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

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



Case Details

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VAERS ID: 1469436 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-06-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD4342 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Cardiac arrest, Cardio-respiratory arrest, Dizziness, Hypoaesthesia, Malaise, Pain in extremity, Respiratory arrest
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-11
   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: ACARD; CAPTOPRIL; NEDAL; CO BESPRES; AMLOPIN [AMLODIPINE BESILATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension (Patient was being treated for hypertension.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021796466

Write-up: cardiovascular and respiratory arrest; cardiovascular and respiratory arrest; Cardio-respiratory arrest; Hands numbness on the next day; The next day he complained of feeling unwell; There was weakness the next day.; The next day he complained of dizziness; Soreness of the left hand on the next day./ pain in the left arm; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number PL-URPL-DML-MLP.4401.2.405.2021_3.744.2021. A 67-year-old male patient received bnt162b2 (COMIRNATY), intramuscularly, administered in Arm Left on 09Jun2021 10:35 (Lot Number: FD4342; Expiration Date: 06Jul2021) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included hypertension from an unknown date, was being treated for hypertension. Concomitant medication(s) included acetylsalicylic acid (ACARD); captopril (CAPTOPRIL); nebivolol hydrochloride (NEDAL); hydrochlorothiazide, valsartan (CO BESPRES); amlodipine besilate (AMLOPIN) taken for an unspecified indication, start and stop date were not reported. The patient experienced cardiovascular and respiratory arrest on 11Jun2021, Cardio-respiratory arrest on 11Jun2021, hands numbness on the next day on 10Jun2021, soreness of the left hand on the next day/ pain in the left arm on 10Jun2021, the next day he complained of feeling unwell on 10Jun2021, there was weakness the next day on 10Jun2021, the next day he complained of dizziness on 10Jun2021. Clinical course was as follows: The next day (10Jun2021) the patient complained of malaise, dizziness, weakness, numbness of hands, pain in the left arm. In the morning hours (approx. 5.00 a.m.) on 11Jun2021 the patient left home, according to HA he went to the market where he was trading - he felt very unwell. He felt very unwell, ambulance was called, resuscitation efforts failed, patient died, time of death 6.07 a.m. Cause of death: Cardio-respiratory arrest. As reported by granddaughter: In the morning of 11Jun2021 The patient left the house, the family assumes that he may have wanted to get to the doctor. The patient died in the ambulance. The patient died on 11Jun2021 6.07 a.m. It was not reported if an autopsy was performed. The outcome of event soreness of the left hand on the next day/ pain in the left arm was unknown, of the other events was fatal. Sender Comment: Malaise, weakness, arm soreness are expected side effects of Comirnata vaccine. Dizziness and numbness of the hands are not listed in the summary of product characteristics, but are among the most commonly reported adverse reactions after mRNA vaccines. The cardio-respiratory arrest that occurred on the second day after vaccination is an unexpected adverse reaction, and it is difficult to assess conclusively whether it could have been related to vaccination. There is a temporal relationship between the administration of the vaccine and the occurrence of the symptoms. The reporter marked the seriousness criteria - death. Malaise Weakness and Pain in upper extremities Relatedness of drug to reaction(s)/event(s) Source of assessment HA expert; Method of assessment WHO-HA system for standardised case causality assessment, Result of Assessment PROBABLE. Numbness of upper extremities, Dizzinness Relatedness of drug to reaction(s)/event(s) Source of assessment HA expert; Method of assessment WHO-HA system for standardised case causality assessment, Result of Assessment POSSIBLE. Respiratory arrest, Cardiac arrest Relatedness of drug to reaction(s)/event(s) Source of assessment HA expert; Method of assessment WHO-HA system for standardised case causality assessment, Result of Assessment Unassessable/Unclassifiable No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1469437 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-05-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7842 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-28
   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: NEBICARD; SUVARDIO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypercholesteremia; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021758732

Write-up: Sudden death - suspected pulmonary embolism; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number PL-URPL-DML-MLP.4401.3.740.2021. A 49-years-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 27May2021 11:34 (Batch/Lot Number: FA7842) as 0.3ml single dose for covid-19 immunisation. Medical history included hypercholesterolaemia, hypertension. He had no allergies. Concomitant medications included nebivolol hydrochloride (NEBICARD) taken for an unspecified indication, start and stop date were not reported; rosuvastatin calcium (SUVARDIO) taken for an unspecified indication, start and stop date were not reported. The patient experienced sudden death - suspected pulmonary embolism on 28May2021 19:00. It was not reported if an autopsy was performed. Death occurred suddenly, while sleeping, after returning from work the day after vaccination against COVID-19. Sender Comment: Comirnates is an mRNA vaccine against COVID-19 (with modified nucleosides). Pulmonary embolism is not an expected adverse effect following administration of this vaccine. Until 10June2021, 1,298 cases of pulmonary embolism following Comirnaty administration were reported in the Regulatory Authority database. The reporter classified them as severe. Due to the reporter''s assessment, the nature of the side effects and the patient''s death, Regulatory Authority classified the report as "serious". Due to the insufficient data, the Regulatory Authority has considered an unclassifiable causal relationship between vaccination and death. Regulatory Authority contacted the appropriate sanitary and epidemiological station by e-mail whether an autopsy had been performed. It cannot be excluded that the patient''s medical history contributed to his death. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: suspected pulmonary embolism


VAERS ID: 1469466 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-06-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Penicillin allergy; Stent placement; Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC2021805547

Write-up: Death by heart attack; This is a spontaneous report from a contactable consumer, (the patient''s granddaughter). A 91-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 23Jun2021 (Lot Number: Unknown) as DOSE 1, SINGLE at the age of 91 years old, for COVID-19 immunization. The patient was not pregnant at time of vaccination. Medical history included hypertension, stroke in 2009, stent placement in 2011, and allergy to penicillin. The patient''s concomitant medications were not reported. The patient didn''t receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient died by heart attack on 24Jun2021, on the day following vaccination with COMIRNATY. Therapeutic measures were taken as a result of death by heart attack and included resuscitation attempt. The patient died on 24Jun2021. An autopsy was not performed. The reported cause of death was heart attack. Information on batch number has been requested.; Reported Cause(s) of Death: Heart attack


VAERS ID: 1469529 (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: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW9127 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ENALAPRIL; EZETROL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: CABG; Hip arthroplasty; Hip fracture; Hypertension; Inguinal hernia repair
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021797039

Write-up: heart infarction; acute myocardial infarction; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB SE-MPA-2021-051129. An 83-year-old male patient received the second dose of bnt162b2 (COMIRNATY) via an unspecified route of administration on an unspecified date in Apr2021 (approx. 1,5 weeks before the reported suspect adverse event) (Batch/Lot Number: EW9127) as single dose for COVID-19 immunisation. Medical history included CABG (Coronary Artery Bypass Graft) in 1993, inguinal hernia repair in 2019, left sided hip arthroplasty in 2018 following hip fracture, hypertension. Concomitant medications included enalapril taken for hypertension; ezetimibe (EZETROL) taken for hypertension. The patient experienced heart infarction (death) in Apr2021, acute myocardial infarction (death) in Apr2021. The patient died in Apr2021. An autopsy was not performed. Clinical course: Reported suspect adverse event was acute myocardial infarction in April 2021. On that day the patient had exercised strenous labour and helped his family carrying logs, then taken a walk with the family during which he was slower than usual and panting quite heavily going uphill. After this the patient probably felt ill and sat down and then shortly after fell forward. Family members immediately started CPR which was continued by ambulance staff, defibrillation was made without result. The patient had not complained about any chest pain during the day. Reporter assessed as serious, death. Probable cause of death was acute myocardial infarction. The family declined autopsy. Outcome of the events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: acute myocardial infarction; heart infarction


VAERS ID: 1469552 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA EFTERS?KS / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension; Obesity; Psoriasis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20212

Write-up: PATIENTEN AVLED; This regulatory authority case was reported by a physician and describes the occurrence of EMBOLIC STROKE (PATIENTEN AVLED) in a 64-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. EFTERS?KS) for COVID-19 vaccination. Concurrent medical conditions included Obesity, Psoriasis and Hypertension. In June 2021, the patient received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. In June 2021, the patient experienced EMBOLIC STROKE (PATIENTEN AVLED) (seriousness criteria death and medically significant). The patient died in June 2021. The reported cause of death was Thromboembolic stroke. It is unknown if an autopsy was performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medication information was provided. No treatment information was provided by the reporter. Action taken with mRNA-1273 in response to the event was not applicable. This is a case of sudden death in a 64-year-old female subject with hx of obesity, psoriasis, hypertension, who died after receiving first dose of vaccine. Very limited information has been provided at this time.; Sender''s Comments: This is a case of sudden death in a 64-year-old female subject with hx of obesity, psoriasis, hypertension, who died after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Thromboembolic stroke


VAERS ID: 1469564 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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: 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: TRPFIZER INC2021843843

Write-up: sudden cardiac death at home; This is a spontaneous report from a contactable physician (chest diseases specialist). This is a report based on information received by Pfizer, license party for bnt162b2. A 54-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient had no known diseases and no cardiac family history. Other medical history was unknown. The patient''s concomitant medications were not reported. The patient experienced sudden cardiac death at home 1 day after 1 vaccination with Biontech vaccine on an unspecified date. The patient died on an unspecified date. An autopsy was not performed. The inquiry did not involve a report of exposure during pregnancy. Outcome of event was fatal. Information on the lot/batch number has been requested.; Sender''s Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of sudden cardiac death due to temporal relationship. Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: sudden cardiac death at home


VAERS ID: 1469749 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-02-20
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042723 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute myocardial infarction, Blood creatinine, Diarrhoea, Dyspnoea, Glomerular filtration rate, Glycosylated haemoglobin, Headache, Pyrexia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-20
   Days after onset: 88
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension; Chronic renal insufficiency; Diabetes mellitus; Hypothyreosis; Polymyalgia rheumatica
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210310; Test Name: Blood creatinine; Test Result: Inconclusive ; Result Unstructured Data: 112 mcmol/L; Test Date: 20210310; Test Name: Estimated glomerular filtration rate; Test Result: Inconclusive ; Result Unstructured Data: 40ml/min/1.73m2; Test Date: 20210310; Test Name: HbA1c; Test Result: Inconclusive ; Result Unstructured Data: 6.5%
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: The Patient passed away on 20.05.2021; Dyspnoea; Headache; Vomiting; Diarrhoea; Pyrexia; This regulatory authority case was reported by a physician and describes the occurrence of ACUTE MYOCARDIAL INFARCTION (Die Patient passed away on 20.05.2021), HEADACHE (Headache), VOMITING (Vomiting), DIARRHOEA (Diarrhoea), PYREXIA (Pyrexia) and DYSPNOEA (Dyspnoea) in an 80-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 300042723) for COVID-19 vaccination. Concurrent medical conditions included Diabetes mellitus, Hypothyreosis, Polymyalgia rheumatica, Arterial hypertension and Chronic renal insufficiency. On 22-Jan-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced HEADACHE (Headache) (seriousness criterion hospitalization), VOMITING (Vomiting) (seriousness criterion hospitalization), DIARRHOEA (Diarrhoea) (seriousness criterion hospitalization) and PYREXIA (Pyrexia) (seriousness criterion hospitalization). On 02-Mar-2021, the patient experienced DYSPNOEA (Dyspnoea) (seriousness criterion hospitalization). On 20-May-2021, the patient experienced ACUTE MYOCARDIAL INFARCTION (The patient passed away on 20.05.2021) (seriousness criteria death, hospitalization and medically significant). In March 2021, HEADACHE (Headache), VOMITING (Vomiting), DIARRHOEA (Diarrhoea), PYREXIA (Pyrexia) and DYSPNOEA (Dyspnoea) had resolved. The patient died on 20-May-2021. The reported cause of death was Acute myocardial infarction. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Blood creatinine: 112 mcmol/l (Inconclusive) 112 mcmol/L. On 10-Mar-2021, Glomerular filtration rate: 40ml/min/1.73m2 (Inconclusive) 40ml/min/1.73m2. On 10-Mar-2021, Glycosylated haemoglobin: 6.5% (Inconclusive) 6.5%. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable. Patient died on 20-May-2021 and was Judged the causal link between the Moderna COVID-19 vaccine and acute myocardial infarction to be unlikely. However, this view regarding causality does not entirely rule out the role of the vaccine. On 11 Mar 2021, lab reports showed TTE dilated LV, large scar anteroapically, anteroseptally, and septally. LVEF 25%. Aortic valve sclerosis, mild pericardial effusion inferobasal 4mm. PH approximately 50mmHg, IVC severely congested. Therapy: 10 Mar 2021 right pleural puncture (transudate) 10 Mar 2021 -15 Mar 2021, Lasix i.v. Company comment Very limited information regarding the events has been provided at this time. Further information is not expected. Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Translation for Case Narrative, Reporter''s comments and Sender''s comments.; Sender''s Comments: Very limited information regarding the events has been provided at this time. Further information is not expected.; Reported Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1469763 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-04-16
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac failure acute, Influenza like illness, Pneumonia
SMQs:, Cardiac failure (narrow), 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: 2021-04-26
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: Atrial fibrillation; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Lymphoma
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20212

Write-up: Beidseitige bakterielle Lungenentz?ndung; flu-like syndrome; Herzversagen; This regulatory authority case was reported by a consumer and describes the occurrence of PNEUMONIA (Beidseitige bakterielle Lungenentz?ndung) and CARDIAC FAILURE ACUTE (Herzversagen) in a 73-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lymphoma in 2016. Concurrent medical conditions included Hypertension and Atrial fibrillation. On 10-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced PNEUMONIA (Beidseitige bakterielle Lungenentz?ndung) (seriousness criteria death, hospitalization and medically significant) and CARDIAC FAILURE ACUTE (Herzversagen) (seriousness criteria death, hospitalization prolonged and medically significant). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like syndrome). The patient died on 26-Apr-2021. The reported cause of death was Acute heart failure and Pneumonia. An autopsy was not performed. At the time of death, INFLUENZA LIKE ILLNESS (flu-like syndrome) outcome was unknown. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Reporter stated the day after the second vaccine the patient started experiencing flu-like symptoms. The patient was admitted to the hospital in intensive care with pneumonia. Reporter stated patient experienced cardiac failure as well. Company Comment: Very limited information regarding these events (pneumonia and cardiac failure) has been provided at this time. Noting history of Atrial fibrillation, hypertension may remain as risk factors. Based on the current available information and temporal association between the use of the product and the start date of the event (flu-like syndrome), a causal relationship cannot be excluded. Autopsy report/death certificate is required for further assessment. No further follow-up information is expected. Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Translation received included sender''s comments updated and historical condition updated. Event added.; Sender''s Comments: Very limited information regarding these events (pneumonia and cardiac failure) has been provided at this time. Noting history of Atrial fibrillation, hypertension may remain as risk factors. Based on the current available information and temporal association between the use of the product and the start date of the event (flu-like syndrome), a causal relationship cannot be excluded. Autopsy report/death certificate is required for further assessment. No further follow-up information is expected.; Reported Cause(s) of Death: Acute heart failure; Pneumonia


VAERS ID: 1469954 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, General physical health deterioration, Heart rate, Lung disorder, Oxygen saturation, Pneumonia aspiration, Pyrexia, Respiratory rate
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Heart rate; Result Unstructured Data: increased; Test Date: 2021; Test Name: Oxygen saturation; Result Unstructured Data: decreased; Test Date: 2021; Test Name: Respiratory rate; Result Unstructured Data: increased
CDC Split Type: CAMODERNATX, INC.MOD20212

Write-up: Pneumonia aspiration; Dyspnoea; General physical health deterioration; Lung disorder; Pyrexia; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Jul-2021 and was forwarded to Moderna on 06-Jul-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PNEUMONIA ASPIRATION (Pneumonia aspiration), DYSPNOEA (Dyspnoea), GENERAL PHYSICAL HEALTH DETERIORATION (General physical health deterioration), LUNG DISORDER (Lung disorder) and PYREXIA (Pyrexia) in a 78-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA ASPIRATION (Pneumonia aspiration) (seriousness criteria death and medically significant), DYSPNOEA (Dyspnoea) (seriousness criterion death), GENERAL PHYSICAL HEALTH DETERIORATION (General physical health deterioration) (seriousness criterion death), LUNG DISORDER (Lung disorder) (seriousness criterion death) and PYREXIA (Pyrexia) (seriousness criterion death). 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 2021, Heart rate: increased (High) increased. In 2021, Oxygen saturation: decreased (Low) decreased. In 2021, Respiratory rate: increased (High) increased. No concomitant medication details were reported. Oxygen therapy was used for treatment, however, no additional treatment information was reported. This is a case of death in a 78-year-old male subject, who died after receiving first dose of vaccine. Very limited information has been provided at this time.; Sender''s Comments: This is a case of death in a 78-year-old male subject, who died after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Cause of death unknown


VAERS ID: 1469979 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Pulmonary embolism
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), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021810759

Write-up: Cardiac arrest; Pulmonary embolism; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 571893. A 32-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On an unspecified date, the patient experienced cardiac arrest and pulmonary embolism. The patient died on an unspecified date. Cause of death were cardiac arrest and pulmonary embolism. 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: Cardiac arrest; Pulmonary embolism


VAERS ID: 1470040 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-05-22
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6126 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Fatigue, Malaise, Nausea, Pyrexia, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-12
   Days after onset: 21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021804230

Write-up: acute lung failure; Fatigue; Fever; Chills; Nausea; Feeling unwell; This is a spontaneous report from a contactable Consumer downloaded from the regulatory authority BE-FAMHP-DHH-N2021-98658. Spontaneous COVID-19 report received by the authorities on 24 Jun 2021. An 89-year-old male patient received BNT162B2 (COMIRNATY), dose 2 via an unspecified route of administration on 05May2021 (Lot Number: EW6126) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced Fever, Malaise, Shivering, Fatigue, Nausea, Pulmonary failure, on 22May2021. Treatment was received for the events. The patient died on 12Jun2021. Reporter comment: Treatment - Yes. Evolution of the ADR - Passed away. Situations - Other: ADE with lung failure is known and predicted in the literature and in postmortem studies in the elderly. Vague complaints with fever and general malaise. Ended up hospitalization with acute lung failure. Passed away. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Treatment - Yes. Evolution of the ADR - Passed away. Situations - Other: ADE with lung failure is known and predicted in the literature and in postmortem studies in the elderly. Vague complaints with fever and general malaise. Ended up hospitalization with acute lung failure. Passed away.; Reported Cause(s) of Death: Fever; Malaise; Shivering; Fatigue; Nausea; lung failure


VAERS ID: 1470165 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-05-03
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Computerised tomogram head, Decreased appetite, Dizziness, Fatigue, Haemoglobin, Ischaemic cerebral infarction, Magnetic resonance imaging head, SARS-CoV-1 test
SMQs:, Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-16
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASPIRIN CARDIO; DILATREND; ALDACTONE [SPIRONOLACTONE]
Current Illness: Anemia; Arterial hypertension; COPD (Vd. a. COPD); Malnutrition
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210508; Test Name: Computerised tomogram head; Test Result: Positive ; Result Unstructured Data: Brain computerised tomography; Test Date: 202105; Test Name: Haemoglobin; Test Result: Positive ; Result Unstructured Data: Positive; Test Date: 20210508; Test Name: Magnetic resonance imaging head; Test Result: Positive ; Result Unstructured Data: Positive; Test Date: 202105; Test Name: SARS-CoV-1 test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by an other health care professional and describes the occurrence of ISCHAEMIC CEREBRAL INFARCTION in a 79-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Anemia, Arterial hypertension, COPD (Vd. a. COPD) and Malnutrition. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN CARDIO), CARVEDILOL (DILATREND) and SPIRONOLACTONE (ALDACTONE [SPIRONOLACTONE]) for an unknown indication. On 31-Mar-2021, the patient received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. On 28-Apr-2021, received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced DECREASED APPETITE, DIZZINESS and FATIGUE. On 07-May-2021, the patient experienced ISCHAEMIC CEREBRAL INFARCTION (seriousness criteria death and medically significant). The patient died on 16-May-2021. It is unknown if an autopsy was performed. At the time of death, DECREASED APPETITE, DIZZINESS and FATIGUE outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-May-2021, Computerised tomogram head: positive (Positive) Brain computerised tomography. On 08-May-2021, Magnetic resonance imaging head: positive (Positive) Positive. In May 2021, Haemoglobin: positive (Positive) Positive. In May 2021, SARS-CoV-1 test: negative (Negative) Negative. For mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown), the reporter considered FATIGUE to be possibly related and ISCHAEMIC CEREBRAL INFARCTION, DECREASED APPETITE and DIZZINESS to be unlikely related. Treatment information was not provided This a report of dead 28 days after receiving the product in a 79-years old patient with concomitant Anemia, Arterial hypertension, COPD and Malnutrition. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: This a report of dead 28 days after receiving the product in a 79-years old patient with concomitant Anemia, Arterial hypertension, COPD and Malnutrition. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. Translation of the source document has been requested.


VAERS ID: 1470906 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-29
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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 INC2021862408

Write-up: myocardial infarction; This is a spontaneous report from a contactable other health professional via regulatory authority. Regulatory authority report number is 577133. A 91-year-old female patient received BNT162B2 (COMIRNATY) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced myocardial infarction on 29Apr2021. The patient died on an unspecified date due to the event. 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: myocardial infarction


VAERS ID: 1470944 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-12
Onset:2021-03-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 4293254 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature increased, C-reactive protein, Chest X-ray, Chest pain, Computerised tomogram thorax, Dyspnoea exertional, Fatigue, Fibrin D dimer, Influenza like illness, Pericardial effusion, Pleural effusion, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: SOTALEX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Defibrillator/pacemaker insertion
Allergies:
Diagnostic Lab Data: Test Name: Chest x-ray; Result Unstructured Data: Test Result:Examinations - Chest x-ray 7 days after my second; Comments: Examinations - Chest x-ray 7 days after second negative vaccine dose; Test Name: CT chest; Result Unstructured Data: Test Result:Injected chest CT scan showing pericardial and pul; Comments: Injected chest CT scan showing pericardial and pulmonary bi-basal effusion; Test Name: C-reactive protein; Result Unstructured Data: Test Result:193; Test Name: FIbrin D-dimer; Result Unstructured Data: Test Result:4000
CDC Split Type: BEPFIZER INC2021804127

Write-up: Fatigue; Flu like symptoms; Body temperature increased; pericardial and bi-basal pulmonary effusion.; increased chest pain when lying down; pericardial and bi-basal pulmonary effusion; shortness of breath on exertion; Sudden death on exertion without knowledge of the underlying pathology; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority BE-FAMHP-DHH-N2021-98437 A 33-year-old male patient received bnt162b2 (COMIRNATY) Solution for injection, via an unspecified route of administration on 12Mar2021 (Lot Number: 4293254) as dose 2, single (at an unknown age) for COVID-19 immunisation. Medical history included defibrillator wearer. Concomitant medication included sotalol hydrochloride (SOTALEX). On 13Mar2021, the patient experienced fatigue, flu like symptoms, body temperature increased, pericardial and bi-basal pulmonary effusion, increased chest pain when lying down, shortness of breath on exertion. The patient was hospitalized from 2021 and outcome of all these events was recovering. Recurrence of symptoms several months after diagnosis. The patient experienced sudden death on exertion without knowledge of the underlying pathology in 2021. It was unknown if an autopsy was performed. Reporters comment: Treatment was Aspirin, colchicine and rest Evolution of the ADR - In progress Examinations included Chest x-ray 7 days after second negative vaccine dose, Injected chest CT scan showing pericardial and pulmonary bi-basal effusion. CRP 193 and D-dimers 4000.; Reporter''s Comments: Treatment was Aspirin, colchicine and rest Evolution of the ADR - In progress Examinations included Chest x-ray 7 days after my second negative vaccine dose, Injected chest CT scan showing pericardial and pulmonary bi-basal effusion. CRP 193 and D-dimers 4000.; Reported Cause(s) of Death: Sudden death on exertion without knowledge of the underlying pathology


VAERS ID: 1470956 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-02-24
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042723 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: End stage renal disease
SMQs:, Rhabdomyolysis/myopathy (broad), Chronic kidney disease (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pramipexol; NEO-MERCAZOLE; Vascord; TORASEMIDE SODIUM; SERESTA; PALEXIA; PANTOPRAZOLE SODIUM
Current Illness: Anxiety disorder; Chronic kidney disease stage 5 (CNI Grad V--); Coronary heart disease; Hyperthyroidism; Macular degeneration; Oedema
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: Chronic kidney disease stage 5; This regulatory authority case was reported by a physician and describes the occurrence of END STAGE RENAL DISEASE (Chronic kidney disease stage 5) in an elderly female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 300042723) for COVID-19 vaccination. Concurrent medical conditions included Chronic kidney disease stage 5 (CNI Grad V--), Macular degeneration, Hyperthyroidism, Coronary heart disease, Oedema and Anxiety disorder. Concomitant products included Pramipexole (Pramipexol), CARBIMAZOLE (NEO-MERCAZOLE), Amlodipine besilate, Olmesartan medoxomil (Vascord), TORASEMIDE SODIUM, OXAZEPAM (SERESTA), TAPENTADOL HYDROCHLORIDE (PALEXIA) and PANTOPRAZOLE SODIUM for an unknown indication. On 18-Feb-2021, the patient received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 24-Feb-2021, after starting mRNA-1273 (COVID-19 Vaccine Moderna), the patient experienced END STAGE RENAL DISEASE (Chronic kidney disease stage 5) (seriousness criteria death and medically significant). The patient died on 24-Feb-2021. The reported cause of death was end stage renal disease. An autopsy was not performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Very limited information regarding this event has been provided at this time. Noting history of Chronic kidney disease stage 5, CAD among others may remain as risk factors. Autopsy report/ death certificate is required for further evaluation.; Sender''s Comments: Very limited information regarding this event has been provided at this time. Noting history of Chronic kidney disease stage 5, CAD among others may remain as risk factors. Autopsy report/ death certificate is required for further evaluation.; Reported Cause(s) of Death: End stage renal disease


VAERS ID: 1470975 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: COPFIZER INC2021845293

Write-up: COVID-19; COVID-19; This spontaneous report from a contactable consumer (patient''s brother) reported similar events for two patients. This is the first of two reports. A male patient of an unspecified age received bnt162b2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient died of COVID-19 two weeks after applying the first dose of Pfizer on an unspecified date. The event resulted in death. The patient died on an unknown date. It was not reported if an autopsy was performed. The cause of death was COVID-19. The outcome of event was fatal. Information on the Lot/Batch number has been requested.; Sender''s Comments: Linked Report(s) : CO-PFIZER INC-2021845296 same reporter, product, AE and different patient; Reported Cause(s) of Death: COVID-19


VAERS ID: 1471105 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-06-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3095 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-09
   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; Smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021804160

Write-up: Sudden death unexplained; This is a spontaneous report from a non-contactable physician from the regulatory authority. The Regulatory Authority report number is DE-PEI-202100095324. A 56-year-old male patient received BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: FC3095), via an unspecified route of administration on 09Jun2021 (at the age of 56 years old) as dose number unknown, single for COVID-19 immunisation. Medical history included arterial hypertension and smoker. The patient''s concomitant medications were not reported. The patient experienced sudden death unexplained on 09Jun2021. The patient was found dead in supermarket parking lot on vaccination day. The patient died on 09Jun2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Vaccinated by the company doctor. History of arterial hypertension, smokers Found dead in supermarket parking lot on vaccination day.; Reported Cause(s) of Death: Sudden death unexplained


VAERS ID: 1471110 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-06-21
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021778843

Write-up: Asystolia; Respiratory distress; This is a spontaneous report from a non-contactable physician from the Regulatory Authority number DE-PEI-202100110216. A 75-year-old female patient received second dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 17Jun2021 (Batch/Lot Number: Unknown) as DOSE 2, 0.3 ML SINGLE for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient received first dose on of Comirnaty on 06May2021 (batch unknown, 0.3 ml). The patient experienced asystolia and respiratory distress on 21Jun2021. The outcome was fatal for Respiratory distress and Asystolia. The patient died on 21Jun2021. It was not reported if an autopsy was performed. No follow-up Information on batch/lot number can be obtained. No further information expected.; Reported Cause(s) of Death: Asystolia; Respiratory distress


VAERS ID: 1471111 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-06-17
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D012A / UNK - / -

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: 2021-06-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021778848

Write-up: Sudden cardiac death; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority, regulatory authority number DE-PEI-202100110217. This spontaneous report was received from a Physician and concerned a 64-year-old male patient. A 64-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 28May2021 (Batch/Lot Number: 1D012A) (at 64 years of age) as DOSE NUMBER UNKNOWN, 0.3ML SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient''s weight was not reported, and height was not reported. The patient experienced sudden cardiac death on 17Jun2021. The patient died on 17Jun2021. An autopsy was not performed. It was mentioned that the death occurred in another country while on vacation. Cremation there. The patient''s outcome was fatal for sudden cardiac death. Relatedness of drug to reactions/events per Source of assessment: regulatory authority. Result of Assessment: D. Unclassifiable. The event ''sudden cardiac death'' occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency. No follow-up attempts possible. No further information expected. Information on lot number already obtained.; Reported Cause(s) of Death: Sudden cardiac death


VAERS ID: 1471113 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-06-01
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary embolism, Wrong product administered
SMQs:, Embolic and thrombotic events, venous (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021779309

Write-up: wrong vaccine administered; Pulmonary embolism; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority, regulatory authority number DE-PEI-202100110227. A 38-years-old male patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: Unknown) via an unspecified route of administration on 15May2021 (at the age of 38 years) as dose 1, 0.3 ml single for covid-19 immunisation and covid-19 vaccine (chadox1 ncov-19) (VAXZEVRIA, Lot number: Unknown), via an unspecified route of administration on 13Mar2021 as dose 1, single for an unspecified indication. The patient''s medical history and concomitant medications were not reported. On 01Jun2021, the patient experienced pulmonary embolism. The patient died on 01Jun2021. The cause of death was lung embolism. It was not reported if an autopsy was performed. The outcome of the event pulmonary embolism was fatal. No follow-up Information on batch/lot number cannot be obtained attempts are possible. No further information expected.; Reported Cause(s) of Death: Lung embolism


