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

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



Case Details

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VAERS ID: 1534548 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-06-01
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH VX9FVK9JKLEV / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202100956431

Write-up: Fever; This is a spontaneous report from a non-contactable consumer. A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route administration on 24May2021 (Batch/Lot Number: VX9FVK9JKLEV, expiration date not provide) at age of 78 years old as a single dose for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced fever on 01Jun2021 with outcome of fatal. The patient died on an unspecified date. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Fever


VAERS ID: 1534549 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0927 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Local reaction
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: ZAPFIZER INC202100956433

Write-up: Local reaction; This is a spontaneous report from a non-contactable consumer. A 79-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration administration on 09Jul2021 (Batch/Lot Number: FD0927) (at the age of 79-year-old) as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced local reaction on 09Jul2021. The patient died on an unspecified date due to local reaction. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Local reaction


VAERS ID: 1534550 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1436 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202100956434

Write-up: Heart attack; Local reaction; This is a spontaneous report from a non-contactable consumer or other non hcp. A 68-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecifed route of administration on 14Jul2021 (Batch/Lot Number: FC1436) at the age of 68 years for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced local reaction and heart attack on 15Jul2021. Outcome of the events was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: heart attack; local reaction


VAERS ID: 1534603 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3064 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Fall, Influenza like illness, Nausea
SMQs:, Acute pancreatitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-28
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Epilepsy; Lactic acidosis syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202100968744

Write-up: Died; Falling/collapsing; Nausea; Flu-like symptoms; This is a spontaneous report from a contactable physician. A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 14Jul2021 (Batch/Lot Number: FE3064) as dose 1, single for covid-19 immunization. Medical history included epilepsy and clovis lactic syndrome. The patient''s concomitant medications were not reported. The patient previously took lamotrigine, seroquel, omeprazole, rivotril, tramadol. The patient experienced flu-like symptoms (influenza like illness) on 16Jul2021, nausea (nausea) on 19Jul2021. On 27Jul2021, patient reported to be falling/collapsing. Patient died on 28Jul2021. An autopsy was not performed. Outcome for other events was unknown.; Sender''s Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event death and the suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: death


VAERS ID: 1534627 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-07-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2090 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Death, Fatigue, Foaming at mouth, SARS-CoV-2 antibody test positive, SARS-CoV-2 test
SMQs:, Convulsions (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Generalised convulsive seizures following immunisation (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus (On treatment); Hypertension (On tdreatment)
Allergies:
Diagnostic Lab Data: Test Date: 20210722; Test Name: SARS-COV-2 PCR; Result Unstructured Data: Test Result:POSITIVE
CDC Split Type: ZAPFIZER INC202100971580

Write-up: Demised; COVID-19 antibody test positive; Tiredness; General body weakness; Foaming from mouth; This is a spontaneous report from a non-contactable consumer. A 64-year-old female patient (unknown pregnant) received the second dose of BNT162b2 via an unspecified route of administration on 21Jul2021 at 09:00 (Batch/Lot Number: FE2090; Expiration Date: Oct2021) as single for COVID-19 immunization. Medical history included hypertension and diabetes mellitus, both on treatment. The patient''s concomitant medications were not reported. On 21Jul2021 at 15:00, the patient experienced tiredness and general body weakness. On 21Jul2021, the patient was also foaming from mouth. On an unspecified date, the patient was found demised in the sitting poisition at home. The patient had a COVID-19 antibody positive test on 22Jul2021 (test done in the mortuary). Tests Sars-cov-2 test: positive on 22Jul2021. It was not reported if an autopsy was performed. The outcome of death was fatal, the outcome of other events was unknown.; Reported Cause(s) of Death: death


VAERS ID: 1534630 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-17
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Agonal respiration, Asthenia, COVID-19 pneumonia, Chest X-ray, Confusional state, Cough, Death, Drug ineffective, Dyspnoea, Headache, Hypoxia, Pain, Respiratory distress, SARS-CoV-2 antibody test
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-24
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210724; Test Name: Chest X-RAY; Result Unstructured Data: Test Result: BILATERAL DIFFUSED INFILTRATES; Test Date: 20210724; Test Name: COVID PCR swab; Result Unstructured Data: Test Result: negative
CDC Split Type: ZAPFIZER INC202100983912

Write-up: Agonal gasps; Hypoxic; Altered mental state; demise; bilateral diffused infiltrates suggestive of Covid-19 pneumonia; bilateral diffused infiltrates suggestive of Covid-19 pneumonia; Distress; Shortness of breath; Cough; Body pain; Body weakness; Headache; This is a spontaneous report from a contactable physician. A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 on 07Jul2021 (Batch/Lot number was not reported) at single dose (at 50 years old) for COVID-19 immunization. Medical history included hypertension. Concomitant medications were not reported. On 17Jul2021, the patient experienced cough, shortness of breath, headache, body pain, body weakness, distressed. On 24Jul2021, 06h30, the patient presented with agonal gasps, altered mental state, hypoxic. On 24Jul2021, 09h45, the patient demised. Relevant tests on 24Jul2021 - chest x-ray: bilateral diffused infiltrates suggestive of Covid-19 pneumonia, Sars-cov-2 antibody test: negative. It was not reported if an autopsy was performed. The lot number for the vaccine BNT162b2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the current available limited information in the case provided, the causal association between the events Death, Covid 19 Pneumonia, drug ineffective, respiratory distress, agonal breathing, hypoxia, confusional state, dysponea, cough and the use of suspect product BNT162B2 cannot be fully assessed. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate. ; Reported Cause(s) of Death: Demised


VAERS ID: 1535706 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-28
Submitted: 0000-00-00
Entered: 2021-08-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Death, Malaise
SMQs:, Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-02
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210808702

Write-up: DEATH; MALAISE; WEAKNESS; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, DE-DCGMA-21190734] concerned a 69 year old male of unspecified race and ethnic origin. The patient''s weight was 80 kilograms, and height was 175 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 and expiry was not reported) dose was not reported, 1 total administered on 28-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 28-MAY-2021, the patient experienced malaise and weakness. On 02-JUN-2021, the patient died and 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 unknown cause of death on 02-JUN-2021. This report was serious (Death).; Sender''s Comments: V0: 20210808702-Covid-19 vaccine ad26.cov2.s- Death, malaise and weakness. 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: 1535796 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-22
Submitted: 0000-00-00
Entered: 2021-08-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205C81A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210803628

Write-up: LOSS OF CONSCIOUSNESS; SHORTNESS OF BREATH; This spontaneous report received from a health care professional via a Regulatory Authority (PHIFDA,PH-PHFDA-300093728) concerned a 71 year old female of an unspecified race and ethnic origin. 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, and batch number: 205C81A expiry: unknown) dose was not reported, frequency 1 total administered on 22-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-JUL-2021, at 16:00 the patient experienced loss of consciousness, shortness of breath. On an unknown date the patient was died due to shortness of breath, and loss of consciousness. 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: 20210803628-COVID-19 VACCINE AD26.COV2.S- loss of consciousness, shortness of breath. 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: SHORTNESS OF BREATH; LOSS OF CONSCIOUSNESS


VAERS ID: 1535802 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-26
Submitted: 0000-00-00
Entered: 2021-08-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 2317218 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Dizziness, Heart rate, Respiratory rate, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210726; Test Name: Blood pressure; Result Unstructured Data: 140/80 (unit not reported); Test Date: 20210727; Test Name: Respiratory rate; Result Unstructured Data: 18 (Beats per minute); Test Date: 20210727; Test Name: Heart rate; Result Unstructured Data: 92 (Count per minute); Test Date: 20210727; Test Name: Body temperature; Result Unstructured Data: 35.5 C; Test Date: 20210727; Test Name: Blood pressure; Result Unstructured Data: 140/80 (unit not reported); Test Date: 20210727; Test Name: Respiratory rate; Result Unstructured Data: 17 (Breath per minute); Test Date: 20210727; Test Name: Heart rate; Result Unstructured Data: 90 (Count per minute); Test Date: 20210727; Test Name: Blood pressure; Result Unstructured Data: 130/80 (unit not reported); Test Date: 20210727; Test Name: Body temperature; Result Unstructured Data: 35.8 C
CDC Split Type: PHJNJFOC20210809945

Write-up: FAINTING; DIZZINESS; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300095068] concerned a 60 year old female, unspecified race and ethnicity. The patient''s height, and weight were not reported. No past medical history were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 2317218, and expiry: UNKNOWN) dose was not reported, 01 total, administered on 26-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-JUL-2021, at 16:00 the patient experienced dizziness, fainting, and Laboratory data included: Blood pressure (NR: not provided) 140/80 unit not reported. On 27-JUL-2021, at 9:00 Laboratory data included: Blood pressure(BP) (NR: not provided) 130/80 unit not reported, Body temperature (NR: not provided) 35.8 Degree Celsius , Cardiac rate (NR: not provided) 92 Count per minute(CPM), and respiratory rate(RR) (NR: not provided) 18 breath per minute(BPM), and at 9:30 Blood pressure (NR: not provided): 140/80 unit not reported, Body temperature (NR: not provided): 35.5 Degree Celsius, Cardiac rate (NR: not provided) 90 Count per minute, Respiratory rate (NR: not provided) 17 Breath per minute. It was unspecified if an autopsy was performed On an unspecified date, the patient died from dizziness, and fainting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210809945-covid-19 vaccine ad26.cov2.s-fainting and dizziness. 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: DIZZINESS; FAINTING


VAERS ID: 1536924 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-29
Submitted: 0000-00-00
Entered: 2021-08-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 212C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Hypotension, Nausea, Seizure, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210729; Test Name: Blood pressure; Result Unstructured Data: HYPOTENSION
CDC Split Type: PHJNJFOC20210810013

Write-up: NAUSEA; HYPOTENSION; VOMITING; SEIZURE; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300095376] concerned a 20 year old female of an unspecified race and ethnic origin. 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: 212C21A, and expiry: unknown) dose was not reported, with frequency 1 total administered on 29-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-JUL-2021, the patient experienced seizure at 05:40, hypotension at 05:45, vomiting at 06:25. Laboratory data included: Blood pressure (NR: not provided) hypotension. On an unspecified date, the patient experienced nausea. On an unspecified date, the patient died from nausea, seizure, hypotension, and vomiting. 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, and Other Medically Important Condition).; Sender''s Comments: V0: 20210810013-COVID-19 VACCINE AD26.COV2.S - Seizure, hypotension, and vomiting. 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). 20210810013-COVID-19 VACCINE AD26.COV2.S -Nausea. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: NAUSEA; SEIZURE; HYPOTENSION; VOMITING


VAERS ID: 1537707 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-29
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Fall
SMQs:, Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202100999550

Write-up: This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 594970. An 86-year-old male patient received BNT162B2 (COMIRNATY, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced fall on 29May2021. Onset Time in Days: 18days. 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: Fall


VAERS ID: 1537939 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100984328

Write-up: Pulmonary embolism; This is a spontaneous report from a contactable consumer (patient''s brother) based on information received by Pfizer from Biontech manufacturer control number: 77376, license party for Comirnaty. A male patient of an unspecified age received bnt162b2 (COMIRNATY, Batch/Lot Number: UNKNOWN), dose 2 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient died of a pulmonary embolism that developed 3 weeks after the second dose of Comirnaty. The patient died on an unspecified date. It was not reported if an autopsy was performed. The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up; Reported Cause(s) of Death: Pulmonary embolism


VAERS ID: 1538032 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-10
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Blood lactic acid, Blood pH, Blood potassium, Blood sodium, Body temperature, Calcium ionised, Cardiac arrest, Haematocrit, Haemoglobin, Investigation, Oxygen saturation, PO2, Physical examination, Venous oxygen saturation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abstains from alcohol; Fistula; Hypercholesterolemia; Lumbago (L5-S1 dyscarthrosis, L5-S1 protrusion); Smoker (1/2 pack daily); Vasectomy; Von Willebrand factor deficiency (He has never needed treatment).
Allergies:
Diagnostic Lab Data: Test Date: 20210710; Test Name: Venous Glucose; Result Unstructured Data: Test Result:579; Test Date: 20210710; Test Name: Venous Lactate; Result Unstructured Data: Test Result:17; Test Date: 20210710; Test Name: Venous pH; Result Unstructured Data: Test Result:7.13; Test Date: 20210710; Test Name: Venous Potassium; Result Unstructured Data: Test Result:3.2; Test Date: 20210710; Test Name: Venous Sodium; Result Unstructured Data: Test Result:228; Test Date: 20210710; Test Name: Temperature of sample; Result Unstructured Data: Test Result:37; Test Date: 20210710; Test Name: Venous Calcium Ionic; Result Unstructured Data: Test Result:0.79; Test Date: 20210710; Test Name: Venous Hematocrit; Result Unstructured Data: Test Result:35; Test Date: 20210710; Test Name: Venous Total Hemoglobin; Result Unstructured Data: Test Result:1.3; Test Date: 20210710; Test Name: Venous Deoxyhemoglobin; Result Unstructured Data: Test Result:(reduced Hb) 78.6; Comments: Venous Deoxyhemoglobin; Test Date: 20210710; Test Name: Venous Oxyhemoglobin; Result Unstructured Data: Test Result:20.6; Test Date: 20210710; Test Name: Physical examination; Result Unstructured Data: Test Result: In a situation of Cardiorespiratory Arrest; Comments: Cardiac massage with cardio compressor. Generalized lightness. Orotracheal intubation with Fastrach; Test Date: 20210710; Test Name: Venous pO2; Result Unstructured Data: Test Result:23; Test Date: 20210710; Test Name: Venous Inspired Oxygen Fraction; Result Unstructured Data: Test Result:100; Test Date: 20210710; Test Name: Venous O2 Saturation; Result Unstructured Data: Test Result:21.
CDC Split Type: ESPFIZER INC202100987888

Write-up: Sudden death/ cardiac arrest; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number ES-AEMPS-956637. A 47-years-old male patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) intramuscular on 30Jun2021 as dose 2, 0.3 ml single for COVID-19 immunization. Medical history included tobacco user (1/2 pack daily), Von Willebrand disease (he has never needed treatment), hypercholesterolaemia, abstains from alcohol, back pain L5-S1 dyscarthrosis, L5-S1 protrusion, fistula, vasectomy from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. No cardiovascular risk factors. Frequent epistaxis in childhood. In follow-up in Hematology due to deficiency of the FVIII / Von Willebrand molecule. He has never needed treatment. Lumbago Mechanical. L5-S1 dyscarthrosis, L5-S1 protrusion .h/ Surgical intervention: fistula and vasectomy. Treatment: Tramadol. No known drug allergies. On 10Jul2021 09:26 patient experienced sudden death/ cardiac arrest. The patient underwent lab tests which included blood glucose: 579 on 10Jul2021, blood lactic acid: 17 on 10Jul2021, blood PH: 7.13 on 10Jul2021, blood potassium: 3.2 on 10Jul2021, blood sodium: 228 on 10Jul2021, body temperature: 37 on 10Jul2021, calcium ionised: 0.79 on 10Jul2021, haematocrit: 35 on 10Jul2021, haemoglobin: 1.3 on 10Jul2021, investigation: (reduced HB) 78.6 on 10Jul2021 Venous Deoxyhemoglobin, oxygen saturation: 20.6 on 10Jul2021, physical examination: in a situation of cardiorespiratory arrest on 10Jul2021 Cardiac massage with cardio compressor. Generalized lightness. Orotracheal intubation with Fastrach, po2: 23 on 10Jul2021, venous oxygen saturation: 100 on 10Jul2021, venous oxygen saturation: 21 on 10Jul2021. Therapeutic measures were taken as a result of sudden death/ cardiac arrest (cardiac arrest). The patient died on 10Jul2021. It was not reported if an autopsy was performed. The patient admitted in a situation of resuscitated cardiac arrest. According to reports, the patient suffered cardiac arrest witnessed at 09:26. At the arrival of the health services (9:40am), an asystole rhythm was noted. Advanced cardiopulmonary resuscitation maneuvers are performed resulting in unsuccessful, so he is transferred to the hospital as a possible non-heart beating donation. Upon arrival at our Unit (10.40 am), cardiac inactivity is observed for 5 minutes, for which death is accredited at 10.46 am on 10Jul2021 according to the criteria of Decree 1723/2012. Physical Examination: In a situation of Cardiorespiratory Arrest. Cardiac massage with cardio compressor. Generalized lightness. Orotracheal intubation with Fastrach. Laboratory Tests: 10Jul2021 Venous Gasometry: Venous pH 7.13, Venous pO2 23, Venous O2 Saturation 21, Venous Total Hemoglobin 1.3, Venous Hematocrit 35, Venous Oxyhemoglobin 20.6, Venous Deoxyhemoglobin (reduced HB) 78.6, Venous Sodium 228, Venous Potassium 3.2, Venous Calcium Ionic 0.79, Venous Glucose 579, Venous Lactate 17, Venous Inspired Oxygen Fraction (FiO2) 100, Temperature of sample 37. Evolution and comments: Upon arrival at the Unit, CPR (cardiopulmonary resuscitation) was stopped and 5 minutes of asystole and therefore death were confirmed. Diagnosis: Cardiorespiratory arrest not recovered. Exitus lethalis. The outcome for event Cardiorespiratory arrest was death. No follow-up attempts are possible. Information about batch number cannot be obtained.; Reported Cause(s) of Death: cardiac arrest.


VAERS ID: 1538226 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Bronchospasm, Culture, Inappropriate schedule of product administration, Multiple organ dysfunction syndrome
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), 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), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 45
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: Culture; Result Unstructured Data: Test Result:Candida albicans, Candida glabrata, Candida tropic; Comments: Candida albicans, Candida glabrata, Candida tropicalis, Corynebacterium striatum, Cytomegalovirus, Escherichia coli, Herpes simplex virus type 1, Staphylococcus capitis and Staphylococcus capitis
CDC Split Type: GBPFIZER INC202100975309

Write-up: Multi-organ failure; Bronchospasm; Dose 1 on 17Dec2020; dose 2 on 17Mar2021; This is a spontaneous report from a contactable other health professional. This is a report received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-ADR 25726178, Safety Report Unique Identifier is GB-MHRA-ADR 25726178. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 17Mar2021 (Batch/Lot number was not reported) at the age of 45-year-old as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 for COVID-19 immunization on 17Dec2020. The patient experienced multi-organ failure and bronchospasm in 2021. The events were reported as serious (hospitalization). The patient underwent lab tests and procedures which included culture: candida albicans, candida glabrata, candida tropicalis, corynebacterium striatum, cytomegalovirus, escherichia coli, herpes simplex virus type 1, staphylococcus capitis and staphylococcus capitis on an unspecified date. The patient died on 01May2021 due to multi-organ failure. An autopsy was not performed. Outcome of multi-organ failure was fatal, of bronchospasm was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Reported Cause(s) of Death: Multi-organ failure


VAERS ID: 1538239 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-03-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Blood test, Cardiac arrest, Computerised tomogram thorax, Deep vein thrombosis, Dyspnoea, Electrocardiogram, Fatigue, Gait disturbance, Inappropriate schedule of product administration, Limb discomfort, Pain in extremity, Pulmonary embolism, Syncope, Ultrasound scan
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, venous (narrow), Parkinson-like events (broad), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-17
   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: ASPIRIN [ACETYLSALICYLIC ACID]; OMEPRAZOLE; PREDNISOLONE; TAMSULOSIN; ZOLEDRONIC ACID
Current Illness: Asthma (Reported again on 12Apr2021and 20Jan2021); Ex-smoker; Giant cell arteritis (Reported several times in Jan2020, Feb2021, and Apr2021); Temporal arteritis; Temporomandibular joint disorder; Vitamin D deficiency.
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchiectasis; Callosity (On foot. Also reported on 24Aug2020.); Cigarette smoker (1-9 cigarettes/day); Dyspnoea; Food poisoning (suspected); Oesophageal disorder; Steroid therapy.
Allergies:
Diagnostic Lab Data: Test Date: 20201217; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result: Unknown results; Test Date: 20210120; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result: Unknown results; Test Date: 20210415; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result: Unknown results; Test Date: 20201215; Test Name: Blood test; Result Unstructured Data: Test Result: Unknown results; Test Date: 20210118; Test Name: Blood test; Result Unstructured Data: Test Result: Unknown results; Test Date: 20210215; Test Name: Blood test; Result Unstructured Data: Test Result: Unknown results; Test Date: 20210308; Test Name: Blood test; Result Unstructured Data: Test Result: Unknown results; Test Date: 20210416; Test Name: Blood test; Result Unstructured Data: Test Result: Unknown results; Test Date: 20210304; Test Name: CT pulmonary angiogram; Result Unstructured Data: Test Result: showed possible bronchiolitis obliterans; Test Date: 20210416; Test Name: Electrocardiogram; Result Unstructured Data: Test Result: Unknown results; Test Date: 20201220; Test Name: Ultrasound scan; Result Unstructured Data: Test Result: Abnormal.
CDC Split Type: GBPFIZER INC202100992316

