac arrhythmia; Possible acute coronary syndrome/fatal cardiac arrhythmia


VAERS ID: 1284393 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-19
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ESOMEPRAZOL [ESOMEPRAZOLE]; CALCI BONE D3
Current Illness: Breast cancer metastatic (gemetastaseerd mammaca)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021473956

Write-up: Died 12 hours later while asleep; This is a spontaneous report from a contactable physician downloaded from regulatory authority-WEB, regulatory authority number is NL-LRB-00517457. A 74-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on 19Apr2021 (Batch/Lot Number: Unknown) at single dose 9at the age of 74 years old) for COVID-19 immunisation; pertuzumab;trastuzumab (PERTUZUMAB;TRASTUZUMAB), via an unspecified route of administration from 14Apr2021 (Batch/Lot Number: Unknown) to an unspecified date, at 60/60MG/ML for an unspecified indication. Medical history included ongoing breast cancer metastatic (gemetastaseerd mammaca). Concomitant medications included esomeprazol [esomeprazole] (ESOMEPRAZOL [ESOMEPRAZOLE]) and calcium carbonate, colecalciferol (CALCI BONE D3), both taken for an unspecified indication, start and stop date were not reported. The patient died 12 hours later while asleep following administration of covid-19 vaccine Pfizer injection. The action taken for pertuzumab;trastuzumab was not applicable. The patient died on 19Apr2021. Autopsy final report follows: there was especially no thrombosis/pulmonary embolism skull autopsy report follows, there would be some congestion in liver and lungs and "a somewhat weak heart", 1 mm pupil difference, further so far gb, it is also not certain that there is a causal relationship between death and vaccination or whether there may be an interaction between pertuzumab/trastuzimab and the vaccine (5 days in between), patient had diarrhea from the pertuzumab /trastuzimab as with previous administrations, but just mobile and felt fit during the day, still has prepared a hotcoldrex before going to sleep so Pt felt a bit unwell. Reporter''s Comment: Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no. Died 12 hours later while asleep. Additional information ADR: no autopsy so far. BSN available: yes. Confounding factors: metastatic breast. Previous COVID-19 infection: No. Autopsy final report follows: there was especially no thrombosis/pulmonary embolism skull autopsy report follows, there would be some congestion in liver and lungs and "a somewhat weak heart", 1 mm pupil difference, further so far gb, it is also not certain that there is a causal relationship between death and vaccination or whether there may be an interaction between pertuzumab/trastuzimab and the vaccine (5 days in between), patient had diarrhea from the pertuzumab /trastuzimab as with previous administrations, but just mobile and felt fit during the day, still has prepared a hotcoldrex before going to sleep so Pt felt a bit unwell. No follow-up attempts are possible; information on batch number cannot be obtained.; Reported Cause(s) of Death: Died 12 hours later while asleep


VAERS ID: 1284396 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-05
Onset:2021-04-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Computerised tomogram, Dyspnoea, Malaise, Myalgia, Pneumonia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-18
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OMEPRAZOLE; METFORMIN; ACETYLSALICYLIC ACID; INSULIN ASPART; AMLODIPINE; ASCAL BRISPER CARDIO NEURO; COZAAR; FUROSEMIDE; ASCAL CARDIO; ATORVASTATIN; ALENDRONIC ACID [ALENDRONATE SODIUM]; INSULIN ASPART PROTAMINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes
Allergies:
Diagnostic Lab Data: Test Name: CT scan; Result Unstructured Data: Test Result:leaking heart valves; Comments: leaking heart valves, fluid in places where it should not be, septic pneumonia etc
CDC Split Type: NLPFIZER INC2021473859

Write-up: OtherAE_2: septic pneumonia; OtherAE_1: Dyspnoea; Not feeling well; Pain in the joints; Muscle pain; COVID-19 LIM This is a non-interventional study report from a contactable consumer downloaded from a regulatory authority-WEB NL-LRB-COVID-00517976, received from Regulatory Authority. A 78-year-old female subject received bnt162b2 (COMIRNATY), via an unspecified route of administration on 05Apr2021 (Batch/Lot Number: Unknown) at age of 78-year-old as 0.3 mL, single for covid-19 immunisation. Medical history included diabetes. Concomitant medications included omeprazole (OMEPRAZOLE) taken for an unspecified indication from 28Jun2017 to an unspecified stop date; metformin (METFORMIN) taken for an unspecified indication from 11Nov2019 to an unspecified stop date; acetylsalicylic acid (ACETYLSALICYLIC ACID) taken for an unspecified indication from 29May2018 to an unspecified stop date; insulin aspart (INSULIN ASPART) taken for an unspecified indication from 22Nov2018 to an unspecified stop date; amlodipine (AMLODIPINE) taken for an unspecified indication from 05Oct2017 to an unspecified stop date; carbasalate calcium (ASCAL BRISPER CARDIO NEURO) taken for an unspecified indication from 28Jun2017 to an unspecified stop date; losartan potassium (COZAAR) taken for an unspecified indication from 24Nov2016 to an unspecified stop date; furosemide (FUROSEMIDE) taken for an unspecified indication from 02Jun2017 to an unspecified stop date; carbasalate calcium (ASCAL CARDIO) taken for an unspecified indication from 28Jun2017 to an unspecified stop date; atorvastatin (ATORVASTATIN) taken for an unspecified indication from 28Jun2017 to an unspecified stop date; alendronate sodium (ALENDRONIC ACID) taken for an unspecified indication from 22Nov2013 to an unspecified stop date; insulin aspart protamine (INSULIN ASPART PROTAMINE) taken for an unspecified indication from 08Jan2015 to an unspecified stop date. The subject experienced otherae_1: dyspnoea, otherae_2: septic pneumonia (death, life threatening) on 13Apr2021, muscle pain on 06Apr2021 with outcome of recovered on 08Apr2021, not feeling well on 08Apr2021 with outcome of not recovered, pain in the joints on 06Apr2021 with outcome of recovered on 08Apr2021. Treatment: Dyspnoea is treated with lots of agents, oxygen, generalized joint pain is treated with paracetamol and pneumonia is treated with oxygen. The subject has not recovered from malaise, recovered from generalized joint pain, recovered from myalgia, the outcome of dyspnoea is fatal and the outcome of pneumonia is fatal. Case Summary and Reporter''s Comments: Muscle pain, Reaction.Treatment: No. Impact qualify of life: slightly. Pain in the joints, Reaction.Treatment: Yes, with: paracetamol. Impact quality of life: Very. Not feeling well, Reaction.Treatment: No. other: stuffy. Impact qualify of life: Very much. OtherAE_1: Dyspnoea: unable to breathe. Reaction.Treatment: Yes, with: lots of resources, oxygen. mild traumatic brain injury: different treatments have been used, oxygen, antibiotics. the complaint concerned several organs, none of the treatments was successful. OtherAE_2: septic pneumonia. Reaction.Treatment: Yes, with: oxygen. Impact qualify of life: Very much. Other: diagnostic procedures: CT (computed tomography) scan. Result: leaking heart valves, fluid in places where it should not be, septic pneumonia etc etc. Immediately after the scan my mother heard that the doctors knew no further treatment. She herself was very clear and approachable, but her organs were failing. On 18Apr2021, the respiration stopped and my mother passed away. And that while she has not had a cold during the entire corona period. We asked whether the vaccination could have caused this and received the honest answer that the doctors still knew too little about the effect of the vaccine to answer this. My mother will therefore go into the books as the umpteenth deceased of the so-called underlying suffering. Previous COVID-19 infection: No. It is unknown if autopsy was done. The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. ; Reported Cause(s) of Death: Dyspnoea; Pneumonia


VAERS ID: 1284419 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-13
Onset:2021-03-26
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Ecchymosis, Lividity, Petechiae
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-26
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021473933

Write-up: Lividity of limbs; Skin ecchymosis (arms and face); Dyspnoea; petechiae on the hands and face; This is a spontaneous report a contactable physician downloaded from the Regulatory Authority. An 86-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 13Mar2021 15:59 (Batch/Lot Number: ER7812; Expiration Date: 30Jun2021) as SINGLE DOSE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On March 26, 2021 at 07:00, the patient experienced petechiae on the hands and face, dyspnoea (the day before death, the emergency medical team was called - the patient refused to go to the hospital). Lividity of limbs, Skin ecchymosis (arms and face) was reported. The outcome of the event petechiae on the hands and face was unknown. The patient died on 26Mar2021. The events lividity, skin ecchymosis, and dyspnoea were considered as fatal. It was not reported if an autopsy was performed. Description of complications: death on March 26, 2021. The reporting person classified them as severe. The URPL also classified the report as severe (death). Sender Comment:Dyspnoea, possibly associated with bruising of the limbs (as a result of hypoxia), petechiae that occurred approximately 2 weeks after vaccination, are an unexpected side effect of Comirnaty. At present, Comirnaty vaccine is associated with the occurrence of immune thrombocytopenia, which may manifest as petechiae, but the association has also not been confirmed. Dyspnoea is a symptom that is not specific and it is difficult to determine its cause based on the available data. Therefore, a causal relationship between the occurrence of symptoms and the administration of the vaccine cannot be assessed. There is a time relationship between the administration of the vaccine and the occurrence of the reaction. The reporting person classified them as severe. URPL also classified the application as heavy. Drug-reaction(s) / Event(s) Matrix for the events Result of Assessment :Unclassifiable Lot number and expiry date already obtained. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Lividity of limbs; Skin ecchymosis (arms and face); Dyspnoea


VAERS ID: 1284420 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-04-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2243 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021473931

Write-up: Death; This is a spontaneous report a contactable physician downloaded from the regulatory authority-WEB [regulatory authority PL-URPL-3-579-2021]. A 92-year-old female patient received the second dose of bnt162b2 (COMIRNATY, lot number: EW2243, expiration date: 17Apr2021), intramuscular, administered in arm left on 13Apr2021 14:10 (at the age of 92-years-old) as 0.3 mL, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced death on 14Apr2021 07:00. The outcome of the event was fatal. The patient died on 14Apr2021. It was unknown if an autopsy was performed. Reaction(s) / Event(s) Assessed Unclassifiable. Sender Comment: In this case, an anaphylactic reaction that may occur up to 24 hours after vaccination cannot be ruled out, but usually occurs within the first hour after vaccination, most often in the first seconds or minutes after vaccination (1). Due to the insufficient amount of information, the causal relationship between the administration of the vaccine and the occurrence of death has not been assessed. There is a time relationship between the administration of the vaccine and the occurrence of death. The reporting person classified them as severe. HA also classified the application as heavy. (1). Adverse Events Following Immunization No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death


VAERS ID: 1284421 (history)  
Form: Version 2.0  
Age: 100.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-10
Onset:2021-03-29
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-30
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021473943

Write-up: Stroke; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority report number: PL-URPL-3-592-2021. A 100-year-old female patient received first dose of bnt162b2 (COMIRNATY), intramuscular, administered in left arm on 10Mar2021 13:17 (lot number: ER7812) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced stroke 19 days after vaccination on 29Mar2021 at 01:00. The outcome of the event was fatal. It is not known whether ischemic or hemorrhagic, because due to the patient''s advanced age and poor prognosis, the family decided not to hospitalize her. The patient died the next day on 30Mar2021. It was not reported if an autopsy was performed. Physician reporting an Adverse Drug Reaction because the event occurred within 4 weeks of vaccination. The reporting person classified it as severe. URPL classified the report as ''severe'' due to the reporter''s assessment, the nature of the adverse reaction and the patient''s death. Sender''s comments: The reported adverse reactions are unexpected in the Summary. Until 18Apr2021, 11 cases of Haemorrhagic Stroke and 17 cases of Ischaemic Stroke have been reported in Regulatory Authority with a patient death outcome. Regulatory Authority does not have information on possible additional circumstances (drugs used, chronic diseases, allergies, etc.) that could have resulted in the adverse reactions described. The temporal relationship argues for a cause and effect relationship. The reporting person classified the report as serious. URPL classified the report as ''severe'' due to the reporter''s assessment, the nature of the adverse reactions and the death of the patient. Reaction event assess: Method of assessment: Result of Assessment: Possible No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Stroke