VAERS ID: 1471114 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-05-25
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8680 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Cardiac failure acute, Pericarditis
SMQs:, Cardiac failure (narrow), Systemic lupus erythematosus (broad), Supraventricular tachyarrhythmias (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021804416

Write-up: Tachyarrhythmia absoluta; Pericarditis; Acute cardiac insufficiency; This is a spontaneous report from a non-contactable physician received from regulatory authority, downloaded from the regulatory authority. The regulatory authority report number is DE-PEI-202100114688. A 66-year-old female patient received BNT162B2 (COMIRNATY, Lot Number: EW8680, strength: 0.3 ml), via an unspecified route of administration on 12May2021 (66-year-old at time of vaccination) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced pericarditis and acute cardiac insufficiency on 25May2021, tachyarrhythmia absoluta on 01Jun2021. Verbatim: This report is serious - death. On 25May2021 the patient experienced Acute cardiac insufficiency, Pericarditis. On 01Jun2021 the patient experienced Tachyarrhythmia absoluta. Stop date of events pericarditis, atrial fibrillation and cardiac failure acute was reported as 01Jun2021. The outcome of the events was fatal. The patient died on 01Jun2021. It was unknown if an autopsy was performed. For all events, relatedness of vaccine to events was "D. Unclassifiable". No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Pericarditis; Acute cardiac insufficiency; Tachyarrhythmia absoluta


VAERS ID: 1471116 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D014A / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Dyspnoea, Nausea
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), 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), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-05
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Apoplexy; Cardiac failure; Cardiac pacemaker insertion; Coronary disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021804178

Write-up: Dyspnea; Heart arrest; Nausea; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority, regulatory authority number DE-PEI-202100114693. A 93-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 04Jun2021 (Batch/Lot Number: 1D014A), at the age of 93-years-old, as dose 2, 0.3 mL, single for COVID-19 immunization. Medical history included ongoing coronary disease, cardiac failure, cardiac pacemaker insertion and apoplexy. The patient''s concomitant medications were not reported. Historical vaccine included BNT162B2 (COMIRNATY), via an unspecified route of administration on 23Apr2021 as dose 1, 0.3 mL, single for COVID-19 immunization. The patient''s weight was not reported, and height was not reported. On 04Jun2021 the patient experienced nausea. On 05Jun2021 the patient experienced dyspnea and heart arrest. The patient''s outcome was fatal for nausea, dyspnea, and heart arrest. The patient died on 05Jun2021. It was not reported if an autopsy was performed. This report is serious - death. Result of Assessment: Comirnaty/event(s): D. Unclassifiable No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Dyspnea; Heart arrest; Nausea


VAERS ID: 1471118 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-09
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3095 / 2 - / OT

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: Arterial hypertension; Coronary disease; Depression; Diabetes mellitus; Hypercholesterolaemia; Polytoxicomania
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021804411

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician from the Regulatory Authority [DE-PEI-202100114702]. A 74-year-old male patient received the second dose of BNT162B2 (COMIRNATY, strength: 0.3 mL, Batch/Lot number: FC3095) via intramuscular at 0.3 mL single on 09Jun2021 at the age of 74-year-old for COVID-19 immunisation. The first dose was on 28Apr2021 at the age of 74-year-old. Ongoing medical history included polytoxicomania from 2004; diabetes mellitus from 2004; hypercholesterolaemia from 2004; coronary disease from 2004; depression from 2004; arterial hypertension from 2004. Concomitant medications were not reported. The patient experienced unknown cause of death. It was unknown if an autopsy was performed. The outcome of event was fatal. Relatedness of drug to reaction(s)/event(s) Source of assessment: Result of Assessment: Unclassifiable No follow-up attempts possible. No further information expected. Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1471124 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-05-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1C006A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Status epilepticus
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-02
   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: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac arrhythmia; Dementia; Infarct myocardial
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021817815

Write-up: Status epilepticus; This is a spontaneous report from a non-contactable physician from the Regulatory Authority, company number DE-PEI-202100116986. A 86-years-old male patient received bnt162b2 (COMIRNATY; Solution for injection, Batch/Lot Number: 1C006A), via an unspecified route of administration on 20May2021 (at age of 86-years-old) as dose number unknown, single for Covid-19 immunization. Medical history included atrial fibrillation, cardiac arrhythmia, dementia, and infarct myocardial all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced status epilepticus on 21May2021. The patient died on 02Jun2021. It was unknown if an autopsy was performed. Result of Assessment was indeterminate. The outcome of event was fatal. Reported Cause(s) of Death: Status epilepticus


VAERS ID: 1471421 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-14
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Multiple organ dysfunction syndrome, Pyrexia, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Sepsis (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-14
   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: Arterial hypertension
Allergies:
Diagnostic Lab Data: Test Name: PCR; Test Result: Positive
CDC Split Type: DEPFIZER INC2021817846

Write-up: Multiple organ failure; Illness and death (14Jun22021) from COVID-19, detected by means of PCR in the clinic after two vaccinations with BioNTech, second vaccination received on 16Mar2021; Pyrexia; vaccination failure; This is a spontaneous report from a non-contactable consumer or other non-health professional from the Regulatory Authority. The regulatory authority number DE-PEI-CADR2021107065. A 86-year-old female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 16Mar2021 as dose 2, single and via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included arterial hypertension from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 14Jun2021, the patient experienced multiple organ failure, death, hospitalization, illness, and death (14Jun22021) from COVID-19, detected by means of PCR in the clinic after two vaccinations with biontech, second vaccination received on 16mar2021, pyrexia, covid-19 pneumonia. The patient underwent lab tests and procedures which included PCR test: positive on an unknown date. The events were reported as serious (hospitalization and fatal). Therapeutic measures were taken as a result of multiple organ failure, illness, and death (14jun22021) from COVID-19, detected by means of pcr in the clinic after two vaccinations with biontech, second vaccination received on 16mar2021, covid-19 pneumonia. The patient died on 14Jun2021. An autopsy was not performed. The outcome of multiple organ failure was reported as fatal; Illness and death (14Jun22021) from COVID-19, detected by means of PCR in the clinic after two vaccinations with BioNTech, second vaccination received on 16Mar2021, pyrexia, COVID-19 pneumonia was not resolved. Sender Comment: Does the patient or concerned person have any allergies? If yes, which? No Information about risk factors or previous illnesses. Arterial hypertension / COVID-19 pneumonia, fulminant course, intubation / ventilation, death caused by multiple organ failure 1st dose batch/LOT number: UNKNOWN 2nd dose batch/LOT number: UNKNOWN No follow-up activities possible. Batch LOT number cannot be obtained. No further information expected.; Reported Cause(s) of Death: Multiple organ failure


VAERS ID: 1471561 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-23
Onset:2021-03-10
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-13
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210310; Test Name: INR; Result Unstructured Data: Test Result:Nothing abnormal; Test Date: 20210310; Test Name: Thrombocyte count; Result Unstructured Data: Test Result:Nothing abnormal
CDC Split Type: DKPFIZER INC2021795501

Write-up: Intracerebral frontal haemorrhage on left side, and spread to ventricular system with signs of increased intracranial pressure.; This is a spontaneous report from a contactable physician downloaded from the regulatory authority DK-DKMA-WBS-0073334. A 84-year-old female patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: EP9598; Expiration Date: 30Jun2021), via an intramuscular on 23Feb2021 as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. There was no information regarding patient concurrent conditions or past medications. On 10Mar2021, 15 days onset first dose, the patient was diagnosed with intracerebral hemorrhage, which describes the occurrence of intracerebral hemorrhage (intracerebral frontal hemorrhage on left side and spread to ventricular system with signs of increased intracranial pressure). Patient did not receive any treatment or medical procedure due to the event. The patient lab tests which included international normalized ratio (INR) and thrombocyte count: Nothing abnormal on 10Mar2021. Patient died on 13Mar2021 and the cause of death was Intracerebral hemorrhage. Only normal confirmation of death was performed. The physician does not think that the death has been reported to the police nor have any autopsy been performed. Causality: Physician comments that he has reported as he cannot rule out a possible relation with vaccine. The physician does not believe that an autopsy has been performed, nor reported to the Police. The reporter is not the physician which have confirmed the death and does not want to report to the Police.; Reported Cause(s) of Death: Intracerebral haemorrhage


VAERS ID: 1471567 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-07
Onset:2021-06-04
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6126 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal cardiac arrest, Foetal death, Maternal exposure during pregnancy, Progesterone
SMQs:, Congenital and neonatal arrhythmias (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: progesterone; Result Unstructured Data: Test Result:16,7 nmol/L
CDC Split Type: EEPFIZER INC2021881381

Write-up: pregnancy at that time was 4 weeks, at the time of abortion (04.06) - 7 + 2; the fetal heart stopped; foetal death; This is a spontaneous report from a non-contactable consumer reported information for both mother and fetus. This is a fetus report. The mother report was downloaded from the regulatory authority-WEB report number RO-NMA-2021-SP37643. A fetus patient of unspecified age and gender received the second dose of BNT162B2 (COMIRNATY), transplacental on 07May2021 (Lot number EW6126) as 0.3 ml single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient mother medical history included endometriosis from 2020 and not ongoing, pregnancy normal from 2021 and not ongoing. Patient mother received the second dose of BNT162B2, intramuscular on an unspecified date as 0.3 ml single dose for covid-19 immunisation. Patient experienced foetal death on 04Jun2021. On 10May2021, the patient mother discovered that she was pregnant. On 04Jun2021, the pregnancy terminated spontaneously. Eventually, the fetal heart stopped and the pregnancy interrupted. On 02Jun2021, the patient mother went emergency department due to bleeding. Progesterone analysis was performed - 16,7 nmol/l. Gepretix (progesterone) 1 capsule orally three times a day was prescribed. The size of the pregnancy at that time was 4 weeks, at the time of abortion (04.06) - 7 + 2. Outcome of events were fatal. Patient died on 04Jun2021. It was not reported if an autopsy was performed. Sender Comment: Serious report due to miscarriage (medically significant). The initial side effects are known, the causal link is considered possible. Previous gynecological problems (endometriosis) may have contributed to the termination of the pregnancy. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : EE-PFIZER INC-2021804367 same product, reporter/ different patient (mother''s case); Reported Cause(s) of Death: foetal death; pregnancy; the fetal heart stopped


VAERS ID: 1471580 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-05-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3014 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Acute myocardial infarction, Adjusted calcium, Alanine aminotransferase, Anti-platelet antibody, Aspartate aminotransferase, Auscultation, Base excess, Basophil count, Blood albumin, Blood alkaline phosphatase, Blood bicarbonate, Blood bilirubin, Blood calcium, Blood chloride, Blood creatine phosphokinase, Blood creatinine, Blood fibrinogen, Blood glucose, Blood lactate dehydrogenase, Blood lactic acid, Blood magnesium, Blood potassium, Blood pressure measurement, Blood sodium, Blood urea, C-reactive protein, Carbon dioxide, Cardio-respiratory arrest, Cardiogenic shock, Chest X-ray, Coronary artery occlusion, Electrocardiogram, Eosinophil count, Fibrin D dimer, Glomerular filtration rate, Haematocrit, Haemoglobin, Heart rate, International normalised ratio, Lymphocyte count, Mean cell haemoglobin, Mean cell volume, Monocyte count, Neutrophil count, Oxygen saturation, PCO2, PO2, Platelet count, Prothrombin level, Prothrombin time, Red blood cell count, SARS-CoV-2 antibody test, Thrombocytopenia, Troponin I, Troponin T, White blood cell count, pH body fluid
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (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), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-05
   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: SIMVASTATIN; KARVEZIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cough (with enalapril); Dyslipidemia; Fracture (Fracture of the tail of the MIT.); Hypertension arterial; Hyperuricemia; Neuropathy (possible C8 neuropathy after CS to C7 arthrodesis); Obstructive sleep apnea hypopnea syndrome (without a clear predominance of supine decubitus and with restful sleep.); Prostate cancer (Low-risk prostate cancer. Treated with RT.); Right bundle branch block (TTE: preserved LVEF without segmented alterations. 33 mmHg PASP.); Tonsillectomy; Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: inguinal hernioplasty, Comment: Bilateral inguinal hernioplasty.
Allergies:
Diagnostic Lab Data: Test Date: 20210505; Test Name: APTT; Test Result: 23.7 s; Test Date: 20210505; Test Name: adjusted calcium; Test Result: 8.4 mg/dl; Test Date: 20210505; Test Name: adjusted calcium; Test Result: 8.3 mg/dl; Test Date: 20210505; Test Name: GPT; Result Unstructured Data: Test Result:66 IU/l; Test Date: 20210505; Test Name: GPT; Result Unstructured Data: Test Result:430 IU/l; Test Date: 20210505; Test Name: Anti-platelet antibodies; Test Result: Negative ; Test Date: 20210505; Test Name: GOT; Result Unstructured Data: Test Result:70 IU/l; Test Date: 20210505; Test Name: GOT; Result Unstructured Data: Test Result:805 IU/l; Test Name: auscultation; Result Unstructured Data: Test Result:CA: Rhythmic, I do not hear murmurs. PA: Vesicular; Comments: CA: Rhythmic, I do not hear murmurs. PA: Vesicular murmur preserved without added noise.; Test Date: 20210505; Test Name: Excess bases; Result Unstructured Data: Test Result:16.5 mmol/L; Comments: BEb BEecf 15.5; Test Date: 20210505; Test Name: Excess bases; Result Unstructured Data: Test Result:16.5 mmol/L; Comments: BEb BEecf 16.6; Test Date: 20210505; Test Name: basophil count; Result Unstructured Data: Test Result:0.2 x10 3/mm3; Test Date: 20210505; Test Name: basophil count; Result Unstructured Data: Test Result:0.1 x10 3/mm3; Test Date: 20210505; Test Name: albumin; Result Unstructured Data: Test Result:3.4 g/dl; Test Date: 20210505; Test Name: albumin; Result Unstructured Data: Test Result:2.9 g/dl; Test Date: 20210505; Test Name: alkaline phosphatase; Result Unstructured Data: Test Result:105 IU/l; Test Date: 20210505; Test Name: hco3; Result Unstructured Data: Test Result:15.8 mmol/L; Test Date: 20210505; Test Name: hco3; Result Unstructured Data: Test Result:13.5 mmol/L; Test Date: 20210505; Test Name: bilirubin; Test Result: 0.4 mg/dl; Test Date: 20210505; Test Name: bilirubin; Test Result: 0.7 mg/dl; Test Date: 20210505; Test Name: calcium; Test Result: 7.7 mg/dl; Test Date: 20210505; Test Name: calcium; Test Result: 7.2 mg/dl; Test Date: 20210505; Test Name: chloride; Result Unstructured Data: Test Result:102 mmol/L; Test Date: 20210505; Test Name: CPK; Result Unstructured Data: Test Result:225 IU/l; Test Date: 20210505; Test Name: CPK; Result Unstructured Data: Test Result:5826 IU/l; Test Date: 20210505; Test Name: creatinine; Test Result: 1.3 mg/dl; Test Date: 20210505; Test Name: creatinine; Test Result: 1.73 mg/dl; Test Date: 20210505; Test Name: fibrinogen; Test Result: 154 mg/dl; Test Date: 20210505; Test Name: glucose; Test Result: 302 mg/dl; Test Date: 20210505; Test Name: glucose; Test Result: 273 mg/dl; Test Date: 20210505; Test Name: LDH; Result Unstructured Data: Test Result:240 IU/l; Test Date: 20210505; Test Name: LDH; Result Unstructured Data: Test Result:1327 IU/l; Test Date: 20210505; Test Name: lactate; Result Unstructured Data: Test Result:15.24 mmol/L; Test Date: 20210505; Test Name: magnesium; Test Result: 3.3 mg/dl; Test Date: 20210505; Test Name: potassium; Result Unstructured Data: Test Result:3.1 mmol/L; Test Date: 20210505; Test Name: potassium; Result Unstructured Data: Test Result:3.8 mmol/L; Test Name: blood pressure; Result Unstructured Data: Test Result:136/117 mmHg; Test Name: blood pressure; Result Unstructured Data: Test Result:80/40 mmHg; Test Date: 20210505; Test Name: sodium; Result Unstructured Data: Test Result:143 mmol/L; Test Date: 20210505; Test Name: sodium; Result Unstructured Data: Test Result:145 mmol/L; Test Date: 20210505; Test Name: urea; Test Result: 48 mg/dl; Test Date: 20210505; Test Name: urea; Test Result: 67 mg/dl; Test Date: 20210505; Test Name: co2; Result Unstructured Data: Test Result:65.9 mmHg; Test Name: x-ray thorax; Result Unstructured Data: Test Result:No significant findings; Test Date: 20210505; Test Name: c-reative protein; Result Unstructured Data: Test Result:0.27 mg/l; Test Date: 20210505; Test Name: c-reative protein; Result Unstructured Data: Test Result:0.32 mg/l; Test Name: EKG; Result Unstructured Data: Test Result:Rhythmic, sinus at approximately 50 bpm. Very aber; Comments: Rhythmic, sinus at approximately 50 bpm. Very aberrated QRS with RBBB and HBAI morphology without clear ST alterations; Test Date: 20210505; Test Name: eosinophil count; Result Unstructured Data: Test Result:0.5 x10 3/mm3; Test Date: 20210505; Test Name: eosinophil count; Result Unstructured Data: Test Result:0.3 x10 3/mm3; Test Date: 20210505; Test Name: fibrin d dimer; Result Unstructured Data: Test Result:60378; Comments: ng/uml; Test Date: 20210505; Test Name: Estimated Glomerular Filtrate; Result Unstructured Data: Test Result:37.0; Comments: ml / min / 1.73m2; Test Date: 20210505; Test Name: Hematocrit; Test Result: 48.1 %; Test Date: 20210505; Test Name: Hematocrit; Test Result: 51.6 %; Test Date: 20210505; Test Name: Hemoglobin; Result Unstructured Data: Test Result:15.2 g/dl; Test Date: 20210505; Test Name: Hemoglobin; Result Unstructured Data: Test Result:15.7 g/dl; Test Name: heart rate; Result Unstructured Data: Test Result:Jl0; Test Name: heart rate; Result Unstructured Data: Test Result:110; Test Date: 20210505; Test Name: INR; Result Unstructured Data: Test Result:1.12; Comments: 1.15; Test Date: 20210505; Test Name: lymphocyte count; Result Unstructured Data: Test Result:3.1 x10 3/mm3; Test Date: 20210505; Test Name: lymphocyte count; Result Unstructured Data: Test Result:2.1 x10 3/mm3; Test Date: 20210505; Test Name: MCH; Test Result: 32.8 pg; Test Date: 20210505; Test Name: MCH; Test Result: 31 pg; Test Date: 20210505; Test Name: MCV; Result Unstructured Data: Test Result:103.5; Comments: fL; Test Date: 20210505; Test Name: MCV; Result Unstructured Data: Test Result:101; Test Date: 20210505; Test Name: monocyte count; Result Unstructured Data: Test Result:1.0 x10 3/mm3; Test Date: 20210505; Test Name: monocyte count; Result Unstructured Data: Test Result:0.4 x10 3/mm3; Test Date: 20210505; Test Name: neutrophil count; Result Unstructured Data: Test Result:10.7 x10 3/mm3; Test Date: 20210505; Test Name: neutrophil count; Result Unstructured Data: Test Result:17.8 x10 3/mm3; Test Name: o2 saturation; Test Result: 80 %; Test Name: o2 saturation; Test Result: 88 %; Test Date: 20210505; Test Name: o2 saturation; Test Result: 32 %; Comments: calculated VBG; Test Date: 20210505; Test Name: o2 saturation; Test Result: 39.3 %; Comments: calculated VBG; Test Date: 20210505; Test Name: pCo2; Result Unstructured Data: Test Result:65.9 mmHg; Test Date: 20210505; Test Name: pCo2; Result Unstructured Data: Test Result:47.4 mmHg; Test Date: 20210505; Test Name: pH; Result Unstructured Data: Test Result:7.0; Test Date: 20210505; Test Name: pH; Result Unstructured Data: Test Result:7.07; Test Date: 20210505; Test Name: platelet count; Result Unstructured Data: Test Result:7 x10 3/mm3; Test Date: 20210505; Test Name: platelet count; Result Unstructured Data: Test Result:181 x10 3/mm3; Test Date: 20210504; Test Name: Platelet count; Result Unstructured Data: Test Result:7000 cells/uL; Test Date: 20210505; Test Name: Platelet count; Result Unstructured Data: Test Result:181000 cells/uL; Test Date: 20210505; Test Name: pO2; Result Unstructured Data: Test Result:29.4 mmHg; Test Date: 20210505; Test Name: pO2; Result Unstructured Data: Test Result:31 mmHg; Test Date: 20210505; Test Name: prothrombin level; Test Result: 78.8 %; Comments: 80.0; Test Date: 20210505; Test Name: prothrombin time; Test Result: 12.9 s; Test Date: 20210505; Test Name: red blood cell count; Result Unstructured Data: Test Result:4.65 x10 6/mm3; Test Date: 20210505; Test Name: red blood cell count; Result Unstructured Data: Test Result:5.07 x10 6/mm3; Test Date: 20210505; Test Name: sars-cov-2 antibody test; Result Unstructured Data: Test Result:52; Comments: AU/ml; Test Date: 20210505; Test Name: troponin I; Result Unstructured Data: Test Result:167473 ng/L; Test Date: 20210505; Test Name: troponin T; Result Unstructured Data: Test Result:105 ng/L; Test Date: 20210505; Test Name: leukocyte count; Result Unstructured Data: Test Result:15.7 x10 3/mm3; Test Date: 20210505; Test Name: leukocyte count; Result Unstructured Data: Test Result:20.86 x10 3/mm3
CDC Split Type: ESPFIZER INC2021758836