Write-up: Deep venous thrombosis; Pulmonary embolism; Cardiac arrest; Pain in extremity; difficulty walking; Dyspnoea/shortness of breath; Fatigue; Heavy legs; suddenly collapsed; Dose 1 on 31Jan2021; dose 2 on 31Mar2021; This is a spontaneous report from a contactable physician received from the Medicines and Healthcare products Regulatory Agency. The regulatory authority report number is GB-MHRA-EMIS-1316-dde7a8f4-9c0d-477f-bfa3-86cbf067b923, Safety Report Unique Identifier GB-MHRA-ADR 25732735. A 75-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on 31Mar2021 (batch/Lot number was not reported) at the age of 75-year-old as 0.3 ml single for COVID-19 vaccination; zoledronic acid (manufacturer unknown), via intravenous from 07Apr2021 (Batch/Lot number was not reported) to an unspecified date, at 5mg/100ml for osteoporosis prophylaxis. Medical history included vitamin d deficiency from 22Feb2021 and ongoing, giant cell arteritis and ongoing (reported several times in Jan2020, Feb2021, and Apr2021), temporal arteritis from 18Dec2020 and ongoing, steroid therapy from 17Dec2020 to 18Feb2021, temporomandibular joint disorder from 14Dec2020 and ongoing, cigarette smoker from 21Aug2020 to an unknown date (1-9 cigarettes/day), asthma from 19Aug2020 and ongoing (reported again on 12Apr2021and 20Jan2021), ex-tobacco user from 19Aug2020 and ongoing, callosity from 19Aug2020 to 17Sep2020 (on foot, also reported on 24Aug2020), suspected food poisoning from 21Aug2020 to 19Sep2020, oesophageal disorder and not ongoing, bronchiectasis and not ongoing, dyspnoea from 04Mar2021. Concomitant medications included aspirin taken for an unspecified indication from 01Jan2021 to an unspecified stop date; omeprazole taken for an unspecified indication from 19Jul2018 to an unspecified stop date; prednisolone taken for an unspecified indication from 20Dec2020 at 80mg once a day then reducing to 30mg around time of death; tamsulosin taken for an unspecified indication from 08Jul2019 to an unspecified stop date. The patient previously took influenza virus for flu vaccination on 24Oct2020, 1st dose of bnt162b2 on 31Jan2021 for covid-19 immunization. The patient experienced pulmonary embolism, deep venous thrombosis and cardiac arrest on 17Apr2021; dyspnoea, fatigue, heavy legs, difficulty walking on 08Apr2021, pain in extremity on 12Apr2021, suddenly collapsed in Apr021. Clinical course: This man was having treatment for giant cell arteritis (GCA) diagnosed Dec2020 and was under joint care of general practitioner (GP) and rheumatology. He was initially on high dose steroids which had gradually been reduced and was on aspirin. Intravenous zoledronic acid was given by the hospital because the patient had a history of oesophageal problems (which would have increased risk of oesophagitis with an oral bisphosphonate). He had a background of respiratory problems (asthma/bronchiectasis) and had tests for persistent dyspnoea on 04Mar2021 - a computerised tomogram pulmonary angiogram (CTPA) scan showed possible bronchiolitis obliterans (which may have been longstanding), but NO evidence of a pulmonary embolism (PE).The initial side effects from zoledronic acid were very marked and he sadly then died of a deep vein thrombosis (DVT)/PE. We wonder if the combination of several risk factors for venous thromboembolism (VTE) (age + vasculitis + steroids - though current expert Rheumatology guidelines (Regulatory Authority for Rheumatology, giant cell arteritis 2000) do not recommend prophylactic anticoagulation in this group) + possible prothrombotic effect of Pfizer COVID vaccine + possible prothrombotic effect of intravenous zoledronic acid may + a week of markedly reduced activity due to severe fatigue/shortness of breath may have resulted in the PE. Initially uneventful 2nd dose Pfizer Covid vaccine on 31Mar21 (1st dose was 31Jan2021). Then, on 08Apr2021, 1 day after first dose of intravenous zoledronic acid infusion to prevent osteoporosis, developed severe fatigue, shortness of breath, heavy legs, difficulty walking more than very short distance (normally very active). This improved slightly after about 6 days but 2 days later (8 days after the intravenous zoledronic acid, and 17 days after 2nd Pfizer COVID vaccine) suddenly collapsed at home in cardiac arrest, sadly resuscitation was unsuccessful. Post mortem showed massive pulmonary embolus, originating from DVTs. The patient underwent lab tests and procedures which included blood pressure measurement with unknown results on 17Dec2020, 20Jan2021, 15Apr2021, blood test with unknown results on 15Dec2020, 18Jan2021, 15Feb2021, 08Mar2021 and 16Apr2021, CT pulmonary angiogram: showed possible bronchiolitis obliterans on 04Mar2021, electrocardiogram: unknown results on 16Apr2021, ultrasound scan: abnormal on 20Dec2020. The patient died on 17Apr2021. An autopsy was performed. The action taken in response to the events for zoledronic acid was not applicable. Outcome of pulmonary embolism, deep venous thrombosis was fatal; of cardiac arrest was not recovered; of dyspnoea, fatigue, heavy legs was recovering; of other events was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Deep venous thrombosis; Autopsy-determined Cause(s) of Death: Pulmonary embolism


VAERS ID: 1538755 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-29
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Bladder cancer, Cardiac failure, Chest pain, Gait disturbance, Microcytic anaemia, Pericardial effusion, Peripheral swelling, Renal failure, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Angioedema (broad), Haematopoietic erythropenia (narrow), Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (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), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Non-haematological malignant tumours (narrow), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-07
   Days after onset: 70
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: Esophageal carcinoma (esophageal cancer, operated on in the initial stage in 2014, regularly monitored at the hospital, all findings regarding this tumor are in order, last from Sep2020); Surgical procedure (operated)
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: HRPFIZER INC202100974257

Write-up: diagnostic bladder cancer; legs began to swell; Heart failure; marked w; Microcytic anemia; Pericardial effusion; Kidney failure; Chest pain; inability to stand on feet; This is a spontaneous report from a contactable consumer received from regulatory authority downloaded from the Regulatory Authority. The regulatory authority report number is HR-HALMED-300049723. A 78-year-old male patient received the second dose of BNT162B2 (COMIRNATY, Batch/Lot Number: unknown), via intramuscular on 17Mar2021 (unknown age at time of vaccination) at 0.3 ml single for COVID-19 immunisation. Medical history included esophageal carcinoma from an unknown date to 2014 (not ongoing; esophageal cancer, operated on in the initial stage in 2014, regularly monitored at the Hospital, all findings regarding this tumor are in order, last from Sep2020), Surgical procedure from an unknown date to 2014 (not ongoing; operated). The patient''s concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (COMIRNATY, Batch/Lot Number: unknown) via intramuscular on 23Feb2021 at 0.3 ml single for COVID-19 immunisation and experienced tightness around the heart. The patient experienced legs began to swell on 29Mar2021, heart failure on 29Mar2021, "marked w" on 29Mar2021, microcytic anemia on 29Mar2021, pericardial effusion on 29Mar2021, kidney failure on 29Mar2021, chest pain on 29Mar2021, inability to stand on feet on 29Mar2021. The events were assessed as serious with criteria of death, hospitalization, and life threatening. Narrative: The person was healthy before vaccination, had a history of oncological disease (esophagus cancer, operated on 6 years ago, without metastases) which was considered cured, was monitored by regular check-ups. Good psychophysical condition, active, no cardiac symptoms before, never taking any chronic therapy. After the first dose he noticed tightness around the heart that he had never felt before, but it did not intensify, after the second dose the pain around the heart reappeared, which he did not communicate immediately, his legs started to swell (he had no similar problems before), day 12th after other doses marked weakness, inability to stand on his feet, hospitalized, COVID negative (SARS-CoV-2 test in Mar2021), pericardial effusion punctured, microcytic anemia, but in the next period the condition does not improve, several subsequent hospitalizations (heart failure, kidney failure, diagnostic bladder cancer in the treatment without proven enlargement and without previous symptoms) and 07Jun2021. death ensues. Reaction / event as reported by initial reporter was pericardial effusion. Additional information on drug: ADR Weakness is adequately labelled; ADR Chest pressure, Chest pain, Swelling of legs, Instability gait, Pericardial effusion, Microcytic anemia, Heart failure, Kidney failure are not adequately labelled. The outcome of diagnostic bladder cancer was unknown; outcome of other events was fatal. The patient died on 07Jun2021. It was unknown if an autopsy was performed. Causality: Due to good health before the vaccine and the sudden onset of symptoms and rapid deterioration, there is a suspicion of an association. A causal relationship between Comirnaty and events Chest pain, Swelling of legs, Instability gait, Pericardial effusion, Microcytic anemia, Heart failure, Kidney failure and Weakness was Unassessable/Unclassifiable per Regulatory Authority (Source of assessment) based on WHO Causality (Method of assessment). Sender Comment: 26Jul2021.Reporter was requested for additional information on the cause of death, autopsy report, hospitalization data, lab. results and batch number. So far no follow-up information have been received. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : HR-PFIZER INC-202100982628 same reporter/patient/drug, different dose/events; Reported Cause(s) of Death: legs began to swell; Heart failure; marked w; Microcytic anemia; Pericardial effusion; Kidney failure; Chest pain; inability to stand on feet


VAERS ID: 1538885 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2707 / 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: 2021-07-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202100987857

Write-up: unexpected death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number is IT-MINISAL02-762282. A 53-year-old male patient received BNT162B2 (COMIRNATY, Formulation: solution for injection, Lot number: FE2707) via intramuscular on 16Jul2021 at 09:56 (age at vaccination 53-year-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took BNT162B2 (COMIRNATY, Formulation: solution for injection, Lot number: FC1526) via intramuscular on 08Jun2021 at 16:55 as dose 1, single for covid-19 immunisation. On 16Jul2021, the patient died (unexpected death). No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1539015 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-18
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure chronic; Chronic atrial fibrillation; COPD
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100976521

Write-up: Death; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. The patient was an 81-year-old male. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified medication(s) within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included chronic obstructive pulmonary disease (COPD), cardiac failure chronic, and chronic atrial fibrillation. The patient had no relevant past drug history. On 22Jun2021 at 15:00, the patient previously received the first single dose of BNT162b2 (COMIRNATY, Lot# and expiration date were not available/not provided to reporter at the time of report completion) intramuscular in the arm left for COVID-19 immunization. On 13Jul2021 at 14:30 (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and expiration date were not available/not provided to reporter at the time of report completion) intramuscular in the arm left for COVID-19 immunization. On 18Jul2021 at 18:30 (5 days 4 hours after the vaccination), the patient experienced death. The outcome of the event was fatal with treatment including standard resuscitation therapy. No autopsy was done. The cause of death was unknown. Since the vaccination, the patient has not been tested for COVID-19. The reporting physician classified the event as serious (death). Information on the lot/batch number has been requested.; Sender''s Comments: Based on the available information, this 81-year-old male with underlying medical histories of chronic obstructive pulmonary disease (COPD), cardiac failure chronic, and chronic atrial fibrillation received the first dose of BNT162B2 vaccine with no reported adverse event. Coincidentally, the patient died five days after the second dose. There was no evidence that the reported death with unknown cause was related to BNT162B2. The underlying medical histories and the advancing age may have played an important contributory role. This case will be re-assessed should additional information becomes available. The impact of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concerns identified as part of this review, as well as any appropriate actions in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Death


VAERS ID: 1539020 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Duodenal ulcer haemorrhage, Oesophagogastroduodenoscopy, Shock haemorrhagic
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hypovolaemic shock conditions (narrow), Gastrointestinal ulceration (narrow), Gastrointestinal haemorrhage (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-14
   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: Test Date: 20210706; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination; Test Date: 20210713; Test Name: Oesophagogastroduodenoscopy; Result Unstructured Data: Test Result:Duodenal ulcer haemorrhage
CDC Split Type: JPPFIZER INC202100979166

Write-up: gastroduodenal ulcer hemorrhage; the state of shock; This is a spontaneous report from a contactable pharmacist received from the Regulatory Authority. Regulatory authority report number is v21122696. The patient was an 80-year and 1-month-old male. Age at vaccination was 80-year and 1-month-old. Body temperature before vaccination was 36.2 degrees centigrade. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 06Jul2021 at unspecified time (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC3661, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 13Jul2021 at 18:20 (seven days after the vaccination), the patient experienced haemorrhage of digestive tract. On 14Jul2021 (eight days after the vaccination), the patient died and was discharged from hospital. The course of the event was as follows: On 08Jun2021 (as reported), the patient was admitted to the reporter hospital. On 06Jul2021, the patient received the first dose of vaccination. On 13Jul2021, Haematemesis and melena occurred, and gastroscope was performed urgently. The result was astroduodenal ulcer hemorrhage. Bleeding stopped with the emergency response, but later blood pressure gradually dropped, and the patient became the state of shock. On 14Jul2021, the patient discharged due to die. The reporting pharmacist classified the event as serious (fatal, hospitalization) 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 pharmacist did not provide any further comment.; Reported Cause(s) of Death: the state of shock; gastroduodenal ulcer hemorrhage


VAERS ID: 1539021 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-12
Onset:2021-07-28
   Days after vaccination:46
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-28
   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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100979176

Write-up: Out-of-hospital cardiac arrest; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The regulatory authority report number is v21119434. A 75-year and 8-month-old female patient received BNT162B2 (COMIRNATY, solution for injection) at single dose on 12Jun2021 at 16:05 at the age of 75-year and 8-month-old for COVID-19 immunisation. Body temperature before vaccination was unknown. The patient had no family history. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). Concomitant medication was not reported. On 28Jul2021 around 15:00 (46 days after the vaccination), the patient experienced out-of-hospital cardiac arrest. On 28Jul2021, patient died. It was unknown if an autopsy was performed. The outcome of event was fatal. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162B2 as unassessable. There was no other possible cause of the event such as any other diseases. The lot number for the vaccine BNT162b2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: Out-of-hospital cardiac arrest


VAERS ID: 1539022 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-07-30
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Pneumonia aspiration
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-30
   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: Medical History/Concurrent Conditions: Cardiac failure; Pneumonia aspiration; Rheumatoid arthritis
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100979190

Write-up: pneumonia aspiration; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. An 84-year-old female patient received BNT162B2 (COMIRNATY), 1st dose intramuscularly on 27Jul2021 (Batch/Lot number and Expiration date were unknown) at age of 84 years old as 0.3ml, a single dose for covid-19 immunisation. Medical history included rheumatoid arthritis, cardiac failure and pneumonia aspiration. The patient''s concomitant medications were not reported. The patient experienced pneumonia aspiration on 30Jul2021 with outcome of fatal. The patient died on 30Jul2021. It was not reported if an autopsy was performed. Clinical course: On 27Jul2021, the patient received the first dose of Comirnaty on visiting care. On 30Jul2021, the patient was transported by ambulance to hospital, and diagnosed with pneumonia aspiration at the hospital. The patient died. The reporting physician classified the event as serious (fatal) and assessed that the event was possibly related to BNT162b2. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender''s Comments: There is not a reasonable possibility that event pneumonia aspiration is related to BNT162B2 per current limited information. This elderly patient had underlying cardiac failure and pneumonia aspiration. The event is more likely intercurrent medical condition. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: pneumonia aspiration


VAERS ID: 1539024 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-22
Onset:2021-07-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0348 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Gastric cancer
SMQs:, Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-22
   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: Medical History/Concurrent Conditions: Gastric cancer stage IV
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100979762

Write-up: Death due to gastric cancer; This is a spontaneous report from a contactable physician received from a Pfizer sales representative. The patient was a 79-year-old male. Body temperature before vaccination, family history, and concomitant medication were not reported. Medical history included end stage of gastric cancer. On an unknown date, the patient previously received the first single dose of BNT162b2 (COMIRNATY, Lot# not reported, Expiration date not reported) for COVID-19 immunization. On 22Jul2021 (the day of vaccination), the patient received the second single dose (30ug) of BNT162b2 (COMIRNATY, Solution for injection, Lot number: FD0348, Expiration date: 31Oct2021) via an intramuscular route for COVID-19 immunization. On 22Jul2021 (the same day of the vaccination), the patient experienced death due to gastric cancer. The patient was in the end stage of gastric cancer and was followed up at home. The patient received the second dose of the vaccination. On the same day, the death was confirmed at home. The patient died on 22Jul2021. It was not reported if an autopsy was performed. The outcome of the event death due to gastric cancer was fatal. The reporting physician classified the event as serious (death) and assessed as possibly related to BNT162b2. The reporting physician considered that the causal relationship between the event and BNT162b2 was low.; Sender''s Comments: Based on the information currently available, the reported event fatal gastric cancer is more likely due to the underlying disease progression, but not related to BNT162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate. ; Reported Cause(s) of Death: Death due to gastric cancer


VAERS ID: 1539025 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0889 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Blood pressure measurement, Blood test, Body temperature, Chest X-ray
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   Days after onset: 22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: WARFARIN POTASSIUM; AMLODIPINE BESILATE; CANDESARTAN CILEXETIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Dementia; Hypertension; Subarachnoid haemorrhage (at the age of 59)
Allergies:
Diagnostic Lab Data: Test Date: 20210728; Test Name: blood pressure; Result Unstructured Data: Test Result:gradually decreasing; Test Date: 20210721; Test Name: blood examination; Result Unstructured Data: Test Result:no abnormalities; Test Date: 20210708; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination; Test Date: 20210721; Test Name: chest X-ray; Result Unstructured Data: Test Result:no abnormalities
CDC Split Type: JPPFIZER INC202100980128

Write-up: Consciousness disturbed; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21122705. An 85-year and 8-month-old male patient received bnt162b2 (COMIRNATY Solution for injection), dose 2 via an unspecified route of administration on 08Jul2021 10:00 (the day of vaccination) (Batch/Lot Number: FD0889; Expiration Date: 30Sep2021) as single dose for covid-19 immunisation at the age of 85-year and 8-month-old. The family history was not provided. The patient had medical histories of hypertension, dementia, atrial fibrillation, and subarachnoid haemorrhage at the age of 59. The concomitant medications included warfarin potassium (WARFARIN), amlodipine besilate (AMLODIPINE), and candesartan cilexetil (CANDESARTAN). On 10Jul2021 (2 days after the vaccination), the patient experienced consciousness disturbed. The course of the event was as follows: Although the patient had dementia, independent gait was possible. The patient walked around and passed urine everywhere, and thus, his movement was active. On 17 of unknown month in 2021, the patient received the first dose of BNT162b2 (COMIRNATY, Lot# unknown, Expiration date unknown) for covid-19 immunisation, and thereafter, no change was observed. Body temperature before vaccination was 36.5 degrees centigrade. On 08Jul2021 (the day of vaccination), around 10:00, the patient received the second dose of BNT162b2 vaccination. On 10Jul2021 (2 days after vaccination), in the evening, the patient suddenly tended to have somnolence. Although the patient responded when his name was called, he became motionless from the bed. No paralysis was noted, and the patient made resistance to caregiving. The patient became unable to take meals, and his response gradually became poor. On 21Jul2021 (13 days after vaccination), fluid intake became impossible, and fluid replacement was performed every day. The blood examination and chest X-ray showed no abnormalities. On 28Jul2021 (20 days after vaccination), the patient had open-mouth breathing, and the blood pressure was gradually decreasing. On 01Aug2021, at 23:00 (24 days after vaccination), the patient died. On 01Aug2021 (24 days after the vaccination), the outcome of the event was fatal. The patient died on 01Aug2021. It was not reported if an autopsy was performed. The reporting physician classified the event, consciousness disturbed 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 patient had medical histories of hypertension and dementia. He also had medical history of subarachnoid haemorrhage at the age of 59. However, independent gait was possible, and the patient had appetite, and no signs of geromarasmus were observed at all. After the second dose of BNT162b2 vaccination, the patient suddenly tended to have somnolence, and no paralysis was noted, and cerebral infarction was deniable. Since the causes of sudden onset of the symptoms other than the vaccination were not considerable, the causality between the event and the vaccination was strongly suspected.; Reported Cause(s) of Death: Consciousness disturbed


VAERS ID: 1539026 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-07-01
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Decreased appetite, Hypotension, Loss of consciousness, Marasmus
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-15
   Days after onset: 14
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: Cholecystitis; Dementia; Parkinson''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100980162

Write-up: Geromarasmus; inappetence; aggravation of consciousness disturbed (consciousness loss); hypotension; aggravation of consciousness disturbed (consciousness loss); This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21119555. The patient was an 87-year and 1-month-old female. Body temperature before vaccination was not reported. Medical history included gallstone cholecystitis, Parkinson''s disease and dementia. Concomitant medications and family history were not provided was provided. The course of the events was as follows: On 01Jun2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration as a single dose for COVID-19 immunization. On 22Jun2021 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration as a single dose for COVID-19 immunization (at the age of 87-year and 1-month-old). On 01Jul2021 (9 days after the vaccination), hypotension, inappetence, and aggravation of consciousness disturbed (consciousness loss) were noted. On 15Jul2021 (23 days after the vaccination), the outcome of the events for inappetence was not recovered and for other events was fatal. It was not reported if an autopsy was performed. The patient developed hypotension, inappetence, and aggravation of consciousness disturbed (consciousness loss) on 01Jul2021, Geromarasmus on 15Jul2021. The reporting physician classified the events as serious (life-threatening conditions) and assessed that the events were related to BNT162b2. Geromarasmus was reported as another possible cause. The outcome of events for inappetence was not resolved, for other events was death on 15Jul2021. The reporting physician commented as follows: The patient had been in a poor condition since before. It was considered that BNT162b2 triggered further aggravation. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Reporter''s Comments: The patient had been in a poor condition since before. It was considered that BNT162b2 triggered further aggravation.; Reported Cause(s) of Death: Geromarasmus; aggravation of consciousness disturbed (consciousness loss); hypotension; aggravation of consciousness disturbed (consciousness loss)


VAERS ID: 1539027 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-06-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Biopsy bone marrow, Blood lactate dehydrogenase increased, Haemophagocytic lymphohistiocytosis, Liver disorder, Multiple organ dysfunction syndrome, Platelet count decreased, Pyrexia
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Sepsis (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-27
   Days after onset: 36
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210623; Test Name: bone marrow examination; Result Unstructured Data: Test Result:hemophagocytosis; Test Date: 20210623; Test Name: LDH; Result Unstructured Data: Test Result:2500 IU/l; Comments: Peak; Test Date: 20210623; Test Name: platelets decreased; Result Unstructured Data: Test Result:10,1000 mL
CDC Split Type: JPPFIZER INC202100980191

Write-up: multiorgan failure progressed; liver disorder progressed; LDH was high; platelet count decreased (to 10,1000/mL); Haemophagocytic syndrome; pyrexia; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21122069. The patient was a 76-year and 5-month-old female. Body temperature before vaccination was not provided. The family history was not provided. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient''s concomitant drug was not reported. On unknown date in 2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# unknown, Expiration date unknown) for COVID-19 immunization. On 21Jun2021 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration at the age of 76-year-old as a single dose for COVID-19 immunization. On 23Jun2021 (2 days after the vaccination), the patient experienced haemophagocytic syndrome. On 27Jul2021 (36 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 23Jun2021, 2 days after the second dose of BNT162b2 vaccination (on 21Jun2021), the patient had pyrexia. Thereafter, liver disorder progressed, and the LDH was high (peak, 2500 IU/L), and the platelet count decreased (to 10,1000/mL). The bone-marrow examination showed hemophagocytosis. The patient was refractory to a steroid and steroid pulse therapy, and multiorgan failure progressed. On 27Jul2021 (36 days after vaccination), the patient died. The outcome of events for haemophagocytic syndrome and multiorgan failure was fatal, for other events was unknown. The patient died on 27Jul2021. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as un-assessable. Other possible cause of the event such as any other diseases was unknown. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: Haemophagocytic syndrome; multiorgan failure progressed


VAERS ID: 1539033 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-07-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9909 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac failure, Pyrexia
SMQs:, Cardiac failure (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure
Allergies:
Diagnostic Lab Data: Test Date: 20210728; Test Name: Body temperature; Result Unstructured Data: Test Result:35.2 Centigrade; Comments: before vaccination; Test Date: 20210729; Test Name: Body temperature; Result Unstructured Data: Test Result:38 to 39 Centigrade; Comments: 22:18
CDC Split Type: JPPFIZER INC202100986318

