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From the 1/14/2022 release of VAERS data:

Found 22,193 cases where Vaccine targets COVID-19 (COVID19) and Patient Died

Government Disclaimer on use of this data



Case Details

This is page 186 out of 222

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VAERS ID: 1702237 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-29
Onset:2021-08-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005235 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Headache, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-06
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Queasy; Headache; Low back pain; Pyrexia; This case was received via Pharmaceutical company (Reference number: 2021TJP087088) on 07-Sep-2021 and was forwarded to Moderna on 08-Sep-2021. This case, reported by a physician, was received by pharmaceutical company via Moderna''s adverse reaction reporting site (TASK0021575). On an unknown date, body temperature before vaccination: 37.2 degrees Celsius. On 29-Aug-2021, the patient received the 1st dose of this vaccine. Pyrexia developed at night. On 30-Aug-2021, headache and low back pain developed. On 01-Sep-2021, queasy developed, and anorexia was noted. On 06-Sep-2021, the patient was pronounced dead at a hospital where the patient was transported. Details are being reviewed by the judicial autopsy. The outcome of pyrexia, headache, low back pain, and queasy was reported as fatal. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The information indicated a possibility of the hematologic disease involvement as another factors. Regarding the details, the investigation results at the facility where the patient was transported are being awaited.; Sender''s Comments: Although the events pyrexia, headache, low back pain, and nausea developed 2 days after the administration of the product mRNA-1273, lack of clinical and diagnostic evaluations limits the causality assessment. The reported information indicated a possibility of the hematologic disease involvement as another factor.; Reported Cause(s) of Death: Pyrexia; Headache; Low back pain; Queasy


VAERS ID: 1702276 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002618 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Parosmia, Pneumonia, Taste disorder
SMQs:, Taste and smell disorders (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-22
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Disorder of taste and smell; Disorder of taste and smell; Pneumonia; This case was received via regulatory authority on 07-Sep-2021 and was forwarded to Moderna on 14-Sep-2021. This case, initially reported to the regulatory authority. On an unknown date, the patient received the 1st dose of the vaccine. On 04-Jul-2021, at 12:45, the patient received the 2nd dose of the vaccine. At 14:00, after the vaccination, the patient experienced breathlessness and disorder of taste and smell. On 13-Jul-2021, as breathlessness worsened, the patient was urgently transported to the reporting hospital and was hospitalized with a diagnosis of pneumonia. Various kinds of treatments were performed, but the patient did not respond to them. On 22-Jul-2021, the patient was confirmed dead. After the death, an autopsy was performed, but COVID-19 virus was not detected. The patient tested negative in all tests performed before death. The outcome of disorder of taste and smell and pneumonia was reports as fatal. Follow-up investigation will be made. Company Comment: Although the events developed after the administration of the vaccine, it is also considered that the event is due to effects from concomitant disease, etc.; Reporter''s Comments: Pneumonia due to an adverse reaction to the vaccine is suspected. COVID-19 infection may be another possible contributing factor. Although the events developed after the administration of the vaccine, it is also considered that the event is due to effects from concomitant disease, etc.; Sender''s Comments: Very limited information regarding these events has been provided at this time. However, patient�s advanced age (88 years old) could be a confounding factor for the fatal event. Causes of death retained as reported by regulatory authority. No further information is expected.; Reported Cause(s) of Death: Taste disorder; Dysosmia; Pneumonia


VAERS ID: 1702283 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-21
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Cerebrovascular accident, Cystitis noninfective, Myocardial infarction, Pneumonia
SMQs:, Myocardial infarction (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Cardiac arrhythmia terms, nonspecific (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-09-02
   Days after onset: 12
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 11 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: LTPFIZER INC202101144185

Write-up: arrhythmia appeared; heart attack; pneumonia; bladder inflammation; He had a stroke; This is a spontaneous report from a contactable physician via regulatory authority with senders (Case) Safety Report Unique Identifier:9cf35815-0a72-47ce-85e8-f4de688b8218. A 75-year-old male patient received the first dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 16Aug2021 at 18:30 (Lot Number: Unknown) at the age of 74-year-old as single dose for COVID-19 immunization. Medical history was unknown. Concomitant medication was none. Prior to vaccination, the patient wasn''t diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The patient didn''t received other vaccines within 4 weeks prior to the COVID vaccine. On 21Aug2021 at 18:30, five days after the first vaccine, the patient was taken to the intensive care unit. He had a stroke. On 23Aug2021, two days later, pneumonia and bladder inflammation added to the stroke. Later, arrhythmia appeared. The patient was transferred on 30Aug2021 from the ICU to the ward. He died of a heart attack on 02Sep2021. Autopsy was unknown. The events resulted in emergency room/department or urgent care. The events resulted in hospitalization on 23Aug2021 and duration of hospitalization was 11 days. Treatment was received for stroke, pneumonia and bladder inflammation. The outcome of heart attack was assessed as fatal. The outcome of other events was not recovered.; Sender''s Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnaty in triggering the onset of fatal event myocardial infarction and other events 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: heart attack


VAERS ID: 1702288 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-05-20
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Cardiac arrest, Cardiac disorder, Coronary artery thrombosis
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: 2021-05-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Autopsy; Result Unstructured Data: Test Result:Acute heart disorder. Coronary artery thrombus
CDC Split Type: LTPFIZER INC202101155749

Write-up: Acute heart disorder; Coronary artery thrombosis; heart stopped; This is a spontaneous report from a contactable consumer and a contactable other health professional downloaded from the regulatory authority, regulatory authority number LT-SMCA-4277. A 66-years-old male patient received second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 04May2021 (Batch/Lot Number: not provided) as single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. On 20May2021, the patient''s heart stopped. The outcome of the events was fatal. The patient died on 20May2021. Cause of death was reported as acute heart disorder and coronary artery thrombosis. An autopsy was performed that autopsy findings indicated acute heart disorder and coronary artery thrombus. Reporter''s comments: The notifier has been contacted for additional information. If further information is received, the case will be re-submitted. The lot number for BNT162B2 was not provided and will be requested during follow up.; Reporter''s Comments: The notifier has been contacted for additional information. If further information is received, the case will be re-submitted.; Reported Cause(s) of Death: Coronary artery thrombosis; Acute heart disorder; heart stopped; Autopsy-determined Cause(s) of Death: Coronary artery thrombus; Acute heart disorder


VAERS ID: 1702293 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-14
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Coronary artery disease, Coronary artery thrombosis
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-14
   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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: LUJNJFOC20210918731

Write-up: ACUTE CORONARY THROMBOSIS; SEVERE CORONARY DISEASE; This spontaneous report received from a physician via a Regulatory Authority (EMEA EVHUMAN NLP, LU-ALMPS-202103018) on 08-SEP-2021 and concerned a 42 year old male of unknown race and ethnicity. The patient''s weight was 145 kilograms, and height was 180 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE389 expiry: unknown) 1 dosage forms, 1 total administered on 12-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 14-AUG-2021, the patient had developed severe coronary disease and acute coronary thrombosis, and he died from coronary thrombosis. An autopsy was performed on an unspecified date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of acute coronary thrombosis and severe coronary disease on 14-AUG-2021. This report was serious (Death).; Reported Cause(s) of Death: CORONARY THROMBOSIS; Autopsy-determined Cause(s) of Death: CORONARY THROMBOSIS


VAERS ID: 1702586 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral thrombosis, Fatigue, Headache, Malaise, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-16
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101143289

Write-up: Cerebral thrombosis; not feeling well; Fatigue; Fever; Headache; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB NL-LRB-00675235. A 45-year-old male patient received the second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 02Aug2021 (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 previously received the first dose of bnt162b2 (COMIRNATY), on unknown date as 0.3 mL single dose for covid-19 immunisation. The patient experienced cerebral thrombosis (death, hospitalization) on 14Aug2021; not feeling well, fatigue, fever, headache on 03Aug2021. Initially a small blood clot in the brain, admitted to brain care and received blood thinners. About 24 hours later a much large blood clot entered the brain which led to death. The outcome of the event cerebral thrombosis was fatal, others was unknown. The patient died on 16Aug2021 due to event cerebral thrombosis. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: cerebral thrombosis


VAERS ID: 1702588 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-06-15
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Cerebral haemorrhage, Coma, Intracranial aneurysm, Magnetic resonance imaging
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), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-16
   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:
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:unknown results; Test Name: Multiple MRI scan; Result Unstructured Data: Test Result:unknown results
CDC Split Type: NLPFIZER INC202101149999

Write-up: Brain hemorrhage (aneurysm); aneurysm cerebral; fell into a coma; This is a spontaneous report received from a contactable consumer downloaded from the regulatory authority-WEB. The regulatory authority report number is NL-LRB-00675372. A 56-year-old male patient received first dose of BNT162B2 (COMIRNATY, solution for injection, Lot Number: FC3143), via an unspecified route of administration on 11Jun2021 at single dose for covid-19 immunisation. The patient medical history was not reported. There was no previous COVID-19 infection. The patient''s concomitant medications were not reported. The patient experienced brain hemorrhage (aneurysm) and aneurysm cerebral on 15Jun2021. Cerebral hemorrhage around noon on 15Jun2021, so 4 days after vaccination. Afterwards neurologist suspects that there may have been a small bleed the night before. On the way to hospital another brain haemorrhage and fell into a coma on 15Jun2021. Subsequently admitted to intensive care. There he had another two times a bleeding. On 16Jun2021 he died (affirmed to be brain dead at 2 p.m.). The patient underwent lab tests included blood test: unknown results, Multiple MRI scan: unknown results. Aneurysm cerebral was treated with drain to drain fluid and a standard protocol for brain haemorrhage. The outcome of events was fatal. The patient died on 16Jun2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Brain hemorrhage (aneurysm); aneurysm cerebral; fell into a coma


VAERS ID: 1702589 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-08
Onset:2021-03-31
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaemia, Blood test, Decreased appetite, Dyspnoea, Faeces discoloured, Haemorrhage urinary tract, Inflammation, Joint swelling, Peripheral swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Arthritis (broad), Noninfectious diarrhoea (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-12
   Days after onset: 42
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VALDISPERT
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210510; Test Name: blood test; Result Unstructured Data: Test Result:high inflammatory; Comments: suspected anemia and for PSA and creatinine, and his doctor had given him a "high inflammatory" result
CDC Split Type: NLPFIZER INC202101150150

Write-up: high inflammatory; anemia; then other problems arose: shortness of breath, loss of appetite, anemia, swollen feet and ankles; then other problems arose: shortness of breath, loss of appetite, anemia, swollen feet and ankles; then other problems arose: shortness of breath, loss of appetite, anemia, swollen feet and ankles; then other problems arose: shortness of breath, loss of appetite, anemia, swollen feet and ankles; Blood clot in urine; Black stools; This is a spontaneous report received from a contactable other health professional downloaded from the regulatory authority-WEB. The regulatory authority report number is NL-LRB-00675473. A 92-year-old male patient received bnt162b2 (COMIRNATY), second single dose via an unspecified route of administration on 08Mar2021 (Batch/Lot Number: Unknown) for covid-19 immunisation. The patient previously received first single dose of bnt162b2 on 31Jan2021 for cooivd-19 immunisation with no adverse reaction. The patient medical history was not reported. Concomitant medication included valeriana officinalis extract (VALDISPERT). The patient had no previous COVID-19 infection. The patient experienced blood clot in urine and black stools 23 days after start vaccine on 31Mar2021. Black stools was treated with Klysma''s and blood clot in urine was treated with Klysma''s. Blood clots disappeared after a few weeks, then other problems arose: shortness of breath, lack of appetite, anemia, swollen feet and ankles on 01May2021. The patient was found dead in bed on 12May2021. Two days before his death, he had had blood drawn on 10May2021 for suspected anemia and for PSA and creatinine, and his doctor had given him a "high inflammatory" result. It was not reported if an autopsy was performed. The outcome of the event blood clot in urine was recovered on 01May2021, of the event black stools was unknown, while of the other events was fatal. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained. ; Reported Cause(s) of Death: Swollen ankles; Shortness of breath; Appetite lost; Appetite lost; anemia; high inflammatory; Swelling of feet


VAERS ID: 1702661 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
   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: NZPFIZER INC202101140867

Write-up: cousin died 2 months ago- cause of death was the vaccination but I don''t know which one - most likely Astra Zeneca.; This is a spontaneous report from a contactable consumer (patient''s cousin) via medical information team. A patient of unspecified age and gender received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The reporter''s cousin died 2 months ago (Jul2021) - cause of death was the vaccination but the reporter does not know which one - most likely Astra Zeneca. It was not reported if an autopsy was performed. The event (Death) occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: died


VAERS ID: 1702682 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210916496

Write-up: DEATH; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300104053] concerned a 56 year old male of unspecified race and ethnic origin. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, frequency 1 total was administered on 26-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced covid-19 infection and suspected clinical vaccination failure. On an unspecified date in the year 2021, the patient died from covid-19. It was unspecified whether autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of covid-19 on an unspecified date in 2021, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender''s Comments: V0:20210916496-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). 20210916496-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: COVID-19


VAERS ID: 1702683 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-18
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Decreased appetite, Dyspnoea, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210916974

Write-up: LOSS OF APPETITE; FEVER; COUGH; DIFFICULTY BREATHING; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300104130] concerned an 83-year-old male patient of unspecified race and ethnic origin. The patient''s weight and height were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on 08-MAY-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 18-AUG-2021, the patient experienced loss of appetite for a week, fever for 2 days which was accompanied by cough and slight difficulty of breathing (difficulty breathing). The patient was hospitalized on unspecified date and for unspecified days. It was unknown if an autopsy was performed. On an unspecified date, the patient died from loss of appetite, fever, cough, difficulty breathing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of loss of appetite, fever, cough, difficulty breathing was fatal. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210916974-COVID-19 VACCINE AD26.COV2.S.- Loss of appetite, Fever, Cough, Difficulty breathing. This events is considered unassessable. The events 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 events.; Reported Cause(s) of Death: LOSS OF APPETITE; FEVER; COUGH; DIFFICULTY BREATHING


VAERS ID: 1702685 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-20
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Dyspnoea, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210917038

Write-up: COUGH; DIFFICULTY OF BREATHING; FEVER; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300104132] concerned a 65 year old male patient of unspecified 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, intramuscular, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total, administered on 08-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 20-AUG-2021, two weeks after receiving Covid-19 vaccine, the patient developed cough, cold accompanied by fever with difficulty of breathing. On an unspecified date, he died from cough, fever and difficulty of breathing. 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: 20210917038-COVID-19 VACCINE AD26.COV2.S- cough, difficulty of breathing, fever. 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: COUGH; FEVER; DIFFICULTY OF BREATHING


VAERS ID: 1702688 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-27
Onset:2021-09-03
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939894 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Fatigue, Insomnia
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: PHMODERNATX, INC.MOD20213

Write-up: passed away; Sleeplessness; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (passed away) in a 35-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 939894) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 27-Aug-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 03-Sep-2021 at 10:55 AM, the patient experienced INSOMNIA (Sleeplessness) and FATIGUE (Tiredness). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, INSOMNIA (Sleeplessness) and FATIGUE (Tiredness) outcome was unknown. Concomitant medications were not provided by the reporter. Treatment information was not provided. Patient wife reported that the patient passed away after having symptoms of the vaccination. Very limited information regarding this event has been provided at this time. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Significant follow up received, death of the patient reported.; Sender''s Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: passed away


VAERS ID: 1702690 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-05
Onset:2021-08-07
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3430 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cough
SMQs:, Anaphylactic reaction (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 INC202101140669

Write-up: Dry cough; 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-300101934 An 89-year-old male patient received bnt162b2 (COMIRNATY) at the age of 89-year-old, intramuscular on 05Aug2021 (Batch/Lot Number: FE3430) as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced dry cough on 07Aug2021 10:00. 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: Dry cough


VAERS ID: 1702745 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202101162913

Write-up: passed away due to covid; passed away due to covid; This is a spontaneous report from a contactable physician. An 86-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included diabetes from 1986 and ongoing. The patient''s concomitant medications were not reported. The patient was hospitalized and recently passed away due to covid. She also has diabetes since 1986. The patient was at the E.R for several days before she was transferred to ICU because of lack of rooms. She was also undergone dialysis at the E.R. The patient was vaccinated of Pfizer Covid Vaccine before she was hospitalized but she said that maybe because of her age and comorbidities that''s why she didn''t make it. Patient is now deceased. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the Fatal events DI and Covid 19 and 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: passed away due to covid; passed away due to covid


VAERS ID: 1702810 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8274 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Asthenia, Loss of consciousness, Somnolence, Speech disorder
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre 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: 2021-08-18
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC202101143092

Write-up: Increasing disturbances of consciousness; Loss of consciousness; Somnolence occured 3 - 4 h hours after vaccination; Weakness generalised occured 3 - 4 h hours after vaccination; Speech disturbances; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number PL-URPL-DML-MLP.4401.1.618.2021. A 51-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 16Aug2021 08:00 (Batch/Lot Number: FD8274; Expiration Date: 01Sep2021) as DOSE2, 0.3ML SINGLE for covid-19 immunisation . The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced speech disturbances (speech disorder) (death) on 16Aug2021 , increasing disturbances of consciousness (altered state of consciousness) (death) on 17Aug2021 , loss of consciousness (loss of consciousness) (death) on 17Aug2021 , resuscitation (resuscitation) (death) on 18Aug2021 , somnolence occured 3 - 4 h hours after vaccination (somnolence) (death) on 16Aug2021 , weakness generalised occured 3 - 4 h hours after vaccination (asthenia) (death) on 16Aug2021. The action taken in response to the event(s) for bnt162b2 was not applicable. The patient died on 18Aug2021. An autopsy was performed and results were not provided.; Reported Cause(s) of Death: Cardiac arrest, unspecified


VAERS ID: 1702812 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-03-16
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, COVID-19, Condition aggravated, Malaise, SARS-CoV-2 test positive, Vaccination site bruising, Vaccination site haematoma
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-23
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: increased; Test Date: 20210316; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: COVID-19 virus test positive
CDC Split Type: PLMODERNATX, INC.MOD20213

Write-up: Felt unwel; Husband''s condition was getting worse day by day; Livid hematoma on the left arm (vaccination site); Livid hematoma on the left arm (vaccination site); After the test, it turned out that husband had COVID; This case was received via Regulatory Agency (Reference number: PL-URPL-DML-MLP.4401.2.597.2021) on 06-Sep-2021 and was forwarded to Moderna on 06-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MALAISE (Felt unwel), CONDITION AGGRAVATED (Husband''s condition was getting worse day by day), VACCINATION SITE HAEMATOMA (Livid hematoma on the left arm (vaccination site)), VACCINATION SITE BRUISING (Livid hematoma on the left arm (vaccination site)) and COVID-19 (After the test, it turned out that husband had COVID) in a 71-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 05-Mar-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced COVID-19 (After the test, it turned out that husband had COVID) (seriousness criterion death). On an unknown date, the patient experienced MALAISE (Felt unwel) (seriousness criterion death), CONDITION AGGRAVATED (Husband''s condition was getting worse day by day) (seriousness criterion death), VACCINATION SITE HAEMATOMA (Livid hematoma on the left arm (vaccination site)) (seriousness criterion death) and VACCINATION SITE BRUISING (Livid hematoma on the left arm (vaccination site)) (seriousness criterion death). The patient died on 23-Mar-2021. The reported cause of death was Feeling unwell, husband''s condition was getting worse day by day, livid hematoma on the left arm (vaccination site), livid hematoma on the left arm (vaccination site) and after the test, it turned out that husband had covid. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, SARS-CoV-2 test positive: positive (Positive) COVID-19 virus test positive. On an unknown date, Body temperature: increased (High) increased. Concomitant medication was not provided. Treatment information was not provided. Company comment: This is a 71-year-old male patient who experienced Covid-19 among other events with fatal outcome. Based on the mechanism of action of mRNA-1273, the event (Covid-19) is assessed as unlikely related to mRNA-1273. However, Very limited information regarding this event has been provided at this time. Details including the date of onset for few events and cause of death/autopsy report is required for further assessment.; Sender''s Comments: This is a 71-year-old male patient who experienced Covid-19 among other events with fatal outcome. Based on the mechanism of action of mRNA-1273, the event (Covid-19) is assessed as unlikely related to mRNA-1273. However, Very limited information regarding this event has been provided at this time. Details including the date of onset for few events and cause of death/autopsy report is required for further assessment.; Reported Cause(s) of Death: Feeling unwell; Husband''s condition was getting worse day by day; Livid hematoma on the left arm (vaccination site); Livid hematoma on the left arm (vaccination site); After the test, it turned out that husband had COVID


VAERS ID: 1702813 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-04-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Cerebral haemorrhage, Cerebrovascular accident, Incorrect route of product administration, Renal failure
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Drug abuse and dependence (broad), Acute central respiratory depression (broad), Cardiomyopathy (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-14
   Days after onset: 24
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: Allergy to insect sting (allergy to wasp); Aneurysm aortic
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC202101155680

Write-up: Stroke; cerebral haemorrhage; Arrest cardiac; kidney function stoppage/ Kidney failure; Inappropriate route of vaccination; This is a spontaneous report received from a contactable Consumer or other non HCP (patient''s granddaughter) downloaded from the Regulatory authority-WEB. The regulatory authority report number is PL-URPL-DML-MLP.4401.2.611.2021. A 72-years-old female patient received bnt162b2 (COMIRNATY), dose 1 subcutaneous on 20Apr2021 16:00 (at age of 72 years) (Batch/Lot Number: Unknown) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Allergy to insect sting (allergy to wasp), aortic aneurysm. The patient''s concomitant medications were not reported. The patient experienced cerebral haemorrhage and stroke, kidney function stoppage/ Kidney failure, cardiac arrest on 13May2021(reported as 25 days after the administration of Pfizer vaccine for Covid). Outcome for events haemorrhage and stroke, cardiac arrest was fatal, for kidney function stoppage/ Kidney failure was unknown. Health result: death (date of death: May 14, 2021, cause of death: cerebral haemorrhage, cardiac arrest). An autopsy was not performed. The reporting person did not classify the severity of the report. HA with due to the nature of the side effects and death, the patient was classified notification as "heavy". The data contained in the electronic report are all at the disposal of HA - in the case of obtaining additional ones information, the next version will be sent. Senders comment: Comirnaty are a mRNA vaccine against COVID-19 (with modified (nucleosides) These adverse reactions were not included in Comirnaty Summary of Product Characteristics. Until August 25, 2021 in the base Regulatory authority reported 454 cases of cardiac arrest (cardiac arrest) after administration of Comirnaty. Temporal union speaks with union cause and effect. The reporting person did not classify the severity. HA due to the nature of side effects and death of the patient qualified the report as "heavy". Relatedness of drug to reaction(s)/event(s): Stroke, Arrest cardiac, Kidney failure: Method of assessment: WHO Result of Assessment: unlikely No follow-up attempts possible. No further information expected. Information on lot number cannot be obtained; Reported Cause(s) of Death: cardiac arrest; cerebral haemorrhage; Stroke


VAERS ID: 1702974 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-05
Onset:2021-08-10
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4442 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-11
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ENOXAPARIN SODIUM; ATORVASTATIN CALCIUM;EZETIMIBE; PREGABALIN; BISOPROLOL; ENALAPRIL; HYDROCHLOROTHIAZIDE; AMLODIPINE; INSULIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC202101135984

Write-up: cardiogenic shock in the context of complete AVB; complete AVB (First-degree atrioventricular block); asystolia; cardiorespiratory arrest; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. This is a report received regulatory authority report number PT-INFARMED-T202108-1913 with Safety Report Unique Identifier PT-INFARMED-T202108-1913. A 67-year-old female patient received BNT162B2 (COMIRNATY), via intramuscular route on 05Aug2021 (Batch/Lot Number: FG4442) as dose number unknown, 0.3 ml single for COVID-19 immunisation. The patient''s medical history was not reported. Concomitant medications included enoxaparin sodium, atorvastatin calcium/ezetimibe, pregabalin, bisoprolol, enalapril, hydrochlorothiazide, amlodipine, and insulin, all taken for unspecified indications, start and stop dates were not reported. On 10Aug2021, the patient presented cardiogenic shock in the context of complete AVB (First-degree atrioventricular block) followed by asystolia and cardiorespiratory arrest associated with the use of Comirnaty Vaccine. The adverse reaction (ADR) appeared about 5 days after the administration of the suspected drug, lasting approximately 16 hours until the patient''s death on 11Aug2021. It was not known whether it was the first or second dose of the suspected drug, so it was not known whether the vaccination schedule remained unchanged, whether it was suspended or whether the reaction appeared after it ended. There was no suspicion of drug interactions. There was no information on previous reactions to the same or other drugs. Specific treatment of the reaction with advanced cardiopulmonary resuscitation maneuvers and a temporary pacemaker. ADR did not improve with treatment. The reporter''s assessment of the causal relationship of Cardiogenic shock with the suspect product was [Method of assessment: unknown] was possible. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: complete AVB (First-degree atrioventricular block); asystolia; cardiorespiratory arrest; Cardiogenic shock


VAERS ID: 1703211 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-06-14
   Days after vaccination:87
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood pressure increased, Blood pressure measurement, Body temperature increased, Cardiac failure, Decreased appetite, Pyrexia
SMQs:, Cardiac failure (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Hypertension (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:220/95 mmHg; Test Name: Pyrexia; Result Unstructured Data: Test Result:high temperatures out of nowhere
CDC Split Type: SKPFIZER INC202101143227

Write-up: blood pressure increase 220/95; high temperatures; Inappetence / Anorexia; weakness of the whole body; heart failure; This is a spontaneous report from a consumer or other non hcp downloaded from the regulatory authority-WEB SK-SUKLSK-20216532. A male patient of an unspecified age received BNT162B2 (COMIRNATY, formulation: Solution for injection, Batch/Lot Number was Unknown), via intramuscular route of administration on 19Mar2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (COMIRNATY, formulation: Solution for injection, Batch/Lot Number was not reported), via unspecified route of administration on unspecified as dose 1, single for COVID-19 immunisation. On 14Jun2021, it was reported, that after second dose the patient�s health state was worsened, the patient experienced cardiac failure and died. On an unspecified date, blood pressure increases 220/95, high temperatures, inappetence and weakness of the whole body. The patient underwent lab tests and procedures which included blood pressure measurement: 220/95 mmHg, pyrexia: high temperatures out of nowhere on an unspecified date. The patient wasn''t received treated for blood pressure or heart failure in the past. The outcome of all the remaining events was unknown. The outcome of cardiac failure was patient died on 14Jun2021. The physician didn�t recommend an autopsy. An autopsy was not performed. Reporter''s comment: The family assumed causal relationship as possible. No follow-up attempts~ are possible, information on batch/lot number cannot be obtained.; Reporter''s Comments: The family assumed causal relationship as possible.; Reported Cause(s) of Death: Cardiac failure


VAERS ID: 1703216 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-06-28
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 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: 2021-06-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SKPFIZER INC202101143246

Write-up: sudden death after COVID-19 vaccination; This is a spontaneous report from a contactable consumer or other non HCP downloaded from the Regulatory authority-WEB [SK-SUKLSK-20217486]. A 82-years-old patient of an unspecified gender received BNT162B2 (COMIRNATY, solution for injection), dose 2 intramuscular on 14Jun2021 (Batch/Lot Number: Unknown) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported sudden death on 28JUN2021, 14 days after second dose vaccine administration. The patient died on 28Jun2021. It was not reported if an autopsy was performed. Outcome was fatal. Sender Comment: After addition of requested information, the causality will be verified. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reporter''s Comments: Additional information were not reported.; Reported Cause(s) of Death: sudden death


VAERS ID: 1703217 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Biopsy, Hepatic steatosis, Toxic cardiomyopathy
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Cardiomyopathy (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: Alcohol rehabilitation; Alcohol use
Allergies:
Diagnostic Lab Data: Test Name: Histopathology; Result Unstructured Data: Test Result:ethyltoxic cardiomyopathy, severe diffuse...; Comments: ethyltoxic cardiomyopathy, severe diffuse ethyltoxic hepatic steatosis of AFL/ALD character.
CDC Split Type: SKPFIZER INC202101143231