Write-up: Cardiogenic shock; Cardiorespiratory arrest; Thrombocytopenia; Left coronary trunk.: Acute occlusion in the distal portion; Myocardial infarction acute; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority-AEMPS-906431. A 78-year-old male patient received BNT162B2 (COMIRNATY), dose 2 intramuscular on 04May2021 (Lot Number: EY3014) (at age of 78-year-old) as DOSE 2, single for covid-19 immunisation. Medical history included hypertension, dyslipidaemia, hyperuricaemia, cough with enalapril, right bundle branch block, OSAHS (Obstructive sleep apnea hypopnea syndrome) without a clear predominance of supine decubitus and with restful sleep , neuropathy peripheral from Jan2016 possible C8 neuropathy after CS to C7 arthrodesis, Low-risk prostate cancer, treated with RT, tonsillectomy, Fracture from 2014, inguinal hernioplasty. Unknown if the patient passed COVID-19. The patient previously took the first dose of BNT162B2 on 12Apr2021 (Lot: EW2243) for covid-19 immunisation. Concomitant medications included simvastatin and hydrochlorothiazide, irbesartan (KARVEZIDE). The patient experienced left coronary trunk.: acute occlusion in the distal portion (coronary artery occlusion) (death, hospitalization) on 04May2021, myocardial infarction acute (acute myocardial infarction) (death, hospitalization) on 04May2021, cardiogenic shock (cardiogenic shock) (death, hospitalization) on 05May2021, thrombocytopenia (thrombocytopenia) (hospitalization, life threatening) on 04May2021, cardiorespiratory arrest (cardio-respiratory arrest) (hospitalization) on 05May2021. Additional information about ADR: One arrest at home, stabilizing of the patient is achieved. The second after leaving home, for a few minutes, it is possible to stabilize the patient in the mobile unit. Sedated and tubed is taken to the hospital.Thrombopenia requires platelet bag.They try to find out what causes those arrests, discover left part of the heart is necrotic due to lack of blood flow. Thrombus that block blood flow in the heart. Reason of admission to facility: 78-year-old male entering facility because of recovered cardiac arrest. PERSONAL HISTORY: HTN and dyslipidemia. Hyperuricemia without podagra: Cough with enalapril. Assessed by CARDIOLOGIST in Nov2016 for right bundle branch block. TTE: preserved LVEF without segmented alterations. 33 mmHg PSAP.mild OSAHS without a clear predominance of supine decubitus and with restful sleep.In Jan2016 possible C8 neuropathy after CS to C7 arthrodesis.In 2014 Fracture of the tail of the MIT.Evaluated annually by UROLOGY (loss to follow-up in 2020) for: Low-risk prostate cancer. Treated with RT.Surgical interventions: tonsillectomy. Bilateral inguinal hernioplasty.BASAL SITUATION: Independent for basic activities of daily life. USUAL TREATMENT: Simvastatin 20mg 0-0-1; Karvezide (Irbesartan / Hydrochlorothiazide) 300/ 1. mg 1-0-0. CURRENT ILLNESS: His relative (daughter) reports onset at rest around 23.00, of oppressive central thoracic pain radiating to the back, with associated vegetative courtship and with asthenia and drowsiness that made standing difficult. They request evaluation by the Emergency Service, who upon arrival on ECG show monomorphic ventricular tachycardia with the semi-unconscious patient, for which they administer an electric shock, with reversion to sinus rhythm, with very aberrated QRS, although with a BCRDI-TH pattern (already described in dl previous ECOs of the patient). These findings are discussed with a referral cardiologist via the Emergency Service coordinator, who refers the referral center to the emergency room for evaluation. During the journey, the patient presented cardiorespiratory arrest, which recovered with the administration of norepinephrine and chest compressions (in about 3 minutes), carrying out Tracheotomy, which was somewhat difficult. Sedation with Propofol was performed and norepinephrine perfusion was maintained, achieving systolic pressures around 100 mmHg. Given these facts, we received a notice from Cardiology of the imminent transfer of the intubated patient to our center. At our assessment, together with Cardiology in the critical care unit at around 00:30, the patient shows data of peripheral hypoperfusion, with generalized cyanosis and acrid coldness. The maximum cardiorespiratory arrest time according to Emergency Service was less than 5 minutes during the entire procedure. Given hemodynamic instability, norepinephrine perfusion was maintained and hypoventilation was observed in the right hemithorax, which was corrected with progression of the orotracheal tube after carrying out portable x-ray. Cardiology performed V-scan at the bedside, observing very severe ventricular dysfunction of the LV, without signs of acute pulmonary thromboembolism. Together, and given the patients initial clinical condition, it was decided to activate the intrahospital infarction code at around 12:45 am and transfer to the hemodynamic room was made after his acceptance. Patient received second dose of SARS-CoV-2 vaccine from Pfizer on 04May. They deny fever, previous edema in Lower Limbs or any other symptoms. Neither episodes of previous angina. Physical exploration -ON HIS ARRIVAL AT THE ER: Orotracheal intubation., cyanotic BP: 136 / 117 HR: Jl0 S02: 80% -ON ADMISSION TO THE ICU: BP: 80 / 40mmHg. HR: II0 bpm. Sat02: 88%. Intubated, adequately sedated, without data on distress. CA: Rhythmic, I do not hear murmurs. PA: Vesicular murmur preserved without added noise. Nondescript abdomen. Upon arrival at the emergency room with anal sphincter relaxation and stool. Lower Limbs without edema or signs of DVT. I do not feel for pedic pulses. Complementary explorations: ECG ON ARRIVAL TO THE EMERGENCY: Rhythmic, sinus at approximately 50 bpm. Very aberrated QRS with RBBB and HBAI morphology without clear ST alterations. X-ray THORAX PORTABLE: No significant findings. Analytics critical care unit 05May2021 00.3SH: - Hemogram: Leukocytes: 15.70 10 "3 / mcL (3.50 - 11.00): neutrophiles: 10.7 1 0 ''3 / mcl. (2 .0 - 7.5); Lymphocytes: 3.1 10 "3 / mcL. (1.0- 4.5); Monocytes: 1.0 10 3 / mcL (0.2- 0.8); Eosinophils: 0.5 10 "3 / mcl. (0.0- 0.5); Basophils: 0.2 10" 3 / mcL (0.0 - 0.2); LUC: 0.20 10 "3 (0.40); Red blood cells: 4.65 10116 / mcL (4.30-S.90); Schistocytes 1% Hemoglobin: 15.2 g / dL (13.0-17.0); Hematocrit: 48.1% (39.0- 50.0); MCV: 103.5 tL (78.0-100.0); MCH: 32.8 pg (27.0- 32.0); Platelets: 7 10 "3 / mcL (130- 45O); Absence of clot in tube Isolated platelet aggregates. -Coagulation: Prothrombin time: 12.9 seconds (9.0-13.0); Prothrombin activity: 78.8% (80.0); I.N.R .: 1.12 (1.15); APTT (T. Cephalin): 23.7 sec (25.0- 35.0); Fibrinogen: 154 mg / dL (150-400); Derived fibrinogen: 281.0 mg / dL (150.0- 400.0); D dimers (high sensitivity): 60378.0 ng uml (500.0); -Venous gasometry: Coagulated sample. Biochemistry: Glucose: 302 mg/dl (70-110); Urea: 48 mg/dl (10-50); Creatinine: 1.30 mg/dl (0.70 - 1.30); Albumin: 3.4 g/dl (3.5-5.2); Calcium: 7.7 mg/dl (8.5 - 10.5); Corrected calcium (albumin): 8.4 mg/dl (8.6-10.2) Sodium: 143 mmol/L (135- 147); Potassium: 3.1 mmo/L (3.5- 5.0); Bilirubin total: 0.4 mg/dl (0.2-1.0); CPK: 225 U/L (<190); Basal troponin T: 105 ng / L (less 7); LDH: 240 U / L (80-235); GPT (ALT): 66 U/L (less 41); GOT (AST): 70 U/L (less 37); CRP: 0.27 mg / L (less 5.00) -Serological determinations: Ab. SARS CoV2 IgG: Positive against Spicule (Sl -RBD) Ac. SARS-CoV2 IgG versus Spicule (Sl RBD): Positive Quantification Ab. SARS-CoV2 IgG S (S J-RBD): 52.70 AU / ml <50.00). IN THE HEMODYNAMIC ROOM 05May2021 02.00H: - Venous blood gases: pH (v): 7.00 (7.35- 7.45); pC02: 65.9 mmHg (38.0-48.0); p02: 29.4 mmHg (20.0- 45.0); HC03: 15.8 mmol / 1 (23.0-28.0); TC02: 1 7.8 mmoI / l Saturation 02 (calculated): 32% (20 - 80); BEb (Excess bases in blood): -16.5 mmol/l BEecf (Excess extracellular liquid bases): -15.5 mmoVl SBC (Standard bicarbonate): 11.2 mmol/I. CORONARYGRAPHY REPORT 05May2021: TECHNIQUE: Percutaneous puncture of (RIGHT RAD: Catheters IL 3.5 of the left coronary artery and JR4 of the right coronary artery. Scope time: 43.6 mm. Duration of the procedure: 257 mm. Contrast: VISLPAQUE -320, dose 380 ce. CONCLUSIONS: Left coronary trunk.: Acute occlusion in the distal portion with TIMI 1 flow in LAD and a bisector branch and 11MI O in LCX. CD: Dominant of great development and caliber with a ostia lesion) that appears moderate without other notable lesions. INTERVENIONSM ON LCA- LAD -LCX: Bivalirudin is requested as an anticoagulant in the pharmacy, in the event of suspicion of thrombopenia with a mechanism similar to HIT, but we are informed that it is not available without immediate availability of another anticoagnlant as an alternative in the context of the patient. The BMW guides are advanced towards the LAD bisector branch and LCX and dilated with a 2 mm balloon at around 3. Some flow is achieved but very transiently and without achieving flow in distal beds with immediate occlusion of the vessels shortly after dilation. Given the pressing clinical instability and that we cannot have a confirmation of the origin of the thrombocytopenia, we decided to administer an initial bolus of 6,000 IU Heparin. In addition, a progressive tendency to hypotension, which is why an IABP was implanted through the left femoral artery. After review of the case by Hematology and Pharmacy and although there is no evidence in this context, they suggest the possibility of starting anticoagulation with Argatroban, which is started after a few minutes. An attempt is made to perform aspiration with a device. Export in LAD but without being able to advance it through the proximal LAD. Multiple attempts are made to inflate with a prolonged 2 mm balloon in LAD, achieving a slight improvement in flow but without succeeding in passing from TIMI 1. It was decided to implant a 2.25x 15 mm Resolute Onyx FA stent in the ostial LCX and a 2.75x26 Resolute Onyx FA stent in LCA-LAD. Acceptable angiographic result at the level of the stents with the LCA-DA stent al or oversized for the distal bed, although no flow in the distal LAD despite new inflations with a 2-mm balloon. Also image of residual thrombus in LCX, although in this case with TIMI 3 flow. Flow was not recovered in the bisector branch. Throughout the procedure, the patient remains with systolic around 50 with BP maintained by the IACB and thus ends the procedure. It is recommended that 600 mg of clopidogrel be administered (250 mg of IV ASA have been administered in the ward due to doubts about the pretreatment by Emergency Service). Relatives are informed of the poor prognosis in the next few hours. ANALYTICAL UPON ADMISSION TO ICU 05May: - Hemogram: Leukocytes: 20.86 10 "3mcL (3.50 - 11.00); Neutrophils: 17.8 10" 3 / mcL (2.0 - 7.5); Lymphocytes: 2.1 10 "3 / mcL (1.0 - 4.5); Monocytes: 0.4 10 "3 / mcL (0.2- 0.8); Eosinophils: 0.3 10" 3 / (0.0- 0.5); Basophils: 0.1 10 "3 / mcL (0.0" 0.2); Hematite is: 5.07 10 "6 / mclL (4.30- 5.90); Hemoglobin: 15.7 g / dL (13.0- L 7.0); Hematocrit: 51.6% (39.0- 50.0); MCV: 101.8 fL (78.0- 100.0 ); MCH: 31.0 pg (27.0- 32 .0): C.Ke.M: 30.5 g / dL (3 1.5 - 34.5); Platelets: 181 10 "3 mcL (130- 450). - Arterial blood gas with oxygen: pH (a): 7.07 (7.35- 7.45); PC02: 47.4 mmHg (35.0- 45.0); P02: 31.0 mmHg (75.0-105.0); Bicarbonate: 13.5 mmol / L (21.0-26.0); Te02: 14.9 mmoVL (22.0 - 29.0); Saturation 02 (calculated): 39.3% (95.0 - 100.0); BEb (excess of bases in blood): -16.5 mmol / L (-3.0 - 3.0); BEecf (Excess of bases in extracellular q): -16.6 mmol/L (3.0-3.0); SBC (Standard Bicarbonate); 11.3 mmo/L (21.0 - 27.0) -Biochemistry: Glucose: 273 mg/dl (70-110); Urea: 67 mg/dl (1O-50); creatinine: 1.73 mg/df (0.70-1.30) Albumin: 2.9 g/dl (3.5-5.2); Calcium: 7.2 mg/dl (8.5 -10.5) Corrected calcium (albumin): 8.3 mg/ df (8.6- 10.2); Phosphorus: 6.9 mg/dl (2.6- 4.8) Sodium: 145 mmol/L (135 - 147); Potassium: 3.8 mmol/L (3.5 - 5.0); Chloride: 102 mmol/L (95-106); Lactate: 15.24 mmol/L (less L80); Tested and advised Magnesium: 3.3 m g / dl (1.3 - 2.7); Total bilirubin: 0.7 mg / dl (0.2-LO); CPK: 5826 U / L (<190); Troponin I (tracking): 167473 n g / L (less 57); Tropon variation 1% (delta): 159398%); LDH: 1327 U / L (80-235); GPT ALT): 430 U / L (less 41); GOT (AST): 805 U / L (less 37) Alkaline phosphatane: 105 U / L (40- 129) Estimated Glomerular Filtration Rate (CKD-EPJ): 37.0 ml / min / 1.73m2. CRP: 0.32 m (less 5.00); 05May2021: Ab. anti-PF4-heparine: NEGATIVE. EVOLUTION IN ICU- INITIAL PERFORMANCE: After several attempts, an intraosseous and a peripheral venous route were cannulated. Analytically, a very severe thrombopenia of 7000 stands out (confirmed by laboratory), with no viable samples for evaluation of the internal environment upon arrival at the emergency room due to their coagulation. Given the life-threatening situation of the patient given the persistence of hemodynamic instability, a multidisciplinary decision was made to perform emergent coronary angiography, despite acute thrombopenia, after rapid transfusion of 2 platelet pools following findings: Tei: Acute occlusion in the distal portion with TIMI 1 flow in LAD and a bisector branch and TIMI O in LCX. RCA: Dominant of great development and caliber with a ostia lesion that seems moderate without other notable lesions. INTERVENIONSM ON LCI- LAD -LCX: Bivalirudin is requested as an anticoagulant in the pharmacy, in the event of suspicion of thrombopenia with a mechanism similar to HIT, but we are informed that it is not available without immediate availability of another anticoagnlant as an alternative in the context of the patient. The BMW guides are advanced towards the LAD bisector branch and LCX and dilated with a 2 mm balloon at around 3. Some flow is achieved but very transiently and without achieving flow in distal beds with immediate occlusion of the vessels shortly after dilation. Given the pressing clinical instability and that we cannot have a confirmation of the origin of the thrombocytopenia, we decided to administer an initial bolus of 6,000 IU Heparin. In addition, a progressive tendency to hypotension, which is why an IABP was implanted through the left femoral artery. After review of the case by Hematology and Pharmacy and although there is no evidence in this context, they suggest the possibility of starting anticoagulation with Argatroban, which is started after a few minutes. An attempt is made to perform aspiration with a device. Export in LAD but without being able to advance it through the proximal LAD. Multiple attempts are made to inflate with a prolonged 2 mm balloon in LAD, achieving a slight improvement in flow but without succeeding in passing from TIMI 1. It was decided to implant a 2.25x 15 mm Resolute Onyx FA stent in the ostial LCX and a 2.75x26 Resolute Onyx FA stent in LCA-LAD. Acceptable angiographic result at the level of the stents with the LCA-DA stent al or oversized for the distal bed, although no flow in the distal LAD despite new inflations with a 2-mm balloon. Also image of residual thrombus in LCX, although in this case with TIMI 3 flow. Flow was not recovered in the bisector branch. Throughout the procedure, the patient remains with systolic around 50 with BP maintained by the IACB and thus ends the procedure. During the procedure, Hematology on call contact us, who recommend establishing a causal relationship between severe acute thrombopenia, large arterial vessel thrombosis and vaccination against SARS-CoV-2 from Pfizer (received second dose on 04May). They advise the administration of immunoglobulins at a dose of 1 mg/kg, which is decided to delay due to figures in the normal range (180 thousand) in the blood count taken a few hours later. However, complementary studies are requested in order to enlarge the diagnosis of severe acute thrombopenia. At 24h, results of Ab. anti-FP4-heparin that are negative. Doubts about the veracity of the initial severe thrombopenia. After performing the coronary angiography, we proceed to transfer him to the Intensive Care Unit. An ultrasound-guided right jugular central venous line is channeled and analgesia is maintained with midazolam and fentanyl, with vasoactive noradrenaline support at high doses. Argatroban sustained perfusion at a rate of 1OmVh as previously commented. Poor evolution in the following hours with a fall in persistent ventricular tachycardia. He has required electrical therapy to recover spontaneous circulation. Deep shock despite maximum inotropic support. Very severe metabolic acidosis and profound hypoxemia despite maximum respiratory support with fi02 of 1. Faced with refractoriness of measures, it was decided to prioritize comfort measures, producing lethal death. Clinical judgment -Exitus letalis on 05May2021 -Acute myocardial infarction secondary to an acute occlusion in the left main coronary artery (distal portion with TIMI 1 flow in LAD and a bisector branch and TIMI O in LCX). Laborious emergent choro angiography with implantation of a drug-eluting stent in LCX ostia and another in LCI-LDA. Unviable angiographic result. - Cardiogenic shock secondary to the above. Intra-aortic counterpulsation balloon. -Cardiorespiratory arrest secondary to the above. Recovery after electrical cardioversion and vasoactive drugs. Orotracheal intubation. 05May. The patient died on 05May2021. It was not reported if an autopsy was performed. The outcome of event thrombocytopenia and cardiorespiratory arrest was resolved on 05May2021, the rest of events with outcome fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Myocardial infarction acute; Cardiogenic shock; Left main coronary artery occlusion


VAERS ID: 1471636 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-30
Onset:2021-02-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Acute kidney injury, Alanine aminotransferase, Antipsychotic drug level, Aspartate aminotransferase, Blood 25-hydroxycholecalciferol, Blood albumin, Blood alkaline phosphatase, Blood bromide, Blood creatine, Blood creatine phosphokinase, Blood glucose, Blood lactate dehydrogenase, Blood parathyroid hormone, Blood phosphorus, Blood potassium, Blood sodium, Blood urea, Body mass index, Body temperature, C-reactive protein, COVID-19 pneumonia, Chest X-ray, Drug ineffective, Fibrin D dimer, Full blood count, Gamma-glutamyltransferase, Glomerular filtration rate, Haematocrit, Haemoglobin, Hepatitis B core antibody, Hepatitis B surface antibody, Hepatitis B surface antigen, Mean cell volume, Oxygen saturation, PO2, Platelet count, Pyrexia, Respiratory failure, Respiratory rate, SARS-CoV-2 antibody test, SARS-CoV-2 test, Serum ferritin, Troponin I, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-17
   Days after onset: 15
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: TAMSULOSINE HCL; PREDNISONE; SINEMET PLUS; LITHIUM CARBONATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute myocardial infarction; Acute pericarditis (secondary to giant cell arteritis on corticoid treatment); Benign prostatic hyperplasia; Bipolar disorder; Dementia; Ischaemic cardiomyopathy; Obesity; Parkinson''s syndrome (on Sinemet treatment)
Allergies:
Diagnostic Lab Data: Test Date: 20210209; Test Name: aTTP; Result Unstructured Data: Test Result:1.02; Test Date: 20210209; Test Name: ALT; Result Unstructured Data: Test Result:9; Test Date: 20210208; Test Name: Litemia; Result Unstructured Data: Test Result:05; Test Date: 20210209; Test Name: AST; Result Unstructured Data: Test Result:34; Test Date: 20210209; Test Name: Calcidiol; Result Unstructured Data: Test Result:70.7; Test Date: 20210209; Test Name: Albumin; Result Unstructured Data: Test Result:38; Test Date: 20210209; Test Name: FA; Result Unstructured Data: Test Result:86; Test Date: 20210209; Test Name: Br; Result Unstructured Data: Test Result:10; Test Date: 20210207; Test Name: Cr; Result Unstructured Data: Test Result:109; Test Date: 20210209; Test Name: Cr; Result Unstructured Data: Test Result:229; Test Date: 20210211; Test Name: Cr; Result Unstructured Data: Test Result:242; Test Date: 20210209; Test Name: Cr-kinase; Result Unstructured Data: Test Result:80; Test Date: 20210209; Test Name: Gluco; Result Unstructured Data: Test Result:11.9; Test Date: 20210207; Test Name: LDH; Result Unstructured Data: Test Result:453; Test Date: 20210209; Test Name: LDH; Result Unstructured Data: Test Result:457; Test Date: 20210209; Test Name: Parathyrin; Result Unstructured Data: Test Result:15.9; Test Date: 20210209; Test Name: Phosphate; Result Unstructured Data: Test Result:1.45; Test Date: 20210207; Test Name: K; Result Unstructured Data: Test Result:4.25; Test Date: 20210209; Test Name: K; Result Unstructured Data: Test Result:4.12; Test Date: 20210211; Test Name: K; Result Unstructured Data: Test Result:3.51; Test Date: 20210207; Test Name: Na; Result Unstructured Data: Test Result:144; Test Date: 20210209; Test Name: Na; Result Unstructured Data: Test Result:146; Test Date: 20210211; Test Name: Na; Result Unstructured Data: Test Result:156; Test Date: 20210209; Test Name: Urea; Result Unstructured Data: Test Result:33.1; Test Name: BMI; Result Unstructured Data: Test Result:30-40; Test Date: 20210207; Test Name: temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Test Date: 20210207; Test Name: Chest X-ray; Result Unstructured Data: Test Result:diffuse bilateral infiltrates; Comments: diffuse bilateral infiltrates; Test Date: 20210207; Test Name: CRP; Result Unstructured Data: Test Result:187; Test Date: 20210209; Test Name: CRP; Result Unstructured Data: Test Result:137.2; Test Date: 20210209; Test Name: lower D-dimer; Result Unstructured Data: Test Result:250; Test Date: 20210207; Test Name: haemogram; Result Unstructured Data: Test Result:lymphopenia 0.79; Comments: without leukocytosis with lymphopenia 0.79.; Test Date: 20210209; Test Name: GGT; Result Unstructured Data: Test Result:74; Test Date: 20210209; Test Name: glomerular filtration; Result Unstructured Data: Test Result:21; Test Date: 20210211; Test Name: glomerular filtration; Result Unstructured Data: Test Result:20; Test Date: 20210209; Test Name: Hematocrit; Test Result: 48 %; Test Date: 20210209; Test Name: Hb; Result Unstructured Data: Test Result:160; Test Date: 20210209; Test Name: Hep B Ac IgG; Result Unstructured Data: Test Result:-; Test Date: 20210209; Test Name: Ac (anti surface); Result Unstructured Data: Test Result:-; Test Date: 20210209; Test Name: HbsAg; Result Unstructured Data: Test Result:-; Test Date: 20210209; Test Name: medium corpuscular volume; Result Unstructured Data: Test Result:92; Test Date: 20210207; Test Name: O2 Sat; Test Result: 94 %; Test Date: 20210209; Test Name: platelets; Result Unstructured Data: Test Result:259.000; Test Date: 20210207; Test Name: pO2; Result Unstructured Data: Test Result:54; Test Name: RR; Result Unstructured Data: Test Result:50; Comments: breaths per minute; Test Date: 20210207; Test Name: RR; Result Unstructured Data: Test Result:50; Comments: breaths per minute; Test Date: 20210209; Test Name: Coronavirus SARS-CoV-2; total Antibodies; Result Unstructured Data: Test Result:-; Test Date: 20210205; Test Name: PCR SARS CoV2; Result Unstructured Data: Test Result:+; Comments: PCR SARS CoV2 +.; Test Date: 20210205; Test Name: rapid antigen test; Result Unstructured Data: Test Result:+; Test Date: 20210207; Test Name: ferritin; Result Unstructured Data: Test Result:1115.6; Test Date: 20210209; Test Name: ferritin; Result Unstructured Data: Test Result:1448.5; Test Date: 20210209; Test Name: TP I; Result Unstructured Data: Test Result:1.12; Test Date: 20210209; Test Name: leucocytes; Result Unstructured Data: Test Result:13.100; Comments: N 11.640; L 910; N 88.7%, L 6.9%
CDC Split Type: ESPFIZER INC2021824389

Write-up: respiratory failure; acute renal failure; COVID-19 pneumonia; Drug ineffective; she began to have febrile peaks on 02Feb; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number ES-AEMPS-926787. A 87-year-old male patient received second dose of bnt162b2 (COMIRNATY, Solution for injection), intramuscular on 30Jan2021 (Batch/Lot Number: EK9788) as 0.3ml single dose for COVID-19 immunization. Patient received first dose of bnt162b2 (COMIRNATY, Solution for injection) dose 1 intramuscular on 09Jan2021 (Batch/Lot Number: EJ6796) as 0.3ml single dose for COVID-19 immunization. Medical history included ischaemic cardiomyopathy from an unknown date and unknown if ongoing, acute myocardial infarction from 2002 to an unknown date, parkinsonism from an unknown date and unknown if ongoing on Sinemet treatment, bipolar disorder, benign prostatic hyperplasia, dementia, pericarditis from an unknown date and unknown if ongoing, secondary to giant cell arteritis on corticoid treatment, obesity from an unknown date and unknown if ongoing. Concomitant medications included tamsulosine HCL taken for benign prostatic hyperplasia from Mar2012 to 07Feb2021; prednisone taken for giant cell arteritis from Aug2019 to 07Feb2021; carbidopa monohydrate, levodopa (SINEMET PLUS) taken for Parkinson''s disease from an unspecified start date to 07Feb2021; lithium carbonate taken for bipolar disorder from Jan2013 to 07Feb2021. The patient experienced respiratory failure and acute renal failure on an unspecified date which leads to hospitalization. The patient experienced drug ineffective on an unspecified date. She began to have febrile peaks on 02feb on 02Feb2021. The patient experienced COVID-19 pneumonia on 02Feb2021 which leads to hospitalization. Therapeutic measures were taken as result of COVID-19 pneumonia, respiratory failure, acute renal failure and she began to have febrile peaks on 02feb (pyrexia). Evolution and treatment: Hospital stay of patient was marked by progressive respiratory failure with marked radiological worsening. Anal progressive elevation of acute phase reactants and onset of acute renal failure AKIN (Acute Kidney injury classification) 3 (dehydration and retention). Intravenous hydration + SV did not improve renal function. The patient underwent lab tests with blood creatine: 109 and blood lactate dehydrogenase: 453 on 07Feb2021. Physician Suspend Remdesivir (200mg) on 07Feb2021. Physician Suspend Remdesivir (100mg) on 08Feb2021 due to renal failure and respiratory worsening, escalated SARS CoV2 treatment with 1 bolus of dexamethasone 20mg. Patient Respiratory discomfort persisted and RR over 50 breaths per minute. The patient underwent lab tests with antipsychotic drug level: 05 on 08Feb2021. The patient underwent lab tests and procedures which included activated partial thromboplastin time: 1.02, alanine aminotransferase: 9, aspartate aminotransferase: 34, blood 25-hydroxycholecalciferol: 70.7, blood albumin: 38, blood alkaline phosphatase: 86, blood bromide: 10, blood creatine: 229, blood creatine phosphokinase: 80, blood glucose: 11.9 and blood lactate dehydrogenase: 457 on 09Feb2021. The patient underwent lab tests with blood creatine: 242 on 11Feb2021. Comfort measures since 12Feb2021, Patient died on 17Feb2021. The outcome of respiratory failure, acute renal failure and she began to have febrile peaks on 02feb was unknown. The patient died on 17Feb2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Summary of Reporter''s Comments text: Patient 81 years old with history: Ischaemic cardiomyopathy, Acute myocardial infarction 2002, idiopathic versus pharmacological parkinsonian syndrome on Sinemet treatment, bipolar disorder (lithemia N, last controls), benign prostatic hyperplasia, probable dementia...; Reported Cause(s) of Death: COVID-19 pneumonia


VAERS ID: 1471693 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-05-03
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, SARS-CoV-2 test, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-03
   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: ELIQUIS; HYPERIUM; MONO-TILDIEM
Current Illness: AFib; Arterial hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210503; Test Name: COVID-19 antigen test; Test Result: Negative
CDC Split Type: FRPFIZER INC2021781100

Write-up: Death sudden; Cardio-respiratory arrest; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority. The regulatory authority report number is FR-AFSSAPS-2021062631. An 82 years old male patient received the second dose of BNT162B2 (COMIRNATY) intramuscularly, at single dose, on an unspecified date, in the last week of Apr2021, for COVID-19 immunisation. Relevant medical history included arterial hypertension from an unspecified date (ongoing) and atrial fibrillation (AFib) from an unspecified date (ongoing). No history of COVID-19 was reported. The patient previously, on 11Mar2021, received the first dose of BNT162B2 (COMIRNATY, Lot. EP9605), at single dose, for COVID-19 immunisation. Concomitant medications included apixaban (ELIQUIS) from an unspecified date, 5 mg, twice daily, for an unknown indication; rilmenidine phosphate (HYPERIUM) from an unspecified date, once daily, for an unknown indication and diltiazem hydrochloride (MONO-TILDIEM) from an unspecified date, once daily, for an unknown indication. On 03May2021: in the morning, good general condition. The patient went to his studio around 9 a.m. He was found by his family around 12:30 p.m., lying in his studio in his chair, no longer breathing (no contact with anyone between 9 a.m. and 12:30 p.m.). Firefighters arrived three quarters of an hour later: patient in cardio-respiratory arrest (at least 45 minutes of no-flow). Heart massage was performed. Arrived from emergency medical and resuscitation service a quarter of an hour later: patient with asystole. Administration of adrenaline (5 x 5 mg in total). No notion of prodrome the days before, nor the morning itself. COVID antigen test negative. The emergency medical and resuscitation service doctor concludes in sudden death. No autopsy was done. In total, sudden death 7 weeks after a 1st dose of BNT162B2 (COMIRNATY) vaccine and apparently around 1 week after a 2nd dose, in an elderly hypertensive patient who had AFib, without prodrome the days before, nor in the morning even. No follow-up attempts are possible, information about lot number cannot be obtained.; Reported Cause(s) of Death: Cardio-respiratory arrest; Death sudden


VAERS ID: 1471700 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-08
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA8016 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LORAZEPAM
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021804157

Write-up: Sudden death unexplained; This is a spontaneous report from a contactable physician from the Regulatory Authority. The regulatory authority number FR-AFSSAPS-2021070154. A 52-year-old female patient received the first dose of BNT162B2 (COMIRNATY, solution for injection) intramuscular, administered in Arm Left on 31May2021 (Lot Number: FA8016) as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. Patient is not considered to be at risk of developing a severe form of COVID-19 disease. Patient has no history of COVID-19. It was unknown if patient got tested. Concomitant medication included lorazepam (TEMESTA) taken for an unspecified indication, start and stop date were not reported. Sudden unexplained death of the patient on 08Jun2021, without witness. Patient was found deceased by her mother sitting on her couch with foamy sputum coming out of nostrils and mouth. Patient was doing well the day before death and was seen mowing the lawn the day before. Realization of a medical certificate of death. Autopsy report has been requested, several reminders made without response. It was not reported if an autopsy was eventually performed. No follow-up attempts are possible. No further information is expected. Reported Cause(s) of Death: Sudden death


VAERS ID: 1471706 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0785 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Blood fibrinogen, Blood pressure measurement, Blood sodium, Body temperature, Coma scale, Computerised tomogram, Glomerular filtration rate, Haemorrhagic stroke, Heart rate, Hemiplegia, Neutrophil count, Oxygen saturation, Platelet count, Respiratory rate, Vomiting, White blood cell count
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-13
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ZYMAD; PARACETAMOL; DIAZEPAM; MACROGOL; PERINDOPRIL; MANNITOL; DICLOFENAC; OXAZEPAM; NEFOPAM HYDROCHLORIDE; RISPERIDONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease (mini-mental state 20/30 in 2017); Aplasia (under plavix in 2014); Carotid arteriosclerosis (2014); COVID-19; Dyslipidaemia; Hypertension arterial; Intracerebral haematoma (under plavix in 2014); Kidney failure chronic
Allergies:
Diagnostic Lab Data: Test Date: 20210609; Test Name: creatinine; Test Result: 82 umol; Test Date: 20210609; Test Name: Fibrinogen; Result Unstructured Data: Test Result:4.4 g/l; Test Date: 20210609; Test Name: Blood pressure; Result Unstructured Data: Test Result:129/77; Test Date: 20210609; Test Name: Blood pressure; Result Unstructured Data: Test Result:11/8; Test Date: 20210609; Test Name: hyponatremia; Test Result: 133 mmol; Test Date: 20210609; Test Name: Body temperature; Result Unstructured Data: Test Result:Normal; Test Date: 20210609; Test Name: Glasgow scale; Result Unstructured Data: Test Result:Glasgow 9 degrading to G6 (Y1V1M4); Test Date: 20210609; Test Name: Computerized tomography; Result Unstructured Data: Test Result:right frontal intra-parenchymal hematoma; Comments: Voluminous right frontal intra-parenchymal hematoma of 7x4x3cm causing a mass effect on the right lateral ventricle and a minimal deviation from the midline. No sign of commitment.; Test Date: 20210609; Test Name: GFR CKD EPI; Result Unstructured Data: Test Result:57 mL/min; Test Date: 20210609; Test Name: heart rate; Result Unstructured Data: Test Result:94 bpm; Test Date: 20210609; Test Name: Pulse; Result Unstructured Data: Test Result:80; Test Date: 20210609; Test Name: Neutophiles; Result Unstructured Data: Test Result:10.82 x10 9/l; Test Date: 20210609; Test Name: Saturation; Test Result: 96 %; Test Date: 20210609; Test Name: Saturation; Test Result: 93 %; Test Date: 20210609; Test Name: Platelet count; Result Unstructured Data: Test Result:398 x10 9/l; Test Date: 20210609; Test Name: Respiratory rate; Result Unstructured Data: Test Result:12; Test Date: 20210609; Test Name: Leucocyte count; Result Unstructured Data: Test Result:12.29 x10 9/l
CDC Split Type: FRPFIZER INC2021817766

Write-up: Haemorrhagic stroke; vomiting; left hemiplegia; This is a spontaneous report from a contactable pharmacist downloaded from the European Medicines Agency (EMA) EudraVigilance-WEB, regulatory authority number FR-AFSSAPS-2021072507. A 83-year-old female patient received bnt162b2 (COMIRNATY, Formulation: solution for injection; Lot Number: FD0785) via intramuscular route of administration in Left Arm on 08Jun2021 as dose 2, single for COVID-19 immunization. Medical history included Chronic renal failure, carotid arteriosclerosis (2014), cerebral haematoma and aplasia from 2014 to an unknown date, under plavix (in 2014), dementia alzheimer''s type from 2017 to an unknown date, dyslipidaemia, hypertension, COVID-19 from an unknown date and unknown if ongoing. Concomitant medications included ZYMAD, paracetamol, diazepam, macrogol, perindopril, mannitol, diclofenac, oxazepam, nefopam hydrochloride, risperidone taken for an unspecified indication, start and stop date were not reported. On 09Jun2021 the patient experienced haemorrhagic stroke; Vomiting and Left hemiplegia. The stop date for Haemorrhagic stroke was reported as 13Jun2021. It was reported that on 09Jun2021 at 07h15, patient found by caregivers with hemibody deficit Left, apathetic, asthenic, aphasic has hypotonia in the arm and lower limbs. Taken care of by a doctor and referred to the emergency room. In the emergency room: no sign of clinical commitment, disturbance of alertness (drowsiness), left hemiplegia, headache, and vomiting. Cardiovascular: regular heart sounds, no murmur, no edema of the lower limbs; Respiratory: no dyspnea, no polypnea. Symmetrical bilateral vesicular murmur; Implementation of a Morphine electric syringe pump for comfort. The patient underwent lab tests and procedures which included blood creatinine: 82 umol, blood fibrinogen: 4.4 g/l, blood pressure measurement: 129/77, blood pressure measurement: 11/8, blood sodium: 133 mmol, body temperature: normal, coma scale: glasgow 9 degrading to g6 (y1v1m4), computerised tomogram: right frontal intra-parenchymal hematoma (Voluminous right frontal intra-parenchymal hematoma of 7x4x3cm causing a mass effect on the right lateral ventricle and a minimal deviation from the midline), No sign of commitment, glomerular filtration rate: 57 ml/min, heart rate: 80, heart rate: 94 bpm, neutrophil count: 10.82 x10 9/l, oxygen saturation: 96%, oxygen saturation: 93%, platelet count: 398 x10 9/l on 09Jun2021. The event "hemiplegia" and "vomiting" caused of patient death on 13Jun2021. An autopsy was not performed. Therapeutic measures were taken as a result of adverse events. The clinical outcome of the event was fatal. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: hemiplegia; Vomiting


