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From the 11/26/2021 release of VAERS data:

Found 19,532 cases where Vaccine targets COVID-19 (COVID19) and Patient Died

Government Disclaimer on use of this data



Case Details

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VAERS ID: 1511228 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-07-12
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory arrest, Malaise, Pyrexia, SARS-CoV-2 test, Swelling, Vaccination site pain
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-13
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia; Pneumothorax
Allergies:
Diagnostic Lab Data: Test Date: 20210712; Test Name: Body temperature; Result Unstructured Data: pyrexia in the 38 degrees Celsius range; Test Date: 2021; Test Name: SARS-COV-2 antigen test; Test Result: Negative ; Result Unstructured Data: nasopharyngeal swab was negative
CDC Split Type: JPTAKEDA2021TJP062969

Write-up: Injection site pain; Swelling; Generalized malaise; Cardio-respiratory arrest; Pyrexia; This regulatory authority case was reported by a physician and describes the occurrence of CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest), VACCINATION SITE PAIN (Injection site pain), SWELLING (Swelling), MALAISE (Generalized malaise) and PYREXIA (Pyrexia) in a 32-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Arrhythmia and Pneumothorax. On 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jul-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jul-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced PYREXIA (Pyrexia) (seriousness criterion death). On 13-Jul-2021, the patient experienced CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) (seriousness criteria death and medically significant). On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection site pain) (seriousness criterion death), SWELLING (Swelling) (seriousness criterion death) and MALAISE (Generalized malaise) (seriousness criterion death). The patient died on 13-Jul-2021. The reported cause of death was Vaccination site pain, Swelling, Cardio-respiratory arrest, Pyrexia and General malaise. An autopsy was performed, but no results were provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) nasopharyngeal swab was negative. On 12-Jul-2021, Body temperature: 38 degrees celsius (High) pyrexia in the 38 degrees Celsius range. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular), the reporter considered CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest), VACCINATION SITE PAIN (Injection site pain), SWELLING (Swelling), MALAISE (Generalized malaise) and PYREXIA (Pyrexia) to be possibly related. After death, CT scan showed no findings of imaging abnormalities leading to death. No relevant concomitant medications were reported. No treatment information was provided. Case comment/sender''s comment: Since the patient had been in cardiac arrest for a long time at the time of the visit, sufficient examination could not be performed, and the apparent cause of death was unknown. It was considered that the possibility of vaccine-related death could not be ruled out in view of the sudden death of the young adult with no particular medical history and the occurrence of accompanying symptoms after the 2nd vaccination, followed by cardio-respiratory arrest. The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. Company Comment: 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. Worldwide unique case identification number: 2021TJP062969; 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: Vaccination site pain; Swelling; Cardio-respiratory arrest; Pyrexia; General malaise


VAERS ID: 1511307 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5089 / 2 - / -
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Interchange of vaccine products
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), Medication errors (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021890414

Write-up: Cardiac arrest; Interchange of vaccine products; This is a spontaneous report from a contactable health professional downloaded from Regulatory Authority. (Regulatory Authority report number: NL-LRB-00598687). A 67-year-old female patient received the second dose of BNT162B2 (COMIRNATY, Lot Number: FC5089; Expiration date was not reported) on 24Jun2021 as dose 2, 0.3 mL, single, with route of administration unspecified, for COVID-19 immunization; and the first dose of covid-19 vaccine nrvv ad (chadox1 ncov-19) (VAXZEVRIA, Lot number and expiration date were not reported) as dose 1, single, with route of administration and therapy date unspecified, for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient did not have a previous COVID-19 infection. On 24Jun2021, the patient had received BNT162B2 (COMIRNATY) as the second dose; when the first dose was with covid-19 vaccine nrvv ad (chadox1 ncov-19) (VAXZEVRIA) (interchange of vaccine products). On 24Jun2021, the patient had cardiac arrest following the administration of BNT162B2. The patient had died on 24Jun2021 due to cardiac arrest. It was unknown if an autopsy was performed.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1511334 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1573 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal cardiac arrest, Foetal exposure during pregnancy
SMQs:, Congenital and neonatal arrhythmias (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (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: NLPFIZER INC202100949716

Write-up: Heart stopped shortly after vaccination; received BNT162B2 (COMIRNATY) dose 1 transplacental; This is a spontaneous report from a contactable consumer. This consumer reported information for both mother and fetus. This is a fetus report. The mother report is a report downloaded from the Regulatory Authority NL-LRB-00616253. A fetus received BNT162B2 (COMIRNATY) dose 1 transplacental on 04Jul2021 (Batch/Lot Number: FE1573) as dose 1, single for covid-19 immunisation when patient mother had pregnant duration of 7 weeks and 3 days. The patient medical history and concomitant medications were not reported. The patient heart stopped shortly after vaccination on 06Jul2021 with fatal outcome. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-2021895854 mother/child case; Reported Cause(s) of Death: Heart stopped shortly after vaccination; received BNT162B2 (COMIRNATY) dose 1 transplacental


VAERS ID: 1511348 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-07-01
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Loss of consciousness, Seizure
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC2021898383

Write-up: Loss of consciousness; Seizure; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300089813. A 67-years-old male patient received bnt162b2 (COMIRNATY), intramuscular on 23Jun2021 (Lot Number: FD5996) at 67 years old as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced loss of consciousness (death) on 01Jul2021 08:00, seizure (death) on 01Jul2021 08:00. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Loss of consciousness; Seizure


VAERS ID: 1511349 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-07-02
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Headache, Malaise
SMQs:, Anticholinergic syndrome (broad), 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: PHPFIZER INC2021898505

Write-up: body malaise; Dizziness; Headache; This is a spontaneous report from a contactable other healthcare professional. This is a report received from the Regulatory authority report number PH-PHFDA-300089917. A 69-year-old female patient received bnt162b2 (COMIRNATY, Batch/Lot number was not reported), intramuscular on 28Jun2021 (at the age of 69years) as dose number unknown, single for Covid-19 immunization. The patient''s medical history and concomitant medications were not reported. On 02Jul2021, the patient experienced dizziness and headache. On an unspecified date, the patient experienced body malaise. The outcome of events dizziness and headache was fatal; outcome of body malaise was unknown. The patient died on an unspecified date. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Dizziness; Headache


VAERS ID: 1511430 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-09
   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: TRIPLIXAM; NOLET; LIPANTHYL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension (second degree); Hypercholesterolemia
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC202100933255

Write-up: Sudden death; This is a spontaneous report from a contactable consumer (wife of patient) received from the Regulatory Authority-WEB, regulatory authority number RO-NMA-2021-SPCOV11955. A 50-year-old male patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: Unknown), via intramuscular route of administration on 08Jun2021, as dose 2, single for COVID-19 immunisation. The patient''s medical history included second degree arterial hypertension and hypercholesterolaemia. Concomitant medications included amlodipine besilate, indapamide, perindopril arginine (TRIPLIXAM) taken for arterial hypertension from 13Jan2020 to 09Jun2021; nebivolol (NOLET) taken for arterial hypertension from 13Jan2020 to 09Jun2021; fenofibrate (LIPANTHYL) taken for hypercholesterolaemia from 13Jan2020 to 09Jun2021. The patient previously received first dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: EY2172), via intramuscular route of administration on 08May2021, as single dose for COVID-19 immunisation. On 09Jun2021, 1 day after the administration of second dose of vaccine, the patient experienced sudden death. It was not reported if an autopsy was performed. It was reported that during the next day after receiving the second dose of the Comirnaty vaccine, the patient experienced sudden death. The reporter noted that the event occurred instantaneously. The patient was not diagnosed with SARS-CoV-2 infection before or after vaccination. No result from the necropsy available in the present report. No other details available regarding this case. The clinical outcome of the event was reported as fatal. No follow-up attempts are possible. No further information expected. Information on 2nd dose batch/lot number cannot be obtained.; Sender''s Comments: Linked Report(s) : RO-NMA-2021-SPCOV11983 NMA; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1511435 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6326 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: SEPFIZER INC2021895944

Write-up: HEART STOP; heart attack; PAIN AT THE VACCINATION SITE; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority, regulatory authority number SE-MPA-2021-057296. This is the first of two reports for the same patient and it refers to the second dose of Comirnaty. A 66-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration in Jun2021 (Lot Number: EW6326), at the age of 66-years-old, as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that the man had pain in his arm for a couple of days even after the first dose. The second dose was given in Jun2021. Reported suspected side effects were pain at the vaccination site on the same day as the vaccination (Jun2021) and cardiac arrest approximately two weeks later. The patient experienced heart stop and heart attack in Jun2021. The events were reported as serious (death). The outcome of the event pain at the vaccination site was unknown. The outcome of the other events was fatal. The reporter stated that the man, according to doctors, died of a heart attack. Autopsy performed on unknown date and results were not provided. Procedure: Fatal. The case was judged to be serious, death. No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : SE-PFIZER INC-2021908347 Same reporter/patient/product, different dose/event; Reported Cause(s) of Death: heart attack


VAERS ID: 1511451 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-05-23
   Days after vaccination:52
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral embolism (Previous event, date missing); Myocardial infarct (Previous event, date missing)
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202100940044

Write-up: CEREBRAL HAEMORRHAGE; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number SE-MPA-2021-061918. An 86-year-old female patient received second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 01Apr2021, as single dose (Lot Number: ET7205) for covid-19 immunisation. Medical history included myocardial infarction and cerebral embolism (previous event, date missing) from an unspecific date and not ongoing. According to the reporter the patient medical history was more extensive, but no more details about other illnesses were provided. The patient''s concomitant medications were not reported. The patient previously received first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 04Mar2021, as single dose (Lot number: EP2166) for covid-19 immunisation. The patient experienced cerebral haemorrhage on 23May2021 and had an onset of approximately 7 weeks and caused the patient death after some time in 2021. The outcome of event was fatal. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cerebral bleeding


VAERS ID: 1512092 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-06-23
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-27
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: DIAGLUCIDE; GLUCOPHAGE [METFORMIN]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetic
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC2021892166

Write-up: Shortness of breath; Body aches; Died; This is a spontaneous report from a contactable other healthcare professional. A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 11Jun2021 as dose 1, single for COVID-19 immunization. Medical history included diabetes mellitus from an unknown date. Concomitant medication included gliclazide (DIAGLUCIDE) and metformin (GLUCOPHAGE) both taken for diabetes mellitus, start and stop date were not reported. On 23Jun2021, the patient experienced shortness of breath and body aches which led to hospitalization on 24Jun2021 and with an unknown outcome. The patient was reported to have died on 27Jun2021. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Sender''s Comments: As there is limited information in the case provided, the causal association between the events "death, dyspnoea and pain" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Died


VAERS ID: 1512109 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-21
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 2021-07-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: COJNJFOC20210756365

Write-up: RESPIRATORY CARDIAC ARREST; This spontaneous report received from a health care professional concerned an 18 year old male patient. The patient''s height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown and Expiry: Unknown) dose, start therapy date were not reported 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-JUL-2021, the patient suffered respiratory cardiac arrest and died. Legal medicine has not provided autopsy reports but family suspected that this might be related to the application of the vaccine. An autopsy was performed on an unspecified date. The action taken with covid-19 vaccine was not applicable. The patient died of respiratory cardiac arrest. This report was serious (Death). Sender''s Comments: V0: 20210756365-covid-19 vaccine. Respiratory cardiac arrest. This event(s) is considered unassessable. The event(s) has an unknown/unclear 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: RESPIRATORY CARDIAC ARREST


VAERS ID: 1512126 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   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: Diabetes.
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of SUDDEN DEATH (Suddenly died at night after 11 days from the second dose. At the first dose diarrhea after 5 days and then dry but suffocating cough, unresponsive to antibiotic. Second dose taken on 05/31/2021 in an 86-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Diabetes. On an unknown date, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. The patient died on 01-May-2021. The reported cause of death was died suddenly at night after 11 days from the second dose to the first dose diarrhea after 5 days and then dry but suffocating cough, unresponsive to antibiotic. second dose 05/31/2021.... It is unknown if an autopsy was performed. Concomitant product use was not provided by the reporter. Treatment information was not provided. Company comment: Limited information regarding the death has been provided at this time and a causal relationship cannot be excluded. Event term, onset date and outcome captured per Authority reporting. Event seriousness per assessment by Authority and per IME list Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-up information received on 26 Jul 2021 included updates to patient''s medical history.; Sender''s Comments: Limited information regarding the death has been provided at this time and a causal relationship cannot be excluded. Event term, onset date and outcome captured per Authority reporting. Event seriousness per assessment by Authority and per IME list; Reported Cause(s) of Death: Suddenly died at night after 11 days from the second dose At the first dose diarrhea after 5 days and then dry but suffocating cough, unresponsive to antibiotic. Second dose taken on 05/31/2021.


VAERS ID: 1512142 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 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: 2021-07-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLOPIDOGREL; SPIRONOLACTONE; METOPROLOL; ESOMEPRAZOLE; HYDROCHLOROTHIAZIDE; APIXABAN; ATORVASTATINE [ATORVASTATIN]; LANOXIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLJNJFOC20210750739

Write-up: MR. DIED; This spontaneous report received from a physician via a Regulatory Authority [NL-LRB-00628059] concerned a 66 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD974 expiry: UNKNOWN) 0.5 ml, 1 dosage forms, 1 total, administered on 06-JUL-2021 for covid-19 immunisation. Concomitant medications included apixaban, atorvastatin, clopidogrel, digoxin, esomeprazole, hydrochlorothiazide, metoprolol, and spironolactone. On 14-JUL-2021, the patient died from sudden cardiac death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210750739-covid-19 vaccine ad26.cov2.s -Mr. died. 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: SUDDEN CARDIAC DEATH


VAERS ID: 1512149 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Altered state of consciousness
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes; Stroke; Urinary tract infection
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by an other and describes the occurrence of ALTERED STATE OF CONSCIOUSNESS (Change of consciousness) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Stroke, Diabetes and Urinary tract infection. On 02-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jul-2021, the patient experienced ALTERED STATE OF CONSCIOUSNESS (Change of consciousness) (seriousness criteria death and medically significant). The patient died on 02-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Concomitant product use was not provided. Treatment information was unknown. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown


VAERS ID: 1512158 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-08
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: Death; This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (Death) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 08-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 12-Jul-2021 The patient died on 12-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product was not provided by the reporter. Treatment information was not provided. Company Comment This is a case of sudden death of a 73yo F who died 4 days after receiving vaccine. Very limited information regarding the event has been provided at this time.; Sender''s Comments: This is a case of sudden death of a 73yo F who died 4 days after receiving vaccine. Very limited information regarding the event has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1512159 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-08
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Death, Heart rate
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic obstructive pulmonary disease; Hypertension (Hypertension with Losartan control); Type 2 diabetes mellitus (Type 2 diabetes mellitus with Glibudon control)
Preexisting Conditions: Medical History/Concurrent Conditions: Lung cancer (Stage IV with left side pleural effusi)
Allergies:
Diagnostic Lab Data: Test Date: 20210710; Test Name: BP; Result Unstructured Data: BP 158/91mmH; Test Date: 20210710; Test Name: body temperature; Test Date: 20210710; Test Name: heart rate
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: death; This regulatory authority case was reported by a pharmacist and describes the occurrence of DEATH (death) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lung cancer (Stage IV with left side pleural effusi). Concurrent medical conditions included Hypertension (Hypertension with Losartan control), Type 2 diabetes mellitus (Type 2 diabetes mellitus with Glibudon control) and Chronic obstructive pulmonary disease. On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on an unknown date 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): On 10-Jul-2021, Blood pressure measurement: (High) BP 158/91mmH. On 10-Jul-2021, Body temperature: 37.4. On 10-Jul-2021, Heart rate: 140. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. Heart Rate 140 falling outside ER, initial rhythm bradycardia, no pulse. Company Comment This is a case of sudden death in a male of unknown age with medical hx of stage 4 lung cancer, DM, HTN, and COPD, who died on unknown date after receiving the 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 male of unknown age with medical hx of stage 4 lung cancer, DM, HTN, and COPD, who died on unknown date after receiving the first dose of vaccine. Very limited information has been provided at this time; Reported Cause(s) of Death: unknown cuase of death


VAERS ID: 1512222 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-19
Onset:2021-06-24
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cognitive disorder, Concomitant disease aggravated, Decreased appetite, Inappropriate schedule of product administration, Lethargy
SMQs:, Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021894521

Write-up: 6 days (second dose), 65 days (first dose); Cognitive disorder; Concomitant disease aggravated; Decreased appetite; Lethargy; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. The regulatory authority report number is 581649. A 60-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on (Batch/Lot number was not reported) as DOSE 2, SINGLE and dose 1 via an unspecified route of administration on 21Apr2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient experienced Cognitive disorder; Concomitant disease aggravated; Decreased appetite; Lethargy on 24Jun2021 (onset 6 days (second dose), 65 days (first dose)). The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Cognitive disorder; Concomitant disease aggravated; Decreased appetite; Lethargy


VAERS ID: 1513233 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-07-07
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2090 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Cerebral haemorrhage, Cerebral thrombosis, Cerebrovascular accident, Coma, Computerised tomogram, Diarrhoea, Pyrexia, Sepsis, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-11
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MELOXICAM; OMEPRAZOLE; LEDERTREXATE [METHOTREXATE]; SIMPONI
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Psoriasis; Rheumatism
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:unknown; Test Name: ct scan; Result Unstructured Data: Test Result:unknown
CDC Split Type: BEPFIZER INC202100932163

Write-up: artificial coma; Cerebral hemorrhage; Sepsis; Cerebral thrombosis; CVA; high fever; Vomiting; Diarrhea; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority, regulatory authority number BE-FAMHP-DHH-N2021-101066. A 51-year-old male patient received bnt162b2 (COMIRNATY) via an unspecified route of administration on 25Jun2021 (Lot Number: Fe2090) as Dose 2, single for covid-19 immunisation. Medical history included psoriasis and rheumatism. Concomitant medications included meloxicam; omeprazole; methotrexate (LEDERTREXATE); golimumab (SIMPONI). The patient developed Cerebral thrombosis and CVA on 09Jul2021, Fever, Vomiting and Diarrhea on 07Jul2021, Coma, Cerebral hemorrhage, and Sepsis on unknown date. Treatment included Blood thinners and blood clot removal by interventional radiologist, artificial coma. Situations - Other: Immunosuppressant and Vaccine Combination. Examinations included Blood analysis, and CT scan. The outcome of the events was death. The patient died on 11Jul2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Treatment - Yes Blood thinners and blood clot removal by interventional radiologist, artificial coma Evolution of the ADR - death Situations - Other: Immunosuppressant and Vaccine Combination Examinations - Blood analysis, ct scan; Reported Cause(s) of Death: CVA; Fever; Vomiting; Diarrhea; Coma; Cerebral hemorrhage; Sepsis; Cerebral thrombosis