VAERS ID: 1284565 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-12
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Acute respiratory failure, Atypical pneumonia, Computerised tomogram, Computerised tomogram thorax, Dizziness, Dyspnoea, Electrocardiogram, General physical health deterioration, Interstitial lung disease, Lung infiltration, Myocardial infarction, Oxygen saturation, Peripheral swelling, Pneumonia, Pulmonary fibrosis, Pulmonary oedema, X-ray
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Angioedema (broad), Interstitial lung disease (narrow), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: AZARGA; ALENDRONAT TEVA; AMLODIPINE TEVA; ATORVASTATIN MYLAN; MONOPROST; OMEPRAZOL TEVA [OMEPRAZOLE]; TROMBYL
Current Illness: Bowen''s disease; Hypertension; Osteoporosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: CT thorax; Result Unstructured Data: Test Result:pulmonary fibrosis; Test Date: 2021; Test Name: CT pulmonary; Result Unstructured Data: Test Result:atypical pneumonia; Comments: suspected pulmonary fibrosis/UIP, inflammatory infiltrates and failure. Honeycombing and traction bronchiectasis bilaterally; Test Date: 2021; Test Name: ECG; Result Unstructured Data: Test Result:inferior STEMI; Test Date: 2021; Test Name: saturation; Result Unstructured Data: Test Result:impaired; Test Date: 2021; Test Name: X-ray; Result Unstructured Data: Test Result:atypical pneumonia; Comments: suspected pulmonary fibrosis/ UIP, inflammatory infiltrates and failure. Honeycombing and traction bronchiectasis bilaterally
CDC Split Type: SEPFIZER INC2021473975

Write-up: Pulmonary fibrosis; Dyspnoea; acute respiratory failure; acute pneumonia; atypical pneumonia; UIP; inflammatory infiltrates and failure; ST-lift/ inferior STEMI; heart attack; pulmonary edema; Her condition slowly deteriorates; legs swell; dizzy; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is SE-MPA-2021-025506 and the safety report unique identifier is SE-VISMA-1617867730677. An 83-year-old female patient received her first dose of BNT162B2 (COMIRNATY, lot number and expiration date were not provided), via an unspecified route of administration on 12Mar2021 at single dose for COVID-19 immunisation. Medical history included hypertension, osteoporosis, and Bowen''s disease which were all ongoing. Concomitant medications included brinzolamide, timolol maleate (AZARGA) eye drops, suspension, alendronate sodium (ALENDRONAT TEVA) tablet, amlodipine besilate (AMLODIPINE TEVA) tablet, atorvastatin calcium (ATORVASTATIN MYLAN) film-coated tablet, latanoprost (MONOPROST), omeprazole (OMEPRAZOL TEVA) gastro-resistant capsule, hard, and acetylsalicylic acid (TROMBYL) tablet. The patient experienced pulmonary fibrosis and dyspnea on Mar2021. After vaccination with COMIRNATY, the patient experienced increasing dyspnea. CT thorax on Mar2021 showed pulmonary fibrosis. After two weeks of dyspnea, the patient was admitted to a hospital from an unspecified date in 2021. Her condition slowly deteriorated, her legs swelled, hyponametry (as reported) and impaired saturation on an unspecified date in 2021. She was treated with oxygen. The patient got dizzy breathing (as reported) and was treated with FURIX and FRAGMIN as thrombosis prophylaxis. X-rays and CT pulmonary on an unspecified date in 2021 showed atypical pneumonia, suspected pulmonary fibrosis /UIP, inflammatory infiltrates and failure. Honeycombing and traction bronchiectasis bilaterally. She received CPAP treatment and continued treatment with antibiotics and prednisolone. About a week after admission, on an unspecified date in 2021, the patient suddenly had ST-lift and a heart attack was suspected. ECG showed inferior STEMI on an unspecified date in 2021. They tried to open the patient''s RCA without success. The condition continued to worsen, and pulmonary edema developed on an unspecified date in 2021. The patient died on an unspecified date in 2021. The causes of death were acute respiratory failure, acute pneumonia due to pulmonary fibrosis, and dyspnea. Autopsy was not performed. The outcome the event "her condition slowly deteriorates" was not recovered and unknown for all other events. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Acute pneumonia; Acute respiratory failure; Pulmonary fibrosis; Dyspnoea


VAERS ID: 1286900 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-04-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-23
   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: Adipositas per magna (magna obesity); Continuous positive airway pressure (CPAP with OSAS); COPD; Coronary artery disease (KHK [coronary heart disease]); Fibrillation cardiac (Flicker arrhythmia); Hypertension arterial (art hypertension); Obstructive sleep apnea syndrome (CPAP with OSAS)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021478244

Write-up: Sudden Cardiac Death; This is as spontaneous report received from a contactable physician downloaded from the regulatory authority. The regulatory authority report number AT-BASGAGES-2021-23973. A 72-year-old male patient received first dose of bnt162b2 (COMIRNATY; solution for injection, lot and expiry were not reported), intramuscular on 22Apr2021 17:00 as single dose for covid-19 immunisation. Medical history included hypertension arterial (art hypertension); Adipositas per magna (magna obesity); continuous positive airway pressure (CPAP) with obstructive sleep apnea syndrome (OSAS); fibrillation cardiac (flicker arrhythmia); coronary artery disease (KHK [coronary heart disease]); and chronic obstructive pulmonary disease (COPD), all were ongoing. The patient''s concomitant medications were not reported. On 23Apr2021 at 05:29, the patient experienced sudden cardiac death. The physician assessed the case as serious. The patient died on 23Apr2021 at 05:29 from sudden cardiac death. It was unknown if autopsy was done. Senders comments: BASGAGES-comment: Follow-up information has been requested. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: sudden cardiac death


VAERS ID: 1286925 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-03-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Bradycardia, Cerebrovascular accident, Computerised tomogram head, Death, Fall, Gaze palsy, Heart rate, Hemiparesis, Ischaemic stroke, NIH stroke scale
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Accidents and injuries (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Ocular motility disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-27
   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: ASPIRIN CARDIO; DAFALGAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic sclerosis; Articulation problem; Atrioventricular block; Complete right bundle branch block; Diastolic dysfunction; Extrasystoles supraventricular; Hip prosthesis insertion (right); Hip prosthesis insertion (left); Muscular weakness; Sinus pause; Stroke; Transient ischaemic attack; Transient ischemic attack
Allergies:
Diagnostic Lab Data: Test Date: 20210326; Test Name: Computerised tomogram head; Result Unstructured Data: Test Result:left sylvian ischemic stroke on distal M1 M2; Comments: left cerebral ischemic stroke on distal M1 M2 thrombus with partial distal recovery. Discrete cortico-subcortical dedifferentiation. ASPECT score 7 - 8. Left superficial cerebral perfusional mismatch. No hemorrhagic component.; Test Date: 20210326; Test Name: heart rate; Result Unstructured Data: Test Result:32/min; Test Date: 20210326; Test Name: NIHSS score; Result Unstructured Data: Test Result:20
CDC Split Type: CHPFIZER INC2021479557

Write-up: died; a stroke of the superficial territory left middle cerebral artery/ left cerebral stroke, severe, with a NIHSS to 20 suggesting an occlusion of the middle cerebral artery and ischaemic stroke; a stroke of the superficial territory left middle cerebral artery/ left cerebral stroke, severe, with a NIHSS to 20 suggesting an occlusion of the middle cerebral artery and ischaemic stroke; fell to the ground; right motor hemi-syndrome and gaze deviation; bradycardia at 32/min; hemi-syndrome noted first as right facio-brachiocrural and hemineglect; This is a spontaneous report received from a contactable physician via a regulatory authority. Regulatory authority report number CH-SM-2021-13985. A 93-year-old male patient received bnt162b2 (COMIRNATY, dose 2) intramuscular on 25Mar2021 (lot number: EP9605) as SINGLE DOSE for COVID-19 immunization. Medical history included transient ischaemic attack, loss of strength in the left upper extremity, sinus pauses, language impairment in the form of difficulty articulating, all in May2020; atrioventricular block from Jun2019 to an unknown date (atrioventricular block 1 and complete D branch block, preoperative cardiac workup aortic sclerosis, BBD, BAV I, frequent SVS), complete right bundle branch block from Jun2019 to an unknown, aortic sclerosis from Jun2019 to an unknown date, diastolic dysfunction grade I, extrasystoles supraventricular from Jun2019 to an unknown date, transient ischaemic attack and amnesic stroke from 1988 to an unknown date; and transient ischaemic attack from 1989 to an unknown date; and hip prosthesis insertion (left) in Oct2019 and right in Jul2019. The patient does not smoke and consume alcohol, has no allergies or intolerances. Concomitant medications included ongoing acetylsalicylic acid (ASPIRIN CARDIO, strength: 100 mg); ongoing paracetamol (DAFALGAN, strength: 1 g). The patient previously took dose 1 of bnt162b2 (COMIRNATY, lot number: EK9788) on 24Feb2021, intramuscular for COVID-19 immunization. On 26Mar2021, the patient fell to the ground and found with a right motor hemi-syndrome and gaze deviation. On arrival of the ambulance, the patient presented severe phasic disorder, with incomprehension disorder and jargon aphasia, forced deviation of the gaze and eyes to the left, a hemi-syndrome noted first as right facio-brachiocrural and hemineglect. During the trip to the ER, bradycardia at 32/min was noted. The events resulted in emergency room visit. On arrival at the emergency room, a stroke of the superficial territory left middle cerebral artery/ left cerebral stroke, severe, with a NIHSS to 20 suggesting an occlusion of the middle cerebral artery and ischaemic stroke noted and confirmed with an occlusion in M1 - M2, at the angio-CT, with on the CT perfusion already areas stuffed, and a territory in penumbra greater than 50%. Thrombolysis with Actilyse (67.5mg) and endovascular surgery were performed under general anesthesia. Intraparenchymal and intraventricular mass bleeding occurred during the procedure. The patient was extubated for a palliative care procedure. The respiratory situation worsened over time, which is why palliative therapy with morphine (1 mg / h) was initiated. The patient underwent lab tests and procedures which included computerised tomogram head which showed left sylvian ischemic stroke on distal M1 M2, left cerebral ischemic stroke on distal M1 M2 thrombus with partial distal recovery. Discrete cortico-subcortical dedifferentiation. ASPECT score 7 - 8. Left superficial cerebral perfusional mismatch. No hemorrhagic component; NIHSS score of 20, all on 26Mar2021. The patient died on the morning of 27Mar2021. An autopsy was not performed. The outcome of a stroke of the superficial territory left middle cerebral artery/ left cerebral stroke, severe, with a NIHSS to 20 suggesting an occlusion of the middle cerebral artery and ischaemic stroke was fatal while the other events was unknown. The causal relationship between Comirnaty and events death and ischaemic stroke was assessed as unrelated. This case was reported as serious (medically significant). Sender''s comment: Large elderly patient (93 years old) died after receiving the 2nd dose of Comirnaty following of an ischemic stroke that occurred the day after vaccination, complicated by an intraparenchymal and intraventricular hemorrhage during thrombectomy surgery. The monographs do not mention ischemic strokes following administration of the vaccine among possible adverse events. A search in a publication did not reveal any additional data. However, the patients with COVID-19 disease have an increased risk of developing strokes, especially of the ischemic type (1) ischemic strokes. Advanced age, as well as antecedents for which the patient is known (TIA, cardiac balance) are among the possible risk factors for stroke. In view of the risk factors predisposing the patient to develop stroke, to the little evidence in the literature, despite the temporal correlation of 1 day between administration and the event of ischemic stroke, at the state of current knowledge we judge the causal role of the Comirnaty vaccine with the ischemic stroke and the death of the patient as unrelated. This judgment of causality does not, however, exclude completely the role of the vaccine. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the available information the events death and ischaemic stroke are attributed to patient''s advanced age and multiple underlying medical conditions including transient ischaemic attack and assessed unrelated to BNT162B2 (COMIRNATY) vaccine.; Reported Cause(s) of Death: a stroke of the superficial territory left middle cerebral artery/ left cerebral stroke, severe, with a NIHSS to 20 suggesting an occlusion of the middle cerebral artery and ischaemic stroke; a stroke of the superficial territory left middle cerebral