VAERS ID: 1471709 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-05-01
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Angiocardiogram, Blood cholesterol, Blood electrolytes, Blood homocysteine, Blood lactate dehydrogenase, Blood pressure measurement, Blood triglycerides, Body mass index, Body temperature, C-reactive protein, Cardiac telemetry, Cerebral haemorrhage, Computerised tomogram, Echocardiogram, Electrocardiogram, Electrophoresis protein, Fibrin D dimer, Full blood count, Glycosylated haemoglobin, Heart rate, High density lipoprotein, Immune thrombocytopenia, Investigation, Liver function test, Low density lipoprotein, Magnetic resonance imaging head, NIH stroke scale, Oxygen saturation, Platelet count, Prothrombin time, Renal function test, SARS-CoV-2 test, Troponin, Vitamin B12
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Haemorrhagic central nervous system vascular conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-06
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: TENORMINE; FLECAINE; SIMVASTATIN; LERCANIDIPINE; CANDESARTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic lymphocytic leukaemia (follow-up every six months, last follow-up in Jan. 2021); Coronary angiograph (normal coronary angiography and ETT in 2012); Dyslipidaemia; Endotracheal intubation (normal coronary angiography and ETT in 2012); Hypertension arterial (Resistant hypertension with last therapeutic modification 1 year ago with addition of candesartan); Junctional tachycardia; Lipoma; Non-smoker (Does not smoke); Pollen allergy (Allergy: pollen)
Allergies:
Diagnostic Lab Data: Test Date: 20210501; Test Name: kaolin partial thromboplastin time; Test Result: 28.4 s; Test Date: 20210501; Test Name: kaolin partial thromboplastin time; Test Result: 28 s; Test Date: 2012; Test Name: coronary angiography; Result Unstructured Data: Test Result:normal; Test Date: 20210501; Test Name: ct; Result Unstructured Data: Test Result:1.66 g/l; Test Date: 20210501; Test Name: ionogram; Result Unstructured Data: Test Result:ok; Test Date: 20210501; Test Name: homocysteine; Test Result: 16.7 umol; Comments: less than 14.9; Test Date: 20210501; Test Name: ldh; Result Unstructured Data: Test Result:unknown; Test Date: 20210501; Test Name: blood pressure; Result Unstructured Data: Test Result:117/ 97; Test Date: 20210501; Test Name: blood pressure; Result Unstructured Data: Test Result:214/109; Test Date: 20210501; Test Name: tg; Result Unstructured Data: Test Result:1.66 g/l; Test Date: 20210501; Test Name: Body mass index; Result Unstructured Data: Test Result:28.06; Test Date: 20210501; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Test Date: 20210501; Test Name: telemetry; Result Unstructured Data: Test Result:no Afib found; Comments: Telemetry: no ACFA found; Test Date: 20210505; Test Name: CT scan; Result Unstructured Data: Test Result:major increase in size of hematoma; Comments: major increase in size of hematoma with subfactorial involvement, mass effect with midline deviation, tetra ventricular and peri mesencephalic cistern flooding leading to resuscitation; Test Date: 20210501; Test Name: CRP; Result Unstructured Data: Test Result:less than 5; Test Date: 2012; Test Name: trans-thoracic echocardiography; Result Unstructured Data: Test Result:normal; Test Date: 20210501; Test Name: ecg; Result Unstructured Data: Test Result:sinus rhythm; Test Date: 20210501; Test Name: serum protein electrophoresis; Result Unstructured Data: Test Result:heterogeneous migration of gamma globulins; Test Date: 20210501; Test Name: fibrin d-dimer; Result Unstructured Data: Test Result:320 ng/ml; Test Date: 20210501; Test Name: blood count; Result Unstructured Data: Test Result:ok; Test Date: 20210501; Test Name: glycosylated hemoglobin; Result Unstructured Data: Test Result:5.3; Test Date: 20210501; Test Name: heart rate; Result Unstructured Data: Test Result:60; Test Date: 20210501; Test Name: heart rate; Result Unstructured Data: Test Result:72; Test Date: 20210501; Test Name: hdl; Result Unstructured Data: Test Result:0.34 g/l; Test Date: 20210501; Test Name: Anti PF4 Zymutest HIA Hyphen biomed; Result Unstructured Data: Test Result:negative; Comments: Anti PF4 Zymutest HIA Hyphen biomed negative; Test Date: 20210501; Test Name: dextro; Result Unstructured Data: Test Result:0.86 g/l; Comments: dextro 0.86g/l; Test Date: 20210501; Test Name: liver function test; Result Unstructured Data: Test Result:ok; Test Date: 20210501; Test Name: ldl; Result Unstructured Data: Test Result:1.1 g/l; Test Date: 20210501; Test Name: brain mri; Result Unstructured Data: Test Result:13X11 mm deep left capsulo-thalamic hematoma; Comments: 13X11 mm deep left capsulo-thalamic hematoma, no clear evidence of cavernoma, USINV; Test Date: 20210501; Test Name: NIHSS; Result Unstructured Data: Test Result:3; Test Date: 20210501; Test Name: oxygen saturation; Test Result: 98 %; Test Date: 20210501; Test Name: platelet count; Result Unstructured Data: Test Result:165; Comments: 165G/l; Test Date: 20210504; Test Name: platelet count; Result Unstructured Data: Test Result:100; Comments: 100G/l; Test Date: 20210505; Test Name: platelet count; Result Unstructured Data: Test Result:9; Comments: 9G/l; Test Date: 20210501; Test Name: prothrombin time; Test Result: 110 %; Comments: TP 110%,; Test Date: 20210501; Test Name: renal function test; Result Unstructured Data: Test Result:ok; Test Date: 20210501; Test Name: PCR COVID; Result Unstructured Data: Test Result:Negative; Comments: PCR COVID on 01May2021: negative; Test Date: 20210501; Test Name: troponin; Result Unstructured Data: Test Result:0.007 ng/ml; Test Date: 20210501; Test Name: vitamin b12; Result Unstructured Data: Test Result:365 pg/mL
CDC Split Type: FRPFIZER INC2021817747

Write-up: Idiopathic thrombocytopenic purpura; Cerebral haemorrhage; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number FR-AFSSAPS-2021073697. A 63-years-old male patient received second dose of bnt162b2 (COMIRNATY, Solution for injection), intramuscular, administered in Arm Left on 20Apr2021 (Batch/Lot Number: EW4815) as dose 2, 0.3 mL, single for covid-19 immunization. Medical history included Diffuse lipoma especially right and left anterior iliac with right iliac resection, CLL (chronic lymphocytic leukemia) diagnosed in 2019, follow-up every six months, last follow-up in Jan2021, Dyslipidemia, Resistant hypertension with last therapeutic modification 1 year ago with addition of candesartan, normal coronary angiography in 2012, Endotracheal intubation (ETT) in 2012, junctional tachycardia. The patient had allergy to pollen and ankle edema after treatment with CCD. The patient was nonsmoker and had occasional alcohol consumption. Body mass index was 28.06. Concomitant medications included atenolol (TENORMINE) taken 25 mg in the morning, flecainide acetate (FLECAINE) taken 100 mg LP in the morning, simvastatin taken 10 mg in the evening, lercanidipine taken 20 mg in the morning and candesartan taken 8 mg in the morning. On 01May2021, the patient experienced cerebral hemorrhage and on 05May2021 patient experienced idiopathic thrombocytopenic purpura. It was reported that on 01May2021 around 6:30 AM, a few minutes after waking up, onset of dizzy sensations associated with heaviness and clumsiness of the right hemisphere. No headache or diplopia associated leading to emergency room. Vitals signs investigation included blood pressure 214/109, heart rate 72 , temp: 36,5 degrees Centigrade, dextro 0.86g/l. Clinically investigation showed right hemicorpus ataxia and dysarthria, i.e. NIH Stroke Scale (NIHSS) was 3, electrocardiogram (ECG) in sinus rhythm, Telemetry showed no afib found and no ACFA found, Brain MRI: 13X11 mm deep left capsulo-thalamic hematoma, no clear evidence of cavernoma $gUSINV. Again, Vitals investigation was done included BP 117/97 FC60 ,sat 98%AA, dextro 1.04g/l. Biological workup included complete blood count (CBC) was ok, platelets 165G/l on arrival, rechecked on 04May2021 at 100G/l then at 9G/l on 05May morning without DIC found, nor heparin previously administered, D-dimer 320ng/ml, TP 110%, TCK 28.4s for a control at 28, Anti PF4 Zymutest HIA Hyphen biomed negative, Ionogram was ok, renal function was ok, Troponin 0.007ng/ml, CRP less than 5, Liver function test ok, Lactate dehydrogenase (LDH) not known, Homocysteine 16.7uM (<14.9), Glycated Hb 5.3, Vitamin B12 365 pg/ml, trans-thoracic echocardiography was normal, Lipid profile included Thyroglobulin (TG) 1.66g/l, Total Cholesterol (TC)1.66g/l, igh-density lipoprotein cholesterol (HDLc) 0.34g/l, low-density lipoprotein cholesterol test (LDLc )1.1g/l, Protein electrophoresis (EPP): heterogeneous migration of gamma globulins, PCR COVID on 01May2021: negative. No virosis. On 05May2021 there was abrupt worsening leading to emergency CT scan which shows major increase in size of hematoma with subfactorial involvement, mass effect with midline deviation, tetra ventricular and peri mesencephalic cistern flooding leading to resuscitation. The diagnosis retained reported as Capsulo-thalamic hematoma probably secondary to hypertensive arteriopathy, Deep thrombocytopenia suspected to be related to ITP. In total, cerebral hemorrhage at D+11 of COMIRNATY resulting in the death of a 63-year-old man with a history of resistant hypertension with junctional tachycardia and CLL with the appearance of ITP a few days later. antiPF4 CA result was negative. On 06May2021 the patient died with massive cerebral and intraventricular hemorrhage. The outcome of events was fatal. Autopsy was not performed. Reporter''s Comments: DIAGNOSIS RETAINED Capsulo-thalamic hematoma probably secondary to hypertensive arteriopathy Deep thrombocytopenia suspected to be related to ITP In total, cerebral hemorrhage at D+11 of COMIRNATY resulting in the death of a 63-year-old man with a history of resistant hypertension with junctional tachycardia and CLL with the appearance of ITP a few days later. antiPF4 CA: neg Imputation made "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 possible. No further information expected.; Reported Cause(s) of Death: massive brain hemorrhage


VAERS ID: 1471728 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC6984 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Chest pain, Dyspnoea exertional, Myocardial infarction, Myocardial ischaemia, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-08
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021758965

Write-up: fatal cardiopulmonary arrest; myocardial ischemia; massive myocardial infarction; Death sudden; dyspnea on exertion; chest pain; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority. Regulatory Authority Report Number: FR-AFSSAPS-2021076522. A 38-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Deltoid Right on 02Jun2021 (Batch/Lot Number: FC6984) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced Sudden death at home 6 days post vaccination on 08Jun2021. The clinical course was reported as: No information on post-vaccination flu-like syndrome. On 08Jun2021, the patient presented with fatal cardiopulmonary arrest. The patient was taken care of by the Emergency Services and died at his home, in the presence of his family. The emergency physician who took care of the patient puts forward the hypothesis of myocardial ischemia / massive myocardial infarction. An autopsy has been requested. Note, the patient complained 2 or 3 days earlier of dyspnea on exertion and chest pain for which he did not consult. The patient died on 08Jun2021. An autopsy was performed, and results were not provided. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: massive myocardial infarction; myocardial ischemia; Cardiopulmonary arrest


VAERS ID: 1471736 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-17
Onset:2021-05-13
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX0893 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Blood count, Blood phosphorus, Blood potassium, Blood pressure measurement, Blood urea, Brain natriuretic peptide, C-reactive protein, Cardiac arrest, Cardio-respiratory arrest, Chest pain, Computerised tomogram, Echocardiogram, Electrocardiogram, Glycosylated haemoglobin, Heart rate, Liver function test, Magnetic resonance imaging, Mean platelet volume, Myocarditis, Oxygen saturation, Paraesthesia, Physical examination, Protein albumin ratio, Renal function test, Troponin, Troponin T, Urine electrolytes
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Peripheral neuropathy (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 (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-23
   Days after onset: 10
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: CELECTOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Loeys-Dietz syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20210513; Test Name: Coronary angiography; Result Unstructured Data: Test Result:Single-trunk lesion; Test Name: blood count; Result Unstructured Data: Test Result:normal; Test Name: phosphates; Result Unstructured Data: Test Result:0.67 mmol/L; Test Name: potassium; Result Unstructured Data: Test Result:5.1 mmol/L; Test Name: blood pressure; Result Unstructured Data: Test Result:139/82 mmHg; Test Name: urea; Result Unstructured Data: Test Result:3.3 mmol/L; Test Name: NT pro-BNP; Result Unstructured Data: Test Result:252 ng/L; Test Name: A thoraco-abdomino-pelvic computed tomography; Result Unstructured Data: Test Result:No abnormality; Comments: no progressive thoraco-abdomino-pelvic lesion, no dissection or aneurysmal dilation of the thoraco-abdominal aorta. No abnormality of the intracerebral arteries, no focal lesion.; Test Name: CRP; Result Unstructured Data: Test Result:8.5 mg/l; Test Name: Cardiac ultrasound; Result Unstructured Data: Test Result:good overall kinetics; Comments: undilated LV (VTDVG = 46ml / m?), not hypertrophied, with good overall and segmental kinetics. LVEF = 74% SB.; Test Name: ECG; Result Unstructured Data: Test Result:regular sinus rhythm; Comments: regular sinus rhythm (HR = 74 bpm), axis normal, no renewal disorder, fine QRS at 90 ms, discreet planing of R from V1 to V3; No repolarization disorder.; Test Name: HbA1c; Test Result: 5.5 %; Test Name: heart rate; Result Unstructured Data: Test Result:72bpm; Test Name: liver function test; Result Unstructured Data: Test Result:normal; Test Date: 20210513; Test Name: brain MRI; Result Unstructured Data: Test Result:at 8:30pm; Comments: Episode of monocular blindness with amnesic episode following coronary angiography. Thrombolysis alert. History of Loeys Dietz type 3 syndrome. Results: no abnormality except in the left vertebral artery: Stable focal dissection at the level of C3 / C4 of stable appearance. Ectasic over its entire length, with staged caliber disparities, with in particular a maximum long expansion in its V2 portion (measured at 7mm in diameter) and a caliber disparity at the exit of the left foramen of C1 (8mm in diameter). No ostial anomaly. Absence of ischemic stroke detected. Note that a scan of 18Nov2020 had shown dolicho-ectasia of the right internal carotid and the left vertebral artery, of comparatively stable appearance.; Test Name: mean platelet volume; Result Unstructured Data: Test Result:7.2fl; Test Name: SAO2; Test Result: 97 %; Test Name: Lung and abdominal exams; Result Unstructured Data: Test Result:normal; Test Name: serum proteins; Result Unstructured Data: Test Result:66 g/l; Test Name: renal assessment; Result Unstructured Data: Test Result:normal; Test Name: troponin; Result Unstructured Data: Test Result:255 ng/L; Test Date: 20210513; Test Name: troponin; Result Unstructured Data: Test Result:337.1 ng/L; Comments: at 5 p.m.; Test Date: 20210513; Test Name: troponin; Result Unstructured Data: Test Result:805.2 ng/L; Comments: at 8p.m.; Test Name: troponin decrease; Result Unstructured Data: Test Result:56 ng/L; Test Name: troponin T; Result Unstructured Data: Test Result:255 ng/L; Test Name: Ionogram; Result Unstructured Data: Test Result:normal
CDC Split Type: FRPFIZER INC2021817729

Write-up: Myocarditis; cardio-respiratory arrest; asystole; tingling in limbs; retrosternal chest pain; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. A 47-year-old female patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: EX0893) dose 1 via intramuscular route of administration in Arm Left on 17Apr2021 as 0.3 ml single for COVID-19 immunisation. Medical history included Loeys Dietz syndrome type 3, by deletion of the SMAD3 gene. Concomitant medication included celiprolol hydrochloride (CELECTOL) taken for an unspecified indication, start and stop date were not reported. The patient has no COVID-19 history. Reported as, On 13May2021: D + 27, the patient is hospitalized following the appearance of retrosternal chest pain burning type accompanied by tingling in the upper limbs. These symptoms appeared while she was driving and under stress following the death of her mother the same day. The chest pain disappeared spontaneously after 1.5 hours. When she arrived in the emergency room, her troponin was positive: 377.1 ng / L at 5 p.m. -$g 805.2 ng / L at 8 p.m. A thoraco-abdomino-pelvic tomodensitometry was performed in the presence of a suspicion of aortic aneurysm: no progressive thoraco-abdomino-pelvic lesion, no dissection or aneurysmal dilation of the thoraco-abdominal aorta. No abnormality of the intracerebral arteries, no focal lesion. The patient was oriented, conscious, hemodynamically stable and eupneic in the ascending aorta. No sign of peripheral hypoperfusion. She is afebrile, normotensive (BP: 139/82 mmHg), her SaO2 is 97% and its HR is 72 bpm. On the cardiac level: no clinical sign of right and left heart failure, but hepato-jugular reflux in connection with Loeys Dietz''s. The rest is normal. Lung and abdominal exams are normal. Biological entry assessment: Blood count: normal, except MPV 7.2fl to 7.2fl, Ionogram: normal, Renal assessment: normal, Liver function test: normal, HbA1c: 5.5%, Serum proteins: 66g / l, Urea: 3.3 mmol / L, Phosphates: 0.67 mmol / L, CRP: 8.5 mg / L, Troponin T: 255 ng / L, NT pro-BNP: 252 ng / L. Cardiac ultrasound: undilated left ventricle (end-diastolic volume of left ventricle = 46ml / m2), not hypertrophied, with good overall and segmental kinetics. left ventricular ejection fraction = 74% SB (Simpson Biplan). No atrial dilation, type 2 mitral profile. Straight undilated cavities, with good longitudinal systolic function (Tricuspid annular plane systolic excursion TAPSE = 26mm, S wave = 12.4cm / s). Tricuspid insufficiency not seen, but no indirect argument for elevation of systolic pulmonary artery pressure. No valve disease. Ascending non-dilated aorta, thin and compliant inferior vena cava, dry pericardium. ECG: regular sinus rhythm (heart rate = 74 bpm), normal axis, no renewal disorder, fine QRS at 90 ms, slight planing of R from V1 to V3; No repolarization disorder. Biological assessment during hospitalization: Potassium: 5.1mmol / L, Troponin decrease: 56 ng / L, the rest of the balance sheet is normal. Coronary angiography 13May2021: Single-trunk lesion. Non-significant lesion of the proximal anterior interventricular artery, including the origin of the first diagonal (bifurcation lesion). Functionally insignificant stenosis. Fractional Flow Reserve FFR = 0.95 (0.98 at rest). Middle anterior interventricular artery muscle bridge. Intermediate lesion of the middle circumflex artery. Brain magnetic resonance imaging on 13May2021 at 8:30 p.m . Episode of monocular blindness with amnesic episode following coronary angiography. Thrombolysis alert. History of Loeys Dietz type 3 syndrome. Results: no abnormality except in the left vertebral artery: Stable focal dissection at the level of C3 / C4 of stable appearance. Ectasic over its entire length, with staged caliber disparities, with in particular a maximum long expansion in its V2 portion (measured at 7mm in diameter) and a caliber disparity at the exit of the left foramen of C1 (8mm in diameter). No ostial anomaly. Absence of ischemic stroke detected. Scan of 18Nov2020 had shown dolicho-ectasia of the right internal carotid and the left vertebral artery, of comparatively stable appearance. The evolution is favorable on the cardiac level. No recurrence of anginal pain and no signs of heart failure during hospitalization. Troponin peak at 255 ng / L, decreasing kinetics thereafter. Scoped monitoring does not reveal any arrhythmia or significant conduction disturbance. Myocardial MRI will be performed externally on 07Jun2021. All in all, diagnosis of probable myocarditis, awaiting confirmation by cardiac MRI without argument for ACS (acute coronary syndrome) or aortic dissection, occurring 27 days after Dose 1 of the COMIRNATY vaccine, in a 47-year-old woman with a history of Loeys Dietz syndrome 3, by deletion of the SMAD3 gene. Evolution: the attending physician was informed that on the night of May 22 to 23 following a recurrence of burning-type chest pain, identical to what she had felt a fortnight earlier, the patient''s husband called the 15 while they were on vacation in the PRIVACY. In view of the patient''s negative cardiological assessment, treatment with analgesics was recommended. 2 hours later, the patient was found in cardio-respiratory arrest by her husband. On arrival at the emergency medical and intensive care unit, the patient was still in cardio-respiratory arrest with asystole and a reactive bilateral mydriasis. It was not possible to resuscitate her, despite the resuscitation maneuvers. The patient died on 23May2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Myocarditis


VAERS ID: 1471799 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-06
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1526 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation paroxysmal; COPD; Hypertension arterial; Hypothyroidism
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021804181

Write-up: Acute pulmonary edema/acute lung edema; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number FR-AFSSAPS-2021081548. An 80-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), intramuscular on 04Jun2021 (Batch/Lot Number: FC1526) as dose 2, single for COVID-19 immunisation. Medical history included atrial fibrillation paroxysmal, hypothyroidism, chronic obstructive pulmonary disease (COPD), and hypertension arterial. The patient''s concomitant medications were not reported. The patient experienced acute pulmonary edema/acute lung edema on 06Jun2021. Time interval between beginning of drug administration and start of reaction/event was reported as 3 days. Treatment: anticoagulant; other treatments not known. The patient died on 06Jun2021 due to acute pulmonary edema/acute lung edema. 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: Acute pulmonary edema/acute lung edema


VAERS ID: 1471805 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-06-20
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA8016 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-22
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: KARDEGIC; PRAVASTINE; SPIRONOLACTONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angioplasty; Appendectomy; Breast cancer (treated by radiotherapy); Cataract extraction; Dyslipidaemia; Hemicolectomy; Hypertension arterial; Hysterectomy; Multiple caesarean sections; Peripheral arterial occlusive disease of the lower limbs
Allergies:
Diagnostic Lab Data: Test Date: 202106; Test Name: coronary angiography; Result Unstructured Data: Test Result:a bitroncular status with occlusion of a marginal; Comments: a bitroncular status with occlusion of a marginal with angioplasty failure.; Test Date: 202106; Test Name: ECG; Result Unstructured Data: Test Result:a lateral ST+ ACS with apical sub-shift
CDC Split Type: FRPFIZER INC2021804308

Write-up: Infarct myocardial; Tamponade cardiac; This is a spontaneous report from a contactable physician from the Regulatory Authority. The regulatory authority number FR-AFSSAPS-2021081644. An 89-year-old female patient received the first dose of bnt162b2 (COMIRNATY) via intramuscular and administered in left arm on 25May2021 (Lot Number: FA8016) as single dose for covid-19 immunisation. Medical history included hemicolectomy, dyslipidaemia, appendicectomy, cataract extraction, peripheral arterial occlusive disease of the lower limbs, breast cancer (treated by radiotherapy), multiple caesarean sections (2 times), hysterectomy, hypertension arterial, angioplasty. There was no COVID test. Concomitant medications included KARDEGIC; PRAVASTINE; SPIRONOLACTONE. The patient experienced infarct myocardial and Tamponade cardiac (death, hospitalization) on 20Jun2021. The patient underwent lab tests and procedures which included Electrocardiogram (ECG) in Jun2021: a lateral ST+ ACS with apical sub-shift; Coronary angiography in Jun2021: found a bitroncular status with occlusion of a marginal with angioplasty failure. The patient died on 22Jun2021. An autopsy was not performed. The clinical course was reported as follows: On 25May2021 vaccination against COVID 19. On 20Jun2021 at around 4am the patient presented with chest pain in the form of tightness radiating into the jaw and both arms. After calling, the ECG shows a lateral ST+ ACS with apical sub-shift. The patient was hospitalized. A coronary angiography was performed and found a bitroncular status with occlusion of a marginal with angioplasty failure. In total 89 years old patient with an out of time ST + ACS, not revascularized, complicated by left ventricular fissure. Evolution: Death of the patient from tamponade on 22Jun2021. No follow-up attempts are possible. No further information is expected. Reported Cause(s) of Death: Infarct myocardial; Tamponade cardiac


VAERS ID: 1471810 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-06-05
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3558 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Bronchopneumopathy, Chest X-ray, Computerised tomogram, Condition aggravated, Fibrin D dimer, Mechanical ventilation, Oxygen saturation, Troponin
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-09
   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: Oxygen therapy (at home saturation between 91 to 93% under 3L); Pulmonary fibrosis
Allergies:
Diagnostic Lab Data: Test Date: 20210605; Test Name: Pulmonary x-ray; Result Unstructured Data: Test Result: significant pulmonary fibrosis; Comments: significant pulmonary fibrosis. Bilateral flocculent alveolar opacities predominant in the right lung. Hypoxemic bronchopneumonia in a Chronic IRS; Test Date: 20210606; Test Name: thoracic ct; Result Unstructured Data: Test Result: Significant pulmonary fibrosis; Comments: No intra or extra-axial hemorrhage. Left frontal ischemic sequela. Significant pulmonary fibrosis and onset of emphysema of the right upper lobe; Test Date: 20210606; Test Name: d dimers; Result Unstructured Data: Test Result:7; Test Date: 20210606; Test Name: non-invasive ventilation; Result Unstructured Data: Test Result:100% F1O2; Test Name: oxygen saturation; Result Unstructured Data: Test Result: between 91 and 93 %; Test Name: oxygen saturation; Test Result: 50 %; Test Date: 20210605; Test Name: oxygen saturation; Test Result: 90 %; Test Date: 202106; Test Name: oxygen saturation; Test Result: 70 %; Comments: under a high concentration mask; Test Date: 20210606; Test Name: troponin; Result Unstructured Data: Test Result: 545
CDC Split Type: FRPFIZER INC2021817754

Write-up: Bronchopneumopathy / Significant pulmonary fibrosis and onset of emphysema of the right upper lobe; Bronchopneumopathy / Significant pulmonary fibrosis and onset of emphysema of the right upper lobe; This is a spontaneous report from a contactable physician from the Regulatory Authority. The regulatory authority report numberFR-AFSSAPS-2021081859. A 71-year-old male patient received the second dose of BNT162B2 (Comirnaty, Solution for injection, Batch/Lot number: FC3558) via an intramuscular route of administration on 24May2021 in the left deltoid as a single dose for COVID-19 immunization. The patient medical history included pulmonary fibrosis and oxygen therapy at home saturation between 91 to 93% under 3L. Concomitant medications were not reported. On 05Jun2021, patient was admitted to emergencies because of anamnesis for 72 hours, dyspnea at the slightest effort, increased in oxygen therapy at home, saturation 90% under 3l, under corticosteroids 40mg IV, and Augmentin on infectious hypothesis. The pulmonary x-ray showed significant pulmonary fibrosis, bilateral flocculent alveolar opacities predominant in the right lung. Hypoxemic bronchopneumonia in a Respiratory Chronic. Patient had respiratory distress 12 days after the 2nd vaccination. The patient was admitted for continued care for deterioration of his respiratory failure acute, saturation at 50, then at 70 under a high concentration mask. Thoracic CT scan was performed on 06Jun2021, which showed no intra or extra-axial hemorrhage. Left frontal ischemic sequela. Significant pulmonary fibrosis and onset of emphysema of the right upper lobe. Biological assessment showed tropo 545, Ddimers at 7. There was establishment of anticoagulation. Patient management included: hospitalization, NIV under 100% F1O2, pressure support at 10, PEP at 5, morphine. There was an establishment of comfort care in the face of the desire for non-therapeutic prolongation. Patient received other treatments of O2. On 09Jun2021, the patient died. It was unknown, if autopsy was performed. The conclusion was fatal post-vaccination hypoxemic pulmonary disease. The possible imputability, obviously without prejudice to the elements investigations that could be carried out within the framework of legal or amicable compensation procedures. No follow-up attempts were possible. No further information was expected. Reported Cause(s) of Death: bronchopneumopathy


VAERS ID: 1471814 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-05-24
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7082 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-25
   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: MORPHINE; INSULIN; KARDEGIC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Autoimmune hepatitis; Diabetes mellitus insulin-dependent; Gougerot-Carteaud syndrome; Heart valve replacement; Hypertension arterial; Sleep apnoea syndrome; Thyroidectomy partial
Allergies:
Diagnostic Lab Data: Test Date: 202105; Test Name: brain MRI; Result Unstructured Data: Test Result:showed acute ischaemia of the left hemi-brain,; Comments: the left cerebellar peduncle and the left ponto-mesencephalic junction, on an occlusion of the vertebral artery
CDC Split Type: FRPFIZER INC2021804302

Write-up: Ischemic stroke; This is a spontaneous report from a contactable physician from the Regulatory Authority. The regulatory authority report number is FR-AFSSAPS-2021082192. An 86-year-old female patient received bnt162b2 (COMIRNATY; Batch/Lot Number: FA7082), via intramuscular, administered in left arm, on 19May2021 as dose 2, single for COVID-19 immunisation. Medical history included arterial hypertension, Gougerot-Carteaud syndrome, heart valve replacement, and sleep apnoea syndrome. The patient with a strong cardiovascular history was also known to have autoimmune hepatitis, partial thyroidectomy, and insulin-requiring diabetes. The patient had no COVID test. Concomitant medications included morphine; insulin; KARDEGIC. All were taken for an unspecified indication, start and stop date were not reported. The patient was also taking corticoids. On 24May2021, it was reported that the patient experienced ischemic stroke. She was admitted to the hospital on day 6 of the vaccination (as reported), with ptosis of the right eye, disturbances of vigilance, and right hemiparesis suggesting a stroke. She underwent an emergency brain MRI which showed acute ischaemia of the left hemi-brain, the left cerebellar peduncle and the left ponto-mesencephalic junction, on an occlusion of the vertebral artery. The patient''s general condition progressively worsened, with disturbances of consciousness and worsening of the motor deficit. On 25May2021, it was reported that death occurred at 8:34 am. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Ischemic stroke


VAERS ID: 1471917 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-16
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-17
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension; Dyslipidaemia; Obesity
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20210709370

Write-up: INFARCT MYOCARDIAL; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, FR-AFSSAPS-MP20214543] concerned a 63 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included arterial hypertension, dyslipidaemia and obesity. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: Unknown, expiry: UNKNOWN) 1 dosage forms, drug start period 2 days, drug last period 2days, duration of drug admin 1 day, 1 total administered on 15-JUN-2021 for covid-19 vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 16-JUN-2021, the patient experienced myocardial infarction/infarct myocardial and was hospitalized (date unspecified). On 17-JUN-2021, the patient died from myocardial infarction/infarct myocardial. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine was not applicable. This report was serious (Death, and Hospitalization Caused / Prolonged); Sender''s Comments: V0: 20210709370-covid-19 vaccine ad26.cov2.s-infarct myocardial. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY; Reported Cause(s) of Death: INFARCT MYOCARDIAL