VAERS ID: 1513282 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-09
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8889 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Blood creatine, Blood creatine phosphokinase MB, Blood glucose, Blood urea, C-reactive protein, Cardiac failure acute, Dyspnoea, Epistaxis, Fatigue, Fibrin D dimer, Glomerular filtration rate, Haematocrit, Haemoglobin, Hypotension, N-terminal prohormone brain natriuretic peptide, Platelet count, Red blood cell count, Respiratory rate, Troponin T, White blood cell count
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Arthritis (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-16
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ALLOPURINOL; ZOPICLONE; APIXABAN
Current Illness: Aortic aneurysm; Aortic valve insufficiency; Cardiac insufficiency; Chronic ischemic heart disease, unspecified; Hypertensive heart disease; Left ventricular failure
Preexisting Conditions: Medical History/Concurrent Conditions: TAVI
Allergies:
Diagnostic Lab Data: Test Date: 20210616; Test Name: Creatine; Result Unstructured Data: Test Result:213 umol/l; Test Date: 20210616; Test Name: CK-MB; Result Unstructured Data: Test Result:9.46 ug/L; Test Date: 20210616; Test Name: Fasting blood glucose; Result Unstructured Data: Test Result:8.8 mmol/L; Test Date: 20210616; Test Name: Urea; Result Unstructured Data: Test Result:7.3 mmol/L; Test Date: 20210616; Test Name: C-reactive protein; Result Unstructured Data: Test Result:23 mg/ml; Test Date: 20210616; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:0.83 mg/l; Test Date: 20210616; Test Name: Estimated GFR; Result Unstructured Data: Test Result:26; Comments: Units:mL/min/{1.73_m2}; Test Date: 20210616; Test Name: Hematocrit; Test Result: 33 %; Comments: Units:{ratio}; Test Date: 20210616; Test Name: Hemoglobin; Result Unstructured Data: Test Result:101 g/l; Test Date: 20210616; Test Name: NT-proBNP; Result Unstructured Data: Test Result:7327 ng/L; Test Date: 20210616; Test Name: Platelet count; Result Unstructured Data: Test Result:283 x10 9/l; Test Date: 20210616; Test Name: RBC count; Result Unstructured Data: Test Result:3.4 x10 12/l; Test Date: 20210616; Test Name: Respiratory rate; Result Unstructured Data: Test Result:on arrival at normal; Test Date: 20210616; Test Name: Respiratory rate; Result Unstructured Data: Test Result:122/81; Comments: Respiratory rate 122/81, frequency 129 x min; Test Date: 20210616; Test Name: Respiratory rate; Result Unstructured Data: Test Result:69/44; Comments: At 11:32 - Respiratory rate 69/44, frequency 109 x min; Test Date: 20210616; Test Name: Troponin T; Result Unstructured Data: Test Result:108.2 ng/L; Test Date: 20210616; Test Name: WBC count; Result Unstructured Data: Test Result:11.3 x10 9/l
CDC Split Type: EEPFIZER INC202100932399

Write-up: Acute decompensated heart failure; Hypotension; Fatigue; Arthralgia; Dyspnoea; Asthenia; Epistaxis; This is a spontaneous report from a contactable consumer (patient''s relative), downloaded from the regulatory authority-WEB, regulatory authority number EE-SAM-438621070521. This spontaneous case report from patient''s relative concerns a 70-year-old male patient who experienced adverse reactions after vaccination with COVID-19 mRNA vaccine. The patient was vaccinated with the second dose of Comirnaty vaccine (lot number FC8889) on 02Jun2021 (age at vaccination unspecified). One week later developed nosebleeds, weakness and tiredness, pain in the knees, difficulty breathing, very low blood pressure. The side effects did not go away, rather the patient felt weaker and weaker. On the morning of 16Jun2021, an ambulance was called and around the same day at noon the patient died in hospital. The patient had previously had an transcatheter aortic valve implantation on 14May2021, which was successful and the patient recovered very quickly after the operation and felt great. The patient was taking allopurinol, apixaban, zopiclone. Anamnesis. On 16Jun2021 08:54, the patient was brought by an ambulance: had heart palpitations for 3 days, shortness of breath, dyspnoea 30 x min. Upon arrival, the patient does not complain of pain, later begins to complain of pain in the right and left sides of the upper abdomen. Respiratory rate on arrival at normal, tachyfrequent. While in the emergency room, breathing became rumbling, on the right side of the lung crackles, respiratory rate decreased, the patient was covered with cold sweat. Asystole occured. Resuscitation was started + cardiac massage. Upon arrival of the anesthesiologist, the patient was intubated, subcutaneous Adrenaline 1 mg x 3, subcutaneous NaBic 8.4% 100.0 was administered. Restored sinus rhythm - after 10 min. Respiratory rate 122/81, frequency 129 x min. At 11:32 - Respiratory rate 69/44, frequency 109 x min. subcutaneous Atropin 1 mg, subcutaneous Adrenaline 2 mg was administered by an anesthesiologist. No respiratory rate, cardiac arrest. Circulation was not restored despite vasopressors and controlled breathing. Lethal outcome at 11:50. Underlying disease: heart failure, left ventricular failure. Concomitant conditions: hypertensive heart disease, chronic ischemic heart disease, aortic (valve) insufficiency; aortic aneurysm, presence of a heart valve prosthesis. Analyses on 16Jun2021: CK-Mbm 9.46 microg/l; CRP 23 mg/ml; D-dimers 0.83 mg/l; eGFR 26 ml/min/1.73 m2; fasting glucose serum/plasma 8.8 mmol/l; WBC 11.3*E9/l; RBC 3.4*E12/l; Hb 101 g/l; Hct 33%; Plt 283*E9/l; creatine 213 umol/l; Nt-proBNP 7327 ng/l; troponin T (hypersensitive) 108.2 ng/l; urea 7.3 mmol/l. On 09Jul2021 additional information from patient''s general practitioner. Cause of death: heart failure, left ventricular failure. Time Interval between Beginning of Drug Administration and Start of Reaction: 1 week for events: Hypotension, Fatigue, arthralgia, Dyspnoea, Asthenia, Epistaxis; 2 weeks for events: Acute decompensated heart failure, Death Sender Comment: Serious side effects, not listed. The causal relationship is considered doubtful because no autopsy was performed and the exact cause of cardiogenic shock is unknown. The patient also has a long-term heart disease, which better explains the decompensation of his heart failure. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Left ventricular failure; Heart failure


VAERS ID: 1513326 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Computerised tomogram head, Haemorrhagic stroke, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-13
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ADENURIC; CANDESARTAN CILEXETIL; LERCANIDIPINE HCL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Date: 20210703; Test Name: blood pressure; Result Unstructured Data: Test Result:157/78 mmHg; Test Date: 20210703; Test Name: cerebral CT; Result Unstructured Data: Test Result:objectifying a hematoma of the brainstem; Comments: with edema of 33x19mm in the axial plane, and 28mm in height, extended to the midbrain, the left cerebral peduncle and the left cerebral hemisphere.; Test Name: PCR COVID-19; Test Result: Negative
CDC Split Type: FRPFIZER INC202100932169

Write-up: Haemorrhagic stroke; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-AM20212038. A 44-year-old male patient received the 2nd dose of BNT162B2 (COMIRNATY, lot number: unknown) intramuscular on 03Jul2021 at age of 44 years old as single dose for COVID-19 immunisation. Medical history included hypertension arterial. The patient had no history of COVID-19. PCR COVID-19 negative. Concomitant medications included febuxostat (ADENURIC), candesartan cilexetil, lercanidipine HCL. The patient experienced hemorrhagic stroke on 03Jul2021. In the evening of the same day, altered consciousness with malaise, preceded by speech disturbances and facial paralysis. When help arrived, Glasgow 6, mydriasis on the left, miosis on the right. Orotracheal sedation and intubation. Persistent hypertension (blood pressure figures not provided), requiring 3 boluses of LOXEN. Blood pressure to 157 / 78mmHg thereafter. Hospitalization and performance of a cerebral computed tomography, objectifying a hematoma of the brainstem with edema of 33x19mm in the axial plane, and 28mm in height, extended to the midbrain, the left cerebral peduncle and the left cerebral hemisphere. No sign of engagement, no image of arterial addition suggesting an aneurysm. No surgical indication retained in this context of hemorrhagic stroke. Stop sedations on 05Jul2021. Glasgow at 4 on 08Jul. Evolution marked by Pneumopathy acquired under mechanical ventilation on 09Jul2021. Faced with the lack of improvement after stopping sedations, limiting and stopping active therapies on 12Jul2021. Death on 13Jul2021. In total, hemorrhagic stroke occurred on the same day as a 2nd dose of BNT162B2 vaccine on hypertensive flare, patient died on D + 10. It was unknown if autopsy was performed. The patient died on 13Jul2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Reported Cause(s) of Death: Haemorrhagic stroke


VAERS ID: 1513328 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3558 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Death, Fatigue, Inappropriate schedule of product administration, Malaise, Myalgia, Somnolence
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202100932121

Write-up: Malaise; Death NOS; drowsiness; Chills; Fatigue; muscle pain; joint pain; First dose of bnt162b2 on 24May2021/ Second dose of bnt162b2 on 08Jul2021; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB FR-AFSSAPS-CF20212056. The reporter was report for the mother. A 71-year-old female patient received bnt162b2 (COMIRNATY, Batch/Lot Number: FC3558), second dose intramuscular on 08Jul2021 at the age of 71-year-old as single dose for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient previous received first dose of bnt162b2 (COMIRNATY, Batch/Lot Number: FE 1248) on 24May2021 for covid-19 immunization. The patient didn''t have long-term illness. The patient had no history of drug allergy. The patient experienced death nos on 12Jul2021, drowsiness, chills, fatigue, muscle pain, joint pain all on 08Jul2021, malaise on an unspecified date. The events were reported as serious per hospitalization. The mother died on 12Jul2021. From 08Jul2021 to 11Jul2021 chills, fatigue, muscle pain, joint pain, drowsiness. Death on 12Jul2021. Malaise on an unspecified date. The patient went to medical consultation. The patient died on 12Jul2021. It was not reported if an autopsy was performed. The outcome of other events was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death NOS


VAERS ID: 1513330 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-05-27
   Days after vaccination:99
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Blood potassium, Blood pressure measurement, C-reactive protein, COVID-19, Culture stool, Diarrhoea, Fall, Glomerular filtration rate, Haemoglobin, Heart rate, Hyperhidrosis, Investigation, Oxygen saturation, Pain, Physical examination, Platelet count, SARS-CoV-2 test, Scan brain, Vaccination failure, White blood cell count
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-03
   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: ALPRAZOLAM; DEXERYL [CHLORPHENAMINE MALEATE;DEXTROMETHORPHAN HYDROBROMIDE;GUAIFENESIN;PHENYLEPHRINE HYDROCHLORID; INNOHEP; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; NEO-MERCAZOLE; NORMACOL [SODIUM PHOSPH
Current Illness: Bipolar disorder (Manic-depressive illness (several hospitalizations in psychiatry)); Chronic renal failure (Chronic renal failure); Chronic venous insufficiency; Cyst ovary; Deafness (paired on the right); Dementia (Beginning neurocognitive disorders with probable vascular etiology); Elephantiasis; Essential hypertension (primitive); Lumbar spinal stenosis (level L4-L5 with history of sciatica); Uterine fibroid
Preexisting Conditions: Medical History/Concurrent Conditions: Cataract (processed); Cholecystectomy; Constipation; Faecaloma; Hip prosthesis insertion; Inguinal hernia repair; Retention urinary (on fecal impaction (Indwelling urinary catheters removal)); Senile macular degeneration (Very disabling senile (atrophic) (exudative) macular degeneration); Varicose vein operation
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: Creatinine; Result Unstructured Data: Test Result:326 umol/l; Comments: there is end-stage renal failure with creatinine at 326 umol/l; Test Date: 20210601; Test Name: serum potassium; Result Unstructured Data: Test Result:4.3 mmol/L; Test Date: 20210601; Test Name: Blood pressure; Result Unstructured Data: Test Result:9/5; Test Date: 20210601; Test Name: CRP; Result Unstructured Data: Test Result:100 mg/l; Test Date: 2021; Test Name: stool culture; Result Unstructured Data: Test Result:absence of clostridium; Comments: Note the absence of clostridium in the stool culture; Test Date: 20210601; Test Name: GFR; Result Unstructured Data: Test Result:10 ml/min; Test Date: 20210601; Test Name: hemoglobin; Result Unstructured Data: Test Result:8.4 g/dl; Test Date: 20210601; Test Name: pulse; Result Unstructured Data: Test Result:89; Comments: pulse 89 bpm; Test Date: 20210601; Test Name: serum content; Result Unstructured Data: Test Result:139 mmol/L; Test Date: 20210528; Test Name: saturation; Test Result: 94 %; Test Date: 20210601; Test Name: saturation; Test Result: 97 %; Test Date: 20210601; Test Name: Physical examination; Result Unstructured Data: Test Result:does not present dyspnea; Comments: The patient does not present dyspnea and the pulmonary auscultation is unremarkable. She has mucus and smelly diarrhea.; Test Date: 20210601; Test Name: platelets; Result Unstructured Data: Test Result:273,000 /mm3; Test Date: 20210521; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210528; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Detection of the Spike N501Y mutation. Profile compatible with the English variant 501Y.V1.; Test Date: 20210601; Test Name: brain scan; Result Unstructured Data: Test Result:unremarkable; Comments: The brain scan performed in the hospital is unremarkable.; Test Date: 20210601; Test Name: leukocytes; Result Unstructured Data: Test Result:19,340 /mm3
CDC Split Type: FRPFIZER INC202100915606

Write-up: fall of mechanical origin; painful; sweats a lot; mucus and smelly diarrhea; Vaccination failure; COVID-19; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number FR-AFSSAPS-DJ20212547. Verbatim: Statement from an ARS doctor in the context of a cluster of vaccine failures in nursing homes. Related cases: DJ20212545; DJ20212542; DJ20212584; DJ20212580; DJ20212572; DJ20212569; DJ20212564; DJ20212561; DJ20212559; DJ20212554; DJ20212551. A 97-years-old female patient received bnt162b2 (COMIRNATY, formulation: Solution for injection, Lot number: EK9788; Expiration Date: 31May2021), via intramuscular route on 17Feb2021 as dose 2, single and received first dose of bnt162b2 (COMIRNATY, formulation: Solution for injection, Lot Number: EJ6788; Expiration Date: 30Apr2021), via intramuscular route on 27Jan2021, as dose 1, single for covid-19 immunization. Medical history included Dementia: Beginning neurocognitive disorders with a probable vascular etiology, Senile (atrophic) (exudative) macular degeneration very debilitating, retention urinary (Urine retention on fecaloma (Indwelling urinary catheterization removal), Constipation and fecaloma, Chronic venous insufficiency with elephantiasis, chronic renal failure, Uterine fibroid, Cholecystectomy, Bipolar disorder (Manic-depressive illness (several hospitalizations in psychiatry), Cataract treatment, Primary essential hypertension, Hip prosthesis insertion, ovarian cyst, right-sided deafness, Lumbar spinal stenosis (Narrowing of the medullary canal in the lumbar region (level L4-L5 with history of sciatica), Treatment of a groin hernia (Inguinal hernia repair) and Varicose vein surgery. Concomitant medications included alprazolam (Strength: 0.25 mg, dose: 1 / -1 / 2-1); chlorphenamine maleate, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride (DEXERYL); tinzaparin sodium (INNOHEP, Strength: 10000/0.5 mL, dose: 5000 iU, 1x/day in the evening); macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL); carbimazole (NEO-MERCAZOLE, Strength: 5 mg, dose: 1 DF, 2x/day 1-0-1); sodium phosphate dibasic, sodium phosphate dibasic dodecahydrate (NORMACOL); morphine sulfate (ORAMORPH); paracetamol; ferrous sulfate (TARDYFERON, strength: 80 mg, 1 DF, 1x/day 0-1-0); lithium carbonate (TERALITHE, Strength: 400 mg, dose: 1 DF, 1x/day 0-0-1) and acebutolol (Strength: 200 mg, dose: 0.5 DF, 1x/day 0-0-1/2), all taken for unspecified indications, start and stop dates were not reported. On 27May2021, the patient fall of mechanical origin at her daughter''s place and the patient was transported to hospital. There was a fracture of the pelvis according to the emergency doctor with instructions not to take support for 15 days. The seriousness criteria captured as hospitalization. On 28May2021, the patient underwent a COVID-19 RT-PCR test which was positive (significant viral shedding). Detection of the Spike N501Y mutation. Profile compatible with the English variant 501Y.V1 (Vaccination failure). Clinically, pulmonary auscultation was unremarkable and 94% SaO2. COVID-19 isolation was done. On 31May2021, the patient was prostrate in her bed in opposition, she refused to eat, drink and take her treatments. On 01Jun2021, in the morning, the patient was not very reactive and her blood pressure was 9/5, pulse 89 bpm, SPO2 97%. The patient did not present dyspnea and the pulmonary auscultation was unremarkable. The brain scan performed in the hospital was unremarkable. She had mucus and smelly diarrhea. Biology showed hemoglobin at 8.4 g / dl, leukocytes at 19,340 / mm3, CRP was at 100 mg/l, platelets at 273,000/mm3, there was end-stage renal failure with creatinine at 326 umol/l and a GFR at 10 ml / min. The serum content is 139 mmol / l and the serum potassium 4.3 mmol / l. When her daughters were present, the patient managed to swallow, she drinks little. She agreed with her daughters on palliative care at the EHPAD and no hospitalization. Oral treatments were stopped except alprazolam as well as HBPM (clearance). The patient was infused with G5%. On 02Jun2021, the patient was painful during treatment and sweats a lot (suspected to be withdrawal from treatment), prompting the prescription of 2 drops of ORAMORPH before treatment and if necessary, every 4 hours. On 03Jun2021, the patient''s death was noted. Note the absence of clostridium in the stool culture. In total, 97-year-old patient who presented with a confirmed vaccine failure with the detection of the English variant in the RT-PCR test on D100 of a 2nd dose of COMIRNATY vaccine and who might have played a role in the patient''s death. The patient also underwent COVID-19 RT-PCR test on 21May2021, which case out to be negative. The outcome of the events: COVID-19 and vaccination failure were fatal and the outcome of rest of the events was unknown. Investigation conclusion: (Lot number: EK9788, Expiration Date: 31May2021) Conclusion: The investigation included reviewing the involved batch records, deviation investigation and 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 EK9788. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. 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) : FR-PFIZER INC-202100915615 same reporter. different patient;FR-PFIZER INC-202100915619 same reporter. different patient;FR-PFIZER INC-202100921915 same patient, different dose, different events;FR-PFIZER INC-202100915193 Same reporter, different patient;FR-PFIZER INC-202100915253 Same reporter, different patient;FR-PFIZER INC-202100915233 Same reporter, different patient;FR-PFIZER INC-202100915226 Same reporter, different patient;FR-PFIZER INC-202100915221 Same reporter, different patient;FR-PFIZER INC-202100915870 Same reporter, different patient;FR-PFIZER INC-202100915259 Same reporter, different patient;FR-PFIZER INC-202100915861 Same reporter, different patient;FR-PFIZER INC-202100915239 Same reporter, different patient; Reported Cause(s) of Death: COVID-19