Write-up: Cardiac failure aggravated; Pyrexia of 38 to 39 degrees Celsius; This is a spontaneous report from a contactable physician received from the Regulatory Authority and COVID-19 Adverse Event Self-Reporting Solution. Regulatory authority report number is v21122093. The patient was an 89-year and 7-month-old male. Age at vaccination was 89-year and 7-month-old. Body temperature before vaccination was 35.2 degrees centigrade. Other medical history included cardiac failure. The patient concomitant medications were not reported. On 28Jul2021 at 14:00 (the day of vaccination), the patient received the first single dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FC9909, Expiration date 30Sep2021) via intramuscular for COVID-19 immunization. On 29Jul2021 at 22:18 (one day after the vaccination), the patient experienced pyrexia of 38 to 39 degrees Celsius. On 29Jul2021 (one day after the vaccination), the patient was admitted to the hospital. On the same day (29Jul2021), the patient experienced cardiac failure aggravated and died at 22:18. On 29Jul2021 (one day after the vaccination), the outcome of the event was fatal. It is unknown if autopsy done. Events were reported as serious with hospitalization. The course of the event was as follows: On 28Jul2021, the patient received the vaccination of Comirnaty. The next day, on 29Jul2021, the patient had a fever at 38-39 degrees and was admitted to hospital. On the same day, the symptom of cardiac failure aggravated, and the patient died at 22:18. The patient originally had a serious cardiac failure, and there was a possibility that fever made cardiac failure aggravate and resulted in his death. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause(s) of the event such as any other diseases was cardiac failure. The reporting physician commented as follows: There was a possibility that fever due to Comirnaty leaded to exacerbation of severe cardiac failure.; Reported Cause(s) of Death: fever made cardiac failure aggravate and resulted in his death; fever made cardiac failure aggravate and resulted in his death


VAERS ID: 1539034 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Heart rate, Lack of spontaneous speech, Oxygen saturation, Oxygen saturation decreased, Respiratory failure, Tachycardia, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hypertension (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-02
   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: Arteriosclerosis obliterans; Cardiac failure chronic; Diabetes mellitus; Diabetic nephropathy; Hypertension; Lower extremities ulcers of; Mitral valve stenosis
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: BP; Result Unstructured Data: Test Result:251/118; Test Date: 20210730; Test Name: BP; Result Unstructured Data: Test Result:174/84; Comments: At 6:30; Test Date: 20210731; Test Name: BP; Result Unstructured Data: Test Result:127/81; Test Date: 20210729; Test Name: body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: Before vaccination; Test Date: 20210730; Test Name: body temperature; Result Unstructured Data: Test Result:37.1 Centigrade; Comments: At 6:30; Test Date: 20210731; Test Name: body temperature; Result Unstructured Data: Test Result:37.0 Centigrade; Test Date: 20210730; Test Name: HR; Result Unstructured Data: Test Result:between 120s and 170s; Test Date: 20210730; Test Name: HR; Result Unstructured Data: Test Result:between 100 and 110; Comments: At 6:30; Test Date: 20210731; Test Name: HR; Result Unstructured Data: Test Result:between 120s and 130s; Test Date: 20210801; Test Name: HR; Result Unstructured Data: Test Result:between 140 and 160; Comments: At 23:45; Test Date: 20210730; Test Name: SpO2; Test Result: 60 %; Test Date: 20210730; Test Name: SpO2; Result Unstructured Data: Test Result:approximately 90 %; Comments: At 6:30; Test Date: 20210731; Test Name: SpO2; Test Result: 89 %
CDC Split Type: JPPFIZER INC202100986325

Write-up: lost his spontaneous speech; Respiratory failure; wheezing; Blood pressure (BP) was 251/118; oxygen saturation (SpO2) was 60%; heart rate (HR) was between 120s and 170s/tachycardia with HR of 140 to 160; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21122079. A 77-year-old male patient received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration (at the age of 77-year-old) on 29Jul2021 10:03 (Lot Number: FC5947; Expiration Date: 30Sep2021) as single dose for covid-19 immunisation. Medical history included Diabetes mellitus, Diabetic nephropathy stage 4, Hypertension, Mitral valve stenosis, Arteriosclerosis obliterans, Lower extremities ulcers of, chronic cardiac failure. The patient''s concomitant medications were not reported. The patient experienced respiratory failure (death) on 30Jul2021 01:45. The patient experienced wheezing on 30Jul2021 01:45, blood pressure (bp) was 251/118 on 30Jul2021, oxygen saturation (spo2) was 60% on 30Jul2021, heart rate (hr) was between 120s and 170s/tachycardia with hr of 140 to 160 on 30Jul2021, lost his spontaneous speech on 31Jul2021 16:00; all medically significant. The clinical course was reported as follows: The patient was a 77-year and 8-month-old male. Body temperature before vaccination was 36.8 degrees Centigrade (29Jul2021). On 30Jul2021 at 01:45 (15 hours and 42 minutes after the vaccination), the patient experienced respiratory failure. On 30Jul2021 at 01:45 (15 hours and 42 minutes after the vaccination), wheezing was found. Blood pressure (BP) was 251/118, and oxygen saturation (SpO2) was 60%. Administration of oxygen at 5 liters (L) was started. The monitor was placed. Then, heart rate (HR) was between 120s and 170s. One ampule (A) of furosemide (LASIX) (20) was intravenously administered. At 6:30, body temperature (BT) was 37.1, BP 174/84, HR between 100 and 110, SpO2 approximately 90% with 10 L of oxygen. On 31Jul2021 (2 days after the vaccination), BT was 37.0 Centigrade, BP 127/81, HR of 120s to 130s, and SpO2 89% (with 10 L of oxygen). During the treatment, drip infusion was given: 500 mL of KN NO.1, a half ampule of aspara potassium (10) (continued for 24 hours). As other treatments, 1 A of furosemide (20) (intravenously, one-shot), 1 g of ceftriaxone and 100 mL of normal saline solution were given, twice (at 10:00 and 16:00), over 30 minutes through drip infusion. The medications above were performed from 30Jul2021 to 01Aug2021. On 31Jul2021 at 16:00, the patient lost his spontaneous speech. On 01Aug2021 at 23:45 (3 days after the vaccination), the patient had tachycardia with HR of 140 to 160, so additional treatment was performed; 100 mL of normal saline solution, and 250 mL of normal saline solution, 100 mL of intravenous hydrocortisone (SOLU-CORTEF) and 1A of famotidine were administered through drip infusion. On 02Aug2021 (4 days after the vaccination), at around 4:00, respiratory status deteriorated rapidly. At 5:57 (02Aug2021), the patient was confirmed dead. The reporting physician classified the event Respiratory failure as serious (Death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was acute on chronic heart failure. The reporting physician commented as follows: The cause of death was acute on chronic heart failure. The possibility of indirect involvement with the vaccine to the death could not be ruled out. Therapeutic measures were taken as a result of events (except Lack of spontaneous speech). The outcome of the event Respiratory failure was fatal, events Oxygen saturation low, Blood pressure increased was recovering, others was unknown. The patient died on 02Aug2021 05:57 due to Respiratory failure and acute on chronic heart failure. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: respiratory failure; acute on chronic heart failure


VAERS ID: 1539035 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1945 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure; Oxygen therapy (home oxygen)
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202100986362

Write-up: cardiopulmonary arrest; lost consciousness; forming at the mouth; physical deconditioning; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21122080. A 79-year-old (reported as 79-year and 5-month-old) male patient received bnt162b2 (COMIRNATY, Solution for injection, Lot number FD1945, Expiration date 31Oct2021), dose 2 via an unspecified route of administration on 30Jul2021 as single dose for covid-19 immunisation. Medical history included cardiac failure, oxygen therapy (home oxygen). The patient''s concomitant medications were not reported. The patient previously received first dose of bnt162b2 on an unspecified date for COVID-19 immunisation. On 30Jul2021 in the morning (the day of vaccination), the patient received the second dose of bnt162b2. Body temperature before vaccination was 36.2 degrees centigrade. On 31Jul2021 at 18:43 (one day after the vaccination), the patient died. The outcome of the event was fatal. The course of the patient''s death was as follows: On 30Jul2021, the patient received the second dose of COVID-19 Vaccine. Since the morning on 31Jul2021, physical deconditioning had occurred. At 17:00, the patient lost consciousness with forming at the mouth, and emergency squad was called. When the arrival of the emergency squad, the patient had cardiopulmonary arrest (CPA). At 18:43, the patient was confirmed dead at hospital. The outcome of event cardiopulmonary arrest was fatal, the rest of events outcome was unknown. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as un-assessable. Other possible causes of the event such as any other diseases were cardiac failure chronic, COPD and diabetes mellitus (DM). The reporting physician commented as follows: The relationship to the vaccination was not clear, but the reporter reported the case because it was the day after the vaccination.; Reported Cause(s) of Death: cardiopulmonary arrest


VAERS ID: 1539036 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-23
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LIXIANA; CRESTOR; SAMSCA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac failure; Dyslipidaemia; Hypertension; Myocardial infarction; Renal failure chronic
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100986418

Write-up: Cardiac failure; This is a spontaneous case from a contactable physician received via a Pfizer sales representative. A 76-year-old male patient received the first dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 04Jul2021 (Lot number unknown, Expiration date unknown) at the age of 76-year-old as single dose for COVID-19 immunization. Medical history included hypertension, atrial fibrillation, dyslipidaemia, cardiac failure, myocardial infarction and renal failure chronic. The family history was not provided. Concomitant medication included edoxaban tosilate (LIXIANA) taken for atrial fibrillation, rosuvastatin calcium (CRESTOR) taken for dyslipidaemia and tolvaptan (SAMSCA) taken for cardiac failure. On 23Jul2021, the patient experienced cardiac failure. The clinical course was as follows: On 04Jul2021 (the day of vaccination), the patient received the first dose of BNT162b2 vaccination. On 23Jul2021 (19 days after vaccination), the patient was confirmed to die due to cardiac failure (probably). Since the patient''s condition was originally poor, the cause of death could not be identified. However, since cardiac failure probably progressed, it was judged that the cause of death was cardiac failure. The reporting physician classified the event as serious (death) and assessed that the event was unrelated to BNT162b2. The cause of death was cardiac failure. Autopsy was not reported. The outcome of event was fatal. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the information currently available, the reported event cardiac failure is more likely due to the progression of underlying disease cardiac failure , but not related to BNT162B2.; Reported Cause(s) of Death: Cardiac failure


VAERS ID: 1539039 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-07
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Cardiac tamponade, Myocardial infarction
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: 2021-07-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100990149

Write-up: Myocardial infarction suspected; suspected to have tamponade or cardiac failure; suspected to have tamponade or cardiac failure; This is a spontaneous report from a contactable physician received via a sales representative. The patient was a 79-year-old female. Body temperature before vaccination was not reported. The patient''s family history was not reported. Medical history included hypertension. Historical Vaccine included the first dose of BNT162b2 (COMIRNATY, Lot number unknown, Expiration date unknown) on unknown date for covid-19 immunisation. The patient''s concomitant drug was not reported. On 04Jul2021 (the day of vaccination), the patient received?the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration as a single dose for COVID-19 immunization. On 07Jul2021 (3 days after the vaccination), the patient experienced myocardial infarction suspected. The patient was suspected to have tamponade or cardiac failure. On 07Jul2021 (3 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 04Jul2021, the patient received the second dose of Comirnaty. The patient had been suffering from hypertension but had no cardiac diseases. On 07Jul2021, the patient ate a smaller breakfast than usual. In the evening, when the patient''s family member came back home, the patient was lying in the room and was already in the state of postmortem rigidity. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 was unknown. Outcome of the events was fatal on 07Jul2021. It was not reported if an autopsy was performed. The reporting physician commented as follows: The presumed time of death was around 12:00. The patient was suspected to have tamponade or cardiac failure. The causality was unknown. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Reporter''s Comments: The presumed time of death was around 12:00. The patient was suspected to have tamponade or cardiac failure. The causality was unknown.; Sender''s Comments: Based on the information given in narrative, the causal relationship between the events myocardial infarction, cardiac tamponade, cardiac failure with fatal outcome and the suspect vaccine BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: suspected to have tamponade or cardiac failure; suspected to have tamponade or cardiac failure; Myocardial infarction suspected


VAERS ID: 1539040 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-12
Onset:2021-06-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Antinuclear antibody, Auscultation, Blood creatine phosphokinase, Blood creatine phosphokinase increased, Blood lactate dehydrogenase, Blood lactate dehydrogenase increased, Blood pressure measurement, Blood test, Body temperature, C-reactive protein, Fall, Fibrin D dimer, Glomerular filtration rate, Glycosylated haemoglobin, Hyperhidrosis, Investigation, KL-6, N-terminal prohormone brain natriuretic peptide, Non-high-density lipoprotein cholesterol, Ovarian cancer, Oxygen saturation, Pain, Polymyositis, Pyrexia, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Anticholinergic syndrome (broad), Accidents and injuries (narrow), Ovarian malignant tumours (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Non-haematological malignant tumours (narrow), Infective pneumonia (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Deep vein thrombosis leg
Preexisting Conditions: Medical History/Concurrent Conditions: Cataract operation; Dermatitis asteatotic (2 years before); Diabetes mellitus; Dyslipidaemia; Erythema facial; Gonarthrosis; Hypertension; Knee arthroplasty (in her 50s); Osteoporosis; Swelling
Allergies:
Diagnostic Lab Data: Test Date: 20210712; Test Name: body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210629; Test Name: CRP; Result Unstructured Data: Test Result:10.08; Test Date: 20210706; Test Name: CRP; Result Unstructured Data: Test Result:6.63; Test Date: 201912; Test Name: D-dimer; Result Unstructured Data: Test Result:more than 16; Test Name: eGFR; Result Unstructured Data: Test Result:between 40 to upper half of 30 mL; Comments: estimated glomerular filtration rate (eGFR) decreased at between 40 to upper half of 30 mL.; Test Name: HbA1c; Result Unstructured Data: Test Result:6.2 to 6.7 %; Test Name: HbA1c; Result Unstructured Data: Test Result:7s %; Comments: in recent days; Test Name: Examinations; Result Unstructured Data: Test Result:revealed presence of ovarian cancer; Test Date: 20210706; Test Name: KL-6; Result Unstructured Data: Test Result:3406; Test Name: Non-HDL cholesterol; Result Unstructured Data: Test Result:150s; Test Date: 20210629; Test Name: NT-proBNP; Result Unstructured Data: Test Result:51.4; Test Date: 20210712; Test Name: SpO2; Test Result: 94 %; Test Date: 20210706; Test Name: WBC; Result Unstructured Data: Test Result:11000; Test Date: 20210706; Test Name: ANA; Result Unstructured Data: Test Result:1280; Test Date: 20210629; Test Name: Auscultation; Result Unstructured Data: Test Result:fine crackles; Test Date: 20210629; Test Name: CK; Result Unstructured Data: Test Result:increase; Test Date: 20210629; Test Name: LDH; Result Unstructured Data: Test Result:increase; Test Date: 20210706; Test Name: LDH; Result Unstructured Data: Test Result:60; Test Name: blood pressure; Result Unstructured Data: Test Result:120s to 130s/60s to 70s; Test Date: 20210629; Test Name: blood drawing; Result Unstructured Data: Test Result:revealed the results of C-reactive protein (CRP); Comments: revealed the results of C-reactive protein (CRP) 10.08, increased lactate dehydrogenase (LDH)- creatinine kinase (CK), and N-terminal pro b-type natriuretic peptide (NT-proBNP) 51.4; Test Date: 20210622; Test Name: body temperature; Result Unstructured Data: Test Result:37s Centigrade; Test Date: 20210706; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade
CDC Split Type: JPPFIZER INC202100990322

Write-up: Polymyositis; Ovarian cancer; increased creatinine kinase; increased lactate dehydrogenase; sweaty; pantalgia; fever; feel down; This is a spontaneous report from a contactable physician via a Pfizer sales representative. An 86-years-old female patient received second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration at the age of 86-years-old on 12Jun2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical historyhypertension, diabetes mellitus, dyslipidaemia, osteoporosis, gonarthrosis of the hip joint and left knee, dermatitis asteatotic 2 years before, facial skin discolouration in Dec2020, and right lower thigh swelling in Dec2019, ongoing deep venous thrombophlebitis. Past history was as follows: the patient underwent total knee arthroplasty (TKA) in her 50s and cataract operation for both eyes in 2015. The course of medical history before vaccination was reported as follows: In 2010, the patient was referred from a physician in Hospital A to the reporting physician''s hospital, and had been received treatment for hypertension, diabetes mellitus, and dyslipidaemia. From 2012, the patient had received treatment for osteoporosis, and also been observed for gonarthrosis of the hip joint and left knee at the reporting physician''s hospital that occasionally obtained information from Hospital A. Blood pressure was 120s to 130s/60s to 70s. Hemoglobin A1c (HbA1c) ranged from 6.2 to 6.7% but moved to 7s% in recent days, so follow-up was continued. (Oral drugs were not changed). (illegible characters) Non-HDL cholesterol was 150s. At another department (nephrology), estimated glomerular filtration rate (eGFR) decreased at between 40 to upper half of 30 mL. No test for albumin had been conducted recently. Skin trouble (itching of the back and lumbar) had persisted around 2 years before, and had been treated as dermatitis asteatotic. It became mostly cured. However, from last December (Dec2020), due to covered by a facial mask, her face, particularly forehead and eyelid turned a red color. That made the patient concern. The patient''s concomitant medications was reported as: Direct oral anticoagulant (DOAC) was continued, because right lower thigh swelling developed in Dec2019, and D-dimer level became more than 16, which was treated as deep venous thrombophlebitis (DVT) but it recurred. The patient had no noteworthy family history. The patient previously received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on unknown date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. On 12Jun2021 (the day of vaccination), the patient experienced polymyositis. On unknown date (unknown days after the vaccination), the patient was admitted to Hospital B due to polymyositis. Starting on 22Jun2021 (10 days after the vaccination), slight fever of 37s degrees Centigrade persisted, and sweaty and pantalgia were also present. On 29Jun2021 (17 days after the vaccination), the patient visited the reporter''s hospital. Neither weight increased nor oedema was noted, but the reporting physician noticed the patient feel down. Blood drawing was performed that revealed the results of C-reactive protein (CRP) 10.08, increased lactate dehydrogenase (LDH)- creatinine kinase (CK), and N-terminal pro b-type natriuretic peptide (NT-proBNP) 51.4. At that moment, fine crackles(Auscultation) were heard. As the patient returned home after receiving blood drawing only, X-ray (XP) images could not be obtained. The patient, prescribed additional diuretic drug, was to be seen by the reporting physician one week later. On 06Jul2021 (24 days after the vaccination), body temperature (BT) was 36.3 degrees Centigrade, CRP 6.63, white blood cells (WBC) 11,000, LDH 60, KL-6 3406, and antinuclear antibody (ANA) increase to 1280. On 12Jul2021 (30 days after the vaccination), BT became 38 degrees Centigrade, and oxygen saturation (SpO2) 94%. Polymyositis (PM)/dermatomyositis (DM) were suspected. The patient was referred to Hospital B. There, polymyositis was confirmed the cause, and the patient was hospitalized. Examinations performed at Hospital B also revealed presence of ovarian cancer. Afterward, the patient died of ovarian cancer. The patient died on an unspecified date. The outcome of the event ovarian cancer was fatal, of the other events was unknown. It was not reported if an autopsy was performed. The reporting physician assessed that polymyositis was possibly related to BNT162b2. Causality and seriousness assessment from an attending physician of Hospital B was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: based on the available information the causality between suspect vaccine comirnaty and the fatal events ovarian cancer polymyositis fever sweaty and pantalgia increased lactate dehydrogenase (LDH)- creatinine kinase (CK cannot be completely ruled out; Reported Cause(s) of Death: Ovarian cancer


VAERS ID: 1539043 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Appendicitis, COVID-19, Clostridium difficile infection, Drug ineffective, Pain, Pyrexia
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: LBPFIZER INC202100988681

Write-up: He contracted Covid; Covid; Which then led him to catch Chlostrydium Dificile; appendicitis; Fever and febrile state; Sensation of pressure in lower stomach; Severe pain; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The following information was provided: A man had an acute and complicated appendicitis following his second shot of Pfizer vaccine. Day 1: fever and febrile state, Day 2: fever, febrile state and sensation of pressure in lower stomach, Day 3: severe pain (appendicitis). He was treated with antibiotics which then led him to catch Clostridium Difficile. In his visits to the ER, he contracted Covid and died of it. Outcome of the events clostridium difficile infection, appendicitis, fever and febrile state, sensation of pressure in lower stomach, severe pain was unknown. The patient died on an unspecified date. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Covid


VAERS ID: 1539061 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-26
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asphyxia, Cardiac failure, Dystonia, Oculogyric crisis, Seizure
SMQs:, Cardiac failure (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Dyskinesia (narrow), Dystonia (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MAJNJFOC20210762095

Write-up: HEART FAILURE; OCULOGYRIC CRISIS; CONVULSION (3 EPISODE); REACTION OF ACUTE GENERALIZED DYSTONIA; LARYNX LOCATION WHICH LED TO ASPHYXIA; This spontaneous report was received from a health care professional and from social media article and concerned a 33 year old female of unknown race and ethnicity. Initial information was processed with additional information received on 28-JUL-2021, 29-JUL-2021, 02-AUG-2021, and 06-AUG-2021. The patient''s height and weight were not reported. Relatives of the patient reported that she had no past medical history. No concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiration date were unknown) dose and vaccination site not reported, 1 total, 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 26-JUL-2021, 15 min after receiving vaccine, the patient experienced upper chest discomfort, oculogyric crisis, stiffness and rigidity, which was similar to post neuroleptic effect. Patient was transferred to a care unit where she got cyanosis on her face, followed by 3 episode of convulsion. Patient did not respond to benzodiazepine and died from a heart failure/ sudden cardiac arrest on 26-JUL-2021. Reporter''s assessment: "reaction of acute generalized dystonia'' where the death case was maybe having a larynx location which led to asphyxia" It was reported that this woman, one man and 2 additional women, all of the same age group, and all employees, received the vaccine on the same day at the same vaccination center and had adverse events. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart failure was fatal. The outcome of oculogyric crisis, larynx location which led to asphyxia, convulsion (3 episode), and reaction of acute generalized dystonia was not recovered. This case is a duplicate of 20210803557 and 20210763598. This case, from the same reporter is linked to 20210762146, 20210762101, 20210762147 and 20210808596.; Sender''s Comments: V0: This spontaneous case, received from a social media article and a health care professional, concerns a 33-year-old woman who died due to heart failure/cardiac arrest the same day she received the Janssen COVID-19 vaccine. The patient had no reported medical history. Fifteen minutes after receiving vaccine, she experienced chest discomfort, oculogyric crisis, and rigidity. She was brought to a care unit, where she became cyanotic and had 3 seizures. She did not respond to benzodiazepine and died due to heart failure. No additional information about her presentation or treatment were provided. Information is limited in this case, including the root cause of her symptoms and a unifying diagnosis. However, given the temporal relationship, a relationship with Janssen Covid-19 vaccine cannot be ruled out and thus the relationship is considered indeterminate.; Reported Cause(s) of Death: SUDDEN CARDIAC ARREST