VAERS ID: 1471921 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-06-15
   Days after vaccination:45
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Blood creatinine, General physical health deterioration, Prothrombin time, Subdural haematoma
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Accidents and injuries (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-20
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ENTRESTO; FUROSEMIDE; BISOPROLOL; ELIQUIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia; Atrial fibrillation; Dilated cardiomyopathy; Hypertension arterial; Myopericarditis
Allergies:
Diagnostic Lab Data: Test Date: 20210615; Test Name: activated partial thromboplastin time; Result Unstructured Data: Test Result:39; Test Date: 20210615; Test Name: serum creatinine; Result Unstructured Data: Test Result:78; Test Date: 20210615; Test Name: prothrombin time; Test Result: 61 %
CDC Split Type: FRPFIZER INC2021795963

Write-up: Hematoma subdural; deterioration of general condition; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-NC20212563, Safety Report Unique Identifier FR-AFSSAPS-2021080152. A 97-year-old male patient received second dose of BNT162B2 (COMIRNATY), via Intramuscular on 01May2021 at DOSE 2, SINGLE for COVID-19 immunisation and apixaban (ELIQUIS) orally from unknown date to 15Jun2021 long term at 2.5 mg, 2x/day for Cerebrovascular accident prophylaxis. Medical History included Myopericarditis, Dilated cardiomyopathy, Hypertension arterial, complete arrhythmia due to atrial fibrillation. The patient previously received the first dose of BNT162B2 (COMIRNATY) on 06Apr2021 lot number: unknown for COVID-19 immunisation. Concomitant medications included sacubitril valsartan sodium hydrate (ENTRESTO), furosemide, and bisoprolol. On 15Jun2021, the patient consults for deterioration of general condition; demonstration of a chronic non-traumatic subdural hematoma. activated partial thromboplastin time 39, prothrombin time 61%, serum creatinine 78. Summary of management: Hospitalization. Patient death on 20Jun2021. Conclusion: Subdural hematoma 1.5 months post vaccination in a patient otherwise on long-term Eliquis. Other treatments included Entresto - Bisoprolol -furosemide. Action taken with apixaban was Permanently Withdrawn. Outcome of the event Hematoma subdural was fatal. Outcome of the event deterioration of general condition was unknown. No follow-up attempts are possible, information on batch number cannot be obtained. Follow-up (24Jun2021): This is a follow-up spontaneous report from a contactable physician via Health Authority - (regulatory authority reference number: FR-AFSSAPS-NC20212563) based on information received by company 1 from company 2 (manufacturer control number: FR-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-062139), license party. This case was received via health authority (Reference number: FR-AFSSAPS-NC20212563) on 24-Jun-2021 and was forwarded company 2 on 24-Jun-2021. This spontaneous case was reported by a physician and describes the occurrence of fatal SUBDURAL HAEMATOMA (Hematoma subdural) in 97-year-old male patient who received apixaban (ELIQUIS) for Cerebrovascular accident prophylaxis. CO-SUSPECT PRODUCTS included tozinameran (COMIRNATY) for COVID-19 vaccination. The patient''s past medical history included Hypertension arterial. On an unknown date, the patient started ELIQUIS (Oral), 2.5 milligram twice a day. On 01-May-2021, the patient started COMIRNATY (Intramuscular), 1 dosage form Total. On 15-Jun-2021, an unknown time after starting ELIQUIS, the patient experienced SUBDURAL HAEMATOMA (seriousness criteria death and medically significant). ELIQUIS (Oral) was withdrawn on 15-Jun-2021. The patient died on 20-Jun-2021. The reported cause of death was Hematoma subdural. It is unknown if an autopsy was performed. The strength of ELIQUIS was 2.5 mg. Causality was not provided for the same. The last dose of COMIRNATY was administered on 01-May-2021. For ELIQUIS (Oral), the reporter did not provide any causality assessments. company 2 Medical Evaluation Comment: This patient had died due to subdural haematoma after receiving apixaban therapy. Based on the anticoagulant nature of apixaban, its role in this fatal event is considered possible.; Sender''s Comments: Company 2 Medical Evaluation Comment: This patient had died due to subdural haematoma after receiving apixaban therapy. Based on the anticoagulant nature of apixaban, its role in this fatal event is considered possible.; Reported Cause(s) of Death: Hematoma subdural


VAERS ID: 1471951 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-05-29
   Days after vaccination:52
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood creatine phosphokinase, Blood fibrinogen, Blood lactate dehydrogenase, Blood pressure measurement, Computerised tomogram, Electroencephalogram, Glomerular filtration rate, Haemoglobin, Haemorrhagic stroke, Hypertension, Neutrophil count, Platelet count, Prothrombin level, White blood cell count
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-18
   Days after onset: 20
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: IRBESARTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adrenal incidentaloma; Bladder tumour resection; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Date: 20210529; Test Name: ALAT; Result Unstructured Data: Test Result:normal; Test Date: 20210529; Test Name: ASAT; Result Unstructured Data: Test Result:normal; Test Date: 20210529; Test Name: cpk; Result Unstructured Data: Test Result:223 IU/l; Test Date: 20210529; Test Name: Fibrinogen; Result Unstructured Data: Test Result:3.5 g/l; Test Date: 20210529; Test Name: ldh; Result Unstructured Data: Test Result:296 IU/l; Test Date: 202105; Test Name: blood pressure; Result Unstructured Data: Test Result:12; Test Date: 20210529; Test Name: 5 STAGE CERVICAL + SKULL + THORACO-ABDOPELVIC SCANNER; Result Unstructured Data: Test Result:right hemispherical deep intraparenchymal hematoma; Comments: Large right hemispherical deep intraparenchymal hematoma 47 x 45 x 41 mm in height with poorly defined contours in favor of a risk of secondary extension with adjacent hemorrhagic rearrangement. Peri-lesional edema with a strong effect of e mass on the ventricular system, compression of the right lateral ventricle and beginning of subfalcor engagement to the left by 8 mm. -Intraventricular hemorrhage in the lateral ventricles. -Left frontal petechiae. -Permeability of the Willis polygon. No aneurysm detected. -No anomaly at the subtentorial level. No tonsillar involvement. -this hematoma is not suggestive of a traumatic origin. Probable hypertensive origin responsible for the fall. -Haematic infiltration of the left hemifacial soft parts with air bubbles within the soft parts without sustraumatic lesions of the facial mass. -No tympano-mastoid filling. -Discussion of a left maxillary hemosinus without associated sinus fracture.; Test Date: 202105; Test Name: CT; Result Unstructured Data: Test Result:right intra-parenchymal hematoma; Comments: : deep right intra-parenchymal hematoma with intra-ventricular flooding; Test Date: 20210601; Test Name: CT; Result Unstructured Data: Test Result:right hemispherical deep hematoma; Comments: relative stability in the size of the right hemispherical deep hematoma with peripheral edema. Stability of the mass effect with collapsed aspect of the right LV, sub-factorial engagement and erasure of cortical grooves. Persistence of haematic flooding of light vehicles and stability of the left frontal petechiae; Test Date: 20210609; Test Name: CT; Result Unstructured Data: Test Result:decrease in the hematoma; Comments: decrease in the hematoma but still a mass effect, more CSF in the periphery in favor of a probable resorption disorder.; Test Date: 20210607; Test Name: EEG; Result Unstructured Data: Test Result:not very reactive; Test Date: 20210529; Test Name: gfr; Result Unstructured Data: Test Result:81; Comments: ml / min / 1.73m2; Test Date: 20210529; Test Name: hg; Result Unstructured Data: Test Result:13.7 g/dl; Test Date: 202105; Test Name: hypertension arterial; Result Unstructured Data: Test Result:221/100 mmHg; Test Date: 20210529; Test Name: PNN; Result Unstructured Data: Test Result:10.19 x10 9/l; Test Date: 20210529; Test Name: Platelets; Result Unstructured Data: Test Result:314 x10 9/l; Test Date: 20210529; Test Name: TP; Result Unstructured Data: Test Result:greater than 100 %; Test Date: 20210529; Test Name: GB; Result Unstructured Data: Test Result:14.62 x10 9/l
CDC Split Type: FRPFIZER INC2021781740

Write-up: Hypertension arterial; Haemorrhagic stroke; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority . A 76-years-old female patient received second dose of bnt162b2 (COMIRNATY), intramuscularly in left arm on 07Apr2021 (Lot Number: EW2239) as single dose for covid-19 immunisation. Medical history included non-secreting adrenal incidentaloma from Feb2014, arterial hypertension, endoscopic bladder tumor resection from 08Aug2020. Concomitant medication included irbesartan. The patient received first dose of bnt162b2 (COMIRNATY), intramuscularly in right arm on 10Mar2021 (Lot Number: EP9605) as single dose for covid-19 immunisation. The patient had consultation with his doctor in May2021 (one week before the stroke). Normal blood pressure(BP): 12. Date of onset of effect was on 29May2021. Active patient who rode a bicycle but left behind by her husband who fould her under the bicycle, unconscious; on arrival of emergency service, facial and cranial trauma GCS 5 (detail?) with HT(hypertension) (221/100 mmHg); IOT after etomidate / celocurine then gammaOH. No traumatic injury except cephalic, immobilization for safety. On arrival at the no DTC localization sign obtained only on the right with Vd 20 mmHg and IP 1.5. Placement of invasive AP, VVC, curarization, sedation by midazolam (bolus 4 mg then 8 mg / h) and sufenta 25 ?g in bolus, then CT. Transfer to intensive care unit since deep right intraparenchymal hematoma suggesting an intracerebral hemorrhage responsible for the accident. Minimal left hemopneumothorax. On CT(computed tomography): deep right intra-parenchymal hematoma with intra-ventricular flooding. On 02Jun2021: on the HD level, very labile patient. No clear hypotension but great hypertension at the slightest stimulation, requiring the introduction of urapidil with significant fluctuations during the day. Neurologically, the patient was GSC 6 (Y1M4V1). The sedations were stopped completely temporarily on two occasions, but the patient each time becomes hypertensive and tachycardic, without however any impact on the ICP, still around 4-6. During these weanings, the patient never responded to the simple command. The pupils are in reactive miosis with spontaneous movement of the eyeballs when the eyes are forced open. The follow-up CT scan performed on 01Jun2021 found: relative stability in the size of the right hemispherical deep hematoma with peripheral edema. Stability of the mass effect with collapsed aspect of the right LV, sub-factorial engagement and erasure of cortical grooves. Persistence of haematic flooding of light vehicles and stability of the left frontal petechiae. On 04Jun2021: no neurological development more than 72 hours after stopping any sedation (very low doses the days before). On 09Jun2021: Stability of the neurological state with a patient still comatose one week after stopping sedations. Glasgow score rated at best at 7 on the right (E2 V1 M4) (motor response M2 on the left). EEG (electroencephalogram) of 07Jun2021 not very reactive. CT today finding a decrease in the hematoma but still a mass effect, more CSF in the periphery in favor of a probable resorption disorder. On 13Jun2021:Little clinical progress in recent days with a patient who still does not respond to the simple command, but sometimes has an M5-oriented response of the upper right limb.On 18Jun2021: Patient, GCS 2 + 1 + 5 = 8 for 17 days, at 3 weeks of severe hemorrhagic stroke. Under psychostimulant for 8 days, lack of relational arousal, reflex cough, pain mimicry, tight bilateral miosis. In short, the persistence of deep brain pain. Possible participation of hydrocephalus but the LP (10cc without pressure) and the ventricular size mean that this possible post-stroke complication did not explain the coma. In total medical opinion in agreement with a therapeutic discontinuation because the intensity of the care seems unreasonable in view of the pejorative functional prognosis and the fragility linked to age. Biology: On 29May2021: ionogram: normal; GFR (Glomerular filtration rate): 81 ml / min / 1.73m2; enzymatic assessment: ASAT(aspartate aminotransferase), ALAT (alanine aminotransferase) normal; CPK(Creatine phosphokinase): 223 (VN: <170 IU / L), LDH (lactate dehydrogenase) 296 (VN: 135-250 IU / L); NFP: GB at 14.62 x10 9/l, haemoglobin (Hg) at 13.7 g / dl, Platelets at 314 x10 9/l, PNN at 10.19 x10 9/l; Plasma coagulation: TP(total protein)$g 100%, Fibrinogen at 3.5 g / L (VN 2 - 4)Imaging: 29May2021: 5 STAGE CERVICAL + SKULL + THORACO-ABDOPELVIC SCANNER in emergency, Skull:-Large right hemispherical deep intraparenchymal hematoma 47 x 45 x 41 mm in height with poorly defined contours in favor of a risk of secondary extension with adjacent hemorrhagic rearrangement. Peri-lesional edema with a strong effect of e mass on the ventricular system, compression of the right lateral ventricle and beginning of subfalcor engagement to the left by 8 mm.Intraventricular hemorrhage in the lateral ventricles.Left frontal petechiae. Permeability of the Willis polygon. No aneurysm detected. No anomaly at the subtentorial level. No tonsillar involvement.-this hematoma was not suggestive of a traumatic origin. Probable hypertensive origin responsible for the fall.Haematic infiltration of the left hemifacial soft parts with air bubbles within the soft parts without sustraumatic lesions of the facial mass. No tympano-mastoid filling. Discussion of a left maxillary hemosinus without associated sinus fracture. Conclusion: Haemorrhagic stroke on hypertensive thrust in a hypertensive patient but with normal BP(blood pressure) one week before the onset of stroke. The patient died on 18Jun2021. An autopsy was not performed. The outcome of the event haemorrhagic stroke was fatal, of the other event was not recovered. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Haemorrhagic stroke


VAERS ID: 1472682 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-02-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Illness, Investigation, Pneumonia, SARS-CoV-2 test
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), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CODEINE PHOSPHATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Brain cancer metastatic (had cyberknife on brain for brain cancer in Jan2021); Haemorrhage brain; Lung cancer (Had lung surgery for lung cancer in Sep2020); Pneumonia; Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)); Surgery (Had lung surgery for lung cancer in Sep2020)
Allergies:
Diagnostic Lab Data: Test Name: oxygen; Result Unstructured Data: Test Result:low; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021783878

Write-up: ill; short of breath; Pneumonia; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number was not reported), via an unspecified route of administration on 09Feb2021 as 1st dose, single for COVID-19 immunization. The patient medical history included lung neoplasm malignant (Had lung surgery for lung cancer in Sep2020), pneumonia, cerebral haemorrhage, steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)), brain cancer metastatic (had cyberknife on brain for brain cancer in Jan2021), surgery from Sep2020 (Had lung surgery for lung cancer in Sep2020). The patient concomitant medication included codeine phosphate (CODEINE PHOSPHATE). On 09Feb2021 the patient experienced pneumonia, ill (illness) (death) on an unspecified date, short of breath (dyspnoea) (death) on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test was negative. The patient died on 09Feb2021. Had lung surgery for lung cancer in Sep2020 and had cyberknife on brain for brain cancer in Jan2021. Was suffering from pneumonia (we were told as a result all of this). The patient not had symptoms associated with COVID-19. The patient was not enrolled in clinical trial. Had the vaccine whilst suffering from pneumonia (had surgery for lung cancer a few months previous). Became ill and short of breath a few hours after the vaccine, taken into hospital as oxygen was low and died on the scan table when asked to lie on her back. The patient had not tested positive for COVID-19 since having the vaccine. The events were reported as fatal. The outcome of the events was fatal on 09Febe021 and autopsy done for the patient No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Pneumonia


VAERS ID: 1472792 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-16
Onset:2021-06-19
   Days after vaccination:154
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-20
   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:
Preexisting Conditions: Medical History/Concurrent Conditions: Agammaglobulinemia; Anticoagulant therapy; Caecal cancer; Prostate cancer; Comments: anticoagulant treatment for AF Hypogammaglobulinemia CA Caecum. CA prostate Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021787479

Write-up: breathless; Product use for unapproved combination; died; Shortness of breath; This is a spontaneous report from a contactable consumer or other non-health care professional received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106260845416620-KQJ0E, Safety Report Unique Identifier GB-MHRA-ADR 25549278. A 79-year-old male patient received first dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number and Expiration date was not reported), via an unspecified route of administration on 16Jan2021 as Dose 1, Single for covid-19 immunization and second dose of covid-19 vaccine nrvv ad (chadox1 ncov-19) (COVID-19 VACCINE ASTRAZENECA), via an unspecified route of administration from 19Jun2021 to 19Jun2021, at Dose 2, Single for immunization. Patient has not had symptoms associated with COVID-19 Patient was not enrolled in clinical trial. Medical history included hypogammaglobulinaemia, anticoagulant treatment for AF, CA Caecum, CA prostate. The patient''s concomitant medications were not reported. On an unspecified date experienced breathless, product use for unapproved combination, on 19Jun2021 experienced shortness of breath. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative covid-19 test. The patient died on 20Jun2021. It was not reported if an autopsy was performed. The outcome of event died was fatal and for events breathless, shortness of breath was unknown. No follow-up attempts are possible; information about the Lot/Batch number cannot be obtained.; Reported Cause(s) of Death: died


VAERS ID: 1473136 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Coagulopathy, SARS-CoV-2 test
SMQs:, Haemorrhage laboratory terms (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-17
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 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021813780

Write-up: Clotting disorder; This is a spontaneous report received from a contactable consumer, the regulatory authority. Regulatory authority report number (GB-MHRA-WEBCOVID-202106291205350020-QXMMD), Safety Report Unique Identifier (GB-MHRA-ADR 25562790). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Patient has not tested positive for COVID-19 since had the vaccine. The patient''s concomitant medications were not reported. On an unspecified date, the patient experienced clotting disorder. On an unspecified date, the patient underwent lab tests and procedures which included sars-cov-2 test: Negative (no-negative covid-19 test). Blood clot 2 weeks after vaccination leading to heart attack and death. The patient died on 17Feb2021. It was not reported if an autopsy was performed. The outcome of the event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Clotting disorder


VAERS ID: 1473324 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-06
Onset:2021-02-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021821560

Write-up: Cardiac arrest; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106300813161440-VKPGU, Safety Report Unique Identifier GB-MHRA-ADR 25565967. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: and Expiration date was unknown), via an unspecified route of administration on 06Feb2021 as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient was not enrolled in clinical trial. The patient experienced cardiac arrest (death) on 06Feb2021. It was reported that the patient received the vaccine and within 20-30 minutes after she suffered a cardiac arrest in the hospital car park and she died. The patient died on 06Feb2021. It was unknown if an autopsy was performed. The outcome of the event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1473368 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-24
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: relevant investigations or tests; Result Unstructured Data: Test Result:Awaiting results; Comments: Awaiting results from tests but told this could take up to 9 month
CDC Split Type: GBPFIZER INC2021821430

Write-up: Heart enlarged; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106301638412570-FOHY5 and Safety Report Unique Identifier is GB-MHRA-ADR 25569624. A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unknown date in Apr2021 as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not enrolled in clinical trial. Patient was not tested positive for COVID-19 since having the vaccine Suspect Reactions. On 24Apr2021, the patient experienced heart enlarged. The patient died on an unspecified date. Patient had relevant investigations or tests conducted and awaiting results from tests but told this could take up to 9-month. The clinical outcome of the event heart enlarged was fatal. The patient died on an unknown date due to heart enlarged and autopsy was not performed. No follow-up attempts are possible. Information about batch no cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Heart enlarged


VAERS ID: 1473442 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-06-27
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-27
   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: IBUPROFEN
Current Illness: Pain
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021829286

Write-up: Sudden death; This is a spontaneous report from a contactable Physician. This is a report received from the Regulatory Authority. A 32-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW3143), via an unspecified route of administration on 16Jun2021 as dose 1, single for covid-19 immunisation. Medical history included ongoing pain. Concomitant medications included Ibuprofen (MANUFACTURER UNKNOWN) for pain from 08Jun2021. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not enrolled in clinical trial. Patient has not tested positive for COVID-19 since having the vaccine. The patient died (sudden death) on 27Jun2021. The relevant investigations conducted as post-mortem awaited. It was unknown if an autopsy was performed. The report does not relate to possible blood clots or low platelet counts. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1473497 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Atrioventricular block, SARS-CoV-2 test
SMQs:, Conduction defects (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021829536

Write-up: Block heart; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107011955369560-XHPF1. Safety Report Unique Identifier GB-MHRA-ADR 25579144. A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH MRNA COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) dose unspecified, via an unspecified route of administration on an unspecified date as Dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. On an unspecified date, the patient experienced block heart and which caused his death on an unknown date. The patient underwent lab test included COVID-19 virus test which showed negative on an unspecified date. Outcome of the event was fatal. An autopsy was not 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: Block heart


VAERS ID: 1473728 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cellulitis, Magnetic resonance imaging, SARS-CoV-2 test, Scan brain, Sepsis
SMQs:, Sepsis (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: MRI; Result Unstructured Data: Test Result:Unknown result; Test Date: 20210215; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: Negative COVID-19 test; Test Name: Scan brain; Result Unstructured Data: Test Result:Unknown result
CDC Split Type: GBPFIZER INC2021845026

Write-up: Cellulitis; Sepsis; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-ADR 25569452, Safety Report Unique Identifier GB-MHRA-ADR 25569452. This case was mother''s first sister. A 75-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot number was not reported) for COVID-19 immunisation and experienced stroke. The patient medical history and concomitant medications were not reported. On an unspecified date, patient experienced cellulitis and sepsis; the patient hospitalized due to cellulitis and died due to sepsis. It was reported that the reporter was deeply concerned the vaccine had caused her (mother''s first sister) death for a few reasons but as she was still in shock and grieving, she could not ask questions until reporter know can had a rational conversation with a medical professional. The main reason of concern was her mum had her first dose in February. Her only dose. Her sister had hers the same week and suffered a stroke 4 days after. She had been advised not to take the 2nd dose. Her mum said she had no side effects but told the paramedics she had been unable to see out her right eye since the vaccine. Following her mum''s death her other sister died 5 weeks later after her 2nd dose of the vaccine due to sepsis, following a hospital stay due to cellulitis. So out of 3 full blood sisters, 2 have died and one left severely impaired. This was really concerning for her. The reporter believed in coincidence but did not believe this was all it was for her family. The reporter''s aunt that died did not live a healthy lifestyle, she was 75, nor did her aunt who had the stroke when she was younger (78) but had a healthier lifestyle now. Out of all 3 my mum was the one who should have outlived the other 2. The reporter was concerned that all 3 had the same vaccine (Pfizer) could it be a gene related or blood related thing that had caused an adverse reaction?? This had made her opt out of having any vaccine and reporter was genuinely terrified of having to have it. As well as being aware there was a deadly virus. Like her mum. The reporter had psoriatic arthritis, leg thrombosis and phlebitis in the past, but on the other hand her daughter was 13. She had asthma and a kidney problem, but reporter was also too scared for her to have it when the time comes until she knew what happened to her mum. The patient underwent lab tests and procedures which included magnetic resonance imaging: unknown result on unspecified date, SARS-COV-2 test: negative on 15Feb2021 (Negative COVID-19 test), scan brain: unknown result on unspecified date. The outcome of the event cellulitis was unknown, and the event sepsis resulted death. 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.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-2021822034 Different dose/patient/event&same product;GB-PFIZER INC-2021845021 Different dose/event&same product/Patient; Reported Cause(s) of Death: Sepsis


VAERS ID: 1473780 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX6537 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Body temperature, Death, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-13
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202105; Test Name: fever; Result Unstructured Data: Test Result:fever
CDC Split Type: HUPFIZER INC2021794943

Write-up: Death; Fever; Weakness; Muscle pain; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority HU-OGYI-477821. A 69-year-old male patient received the second dose of BNT162B2 (COMIRNATY, solution for injection, Lot number EX6537), via intramuscular in left arm on 04May2021 at 0.3 ml single for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (COMIRNATY, solution for injection, Lot number ET7205), via intramuscular on 30Mar2021 as single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. On 13May2021 the patient was found dead in his home. The cause of death was unknown. 1 week after the second dose, the patient complained about experiencing fever, weakness and muscle pain. The outcome of the events fever, weakness and muscle pain at the time of death was unknown. It was unknown if an autopsy was performed. Sender Comment: Due to lack of information, the causal relationship cannot be assessed between the suspected drug and the adverse event until further information is received. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: death


VAERS ID: 1473781 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-03-22
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1831 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, COVID-19, COVID-19 pneumonia, Cardiopulmonary failure, Chest X-ray, Fibrin D dimer, SARS-CoV-2 test, Vaccination failure
SMQs:, Cardiac failure (narrow), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-29
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiomegaly; Diabetes mellitus; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210322; Test Name: Chest X-ray; Result Unstructured Data: Test Result:Covid pneumonia; Test Date: 20210322; Test Name: c-reactive protein; Result Unstructured Data: Test Result:Elevated; Test Date: 20210322; Test Name: fibrin d dimer; Result Unstructured Data: Test Result:Elevated; Test Date: 20210322; Test Name: COVID-19 antigen test; Test Result: Positive
CDC Split Type: HUPFIZER INC2021794945

Write-up: Vaccination failure; COVID-19; COVID-19 pneumonia; Cardiopulmonary insufficiency; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority. The regulatory authority report number is HU-OGYI-478321. A 92-years-old female patient received second dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: EL1831 and Expiration date: unknown), intramuscularly, administered in left arm on 05Mar2021 as dose 2, 0.3 ml single, dose 1 intramuscularly on 12Feb2021 (Batch/Lot Number: EL0725) as dose 1, 0.3 ml single for covid-19 immunisation. Medical history included hypertension, cardiomegaly and diabetes mellitus from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient was hospitalized on 22Mar2021 after experiencing Covid-19 symptoms. Antigen test was positive. Chest X-ray showed covid pneumonia. D-dimer and CRP levels were elevated. The patient received therapy, but her condition progressed. The patient was hospitalized for events from 22Mar2021 to an unknown date. Outcome of events was fatal. The patient died on 29Mar2021 at 18:10 due to cardiorespiratory insufficiency. An autopsy was not performed. No follow-up attempts possible. No further information expected. Sender Comment: According to the SmPC of COMIRNATY, immunity usually develops 7 days after the second dose. The patient got infected with Covid-19 17 days after the second dose, therefore vaccination failure is possible. The case is serious because the outcome was fatal. Further information is not expected.; Reported Cause(s) of Death: Vaccination failure; COVID-19 pneumonia; COVID-19; Cardiorespiratory insufficiency


VAERS ID: 1473783 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-04
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Computerised tomogram head, General physical health deterioration, Pneumonia, SARS-CoV-2 test
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-23
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hospitalization (Because of a suspected stroke); Intensive care; Multiple fractures; Polytraumatism; Pulmonary embolism; Rehabilitation therapy; Road traffic accident
Allergies:
Diagnostic Lab Data: Test Date: 20210324; Test Name: Cranial CT; Result Unstructured Data: Test Result:Did not show abnormalities; Test Date: 20210319; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210321; Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: HUPFIZER INC2021803758

Write-up: Cardiac decompensation; General condition worsened; Bronchopneumonia; This is a spontaneous report from a contactable physician from the Regulatory Authority. A 49-year-old male patient received BNT162B2 (COMIRNATY; Lot Number was not reported), intramuscular, on 04Apr2021, as dose 1, 0.3 mL, single, for COVID-19 immunization. The patient''s medical history included pulmonary embolism from 2015; intensive therapy between 17Aug2020 and 29Aug2020 after getting hit by a car (17Aug2020) which caused several fractures and polytraumatism (17Aug2020 to 29Aug2020), rehabilitation program started to improve his physical condition (17Aug2020 to 29Aug2020); and on 24Mar2021, the patient was hospitalized again and had examinations because of a suspected stroke, but cranial CT (computed tomography) did not show abnormalities. The patient''s concomitant medications were not reported. The patient previously took rivaroxaban (XARELTO) for pulmonary embolism. In Apr2021, the patient started coughing and developed fever which was assessed as bronchopneumonia (hospitalized on an unspecified date). COVID-19 PCR test on 19Mar2021 and 21Mar2021 were negative. After receiving antibiotic treatment, the patient seemed to get better, but his general condition worsened and passed away on 23Apr2021 at 04:00 due to cardiac decompensation (23Apr2021; hospitalized on an unspecified date). The outcome of "Cardiac decompensation" and "General condition worsened" was fatal. The patient was recovering from the other event. The patient died on 23Apr2021. It was unknown if an autopsy was performed. Sender comments: Based on the discharge summary, the patient never fully recovered from his polytraumatism (polytrauma) caused by the accident which eventually led to his death. Therefore, the causal relationship is not related 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; information about lot or batch number cannot be obtained.; Reported Cause(s) of Death: General condition worsened; Polytrauma; Decompensation cardiac


VAERS ID: 1473784 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-06-09
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001946 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-09
   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: ZYLLT; FURON [FUROSEMIDE]; VITAMIN D3 FRESENIUS; KALDYUM; EMOZUL
Current Illness: Hypertension; Osteoporosis; Polyarthritis
Preexisting Conditions: Medical History/Concurrent Conditions: Acute bronchitis; Atherosclerosis; Toxic shock syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUMODERNATX, INC.MOD20212

Write-up: Death; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death) in a 96-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 3001946 and 3002916) for COVID-19 vaccination. The patient''s past medical history included Toxic shock syndrome, Acute bronchitis and Atherosclerosis. Concurrent medical conditions included Polyarthritis, Hypertension and Osteoporosis. Concomitant products included CLOPIDOGREL BISULFATE (ZYLLT), FUROSEMIDE (FURON [FUROSEMIDE]), COLECALCIFEROL (VITAMIN D3 FRESENIUS), POTASSIUM CHLORIDE (KALDYUM) and ESOMEPRAZOLE MAGNESIUM (EMOZUL) for an unknown indication. On 11-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 08-Jun-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .5 milliliter. Death occurred on 09-Jun-2021 The patient died on 09-Jun-2021. The cause of death was not reported. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered DEATH (Death) to be unlikely related. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable. Company Comment This a report of dead one day after the second dose of the product in an old polymorbid patient with many confounders. Autopsy was not performed. Very limited information regarding the event has been provided for inferring causality. Further information is not expected; Sender''s Comments: This a report of dead one day after the second dose of the product in an old polymorbid patient with many confounders. Autopsy was not performed. Very limited information regarding the event has been provided for inferring causality. Further information is not expected; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1473795 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-03-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-15
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: 2021-03-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021804022