VAERS ID: 1513558 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-07-11
   Days after vaccination:101
Submitted: 0000-00-00
Entered: 2021-07-29
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: 2021-07-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021900255

Write-up: Sudden death; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107141750038190-M84YD, and Safety Report Unique Identifier is GB-MHRA-ADR 25650882. A 72-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Apr2021 (batch/lot number: not known) as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. It was unsure if patient is enrolled in clinical trial. Patient has not had symptoms associated with COVID-19 and has not had a COVID-19 test. The patient experienced sudden death on 11Jul2021 with outcome of fatal. The event was considered serious (fatal). The patient died on 11Jul2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: sudden death


VAERS ID: 1513717 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocardial infarction, SARS-CoV-2 test
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALLOPURINOL; EMPAGLIFLOZIN; NITROLINGUAL; RISPERIDONE; SERTRALINE
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 INC2021906787

Write-up: Heart attack; This is a spontaneous report from a contactable consumer received from the Medicines and Healthcare products Regulatory Agency (MHRA).The regulatory authority report number is GB-MHRA-WEBCOVID-202107151400228600-UZ7JG Safety Report Unique Identifier GB-MHRA-ADR 25656841. The 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported) via an unspecified route of administration on an unspecified date in 2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history was not reported. The concomitant medications included allopurinol (ALLOPURINOL); empagliflozin (EMPAGLIFLOZIN); glyceryl trinitrate (NITROLINGUAL); risperidone (RISPERIDONE); sertraline (SERTRALINE). Patient did not have symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient experienced heart attack on an unspecified date. On 15May2021 the patient died. It was not reported if an autopsy was performed. The patient underwent lab tests and procedures which included Covid-19 virus test and results showed negative on No - Negative COVID-19 test. No follow-up attempts are possible, Information about batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Heart attack


VAERS ID: 1513830 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-20
Onset:2021-06-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8289 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal death, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (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: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100918442

Write-up: Maternal exposure during pregnancy; passed fetus; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107151745184040-DBXBI, Safety Report Unique Identifier GB-MHRA-ADR 25658593. This consumer reported information for both mother and fetus. This is a fetus report. A fetus patient of unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via transplacental on 20Jun2021 (Lot Number: FC8289) as single dose for COVID-19 immunisation. The patient medical history included folic acid supplementation. The patient''s mother was 34-year-old female who received dose 1 of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FC8289) on 20Jun2021 for COVID-19 immunisation. The mother''s medical history included pregnancy and folic acid supplementation. Concomitant medication included folic acid taken for folic acid supplementation, start and stop date were not reported. The patient experienced passed fetus in 2021 and maternal exposure during pregnancy on 20Jun2021. Patient was exposed to the medicine first-trimester (1-12 weeks). The case was reported as serious due to other medically important condition. The patient died in 2021. It was not reported if an autopsy was performed. Outcome of events was fatal. No follow up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-2021906841 maternal case; Reported Cause(s) of Death: Maternal exposure during pregnancy; passed fetus


VAERS ID: 1513849 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-06-20
   Days after vaccination:46
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral ischaemia
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: 2021-06-24
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC202100932182

Write-up: Ischaemia cerebral; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority, regulatory authority number GR-GREOF-20216008. A 71-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 05May2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced ischaemia cerebral (death, medically significant) on 20Jun2021. The patient died on 24Jun2021. Outcome of the event was fatal. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: ischaemia cerebral


VAERS ID: 1513850 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-11
Onset:2021-04-23
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Cerebrovascular accident
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC202100932198

Write-up: cardiac arrest; Stroke; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority, regulatory authority number GR-GREOF-20216011. A 74-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 11Apr2021 as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced stroke on 23Apr2021, cardiac arrest on an unknown date. The patient died on 28Apr2021. This report assessed as serious, medically significant and caused death. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest; stroke


VAERS ID: 1513873 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC202100962750

Write-up: brain hemorrhage; This is a spontaneous report from a contactable physician through another manufacturer (Bayer). The physician reported similar events for two patients. This is the first of two reports. An 85-years-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization and rivaroxaban (XARELTO), via an unspecified route of administration from an unspecified date for about 6 months (Batch/Lot number was not reported) to an unspecified date, at 20 mg for atrial fibrillation. Relevant medical history included atrial fibrillation from an unknown date. The patient''s concomitant medications were not reported. The patient received his rivaroxaban dose, and on that day 6 hours later got vaccinated with the first dose of bnt162b2. On an unknown date the patient experienced brain haemorrhage and passed away. The action taken with rivaroxaban was not applicable. The patient died on an unknown date. The cause of death was brain haemorrhage. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about batch number cannot be obtained.; Sender''s Comments: The association between the event fatal brain hemorrhage with COMIRNATY use can not be fully excluded based on the limited information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : GR-PFIZER INC-202100965567 same reporter, drug,event, different patient; Reported Cause(s) of Death: brain haemorrhage


VAERS ID: 1513874 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-21
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC202100965567

Write-up: brain hemorrhage; This is a spontaneous report from a contactable physician through another manufacturer. The physician reported similar events for two patients. This is the second of two reports. An 80-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 21Jul2021 (Batch/Lot number was not reported) as Dose 2, single for COVID-19 immunization and rivaroxaban (XARELTO), via an unspecified route of administration from an unspecified date for about 2 years (Batch/Lot number was not reported), at 20 mg for atrial fibrillation. Relevant medical history included atrial fibrillation. The patient''s concomitant medications were not reported. The patient previously received bnt162b2 (COMIRNATY), dose 1 on an unknown date for COVID-19 immunization. The patient received his rivaroxaban dose, and 12 hours later got vaccinated with the second dose. On an unknown date the patient experienced brain haemorrhage and passed away. The action taken with rivaroxaban was not applicable. The patient died on an unknown date. The cause of death was brain haemorrhage. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about batch number cannot be obtained.; Sender''s Comments: The association between the event fatal brain hemorrhage with COMIRNATY use can not be fully excluded based on the limited information available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : GR-PFIZER INC-202100962750 same reporter, drug,event, different patient; Reported Cause(s) of Death: brain haemorrhage


VAERS ID: 1513918 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-05-11
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001650 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes mellitus; Hypertension; Ischemic heart disease; Kidney failure chronic
Preexisting Conditions: Medical History/Concurrent Conditions: Congestive heart failure
Allergies:
Diagnostic Lab Data: Test Date: 20210505; Test Name: COVID-19 antigen test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 antigen test; Test Date: 20210505; Test Name: COVID-19 PCR test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 PCR test; Test Date: 20210506; Test Name: COVID-19 PCR test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 PCR test
CDC Split Type: HUMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH in a 54-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 3001650 and 3001946) for COVID-19 vaccination. The patient''s past medical history included Congestive heart failure. Concurrent medical conditions included Kidney failure chronic, Diabetes mellitus since 2010, Hypertension and Ischemic heart disease. On 07-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. Death occurred on 11-May-2021 The patient died on 11-May-2021. The reported cause of death was Congestive heart failure. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 antigen test and negative (Negative) Negative COVID-19 PCR test. On 06-May-2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 PCR test. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered DEATH to be not related. Concomitant product use was not provided by the reporter. No treatment information was provided. Sender''s comments: The reporter physician assessed the event as not related to the suspected vaccine. The case was considered serious because the outcome was fatal. Further information was not expected. This a report of death 7 days after receiving the second dose of the product in a 54-years old multimorbidity patient. Although a temporal association exists, there are important confounders/co-suspects for the event, and death certificate states congestive heart failure (a pre-existing condition) as cause of death. Very limited information regarding the events has been provided for inferring causality. Further information is not expected.; Sender''s Comments: This a report of death 7 days after receiving the second dose of the product in a 54-years old multimorbidity patient. Although a temporal association exists, there are important confounders/co-suspects for the event, and death certificate states congestive heart failure (a pre-existing condition) as cause of death. Very limited information regarding the events has been provided for inferring causality. Further information is not expected.; Reported Cause(s) of Death: Congestive heart failure


VAERS ID: 1513940 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-02-26
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-10
   Days after onset: 42
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: ITPFIZER INC202100939373

Write-up: large brain hematoma; hemiparesis; ''... likely thrombotic events'' of the right middle cerebral artery; red infarct; ''... likely thrombotic events'' of the right middle cerebral artery; red infarct; This is a spontaneous report from a contactable consumer or other non-healthcare professional downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-755053. A 90-year-old male patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EL0725, Expiration date not reported), via intramuscular, administered in deltoid left on 17Feb2021 15:51 (at the age of 90-year-old) at 0.3 mL as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced thrombotic events of the right middle cerebral artery and red infarction on 26Feb2021. According to the reporter (daughter), who lives in a nursing home reported that on 26Feb2021, the patient had a hemiparesis which required the patient to be admitted to the neurology department (for 3 weeks) and where large brain hematoma was diagnosed. Discharged at the end of March, the patient had registered a marked improvement in paresis. He contracted the covid in the facility where the patient was resided. He was hospitalized again. The duration of the symptoms manifested by the patient was 44 days. The patient passed away on 10Apr2021. It was not reported if an autopsy was performed. The outcome of the events likely thrombotic events of the right middle cerebral artery, red infarction was fatal. The outcome for other events was unknown. Sender''s comments: The reporter was contacted for further information. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: ''... likely thrombotic events'' of the right middle cerebral artery; red infarct; ''... likely thrombotic events'' of the right middle cerebral artery; red infarct


VAERS ID: 1513946 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-06-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5089 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-26
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ischemic stroke
Allergies:
Diagnostic Lab Data: Test Name: blood chemistry tests; Result Unstructured Data: Test Result:normal signs of inflammation and coagulation...; Comments: ...factors; Test Name: reports a temperature; Result Unstructured Data: Test Result:40.5 Centigrade; Comments: degrees
CDC Split Type: ITPFIZER INC202100948746

Write-up: index of inflammation and coagulation within the limits followed by sudden hyperpyrexia not responsive to therapy; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-757692. A 78-years-old female patient received bnt162b2 (COMIRNATY, solution for injection), dose 1 intramuscular, administered in Deltoid Left on 22Jun2021 17:14 (at the age of 78 years old) (Batch/Lot Number: FC5089) as dose 1, 0.3 ml, single for COVID-19 immunisation. Medical history included ischemic stroke.The patient''s concomitant medications were not reported. On 22Jun2021, the same day of vaccination, the patient experienced hyperpyrexia (the reporter reports a temperature of 40.5 degrees) she does not respond to any antipyretic treatment. Index of inflammation and coagulation within the limits followed by sudden hyperpyrexia not responsive to therapy. The patient has undergone blood chemistry tests which reveal normal signs of inflammation and coagulation factors. On 25Jun the patient is transferred with 118 to the infectious diseases department and she dies the next day. The patient was staying in a rehabilitation center due to a previous ischemic stroke. Therapeutic measures were taken as a result of the event. The patient underwent lab tests and procedures which included blood chemistry tests: normal signs of inflammation and coagulation on an unspecified date, reports a temperature: 40.5 centigrade on an unspecified date. The outcome of the event was fatal. The patient died on 26Jun2021. It was not reported if an autopsy was performed. Reporter Comment: Vaccination in a patient with rehabilitation hospitalization code 56 for ischemic stroke outcomes. Sender Comment: The reporter has been contacted to find some information. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Vaccination in a patient with rehabilitation hospitalization code 56 for ischemic stroke outcomes; Sender''s Comments: The reported event ?hyperpyrexia'' was confirmed with temperature value below 41.5?C, a value which, from a medical point of view is not consistent with ?hyperpyrexia''. The Company therefore coded this event as ?pyrexia''.; Reported Cause(s) of Death: Unknown; index of inflammation and coagulation within the limits followed by sudden hyperpyrexia not responsive to therapy


VAERS ID: 1513947 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-07-02
   Days after vaccination:107
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-14
   Days after onset: 12
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: DIBASE; DUOPLAVIN; EZEQUA; SINEMET; BIFRIL [ZOFENOPRIL]; CARDICOR; PEPTAZOL [PANTOPRAZOLE]; DIURESIX [TORASEMIDE]; DOMPERIDONE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202107; Test Name: CT scan; Result Unstructured Data: Test Result:not provided; Test Date: 20210706; Test Name: positive sarscov2 pcr swab; Result Unstructured Data: Test Result:positive
CDC Split Type: ITPFIZER INC202100948938

Write-up: Fever, bilateral pneumonia, positive SarsCov2 PCR swab. Vaccination failure; Fever, bilateral pneumonia, positive SarsCov2 PCR swab. Vaccination failure; Covid-19; Fever, bilateral pneumonia, positive SarsCov2 PCR swab. Vaccination failure; This is as spontaneous report received from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is IT-MINISAL02-757760. A 85-years-old female patient received second dose of bnt162b2 (COMIRNATY, solution for injection), intramuscular on 17Mar2021 (Batch/Lot Number: ET1831; Expiration Date: 30Jun2021) as dose 2, 0.3ml single and received first dose of intramuscular on 19Feb2021 (Batch/Lot Number: EJ790; Expiration Date: 31May2021) as dose 1, 0.3ml single for covid-19 immunization.Medical history was not reported.Concomitant medications included colecalciferol (DIBASE); acetylsalicylic acid, clopidogrel bisulfate (DUOPLAVIN) ;duloxetine hydrochloride (EZEQUA); carbidopa monohydrate, levodopa (SINEMET); zofenopril (BIFRIL [ZOFENOPRIL]); bisoprolol fumarate (CARDICOR); pantoprazole (PEPTAZOL [PANTOPRAZOLE]); torasemide (DIURESIX [TORASEMIDE]); domperidone (DOMPERIDONE). On 02Jul2021, the patient experienced Fever, Covid-19, bilateral pneumonia and vaccination failure. On 06Jul2021, patient had positive SarsCov2 PCR swab. It was reported that patient had close contact with confirmed case of covid19 on 28Jun2021 and had onset of fever on 02jul2021, positive swab for covid19 on 06jul2021. There was worsening of the clinical picture up to the need for hospitalization for reported bilateral pneumonia so far patient have not had access to the chest CT scan performed in the hospital and subsequent death on 14Jul2021. There was reporting on suspected therapeutic failure of the vaccine. Therapeutic actions taken included antipyretic and antibiotic therapy, then hospitalization required. On 14Jul2021, the patient died. It was unknown whether autopsy was performed or not. Reporter''s comment: chronic therapy: dibase, duoplavin, ezequa, sinemet, bifril, cardicor, peptazol, diuresix, domperidone, Sender''s comment: 20Jul: Sender''s comments: First dose batch: EJ790; Second dose batch: ET1831 No follow-up attempts possible. No further information expected. Information on lot# already obtained.; Reported Cause(s) of Death: suspected bilateral pneumonia


VAERS ID: 1513951 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-13
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0688 / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute coronary syndrome, Troponin
SMQs:, Myocardial infarction (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-13
   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: Diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: Troponin; Result Unstructured Data: Test Result:no results
CDC Split Type: ITPFIZER INC202100939315

Write-up: acute coronary syndrome Non-ST elevation myocardial infarction; This is a spontaneous report from a contactable physician downloaded from the regulatory authority with regulatory authority number IT-MINISAL02-759111. A 59-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: FF0688) via intramuscularly administered in Arm Left on 10Jul2021 (Batch/Lot Number: FF0688) as Dose Number Unknown, 0.3 mL Single for covid-19 immunization. Medical history included diabetes mellitus from 12Jul2021 to an unknown date. The patient''s concomitant medications were not reported. The patient experienced acute coronary syndrome non-st elevation myocardial infarction (death, medically significant) on 13Jul2021. The patient underwent lab tests and procedures which included troponin: no results provided on 14Jul2021. Therapeutic measures were taken as a result of acute coronary syndrome non-st elevation myocardial infarction. The patient died on 13Jul2021. It was not reported if an autopsy was performed. The outcome of event was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: acute coronary syndrome Non-ST elevation myocardial infarction


VAERS ID: 1513955 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-29
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: ITPFIZER INC202100916408

Write-up: three people in apparent good health, about 50, died 24 h after the administration of the Comirnaty vaccine; This is a spontaneous report from a contactable physician through a company representative. The physician reported safety information for three patients. This is the first out of three cases. A adult patient of an unspecified gender received BNT162B2 (COMIRNATY; Solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as Dose number Unknown, Single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On an unknown date, it was reported by the physician that in the last two weeks (the last case yesterday) three people in apparent good health, about 50, died 24 h after the administration of the Comirnaty vaccine. The event occurred after using the product. They were waiting for the results of autopsies. The patient died on an unspecified date. The clinical outcome of the event was fatal.; Sender''s Comments: As there is limited information in the case provided, the causal association between the event of death and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer 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: 1513956 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-29
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: ITPFIZER INC202100916580

Write-up: three people in apparent good health, about 50, died 24 h after the administration of the Comirnaty vaccine; This is a spontaneous report from a contactable physician via a company representative. The physician reported safety information for three patients. This is the third out of three cases. An adult patient of an unspecified gender received BNT162B2 (COMIRNATY, Solution for injection, Lot number- unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The physician reported that in the last two weeks, the last case yesterday (as reported) three people in apparent good health, about 50, died 24 hours after the administration of the Comirnaty vaccine. The event occurred after using the product. The patient died on an unspecified date and cause of death was unspecified. The autopsy was performed, and they were waiting for the results of autopsies. Nothing more than what was previously communicated to the reporter.; Sender''s Comments: As there is limited information in the case provided, the causal association between the event of death and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer 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: 1513957 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocardial ischaemia
SMQs:, Other ischaemic heart disease (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: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100909766