Write-up: hepatic steatosis diffuse ethyltoxic; ethyltoxic cardiomyopathy; This is a spontaneous report from a contactable physician downloaded from the Agency. Regulatory authority number SK-SUKLSK-20217781. A 39-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection, lot number was not reported), via intramuscular on unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history included that alcohol use and alcohol rehabilitation. The patient''s concomitant medications were not reported. The patient experienced toxic cardiomyopathy and hepatic steatosis. The patient underwent lab test and procedure included histopathological (biopsy) and resulted into ethyltoxic cardiomyopathy, severe diffuse ethyltoxic hepatic steatosis of AFL/ALD character. For a long time, the patient probably suffered from reactive anorexia with episodes of vomiting. At the time of death 0.89 per mille was measured, about a week before death probably the patient drank alcohol and had swelling of the face. The patient was repeatedly hospitalized for inebriation and was after a 3-month alcohol rehabilitation. The patient died unspecified date. The autopsy was performed and results were not available. Health authority comment: The Primary source was the pathologist and the causality was assessed as not related to vaccination (unlikely). No follow-up attempts were possible. No further information was expected. Information on batch/lot number could not be obtained.; Reporter''s Comments: The Primary Source was the pathologist and the causality was assessed as not related to vaccination (unlikely).; Reported Cause(s) of Death: Hepatic steatosis diffuse ethyltoxic; Ethyltoxic cardiomyopathy


VAERS ID: 1703231 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-08-04
   Days after vaccination:125
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Chest X-ray, Echocardiogram, Electrocardiogram, Pneumonia
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-11
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Accident cerebrovascular; Chronic renal insufficiency; Diabetes mellitus; Hypertension; Ischaemic heart disease; Myocardial infarct
Allergies:
Diagnostic Lab Data: Test Name: chest X-ray; Result Unstructured Data: Test Result:right-sided bronchopneumonia; Test Name: Echocardiography; Result Unstructured Data: Test Result:educed systolic function, EF 35%; Test Name: ECG; Result Unstructured Data: Test Result:acute lower myocardial infarction with extensive i; Comments: acute lower myocardial infarction with extensive ischaemia, probably with stenosis of the brain stem
CDC Split Type: SKPFIZER INC202101143286

Write-up: Pneumonia; acute STEMI; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency-WEB SK-SUKLSK-20218566. A 80-years-old male patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number; Unknown and Expiry date was not reported), dose 2 via intramuscular on Apr2021 as dose 2, single for covid-19 immunisation. Medical history included myocardial infarction, Ischaemic heart disease, chronic kidney disease, diabetes mellitus, cerebrovascular accident and Hypertension. The concomitant medications were not reported. Historical vaccine included first dose of (COMIRNATY, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on an unspecified date in Mar2021 as dose 1, single for covid-19 immunisation. The patient experienced pneumonia and acute stemi on 04Aug2021. Treatment for acute coronary syndrome, for heart failure (diuretics, inotropic support) and antibiotic treatment were started. After the initial improvement of the clinical picture and inflammatory parameters, bilateral pneumonia developed, antibiotic treatment after consultation with an infectologist was changed. The ECG showed an acute lower myocardial infarction with extensive ischaemia, probably with stenosis of the brain stem. The hospitalization was complicated by the paroxysmal atrial fibrillation with a decrease in perfusion pressure of tissues and multiorgan failure developed. High doses of vasopressors were needed. Despite comprehensive treatment, the patient gradually did not respond to vasopressors (doses for resuscitation) and on 11Aug2021 at 09:15 am. he was pronounced dead. It was not reported if an autopsy was performed. The patient underwent lab tests and procedures which included chest x-ray: right-sided bronchopneumonia, echocardiogram: reduced systolic function, ef 35%, electrocardiogram: acute lower myocardial infarction with extensive ischaemia (probably with stenosis of the brain stem) all on an unspecified date. The outcome of events was Fatal. Health authority comments: The physician was contacted by the physician suggested that death is related to vaccination. The conclusion from the pathologist is not available. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reporter''s Comments: The physician was contacted by the SIDC and the physician suggested that death is related to vaccination. The conclusion from the pathologist is not available.; Reported Cause(s) of Death: unknown


VAERS ID: 1703232 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Aspergillus test, Blood immunoglobulin E, Blood immunoglobulin G, Blood immunoglobulin M, Blood lactate dehydrogenase, Bordetella test, C-reactive protein, CD4 lymphocytes, CD8 lymphocytes, Candida test, Chlamydia test, Complement factor C3, Complement factor C4, Computerised tomogram, Echocardiogram, Enzyme level test, Interleukin level, Investigation, Legionella test, Mycoplasma test, Neutrophil count, Oxygen saturation, Pneumonia, Prostatic specific antigen, SARS-CoV-2 antibody test, Streptococcus test, T-lymphocyte count, Troponin T, Tumour marker test, Ultrasound abdomen, White blood cell count, X-ray
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Ischaemic heart disease
Allergies:
Diagnostic Lab Data: Test Name: galaktomanan; Result Unstructured Data: Test Result:negative index; Test Name: IgE (A); Result Unstructured Data: Test Result:19,50 IU/ml; Test Name: IgG; Result Unstructured Data: Test Result:6,99 g/l; Test Name: IgM; Result Unstructured Data: Test Result:0,41 g/l; Test Name: LDH; Result Unstructured Data: Test Result:elevated; Test Name: Bordetella pertussis IgA, IgM, I; Result Unstructured Data: Test Result:18,5 U; Test Name: S_anti-Pertussis IgG; Result Unstructured Data: Test Result:negative; Test Name: S_anti-Pertussis IgM; Result Unstructured Data: Test Result:negative; Test Name: Kandid antigen; Result Unstructured Data: Test Result:negative index; Test Name: CD4; Result Unstructured Data: Test Result:0,14 10*6/mL; Test Name: CD4; Result Unstructured Data: Test Result:18,4 %; Test Name: CD8; Result Unstructured Data: Test Result:0,27 10*6/mL; Test Name: CD8; Result Unstructured Data: Test Result:36,3 %; Test Name: S_anti-Chl. pneumon IgM; Result Unstructured Data: Test Result:negative index; Test Name: S_anti-Chl. pneumon. IgA; Result Unstructured Data: Test Result:3,65; Test Name: S_anti-Chl.pneumon.IgG; Result Unstructured Data: Test Result:95,97 RU/ml; Test Name: S_C3 komplement; Result Unstructured Data: Test Result:1,41 g/l; Test Name: S_C4 komplement; Result Unstructured Data: Test Result:0,35 g/l; Test Name: CT scan; Result Unstructured Data: Test Result:atypical pneumonia; Comments: multiple zones of consolidation in the pulmonary parenchyma of the bilateral dominant in the left upper lung lobe first on the basis of inflammatory infiltration, very similar atypical pneumonia, with mediastinal and bilateral hilar LAP, without a clear description of the tumorous process - recommended examination after corrective treatmen; Test Name: CRP; Result Unstructured Data: Test Result:elevated; Test Name: CRP; Result Unstructured Data: Test Result:60,41 mg/l; Comments: 60,41; 62,50; 58,34; 35,03; 63,73; 87,87;; Test Name: CRP; Result Unstructured Data: Test Result:62,5 mg/l; Test Name: CRP; Result Unstructured Data: Test Result:58,34 mg/l; Test Name: CRP; Result Unstructured Data: Test Result:35,03 mg/l; Test Name: CRP; Result Unstructured Data: Test Result:63,73 mg/l; Test Name: CRP; Result Unstructured Data: Test Result:87,87 mg/l; Test Name: CRP; Result Unstructured Data: Test Result:137,82 mg/l; Test Name: CRP; Result Unstructured Data: Test Result:180,21 mg/l; Test Name: CRP; Result Unstructured Data: Test Result:149,16 mg/l; Test Name: echocardiography; Result Unstructured Data: Test Result:normal; Test Name: S_ALT; Result Unstructured Data: Test Result:0,48 ukat/l; Test Name: S_ALT; Result Unstructured Data: Test Result:0,53; Test Name: S_ALT; Result Unstructured Data: Test Result:0,76; Test Name: S_ALT; Result Unstructured Data: Test Result:1,48; Test Name: S_ALT; Result Unstructured Data: Test Result:1,15; Test Name: S_ALT; Result Unstructured Data: Test Result:0,91; Test Name: S_ALT; Result Unstructured Data: Test Result:0,94; Test Name: S_ALT; Result Unstructured Data: Test Result:0,76; Test Name: S_ALT; Result Unstructured Data: Test Result:0, 64; Test Name: S_AST; Result Unstructured Data: Test Result:0,77 ukat/l; Test Name: S_AST; Result Unstructured Data: Test Result:0,73; Test Name: S_AST; Result Unstructured Data: Test Result:0,92; Test Name: S_AST; Result Unstructured Data: Test Result:1,81; Test Name: S_AST; Result Unstructured Data: Test Result:0,83; Test Name: S_AST; Result Unstructured Data: Test Result:0,89; Test Name: S_AST; Result Unstructured Data: Test Result:0,98; Test Name: S_AST; Result Unstructured Data: Test Result:0,95; Test Name: S_AST; Result Unstructured Data: Test Result:0,7; Test Name: S_Interleuk�n-6; Result Unstructured Data: Test Result:64,8 pg/mL; Test Date: 20210726; Test Name: unspecified test; Result Unstructured Data: Test Result:negative; Test Name: S_anti - Legionella IgG; Result Unstructured Data: Test Result:negative index; Test Name: S_anti - Legionella IgM; Result Unstructured Data: Test Result:negative index; Test Name: S_Mycoplasm pneum. IgA; Result Unstructured Data: Test Result:4,03 U/mL; Test Name: S_Mycoplasma pneum. IgG; Result Unstructured Data: Test Result:62,83; Test Name: NEUT#; Result Unstructured Data: Test Result:8,33 10*6/mL; Test Name: NEUT#; Result Unstructured Data: Test Result:9,28 10*6/mL; Test Name: NEUT#; Result Unstructured Data: Test Result:7,21 10*6/mL; Test Name: NEUT#; Result Unstructured Data: Test Result:11,08 10*6/mL; Test Name: NEUT#; Result Unstructured Data: Test Result:6,68 10*6/mL; Test Name: NEUT#; Result Unstructured Data: Test Result:8,69 10*6/mL; Test Name: NEUT#; Result Unstructured Data: Test Result:10,5 10*6/mL; Test Name: NEUT#; Result Unstructured Data: Test Result:9,68 10*6/mL; Test Name: NEUT#; Result Unstructured Data: Test Result:10,36 10*6/mL; Test Name: oxygen saturation; Test Result: 93 %; Test Name: PSA; Result Unstructured Data: Test Result:elevated; Test Name: Sars-cov-2 IgG; Result Unstructured Data: Test Result:87,60; Comments: showed positivity only in the IgG after vaccination; Test Name: Sars-cov-2 IgM; Result Unstructured Data: Test Result:negative; Test Name: S_ASLO; Result Unstructured Data: Test Result:<53 IU/ml; Test Name: CD3; Result Unstructured Data: Test Result:0,24 10*6/mL; Test Name: CD3; Result Unstructured Data: Test Result:32,6 %; Test Name: Troponin T hs; Result Unstructured Data: Test Result:48,5; Test Name: Troponin T hs; Result Unstructured Data: Test Result:53,5; Test Name: Troponin T hs; Result Unstructured Data: Test Result:45,2; Test Name: ca 72-4; Result Unstructured Data: Test Result:Result not provided; Test Name: abdomen USG; Result Unstructured Data: Test Result:liver steatosis; Comments: very similar liver steatosis, pancreatic steatofibrosis and bilateral nephropathy.; Test Name: leukocythes; Result Unstructured Data: Test Result:leucocythosis; Test Name: WBC; Result Unstructured Data: Test Result:11,25 10*6/mL; Test Name: WBC; Result Unstructured Data: Test Result:12,44 10*6/mL; Test Name: WBC; Result Unstructured Data: Test Result:8,13 10*6/mL; Test Name: WBC; Result Unstructured Data: Test Result:15,40 10*6/mL; Test Name: WBC; Result Unstructured Data: Test Result:8,66 10*6/mL; Test Name: WBC; Result Unstructured Data: Test Result:11,54 10*6/mL; Test Name: WBC; Result Unstructured Data: Test Result:13,85 10*6/mL; Test Name: WBC; Result Unstructured Data: Test Result:12,08 10*6/mL; Test Name: WBC; Result Unstructured Data: Test Result:12,94 10*6/mL; Test Date: 20210721; Test Name: x ray; Result Unstructured Data: Test Result:bronchovascular findings; Comments: diffusely multiplied bronchovascular findings bilateral, on the left side with provocative character, very similar based on infiltrative changes. Apical left homogeneous shading, oval nodular shading projecting into the ventral section 4.-6. ribs on the right size up to 12mm, one similar on the left. Conclusion: Multiple zones of consolidation in the lung parench bil.
CDC Split Type: SKPFIZER INC202101143282

Write-up: Bronchopneumonia, organism unspecified; This is a spontaneous report from a contactable physician downloaded from the Regulatory authority-WEB, regulatory authority number SK-SUKLSK-20218585. A 93-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number was not reported), dose 2 intramuscular on an unspecified date in Feb2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient''s medical history included arterial hypertension, and Ischaemic heart disease from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient''s historical vaccine included bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number was not reported), dose 1 via an unspecified route of administration, on an unspecified date in Jan2021 as DOSE 1, SINGLE for COVID-19 immunisation. On an unspecified date, the patient experienced bronchopneumonia, organism unspecified. The patient was admitted to hospital due to weakness, cough, inappetence and hyposaturation 93% in bronchopneumonia. On X-ray of the chest on 21Jul201 showed diffusely multiplied broncho vascular findings bilateral, on the left side with provocative character, very similar based on infiltrative changes. Apical left homogeneous shading, oval nodular shading projecting into the ventral section 4-6 ribs on the right size up to 12mm, one similar on the left with conclusion: Multiple zones of consolidation in the lung parenchyma bilateral. Laboratory tests showed elevation of CRP with leucocytosis and neutrophilia, retention of nitrogenous substances in known renal disease, highly elevated oncomarkers (PSA, Cyfra, LDH, Ca 72-4). The patient was hydrated, aminopenicillins (unspecified) administered, which for IgA positivity of M. pneumoniae and Ch. pneumoniae tetracyclines was added. On abdomen USG very similar liver steatosis, pancreatic steatofibrosis and bilateral nephropathy. CT scan finding of multiple zones of consolidation in the pulmonary parenchyma of the bilateral dominant in the left upper lung lobe first on the basis of inflammatory infiltration, very similar atypical pneumonia, with mediastinal and bilateral hilar LAP, without a clear description of the tumorous process - recommended examination after corrective treatment. Bilateral fluidothorax was found, otherwise without signs of secondaryisms. Echocardiography within normal limits. For sore throat and suspected yeast oropharyngitis antifungal drug was added to the treatment, due to bilateral fluidothorax and diuretics. Due to the significant increase in leucocytosis despite antibiotics treatment, an infectologist was consulted and treated with a third-generation cephalosporin (unspecified). At the mentioned treatment, there was not an improvement in the patient''s condition. Laboratory showed an increased inflammatory parameters, therefore a specialized pneumology department was consulted. Repeated the microbiological examination were without detecting the infectious agent. Examination of the SARS-CoV-2 antibodies showed positivity only in the IgG after vaccination. Antibiotic therapy was changed to meropenem and linezolid in cooperation with an infectologist, immunostimulants, vitamin therapy and nutritional support were added. Despite comprehensive care and the above treatment, not able to favourably influence the patient''s condition, the body''s reserves were depleted and on 12-Aug-2021 at 22:30 hours, the exitus letalis was stated. Additional information, including information about autopsy, were not reported. On 26Jul2021, unspecified test: negative. TT, 27Jul2021: medium massive Enterobacter cloacae, medium mass Yeast microorganisms. Result Unstructured Data: FW 56/56 Pertussis: Bordetella pertussis IgA, IgM, I: 18,5 U, S_anti-Pertussis IgM: negative. U, S_anti-Pertussis IgG: negative. U, Immunological examination: S_C3 complement: 1,41 g/l, S_C4 complement: 0,35 g/l, S_CIK: 31, S_IgE (A): 19,50 IU/ml, S_CRP: 60,41; 62,50; 58,34; 35,03; 63,73; 87,87; 137,82; 180,21; 149,16 mg/l, S_IgG: 6,99 g/l, S_IgA: 2,74 g/l, S_IgM: 0,41 g/l, S_ASLO: <53,4 IU/ml, S_Interleukin-6: 64,8 pg/ml, Immunophenotyping: CD3: 32,6 %, CD3 abs.: 0,24 x10^9/l, CD4: 18,4 %, CD4 abs.: 0,14 x10^9/l, CD8: 36,3 %, CD8 abs.: 0,27 x10^9/l, IRI: 0,51 , CD3/HLA-DR: 2,1 %, Myoplasm: S_Mycoplasm pneumoniae. IgA: 4,03 S_anti - Legionella IgM: negative. index, S_anti - Legionella IgG: negative. U/ml, Enzymes: S_AST: 0,77; 0,73; 0,92; 1,81; 0,83; 0,89; 0,98; 0,95; 0,70 ukat/l, S_ALT: 0,48; 0,53; 0,76; 1,48; 1,15; 0,91; 0,94; 0,76; 0,64 ukat/l, WBC: 11,25; 12,44; 8,13; 15,40; 8,66; 11,54; 13,85; 12,08; 12,94 x10^9/l, Neut: 8,33; 9,28; 7,21; 11,08; 6,68; 8,69; 10,50; 9,68; 10,36 x10^9/l, SARS CoV-2 IgM: negative, SARS CoV-2 IgG: 87,60 , Mycotic infections: Aspergil antigen (galactomanan: negative. index, Candid antigen (manan): negative index, Troponin T hs: 48,5; 53,5; 45,2 , S_Mycoplasma pneumiae. IgG: 62,83 RU/ml, S_anti-Chl. pneumoniae. IgM: negative. index, S_anti-Chl.pneumoniae. IgG: 95,97 RU/ml, S_anti-Chl. pneumon. IgA: 3,65 index Chl. pneumoniae DNA PCR, 26-Jul-2021: negative. TAMP_Mycoplasma pneumoniae DNA PCR. The physician was contacted by the agency and the physician suggested that death was related to vaccination. The conclusion from the pathologist was not available. The patient died on 12Aug2021. It was not reported whether an autopsy was performed. No follow-up attempts are possible, information about batch number cannot be obtained. Health Authority comment: The physician was contacted by the agency and the physician suggested that death is related to vaccination. The conclusion from the pathologist is not available.; Reporter''s Comments: The physician was contacted by the agency and the physician suggested that death is related to vaccination. The conclusion from the pathologist is not available.; Reported Cause(s) of Death: exitus letalis


VAERS ID: 1703233 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-10
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Asthenia, Auscultation, Bilirubin conjugated, Blood bilirubin, Blood pressure measurement, Blood test, Body temperature, C-reactive protein, Cardiac failure, Chest X-ray, Computerised tomogram head, Echocardiogram, Ejection fraction, Electrocardiogram ambulatory, Fall, Fibrin D dimer, Gamma-glutamyltransferase, Haematology test, Haemoglobin, Heart rate, Hepatic enzyme, Inflammation, Myoglobin blood, N-terminal prohormone brain natriuretic peptide, Neutrophil count, Platelet count, Syncope, Ultrasound abdomen, Vertigo, White blood cell count
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Vestibular disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-10
   Days after onset: 61
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: Atrial fibrillation (persistent/The patient was treated with Non-Vitamin K Antagonist Oral Anticoagulants (NOACs).)
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension (The patient was treated with Non-Vitamin K Antagonist Oral Anticoagulants (NOACs).); Ischaemic heart disease (The patient was treated with Non-Vitamin K Antagonist Oral Anticoagulants (NOACs).); Prostatectomy (due to prostate cancer (tumor)); Transcatheter aortic valve implantation
Allergies:
Diagnostic Lab Data: Test Name: SGPT; Result Unstructured Data: Test Result:1.39; Comments: Units:ukat/L; Test Name: SGPT; Result Unstructured Data: Test Result:1.7; Comments: Units:ukat/L; Test Name: SGOT; Result Unstructured Data: Test Result:0.48; Comments: Units:ukat/L; Test Name: SGOT; Result Unstructured Data: Test Result:0.49; Comments: Units:ukat/L; Test Name: SGOT; Result Unstructured Data: Test Result:0.5; Comments: Units:ukat/L; Test Name: SGOT; Result Unstructured Data: Test Result:0.53; Comments: Units:ukat/L; Test Name: auscultation; Result Unstructured Data: Test Result:basal crepe in the lungs; Test Name: Bilirubin conjugated; Result Unstructured Data: Test Result:14.8 umol/l; Test Name: Bilirubin total; Result Unstructured Data: Test Result:46.9 umol/l; Test Name: blood pressure; Result Unstructured Data: Test Result:normotensive; Test Name: cardiac markers during cardiac decompensation; Result Unstructured Data: Test Result:increased; Test Name: body temperature; Result Unstructured Data: Test Result:normal; Test Name: chest x-ray; Result Unstructured Data: Test Result:traced stasis of small (pulmonary) circuit; Comments: pulmonary parenchyma without recent focal inflamatory changes, diaphragm was vaulted, free angles. Heart transversely enlarged, with coiled desc. aorta, ateroscelerotic plates in A arch. Stent graft in the shadow of the heart.; Test Name: CT (Computed Tomography); Result Unstructured Data: Test Result:neurologic etiology was excluded; Test Name: C-reactive protein; Result Unstructured Data: Test Result:47.86 mg/l; Test Name: C-reactive protein; Result Unstructured Data: Test Result:74.72 mg/l; Test Name: C-reactive protein; Result Unstructured Data: Test Result:87.32 mg/l; Test Name: Echocardiography; Result Unstructured Data: Test Result:undilated left ventricular; Comments: during diastole 51 milimeters (mm), concentric hypertrophy, heart-walls 13-14 milimeters (mm), without regional kinetic discrepancies, left atrium = 51 mm. Without effusion. Replacement in Ao position max gradient to 24 mmHg, trace AoR, TR I-II, mitral valve with normal perfusion, pulmonary valve - without possibility of examination.; Test Name: elevation fraction (EF); Test Result: 50 %; Test Name: ECG HOLTER; Result Unstructured Data: Test Result:atrial fibrillation; Comments: used in the differential diagnosis of syncopes, pulse rate 83/min, no others pathologic findings were observed; Test Name: D-dimer; Result Unstructured Data: Test Result:slightly increased; Test Name: Gamma-glutamyltransferase; Result Unstructured Data: Test Result:2.85; Comments: Units:ukat/L; Test Name: Gamma-glutamyltransferase; Result Unstructured Data: Test Result:3.98; Comments: Units:ukat/L; Test Name: Gamma-glutamyltransferase; Result Unstructured Data: Test Result:3.22; Comments: Units:ukat/L; Test Name: hematological tests; Result Unstructured Data: Test Result:confirm an increased value of C-reactive protein w; Test Name: Hemoglobin; Result Unstructured Data: Test Result:148 g/l; Test Name: Hemoglobin; Result Unstructured Data: Test Result:128 g/l; Test Name: Hemoglobin; Result Unstructured Data: Test Result:131 g/l; Test Name: pulse rate; Result Unstructured Data: Test Result:normal; Test Name: pulse rate; Result Unstructured Data: Test Result:83; Comments: unit: /min; Test Name: hepatic enzymes; Result Unstructured Data: Test Result:a slight elevation; Test Name: Myoglobin blood; Result Unstructured Data: Test Result:1060 ug/L; Test Name: Myoglobin blood; Result Unstructured Data: Test Result:213 ug/L; Test Name: Neutrophils; Result Unstructured Data: Test Result:5.93 x10 9/l; Test Name: Neutrophils; Result Unstructured Data: Test Result:5.47 x10 9/l; Test Name: Neutrophils; Result Unstructured Data: Test Result:11.92 x10 9/l; Test Name: NT-proBNP; Result Unstructured Data: Test Result:3940 ng/L; Test Name: NT-proBNP; Result Unstructured Data: Test Result:increased; Test Name: Platelet count; Result Unstructured Data: Test Result:128 x10 9/l; Test Name: Platelet count; Result Unstructured Data: Test Result:105 x10 9/l; Test Name: Platelet count; Result Unstructured Data: Test Result:132 x10 9/l; Test Name: Abdominal ultrasonography; Result Unstructured Data: Test Result:hepatopathy, pancreatic lipomatosis, mild; Comments: cholecystolithiasis and Nephrolithiasis I. sin.; Test Name: Leukocyte count; Result Unstructured Data: Test Result:15.13 x10 9/l; Test Name: Leukocyte count; Result Unstructured Data: Test Result:8.32 x10 9/l; Test Name: Leukocyte count; Result Unstructured Data: Test Result:9.16 x10 9/l
CDC Split Type: SKPFIZER INC202101150119

Write-up: head spinning; generalised weakness; repeated syncopes; falls at home; Inflammatory syndrome of unknown etiology (agens not detected); Cardiac failure; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority-WEB SK-SUKLSK-20218688. A 75-year-old male patient received second dose of BNT162B2(COMIRNATY, Lot Number: EP2163), intramuscular on 01Jun2021 at single dose for covid-19 immunisation. Medical history included ongoing atrial fibrillation (persistent), Ischaemic heart disease, arterial hypertension. The patient was treated with Non-Vitamin K Antagonist Oral Anticoagulants (NOACs). The patient underwent transcatheter aortic valve implantation (TAVI) and prostatectomy (in 2020 - due to tumor of prostate). The patient''s concomitant medications were not reported. The patient experienced inflammatory syndrome of unknown etiology (agens not detected) and cardiac failure on 10Jun2021, head spinning, generalised weakness, repeated syncopes and falls at home on an unspecified date. Patient was hospitalised due to generalised weakness, repeated syncopes, head spinning and falls at home in 2 and 1/2 weeks after the administration of 2nd dose of vaccine (Comirnaty). CT (Computed Tomography) of head was realised at urgent depertment, patient was examinated by neurologist (neurologic etiology was excluded). The patient was normotensive, with normal pulse rate, normal body temperature, and auscultation of basal crepe in the lungs. Laboratory results confirm an increased value of C-reactive protein with leukocytosis (in hematological tests), a slight elevation of hepatic enzymes was observed, NTproBNP was increased, cardiac markers during cardiac decompensation were increased, D-dimer was slightly increased, no other dynamic changes were observed. Chest X-ray showed traced stasis of small (pulmonary) circuit, pulmonary parenchyma without recent focal inflamatory changes, diaphragm was vaulted, free angles. Heart transversely enlarged, with coiled desc. aorta, ateroscelerotic plates in A arch. Stent graft in the shadow of the heart. Abdominal ultrasonography showed hepatopathy, pancreatic lipomatosis, mild cholecystolithiasis and Nephrolithiasis I. sin. Echocardiography showed undilated left ventricular, during diastole 51 milimeters (mm), concentric hypertrophy, heart-walls 13-14 milimeters (mm), without regional kinetic discrepancies, elevation fraction (EF) = 50%, left atrium = 51 mm. Without effusion. Replacement in Ao position max gradient to 24 mmHg, trace AoR, TR I-II, mitral valve with normal perfusion, pulmonary valve - without possibility of examination. An ECG holter was used in the differential diagnosis of syncopes, atrial fibrillation with pulse rate 83/min was examined, no others pathologic findings were observed. Inflammatory syndrome was observed at patient (infection agens was not cultivated), antibiotic treatments (cephalosporins of 3rd generetion - Ceftriaxon) were used. Patient was hydrated, mineralogram was corrected. Patient�s health condition became better and patient was discharged on 01Jul2021. In 1 month after discharge, on 10Aug2021 the patient was pronouced dead. The patient underwent lab tests included SGPT: 1.39 ukat/L , SGPT: 1.7 ukat/L , SGOT: 0.48 ukat/L , SGOT: 0.49 ukat/L , SGOT: 0.5 ukat/L , SGOT: 0.53 ukat/L , bilirubin conjugated: 14.8 umol/l, Bilirubin total: 46.9 umol/l, c-reactive protein: 47.86 mg/l, c-reactive protein: 74.72 mg/l, c-reactive protein:87.32 mg/l. Gamma-glutamyltransferase: 2.85 ukat/L, Gamma-glutamyltransferase: 3.98 ukat/L, Gamma-glutamyltransferase: 3.22 ukat/L, Hemoglobin: 148g/l, Hemoglobin:128 g/l, Hemoglobin: 131g/l, Myoglobin blood: 1060 ug/L, Myoglobin blood: 213 ug/L, Neutrophils: 5.93 x10 9/l, Neutrophils: 5.47 x10 9/l, Neutrophils: 11.92 x10 9/l, NT-proBNP: 3940 ng/L, Platelet count: 128 x10 9/l, Platelet count: 105x10 9/l, Platelet count: 132x10 9/l, Leukocyte count: 15.13 x10 9/l, Leukocyte count: 8.32 x10 9/l, Leukocyte count: 9.16 x10 9/l. The outcome of event "Inflammatory syndrome of unknown etiology (agens not detected)" and "Cardiac failure" was fatal and other events was unknown. The patient died on 10Aug2021. It was not reported if an autopsy was performed. Reporter''s comments: The physician was contacted by the regulatory authority and the physician suggested that death is related to vaccination. The conclusion from the pathologist is not available.; Reporter''s Comments: The physician was contacted by the regulatory authority and the physician suggested that death is related to vaccination. The conclusion from the pathologist is not available.; Reported Cause(s) of Death: Cardiac failure; Inflammatory syndrome of unknown etiology (agens not detected)


VAERS ID: 1703658 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-02
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue
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: IEMODERNATX, INC.MOD20213

Write-up: Extreme Tiredness; This case was received via Regulatory Authority (Reference number: IE-HPRA-2021-079151) on 08-Sep-2021 and was forwarded to Moderna on 08-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (Extreme Tiredness) in a 92-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 immunisation. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced FATIGUE (Extreme Tiredness) (seriousness criterion death). The reported cause of death was extreme tiredness. It is unknown if an autopsy was performed. No concomitant product was reported. No treatment medication was reported. Company Comment : Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.; Sender''s Comments: Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.; Reported Cause(s) of Death: Extreme Tiredness


VAERS ID: 1703772 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202101191323

Write-up: died the next morning after getting the vaccine after jogging.; This is a spontaneous report from a contactable consumer. A 19-year-old female patient received BNT162B2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient died the next morning after getting the vaccine after jogging on an unspecified date. Caller stated the vaccine is causing death, permanent disability, blindness, heart attacks, strokes, and blood clots being the number 1 thing. The patient died on an unspecified date. It was not reported if an autopsy was performed. The following information on the lot/batch number has been requested.; Reported Cause(s) of Death: died the next morning after getting the vaccine after jogging.