VAERS ID: 1286936 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-18
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-18
   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: Osteochondrosis; Venous thrombosis NOS
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021473578

Write-up: Exitus letalis; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB [regulatory authority number:DE-PEI-202100042980]. An 80-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 09Apr2021 (Batch/Lot Number: Unknown) as a single dose for COVID-19 immunization. Medical history included venous thrombosis NOS from Nov2020 and ongoing and osteochondrosis from Nov2020 and ongoing. The patient''s concomitant medications were not reported. The patient experienced exitus letalis (sudden death)/sudden death unexplained on 18Apr2021. The patient died on 18Apr2021. It was unknown if an autopsy was performed. This report is serious - death, life threatening. Causality assessment: D. Unclassifiable by Regulatory Authority. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Exitus letalis


VAERS ID: 1286940 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-28
Onset:2021-04-12
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: CT thorax; Result Unstructured Data: Test Result:showed fulminant right heart strain and a severely; Comments: showed fulminant right heart strain and a severely hypertrophied left ventricle.
CDC Split Type: DEPFIZER INC2021478252

Write-up: fatal pulmonary embolism; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB DE-PEI-202100045148. This is a report received from the Regulatory Authority A 72-year-old female patient received bnt162b2 (COMIRNATY) at the age of 72-years-old, via an unspecified route of administration on 28Mar2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced fatal pulmonary embolism on 12Apr2021. The patient underwent lab tests and procedures which included computerised tomogram: showed fulminant right heart strain and a severely hypertrophied left ventricle on an unspecified date. The patient died on 12Apr2021. It was not reported if an autopsy was performed. The outcome of the event was fatal. Reporter comment: CT thorax rescue service in emergency physician accompaniment during ongoing resuscitation: Continuation of resuscitation according to guidelines with regular administration of epinephrine and rhythm analysis every 2 minutes. Continue PEA, intermittent sinus rhythm with palpable peripheral pulses, then ROSC. Then after 1-2 minutes PEA again and start CPR measures with administration of epinephrine. A total of 3 green accesses, 2 left hand, 1 right foot. A norepinephrine as well as epinephrine perfusor was applied. -1 st overview ultrasonography - showed fulminant right heart strain and a severely hypertrophied left ventricle. We opt for lysis in the differential diagnosis pulmonary artery embolism. Bel sinus rhythm and a clearly palpable peripheral pulse, the decision was then made to perform a CT of the lungs with CT and a cranial CT scan. There central to subsegmental pulmonary artery embolism loaded . In addition, contrast pooling in the dorsal hepatic veins was seen in the recumbent position as an indication of very limited pumping capacity of the heart. The extensive soft tissue emphysema on both sides pectoral with rupture of the right pectoralis muscle and rib series fracture of the 2,-6th rib ipsilateral, the sternal fracture as well as the ventral mantle pneumothorax on the right side were considered to be a consequence of cardiopulmonary resuscitation because the patient did not show any abnormalities in the physical examination at the beginning. After completion of the CT scan, asystole was evident on transport to the shock room. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Summary of reporter''s comments: Continuation of resuscitation according to guidelines with regular administration of epinephrine and rhythm analysis every 2 minutes. Continue PEA, intermittent sinus rhythm with palpable peripheral pulses, then ROSC. Opted for lysis in the differential diagnosis pulmonary artery embolism. Bel sinus rhythm and a clearly palpable peripheral pulse, the decision was then made to perform a CT of the lungs with CT and a cranial CT scan.; Reported Cause(s) of Death: Lung embolism


VAERS ID: 1286947 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-04-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021483945

Write-up: Pulmonary embolism; This is a spontaneous report from a non-contactable other hcp downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DE-PEI-202100046888. A 67-years-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 20Apr2021 (Batch/Lot Number: EW8904) as 0.3 mL, single for covid-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient''s weight was not reported, and height was not reported. On 20Apr2021 the patient experienced Pulmonary embolism. The patient''s outcome was: fatal for Pulmonary embolism. The patient died on 20Apr2021. It was not reported if an autopsy was performed. Causal relationship between the adverse event(s) and the administration of COMIRNATY was assessed as unclassifiable by the Regulatory Authority. No follow-up attempts needed/possible, follow-up automatically provided by Regulatory Authority. ; Reported Cause(s) of Death: Pulmonary embolism


VAERS ID: 1286952 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-22
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021473561

Write-up: Stroke on the day after vaccination, death 11 days after vaccination; Dizziness; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority. regulatory authority number DE-PEI-CADR2021053047. An 82-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 09Apr2021 (Batch/Lot Number: Unknown) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. 10Apr2021, the patient experienced stroke on the day after vaccination, death 11 days after vaccination and dizziness. The outcome of the event dizziness was not recovered. The patient died on 22Apr2021. An autopsy was not performed. Sender Comment: Are you or the person concerned known of any allergies? If yes, which? No. Information on risk factors or previous illnesses None. / Dizziness, gait, speech and swallowing impairment, admission to neurology, worsening up to death. Causality assessment: D. Unclassifiable. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Stroke


VAERS ID: 1286953 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-20
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-09
   Days after onset: 20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021478554

Write-up: death; Dyspnoea; This is a spontaneous report from a non-contactable consumer downloaded from the Agency Regulatory Authority-WEB. Regulatory authority report number DE-PEI-CADR2021053430. An 86-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 17Mar2021 (Lot Number: ER7812, unknown expiration) at 0.3 ml, single for COVID-19 immunisation. Medical history included reported as none. The patient''s concomitant medications were not reported. The patient experienced dyspnoea on 20Mar2021. The experienced death on 09Apr2021 due to unknown cause. The patient had not yet recovered from dyspnoea. It was unknown if an autopsy was performed. The events were assessed by Regulatory Authority as "D. Unclassifiable" to COMIRNATY. Sender Comment: Do you or the person concerned have any known allergies? If yes, which ones? No. Information on risk factors or previous illnesses: None / Both parents are deceased. No follow-up attempts are possible; information about batch number was already obtained.; Reported Cause(s) of Death: death


VAERS ID: 1286958 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19; Result Unstructured Data: Test Result:Positive 3 weeks
CDC Split Type: DEPFIZER INC2021480459

Write-up: passed away; Two months later he experienced corona/had the mutant B.1.1.7; Two months later he experienced corona/had the mutant B.1.1.7; This is a spontaneous report from a contactable consumer based on information received by Pfizer from Biontech [manufacturer control number: 47508], license party for Comirnaty. A male patient of an unspecified age received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on Dec2020 (Batch/Lot number was not reported) as single dose, then dose 2 via an unspecified route of administration on Jan2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, two months later, the patient experienced corona. He was positive for 3 weeks and infected me, his daughter and his carer. In the 4th week the patient passed away. The patient had the mutant B.1.1.7. The patient died on an unspecified date. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: passed away


VAERS ID: 1286959 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-27
Onset:2021-04-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   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: DEPFIZER INC2021482893

Write-up: myocardial infarction; This is a spontaneous report from a non-contactable physician. This is a report based on information received by Pfizer from Biontech [manufacturer control number: 47250], license party for BNT162B2. A 56-year-old male patient received BNT162B2 (COMIRNATY), dose 1 via an unspecified route of administration on 27Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 28Apr2021, the patient experienced myocardial infarction. The patient died on 28Apr2021 one day after his first vaccination due to myocardial infarction. It was unknown if an autopsy was performed. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender''s Comments: Based on the limited information provided, causality relationship cannot be clearly established and cannot be excluded. The case will be reassessed should additional information become available.~ The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. ; Reported Cause(s) of Death: myocardial infarction


VAERS ID: 1286960 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (brother and niece/mutant B.1.1.7.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021484019

Write-up: got corona with the Mutant B.1.1.7; got corona with the Mutant B.1.1.7; This is a spontaneous report from a contactable consumer (patient''s niece). This is a report based on information received by Pfizer, COMIRNATY. The consumer reported similar events for two patients, this is the second of two reports. A female patient of an unspecified age received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included patient''s brother had the vaccination with Biontech in Dec 2020/ Jan 2021. Two months later (2021) he experienced corona, had the mutant B.1.1.7. He was positive for 3 weeks and infected his daughter (niece) and his carer. In the 4th week he passed away. The patient''s concomitant medications were not reported. The patient experienced got corona with the mutant b.1.1.7 and died on an unspecified date. It was not reported if an autopsy was performed. Information on lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-2021480459 Same reporter/drug, similar events, different patients; Reported Cause(s) of Death: got corona with the Mutant B.1.1.7; got corona with the Mutant B.1.1.7


VAERS ID: 1286974 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-04-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood sodium, C-reactive protein, Haemoglobin, Infection, Loss of consciousness, White blood cell count
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-11
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: TOLTERODINE; FRAGMIN; PREDNISOLONE; METOPROLOLSUCCINAT HEXAL; OXYCODONE; ONDANSETRON; PANTOPRAZOLE; METHADONE; GABAPENTIN; LORAZEPAM; IBUPROFEN; ZOPICLONE; TRASTUZUMAB; ALENDRONIC ACID; LAXOBERAL; CITALOPRAM; GANGIDEN; PARACETAMOL; CALCIUM
Current Illness: Breast cancer metastatic (metastasis to lungs); Decreased appetite; Dizziness; Osteopenia; Palliative care; Vomiting
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Pneumonia (hospitalised a couple of times wiht pneumonia and bloody sputum)
Allergies:
Diagnostic Lab Data: Test Date: 20210408; Test Name: Sodium; Result Unstructured Data: Test Result:128 mmol/L; Test Date: 20210408; Test Name: C-reactive protein; Result Unstructured Data: Test Result:425 mg/l; Test Date: 20210408; Test Name: Hemoglobin; Result Unstructured Data: Test Result:5.5 mmol/L; Test Date: 20210408; Test Name: Leucocyte count; Result Unstructured Data: Test Result:65; Comments: Unit not specfied; Test Date: 20210408; Test Name: Leucocyte count; Result Unstructured Data: Test Result:57.1 x10 9/l
CDC Split Type: DKPFIZER INC2021483954