Write-up: Myocardium color changed to white; This is a spontaneous report from a contactable physician received from a sales representative. A 59-year-old male patient received first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number was not reported, Expiration date was not reported) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. Body temperature before vaccination and family history were not reported. Medical history included mild hypertension. Concomitant medications were not reported. On an unknown date at an unknown time (2 days after the vaccination), the patient experienced myocardium color changed to white. On an unknown date (2 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On an unknown date, the patient received the first dose of COMIRNATY at a mass inoculation venue. On the following day, the patient was well. On an unknown date (2 days after the vaccination), the patient did not wake up in the morning; therefore, his mother entered his room and found he died on his stomach on the desk. The patient was taken to hospital. As a result of autopsy, the cause of death was myocardium color changed to white. The reporting physician did not report seriousness of the event or causality between the event and BNT162b2. The reporter was the patient''s primary care physician, the information obtained was from the patient''s parent. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected; Sender''s Comments: Based on the limited information in the case and a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported fatal event of Myocardial Ischemia. 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: Myocardium color changed to white; Autopsy-determined Cause(s) of Death: Myocardium color changed to white


VAERS ID: 1513984 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100923780

Write-up: Subarachnoid haemorrhage; This is a spontaneous case from a contactable pharmacist received via a Pfizer sales representative. The patient was a female in her 60s. The body weight and height were unknown. The family history was not provided. The patient had medical history of hypertension. The patient''s concomitant drugs were not reported. The patient was working as a caregiver. She was working at night work. The patient''s concomitant medications were not reported. On unknown date in 2021 (the day of vaccination, at an unspecified age), the patient received a dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration as a unknown dose number, single for COVID-19 immunization. On unknown date in 2021 (unknown days/hours/minutes after the vaccination), the patient experienced subarachnoid haemorrhage. On unknown date in 2021 (unknown days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On unknown date in 2021, several days after the patient received a dose of BNT162b2 vaccination, she experienced subarachnoid haemorrhage. After the whole day, the patient died. The causality between the event and BNT162b2 was not provided. The patient died on an unspecified date in 2021. It was unknown if the 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: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of fatal event subarachnoid hemorrhage cannot be excluded.But also consider relevant medical history of hypertension present.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: Subarachnoid haemorrhage


VAERS ID: 1513989 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-09
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5295 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, 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: 2021-07-09
   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: Disuse syndrome (undergoing hospital treatment); Pneumonia aspiration (undergoing hospital treatment)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210706; Test Name: body temperature; Result Unstructured Data: Test Result:37.2 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202100935477

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21120777. The patient was a 95-year and 4-month-old male. Body temperature before vaccination was 37.2 degrees centigrade. The family history was not provided. The patient was undergoing hospital treatment for posttraumatic disuse syndrome and repeated episodes of pneumonia aspiration. On 06Jul2021 at 14:00 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC5295, Expiration date 30Sep2021) via an unspecified route of administration as a single dose, at age of 95-year-old of vaccination, for COVID-19 immunization. On 09Jul2021 at 23:47 (3 days/9 hours/47 minutes after the vaccination), the patient experienced cardio-respiratory arrest. On 09Jul2021 (3 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The patient was being admitted to the hospital for undergoing medical treatment because he repeatedly had posttraumatic disuse syndrome and pneumonia aspiration. From 20Jun2021 to 03Jul2021, the patient was receiving oral administration for pneumonia. Although the patient had a large amount of sputum, the fever decreased, and thus, he received the first dose of BNT162b2 vaccination on 06Jul2021 (the day of vaccination). On 09Jul2021, at 23:47, the patient had respiratory arrest at the time of round. At the time of physical examination, the patient had cardiac arrest. At 23:52, the patient was confirmed to die. It was not reported if an autopsy was performed. The reporting physician classified the event 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 pneumonia.; Reported Cause(s) of Death: pneumonia; Cardio-respiratory arrest


VAERS ID: 1513990 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-19
Onset:2021-06-21
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Biopsy heart, Blood pressure measurement, Blood test, Body temperature, C-reactive protein, Computerised tomogram, Echocardiogram, Procalcitonin, Urine analysis, Viral myocarditis, White blood cell count
SMQs:, Cardiomyopathy (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-30
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210625; Test Name: Myocardial biopsy; Result Unstructured Data: Test Result:the diagnosis of acute myocarditis was made; Test Date: 20210625; Test Name: blood pressure; Result Unstructured Data: Test Result:in 80s; Comments: In pre-shock state; Test Date: 20210625; Test Name: blood test; Result Unstructured Data: Test Result:Deviation of cardiac enzymes; Test Date: 20210621; Test Name: body temperature; Result Unstructured Data: Test Result:39 Centigrade; Test Date: 20210621; Test Name: body temperature; Result Unstructured Data: Test Result:went down temporarily during the day, but it went Centigrade; Comments: up in the evening, indicating no improvement; Test Date: 20210624; Test Name: body temperature; Result Unstructured Data: Test Result:39 Centigrade; Test Date: 20210624; Test Name: CT; Result Unstructured Data: Test Result:None of origin of pyrexia; Test Date: 20210624; Test Name: CRP; Result Unstructured Data: Test Result:5.26; Test Date: 20210624; Test Name: echocardiography; Result Unstructured Data: Test Result:increase in echogenicity at a portion of mitral; Comments: valve; Test Date: 20210624; Test Name: procalcitonin; Result Unstructured Data: Test Result:0.79; Test Date: 20210624; Test Name: urine analysis; Result Unstructured Data: Test Result:No pyuria; Test Date: 20210624; Test Name: WBC; Result Unstructured Data: Test Result:7910
CDC Split Type: JPPFIZER INC202100935489

Write-up: This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21120810. The patient was a 61-year and 7-month-old female. Body temperature before vaccination was unknown. The patient''s family history was unknown. Information was unknown reported 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 19Jun2021 (the day of vaccination), the patient received the first dose of COVID-19 Vaccine (Manufacturer Unknown, Lot number and Expiration date unknown) via an unspecified route of administration as a single dose, at age of 61-year-old of vaccination, for COVID-19 immunization. On 21Jun2021 (2 days after the vaccination), the patient experienced viral myocarditis. On 25Jun2021 (6 days after the vaccination), the patient was admitted to the hospital. On 30Jun2021, (11 days after the vaccination) the patient died. The outcome of the event was Fatal. The course of the event was as follows: On 19Jun2021 (the day of vaccination), the patient received the first dose of Coronavirus vaccination. On 21Jun2021 (2 days after the vaccination), pyrexia of 39 degrees Centigrade developed. In the observation, body temperature went down temporarily during the day, but it went up in the evening, indicating no improvement. On 24Jun2021 (5 days after the vaccination), as the patient was refused to be seen by a primary care physician, she visited the reporting physician''s hospital for initial consultation. No pharyngodynia, cough, diarrhoea or dysgeusia was present. The symptom of cystitis such as pollakiuria or feeling of residual urine was also absent. Body temperature was 39 degrees Centigrade at the time of awakening on the reporting hospital visit day. On blood test, white blood cell count (WBC) was not increased which was at 7910, but C-reactive protein (CRP) and procalcitonin levels were increased to 5.26 and 0.79, respectively. No pyuria was noted on urine analysis. Although computerised tomogram (CT) was also conducted, apparent origin of pyrexia was not found. However, on echocardiography, endocarditis infective or other disease was suspected because an increase in echogenicity was noted at a portion of mitral valve. The reporting physician recommended hospitalization to the patient for treatment on the same day, but the patient refused it. Instead of that, she was planned to be hospitalized on the next day (25Jun2021). On 25Jun2021 (6 days after the vaccination), the patient visited the reporting hospital on foot. However, blood pressure was in 80s, and the patient was in pre-shock state. Deviation of cardiac enzymes was found on blood test. Urgent catherization was thus performed. Coronary artery stenosis was not present. Myocardial biopsy was conducted. Then, the diagnosis of acute myocarditis was made. Since shock state persisted, intubation was conducted under the same state. Intra-aortic balloon pumping (IABP) and percutaneous cardiopulmonary support (PCPS) were carried out, and pacemaker was placed temporarily. Although the patient was also treated with supportive management of circulation dynamics in the intensive-care unit (ICU), myocarditis was deteriorated into the fulminant stage. On the same day, at night, the patient lost her own electrical activity of the heart, and went into A-systole entirely, which resulted in total dependence on artificial heart-lung machine. Systemic circulation could be barely maintained through intravenous drip infusion and blood transfusion; however, maintaining was difficult for this patient with no spontaneous circulation. On 29Jun2021 (10 days after the vaccination), the patient was transferred to another hospital for the purpose of Impella insertion, which was placed on the same day; nevertheless, circulatory maintenance was too difficult for her. On 30Jun2021 (11 days after the vaccination), the patient died. It was not reported that if an autopsy was performed. The reporting physician classified the event as serious (Death) and assessed the causality between the event and COVID-19 Vaccine as unassessable. There was no other possible cause of the event such as any other diseases. The lot number for the vaccine was not provided and will be requested during follow up.; Reported Cause(s) of Death: Viral myocarditis


VAERS ID: 1513992 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-05-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Biopsy skin, Blood lactate dehydrogenase, Body temperature, C-reactive protein, Computerised tomogram, Haemoglobin, Investigation, Lymphoproliferative disorder, Myocardial ischaemia, Pancytopenia, Platelet count, Pyrexia, White blood cell count
SMQs:, Agranulocytosis (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Other ischaemic heart disease (narrow), Myelodysplastic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Haematological tumours of unspecified malignancy (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-03
   Days after onset: 37
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 31 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CLOPIDOGREL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Name: Random skin biopsy; Test Result: Negative ; Test Name: LDH; Result Unstructured Data: Test Result:670 IU/l; Comments: High; Test Name: body temperature; Result Unstructured Data: Test Result:37.2 Centigrade; Test Date: 20210526; Test Name: body temperature; Result Unstructured Data: Test Result:35.2 Centigrade; Comments: before vaccination; Test Name: CT; Result Unstructured Data: Test Result:splenic mass with the size of 22 mm; Comments: CT at hospitalization; Test Name: CRP; Test Result: 7.26 mg/dl; Test Name: Hb; Result Unstructured Data: Test Result:less than 6 g/dl; Comments: decreased; Test Name: soluble IL2R; Result Unstructured Data: Test Result:13,500 IU/ml; Comments: increased; Test Name: platelet; Result Unstructured Data: Test Result:48 x10 3/mm3; Test Name: platelet; Result Unstructured Data: Test Result:less than 10 x10 3/mm3; Test Name: white blood cell; Result Unstructured Data: Test Result:about 800-1,000; Comments: decreased
CDC Split Type: JPPFIZER INC202100935501

Write-up: possible myocardial ischaemia due to decreased hematocytes; possible lymphoproliferative disease including primary spleen malignant lymphoma and intravascular lymphoma; pancytopenia; Pyrexia; This is a spontaneous report from a contactable primary physician received from (PMDA). Regulatory authority report number is v21120780. The patient was a 92-year and 7-month-old female. On 26May2021 at 13:20 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY2173, Expiration date 31Aug2021) via an unspecified route of administration as a single dose at the age of 92-year-old for COVID-19 immunization. Body temperature before vaccination was 35.2 degrees centigrade on 26May2021. The patient had no specific family history. Medical history included hypertension. Concomitant medications included oral clopidogrel. On 27May2021 at unknown time (one day after the vaccination), the patient experienced pyrexia and pancytopenia. On 02Jun2021 (seven days after the vaccination), the patient was admitted to the hospital. On 03Jul2021 (one month and one week after the vaccination), the patient was died and discharged from the hospital. On 03Jul2021 (one month and one week after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 27May2021, the patient started to experience Consciousness disturbed and Inappetence. On 02Jun2021, the patient was transferred by ambulance and admitted to the hospital. Pyrexia of 37.2 degrees Celsius, C-reactive protein was 7.26 mg/dL, high LDH (lactate dehydrogenase) of 670 U/L, low platelets of 48 x10 3/mm3 were noted. Computerised tomogram at hospitalization showed splenic mass with the size of 22 mm. Although antibacterial drug was administrated for the doubt of urinary tract infection, the symptoms did not improve. The decrease of hematocytes progressed to white blood cell about 800-1,000 (unit was no provided), hemoglobin less than 6 g/dL, platelet less than 10 x10 3/mm3, therefore red blood cell and platelet transfusions were performed appropriately. Soluble interleukin 2 receptor increased to 13,500 U/mL. Random skin biopsy was performed for the doubt of intravascular lymphoma, but the result was negative. The addition of detailed examination including bone marrow examination was considered for lymphoproliferative disease. However, it was discussed with the patient family, further examination was not performed because of the decrease of hematocytes and bad general physical condition. On 03Jul2021 (one month and one week after the vaccination), the patient died. Immediate cause of death was considered as possible myocardial ischaemia due to decreased hematocytes. Autopsy was suggested for detailed examination of pancytopenia and immediate cause of death, but the patient family did not desire that. The reporting physician classified the event as serious (death, hospitalization) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause(s) of the event such as any other diseases were possible lymphoproliferative disease including primary spleen malignant lymphoma and intravascular lymphoma. Outcome of the event pyrexia was unknown, of other events was fatal. The reporting physician commented as follows: Regarding the symptoms described above, the possibility of the relationship to the vaccination was not high at the present moment because there were no report found from clinical trials to the extent that we could search, no description in the package insert, no cohesive report at the present moment even though pancytopenia were found in the adverse event reports. However, it cannot be denied because other causes were not proved.; Reporter''s Comments: Regarding the symptoms described above, the possibility of the relationship to the vaccination was not high at the present moment because there were no report found from clinical trials to the extent that we could search, no description in the package insert, no cohesive report at the present moment even though pancytopenia were found in the adverse event reports. However, it cannot be denied because other causes were not proved.; Reported Cause(s) of Death: possible myocardial ischaemia due to decreased hematocytes; Pancytopenia


VAERS ID: 1513993 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-07-14
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0201 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Biopsy bone marrow, Blood test, Immune thrombocytopenia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-19
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: Bone marrow examination; Result Unstructured Data: Test Result:idiopathic thrombocytopenic purpura; Test Date: 20210715; Test Name: Blood test; Result Unstructured Data: Test Result:idiopathic thrombocytopenic purpura
CDC Split Type: JPPFIZER INC202100935506

Write-up: idiopathic thrombocytopenic purpura; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21120811.?? The patient was an 80-year and 3-month-old male. On 25Jun2021 (the day of vaccination), the patient received?the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EW0201, Expiration date 30Sep2021) via an unspecified route of administration as a single dose at the age of 80-year-old for COVID-19 immunization. Body temperature before vaccination was unknown. The patient''s family history and medical history were not reported. 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 04Jun2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# FA2453, Expiration date 31Aug2021) for COVID-19 immunization. On 14Jul2021 (19 days after the vaccination), the patient experienced idiopathic thrombocytopenic purpura. On 19Jul2021 (24 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: From 12Jul2021, petechiae was noted on the body trunk and the upper and lower extremities. From 13Jul2021, haemorrhage from the tracheostomy stoma was noted. On 15Jul2021, the patient visited the reporting hospital, and idiopathic thrombocytopenic purpura (ITP) was diagnosed based on blood test and bone marrow examination. Treatment with intravenous dexamethasone at 1 g was ineffective. On 18Jul2021, pulmonary alveolar haemorrhage was found. Dexamethasone was switched to steroid pulse therapy and platelet transfusion was also performed, but they were ineffective. On 19Jul2021, the patient died. It was unknown if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the event was related to BNT162b2. The reporting physician considered that other possible causes of the event such as any other diseases were unassessable. The reporting physician commented as follows: Since the event occurred after the vaccination, the event was considered related to BNT162b2. The patient''s serum was stored and can be provided as necessary.; Reporter''s Comments: Since the event occurred after the vaccination, the event was considered related to BNT162b2. The patient''s serum was stored and can be provided as necessary.; Reported Cause(s) of Death: Idiopathic thrombocytopenic purpura


VAERS ID: 1513994 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0573 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-16
   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:
CDC Split Type: JPPFIZER INC202100935620

Write-up: Myocardial infarction; fell; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21120839. An 89-year and 3-month-old female patient received?the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# EY0573, Expiration date 30Sep2021) via an unspecified route of administration on 16Jul2021 at 10:15 (at 89-year and 3-month-old) as a single dose for COVID-19 immunization. The patient''s family history and medical history were not reported. Body temperature before vaccination was not reported. On 25Jun2021, the patient previously received the first single dose of BNT162b2 (COMIRNATY, Lot# EY0573, Expiration date 30Sep2021) for COVID-19 immunization. On 16Jul2021 at around 19:00 (0 day after the vaccination), the patient experienced myocardial infarction. On 16Jul2021 (0 day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 16Jul2021 at around 19:00, when the patient was about to go to toilet, she fell and was then urgently transferred to general hospital. Myocardial infarction was diagnosed and treatment was performed, but the patient died. The outcome of event fall at death time was unknown. It''s unknown if autopsy performed. The cause of death was reported as myocardial infarction. The reporting physician classified the event myocardial infarction as serious (death) and considered that the causality between the event and BNT162b2 was unassessable. The reporting physician did not report other possible causes of the event myocardial infarction such as any other diseases.; Reported Cause(s) of Death: Myocardial infarction


VAERS ID: 1513997 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-19
Onset:2021-07-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Computerised tomogram head, Ruptured cerebral aneurysm, Subarachnoid haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-21
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210719; Test Name: Head CT; Result Unstructured Data: Test Result:diagnosed as severe subarachnoid haemorrhage; Comments: diagnosed as severe subarachnoid haemorrhage due to right middle cerebral arterial thrombosed aneurysm ruptured
CDC Split Type: JPPFIZER INC202100935635

Write-up: severe subarachnoid haemorrhage; right middle cerebral arterial thrombosed aneurysm ruptured; consciousness disturbed; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21121166. A 71-year and 7-month-old male patient received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN) on 19Jul2021 09:00 at single dose (at the age of 71-year and 7-month-old) for COVID-19 immunisation. Medical history and concomitant medications were not reported. Body temperature before vaccination was not reported. The patient family history was not reported. On 19Jul2021 at 09:00 (the day of vaccination), the patient received COVID-19 Vaccine (Manufacturer, Lot number and Dose number unknown) via an unspecified route of administration as a single dose for COVID-19 immunization. On 19Jul2021 at 11:50 (2 hours and 50 minutes after the vaccination), the patient experienced subarachnoid haemorrhage. The course of the event was as follows: On 19Jul2021 before noon (the day of vaccination), after returning home, the patient suddenly experienced consciousness disturbed and was emergently transferred to a hospital. Head computerised tomogram was performed, and the patient was diagnosed with severe subarachnoid haemorrhage due to right middle cerebral arterial thrombosed aneurysm ruptured. Conservative treatment was chosen because it was judged to be difficult to save the life. On 21Jul2021 at around 03:00 (two days after the vaccination), the patient was discharged with death. The outcome of subarachnoid haemorrhage and right middle cerebral arterial thrombosed aneurysm ruptured was fatal. The outcome of consciousness disturbed was unknown. The reporting physician classified the event as serious (fatal) and assessed the causality between the event and COVID-19 Vaccine as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: It is said that the cause of cerebral arterial aneurysm is inflammation of arterial wall. Aneurysm was not originally indicated, and it was hard to consider that cerebral arterial aneurysm ruptured was due to the vaccination. However, vasculitis after vaccination was included in reactions to be reported, and the possibility was not completely denied that the vaccination evoked some kind of inflammation in artery and caused aneurysm ruptured in this case, therefore we report the event. Pfizer is marketing authorization holder of COVID-19 Vaccine in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of COVID-19 Vaccine has submitted the same report to the regulatory authorities. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: right middle cerebral arterial thrombosed aneurysm ruptured; Subarachnoid haemorrhage