VAERS ID: 1703796 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-01
Onset:2021-09-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCVG6 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-02
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Intestinal perforation (Colonperforation); Nicotine addiction; Peritonitis
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101166997

Write-up: Sudden death unexplained; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority-WEB [DE-PEI-202100182701], Safety Report Unique Identifier [DE-PEI-202100182702]. A 75-year-old male patient received bnt162b2 (COMIRNATY, Batch/Lot Number: SCVG6), via an unspecified route of administration on 01Sep2021 (at the age of 75-years-old) as dose number unknown, 0.3ml single for COVID-19 immunisation. Medical history included arterial hypertension and nicotine addiction from an unknown date and unknown if ongoing, intestinal perforation (Colonperforation) and peritonitis from an unknown date and not ongoing. The patient''s concomitant medications were not reported. On 01Sep2021, the patient experienced sudden death unexplained. The outcome of the event was fatal. The patient died on 02Sep2021. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden death unexplained


VAERS ID: 1703798 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D020A / 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: Medical History/Concurrent Conditions: Depression; Hypertension; Obesity; Type II diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101194055

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority-WEB DE-PEI-202100184667. A 60-year-old Female patient received bnt162b2 (COMIRNATY) on 03Aug2021 at the age of 60-year-old (lot: 1D020A) as 0.3 ml single dose for covid-19 immunisation. Medical history included Type II diabetes mellitus, Hypertension, Obesity, Depression. Concomitant medications were not reported. The patient experienced also Unknown cause of death. This report is serious due to death. Assessment: Comirnaty/ Unknown cause of death: D. Unclassifiable. It was unknown if Autopsy Done. The outcome of the event was fatal. No follow-up attempts are possible, information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1703801 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-05
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Circulatory collapse
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-05
   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: DEJNJFOC20210928706

Write-up: ACUTE CIRCULATORY FAILURE; This spontaneous report received from a physician via Regulatory Authority (DE-PEI-202100186382) on 15-SEP-2021 concerned a 78 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: XD975 expiry: UNKNOWN) dose was not reported, administered on 30-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-SEP-2021, the patient experienced acute circulatory failure and died on the same day. 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).


VAERS ID: 1703860 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: real time reverse transcriptase (RT-PCR) test; Test Result: Positive
CDC Split Type: FIPFIZER INC202101197997

Write-up: one was vaccinated with two doses, COVID-19 likely contributed to their death; one was vaccinated with two doses, COVID-19 likely contributed to their death; This is a literature report from the regulatory authority. Authors describe their experiences in controlling it. Cases were detected among patients, healthcare workers (HCW) and in the community. Both symptomatic and asymptomatic infections were found among vaccinated HCW, and secondary transmission occurred from those with symptomatic infections despite use of personal protective equipment (PPE). Authors defined a case-patient or HCW-case as a person with a positive SARS-CoV-2 RT-PCR test with a known exposure to a SARS-CoV-2 outbreak, either when admitted (patient) or when working in one of the four healthcare facilities (HCW). In total, 58 case-patients were detected, 18 of whom died. For the deceased case-patients, the median age was 80 years (range: 62-96), 11 were men, one was vaccinated with two doses, 11 with one dose and six were unvaccinated. For the majority of the deceased case-patients, COVID-19 likely contributed to their death. All had an underlying condition requiring hospital treatment prior to COVID-19 infection. There were 45 HCW-cases in four healthcare facilities (the central hospital and three primary care facilities; Table 1). There were no hospitalisations or deaths among the HCW-cases. Secondary infections (n = 62) occurred also in community in close contacts of case-patients and HCW-cases. In conclusion, this outbreak demonstrated that, despite full vaccination and universal masking of HCW, breakthrough infections by the Delta variant via symptomatic and asymptomatic HCW occurred, causing nosocomical infections. As the Delta variant continues to spread, we suggest that utilization of FFP2/3 respirators while treating COVID-19 patients should be included in national guidelines. A patient of unspecified age and gender received bnt162b2, dose 1 and dose 2 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. One patient was vaccinated with two doses, COVID-19 likely contributed to death. The patient underwent lab tests and procedures which included real time reverse transcriptase (RT-PCR) test: positive. 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 requested. No further information is expected.; Sender''s Comments: A possible contributory role of the suspect products cannot be excluded for the reported events based on the known safety profile The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.; Reported Cause(s) of Death: one was vaccinated with two doses, COVID-19 likely contributed to their death


VAERS ID: 1704526 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / IM

Administered by: Senior Living       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-10
   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: Risperidone, Venlafaxine, Metformin, Simvastatin, Dipyridamole, Omeprazole, Aspirin, Amlodipine, Lorazepam, Perindopril, Senna, Ideos, Lactulose
Current Illness: None
Preexisting Conditions: Hyperlipidemia, Depression, Hypertension, GORD
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death


VAERS ID: 1704855 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-03
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-03
   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: Arterial hypertension; Obesity
Preexisting Conditions: Comments: Arterial hypertension Obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20210927988

Write-up: DEATH UNEXPLAINED; This spontaneous report received from a physician by a Regulatory Authority (FR-AFSSAPS-NT20213771) on 15-SEP-2021 concerned a 63 year old female of unspecified race and ethnic origin. The patient''s weight was 90 kilograms, and height was 166 centimeters. The patient''s concurrent conditions included: obesity, and arterial hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown expiry: Unknown) 1 dosage forms, 1 total, administered on 28-MAY-2021 for severe acute respiratory syndrome (SARS-CoV-2) vaccination (drug start period: 99 days). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 03-SEP-2021, the patient died due to an unknown cause (unexplained death). It was unspecified if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died due to unexplained death on 03-SEP-2021. This report was serious (Death).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1704856 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-07-23
   Days after vaccination:183
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-05
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PERMIXON; KEPPRA [LEVETIRACETAM]; CRESTOR; PLAVIX; KARDEGIC; METFORMINE [METFORMIN]
Current Illness: Arterial stent insertion; Arteritis obliterans (Peripheral artery disease (stent and surgery)); Dysphagia; Non-insulin-dependent diabetes mellitus; Right hemiplegia; Secondary epilepsy
Preexisting Conditions: Medical History/Concurrent Conditions: Benign prostatic hyperplasia; Peripheral vascular disease; Stroke (with right hemiplegia)
Allergies:
Diagnostic Lab Data: Test Date: 20210723; Test Name: PCR COVID; Test Result: Positive
CDC Split Type: FRPFIZER INC202101166930

Write-up: alteration of general condition; Vaccination failure; COVID-19 respiratory infection; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-NY20214157. A 75-year-old male patient received BNT162B2 (COMIRNATY), intramuscularly on 21Jan2021 (Batch/Lot Number: EJ6788; Expiration Date: 30Apr2021) as dose 1, single and intramuscularly on 11Feb2021 (Batch/Lot Number: EJ6788; Expiration Date: 30Apr2021) as dose 2, single for COVID-19 immunisation. Medical history included ongoing arteritis obliterans (Peripheral artery disease, stent and surgery), deglutition disorder/swallowing disorder from 2014 and ongoing, ongoing non-insulin-dependent diabetes mellitus (NIDDM), ongoing arterial stent insertion, secondary epilepsy from 2014 and ongoing, stroke in 2014 with ongoing right hemiplegia and benign prostatic hyperplasia. Concomitant medications included serenoa repens extract (PERMIXON) taken for benign prostatic hyperplasia; levetiracetam (KEPPRA) taken for secondary epilepsy; rosuvastatin calcium (CRESTOR) taken for stroke; clopidogrel bisulfate (PLAVIX) taken for stroke; acetylsalicylate lysine (KARDEGIC) taken for stroke and metformine (METFORMIN) taken for NIDDM. The patient was a resident in an Accommodation Facility for Dependent Elderly. It was reported PCR COVID positive on 23Jul2021. On 24Jul fever which persisted the following day. On 27Jul2021, the patient experienced productive cough. On 31Jul, desaturation under oxygen therapy at 3 litres. Intense fatigue, anorexia. On 4Aug sudden deterioration. No hospitalization. On 5Aug death around 3am. Vaccine failure was confirmed. The patient died on 05Aug2021. An autopsy was not performed. According to the Product Quality Complaint Group: 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 EJ6788. 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. Agency concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The testing 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. Reporter Comment: A 75-year-old man, vaccinated for more than 5 months with 2 doses of COMIRNATY vaccine, presented, in the context of a cluster in an Accommodation Facility for Dependent Elderly, a positive COVID PCR, a productive cough followed by desaturation and a significant alteration of his general condition. No hospitalization. Sudden deterioration and death of the patient 13 days after the positive PCR result. Case corresponding to a failure of vaccination with 2 doses of COMIRNATY in a very elderly subject. No follow-up attempts are needed. No further information is expected.; Reporter''s Comments: A 75-year-old man vaccinated for more than 5 months with 2 doses of COMIRNATY vaccine, presented in the context of a cluster in an Accommodation Facility for Dependent Elderly, a positive COVID PCR, productive cough followed by desaturation and significant alteration of his general condition. No hospitalization. Sudden deterioration and death of the patient 13 days after the positive PCR result. Case corresponding to a failure of vaccination with 2 doses of COMIRNATY in a very elderly subject.; Reported Cause(s) of Death: Vaccination failure; COVID-19 respiratory infection; alteration of general condition


VAERS ID: 1704878 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Multimorbidity
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20210925211

Write-up: DEATH; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION/INFECTED WITH COVID; This spontaneous report received from a consumer via social media concerned 4 patients aged between 73 and 87 years of unspecified race and ethnicity. The patient''s height, and weight were not reported. The patients mostly had co-morbidities at risk of a severe form. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) frequency 1 total, dose and start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced suspected clinical vaccination failure, and suspected covid-19 infection/infected with covid. For the 17 cases of infection where the variant was known, it was always the delta variant. On an unspecified date, the patient died. The cause of death was unknown. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on an unspecified date, and the outcome of suspected covid-19 infection/infected with covid and suspected clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition). This report was associated with a product quality complaint: 90000193325.; Sender''s Comments: V0. 20210925211-covid-19 vaccine ad26.cov2.s- suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS V0: 20210925211-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: 1705330 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-08-05
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1E028A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-05
   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: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101180581

Write-up: Unknown cause of death; This is as spontaneous report received from a consumer downloaded from the Medicine Agency (MA) EudraVigilance-WEB. The regulatory authority report number is DE-PEI-CADR2021174463 Safety report unique identifier DE-PEI-202100183068. A 74-Year-old male patient received bnt162b2 (COMIRNATY) on 21Jul2021 (lot: 1E028A) as 0.3 ml single dose (reported as Dosage text: 2) for covid-19 immunisation. Medical history included ongoing Hypertension. Concomitant medications were not reported. On 05Aug2021 the patient experienced Unknown cause of death. This report is serious due to death. Relatedness Assessment for Unknown cause of death was D. Unclassifiable. Source of assessment: PEI. Information on risk factors or previous illnesses High blood pressure. It was not reported if Autopsy Done. The outcome of the event was fatal. Sender Comment: Information on risk factors or previous illnesses High blood pressure. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1705343 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-25
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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 INC202101205236

Write-up: a friend died 1 week after the second vaccination; This is a spontaneous report based on information received by Pfizer [manufacturer reference number: 86357], license party for COMIRNATY. A contactable other HCP (naturopath office) reported that a 55-year-old female patient (reporter''s friend) received bnt162b2 (COMIRNATY) first dose on 25Apr2021 and second dose 21May2021, both (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. She died 1 week after the second vaccination. It was unknown if Autopsy Done. The outcome of the event was fatal.; Sender''s Comments: Based on the limited information provided and close temporal relationship the causal association or the role of the vaccine BNT162B2 in the unknown cause of death of the patient cannot be completely excluded. The case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: died 1 week after the second vaccination


VAERS ID: 1705427 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7053 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Disease recurrence, Pancreatitis acute, Pulmonary embolism, SARS-CoV-2 test
SMQs:, Acute pancreatitis (narrow), Embolic and thrombotic events, venous (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Embolism pulmonary; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101166635

Write-up: Acute pancreatitis; Embolism pulmonary; Embolism pulmonary/had history of pulmonary embolism; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) EudraVigilance-WEB, regulatory authority number FR-AFSSAPS-BX20218233. A 75-year-old female patient received BNT162B2 (COMIRNATY), dose 2 intramuscular on 25Aug2021 (Batch/Lot Number: FE7053) as single dose for COVID-19 immunisation. Medical history included hypertension and pulmonary embolism. Patient did not had history of COVID-19 (COVID-19 virus test: negative on unknown date). The patient''s concomitant medications were not reported. Patient experienced death on day 1 of dose 2 (26Aug2021) with right pulmonary embolism and acute pancreatitis (hemorrhagic infiltrate of the parenchyma) at autopsy. Outcome of the events was fatal. NB: Allocation made without prejudice to the investigative elements that could be carried out within the framework of legal or amicable compensation procedures. No follow-up activities possible. No further information expected.; Reported Cause(s) of Death: Embolism pulmonary/had history of pulmonary embolism; right pulmonary embolism; Acute pancreatitis; Autopsy-determined Cause(s) of Death: Right Embolism pulmonary; hemorrhagic infiltrate of the pancreatic parenchyma.


VAERS ID: 1705518 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-13
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, Diarrhoea, Drug ineffective
SMQs:, Lack of efficacy/effect (narrow), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-21
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiac failure; Peripheral arterial occlusive disease; Polycystic kidney
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20210928443

Write-up: DRUG INEFFECTIVE; DIARRHEA; COVID-19 PNEUMONITIS; This spontaneous report received from a pharmacist via Regulatory Authority (FR-AFSSAPS-MP20217348) on 15-SEP-2021 concerned an 87 year old female of an unspecified race and ethnic origin. The patient''s height, and weight were not reported. The patient''s concurrent conditions included polycystic kidney, cardiac failure and peripheral arterial occlusive disease. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD955 and expiry: unknown) 1 dosage forms, frequency time 1 total administered on 17-MAY-2021 for covid-19 vaccination. No concomitant medications were reported. On 13-AUG-2021, the patient experienced drug ineffective, diarrhea and Covid-19 pneumonitis. On 21-AUG-2021, the patient died from multiorgan failure. An autopsy was not performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died of drug ineffective, diarrhea and covid-19 pneumonitis on 21-AUG-2021. This report was serious (Death).; Reported Cause(s) of Death: MULTIORGAN FAILURE


VAERS ID: 1705532 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-07-01
   Days after vaccination:140
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, COVID-19, Cerebellar atrophy, Coma scale, Coma scale abnormal, Computerised tomogram head, Computerised tomogram thorax, Confusional state, Dysphagia, Eating disorder, Epistaxis, Facial bones fracture, Fall, Fracture, Gait disturbance, General physical health deterioration, Hyperleukocytosis, Lymphocyte count, Lymphopenia, Oxygen saturation, Oxygen saturation decreased, Pneumonia aspiration, Respiratory disorder, SARS-CoV-2 test, Urine analysis, Vaccination failure
SMQs:, Haematopoietic leukopenia (narrow), Lack of efficacy/effect (narrow), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Malignancy related conditions (narrow), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Osteoporosis/osteopenia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-30
   Days after onset: 29
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: ZOPICLONE; INORIAL; LERCAN; GANFORT; COMBIGAN; ALLOPURINOL
Current Illness: Artificial cardiac pacemaker wearer; Atrioventricular block complete; Cognitive disturbance; Hypertension arterial
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Glaucoma; Hyperuricaemia; Insomnia
Allergies:
Diagnostic Lab Data: Test Date: 20210728; Test Name: Glasgow; Result Unstructured Data: Test Result:14; Test Date: 20210723; Test Name: Cerebral CT scan; Result Unstructured Data: Test Result:cerebellar atrophy; Comments: undisplaced fracture of the posterior wall of the right carotid duct without vascular injury. No bleeding, no mass effect. Partial left ethmoid-maxillary filling with known fracture of the perpendicular blade of the ethmoid.; Test Date: 20210728; Test Name: Thoracic CT scan; Result Unstructured Data: Test Result:suspected inhalation injury; Comments: frosted glass converge into alveolar cells in the declining areas of all the lobes. This aspect is more suggestive of inhalation injury than of COVID lung disease.; Test Date: 20210723; Test Name: CRP; Result Unstructured Data: Test Result:86 mg/l; Test Date: 20210723; Test Name: Lymphocytes; Result Unstructured Data: Test Result:0.44 x10 9/l; Test Date: 20210725; Test Name: Oxygen saturation; Test Result: 82 %; Test Date: 20210726; Test Name: Oxygen saturation; Test Result: 89 %; Test Date: 20210727; Test Name: Oxygen saturation; Test Result: 90 %; Test Date: 20210728; Test Name: Oxygen saturation; Test Result: 94 %; Test Date: 20210729; Test Name: Oxygen saturation; Test Result: 90 %; Test Date: 20210722; Test Name: COVID-19 PCR; Test Result: Positive ; Test Date: 20210722; Test Name: ECBU; Result Unstructured Data: Test Result:sterile
CDC Split Type: FRPFIZER INC202101166937

Write-up: nose fracture; fall; epistaxis; difficulty walking/walking disorders; need for assistance to eat; Glasgow score 14 (confused words); confused words/Confusional syndrome; 89% SaO2; lymphopenia; cerebellar atrophy; Undisplaced fracture of the posterior wall of the right carotid duct/known fracture of the perpendicular blade of the ethmoid; Vaccination failure; PCR COVID positive; General physical health deterioration; inhalation pneumopathy/inhalation pneumonia; Hyperleukocyturia; swallowing disorders; respiratory degradation; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. Regulatory Authority Report Number: FR-AFSSAPS-NY20214132 and a follow-up spontaneous report received from a Product Quality Complaint Group. A 99-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 11Feb2021 (Batch/Lot Number: EJ6788) as DOSE 2, SINGLE, dose 1 intramuscular on 21Jan2021 (Batch/Lot Number: EJ6788) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included ongoing Atrioventricular block complete, ongoing Cognitive disturbance, ongoing Hypertension arterial, ongoing Artificial cardiac pacemaker wearer, Hyperuricaemia, Allergy, Insomnia, Glaucoma. Concomitant medications included zopiclone taken for insomnia; bilastine (INORIAL) taken for Allergy; lercanidipine hydrochloride (LERCAN) taken for hypertension; bimatoprost, timolol maleate (GANFORT) taken for glaucoma; brimonidine tartrate, timolol maleate (COMBIGAN) taken for glaucoma; allopurinol taken for hyperuricaemia. The patient experienced general physical health deterioration on 20Jul2021, inhalation pneumopathy/inhalation pneumonia in Jul2021, vaccination failure and PCR COVID positive on 22Jul2021, difficulty walking/walking disorders on 20Jul2021, need for assistance to eat in Jul2021, fall on 21Jul2021 05:00, epistaxis on 21Jul2021, nose fracture on 22Jul2021, cerebellar atrophy on 23Jul2021, undisplaced fracture of the posterior wall of the right carotid duct/known fracture of the perpendicular blade of the ethmoid on 23Jul2021, hyperleukocyturia in Jul2021, glasgow score 14 on 28Jul2021, 89% sao2 on 25Jul2021, lymphopenia on 23Jul2021, swallowing disorders in Jul2021, respiratory degradation in Jul2021, confused words/confusional syndrome on 27Jul2021. Outcome of general physical health deterioration and inhalation pneumopathy/inhalation pneumonia was fatal, outcome of vaccination failure and PCR COVID positive was not recovered, outcome of other events was unknown. The patient died on 30Jul2021. An autopsy was not performed. The clinical course was reported as: A 99-year-old man, vaccinated for more than 6 months with 2 doses of COMIRNATY vaccine, presented, in the context of a cluster in an nursing home, an alteration of his general condition with difficulty walking and need for assistance to eat, then a fall. Hospitalization complicated by an inhalation pneumopathy, without any sign of COVID pneumopathy on the scan. Presence of lymphopenia. Death a few days later due to the consequences of the inhalation pneumopathy and in a context of implementation of comfort care. No information about variant. On 20Jul2021 walking disorders, need to provide food aid in the context of a COVID cluster. On 21Jul2021 at 5 a.m., collapsed in his room, severe epistaxis. On 22Jul2021, transfer to the emergency room, PCR COVID positive. Diagnosis of nose fracture. Hospitalization in the geriatric sector. Sterile ECBU (urine examination). On 23Jul2021: lymphopenia at 0.44 G / L, CRP 86 mg / L, non productive fatty cough, no indrawing or dyspnea. Cerebral CT: cerebellar atrophy. Undisplaced fracture of the posterior wall of the right carotid duct without vascular injury. No bleeding, no mass effect. Partial left ethmoid-maxillary filling with known fracture of the perpendicular blade of the ethmoid. Apyretic patient. Urinary globe evacuated. Hyperleukocyturia but no germ. On 25Jul2021 82% desaturation following a false route, then stabilization of the oxygen saturation at 92 under 2-liter glasses. Presence of swallowing disorders. The patient is asleep but can be woken up. Introduction of AUGMENTIN for the prevention of aspiration pneumonia and urinary tract infection. On 26Jul2021 89% SaO2 (oxygen saturation), crackling on the left base. AUGMENTIN continued. On 27Jul2021 SaO2 90% under 6 liters of O2. Confusional syndrome, slight neurological improvement. Sweats, ronchi and crackles on the left base. So critical situation with respiratory degradation. On 28Jul2021 SaO2 94% under 6 liters of O2. Awake patient, Glasgow score 14 (confused words). Bibasal crackles predominantly on the left, without indrawing or dyspnea. Thoracic CT scan: ground glass confluent in alveolar in the declining areas of all the lobes. This aspect is more suggestive of inhalation injury than of COVID lung disease. On 29Jul2021: SaO2 90% under 6 liters. Patient not very reactive, moaning, with polypnea and discomfort. Start of midazolam for comfort and orientation towards pure supportive care. On 30Jul2021 death at 5.30 a.m. PQC investigational result: 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 EJ6788. 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. Company 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 are possible. No further information is expected.; Reporter''s Comments: 99 yo man, vaccinated for more than 6 months with 2 doses of COMIRNATY, in the context of an nursing home cluster, an alteration in his general condition with difficulty in walking and the need for help to eat, then a fall. Hospitalization complicated by aspiration pneumonia, with no sign of COVID lung disease on CT scan. Presence of lymphopenia. Death a few days later from the consequences of inhalation pneumonia and in the context of the implementation of comfort care. No information on the variant.; Reported Cause(s) of Death: general physical health deterioration; inhalation pneumonia


VAERS ID: 1705533 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-07-23
   Days after vaccination:141
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Abdominal pain, Alanine aminotransferase, Alanine aminotransferase increased, Aspartate aminotransferase, Aspartate aminotransferase increased, Bladder disorder, Blood bilirubin, Blood creatine increased, Blood creatinine, Blood potassium, Breast hyperplasia, Breast mass, C-reactive protein, COVID-19 pneumonia, Computerised tomogram, Condition aggravated, Cough, Decreased appetite, Dehydration, Diarrhoea, Diverticulum intestinal, Fall, Fatigue, Hyperkalaemia, Hypernatraemia, N-terminal prohormone brain natriuretic peptide, N-terminal prohormone brain natriuretic peptide increased, Oxygen saturation decreased, Palliative care, Psychomotor hyperactivity, Refusal of treatment by patient, SARS-CoV-2 test, Skin injury, Troponin, Troponin increased, Vaccination failure, Wound
SMQs:, Cardiac failure (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Akathisia (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific dysfunction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Chronic kidney disease (broad), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-09
   Days after onset: 17
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: ELIQUIS; FUROSEMIDE; INEXIUM [ESOMEPRAZOLE MAGNESIUM]; MOLSIDOMINE; RAMIPRIL
Current Illness: Arrhythmia; Cardiac failure; Dementia; Hypertension arterial
Preexisting Conditions: Medical History/Concurrent Conditions: Living in nursing home; Transient ischaemic attack
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: ALAT; Result Unstructured Data: Test Result:42 IU/l; Test Date: 20210803; Test Name: ASAT; Result Unstructured Data: Test Result:52 IU/l; Test Date: 20210803; Test Name: bilirubin; Result Unstructured Data: Test Result:8 umol/l; Test Date: 20210803; Test Name: creatinine; Result Unstructured Data: Test Result:166 umol/l; Test Date: 20210803; Test Name: Blood potassium; Result Unstructured Data: Test Result:4.54 mmol/L; Test Date: 20210803; Test Name: CT; Result Unstructured Data: Test Result:Moderate COVID impairment; Comments: Moderate COVID impairment of the lung parenchyma (approximately 40%). No dilation of the urinary tract. Mass of the left breast: probable phyllodes. Uncomplicated sigmoid colonic diverticulosis.; Test Date: 20210803; Test Name: CRP; Result Unstructured Data: Test Result:47.8 mg/l; Test Date: 20210803; Test Name: NT-proBNP; Result Unstructured Data: Test Result:6414 ng/L; Test Date: 20210726; Test Name: COVID-19 PCR test; Test Result: Positive ; Test Date: 20210803; Test Name: Troponin; Result Unstructured Data: Test Result:65 ug/L
CDC Split Type: FRPFIZER INC202101166947