Write-up: suddenly unconscious and dies 2 days after; Infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. A 45-years-old female patient received second dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: ET3674; Expiration Date: 31Jul2021) intramuscular on 07Apr2021 as a single dose for COVID-19 immunization. Medical history included dizziness, decreased appetite and vomiting (from Apr2021 and ongoing), breast cancer metastatic from 2014 and ongoing (metastasis to lungs), pneumonia from 2020 to an unknown date (hospitalized a couple of times with pneumonia and bloody sputum), atrial fibrillation (from an unknown date and unknown if ongoing), ongoing palliative care and osteopenia. Concurrent condition included depression, neuropathic pain, constipation, pain, heart rate irregular, gastric ulcer and urination difficulty. The patient had no fever in the days up to vaccination. Concomitant medications included citalopram (CITALOPRAM) taken for depression from 15Apr2014, gabapentin (GABAPENTIN) taken for neuralgia from 20Nov2018, ibuprofen (IBUPROFEN) taken for pain from 18Jan2020, pantoprazole (PANTOPRAZOLE) taken for gastric ulcer from 09Apr2020, paracetamol (PARACETAMOL) taken for pain from 02May2020, sodium picosulfate (LAXOBERAL) taken for constipation from 26Jun2020, metoprolol succinate (METOPROLOLSUCCINAT HEXAL) taken for heart rate irregular from 14Oct2020, dalteparin sodium (FRAGMIN) taken for thrombosis prophylaxis from 16Oct2020, tolterodine (TOLTERODINE) taken for dysuria from 06Nov2020, zopiclone (ZOPICLONE) taken for insomnia from 06Nov2020, prednisolone (PREDNISOLONE) taken for adrenocortical steroid therapy from 29Dec2020, methadone (METHADONE) taken for pain from 29Dec2020, ondansetron (ONDANSETRON) taken for prophylaxis of nausea and vomiting from 06Jan2021, oxycodone (OXYCODONE) taken for pain from 29Jan2021, macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (GANGIDEN) taken for constipation from 29Jan2021 and lorazepam (LORAZEPAM) taken for sedative therapy from 05Feb2021. All medications were administered till an unspecified stop date. On an unspecified date, patient took trastuzumab (TRASTUZUMAB) taken for palliative care, alendronic acid (ALENDRONIC ACID) and triamcinolone hexacetonide (TRICA) for an unknown indication and calcium carbonate, vitamin D NOS (CALCIUM + VIT D) taken for vitamin supplementation. The patient previously took Gemcitabin for palliative care. Patient received first dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: ER2659; Expiration Date: 30Jun2021) intramuscular on 17Mar2021 as a single dose previously for COVID-19 immunization. The patient had an infection on 08Apr2021 and was hospitalized. The patient underwent lab tests and procedures which included blood sodium: 128 mmol/l, c-reactive protein: 425 mg/l, haemoglobin: 5.5 mmol/l, white blood cell count: 65 (Unit not specified) and white blood cell count: 57.1 x10 9/l. Therapeutic measures were taken because of infection. On 09Apr2021, patient was suddenly unconscious. On 11Apr2021, treatment with piperacillin/tazobactam was started. The patient died on 11Apr2021 due to infection and suddenly unconscious. No autopsy has been performed due to the circumstances. Outcome of the event suddenly unconscious was not recovered as the patient died 2 days after. The physician reported this event due to the severity of the case but stated that the causality between vaccination and the death is less likely. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Infection


VAERS ID: 1286976 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatine phosphokinase MB, Blood pressure measurement, C-reactive protein, Condition aggravated, Decreased appetite, Dysgeusia, Dysphagia, Dyspnoea, Fall, Glomerular filtration rate, Heart rate, Hypoaesthesia oral, Hypotension, Influenza A virus test, Influenza B virus test, Myocardial infarction, N-terminal prohormone brain natriuretic peptide, Peripheral swelling, Platelet count, SARS-CoV-2 test, Troponin I, Vomiting
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Dehydration (broad), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-05
   Days after onset: 4
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: TRIFAS [TORASEMIDE]; VERAPAMIL
Current Illness: Atrial fibrillation; Congestive heart failure; Hearing loss; Hip prosthesis user (prosthesis in the right hip joint due to arthrosis); Prostatic hyperplasia; Radiculopathy; Spinal stenosis; Umbilical hernia; Vision decreased
Preexisting Conditions: Medical History/Concurrent Conditions: Appendectomy (At a young age); Hip prosthesis insertion; Overweight; Rehabilitation therapy; Varicose vein operation; Varicose veins of lower extremities (on both legs)
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: CK-MB; Result Unstructured Data: Test Result:114 mcg/l; Test Date: 20210405; Test Name: blood pressure; Result Unstructured Data: Test Result:80/70, low mmHg; Test Date: 202104; Test Name: CRP; Result Unstructured Data: Test Result:109 g/l; Test Date: 202104; Test Name: eGFR; Result Unstructured Data: Test Result:44; Test Date: 20210405; Test Name: pulse; Result Unstructured Data: Test Result:120 xmin; Test Date: 20210405; Test Name: Influenza A virus test; Test Result: Negative ; Test Date: 20210405; Test Name: Influenza B virus test; Test Result: Negative ; Test Date: 202104; Test Name: proBNP; Result Unstructured Data: Test Result:23 502 ng/L; Test Date: 20210405; Test Name: platelet count; Result Unstructured Data: Test Result:200, normal; Test Date: 20210405; Test Name: SARS-CoV-2 PCR test; Test Result: Negative ; Test Date: 202104; Test Name: Tnl; Result Unstructured Data: Test Result:68 907 ng/L
CDC Split Type: EEPFIZER INC2021478328

Write-up: Hypotension; Myocardial infarction/sudden cardiac death over asystole (ineffective resuscitation); Fall; Decreased appetite; Vomiting; shortness of breath, dificulty breathing, decreased load capacity; swelling of the legs worsened; worsening of chronic cardiovascular insufficiency; Swallowing difficult; Dysgeusia; numbness in his mouth; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB, regulatory authority number EE-SAM-34222104154. An 86-year-old male patient received bnt162b2 (COMIRNATY), intramuscular second dose on 01Apr2021 12:00 (Batch/Lot Number was not provided) at 0.3 mL, single for covid-19 immunisation. The patient''s medical history included ongoing Umbilical hernia, Appendectomy (At a young age), ongoing Vision decreased, ongoing Hip prosthesis user (prosthesis in the right hip joint due to arthrosis), ongoing Prostatic hyperplasia, ongoing Radiculopathy, ongoing Hearing loss, ongoing Congestive Heart failure, ongoing Spinal stenosis, Varicose veins of lower extremities (on both legs), ongoing Atrial fibrillation, rehabilitation at hospital in 2016, Hip joint surgery, varicose veins operations, and overweight. The patient''s concomitant medications included torasemide (TRIFAS [TORASEMIDE]) and verapamil. On 05Apr2021, the patient experienced hypotension and myocardial infarction. On 03Apr2021, the patient experienced decreased appetite, vomiting. On 01Apr2021, the patient experienced swallowing difficult, dysgeusia, and worsening of chronic cardiovascular insufficiency. On 04Apr2021 22:00, the patient experienced fall. On 02Apr2021, the patient shortness of breath, dificulty breathing, decreased load capacity, swelling of the legs worsened. In Apr2021, the patient numbness in his mouth. The event was also described as follows: On 01Apr2021, the patient had a bad tasted in his mouth, had difficulty swallowing. On 02Apr2021, the patient complained of bad taste when eating, shortness of breath, difficulty breathing, decreased load capacity, swelling of the legs worsened. He denies chest pain in the last week On 03Apr2021, the patient did not want to eat, in the evening began to vomit. On 04Apr2021, the patient did not eat, in the evening fell at 22:00, could not get up. On 05Apr2021, his blood pressure was low (80/70 mmHg), pulse 120x/min; an ambulance was called. The patient was hospitalized. He died at 4:15 pm on suspicion of a thrombus or heart attack. the patient was hospitalized on an emergency basis due to heart failure and probable heart attack of unknown time. At 16.25 exitus letalis - sudden cardiac death over asystole (ineffective resuscitation). A few days before getting into the emergency department (he doesn''t remember exactly when) he felt a numbness in his mouth (Apr2021), there were no pain in his throat or neck. Feeling worse in recent days. A medical history may indicate that the condition worsened after the 2nd dose of Comirnaty, but complaints rather indicated worsening of chronic cardiovascular insufficiency and possible concomitant unspecified infection. The patient underwent lab tests and procedures which included CK-MB: 114 mcg/l on Apr2021, CRP: 109 g/l on Apr2021, eGFR: 44 on Apr2021, influenza a virus test: negative on 05Apr2021, influenza b virus test: negative on 05Apr2021, proBNP: 23 502 ng/l on Apr2021, platelet count: 200, normal on 05Apr2021, SARS-CoV-2 PCR test: negative on 05Apr2021, Tnl: 68 907 ng/l on Apr2021. Based on the marked increase in cardiac markers, it can be said that the patient had damage to the heart muscle. The increase in CRP may have been due to an infection with an unclear origin or extensive damage to the heart muscle. It remains unclear whether post-vaccination reactions were already due to myocardial infarction or subsequent myocardial infarction; vomiting and others were side effects of the vaccine. The event hypotension and myocardial infarction caused hospitalization on 05Apr2021 and emergency room visit. The patient died on 05Apr2021. An autopsy was performed and results were not provided. The outcome of the event numbness in his mouth was unknown. The outcome of the other events was fatal. Sender Comment: Serious side effect with fatal outcome. An additional data revealed that this was a myocardial infarction and the causal link is considered doubtful.; Reported Cause(s) of Death: sudden cardiac death over asystole (ineffective resuscitation); Hypotension; Decreased appetite; Swallowing difficult; Dysgeusia; Vomiting; Fall; shortness of breath, dificulty breathing, decreased load capacity; swelling of the legs worsened; worsen


VAERS ID: 1286980 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-03-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Clostridium test positive, Culture stool, Diarrhoea, Muscle strain, Respiratory distress, Respiratory fatigue, SARS-CoV-2 antibody test, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Pseudomembranous colitis (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (already overcome the Covid infection); COVID-19 (already overcome the Covid infection); Dyslipidaemia; Gallbladder disease NOS (admitted for gallbladder problems); Hiatus hernia; Paroxysmal atrial fibrillation; Renal disorder (resolved)
Allergies:
Diagnostic Lab Data: Test Name: Stool culture; Result Unstructured Data: Test Result:Detection of C. difficile toxin A: POSITIVE.; Comments: Detection of C. difficile toxin A: POSITIVE. BILIS SAMR aerobic bacteriological culture: Positive; Test Date: 20210222; Test Name: COVID-19 antibody test; Test Result: Positive ; Test Date: 20210315; Test Name: COVID-19 antibody test; Test Result: Positive ; Test Date: 20210331; Test Name: COVID-19 antigen test; Test Result: Negative
CDC Split Type: ESPFIZER INC2021431587

Write-up: Detection of C. difficile toxin A: POSITIVE, BILIS SAMR aerobic bacteriological culture: Positive; fatigued breathing; rib strain; Diarrhea; Respiratory distress, acute decrease of saturation; This is as spontaneous report received from a contactable pharmacist downloaded from the Regulatory Authority-WEB. The regulatory authority report number is ES-AEMPS-812998. An 89-year-old male patient received the first dose of BNT162B2 (COMIRNATY, lot number: EW2239; expiration date: 31Jul2021), intramuscularly on 30Mar2021 11:00 (at 89-year-old) at single dose for COVID-19 immunisation. Medical history included covid-19 from 22Feb2021, hiatus, covid-19 from 15Mar2021, Paroxysmal atrial fibrillation, dyslipidaemia. The patient had already overcome the Covid infection in Feb2021 and Mar2021. He had been admitted for gallbladder problems and has had covid-19 sequelae at the renal level that had resolved. The patient''s concomitant medications were not reported. The patient previously took fluoxetine, enoxaparin sodium (INHIXA, 4.000 UI (40 MG)/0.4 ML injectable solution), acetylsalicylic acid (ADIRO, 300MG gastroresistant tablets EFG), omeprazole (OMEPRAZOLE), bisoprolol. The patient experienced diarrhea (hospitalization) on 30Mar2021, respiratory distress, acute decrease of saturation (hospitalization) on 30Mar2021. Clinical details: the patient was administered the covid-19 vaccine on 30Mar2021 at 11:00 am (yesterday), on 31Mar2021 at around 6am (today), the social health center where he resided informed that the patient was suffering from fatigued breathing, rib strain, oxygen desaturation, after administering medication to alleviate the symptoms and there was no improvement, it was decided to admit him to hospital. The patient underwent lab tests and procedures which included culture stool: Detection of C. difficile toxin A: POSITIVE, BILIS SAMR aerobic bacteriological culture: Positive on an unspecified date, COVID-19 antibody test: positive on 22Feb2021, COVID-19 antibody test: positive on 15Mar2021, COVID-19 antigen test: negative on 31Mar2021. The outcome of the events was recovering. The patient died on 30Mar2021 (as reported). The cause of death was reported as cardiorespiratory arrest. It was unknown if autopsy was done.; Reported Cause(s) of Death: Cardiorespiratory arrest