VAERS ID: 1513998 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-19
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac arrest, Catheterisation cardiac, Computerised tomogram abdomen, Echocardiogram, Loss of consciousness, Myocarditis
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-20
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation paroxysmal; Diabetes mellitus; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Test Date: 20210719; Test Name: cardiac catheterization; Result Unstructured Data: Test Result:no significant findings; Test Date: 20210719; Test Name: Chest Abdominal CT; Result Unstructured Data: Test Result:no significant findings; Test Date: 20210719; Test Name: echocardiography; Result Unstructured Data: Test Result:no significant findings
CDC Split Type: JPPFIZER INC202100935999

Write-up: Myocarditis suspected; asystole; collapse without consciousness; This is a spontaneous report from a contactable nurse received from the Regulatory Authority. Regulatory authority report number is V21120833. A 76-year and 2-month-old male patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC3661, Expiration date 30Sep2021) via intramuscular on 17Jul2021 at 10:00 at 76 years old as a single dose for COVID-19 immunization. Body temperature before vaccination was 36.4 degrees Centigrade. The patient family history was not reported. The patient had primary diseases of diabetes mellitus, hypertension, and atrial fibrillation paroxysmal. The patient''s concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on an unspecified date for COVID-19 immunization. On 19Jul2021 at 08:50 (2 days after the vaccination), the patient experienced myocarditis suspected. On 19Jul2021 (2 days after the vaccination), the patient was admitted to the hospital. On 20Jul2021 (3 days after the vaccination), the patient died. The course of the event was reported as follows: On 19Jul2021, in the morning, when a groan was heard from the bathroom at home, the patient''s family members went and saw what happened. There, they found the patient collapse without consciousness. An emergency service was required. When the medical services arrived, the patient was in asystole. With cardiopulmonary resuscitation, thoracoabdominal computerised tomography (Chest Abdominal CT), echocardiography and cardiac catheterization were performed to search for the cause of cardiopulmonary arrest (CPA); however, no significant findings were noted. As the patient was post-vaccinated for BNT162b2 intramuscular injection, the possibility of vaccine adverse reaction (arrhythmia caused by myocarditis) could not be denied. On 20Jul2021, the patient passed away. Pathological autopsy was conducted at this time. However, there were no macroscopical abnormalities on the heart. At the time of reporting, the reporter was waiting for final results of pathological autopsy. The outcome of the events was fatal. The reporting nurse classified the event as serious (hospitalization and fatal) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases were not reported. No follow-up attempts are possible, no further information is expected.; Reported Cause(s) of Death: asystole; collapse without consciousness; Myocarditis suspected


VAERS ID: 1514025 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-13
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0201 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory arrest, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-13
   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: DACTIL; FEBRICET; MYSLEE; LENDORMIN; AMLODIPINE OD
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Hyperuricaemia; Insomnia; Osteoporosis
Allergies:
Diagnostic Lab Data: Test Date: 20210708; Test Name: body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021894563

Write-up: Cardio-respiratory arrest; loss of consciousness while taking a bath; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is V21119368. This physician reported different events for different doses. This is the first of 2 reports. This case is serious. The other case is non-serious. A 81-year and 10-month-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 08Jul2021 09:50 (Batch/Lot Number: EW0201; Expiration Date: 30Sep2021) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included hypertension, insomnia, hyperuricaemia, and osteoporosis from unspecified dates. Body temperature before vaccination was 36.9 degrees centigrade on 08Jul2021. The family history was not provided. Patient historically received first dose of COMIRNATY (Lot#FA2453, Expiration date 31Aug2021) on unspecified date in 2021 and experienced mild pain. Concomitant medications included piperidolate hydrochloride (DACTIL); paracetamol (FEBRICET); zolpidem tartrate (MYSLEE) 10 mg; brotizolam (LENDORMIN) 0.25 mg; amlodipine (AMLODIPINE OD) 2.5 mg taken for an unspecified indication, start and stop date were not reported. On 13Jul2021 at 17:15 (5 days after the vaccination), the patient experienced cardio-respiratory arrest. On 13Jul2021 (5 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On unknown date in 2021, the patient experienced only mild pain as a side reaction after receiving the first dose of BNT162b2 vaccination. On 08Jul2021 (the day of vaccination), at the hospital visit, the patient''s condition was as usual without any changes . The patient was speaking loudly as usual. On 13Jul2021 (5 days after vaccination), the patient was found to have loss of consciousness while taking a bath (she had cardio-respiratory arrest). A phone call was received from the police. The patient died on 13Jul2021. It was not reported if an autopsy was performed. The reporting physician classified the event 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 not reported. The reporting physician commented as follows: There was only contact from the police.; Sender''s Comments: Linked Report(s) : JP-PFIZER INC-2021896494 same patient, same drug, different dose and event; JP-PFIZER INC-2021896494 same patient, same drug, different dose and event; Reported Cause(s) of Death: loss of consciousness while taking a bath; Cardio-respiratory arrest


VAERS ID: 1514026 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cerebrovascular disorder, Circulatory collapse, Death
SMQs:, Anaphylactic reaction (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Diabetes mellitus; Diabetic nephropathy; Dialysis (3 times per week, 4 hours per session); Haemodialysis; Hypertension; Old cerebral infarction; Renal failure; Smoker
Allergies:
Diagnostic Lab Data: Test Date: 20210709; Test Name: body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021894565

Write-up: collapse; high risk of onset of cerebrovascular disorder; Unknown cause of death; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The regulatory authority report number is v21119322. A 59-year-old (also reported as 59-year and 10-month-old) male patient received BNT162B2 (COMIRNATY, solution for injection, lot number: FC3661, expiration date: 30Sep2021), via an unspecified route of administration on 09Jul2021 at 14:00 (at the age of 59-years-old -as reported) at dose 1, single for COVID-19 immunization. Body temperature before vaccination on 09Jul2021 was 36.9 degrees Centigrade. The patient''s family history was not provided. On 12Feb2014, he began to receive haemodialysis. On 02Sep2017, he started receiving maintenance dialysis 3 times per week, 4 hours per session at the outpatient department of the reporting hospital. The patient had underlying diseases such as diabetes mellitus, hypertension, angina pectoris, and old cerebral infarction. He had renal failure due to diabetic nephropathy according to the referral of the previous physician. The patient also had smoking history. The patient''s concomitant medications were not reported. On 09Jul2021 at 14:00 (the day of vaccination), the patient received the first dose of BNT162B2 (COMIRNATY). On Jul2021, reported as between 09Jul2021 and 12Jul2021 (between the day of vaccination and 2 days after the vaccination), the patient experienced unknown cause of death. On 12Jul2021 (reported as 2 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 09Jul2021 at 14:00 (the day of vaccination), the patient received the first dose of BNT162B2 vaccination before usual dialysis. Thereafter, dialysis was initiated. At 18:41 (4 hours and 41 minutes after vaccination), the patient went home without abnormalities after the completion of the dialysis. On 12Jul2021 (2 days and 10 hours after vaccination), since the patient did not visit the reporting hospital for dialysis, the physician contacted his family. Then, the patient was found to have collapsed at his home. Although cardiopulmonary resuscitation (CPR) was performed, return of spontaneous circulation was not obtained, and the patient was confirmed to have died. The patient died on 12Jul2021. The cause of death was unknown. As of this date, an autopsy was being performed. The outcome of all other events was unknown. The reporting physician classified the event "unknown cause of death" as serious (death) and assessed the causality between the event and BNT162B2 as unassessable. Other possible cause of the event such as any other diseases was as follows: It was considered that the patient had a high risk of onset of cerebrovascular disorder (Jul2021). The reporting physician commented as follows: It was considered that the patient had a high risk of onset of cerebrovascular disorder.; Reporter''s Comments: It was considered that the patient had a high risk of onset of cerebrovascular disorder.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1514032 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-07-07
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5423 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Body temperature, Cardio-respiratory arrest, Computerised tomogram, Cytology, Decreased appetite, Drowning, Imaging procedure
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), Accidents and injuries (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-09
   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: Asthma; Chronic obstructive pulmonary disease; Lung neoplasm
Allergies:
Diagnostic Lab Data: Test Date: 20210705; Test Name: body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: Before vaccination; Test Date: 20210709; Test Name: whole-body CT; Result Unstructured Data: Test Result:showed no obvious haemorrhage or infarction; Comments: showed no obvious haemorrhage or infarction, and other significant findings. Water was found in the trachea.; Test Date: 20201216; Test Name: Cytology of sputum; Result Unstructured Data: Test Result:class III B; Comments: lung cancer screening; Test Date: 20201216; Test Name: Imaging; Result Unstructured Data: Test Result:no problem was found; Comments: lung cancer screening
CDC Split Type: JPPFIZER INC2021894863

Write-up: lethal arrhythmia was considered likely; Drowning; Cardio-respiratory arrest; Appetite impaired; This is a spontaneous report from a contactable physician via a Pfizer sales representative and from the regulatory authority. Regulatory authority report number is v21119804. A 73-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 05Jul2021 16:09 (Lot Number: EY5423; Expiration Date: 31Aug2021) as dose 1, single (at the age of 73 years old) for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), asthma and suspected pulmonary tumour; all from an unknown date. The patient''s concomitant medications were not reported. The patient previously took SYMBICORT and THEOPHYLLINE from 21Dec2020 to an unspecified date, CYLMIN from Feb2021 to an unspecified date. On 09Jul2021 (4 days after the vaccination), the patient experienced death. The course of the event was as follows: On 05Jul2021 (the day of vaccination), at 16:09, the patient received the first dose of COMIRNATY vaccination at the reporting hospital and the patient had no particular adverse reaction. On 07Jul2021 (5 days, 7 hours, and 51 minutes after vaccination), the patient had appetite impaired. On 08Jul2021, at 23:00 (7 days, 6 hours, and 51 minutes after vaccination, as reported) which was also reported as 09Jul2021 at around 23:00, the patient took a bath as usual. Although usually the patient got out of a bath in approximately 30 minutes, he did not. So at 23:50 (7 days, 7 hours, and 41 minutes after vaccination, as reported), his wife went to see how the patient was doing, and it was found that his face was in the bathtub (also reported that family member went to check the situation and found the patient sank in a bathtub), and an ambulance was called. When the ambulance service arrived, the patient had cardio-respiratory arrest. The patient was emergently transferred to the general hospital. The patient received treatments such as a vasopressor and others; however, he did not recover. It was reported that the patient was transferred to a nearby flagship hospital, in ambulance; however, death was confirmed. On 09Jul2021 at 00:55 (7 days, 8 hours, and 46 minutes after vaccination, as reported), the patient was confirmed to die. The whole-body CT showed no obvious haemorrhage or infarction, and other significant findings. Water was found in the trachea. On 12Jul2021, the patient''s wife contacted the reporting hospital about this, where the patient received COMIRNATY. The patient had underlying diseases of COPD and asthma and regularly visited the reporting hospital. On 16Dec2020, the patient visited the reporting hospital to undergo lung cancer screening. No problem was found with imaging and the result of cytology with sputum was class III B. Thus, the patient was advised to visit a nearby flagship hospital and the patient said he was going to visit in around March. During that period, on 21Dec2020, the patient visited the reporting hospital again and was diagnosed with COPD and asthma, for which budesonide (SYMBICORT) and theophylline were prescribed. In Jan2021, the patient visited the reporting hospital twice. In Feb2021, theophyline (CYLMIN) was prescribed and that was the last visit to the reporting hospital before the COMIRNATY vaccination. On unspecified date, lethal arrhythmia was considered likely. The patient underwent lab tests and procedures which included lung cancer screening on 16Dec2020, imaging: no problem was found and cytology with sputum: class III B; body temperature: 36.9 centigrade on 05Jul2021 before vaccination; whole-body computerised tomogram (CT): showed no obvious haemorrhage or infarction, and other significant findings. Water was found in the trachea on 09Jul2021. Therapeutic measures were taken as a result of drowning due to an accident and cardio-respiratory arrest. The outcome of the event appetite impaired was unknown while fatal for the other events. The patient died on 09Jul2021. There was no incidence by an autopsy by the police. An autopsy was performed that showed that the death was drowning due to an accident. The reporting physician classified the event as serious (death) and assessed that the event was possibly related to BNT162b2. The reporting physician classified the event 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 unknown. The reporting physician commented as follows: Causality between the event and COMIRNATY was considered remotely related. Details of the cause of death were unknown. The causality between the event and BNT162b2 vaccination was unknown. The patient took a bath by himself, and it was unlikely that significant pathological condition occurred before taking a bath. Since no cerebrovascular disorder was observed, lethal arrhythmia was considered likely; however, it was not certain.; Sender''s Comments: The 73-year-old male patient had medical history included chronic obstructive pulmonary disease (COPD), asthma and suspected pulmonary tumour, and was given medications including budesonide (SYMBICORT) and theophyline (CYLMIN). Around 7 days after vaccination, it was found that his face was in the bathtub, and cardio-respiratory arrest was confirmed. An autopsy was performed that showed that the death was drowning due to an accident. Based on information available, the fatal event drowning was unrelated to BNT162B2 (COMIRNATY). The suspected lethal arrhythmia was more likely due to his underlying disease(s), and/or medication theophyline (CYLMIN), and unlikely causally related to vaccine of BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.; Reported Cause(s) of Death: Cardio-respiratory arrest; lethal arrhythmia was considered likely; Autopsy-determined Cause(s) of Death: drowning due to an accident.


VAERS ID: 1514084 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0583 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021902730

Write-up: the patient died; This is a spontaneous report from a contactable healthcare professional via Medical Information Team. The patient was an 84-year and female. On an unspecified date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# and expiration date were unknown). On 14Jul2021 (the day of vaccination), the patient received?the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0583, Expiration date 31Oct2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 16Jul2021 (2 days after the vaccination), the patient died. The outcome of the event was death. The course of the event was as follows: On 14Jul2021, the patient was vaccinated with the second dose of BNT162b2 by a healthcare professional who visited the facility where the patient lived. On 16Jul2021, in the morning, the patient died. The seriousness of the event was serious, and the causality between the event and BNT162b2 was unknown. Other possible cause of the event such as any other diseases was unknown. The reporter did not know the causality between the event and BNT162b2 and also did not know whether it should be regarded as an adverse event or just geromarasmus.; Sender''s Comments: The causal relationship between BNT162b2 and the event death cannot be excluded as 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: the patient died


VAERS ID: 1514085 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pneumonia bacterial
SMQs:, 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: Medical History/Concurrent Conditions: COPD; Diabetes mellitus; Smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021902731

Write-up: Pneumonia bacterial; This is a spontaneous report from a contactable consumer (patient''s brother) received via Medical information group. A 79-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. Medical history included diabetes mellitus (the level was relatively high) and mild COPD (he was a smoker). The patient was receiving the drugs for diabetes mellitus. The patient''s concomitant medications were not reported. On an unspecified date (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date were unknown) via an unspecified route of administration as single dose for COVID-19 immunization. On an unspecified date (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date were unknown) via an unspecified route of administration as single dose for COVID-19 immunization. On an unspecified date (18 days after the vaccination), the patient suddenly died. It was not reported if an autopsy was performed. According to the death certificate, the cause of death was bacterial pneumonia. The reporter stated as follows: The death certificate said that the cause of death was bacterial pneumonia. The reporter asked the physician about the causality, but the physician said that it could not be said for certain because the vaccine case was the first one for the physician. The reporter could not understand that the patient died after the vaccination although the patient carried on a normal life. The patient was given a permission to receive the vaccination. The reporter considered that the vaccine might influence the event. Although the reporter attempted to contact Regulatory Authority, but it was not helpful. The reporter was informed of the phone number of the pharmaceutical company by the local government. As the vaccine has just started it was somewhat understandable, but the local government did not answer clearly saying if these cases become public people would not get vaccine (incomprehensible). The magazines said that around 300 people died. The reporter considered that it might be useless if the reporter reported this case to them, but would like them to record the case although the reporter might not be informed the result. Ultimately the case should be reported to Regulatory Authority but they have done nothing. The reporter would like to know if such cases have been reported before, and if COPD might influence the lung etc. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Pneumonia bacterial


VAERS ID: 1514177 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-08
Onset:2021-05-14
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Antipsychotic drug level, Blood calcium, Cardiac arrest, Muscular weakness
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (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), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-16
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LORAZEPAM; LEVOTHYROXINE; CINACALCET; OLANZAPINE; VALPROIC ACID; IRBESARTAN; LITHIUMCARBONAAT
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: lithium; Result Unstructured Data: Test Result:low reference values; Test Name: Calcium; Result Unstructured Data: Test Result:good
CDC Split Type: NLPFIZER INC202100932317

Write-up: Cardiac arrest; Muscle weakness; This is as spontaneous report received from a contactable physician downloaded from the Regulatory Authority. The regulatory authority report number NL-LRB-00627422. A 60-year-old male patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 08May2021 (Batch/Lot Number: Unknown) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included lorazepam taken for an unspecified indication, start and stop date were not reported; levothyroxine taken for an unspecified indication, start and stop date were not reported; cinacalcet taken for an unspecified indication, start and stop date were not reported; olanzapine taken for an unspecified indication, start and stop date were not reported; valproic acid taken for an unspecified indication, start and stop date were not reported; irbesartan taken for an unspecified indication, start and stop date were not reported; lithium carbonate (LITHIUMCARBONAAT) taken for an unspecified indication, start and stop date were not reported. On 14May2021, 6 days after start vaccine, the patient experienced muscle weakness. The outcome of muscle weakness was fatal. It was reported muscle weakness throughout the body, however, predominantly in the lower extremities, developing over a few days, with inability to get up from a chair independently and fall next to the bed. Referred to by the general practitioner (GP) as not matching a hemi image. No additional confusion. To the best of our knowledge, the patient has not been previously aware of this complaint. About two weeks before death still in good health seen by doctor. Patient developed muscle weakness in his whole body, but the muscle weakness became severe in his lower extremities. Patient was not able to stand up from his chair on his own and fell next to his bed. Patient was in seemingly good health two weeks before his death. Cause of death was uncertain but reported as cardiac arrest. No autopsy was done. It was also reported cause of death was Unclear. Family didn''t want an autopsy. The physician considered a possible relationship with Covid vaccine. Forensic physician has been involved by telephone, however, considered the possibility that it would be a Covid side side effect small. The patient underwent lab tests and procedures which included lithium: low reference values on an unknown date; calcium: good on an unknown date. The patient died on 16May2021. 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: Muscle weakness; Unclear. Family did not want an autopsy. The GP took into account a possible relationship with the Covid vaccine. Forensic doctor has been involved by telephone, however, considered the chance that it would be a Covid side effect was