Write-up: psychomotor agitation; sudden desaturation; dehydration; tearing of the subcutaneous route; condition aggravated/deterioration of his condition; anorexia; end-of-life support; eupneic, greasy cough; painful bloated abdomen; with suspicion of bladder globe; painful bloated abdomen; Mass of the left breast: probable phyllodes; Mass of the left breast: probable phyllodes; Uncomplicated sigmoid colonic diverticulosis; hypernatremia; creatinemia; ASAT 52 IU / L; ALAT 42 IU / L; Troponins 65 ug / L; NT-proBNP 6414 ng / L; moderate hyperkalaemia; Refusal of treatment by patient; COVID-19 pneumonitis; Vaccination failure; fatigue; watery stools; fall with scalp wound; fall with scalp wound; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-NY20214150 and a follow-up report received from Product Complaint Team.. A 95-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 04Mar2021 (Batch/Lot Number:EP2166; Expiration Date: 31May2021) as DOSE 2, SINGLE, dose 1 intramuscular on 11Feb2021 (Batch/Lot Number: EJ6788; Expiration Date: 30Apr2021) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included ongoing hypertension, transient ischaemic attack, ongoing arrhythmia, ongoing dementia, ongoing cardiac failure, living in residential institution. Concomitant medications included apixaban (ELIQUIS) taken for arrhythmia; furosemide taken for cardiac failure; esomeprazole magnesium (INEXIUM [ESOMEPRAZOLE MAGNESIUM]); molsidomine taken for cardiac failure; ramipril taken for cardiac failure. The patient experienced covid-19 pneumonitis and vaccination failure on 26Jul2021, condition aggravated/deterioration of his condition and anorexia on 03Aug2021, fall with scalp wound, psychomotor agitation on 05Aug2021, sudden desaturation 05Aug2021, dehydration on 05Aug2021, tearing of the subcutaneous route on 05Aug2021, moderate hyperkalaemia in Aug2021, refusal of treatment by patient in Aug2021, fatigue on 25Jul2021, watery stools on 25Jul2021, painful bloated abdomen on 05Aug2021, end-of-life support on 06Aug2021, eupneic, greasy cough on 05Aug2021, painful bloated abdomen on 05Aug2021, with suspicion of bladder globe on 05Aug2021, mass of the left breast: probable phyllodes in Aug2021. The patient died on 09Aug2021. An autopsy was not performed. The outcome of COVID-19 pneumonitis and Vaccination failure was fatal, outcome of other events was unknown. The clinical course was reported as: A 95-year-old woman, vaccinated for about 5 months with 2 doses of COMIRNATY vaccine, presented with COVID pneumopathy (40% involvement on CT scan) in the context of a cluster in accommodation facility for dependent elderly people. Hospitalization at home in a context of opposition to care. Death of the patient 2 weeks after detection of COVID by PCR. Case corresponding to a failure of vaccination with 2 doses of COMIRNATY in a very elderly subject. On 23Jul2021 the patient had a fall with scalp wound; on 25Jul2021 the patient experienced fatigue, watery stools; On 26Jul2021 COVID PCR tested Positive; On 27Jul2021 the patient returned to the emergency room because the wound is bleeding following the fall of 23Jul2021. On 03Aug2021 the patient experienced deterioration of his condition with anorexia, O2 to 2L, hospitalized on 05Aug2021 following a sudden desaturation, deterioration of the general condition with psychomotor agitation, dehydration, desaturation, tearing of the subcutaneous route. On admission, eupneic, greasy cough, crackling at the bases, painful bloated abdomen with suspicion of bladder globe. No digestive disorder. TAP scanner identified moderate COVID impairment of the lung parenchyma (approximately 40%). No dilation of the urinary tract. Mass of the left breast: probable phyllodes. Uncomplicated sigmoid colonic diverticulosis. Biology identified hypernatremia, moderate hyperkalaemia (4.54 mmol / L), creatinemia 166 �mol / L (IRA KDIGO 2), ASAT 52 IU / L, ALAT 42 IU / L, Bilirubin 8 �M, PCR 47.8 mg / L, Troponins 65 �g / L, NT-proBNP 6414 ng / L. Behavior in opposition to care. Returned on 06Aug2021 in home hospitalization for end-of-life support under midazolam, morphine and minimal hydration. Death on 09Aug2021 at the accommodation facility for dependent elderly people. PQC investigation result: 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 EJ6788 and EP2166. 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. Agency 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 are possible, no further information is expected.; Reported Cause(s) of Death: Covid-19 pneumonitis with general condition aggraveted; refusal of treatment


VAERS ID: 1705534 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-05-21
   Days after vaccination:99
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Adult failure to thrive, Body temperature, COVID-19, Diet refusal, General physical health deterioration, Oxygen saturation, SARS-CoV-2 test, Slipping rib syndrome, Vaccination failure, Vomiting
SMQs:, Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-15
   Days after onset: 86
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PANTOPRAZOLE; CITALOPRAM HYDROBROMIDE; ZOCOR; VITAMIN D2; FUROSEMIDE; KARDEGIC; VITAMINE B12; LIORESAL
Current Illness: AFib; Bedridden; Stroke; Vascular dementia
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia; Arterial hypertension; Atrial fibrillation; Cerebrovascular accident; Prophylaxis; Vitamin B12 supplementation; Vitamin D supplementation
Allergies:
Diagnostic Lab Data: Test Date: 20210722; Test Name: body temperature; Result Unstructured Data: Test Result:38.5 Centigrade; Comments: at 7 p.m; Test Date: 20210723; Test Name: body temperature; Result Unstructured Data: Test Result:39 Centigrade; Test Date: 20210723; Test Name: SaO2; Test Result: 96 %; Test Date: 20210723; Test Name: PCR COVID; Test Result: Positive
CDC Split Type: FRPFIZER INC202101166917

Write-up: Adult failure to thrive; slip syndrome / post-COVID slip syndrome; deterioration of the general condition; refusal to eat and drink; Vaccination failure; COVID-19 respiratory infection; vomiting; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is FR-AFSSAPS-NY20214159. A 99-year-old female patient received the second dose and the first dose of BNT162B2 (COMIRNATY), the second dose on 11Feb2021, the first dose on 21Jan2021, both via intramuscular (Lot Number: EJ6788; Expiration Date: 30Apr2021) as single does for COVID-19 immunization. Medical history included ongoing stroke with grabatisation, complete arrhythmia by atrial fibrillation, ongoing vascular dementia, arterial hypertension, prophylaxis, cerebrovascular accident, vitamin d supplementation, vitamin b12 supplementation, ongoing bedridden and ongoing AFib. Concomitant medications included pantoprazole taken for prophylaxis, citalopram hydrobromide taken for bedridden, simvastatin (ZOCOR) taken for cerebrovascular accident, vitamin d2 taken for vitamin d supplementation, furosemide taken for hypertension arterial, acetylsalicylate lysine (KARDEGIC) taken for AFib, cyanocobalamin (VITAMINE B12) taken for vitamin B12 supplementation and baclofen (LIORESAL) taken for bedridden. On 23Jul2021, the patient experienced COVID-19 respiratory infection. The patient vaccinated for more than 5 months with 2 doses of COMIRNATY vaccine, presented, in a cluster context in an nursing home, a respiratory infection with positive PCR COVID. On 07Aug2021, the patient experienced adult failure to thrive. She was managed with oxygen therapy but developed a geraitric cachexia one week later. No hospitalization. The patient died 23 days after the positive PCR result. On 21May2021, the patient experienced vomiting. On 22Jul2021, the patient experienced fever at 38.5 C at 7 p.m. On 23Jul2021, the patient experienced fever at 39 C in the morning, SaO2 at 96%, wheezing, put under O2 at 1.5L. PCR COVID positive. Maintenance of oxygen therapy at 1.5l until 30Jul2021 without real respiratory signs. On 07Aug2021, deterioration of the general condition with refusal to eat and drink, slip syndrome. On 15Aug2021, the patient death in the morning from post-COVID slip syndrome. Case forming part of a cluster in an accommodation facility for dependent elderly people, confirmed vaccine failure. Autopsy was none. The outcome of vaccination failure, COVID-19, adult failure to thrive and slipping rib syndrome was fatal. The outcome of other events was unknown. On 09Sep2021, investigation result received from Product Complaint Team: 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 EJ6788.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. It 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.; Reporter''s Comments: 99-year-old woman, vaccinated for more than 5 months with 2 doses of COMIRNATY vaccine, who presents, in a cluster context in an accommodation facility for dependent elderly people, a respiratory infection with positive COVID PCR. Supported by oxygen therapy but evolution a week later to slip syndrome. No hospitalization. Death of the patient 23 days after the positive result of the PCR. Case corresponding to failure of vaccination with 2 doses of COMIRNATY in the very elderly.; Reported Cause(s) of Death: Adult failure to thrive; Slipping rib syndrome; COVID infection with slip syndrome; COVID infection with slip syndrome


VAERS ID: 1705786 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Death, Feeling abnormal, Headache, Off label use, Product use issue, Tenderness, Vaccination site pain, Vomiting
SMQs:, Acute pancreatitis (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-05
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DESOGESTREL; LEVOTHYROXINE
Current Illness: Breast feeding
Preexisting Conditions: Medical History/Concurrent Conditions: Contraception; Hypothyroidism
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101176267

Write-up: Death; vomiting; Headache; Vaccination site tenderness; Tenderness; axillary tenderness; patient was ongoing breast feeding; patient was ongoing breast feeding; Feels awful; This is a spontaneous report from a contactable physician. This is the first of two reports. This is a mother report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109061511549570-1ZNIO, Safety Report Unique Identifier GB-MHRA-ADR 25900926. A 25-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: FE8087), via an unspecified route of administration on 21Aug2021 (at the age of 25-year-old) at single dose for COVID-19 immunisation. Medical history included ongoing breast feeding, contraception, hypothyroidism. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant. Patient is not enrolled in clinical trial. Concomitant medications included desogestrel taken for contraception from 02Mar2015; levothyroxine taken for hypothyroidism from 19Jan2017. The patient experienced death/death unexplained on 05Sep2021; vomiting, headache, vaccination site tenderness and tenderness, all on 31Aug2021; felt awful in 2021. It was reported that patient died on 05Sep2021. Cause of death not currently known, but had presented on 31Aug2021 complaining of headaches, vomiting and vaccination site and axillary tenderness post vaccination. Described feeling awful since her second vaccination in 2021. Patient has not tested positive for COVID-19 since having the vaccine. This report did not relate to possible blood clots or low platelet counts. Relevant investigations or tests conducted included awaiting post-mortem. The patient died on 05Sep2021. It was unknown if an autopsy was performed. The outcome of the other events was unknown. This report was reported as serious due to death. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101182782 Baby case; Reported Cause(s) of Death: death


VAERS ID: 1705877 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: ADAMTS13 activity assay, Activated partial thromboplastin time, Antinuclear antibody, Blood bilirubin unconjugated, Blood creatinine, Blood fibrinogen, Blood lactate dehydrogenase, Blood smear test, Blood test, Coagulation test, Coombs direct test, Coombs indirect test, Cytomegalovirus test, Epstein-Barr virus test, Full blood count, HIV test, Haemoglobin, Haptoglobin, Hepatitis B virus test, Hepatitis C virus test, Immune thrombocytopenia, International normalised ratio, Investigation, Platelet count, Renal function test, Reticulocyte count, White blood cell count
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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Insulin therapy; Steroid diabetes
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: aPTT; Test Result: 24 s; Test Date: 2021; Test Name: rapid ADAMTS13 test; Result Unstructured Data: Test Result:demonstrating markedly reduced activity (below 10%; Comments: demonstrating markedly reduced activity (below 10%) with high titer of anti-ADAMTS13 antibodies according to enzyme-linked immunosorbent assay (ELISA) in serum (40 U/mL; n.v. 12-15 U/mL), thus confirming the diagnosis of immune-mediated thrombotic thrombocytopenic purpura.; Test Date: 2021; Test Name: anti-nuclear antibodies; Result Unstructured Data: Test Result:1/640; Comments: normal values <1/80; Test Date: 2021; Test Name: unconjugated bilirubin; Test Result: 5.5 mg/dl; Comments: increased; Test Date: 2021; Test Name: Creatinine; Result Unstructured Data: Test Result:0.88; Test Date: 2021; Test Name: Fibrinogen; Test Result: 141 mg/dl; Test Date: 2021; Test Name: lactate dehydrogenase; Result Unstructured Data: Test Result:1905 IU/l; Comments: increased; Test Date: 2021; Test Name: Peripheral blood smear examination; Result Unstructured Data: Test Result:revealed increased number of schistocytes (10% per; Comments: revealed increased number of schistocytes (10% per field).; Test Date: 2021; Test Name: Hemolysis markers; Result Unstructured Data: Test Result:were present, including increased reticulocytes, i; Comments: were present, including increased reticulocytes, increased lactate dehydrogenase (1905 U/L, n.v: 0- 248), increased unconjugated bilirubin (5.5 mg/dL, n.v: 0.30-1.20) and reduced haptoglobin (less than 7 mg/dl); Test Date: 2021; Test Name: Coagulation test; Result Unstructured Data: Test Result:were within normal limits; Test Date: 2021; Test Name: direct antiglobulin test; Test Result: Negative ; Test Date: 2021; Test Name: indirect antiglobulin test; Test Result: Negative ; Test Date: 2021; Test Name: tumor markers and infectious screening for cytomegalovirus (CMV); Test Result: Negative ; Test Date: 2021; Test Name: infectious screening for Epstein-Barr virus (EBV); Test Result: Negative ; Test Date: 2021; Test Name: Complete blood count (CBC); Result Unstructured Data: Test Result:revealed grade 3 anemia (Hb 6.1 g/dl); Comments: revealed grade 3 anemia (Hb 6.1 g/dl) and thrombocytopenia (PLT 46.000/mmc); Test Date: 2021; Test Name: Complete blood count (CBC); Result Unstructured Data: Test Result:showed severe anemia (Hb 5.6 g/dl) and thrombocyto; Comments: showed severe anemia (Hb 5.6 g/dl) and thrombocytopenia (PLT 23.000/mmc) with normal white blood cell count.; Test Date: 2021; Test Name: Hb; Result Unstructured Data: Test Result:6.1 g/dl; Test Date: 2021; Test Name: Hb; Result Unstructured Data: Test Result:5.6 g/dl; Test Date: 2021; Test Name: haptoglobin; Result Unstructured Data: Test Result:less than 7 mg/dl; Comments: reduced; Test Date: 2021; Test Name: infectious screening for Hepatic B virus (HBV); Test Result: Negative ; Test Date: 2021; Test Name: infectious screening for Hepatic C virus (HBV); Test Result: Negative ; Test Date: 2021; Test Name: Human immunodeficiency virus (HIV); Test Result: Negative ; Test Date: 2021; Test Name: infectious screening for Human immunodeficiency virus (HIV); Test Result: Negative ; Test Date: 2021; Test Name: INR; Result Unstructured Data: Test Result:1.14; Test Date: 2021; Test Name: Autoimmunity screening; Result Unstructured Data: Test Result:revealed the presence of anti nuclear antibodies (; Comments: revealed the presence of antinuclear antibodies (ANA) 1/640 (normal values less than 1/80); Test Date: 2021; Test Name: clinical examination; Result Unstructured Data: Test Result:diffuse petechiae and venipuncture hematomas were; Comments: diffuse petechiae and venipuncture hematomas were observed.; Test Date: 2021; Test Name: PLASMIC scoring evaluation; Result Unstructured Data: Test Result:classified the patient as high risk of severe; Comments: classified the patient as high risk of severe ADAMTS13 deficiency (6 points); Test Date: 2021; Test Name: tumor markers and infectious screening for ePSTEIN-bARR VIRUS (EBV); Test Result: Negative ; Test Name: PLT; Result Unstructured Data: Test Result:30,000 /mm3; Test Date: 2021; Test Name: PLT; Result Unstructured Data: Test Result:46,000 /mm3; Comments: thrombocytopenia; Test Date: 2021; Test Name: PLT; Result Unstructured Data: Test Result:23,000 /mm3; Comments: thrombocytopenia; Test Date: 2021; Test Name: renal function tests; Result Unstructured Data: Test Result:were within normal limits; Test Date: 2021; Test Name: reticulocytes; Result Unstructured Data: Test Result:increased; Test Date: 2021; Test Name: Reticulocytes; Test Result: 28 %; Test Date: 2021; Test Name: white blood cell count; Result Unstructured Data: Test Result:normal; Test Date: 2021; Test Name: white blood cell count; Result Unstructured Data: Test Result:9,260 /mm3
CDC Split Type: ITPFIZER INC202101198080

Write-up: Immune-mediated thrombotic thrombocytopenic purpura; This is a literature report from the This author reported similar events for two patients. This is first of two reports. Here we report a case of iTTP following the first dose of Pfizer-BioNTech COVID-19 vaccine. Case 1. In April 2021, an 83-year-old female patient was admitted to the emergency room with severe anemia and macro-hematuria, in the absence of fever, neurological signs and renal impairment. In clinical examination, diffuse petechiae and venipuncture hematomas were observed. The patient suffered from undifferentiated connective tissue disease treated with low-dose steroids and steroid-induced diabetes mellitus. First dose of Pfizer-BioNTech COVID-19 vaccine was administered fourteen days prior to admission. One week before the admission, the patient was admitted briefly at another center due to fatigue and appearance of petechiae. Complete blood count (CBC) count revealed grade 3 anemia (Hb 6.1 g/dl) and thrombocytopenia (PLT 46.000/mmc), requiring transfusion support. However, the patient refused hospital admission and was discharged. Seven days later, at admission to our center, the CBC showed severe anemia (Hb 5.6 g/dl) and thrombocytopenia (PLT 23.000/mmc) with normal white blood cell count. Hemolysis markers were present, including increased reticulocytes, increased lactate dehydrogenase (1905 U/L, n.v: 0- 248), increased unconjugated bilirubin (5.5 mg/dL, n.v: 0.30-1.20) and reduced haptoglobin (less than 7 mg/dL) (table 2). Coagulation and renal function tests were within normal limits. Both direct and indirect antiglobulin test resulted negative. Peripheral blood smear examination revealed increased number of schistocytes (10% per field). The PLASMIC scoring evaluation classified the patient as high risk of severe ADAMTS13 deficiency (6 points)6 . In the meantime, both tumor markers and infectious screening for Hepatitis B virus (HBV), Hepatitis C virus (HCV), Human immunodeficiency virus (HIV), Cytomegalovirus (CMV) and Epstein-Barr virus (EBV) resulted negative. Autoimmunity screening revealed the presence of anti-nuclear antibodies (ANA) 1/640 (normal values less than 1/80). A rapid ADAMTS13 test was performed demonstrating markedly reduced activity (below 10%) with high titer of anti-ADAMTS13 antibodies according to enzyme-linked immunosorbent assay (ELISA) in serum (40 U/mL; n.v. 12-15 U/mL), thus confirming the diagnosis of immune-mediated thrombotic thrombocytopenic purpura. She was promptly started on intravenous (i.v.) metilprednisolone 1 mg/kg and daily sessions of plasma exchange in combination with the humanized anti-von Willebrand Factor nanobody, caplacizumab. Caplacizumab was administered i.v. at the dosage of 10 mg before the first plasma-exchange, followed by 10 mg subcutaneous injections after each plasma-exchange. She was transfused with several units of concentrated red blood cells. After the initial clinical benefit with hematuria resolution and initial signs of hematological recovery with platelet count of 30.000/mmc, the patient passed away after only two days of treatment, probably due to a sudden cardiovascular event. In the first case, the patient also suffered from undifferentiated connective tissue disorder, an autoimmune disease that might have been a predisposing factor to post-vaccination TTP. In the literature, there is evidence of vaccine induced autoimmunity, adjuvant-induced autoimmunity and antibody cross-reaction in both experimental models as well as human patients In our cases, the development of another disease characterized by an increased thrombotic risk was described following a mRNA COVID-19 vaccine. Furthermore, the clinical cases we have described confirm that even a single administration of vaccine can induce the development of autoimmune manifestations especially in predisposed subjects. In the case of development of antibodies against ADAMTS13 the consequences can be very serious and even fatal. Therefore, it is always necessary to carry out an in-depth anamnesis before the administration of COVID-19 vaccines, and a careful clinical surveillance in the post-vaccine period must be taken into consideration in patients with autoimmune diseases or a clinical or family history leading to the suspicion of an autoimmune diathesis. Table 2. Case 1: clinical and laboratory characteristics at diagnosis. Age 83 years; Sex Female; Comorbidities undifferentiated connective tissue disease; meta-steroid diabetes mellitus; MedicationsLow dose steroids; insulin therapy; Time from vaccination to admission: Fourteen days; Hb 5.6 g/dl (n.v. 12-16 g/dl); PLT23,000/mmc (n.v. 130,000-400,000/mmc); WBC 9,260/mmc (n.v. 4,800-10,800/mmc); INR1.14 (n.v. 0.8-1,2); aPTT 24 sec (n.v. 24-36 sec); Fibrinogen 141 mg/dL (n.v. 170-400); Reticulocytes 28% (n.v. 0-25%); LDH 1905 U/L (n.v. 0-248 U/L); Haptoglobin less than 7 mg (n.v. 36-145 mg/dL); Unconjugated bilirubin5.5 mg/dL(n.v. 0.30-1.20); Creatinine 0.88 (n.v. 0.51-0.95). No follow-up attempts are needed; information about batch/lot number cannot be obtained.; Sender''s Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of Immune thrombocytopenia due to temporal relationship. 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) : IT-PFIZER INC-202101198207 Same article/drug/event; Different patient; Reported Cause(s) of Death: Immune-mediated thrombotic thrombocytopenic purpura


VAERS ID: 1706055 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-31
Onset:2021-09-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0203 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acidosis, Base excess, Blood bicarbonate, Blood creatine phosphokinase, Blood creatine phosphokinase MB, Blood glucose, Body temperature, Cardio-respiratory arrest, Cardiomegaly, Computerised tomogram, Fall, Fibrin D dimer, Fibrin D dimer increased, Loss of consciousness, Myocardial infarction, PCO2, PO2, Platelet count, Pyrexia, Thrombocytopenia, Thrombosis, Troponin, Vomiting, pH body fluid
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haematopoietic thrombocytopenia (narrow), Lactic acidosis (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-02
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: GASMOTIN; URSO [URSODEOXYCHOLIC ACID]; ROHYPNOL; EPINASTINE; DAIOKANZOTO; INVEGA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gross obesity (body weight of more than 120 kg); Schizophrenia (the patient was admitted to hospital and received treatment in the spring of 2021); Weight increased (after discharge)
Allergies:
Diagnostic Lab Data: Test Date: 20210902; Test Name: B.E.; Result Unstructured Data: Test Result:-17.8; Test Date: 20210902; Test Name: HCO3; Result Unstructured Data: Test Result:19.9; Test Date: 20210902; Test Name: CK; Result Unstructured Data: Test Result:251; Test Date: 20210902; Test Name: CKM-B; Result Unstructured Data: Test Result:22; Test Date: 20210902; Test Name: BS; Result Unstructured Data: Test Result:265; Test Date: 20210831; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination; Test Date: 20210902; Test Name: AiCT; Result Unstructured Data: Test Result:no cerebral haemorrhage or macroangiopathy; Test Date: 20210902; Test Name: D-dimer; Result Unstructured Data: Test Result:8.7; Test Date: 20210902; Test Name: pCO2; Result Unstructured Data: Test Result:114.0; Test Date: 20210902; Test Name: pH; Result Unstructured Data: Test Result:6.873; Test Date: 20210902; Test Name: Platelets; Result Unstructured Data: Test Result:146000; Comments: mild decrease; Test Date: 20210902; Test Name: pO2; Result Unstructured Data: Test Result:32; Test Date: 20210902; Test Name: Troponin; Result Unstructured Data: Test Result:36.4
CDC Split Type: JPPFIZER INC202101153568

Write-up: fell backward/cardio-respiratory arrest; loss of consciousness; suddenly experienced vomiting; fell backward; pathological condition due to thromboembolism such as pulmonary thromboembolism and myocardial infarction/Thrombosis (including thromboembolism) (with thrombocytopenia only); Thrombocytopenia; marked acidosis; pyrexia; high value of D-dimer; myocardial infarction; cardiomegaly to a small degree (right side of the heart was also enlarged); This is a spontaneous report from a contactable physician received from the Agency. Regulatory authority report number is v21126506. A 47-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 31Aug2021 (Batch/Lot Number: EW0203; Expiration Date: 30Sep2021) as dose 2, single for Covid-19 immunization; paliperidone (INVEGA), oral from an unspecified date (Batch/Lot number was not reported) to an unspecified date for an unspecified indication. Medical history included schizophrenia (not ongoing; the patient was admitted to hospital and received treatment in the spring of 2021), weight increased (after discharge), and gross obesity (body weight of more than 120 kg). Concomitant medications included mosapride citrate (GASMOTIN), ursodeoxycholic acid (URSO), flunitrazepam (ROHYPNOL), epinastine (EPINASTINE), and glycyrrhiza spp. root, rheum spp. rhizome (DAIOKANZOTO); all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of Comirnaty (lot number: EW0203, expiration date: 30Sep2021) on 10Aug2021 for Covid-19 immunization. The patient was a 47-year-old male (age at vaccination was 47 years old). Body temperature before vaccination was 36.7 degrees centigrade. Family history was not reported. On 02Sep2021 at 11:30 (2 days after the vaccination), the patient experienced thrombosis (including thromboembolism) (with thrombocytopenia only). On 02Sep2021 (2 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The patient had past medical history of schizophrenia, for which the patient was admitted to hospital and received treatment in the spring of 2021. After discharge, the patient had oral intake increased and weight increased (The patient weight was over 120 kg) at a fast rate. On 10Aug2021 and (blank)Aug2021, the patient received BNT162b2 (lot number: EW0203). On 01Sep2021, the patient developed pyrexia but had no particular change. On 02Sep2021 at around 11:30, when the patient started to eat meal, the patient suddenly experienced vomiting and fell backward. The patient''s mother witnessed this; however, due to poor physical condition, the mother contacted a wife (nurse) of the head family who lived nearby and the nurse judged that the patient had cardio-respiratory arrest, requested ambulance, and initiated cardiopulmonary resuscitation (CPR). When emergency squad arrived, the patient was in asystole and CPR was continued. At 12:04, a physician of air ambulance arrived at the patient''s home. The patient was in asystole, for which adrenaline 1 ampule (A) was intravenously administered and endotracheal intubation was performed (there was no foreign body in respiratory tract). Subsequently, asystole persisted, and adrenaline was administered 3 times in total. At 12:26, the patient arrived at hospital. After the patient arrived at hospital at 12:26, asystole persisted although adrenaline was administered. At 12:36, CPR was discontinued. At 12:41, death was confirmed. Blood test showed marked acidosis (pH 6.873, carbon dioxide partial pressure [pCO2] 114.0, oxygen partial pressure [pO2] 32, bicarbonate [HCO3] 19.9, base excess [B.E.] -17.8), D-dimer 8.7, troponin 36.4; there were no other extremely abnormal values. Mild decrease in platelets was noted at 146000. Creatine kinase (CK) was 251 (CKM-B was 22), and blood glucose (BS) was 265. Autopsy imaging (AiCT) showed no cerebral haemorrhage or macroangiopathy. Since no contrast-enhanced CT was performed, assessment of pulmonary artery was difficult, but there was a possibility of pulmonary artery thrombosis. No apparent calcification was noted in coronary artery. The outcome of other events was unknown. The patient died on 02Sep2021 due to thrombosis and thrombocytopenia. An autopsy was not performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases were gross obesity, body weight of more than 120 kg, and risk of thrombus due to oral medication INVEGA, etc. The reporting physician commented as follows: The patient originally had schizophrenia and gross obesity. After the patient received the second dose of BNT162b2 on 31Aug2021, the patient developed pyrexia on 01Sep2021, sudden vomiting at lunch on 02Sep2021, followed by loss of consciousness and a state of cardiopulmonary arrest (CPA). No apparent airway obstruction or asphyxia was noted. AiCT showed no cerebral haemorrhage or macroangiopathy. Since blood test revealed high value of D-dimer and cardiomegaly to a small degree (right side of the heart was also enlarged), there was a possibility of pulmonary embolism. In addition, since the patient was at acute phase, increase in myogenic enzymes and troponin was not clear; however, there was a good chance of CPA due to arrhythmia caused by myocardial infarction, etc. In any case, pathological condition due to thromboembolism such as pulmonary thromboembolism and myocardial infarction was considered (pathological autopsy was not performed at the request of family member). The case was reported although it was not clear whether the vaccine was involved in thrombus formation because of obesity the patient originally had and involvement of drugs.; Reporter''s Comments: The patient originally had schizophrenia and gross obesity. After the patient received the second dose of BNT162b2 on 31Aug2021, the patient developed pyrexia on 01Sep2021, sudden vomiting at lunch on 02Sep2021, followed by loss of consciousness and a state of cardiopulmonary arrest (CPA). No apparent airway obstruction or asphyxia was noted. AiCT showed no cerebral haemorrhage or macroangiopathy. There was a possibility of pulmonary embolism thromboembolism.; Reported Cause(s) of Death: Thrombocytopenia; pathological condition due to thromboembolism such as pulmonary thromboembolism and myocardial infarction/Thrombosis (including thromboembolism) (with thrombocytopenia only)