VAERS ID: 1286999 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-04-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Activated partial thromboplastin time ratio, Alanine aminotransferase, Amylase, Basophil count, Blood bilirubin, Blood creatine phosphokinase, Blood creatinine, Blood fibrinogen, Blood glucose, Blood lactate dehydrogenase, Blood potassium, Blood sodium, Blood urea, C-reactive protein, Chest X-ray, Computerised tomogram head, Electrocardiogram, Eosinophil count, Haematocrit, Haemoglobin, Haemolysis, Heart rate, International normalised ratio, Ischaemic stroke, Jaundice, Lipaemic index score, Lymphocyte count, Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean cell volume, Mean platelet volume, Monocyte count, Neutrophil count, Platelet count, Prothrombin level, Prothrombin time, Red blood cell count, Red cell distribution width, SARS-CoV-2 test, SARS-CoV-2 test negative, Scan brain, Troponin T, White blood cell count
SMQs:, Cholestasis and jaundice of hepatic origin (narrow), Haemolytic disorders (narrow), Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-20
   Days after onset: 4
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: Medical History/Concurrent Conditions: COVID-19; Flutter atrial; Glaucoma; Hypertensive heart disease; Hypoacusis; Macular degeneration; Comments: Ha pasado la COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210416; Test Name: Activated partial thromboplastin time; Test Result: 35.5 s; Test Date: 20210416; Test Name: Activated partial thromboplastin time ratio; Result Unstructured Data: Test Result:1.12; Test Date: 20210416; Test Name: GPT; Result Unstructured Data: Test Result:7.9 IU/l; Test Date: 20210416; Test Name: Amylase; Result Unstructured Data: Test Result:36 IU/l; Test Date: 20210416; Test Name: Absolute basophils; Result Unstructured Data: Test Result:0.02 x10 9/l; Test Date: 20210416; Test Name: Basophils; Test Result: 0.2 %; Test Date: 20210416; Test Name: Total bilirubin; Test Result: 0.73 mg/dl; Test Date: 20210416; Test Name: Creatine kinase; Result Unstructured Data: Test Result:61 IU/l; Test Date: 20210416; Test Name: Creatinine; Test Result: 0.98 mg/dl; Test Date: 20210416; Test Name: Derivative fibrinogen; Test Result: 411 mg/dl; Test Date: 20210416; Test Name: Glucose; Test Result: 113.2 mg/dl; Test Date: 20210416; Test Name: LDH; Result Unstructured Data: Test Result:212 IU/l; Test Date: 20210416; Test Name: Potassium; Result Unstructured Data: Test Result:3.96 mEq/l; Test Date: 20210416; Test Name: Sodium; Result Unstructured Data: Test Result:139 mEq/l; Test Date: 20210416; Test Name: Urea; Test Result: 41.2 mg/dl; Test Name: Chest X-ray; Result Unstructured Data: Test Result:cardiomegaly; Test Name: Brain CT scan; Result Unstructured Data: Test Result:no findings of acute intracranial pathology; Comments: Diffuse parenchymal shrinkage. Signs of cerebral microangiopathy; Test Date: 20210416; Test Name: C-reactive protein; Result Unstructured Data: Test Result:2.74 mg/l; Test Name: electrocardiogram; Result Unstructured Data: Test Result:atrial fibrillation at 100 bpm; Test Date: 20210416; Test Name: Absolute eosinophils; Result Unstructured Data: Test Result:1.19 x10 9/l; Test Date: 20210416; Test Name: Eosinophils; Test Result: 13.1 %; Test Date: 20210416; Test Name: Hematocrit; Test Result: 45.7 %; Test Date: 20210416; Test Name: Hemoglobin; Result Unstructured Data: Test Result:16 g/dl; Test Date: 20210416; Test Name: Hemolysis rate; Test Result: 3 mg/dl; Test Name: heart rate; Result Unstructured Data: Test Result:100; Comments: bpm; Test Date: 20210416; Test Name: INR; Result Unstructured Data: Test Result:1.55; Test Date: 20210416; Test Name: Jaundice index; Test Result: 1 mg/dl; Test Date: 20210416; Test Name: Lipemic rate; Test Result: 11 mg/dl; Test Date: 20210416; Test Name: Absolute lymphocytes; Result Unstructured Data: Test Result:2.82 x10 9/l; Test Date: 20210416; Test Name: Lymphocytes; Test Result: 31.2 %; Test Date: 20210416; Test Name: Mean corpuscular hemoglobin erythrocyte; Test Result: 32.1 pg; Test Date: 20210416; Test Name: Mean corpuscular erythrocyte corpuscular hemoglobin concentration; Result Unstructured Data: Test Result:35 g/dl; Test Date: 20210416; Test Name: Mean corpuscular volume; Result Unstructured Data: Test Result:91.6 fl; Test Date: 20210416; Test Name: Mean platelet volume; Result Unstructured Data: Test Result:10.8 fl; Test Date: 20210416; Test Name: Absolute monocytes; Result Unstructured Data: Test Result:0.88 x10 9/l; Test Date: 20210416; Test Name: Monocytes; Test Result: 9.7 %; Test Date: 20210416; Test Name: Absolute neutrophils; Result Unstructured Data: Test Result:4.14 x10 9/l; Test Date: 20210416; Test Name: Neutrophils; Test Result: 45.8 %; Test Date: 20210416; Test Name: Platelets; Result Unstructured Data: Test Result:232 x10 9/l; Test Date: 20210416; Test Name: Prothrombin activity; Test Result: 56 %; Test Date: 20210416; Test Name: Prothrombin time; Test Result: 17.3 s; Test Date: 20210416; Test Name: Red blood cells; Result Unstructured Data: Test Result:4.99 x10 12/l; Test Date: 20210416; Test Name: Extent of erythrocyte distribution; Test Result: 14.9 %; Test Date: 20210417; Test Name: SARS-CoV-2 PCR test; Result Unstructured Data: Test Result:Negative; Test Date: 20210416; Test Name: COVID-19 antigen test negative; Result Unstructured Data: Test Result:Negative; Test Date: 20210419; Test Name: Scan brain; Result Unstructured Data: Test Result:No intra or extraaxial bleeding outbreaks; Comments: or early signs of acute ischemia are observed. Midline not displaced. Basal and peritroncular free cisterns. Signs of cerebral microangiopathy.; Test Date: 20210416; Test Name: Troponin T ultrasensitive; Result Unstructured Data: Test Result:47.15 ng/L; Test Date: 20210416; Test Name: Leukocytes; Result Unstructured Data: Test Result:9.05 x10 9/l
CDC Split Type: ESPFIZER INC2021478250

Write-up: Ischaemic stroke; This is a spontanoeus report from a contactable pharmacist downloaded from the regulatory authority [ES-AEMPS-840326]. A 92-year-old male patient received the second dose of bnt162b2 (COMIRNATY, Lot Number: EW4815) via an unspecified route of administration on 16Apr2021 (at the age 92-year-old) as single dose for COVID-19 immunization. Medical history included COVID-19, macular degeneration, hypoacusis, flutter atrial, glaucoma and hypertensive heart disease. The patient''s concomitant medications were not reported. The patient previously took omeprazole, atorvastatin, ramipril, acenocoumarol (SINTROM), furosemide (SEGURIL), dutasteride, tamsulosin hydrochloride (DUODART) and bimatoprost, timolol maleate (GANFORT). The patient previously received the first dose of bnt162b2 (COMIRNATY, Lot Number: ER9470) on 26Mar2021 as single dose for COVID-19 immunization. The patient experienced ischaemic stroke on 16Apr2021. The patient was hospitalized on unspecified date due to the event. Further reported as follows: This male patient who on 16Apr2021, after waking up from a nap, suffered an abrupt loss of consciousness with no subsequent recovery until the time of anamnesis. A few hours before this episode he was immunized with the second dose of Covid-19 vaccine. Coma with extensor response of right extremities and left lower extremity to pain. Mild withdrawal movement with left upper extremity to pain. Left pupil myotic, right not assessable due to previous cataract surgery. The patient emitted some unintelligible sound. No spontaneous eye opening. Bilateral extensor cutaneous-plantar reflex. Flaccid right hemiplegia and flaccid left hemiparesis. In the emergency room: Rest without alterations of interest. Sars-Cov-2 rapid antigen test (16Apr2021): negative and SARS-CoV-2 PCR test (17Apr2021): negative. Electrocardiogram on unspecified date: atrial fibrillation at 100 bpm. Chest X-ray on unspecified date: cardiomegaly. Brain CT scan on unspecified date: no findings of acute intracranial pathology at the present time. Diffuse parenchymal shrinkage. Signs of cerebral microangiopathy. Clinical judgment: Probable vertebrobasilar ischemic stroke. Poor functional and vital prognosis in the short/medium term. Exitus on 20Apr2021. Scan brain (19Apr2021): It is compared with previous study of 2019. No intra or extraaxial bleeding outbreaks or early signs of acute ischemia are observed. Midline not displaced. Basal and peritroncular free cisterns. The ventricular system has a discreetly enlarged size, but according to the enlargement of the cortical furrows. Small hypodensive lesions, patched, in periventricular white substance, compatible with ischemic-degenerative lesions. Calcified atheromatosis of both carotid siphons. Bone structures without significant alterations. Occupation of both external auditory canals by dense soft tissue material in probable relation to cerumen. Signs of cerebral microangiopathy. On 16Apr2021, laboratory tests were as follows: Red blood cells 4.99 x 10e12/L 4.3-5.8; Hemoglobin 16 g/dl 13-17.8; Hematocrit 45.7 % 41-52; Mean corpuscular volume 91.6 fL 80-96; Mean corpuscular hemoglobin erythrocyte 32.1 pg 26-33; Mean corpuscular erythrocyte corpuscular hemoglobin concentration 35 g/dl 31-36; Extent of erythrocyte distribution 14.9 % 11-15.5; Leukocytes 9.05 x 10e9/L 4-12; Neutrophils % 45.8 % 45-75; Absolute neutrophils 4.14 x 10e9/L 1.8-7.5; Lymphocytes % 31.2 % 22-50; Absolute lymphocytes 2.82 x 10e9/L 1-4.5; Monocytes % 9.7 % 3.4-10; Absolute monocytes 0.88 x 10e9/L 0.2-1; Eosinophils % 13.1* % 0-7; Absolute eosinophils 1.19* x 10e9/L 0-0.6; Basophils % 0.2 % 0-1.5; Absolute basophils 0.02 x 10e9/L 0-0.2; Platelets 232 x 10e9/L 150-450; Mean platelet volume 10.8 fl 8-13. Prothrombin activity 56 * % 70-120; Prothrombin time 17.3 * sec 10-15; INR 1.55 * 0.7-1.2; Activated partial thromboplastin time (aPTT) 35.5 sec 26-42; Activated partial thromboplastin time (aPTT). Ratio 1.12 0.75-1.2; Derivative fibrinogen 411 mg / dl 150-600. CLINICAL CHEMISTRY: Glucose 113.2 * mg / dl 65-110; Urea 41.2 mg / dl 10-50; Creatinine 0.98 mg / dl 0.6-1.4; Total bilirubin 0.73 mg / dl 0.1-1.2; Sodium 139 mEq/l 135-145; Potassium 3.96 mEq/l 3.5-5.3; LDH 212 IU/l 135-225; Creatine kinase (CK) 61 IU/l 24-195; GPT 7.9 IU/l 5-40; Amylase 36 IU/l 10-100; Troponin T ultrasensitive 47.15 * ng/l 0-14; Hemolysis rate. 3 mg/dl 0-35; Lipemic rate 11 mg/dl 0-300; Jaundice index 1 mg/dl 0-10. C-reactive protein 2.74 mg/l -6. The patient died on 20Apr2021. Cause of death was Ischaemic stroke. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Ischaemic stroke