VAERS ID: 1539189 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-21
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: 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: PHJNJFOC20210809950

Write-up: FEVER; DIFFICULTY OF BREATHING (DOB); This spontaneous report received from a pharmacist via a Regulatory Authority [PH-PHFDA-300095404] concerned a 66 year old female 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, intramuscular, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on 20-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 21-JUL-2021 10:00 (one day after being vaccinated), the patient experienced fever and after 2 hours at 12:00 had difficulty of breathing (DOB). On an unspecified date, the patient died from fever, and difficulty of breathing (DOB). It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: 20210809950-COVID-19 VACCINE AD26.COV2.S-fever, difficulty of breathing (DOB). 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: FEVER; DIFFICULTY OF BREATHING (DOB)


VAERS ID: 1539191 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202101000525

Write-up: Dead on arrival; This is a spontaneous report from a contactable other health care professional. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300094004. A 33-year-old female patient received BNT162B2(COMIRNATY), via intramuscular of administration on 16Jul2021, at 33-year-old, as unknown dose number as single dose (Batch/Lot number was not reported) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced dead on arrival on 17Jul2021 19:52. The outcome of event was fatal. The event was reported as serious due to fatal outcome. 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: Dead on arrival


VAERS ID: 1540215 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-05
Onset:2021-06-06
   Days after vaccination:62
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Monoplegia, Pain in extremity, Vaccination site haematoma, Vaccination site nodule, Vaccination site scar
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC2021899325

Write-up: Paralyzed arm, and Death.; scar from vaccine no. 1; hematoma from the neck to the shoulder; small painful nodule; The pain in the arm progressed; Paralyzed arm, and Death.; This is a spontaneous report from a contactable consumer or other non hcp. A 87-years-old male patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EP9605, Expiration date was not reported), dose 1 via intramuscular, administered in arm right on 05Apr2021 (age at vaccination 87 years) as single dose and second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: ER7449, Expiration date was not reported), dose 2 via intramuscular, administered in arm right on 03May2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced death on 06Jun2021, paralysed arm on an unspecified date, on an unspecified date scar from vaccine no. 1, hematoma from the neck to the shoulder, small painful nodule, pain in the arm progressed. Reported stated, he was upset that anyone was interested in this case and found the photos to be more explicit than the words. omitted, the attached photo (picture of the patient''s arm). His desire to go on vacation was such that he insisted on giving the second injection to regain the freedom to travel. To reassure reporter he told him about the covid arm and when he only had 2 fingers left where he felt "like flowing water", he told reporter it''s the end", thought he was talking about the disease, not his life. Patient received treatment for small painful nodule, treated with Paracetamol 500mg and Voltaren Dolo. For pain in the arm progressed, he treated himself with Tramadol + Stilnox to sleep, and massage with Voltaren Dolo and hot water bottles which seemed to relieve him. The patient died on 06Jun2021. It was not reported if an autopsy was performed. The outcome of event scar from vaccine no. 1, hematoma from the neck to the shoulder, small painful nodule, pain in the arm progressed was not recovered. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: death; Paralyzed arm


VAERS ID: 1540245 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-17
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocarditis, Pulmonary embolism, Thrombocytopenia, Thrombosis, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210807037

Write-up: LUNG EMBOLISM; THROMBOSIS; THROMBOCYTOPENIA; MYOCARDITIS; VENTRICULAR FIBRILLATION; This spontaneous report received from a physician via the regulatory authority, case reference number DE-PEI-202100149468, and concerned a 27 year-old male patient 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, route of administration not reported, batch number XD974 expiry date not reported), dose not reported, administered on 10-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-JUL-2021, the patient experienced ventricular fibrillation. On unspecified dates, the patient developed lung embolism, thrombosis, thrombocytopenia, and myocarditis. The patient was hospitalized on an unspecified date. On 17-JUL-2021, the patient died from an unknown cause of death. An autopsy was performed on an unspecified date, the results of which were not reported. The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. The outcome was reported as fatal for lung embolism, thrombosis, thrombocytopenia, myocarditis and ventricular fibrillation. This report was serious (death, life-threatening and caused/prolonged hospitalization).; Sender''s Comments: V0: This spontaneous report received from a Regulatory Authority (DE-PEI-202100149468) concerns a 27-year-old male patient of unspecified ethnicity who was found to have ventricular fibrillation, lung embolism, thrombosis, thrombocytopenia, and myocarditis 7 days after receiving the Janssen Covid-19 vaccine. The patient died from an unspecified cause on an unspecified date. No other pertinent information reported. Information regarding other potential etiologies was insufficient and precludes a complete and meaningful assessment. The relationship of capillary leak syndrome to vaccination is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1541179 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / 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: 2021-07-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EUCREAS; TEMERIT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101010579

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-CN20212437. A 67-year-old female patient received second dose of BNT162B2(COMIRNATY), via intramuscular of administration on 15Jul2021, as single dose(Batch/Lot number was not reported) for covid-19 immunisation. Medical history included type 2 diabetes and hypertension. Concomitant medications included metformin hydrochloride, vildagliptin (EUCREAS) taken for type 2 diabetes from an unknown date;nebivolol hydrochloride (TEMERIT)(strength 5 mg) taken for hypertension from an unknown date. The patient''s COVID-19 history and PCR testing history and allergic history were unknown. The patient experienced cardiorespiratory arrest on 16Jul2021 13:00 and died at 16Jul2021 13:45. The outcome of event was fatal. It was not reported if an autopsy was performed. The event was reported as serious due to fatal outcome. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Cardiorespiratory arrest


VAERS ID: 1541675 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-18
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW9127 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatine phosphokinase, Blood glucose, Blood glucose abnormal, Blood lactate dehydrogenase, C-reactive protein, COVID-19, COVID-19 pneumonia, Cardiac failure, Cardiac failure congestive, Chest X-ray, Death, Renal failure, Renal function test, SARS-CoV-2 test, Urinary tract infection, Urine analysis, Vaccination failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (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), Cardiomyopathy (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-21
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic renal insufficiency; Diabetic polyneuropathy; Gross obesity; Ischemic heart disease; Pulmonary embolism; Type II diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210418; Test Name: Creatine kinase; Result Unstructured Data: Test Result:16860; Comments: Units: U/L; Test Date: 20210418; Test Name: blood glucose; Result Unstructured Data: Test Result:unknown results; Test Date: 20210418; Test Name: LDH; Result Unstructured Data: Test Result:1532; Comments: Units: U/L; Test Date: 20210418; Test Name: Chest X-ray; Result Unstructured Data: Test Result:no infiltration was seen; Comments: diaphragm was pressed up on both sides with a sharp contour, no infiltration was seen; Test Date: 20210418; Test Name: C-reactive protein; Result Unstructured Data: Test Result:185.1 mg/l; Test Date: 20210418; Test Name: renal function; Result Unstructured Data: Test Result:impaired; Test Date: 20210418; Test Name: COVID-19 antigen test; Test Result: Positive ; Test Date: 20210418; Test Name: urinary tests; Result Unstructured Data: Test Result:urinary infection considered
CDC Split Type: HUPFIZER INC2021781864

Write-up: congestive heart failure; COVID-19 pneumonia; cardiac decompensation; chronic renal insufficiency/exacerbated the patient''s underlying conditions.; death; COVID-19; urinary infection; blood glucose values; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB HU-OGYI-456121. A 66-year-old female patient received the first dose of BNT162b2 (COMIRNATY, concentrate for dispersion for injection, 30 micrograms of COVID-19 mRNA Vaccine, MAH: BioNTech Manufacturing GmbH/ Pfizer) on 05Mar2021 (batch number: EP2163) via unspecified route as a single dose and the second dose of BNT162b2 (COMIRNATY, batch number: EW9127) on 09Apr2021 at 11:16 at 0.3 ml as a single dose intramuscularly in the left arm, both doses for COVID-19 immunization. Medical history included type II diabetes mellitus, diabetic polyneuropathy, extreme obesity, chronic renal insufficiency since 2018, pulmonary embolism in 2018, and ischemic heart disease. Concomitant medications were not reported. On 18Apr2021 the patient was hospitalized due to increasing weakness and dyspnoea. Lab data included elevated CK (Creatine Kinase)(16860 U/L), LDH(lactate dehydrogenase) (1532 U/L), CRP(C-reactive protein) (185.1 mg/L) and impaired renal function were confirmed in laboratory tests. The diaphragm was pressed up on both sides due to extreme obesity, but no infiltration was seen on chest X-ray. Although, intensive therapy consultation described COVID-19 pneumonia, which exacerbated the patient''s underlying conditions. Based on urinary tests, urinary infection was considered. Diuretics were started parenterally with dexamethasone and LMWH with gastric protection. Parenteral antibiotic therapy was used. Insulin therapy was started due to blood glucose values. The patient received oxygen supplementation. During observation, in addition to the therapy used, the patient''s condition progressed, therefore an intensive consultation was requested. Based on the patient''s advanced chronic underlying diseases, no improvement was expected from Intensive Care Unit treatment. Continuation of initiated therapy was recommended. Despite the applied treatments, her condition continued to deteriorate, and the patient died among the symptoms of respiratory failure caused by cardiac decompensation on 21Apr2021, at 01:30 a.m. Autopsy was not done. Cause of death was congestive heart failure due to chronic ischemic heart disease and chronic renal insufficiency. The outcome of the events urinary infection and blood glucose values was unknown, while of other events was fatal. Sender''s comments: The patient died 12 days after the second dose of Comirnaty due to COVID-19 which worsened her congestive heart failure and other underlying diseases. COVID-19 antigen test was positive 9 days after the second dose, therefore vaccination failure is considered possible with Comirnaty. The case is serious due to fatal outcome. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: vaccination failure; death; COVID-19; COVID-19 pneumonia; cardiac decompensation; chronic renal insufficiency; Congestive heart failure


VAERS ID: 1541726 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-07-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2707 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Sudden death, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:160/90 mmHg
CDC Split Type: ITPFIZER INC202101004158

Write-up: AFTER 1ST DOSE IN THE NIGHT 3 EPISODES OF VOMITING IN THE MORNING THE DOCTOR ADMINISTERED 1 Vial OF PLASIL, Blood Pressure 160/90. DURING THE DAY OF 6 REMAINS ASYMPTOMATIC UNTIL 6.30 PM SUDDEN DEATH; AFTER 1ST DOSE IN THE NIGHT 3 EPISODES OF VOMITING IN THE MORNING THE DOCTOR ADMINISTERED 1 Vial OF PLASIL, Blood Pressure 160/90. DURING THE DAY OF 6 REMAINS ASYMPTOMATIC UNTIL 6.30 PM SUDDEN DEATH; AFTER 1ST DOSE IN THE NIGHT 3 EPISODES OF VOMITING IN THE MORNING THE DOCTOR ADMINISTERED 1 Vial OF PLASIL, Blood Pressure 160/90. DURING THE DAY OF 6 REMAINS ASYMPTOMATIC UNTIL 6.30 PM SUDDEN DEATH; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) -WEB, regulatory authority number IT-MINISAL02-764381. A 59-year-old male patient received bnt162b2 (COMIRNATY, Solution for Injection), dose 1 via intramuscular, administered in Deltoid Left on 05Jul2021 17:05 (Batch/Lot Number: FE2707, Expiry date was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 06Jul2021, the patient experienced after 1st dose in the night 3 episodes of vomiting in the morning the doctor administered 1 vial of plasil, blood pressure 160/90. during the day of 6 remains asymptomatic until 6.30 pm sudden death. Laboratory tests on an unspecified date included blood pressure measurement: 160/90 mmhg. The doctor administered 1 vial of plasil for vomiting. The patient died on 06Jul2021 at 06:30 pm. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: after 1st dose in the night 3 episodes of vomiting in the morning the doctor administered 1 vial of plasil, blood pressure 160/90. during the day of 6 remains asymptomatic until 6.30 pm sudden death; after 1st dose in the night 3 episodes of vomiting


VAERS ID: 1541806 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-06-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Cardiac failure, Haemoglobin, Oxygen saturation, Pancytopenia, Platelet count, Pyrexia, White blood cell count
SMQs:, Cardiac failure (narrow), Agranulocytosis (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Myelodysplastic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-28
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210628; Test Name: Haemoglobin; Result Unstructured Data: Test Result:6.8 g/dl; Test Date: 20210628; Test Name: SpO2; Test Result: 80 %; Comments: After 10 L of oxygen was administered.; Test Date: 20210628; Test Name: Platelet; Result Unstructured Data: Test Result:1000; Comments: Unit: /micro L; Test Date: 20210624; Test Name: WBC; Result Unstructured Data: Test Result:900; Comments: Unit: /micro L; Test Date: 20210628; Test Name: WBC; Result Unstructured Data: Test Result:800; Comments: Unit: /micro L
CDC Split Type: JPPFIZER INC202100995987

Write-up: Pancytopenia; poor consciousness persisted; Pyrexia; The poor oxygenation was considered caused by cardiac failure; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21122390. A 79-years and 11-month-old female patient received first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration on 23Jun2021 (the day of vaccination) (at age of 79-years-old) as dose 1, single for COVID-19 immunization. Body temperature before vaccination was not reported. The patient''s family history and medical history were not reported. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). Patient medical history and concomitant medications were not reported. On 28Jun2021 (5 days after the vaccination), the patient experienced pancytopenia. The course of the event was as follows: On 23Jun2021, after the vaccination, the patient presented with pyrexia from the night. On 24Jun2021, blood test showed a low white blood cell count at 900/micro L. Pyrexia and poor consciousness persisted thereafter. On 28Jun2021, in the morning, SpO2 was 80%, indicating no improvement with 10 L of oxygen, and the patient was intubated. White blood cell was 800/micro L, haemoglobin was 6.8 g/dL, and platelet was 1000/micro L, which showed pancytopenia. The poor oxygenation was considered caused by cardiac failure associated with anemia on an unknown date in 2021. Blood transfusion was performed but did not improve the patient''s condition. On 28Jun2021, the patient was confirmed dead. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 was unassessable. There was no other possible cause of the event such as any other diseases. Outcome of the events was fatal. It was not reported if an autopsy was performed. On 28Jun2021 (5 days after the vaccination), the outcome of the event (Pancytopenia) was fatal. The Outcome of all other events are unknown. Information about lot/batch number has been requested.; Reported Cause(s) of Death: Pancytopenia


VAERS ID: 1541860 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-10
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: 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: Congestive cardiac failure; Hypertension; Renal failure
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: LSJNJFOC20210816481

Write-up: DEATH; This spontaneous report was received from a consumer and concerned a 57 year-old male patient. The patient''s height and weight were not reported. The patient''s concurrent conditions included hypertension, renal failure and congestive cardiac failure (CCF). The patient received COVID-19 vaccine Ad26.CoV2.S (suspension for injection, intramuscular, batch number and expiry date not reported), dose and administration date not reported for prophylactic vaccination. The company will conduct follow-up to try and obtain the batch number. No concomitant medications were reported. On an unspecified date, within 12 hours of vaccination, it was reported that the patient died. No cause of death was reported and it was not reported if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (death). This case, from the same reporter, is linked to cases 20210816486, 20210816511 and 20210816515.; Sender''s Comments: V0: This spontaneous report received from consumer and concerned a 57 year-old male who died within 12 hours of receiving the Janssen COVID-19 vaccine. Medical history includes hypertension, renal failure and congestive cardiac failure. Concomitant medications were not reported. Laboratory studies, imaging or other diagnostics were not provided. Information is limited in this case, however, considering the temporal relationship with vaccination, a relationship with Janssen Covid-19 vaccine cannot be ruled out. Therefore, the relationship is considered indeterminate. This case will be reassessed if new information is received.; Reported Cause(s) of Death: DEATH


VAERS ID: 1541944 (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: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral infarction, Magnetic resonance imaging
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-16
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: MRI; Result Unstructured Data: Test Result:unknown; Comments: MRI related to brainstem activity.
CDC Split Type: NLPFIZER INC202101004145

Write-up: Brain hemorrhage leading to death; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority NL-LRB-00646770. This consumer reported similar events for two patients. This is the first of two reports. A 56-year-old male patient received first dose of BNT162B2 (COMIRNATY, formulation: Solution for injection, Lot Number: unknown), via on an unspecified route of administration on 11Jun2021 as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. No previous COVID-19 infection. On 15Jun2021, 4 days after start the patient had brain hemorrhage leading to death. The patient then died due to the brain hemorrhage on 16Jun2021. The patient received treatment for Cerebral infarction is treated with keeping him in a coma. A day later they got him out of the coma, after which patient had another cerebral hemorrhage. Patient was declared brain dead after that. Reported stated that this happened to my cousin and good friend whom I saw four days before his vaccination. I hear around me that more and more people end up in hospital because of a brain hemorrhage after vaccination. The patient underwent lab test which included magnetic resonance imaging to measure the brain stem activity on an unknown date result as unknown. The outcome of cerebral infarction is fatal. It was reported unknown if an autopsy was performed. Information on the lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101011663 same reporter/drug/event, different patient; Reported Cause(s) of Death: Brain hemorrhage


VAERS ID: 1541957 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-21
Submitted: 0000-00-00
Entered: 2021-08-11
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: 2021-07-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLJNJFOC20210814147

Write-up: DEATH; This spontaneous report received from a physician via a Regulatory Authority [PL-URPL-3-840-2021] concerned a 48 year old female with 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: XE389, expiry: 10-OCT-2021) 0.5 (unspecified unit) dose, first dose, 1 total administered in left arm on 17-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-JUL-2021, the patient died from unknown cause of death. 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: 20210814147-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: 1545793 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-05-27
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3599 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Alanine aminotransferase, Angiogram, Aspartate aminotransferase, Blood creatine phosphokinase, Blood creatine phosphokinase MB, Blood lactate dehydrogenase, Cardiogenic shock, Cardiomyopathy, Dyspnoea exertional, Echocardiogram, Ejection fraction, Fibrin D dimer, N-terminal prohormone brain natriuretic peptide, Platelet count, Troponin T
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), 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), Pulmonary hypertension (broad), Cardiomyopathy (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: GPt; Result Unstructured Data: Test Result:1396; Test Name: CT angio; Result Unstructured Data: Test Result:no pulmonary embolism; Comments: 1) No evidence of a central pulmonary embolism or at the level of the lobes and segment arteries. Phase identifiable aorta without a tangible dissection membrane. 2) Heart globally enlarged / dilated. Pronounced signs of stress on the right heart. Larger pleural effusions bilaterally (right$g left), a.e. as part of cardiac decompensation. 3) Pneumonic consolidations peribronchially-central in the right upper lobe as in bronchopneumonia. In addition, at least two cavernous formations / fusions in the right upper lobe (series 6, IMA 61) or in the right lower lobe apically (series 6, IMA 66; Test Name: GOT; Result Unstructured Data: Test Result:838; Comments: U/l; Test Name: CK; Result Unstructured Data: Test Result:208; Test Name: CK-MB; Result Unstructured Data: Test Result:6.87 ng/ml; Comments: norm <3.6145 pf / ml (<116); Test Name: LDH; Result Unstructured Data: Test Result:987; Test Date: 20210531; Test Name: echo; Result Unstructured Data: Test Result:Dilated cardiomyopathy; Comments: Dilated cardiomyopathy with severely impaired LV function in diffuse hypokinesia. Mitral valve regurgitation 2 . Tricuspid valve insufflation 1 ''. No right heart strain. No pericardial effusion.; Test Name: LVEF; Result Unstructured Data: Test Result:<20 %; Test Name: D-dimer; Result Unstructured Data: Test Result:19.2 mg/l; Test Name: Nt proBNP; Result Unstructured Data: Test Result:12; Test Name: platelet; Result Unstructured Data: Test Result:96.000; Test Name: troponin T; Result Unstructured Data: Test Result:0.80 ng/ml
CDC Split Type: DEPFIZER INC202100987803

Write-up: Cardiogenic shock; Cardiomyopathy; Acute kidney failure; Dyspnoea exertional; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100137304. A 39-years-old female patient received bnt162b2 (COMIRNATY; Solution for injection), via an unspecified route of administration on 28Apr2021 (at the age of 39-years-old) (Lot Number: EX3599) as DOSE NUMBER UNKNOWN, SINGLE for Covid-19 immunisation. The patient medical history and patient''s concomitant medications were not reported. The patient experienced Cardiogenic shock, Cardiomyopathy, Acute kidney failure, Dyspnoea exertional on 27May2021. The patient underwent lab tests and procedures which included Alanine aminotransferase: 1396 on an unspecified date, Angiogram: No pulmonary embolism on an unspecified date 1) No evidence of a central pulmonary embolism or at the level of the lobes and segment arteries. Phase identifiable aorta without a tangible dissection membrane. 2) Heart globally enlarged / dilated. Pronounced signs of stress on the right heart. Larger pleural effusions bilaterally (right$g left), a.e. as part of cardiac decompensation. 3) Pneumonic consolidations peribronchially-central in the right upper lobe as in bronchopneumonia. In addition, at least two cavernous formations / fusions in the right upper lobe (series 6, IMA 61) or in the right lower lobe apically (series 6, IMA 66 , aspartate aminotransferase: 838 on an unspecified date U/l , blood creatine phosphokinase: 208 on an unspecified date, Blood creatine phosphokinase mb: 6.87 ng/ml on an unspecified date norm <3.6145 pf / ml (<116) , blood lactate dehydrogenase: 987 on an unspecified date, Echocardiogram: dilated cardiomyopathy on 31May2021 Dilated cardiomyopathy with severely impaired LV function in diffuse hypokinesia. Mitral valve regurgitation 2. Tricuspid valve insufflation 1''. No right heart strain. No pericardial effusion, ejection fraction: <20 % on an unspecified date, fibrin d dimer: 19.2 mg/l on an unspecified date, n-terminal prohormone brain natriuretic peptide: 12 on an unspecified date, platelet count: 96.000 on an unspecified date, Troponin t: 0.80 ng/ml on an unspecified date. The patient died on an unspecified date. It was unknown if an autopsy was performed or not. No follow-up attempts possible. No further information expected; Reporter''s Comments: Summary Reporter Comment: LVEF <20% Echo 31May2021 Dilated cardiomyopathy with severely impaired LV function in diffuse hypokinesia. Mitral valve regurgitation 2 . Tricuspid valve insufflation 1 ''. No right heart strain. No pericardial effusion. D-dimers 19.2 mg / l (norm <0.5 Thrombocytes 96,000 GOT 835 U / l (nomr <35) GPt 1396 (norm <35); Reported Cause(s) of Death: the patient experienced Dyspnoea exertional, Cardiogenic shock, Cardiomyopathy, Acute kidney failure