Write-up: Death; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority report. An 88-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 18Mar2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced death on 19Mar2021. The outcome of the event was fatal. The patient died on 19Mar2021. An autopsy was performed, and results were not provided. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Death


VAERS ID: 1473798 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-07
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-17
   Days after onset: 10
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: ROSUVASTATIN; ESOMEPRAZOLE; VITAMIN D NOS; ESCITALOPRAM; SINEMET
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Body mass index increased; Dementia; Parkinson''s disease
Allergies:
Diagnostic Lab Data: Test Date: 20210607; Test Name: CT pulmonary angiogram; Result Unstructured Data: Test Result:large volumebilateral central pulmonary emboli; Comments: large volume bilateral central pulmonary emboli with CT evidence of right heart strain.
CDC Split Type: IEPFIZER INC2021804214

Write-up: ct evidence of right heart strain/myocardial strain; Presented with symptoms and signs suggestive of pulmonary embolism large volume bilateral central pulmonary emboli; Immobile; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. A 75-year-old female patient received BNT162B2 (COMIRNATY, solution for injection, lot number: unknown) on 03Jun2021 as dose 2, single via unspecified route of administration for COVID-19 immunisation. Medical history included body mass index increased, dementia and Parkinson''s disease. Concomitant medications included rosuvastatin; esomeprazole; vitamin d nos; escitalopram; and carbidopa, levodopa (SINEMET); all taken for an unspecified indication, start and stop date were not reported. 4 days after vaccination, on 07Jun2021, the patient was immobile in setting of increased body mass index and presented to hospital with signs and symptoms suggestive of pulmonary embolism. CT pulmonary angiogram was carried out, which demonstrated large volume bilateral central pulmonary emboli with CT evidence of right heart strain (also reported as myocardial strain). The patient was treated with Enoxaparin. It was reported that the patient was very unwell and unfortunately passed away 10 days later. All events were fatal. The patient died on 17Jun2021. An autopsy was not performed. It was reported that there was a temporal association with the second dose of COVID-19 vaccine, however other risk factors for venous thromboembolism were identified. It was noted that the case was discussed with a Coroner. Follow-up information was received by the HPRA from the reporting healthcare professional on 25Jun2021: The patient did not undergo a post-mortem as the cause of death was clear; bilateral pulmonary emboli. It was reported that the Coroner who felt that a post-mortem would not assist in determining if there was an association between the vaccine and her cause of death. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Immobile; Presented with symptoms and signs suggestive of pulmonary embolism large volume bilateral central pulmonary emboli; ct evidence of right heart strain/myocardial strain


VAERS ID: 1473799 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Myocarditis
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Overweight
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021848486

Write-up: Myocarditis; Death; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. Regulatory authority number IE-HPRA-2021-077918, Safety Report Unique Identifier IE-HPRA-2021-077918. A 38-years-old male patient received second dose bnt162b2 (COMIRNATY, Solution for injection, Lot number and expiry date was not reported), via unspecified route of administration on 03Jun2021 as a single dose for covid-19 immunisation. Medical history included overweight, hypertension from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient previously took first dose on an unspecified date as a single dose for covid-19 immunisation and experienced malaise. It was reported that the patient was unwell after his first dose of vaccine but he was okay after second dose. Two days after the second dose on 05Jun2021 the patient died, on an unspecified date myocarditis. It was also reported that the autopsy results showed myocarditis, the reporter queried possible complication of vaccine. Outcome of the events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be requested. No further information is expected.; Reported Cause(s) of Death: Death; Myocarditis


VAERS ID: 1473821 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-23
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-30
   Days after onset: 28
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RESELIGO
Current Illness: Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Osteoarthritis knee; Prostate cancer (which was well controlled with Reseligo.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ISPFIZER INC2021817737

Write-up: Death; Shortness of breath/difficulty breathing; Feeling sick; Chills; Malaise; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number IS-IMA-3287. A 84-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: Unknown, Expiration date: Unknown), via an unspecified route of administration on 23Mar2021 as dose 2, single for covid-19 immunisation. Medical history included prostate cancer, which was well controlled with Reseligo, ongoing hypertension, Osteoarthritis knee. Concomitant medications included goserelin acetate (RESELIGO) taken for prostate cancer, start and stop date were not reported. On an unspecified date of Mar2021 One week after the vaccination, the patient experienced shortness of breath/difficulty breathing, feeling sick, chills and malaise. He got better in-between before getting worse again. Stroke was not suspected. He passed away at home after a few days(on 30Mar2021) of malaise and chills, after the paramedics arrived. Cause of death was unknown. It was not reported if an autopsy was performed. The outcome of the events shortness of breath/difficulty breathing, feeling sick, chills and malaise was unknown. The patient died on 30Mar2021. It was unknown whether Autopsy was done. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Death


VAERS ID: 1474137 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Fall, Malaise
SMQs:, Anticholinergic syndrome (broad), Accidents and injuries (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC2021845865

Write-up: Dizziness; Fall; Malaise; This is a Non-Interventional Study report from a contactable Consumer. This is a report received from the on-line database search. Regulatory authority report number 000943098. This information was initially reported to Health Canada on 19Mar2021 from an unknown Market Authorization Holder AER# unspecified. An 85-year-old male patient received bnt162b2 (reported as COVID-19 VACCINE, Batch/Lot number was not reported), intramuscularly on an unspecified date as single dose for covid-19 immunisation; leuprorelin acetate (ELIGARD), subcutaneously from an unspecified date to an unspecified date, then from an unspecified date to an unspecified date, both at 30 mg 1 every 4 Months for prostate cancer. The patient''s medical history and concomitant medications were not reported. The patient experienced dizziness, fall, malaise on an unspecified date. The events were reported as serious, serious criteria was reported as death. The action taken in response to the events for bnt162b2 and leuprorelin acetate was unknown. The patient died on an unspecified date. It was not reported if an autopsy was performed. 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: Based on temporal association, the causal relationship between bnt162b2 and the events dizziness and malaise cannot be excluded. The event fall is not considered to be directly related to the suspect drug; it is most likely due to another event or an external factor. The causal relationship of pre-existing prostate cancer cannot be excluded as well; the status of prostate cancer, patient overall health condition as of vaccination day, and circumstances surrounding death were not reported. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Dizziness; Fall; Malaise


VAERS ID: 1474152 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-27
Onset:2021-05-01
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-06
   Days after onset: 5
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MILURIT; RIVOCOR; MEDORAM [RAMIPRIL]
Current Illness: Atherosclerosis generalised (1-3 grade); Emphysema pulmonary; Hypertension; Hyperuricemia; Ischaemic heart disease; Non-smoker
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC2021818208

Write-up: Deep vein thrombosis of the right tibia; Acute massive pulmonary embolism; This is a spontaneous report from a contactable consumer or other non-health professional downloaded from the WEB. The regulatory authority report number is CZ-CZSUKL-21007607. An 87-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 27Mar2021 (batch/lot number: unknown) as single dose for covid-19 immunisation. Ongoing medical history included chronic pulmonary emphysema, non-smoker, hyperuricemia, hypertension, ischaemic heart disease and general atherosclerosis of arteries 1-3 grade. The reporter was not aware of the patient''s chronic diseases. Concomitant medication included allopurinol (MILURIT); bisoprolol fumarate (RIVOCOR); ramipril (MEDORAM). The patient previously took the first dose of bnt162b2 (COMIRNATY, batch/lot number not provided) before 27Mar2021 for COVID-19 immunisation. After the vaccination, he was without problems. In May2021, the patient experienced deep vein thrombosis of the right tibia followed by acute massive pulmonary embolism, after the second dose of the bnt162b2 vaccine. The event deep vein thrombosis of the right tibia was reported as serious (death, disability, medically significant, life threatening) and acute massive pulmonary embolism as serious (death, medically significant, life threatening). The patient died on 06May2021. An autopsy was performed that revealed acute massive bilateral embolism. Outcome of events was fatal. No follow-up attempts are possible, information on lot/batch number cannot be obtained.; Reported Cause(s) of Death: Deep vein thrombosis of the right tibia; Autopsy-determined Cause(s) of Death: Acute massive pulmonary embolism


VAERS ID: 1474175 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-17
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocarditis
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Closed spina bifida; Coronary sclerosis (moderate)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210718302

Write-up: ACUTE MYOCARDITIS; This spontaneous report received from a physician via a Regulatory Authority (EMEA EVHUMAN NLP, DE-PEI-202100122807) concerned a 35 year old male. The patient''s height, and weight were not reported. The patient''s past medical history included closed spina bifida, and coronary sclerosis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD974, expiry: UNKNOWN) dose was not reported, 1 total, administered on 14-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-JUN-2021, the patient experienced acute myocarditis and died from acute myocarditis. An autopsy was performed on an unspecified date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210718302-Covid-19 vaccine ad26.cov2.s-Acute myocarditis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: Acute myocarditis; Autopsy-determined Cause(s) of Death: Acute myocarditis


VAERS ID: 1474489 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-05-30
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-15
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: 2021-05-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Coronary heart disease; Heart failure NYHA class III
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021818164

Write-up: death; This is a spontaneous report from a non-contactable consumer downloaded from the WEB, regulatory authority number DE-PEI-CADR2021099644, Safety Report Unique Identifier DE-PEI-202100092567. Additional reference number DE-CADRPEI-2021099644. A 75-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 26May2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included ongoing coronary heart disease, ongoing Heart failure NYHA class III. The patient''s concomitant medications were not reported. On 30May2021 the patient experienced Unknown cause of death. The patient died on 30May2021. It was not reported if an autopsy was performed. Sender Comment: Does the patient or concerned person have any allergies? If yes, which? None. Information about risk factors and previous illnesses: Coronary heart disease, Heart failure NYHA class III. Relatedness of drug to reaction(s)/event: Source PEI: Result: Unclassifiable No follow-up activities possible. Batch/LOT number cannot be obtained. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1474557 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021817646

Write-up: heart attack/infarct myocardial; This is a spontaneous report from a non-contactable consumer downloaded from the WEB. The regulatory authority number is DE-PEI-CADR2021106595 and Safety report unique identifier is DE-PEI-202100100125. A 77-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient''s weight and height were not reported. The patient''s medical history, concurrent conditions and concomitant medications were not reported. The patient experienced heart attack/infarct myocardial on an unspecified date. This report is serious - death. The outcome of the event infarct myocardial was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. Cause of death was infarct myocardial. Sender Comment: Information about risk factors and previous illnesses: None Result of Assessment: UNCLASSIFIABLE No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: infarct myocardial


VAERS ID: 1474575 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-06-08
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1C006A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Death, Diarrhoea, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-10
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma bronchial; Diabetes mellitus insulin-dependent (diabetes mellitus IIb); Metabolic syndrome (metabolic syndrome with insulinpfl); Myasthenia gravis; Schizophrenia
Preexisting Conditions: Medical History/Concurrent Conditions: Drug allergy; Penicillin allergy (questionable)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021818156

Write-up: Unknown cause of death; Vomiting; Diarrhea, stool retention; Belly ache; This is a spontaneous report from a contactable consumer or other non HCP downloaded from the Regulatory Authority DE-PEI-CADR2021107263, Safety Report Unique Identifier DE-PEI-202100101286. A male adult patient received BNT162b2 (COMIRNATY, lot number 1C006A, Strength: 0.3 ml) via unspecified route of administration on 19May2021 as single dose for COVID-19 immunisation. The patient''s medical history and concurrent conditions included: ongoing metabolic syndrome with insulinpfl, ongoing diabetes mellitus insulin-dependent (Diabetes mellitus IIb), ongoing asthma bronchial, ongoing myasthenia gravis, ongoing schizophrenia. The patient had allergy to diclofenac, questionable penicillin. No concomitant medication reported. On 08Jun2021 the patient experienced belly ache, vomiting, diarrhea. On 10Jun2021, the patient experienced unknown cause of death. The clinical course was reported as: On 08Jun2021, the patient experienced first abdominal pain, vomiting, stool retention, no improvement despite hyoscine butylbromide (BUSCOPAN) and bisacodyl (DULCOLAX). On 10Jun2021, the patient was found dead in his room by roommate. The emergency doctor has called the family doctor who, together with the criminal police, examined the corpse and initiated obedience, which was refused by the responsible public prosecutor. The patient''s outcome was not recovered for Belly ache, not recovered for Vomiting, not recovered for Diarrhea, fatal for unknown cause of death. Relatedness of drug to reaction(s)/event(s) assessed by PEI, Result of Assessment: "D. Unclassifiable". No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1474580 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-11
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Cerebral haemorrhage, Hypertension
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral haemorrhage (treatment with Eliquis)
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:240 mmHg
CDC Split Type: DEPFIZER INC2021818149

Write-up: Death from cerebral haemorrhage and blood pressure of 240 / unknown; Hypertension; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021107463. Safety Report Unique Identifier DE-PEI-202100101410. An 83-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 04Jun2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. Medical history included cerebral haemorrhage from 2019 to an unknown date treatment with Eliquis. No concomitant medication reported. The patient''s weight was 84 kg, and height was 186 cm. On 11Jun2021, the patient experienced cerebral haemorrhage and hypertension. It was reported as death from cerebral haemorrhage and blood pressure of 240 / unknown. This report is serious due to death. The patient underwent lab tests and procedures which included blood pressure: 240 mmhg on unspecified date. The patient''s outcome was fatal for cerebral haemorrhage, not recovered/not resolved for hypertension. The patient died on 2021 (also reported as 26Apr2021). An autopsy was not performed. Sender Comment: Does the patient or concerned person have any allergies? If yes, which? None Information about risk factors and previous illnesses. Already cerebral hemorrhage under Eliquis in 2019. However, blood pressure was never that high as on that day, suspicion of thrombus from vaccination, resulting in increased blood pressure and cerebral hemorrhage. / Sudden collapse, cerebral hemorrhage and result of death; Reported Cause(s) of Death: Cerebral haemorrhage


VAERS ID: 1474613 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-05-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH IC007A / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac dysfunction, Inappropriate schedule of product administration
SMQs:, Cardiac failure (broad), Cardiomyopathy (broad), Medication errors (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: Aortic valve stenosis; Arterial hypertension; Arteriosclerotic heart disease; Coronary heart disease; Heart failure; Internal carotid artery stenosis; Leg paresis; Pulmonary hypertension; Spinal stenosis; Tricuspid stenosis
Preexisting Conditions: Medical History/Concurrent Conditions: Stent placement
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021818205

Write-up: Cardiac dysfunction; first dose on 08Apr2021 and second dose on 20May2021; This is a spontaneous report from a non-contactable consumer downloaded from a regulatory authority-WEB, regulatory authority number DE-PEI-CADR2021109496. Safety Report Unique Identifier DE-PEI-202100104365. A 93-year-old male patient received bnt162b2 (COMIRNATY, Lot Number: IC007A), intramuscular on 20May2021 at 93 years old as dose 2, 0.3 mL single for COVID-19 immunization. Ongoing medical history included pulmonary hypertension, arteriosclerotic heart disease, arterial hypertension, coronary heart disease, tricuspid stenosis, aortic valve stenosis, internal carotid artery stenosis, spinal stenosis, leg paresis, and heart failure. The patient also had stent implantation on an unspecified date. The patient''s concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (COMIRNATY, Lot Number: EW8904), on 08Apr2021 for COVID-19 immunization and experienced brain stem infarction with global aphasia. On 26May2021, the patient experienced cardiac dysfunction which led to a fatal outcome. The patient received the first dose on 08Apr2021 and second dose on 20May2021. The patient died on an unspecified date due to cardiac dysfunction. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cardiac dysfunction


VAERS ID: 1474622 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-06-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Rheumatism
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021818137

Write-up: death sudden/died 1 day after vaccination; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB. The regulatory authority number is DE-PEI-CADR2021114008 and Safety Report Unique Identifier is DE-PEI-202100109022. A 69-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 18Jun2021 (Batch/Lot number was not reported) as dose 2, 0.3 ml single for COVID-19 immunisation. The patient''s weight was 55 kg, and height was 164 cm. Medical history included slight rheumatism but with diet managed. No pills needed. The patient has no known allergies. The patient''s concomitant medications were not reported. Historical vaccine included BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. On 19Jun2021, the patient experienced death sudden/died 1 day after vaccination. Prior to that, patient was healthy except for mild rheumatism. This report is serious - death. The outcome of the event was fatal. Resuscitation was not possible. The patient died on 19Jun2021. An autopsy was not performed. Cause of death was unknown. Relatedness of drug to reaction(s)/event from source of assessment was Unclassifiable. Sender Comment: Does the patient or concerned person have any allergies? If yes, which? NO. Information about risk factors and previous illnesses. Slight rheumatism but with diet managed. No pills needed / Sudden death. Resuscitation not possible. Biopsy not performed yet. 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: 1474645 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-04-26
   Days after vaccination:55
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Brain stem infarction, Computerised tomogram, Disturbance in attention, Hemiparesis, Thalamic infarction
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Depression (excl suicide and self injury) (broad), Hypoglycaemia (broad)

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: Arterial occlusive disease; Renal insufficiency
Preexisting Conditions: Medical History/Concurrent Conditions: Basilar artery thrombosis
Allergies:
Diagnostic Lab Data: Test Date: 20210426; Test Name: Control CT; Result Unstructured Data: Test Result:thalamic and brainstem infarcts
CDC Split Type: DEPFIZER INC2021818119

Write-up: Right hemiparesis; Multiple brain stem infarcts; Thalamic infarct; Reduced vigilance; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB (Regulatory Authority Number: DE-PEI-CADR2021115857, Safety Report Unique Identifier: DE-PEI-202100111835). A 93-year-old female patient received BNT162B2 (COMIRNATY; solution for injection; strength: 0.3 ml), intramuscularly on 02Mar2021 (batch/lot number was not reported) as dose number unknown, 0.3 ml single for COVID-19 immunization. Medical history included ongoing renal insufficiency stage II, ongoing arterial occlusive disease, and basilar artery thrombosis. The patient has no known allergies. The patient''s concomitant medications were not reported. On 26Apr2021, the patient experienced reduced vigilance, right hemiparesis, multiple brain stem infarcts, and thalamic infarct. The etiology was unclear, there was atrial fibrillation, no stenosis, and no AK (unspecified). Endovascular therapy (EVT) of the A. bas (as reported) was initiated. The patient had no reaction to waking. In control computerized tomogram (CT), it showed thalamic and brainstem infarcts. The outcome of the event vigilance decreased was not recovered. The patient died due to hemiparesis (right), brain stem infarction, and thalamic infarction on 26Apr2021. An autopsy was not performed. Relatedness of the vaccine to the events was unclassifiable. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Thalamic infarct; Multiple brain stem infarcts; Hemiparesis


VAERS ID: 1474834 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-15
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 INC2021810787

Write-up: adverse event following immunization (death); This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 571916. A 46-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced adverse event following immunization (death) on an unspecified date. The patient died on unspecified date. 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: adverse event following immunization (death)


VAERS ID: 1474841 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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 INC2021894526

Write-up: Pneumonia; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 583020. A 94-year-old female patient received BNT162B2 (COMIRNATY, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced pneumonia on an unspecified date. The outcome of the event was 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: Pneumonia


VAERS ID: 1474874 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021824730

Write-up: bilateral pulmonary embolism; This is a spontaneous report from a non-contactable consumer based on information received by Pfizer from Biontech [manufacturer control number: 70343, license party for Comirnaty. A 47-years old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot Number: NOT KNOWN) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient died suddenly one and half weeks after vaccination with a bilateral pulmonary embolism. 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: bilateral pulmonary embolism


VAERS ID: 1474885 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-15
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: DEPFIZER INC2021877195

Write-up: Death; This is a spontaneous report from a contactable physician via a sales representative. A 60-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 medical history and concomitant medications were not reported. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of the event was Fatal. Lot/batch number has been requested.; Sender''s Comments: Death of unknown cause is assessed related as a cautionary measure and for reporting purposes. The underlying disease may provide an alternative cause. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Death


VAERS ID: 1475265 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-30
Onset:2021-05-13
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aphasia, Cerebral infarction, Condition aggravated, Myocardial infarction, Pneumonia aspiration
SMQs:, Myocardial infarction (narrow), Ischaemic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-11
   Days after onset: 29
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021778754

Write-up: Infarct myocardial; Pneumonia aspiration; Brain infarction; Aphasia; Condition worsened; This is a spontaneous report from a non-contactable physician from country downloaded from the regulatory authority-WEB, regulatory authority number DE-PEI-202100111346. A 81-years-old male patient received second dose of bnt162b2 (COMIRNATY, Solution for Injection, Lot Number: EX3510), via an unspecified route of administration on 30Apr2021(81-years-old at the time of vaccination) as dose 2, 0.3 ml single for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient''s weight was not reported, and height was not reported. It was reported that the patient was treated with Comirnaty (mRNA TOZINAMERAN). The patient previously received first dose of bnt162b2 (COMIRNATY, Solution for Injection, Lot Number: Unknown), via an unspecified route of administration on 26Mar2021 as single for covid-19 vaccination. On 13May2021 the patient experienced condition worsened and aphasia. On 18May2021 he experienced brain infarction. On 25May2021 he experienced pneumonia aspiration and infarct myocardial. On 11Jun2021, patient was died and cause of death was due to Brain infarction,Condition worsened, Aphasia, Pneumonia aspiration, Infarct myocardial. It was unknown if autopsy was performed for the patient. The outcome of all the events was reported as fatal. This report is serious ? death Relatedness of drug to reactions/events Source of assessment: regulatory authority Result of Assessment: C. Inconsistent causal association to immunization No follow-up attempts possible. No further information expected. Information on lot# already obtained. ; Reported Cause(s) of Death: Aphasia; Condition worsened; Brain infarction; Infarct myocardial; Pneumonia aspiration


VAERS ID: 1475360 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-10
Onset:2021-03-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Alanine aminotransferase, Amylase, Aspartate aminotransferase, Asthenia, Auscultation, Base excess, Bilirubin urine, Blood albumin, Blood bicarbonate, Blood bilirubin, Blood calcium, Blood creatinine, Blood fibrinogen, Blood glucose, Blood ketone body, Blood lactate dehydrogenase, Blood osmolarity, Blood pH, Blood potassium, Blood pressure measurement, Blood sodium, Blood urea, Body temperature, C-reactive protein, Carbon dioxide, Condition aggravated, Creatinine urine, Decreased appetite, Diarrhoea, Dysuria, Eosinophil count, General physical health deterioration, Glomerular filtration rate, Glucose urine, Haematocrit, Haemoglobin, Heart rate, International normalised ratio, Lymphocyte count, Micturition urgency, N-terminal prohormone brain natriuretic peptide, Nausea, Neutrophil count, Nitrite urine, Oedema peripheral, Oxygen saturation, PCO2, PO2, Physical examination, Platelet count, Pollakiuria, Protein total, Protein urine, Prothrombin level, Prothrombin time, Prothrombin time ratio, Red blood cell count, Red blood cells urine, Renal pain, Sleep disorder, Urinary sediment, Urine osmolarity, Urine output, Urine potassium, Urine sodium, Urobilinogen urine, Venous oxygen saturation, White blood cell count, White blood cells urine, pH urine
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Noninfectious diarrhoea (narrow), Proteinuria (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-31
   Days after onset: 20
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: Anaemia; Bladder cancer; Blindness; Breast cancer; Chronic kidney disease; Cognitive impairment (Mild cognitive impairment); DVT; Hearing loss (Moderate hearing loss); Renal artery thrombosis; Subdural haematoma
Allergies:
Diagnostic Lab Data: Test Date: 20210320; Test Name: aPTT; Result Unstructured Data: Test Result:33.4; Test Date: 20210320; Test Name: aPTT ratio; Result Unstructured Data: Test Result:1.02; Test Date: 20210320; Test Name: GPT; Result Unstructured Data: Test Result:7; Test Date: 20210320; Test Name: Amylase; Result Unstructured Data: Test Result:127; Test Date: 20210320; Test Name: GOT; Result Unstructured Data: Test Result:11; Test Name: Cardiac auscultation; Result Unstructured Data: Test Result:rhythmic without murmur; Test Name: Pulmonar auscultation; Result Unstructured Data: Test Result:mvc with bibasal creapitants up to 2/3 lower; Comments: Conserved vesicular murmur with bibasal creapitants up to 2/3 lower; Test Date: 20210320; Test Name: Venous blood excess base; Result Unstructured Data: Test Result:23.4; Test Date: 20210320; Test Name: Venous blood standard base excess; Result Unstructured Data: Test Result:24.6; Test Date: 20210320; Test Name: Urine Bilirubin; Test Result: Negative ; Test Date: 20210320; Test Name: Albumin; Result Unstructured Data: Test Result:3.2; Test Date: 20210320; Test Name: Albumin; Result Unstructured Data: Test Result:2.8; Test Date: 20210320; Test Name: Bicarbonate of blood; Result Unstructured Data: Test Result:7.5; Test Date: 20210320; Test Name: Venous blood standard bicarbonate; Result Unstructured Data: Test Result:6.6; Test Date: 20210320; Test Name: Total bilirubin; Result Unstructured Data: Test Result:0.16; Test Date: 20210320; Test Name: Calcium; Result Unstructured Data: Test Result:7.0; Test Date: 20210320; Test Name: Calcium corrected for Albumin; Result Unstructured Data: Test Result:7.6; Test Date: 20210320; Test Name: Calcium ionic venous blood; Result Unstructured Data: Test Result:1.02; Test Date: 20210320; Test Name: Creatinine; Result Unstructured Data: Test Result:5.32; Test Date: 20210320; Test Name: Creatinine; Result Unstructured Data: Test Result:5.09; Test Date: 20210320; Test Name: Derived fibrinogen; Result Unstructured Data: Test Result:6.93; Test Date: 20210320; Test Name: Glucose; Result Unstructured Data: Test Result:94; Test Date: 20210320; Test Name: Glucose; Result Unstructured Data: Test Result:86; Test Date: 20210320; Test Name: Ketones; Test Result: Negative ; Test Date: 20210320; Test Name: LDH; Result Unstructured Data: Test Result:194; Test Date: 20210320; Test Name: Venous blood lactate; Result Unstructured Data: Test Result:1.1; Test Date: 20210320; Test Name: Calculated osmolality; Result Unstructured Data: Test Result:304.0; Test Date: 20210320; Test Name: venous blood pH; Result Unstructured Data: Test Result:6.95; Test Date: 20210320; Test Name: Potassium; Result Unstructured Data: Test Result:3.20; Test Name: Blood pressure; Result Unstructured Data: Test Result:137/62 mmHg; Test Date: 20210320; Test Name: Sodium; Result Unstructured Data: Test Result:140; Test Date: 20210320; Test Name: Urea; Result Unstructured Data: Test Result:176; Test Date: 20210320; Test Name: Urea; Result Unstructured Data: Test Result:163; Test Name: Body temperature; Result Unstructured Data: Test Result:35.6 Centigrade; Test Date: 20210320; Test Name: Venous blood total carbon dioxide; Result Unstructured Data: Test Result:8.6; Test Date: 20210320; Test Name: C-reactive protein; Result Unstructured Data: Test Result:30.3; Test Date: 20210320; Test Name: Creatinine Urine; Result Unstructured Data: Test Result:65; Test Date: 20210320; Test Name: Eosinophils; Test Result: 4.80 %; Test Date: 20210320; Test Name: ESTIMATED GFR (CKD-EPI); Result Unstructured Data: Test Result:6; Test Date: 20210320; Test Name: ESTIMATED GFR (CKD-EPI); Result Unstructured Data: Test Result:7; Test Date: 20210320; Test Name: Urine glucose; Result Unstructured Data: Test Result:Normal; Test Date: 20210320; Test Name: Hematocrit; Result Unstructured Data: Test Result:26.70; Test Date: 20210320; Test Name: Hematocrit; Result Unstructured Data: Test Result:29; Test Date: 20210320; Test Name: Hemoglobin; Result Unstructured Data: Test Result:9.10; Test Date: 20210320; Test Name: Hemoglobin; Result Unstructured Data: Test Result:8.50; Test Name: Heart Rate; Result Unstructured Data: Test Result:63 bpm; Test Date: 20210320; Test Name: INR; Result Unstructured Data: Test Result:1.10; Test Date: 20210320; Test Name: Lymphocytes; Test Result: 22.90 %; Test Date: 20210320; Test Name: Neutrophils; Test Result: 61.70 %; Test Date: 20210320; Test Name: Neutrophils; Test Result: 66.40 %; Test Date: 20210320; Test Name: Nitrite; Test Result: Negative ; Test Date: 20210320; Test Name: NT-proBNP; Result Unstructured Data: Test Result:6260.00; Test Name: Oxygen saturation; Test Result: 98 %; Test Date: 20210320; Test Name: pCO2; Result Unstructured Data: Test Result:35; Test Date: 20210320; Test Name: Urine pH; Result Unstructured Data: Test Result:5.0; Test Name: Physical examination; Result Unstructured Data: Test Result:pitting edema to the knees; Comments: Abdomen: soft depressible, painful on palpation of both flanks and renal fossa predominantly on the left, negative percussion fist, RHA present without signs of peritoneal irritation. Miembros inferiores: pitting edema to the knees with evidence of chronic venous insufficiency without Deep Vein Thrombosis.; Test Date: 20210320; Test Name: Platelet count; Result Unstructured Data: Test Result:220; Test Date: 20210320; Test Name: Platelet count; Result Unstructured Data: Test Result:218; Test Date: 20210320; Test Name: pO2; Result Unstructured Data: Test Result:23; Test Date: 20210320; Test Name: Total proteins; Result Unstructured Data: Test Result:6.5; Test Date: 20210320; Test Name: Urine Proteins; Result Unstructured Data: Test Result:500; Test Date: 20210320; Test Name: Prothrombin activity; Result Unstructured Data: Test Result:87; Test Date: 20210320; Test Name: Prothrombin time; Result Unstructured Data: Test Result:12; Test Date: 20210320; Test Name: Prothrombin time ratio; Result Unstructured Data: Test Result:1.11; Test Date: 20210320; Test Name: Red blood cell count; Result Unstructured Data: Test Result:2.92; Test Date: 20210320; Test Name: Red blood cell count; Result Unstructured Data: Test Result:2.73; Test Date: 20210320; Test Name: Urine Red Blood Cells; Result Unstructured Data: Test Result:50; Test Date: 20210320; Test Name: Urinary sediment; Result Unstructured Data: Test Result:Intense leukocyturia; Comments: Intense leukocyturia Severe bacteriuria; Test Date: 20210320; Test Name: urine Osmolality; Result Unstructured Data: Test Result:228; Test Date: 20210320; Test Name: Density; Result Unstructured Data: Test Result:1009; Test Date: 20210320; Test Name: Urine potassium; Result Unstructured Data: Test Result:5.8; Test Date: 20210320; Test Name: Sodium urine; Result Unstructured Data: Test Result:61; Test Date: 20210320; Test Name: Urobilinogen; Result Unstructured Data: Test Result:Normal; Test Date: 20210320; Test Name: Blood saturation venous blood oxygen; Result Unstructured Data: Test Result:39.1; Test Date: 20210320; Test Name: White blood cell; Result Unstructured Data: Test Result:8.25; Test Date: 20210320; Test Name: White blood cell count; Result Unstructured Data: Test Result:6.91; Test Date: 20210320; Test Name: White blood cells urine; Result Unstructured Data: Test Result:500
CDC Split Type: ESPFIZER INC2021778932