VAERS ID: 1706079 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-08-26
   Days after vaccination:104
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal heart rate, Foetal heart rate abnormal, Maternal exposure before pregnancy
SMQs:, 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: 2021-08-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: fetal heart rate; Result Unstructured Data: Test Result:no fetal heartbeat
CDC Split Type: JPPFIZER INC202101163799

Write-up: the patient''s mother was pregnant confirmed by previous doctor on 03Aug2021(the patient''s mother received the first single dose on 14May2021 ); no fetal heartbeat; This is a spontaneous report from a contactable physician received via COVID-19 adverse event self-reporting solution. This physician reported information for both mother and fetus. This is a fetus report. A fetus patient of an unspecified gender received BNT162B2 (COMIRNATY; Solution for injection; Batch/Lot Number: EY2173; Expiration Date: 31Aug2021), via transplacental route which was administered to her mother in her left arm on 14May2021 at 13:45 as dose 1, single for COVID-19 immunisation for her mother. The patient medical history was not reported. Concomitant medication included folic acid. The patient was 9 weeks and 1day fetus. The patient''s mother was a 29-year-old female. The patient''s mother did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient''s mother received folic acid supplement within 2 weeks of vaccination. Prior to vaccination, the patient''s mother was not diagnosed with COVID-19. Since the vaccination, the patient''s mother has not been tested for COVID-19. Other medical history included the patient''s mother had eating disorder. The patient experienced maternal exposure before pregnancy on 14May2021 at 13:45. The last menstrual period of the patient''s mother was from 16Jun2021 and for 7 days. Pregnancy was established by using an ovulation-inducing drug. On 03Aug2021, the patient''s mother was pregnant confirmed by previous doctor. Date of LMP of the patient''s mother was 22Jun2021. On 17Aug2021, the patient''s mother was referred to the hospital (equivalent to 8week and 6days from the last menstrual period). GS (gestational sac) was 24.0mm (equivalent to 6week and 4days). On 26Aug2021 at 08:45, the outline of the fetus is blurred and there was no fetal heartbeat. Abortion missed was confirmed and it was reported that the patient''s mother was pregnant confirmed by previous doctor on 03Aug2021and the patient''s mother received the first single dose on 14may2021. The patient died on 26Aug2021.for the reported events. It was not reported if an autopsy was performed.; Sender''s Comments: Based on the temporal relationship, the association between the fatal event "no fetal heartbeat" 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.,Linked Report(s) : JP-PFIZER INC-202101134558 maternal/fetus case; Reported Cause(s) of Death: the patient''s mother was pregnant confirmed by previous doctor on 03Aug2021(the patient''s mother received the first single dose on 14May2021 ); no fetal heartbeat


VAERS ID: 1706080 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-07-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0348 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic dissection, Body temperature, Cardio-respiratory arrest, Myocardial ischaemia, Shock
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (broad), Other ischaemic heart disease (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210707; Test Name: body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: Before the first vaccination; Test Date: 20210728; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: Before the second vaccination
CDC Split Type: JPPFIZER INC202101169532

Write-up: Aortic dissection acute; shock; myocardial ischaemia; cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21126118. A 74-year-old male patient (reported as 74-year and 4-month-old) received bnt162b2 (COMIRNATY), via an unspecified route of administration on 28Jul2021 (Batch/Lot Number: FD0348; Expiration Date: 31Oct2021) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 07Jul2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# FC9880, Expiration date 30Sep2021) for COVID-19 immunization. The patient experienced aortic dissection acute, shock, myocardial ischaemia, and cardio-respiratory arrest (all leading to death) on 29Jul2021. The events resulted in emergency room visit. The patient underwent lab tests and procedures which included body temperature: 36.0 centigrade on 07Jul2021 (Before the first vaccination), body temperature: 36.2 centigrade on 28Jul2021 (Before the second vaccination). The patient died on 29Jul2021. An autopsy was not performed. On 29Jul2021 (one day after the vaccination), the patient experienced aortic dissection acute. On 29Jul2021 (one day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 29Jul2021 (one day after vaccination), the patient had chest pain while he was dancing. The patient was emergently transferred to the previous hospital. The patient had shock. The patient was diagnosed as having aortic dissection acute with myocardial ischaemia. Although the patient was transferred to the reporting hospital for treatment, he had cardio-respiratory arrest, he did not recover, and died. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: The causality between the event and BNT162b2 vaccination was unassessable.; Reported Cause(s) of Death: shock; myocardial ischaemia; cardio-respiratory arrest; Aortic dissection acute


VAERS ID: 1706082 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-08-24
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Hypercholesterolaemia; Hypertension; Obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101172950

Write-up: Haemorrhage intracranial; This is a spontaneous report from a contactable physician via sales representative. A 42-years-old female patient received bnt162b2 (COMIRNATY), intramuscular on 20Aug2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, 0.3 ML SINGLE for COVID-19 immunisation. Medical history included hypertension, hypercholesterolaemia, and obesity. Concomitant medications were not reported. The patient experienced haemorrhage intracranial on 24Aug2021. The patient died on an unspecified date. It was unknown if an autopsy was performed. The reporting physician considered that there was no causal relationship between the event of haemorrhage intracranial and BNT162b2. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the events haemorrhage intracranial cannot be excluded but consider also patient medical history of hypertension and her at risk condition of obesity. 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: haemorrhage intracranial


VAERS ID: 1706116 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-05-20
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX6537 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: QUETIAPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic dilatation; Asthma; Hepatomegaly
Allergies:
Diagnostic Lab Data:
CDC Split Type: LTPFIZER INC202101169450

Write-up: Found dead/blood clot has formed and a heart failure has occurred/coronary artery thrombosis; Found dead/blood clot has formed and a heart failure has occurred/Acute heart failure; This is a spontaneous report from a contactable consumer (parent) and physician via regulatory authority with senders (Case) Safety Report Unique Identifier: d0d3e6ef-e886-4a2b-a57c-bd135be1cab9. A 66-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 04May2021 14:15 at the age of 66 years old (Lot Number: EX6537) as DOSE 2, SINGLE for COVID-19 immunization in the doctor''s office/urgent care. The patient previously had COMIRNATY on 13-APR-2021 dose 1, lot number: EW9127 for COVID-19 immunization. Medical history included dilated aorta, enlarged liver and asthma from an unknown date and unknown if ongoing. Concomitant medication(s) included quetiapine taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient has been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20May2021, the patient was found dead. A blood clot has formed and a heart failure has occurred on 20May2021. The patient experienced acute heart failure caused by the coronary artery thrombosis on 20May2021. No treatment was given to the patient for the events. The patient died on 20May2021. An autopsy was performed that revealed acute heart failure caused by the coronary artery thrombosis.; Reported Cause(s) of Death: Found dead/blood clot has formed and a heart failure has occurred/coronary artery thrombosis; Found dead/blood clot has formed and a heart failure has occurred/Acute heart failure; Autopsy-determined Cause(s) of Death: Acute heart failure caused by the coronary artery thrombosis; Acute heart failure caused by the coronary artery thrombosis


VAERS ID: 1706177 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-22
   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 INC202101166908

Write-up: myocarditis (diagnosis after obduction); This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB NL-LRB-00676644. A 40-years-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 22Aug2021 at 40-years-old (Batch/Lot Number: Unknown) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. There was no previous COVID-19 infection. The patient previously took first dose of bnt162b2 (COMIRNATY) for covid-19 immunisation on 31Jul2021. 3wk after 2nd vaccine, patient died of sudden cardiac death, healthy man, at autopsy myocarditis (with many lymphocytes in tissue) was found as the cause of death. It is unclear whether there is a relationship with the vaccination. BSN was available. Diagnostic procedures: assessment, performed. The patient experienced myocarditis (diagnosis after obduction) on 22Aug2021 (as reported). The patient died on 22Aug2021(but also reported that death occurred 3 wks after second vaccine and 1 day after start, due to confusing information latency not certain). An autopsy was performed that revealed at autopsy is myocarditis (with many lymphocytes in tissue). Sender Comment: Reported mentions first vaccine on 31Jul, second one on 22Aug, death on 22Aug, but also death occurred 3 wks after second vaccine. We have asked for correction. Reporter''s comments Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes ADRs: 3wk after 2nd vaccine, patient died of sudden cardiac death, healthy man, at autopsy myocarditis (with many lymphocytes in tissue) was found as the cause of death. It is unclear whether there is a relationship with the vaccination. On the advice of Agency, report to LAREB Date: 31Jul2021 myocarditis Additional information ADR: myocarditis was found at autopsy BSN available: yes Previous COVID-19 infection: No diagnostic procedures: assessment, performed. The lot number for BNT162b2 was not provided and will be requested during follow up.; Reporter''s Comments: Summary of reporter''s comments: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes ADRs: 3wk after 2nd vaccine, patient died of sudden cardiac death, healthy man, at autopsy myocarditis (with many lymphocytes in tissue) was found as the cause of death. It is unclear whether there is a relationship with the vaccination. On the advice of Agency, report to LAREB Date: 31Jul2021 Additional information ADR available; Reported Cause(s) of Death: myocarditis; Autopsy-determined Cause(s) of Death: at autopsy is myocarditis (with many lymphocytes in tissue)


VAERS ID: 1706211 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-17
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 2 LA / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-02
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC202101169210

Write-up: heart attack; This is a spontaneous report from a contactable consumer received via a lawyer from Agency. A 79-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration, administered in upper left arm on 04Feb2021 (Batch/Lot Number: EJ6134) as dose 2, single for COVID-19 immunisation. The patient had previously received the first dose of BNT162B2 (COMIRNATY) on 14Jan2021, administered into left upper arm, batch number EJ6795, for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced heart attack on 17Feb2021. He was hospitalized for heart attack from 17Feb2021 and was discharged on an unspecified date in Feb2021. The patient had a second heart attack on 28Feb2021 and died on 02Mar2021. It was not reported if an autopsy was performed. The reporter believed that the patient died as a result of not tolerating the vaccine. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: heart attack


VAERS ID: 1708016 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-08-03
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002618 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Subarachnoid haemorrhage, Vertebral artery dissection
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-08-20
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Subarachnoid hemorrhage due to a ruptured aneurysm; Subarachnoid hemorrhage due to a ruptured aneurysm; This case was received via company (Reference number: 2021TJP088181) on 09-Sep-2021 and was forwarded to Moderna on 09-Sep-2021. This case, initially reported to the regulatory authority by a (physician), was received via the regulatory authority (Ref, v21126334). On 01-Jul-2021, the patient received the 1st dose of this vaccine. On an unknown date, body temperature before vaccination: 36.4 degrees Celsius. On 30-Jul-2021, the patient received the 2nd dose of this vaccine. On 03-Aug-2021, around 12:40, the patient was urgently transferred to hospital due to sudden disturbed consciousness. The patient''s level of consciousness on arrival was JSC3-100 and GCS E1V1M4. Head CT showed acute hydrocephalus and subarachnoid hemorrhage. After immediate cerebral ventricular drainage, cerebral angiography revealed bilateral vertebral artery dissecting aneurysms. It was considered to be subarachnoid hemorrhage caused by a ruptured aneurysm, and the patient was hospitalized. Because the left side was largely dominant, the vertebral artery was occluded through an emergency craniotomy to prevent rebleeding, but rupture recurred on the same day, causing clinical brainstem dysfunction. On 20-Aug-2021, the patient was confirmed dead. Autopsy was performed on the same day, and the results were pending. The outcome of subarachnoid hemorrhage due to a ruptured aneurysm was reported as fatal. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The patient''s cause of death was brainstem injury due to ruptured vertebral artery dissection and is most likely to be due to hypertension and arteriosclerosis. Although the causal relationship with this vaccine is thought to be low, it would be best to make a final decision based on the results of the autopsy. Other factors may include hypertension and arteriosclerosis. Although the events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273), it is also considered that the events are due to effects from concomitant disease or the patient''s predisposing factors, etc.; Sender''s Comments: This case concerns a 45 year old male patient, who experienced unexpected serious events of subarachnoid hemorrhage and vertebral artery dissection (both fatal). The serious events occurred 3 days after the second dose of mRNA-1273 vaccine. The events were considered possibly related to mRNA-1273 vaccine per the reporter''s assessment. Autopsy was performed and the results were pending. The benefit-risk relationship of the vaccine is not affected by this report.; Reported Cause(s) of Death: Subarachnoid haemorrhage; Vertebral artery dissection


VAERS ID: 1708104 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-07-01
   Days after vaccination:61
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asphyxia, Dyspnoea, Illness
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD (in the early stages of COPD)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101207609

Write-up: died in early Jul2021 due to suffocated miserably at home alone; breathing problems; sick; This is a spontaneous case from a contactable consumer received via other manufacturer Regulatory Authority. A 68-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on May2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (in the early stages of COPD). The patient''s concomitant medications were not reported. The patient received BNT162B2 (COMIRNATY) vaccine in end of May2021 and after the vaccination developed breathing problems and was sick. She died in early Jul2021. She suffocated miserably at home alone. The patient died on Jul2021. It was not reported if an autopsy was performed. Information about batch number has been/will be requested via follow-up attempt.; Reported Cause(s) of Death: Suffocation


VAERS ID: 1708151 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-01
Onset:2021-09-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Chest pain, Dyspnoea, Electrocardiogram, Extra dose administered, Hyperhidrosis, Interchange of vaccine products, Myocardial infarction, Off label use, Oropharyngeal pain, SARS-CoV-2 test, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Medication errors (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210903; Test Name: ECG; Result Unstructured Data: Test Result:inferior wall MI (myocardial infarction) was noted; Test Date: 20210902; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: BHPFIZER INC202101194949

Write-up: generalized body weakness; Shortness Of Breath; burning sensation at his chest that does not radiate to shoulder; sweating; ECG was done and inferior wall MI was noted; sore throat; SARS-CoV-2 test positive; bnt162b2 as booster; bnt162b2 as booster; bnt162b2 as booster; This is spontaneous report from a contactable pharmacist at regulatory authority. This is a report received via email form the National Health Regulatory Authority. Health authority number unknown. A 59-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Sep2021 (Batch/Lot number was not reported) as dose 3, single (booster) for covid-19 immunisation. Medical history included diabetes mellitus. The patient''s concomitant medications were not reported. The patient previously took covid-19 vaccine nrvv ad26 (gam-covid-vac) (SPUTNIK) for covid-19 immunization, first dose on 19Feb2021, second dose on 12Mar2021. The patient experienced generalized body weakness, shortness of breath, burning sensation at his chest that does not radiate to shoulder, sweating, and ECG was done and inferior wall MI (myocardial infarction) was noted on 03Sep2021, sore throat, and sars-cov-2 test positive on 02Sep2021. The events required emergency room visit. Seriousness criteria for event sars-cov-2 test positive was medically significant, for other events generalized body weakness, shortness of breath, burning sensation at his chest that does not radiate to shoulder, sweating, and ECG was done and inferior wall MI (myocardial infarction) was noted, sore throat was death. Clinical course: On the second day after taking the booster dose, he presented to A/E by ambulance with generalized body weakness (2 pm). He denied any symptoms at the time of taking the vaccine, but admitted that he has sore throat one day prior to his presentation to A/E. After 3 hours, he developed sudden SOB (shortness of breath) associated with burning sensation at his chest that does not radiate to shoulder. No other symptoms were noted. At (5:30 pm), he developed sweating and burning sensation in the chest. ECG was done and inferior wall MI was noted. He was referred to cardiology and they shifted him to another hospital (Death). The outcome of event sars-cov-2 test positive was unknown, outcome of other events generalized body weakness, shortness of breath, burning sensation at his chest that does not radiate to shoulder, sweating, and ECG was done and inferior wall MI (myocardial infarction) was noted, sore throat 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 on the lot/batch number cannot be obatined.; Reported Cause(s) of Death: generalized body weakness; Shortness Of Breath; burning sensation at his chest that does not radiate to shoulder; sweating; ECG was done and inferior wall MI was noted; sore throat


VAERS ID: 1708155 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRPFIZER INC202101204680

Write-up: died of covid; died of covid; This is a spontaneous report from a contactable consumer (unknown relationship with patient) from Customer Service. This consumer reported similar events for two patients. This is the first of two reports. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced died of covid on an unspecified date , died of covid on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. Reporter wants to know if he will have to take the vaccine every year. He wants to know if the vaccine is effective, because two people who took the vaccine died of covid. The batch number has been requested in follow-up activities.; Sender''s Comments: Linked Report(s) : BR-PFIZER INC-202101212063 Same reporter, product and events / different patients; Reported Cause(s) of Death: died of covid


VAERS ID: 1708156 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRPFIZER INC202101212063

Write-up: died of covid; died of covid; This is a spontaneous report from a contactable consumer (unknown relationship with patient) from customer Service. This consumer reported similar events for two patients. This is the second of two reports. A patient of an unknown age and gender received BNT162B2 (COMIRNATY) at single dose via an unknown route on an unknown date for Covid-19 immunization. Medical history and concomitant rug were not provided. The patient took the vaccine died of covid. The reporter wanted to know if the vaccine was effective. Outcome of the event was fatal. The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: Linked Report(s) : BR-PFIZER INC-202101204680 Same reporter, product and events / different patients; Reported Cause(s) of Death: died of covid; died of covid


VAERS ID: 1708168 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202101197454

Write-up: died; This is a spontaneous report from Pfizer received from a contactable consumer. A 16-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient died five days after he took the vaccine. 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: died


VAERS ID: 1709251 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-29
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCRM8 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101166866

Write-up: Sudden death unexplained, cause unknown; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB (Regulatory Authority report number: DE-PEI-202100182698). A 69-year-old female patient received BNT162B2 (COMIRNATY, Lot Number: SCRM8; Expiration date was not reported) on 26Aug2021 as dose number unknown, single, with route of administration unspecified, for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 29Aug2021, the patient had sudden death explained, cause was unknown. It was unknown if an autopsy was performed. The reporter''s assessment on the causal relationship between the suspect vaccine and the event was unclassifiable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden death unexplained, cause unknown


VAERS ID: 1709254 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-07-07
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7958 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Cerebral haemorrhage, Cerebral venous sinus thrombosis, Computerised tomogram, Electroencephalogram
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, venous (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow)

Life Threatening? Yes
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: angiography of neck and head; Result Unstructured Data: Test Result:unknown results; Test Name: CT; Result Unstructured Data: Test Result:unknown results; Test Name: EEG; Result Unstructured Data: Test Result:unknown results
CDC Split Type: DEPFIZER INC202101180490

Write-up: Cerebral bleeding; Thrombosis of venous sinuses; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority number is DE-PEI-202100183921. A 61-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 29Jun2021 (Batch/Lot Number: FD7958) as DOSE NUMBER UNKNOWN, SINGLE (at the age of 61 years) for covid-19 immunisation. The patient has no relevant medical history medical history. Concomitant medications were not reported. The patient experienced cerebral bleeding and thrombosis of venous sinuses on 07Jul2021. The patient was hospitalized from the events and was considered life-threatening. The patient underwent lab tests and procedures which included angiography of neck and head, computerised tomogram (CT) and electroencephalogram (EEG) with unknown results. The outcome of the events was fatal as the patient died on 07Jul2021. It was unknown if an autopsy was performed. No follow-up attempts possible. No further information expected. Information about batch/lot number already obtained.; Reported Cause(s) of Death: cerebral bleeding; Thrombosis of venous sinuses


VAERS ID: 1709255 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-20
Onset:2021-07-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0900 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Cardiac failure acute, Dyspnoea
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Retroperitoneal fibrosis (broad), 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: Medical History/Concurrent Conditions: COPD; Diabetes mellitus; Hypercholesteremia; Pulmonary embolism (from other sources); Thrombosis (from other sources)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101180622

Write-up: Dyspnoea; Back ache; Acute heart failure; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority number DE-PEI-202100183923. An adult patient of an unspecified age and gender received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: FF0900), via an unspecified route of administration on 20Jul2021 as dose number unknown, 0.3 mL single for COVID-19 immunisation. Medical history included diabetes mellitus, COPD, hypercholesteremia, and suspected pulmonary embolism and thrombosis from other sources. The patient''s concomitant medications were not reported. On 20Jul2021, the patient experienced dyspnoea and back ache. The patient also experienced acute heart failure on an unspecified date in 2021. The patient died on an unspecified date in 2021. It was not reported if an autopsy was performed. The patient died due to dyspnoea, back ache, and acute heart failure. The reporter assessed the relatedness of the events dyspnoea, acute heart failure, and back ache as unclassifiable via PEI. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Acute heart failure; Dyspnoea; Back pain


VAERS ID: 1709260 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-17
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2655 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Herpes zoster, Interstitial lung disease
SMQs:, Interstitial lung disease (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aneurysm aortic; Arterial hypertension; Benign prostatic hyperplasia; Cholelithiasis; Dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101194154

Write-up: Unknown cause of death; Interstitial pneumonia; Herpes zoster; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority number is DE-PEI-202100184672. A 74-year-old male patient received BNT162B2 (COMIRNATY Solution for injection), via an unspecified route of administration, on an unspecified date (Batch/lot number: ER2655), as dose number unknown, 0.3ml single, for COVID-19 immunisation. Relevant medical history included cholelithiasis, arterial hypertension, aneurysm aortic, dementia, and benign prostatic hyperplasia all from unknown dates, not reported if ongoing or not. Concomitant medications were not reported. On 17Apr2021, the patient experienced herpes zoster. In May2021, the patient experienced interstitial pneumonia. On an unspecified date, the patient died with unknown cause of death. Autopsy was not performed. The outcome of the events herpes zoster and interstitial pneumonia was unknown. The health authority assessed this report as serious (other). The health authority assessed the relatedness of COMIRNATY to all events as unclassifiable (Event assessment: COMIRNATY/all events/PEI/Result of Assessment: D. Unclassifiable). No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1709267 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SLRM8 / 2 - / -

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: Medical History/Concurrent Conditions: Arterial hypertension; Arthroplasty of hip
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101194241

Write-up: Unknown cause of death; This is a spontaneous report downloaded from the regulatory authority -PEI-202100185493. A female patient (unknown age) received the second dose of BNT162B2 (COMIRNATY, Lot No. SLRM8) at single dose for COVID-19 immunisation on unknown date. Relevant history included hypertension and arthroplasty of hip. Relevant concomitant drug was unknown. The patient previously received the first dose of Comirnaty at 0.3 ml for COVID-19 immunisation on 14Jul2021. The patient experienced also unknown cause of death on unspecified date. Unknown if autopsy performed or not. Event assessment : Comirnaty/ event /PEI /Result of Assessment: Unclassifiable. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1709277 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8405 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-25
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arteriosclerosis; Dissecting aortic aneurysm, abdominal; Comments: 23.8.
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101195316

Write-up: Acute myocardial infarction; postoperative malaise; Fall; Fall with olecranon fracture; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100187188. An 84-year-old female patient received bnt162b2 (COMIRNATY, 0.3 ml), via an unspecified route of administration on 23Aug2021 (Lot Number: FE8405) at the age of 84-year-old as single dose for covid-19 immunisation. Medical history included dissecting aortic aneurysm, abdominal and arteriosclerosis. The patient''s concomitant medications were not reported. The patient experienced fall on 24Aug2021, acute myocardial infarction on 25Aug2021. Clinical course: 24Aug2021, patient experienced fall with olecranon fracture. On 25Aug2021, she had operation, postoperative malaise, resuscitation requirement and myocardial infarction, patient was in death. The patient died on 25Aug2021 for events. It was not reported if an autopsy was performed. The patient''s outcome was fatal for events. Causality assessment provided by regulatory authority (PEI) for acute myocardial infarction and fall as indeterminate. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: postoperative malaise; Fall with olecranon fracture; Fall; Acute myocardial infarction


VAERS ID: 1709280 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-09
Onset:2021-02-02
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101195136

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority regulatory authority number DE-PEI-202100187277. An 89-year-old female patient received bnt162b2 (COMIRNATY, 0.3 ml), via an unspecified route of administration on 09Jan2021 (batch/lot number: unknown) at the age of 89-year-old as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced unknown cause of death on 02Feb2021. The patient died on 02Feb2021. It was not reported if an autopsy was performed. The patient''s outcome was fatal for event. Event assessment: Comirnaty/ event /PEI /Result of Assessment: D. Unclassifiable. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1709281 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-09
Onset:2021-01-26
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101195180

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100187278. An elderly male patient received bnt162b2 (COMIRNATY, Strength:0.3ml), via an unspecified route of administration on 09Jan2021 (Batch/Lot Number: Unknown) as dose number unknown, single for covid-19 immunisation. The patient''s medical history and concomitant medications was not reported. The patient experienced unknown cause of death on 26Jan2021. The patient died on 26Jan2021. It was not reported if an autopsy was performed. Assessment: Comirnaty/ Unknown cause of death / PEI: D. Unclassifiable No follow-up attempts are possible, information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1709282 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-09
Onset:2021-01-22
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101195142

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority, regulatory authority number DE-PEI-202100187279. An 85-year-old male patient received bnt162b2 (COMIRNATY, Batch/Lot Number: Unknown, strength: 0.3 ml), via an unspecified route of administration on 09Jan2021 at the age of 85-year-old as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced unknown cause of death on 22Jan2021. The patient died on 22Jan2021. It was not reported if an autopsy was performed. PEI event assessment for Comirnaty was D. Unclassifiable. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1709283 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101195361

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority, authority number DE-PEI-202100187280. A 93-years-old female patient received bnt162b2 (COMIRNATY, strength: 0.3 ml), via an unspecified route of administration on 21Jan2021 (Batch/Lot Number: Unknown) as dose number unknown, single for covid-19 immunisation at age of 93 years old. The patient medical history and concomitant medications were not reported. The patient experienced unknown cause of death on 21Jan2021. The patient died on 21Jan2021 (also reported as 27Jan2021). It was not reported if an autopsy was performed. The PEI assessment for Unknown cause of death with the suspect product Comirnaty is D. Unclassifiable. No follow-up attempts are possible. No further information is expected. Lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1709284 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-30
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101195175

Write-up: Unknown cause of death; This is a spontaneous report downloaded from the regulatory authority DE-PEI-202100187281 from a non-contactable physician. An 86 years old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 21Jan2021 at the age of 85 years old, 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 unknown cause of death on 30Jan2021. The patient died on 30Jan2021. It was not reported if an autopsy was performed.Event assessment: Comirnaty/ event /PEI /Result of Assessment: D. Unclassifiable. No follow-up attempts are possible. Information on batch/lot number cannot be obtained. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1709285 (history)  
Form: Version 2.0  
Age: 97.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-17
Onset:2021-01-22
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101195149