VAERS ID: 1287000 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-18
Onset:2021-04-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW9127 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-20
   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: SINTROM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ischemic stroke (Treated with Sintrom)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021484496

Write-up: Hemorrhage intracranial; This is a spontaneous report from a contactable pharmacist downloaded from the Agency Regulatory Authority-WEB, regulatory authority number ES-AEMPS-840727. A 74-years-old female patient received BNT162B2 (COMIRNATY), dose 1 via an unspecified route of administration on 18Apr2021 (Batch/Lot Number: EW9127) as single dose for covid-19 immunisation. Medical history included ischaemic stroke from Oct2020 to an unknown date (Treated with SINTROM). Concomitant medication(s) included acenocoumarol (SINTROM) taken for anticoagulant therapy from an unspecified start date and ongoing. The patient died on 20Apr2021 as a result of intracranial hemorrhage. 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: Hemorrhage intracranial


VAERS ID: 1287014 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-20
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Cardiac failure; Diabetes
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021483942

Write-up: Death unexplained; This is a spontaneous report from a contactable physician, downloaded from the regulatory authority, Regulatory Authority Report Number: FR-AFSSAPS-AM20211084. A 79-years-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 15Apr2021 (Batch/Lot Number: EW4815) in right deltoid, as single dose for COVID-19 immunization. Medical history included diabetes, cardiac failure and arterial hypertension. The patient''s concomitant medications were not reported. The patient had an unexplained death on 20Apr2021, where the patient was discovered at home without further information. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1287144 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-03-10
   Days after vaccination:68
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Acute respiratory failure, Angiotensin converting enzyme, Anti-cyclic citrullinated peptide antibody, Antineutrophil cytoplasmic antibody, Antinuclear antibody, COVID-19 pneumonia, Chlamydia test, Complement factor, Complement factor C3, Complement factor C4, Condition aggravated, Cytomegalovirus test, Epstein-Barr virus test, HIV test, Influenza A virus test, Influenza B virus test, Interstitial lung disease, Investigation, Legionella test, Pneumonia, Rheumatoid factor, SARS-CoV-2 test, Serology test, Shock, Urine analysis
SMQs:, Anaphylactic reaction (narrow), Interstitial lung disease (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-03
   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: KARDEGIC; TAHOR; VALSARTAN; MOPRAL [OMEPRAZOLE]; NEBIVOLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Bentall procedure; Bilateral inguinal hernia; Heart failure (ETT: LV ejection fraction: 35%; minimal HVG, no RV dysfunction); Hypercholesterolemia; Implantable defibrillator insertion (Installation of Automatic Implantable Defibrillator DAI); Interstitial pneumonitis; Mitral valve repair (Aortic bioprosthesis + mitral annuloplasty in 2016, for bicuspid); Prostatectomy; Prosthesis implantation (Aortic bioprosthesis + mitral annuloplasty in 2016, for bicuspid); Tachycardia ventricular (Several episodes of postoperative ventricular tachycardia)
Allergies:
Diagnostic Lab Data: Test Name: angiotensin converting enzyme; Result Unstructured Data: Test Result:normal; Test Name: Anti-CCP antibodies; Test Result: Negative ; Test Name: Anti-neutrophil cytoplasm antibody; Test Result: Negative ; Test Name: Anti-nuclear antibodies; Result Unstructured Data: Test Result:Anti-nuclear antibodies 1/80 without specificity; Comments: without anti-DNA; Test Name: Chlamydiae psittacci serology; Test Result: Negative ; Test Name: CH50; Result Unstructured Data: Test Result:normal; Test Name: C3; Result Unstructured Data: Test Result:normal; Test Name: C4; Result Unstructured Data: Test Result:normal; Test Name: PCR CMV; Test Result: Negative ; Test Name: EBV PCR; Result Unstructured Data: Test Result:Weakly positive blood; Comments: 2.85 log (713 copies / mL); Test Name: HIV serology; Test Result: Negative ; Test Name: influenza A; Test Result: Negative ; Test Name: influenza B; Test Result: Negative ; Test Name: Anti B2 GpI antibodies; Result Unstructured Data: Test Result:IgM negative; Comments: IgG doubtful; control in progress; Test Name: Anti MBG; Test Result: Negative ; Test Name: Blood aspergillary antigenemia and LBA:; Test Result: Negative ; Test Name: legionella antigenuria; Test Result: Negative ; Test Name: rheumatoid factor; Test Result: Negative ; Test Name: PCR COVID-19; Test Result: Negative ; Test Name: Mycoplasma pneumoniae serology; Test Result: Negative ; Test Name: Q fever serology; Test Result: Negative ; Test Name: pneumococcal antigenuria; Test Result: Negative
CDC Split Type: FRPFIZER INC2021478243

Write-up: Interstitial pneumonitis; Condition aggravated; acute respiratory failure; nosocomial pulmonary superinfection; severe ARDS; post-ARDS [acute respiratory distress syndrome] shock; hypothesis of post-vaccination inflammatory pneumonia Covid-19; This is a spontaneous report received from a contactable pharmacist downloaded from ta regulatory authority-WEB. The regulatory authority report number is FR-AFSSAPS-BX20213604. A 68-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 01Mar2021 (Batch/Lot Number: Unknown) as single dose for COVID-19 immunisation; amiodarone hydrochloride (CORDARONE), oral from Jan2021 (Batch/Lot Number: Unknown) to 22Mar2021, at 200 mg for arrhythmia. Medical history included aortic bioprosthesis + mitral annuloplasty in 2016, for bicuspid, several episodes of postoperative ventricular tachycardia, installation of Automatic Implantable Defibrillator DAI, heart failure in Jan2021 (ETT [trans-thoracic echocardiography]: LV ejection fraction: 35%; minimal HVG [left ventricular hypertrophy], no RV dysfunction), arterial hypertension, hypercholesterolemia, Bilateral inguinal hernia, Bentall procedure, Prostatectomy, interstitial pneumonitis. No information available on a history of infection with SARS-CoV-2, nor on the performance of screening tests. Concomitant medications included acetylsalicylate lysine (KARDEGIC), atorvastatin calcium (TAHOR), valsartan, omeprazole (MOPRAL [OMEPRAZOLE]), nebivolol (NEBIVOLOL) taken for unspecified indications, start and stop dates were not reported. The patient previously received bnt162b2 (COMIRNATY), dose 1 on 02Feb2021 (Batch/Lot Number: Unknown) for COVID-19 immunisation. The patient experienced interstitial pneumonitis, condition aggravated on 10Mar2021. On 10Mar2021 (9 days after second dose): hospitalization for dyspnea worsening for several weeks. Respiratory degradation during hospitalization, transfer to intensive care unit on 21Mar2021. Supported using Sedation, curarization, respiratory assistance in prone position for severe ARDS [acute respiratory distress syndrome (in adults)]. Initiation of a test corticosteroid therapy at 1 mg / kg from 22Mar2021. Evolution: Death on 03Apr2021 from post-ARDS [acute respiratory distress syndrome] shock. Diagnostic hypothesis: acute respiratory failure on probable nosocomial pulmonary superinfection of an ARDS on acute interstitial pneumonia, possibly drug related to amiodarone. The hypothesis of post-vaccination inflammatory pneumonia Covid-19 is also raised by the resuscitator. Additional tests on an unspecified date includes: Negative legionella antigenuria, Negative pneumococcal antigenuria, Q fever serology negative, Chlamydiae psittacci serology negative, Mycoplasma pneumoniae serology negative, HIV serology: negative, Blood aspergillary antigenemia and AML: negative, PCR COVID-19, influenza a and influenza B: negative, Weakly positive blood EBV PCR at 2.85 log (713 copies / mL), PCR CMV blood negative, Anti-nuclear antibodies 1/80 without specificity without anti-DNA, Anti-neutrophil cytoplasm antibody negative, Anti MBG negative, Anti-CCP antibodies and rheumatoid factor negative, Anti B2 GpI antibodies: IgM negative, IgG doubtful; control in progress, C3 C4 CH50 normal, and Normal angiotensin converting enzyme. The action taken in response to the events for amiodarone hydrochloride was permanently withdrawn on 22Mar2021. The patient died on 03Apr2021. An autopsy was not performed. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained; Reported Cause(s) of Death: post-ARDS shock; Interstitial pneumonitis; Condition aggravated; acute respiratory failure; nosocomial pulmonary superinfection; severe ARDS; hypothesis of post-vaccination inflammatory pneumonia Covid-19


VAERS ID: 1287145 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-03-01
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body mass index, COVID-19 pneumonia, Gene sequencing, Polymerase chain reaction, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-23
   Days after onset: 52
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Obesity (Body mass index 30); Renal transplant (with immunosuppressive therapy)
Allergies:
Diagnostic Lab Data: Test Name: BODY MASS INDEX; Result Unstructured Data: Test Result:30; Test Date: 20210324; Test Name: Sequencing; Result Unstructured Data: Test Result:V3 variant; Comments: (WGS 20J / 501Y.V3).; Test Date: 20210324; Test Name: PCR; Result Unstructured Data: Test Result:POSITIVE
CDC Split Type: PFIZER INC2021483951

Write-up: Vaccination failure; COVID-19 pneumonia; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AFSSAPS-BX20213667. A 54-years-old male patient received first dose of bnt162b2 (COMIRNATY Batch/Lot Number: EJ6788), intramuscular on 27Jan2021 as 1 DF, single, second dose intramuscular on 24Feb2021 (Batch/Lot Number: EJ6789) as 1 DF, single for covid-19 immunisation. Medical history included renal transplant with immunosuppressive therapy, hypertension, obesity Body mass index 30. The patient''s concomitant medications were not reported. On 24Mar2021, The patient experienced vaccination failure and On Mar2021, experienced covid-19 pneumonia. On 25Mar2021, the patient was hospitalized, and he was discharged from the hospital on 29Mar2021. On 01Apr2021, the patient was admitted directly in intensive care and he died on 23Apr2021. From 25Mar2021 to an unknown date the patient was hospitalized for vaccination failure and covid-19 pneumonia. The patient underwent lab tests and procedures which included body mass index: 30 on, gene sequencing: v3 variant on 24Mar2021 (WGS 20J / 501Y.V3), polymerase chain reaction: positive on 24Mar2021. It was not reported if an autopsy was performed. On 23Apr2021, The patient was died. No FU attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19 pneumonia; Vaccination failure


VAERS ID: 1287146 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-04-14
   Days after vaccination:70
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-23
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac disorder; Obesity; Respiratory disorder
Allergies:
Diagnostic Lab Data: Test Date: 20210418; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:positive
CDC Split Type: FRPFIZER INC2021483956

Write-up: severe COVID-19; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-BX20213668. Brief dossier, no further information available. A 69-years-old male patient received first dose of BNT162B2 (COMIRNATY, solution for injection, Lot no: EJ6134, expiration date: unknown) via an intramuscular route of administration on 03Feb2021 at single dose and second dose of BNT162B2 (COMIRNATY, solution for injection, Lot no: EJ6789, expiration date: unknown) via an intramuscular route of administration on 25Feb2021 at single dose for COVID-19 immunization. Patient medical history included obesity, cardiac disorder and respiratory disorder. Concomitant medications were not reported. On 14Apr2021 about a month and a half after vaccination patient experienced severe covid-19 (death, hospitalization), vaccination failure (death). The patient was hospitalized for severe covid-19 from 18Apr2021 to an unknown date. On19Apr2021 patient was transfer to intensive care unit with 100% Optiflow oxygen therapy. On 22Apr2021 intubation patient Condition considered severe. Therapeutic measures were taken as a result of severe covid-19. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 18Apr2021, Sequencing pending. The patient died on 23Apr2021.It was not reported if an autopsy was performed. ; Reported Cause(s) of Death: vaccination failure; severe COVID