Write-up: General physical health deterioration; Edema limbs; Condition worsened; Hyporexia; Sleep disturbed; Asthenia; Kidney pain; Nausea; Daily intestinal pattern alternated with diarrhea; Dysuria; Urinary urgency; Urinary frequency; This is a spontaneous report downloaded from the regulatory authority-WEB, regulatory authority number (ES-AEMPS-834681). A contactable consumer or other non hcp reported that a 92-year-old non pregnant female patient received bnt162b2 (COMIRNATY COVID-19 VACCINE, Formulation:Solution for injection), via intramuscular on 10Mar2021 (age at vaccination was 92 years) (Batch/Lot Number: ET1831) as dose 2, single for covid-19 immunization. Medical history included breast cancer from Oct2017 to an unknown date, deep vein thrombosis, subdural hematoma, chronic kidney disease, anemia, bladder cancer from 2004, renal artery thrombosis. AEG, total blindness, eupneic, tolerating ambient air, afebrile, normocoloured, moist oral mucosa. Cardiac auscultation: rhythmic without murmur, Pulmonar auscultation: Conserved vesicular murmur with bibasal creapitants up to 2/3 lower. Abdomen: soft depressible, painful on palpation of both flanks and renal fossa predominantly on the left, negative percussion fist, RHA present without signs of peritoneal irritation. Membros inferiors: pitting edema to the knees with evidence of chronic venous insufficiency without Deep Vein Thrombosis. The patient previously received first dose of bnt162b2 on 17-FEB-2021 (Batch/lot number: EL0725) for covid-19 immunization. The patient''s concomitant medications were not reported. The patient previously took ixia plus, mastical, clexane, aranesp for unspecified indication. On 10Mar2021, the patient experienced alteration of the sleep-wake cycle, with arreactivity during the day, asthenia, hyporexia associated with chills, sweating and back pain at the level of both renal fossae, she refers to dysuria, urgency, frequency, with reduction of diuresis and edema in both limbs. Daily intestinal pattern alternated with diarrhea (operated patient). They report worsening of her condition since vaccination with comirnaty. Blood pressurewas137/62 mmHg, Heart Rate: 63 bpm, SATO2: 98%, Temperature 35.6 degree Centigrade. The patient was admitted to hospital for the events. On 31Mar2021 was died due to worsening of chronic renal failure. The patient underwent lab tests and procedures which included activated partial thromboplastin time: 33.4, activated partial thromboplastin time: 1.02, alanine aminotransferase: 7, amylase: 127, aspartate aminotransferase: 11, base excess: 23.4, base excess: 24.6, bilirubin urine: negative, blood albumin: 3.2, blood albumin: 2.8, blood bicarbonate: 7.5, blood bicarbonate: 6.6, blood bilirubin: 0.16 on 20Mar2021 auscultation: rhythmic without murmur, auscultation: mvc with bibasal creapitants up to 2/3 lower on Conserved vesicular murmur with bibasal creapitants up to 2/3 lower on an unspecified date. The outcome of events sleep disturbed, asthenia, kidney pain, nausea, daily intestinal pattern alternated with diarrhea was not resolved. The other events were fatal. No follow-up attempts possible. No further information expected. Lot/Batch number already obtained.; Reported Cause(s) of Death: Chronic renal failure


VAERS ID: 1475570 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-04-12
   Days after vaccination:53
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNK / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Chest pain, Oxygen saturation, SARS-CoV-2 test, Sudden death, Vaccination failure
SMQs:, Torsade de pointes/QT prolongation (broad), Lack of efficacy/effect (narrow), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-29
   Days after onset: 17
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 arrhythmia; Cardiac failure; Diabetes mellitus non-insulin-dependent; Kidney failure
Allergies:
Diagnostic Lab Data: Test Date: 20210414; Test Name: saturation; Test Result: 95 %; Test Date: 20210419; Test Name: saturation; Test Result: 96 %; Test Date: 20210412; Test Name: covid pcr; Test Result: Positive
CDC Split Type: FRPFIZER INC2021781218

Write-up: sudden DEATH; chest pain just before death; Vaccination failure; COVID-19 PCR positive; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB FR-AFSSAPS-AN20212320, Safety Report Unique Identifier FR-AFSSAPS-2021077914. A 91-year-old female patient received BNT162B2 (COMIRANTY; Solution for injection; Lot number Unknown; expiration date: not reported) via intramuscular, administered in left arm on 18Feb2021 as dose 2, single and intramuscular, administered in left arm on 27Jan2021 (Batch/Lot Number: EJ6795) as dose 1, single for COVID-19 immunization. Time between injections was 3 weeks. Person was at risk of developing severe COVID-19 disease (age and history). Medical history included arrhythmia, type 2 diabetes mellitus, hypertension, cardiac failure, renal failure. The patient''s concomitant medications were not reported. The patient experienced vaccination failure (medically significant) and covid-19 pcr positive (non-serious) on 12Apr2021, chest pain just before death and sudden death on 29Apr2021. Cause of death was unknown. Autopsy was not done. It was reported that, 2 months later, on 12Apr2021, the patient was positive for COVID-19 (PCR +). The patient presented on 14Apr2021 a dyspnea with a saturation at 95%, on 19Apr2021 coughing congestion dyspnea sat at 96% without O2 put under solupred clamoxyl. Favourable evolution in this patient treated for cardiac insufficiency, disappearance of respiratory signs but sudden DEATH on 29Apr2021 while she was phoning her son. Complained of chest pain just before death. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 12Apr2021, oxygen saturation: 95 % on 14Apr2021, oxygen saturation: 96 % on 19Apr2021. Patient received treatments with antipyretic and anticoagulant. Treatment was started on ventoline. Favourable evolution in this patient was treated for heart failure. The patient died on 29Apr2021. Conclusion was patient presented 2 months after a second dose of COMIRNATY vaccine against COVID-19 with confirmed and symptomatic vaccine failure. NB: Imputation made "without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable compensation procedures". The outcome of the events chest pain just before death and sudden death was fatal, vaccination failure and covid-19 pcr positive was reported as recovered on an unspecified date. Upon FU (PRD SRD 28Jun2021), For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 5573939 (see File attachment in this investigation record) The complaint for "fatal outcome" of "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, evaluation of reference sample, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot "EJ6795". A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality, regulatory, validation and stability. PGS Puurs concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that a regulatory notification was required. The reported defect could not be confirmed on the evaluation of reference samples. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : 2021781227 same drug, different patient; Reported Cause(s) of Death: unknown


VAERS ID: 1476427 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-07-03
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-07
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fever
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Feverish; This regulatory authority case was reported by an other health care professional and describes the occurrence of PYREXIA (Feverish) in a 41-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Fever. On 11-Jun-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 03-Jul-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced PYREXIA (Feverish) (seriousness criterion death). The patient died on 07-Jul-2021. The reported cause of death was Feverish. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Negative. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not reported. Patient died of high fever/brain dead from high fever the vaccine caused. Patient was not enrolled in clinical trial. Treatment medication was not reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) for events was not applicable. Company Comment This case concerns the death of a 41-year-old male after receiving both doses of mRNA-1273 vaccine. Although a temporal association exist, it is not enough to assess the fatal outcome of the event of fever as being causally association with the product use, In addition to fever occurring 26 days post last dose of vaccine, the patient is reported to have a history of fever (origin) not provided as well as critical other relevant details such as detailed medical history and clinical findings are lacking. No additional information is expected.; Sender''s Comments: This case concerns the death of a 41-year-old male after receiving both doses of mRNA-1273 vaccine. Although a temporal association exist, it is not enough to assess the fatal outcome of the event of fever as being causally association with the product use, In addition to fever occurring 26 days post last dose of vaccine, the patient is reported to have a history of fever (origin) not provided as well as critical other relevant details such as detailed medical history and clinical findings are lacking. No additional information is expected; Reported Cause(s) of Death: Feverish


VAERS ID: 1476505 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blindness, Death
SMQs:, Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021822034

Write-up: unable to see out her right eye since the vaccine; Following my mums death; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-ADR 25569452, Safety Report Unique Identifier GB-MHRA-ADR 25569452. This case was mother (mum) report case. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient medical history and patient''s concomitant medications were not reported. It was reported that the reporter''s mum (patient) had her first dose in Feb2021. Her only dose. Her sister had hers the same week and suffered a stroke 4 days after. She has been advised not to take the 2nd dose. My mum said she had no side effects but told the paramedics she had been unable to see out her right eye since the vaccine. Following my mums death her other sister died 5 weeks later after her 2nd dose of the vaccine due to sepsis, following a hospital stay due to cellulitis. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of event unable to see out her right eye was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-2021845026 same product,different dose/event/patient;GB-PFIZER INC-2021845021 same product,different dose/event/patient;GB-PFIZER INC-2021845031 same product,different dose/event/patient; Reported Cause(s) of Death: death


VAERS ID: 1476541 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-05-31
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX6537 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiopulmonary failure, Cerebral venous thrombosis, Headache, Ischaemic cerebral infarction
SMQs:, Cardiac failure (narrow), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HRPFIZER INC2021849489

Write-up: cardiopulmonary insufficiency; Headache; Ischemic cerebral infarction; Cerebral venous thrombosis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB regulatory authority number HR-HALMED-300049099. A 48-years-old male patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Dose: 0.3 mL, Lot number: EX6537, Expiration date: unknown) intramuscular, administered at an unspecified anatomical location on 12May2021 (age at vaccination was unknown) as dose 1, 0.3 ml single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient was found dead in the yard and a court autopsy was ordered. Fatal outcome in the form of autopsy-determined central venous thrombosis (CVT) with consequent ischemic infarction of the medulla oblongata and right basal ganglia of the brain on 31May2021. The events as reported by initial reporter included patient experienced headache and cardiopulmonary insufficiency. The additional information received on 23Jun2021 included that the patient was vaccinated 2 weeks earlier with the second dose of Pfizer vaccine. The additional information received on 25Jun2021 included the correction of the previously mentioned (and now verified) orally obtained subsequent information was required, he received only the first vaccine. The reporter listed the symptoms by assumption, because the application form was required as mandatory information, but of course the reporter did not know exactly what symptoms the patient had before his death, because he passed away suddenly in his own backyard. An autopsy had already established the above and regarding the letter from the assembly to pay attention to the Blood Coagulation Syndrome (a consequence of which is a possible Cerebral Vein Thrombosis) associated with vaccination, reporter considered it necessary to report this death as a possible consequence related to previous vaccination of the deceased. ADR was not adequately labelled. A casual relationship between Comirnaty and events Ischemic cerebral infarction and Cerebral venous was assessing: Source of assessment: Regulatory Authority. Method of assessment: WHO. Causality. Result of Assessment: Unassessable/Unclassifiable. The outcome of the events ischemic cerebral infarction and cerebral venous thrombosis was fatal. The outcome of the events cardiopulmonary insufficiency and headache was unknown. No follow-up attempts are possible. No further information expected.; Autopsy-determined Cause(s) of Death: Fatal outcome in the form of autopsy-determined central venous thrombosis (CVT) with consequent ischemic infarction of the medulla oblongata and right basal ganglia of the brain.; Fatal outcome in the form of autopsy-determined central venous thrombo


VAERS ID: 1476543 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-05-01
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral infarction, Coma, Computerised tomogram, Fall, Hemiparesis, Inflammatory marker increased, Inflammatory marker test, Investigation, Lymphopenia, Pyrexia, Renal impairment, SARS-CoV-2 test, Urinary tract infection
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Haematopoietic leukopenia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-07
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; COPD; Hypertension; Ischemic heart disease
Allergies:
Diagnostic Lab Data: Test Date: 202105; Test Name: Cranial CT; Result Unstructured Data: Test Result:confirmed a cerebral infarction; Comments: showed previous ischemic vascular lesions and possible signs of new ones; Test Date: 202105; Test Name: inflammatory parameters; Result Unstructured Data: Test Result:elevated; Test Date: 202105; Test Name: Laboratory; Result Unstructured Data: Test Result:narrowed kidney function and lymphocytopenia; Test Date: 20210506; Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: HUPFIZER INC2021818683

Write-up: Cerebral infarction; left sided hemiparesis; fall; comatose; narrowed kidney function; lymphocytopenia; urinary tract infection; fever; elevated inflammatory parameters; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number HU-OGYI-491821. This spontaneous, serious, medically confirmed case was reported on 14Jun2021 by a physician and concerns the occurrence of cerebral infarction resulting in death after COMIRNATY injection for active immunization to prevent COVID-19. A 97-year-old female patient received BNT162B2 (COMIRNATY, Batch/Lot Number: Unknown), intramuscularly on 23Apr2021 (at an unspecified age) as dose 2, 0.3 ml single for COVID-19 immunisation. Medical history included hypertension, ischemic heart disease, atrial fibrillation and COPD (Chronic obstructive pulmonary disease), all from an unknown date and unknown if ongoing. Concomitant drugs were not reported. The patient experienced cerebral infarction (death, hospitalization) on 05May2021. The patient was hospitalized for cerebral infarction from 05May2021 to an unknown date. Clinical details: On 05May2021 the patient was admitted to the hospital with left sided hemiparesis after a fall caused by cerebral infarction which was confirmed with a CT. The patient was comatose. Laboratory results showed narrowed kidney function and lymphocytopenia. Covid-19 PCR test was negative on 06May2021. Cranial CT showed previous ischemic vascular lesions and possible signs of new ones. Considering the patient''s old age, enoxaparine therapy and thrombectomy was not an option. Antibiotic therapy was started because the patient developed urinary tract infection and fever with elevated inflammatory parameters, but she passed away on 07May2021 due to another cerebral infarction. The outcome of event cerebral infarction was fatal. Outcome of the other events was unknown. The patient died on 07May2021. It was not reported if an autopsy was performed. Sender Comment: As the event is associated with the patient''s cardiovascular diseases, 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. Stop date was provided as 07May2021 with outcome fatal. No follow-up attempts are possible, information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: Cerebral infarction


VAERS ID: 1476544 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-05-01
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-07-16
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: 2021-05-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021818686

Write-up: death; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number HU-OGYI-508421. This serious, spontaneous case was reported by a physician on 17Jun2021, concerning the occurrence of death after the use of Comirnaty concentrate for dispersion for injection (MAH: BioNTech Manufacturing GmbH). A 75-year-old female patient received BNT162B2 (COMIRNATY, Batch/Lot Number: Unknown), via an unspecified route of administration on 22Apr2021 (at an unspecified age) as dose 1, 0.3 ml single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced death on 01May2021. It was not reported if an autopsy was performed. Sender Comment: Death after vaccination with Comirnaty is not expected. TTO is 9 days. Dechallenge and rechallenge were not applicable. The causal relationship between the suspected drug and the event is considered not assessable per lack of information. The case is considered serious due to fatal outcome. No follow-up attempts are possible, information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: death


VAERS ID: 1476545 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-04-06
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, 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: 2021-04-12
   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: INSULATARD HUMAN; CONTROLOC [PANTOPRAZOLE]; CORYOL [CARVEDILOL]; NOVIFORM [FOSINOPRIL SODIUM]; ACTRAPID; EBRANTIL [URAPIDIL]; MALTOFER FOL; IMBRUVICA; LAPIDEN
Current Illness: Clostridium difficile colitis
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic lymphocytic leukemia; Congestive heart failure; Diabetes mellitus; Hypertension; Kidney failure chronic
Allergies:
Diagnostic Lab Data: Test Date: 20210406; Test Name: COVID-19 antigen test; Test Result: Positive
CDC Split Type: HUPFIZER INC2021846236

Write-up: positive COVID-19 test with symptoms/ fever, back pain and coughing; COVID-19 pneumonia; Vaccination failure; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is HU-OGYI-543721. A 63-years-old female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: unknown), via intramuscular on 30Mar2021 as a dose 2, 0.3 mL, single and the patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: EP2166), via an unspecified route of administration on 26Feb2021 as a dose 1, single for COVID-19 immunisation. The patient''s medical history included chronic lymphocytic leukemia from an unspecified date in 2004 and unknown if ongoing, ongoing clostridium difficile colitis, which contributed to her general state from an unspecified date in Aug2020, congestive heart failure, unknown if ongoing, kidney failure chronic, unknown if ongoing, hypertension, unknown if ongoing and diabetes mellitus, unknown if ongoing. The patient''s concomitant medications included insulin human injection, isophane (INSULATARD HUMAN), pantoprazole (CONTROLOC [PANTOPRAZOLE]), 20 mg, 1x/day, carvedilol (CORYOL [CARVEDILOL]), 25 mg, 12h, oral, fosinopril sodium (NOVIFORM [FOSINOPRIL SODIUM]), 20 mg, 1x/day, oral, insulin (ACTRAPID), urapidil (EBRANTIL [URAPIDIL]), 60 mg, 1x/day, oral, ferric hydroxide polymaltose complex, folic acid (MALTOFER FOL), oral, indapamide (LAPIDEN), 1.5 mg, oral, all taken for an unspecified indication and ibrutinib (IMBRUVICA), 140 mg, oral for COVID-19 immunisation. The patient experienced positive COVID-19 test with symptoms/ fever, back pain and coughing, COVID-19 pneumonia and vaccination failure on 06Apr2021. It was reported that, the physician concerned the occurrence of Covid-19 infection and pneumonia resulting in death after COMIRNATY injection for active immunization to prevent COVID-19. On 26Feb2021, the patient received the first dose (batch number: EP2166) and on 30Mar2021, received the second dose of 0.3 ml COMIRNATY concentrate for dispersion for injection (tozinameran (COVID-19 mRNA Vaccine embedded in lipid nanoparticles), batch number: unknown, expiry date: unknown, MAH: BioNTech Manufacturing GmbH/Pfizer) to prevent Covid-19. The patient was hospitalized on 06Apr2021 after experiencing fever, back pain and coughing. Antigen test was positive. COVID pneumonia was also confirmed. The patient received therapy, but her condition rapidly deteriorated and passed away on 12Apr2021. The cause of death was reported as COVID-19 on 12Apr2021. Autopsy was not performed. On 06Apr2021, the patient underwent lab tests and procedures which included COVID-19 antigen test, resulted as positive. The outcome of the events was fatal. Sender''s Comments: According to the Summary of product characteristics (SmPC) of Comirnaty, immunity usually develops 7 days after the second dose of the vaccine. The patient got infected with the virus 12 days after the second those, therefore vaccination failure is possible. Also, the patient had an ongoing Clostiridium difficile infection, which possibly contributed to the event. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1476553 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-04-20
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9480 / 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: 2021-04-20
   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: Stent placement
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021810608

Write-up: Had a myocardial infarct and died; This is a spontaneous report from a contactable physician, downloaded from a regulatory authority-WEB received from a regulatory authority, Regulatory Authority Number: IE-HPRA-2021-074109. A 70-years-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 10Apr2021 (Batch/Lot Number: ER9480) as DOSE 1, 0.3 ML SINGLE for COVID-19 immunisation. Medical history included stent placement from 20Apr2021 to an unknown date. The patient was not taking any concomitant medication. The patient experienced myocardial infarction following vaccination with Comirnaty for COVID-19 immunisation. It was reported that ten days after the first dose of the vaccine was administered, on 20Apr2021, the patient experienced myocardial infarction and died after the stent was inserted. Therapeutic measures were taken as a result of the event. The patient died on 20Apr2021. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Had a myocardial infarct and died


VAERS ID: 1476728 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-04-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001941 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Disseminated intravascular coagulation, Musculoskeletal pain, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-09
   Days after onset: 41
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: Essential thrombocytosis; Neutrophilia; Splenectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: Piressia intermittente (40) per 4 settimane dalla vaccinazione. Severa artromialgia (controllabile solo con oxicodone). Decesso in seguito a ipotetico quadro di coagulazione intravascolare disseminata; Piressia intermittente (40) per 4 settimane dalla vaccinazione. Severa artromialgia (controllabile solo con oxicodone). Decesso in seguito a ipotetico quadro di coagulazione intravascolare disseminata; Piressia intermittente (40) per 4 settimane dalla vaccinazione. Severa artromialgia (controllabile solo con oxicodone). Decesso in seguito a ipotetico quadro di coagulazione intravascolare disseminata; This regulatory authority case was reported by a physician and describes the occurrence of DISSEMINATED INTRAVASCULAR COAGULATION (Piressia intermittente (40) per 4 settimane dalla vaccinazione. Severa artromialgia (controllabile solo con oxicodone). Decesso in seguito a ipotetico quadro di coagulazione intravascolare disseminata), MUSCULOSKELETAL PAIN (Piressia intermittente (40) per 4 settimane dalla vaccinazione. Severa artromialgia (controllabile solo con oxicodone). Decesso in seguito a ipotetico quadro di coagulazione intravascolare disseminata) and PYREXIA (Piressia intermittente (40) per 4 settimane dalla vaccinazione. Severa artromialgia (controllabile solo con oxicodone). Decesso in seguito a ipotetico quadro di coagulazione intravascolare disseminata) in an 82-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001941) for COVID-19 vaccination. The patient''s past medical history included Neutrophilia on 01-Dec-2020, Essential thrombocytosis on 01-Jan-2000 and Splenectomy on 01-Jan-2013. On 29-Apr-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced DISSEMINATED INTRAVASCULAR COAGULATION (Piressia intermittente (40) per 4 settimane dalla vaccinazione. Severa artromialgia (controllabile solo con oxicodone). Decesso in seguito a ipotetico quadro di coagulazione intravascolare disseminata) (seriousness criteria death and medically significant), MUSCULOSKELETAL PAIN (Piressia intermittente (40) per 4 settimane dalla vaccinazione. Severa artromialgia (controllabile solo con oxicodone). Decesso in seguito a ipotetico quadro di coagulazione intravascolare disseminata) (seriousness criterion death) and PYREXIA (Piressia intermittente (40) per 4 settimane dalla vaccinazione. Severa artromialgia (controllabile solo con oxicodone). Decesso in seguito a ipotetico quadro di coagulazione intravascolare disseminata) (seriousness criterion death). The patient died on 09-Jun-2021. The reported cause of death was Disseminated intravascular coagulation, Arthromyalgia and Intermittent pyrexia. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was given Laboratory data was mentioned as the person undergoes C-reactive protein test on 14 May 2021 and results was not given No treatment information was given. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter''s Comments: Decesso dopo 42 giorni di malattia, iniziata il giorno della vaccinazione.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Reported Cause(s) of Death: Intermittent pyrexia; Disseminated intravascular coagulation; Arthromyalgia


VAERS ID: 1476797 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-06-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7959 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021824631

Write-up: 47-year-old patient vaccinated with the first dose of anti covid pfizer at 2.36 pm, suffered respiratory failure and went into cardio respiratory arrest at about 5.45 pm with subsequent death; 47-year-old patient vaccinated with the first dose of anti covid pfizer at 2.36 pm, suffered respiratory failure and went into cardio respiratory arrest at about 5.45 pm with subsequent death; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB:IT-MINISAL02-750553. A 47-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in left shoulder on 25Jun2021 14:36 at the age of 47-year-old (Batch/Lot Number: FD7959; Expiration Date: 31Oct2021) as single dose for COVID-19 immunisation. Medical history included asthma, tobacco user. The patient''s concomitant medications were not reported. The patient experienced respiratory failure and went into cardio respiratory arrest at about 5.45 pm with subsequent death (death) on 25Jun2021 17:45 about 4 hours after vaccination. He received cardiopulmonary resuscitation at home performed by Emergency operators. The patient died on 25Jun2021. It was not reported if an autopsy was performed. Reporter''s comments: 47-year-old patient, about 4 hours after vaccination against covid with the first pfizer dose, presents with acute respiratory failure and cardio-respiratory arrest with subsequent death. Sender''s comments: Once the reporter has been contacted, the death certificate and further documentation 118 (Emergency call) are awaited. On 30Jun2021, clinical documentation relating to the death is attached.; Reporter''s Comments: 47-year-old patient, about 4 hours after vaccination against covid with the first pfizer dose, presents with acute respiratory failure and cardio-respiratory arrest with subsequent death.; Reported Cause(s) of Death: 47-year-old patient vaccinated with the first dose of anti covid pfizer at 2.36 pm, suffered respiratory failure and went into cardio respiratory arrest at about 5.45 pm with subsequent death; 47-year-old patient vaccinated with the first dose of ant


VAERS ID: 1476865 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7338 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Cyanosis, Gastrointestinal haemorrhage, Haematemesis, Heart rate, Loss of consciousness, Oxygen saturation, Peripheral coldness, Respiratory arrest, Vaccination site pain, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-12
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bedridden; Extremity contracture; Hypertension; Multiple cerebral infarction; Osteoporosis; Vascular dementia
Allergies:
Diagnostic Lab Data: Test Date: 20210611; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:107/62 mmHg; Test Date: 20210612; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:70/64 mmHg; Comments: at 20:20; Test Date: 20210608; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination; Test Date: 20210611; Test Name: Body temperature; Result Unstructured Data: Test Result:36 Centigrade; Test Date: 20210612; Test Name: Body temperature; Result Unstructured Data: Test Result:36 Centigrade; Comments: at 20:20; Test Date: 20210611; Test Name: Pulse; Result Unstructured Data: Test Result:83; Test Date: 20210612; Test Name: Pulse; Result Unstructured Data: Test Result:74; Comments: at 20:20; Test Date: 20210611; Test Name: SpO2; Test Result: 98 %; Test Date: 20210612; Test Name: SpO2; Result Unstructured Data: Test Result:difficult to measure %; Comments: at 17:20
CDC Split Type: JPPFIZER INC2021757135

Write-up: Haemorrhage of digestive tract; Massive haematemesis; Loss of consciousness; Respiratory arrest; Cyanosis; Vomiting; Cold extremities; Slight vaccination site myalgia; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21115640. An 84-year-old female patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA7338, Expiration date 30Sep2021) via an unspecified route of administration as a single dose on 08Jun2021 at 22:33 (at the age of 84-years-old) for COVID-19 immunization. Body temperature before vaccination was 36.2 degrees centigrade on 08Jun2021. Medical history included hypertension, osteoporosis, multiple cerebral infarction, vascular dementia, extremity contracture, and bedridden. Family history was not reported. On 08Jun2021 at 22:33 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY). On the next day of vaccination (09Jun2021), the patient felt slight vaccination site myalgia. On 12Jun2021 at 17:20 (3 days 18 hours 47 minutes after the vaccination), the patient experienced vomiting. Then cold extremities, cyanosis, massive haematemesis, loss of consciousness, respiratory arrest, haemorrhage of digestive tract were developed. On 12Jun2021 (4 days after the vaccination), the outcome of the event (haemorrhage of digestive tract) was fatal. The course of the event was as follows: On the following day of the vaccination (09Jun2021), the patient had slight vaccination site myalgia but had no pyrexia. On 11Jun2021, the patient visited a facility for a short stay. The patient had no particular change and ate meals at full. Body temperature was 36 degrees centigrade, blood pressure was 107/62 mmHg, pulse was 83, and SpO2 was 98%. On 12Jun2021 (4 days after the vaccination) at 17:20, the patient vomited but had no consciousness disturbed. Subsequently, the patient had cold extremities but no cyanosis. SpO2 could not be measured and infusion was initiated. At 20:20, blood pressure was 70/64 mmHg, pulse was 74, and body temperature was 36 degrees centigrade. At 20:55, the patient had cyanosis. At 21:20, the patient had massive haematemesis, loss of consciousness, and respiratory arrest. At 21:52, physician at the facility confirmed death due to haemorrhage of digestive tract. In Feb2020, the patient was certified as long-term care need level 3. However, due to progression of extremity contracture, the patient was bedridden. It was assumed that the patient was at long-term care need level 5 since the patient needed full assistance including eating meals. The reporting physician classified the event (haemorrhage of digestive tract) as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was upper gastrointestinal haemorrhage. Outcome of haemorrhage of digestive tract was fatal, while outcome of other events was unknown. The patient died on 12Jun2021. It was unknown if an autopsy was performed.; Reported Cause(s) of Death: Haemorrhage of digestive tract


VAERS ID: 1476896 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-20
Onset:2021-06-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7812 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Body temperature, Cardio-respiratory arrest, Computerised tomogram, Pneumonia, SARS-CoV-2 test, White blood cell count
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-21
   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: Coagulation disorder; Dementia; Dialysis; Renal disease
Allergies:
Diagnostic Lab Data: Test Date: 20210620; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination; Test Date: 20210621; Test Name: CT; Result Unstructured Data: Test Result:suggestive of pneumonia; Test Date: 20210621; Test Name: blood was collected during dialysis; Result Unstructured Data: Test Result:slight increase in inflammatory reaction; Test Date: 20210621; Test Name: white blood cell; Result Unstructured Data: Test Result:slight increase; Test Date: 20210621; Test Name: collection for COVID-19 PCR test; Result Unstructured Data: Test Result:was conducted
CDC Split Type: JPPFIZER INC2021769906