VAERS ID: 1514179 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202100932342

Write-up: Death: Heart failure; This is a spontaneous report from a contactable consumer or other non HCP downloaded from the regulatory authority, regulatory authority number NL-LRB-00628507. A 95-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 14Jul2021 at the age of 95-years-old (Batch/Lot Number: Unknown) as single dose for COVID-19 immunisation. Historical vaccine included bnt162b2 (COMIRNATY), dose 1 on 10Jun2021 at 0.3 mL for COVID-19 immunisation. Previous COVID-19 infection was no. The patient''s concomitant medications were not reported. The patient experienced death: heart failure on 14Jul2021. The patient died on 14Jul2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Heart failure


VAERS ID: 1514180 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-06-07
   Days after vaccination:102
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EMO477 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Coma, Pemphigoid
SMQs:, Severe cutaneous adverse reactions (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-29
   Days after onset: 22
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: Medical History/Concurrent Conditions: Bullous pemphigoid
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202100932337

Write-up: itchy blisters; half coma; This is a spontaneous report from a contactable consumer or other non HCP downloaded from the Regulatory Authority, regulatory authority number NL-LRB-00629717. An 84-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 25Feb2021 (Batch/Lot Number: EMO477) as single dose for COVID-19 immunisation. Medical history included bullous pemphigoid from 28Jan2021. Previous COVID-19 infection was no. Historical vaccine included bnt162b2 (COMIRNATY), dose 1 on 28Jan2021 for COVID-19 immunisation and experienced bullous pemphigoid. The patient''s concomitant medications were not reported. The patient experienced half coma (death) on 07Jun2021, itchy blisters (death) on an unspecified date. There was dermatologist consultation. The itchy blisters kept getting worse and opened and stronger drugs and ointments were used to suppress this. On 07Jun2021 there was a severe setback. In a sort of semi-coma ever since. Bullous pemphigoid was treated with prednisone, dermovate 2dd, pregabaline and paracetamol. The bullous pemphigoid became worse and the blisters kept opening up. Different medications were used to treat this. On 07Jun2021 patient''s condition worsened and she became comatose. She died weeks later. The outcome of bullous pemphigoid was fatal and the outcome of coma was fatal. The patient died on 29Jun2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202100935982 the same patient different dose and event; Reported Cause(s) of Death: half coma; itchy blisters


VAERS ID: 1514197 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-07-08
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FDS996 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: PHPFIZER INC202100930669

Write-up: fever; This is a spontaneous report from a contactable other hcp. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300091349. A 71-year-old female patient received bnt162b2 (COMIRNATY) at the age of 71-year-old, intramuscular on 25Jun2021 (Batch/Lot Number: FDS996) as dose number unknown, single for covid-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced fever on 08Jul2021 11:30. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of the event died was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: fever


VAERS ID: 1514198 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-07-08
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FDS996 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Flank pain, Pyrexia, Urine copper
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (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:
CDC Split Type: PHPFIZER INC202100936038

Write-up: Fever; Flank pain; Urine copper; This is a spontaneous report from a contactable other healthcare professional. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300091368. A 71-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 25Jun2021 (at age of 71-year-old, Batch/Lot Number: FDS996) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced fever (death) on 08Jul2021, flank pain (death) on 08Jul2021, urine copper (death) on 08Jul2021. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Fever; Flank pain; Urine copper


VAERS ID: 1514199 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Asthenia, Chills, Guillain-Barre syndrome, Nausea, Pyrexia, Throat irritation
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Demyelination (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (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: PHPFIZER INC202100936039

Write-up: CHILLS; FEVER; THROAT ITCHINESS; NAUSEA; EPIGASTRIC PAIN; WEAKNESS; ASCENDING PARALYSIS; This is a spontaneous report from a contactable other health professional. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300091403. A 40-year-old female patient received bnt162b2 (COMIRNATY), intramuscularly on 30Jun2021 (Batch/Lot Number: FD5996) as single dose for covid-19 immunization at age of 40-year-old. The patient''s medical history and concomitant medications were not reported. The patient experienced chills, fever, throat itchiness, nausea, epigastric pain, weakness and ascending paralysis (death) on 01Jul2021 at 06:00. The patient dead on unspecified date because of the events. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: CHILLS; FEVER; THROAT ITCHINESS; NAUSEA; EPIGASTRIC PAIN; BODY WEAKNESS; ASCENDING PARALYSIS


VAERS ID: 1514200 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-26
Onset:2021-06-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Dizziness, Dyspnoea, Pallor, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (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: PHPFIZER INC202100936040

Write-up: Dizziness; DOB; body weakness; Vomiting; Pale lips; This is a spontaneous report from a contactable other health care professional received from the regulatory authority. Regulatory authority report number PH-PHFDA-300091979. A 62-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 26Jun2021 (Batch/Lot number was not reported) as dose number unknown, single at the age of 62-year-old for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced body weakness, vomiting, and pale lips, all on 26Jun2021 16:05, dizziness and DOB (difficult of breathing) both on 05Jul2021 10:00. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Dizziness; DOB; body weakness; Vomiting; pale lips


VAERS ID: 1514202 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-07-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Malaise, Oropharyngeal pain
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202100936042

Write-up: body malaise; Sore throat; Dyspnea; This is a spontaneous report from a contactable other Health Professional (hcp). This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300092307. A 73-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 28Jun2021 (Batch/Lot Number: FD5996) (at the age of 73-years-old) as single dose for covid-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced sore throat on 01Jul2021, dyspnea on 01Jul2021, body malaise on an unspecified date. The patient died on an unspecified date. The outcome of the event body malaise was unknown. The outcome of other events was fatal. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sore throat; Dyspnea


VAERS ID: 1514203 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-07-05
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Headache
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC2021898507

Write-up: Headache; Dizziness; This is a spontaneous report from a contactable healthcare professional received from the Regulatory Authority. (Regulatory Authority report number: PH-PHFDA-300090419). A 77-year-old female patient received BNT162B2 (COMIRNATY, Lot Number: FD5996; Expiration date was not reported), intramuscular on 29Jun2021 as dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 05Jul2021 (10:50), the patient had headache and dizziness. The patient had died in Jul2021 due to headache and dizziness. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: headache; dizziness


VAERS ID: 1514207 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-30
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: PLPFIZER INC202100913794

Write-up: the death of a 21-year-old girl the day after receiving the vaccine.; This is a spontaneous report from a contactable consumer received by e-mail. Based on this source document 3 cases have been created. This is case 3 out of 3 for the patient number 3. A 21-years-old (pregnant: unknown) female patient received bnt162b2 (COMIRNATY, formulation: Solution for injection), 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 medical history was not reported. The patient''s concomitant medications were not reported. It was heard about a death of a 21-year-old girl the day after receiving the vaccine. The patient died on an unspecified date. In addition, reporter was asking for new data on serious post-vaccination reactions occuring at later time from vaccination. was there also information available where it had been confirmed that vaccination had an effect on death. It was not reported if an autopsy was performed.; Sender''s Comments: Linked Report(s) : PL-PFIZER INC-202100913796 same reporter, different patient;PL-PFIZER INC-202100913797 same reporter, different patient; Reported Cause(s) of Death: the death of a 21-year-old girl the day after receiving the vaccine.


VAERS ID: 1514265 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-30
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: ROPFIZER INC202100937252

Write-up: "it seems that" 2 days after immunisation died; This is a spontaneous report from a contactable physician. This report was received via a Pfizer sales representative. A 14-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 experienced "it seems that" 2 days after immunisation patient died. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. The information about lot number and expiration date cannot be obtained. No further information is expected.; Sender''s Comments: Based on the current available limited information in the case provided, the causal association between the event of Death due to unknown cause and the use of suspect product BNT162B2 cannot be fully assessed. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authority, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1514301 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: SKPFIZER INC2021904974

Write-up: Cardiac failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority; SK-SUKLSK-20217167. A 48-year-old patient of an unspecified gender received bnt162b2 (COMIRNATY), intramuscular on an unspecified date (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced cardiac failure with fatal outcome on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. Causality assessment assessed by the pathologist is not yet available. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Cardiac failure


VAERS ID: 1514320 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-07
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: Death; This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 07-Jul-2021 The patient died on 07-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications are reported by the reporter. No treatment information is provided. This is a case of death in a 71-year-old male subject, who died 5 days 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 71-year-old male subject, who died 5 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1514321 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-12
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       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: 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: TWMODERNATX, INC.MOD20212

Write-up: Myocarditis; This regulatory authority case was reported by a pharmacist and describes the occurrence of MYOCARDITIS (Myocarditis) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jul-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria death and medically significant). The reported cause of death was Myocarditis. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was provided. This is a case of sudden death in a 70-year-old male subject, who died 3 days after receiving the dose of vaccine. Very limited information has been provided at this time. Awaiting case translation.; Sender''s Comments: This is a case of sudden death in a 70-year-old male subject, who died 3 days after receiving the dose of vaccine. Very limited information has been provided at this time. Awaiting case translation.; Reported Cause(s) of Death: Myocarditis


VAERS ID: 1514322 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939697 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: Death; This regulatory authority case was reported by a pharmacist and describes the occurrence of DEATH (Death) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939697) for COVID-19 vaccination. No Medical History information was reported. On 10-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 11-Jul-2021 The patient died on 11-Jul-2021. The cause of death was not reported. An autopsy was not performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided. Treatment information was not provided. 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: 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: Unknown death


VAERS ID: 1514323 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939600CDC / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: death; This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (death) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939600CDC) for COVID-19 vaccination. Previously administered products included for Influenza immunization: influenza vaccine (Patient had no history of injections or adverse drug reactions.); for an unreported indication: Streptococcus pneumoniae (Patient had no history of adverse drug reactions.). Concurrent medical conditions included Hypertension. On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. Death occurred on 12-Jul-2021 The patient died on 12-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. The concomitant medication use was not provided. Treatment information was not provided by the reporter. This is a case of a 67-year-old male patient who received first dose of mRNA-1273 and died on the same day. Very limited information regarding this event has been provided at this time. No detailed information regarding patient''s medical history nor concomitant medications was provided. Furthermore, the exact cause of death was not provided. It is also unknown if an autopsy was performed. Causality is confounded with patient''s advanced age and medical history of hypertension.; Sender''s Comments: This is a case of a 67-year-old male patient who received first dose of mRNA-1273 and died on the same day. Very limited information regarding this event has been provided at this time. No detailed information regarding patient''s medical history nor concomitant medicatons was provided. Furthermore, the exact cause of death was not provided. It is also unknown if an autopsy was performed. Causality is confounded with patient''s advanced age and medical history of hypertension.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1514324 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-09
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-09
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: Death; This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (Death) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 09-Jul-2021 The patient died on 09-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The concomitant medications on use were not provided. No treatment information was provided. Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Sender''s Comments: Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1514326 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: Death; This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (Death) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 08-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 10-Jul-2021 The patient died on 10-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant products were not provided. Treatment medication were not reported. Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Sender''s Comments: Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1514327 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-14
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Ill-defined disorder
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: No medical history was provided.
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: ill-defined disorder; This regulatory authority case was reported by an other and describes the occurrence of ILL-DEFINED DISORDER (ill-defined disorder) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided. On 09-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced ILL-DEFINED DISORDER (ill-defined disorder) (seriousness criterion death). The patient died on 14-Jul-2021. The reported cause of death was Ill-defined disorder. It is unknown if an autopsy was performed. No concomitant medication was given. No treatment medication was given. Company Comment: This is a case of sudden death in a 79-year-old female subject, who died 5 days after receiving the dose of vaccine. Very limited information has been provided at this time. Awaiting case translation.; Sender''s Comments: This is a case of sudden death in a 79-year-old female subject, who died 5 days after receiving the dose of vaccine. Very limited information has been provided at this time. Awaiting case translation.; Reported Cause(s) of Death: ill-defined disorder


VAERS ID: 1514328 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-06
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
   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: COPD
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: Other; This regulatory authority case was reported by a pharmacist and describes the occurrence of DEATH (Other) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included COPD. On 04-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 06-Jul-2021 The patient died on 06-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided. Treatment information was not provided. Company comment:This is a case of an 81-year-old female patient who died after vaccination with mRNA-1273. Very limited information regarding this event has been provided at this time. The patient''s advanced age and underlying medical history of Chronic obstructive pulmonary disease significantly confound causality. No further information is expected.; Sender''s Comments: This is a case of an 81-year-old female patient who died after vaccination with mRNA-1273. Very limited information regarding this event has been provided at this time. The patient''s advanced age and underlying medical history of Chronic obstructive pulmonary disease significantly confound causality. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1514329 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-10
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939599-CDC / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: Death; This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (Death) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939599-CDC) for COVID-19 vaccination. No Medical History information was reported. On 02-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 10-Jul-2021 The patient died on 10-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. No concomitant medication reported. No treatment information was provided. Company comments:This is a case of a 74-year-old female patient who died 8 days following vaccination with mRNA-1273. Very limited information regarding this event has been provided at this time. No information regarding patient''s medical history nor concomitant medications was provided. Furthermore, the exact cause of death was not provided. It is also unknown if an autopsy was performed. Causality is confounded with patient''s advanced age.; Sender''s Comments: This is a case of a 74-year-old female patient who died 8 days following vaccination with mRNA-1273. Very limited information regarding this event has been provided at this time. No information regarding patient''s medical history nor concomitant medicatons was provided. Furthermore, the exact cause of death was not provided. It is also unknown if an autopsy was performed. Causality is confounded with patient''s advanced age.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1514330 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939599-CDC / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-03
   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: TWMODERNATX, INC.MOD20212

Write-up: other; This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (other) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939599-CDC) for COVID-19 vaccination. No Medical History information was reported. On 02-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. Death occurred on 03-Jul-2021 The patient died on 03-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. Treatment for the events were not provided. Very Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded.; Sender''s Comments: Very Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1514331 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-07
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: Death; This regulatory authority case was reported by a pharmacist and describes the occurrence of DEATH (Death) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 07-Jul-2021 The patient died on 07-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This is a case of a 56-year-old female patient who died 5 days following vaccination with mRNA-1273. Very limited information regarding this event has been provided at this time. No information regarding patient''s medical history nor concomitant medications was provided. Furthermore, the exact cause of death was not provided. It is also unknown if an autopsy was performed.; Sender''s Comments: This is a case of a 56-year-old female patient who died 5 days following vaccination with mRNA-1273. Very limited information regarding this event has been provided at this time. No information regarding patient''s medical history nor concomitant medications was provided. Furthermore, the exact cause of death was not provided. It is also unknown if an autopsy was performed.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1514334 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939599-CDC / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
   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: Diabetes; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Peritoneal dialysis; Renal disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: Death; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (Death) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939599-CDC) for COVID-19 vaccination. The patient''s past medical history included Renal disease and Peritoneal dialysis. Concurrent medical conditions included Diabetes and Hypertension. On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 06-Jul-2021 The patient died on 06-Jul-2021. The cause of death was not reported. An autopsy was not performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product was not provided by the reporter. Treatment product was not provided by the reporter. A 74-year-old female patient who received mRNA-1273 died the same day after the first dose of vaccine. Medical history included RENAL DISEASE undergoing PERITONEAL DIALYSIS, DIABETES AND HYPERTENSION. Patient''s comorbidities may confound the event. The cause of death was not reported. Very limited information has been reported at this time. Further information is not expected.; Sender''s Comments: A 74-year-old female patient who received mRNA-1273 died the same day after the first dose of vaccine. Medical history included RENAL DISEASE undergoing PERITONEAL DIALYSIS, DIABETES AND HYPERTENSION. Patient''s comorbidities may confound the event. The cause of death was not reported. Very limited information has been reported at this time. Further information is not expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1514335 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-09
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-09
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: UNEVALUABLE EVENT; This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of DEATH (UNEVALUABLE EVENT) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 09-Jul-2021 The patient died on 09-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not reported. Treatment medications were not reported. An 80-year-old male patient who received mRNA-1273 died three days after the first dose of vaccine. No medical history or conmeds were provided. Patient''s advanced age could carry with it some comorbidities which may confound the event. Very limited information has been reported at this time. Further information is not expected.; Sender''s Comments: An 80-year-old male patient who received mRNA-1273 died three days after the first dose of vaccine. No medical history or conmeds were provided. Patient''s advanced age could carry with it some comorbidities which may confound the event. Very limited information has been reported at this time. Further information is not expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1514336 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-11
Onset:2021-07-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Carbon dioxide, Death, Echocardiogram, Vaccination complication
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: CO2; Test Result: Inconclusive ; Result Unstructured Data: 21; Test Name: Echocardiogram; Test Result: Inconclusive ; Result Unstructured Data: No pericardial effusion
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: Unknown cause of death; Vaccination adverse reaction; This regulatory authority case was reported by a pharmacist and describes the occurrence of DEATH (Unknown cause of death) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension. On 11-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jul-2021, the patient experienced DEATH (Unknown cause of death) (seriousness criteria death and medically significant) and VACCINATION COMPLICATION (Vaccination adverse reaction). The patient died on 11-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Carbon dioxide: 21 (Inconclusive) 21. On an unknown date, Echocardiogram: no pericardial effusion (Inconclusive) No pericardial effusion. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. There was no concomitant medication reported. CPR was performed. Asystole throughout the clinical course was noted. This is a case of Death in a 69-year-old female patient with a medical history of hypertension who died 1 day after receiving the dose 1 of the product mRNA-1273. Very limited information regarding the event (cause of death and clinical and diagnostic information) has been provided at this time insufficient for causality assessment. Additional information (translation) is awaited.; Sender''s Comments: This is a case of Death in a 69-year-old female patient with a medical history of hypertension who died 1 day after receiving the dose 1 of the product mRNA-1273. Very limited information regarding the event (cause of death and clinical and diagnostic information) has been provided at this time insufficient for causality assessment. Additional information (translation) is awaited.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1514337 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-02
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: death; This regulatory authority case was reported by an other and describes the occurrence of DEATH (death) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. Concomitant product use was not provided by the reporter. Treatment medication was not provided by the reporter. Very limited information regarding the event has been provided at this time. Further information may be provided after translation.; Sender''s Comments: Very limited information regarding the event has been provided at this time. Further information may be provided after translation.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1514338 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-04
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: death; This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (death) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 04-Jul-2021 The patient died on 04-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information was mentioned by reporter. No treatment medication information was mentioned by reporter. Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Sender''s Comments: Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1514340 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-09
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-09
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: Headache; This regulatory authority case was reported by an other health care professional and describes the occurrence of HEADACHE (Headache) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jul-2021, the patient experienced HEADACHE (Headache) (seriousness criterion death). The patient died on 09-Jul-2021. The reported cause of death was Headache. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment information was provided. Action taken with vaccine was not applicable. This is a case of a 90-year-old male patient who developed headache six days following the administration of mRNA-1273 (Moderna COVID-19 Vaccine). The patient subsequently died. Very limited information regarding this event has been provided at this time. No information regarding the patient''s medical history, concomitant medications or autopsy results is available at this moment. The translation of the source document has been requested.; Sender''s Comments: This is a case of a 90-year-old male patient who developed headache six days following the administration of mRNA-1273 (Moderna COVID-19 Vaccine). The patient subsequently died. Very limited information regarding this event has been provided at this time. No information regarding the patient''s medical history, concomitant medications or autopsy results is available at this moment. The translation of the source document has been requested.; Reported Cause(s) of Death: Headache