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority, regulatory authority number DE-PEI-202100187283. A 97-year-old female patient received bnt162b2 (COMIRNATY, strength: 0.3 ml), via an unspecified route of administration on 17Jan2021 at age of 97-year-old (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced unknown cause of death on 22Jan2021. The patient''s outcome was: fatal for Unknown cause of death. The patient died on 22Jan2021. It was not reported if an autopsy was performed. Assessment: Comirnaty/ Unknown cause of death / PEI: D. Unclassifiable No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1709286 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-16
Onset:2021-02-01
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101195170

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority DE-PEI-202100187288. An 85-years-old male patient received bnt162b2 (COMIRNATY, strength: 0.3 ml), via an unspecified route of administration on 16Jan2021 (Batch/Lot Number: Unknown) as dose number unknown, single for covid-19 immunisation at age of 85 years old. The patient''s medical history and concomitant medications were not reported. The patient experienced unknown cause of death on 01Feb2021. The patient died on 01Feb2021. It was not reported if an autopsy was performed. Assessment: Comirnaty/ Unknown cause of death / PEI: D. Unclassifiable No follow-up attempts are possible, information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1709287 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-18
Onset:2021-01-28
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101195342

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority DE-PEI-202100187290. A 96-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 18Jan2021 (Batch/Lot Number: Unknown, at age of 96 years old) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced unknown cause of death on 28Jan2021. The patient died on 28Jan2021. It was unknown if an autopsy was performed. Assessment: Comirnaty/ Unknown cause of death: D. Unclassifiable No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1709288 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-02-01
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101195161

Write-up: Unknown cause of death; This is a spontaneous report from a physician downloaded from the Regulatory Authority-WEB DE-PEI-202100187292. A 80-year-old male patient received bnt162b2 (COMIRNATY) via an unspecified route of administration on 19Jan2021 at age of 80-year-old (Batch/Lot Number: Unknown) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced unknown cause of death on 01Feb2021. It was not reported if an autopsy was performed. Causality assessment for event unknown cause of death with BNT162B2 per PEI: D. Unclassifiable No follow-up attempts are possible, information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1709395 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-06-09
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D012A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Body temperature increased, Death, Decreased appetite, Dizziness, Fatigue, Headache, Inflammatory marker test, Listless, Lumbar puncture, Magnetic resonance imaging, Meningitis, Vaccination site pain
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-14
   Days after onset: 35
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: Breast cancer female NOS (surgically removed, irradiated, was checked regularly); Cancer of skin; Lymphadenectomy; Skin cancer excision
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: temperature; Result Unstructured Data: Test Result:slightly raised temperature; Test Name: Inflammation values; Result Unstructured Data: Test Result:very bad; Test Date: 20210708; Test Name: lumbar puncture; Result Unstructured Data: Test Result:no clear diagnosis; Comments: suspicion of meningitis as the side effect of the puncture; Test Name: MRI; Result Unstructured Data: Test Result:no clear diagnosis
CDC Split Type: DEPFIZER INC202101180451

Write-up: died on 14Jul2021/ died unexpectedly/No clear cause of death.; Light headedness; Headache; Tiredness; no appetite; injection site pain; Listlessness; slightly raised temperature; Suspicion of meningitis; This is a spontaneous report from a non-contactable consumer or other non HCP downloaded from the Regulatory Authority-WEB [DE-PEI-CADR2021174617], Safety Report Unique Identifier [DE-PEI-202100183336]. A 73-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 26May2021 (Batch/Lot Number: 1D012A) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included breast cancer female from 2017 and unknown if ongoing (surgically removed, irradiated, was checked regularly), skin cancer from 2017 and unknown if ongoing; skin cancer was removed, as well as lymph nodes on the groin on unspecified dates. The patient''s concomitant medications were not reported. The patient experienced three weeks of very severe headaches, dizziness (light headedness), fatigue (tiredness) all from 09Jun2021; no appetite, pain at injection site, listlessness and slightly raised temperature on an unspecified date in 2021. Appointment for MRI no clear diagnosis, CT scan. It no longer came to that. Emergency admission on 05Jul2021. No clear diagnosis was made, lumbar puncture on 08Jul2021 showed suspicion of meningitis (side effect of the puncture), when the cerebrospinal fluid was punctured again, he died unexpectedly on 14Jul2021. No clear cause of death. The events further described as extremely severe headache, MRI no clear diagnosis, admission to hospital 05Jul2021. Inflammation values very bad, meningitis after puncture of the spinal cord, died on 14Jul2021. The patient underwent lab tests and procedures which included lumbar puncture: no clear diagnosis; suspicion of meningitis as the side effect of the puncture on 08Jul2021, magnetic resonance imaging: no clear diagnosis on an unspecified date, temperature: slightly raised on an unspecified date in 2021 and inflammation values: very bad on an unspecified date. The patient died on 14Jul2021. It was not reported if an autopsy was performed. The patient did not recover from lightheadedness, headache, tiredness and the outcome of the other events was unknown. Event assessment: unknown cause of death, light headedness, headache, tiredness/PEI: D. Unclassifiable. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1709396 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-13
Onset:2021-05-28
   Days after vaccination:104
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac disorder, Coma, Immune system disorder, Oxygen saturation, Oxygen saturation decreased, Pericardial effusion
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Autoimmune disorder; Parkinson''s disease
Preexisting Conditions: Medical History/Concurrent Conditions: Solitary kidney
Allergies:
Diagnostic Lab Data: Test Date: 20210528; Test Name: oxygen saturation; Test Result: 40 %
CDC Split Type: DEPFIZER INC202101180562

Write-up: Excessive accumulation of water in the heart.; Excessive accumulation of water in the heart.; Through oxygen reduction/oxygen saturation only of 40 per cent.; coma; Immune system can no longer cope with it at that age.; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority, regulatory authority number DE-PEI-CADR2021174672; Safety Report Unique Identifier DE-PEI-202100183059. A 92-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 13Feb2021 (Batch/Lot number was not reported) as dose number unknown, 0.3ml single for covid-19 immunisation. Medical history included ongoing Parkinson''s disease, ongoing autoimmune disorder and one kidney. The patient had no known allergies. The patient''s concomitant medications were not reported. On 28May2021, the patient experienced excessive accumulation of water in the heart (heart disorder). Due to extreme water accumulation at the heart, oxygen saturation was only at 40%. Through oxygen reduction, patient was intubated and was in coma. Patient was 3 weeks in intensive care unit until death. Patient was previously stable. Immune system can no longer cope with it at that age in 2021. The patient died on an unspecified date due to the events. It was not reported if an autopsy was performed. Heart disorder/PEI: D. Unclassifiable No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Through oxygen reduction/oxygen saturation only of 40 per cent; coma; Excessive accumulation of water in the heart.; Immune system can no longer cope with it at that age.; Excessive accumulation of water in the heart.


VAERS ID: 1709397 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-17
Onset:2021-07-01
   Days after vaccination:45
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Circulatory collapse, Myocarditis bacterial, Portosplenomesenteric venous thrombosis, Pulmonary fibrosis
SMQs:, Anaphylactic reaction (narrow), Interstitial lung disease (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (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, venous (narrow), Thrombophlebitis (broad), Ischaemic colitis (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-02
   Days after onset: 63
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: DEPFIZER INC202101180493

Write-up: Lung fibrosis; Complete circulatory collapse/circulatory failure; Portosplenomesenteric venous thrombosis; eColi bacteria on heart valves/myocarditis; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB (Regulatory Authority report number: DE-PEI-CADR2021174810). A 74-year-old male patient received the second dose of BNT162B2 (COMIRNATY, Lot number and expiration date were not reported) on 17May2021 as dose 2, 0.3 ml, single, with route of administration unspecified, for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 01Jul2021, the patient had lung fibrosis, complete circulatory collapse/circulatory failure, portosplenomesenteric venous thrombosis and e. coli bacteria on heart valves/myocarditis. The patient was hospitalized in Jul2021 due to the events. The outcome of the events, portosplenomesenteric venous thrombosis and e. coli bacteria on heart valves/myocarditis, was not recovered. The patient had died on 02Jul2021. The reported causes of death were lung fibrosis and complete circulatory collapse/circulatory failure. It was unknown if an autopsy was performed. The reporter''s assessment on the causal relationship between the suspect vaccine and the events was inconsistent causal association to immunization. No follow-up attempts are possible. No further information is expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Complete circulatory collapse/circulatory failure; Lung fibrosis


VAERS ID: 1709399 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-18
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood culture, Decreased appetite, Diarrhoea, Gait inability, Multiple organ dysfunction syndrome, Rash macular, Thrombosis
SMQs:, Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-30
   Days after onset: 29
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute myocardial infarction (Hospitalised from 07Jul2021 to 12Jul2021); Aortic valve replacement; Aortic valve stenosis (symptomatic high-grade aortic valve stenosis); Arterial hypertension; Atrial fibrillation (persistent); COVID-19 pneumonia (severe course of disease, treatment from 31Mar2021 - 15Apr2021); Urosepsis (nitrite negative urinary tract infection)
Allergies:
Diagnostic Lab Data: Test Name: blood culture; Result Unstructured Data: Test Result:E. coli detection; Comments: Before vaccination
CDC Split Type: DEPFIZER INC202101180553

Write-up: Thrombosis; could not walk; red spots appeared on her buttockswhich then spread down her right leg; Multiple organ failure; in the following week she became increasingly physically weak; diarrhea; was no longer hungry; This is as spontaneous report received from a non-contactable consumer downloaded from the regulatory authority report number is DE-PEI-CADR2021175259, Safety report unique identifier DE-PEI-202100183583. A 90-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 18Aug2021 (Batch/Lot number was not reported) as dose 1, 0.3 ml single for covid-19 immunisation. Medical history included COVID-19 pneumonia from Apr2021 to an unknown date (severe course of disease, treatment from 31Mar2021 to 15Apr2021, discharge back in senior living community), aortic valve stenosis from Apr2021 to an unknown date (symptomatic high-grade aortic valve stenosis), persistent atrial fibrillation from Apr2021 to an unknown date, acute myocardial infarction (hospitalised from 07Jul2021 to 12Jul2021), arterial hypertension, urosepsis (nitrite negative urinary tract infection), and implantation of aortic biocardial valve 23 mm on May2020. The patient has no known allergies. The patient''s concomitant medications were not reported. On 20Aug2021 the patient experienced Thrombosis, Multiple organ failure. The clinical course of events were reported as follows: A 90 year old lady with previous diseases COVID-19 -pneumonia (Apr2021) (severe course of disease, treatment from 31Mar2021 - 15Apr2021, discharge back in senior living community), symptomatic high-grade aortic valve stenosis, implantation of aortic biocardial valve 23 mm (May2020), persistent atrial fibrillation from Apr2021, CHA2DS2-VASc score 4 (unspecified), arterial hypertension, from 07Jul2021 to 12Jul2021 hospitalization NSTEMI (acute myocardial infarction), urosepsis for nitrite negative urinary tract infection, detection of E.coli (blood culture), discharge to senior living community. The woman was doing well, she can walk with a rollator, eat by herself, wash herself, is mentally well, reads the newspaper every day. The COVID-19 infection was not yet half a year past, since she was in a senior living community, the family doctor thought she should be vaccinated now. She was vaccinated for the first time after (clarification) after 5 months of surviving the course of the disease. She got the vaccination on 18Aug2021, in the following week she became increasingly physically weak, diarrhea, was no longer hungry, could not walk, was weak. On 29Aug2021, red spots appeared on her buttocks, which then spread down her right leg. On 30Aug2021, around noon, she was taken to the hospital by ambulance. There an immediate emergency surgery, she had thrombi in the right groin, so that she would not lose her leg. After the operation, in the recovery room, it was found that the thrombi were now also present in the brain, the entire body was affected. She had excluded intensive medical treatment in her living will. She was treated with painkillers and the reporter accompanied her to her death, which occurred after multiple organ failure at 23:27 on 30Aug2021. The patient died on 30Aug2021. It was not reported if an autopsy was performed. The patient''s outcome was: fatal for Thrombosis, fatal for Multiple organ failure. Outcome of the remaining events was unknown. No follow-up attempts are possible. Information on lot and batch numbers cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Multiple organ failure; Thrombosis


VAERS ID: 1709400 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-04-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3599 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Chills, Death, Decreased appetite, Diarrhoea, Dysstasia, General physical health deterioration, Head discomfort, Headache, Hypotension, Incontinence, Malaise, Myalgia, Nausea, Paraesthesia, Tachycardia, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-09
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiac arrhythmia; COPD; Renal insufficiency
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101194193

Write-up: feeling unwell; Headache; head pressure; massive deterioration of the whole condition; Muscle pain; Chills; Nausea; Vomiting; Tingling; loss of appetite; incontinence; diarrhoea; low blood pressure; loss of strength; unable to stand up independently; Unknown cause of death; Tachycardia; This is a spontaneous report from a non-contactable consumer or other non-HCP downloaded from the Regulatory Authority-WEB DE-PEI-CADR2021175527. An 80-year-old male patient received the first dose of BNT162B2 (COMIRNATY, Lot Number: Ex3599) (mRNA tozinameran), at the age of 80 years old, on 29Apr2021 at single dose for COVID-19 immunisation. Medical history included renal insufficiency, cardiac arrhythmia, chronic obstructive pulmonary disease (COPD), all were ongoing. The patient''s concomitant medications were not reported. On 29Apr2021, the patient experienced tachycardia. On 09May2021, the patient experienced unknown cause of death. This report is serious - death. Relatedness of BNT162B2 to events was assessed as D. Unclassifiable by the PEI. The patient died on 09May2021. It was not reported if an autopsy was performed. The outcome of event unknown cause of death was fatal. The outcome of other events was not recovered. Sender''s comment: The patient had no known allergies. Information on risk factors or previous illnesses: Renal insufficiency, cardiac arrhythmia, COPD, etc. After vaccination, feeling unwell, headache and head pressure occurred. On the 5th day massive deterioration of the whole condition. Muscle pain, chills, nausea, vomiting, tingling, loss of appetite, incontinence, diarrhoea, low blood pressure, loss of strength and unable to stand up independently. Hour by hour, the symptoms worsened until death. During which he was fully conscious and a great need for water. Relatedness of BNT162B2 to events was assessed as D. Unclassifiable by the PEI. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1709402 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-07
Onset:2021-06-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Blood creatinine, Blood creatinine increased, Blood lactic acid, Blood lactic acid increased, Coagulopathy, Cytokine release syndrome, Haematemesis, Hypotension, Malaise, Multiple organ dysfunction syndrome, Nausea, Petechiae, Platelet count, Platelet count decreased, Pyrexia, Tachycardia, Thrombosis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haematopoietic thrombocytopenia (narrow), Lactic acidosis (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (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), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal haemorrhage (narrow), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Dehydration (broad), Hypokalaemia (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-16
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Asplenia; Blood pressure high; Depression; Panic disorder; Unspecified disorder of thyroid
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Post-mortem examination; Result Unstructured Data: Test Result:Death Fulminant disseminated coagulopathy; Comments: Death Fulminant disseminated coagulopathy with multi-organ failure due to microthrombi as a result of corona inoculation, according to clinical indications. Extensive epidermal detachment and spotty bleeding into the skin of the head, trunk and extremities as well as into the mucous membranes. Initial, blackish desiccation of the finger and toe extremities, the tip of the nose and the skin of the face. Watery swelling of the tissues. Cerebral oedema (1400 g). Small blood clot in the left cerebral hemisphere. Congested cerebral veins. Thoracic as well as abdominal effusions. Pulmonary oedema on both sides with water cushion-like consistency of the tissue. Fragile tissue. Clay-yellow, brittle, flaccid and patchy livid bleeding of the heart tissue. Bleeding under the inner lining of the heart in the inflow pathway of the left ventricular wall. Pale brown, friable liver tissue with spotty haemorrhages and areas that have blanched off in places. Faded kidney tissue with numerous spotty haemorrhages. Spleen not depictable, as after removal in the past. Gastric and intestinal mucosa reddish discoloured, bloody contents in the intestine.; Test Date: 20210608; Test Name: creatinine; Result Unstructured Data: Test Result:rise; Test Date: 20210608; Test Name: lactate; Result Unstructured Data: Test Result:rise; Test Date: 20210608; Test Name: platelets; Result Unstructured Data: Test Result:drop
CDC Split Type: DEPFIZER INC202101194190

Write-up: high fever of up to 40 �C; malaise; nausea; Multiple organ failure; massive cytokine release syndrome; fulminant disseminated coagulopathy; microthrombi; vomited blood; hypotension; tachycardia; multiple petechiae all over her body; a drop in platelets; a rise in creatinine; a rise in lactate; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the regulatory authority DE-PEI-CADR2021175687, Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100184546. A 50-year-old female patient received the second dose of BNT162B2 (COMIRNATY, Lot Number: Unknown, strength: 0.3 ml) (mRNA tozinameran), at the age of 50 years old, on 07Jun2021 at 11:00 at single dose for COVID-19 immunisation. Medical history included asplenia, high blood pressure, depression, anxiety and panic disorders, unspecified thyroid disease, all were ongoing. The patient''s concomitant medications were not reported. On 07Jun2021, the patient experienced cytokine release syndrome, coagulopathy, multiple organ failure and microthrombi. According to the medical report of the university hospital dated 21Jun2021, patient had received her second vaccination with "Biontec" on 07Jun2021 at around 11:00. Approximately one hour later, she developed a high fever of up to 40 �C, malaise and nausea and lay down at home. During the night, she vomited blood and was initially admitted to hospital. Patient developed hypotension, tachycardia, multiple petechiae all over her body, a drop in platelets, a rise in creatinine and a rise in lactate. As a result, patient was transferred to a university hospital on 08Jun2021. In the course of her treatment, she suffered multiple organ failure. Patient was connected to dialysis and a heart-lung machine. Furthermore, there was necrosis of the extremities and reduced blood flow to various organs due to microthrombi. Patient died on 16Jun2021 at a university hospital and had been stopped by a medical officer at a crematorium. According to the death certificate, patient died of fulminant disseminated coagulopathy with multi-organ failure due to microthrombi. This was the result of a massive cytokine release syndrome, the cause of which could have been asplenia or a reaction after corona vaccination. This report is serious - hospitalization. The patient underwent lab tests and procedures which included platelets: drop on 08Jun2021, creatinine: rise on 08Jun2021, lactate: rise on 08Jun2021, post-mortem examination: Death Fulminant disseminated coagulopathy with multi-organ failure due to microthrombi as a result of corona inoculation, according to clinical indications (Extensive epidermal detachment and spotty bleeding into the skin of the head, trunk and extremities as well as into the mucous membranes. Initial, blackish desiccation of the finger and toe extremities, the tip of the nose and the skin of the face. Watery swelling of the tissues. Cerebral oedema (1400 g). Small blood clot in the left cerebral hemisphere. Congested cerebral veins. Thoracic as well as abdominal effusions. Pulmonary oedema on both sides with water cushion-like consistency of the tissue. Fragile tissue. Clay-yellow, brittle, flaccid and patchy livid bleeding of the heart tissue. Bleeding under the inner lining of the heart in the inflow pathway of the left ventricular wall. Pale brown, friable liver tissue with spotty haemorrhages and areas that have blanched off in places. Faded kidney tissue with numerous spotty haemorrhages. Spleen not depictable, as after removal in the past. Gastric and intestinal mucosa reddish discoloured, bloody contents in the intestine). Therapeutic measures were taken as a result of events. The patient died on 16Jun2021. Autopsy results available. The outcome of events multiple organ failure, cytokine release syndrome, coagulopathy and microthrombi was fatal. The outcome of other events was unknown. Sender''s comment: It was unknown that the patient had known allergies. Information on risk factors or previous illnesses - Asplenia, high blood pressure, depression, anxiety and panic disorders, unspecified thyroid disease. Patient died on 16Jun2021. According to the death certificate, patient died of fulminant disseminated coagulopathy with multi-organ failure due to microthrombi. This was the result of a massive cytokine release syndrome, the cause of which could have been asplenia or a reaction after corona vaccination. According to the medical report of the university hospital dated 21Jun2021, patient had received her second vaccination with "Biontec" on 07Jun2021 at around 11:00. Approximately one hour later, she developed a high fever of up to 40 �C, malaise and nausea and lay down at home. During the night, she vomited blood and was initially admitted to hospital. Patient developed hypotension, tachycardia, multiple petechiae all over her body, a drop in platelets, a rise in creatinine and a rise in lactate. As a result, patient was transferred to a university hospital on 08Jun2021. In the course of her treatment, she suffered multiple organ failure. Patient was connected to dialysis and a heart-lung machine. Furthermore, there was necrosis of the extremities and reduced blood flow to various organs due to microthrombi. Causal relationship between the events and the administration of BNT162B2 was assessed as "Unclassifiable (D)". The lot number for BNT162B2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: Multiple organ failure; fulminant disseminated coagulopathy; microthrombi; massive cytokine release syndrome; Autopsy-determined Cause(s) of Death: Multiple organ failure; Fulminant disseminated coagulopathy; microthrombi


VAERS ID: 1709403 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-22
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Confusional state, Death, Movement disorder, Parkinson's disease, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-03
   Days after onset: 64
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: Parkinson''s disease NOS
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101194202

Write-up: Severe Parkinson''s episode; confusion; inability to move; no longer responsive; died 5 weeks after vaccination; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021175975, Safety Report Unique Identifier DE-PEI-202100184388. An 83-year-old male patient received 1st dose of BNT162B2 (COMIRNATY) at single dose via an unknown route on 22Jul2021 for COVID-19 immunisation. Medical history included ongoing Parkinson''s disease NOS. Before the vaccination, the person was able to organize everyday life completely independently/ previously self-dependent. Even driving a car was not a problem. Drugs against Parkinson''s symptoms worked. Concomitant drug was not provided. Patient took drugs against Parkinson''s symptoms. The patient experienced severe Parkinson''s episode after the first vaccination, requiring full care one week after vaccination, and died on 03Sep2021, 5 weeks after vaccination. The clinical course was reported as follows: After the first vaccination followed the confusion both days as well inability to move. Afterward admission to the hospital. A little improvement after a week. Afterward two weeks of geriatrics with moderate improvement. Short-term care followed in a nursing home (Care level increased from 2 to 5) - no longer responsive. Died on 03Sep2021, after 12 days in the nursing home. Outcome of severe Parkinson''s episode was unknown. This report was serious with seriousness criteria of death. The PEI assessment for all the events with the suspect product Comirnaty is: D. Unclassifiable . No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: died 5 weeks after vaccination


VAERS ID: 1709404 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-31
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute hepatic failure, Acute kidney injury, Peritonitis, Portal vein thrombosis, Respiratory failure, Sepsis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, venous (narrow), Gastrointestinal perforation (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (broad), Sepsis (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Obesity
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210928163

Write-up: Sepsis; Respiratory insufficiency; Portal vein thrombosis; Acute liver failure; Peritonitis; Acute kidney failure; This spontaneous report received from a consumer Via a Regulatory authority (EVHUMAN Vaccines, DE-PEI-CADR2021176596) on 15-SEP-2021 concerned a 57 year old male of an unspecified race and ethnic origin. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: obesity. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, frequency time 1 total administered on 01-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported at the time of vaccination. On 31-AUG-2021, the patient experienced peritonitis, acute kidney failure, acute liver failure and portal vein thrombosis. On 02-SEP-2021, He experienced sepsis and respiratory insufficiency. He was hospitalized on an unspecified date and died from sepsis and respiratory insufficiency. It was unspecified if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from peritonitis, acute kidney failure, acute liver failure, and portal vein thrombosis. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: Sind bei Ihnen oder der betroffenen Person Allergien bekannt? Wenn ja, welche?neinAngaben zu Risikofaktoren oder VorerkrankungenAdipositas / Aufnahme bei abdominellen Schmerzen seit 2 Wochen. Pfortaderthrombose. Sepsis bei spontanbakterieller Peritonitis. Akutes Leber- und Nierenversagen. Therapie mit Immunglobulinen. CVVHD. Reanimation.; Reported Cause(s) of Death: SEPSIS; RESPIRATORY INSUFFICIENCY


VAERS ID: 1709405 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-06
Onset:2021-05-21
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aneurysm (aneurysm discovered accidentally 15 years ago and successfully operated on); Kidney donor; Thrombosis leg; Varicose veins
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101195203

Write-up: Stroke with heart failure.; Stroke with heart failure.; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority number DE-PEI-CADR2021176654. A 64-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 06May2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Thrombosis in leg from unknown date to unknown date, aneurysm discovered accidentally 15 years ago from 2006 to an unknown date and successfully operated on, varicose vein from an unknown date, gave the reporter a kidney from an unknown date. The patient''s concomitant medications were not reported. The patient experienced stroke with heart failure on 21May2021. The patient gave the reporter a kidney from birth and took Marcomar about 15 years ago because of a thrombosis in his leg. He also had severe problems with varicose veins. Before the vaccination, however, his brain was completely checked (aneurysm discovered accidentally 15 years ago and successfully operated on) and declared healthy enough. The patient was super to be together, healthy and athletic, pulled up trees as they say and collapsed while walking 2 weeks after the 1st vaccination, fell over without reflexes and was dead. The immediate cardiopulmonary resuscitation, emergency doctor. It didn''t help at all. The outcome of the event was fatal. The patient died on 21May2021. An autopsy was not performed. Sender''s comment: Information about risk factors or previous illnesses No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Stroke with heart failure.; Stroke with heart failure.