Write-up: Suspected pneumonia; Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21115887. The patient was an 84-year and 0-month-old male. Body temperature before vaccination was 36.2 degrees centigrade. Family history was not reported. Medical history included renal disease, disease of blood not clotting properly, dementia, and dialysis. On 20Jun2021 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA7812, Expiration date 30Sep2021) via an unspecified route of administration as a single dose (dose 1, single) for COVID-19 immunization. On 21Jun2021 (1 day after the vaccination), the patient experienced cardio-respiratory arrest and suspected pneumonia. On 21Jun2021 (1 day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On the following day of the vaccination (on 21Jun2021), the patient underwent maintenance dialysis on an outpatient basis. Dialysis itself has had no marked change since its introduction. On 21Jun2021, blood was collected during dialysis, which showed slight increase in white blood cell and inflammatory reaction. CT was suggestive of pneumonia and the patient was scheduled to receive treatment with oral medication. However, after collection for COVID-19 PCR test sample was conducted, the patient experienced cardio-respiratory arrest while watching TV in dialysis room. Resuscitation was performed and spontaneous circulation returned; however, on the same day, the patient died and was discharged from the hospital. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The outcome of the event pneumonia was unknown while the outcome of the other event was fatal. The patient died on 21Jun2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1476897 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-13
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Brain natriuretic peptide, C-reactive protein, Cardiac failure acute, Myocardial infarction, SARS-CoV-2 test
SMQs:, Cardiac failure (narrow), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Myocardial infarction old
Allergies:
Diagnostic Lab Data: Test Name: BNP; Result Unstructured Data: Test Result:223.7 pg/mL; Test Name: CRP; Test Result: Negative ; Test Name: COVID-19 antigen test; Test Result: Negative
CDC Split Type: JPPFIZER INC2021769908

Write-up: cardiac failure acute associated with myocardial infarction old; cardiac failure acute associated with myocardial infarction old; This is a spontaneous report from a contactable physician (coroner) received from the regulatory authority. Regulatory authority report number is v21115905. The patient was a 68-year and 0-month-old female. Body temperature before vaccination was not reported. Medical history included myocardial infarction old. Family history was not provided. On an unspecified date, the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration as a single dose for COVID-19 immunization. On 10Jun2021 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date was not reported) an unspecified route of administration as a single dose for COVID-19 immunization. On 13Jun2021 at 12:57 (3 days after the vaccination), the patient died. An autopsy was performed. The possible cause of death confirmed by autopsy was cardiac failure acute associated with myocardial infarction old. The course of the events was as follows: The patient went to do agricultural work without a poor physical condition. Afterwards, the patient was found lying on the field. The patient was transferred to a hospital by an ambulance but resuscitation did not work. An emergency blood test showed negative for COVID-19 antigens, CRP (C-reactive protein) showed negative and BNP (brain natriuretic peptide) was 223.7 pg/mL. Anatomical findings: Cardiac hypertrophy, fibrosis and thinning of the entire ventricular anterior wall, and left anterior descending coronary artery occlusion. The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. Cardiac failure acute associated with myocardial infarction old was considered as a possible cause of the event. The reporting physician commented as follows: The patient died due to acute aggravation of the underlying disease.; Autopsy-determined Cause(s) of Death: Cardiac failure acute associated with myocardial infarction old; Cardiac failure acute associated with myocardial infarction old


VAERS ID: 1476910 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-06-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-16
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure; Cerebral infarction; Diabetes mellitus; Myocardial infarction
Allergies:
Diagnostic Lab Data: Test Date: 20210614; Test Name: oxygen saturation; Result Unstructured Data: Test Result:decreased; Test Date: 20210614; Test Name: X-ray; Result Unstructured Data: Test Result:extensive infiltrative shadow
CDC Split Type: JPPFIZER INC2021771466

Write-up: Pneumonia; This is a spontaneous report from a contactable physician received via the Agency. The patient was an elderly male. 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. Other medical history included cardiac failure, myocardial infarction, diabetes mellitus and cerebral infarction. On 14Jun2021 in the morning (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5420, Expiration date 31Aug2021) intramuscular for COVID-19 immunization at a hospital. On 14Jun2021 (the day of vaccination), the patient experienced pneumonia. On 16Jun2021 (2 days after the vaccination), the patient died. The outcome of the event was fatal with treatment including antibiotic. The cause of death was pneumonia. (The event resulted in death.) An autopsy was not performed. The course of the events was as follows: On 14Jun2021, after the vaccination, no abnormalities were noted. At noon, tube feeding was performed, afterwards oxygen saturation decreased, and pyrexia was noted. X-ray showed extensive infiltrative shadow and a diagnosis of pneumonia was made. Antibiotic therapy was performed. On 16Jun2021, the patient died. Since the vaccination, the patient had not been tested for COVID-19.; Sender''s Comments: Based on the close temporal relationship, the association between the event fatal pneumonia with COMIRNATY use could not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Pneumonia


VAERS ID: 1476932 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-20
Onset:2021-06-24
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 1 - / -

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: 2021-06-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Atrial fibrillation; Cardiac failure chronic
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021777969

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21116068. The patient was an 83-year and 5-month-old male. The patient''s age at the time of vaccination was 83 years old. Body temperature before vaccination was not provided. The family history was not provided. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations, and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 20Jun2021 at 13:50 (the day of vaccination), the patient received the first dose of BNT162B2 (COMIRNATY, solution for injection, lot number: FC3661, expiration date: 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 24Jun2021 at 11:45 (3 days, 21 hours, and 55 minutes after the vaccination), the patient experienced cardiac-respiratory arrest. On 24Jun2021 at 12:49 (3 days, 22 hours, and 59 minutes after the vaccination), the outcome of the event was fatal. It was unknown if an autopsy was done. The course of the event was as follows: The patient was receiving home visit medical care. On 24Jun2021 (4 days after vaccination), the patient visited the reporting hospital for bathing by day care. At the hospital visit, there were no abnormalities in particular and the patient moved to the bathroom. Thereafter, when a day care staff member tried to assist his bathing, the patient had lost his consciousness. The patient was examined; however, he had already been in cardiac-respiratory arrest. Thus, resuscitation was performed; however, it was ineffective, and the patient was confirmed dead at 12:49. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 was unassessable. Other possible causes of the event such as any other diseases included atrial fibrillation and cardiac failure chronic.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1476937 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-20
Onset:2021-06-22
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5423 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood loss anaemia, Cardiac arrest, Circulatory collapse, Electrocardiogram, Faeces discoloured, Fall, Loss of consciousness, Malaise, Pallor, Upper gastrointestinal haemorrhage
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), 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), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-24
   Days after onset: 2
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: Diabetes mellitus (details about oral medications were unknown)
Allergies:
Diagnostic Lab Data: Test Date: 20210624; Test Name: Initial waveform; Result Unstructured Data: Test Result:asystole
CDC Split Type: JPPFIZER INC2021778019

Write-up: the patient was found by her family lying down at home; The initial waveform was asystole; physician presumed that upper gastrointestinal haemorrhage/haemorrhagic anaemia; physician presumed that upper gastrointestinal haemorrhage/haemorrhagic anaemia; circulatory collapse with ensuing cardiac arrest but was unsure.; Malaise; Black stools; Fall; Pallor facial; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21116059. A 68-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 20Jun2021 (at the age of 68-year-old) (Batch/Lot Number: EY5423; Expiration Date: 31Aug2021) as dose 2, single for covid-19 immunisation. Medical history included diabetes mellitus (details about oral medications were unknown). The patient''s concomitant medications were not reported. The patient received first dose of bnt162b2 for covid-19 immunisation on an unspecified date. On 22Jun2021 at unknown time (2 days after the vaccination), the patient experienced pallor facial. On 23Jun2021 at unknown time (3 days after the vaccination), the patient experienced malaise and black stools (onset date and time was also reported as at 08:30 on 24Jun2021). The patient had a fall at home. On 24Jun2021 at unknown time (4 days after the vaccination), the patient was found by her family lying down at home and the initial waveform was asystole at unknown time. On 24Jun2021 (4 days after the vaccination), the outcome of the events malaise and black stools was fatal, while that of the others was not reported. It was not reported whether autopsy was done. The course of the events was as follows: On 20Jun2021 (the day of vaccination), the patient was vaccinated. On 22Jun2021 (2 days after the vaccination), pallor facial was noted. On 23Jun2021 (3 days after the vaccination), malaise developed and black stools were noted. Moreover, according to the report from the family, the patient had a fall at home. On 24Jun2021 (4 days after the vaccination), the patient was found by her family lying down at home and was transported by ambulance to the reporting hospital. On arrival at the reporting hospital, electrocardiogram initial waveform was asystole, chest compression was continued, and adrenaline 1 mg was administered every 4 minutes with a total of 5 syringes, but resuscitation was considered impossible. At 09:16, death confirmation was performed, and a contact was made to the police station of the jurisdiction because of the unnatural death. The reporting physician classified the events malaise and black stools as serious (death) and assessed the causality between the events malaise and black stools and bnt162b2 as unassessable. The seriousness and causality of the other events were not reported. Other possible causes of the events malaise and black stools such as any other diseases were reported as unknown. The reporting physician commented as follows: Based on the information from the family, the attending physician presumed that upper gastrointestinal haemorrhage/haemorrhagic anaemia had led to circulatory collapse with ensuing cardiac arrest but was unsure. The patient died on 24Jun2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Black stools; Malaise


VAERS ID: 1476938 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-05-31
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4811 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Body temperature, Chest X-ray, Pneumonia bacterial
SMQs:, Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BAYASPIRIN; CLOPIDOGREL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bilateral pneumonia; Cerebellar infarction; Coronary stent placement; Urinary tract infection
Allergies:
Diagnostic Lab Data: Test Date: 20210531; Test Name: Blood test; Result Unstructured Data: Test Result:unknown results; Test Date: 20210511; Test Name: Body temperature; Result Unstructured Data: Test Result:35.9 Centigrade; Comments: before vaccination; Test Date: 20210531; Test Name: Chest XP; Result Unstructured Data: Test Result:unknown results
CDC Split Type: JPPFIZER INC2021778021

Write-up: Pneumonia bacterial; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21116058. The patient was a 73-year and 0-month-old male. Body temperature before vaccination was 35.9 degrees centigrade. Family history was not reported. Medical history included cerebellar infarction, past coronary stent placement, and bilateral pneumonia (16Apr2021-20Apr2021) and urinary tract infection (UTI) (normal saline 100 ml + BAKFOSE 1g x 2 times/day). Concomitant medications included acetylsalicylic acid (BAYASPIRIN) orally and clopidogrel (CLOPIDOGREL) orally. On 11May2021 at 16:10 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EW4811, Expiration date 31Jul2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 31May2021 (20 days after the vaccination), the patient experienced pneumonia bacterial. On 01Jun2021 at 21:55 (21 days after the vaccination), the patient died. The outcome of the event was fatal. It was not reported whether autopsy was done. The course of the event was as follows: On 31May2021 (20 days after the vaccination), pneumonia bacterial developed (it was diagnosed based on chest X-ray photography (XP) and blood test). On 01Jun2021 at 21:55 (21 days after the vaccination), the patient died. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases.; Reported Cause(s) of Death: Pneumonia bacterial


VAERS ID: 1476945 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-05-26
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4811 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Body temperature, Chest X-ray, Computerised tomogram, Pneumonia bacterial
SMQs:, Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-30
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BAYASPIRIN; PHYSIOLOGICAL SALINE SOLUTION; MEROPENEM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bilateral pneumonia (PHYSIOLOGICAL SALINE TH 100 mL and MEROPENEM 0.5 g x twice per day were administered); Late effects of cerebral infarction
Allergies:
Diagnostic Lab Data: Test Date: 20210526; Test Name: blood examination; Result Unstructured Data: Test Result:bilateral pneumonia bacterial; Test Date: 20210511; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination; Test Date: 20210526; Test Name: chest x-ray; Result Unstructured Data: Test Result:bilateral pneumonia bacterial; Test Date: 20210526; Test Name: computerised tomogram; Result Unstructured Data: Test Result:bilateral pneumonia bacterial
CDC Split Type: JPPFIZER INC2021778235

Write-up: Pneumonia bacterial; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21116057. The patient was an 87-year and 6-month-old male. Body temperature before vaccination was 36.5 degrees Centigrade. The family history was not provided. The patient had medical histories of late effects of cerebral infarction, and bilateral pneumonia (from 26Mar2021 to 30May2021), for which PHYSIOLOGICAL SALINE TH 100 mL and MEROPENEM 0.5 g x twice per day were administered. The concomitant medication included BAYASPIRIN. On 11May2021 at 16:15 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EW4811, Expiration date 31Jul2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 26May2021 (14 days after the vaccination), the patient experienced pneumonia bacterial. On 30May2021 (19 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 26May2021, the patient had bilateral pneumonia bacterial (it was diagnosed on chest X-ray, 1computerised tomogram (CT), and the blood examination). On 30May2021, at 10:06, the patient died. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases.; Reported Cause(s) of Death: Pneumonia bacterial


VAERS ID: 1476953 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-06-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5423 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Cardiac arrest, Depressed level of consciousness, Respiratory arrest, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: NONE
Allergies:
Diagnostic Lab Data: Test Date: 20210624; Test Name: blood pressure; Result Unstructured Data: Test Result:100 mmHg; Test Date: 20210623; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021779099

Write-up: Respiratory arrest; Cardiac arrest; depressed level of consciousness; vomiting; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21116118. The patient was a 71-year and 1-month-old male. Body temperature before vaccination was 36.4 degrees Centigrade. The family history was not provided. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 23Jun2021 at 13:57 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5423, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 24Jun2021 at 09:00 (19 hours and 3 minutes after the vaccination), the patient experienced respiratory arrest and cardiac arrest. On 24Jun2021 (one day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 23Jun2021 (the day of vaccination), at 13:57, the patient received the first dose of BNT162b2 vaccination. On 24Jun2021 (one day after vaccination), the patient had vomiting and depressed level of consciousness after breakfast, and he was transferred to the reporting hospital. At the hospital visit, the patient had respiratory arrest. Several minutes after cardiac massage was performed, the breathing restored. The blood pressure resolved to 100 mmHg; however, approximately 10 minutes later, when the patient was moved, he had respiratory arrest again and cardiac arrest. Physician office visit for events. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases.; Reported Cause(s) of Death: vomiting; depressed level of consciousness; Respiratory arrest; Cardiac arrest


VAERS ID: 1476955 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-06-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cerebral haemorrhage, Fall, Subdural haematoma
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-19
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic kidney disease; Hypertension; Myocardial infarction old
Allergies:
Diagnostic Lab Data: Test Date: 20210615; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021779194

Write-up: Right subcortical haemorrhage; Right subdural haematoma; fell while doing housework in the kitchen; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21116117. The patient was an 83-year and 3-month-old female. Body temperature before vaccination was 36.5 degrees centigrade. The patient had no family history. Medical history included hypertension, chronic kidney disease, and myocardial infarction old. Concomitant medications were not reported. On 25May2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number EY5420, Expiration date 31Aug2021). On 15Jun2021 at 15:00 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5420, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 17Jun2021 at 23:05 (2 days and 8 hours after the vaccination), the patient experienced right subcortical haemorrhage and right subdural haematoma. On 19Jun2021 (4 days after the vaccination), the outcome of the events was fatal. It was not reported whether autopsy was done. The course of the events was as follows: On 17Jun2021 (2 days after the vaccination), the patient fell while doing housework in the kitchen and was transported to the reporting hospital. Right subcortical haemorrhage and right subdural haematoma were diagnosed, and the patient was urgently admitted to the hospital under endotracheal intubation and ventilator management. She was considered ineligible for surgery, and on 19Jun2021 at 07:37 (4 days after the vaccination), her death was confirmed. The reporting physician classified the events as serious (death) and assessed that the causality between the events and BNT162b2 as unassessable. It was not reported whether there was other possible cause of the events such as any other diseases. The reporting physician commented as follows: The causal relationship with the BNT162b2 intramuscular injection was unknown.; Reported Cause(s) of Death: Right subcortical haemorrhage; Right subdural haematoma


VAERS ID: 1476975 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-06-19
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021780077

Write-up: Cardio-respiratory arrest; This is a spontaneous case from a contactable pharmacist received via a Pfizer sales representative. A 75-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 15Jun2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received BNT162b2 (COMIRNATY) as 1st dose on an unspecified date for COVID-19 immunisation. On 19Jun2021 (4 days after vaccination), the patient was admitted to the hospital for cardio-respiratory arrest. The outcome of the event (fatal). The causality between the event and BNT162B2 was not provided. Information on the batch/lot number has been requested.; Sender''s Comments: A causal relationship between the event cardio-respiratory arrest and suspect product BNT162B2 (COMIRNATY), cannot be excluded based on the information provided, suspect product profile and a temporal association in this 75-year-old male patient. This case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1476983 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-07
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Investigation, Pleural effusion, Pneumonia, Pyrexia, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-13
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LIXIANA; MEMANTINE [MEMANTINE HYDROCHLORIDE]; LANSOPRAZOLE; DEPAKENE-R; QUETIAPINE [QUETIAPINE FUMARATE]; YOKUKANSAN; TIAPRIDE [TIAPRIDE HYDROCHLORIDE]; LEXAPRO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Dementia Alzheimer''s type; Old cerebral infarction (the patient was hospitalized)
Allergies:
Diagnostic Lab Data: Test Date: 20210607; Test Name: Body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: before vaccination; Test Date: 202106; Test Name: Investigation; Result Unstructured Data: Test Result:pneumonia and bilateral pleural effusion; Comments: left-sided pneumonia and bilateral pleural effusion
CDC Split Type: JPPFIZER INC2021783427

Write-up: Pyrexia; Respiratory failure; Left-sided pneumonia; Bilateral pleural effusion; This is a spontaneous report from a contactable physician received via COVID-19 regulatory authority. Regulatory authority report number is v21116361. The patient was a non-pregnant 90-year and 9-month old female. Body temperature before vaccination was 36.0 degrees centigrade on 07Jun2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received edoxaban tosilate (LIXIANA) 30 mg, memantine hydrochloride (MEMANTINE) 20 mg, lansoprazole 15 mg, valproate sodium (DEPAKENE-R) 800 mg, quetiapine fumarate (QUETIAPINE) 50 mg, angelica acutiloba root, atractylodes lancea rhizome, bupleurum falcatum root, cnidium officinale rhizome, glycyrrhiza spp. root, poria cocos sclerotium, uncaria spp. Hook (TSUMURA YOKUKANSAN) extract granule 7.5 g, tiapride hydrochloride (TIAPRIDE) 10% 0.15 g, and escitalopram oxalate (LEXAPRO) 20 mg within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included dementia Alzheimer''s type, atrial fibrillation, and old cerebral infarction. It was reported that the patient has been hospitalized due to Alzheimer''s type, atrial fibrillation, and old cerebral infarction. On 07Jun2021 at 13:30 (the day of vaccination, at 90-year-old), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0779, Expiration date 31Aug2021) intramuscular in the arm left for COVID-19 immunization. On 10Jun2021 at 17:15 (3 days 3 hours 45 minutes after the vaccination), the patient experienced pyrexia and respiratory failure. The outcome of the events was fatal with treatment including antimicrobial agent and oxygen. Since the vaccination, the patient has not been tested for COVID-19. The course of the events was as follows: The patient has been hospitalized due to dementia. On 10Jun2021, the patient developed pyrexia and respiratory failure. Investigation revealed left-sided pneumonia and bilateral pleural effusion in Jun2021. Intravenous infusion of UNASYN-S and administration of oxygen were initiated. On 13Jun2021, the patient died. Upon follow-up on 26Jun2021, the course of the events was reported as follows: On 10Jun2021 in the evening, the patient developed pyrexia, followed by progression of respiratory failure. Antimicrobial agent and oxygen were administered; however, on 13Jun2021 at 20:36, the patient died. The reporting physician classified the event as serious (death). The reporting physician assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was aspiration. The reporting physician commented as follows: The events and the vaccine seemed poorly related. It was unknown if the autopsy was performed.; Reported Cause(s) of Death: Pyrexia; Respiratory failure; Left-sided pneumonia; Bilateral pleural effusion


VAERS ID: 1476989 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-06-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, C-reactive protein, Dehydration, Laboratory test, Pyrexia, Respiratory arrest, Urinary tract infection, Urine analysis
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-25
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ELIQUIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Infective spondylitis; Pericarditis infective; Sleep apnoea syndrome (AHI (apnea hypopnea index) 42.1 times/h); Urinary tract infection
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:decreasing Centigrade; Comments: After the treatment; Test Date: 20210618; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination; Test Date: 20210618; Test Name: Body temperature; Result Unstructured Data: Test Result:over 39 Centigrade; Comments: around 4 hours after the vaccination; Test Date: 20210621; Test Name: Body temperature; Result Unstructured Data: Test Result:37.7 Centigrade; Test Date: 20210622; Test Name: CRP; Result Unstructured Data: Test Result:11.3; Comments: increase; Test Date: 20210622; Test Name: apnea hypopnea index; Result Unstructured Data: Test Result:42.1; Comments: times/h; Test Date: 20210622; Test Name: Cloudy urine; Result Unstructured Data: Test Result:cloudiness
CDC Split Type: JPPFIZER INC2021785362

Write-up: dehydration; Respiratory arrest; urinary tract infection; Pyrexia of over 39 degrees Centigrade; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21116206. The patient was an 89-year and 10-month-old male. Body temperature before vaccination was 36.7 degrees Centigrade. Medical history included pyogenic spondylitis, pericarditis infective, urinary tract infection and sleep apnoea syndrome. Concomitant medications included oral apixaban (ELIQUIS). No information on family history was provided. On 18Jun2021 at 12:30 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# FA2453, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization when 89 years old. On 25Jun2021 at 02:10 (7 days after the vaccination), the patient developed respiratory arrest and died. It was not reported if an autopsy was performed. The course of the event was as follows. On 18Jun2021 (around 4 hours after the vaccination), pyrexia of over 39 degrees Centigrade was noted. The pyrexia was considered to be an adverse reaction due to BNT162b2, acetoaminophen suppository was administered and then his progress was observed. The pyrexia was decreasing for a while. On 21Jun2021, pyrexia (37.7 degrees Centigrade) recurred. Because of the patient had past history of pyogenic spondylitis, pericarditis infective and urinary tract infection, this episode was considered to be. On 22Jun2021, CRP (C-reactive protein) measured on that day was 11.3 indicating increase, and cloudiness of urine was noted. On 23Jun2021 (5 days after vaccination), the treatment for urinary tract infection was started aztreonam (AZACTZM injection). The patient also had sleep apnoea syndrome (AHI [apnea hypopnea index] 42.1 times/h). At 2:10 on 25Jun2021, the patient died of respiratory arrest. The reporting physician classified the event respiratory arrest as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. The reporting physician considered that there was possible cause of the event such as any other diseases. The reporting physician commented as follows: A possibility that BNT162b2 triggered infection to acutely worsen (including occurrence of sepsis) could not be ruled out. Also, another possibility that pyrexia and dehydration influenced the sleep apnoea syndrome could not be denied, either.; Reported Cause(s) of Death: Respiratory arrest


VAERS ID: 1476990 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-14
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7338 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory arrest, Nausea, Physical deconditioning, 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), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-15
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anticoagulant therapy (taking a blood-thinning medicine(detailed unknown)); Atrial fibrillation; Cardiac failure; Hypertension (on drug treatment)
Allergies:
Diagnostic Lab Data: Test Date: 20210608; Test Name: Body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021785363

Write-up: Cardio-respiratory arrest; Vomiting; Physical deconditioning; Nausea; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21116273. A 79-years-old male patient received the first dose of BNT162B2 (COMIRNATY), dose 1 via an unspecified route of administration on 08Jun2021 (Lot Number: FA7338; Expiration Date: 30Sep2021) as single dose for covid-19 immunisation. The patient was a 79-year-old male. Body temperature before vaccination was 36.1 degrees centigrade. Family history was not reported. Medical history included hypertension (on drug treatment) and historical conditions of hypertension, cardiac failure, and atrial fibrillation. Concomitant medications included a drug for hypertension and a blood-thinning medicine (details unknown). On 08Jun2021 at unknown time (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA7338, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 14Jun2021 at unknown time (6 days after the vaccination), the patient noticed physical deconditioning and experienced nausea and vomiting. On 15Jun2021 at unknown time (7 days after the vaccination), the patient experienced cardio-respiratory arrest and death. On 15Jun2021 (7 days after the vaccination), the outcome of the event death was fatal, while for the other events was not reported. It was not reported whether autopsy was done. The course of the events was as follows: The patient had historical conditions of hypertension, cardiac failure, and atrial fibrillation and was visiting the clinic. On 08Jun2021 (the day of vaccination), the patient received the first dose of the new coronavirus vaccine at the reporting hospital. On 14Jun2021 (6 days after the vaccination), the patient noticed physical deconditioning and experienced nausea and vomiting. On 15Jun2021 at 18:00 (7 days after the vaccination), when arriving home, the patient''s son found him lying in the toilet and called an ambulance. On arrival of the ambulance, the son, who was a nurse, was performing cardiac massage, but the patient was in a state of cardiopulmonary arrest (CPA). The patient was asystole after being carried inside the vehicle. There were no findings suggestive of asphyxia at the time of discovery, and it seemed that the patient was about to get out after finishing urination. On arrival at the reporting hospital, cardio-respiratory arrest confirmed, and asystole was noted on the monitor. The pupils were dilated in 5 mm, and no light reflex was noted. At 19:02, death was confirmed. The police involved to handle this as unusual death. The reporting physician classified the event death as serious (death) and assessed the causality between the event death and BNT162b2 as unassessable. The seriousness and causality of the other events were not reported. Other possible cause of the event death such as any other diseases: The patient had historical conditions of hypertension, cardiac failure, and atrial fibrillation and was regularly visiting the clinic. The reporting physician commented as follows: Considering the historical condition of atrial fibrillation, thromboembolism was highly possible. Although this case occurred a week after the vaccination, the causal relationship with the vaccine was unknown. Patient died on 15Jun2021 19:02. Outcome of physical deconditioning, nausea and vomiting were unknown. It was unknown if an autopsy was performed.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1476991 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-06-11
   Days after vaccination:50
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 2 - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-20
   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: Atrial fibrillation; Dementia Alzheimer''s type; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210422; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination; Test Date: 20210611; Test Name: Head CT; Result Unstructured Data: Test Result:cerebral infarction; Comments: showed extensive cerebral infarction from the cerebrum to the cerebellum; Test Date: 20210611; Test Name: ECG; Result Unstructured Data: Test Result:atrial fibrillation; Comments: showed atrial fibrillation
CDC Split Type: JPPFIZER INC2021785373

Write-up: Cerebral infarction; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21116290. The patient was a 95-year-old female. Body temperature before vaccination was 36.7 degrees Centigrade. The family history was not provided. The patient had medical histories of dementia Alzheimer''s type, hypertension, and atrial fibrillation. On unknown date in 2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# ET3674, Expiration date 31Jul2021). On 22Apr2021 at 10:00 (the day of vaccination, at 95-year-old), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EX3617, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 11Jun2021 at 06:00 (one month, 19 days, and 20 hours after the vaccination), the patient experienced cerebral infarction. On 20Jun2021 (one month and 19 days, and 20 hours after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 11Jun2021, at 06:00 (one month, 15 days, and 20 hours after vaccination), when the staff member went the rounds, he/she noticed that the patient had no respiratory reaction. Immediately, the patient was emergently transferred to the reporting hospital. When the patient arrived at the hospital, she had coma and quadriplegia, and an ECG showed atrial fibrillation. Head CT showed extensive cerebral infarction from the cerebrum to the cerebellum. On 20Jun2021, the patient died. It was unknown if autopsy was performed. The reporting physician classified the event as serious (life-threatening, hospitalization, and death) and assessed that the event was unrelated to BNT162b2. Other possible cause of the event such as any other diseases was atrial fibrillation. The reporting physician commented as follows: The cerebral infarction was caused by atrial fibrillation of medical history. The vaccination was difficult to consider to be the cause of the event.; Reported Cause(s) of Death: Cerebral infarction


VAERS ID: 1477008 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-06-24
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7338 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-25
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiovascular disease, unspecified (required regular visit to hospital); Interstitial pneumonia (required regular visit to hospital)
Allergies:
Diagnostic Lab Data: Test Date: 20210622; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: Before vaccination; Test Date: 20210624; Test Name: Body temperature; Result Unstructured Data: Test Result:37.7 degrees Centigrade
CDC Split Type: JPPFIZER INC2021786056

Write-up: Cardio-respiratory arrest; Pyrexia (37.7 degree C); Cough; This is a spontaneous report from a contactable physician received via regulatory authority, report number is v21116391. A 75-year-old male received bnt162b2 (COMIRNATY, Solution for injection, Lot number: FA7338, Expiration date: 30Sep2021) intramuscular in the left arm on 22Jun2021 at 10:00 (the day of vaccination) (at the age of 75-year-old) as dose 1, single for COVID-19 immunization. Medical history included interstitial pneumonia/ bronchial disorder (required regular visit to hospital) and heart disease/ cardiovascular disease (required regular visit to hospital). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Since the vaccination, the patient has not been tested for COVID-19. Body temperature before vaccination was 36.4 degrees Centigrade. Concomitant medication was not reported. On 24Jun2021 (2 days after the vaccination), the patient developed pyrexia of 37.7 degrees Centigrade and cough. On 25Jun2021, the patient family member came to the hospital to get antipyretic and chough medicine. On 25Jun2021 (reported as when having lunch), he developed dyspnoea which led to cardio-respiratory arrest. At the hospital where the patient was transferred, the patient''s death was confirmed on 25Jun2021. The event resulted in death. The cause of death was unknown. It was unknown if the patient received the treatment. The patient was regularly visiting another hospital for bronchial disorder and cardiovascular disease. The clinical outcome of the event cardio-respiratory arrest, pyrexia (37.7 degree C) and cough was fatal. The patient died on 25Jun2021 due to cardio-respiratory arrest. An autopsy was performed and further examination was being performed. The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. It was not reported if there was other possible cause of the event such as any other diseases.; Reported Cause(s) of Death: Cardio-respiratory arrest


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