VAERS ID: 1545988 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-06-12
   Days after vaccination:57
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-25
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial calcification
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987716

Write-up: Multiple strokes with death as a result; This is a spontaneous report from a non-contactable consumer or other non-healthcare professional downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021139092, Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100136554. An 84-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 16Apr2021 as dose 2, single for covid-19 immunization. Medical history included arteriosclerosis from an unknown date and unknown if ongoing. The patient was not concerned known of any allergies. Information on risk factors or previous illnesses included a lot of medication, including blood thinners, calcified arteries, otherwise in good condition according to age. The patient experienced multiple strokes with death as a result on 12Jun2021. The patient died on 25Jun2021. An autopsy was not performed. Cause of Death reported as Stroke. COMIRNATY/ Stroke/ Unclassifiable. No follow-up attempts are possible, information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Stroke


VAERS ID: 1545989 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-08
Onset:2021-04-12
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Zenker diverticulum
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987642

Write-up: Severe stroke resulting in death; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB DE-PEI-CADR2021140007 and Safety Report Unique Identifier DE-PEI-202100137631. An 84-years-old male patient received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 08Mar2021 as second dose, single for COVID-19 immunization. Medical history included ongoing Zenker diverticulum. The patient''s concomitant medications were not reported. On 12Apr2021, the patient experienced severe stroke resulting in death. The patient died on 28Apr2021. It was not reported if an autopsy was performed. Reaction: Accident cerebrovascular. Source of assessment: RA Result of assessment: D. Unclassifiable Sender Comment: Are you or the person concerned known of any allergies? If yes, which? No information on risk factors or previous illnesses Zenker''s diverticulum, otherwise completely normal findings. No follow-up attempts are possible. No further information is expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Accident cerebrovascular


VAERS ID: 1545993 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-07-05
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D018A / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Brain oedema, Cerebral haemorrhage, Cerebral venous sinus thrombosis, Coma scale, Computerised tomogram, Computerised tomogram head, Dysarthria, Headache, Illness, Magnetic resonance imaging, Monoplegia, Seizure, VIth nerve paralysis, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Haemorrhagic central nervous system vascular conditions (narrow), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-09
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Glasgow Coma Scale; Result Unstructured Data: Test Result:deterioration < 8 points; Test Name: Computerised tomography; Result Unstructured Data: Test Result:cerebral bleeding evidence; Comments: suspected Subarachnoid hemorrhage; Test Name: Computerised tomography; Result Unstructured Data: Test Result:progressing cerebral oedema; Comments: on account of increased cerebral pressure.; Test Date: 20210706; Test Name: cranial computed tomography; Result Unstructured Data: Test Result:cerebral sinus vein thrombosis; Test Date: 20210706; Test Name: magnetic resonance tomography; Result Unstructured Data: Test Result:evidence of cerebral sinus thrombosis; Comments: and a brain oedema, convulsion.
CDC Split Type: DEPFIZER INC202100988686

Write-up: Thrombosis of venous sinuses; Brain oedema; Intra-cerebral hemorrhage; Seizure; abducens paralysis right; paralysis of arm; Vomiting; feeling of sickness; Headache; acute neurological symptoms with dysarthria; This is a spontaneous report from a non-contactable consumer or other non-Healthcare Professional downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021141885. A 36-years-old male patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Dose: 0.3 mL, Lot number: 1D018A, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 11Jun2021 (age at vaccination was unknown) as dose 2, 0.3ml single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient did not have any allergies. Information on risk factors or previous diseases was reported as none. The patient previously took first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 12May2021 (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. On 05Jul2021, the patient was referred to hospital on account of vomiting, feeling of sickness. Headache, acute neurological symptoms with dysarthria, subsequently in hospital paralysis of arm and abducens paralysis right. Computerised tomography with cerebral bleeding evidence, suspected subarachnoid hemorrhage on an unspecified date and cranial computed tomography with Clinical Target Volume on 06Jul2021 with urgent suspicion of a cerebral sinus vein thrombosis. On 06Jul2021, the patient experienced thrombosis of venous sinuses, brain oedema, intra-cerebral hemorrhage and seizure. On 06Jul2021, magnetic resonance tomography with evidence of cerebral sinus thrombosis and a brain oedema, convulsion. On 06Jul2021, papillademae. Emergency medical flight on 07Jul2021 at 6:10 am. Intubation and respiration, external ventricular drain apparatus, with Glasgow Coma Scale deterioration < 8 points on an unspecified date. Right computerised tomography with evidence of progressing cerebral oedema on account of increased cerebral pressure on an unspecified date. Hemicraniectomy was done on 07Jul2021. Anti-convulsive treatment, cerebral oedema treatment, antibiotic screening, anti-coagulation. Progressive sinus venal thrombosis despite decompressive measures, maximal brain pressure therapy, anti-coagulation and intensive therapy. Subsequently, fatal cerebral congestion bleeding and progressive cerebral oedema with irreversible brain pressure. The patient died on 09Jul2021. Death with unfavorable cerebral prognosis on 09Jul2021. An autopsy was not performed. This report was reported as serious-death. The outcome of the events thrombosis of venous sinuses, brain oedema and intra-cerebral hemorrhage was reported as fatal. The outcome of the event seizure was reported as not resolved. The outcome of the other events was unknown. Sender comment: Do you or the person concerned have any allergies? If so, which ones? None Information on risk factors or previous diseases none. No follow-up attempts are needed. No further information expected.; Reported Cause(s) of Death: Brain oedema; Intra-cerebral hemorrhage; Thrombosis of venous sinuses


VAERS ID: 1546001 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-04-11
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987538

Write-up: Infarct myocardial; This is a spontaneous report received from a non-contactable consumer downloaded from the Regulatory Authority-WEB. The regulatory authority report number is DE-PEI-CADR2021150259, Safety report unique identifier DE-PEI-202100150004. A 51-year-old male patient received first dose of BNT162B2 (COMIRNATY) Lot number ER7812, on 25Mar2021 at single dose for COVID-19 immunisation. Medical history included smoker. Concomitant medication was not reported. On 11Apr2021 the patient experienced Infarct myocardial which resulted in death. Sender Comment: Information on risk factors or previous illnesses smoker, professional soldier Relatedness of drug to reactions/events Source of assessment: RA Result of Assessment: D. Unclassifiable No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1546048 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-03
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Malnutrition; Pancolitis
Allergies:
Diagnostic Lab Data: Test Date: 20210703; Test Name: SARS-CoV-2 PCR test; Result Unstructured Data: Positive
CDC Split Type: ESJNJFOC20210813142

Write-up: ASYMPTOMATIC COVID-19; This spontaneous report received from a physician via a Regulatory Authority [NLP, ES-AEMPS-950071] concerned a 69 year old female of unknown race and ethnicity. The patient''s height, and weight were not reported. The patient''s past medical history included: pancolitis, and malnutrition. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD955 and expiry: UNKNOWN) 0.5 ml, duration 1 day, 1 total administered on 03-MAY-2021 for covid-19 vaccination. The drug start period and drug last period were 62 days. No concomitant medications were reported. On 03-JUL-2021, the patient experienced asymptomatic covid-19. Laboratory data included: SARS-CoV-2 PCR test (NR: not provided) Positive. On 05-JUL-2021, the patient died from multiple organ failure, intestinal ischemia, and septic shock. An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of asymptomatic covid-19 was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210813142-COVID-19 VACCINE AD26.COV2.S.- Asymptomatic covid-19. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: MULTIPLE ORGAN FAILURE; INTESTINAL ISCHEMIA; SEPTIC SHOCK


VAERS ID: 1546066 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aphasia, Coma, Confusional state, Death, Leukocytosis, Pneumonia, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (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), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-05
   Days after onset: 8
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: XERISTAR; NEURONTIN; XELEVIA; ACETYLSALICYLIC ACID; OMEPRAZOLE; PAZITAL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthrosis; Cavernoma (left stable cerebral cavernoma); Cholecystectomy; COVID-19; Neuropathy (cranial neuropathy VI); Spinal canal stenosis (lumbar canal stenosis); TIA; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 PCR; Test Result: Negative
CDC Split Type: ESPFIZER INC202100987891

Write-up: bilateral pneumonia; loss of speech; comatose state; leucocytosis; vomit; Death; This is a spontaneous report from a contactable consumer or other non Health Professional downloaded from the Regulatory Authority-WEB ES-AEMPS-956110. A 88-year-old non-pregnant female patient received second dose of bnt162b2 (COMIRNATY solution for injection, Batch/Lot number: EK9788), via an unspecified route of administration on 28Jan2021 as dose 2, single for COVID-19 immunisation. The medical history of the patient included Cavernoma, Neuropathy from 2013 to unknown date, TIA from 2016 to unknown date, TIA from 2020 to unknown date, Cholecystectomy, Type 2 diabetes mellitus, Arthrosis, Spinal canal stenosis and COVID-19. The concomitant medications of the patient included duloxetine hydrochloride (XERISTAR), gabapentin (NEURONTIN), sitagliptin phosphate (XELEVIA), acetylsalicylic acid (ACETYLSALICYLIC ACID), omeprazole (OMEPRAZOLE), paracetamol, tramadol hydrochloride (PAZITAL). The patient was not pregnant at the time of vaccination. The patient previously received the first dose of COMIRNATY (solution for injection, Batch/Lot number: EM0477) on 07Jan2021 as single dose for COVID-19 immunisation. On 28Jan2021, the patient experienced vomit, loss of speech, comatose state, leucocytosis and the patient experienced bilateral pneumonia on 03Feb2021. The patient was hospitalized from 03Feb2021 to an unknown date for vomit and bilateral pneumonia. The patient underwent lab tests and procedures which included COVID-19 PCR: negative on an unspecified date. Therapeutic measures were taken as a result of bilateral pneumonia that included bronchodilators and antibiotic is started broad spectrum antibiotic but in the face of a fatal short-term prognosis, it was decided to apply measures of comfort and sedation. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: vomit; bilateral pneumonia; loss of speech; comatose state; leucocytosis


VAERS ID: 1546084 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESJNJFOC20210812235

Write-up: ICTUS; This spontaneous report received from a health care professional concerned a 36 year old male of unspecified race and ethnic origin. 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 administration and batch number were not reported, expiry: unknown) dose, start therapy date were not reported,1 total administered 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 ictus and two weeks after vaccination the patient died due to ictus. 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). This case, from the same reporter is linked to 20210806771.; Sender''s Comments: V0:20210812235-COVID-19 VACCINE AD26.COV2.S-Ictus. 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: ICTUS


VAERS ID: 1546090 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-06-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood culture, Body temperature, Chest X-ray, Computerised tomogram, Death, Dyspnoea, Increased upper airway secretion, Inflammatory marker test, Lung opacity, Pyrexia, SARS-CoV-2 test, SARS-CoV-2 test negative, Specialist consultation, Urine analysis
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-23
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve repair (due to valvular bleeding); Atrial fibrillation; Coronary artery disease; Hypertension; Memory impairment; Metabolic syndrome; Pacemaker insertion (cardiac) (inserted due to sick sinus syndrome); Renal failure; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: Blood culture; Result Unstructured Data: Test Result:no growth; Test Name: Body temperature; Result Unstructured Data: Test Result:41.2 Centigrade; Test Date: 20210618; Test Name: Body temperature; Result Unstructured Data: Test Result:38.5 Centigrade; Test Name: lung image; Result Unstructured Data: Test Result:Minor inflammatory spectral finding; Comments: Minor inflammatory spectral finding in the low lobe; Test Date: 202102; Test Name: computed tomography; Result Unstructured Data: Test Result:cirrhosis of the liver; Test Name: inflammatory values; Result Unstructured Data: Test Result:moderate; Test Name: Covid test; Test Result: Negative ; Test Name: Covid test; Test Result: Negative ; Test Name: Covid test; Test Result: Negative ; Test Date: 202106; Test Name: gastroenterologist; Result Unstructured Data: Test Result:NASH condition; Comments: it seems that mainly nonalcoholic steatohepatitis (NASH) type of condition in the background.; Test Name: Urine; Result Unstructured Data: Test Result:no obvious infectious
CDC Split Type: FIPFIZER INC202100987847

Write-up: Death; Lung opacity; SARS-CoV-2 test negative; Dyspnoea; Increased upper airway secretion; Pyrexia; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FI-FIMEA-20213702. An 86-year-old female patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number was not reported), intramuscular on 17Jun2021 (Age of vaccination: Unknown) as DOSE 2, SINGLE for covid-19 immunization. Historical vaccine included first dose of BNT162B2 (COMIRNATY, Solution injection, Lot number/Expiration date: Unknown) for covid-19 immunization. Medical history included memory impairment, type 2 diabetes mellitus, metabolic syndrome, coronary artery disease, hypertension, atrial fibrillation, cardiac pacemaker insertion as inserted due to sick sinus syndrome , aortic valve repair from 2014 to 2014 due to valvular bleeding , renal failure. The patient''s concomitant medications were not reported. On 18Jun2021 the patient experienced lung opacity, sars-cov-2 test negative, dyspnoea, increased upper airway secretion, pyrexia. 17Jun21 on Thursday the patient received Pfizer second covid vaccine (first received on 24Feb Comirnaty). The next day, a rising fever ad 38.5., During several hours developed severe shortness of breath and mucus. Initiated iv antibiotic. Fever increased despite strong iv antibiotics ad 41.2. Covid test repeatedly (3x) negative. In blood cultures there is no growth, in the urine there is no obvious infectious, in lab tests the inflammatory values are moderate all the time. Minor inflammatory spectral finding in the low lobe in the lung image. On 23Jun2021 the patient died. The patient underwent lab tests and procedures which included blood culture: no growth on an unspecified date, body temperature: 41.2 centigrade on an unspecified date, body temperature: 38.5 centigrade on 18Jun2021 , chest x-ray: minor inflammatory spectral finding on Minor inflammatory spectral finding in the low lobe , computerised tomogram: cirrhosis of the liver on Feb2021 , inflammatory marker test: moderate on an unspecified date, sars-cov-2 test: negative on an unspecified date, sars-cov-2 test: negative on an unspecified date, sars-cov-2 test: negative on an unspecified date, specialist consultation: nash condition on Jun2021 it seems that mainly nonalcoholic steatohepatitis (NASH) type of condition in the background , urine analysis: no obvious infectious on an unspecified date. The patient died on 23Jun2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected. Batch/Lot numbers cannot be obtained.; Reported Cause(s) of Death: Lung opacity; SARS-CoV-2 test negative; Dyspnoea; Increased upper airway secretion; Pyrexia; Death


VAERS ID: 1546175 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-07-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7010 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202100996498

Write-up: Death unexplained; This is a spontaneous report received from a contactable other health professional downloaded from a regulatory authority. A 38-year-old male patient received bnt162b2 (COMIRNATY), first single dose intramuscular, administered in Arm Right on 26Jul2021 11:20 (Batch/Lot Number: FE7010) for covid-19 immunisation at age of 38-year-old. The patient medical history was not reported. The patient had no history of allergy or hypersensitivity to certain substances or other declared vaccines. The patient''s concomitant medications were not reported. Without any clinical warning signs known by the declarant to date, the patient''s death was observed on the public highway in the afternoon of 26Jul2021, with urgent care by the Emergency Service. The autopsy is scheduled for Friday 30Jul2021.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1546228 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-07-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4213 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Angioedema, Hypersensitivity
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-27
   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: Peanut allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Angioedema; Antiallergic therapy; Drug allergy; Mite allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202100987871

Write-up: Allergic reaction; angioedema; This is a spontaneous report received from a contactable pharmacist downloaded from the Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-MP20215744. A 22-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in arm left on 26Jul2021 14:20 (Lot Number: FF4213) at the age of 22-years-old as single dose for covid-19 immunisation. Medical history included respiratory allergy to mites and ongoing food allergy to peanuts, demonstrated by skin tests in 2001 (consultation in allergology following angioedema), since then, peanut and peanut oil avoidance recommendations and emergency kit within reach; drug allergy; antiallergic background treatment (specialty not found) which would had been interrupted. Family history of allergies in mother (allergy to dust mites and cat hair), father (history of angioedema). Patient was not considered to be at risk of developing a severe form of COVID-19 disease. Patient previously received treatment with epinephrine hydrochloride (ANAPEN) syringes within reach. On 26Jul2021 at 2:55 p.m., patient exit from the vaccination center after a 30-minute surveillance during which no symptoms were reported. On 26Jul2021 in the evening: evening meal at the restaurant, ingestion of a sauce with doubt about the presence of peanuts, 10 minutes later, a tingling sensation in the neck, pruritus, respiratory problems and the onset of edema in the neck. The patient identifies an allergic reaction, no Anapen within reach, he went home alone to take his treatment. At home, deterioration of his condition with discomfort. His sister called the fire department. The patient died in the ambulance at 12:20 a.m. Conclusion: Allergic reaction with angioedema in the patient with a history of food allergy, more than 6 hours after a first dose of Comirnaty and immediately following a probable ingestion of a food allergen. Patient died on 27Jul2021 at 12:20 a.m.. Autopsy initially refused but requested subsequently (had not performed). No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: angioedema; Allergic reaction


VAERS ID: 1546234 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-23
Onset:2021-07-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4213 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-28
   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: RISPERDAL; KARDEGIC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Psychotic disorder NOS; Stroke (at age 20)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202100996406

Write-up: Death unexplained; patient found in his room with vomiting, painful face; patient found in his room with vomiting, painful face; tired; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-NT20212991. A 38-years-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 23Jul2021 (Batch/Lot Number: FF4213) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included stroke at age 20 , psychotic disorder. Concomitant medication(s) included risperidone (RISPERDAL) taken for an unspecified indication, start and stop date were not reported; acetylsalicylate lysine (KARDEGIC) taken for an unspecified indication, start and stop date were not reported. The patient experienced death unexplained on 28Jul2021. Day 2 (25Jul2021) : family walk. The patient feels tired. The family finds him "a little less well". Day 5 (28Jul2021): patient found in his room with vomiting, painful face and 7 open sachets of KARDEGIC. The patient died on 28Jul2021. An autopsy was performed and results were not provided. Outcome of death was fatal, of others was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: death of undetermined cause, possibly vascular


VAERS ID: 1546241 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-04-30
Onset:2021-04-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
   Days after onset: 62
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202100987903

Write-up: Foetal cardiac arrest; 30Apr2021, 2nd injection of bnt162b2, 11May2021, ovulation period, 21May2021, diagnosis of pregnancy.; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority -WEB, regulatory authority number FR-AFSSAPS-NY20213048. This consumer reported information for both mother and fetal. This is a fetal report. Foetus patient without specified medical history. Concomitant medications were not reported. The patient''s mother received bnt162b2 (COMIRNATY, concentrate for injection. COVID-19 mRNA vaccine (modified nucleoside) (mRNA encoding the peak viral protein (S) of SARS-CoV-2), lot number ET6956) Intramuscularly administered in left arm on 30Apr2021 for Vaccination against covid-19. The fetus of an unspecified gender received the same vaccine transplacentally. On 01Jul2021, 63 Day after the last drug administration, the patient developed fetal cardiac arrest which led to death on 01Jul2021. Fetal cardiac arrest at 9 weeks of amenorrhea, 63 days after the second injection of the bnt162b2 vaccine by the mother. 30Apr2021, 2nd injection of bnt162b2, 11May2021, ovulation period, 21May2021, diagnosis of pregnancy. 01Jul2021, announces that the heart of the embryo has stopped. Miscarriage at 2 months of pregnancy. The event foetal cardiac arrest resulted in death. The patient diead on 01Jul2021. It was unknown if an autopsy was performed. The cause of death was foetal cardiac arrest. The outcome of foetal cardiac arrest was fatal. The outcome of other event was unknown. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202100988084 fetal/maternal case; Reported Cause(s) of Death: Foetal cardiac arrest


VAERS ID: 1546245 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-23
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Troponin, Troponin abnormal
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-24
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypercholesterolaemia
Allergies:
Diagnostic Lab Data: Test Date: 20210123; Test Name: troponin; Result Unstructured Data: Test Result:16000
CDC Split Type: FRPFIZER INC202100987854

Write-up: Troponin abnormal; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-PB20214903 A 75-year-old male patient received first dose of bnt162b2 (COMIRNATY), Intramuscularly on 19Jan2021 (lot number EJ6795) as single dose for COVID-19 immunisation. Medical history included hypercholesterolemia as antecedents. Concomitant medications were not reported. He presented on 23Jan2021 a troponin at 16,000 the day before his death. It was unknown if Autopsy Done. The outcome of the event was fatal on 24Jan2021. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Troponin abnormal


VAERS ID: 1546281 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-23
Onset:2021-06-20
   Days after vaccination:117
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Dehydration, Epistaxis, Fall, Personality disorder, Renal failure, SARS-CoV-2 test, Selective eating disorder, Sudden death, Vaccination failure
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Lack of efficacy/effect (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (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), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-28
   Days after onset: 38
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TOVIAZ; SOTALOL AF [SOTALOL HYDROCHLORIDE]; SERESTA; APIXABAN; MIRTAZAPINE; CIRCADIN; LASILIX [FUROSEMIDE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure; Cardiac ischemia; Cardiac pacemaker insertion; Dementia of the Alzheimer''s type NOS; Hypercholesterolemia; Neuralgia
Allergies:
Diagnostic Lab Data: Test Date: 20210727; Test Name: COVID-19 PCR +; Test Result: Positive ; Comments: variant L452R
CDC Split Type: FRPFIZER INC202101004086

Write-up: dehydration with renal failure; Asthenic patient; food / drink stop; dehydration with renal failure; Sudden death; Vaccination failure; COVID-19; fall; espitaxis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-TO20216127, Safety Report Unique Identifier FR-AFSSAPS-2021103108. A 92-year-old male patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number: EJ6788, Expiration Date was not reported) via intramuscular on 23Feb2021 as dose 2, single and received first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported, Expiration Date was not reported) via intramuscular on 02Feb2021 as dose 1, single for COVID-19 immunization. The patient''s medical history included dementia of the alzheimer''s type NOS, cardiac failure, cardiac pacemaker insertion from 2005, neuralgia, hypercholesterolemia, possible cardiac ischemic sequelae. Concomitant medications included fesoterodine fumarate (TOVIAZ), sotalol hydrochloride (SOTALOL AF [SOTALOL HYDROCHLORIDE]), oxazepam (SERESTA), apixaban, mirtazapine, melatonin (CIRCADIN), furosemide (LASILIX [FUROSEMIDE]), all taken for unknown indications from an unknown date. It was reported that, the patient was hospitalized for fall and epistaxis on 20Jun2021 and on 27Jul2021 PCR +, variant L452R. Asthenic patient, food/drink stop, dehydration with renal failure. Patient was found dead in his bed on 28Jul2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive (variant L452R) on 27Jul2021. The patient died on 28Jul2021. It was not reported if an autopsy was performed. Follow up attempts are completed. No further information is expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1546286 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-19
Onset:2021-04-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 2 - / OT

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: 2021-04-01
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Reduced general condition
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210420; Test Name: SARS-CoV-2 test; Test Result: Positive ; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:negative; Comments: the day before vaccination
CDC Split Type: FRPFIZER INC202100996227

Write-up: COVID-19 aggravated; Covid confirmed by antigen test.; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-TS20213242. An 85-years-old female patient received second dose of BNT162B2 (COMIRNATY, formulation: solution for injection, batch/lot number: EW4815) intramuscularly on 19Apr2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient''s medical history included ongoing general physical health deterioration. The patient''s concomitant medications were not reported. On 20Apr2021, patient confirmed COVID by antigen test. Possible contamination by his daughter who made her second corona in 1 year, the first time was not infected. The patient was hospitalized for COVID-19 aggravated (COVID-19) from Apr2021 to an unknown date. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on 20Apr2021 the day before - negative. The patient died in Apr2021 due to COVID-19 aggravated and COVID confirmed by antigen test. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information was expected.; Reported Cause(s) of Death: COVID-19 aggravated; Covid confirmed by antigen test.