VAERS ID: 1709406 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral thrombosis, Extra dose administered, Intracardiac thrombus, Off label use
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101195451

Write-up: received 3rd dose of bnt162b2; received 3rd dose of bnt162b2; Blood clots in the heart. Then liver failure which led to death. In 2 relatives.; Blood clots in the brain. Then liver failure which led to death. In 2 relatives.; This is a spontaneous report from a consumer downloaded from the regulatory authority DE-PEI-CADR2021177021 Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100187038. A 78-year-old male patient received bnt162b2 (COMIRNATY) dose 3 via an unspecified route of administration on 01Aug2021 (Batch/Lot Number: Unknown) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. No known allergy. The patient experienced blood clots in the heart and brain on an unspecified date in Aug2021. It reported that one week after the 3rd vaccination, the patient died of blood clots in his brain and heart in Aug2021. The blood clots formed within a week. They did MRI immediately after the vaccination and just before he died. The patient died on an unspecified date. It was not reported if an autopsy was performed. Causal relationship between the events and the administration of bnt162b2 was assessed as "Unclassifiable (D)" by the PEI. The lot number for bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: Cardiac thrombosis; Thrombosis cerebral


VAERS ID: 1709407 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-02-07
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood electrolytes, Condition aggravated, Electrolyte imbalance
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-11
   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: Alcoholic; Hepatic cirrhosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210207; Test Name: Blood electrolytes; Result Unstructured Data: Test Result:abnormal; Comments: disturbance
CDC Split Type: DEPFIZER INC202101195448

Write-up: Condition worsened; Death due to severe electrolyte disturbance; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority DE-PEI-CADR2021177485. An 81-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration in Jan2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included ongoing alcoholic, ongoing hepatic cirrhosis. The patient''s concomitant medications were not reported. The patient experienced death due to severe electrolyte disturbance on 07Feb2021. Condition worsened, admission to hospital where he died. The patient underwent lab tests and procedures which included blood electrolytes: abnormal (disturbance) on 07Feb2021. The patient died on 11Feb2021. It was unknown if an autopsy was performed. Sender Comment: Information on risk factors or previous illnesses - Alcoholic, cirrhosis of the liver. Condition worsened, admission to hospital where he died. Causal relationship between the event/s and the administration of CORMINATY was assessed as "Unclassifiable (D)" by the PEI. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Death due to severe electrolyte disturbance; Condition worsened


VAERS ID: 1709423 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-01
Onset:2021-09-05
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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: 2021-09-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Artificial anus; Dialysis
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101210954

Write-up: Cardiac arrest; This is a spontaneous report from a contactable consumer based on information received by Pfizer from BioNTech (manufacturer control number: 86578), license party for BNT162B2 (COMIRNATY). An 82-year-old male patient received BNT162B2 (COMIRNATY; solution for injection), via an unspecified route of administration on 01Sep2021 (lot number was not reported) as dose 2, single for COVID-19 immunization. Medical history included dialysis and artificial anus. The patient''s concomitant medications were not reported. The patient previously received BNT162B2 (COMIRNATY) on an unspecified date (lot number was not reported) as dose 1, single for COVID-19 immunization. On 05Sep2021, the patient experienced cardiac arrest which caused hospitalization on the same day. Therapeutic measures were taken as result of the event. The patient died due to cardiac arrest on 05Sep2021. It was unknown if an autopsy was performed or not. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1709545 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Dizziness, Fall, Headache, Injury, Migraine, Nausea, Sudden death, Syncope, Urticaria, Vertigo
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Vestibular disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-24
   Days after onset: 23
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: Low blood pressure
Allergies:
Diagnostic Lab Data: Test Date: 202106; Test Name: blood pressure; Result Unstructured Data: Test Result:decreased
CDC Split Type: FIPFIZER INC202101193885

Write-up: died suddenly and unexpectedly; Blood pressure decreased; Vertigo; Syncope/fainted; Headache; Migraine; Nausea; Fall; Urticaria; Dizziness/giddiness; Injury; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number FI-FIMEA-20214358. This consumer reported information for both first and second vaccine dose. This is the report for the second vaccine dose. A 76-year-old female patient received second dose of BNT162B2 (COMIRNATY, Batch/Lot Number: UNKNOWN), via an unspecified route of administration on 01Jun2021 at single dose for covid-19 immunisation. Medical history included low blood pressure. The patient''s concomitant medications were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY) for COVID-19 immunisation and experienced headaches, migraine, vertigo and dizziness. The patient experienced blood pressure decreased, vertigo, syncope/fainted, headache, migraine, nausea, fall, urticaria, dizziness/giddinesson and injury on Jun2021. My mother received the second dose of coronary vaccine on 01Jun2021. She died suddenly and unexpectedly on 24Jun2021. The cause of death has not yet been determined, at least I have not been notified. Before her death, she had fainted and fallen and injured herself. After the 2nd dose of the coronary vaccine, she also told me about the following side effects: migraine, urticaria, giddiness, dizziness, nausea. Possibly side effects were also associated with a drop in blood pressure (she also had low blood pressure anyway). She went to the doctor because of the symptoms and got the medicine for urticaria. The outcome of events was fatal. The patient died on 24Jun2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : FI-PFIZER INC-202101203928 same patient/different vaccine dose number; Reported Cause(s) of Death: died suddenly and unexpectedly; Blood pressure decreased; Vertigo; Syncope/fainted; Headache; Migraine; Nausea; Fall; Urticaria; Dizziness/giddiness; Injury


VAERS ID: 1709569 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-08-13
   Days after vaccination:58
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5435 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-16
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure; Hypertension arterial; Thrombocythaemia
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Fever; Result Unstructured Data: Test Result:High; Test Date: 20210813; Test Name: Covid-19 test: PCR / serology; Result Unstructured Data: Test Result:Positive; Comments: Delta variant
CDC Split Type: FRPFIZER INC202101194030

Write-up: Vaccination failure occurred 2 months after a complete vaccination schedule with the COVID 19 COMIRNATY vaccine. Death of the patient; Vaccination failure occurred 2 months after a complete vaccination schedule with the COVID 19 COMIRNATY vaccine. Death of the patient; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-AN20213534. A 88-year-old patient of an unspecified gender received bnt162b2 (COMIRNATY, Formulation: Solution for injection), dose 2 intramuscularly on 16Jun2021 (Batch/Lot Number: FC5435) as DOSE 2, SINGLE and dose 1 intramuscularly on 21May2021 (Batch/Lot Number: FA7082) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included Hypertension arterial, thrombocythaemia and Cardiac failure from an unknown date and unknown if ongoing. The patient did not have COVID previously. The patient''s concomitant medications were not reported. The allergy and hypersensitivity medical history was unknown. The patient had vaccination failure occurred 2 months after a complete vaccination schedule with the COVID 19 comirnaty vaccine on 13Aug2021. After the vaccination (onset 2 months later), the patient had diarrhea, dyspnea with desaturation and high fever. It was reported the patient had risk of developing a severe form of COVID-19 disease as age and history. On 13Aug2021, the Covid-19 test (PCR / serology) was positive for DELTA variant. The patient died on 16Aug2021. It was reported that death of the patient at Day 3 of the positive test. An autopsy was not performed. No follow-up attempts possible. No further information expected. Information about batch number has been obtained.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101194027 same claster of reports;FR-PFIZER INC-202101186645 same cluster of reports;FR-PFIZER INC-202101194020 same cluster of reports;FR-PFIZER INC-202101186630 same cluster of reports; Reported Cause(s) of Death: COVID-19


VAERS ID: 1709571 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-09
Onset:2021-08-14
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-14
   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: Hypertension arterial; Obesity
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101195037

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician downloaded from the regulatory authority FR-AFSSAPS-BS20211706. A 56-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Right on 09Aug2021 (Lot number: unknown) as dose 1, single for covid-19 immunisation. Medical history included ongoing arterial hypertension and obesity. No medical history of COVID and without COVID test. The patient''s concomitant medications were not reported. Day5, on 14Aug2021, while the patient was mowing his lawn, he felt pain in his chest. He lay down but never got up. The patient experienced cardio-respiratory arrest on 14Aug2021. The patient died on 14Aug2021 due to event of cardio-respiratory arrest. An autopsy was not performed. Despite all research, no additional information was obtained, after a call from the declaring attending physician and after trying to obtain the intervention sheet of the emergency medical and resuscitation service but without success. The lot number for BNT162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1709584 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-17
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-04
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Hypertension; Sleep apnea syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101194738

Write-up: covid-19; covid-19; covid-19; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-GR20213568. A 82-year-old (also reported as 83-year-old) male patient received bnt162b2 (COMIRNATY), dose 2 intramuscularly on 11May2021 (Batch/Lot Number: Unknown) as dose 2, 0.3 mL, single; dose 1 intramuscularly on an unspecified date (Batch/Lot Number: Unknown) as dose 1, single, both for COVID-19 immunisation. Medical history included COVID-19, arterial hypertension/high blood pressure, sleep apnea. Concomitant medications were not reported. On 17Jul2021, COVID infection despite 2 doses of vaccine. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 17Jul2021. The patient died on 04Aug2021. An autopsy was not performed. The outcome of events was fatal. The lot number for bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: COVID-19; COVID-19; Covid-19


VAERS ID: 1709595 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-24
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19, Drug ineffective, Gastrointestinal haemorrhage, Melaena, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atherosclerosis; Cancer of prostate; Chronic renal failure; Hypertension arterial; Pelvic fracture
Allergies:
Diagnostic Lab Data: Test Date: 20210624; Test Name: body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210624; Test Name: SARS-CoV-2 PCR test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101193378

Write-up: PCR positive for COVID 19; PCR positive for COVID 19 with onset of cough then vesicular murmur at right pulmonary base; digestive hemorrhage exoterized by melena; digestive hemorrhage exoterized by melena; This is as spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-LY20218263. A 98-year-old male patient received bnt162b2 (COMIRNATY) intramuscular, as DOSE 2, SINGLE administered in Arm Left on 05Mar2021 (Lot Number: EP2166) and DOSE 1, SINGLE on unknown date (Lot Number unknown) for covid-19 immunisation. Medical history included hypertension arterial, chronic renal failure, prostate cancer, pelvic fracture, and Obliterating arterial disease of the lower limbs left leg. History COVID: No. The patient''s concomitant medications were not reported. 19Jun2021: contact with her grandson who tested positive for COVID 19 on 23Jun2021. A priori no variant. 24Jun2021: PCR positive for COVID 19 with onset of cough then vesicular murmur at right pulmonary base. Hyperthermia at 38 C and physical asthenia. Progressive worsening with the appearance of a digestive hemorrhage exoterized by melena. EVOLUTION: 01Jul2021: Death of the patient. The cause of death was Gastrointestinal bleeding, Melena and PCR positive for COVID 19. It was unknown if Autopsy was done.; Reported Cause(s) of Death: PCR positive for COVID 19; PCR positive for COVID 19; Melena; Gastrointestinal bleeding


VAERS ID: 1709612 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-08-04
   Days after vaccination:166
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, COVID-19 pneumonia, General physical health deterioration, Nausea, Oxygen saturation, SARS-CoV-2 antibody test, SARS-CoV-2 test, Vaccination failure
SMQs:, Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-27
   Days after onset: 23
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: VIDAZA
Current Illness: Diabetes (type 1); Myelodysplasia; Proctocolitis (Ulcerative colitis discovered in 2003, initial medical treatment)
Preexisting Conditions: Medical History/Concurrent Conditions: Myelodysplastic syndrome (treatment with VIDAZA for border syndrome MDS (Myelodysplastic syndrome) / myeloproliferative); Myeloproliferative disorder (treatment with VIDAZA for border syndrome MDS (Myelodysplastic syndrome) / myeloproliferative); Myocardial infarction; Single bypass; Sleep apnea syndrome (initially fitted (no longer using the device for a month)); Total colectomy (total colectomy in 2010, ostomy pouch.)
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: desaturation; Test Result: 85 %; Comments: Call during the night from 24Aug to 25Aug for 85% desaturation despite Oxygen at 15 liters at high concentration mask (oxygen therapy mask); Test Date: 202108; Test Name: desaturation; Test Result: 92 %; Comments: Put under oxygen in COVID service, saturation hardly remains at 92% despite oxygen at 100% FiO2 probable part of the heart associated; Test Date: 20210821; Test Name: desaturation; Test Result: 86 %; Comments: under oxygen 5 L / min; Test Date: 20210821; Test Name: desaturation; Test Result: 96 %; Comments: Increase in oxygen therapy to 10 L / min, with 96% saturation; Test Date: 20210824; Test Name: desaturation; Test Result: 88 %; Comments: under oxygen at 10 L / min; Test Date: 20210814; Test Name: Anti SARS-CoV-2 IgG Ab serology; Result Unstructured Data: Test Result:3.51; Test Date: 20210813; Test Name: Covid-19 PCR test; Test Result: Positive ; Comments: Delta variant
CDC Split Type: FRPFIZER INC202101195071

Write-up: nausea; asthenia; deterioration of general condition; vaccination failure; COVID-19 pneumonitis; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-MP20217346. A 71-years-old male patient received second dose of bnt162b2 (COMIRNATY, solution for injection; Batch/Lot Number: EJ6788) via an unspecified route of administration on 19Feb2021 as single dose and first dose of COMIRNATY (solution for injection; Batch/Lot Number: ER0641) via an intramuscular route of administration on 22Jan2021 as single dose for COVID-19 immunisation. Medical history included colitis from 2003 and ongoing, Ulcerative colitis discovered in 2003, initial medical treatment. Ongoing diabetes mellitus type 1 and myelodysplastic syndrome. Myocardial infarction from 1988 to an unknown date and myocardial infarction from 1997 to an unknown date. Total colectomy from 2010 to an unknown date, ostomy pouch, Coronary artery bypass from 1998 to an unknown date. Sleep apnoea syndrome from an unknown date and unknown if ongoing initially fitted (no longer using the device for a month). Myelodysplastic syndrome and myeloproliferative neoplasm from an unknown date and unknown if ongoing treatment with VIDAZA for border syndrome MDS (Myelodysplastic syndrome) / myeloproliferative. Concomitant medication included azacitidine (VIDAZA) taken for an Myelodysplastic syndrome, start and stop date were not reported. On 13Aug2021 the patient experienced vaccination failure, covid-19 pneumonitis and on 04Aug2021 experienced nausea, asthenia, deterioration of general condition. The patient was hospitalized for nausea, asthenia and deterioration of general condition from 04Aug2021 to an unknown date. The patient underwent lab tests and procedures which included oxygen saturation: 85 % on Aug2021. Call during the night from 24Aug to 25Aug for 85% desaturation despite Oxygen at 15 liters at high concentration mask (oxygen therapy mask), oxygen saturation: 92 % on Aug2021 Put under oxygen in COVID service, saturation hardly remains at 92% despite oxygen at 100% FiO2 probable part of the heart associated with a slight improvement in symptoms after bolus of FUROSEMIDE of 40 mg, oxygen saturation: 86 % on 21Aug2021 under oxygen 5 L / min , oxygen saturation: 96 % on 21Aug2021 Increase in oxygen therapy to 10 L / min, with 96% saturation , and bolus of furosemide. oxygen saturation: 88 % on 24Aug2021 under oxygen at 10 L / min, On 14Aug2021 sars-cov-2 antibody test result was 3.51, and On 13Aug2021 sars-cov-2 test result was positive Delta variant. Therapeutic measures were taken as a result of covid-19 pneumonitis . Progressive deterioration. The patient died on 27Aug2021. An autopsy was not performed. Complete file, no further information. The outcome of the event vaccination failure, covid-19 pneumonitis was fatal and for other events outcome was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Multiorgan failure


VAERS ID: 1709617 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-07
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Blood immunoglobulin G, Blood pressure measurement, Body temperature, COVID-19 pneumonia, Cardiac arrest, Computerised tomogram, Drug ineffective, Heart rate, Hypertension, Hypotension, Jugular vein thrombosis, Oxygen saturation, PO2, Pneumonia, Respiratory rate, SARS-CoV-2 test, Septic shock, Shock, Tachycardia, Ultrasound Doppler, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (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, venous (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-19
   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: OXAZEPAM; TEGRETOL; CYMBALTA; ABILIFY
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Epilepsy; Gastric bypass; Morbid obesity; Personality disorder; Ruptured cerebral aneurysm
Allergies:
Diagnostic Lab Data: Test Date: 20210807; Test Name: igG; Result Unstructured Data: Test Result:23737.4; Comments: 23737.4 AU / ml; Test Date: 20210819; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:150-160 mmHg; Comments: at 4 am; Test Date: 20210819; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:95 mmHg; Comments: at 7 am; Test Date: 20210817; Test Name: body temperature; Result Unstructured Data: Test Result:39 Centigrade; Test Date: 20210818; Test Name: body temperature; Result Unstructured Data: Test Result:38.6 Centigrade; Test Date: 20210819; Test Name: body temperature; Result Unstructured Data: Test Result:40 Centigrade; Comments: at 4 am; Test Date: 20210819; Test Name: body temperature; Result Unstructured Data: Test Result:fever Centigrade; Comments: at 7 am; Test Date: 20210807; Test Name: CT scan with a contrast injection; Result Unstructured Data: Test Result:no proximal pulmonary embolism; Comments: parenchymal damage estimated at 80%; Test Date: 20210819; Test Name: heart rate; Result Unstructured Data: Test Result:150/min; Comments: at 4 am; Test Date: 20210819; Test Name: heart rate; Result Unstructured Data: Test Result:170/min; Comments: at 7 am; Test Date: 20210818; Test Name: FiO2; Test Result: 50 %; Comments: at 8 pm; Test Date: 20210819; Test Name: FiO2; Test Result: 50 %; Comments: at 7 am; Test Date: 20210819; Test Name: paO2; Result Unstructured Data: Test Result:142; Comments: at 7 am under 50% FiO2; Test Date: 20210818; Test Name: respiratory rate; Result Unstructured Data: Test Result:40/min; Comments: at 8 pm; Test Date: 20210819; Test Name: respiratory rate; Result Unstructured Data: Test Result:40-50/min; Comments: at 7 am; Test Date: 20210809; Test Name: SARS-CoV-2 PCR test; Result Unstructured Data: Test Result:delta variant; Comments: variant search: delta +; Test Date: 20210817; Test Name: Doppler ultrasound; Result Unstructured Data: Test Result:small thrombosis on the left jugular; Comments: central venous catheter
CDC Split Type: FRPFIZER INC202101194379

Write-up: Vaccination failure; SARS CoV2 pneumonia; tachycardia; hypotension; shock; disturbances of consciousness; septic shock; hypertensive blood pressure; asystole; ventricular fibrillating rhythm; thrombosis on the left jugular central venous catheter; Ventilator-associated pneumonia; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-NC20214043. A 47-year-old female patient received BNT162B2 (COMIRNATY), 1st dose on an unknown date, 2nd dose on an unknown date , both at single dose intramuscular for COVID-19 immunisation. Medical history included morbid obesity, ruptured cerebral aneurysm with sequelae epilepsy, personality disorder, and surgical autonomous gastric bypass at place of residence. Concomitant drugs included oxazepam, carbamazepine (TEGRETOL LP), duloxetine hydrochloride (CYMBALTA), and aripiprazole (ABILIFY). The 2nd vaccine dose was completed dating back to more than 3 months (as of 13Sep2021) according to the doctor declaring during the declaration in Aug2021. The serious adverse event was reported as vaccination failure with onset date of 07Aug2021 and seriousness criteria of death, and ventilator-associated pneumonia with onset date of 10Aug2021 and seriousness criteria of medially significant. The clinical course was reported as follows: Patient was hospitalized in intensive care on 07Aug2021 in front of an acute respiratory distress syndrome on SARS CoV2 pneumonia. After unsuccessful initiation, decision non-invasive ventilation orotracheal intubation on 07Aug2021 and put on mechanical ventilation. Realization of a single prone position. Patient received treatment with dexamethasone 30 mg gradually decreasing over 10 days associated with an injection of tocilizumab 800 mg. Patient experienced PCR COVID + Delta variant. Mode of contamination: context of family contagion. Note that the Sars-Cov 2 serology was positive with an IgG level of 23737.4 AU / ml. On 10Aug2021, on Day 3 of mechanical ventilation, diagnosis of pneumonia acquired with early mechanical ventilation. Patient was started with antibiotic therapy Extubating on 14Aug2021 with prophylactic ventilation non invasive relay for 24 hours. On 17Aug2021, patient had persistence of fever at 39 C without biological inflammatory syndrome except for a slight polynucleosis. No obvious infectious call point. A Doppler ultrasound reveals a small thrombosis on the left jugular central venous catheter motivating the withdrawal of this catheter and curative anticoagulation by heparin in electrical syringe driver. Patient was discharged from intensive care on 18Aug2021 and transfer for further support. On 18Aug2021 at 8 p.m., patient under high flow oxygen 60L / min, FiO2 50%. Polypnea at 40 / min, superficial well tolerated, stable hemodynamics, Fever at 38.6 C without signs of poor tolerance. Slight mottling of the lower limbs. On the neurological level, the patient was conscious with inappropriate remarks. On 19Aug2021 at 4 a.m. patient had fever up to 40 C with tachycardia at 150 / min, with hemodynamics otherwise preserved - tendency to hypertensive blood pressure at 150-160 mmHg. She was started of probabilistic antibiotic therapy. on 19Aug2021 at 7:00 am, Called for resuscitation because the tachycardia increased to 170 / min with hypotension at 95 mmHg and persistence of fever despite the antibiotic therapy started. Polypnea at 40-50 / min. Blood gas with paO2 at 142 under 50% FiO2. The patient deteriorates rapidly with a state of shock, respiratory distress and disturbances of consciousness requiring her transfer to intensive care. The patient presented in a state of septic shock requiring the initiation of norepinephrine. In the face of respiratory failure and disturbances of consciousness, the patient was intubated and ventilated. During the course of anesthetic induction, his hemodynamic state deteriorates further with major hypotension and then asystole requiring external cardiac massage. A ventricular fibrillating rhythm was recovered requiring ineffective external electric shocks. After 30 minutes of external cardiac massage, death was declared on 19Aug2021. Lab data included on 07Aug2021: CT scan with a contrast injection: no proximal pulmonary embolism, parenchymal damage estimated at 80%. 09Aug2021: variant search: delta +. It was concluded that patient experienced vaccine failure with severe delta-variant COVID-19. Evolution towards refractory shock leading to death. Outcome of vaccination failure and SARS CoV2 pneumonia was death. Outcome of ventricular fibrillating rhythm was resolved on 19Aug2021. Outcome of the other events was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Vaccination failure; SARS CoV2 pneumonia


VAERS ID: 1709691 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-31
Onset:2021-09-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG9428 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-02
   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: SIFROL; STALEVO [CARBIDOPA MONOHYDRATE;ENTACAPONE;LEVODOPA]; TERALITHE; MIANSERINE [MIANSERIN]; IMOVANE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression NOS (from 30 years); Parkinson''s disease (advanced and disabling)
Allergies:
Diagnostic Lab Data: Test Date: 20210622; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101195437

Write-up: Death unexplained; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number FR-AFSSAPS-NT20213816. A 74-year-old female patient received bnt162b2 (COMIRNATY, Lot Number: FG9428), dose 1 intramuscular, administered in arm left on 31Aug2021 16:00 as single dose for covid-19 immunisation. Medical history included advanced and disabling parkinson''s disease, severe depression for 30 years. Concomitant medications included pramipexole dihydrochloride (SIFROL); carbidopa monohydrate, entacapone, levodopa (STALEVO); lithium carbonate (TERALITHE); mianserine (MIANSERIN); and zopiclone (IMOVANE). The patient experienced death unexplained on 02Sep2021. Description of the adverse reaction: Lucid patient, perfectly aware of her situation. Dependent person GIR (iso-resource group) 3. First injection of COMIRNATY on 31Aug2021 at 16h. Two days later, the patient was found dead on her knees in her nursing home room at 5:45 am. She didn''t call during the night, with a normal bedtime, as usual. No post-vaccination incident. The patient was in great shape the day before and did not complain of any problems. No edema of the lower limbs observed, nor frothy foam around the mouth. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 22Jun2021. The patient died on 02Sep2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1709695 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-05
Onset:2021-08-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-06
   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: Stroke
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Death NOS; This case was received via regulatory authority reference number: FR-AFSSAPS-PB20215954) on 09-Sep-2021 and was forwarded to Moderna on 09-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death NOS) in a 90-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Concurrent medical conditions included Stroke. On 05-Aug-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. Death occurred on 06-Aug-2021 The patient died on 06-Aug-2021. The cause of death was not reported. It is unknown if an autopsy was performed. The concomitant medications were not reported. The treatment information was not provided. Company Comment - This case concerns a 90-year-old, female with a history of stroke , who experienced the unexpected event of death . The event occurred approximately 2 days after the second dose of mRNA-1273 Moderna vaccine. The medical history, of stroke, could be a potentially confounder for the case. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this single report. Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Translation received on 16-Sep-2021 contains no new information.; Sender''s Comments: This case concerns a 90-year-old, female with a history of stroke , who experienced the unexpected event of death . The event occurred approximately 2 days after the second dose of mRNA-1273 Moderna vaccine. The medical history, of stroke, could be a potentially confounder for the case. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this single report.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1709717 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-08-01
   Days after vaccination:123
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Auscultation, Blood pressure measurement, Body temperature, C-reactive protein, COVID-19, Cardiac arrest, Cardiovascular examination, Coma scale, Computerised tomogram thorax, Confusional state, Cough, Drug ineffective, Electrocardiogram, Gastrointestinal examination, Heart rate, Investigation, Neurological examination, Oxygen saturation, PCO2, PO2, Rheumatological examination, SARS-CoV-2 test, Scan brain, Troponin, Urinary incontinence, Vomiting, pH body fluid
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-23
   Days after onset: 22
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: RITUXIMAB; METHOTREXATE; SPECIAFOLDINE; CORTANCYL; FLECAINE; SECTRAL; DOXAZOSIN; INEXIUM [ESOMEPRAZOLE MAGNESIUM]; DOLIPRANE; VESICARE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthritis rheumatoid; Benign prostatic hyperplasia; Bouveret syndrome I; Cognitive disturbance (unlabeled early cognitive impairment)
Allergies:
Diagnostic Lab Data: Test Name: auscultation; Result Unstructured Data: Test Result:few crackles at both bases; Test Name: blood pressure; Result Unstructured Data: Test Result:9/6; Test Name: temperature; Result Unstructured Data: Test Result:38.4 Centigrade; Test Name: Cardiovascular examination; Result Unstructured Data: Test Result:no sign of left or right heart failure; Comments: no sign of left or right heart failure, notably no edema of the lower limbs, no hepato-jugular reflux and no jugular turgor. The calves are soft and painless, pulses are present and the heart sounds are regular without murmurs; Test Name: GCS; Result Unstructured Data: Test Result:15; Test Name: thoracic CT scan; Result Unstructured Data: Test Result:moderate involvement typical COVID-19 estimated at; Test Name: CRP; Result Unstructured Data: Test Result:89 mg/l; Test Name: ECG; Result Unstructured Data: Test Result:regular acute rhythm, AF type; Test Name: Abdominal examination; Result Unstructured Data: Test Result:painless soft depressible abdomen; Comments: no palpable mass, regular transit, no functional urinary signs; Test Name: pulse; Result Unstructured Data: Test Result:72; Comments: bpm; Test Name: Electrolytes; Result Unstructured Data: Test Result:normal; Test Name: Neurological examination; Result Unstructured Data: Test Result:patient well oriented in space and time; Comments: persistence of a ptosis in the left eye without any other sign of localization or sensory-motor deficit. The steo-tendinous reflexes are present.; Test Name: oxygen saturation; Test Result: 99 %; Comments: under 2 liters of oxygen; Test Name: PCO2; Result Unstructured Data: Test Result:36.5; Test Name: pH; Result Unstructured Data: Test Result:7.44; Test Name: PO2; Result Unstructured Data: Test Result:80 mmHg; Test Name: Rheumatological examination; Result Unstructured Data: Test Result:deformity of the phalangeal joints in relat.to RA; Test Date: 20210817; Test Name: COVID-19 PCR; Test Result: Positive ; Test Date: 20210817; Test Name: COVID-19 virus test; Test Result: Positive ; Test Date: 20210815; Test Name: SARS-CoV-2 test; Test Result: Positive ; Test Name: cerebral scan; Result Unstructured Data: Test Result:without abnormality; Test Name: Troponin; Result Unstructured Data: Test Result:46.5
CDC Split Type: FRPFIZER INC202101194611