VAERS ID: 1514341 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-05
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: Death; This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 05-Jul-2021 The patient died on 05-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Concomitant product was not provided. Treatment medication was not reported. Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Sender''s Comments: Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1514343 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-09
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Lethargy
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-09
   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: No adverse event (Medical history not reported)
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: fatigue; Lethargy; This regulatory authority case was reported by an other health care professional and describes the occurrence of FATIGUE (fatigue) and LETHARGY (Lethargy) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jul-2021, the patient experienced FATIGUE (fatigue) (seriousness criterion death) and LETHARGY (Lethargy) (seriousness criterion death). The patient died on 09-Jul-2021. The reported cause of death was Fatigue and Lethargy. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not provided by the reporter. Treatment information was not provided.; Sender''s Comments: This is a case of sudden death in a 88-year-old male subject, who died 6 days after receiving the dose of vaccine. Very limited information has been provided at this time. Awaiting case translation.; Reported Cause(s) of Death: Fatigue; Lethargy


VAERS ID: 1514345 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-12
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: Death; This regulatory authority case was reported by a pharmacist and describes the occurrence of DEATH (Death) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 08-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 12-Jul-2021 The patient died on 12-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product was not provided by the reporter Treatment medication was not provided by the reporter. Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Sender''s Comments: Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1514347 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-09
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Fatigue
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (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: TWMODERNATX, INC.MOD20212

Write-up: fatigue; Diarrhea; This regulatory authority case was reported by an other and describes the occurrence of FATIGUE (fatigue) and DIARRHOEA (Diarrhea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, the patient experienced FATIGUE (fatigue) (seriousness criterion death) and DIARRHOEA (Diarrhea) (seriousness criterion death). The reported cause of death was Fatigue and Diarrhea. It is unknown if an autopsy was performed. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication were not provided Treatment medication were not reported This is a case of death in a 69-year-old female patient, 8 days after receiving an unspecified dose of vaccine (Lot number unknown). Very limited information regarding the clinical details pertaining to death, medical history, and the concomitant medications was provided at this time. No further information is expected.; Sender''s Comments: This is a case of death in a 69-year-old female patient, 8 days after receiving an unspecified dose of vaccine (Lot number unknown). Very limited information regarding the clinical details pertaining to death, medical history, and the concomitant medications was provided at this time. No further information is expected.; Reported Cause(s) of Death: Fatigue; Diarrhea


VAERS ID: 1514357 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-13
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Decreased appetite, Pyrexia, Vaccination complication
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: Fever; Loss of appetite; Other; This regulatory authority case was reported by an other health care professional and describes the occurrence of PYREXIA (Fever), DECREASED APPETITE (Loss of appetite) and VACCINATION COMPLICATION (Other) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 04-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2021, the patient experienced PYREXIA (Fever) (seriousness criterion death), DECREASED APPETITE (Loss of appetite) (seriousness criterion death) and VACCINATION COMPLICATION (Other) (seriousness criterion death). The patient died on 13-Jul-2021. The reported cause of death was Fever and loss of appetite. It is unknown if an autopsy was performed. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment information not provided. No concomitant medication not provided.; Sender''s Comments: This fatal case concerns a 77-year-old male with serious unexpected events of pyrexia, decreased appetite, and vaccination complication. Event latency 10 days after mRNA-1273. Cause of death reported as fever and loss of appetite. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Fever; Loss of appetite


VAERS ID: 1514824 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2090 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Death, SARS-CoV-2 antibody test positive
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-13
   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: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210713; Test Name: Covid-19 test; Test Result: Positive
CDC Split Type: ZAPFIZER INC202100909552

Write-up: Death; Covid-19 test positive; This is a spontaneous report received from a contactable other health care professional. A 69-years-old female patient received first dose of BNT162b2 (COMIRNATY, Batch/Lot Number: FE2090, Expiration Date: Oct2021), via unspecified route of administration on 12Jul2021 18:21 (at the age of 69-years-old) as dose 1, single for COVID-19 immunisation. The diluent batch details Batch: S9846D, expiry date May2023. The vaccine was reconstituted on 12Jul2021. Medical history included hypertension. The patient concomitant medications were not reported. The patient was reported to had tested positive for COVID-19 and died on 13Jul2021. The event death assessed as serious (death) and while other event was non-serious. It was not reported if an autopsy was performed. The outcome of the event death was reported as fatal and while for other was unknown. No further details was available at the time of this report.; Sender''s Comments: As there is limited information in the case provided, the causal association between the event death and the suspect drug BNT162b2 cannot be 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: Death


VAERS ID: 1514883 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Contusion, Headache, Malaise, Pneumonia, Unresponsive to stimuli, Vascular dementia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Dementia (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-15
   Days after onset: 44
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 INC202100908577

Write-up: Pneumonia; vascular dementia; bottom half of her body was severely bruised; headaches; generally feeling sick; became totally unresponsive; This is a spontaneous report from a contactable consumer or other non hcp reporting on behalf of the patient. A 83-year-old non-pregnant female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiry date was not reported, age at vaccination: 83-year-old), via an unspecified route of administration on 06Apr2021 as dose 1, single for covid-19 immunisation administered in Facility. The patient medical history was not reported. The patient was not diagnosed with covid prior to vaccination and was not tested for covid post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination but was not too sure. On 10Apr2021, the patient experienced headaches and generally feeling sick and stated that she was dying constantly, shortly after receiving the injection up until she became totally unresponsive which was approximately 10 days after receiving the injection. She had signs of blood clotting as the bottom half of her body was severely bruised for a short period prior to her eventual death at just after midnight on the 15-May-2021 and cause of death was due to pneumonia and vascular dementia. An autopsy was not performed. All the events were life threatening. No treatment was received for the events. The outcome of pneumonia and vascular dementia was fatal and all other events was unknown.; Reported Cause(s) of Death: Pneumonia; vascular dementia


VAERS ID: 1514946 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-15
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRJNJFOC20210760742

Write-up: UNSPECIFIED CARDIAC ARREST; This spontaneous report received from a health care professional concerned a male of unspecified age, race and ethnicity unknown. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, frequency 1 total, administered on 13-Jul-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-Jul-2021, at night, the patient died from an unspecified cardiac arrest. An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on 15-Jul-2021. This report was serious (Death).; Sender''s Comments: V0:20210760742-JANSSEN COVID-19 VACCINE Ad26.COV2.S- unspecified cardiac arrest with fatal outcome- 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: UNSPECIFIED CARDIAC ARREST


VAERS ID: 1514957 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-05-17
   Days after vaccination:53
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-29
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20200527; Test Name: Nasal Swab; Test Result: Negative
CDC Split Type: CAPFIZER INC202100923666

Write-up: Patient developed acute leukemia which was only diagnosed May 27 after a brain hemmorhage.; Patient developed acute leukemia which was only diagnosed May 27 after a brain hemmorhage.; This is a spontaneous report received from a contactable consumer. A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration on 25Mar2021 at 09:15 (at the age of 65-year-old) as dose number unknown, single for COVID-19 immunization. The patient''s medical history was not reported. The patient did not receive any other medications within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 17May2021 at 06:00, the patient developed brain haemorrhage and on 27May2021, the patient diagnosed with acute leukaemia. The adverse events resulted into emergency room/department or urgent care. The patient was hospitalized for 2 days. Treatment included for adverse event was blood cleaning machine. The patient underwent lab tests and procedures which included nasal swab: negative on 27May2020. The patient died on 29May2021. The cause of death was brain haemorrhage resulting from acute leukaemia. It was not reported if an autopsy was performed. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: Brain hemmorrhage resulting from acute leukemia


VAERS ID: 1514977 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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 INC202100933372

Write-up: Covid; This is a spontaneous report from a non-contactable consumer or other non hcp received from a Pfizer colleague. A patient of unspecified age and gender received 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 UNKNOWN DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter shared he was aware of someone who had died of Covid despite receiving the Pfizer Covid vaccine, reporter informed that he was aware of someone who had died of Covid following the vaccination with the Pfizer vaccine. He stated the death had been reported via local channels. The patient was died due to Covid. It was unknown if the patient was tested for COVID-19 prior vaccination. It was unknown if an autopsy was performed to the patient. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Covid


VAERS ID: 1515811 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-06-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD4555 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Inappropriate schedule of product administration
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-24
   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: Coronary artery stenosis; Coronary sclerosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202100939680

Write-up: fresh myocardial infarction in the posterior wall of the left ventricle; first dose on 06May2021; second dose on 17Jun2021; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. A 55-year-old male patient received second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 17Jun2021 (Batch/Lot Number: FD4555) as dose 2, single for covid-19 immunisation. Medical history included ongoing Coronary sclerosis and Coronary artery stenosis. The patient''s concomitant medications were not reported. Patient received first dose of bnt162b2 on 06May2021 with Batch/lot number: EY7015. On 24Jun2021 the patient experienced Acute myocardial infarction, true posterior wall infarction death. The patient died on 24Jun2021 from Acute myocardial infarction, true posterior wall infarction. The autopsy determined cause of death was reported to be: Acute myocardial infarction, true posterior wall infarction. Post-mortem findings: Cause of death: Fresh myocardial infarction pathology. Fresh myocardial infarction in the posterior wall of the left ventricle. Acute pulmonary congestion. First degree hepatic congestion. External description of corpse: A 180 cm tall corpse in normal DC. The skin is pale greyish-white, with blotchy blue-violet death marks on the back. Lying venous catheter in the left lateral neck region. The skin of the thorax shows some current marks (after resuscitation). Sender''s comments: No further information available. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: fresh myocardial infarction in the posterior wall of the left ventricle


VAERS ID: 1515822 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-17
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD6840 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-17
   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: Mitral valve insufficiency
Preexisting Conditions: Medical History/Concurrent Conditions: Mitral valve prolapse (no regular medication use).
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202100939704

Write-up: death NOS/ lifeless in bed; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. A 33-years-old female patient received second dose of BNT162B2 (COMIRNATY, lot number: FD6840), via an unspecified route of administration on 06Jul2021 at single dose for COVID-19 immunisation. Medical history included mitral valve insufficiency (continuing) and mitral valve prolapse (no regular medication use). Concomitant medications were not reported. The patient previously received first single dose of COMIRNATY on 08Jun2021 for COVID-19 immunisation. On 17Jul2021 the patient experienced death NOS. Found lifeless in bed on 17Jul2021, autopsy ordered. Autopsy report pending for cause of death. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: death NOS/ lifeless in bed


VAERS ID: 1515829 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-05
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Herpes zoster
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Opportunistic infections (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 INC202100963299

Write-up: Cerebrovascular accident; Herpes zoster; This is a spontaneous report from a contactable other health professional via the Regulatory authority report number is 588772. A 90-year-old male 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 cerebrovascular accident and herpes zoster on 05Jun2021. Onset Time in Days: 10 days. The outcome of the events 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. No further information is expected.; Reported Cause(s) of Death: Cerebrovascular accident; Herpes zoster


VAERS ID: 1515830 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-13
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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 INC202100963302

Write-up: Cerebrovascular accident; This is a spontaneous report from a contactable other health professional via the Regulatory Authority report. A 64-year-old male 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 cerebrovascular accident on 13May2021. 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. No further information is expected.; Reported Cause(s) of Death: Cerebrovascular accident


VAERS ID: 1515849 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ 6797 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Aspartate aminotransferase, Bacterial test positive, Blood creatinine, Blood creatinine increased, Blood urea, Blood urea increased, Cardiac arrest, Dermatitis allergic, General physical health deterioration, Hepatitis A, Malaise, Mycobacterium tuberculosis complex test, Platelet count, Platelet count decreased, Rash, Red blood cell count, Red blood cells urine, Red blood cells urine positive, Sepsis, Somnolence, Urinary sediment present, Urine analysis, White blood cell count, White blood cell count increased, White blood cells urine, White blood cells urine positive
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Liver infections (narrow), Anaphylactic reaction (narrow), Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Tubulointerstitial diseases (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-03-04
   Days after onset: 34
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: VIGANTOL [COLECALCIFEROL]; ALLERGO-COMOD; FRAXIPARINE MULTI; NOLPAZA; ZODAC; CALCICHEW D3
Current Illness: Alzheimer''s disease (according to Mini-Mental State Exam - moderate dementia); Asymptomatic bacteriuria (with identification Klebsiella Pneumoniae); Cerebral atherosclerosis; Hypertension arterial (that time without therapy); Incontinence of urine; Ischaemic heart disease (myocardial infarction can''t be excluded (2004)); Non-smoker; Omalgia (according to X-ray, sclerotic focus in the great tubercle of humerus (14x8.5 mm)); Sinus bradycardia (with heart rate 38-45/min with transitional loss of consciousness, on ECG without ischemic changes)
Preexisting Conditions: Medical History/Concurrent Conditions: Appendicectomy; Cholecystectomy; Choledocholithiasis (state after endoscopic retrograde cholangiopancreatography March 2016); Conjunctivitis allergic; Delivery; Endoscopic retrograde cholangiopancreatography (with the extraction of concrement); Gastric ulcer surgery; Humerus fracture; Hysterectomy; Myocardial infarction; Osteoporosis; Urinary infection
Allergies:
Diagnostic Lab Data: Test Date: 20210301; Test Name: ASAT; Result Unstructured Data: Test Result:0.67 ukat/L; Test Date: 20210304; Test Name: ASAT; Result Unstructured Data: Test Result:1.68 ukat/L; Test Date: 20210301; Test Name: Creatinine; Result Unstructured Data: Test Result:104 umol/l; Test Date: 20210304; Test Name: Creatinine; Result Unstructured Data: Test Result:198 umol/l; Test Date: 20210301; Test Name: Urea; Result Unstructured Data: Test Result:7 mmol/L; Test Date: 20210304; Test Name: Urea; Result Unstructured Data: Test Result:17.5 mmol/L; Test Name: infectious hepatitis; Test Result: Negative ; Test Name: TBC; Test Result: Negative ; Test Date: 20210301; Test Name: Platelet count; Result Unstructured Data: Test Result:149 x10 9/l; Test Date: 20210301; Test Name: Platelet count; Result Unstructured Data: Test Result:246 x10 9/l; Test Date: 20210304; Test Name: Platelet count; Result Unstructured Data: Test Result:45 x10 9/l; Test Date: 20210301; Test Name: RBC count; Result Unstructured Data: Test Result:4.95 x10 12/l; Test Date: 202103; Test Name: Red blood cells urine; Result Unstructured Data: Test Result:11-20; Test Date: 202103; Test Name: Epithelial cells urine; Result Unstructured Data: Test Result:5-10; Test Date: 202103; Test Name: Urine analysis; Result Unstructured Data: Test Result:3; Comments: identification of bacteria; Test Date: 20210301; Test Name: White blood cell count; Result Unstructured Data: Test Result:8.8 x10 9/l; Test Date: 20210304; Test Name: White blood cell count; Result Unstructured Data: Test Result:15.3 x10 9/l; Test Date: 202103; Test Name: White blood cells urine; Result Unstructured Data: Test Result:21-40
CDC Split Type: CZPFIZER INC2021905564