VAERS ID: 1287149 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-03-09
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Adjusted calcium, Altered state of consciousness, Blood calcium, Blood creatinine, Blood glucose, Blood potassium, Blood sodium, Blood urea, C-reactive protein, COVID-19, Dehydration, Glomerular filtration rate, Haemoglobin, Hypernatraemia, Mood altered, N-terminal prohormone brain natriuretic peptide, Platelet count, Pneumonia, Respiratory failure, SARS-CoV-2 test, Troponin, Vaccination failure, White blood cell count
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (narrow), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 22
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: RAMIPRIL; KARDEGIC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Carcinoma skin (of right leg); Carotid artery atheroma; Glaucoma (chronic); Optic nerve disorder (optic nerve degeneration); Prostate adenoma (benign prostatic hyperplasia treated with surgery); TIA
Allergies:
Diagnostic Lab Data: Test Date: 20210329; Test Name: Blood corrected calcium; Result Unstructured Data: Test Result:2.43 mmol/L; Test Date: 20210329; Test Name: Blood calcium; Result Unstructured Data: Test Result:2.33 mmol/L; Test Date: 20210329; Test Name: Creatinine; Result Unstructured Data: Test Result:119 umol/l; Comments: stable renal failure; Test Date: 20210329; Test Name: Blood glucose; Result Unstructured Data: Test Result:7.01 mmol/L; Test Date: 20210329; Test Name: Blood potassium; Result Unstructured Data: Test Result:4.4 mmol/L; Comments: normal; Test Date: 20210329; Test Name: Blood sodium; Result Unstructured Data: Test Result:154 mmol/L; Comments: hypernatremia; Test Date: 20210329; Test Name: Urea; Result Unstructured Data: Test Result:13.9 mmol/L; Comments: stable renal failure; Test Date: 20210329; Test Name: CRP; Result Unstructured Data: Test Result:134 mg/l; Comments: laboratory signs of inflammation; Test Date: 20210329; Test Name: Glomerular filtration rate; Result Unstructured Data: Test Result:44 ml/min; Comments: stable renal failure; Test Date: 20210329; Test Name: Hemoglobin; Result Unstructured Data: Test Result:147 g/l; Comments: no anemia; Test Date: 20210329; Test Name: Pro-BNP; Result Unstructured Data: Test Result:15255; Test Date: 20210329; Test Name: Platelet count; Result Unstructured Data: Test Result:243 x10 9/l; Test Date: 20210323; Test Name: PCR COVID-19 test; Result Unstructured Data: Test Result:negative; Test Date: 20210329; Test Name: RT PCR COVID-19 test; Result Unstructured Data: Test Result:positive; Comments: target 1 (protein envelope) at 13.2 and target 2 (nucleocapsid protein ) at 14.2; Test Date: 20210329; Test Name: SARS-CoV2 variant screening; Result Unstructured Data: Test Result:UK variant VOC202012/01; Test Date: 20210329; Test Name: Troponin; Result Unstructured Data: Test Result:112; Test Date: 20210329; Test Name: Leukocyte count; Result Unstructured Data: Test Result:11.4 x10 9/l; Comments: laboratory signs of inflammation
CDC Split Type: FRPFIZER INC2021483960

Write-up: consciousness disorder; hypernatremia due to dehydration; hypernatremia due to dehydration; general state alteration; Vaccination failure; Covid-19 test returned positive; respiratory failure due to Covid-19 infection; the first signs of pneumonia; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Medicines Agency (MA) -WEB, regulatory authority number FR-AFSSAPS-GR20211364. A 98-year-old male patient received first bnt162b2 (Pfizer vaccine, solution for injection) (Batch/Lot Number: EJ6789) on 05Feb2021 via intramuscular route of administration as 30 ug, at single dose and on 04Mar2021, second dose (Batch/Lot Number: EP2166) as 30 ug, at single dose for covid-19 immunization. A 98-year-old male patient with a medical history of optic nerve degeneration, benign prostatic hyperplasia treated with surgery, right leg carcinoma, transient ischemic attack in Apr2014, carotid artery atheroma, chronic glaucoma. Also prostatic adenoma from an unknown date and unknown if ongoing , TIA from Apr2014 to an unknown date , carcinoma skin from an unknown date and unknown if ongoing , optic nerve disorder from an unknown date and unknown if ongoing , glaucoma from an unknown date and unknown if ongoing , carotid artery atheroma from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced vaccination failure (death) on 29Mar2021. The patient died on 01Apr2021. An autopsy was not performed. Course of the events : On 05Feb2021, first dose of COVID-19 mRNA Vaccine (nucleoside modified) (COMIRNATY) was administered (lot number EJ 6789), followed by the second dose on 04Mar2021 (lot number EP 2166). On 09Mar2021, the patient was hospitalized for general state alteration, and discharged on 23Mar2021 with negative PCR Covid-19 test. On 26Mar2021, the patient presented the first signs of pneumonia. On 29Mar2021, the patient was hospitalized for dyspnea with bronchial congestion and breathing pauses. On the same day, nasopharyngeal real-time polymerase chain reaction (RT-PCR) Covid-19 test returned positive, target 1 (protein envelope) at 13.2 and target 2 (nucleocapsid protein ) at 14.2. SARS-CoV2 variant screening showed the UK variant VOC202012/01. Blood work up in an emergency unit showed no anemia with hemoglobin at 147 g/L and platelets at 243 x 10^9/L, laboratory signs of inflammation with leucocytes at 11.4 x 10^9/L and CRP at 134 mg/L probably related to pulmonary superinfection in the context of Covid-19 infection. Stable renal failure with creatinine at 119 uM (glomerular filtration rate (GFR) at 44ml/min), urea 13.9 mM. Blood electrolytes analysis showed hypernatremia at 154 mM, and normal potassium level at 4.4 mM..Blood glucose was at 7.01 mM, calcium at 2.33 and corrected calcium at 2.43 mM. proBNP was at 15255 and troponins at 112. Overall, the patient was hospitalized for acute respiratory failure due to Covid-19 infection in the context of a general and especially cardiac vulnerability. The patient presented hypernatremia due to dehydration, which contributed to a consciousness disorder. Long-standing treatment included ramipril (unspecified tradename), 5 mg in the morning, DL-lysine acetylsalicylate (KARDEGIC 75 mg, powder for oral solution in sachet dose) 1 sachet at noon. Patient''s family requested only palliative care. On 01Apr2021, the patient presented alternation of long breathing pauses followed by polypnea with agitation. Patient passed away. The outcome of the event general state alteration was recovered on 23Mar2021 and other events was fatal. No FU attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19 infection


VAERS ID: 1287165 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-21
   Days after onset: 20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLOR; TRIATEC [HYDROCHLOROTHIAZIDE;RAMIPRIL]; SECTRAL; LEVODOPA; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; CARBOPLATIN;ETOPOSIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Cognitive impairment; Osteoporosis; Small cell lung cancer (in partial remission); Vertebroplasty
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021478245

Write-up: Dyspnea; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB FR-AFSSAPS-MA20211446. Safety Report Unique Identifier FR-AFSSAPS-2021042867. A 79-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 20Apr2021 (at the age of 79-years-old) (Batch/Lot Number: EW4815) as single dose for covid-19 immunisation. Medical history included small cell lung cancer in partial remission , osteoporosis, Arterial hypertension, vertebroplasty from Mar2021, cognitive impairment. The patient received first dose of COMIRNATY on 30Mar2021 for COVID-19 vaccination and no adverse reaction. Concomitant medications included amlodipine besilate (AMLOR); hydrochlorothiazide, ramipril (TRIATEC [HYDROCHLOROTHIAZIDE;RAMIPRIL]); acebutolol hydrochloride (SECTRAL); levodopa (LEVODOPA); macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]); carboplatin;etoposide (CARBOPLATIN;ETOPOSIDE) taken for an unspecified indication from an unspecified start date to 01Apr2021. Death occurred during the night of April 20 to 21 due to dyspnea. The patient died on 21Apr2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information requested.; Reported Cause(s) of Death: Dyspnea


VAERS ID: 1287169 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-03-31
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood alkaline phosphatase, Blood bilirubin, Blood calcium, Blood creatine phosphokinase, Blood creatinine, Blood fibrinogen, Blood lactate dehydrogenase, Blood potassium, Blood pressure measurement, Blood sodium, Blood urea, Body temperature, C-reactive protein increased, Coma scale, Computerised tomogram, Electroencephalogram, Encephalitis, Fibrin D dimer, Gamma-glutamyltransferase, Glomerular filtration rate, HIV antibody, Haemoglobin, Headache, Hypertension, Investigation, Legionella test, Lumbar puncture, Neutrophil count, Platelet count, Polymerase chain reaction, Prothrombin time, SARS-CoV-2 antibody test, White blood cell count
SMQs:, Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (narrow), Hypertension (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   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: STILNOX; BIPRETERAX [INDAPAMIDE;PERINDOPRIL ARGININE]; DOLIPRANE; TRANSIPEG [MACROGOL]; KARDEGIC; SEROPLEX; BISOCE; PERINDOPRIL; ZOLPIDEM; AMLOR; GLUCOSE; KALEORID
Current Illness: Anginal attack; Osteoarthritis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210406; Test Name: neutrophil count; Result Unstructured Data: Test Result:8213; Test Date: 20210331; Test Name: Platelet count; Result Unstructured Data: Test Result:231000; Test Date: 20210331; Test Name: PCR test for covid 19; Result Unstructured Data: Test Result:negative; Test Date: 20210331; Test Name: Prothrombin time; Test Result: 93 %; Test Date: 20210406; Test Name: SARS COV2 serology; Result Unstructured Data: Test Result:Antibody antiprotein S increased at 2245 u/mL; Test Date: 20210331; Test Name: white blood cell; Result Unstructured Data: Test Result:94000; Test Date: 20210406; Test Name: white blood cell; Result Unstructured Data: Test Result:10850; Test Date: 20210331; Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result:normal; Test Date: 20210331; Test Name: Aspartate aminotransferase; Result Unstructured Data: Test Result:normal; Test Date: 20210331; Test Name: Alkaline phosphatase; Result Unstructured Data: Test Result:15; Test Date: 20210331; Test Name: Bilirubin; Result Unstructured Data: Test Result:26; Test Date: 20210331; Test Name: calcium; Result Unstructured Data: Test Result:2.5; Test Date: 20210331; Test Name: CPK; Result Unstructured Data: Test Result:1917; Test Date: 20210406; Test Name: creatinine; Result Unstructured Data: Test Result:394; Test Date: 20210331; Test Name: fibrinogen; Result Unstructured Data: Test Result:4.75; Test Date: 20210331; Test Name: Blood lactate dehydrogenase; Result Unstructured Data: Test Result:272; Test Date: 20210331; Test Name: potassium; Result Unstructured Data: Test Result:2.8; Test Date: 202103; Test Name: blood pressure; Result Unstructured Data: Test Result:200/10; Test Date: 20210331; Test Name: blood pressure; Result Unstructured Data: Test Result:190/80; Test Date: 20210331; Test Name: sodium; Result Unstructured Data: Test Result:134; Test Date: 20210406; Test Name: urea; Result Unstructured Data: Test Result:9.8 then 17; Test Name: Body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210331; Test Name: Body temperature; Result Unstructured Data: Test Result:39 Centigrade; Test Date: 20210406; Test Name: glasgow; Result Unstructured Data: Test Result:7; Test Date: 20210407; Test Name: TDM; Result Unstructured Data: Test Result:No bleeding; Test Date: 20210406; Test Name: CRP; Result Unstructured Data: Test Result:43; Test Date: 20210407; Test Name: EEG; Result Unstructured Data: Test Result:very disturbed electrogenesis; Test Date: 20210331; Test Name: fibrin D-Dimer; Result Unstructured Data: Test Result:1230; Test Date: 20210331; Test Name: Gamma-glutamyl transferase; Result Unstructured Data: Test Result:63; Test Date: 20210331; Test Name: glomerular filtration rate; Result Unstructured Data: Test Result:83 ml/min; Test Date: 20210406; Test Name: glomerular filtration rate; Result Unstructured Data: Test Result:19 ml/min; Test Date: 20210331; Test Name: hemoglobin; Result Unstructured Data: Test Result:11.5; Test Date: 20210406; Test Name: HIV serology; Result Unstructured Data: Test Result:negative; Test Date: 20210331; Test Name: pneumococcal antigenic test; Result Unstructured Data: Test Result:negative; Test Date: 20210331; Test Name: legionella antigenic test; Result Unstructured Data: Test Result:negative; Test Date: 20210406; Test Name: lumbar puncture; Result Unstructured Data: Test Result:protein 0.43, Lactate 2.25; Test Date: 20210331; Test Name: neutrophil count; Result Unstructured Data: Test Result:7400
CDC Split Type: FRPFIZER INC2021483935