VAERS ID: 1546298 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-11
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, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Lack of efficacy/effect (narrow), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: real-time reverse transcriptase PCR; Test Result: Positive.
CDC Split Type: FRPFIZER INC202101012192

Write-up: SARS-CoV-2 infection; SARS-CoV-2 infection; sudden death; This is a literature report from the Regulatory Authority, 2021; DOI: 10.1016/j.cmi.2021.06.038 entitled SARS-CoV-2 infection in a long-term care facility after COVID-19 BNT162b2 mRNA vaccination. A 98-year-old female patient received the first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced SARS-CoV-2 infection and sudden on an unspecified date, which were reported as fatal. The patient underwent lab tests and procedures which included real-time reverse transcriptase polymerase chain reaction (PCR): positive on an unspecified date. The patient died on an unspecified date. The cause of death was reported as SARS-CoV-2 infection and sudden death. It was not reported if an autopsy was performed. Coronavirus disease 2019 (COVID-19) is a life-threatening disease, especially for older individuals and people with multiple risk factors. Geriatric environments are therefore at high risk of COVID- 19 outbreaks with increased mortality. We describe an outbreak of nosocomial COVID-19 in a long-term care facility (LTCF) starting 1 month after a double-dose vaccination campaign with the BNT162b2 mRNA vaccine. The 93 residents of the LTCF included 66 females and 27 males with a median age of 88 years (range 63-99 years), none of them immunocompromised. Seventy residents (75.3%) and 38 HCWs (52.1%) were fully vaccinated with two doses of the BNT162b2 mRNA vaccine on 25Jan2021 and 15Feb2021. Among the other 23 residents (24.7%) not vaccinated at the beginning of the outbreak, 11 were not vaccinated due to the residents'' decision, two received one dose of vaccine, and ten received two doses on 9Apr2021 and 30Apr2021 each during the outbreak. Between 15Mar2021 and 06May2021, 40 subjects tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection using either rapid antigen detection (n=18) (Biosynex COVID-19 BSS IgG/IgM) and/or real-time reverse transcriptase PCR (RT-PCR) tests (Biosynex) (n=22) on nasopharyngeal swabs. These COVID-19 cases included 24/93 residents (25.8%) and 16/73 healthcare workers (HCWs) (21.9%). Positive residents were older and more frequently male than their uninfected counterparts: age 91 years (range 72-99 years) and 87 years (range 63-97 years), and of these 10/24 (41.7%) and 17/69 (24.66%) were male, respectively. COVID-19 cases were more frequent among residents who were not fully vaccinated (12/23, 52.2%) than among fully vaccinated residents (12/70, 17.1%). Residents who were vaccinated versus those not fully vaccinated were asymptomatic (four versus two) or displayed mild (four versus three), moderate (four versus four) or severe (none versus three) symptoms. One unvaccinated 83-year-old woman died 1 month after being hospitalized and a 98-year-old fully vaccinated female resident died of sudden death. Variant screening by RT-PCR (COMPANY NAME., COUNTRY NAME) and Sanger sequencing of the spike protein gene identified the SARSCov- 2 alpha variant in all positive samples. Quantitative measurement of anti-spike (S) IgG (Abbott SARS-CoV-2 IgG II Quant assay) was carried out for 79 residents on 6Apr2021, including 62 fully vaccinated residents who all except one displayed positive serology. Three vaccinated residents were infected after that date despite previous high anti-S IgG titres (1452, 4842 and 2861 AU/mL, respectively). To assess the effectiveness of the BNT162b2 mRNA vaccine, we conducted a time-to-event analysis using a multivariate proportional hazard Cox model with vaccination status, age, and gender as covariates. The hazard of developing a SARS-CoV-2 infection was, for fully vaccinated residents, 0.32 times that of subjects who were not fully vaccinated (95%CI 0.14-0.73, p 0.006). Male residents were at significantly higher risk of developing COVID-19 (HR 2.79, 95%CI 1.18-6.59, p 0.02), as were older subjects with an HR of 1.62 for a 5-year increase in age (95%CI 1.16-2.27, p 0.005). The adjusted hazard ratio (HR) for fully versus not fully vaccinated residents was used to estimate the vaccine effectiveness ((1-HR) x100) at 68% (95%CI 27-86%). Sixteen unvaccinated HCWs (16/35, 45.7%; median age 35 years, r 19-59) tested positive for COVID-19 with mild to moderate symptoms, while all the vaccinated HCWs were COVID-19-negative (p < 0.0001). Our results confirm that the BNT162b2 mRNA vaccine was highly effective in preventing COVID-19 infection. Residents who were not fully vaccinated were three times more likely to develop COVID-19. The protective effect of the vaccine is also underscored by the fact that none of the vaccinated residents developed severe COVID-19, whereas this was the case for three residents who were not fully vaccinated. Most of the vaccinated residents had anti-SIgG at the time of the outbreak. Several data on vaccination report the effectiveness of a two-dose regimen with BNT162b2 mRNA vaccine in preventing COVID-19, both in the general population and in older people, including those infected by the alpha variant. Our study confirms the protective effect of the vaccine but underscores that elderly people, despite being vaccinated and displaying positive anti-S IgG up to 4842 AU/mL, are at greater risk of SARS-CoV-2 infection. In our cohort, the vaccine effectiveness (68%) appears lower than the 95% previously reported by Polack et al., possibly related to the age of the LTCF patients reported with natural immunity which, although effective in preventing COVID-19, is lower in older people. This outbreak highlights the critical importance of a high rate of vaccination of residents and HCWs.; Sender''s Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: sudden death; SARS-CoV-2 infection


VAERS ID: 1546839 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-05-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5831 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-17
   Days after onset: 66
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202100987848

Write-up: 12May2021 headache; 17Jul2021: Temporal occipital cortical-subcortical stroke. Upon awakening aphasic, right hemisyndrome. Access to the emergency room at 8.30; 12May2021 headache; 17Jul2021: Temporal occipital cortical-subcortical stroke. Upon awakening aphasic, right hemisyndrome. Access to the emergency room at 8.30; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number IT-MINISAL02-763201. A 68-year-old male patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot Number: FA5831) via intramuscular route, administered in Left Arm on 12May2021 at 18:09 (68-year-old at vaccination) as Dose 2, 0.3 mL, single for Covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient previously received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot Number: EW2246) via unspecified route of administration on 21 Apr2021 at 13:44 as Dose 1, 0.3 mL, single for Covid-19 immunization. The patient had no adverse event after first dose of vaccination. Physician commented that the second dose of Pfizer vaccine was administered on last 12May, so more than two months before the date of the stroke that led to the death. However, already from the same day of the second dose of Pfizer the patient presented a headache in the left parieto-temporal region of moderate intensity (never had in the past), daily with subsequent improvement but never complete remission. Furthermore, it was reported that the patient had a prior history of completely false before stroke. On 17Jul2021, the patient experienced Temporal occipital cortical-subcortical stroke. Upon awakening aphasic, right hemisyndrome. Access to the emergency room at 8.30. The patient died on 17Jul2021. It was not reported if an autopsy was performed. Health authority comment: Lot and expiry date of physiological solution not available; vaccine reconstitution time not available. No follow-up attempts possible. No further information expected.; Reporter''s Comments: The second dose of Pfizer vaccine was administered on last 12May , so more than two months before the date of the stroke that led to the death. However, already from the same day of the second dose of Pfizer the patient presented a headache in the left parieto-temporal region of moderate intensity (never had in the past), daily with subsequent improvement but never complete remission. Furthermore, it is reported that the patient had a prior history of completely false before stroke; Reported Cause(s) of Death: stroke


VAERS ID: 1547035 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral venous sinus thrombosis, Maternal exposure during pregnancy
SMQs:, Embolic and thrombotic events, venous (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100987608

Write-up: Cerebral venous sinus thrombosis; 25-year-old pregnant female patient received bnt162b2 (COMIRNATY, Solution for injection, Lot number: not reported, Expiration date: not reported), intramuscular on an unspecified date; This is a spontaneous report from a contactable pharmacist received from a Pfizer sales representative. A 25-year-old pregnant female patient received bnt162b2 (COMIRNATY, Solution for injection, Lot number: not reported, Expiration date: not reported), intramuscular on an unspecified date as dose number unknown, single for COVID-19 immunisation. Body temperature before vaccination, family history, medical history, and concomitant medication were not reported. On an unknown date, the patient experienced cerebral venous sinus thrombosis. On an unknown date, the patient was admitted to the reporting hospital. The course of the event was as follows: The patient was in early pregnancy. On an unknown date, the patient experienced cerebral venous sinus thrombosis after receiving intramuscular BNT162b2. On an unknown date, the patient died after admission to the hospital. The reporting pharmacist reported that the causal relationship was unknown. The reporting pharmacist classified the event as serious (death) and assessed the causality between the event and BNT162b2 was unknown. Therapeutic measures were taken as a result of cerebral venous sinus thrombosis. The patient died on an unspecified date. It was not reported if an autopsy was performed.On an unknown date, the outcome of the event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events: Cerebral Venous Sinus Thrombosis And Maternal Exposure During Pregnancy and the administration of the vaccine 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: Cerebral venous sinus thrombosis


VAERS ID: 1547043 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-20
Onset:2021-08-01
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1945 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Coronary artery disease, Death, Glycosylated haemoglobin
SMQs:, Other ischaemic heart disease (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Reflux oesophagitis; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Chest pain
Allergies:
Diagnostic Lab Data: Test Name: HbA1c; Test Result: 8.5 %
CDC Split Type: JPPFIZER INC202101008072

Write-up: Death; coronary artery lesion; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21122550. A 53-year and 4-month-old male patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, lot number: FD1945, Expiration date: 31Oct2021), via an unspecified route of administration, on 20Jul2021 at 15:30 (the day of vaccination), (at the age of 53-year and 4-month-old) as a single dose for covid-19 immunization. The patient medical history included ongoing type 2 diabetes mellitus (taking medication) from an unknown start date, ongoing reflux oesophagitis (taking medication) from an unknown start date, and chest pain (past history) around 10Jul. Body temperature before vaccination, family history was not reported. The patient concomitant medications included uspecified 2 diabetes mellitus and reflux oesophagitis medications. In Aug2021 (after the vaccination), the patient experienced death. The course of the event was as follows: On 20Jul2021, the patient received the first dose of the vaccine. Afterwards, the patient did not have poor health condition. On the night of 03Aug2021 (around 23:00), the patient''s housemate noticed his abnormality and requested an ambulance. The patient was taken to a hospital while undergoing cardiopulmonary resuscitation. Afterwards, the patient received treatment; however, the death was confirmed (at an unknown time). The cause of death was unknown; thus, an autopsy was scheduled to be performed at Police Station A on 05Aug2021. The patient was a (masked) and a consulate is intervening. Outcome of the event coronary disease was unknown. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was chest pain (past history) around 10Jul. The reporting physician commented as follows: The patient had uncontrolled diabetes mellitus (haemoglobin A1c (HbA1c): 8.5%). The possibility of coronary artery lesion could not be ruled out. The reporting physician requested to contact Police Station A for the autopsy result. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1547058 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-12
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: 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: Leg ulcer; Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: LSJNJFOC20210816486

Write-up: DEATH; This spontaneous report received from a consumer concerned a 68 year old male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: limb ulcer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced death within 12 hours of vaccination. The cause of death was unknown and 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: This spontaneous report received from consumer and concerned a 68 year-old male who died within 12 hours of receiving the Janssen COVID-19 vaccine. Medical history includes limb ulcer. Concomitant medications were not reported. Laboratory studies, imaging or other diagnostics were not provided. Information is limited in this case, however, considering the temporal relationship with vaccination, a relationship with Janssen Covid-19 vaccine cannot be ruled out. Therefore, the relationship is considered indeterminate. This case will be reassessed if new information is received.; Reported Cause(s) of Death: DEATH CAUSE UNKNOWN


VAERS ID: 1547059 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: LSJNJFOC20210816511

Write-up: DEATH; This spontaneous report received from a consumer concerned a 73 year old male. Case reference numbers include The patient''s height, and weight were not reported. The patient''s concurrent conditions included hypertension. The patient received COVID-19 vaccine Ad26.CoV2.S (suspension for injection, intramuscular, batch number and expiry date not reported) dose and vaccination date not reported, once in total, for prophylactic vaccination. No concomitant medications were reported. The company will perform follow-up to obtain the batch number. On an unspecified date, within 12 hours of vaccination, it was reported that the patient had died. The cause of death was not reported and it was also not reported if an autopsy was performed. The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. This report was serious (death). This case, from the same reporter, is linked to cases 20210816481, 20210816515 and 20210816486.; Sender''s Comments: V0: This spontaneous report received from a consumer and concerned a 73 year-old male who died within 12 hours of receiving the Janssen COVID-19 vaccine. Medical history includes hypertension. Concomitant medications were not reported. Laboratory studies, imaging or other diagnostics were not provided. Information is limited in this case, however, considering the temporal relationship with vaccination, a relationship with Janssen Covid-19 vaccine cannot be ruled out. Therefore, the relationship is considered indeterminate. This case will be reassessed if new information is received.; Reported Cause(s) of Death: DEATH


VAERS ID: 1547060 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: LSJNJFOC20210816515

Write-up: DEATH; This spontaneous report received from a consumer concerned a 74 year old female. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced death within 12 hours of vaccination. Cause of death was unknown and it was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: This spontaneous report received from a consumer and concerned a 74 year-old female who died within 12 hours of receiving the Janssen COVID-19 vaccine. Medical history was not reported. Concomitant medications were not reported. Laboratory studies, imaging or other diagnostics were not provided. Information is limited in this case, however, considering the temporal relationship with vaccination, a relationship with Janssen Covid-19 vaccine cannot be ruled out. Therefore, the relationship is considered indeterminate. This case will be reassessed if new information is received.; Reported Cause(s) of Death: DEATH CAUSE UNKNOWN


VAERS ID: 1547170 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood uric acid, Death, Myocardial infarction, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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: The patient had history of many diseases (unspecified).
Allergies:
Diagnostic Lab Data: Test Name: Uric acid; Result Unstructured Data: high
CDC Split Type: PHJNJFOC20210811199

Write-up: DEAD ON ARRIVAL; HEART ATTACK; HANDS WERE SWOLLEN; This spontaneous report received from a consumer via a company representative concerned a 7 decade old male of unspecified race and ethnicity. The patient''s height, and weight were not reported. The patient had a history of many diseases (unspecified). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, 3 days after getting vaccinated the patient experienced heart attack and was dead on arrival to the hospital. It was reported that the patient had swollen hands. Laboratory data (dates unspecified) included: Uric acid (NR: not provided) high. On an unspecified date, the patient died from unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on arrival on an unspecified date, and the outcome of heart attack and hands were swollen was not reported. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to 20210816399.; Sender''s Comments: V0: 20210811199-covid-19 vaccine ad26.cov2.s -Dead on arrival, Heart attack. 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: 1547172 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210816399

Write-up: DEATH; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age, sex, ethnicity and race. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN and Expiry: UNKNOWN) dose, frequency 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient died three days after receiving vaccine and 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 outcome was fetal. This report was serious (Death). This case, from the same reporter is linked to 20210811199.; Sender''s Comments: V0: 20210816399-COVID-19 VACCINE AD26.COV2.S.- Death. This event is considered unassessable. The event has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1547292 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-21
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Embolic stroke, Embolism venous, Guillain-Barre syndrome, Pulmonary embolism
SMQs:, Peripheral neuropathy (narrow), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (narrow), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-23
   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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTJNJFOC20210809369

Write-up: DEEP VEIN THROMBOSIS; PULMONARY THROMBOEMBOLISM; VENOUS THROMBOEMBOLISM; EMBOLIC STROKE; GUILLAIN-BARRE SYNDROME; This spontaneous report was received from a physician via the Regulatory Authority, case reference number PT-INFARMED-J202107-4266, and concerned a 58 year old female. Initial information was processed with additional information received on 06-AUG-2021. 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: XD955) .5 ml, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced Guillain-Barre Syndrome. On 21-JUL-2021, the patient experienced embolic stroke, deep vein thrombosis, pulmonary thromboembolism, and venous thromboembolism. On 23-JUL-2021 the patient died due to an unspecified cause. It was unknown if an autopsy was performed. The outcome for the events deep vein thrombosis, pulmonary thromboembolism, venous thromboembolism and embolic stroke were fatal. The outcome of Guillain-Barre syndrome was not reported. This report was serious (Death, and Other Medically Important Condition).; Reporter''s Comments: Sender''s Comments: This spontaneous report, received from a physician via the Regulatory Authority, (case reference number PT-INFARMED-J202107-4266), concerning a 58-year-old female of unknown ethnicity who experienced Guillain-Barre Syndrome on an unspecified date. She was also reported to have experienced time an, embolic stroke, deep vein thrombosis, pulmonary thromboembolism, and venous thromboembolism 67 days post vaccination. She and died 2 days later. It was unknown if an autopsy was performed. No other pertinent information is reported. Information is limited in this case, and the occurrence of the events could represent background incidence of such events in the general population. Therefore, the relationship of GBS, embolic stroke, deep vein thrombosis, pulmonary thromboembolism, and venous thromboembolism to vaccination is considered unclassifiable due to insufficient information.


VAERS ID: 1548803 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-18
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 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 Date: 202104; Test Name: PCR; Result Unstructured Data: Test Result:Variant B.1.1.7
CDC Split Type: ATPFIZER INC202101016121

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority. The regulatory authority report number is AT-BASGAGES-2021-39206. A 91-years-old female patient received bnt162b2 (Comirnaty, solution for injection, Lot Number: EJ6797 and expiry date was not reported), dose 2 via an unspecified route of administration on an unspecified date in 2021 as dose 2, single and bnt162b2 (Comirnaty, solution for injection, Lot Number: EL1491 and expiry date was not reported), dose 1 via an unspecified route of administration on 12Jan2021 as Dose 1, single both for COVID-19 immunization. No relevant medical history and no concomitant medications were reported. On 18Apr2021, the patient experienced sars-cov-2 infection and vaccination failure. The patient underwent lab tests and procedures which PCR with results variant b.1.1.7 on an unspecified date in Apr2021. The patient died on an unspecified date due to SARS-CoV-2 infection. The case was assessed as serious. It was not reported if an autopsy was performed. Product quality complaint Conclusion for EL1491: 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 EL1491. 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. Product quality complaint Conclusion for EJ6797: The investigation included reviewing the involved batch records, deviation investigation, evaluation of reference samples, 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 "EJ6797". 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 a regulatory notification was required. The reported defect could not be confirmed on the reference samples. No root cause or CAPA were identified as the complaint was not confirmed. The outcome was fatal for SARS-CoV-2 infection. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: SARS-CoV-2 infection


VAERS ID: 1548809 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-18
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PS.FC.2336 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: ADAMTS13 activity assay, ADAMTS13 activity decreased, Autoimmune disorder, Coagulation test, Coagulopathy, Pericardial haemorrhage, Platelet count, Sudden death, Thrombocytopenia, Thrombotic thrombocytopenic purpura
SMQs:, Torsade de pointes/QT prolongation (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (broad), Renovascular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Diflucan; BIKTARVY; EUSAPRIM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: HIV infection (Recent diagnosis of HIV with rapid drop in viral load under HIV inhibitors)
Allergies:
Diagnostic Lab Data: Test Date: 20210618; Test Name: ADAMTS13 activity decreased; Result Unstructured Data: Test Result:decreased; Test Date: 20210618; Test Name: Coagulation disorder; Result Unstructured Data: Test Result:Coagulation disorder; Test Date: 20210618; Test Name: Thrombocytopenia; Result Unstructured Data: Test Result:Thrombocytopenia
CDC Split Type: BEPFIZER INC202100987820

Write-up: Sudden death on 18Jun; Blood clotting problem, Coagulation disorder; Autopsy shows much bloody pericardial fluid, Effusion pericardial bloody; thrombotic thrombocytopenic purpura; Thrombocytopenia; Postmortem Diagnostics shows presence of ADAMTS13 inhibitor, ADAMTS13 activity decreased; Autoimmune disorder; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number BE-FAMHP-DHH-N2021-102885. A 52-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 05Jun2021 (Lot Number: PS.FC.2336) as dose 1, single for covid-19 immunisation; fluconazole (DIFLUCAN 100 mg), via an unspecified route of administration from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at 1 DF 1x/day for an unspecified indication; bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate (BIKTARVY), via an unspecified route of administration from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at 1 DF 1x/day for an unspecified indication; sulfamethoxazole, trimethoprim (EUSAPRIM) via an unspecified route of administration from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at 0.5 DF 1x/day for an unspecified indication. Medical history included hiv infection, recent diagnosis of HIV with rapid drop in viral load under HIV inhibitors. Concomitant medications were not reported. The patient experienced sudden death, blood clotting problem, coagulation disorder, autopsy shows much bloody pericardial fluid, effusion pericardial bloody, thrombotic thrombocytopenic purpura, thrombocytopenia, postmortem diagnostics showed presence of ADAMTS13 inhibitor, ADAMTS13 activity decreased, autoimmune disorder on 18Jun2021. It was unknown if therapeutic measures were taken as a result of event. The patient died on 18Jun2021. An autopsy was performed that revealed autopsy showed abundant bloody pericardial fluid. Postmortem diagnosis shows presence of adamts13 inhibitor which allows the diagnosis of an acquired thrombotic thrombocytopenic purpura, which is often autoimmune and possibly vaccine related. Underlying patient had a recent diagnosis of hiv with rapid drop in viral load under hiv inhibitors. The action taken in response to the event, for fluconazole; bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate; sulfamethoxazole, trimethoprim was unknown. The outcome of events was fatal.; Reported Cause(s) of Death: Sudden death on 18Jun; Blood clotting problem, Coagulation disorder; Autopsy shows much bloody pericardial fluid, Effusion pericardial bloody; thrombotic thrombocytopenic purpura; Thrombocytopenia; Postmortem Diagnostics shows presence of ADAMTS13 in; Autopsy-determined Cause(s) of Death: Autopsy shows abundant bloody pericardial fluid. Postmortem diagnosis shows presence of ADAMTS13 inhibitor which allows the diagnosis of an acquired thrombotic thrombocytopenic purpura, which is often autoimmune and possibly vaccine related. Underlyi