Write-up: condition aggravated/ generalized worsened health condition/ health condition was worsened; allergic facial exanthema; allergic facial exanthema; Sepsis; Heart arrest; sleepy; malaise; white blood cell count: 15.3 on 04Mar2021; Creatinine: 198 umol/l on 04Mar2021; urea: 17.5 mmol/l on 04Mar2021; Platelet count: 45 x10 9/l on 04Mar2021; Red blood cells urine: 11-20 in Mar2021; Urine analysis: 3 identification of bacteria; White blood cells urine: 21-40 in Mar2021; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. A 74-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 28Jan2021 (Lot Number: EJ 6797) as single dose for covid-19 immunisation. Medical history included Endoscopic retrograde cholangiopancreatography with the extraction of concrement from Mar2016 and not ongoing; Cholecystectomy from an unknown date and not ongoing (state after cholecystectomy); ongoing arterial hypertension III. grade according to WHO, that time without therapy; ongoing brain atherosclerosis; Appendicectomy (state after appendectomy) not ongoing; ongoing Omalgia on the right side, according to X-ray - state after surgical neck fracture in the past, sclerotic focus in the great tubercle of humerus (14x8.5 mm), sharply defined, analgetics with effect; state after surgery of stomach from 2011 and not ongoing; ongoing Alzheimer''s disease according to Mini-Mental State Exam - moderate dementia; ongoing Incontinence of urine; 3 childrens, deliveries without complications and not ongoing; ongoing Ischaemic heart disease (myocardial infarction can''t be excluded (2004)); ongoing Sinus bradycardia with heart rate 38-45/min with transitional loss of consciousness, on ECG without ischemic changes, probably due to therapy with beta-blocators in Apr2019; Hysterectomy (state after hysterectomy) not ongoing; choledocholithiasis, state after endoscopic retrograde cholangiopancreatography in March 2016 with the extraction of concrement and not ongoing; ongoing Non-smoker; ongoing Asymptomatic bacteriuria with identification Klebsiella Pneumoniae from Mar2019; not ongoing Urinary infection etiology - e.coli; Osteoporosis; Conjunctivitis allergic; she did not drink alcohol. Concomitant medications included colecalciferol (VIGANTOL [COLECALCIFEROL]) taken for osteoporosis from 19Mar2020 to 26Feb2021; cromoglicate sodium (ALLERGO-COMOD) taken for Conjunctivitis allergic from 12Jan2021 to 16Feb2021; nadroparin calcium (FRAXIPARINE MULTI) taken for Ischaemic heart disease from 30Mar2019 to 01Mar2021, then from 01Mar2021 to 04Mar2021; pantoprazole sodium sesquihydrate (NOLPAZA) taken for Gastric ulcer surgery from 01Oct2010 to 28Feb2021; cetirizine hydrochloride (ZODAC) taken for Allergic conjunctivitis from 14Nov2020 to 17Feb2021; calcium carbonate, colecalciferol (CALCICHEW D3) taken for osteoporosis from 08Apr2020 to 28Feb2021. The patient experienced condition aggravated (death, hospitalization, disability, medically significant, life threatening) on 29Jan2021, allergic facial exanthema (death, hospitalization, disability, medically significant, life threatening) on 29Jan2021. The patient experienced Sepsis (death) and Heart arrest (death) on an unspecified date. It was reported that: the patient experienced the following adverse reaction after the administration of the 1st dose of COMIRNATY vaccine: allergic exanthema on the face, generalized worsened health condition. On 29Jan2021, it appeared allergic exanthema on the face with no reaction on antihistaminics, the patient received Prednison. The next days she still had exanthema, she was malaise and sleepy. On 18Feb2021 it had to be given the second dose, but the patient''s health condition was worsened, so the second dose was not administrated. The health condition was still worsening during the next few days and the patient died on 04Mar2021. An autopsy was not performed. The patient underwent lab tests and procedures which included aspartate aminotransferase (ASAT): 0.67 ukat/l on 01Mar2021, 1.68 ukat/l on 04Mar2021; Creatinine: 104 umol/l on 01Mar2021, 198 umol/l on 04Mar2021; urea: 7 mmol/l on 01Mar2021, 17.5 mmol/l on 04Mar2021; infectious hepatitis: negative on an unspecified date; Platelet count: 149 x10 9/l on 01Mar2021, 246 x10 9/l on 01Mar2021, 45 x10 9/l on 04Mar2021; red blood cell count: 4.95 x10 12/l on 01Mar2021; Red blood cells urine: 11-20 in Mar2021; Epithelial cells urine: 5-10 in Mar2021; Urine analysis: 3 identification of bacteria in Mar2021; white blood cell count: 8.8 x10 9/l on 01Mar2021, 15.3 on 04Mar2021. White blood cells urine: 21-40 in Mar2021; TBC negative on an unspecified date. Therapeutic measures were taken as a result of allergic facial exanthema. The outcome of events condition aggravated/ generalized worsened health condition/ health condition was worsened, allergic facial exanthema, Sepsis and Heart arrest was fatal; of the other events was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sepsis; Heart arrest; allergic facial exanthema; condition aggravated/ generalized worsened health condition/ health condition was worsened; allergic facial exanthema


VAERS ID: 1515872 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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 INC202100941122

Write-up: sudden death due to cardiac arrest; This is a spontaneous report received by Pfizer from Biontech (manufacturer for bnt162b2 (COMIRNATY), from a non-contactable physician. A 52-year-old male patient received bnt162b2 (COMIRNATY) on an unspecified date as single dose (lot: unknown) for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient has died due to sudden cardiac arrest 5 weeks after COMIRNATY administration. According to the physician no autopsy was performed, thus causal relation could hardly be assessed. The outcome of the event was fatal. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender''s Comments: Based on the temporal relationship, the association between the fatal event sudden cardiac arrest with COMIRNATY use can 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: Cardiac arrest


VAERS ID: 1515899 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-10-28
Onset:2021-05-01
   Days after vaccination:185
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / 2 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER GR26607 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood gases, Blood test, C-reactive protein, Circulatory collapse, Computerised tomogram, Computerised tomogram thorax, Confusional state, Cyanosis, Dizziness, Dyspnoea, Heart rate irregular, Muscular weakness, Pneumocystis jirovecii pneumonia, Pneumocystis test, Renal failure, Respiratory failure, Sepsis, Septic shock, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (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), Dementia (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (narrow), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-19
   Days after onset: 18
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: ANAFRANIL; ANAFRANIL; FOLIMET; LITAREX [LITHIUM CITRATE]; METHOTREXATE PARANOVA; TRUXAL [CHLORPROTHIXENE HYDROCHLORIDE]
Current Illness: Fall (Acute admission due to fall at home)
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic depression; Rheumatoid arthritis
Allergies:
Diagnostic Lab Data: Test Date: 202105; Test Name: Arterial blood gases; Result Unstructured Data: Test Result:No results reported; Test Date: 20210503; Test Name: Blood test; Result Unstructured Data: Test Result:Affected infection count; Test Name: CT scan; Result Unstructured Data: Test Result:Bilateral infiltration; Test Date: 20210503; Test Name: Computerized tomogram thorax; Result Unstructured Data: Test Result:Multiple infiltrates. Signs of pneumonia.; Test Date: 20210503; Test Name: C-reactive protein; Result Unstructured Data: Test Result:Increasing; Test Date: 20210507; Test Name: Pneumocystis test; Result Unstructured Data: Test Result:Positive for Pneumocystis pneumonia
CDC Split Type: DKPFIZER INC202100915827

Write-up: Sepsis; Respiratory failure. The patient was intubated; Confused; Heart rate irregular; Shaking; Pneumocystis jiroveci pneumonia; Blue around the lips (sign of cyanosis); Difficulty breathing; Dizziness; Muscle weakness; Kidney failure; Circulatory failure; Septic shock; This is a spontaneous report from a contactable physicians and consumer downloaded from the regulatory authority, regulatory authority number DK-DKMA-WBS-0072312. A 74-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 26Mar2021 (Batch/Lot Number: ER2659) as dose 2, single for COVID-19 immunization; adalimumab (IMRALDI), subcutaneous from 28Oct2020 (Batch/Lot Number: GR26607) to 22Apr2021, at 40 mg, once every 14 days for rheumatoid arthritis. Historical vaccine included BNT162B2 (COMIRNATY), via an unspecified route of administration on 04Mar2021 (Batch/Lot Number: ET3674) as dose 1, single for COVID-19 immunization. Medical history included fall (had acute admission due to fall at home), chronic depression and rheumatoid arthritis. No medical history of pneumonia has been described in the last 10 years. Concomitant medications included clomipramine hydrochloride (ANAFRANIL) taken for depression from 2016 to 2021; clomipramine hydrochloride (ANAFRANIL RETARD) taken for depression from 1988 to 2021; folic acid (FOLIMET) taken for rheumatoid arthritis from 2005 to 2021; lithium citrate (LITAREX) taken for depression from 2019 to 2021; methotrexate (METHOTREXATE PARANOVA) taken for rheumatoid arthritis from 2005 to 2021; and chlorprothixene hydrochloride (TRUXAL) taken for depression from 1988 to 2021. On 02May2021 the patient developed Pneumocystis jiroveci pneumonia together with Blue lips, Difficulty breathing, Dizziness and Muscle weakness. On 03May2021 the patient was confused, had an irregular heart rate and was shaking. On 07May2021 the patient developed respiratory failure and on 16May2021 the patient developed sepsis. In May2021, at unknown date, but after 14 days of treatment at the hospital, the condition of the patient got worse with beginning kidney failure and circulatory failure. At admission there was sign of pneumonia and the patient was started up with tazocin (PIPERACILLIN and Tazobactam). Despite treatment, progression in the condition was observed and the patient became increasingly oxygen-demanding. The patient was transferred to intensive department and had to be intubated. Changed to treatment with Sulfotrim (SULFAMETHOXAZOLE AND TRIMETHOPRIM) (intravenous) as usual instructions, but the patient was still oxygen-demanding and on a respirator. After 14 days of treatment the patient developed kidney failure. She shows no signs of waking up despite that she had come out of sedation after tracheostomy. There was circulatory failure and she was given increasing doses of Noradrenaline. The treatment seems hopeless due to the severely affected patient and prolonged treatment. Active treatment was discontinued after conversation with the patient''s daughter. Reported causes of death: Pneumocystis jiroveci pneumonia, Kidney failure, Circulatory failure, Septic shock, sepsis. Only normal confirmation of death was performed postmortem. The other physician stated that no autopsy has been performed and he didn''t think that an inquest had been performed. The death has not been reported to the police, as the vaccine was first suspected of causing the events on 17Jun2021, approximately 1 month after the death. Tests results: Pneumocystis test (07May2021): Positive for Pneumocystis pneumonia (Pneumocystis (DNA) detected from oral mouthwash samples), Computerized tomogram thorax (03May2021): Multiple infiltrates. Signs of pneumonia. C-reactive protein (03May2021): increasing, Blood test (03May2021): affected infection count, arterial blood gases (May2021): No result reported, CT scan: Bilateral infiltration. The patient died on 19May2021. An autopsy was not performed. The ADRs were by the reporter reported as resulting in hospitalization on 03May2021 and being life-threatening and then fatal on 19May2021. Causality: Both drugs were reported as being suspected of causing the ADR. The other physician stated that the most obvious explanation for the pneumonia would be due to treatment with Imraldi. He believes that there is no causal relationship between the vaccine and the pneumonia and death. Additionally, he stated that healthy people very rarely get this type of pneumonia and underlined that the patient was on this immunosuppressive medication (Imraldi). On the other hand, the original reporter (physician) had another opinion. The fact that the patient has been vaccinated against covid-19 came out of a conversation on 17Jun2021, after the patient''s death. Hereafter, the original reporter (physician) reported Comirnaty as suspect drug as well - even though she was not convinced about a causal relationship between the vaccine and ADR. As a causal relationship between the vaccine and the ADR cannot be ruled out, the case is medically confirmed. Sender Comment: COMMENT FROM DKMA: Duplicate case DK-DKMA-WBS-0075521 (DK-DKMA-ADR 25575778) has been merged with this master case before submission to EV.; Reported Cause(s) of Death: cyanosis; Difficulty breathing; Dizziness; Muscle weakness; irregular heart rate; shaking; respiratory failure; sepsis; confused; Septic shock; Pneumocystis jiroveci pneumonia; Circulatory failure; Kidney failure


VAERS ID: 1515916 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-14
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1433 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SELO-ZOK; ALPRAZOLAM KRKA; OLANZAPIN ACCORD; ATORVASTATIN 1A FARMA; QUETIAPIN ACCORD; MIRTAZAPIN
Current Illness: Depression; Hypercholesterolemia; Hypertension; Paranoid type schizophrenia; Smoker
Preexisting Conditions: Medical History/Concurrent Conditions: Heart disease, unspecified (not known with current heart disease, but is described in an earlier anamnesis.); Mental disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC202100939670

Write-up: cardiac arrest; This is a spontaneous report downloaded from the Medicines Agency (MA) -WEB [DK-DKMA-WBS-0078255]. The case was received from a contactable physician via The Danish Medicines Agency (DKMA). A 68-year-old female patient received first dose of bnt162b2 (COMIRNATY,(tozinameran (INN), Batch number: FC1433) via intramuscular on 04Jul2021 as dose 1, single for COVID-19 immunisation. There is no information regarding past medication. Patient concurrent conditions included smoker, depression, hypertension, hypercholesterolemia and paranoid type schizophrenia. Patient medical history included heart disease, unspecified (not known with current heart disease, but is described in an earlier anamnesis). Concomitant medication included metoprolol succinate (SELO-ZOK) tablet at 100 mg, 1x/day for hypertension from 06Nov2014; alprazolam (ALPRAZOLAM KRKA) tablet at 0.5 mg, 1x/day for mental disorder from 24Mar2021; olanzapine (OLANZAPIN ACCORD) tablet at 20 mg, 1x/day for an unspecified indication from 24Mar2021; atorvastatin calcium trihydrate (ATORVASTATIN 1A FARMA) tablet for hypercholesterolaemia from 07Oct2015 at 135 mg, 1x/day; quetiapine fumarate (QUETIAPIN ACCORD) tablet for schizophrenia from 24Mar2021 at 300 mg, 1x/day; mirtazapine (MIRTAZAPIN "2CARE4") tablet for depression from 22Sep2015 at 7.5 mg, 1x/day. On 14Jul2021 the patient developed cardiac arrest. The patient died on 14Jul2021. An autopsy was not performed. The ADRs were by the reporter reported as being fatal. No treatment or medical procedure due to the ADR was reported. The ADR cardiac arrest was fatal. Reported cause of death: cardiac arrest. There is no information regarding test results. Causality: The reporter states that it was not known that the patient has a heart disease, however the reporter has found it stated in an anamnesis.Brighton scale criteria: time onset first reaction was 10 day. acute reaction was no. rapid progression was no. duration of reaction was no answer. Skin and mucous membrane symptoms was none. Airway symptoms was none. Cardiovascular symptoms was none. Gastrointestinal symptoms was none. Blood pressure: min. no value. max. no value. S-tryptase, acute: no value. S-tryptase, base: no value. Temperature, max: no value. Sender Comment: Version 001 was not submitted to EV. Version 002, should be considered as version 1 No follow-up attempts possible. No further information expected. =; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1515976 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-03
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3098 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram head, 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: 2021-07-03
   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: Diabetes mellitus; Hypertension arterial
Preexisting Conditions: Medical History/Concurrent Conditions: Dyslipidemia; Hypothyroidism; Traffic accident
Allergies:
Diagnostic Lab Data: Test Date: 20200630; Test Name: CRANIAL Computerised tomogram; Result Unstructured Data: Test Result:without ventricular septal defects...; Comments: ...according to the usual protocol: No images are observed that suggest acute intra- or extra-axial bleeding. The ventricular system is normal in size and shape. Focal intraparenchymal lesions are not identified at both the infra- and supratentorial levels. Centered midline. Wide and free base cisterns. Bone and soft tissues without significant alterations. Diagnosis: Study without findings that suggest acute pathology at this time.
CDC Split Type: ESPFIZER INC2021905384

Write-up: Death sudden; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority. A 53-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration, administered in Arm on Thursday 01Jul2021 (Lot Number: FC3098) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing Hypertension arterial, ongoing diabetes mellitus, hypothyroidism from an unknown date, dyslipidaemia from an unknown date, road traffic accident on 30Jun2020. The patient''s concomitant medications were not reported. The patient previously took bnt162b2 (COMIRNATY) Lot number: FC3098 for covid-19 immunisation on 10Jun2021, pitavastatin calcium (ALIPZA 2mg, film-coated tablets), insulin glulisine (APIDRA 100iu/ml SOLUTION INJECTABLE IN CARTRIDGE), ramipril 2,5mg tablets and acetylsalicylic acid (ADIRO 100mg tablets gastro-resistant). The patient experienced death sudden on Saturday 03Jul2021.it was unknown whether an autopsy was done. It was reported that he was found dead in his home, discarding the suicide. At the date of notification (05Jul2021) the pharmacist was unaware of the causes of death as no access to the data related to the autopsy performed. He had a traffic accident the day before vaccination with a computed tomography, which results are: cranial Computerised tomogram WITHOUT / WITH CONTRAST: Description of the Exploration: Findings: A head Computerised tomogram is performed without ventricular septal defects according to the usual protocol: No images are observed that suggest acute intra- or extra-axial bleeding. The ventricular system is normal in size and shape. Focal intraparenchymal lesions are not identified at both the infra- and supratentorial levels. Centered midline. Wide and free base cisterns. Bone and soft tissues without significant alterations. Diagnosis: Study without findings that suggest acute pathology at this time. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death sudden


VAERS ID: 1516030 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-20
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Capillary leak syndrome
SMQs:, Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-14
   Days after onset: 24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESJNJFOC20210759328

Write-up: CAPILLARY LEAK SYNDROME; This spontaneous report received from a physician via a Regulatory Authority concerned a 50 year old female. The patient''s height, and weight were not reported. The patient''s past medical history included covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 21C14-04 expiry: UNKNOWN) 0.5 ml, 1 total administered on 17-JUN-2021 for covid-19 immunisation. No concomitant medications were reported. The drug start period (latency) was 4 days. On 20-JUN-2021, the patient experienced capillary leak syndrome, and was hospitalized (date unspecified). On 14-JUL-2021, the patient died from capillary leak syndrome. It was unknown if autopsy was performed. Action taken with covid-19 vaccine ad26.cov2.s was not applicable This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: This spontaneous report received from a physician via a Regulatory Authority concerns a 50-year-old female patient who developed capillary leak syndrome 4 days after receiving the Janssen COVID-19 vaccine. She died 24 days after the hospitalization. It was unknown if autopsy was performed. The patient''s past medical history included covid-19. No additional information is provided. Information regarding other potential etiologies was insufficient; considering the temporal relationship, the event is assessed to have an indeterminate relationship with vaccination.; Reported Cause(s) of Death: CAPILLARY LEAK SYNDROME


VAERS ID: 1516032 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / 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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESJNJFOC20210761689

Write-up: DEATH; This spontaneous report received from a health care professional concerned a 33 year old male of unknown race and ethnicity The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry date: Unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The reporter heard from a lady during break in the store that the patient died after receiving vaccine, on an unspecified date. The cause of death was unknown. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210761689-covid-19 vaccine ad26.cov2.s-Death. 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: UNKNOWN CAUSE OF DEATH


VAERS ID: 1516064 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blister, Fluid retention, Pneumonia, Pulmonary oedema, Renal failure, Skin weeping
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Severe cutaneous adverse reactions (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
   Days after onset: 35
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC202100939759

Write-up: Pneumonia; Kidney failure; Blister; Skin oozing; Pulmonary oedema; Fluid retention; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority. A 76-year-old male patient received bnt162b2 (COMIRNATY) via an unspecified route of administration on 16Jun2021 (Batch/Lot Number: UNKNOWN) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced blister, skin oozing, pulmonary oedema, fluid retention, kidney failure, and pneumonia in Jun2021. All considered serious due to death. The patient died on 06Jul2021. It was not reported if an autopsy was performed. 08Jul2021 initial consumer: 16Jun2021 received the 2nd dose of Comirnaty (Pfizer-BionTech) vaccine. Large cellular fluid blotch on left footpad after a few days. Was sent home, despite a leak of cell fluid in his system, treatment error. Followed up a few days later with a similar, but larger, right tibial plateau. Delivered to hospital 27Jun2021 by ambulance as person was bleeding heavily with cell fluids out of body in the morning. Cellular fluids spread throughout the body, lungs and abdomen. It is not known what caused it, according to doctors. Pneumonia and loss of kidney function. Person died 06Jul2021. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: blister; skin oozing; pulmonary oedema; fluid retention; kidney failure; pneumonia


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