Write-up: drug ineffective; Covid-19; asthenia; febrile confusion; cardiovascular arrest; cough; vomiting; urinary incontinence; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB FR-AFSSAPS-RS20212810. A 77-year-old male patient received BNT162B2 (COMIRNATY), first dose via an unspecified route of administration on an unspecified date in 2021 (Lot Number: ER2659) as single dose, and second dose intramuscular on 31Mar2021 (Lot Number: ET7205) as single dose for COVID-19 immunisation. The patient''s medical history included benign prostatic hyperplasia, cognitive disturbance (unlabeled early cognitive impairment), Bouveret syndrome I, and arthritis rheumatoid. The patient''s concomitant medications included rituximab taken for rheumatoid arthritis, methotrexate, folic acid (SPECIAFOLDINE), prednisone (CORTANCYL), flecainide acetate (FLECAINE), acebutolol hydrochloride (SECTRAL), doxazosin, esomeprazole magnesium (INEXIUM), paracetamol (DOLIPRANE), and solifenacin succinate (VESICARE). The patient experienced cardiovascular arrest on 23Aug2021 21:00; drug ineffective and COVID-19 on 17Aug2021; and asthenia, febrile confusion, cough, vomiting, urinary incontinence, all on Aug2021. The events asthenia, febrile confusion, vomiting and urinary incontinence resulted in emergency room visit, and the event cough resulted in physician office visit. The patient was hospitalized from 19Aug2021 to 23Aug2021 for drug ineffective, COVID-19, asthenia and febrile confusion. The patient underwent lab tests and procedures which included auscultation: few crackles at both bases on an unspecified date; blood pressure: 9/6 on an unspecified date; temperature: 38.4 Centigrade on an unspecified date; cardiovascular examination: no sign of left or right heart failure (no sign of left or right heart failure, notably no edema of the lower limbs, no hepato-jugular reflux and no jugular turgor. The calves are soft and painless, pulses are present and the heart sounds are regular without murmurs) on an unspecified date; GCS: 15 on an unspecified date; thoracic CT scan: moderate involvement typical covid-19 estimated at on an unspecified date; CRP: 89 mg/l on an unspecified date; ECG: regular acute rhythm, AF type on an unspecified date; abdominal examination: painless soft depressible abdomen (no palpable mass, regular transit, no functional urinary signs) on an unspecified date; pulse: 72 bpm on an unspecified date; electrolytes: normal on an unspecified date; neurological examination: patient well oriented in space and time (persistence of a ptosis in the left eye without any other sign of localization or sensory-motor deficit. The steo-tendinous reflexes are present) on an unspecified date; oxygen saturation: 99 % (under 2 liters of oxygen) on an unspecified date; PCO2: 36.5 on an unspecified date; pH: 7.44 on an unspecified date; PO2: 80 mmHg on an unspecified date; rheumatological examination: deformity of the phalangeal joints in relation to RA on an unspecified date; COVID-19 PCR: positive on 17Aug2021; COVID-19 virus test: positive on 17Aug2021; SARS-CoV-2 test: positive on 15Aug2021; cerebral scan: without abnormality on an unspecified date; troponin: 46.5 on an unspecified date. Therapeutic measures were taken as a result of cardiovascular arrest, COVID-19 and cough. The patient died on 23Aug2021 due to cardiovascular arrest. An autopsy was not performed. The outcome of the event cardiovascular arrest was fatal and the outcome of the other events was unknown. The clinical course was reported as follows: On 19Aug2021 (4, 5 months later), the patient was referred to hospital for asthenia, febrile confusion with positive COVID test on 17Aug2021. Research of the variant was not known. Evolution was death. Overall: Suspected vaccine failure 4 1/2 months after Dose 2 of COMIRNATY vaccine in a 77 year old patient. Additional information obtained by the Regional Pharmacovigilance Center from the reporter: Patient hospitalized 19-23Aug2021 for management of febrile confusion over Covid 19 pneumonia. History of illness: Patient is referred by the fire department for asthenia, febrile confusion. Positive COVID test on 17Aug2021. The patient presented with a severe cough on the night of 15-16Aug2021, was seen by his nephew physician on 16Aug and put on azithromycin antibiotics which he took for two days. The COVID PCR on 17Aug came back positive. The wife was also tested positive but asymptomatic. The evolution was marked by agitation, confusion with the appearance of vomiting, then asthenia and urinary incontinence in a febrile picture, leading the patient to consult the emergency room where a normal state of consciousness is found with a conscious patient, a temporospatial disorientation but well oriented in space, confused patient. Presence of a ptosis of the left eyelid without anomaly of the cranial pairs. Eupnea with a saturation of 99% under 2 liters of oxygen and the rest of the examination is without particularity. On biology, biological inflammatory syndrome with a CRP (C-reactive protein) of 89 mg/L without hyperleukocytosis. normal. Troponin is 46.5. Blood gas: pH 7.44, PO2 80 mmHg, PCO2 36.5. The ECG(Echocardiogram) is in regular acute rhythm, AF(atrial fibrillation) type. The thoracic imaging shows a moderate involvement typical COVID-19 estimated at 10-25% and the cerebral scan is without abnormality. After cardiological advice, Eliquis 5 mg x 2 per day was introduced without modification of the usual treatment, and the patient was hospitalized for further management. Examination at entry: Saturation on 97% on 1 liter, temperature 38.4C, no change in general condition, patient not malnourished, no signs of dehydration, eupneic, no signs of acute or chronic respiratory failure, no signs of struggle. On auscultation, a few crackles at both bases. Cardiovascular examination: blood pressure 9/6 with a pulse of 72 bpm, no sign of left or right heart failure, notably no edema of the lower limbs, no hepato-jugular reflux and no jugular turgor. The calves are soft and painless, pulses are present and the heart sounds are regular without murmurs. Neurological examination: GCS 15, patient well oriented in space and time, persistence of a ptosis in the left eye without any other sign of localization or sensory-motor deficit. The steo-tendinous reflexes are present. Rheumatological examination: deformity of the phalangeal joints in relation to his RA. Abdominal examination: painless soft depressible abdomen, no palpable mass, regular transit, no functional urinary signs. Rest of the examination without particularity. Evolution: Confusional febrile picture at Day 6 of Sars-Cov2 infection with moderate involvement on CT scan, estimated at 10-25%. The brain scan did not reveal any sign that could explain the clinical symptomatology. On the other hand, episodes of confusion during fever peaks with a return to normal consciousness in the apyrexia phase. The examination did not reveal any meningeal syndrome, the neck was flexible. There was no indication to perform a lumbar puncture. Regarding the AF of recent discovery, maintenance of the anticoagulant treatment by Eliquis 5 mg x 2/day with a normal renal function. On the respiratory level, the evolution is marked by the installation of a desaturation on the weekend of 22Aug2021, with an increase of the oxygen requirements going up to 6 liters/min. The biology showed an increase in the biological inflammatory syndrome. In view of these clinical arguments, the decision was made to start therapy with Augmentin 1 g x 3/day, with the introduction of dexamethasone 6 mg for 10 days. Unfortunately the patient presented a cardiovascular arrest on the night of 23Aug2021 at 21h. He received ventilation with cardiopulmonary massage, then orotracheal intubation with 15 minutes of massage with 5 mg of Adrenalin, without recovery. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cardiovascular arrest


VAERS ID: 1709718 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-22
Onset:2021-08-22
   Days after vaccination:92
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3558 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Body temperature, COVID-19 pneumonia, Computerised tomogram head, Emergency care examination, Oxygen saturation, SARS-CoV-2 antibody test, SARS-CoV-2 test, Vaccination failure, X-ray
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-04
   Days after onset: 13
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: HYTACAND; ELIQUIS; CORDARONE; BISOPROLOL; ATARAX [HYDROXYZINE HYDROCHLORIDE]; FLECTOR [DICLOFENAC EPOLAMINE]; UROREC; RELVAR; RHINOCORT [BUDESONIDE]; PAROEX; AMLODIPINE; DOLIPRANE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthmatoid bronchitis; Benign prostatic hyperplasia; Essential hypertension; Falcine meningioma (Meningioma of the brain scythe); Leukoaraiosis; Pain; Sinus tachycardia
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: Thoracic angio-scanner; Result Unstructured Data: Test Result:compatible with a COVID-19 infection with moderate; Comments: compatible with a COVID-19 infection with moderate (10 - 25%) damage to the pulmonary parenchyma. No argument for bacterial superinfection. Absence of pulmonary embolism detected up to the lobar.; Test Date: 20210825; Test Name: body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210825; Test Name: Brain CT scan; Result Unstructured Data: Test Result:did not show any recent haemorrhagic lesion.; Test Date: 20210825; Test Name: Emergency room examination; Result Unstructured Data: Test Result:bilateral crackles, negative trauma assessment; Comments: bilateral crackles, negative trauma assessment; Test Date: 20210825; Test Name: oxygen saturation; Test Result: 87 %; Comments: SpO2 87% with AA then 92% under 3L of O2; Test Date: 20210826; Test Name: oxygen saturation; Test Result: 92 %; Comments: under 5L of O2 with 92% SpO2; Test Date: 20210826; Test Name: SarsCov2 IgG (anti-Spike) serology; Test Result: Negative ; Test Date: 20210825; Test Name: SARS-COV2 PCR test; Test Result: Positive ; Comments: Strong positive SARS-COV2 PCR test (very contagious patient). Hospitalization in infectiology following PEC. Sequencing in progress.; Test Date: 20210825; Test Name: Pulmonary x-ray; Result Unstructured Data: Test Result:Diffuse interstitial syndrome with thickening hilu; Comments: Diffuse interstitial syndrome with thickening hilum.
CDC Split Type: FRPFIZER INC202101193956

Write-up: Vaccination failure; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable physician downloaded from the regulatory authority FR-AFSSAPS-SE20212279. A 92-year-old male patient received bnt162b2 (COMIRNATY), second single dose intramuscularly, administered in arm left on 22May2021 (Batch/Lot Number: FC3558), and first single dose 1 intramuscular, administered in arm left on 20Apr2021 (Batch/Lot Number: Unknown) for covid-19 immunisation. Medical history included leukoaraiosis, essential hypertension, asthmatoid bronchitis, sinus tachycardia, meningioma of the brain scythe (falcine meningioma), benign prostatic hyperplasia, and pain. Concomitant medications included candesartan cilexetil, hydrochlorothiazide (HYTACAND); apixaban (ELIQUIS); amiodarone hydrochloride (CORDARONE); bisoprolol; hydroxyzine hydrochloride (ATARAX); diclofenac epolamine (FLECTOR); silodosin (UROREC); fluticasone furoate, vilanterol trifenatate (RELVAR); budesonide (RHINOCORT); chlorhexidine gluconate (PAROEX); amlodipine; paracetamol (DOLIPRANE) taken if pain. On 22Aug2021, the patient experienced cough and rhinitis. From 23Aug2021 to 25Aug2021 repeated falls. Taken by firefighters on 25Aug2021 to the emergency room. Emergency room examination on 25Aug2021: SpO2 87% with AA then 92% under 3L of O2, fever at 38 �C, bilateral crackles, negative trauma assessment. Pulmonary x-ray: diffuse interstitial syndrome with thickening hilum. Thoracic angio-scanner compatible with a COVID-19 infection with moderate (10 - 25%) damage to the pulmonary parenchyma. No argument for bacterial superinfection. Absence of pulmonary embolism detected up to the lobar. Strong positive SARS-COV2 PCR test (very contagious patient). Hospitalization in infectiology following PEC. Sequencing in progress. SarsCov2 IgG (anti-Spike) serology on 26Aug2021: negative. Evolution: Patient agitated and confused on 26Aug2021 under 5L of O2 with 92% SpO2. Brain CT scan on 25Aug2021 did not show any recent haemorrhagic lesion. RCP of 27Aug2021: ATU validation of Casirivimab-indesimab in individual compassionate ATU. Rapid deterioration of the patient''s clinical condition with signs of acute respiratory distress and a rapid increase in oxygen requirements up to 15l / min with morphine 0.7mg / h and LASILIX 3 times a day, anxiolytic treatment for agitation. Joint management with the palliative care team. Patient died on 04Sep2021. Conclusion: Vaccination failure confirmed in a 92-year-old patient after a complete vaccination schedule of two doses of COMIRNATY: Hypoemic SARS-Cov2 pneumonia 3 months after the 2nd dose, patient who died during hospitalization. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected. Batch number not known for first dose.; Reported Cause(s) of Death: Vaccination failure; SARS CoV 2 pneumonia


VAERS ID: 1709720 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-08-23
   Days after vaccination:180
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, Cardiopulmonary failure, Investigation, Oxygen saturation, SARS-CoV-2 test, Vaccination failure
SMQs:, Cardiac failure (narrow), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-04
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ELIQUIS; NICORANDIL; LEVOTHYROX; SALBUTAMOL; SEEBRI BREEZHALER; SERETIDE DISKUS [FLUTICASONE PROPIONATE;SALMETEROL XINAFOATE]; TADENAN; COLECALCIFEROL; PARACETAMOL; MOVICOL [MACROGOL 4000;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Arterial disorder; Asthma; Atrial flutter; Bilateral cataracts; Cardiac ablation; Cessation of smoking; Chronic obstructive airways disease (in a former smoker, emphysema); Constipation; Emphysema; Hypercholesterolaemia; Hypertension arterial; Hypothyroidism (after treatment with amiodarone); Peptic ulcer; Prostate adenoma; Squamous cell carcinoma; Surgery
Allergies:
Diagnostic Lab Data: Test Date: 20210903; Test Name: Lung examination; Result Unstructured Data: Test Result:suspect a bronchial superinfection; Comments: finding crackles of the bases and diffuse bronchial rales making suspect a bronchial superinfection; Test Name: screening; Result Unstructured Data: Test Result:Unknown Results; Comments: Screening PCR test (results returned on 07Sep2021): Detection of the E484K mutation - Absence; Detection of the E484Q Mutation - Absence; Detection of the L452R Mutation - Presence; Interpretation: Probable infection with a delta variant; Test Date: 20210903; Test Name: Saturation; Test Result: 81 %; Comments: desaturation of 81% in ambient air; Test Date: 20210810; Test Name: PCR; Test Result: Negative ; Comments: during hospitalization in Geriatrics until 12Aug2021; Test Date: 20210823; Test Name: PCR; Test Result: Positive ; Comments: PCR test carried out in town; Test Date: 20210903; Test Name: PCR; Test Result: Positive ; Comments: Nucleocapsid 1 gene: strong positive (CT Nucleocapsid 1 gene: 20.60); Nucleocapsid 2 gene: strong positive (CT Nucleocapsid 2 gene: 20.60); cell control: valid (CT cell control: 21.60); Screening PCR test (results returned on 07Sep2021): Detection of the E484K mutation - Absence of the mutation; Detection of the E484Q Mutation - Absence of the mutation. ; Detection of the L452R Mutation - Presence of the mutation; Interpretation: Probable infection with a delta variant. Request for sequencing.
CDC Split Type: FRPFIZER INC202101194342

Write-up: hypoxic heart failure; Vaccination failure; Pneumopathie COVID 19; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number FR-AFSSAPS-SE20212373. A 92-year-old male patient received BNT162B2 (COMIRNATY), dose 2 intramuscular, administered in arm right on 24Feb2021 (Batch/Lot Number: EP9598) as single dose, dose 1 intramuscular, administered in arm right on 03Feb2021 (Batch/Lot Number: EJ6788) as single dose for COVID-19 immunisation. Medical history included atrial flutter, atrial fibrillation, hypertension arterial, peptic ulcer, prostatic adenoma from 2004, hypothyroidism after treatment with amiodarone, left temporal squamous cell carcinoma from 2010, bilateral cataract from 1995, right and left inguinal surgery from 2000 to 2004, chronic obstructive airways disease in a former smoker, emphysema, left leg femoral arterial disease, hypercholesterolaemia, squamous cell carcinoma left hand from 2019, flutter ablation from 2001, asthma and constipation. Patient had no known allergy. Toxic habits: smoking cessation. Patient did not have previous COVID-19. Concomitant medication included apixaban (ELIQUIS), nicorandil, levothyroxine sodium (LEVOTHYROX), glycopyrronium bromide (SEEBRI BREEZHALER), fluticasone propionate, salmeterol xinafoate (SERETIDE DISKUS [FLUTICASONE PROPIONATE;SALMETEROL XINAFOATE]), prunus africana extract (TADENAN), colecalciferol, paracetamol, all taken for an unspecified indication, start and stop date were not reported; salbutamol taken for asthma, start and stop date were not reported; macrogol 4000, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL [MACROGOL 4000; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE]), taken for constipation, start and stop date were not reported. Patient had PCR test on 10Aug2021 during hospitalization in Geriatrics until 12Aug2021: negative. Patient tested positive for SARS-CoV-2 on 23Aug2021 (PCR test carried out in town). Progressive worsening of his respiratory state motivating the arrival of emergency doctor on 03Sep2021: observation of desaturation of 81% in ambient air. Patient referred to the Emergency Department. In Emergencies: correct saturation under 2L of oxygen. Lung examination finding crackles of the bases and diffuse bronchial rales making suspect a bronchial superinfection. In this context, initiation of antibiotic therapy with ceftriaxone and spiramycin (ROVAMYCINE), in combination with corticosteroid therapy with dexamethasone. Patient transferred to Infectious Disease for further treatment. Evolution: unfavorable respiratory evolution with high respiratory congestion requiring a very rapid increase in oxygen requirements. In the face of unfavorable development, discussion of this patient''s situation in a collegial manner with the resuscitators: admission to intensive care unit deemed unreasonable due to the patient''s age and his comorbidities. Implementation of comfort care. Very rapid onset of hypoxic heart failure leading to death of the patient on 04Sep2021 at 09:17. Biology: PCR test on 03Sep2021: Nucleocapsid 1 gene: strong positive (CT Nucleocapsid 1 gene: 20.60); Nucleocapsid 2 gene: strong positive (CT Nucleocapsid 2 gene: 20.60); cell control: valid (CT cell control: 21.60); Interpretation: SARS-CoV-2 infection - highly contagious patient. Screening PCR test (results returned on 07Sep2021): Detection of the E484K mutation - Absence of the mutation; Detection of the E484Q Mutation - Absence of the mutation. ; Detection of the L452R Mutation - Presence of the mutation; Interpretation: Probable infection with a delta variant. Request for sequencing. Conclusion: Serious confirmed vaccine failure 6 months after a complete vaccination schedule at 2 doses of BNT162B2 leading to the death of a 92-year-old patient with a history of post-smoking Chronic obstructive airways disease, hypertension and Atrial flutter and AFib (patient in independent residence) . PCR screening for probable delta variant infection. Patient died on 04Sep2021. Autopsy was not done. N.B. Accountability without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable compensation procedures. Therapy 1985; 40: 111-8. No follow-up attempts are needed. No further information is expected. ; Reported Cause(s) of Death: Vaccination failure; hypoxic heart failure; Pneumopathie COVID 19


VAERS ID: 1709721 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-23
Onset:2021-08-18
   Days after vaccination:176
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Decreased appetite, Fatigue, General physical health deterioration, Pain, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-04
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Embolism pulmonary; Goiter; Hernial eventration; Hypertension arterial; Knee prosthesis insertion; Polyp; Type 2 diabetes mellitus; Umbilical hernia
Allergies:
Diagnostic Lab Data: Test Date: 20210818; Test Name: PCR COVID; Test Result: Positive ; Comments: Origin : Nasal swab : RNA Nucleocapsid result: 18.6 (strong positive); RNA polymerase result: 18.8 (strong positive) Interpretation: Infection with SARS-CoV-2, contagious patient mutation search : Detection of the E484K mutation: No mutation Detection of the E484Q mutation: Absence of the mutation Detection of the L452R mutation : Presence of the mutation Interpretation: Suspicion of a delta variant
CDC Split Type: FRPFIZER INC202101194747

Write-up: general deterioration; Fatigue; pain; loss of appetite; COVID-19; COVID-19; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number FR-AFSSAPS-SE20212403. A 91-year-old (also reported as 92-year-old) female patient received bnt162b2 (COMIRNATY), dose 2 intramuscularly on 23Feb2021 (Lot Number: EJ6789; Expiration Date: 31May2021) as dose 2, single; dose 1 intramuscularly on 02Feb2021 (Lot Number: EJ6788; Expiration Date: 30Apr2021) as dose 1, single for COVID-19 immunisation. The patient was residing in an residential facility for dependent elderly people. Medical history included hypertension arterial, hernial eventration, benign polyp, umbilical hernia, goiter, embolism pulmonary, advanced type 2 diabetes mellitus, right and left knee prosthesis insertion. Concomitant medications were not reported. The patient was at risk of developing a severe form of COVID-19. No COVID-19 before the episode of 18Aug2021. It was unknown if the patient was tested (no information before the PCR of 18Aug2021 positive). Habitual treatment not reported. On 18Aug2021, patient tested positive for SARS-CoV-2 in a cluster context in her living unit (systematic screening). Patient who presented a general deterioration of the general state before the positive PCR. Symptoms presented: Fatigue, pain, loss of appetite. No desaturation, no hyperthermia. Treatment received for the events which included with morphine, scopolamine, LOVENOX and hydration. BIOLOGY:- PCR of 18Aug2021 performed. Origin: Nasal swab:- RNA Nucleocapsid result: 18.6 (strong positive);- RNA polymerase result: 18.8 (strong positive) Interpretation: Infection by SARS-CoV-2, contagious patient mutation search: Detection of the E484K mutation: No mutation. Detection of the E484Q mutation: Absence of the mutation. Detection of the L452R mutation : Presence of the mutation. Interpretation: Suspicion of a delta variant. CONCLUSION: Severe confirmed vaccine failure (death) approximately 6 months after a complete 2-dose bnt162b2 vaccine regimen in a 92-year-old (as reported) patient, in the context of a cluster of Covid-19 infections. Screening PCR in favor of a probable infection by the delta variant. The investigation results of bnt162b2 (Lot EJ6788) included: Conclusion as follows: 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 EJ6788. 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. PGS Puurs concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that 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. The investigation results of bnt162b2 (Lot EJ6789) included: Conclusion as follows: 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 EJ6789. 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. PGS Puurs concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that 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. The patient died on 04Sep2021. An autopsy was not performed. The outcome of COVID-19 was fatal. The outcome of other events was unknown.; Reported Cause(s) of Death: COVID-19; COVID-19


VAERS ID: 1709729 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-08-31
   Days after vaccination:202
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, COVID-19 pneumonia, Hyperthermia, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Accidents and injuries (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: 2021-09-05
   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: DICLOFENAC ARROW [DICLOFENAC SODIUM]; BISOPROLOL BGR; LOXAPAC [LOXAPINE SUCCINATE]; LASILIX [FUROSEMIDE]; TARDYFERON; SERESTA; ELIQUIS; ALPRAZOLAM ALTER; CLOPIXOL [ZUCLOPENTHIXOL HYDROCHLORIDE]; GAVISCON [SODIUM ALGINATE;SODIUM BICARBONATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure; Diabetes; Dizziness; Hernia; Hypercholesterolaemia; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Name: Hyperthermia; Result Unstructured Data: Test Result:40.6 Centigrade; Test Date: 20210831; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: Variant Delta
CDC Split Type: FRPFIZER INC202101194503

Write-up: Vaccination failure; COVID-19 pneumonia; COVID-19; This is a spontaneous report from a contactable other hcp downloaded from the regulatory authority number FR-AFSSAPS-TO20217658. A 94-year-old female patient received bnt162b2 (COMIRNATY), Formulation: Solution for injection, Batch/Lot Number: EJ6788, Expiry date was not reported), via intramuscular route of administration on 10Feb2021 in Arm Left as dose 2, single for COVID-19 immunization and patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: EJ6788, Expiry date was not reported), via intramuscular route of administration on 21Jan2021 in Arm Left as dose 1, single for COVID-19 immunization. The Patient Medical history included hypertension from an unknown date and unknown if ongoing , diabetes mellitus from an unknown date and unknown if ongoing , hypercholesterolaemia from an unknown date and unknown if ongoing , cardiac failure from an unknown date and unknown if ongoing , hernia from an unknown date and unknown if ongoing , dizziness from an unknown date and unknown if ongoing. Concomitant medication included diclofenac sodium (DICLOFENAC ARROW [DICLOFENAC SODIUM]) taken for an unspecified indication, start and stop date were not reported; bisoprolol fumarate (BISOPROLOL BGR) taken for an unspecified indication, start and stop date were not reported; loxapine succinate (LOXAPAC [LOXAPINE SUCCINATE]) taken for an unspecified indication, start and stop date were not reported; furosemide (LASILIX [FUROSEMIDE]) taken for an unspecified indication, start and stop date were not reported; ferrous sulfate (TARDYFERON) taken for an unspecified indication, start and stop date were not reported; oxazepam (SERESTA) taken for an unspecified indication, start and stop date were not reported; apixaban (ELIQUIS) taken for an unspecified indication, start and stop date were not reported; alprazolam (ALPRAZOLAM ALTER) taken for an unspecified indication, start and stop date were not reported; zuclopenthixol hydrochloride (CLOPIXOL [ZUCLOPENTHIXOL HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported; sodium alginate, sodium bicarbonate (GAVISCON [SODIUM ALGINATE;SODIUM BICARBONATE]) taken for an unspecified indication, start and stop date were not reported; potassium chloride (DIFFU K) taken for an unspecified indication, start and stop date were not reported; lansoprazole (LANSOPRAZOLE ALMUS) taken for an unspecified indication, start and stop date were not reported. On 31Aug2021, the patient experienced vaccination failure, COVID-19 and COVID-19 pneumonia. The patient underwent lab tests and procedures which included hyperthermia: 40.6 centigrade, sars-cov-2 test: positive on 31Aug2021 Variant Delta, Desaturation, Putting on oxygen. Call for urgent medical assistance. Therapeutic measures were taken as a result of COVID-19. The patient died on 05Sep2021. An autopsy was not performed. The outcome for the events was Fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Pneumonia covid-19


VAERS ID: 1709730 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-08-31
   Days after vaccination:200
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Drug ineffective, Hyperthermia, Oxygen saturation decreased, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Accidents and injuries (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-09
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Benign prostatic hyperplasia; Cardiac failure; COPD
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101194729

Write-up: Desaturation; Cough; Vaccination failure; COVID-19 confirmed by positive COVID-19 test; Hyperthermia 38.3�; This is a spontaneous report from a contactable physician downloaded from the European Medicines Agency (EMA) EudraVigilance-WEB. This is a report received from the European Medicines Agency (EMA) EudraVigilance-WEB, regulatory authority number FR-AFSSAPS-TO20217774. A 96-years-old male patient received first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: EJ6788, Expiration Date: Not reported), via intramuscular route of administration in left arm on 21Jan2021 as dose 1, single for covid-19 immunization and second dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: EJ6788, Expiration Date: Not reported), via intramuscular route of administration in left arm on 12Feb2021 as dose 2, single for covid-19 immunization. Medical history included cardiac failure, benign prostatic hyperplasia and chronic obstructive pulmonary disease. The patient concomitant medications were not reported. On 31Aug2021, the patient experienced vaccination failure, covid-19 confirmed by positive covid-19 test and hyperthermia 38.3 degree. On 04Sep2021, the patient experienced cough. On 05Sep2021, the patient experienced desaturation. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The patient died on 09Sep2021. An autopsy was not performed and the reported cause of death was Pneumonie covid-19. Outcome of the events were fatal.; Reported Cause(s) of Death: Pneumonie covid-19


VAERS ID: 1709763 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-04-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER1741 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Chest pain, Death, Dyspepsia, Dyspnoea, Gastrointestinal pain, Headache, Inappropriate schedule of product administration, Nausea, Neck pain, Pain in extremity, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-30
   Days after onset: 75
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CALCIUM + D3 [CALCIUM CARBONATE;COLECALCIFEROL]; DIAMORPHINE; FYBOGEL MEBEVERINE; GABAPENTIN; LEVOTHYROXINE
Current Illness: Abstains from alcohol; Non-tobacco user
Preexisting Conditions: Medical History/Concurrent Conditions: Hypothyroidism (managed this well with medication.); Spinal stenosis lumbar; Ulcerative colitis
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101182301

Write-up: Death unexplained; Heartburn; Back pain; Leg pain; Chest pain; Head pain; Neck pain; Shortness of breath; Nausea; Gut pain; patient received dose 1 on 26Jan2021 & second dose on 16Apr2021; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority report number is GB-MHRA-WEBCOVID-202109020316109570-LHNV6. Safety Report Unique Identifier is GB-MHRA-ADR 25893033. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Apr2021 (Lot Number: ER1741) as dose 2, single for COVID-19 immunisation . Medical history included low thyroid - hypothyroidism, but managed this well with medication, stenosis of the lumbar/ lumbar spinal stenosis, colitis ulcerative, non-tobacco user, abstains from alcohol. Patient managed ulcerative colitis well and ate very healthy and watched her weight. Patient never smoked, never consumed alcohol, ate healthy, took regular exercise and never ever had high blood pressure or angina. Patient has not had symptoms associated with COVID-19. Concomitant medications included calcium carbonate, colecalciferol, diamorphine taken for lumbar spinal stenosis, mebeverine hydrochloride, plantago ovata husk (FYBOGEL MEBEVERINE) taken for colitis ulcerative, gabapentin taken for lumbar spinal stenosis, and levothyroxine taken for hypothyroidism. Historical vaccine included the first dose of BNT162B2 on 26Jan2021 (Lot number: E442243) for COVID-19 immunisation. On 17Apr2021, the patient experienced heartburn, back pain, leg pain, chest pain, head pain, neck pain, shortness of breath, nausea, and gut pain. Events were described as follows: patient began suffering heartburn, chest pain and upper back pain 1 day after the second vaccine injection. Symptoms also included leg pain, abdominal/gut pain, nausea, headaches. Patient was too terrified to call for an ambulance or ask for medical advice incase she went into hospital and never came out. The above symptoms were then present each day intermittently for several weeks. Patient has not tested positive for COVID-19 since having the vaccine. The events were considered medically significant and has not recovered from them. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on an unspecified date. The patient then has an unexplained death on 30Jun2021. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: unexplained death


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