VAERS ID: 1548821 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-29
Onset:2021-06-12
   Days after vaccination:75
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001530 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-14
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PANTOPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acid reflux (esophageal) (segnalato reflusso, data diagnosi esatta non nota, trattato dal 10.12.2013,); Hip replacement (protesi anca destra)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: Thrombose der Arteria Basilaris; Thrombose der Arteria Basilaris; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ISCHAEMIC STROKE (Thrombose der Arteria Basilaris) and ARTERIAL THROMBOSIS (Thrombose der Arteria Basilaris) in a 72-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch nos. 3001941 and 3001530) for COVID-19 vaccination. The patient''s past medical history included Acid reflux (esophageal) (segnalato reflusso, data diagnosi esatta non nota, trattato dal 10.12.2013,) and Hip replacement (protesi anca destra) in March 2021. Concomitant products included PANTOPRAZOLE from 10-Dec-2013 to 14-Jun-2021 for an unknown indication. On 29-Mar-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jun-2021, the patient experienced ISCHAEMIC STROKE (Thrombose der Arteria Basilaris) (seriousness criteria death, hospitalization and medically significant) and ARTERIAL THROMBOSIS (Thrombose der Arteria Basilaris) (seriousness criteria death and hospitalization). The patient died on 14-Jun-2021. The reported cause of death was Arterial thrombosis and Ischaemic stroke. An autopsy was not performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment medication details was reported. Company comments: This is a case of ischaemic stroke and arterial thrombosis which caused the death of a 72-year-old male with history of acid reflux.. Very limited information has been provided at this time. No further information is expected. Reviewed pending translation.; Sender''s Comments: This is a case of ischaemic stroke and arterial thrombosis which caused the death of a 72-year-old male with history of acid reflux.. Very limited information has been provided at this time. No further information is expected. Reviewed pending translation.; Reported Cause(s) of Death: Arterial thrombosis; Ischaemic stroke


VAERS ID: 1548845 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-19
Onset:2021-07-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral venous sinus thrombosis, Computerised tomogram head, Interchange of vaccine products, Magnetic resonance imaging head
SMQs:, Embolic and thrombotic events, venous (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202107; Test Name: CT skull; Result Unstructured Data: Test Result:Sinus vein thrombosis with stasis bleeding.; Test Date: 202107; Test Name: MR skull; Result Unstructured Data: Test Result:Sinus vein thrombosis with stasis bleeding.
CDC Split Type: DEPFIZER INC202100996168

Write-up: Sinus vein thrombosis with congestive bleeding; interchange of vaccine products; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority, regulatory authority number DE-PEI-202100152859. A 38-years-old male patient received second dose of bnt162b2 (COMIRNATY; Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 19Jul2021 (at the age of 38-years-old) as a DOSE 2, SINGLE for covid-19 immunisation and covid-19 vaccine nrvv ad (chadox1 ncov-19) (VAXZEVRIA), via an unspecified route of administration on an un-specified date in May2021 (Batch/Lot Number: UNKNOWN), as a DOSE 1, SINGLE for an unspecified indication. The patient medical history and no concomitant medications. The patient experienced interchange of vaccine products on 19Jul2021, and experienced sinus vein thrombosis with congestive bleeding on 22Jul2021. The patient underwent lab tests and procedures which included computerised tomogram head that reflected sinus vein thrombosis with stasis bleeding and magnetic resonance imaging head that reflected sinus vein thrombosis with stasis bleeding on an unspecified date in Jul2021. It was reported as, 3 days after vaccination, on 22Jul2021 the patient experienced Thrombosis of venous sinuses (Sinus vein thrombosis with stasis bleeding). Assessment (source:PEI) was given as unclassifiable. The event required hospitalization and patient died on an unspecified date. It was not reported if an autopsy was performed. Outcome of the Sinus vein thrombosis with congestive bleeding was fatal whereas, interchange of vaccine products was unknown. No follow-up activities possible. No further information expected. Batch/LOT number could not be obtained. ; Reported Cause(s) of Death: Thrombosis of venous sinuses


VAERS ID: 1548884 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-02
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abscess neck, Asthenia, Cerebrovascular accident, Head discomfort, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210817073

Write-up: STROKE; ABSCESS ON THE NECK; SWOLLEN HEAD; WEAKNESS; FEVER; This spontaneous report received from a consumer via a Regulatory Authority [DE-PEI-CADR2021150254] concerned a 69 year old female. The patient''s weight was 50 kilograms, and height was 160 centimeters. The patient''s concurrent conditions included: asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 21C1601) dose was not reported, 1 total, administered on 30-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUL-2021, the patient experienced abscess on the neck, swollen head, weakness and fever. On 20-JUL-2021, the patient experienced stroke. On an unspecified date, the patient died from accident cerebrovascular. It was unknown if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of stroke on an unspecified date, and had not recovered from weakness, fever, abscess on the neck, and swollen head. This report was serious (Death).; Sender''s Comments: V0: 20210817073-covid-19 vaccine ad26.cov2.s- stroke. 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: ACCIDENT CEREBROVASCULAR


VAERS ID: 1548896 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-10
Onset:2021-07-24
   Days after vaccination:75
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8679 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Auscultation, Blood bicarbonate, Blood bilirubin, Blood chloride, Blood creatinine, Blood glucose, Blood osmolarity, Blood potassium, Blood pressure measurement, Blood sodium, Blood urea, C-reactive protein, COVID-19 pneumonia, Chest X-ray, Gamma-glutamyltransferase, Haemoglobin, Heart rate, International normalised ratio, Lymphocyte count, N-terminal prohormone brain natriuretic peptide, Neutrophil count, Oxygen saturation, PCO2, PO2, Physical examination, Platelet count, Prothrombin level, Prothrombin time, Respiratory rate, SARS-CoV-2 test, Vaccination failure, White blood cell count, pH body fluid
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: 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: ACFOL; AMLODIPINE; ELIGARD; ELIQUIS; FLUDROCORTISONE; FUROSEMIDE; MASTICAL D; OMEPRAZOLE; PREDNISONE; HIDROFEROL; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adverse drug reaction; Aortic regurgitation; Atrial fibrillation; Blood pressure high; Chronic kidney disease stage 3 ((IgA vasculitis)); Colon cancer; Dysautonomia; Dyslipidemia; Henoch Shonlein purpura (Renal + cutaneous outbreak); Iron deficiency anemia; Lacunar stroke; Microangiopathy; Pulmonary embolism; Urinary tract infection
Allergies:
Diagnostic Lab Data: Test Name: ALT; Result Unstructured Data: Test Result:18 IU/l; Test Name: AST; Result Unstructured Data: Test Result:33 IU/l; Test Name: Cardiac Auscultation; Result Unstructured Data: Test Result:arrhythmic, I do not auscultate murmurs; Comments: arrhythmic, I do not auscultate murmurs...(interfered with by respiratory sounds); Test Name: Lung auscultation; Result Unstructured Data: Test Result:Vesicular murmur decreased, rales in both lung...; Test Name: Pulmonary Auscultation; Result Unstructured Data: Test Result:CVS, bilateral rales (auscultation performed in...; Test Name: arterial bicarbonate; Result Unstructured Data: Test Result:31.6 mmol/L; Test Name: Total Bilirubin; Test Result: 0.2 mg/dl; Test Name: Chloride; Result Unstructured Data: Test Result:119 mmol/L; Test Name: Creatinine; Test Result: 1.88 mg/dl; Test Name: Glucose; Test Result: 141 mg/dl; Test Name: Osmolality calculated; Result Unstructured Data: Test Result:Unknown results mosm/kg; Comments: Not calculable; Test Name: Potassium; Result Unstructured Data: Test Result:3.7 mmol/L; Test Name: Blood Pressure; Result Unstructured Data: Test Result:110/50; Test Name: Blood Pressure; Result Unstructured Data: Test Result:102/52; Test Name: Sodium; Result Unstructured Data: Test Result:158 mmol/L; Test Name: Urea; Test Result: 90 mg/dl; Test Name: Chest X-ray; Result Unstructured Data: Test Result:increased CTI, free costophrenic sinuses; Comments: bilateral interstitial parenchymal infiltrate.; Test Name: Protein c-reactive; Result Unstructured Data: Test Result:221.9 mg/l; Test Name: Gamma-Glutamyltransferase; Result Unstructured Data: Test Result:29 IU/l; Test Name: Hemoglobin; Result Unstructured Data: Test Result:8.9 g/dl; Test Name: Heart rate; Result Unstructured Data: Test Result:62; Comments: Beats for minute; Test Name: INR; Result Unstructured Data: Test Result:1.41; Test Name: Lymphocytes; Result Unstructured Data: Test Result:0.9; Comments: 10*3/ul; Test Name: Neutrophil; Result Unstructured Data: Test Result:6.5; Comments: 10*3/ul; Test Name: NT proBNP; Result Unstructured Data: Test Result:11029 pg/mL; Test Name: arterial O2 saturation; Test Result: 80.9 %; Test Name: saturation; Test Result: 85 %; Test Name: saturation; Test Result: 97 %; Test Name: arterial PCO2; Result Unstructured Data: Test Result:44.300 mmHg; Test Name: arterial pH; Result Unstructured Data: Test Result:7.462; Test Name: Abdomen; Result Unstructured Data: Test Result:air-fluid noises, Soft, depressible; Comments: not painful on palpation. I did not palpate masses or visceromegaly. No data on lung infection.; Test Name: Lower limbs; Result Unstructured Data: Test Result:no edema, no DVT data; Test Name: Platelets; Result Unstructured Data: Test Result:180; Comments: 10*3/ul; Test Name: arterial PO2; Result Unstructured Data: Test Result:46.4 mmHg; Test Date: 20210724; Test Name: arterial PO2; Result Unstructured Data: Test Result:Unknown results mmHg; Test Name: Prothrombin activity; Test Result: 50 %; Test Name: Prothrombin time; Test Result: 16.5 s; Test Name: Breaths per minute; Result Unstructured Data: Test Result:22; Comments: Breaths per minute; Test Date: 20210724; Test Name: COVID-19 antigen test; Test Result: Positive ; Test Date: 20210725; Test Name: COVID-19 PCR test; Test Result: Positive ; Test Name: Leukocytes; Result Unstructured Data: Test Result:7.76; Comments: 10*3/ul
CDC Split Type: ESPFIZER INC202101003420

Write-up: COVID-19 pneumonia; vaccination failure; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. A 85-year-old male patient received first dose of BNT162B2 (COMIRNATY, formulation: Solution for injection, Batch/Lot Number: EX8679), via intramuscularly on 10May2021 as single dose for COVID-19 immunization. The patient received second dose of BNT162B2 (COMIRNATY, formulation: Solution for injection, Batch/Lot Number: EW2239), via intramuscularly on 14Apr2021 as single dose for COVID-19 immunization. Medical history included hypertension, adverse drug reaction (ADR to trazodone (akathisia)), dyslipidaemia (No Diabetes mellitus), atrial fibrillation and aortic valve incompetence, henoch-schonlein purpura from 2020 to an unknown date (Renal + cutaneous outbreak), chronic kidney disease (IgA vasculitis), pulmonary embolism, autonomic nervous system imbalance, lacunar stroke, Microangiopathy, Colon cancer, Urinary tract infection and Iron deficiency anemia all from an unknown date and unknown if ongoing. Concomitant medications included folic acid (ACFOL); amlodipine (AMLODIPINE); leuprorelin acetate (ELIGARD); apixaban (ELIQUIS); fludrocortisone (FLUDROCORTISONE); furosemide (FUROSEMIDE); calcium carbonate, colecalciferol (MASTICAL D); omeprazole (OMEPRAZOLE); prednisone (PREDNISONE); calcifediol (HIDROFEROL) and paracetamol (PARACETAMOL) all concomitant medications were taken for an unspecified indication, start and stop date were not reported. It was reported that the patient who woke up with a regular general condition, afebrile with stable hemodynamics, experienced COVID-19 pneumonia with vaccination failure on 24Jul2021. The patient underwent lab tests and procedures which included alanine aminotransferase: 18 IU/l on an unspecified date, aspartate aminotransferase: 33 IU/l on an unspecified date, auscultation: arrhythmic, (I do not auscultate murmurs (interfered with by respiratory sounds)), auscultation: Vesicular murmur decreased, rales in both lung fields (Anamnesis made difficult by the patient''s baseline situation. At our evaluation, a patient with significant respiratory effort, non-productive cough. It did not impress with pain on other levels) on an unspecified date, auscultation: CVS, bilateral rales (auscultation performed in anterior fields) on an unspecified date, blood bicarbonate: 31.6 mmol/l on an unspecified date, blood bilirubin: 0.2 mg/dl on an unspecified date, blood chloride: 119 mmol/l on an unspecified date, blood creatinine: 1.88 mg/dl on an unspecified date, blood glucose: 141 mg/dl on an unspecified date, blood osmolarity: not calculable mosm/kg on an unspecified date, blood potassium: 3.7 mmol/l on an unspecified date, blood pressure measurement: 110/50 on an unspecified date, blood pressure measurement: 102/52 on an unspecified date, blood sodium: 158 mmol/l on an unspecified date, Blood urea: 90 mg/dl on an unspecified date, Chest X-ray: increased CTI, free costophrenic sinuses, bilateral interstitial parenchymal infiltrate on an unspecified date, C-reactive protein: 221.9 mg/l on an unspecified date, Gamma-glutamyltransferase: 29 IU/l on an unspecified date, Haemoglobin: 8.9 g/dl on an unspecified date, Heart rate: 62 Beats for minute on an unspecified date, International normalised ratio: 1.41on an unspecified date, Lymphocyte count: 0.9 10E3 / microL on an unspecified date, Neutrophil count: 6.5 10E3 / microL on an unspecified date, N-terminal prohormone brain natriuretic peptide: 11029 pg/mL on an unspecified date, Oxygen saturation: 80.9% on an unspecified date, Oxygen saturation: 85% and 97%on an unspecified date, PCO2: 44.300mmHg on an unspecified date, pH body fluid:7.462 on an unspecified date, Platelet count: 180 10E3 / microL on an unspecified date, PO2: :46.4mmHg on an unspecified date, Prothrombin level: 50% on an unspecified date, Prothrombin time: 16.5 seconds on an unspecified date, Respiratory rate: 22 Breaths per minute on an unspecified date, White blood cell count: 7.76x10E3 /microL on an unspecified date, SARS-CoV-2 test: Positive (antigen test) on 24Jul2021, SARS-CoV-2 test: Positive CT = 16 (PCR test) on25Jul2021. Physical examination included Abdomen: air-fluid noises and soft, depressible, not painful on palpation. The patient did not palpate masses or visceromegaly. No data on lung infection, on an unspecified date. Physical examination of lower limbs: no edema, no DVT data on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. Outcome of the event vaccination failure was reported as Unknown at this time of the report. Clinical judgment: - COVID + bilateral pneumonia. Brescia 2. Seimc-Score 23. Respiratory failure secondary to the above, Acute renal failure on CKD. FG CDK-EPI 31.9. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19 pneumonia; vaccination failure


VAERS ID: 1548906 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-03
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart failure (Known and effectively treated moderate heart failure); Hypercholesterolemia; Hypertension arterial
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202100996158

Write-up: Decompensation cardiac; Feeling sick; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB FR-AFSSAPS-NC20213150.A 86-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 01May2021 (Batch/Lot Number: Unknown) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included heart failure, Known and effectively treated moderate heart failure, hypercholesterolemia, Hypertension arterial.The patient''s concomitant medications were not reported. Malaise and cardiac decompensation that required hospitalization and created loss of independence and a 2nd cardiac decompensation that resulted in death 7 weeks later.Her father felt ill a few hours after the 1st injection of the vaccine and 48 hours after he had the malaise and the decompensation, after his hospitalization, he came to my house and I and I had to hospitalize him again where he died after 2 days.The patient was vaccinated on 01May. At the end of the day, he feels tired. He had a very bad night from May 1st to 2nd and from May 2nd to 3rd. He was breathless on 02May. On 03May21, he felt unwell in the yard of his house. He was then transported and hospitalized near his home. A diagnosis of cardiac decompensation was made. After 10 days of hospitalization, which were difficult for the patient (initially autonomous and active, he became dependent and depressed), the patient was transferred to the Follow-up Care and Rehabilitation for 3 to 4 weeks. His daughter decided to take him home by car, with the doctors agreement.At his daughter''s home, the patient was again short of breath (as soon as he ate, he had dyspnea) with progressive deterioration. He was hospitalized again for a new cardiac decompensation with a fatal evolution 2 days after the beginning of his re-hospitalization.The patient died on an unspecified date. It was not reported if an autopsy was performed. Outcome of decompensation was fatal, of malaise was recovered. No follow-up attempts are possible, information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Decompensation cardiac


VAERS ID: 1548910 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-13
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2707 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dermatosclerosis; Hypertension arterial; Polyarthritis; Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202100996116

Write-up: Retrosternal chest pain; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB FR-AFSSAPS-RE20212058 An 85-years-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Right on 10Jul2021 (Batch/Lot Number: FE2707) as dose 1, single for covid-19 immunisation. Medical history included Hypertension arterial, Stroke, Dermatosclerosis, Polyarthritis. The patient''s concomitant medications were not reported. Patient considered to be at risk of developing a severe form of COVID-19 disease, not having contracted COVID-19, not having performed a COVID-19 test. On 10Jul2021, First injection intramuscular with COMIRNATY in right arm. On 12Jul2021, Nothing to report. On 13Jul2021, Appearance of intense retrosternal chest pain leading to the death of the patient. The patient died on 13Jul2021. 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: Intense retrosternal chest pain


VAERS ID: 1549926 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anti-neutrophil cytoplasmic antibody positive vasculitis, Antineutrophil cytoplasmic antibody, Asthenia, Oxygen saturation, Oxygen saturation decreased, Pulmonary alveolar haemorrhage, Renal failure, Slow speech
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Interstitial lung disease (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), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Vasculitis (narrow), Chronic kidney disease (narrow), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-29
   Days after onset: 18
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: Disuse syndrome; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: MPO-ANCA; Result Unstructured Data: Test Result:Most positive; Comments: MPO-ANCA$g=300; Test Date: 20210712; Test Name: SpO2; Result Unstructured Data: Test Result:Decreased
CDC Split Type: JPPFIZER INC202100999793

Write-up: The patient had pulmonary alveolar haemorrhage and renal failure.; The patient had pulmonary alveolar haemorrhage and renal failure.; SpO2 decreased; Anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis; the patient spoke slowly; lacked energy; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21122421. A 88-year and 9-month-old male patient received bnt162b2 (COMIRNATY, Solution for injection), dose 1 via an unspecified route of administration on 10Jul2021 (the day of vaccination) (Lot number: unknown, Expiration date: unknown) as dose 1, single for covid-19 immunisation. The patient had medical histories of hypertension and disuse syndrome. The family history was not provided. The patient''s concomitant medications were not reported. Body temperature before vaccination was not provided. On 11Jul2021 (one day after vaccination), the patient spoke slowly, and he lacked energy. On 12Jul2021 (2 days after the vaccination), the patient experienced anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis. Since the SpO2 decreased, an ambulance was called at the direction of the visiting physician. The patient had pulmonary alveolar haemorrhage and renal failure. Based on the examination findings of positive P-ANCA (perinuclear ANCA), the patient was diagnosed with ANCA associated vasculitis. On 14Jul2021 (4 days after vaccination), the blood test showed MPO-ANCA$g=300, most positive. On 29Jul2021 (19 days after the vaccination), the patient died. It was not reported if an autopsy was performed. The outcome of the events were unknown. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. It was not reported whether there was other possible cause of the event such as any other diseases.The reporting physician commented as follows: Although it was unknown whether the event was induced by the vaccination or not, the event became severe obviously affected by the vaccination, and thus, this case was reported. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis


VAERS ID: 1553546 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Myocarditis, Palpitations
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210814534

Write-up: VACCINE INDUCED MYOCARDITIS; MALIGNANT ARRHYTHMIA; HEART RACING; This spontaneous report received from a physician via a Regulatory Authority concerned a 40 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, and batch number: Unknown, Expiry: Unknown) dose not reported,1 total, 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 vaccine induced myocarditis, malignant arrhythmia, and heart racing. On 2021, the patient died from unknown cause of death. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of vaccine induced myocarditis and malignant arrhythmia on 2021, and the outcome of heart racing was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender''s Comments: V0-20210814534-Covid-19 vaccine ad26.cov2.S- Vaccine induced myocarditis, Malignant arrhythmia, Heart racing. 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: 1553588 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-06-24
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7958 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-04
   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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101004009

Write-up: Dyspnoea/breathing slightly difficult; Acute pneumonia; Cough/dry cough; This is a spontaneous report from a non-contactable consumer downloaded from the Agency Regulatory Authority-WEB [DE-PEI-CADR2021142173]. A 100-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 21Jun2021 (Lot Number: FD7958) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 24Jun2021 the patient experienced Cough. On 29Jun2021 the patient experienced Dyspnoea, Acute pneumonia. The outcome of all events was fatal. Clinical course reported that patient got a slight dry cough about three days after the vaccination, which made breathing slightly difficult after a few days. Called a doctor 1 week after the vaccination, who then diagnosed pneumonia. The patient did not want to be admitted to the hospital. It was then treated with antibiotics as well as inhalation and expectorant drugs at home. The cough was relieved, but the shortness of breath was not. On 03Jul2021 called emergency doctor because of increasing difficulty breathing, he still supplied fluid and oxygen. On 04Jul2021, patient was died at breakfast in the morning. The patient died on 04Jul2021. It was not reported if an autopsy was performed. Senders comment: Are you or the person concerned known of any allergies? If yes, which? no. Information on risk factors or previous illnesses: Very old age and the resulting physical old age. Living in one''s own house was only possible with the help of relatives. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cough/dry cough; Dyspnoea/breathing slightly difficult; Acute pneumonia