Write-up: Meningoencephalitis; Hypertension; Headache; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-MP20211532. An 87-years-old female patient received first dose of BNT162B2 (COMIRNATY, solution for injection, Lot Number: ET3620) via intramuscular route on 19Mar2021 as 1 DF, single for COVID-19 immunization. The patient medical history included Anginal attack from 1999, osteoarthritis (both ongoing). The patient concomitant medications included on 07Apr2021 zolpidem tartrate (STILNOX); indapamide, perindopril arginine (BIPRETERAX [INDAPAMIDE;PERINDOPRIL ARGININE]); paracetamol (DOLIPRANE); macrogol (TRANSIPEG [MACROGOL]); acetylsalicylate lysine (KARDEGIC); escitalopram oxalate (SEROPLEX); bisoprolol fumarate (BISOCE); zolpidem (ZOLPIDEM); amlodipine besilate (AMLOR); glucose (GLUCOSE); potassium chloride (KALEORID) and perindopril (PERINDOPRIL) on 05Apr2021. On 06Apr2021 the patient experienced meningoencephalitis, on 31Mar2021 patient experienced hypertension, headache. On 31Mar2021 the patient was hospitalized for meningoencephalitis, hypertension, headache. On 31Mar2021 the patient underwent lab tests and procedures which included alanine aminotransferase: normal, aspartate aminotransferase: normal, Alkaline phosphatase: 15, blood bilirubin: 26, calcium: 2.5, CPK: 1917, fibrinogen: 4.75, lactate dehydrogenase: 272, potassium: 2.8, blood pressure measurement: 200/10, blood pressure measurement: 190/80, blood sodium: 134, on 06Apr2021 blood creatinine: 394 , blood urea: 17, on 05Apr2021 blood urea: 9.8. Disease history: Patient found on 31Mar2021 on the ground by her daughter confusing, extremities trembling. In emergencies: body temperature at 39, blood pressure at 190 / 80mmHg. Patient hospitalized on 31Mar2021: Hemoglobin 11.5, platelets 231000, white blood cell 94000, neutrophil 7400, PT 93%, fibrinogen 4.75, D-Dimere 1230, sodium 134, potassium 2.8, glomerular filtration rate 83, Calcium 2.5, TGO and TGP normal, GGT 63, ALP 15, bilirubin 26, CPK 1917, LDH 272. COVID-19 PCR, antigen for Legionella and pneumococcus were negative. The patient had received one vial of cefotaxim (CLAFORAN), paracetamol (PERFALGAN) and furosemide (LASILIX). Introduction of Amoxicillin 12g (2gx6) and aciclovir (ZOVIRAX) 625 mgx3. On the weekends, she remained a little confused and feverish in the morning at 38. On 05Apr2021, evening, the neurological state deteriorated in terms of confusion with on 06Apr2021, a patient with glasgow 7, WBC 10850 with neutrophil 8213, CRP 43, glomerular filtration rate 19 ml / min, urea at 9.8. The urine was haematuric: a search for amoxicillin crystals on direct examination, amoxicillin was stopped on 06Apr2021 morning, in the morning on suspicion of nephrotoxicity by crystalluria (taking into account the PL and negative blood culture). Perindopril is stopped. (File MP20211529). A control lumbar puncture was performed on 06Apr2021, showing: protein 0.43, Lactate 2.25. Renal function deteriorated: creatinine 394, urea 17. HIV serology negative, SARS COV2 serology (Antibody antiprotein S elevated to 2245 u / mL). The patient received from 07Apr2021: IV bicarbonate, calciparin 5000x2 and doxycyclin (VIBRAVEINEUSE), concomitant medications were stopped. The EEG showed a very disturbed electrogenesis, associating an anterior slowing predominantly on the right frontal, di or triphasic elements of relatively diffuse projection predominantly centroparietal, sometimes taking a pseudo-periodic aspect, a discontinuous aspect of the tracing and a rhythm. Delta brush type at the vertex and in the right frontal branches. The association of this disturbance of this electrogenesis with the presence of myoclonus and permanent complex abnormal movements should lead to a search in this context for a prion disease and to perform a brain MRI. Control of EEG desirable based on clinical progress. A brain control CT scan does not show bleeding but remains artefacted by head movements. Abdominal CT scan showing no digestive lesion or urinary obstruction. Patient died during the weekend of 10-11Apr2021. Therapeutic measures were taken as a result of meningoencephalitis, hypertension, headache. The patient died during the weekend of 10Apr2021-11Apr2021. It was not reported if an autopsy was performed. The outcome of the events was fatal for Meningoencephalitis and not recovered for hypertension and headache. No FU attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : FR-AFSSAPS-2021043164; Reported Cause(s) of Death: Meningoencephalitis


VAERS ID: 1287178 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-31
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Blood pressure measurement, Blood urea, Body temperature, Brain natriuretic peptide, C-reactive protein, COVID-19, Coma scale, Computerised tomogram, Drug ineffective, Electrocardiogram, Haemoglobin, Heart rate, Lymphocyte count, Oxygen saturation, Procalcitonin, SARS-CoV-2 test, Troponin, White blood cell count, X-ray
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: 2021-04-14
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ATACAND; ASPIRIN PROTECT; CORVASAL [MOLSIDOMINE]; INEGY; CARDENSIEL; INEXIUM [ESOMEPRAZOLE SODIUM]; DAFALGAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Coronary artery disease (Stented coronary artery disease); Diabetes (Untreated diabetes); Duodenal neoplasm (Clip-on duodenal angioma clipped); Obstructive sleep apnea syndrome (obstructive sleep apnea syndrome with device); Stent placement
Allergies:
Diagnostic Lab Data: Test Name: Creatinine; Result Unstructured Data: Test Result:124 umol/l; Test Date: 20210405; Test Name: blood pressure; Result Unstructured Data: Test Result:130/67; Test Name: urea; Result Unstructured Data: Test Result:10.9 mmol/L; Test Date: 20210405; Test Name: body temperature; Result Unstructured Data: Test Result:37.8; Test Name: BNP; Result Unstructured Data: Test Result:205 pg/mL; Test Date: 20210405; Test Name: Glasgow; Result Unstructured Data: Test Result:15; Test Name: Computed tomography; Result Unstructured Data: Test Result:attack between 25 and 50%, predominantly left base; Comments: attack between 25 and 50%, predominantly left base and right apex. Pulmonary emphysema; Test Name: CRP; Result Unstructured Data: Test Result:90 mg/l; Comments: regressed; Test Name: ECG; Result Unstructured Data: Test Result:sinus rhythm 75 / min; Comments: sinus rhythm 75 / min, no repolarization disorder; Test Name: ECG; Result Unstructured Data: Test Result:sinus rhythm 75 / min, no repolarization disorder; Test Name: Hb; Result Unstructured Data: Test Result:11.8 g/dl; Test Date: 20210405; Test Name: heart rate; Result Unstructured Data: Test Result:74 bpm; Test Name: lymphocyte count; Result Unstructured Data: Test Result:0.4 g/l; Test Name: SaO2; Test Result: 97 %; Comments: under high concentration mask 15l / min; Test Date: 20210405; Test Name: SaO2; Test Result: 65 %; Test Date: 20210407; Test Name: SaO2; Result Unstructured Data: Test Result:88-90 %; Test Name: Procalcitonin; Test Result: Negative ; Test Name: procalcitonine; Result Unstructured Data: Test Result:0.17 ng/ml; Test Date: 20210331; Test Name: PCR; Test Result: Positive ; Comments: variant; Test Name: troponin; Result Unstructured Data: Test Result:71 ng/L; Test Name: Leukocytes; Result Unstructured Data: Test Result:6 g/l; Test Name: x-ray; Result Unstructured Data: Test Result:bilateral, severe, interstitial lung damage
CDC Split Type: FRPFIZER INC2021478246

Write-up: Vaccination failure/31Mar2021, the patient had a PCR (COVID-19) positive with the variant; 31Mar2021, the patient had a PCR (COVID-19) positive with the variant; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number FR-AFSSAPS-NC20211677. An 86-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 25Feb2021 (batch/lot number and expiry date was not reported) as single dose, dose 1 via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as single dose for COVID-19 immunisation. Medical history included arterial hypertension, untreated diabetes, stented coronary artery disease, obstructive sleep apnea syndrome with device, and duodenal angioma clipped. Concomitant medications included candesartan cilexetil (ATACAND); acetylsalicylic acid (ASPIRIN PROTECT); molsidomine (CORVASAL); ezetimibe, simvastatin (INEGY); bisoprolol fumarate (CARDENSIEL); esomeprazole sodium (INEXIUM); and paracetamol (DAFALGAN); all taken for an unspecified indication, start and stop date were not reported. Clinical signs and chronology of facts: On 31Mar2021, the patient had a PCR (COVID-19) positive with the variant (contact case of his wife), without initial symptoms. On 05Apr2021, he was admitted urgently for dyspnea; 65% SaO2 in AA. BP 130/67, heart rate 74bpm. Glasgow 15, temperature 37.8. Polypnea with predominant crackles on the left, supple abdomen. Computed tomography (unspecified date): attack between 25 and 50%, predominantly left base and right apex. Pulmonary emphysema. Finally, 97% SpO2 under high concentration mask 15l / min. Biology (unknown date): leukocytes 6 G / l, lymphocyte: 0.4G / l, Hemoglobin: 11.8g / dl, troponin 71ng / l, BNP 205pg / ml, procalcitonine 0.17ng / ml, creatinine: 124umol / l, urea 10.9mmol / l. The patient had stable hemodynamics, no mottling, no heart murmur. ECG (unspecified date): sinus rhythm 75 / min, no repolarization disorder. Overall: severe COVID 19 in 86-year-old patient despite vaccination. Summary of management: Hospitalization in intensive care, put on high flow oxygen therapy (Optiflow), corticosteroid therapy, probabilistic ATB. Evolution : Stable state on 06Apr2021. On 07Apr2021, precarious respiratory state despite high concentration mask 15L + optiflow 60L 100% but well tolerated by the patient, no complaint. 88-90% saturation with rapid desaturation. X-ray (unspecified date): bilateral, severe, interstitial lung damage. CRP regressed (90mg / l), PCT (procalcitonin): negative. 09Apr2021, start of non-invasive ventilation (1hxa / d). On 12Apr2021: 88% under continuous non-invasive ventilation , very exhausted. No pain. On 13Apr2021: Patient on propofol + morphine, limitation of active therapies. 14Apr2021: introduction to Hypnovel, patient at the end of his life and death at 1 p.m. Conclusion: Vaccine ineffectiveness with fatal post-vaccination COVID19. The patient died on 14Apr2021 at 1 PM due to COVID-19. It was not reported if an autopsy was performed. No follow-up attempts are possible; information on the lot/batch number cannot be obtained.; Reported Cause(s) of Death: COVID-19


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