VAERS ID: 1554595 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2707 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthma, Bronchospasm, Cough, Myocardial infarction, Pain
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101004079

Write-up: severe asthma attack; Aches; cough; Bronchospasm; Infarct myocardial; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. A 67-year-old female patient received BNT162B2 (COMIRNATY), intramuscularly on 15Jul2021 (lot number FE2707) as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced aches, cough, onset of bronchospasm on 16Jul2021 worsening despite the ventolin taken repeatedly. Hospitalization in severe asthma attack on 19Jul2021. Admission to the emergency room on 19Jul2021. Gradual improvement under treatment of severe asthma attack. The patient died of infarct myocardial in 2021. No autopsy was done. The outcome of event infarct myocardial was fatal, outcome of other events were resolving. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1554604 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-07-01
   Days after vaccination:126
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-28
   Days after onset: 27
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Atrial fibrillation; CVA; Ex-alcoholic (weaned alcoholism); Stroke
Allergies:
Diagnostic Lab Data: Test Date: 20210728; Test Name: desaturation; Test Result: 65 %; Test Date: 20210727; Test Name: COVID-19 antigen test; Test Result: Positive ; Test Date: 20210727; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: L452R mutation
CDC Split Type: FRPFIZER INC202101004096

Write-up: COVID-19; Vaccination failure; intestinal obstruction; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority FR-AFSSAPS-SE20211964. A 90-years-old female patient received first dose of bnt162b2 (Comirnaty, Solution for injection, lot number: EJ6788), via an unspecified route of administration on 04Feb2021 as dose 1, single and second dose of bnt162b2 (Comirnaty, Solution for injection, lot number: EJ6789), via intramuscular route of administration in left arm on 25Feb2021 as dose 2, single at nursing home; both were for COVID-19 immunisation. The patient medical history included arterial hypertension, atrial fibrillation, stroke, CVA (Cerebrovascular accident), weaned alcoholism. Patient at risk of developing a severe form of COVID-19 disease due to high blood pressure and age. Received anticoagulant as treatment. Concomitant medications were not reported. On 27Jul2021, the patient experienced vaccination failure, COVID-19 with desaturation and intestinal obstruction. She was in a retirement home. Due to vaccination failure, she was die. It was unknown if autopsy was done. On 28Jul2021, she was hospitalized. Portal declaration made on 29Jul2021, medically confirmed. Contracted COVID-19 with L452R mutation with a positive antigen test on 27Jul confirmed by PCR test. Appearance of severity criteria with desaturation at 65% on 28Jul leading to emergency hospitalization and death a few hours later. In emergencies was also diagnosed with intestinal obstruction. Conclusion: declaration of a vaccination failure (Dose2 on 25Feb2021) with the COMIRNATY vaccine in a 90-years-old patient who contracted COVID-19 (positive antigen test on 27Jul) with desaturation and death on 28Jul2021. The patient was died on 28Jul2021.; Reported Cause(s) of Death: Vaccination failure


VAERS ID: 1554645 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-17
Onset:2021-05-02
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-02
   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: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101005991

Write-up: 5-month-old male patient; Death; This is a spontaneous report from a contactable consumer received from a regulatory authority. A 5-month-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 17Apr2021 (Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. T The patient died on 02May2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on unknown 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: death


VAERS ID: 1554666 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-25
Onset:2021-05-03
   Days after vaccination:98
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, Drug ineffective, Dyspnoea, X-ray
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-09
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension (Arterial hypertension); Bilateral inguinal hernia (Bilateral inguinal hernia); Carotid artery stenosis (bilateraly carotid artery stenosis 50-55%); Diabetes mellitus (Diabetes); Hemiparesis (right) (right-side Hemiparesis); Psychoorganic syndrome (Psychoorganic syndrome)
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebrovascular event (Cerebrovascular stroke 2015.); Lichenoid dermatitis (dermatitis lichenoids submammary region)
Allergies:
Diagnostic Lab Data: Test Date: 20210506; Test Name: X-ray; Result Unstructured Data: Test Result:radiological development of COVID 19 pneumonia
CDC Split Type: HRPFIZER INC202100990652

Write-up: Drug ineffective; radiological development of COVID 19 pneumonia; Breathing difficult; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB regulatory authority number HR-HALMED-300049880. A 83-year-old female patient received second dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number: unknown), via intramuscular route of administration, administered on 25Jan2021 as dose 2, 0.3 mL, single and patient received first dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number: unknown), via intramuscular route of administration, administered on Jan2021 as dose 1, 0.3 mL, single for covid-19 immunization. Medical history included Lichenoid dermatitis from an unknown date and unknown if ongoing (dermatitis lichenoids submammary region), ongoing diabetes mellitus (Diabetes), ongoing carotid artery stenosis (bilateraly carotid artery stenosis 50-55%), ongoing Psychoorganic syndrome, cerebrovascular event from an unknown date to 2015 (Cerebrovascular stroke 2015), ongoing Bilateral inguinal hernia, ongoing Arterial hypertension, ongoing hemiparesis right (right-side Hemiparesis). Concomitant medications were not reported. The patient experienced drug ineffective on 03May2021, radiological development of covid 19 pneumonia on 03May2021, breathing difficult on 03May2021. The patient was hospitalized for drug ineffective from 06May2021 to an unknown date. The patient was hospitalized for radiological development of covid 19 pneumonia from 06May2021 to an unknown date. The patient was hospitalized for breathing difficult from 06May2021 to an unknown date. The patient underwent lab tests and procedures which included x-ray: radiological development of covid 19 pneumonia on 06May2021. Therapeutic measures were taken with antiviral treatment, and oxygen replacement therapy as a result of event drug ineffective, radiological development of covid 19 pneumonia, breathing difficult. ADR is adequately labelled was No. The patient died on 09May2021. It was not reported if an autopsy was performed. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1554668 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-06
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD4555 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest X-ray, Laboratory test, Pulmonary embolism, Ultrasound abdomen, Urinary tract infection, Venous thrombosis limb
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cachexia; Chemotherapy; Malignant neoplasm of colon; Peritoneal metastases
Allergies:
Diagnostic Lab Data: Test Date: 20210706; Test Name: Chest X-ray; Result Unstructured Data: Test Result:no novum abnormalities; Comments: other than urinary tract infection were confirmed; Test Date: 20210706; Test Name: Laboratory test; Result Unstructured Data: Test Result:no novum abnormalities; Comments: other than urinary tract infection were confirmed; Test Date: 20210706; Test Name: Ultrasound abdomen; Result Unstructured Data: Test Result:no novum abnormalities; Comments: other than urinary tract infection were confirmed
CDC Split Type: HUPFIZER INC202101003331

Write-up: Pulmonary embolism; profuse thrombosis of femoral veins both sides; urinary tract infection; This is a spontaneous report from a contactable physician downloaded from the regulatory authority HU-OGYI-673321. A 68-year-old female patient received the second dose of BNT162B2 (COMIRNATY, lot number: FD4555, strength: 0.3 ml) (tozinameran), via intramuscular in left arm on 02Jul2021 at 09:21 at 0.3 ml, single dose for COVID-19 immunisation. Medical history included malignant neoplasm of colon since 2018, cachexia, peritoneal metastases and several combined chemotherapeutic treatment since 2019. The patient''s concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: FD1921) on 10Jun2021 at single dose for COVID-19 immunisation. On 06Jul2021, the patient went to the emergency department due to severe abdominal pain. In her home, she experienced frequent urination stimuli, temporary inability to urinate, and then bloody urine. Her stool was a little looser the day before. There was no vomiting. When the patient arrived, she had no difficulty breathing, she was complaining of severe diffuse abdominal pain. Her legs were swollen since a couple of weeks. Abdominal ultrasound, chest X-ray and laboratory examination were performed, no novum abnormalities other than urinary tract infection were confirmed. Hospitalization was recommended due to significant deterioration, severe pain, and dyspnea. Dyspnea did not improve after oxygen support. Her limbs became cool, damp, and she died on 06Jul2021 at 18:30. Autopsy was done, pulmonary embolism due to profuse thrombosis of femoral veins both sides were confirmed as cause of death. Stop date of event pulmonary embolism was reported as 06Jul2021. The outcome of the events pulmonary embolism and profuse thrombosis of femoral veins both sides was fatal. The outcome of the event urinary tract infection was unknown. Sender''s Comment: The patient died 4 days after BNT162B2 vaccination. Cause of death was pulmonary embolism, probably associated with the patient''s underlying disease. The causal relationship between the reported death and Comirnaty is considered unlikely. The case is serious due to hospitalization and fatal outcome. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: profuse thrombosis of femoral veins both sides; Autopsy-determined Cause(s) of Death: Pulmonary embolism


VAERS ID: 1554744 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-19
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0207 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Body temperature, Brain herniation, Cerebral haemorrhage, Computerised tomogram head
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-24
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210719; Test Name: Three-dimensional CT angiography/venography; Result Unstructured Data: Test Result:No apparent cause was found; Test Date: 20210715; Test Name: Body temperature; Result Unstructured Data: Test Result:36 Centigrade; Comments: before vaccination; Test Date: 20210719; Test Name: Head CT; Result Unstructured Data: Test Result:Subcortical haemorrhage; Comments: in the left parietal lobe
CDC Split Type: JPPFIZER INC202101001002

Write-up: brain herniation; Cerebral haemorrhage resulted from consciousness disturbed; This is a spontaneous report from a contactable physician received from a regulatory authority. A 49-year and 11-month-old female patient received?the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EW0207, Expiration date 30Sep2021) on 15Jul2021 at 10:00 at single dose for COVID-19 immunization. Body temperature before vaccination was 36 degrees centigrade. The patient''s family history and medical history were not reported. There were no points to be considered on the vaccine screening questionnaire. The patient''s concomitant medications were not reported. On 15Jul2021 at 10:00 (the day of vaccination), the patient received?the first dose of BNT162B2. On 19Jul2021 at 10:30 (4 days/hours/minutes after the vaccination), the patient experienced consciousness disturbed. On 24Jul2021 (9 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 19Jul2021, since the patient presented with headache, she made a call to her husband. Thereafter, due to progressing consciousness disturbance, the patient was urgently transferred to the reporting hospital. Head computed tomography (CT) showed subcortical haemorrhage in the left parietal lobe. Three-dimensional CT angiography/venography was performed, but no apparent cause was found. Because of the large haematoma and the sign of brain herniation, craniotomy was performed to remove the haematoma. On 24Jul2021, the patient was discharged dead due to brain herniation. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 was unassessable. There was no other possible cause of the event such as any other diseases. Outcome of the events was fatal. The patient died on 24Jul2021. It was not reported if an autopsy was performed. Reporter''s comment: The patient had cerebral haemorrhage and died. The causal relationship was unknown. However, this case was considered necessary to be reported.; Reporter''s Comments: The patient had cerebral haemorrhage and died. The causal relationship was unknown. However, this case was considered necessary to be reported.; Reported Cause(s) of Death: Cerebral haemorrhage resulted from consciousness disturbed; Brain herniation


VAERS ID: 1554745 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-20
Onset:2021-06-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cholelithiasis, Computerised tomogram, Dysphonia, Subarachnoid haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Parkinson-like events (broad), Gallbladder related disorders (narrow), Gallstone related disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-23
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210621; Test Name: contrast-enhanced CT; Result Unstructured Data: Test Result:Unkown results; Comments: for gallstones
CDC Split Type: JPPFIZER INC202101001980

Write-up: Subarachnoid haemorrhage; symptom of difficulty in voicing; gallstones; This is a spontaneous case from a contactable physician received via a Pfizer sales representative. An 86-year-old female patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) on 20Jun2021 at single dose for COVID-19 immunization. Medical history included hypertension. The family history was not provided. The patient''s concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (Lot number unknown, Expiration date unknown) on an unspecified date at single dose for COVID-19 immunization. On 20Jun2021 (the day of vaccination), the patient received the second dose of BNT162B2. On 23Jun2021 (3 days after the vaccination), the patient experienced subarachnoid haemorrhage. On 23Jun2021 (3 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 20Jun2021 (the day of vaccination), the patient received the second dose of BNT162B2 vaccination. On 21Jun2021 (1 day after vaccination), the patient visited another hospital for contrast-enhanced computerised tomogram (CT) for gallstones. After the CT, the patient had a symptom of difficulty in voicing. On 23Jun2021 (3 days after vaccination), the patient died of subarachnoid haemorrhage. The causality between the event and BNT162b2 was not provided. The patient died on 23Jun2021. It was not reported if an autopsy was performed. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the information currently available and known drug safety profile, the reported event subarachnoid haemorrhage more likely represented intercurrent illness, but not related to BNT162B2. The patient''s underlying risk factors/predisposing condition hypertension and the advanced age of the patient have been assessed to provide alternative explanations. 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: Subarachnoid haemorrhage


VAERS ID: 1554747 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Blood pressure measurement, Blood pressure systolic, Blood pressure systolic decreased, Body temperature, C-reactive protein, C-reactive protein increased, Heart rate, Heart rate increased, Movement disorder, Oxygen saturation, Oxygen saturation decreased, Pyrexia, Respiratory arrest
SMQs:, Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:99/60; Comments: with antibiotic and oxygen administration; Test Date: 20210702; Test Name: blood pressure; Result Unstructured Data: Test Result:normal; Test Date: 20210703; Test Name: systolic blood pressure; Result Unstructured Data: Test Result:70; Test Date: 20210703; Test Name: body temperature; Result Unstructured Data: Test Result:37.0 Centigrade; Comments: in the afternoon; Test Date: 20210703; Test Name: body temperature; Result Unstructured Data: Test Result:39.0 Centigrade; Comments: in the evening; Test Name: CRP; Result Unstructured Data: Test Result:high; Test Name: pulse rate; Result Unstructured Data: Test Result:decreased to 50; Test Date: 20210703; Test Name: pulse rate; Result Unstructured Data: Test Result:130-131; Test Name: SpO2; Result Unstructured Data: Test Result:decreased to around 90; Test Name: SpO2; Result Unstructured Data: Test Result:improved to 97; Comments: with antibiotic and oxygen administration; Test Date: 20210702; Test Name: SpO2; Result Unstructured Data: Test Result:normal
CDC Split Type: JPPFIZER INC202101007558

Write-up: the patient had difficulty in moving and it became easy for the patient to fall over; systolic blood pressure was 70; Pulse rate was 130-131; SpO2 decreased to around 90; pyrexia from 37.0 to 39.0; consciousness was slightly unclear; high level of CRP; Respiratory arrest; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 9-decade-old patient of an unspecified gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on 01Jul2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. On 01Jul2021, the patient of unknown gender in late 80s received BNT162b2 (COMIRNATY, Solution for injection, Dose number, Lot number and Expiration date were not reported) via an unspecified route of administration as the first single dose for COVID-19 immunization at a medical facility different from the reporter''s. On 02Jul2021 (1 day after the vaccination), the patient had difficulty in moving and it became easy for the patient to fall over. Therefore, the patient was admitted to the reporter''s hospital. The patient''s consciousness was slightly unclear, so the patient visited the neurosurgery department. There were no problems in particular. Since high level of CRP (C-reactive protein) was noted, the patient was referred to the internal medicine. Shortly after the hospitalization, blood pressure and SpO2 (oxygen saturation percutaneous) were in normal range. One day after the hospitalization (03Jul2021) in the afternoon, the patient developed fever of 37.0 degrees Centigrade. In that evening, it went up to 39.0 degrees Centigrade. Pulse rate was 130-131, and systolic blood pressure was 70. SpO2 decreased to around 90, but SpO2 and blood pressure improved to 97 and 99/60 respectively with antibiotic and oxygen administration. However, several days after, pulse rate decreased to 50 and respiratory arrest developed, and then the patient died. It was unknown whether autopsy was performed. The reporting physician''s opinion was as follows: The causal relationship between the with BNT162b2 was unknown. Since the symptoms occurred after the vaccination resulted in death, this case was reported. The outcome of respiratory arrest was fatal, outcome of systolic blood pressure was 70, spo2 decreased to around 90 was recovering, outcome of other events was unknown. The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events movement disorder, Blood pressure systolic decreased, Altered state of consciousness, heart rate increased, oxygen saturation decreased and respiratory arrest cannot be totally excluded/assessed. The case will be reassessed when the information particularly about patient''s medical history and concomitant medication 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: Respiratory arrest


VAERS ID: 1554749 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-08-01
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

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: Test Date: 20210721; Test Name: body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101007602

Write-up: Death; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A 54-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 21Jul2021 (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 was a 54-year-old male. Body temperature before vaccination was 36.0 degrees centigrade. The patient had no medical history or history of allergy according to the screening questionnaire. On 21Jul2021 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date were not reported) intramuscularly as a single dose for COVID-19 immunization. On 01Aug2021 (eleven days after the vaccination), the patient died. Cause of death was unknown. The course of the event was as follows: On 21Jul2021, the day of vaccination, the wife of the patient was visiting the reporter clinic, and the patient received the first dose of Comirnaty with the wife. On 03Aug2121, the local police found the vaccination coupon and the patient registration card and contacted the reporter to inform that the patient had died at home on 01Aug2021. On 04Aug2021, the son of the patient called the reporter to cancel the second dose because the patient had died. The son told that the patient played golf with the wife on 28Jul2021 (seven days after the vaccination). The clinic had not heard of poor condition or anything. Legal autopsy was performed as suspicious death. There was no more information as of this report. The reporting physician classified the event as serious (death) and commented the causality was unknown. Information on the lot/batch number has been requested.; Sender''s Comments: The information on the circumstances of the patient''s death is too limited to perform a meaningful company causality assessment: this event is handled as related to the suspect product BNT162B2 as a cautionary measure and for reporting purposes. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1554750 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Vaccination complication
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: JPPFIZER INC202101025315

Write-up: Vaccination adverse reaction; This is a spontaneous report from a non-contactable consumer (a patient''s relative) via Pfizer sales representative. A patient of unspecified age and gender received BNT162b2 (COMIRNATY, Batch/Lot number was not reported) on an unspecified date (at an unspecified age) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced side reactions with vaccine manufactured by Pfizer (Vaccination adverse reaction). On 05Aug2021 at 13:34, the consumer reported via phone that the patient died from side reactions with vaccine manufactured by Pfizer 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: Vaccination adverse reaction


VAERS ID: 1554751 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-15
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: WARFARIN; BAYASPIRIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure; Chronic kidney disease; Renal failure; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210707; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021904535

Write-up: death/ Acute cardiac death was reported as possible causes of the event such as any other diseases; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21119953. A 82-year-old (reported as 82-year and 7-month-old) male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 07Jul2021 (Batch/Lot Number: FC5947; Expiration Date: 30Sep2021) as DOSE 1, SINGLE for COVID-19 immunization. Body temperature before vaccination was 36.7 degrees Centigrade. Medical history included chronic kidney disease, type 2 diabetes mellitus, renal failure and cardiac failure; all from an unknown date and unknown if ongoing. Concomitant medications included warfarin and acetylsalicylic acid (BAYASPIRIN) both taken for an unspecified indication from an unspecified start date and ongoing. On 15Jul2021 at 14:00 (8 days after the vaccination), the patient died. The course of the events was as follows: On 07Jul2021, the patient received the vaccine. After the vaccination, he was observed for 30 minutes and then he returned home. The police informed the reporter that the patient was found dead at home on 15Jul2021. The reporting physician classified the event as serious (fatal outcome) and assessed that the event was not related to BNT162b2. Acute cardiac death was reported as possible causes of the event such as any other diseases. The reporting physician commented as follows: The patient had renal failure and cardiac failure and he was supposed to receive hemodialysis, and just prior to that, he died. Therefore, it was considered that the event was not related to BNT162b2 directly. It was not reported if an autopsy was performed.; Sender''s Comments: The 82-year-old died just prior to receive hemodialysis for her underlying renal failure and cardiac failure. The reported acute cardiac death was likely due to her pre-existing diseases/conditions and unrelated to vaccine of BNT162b2.; Reported Cause(s) of Death: Cardiac death


VAERS ID: 1554813 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-07-25
   Days after vaccination:150
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Blood creatinine, Blood sodium, Body temperature, C-reactive protein, COVID-19, COVID-19 pneumonia, Chest X-ray, Diarrhoea, Dyspnoea, Eosinophil count, Fibrin D dimer, Glomerular filtration rate, Haematocrit, Haemoglobin, Hypoxia, Investigation, Lymphocyte count, Oxygen saturation, Platelet count, SARS-CoV-2 test, Tachypnoea, Vaccination failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), 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), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-28
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: DOXAZOSIN; AMLODIPINE; ELTROXIN; GLICLAZIDE; OMNIC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Benign prostatic hypertrophy; Diabetes; Hypertension; Hypothyroidism; Non-smoker
Allergies:
Diagnostic Lab Data: Test Date: 20210725; Test Name: Creatinine; Result Unstructured Data: Test Result:130 umol/l; Comments: raised; Test Date: 20210725; Test Name: sodium; Result Unstructured Data: Test Result:134 mmol/L; Test Date: 20210725; Test Name: body temperature; Result Unstructured Data: Test Result:37.1; Test Date: 20210725; Test Name: chest x-ray; Result Unstructured Data: Test Result:Confulent air space shadowing at periphery of the; Comments: Confulent air space shadowing at periphery of the right upper lobe. Patchy consolidation at periphery of left middle to lower lung zones. Findings suggestive of COVID pneumonia; Test Date: 20210725; Test Name: CRP; Result Unstructured Data: Test Result:60.6 mg/l; Comments: raised; Test Date: 20210725; Test Name: eosinophils; Result Unstructured Data: Test Result:0.0 x10 9/l; Test Date: 20210725; Test Name: D-Dimer; Result Unstructured Data: Test Result:880 ng/ml; Comments: raised; Test Date: 20210725; Test Name: EGFR; Result Unstructured Data: Test Result:47; Comments: raised; Test Date: 20210725; Test Name: haematocrit; Test Result: 38 %; Test Date: 20210725; Test Name: haemoglobin; Result Unstructured Data: Test Result:13.3 g/dl; Comments: decreased; Test Date: 20210725; Test Name: red cell count; Result Unstructured Data: Test Result:4.37 x10 12/l; Test Date: 20210725; Test Name: lymphocytes; Result Unstructured Data: Test Result:0.66 x10 9/l; Comments: decreased; Test Date: 20210725; Test Name: SpO2; Test Result: 83 %; Test Date: 20210725; Test Name: SpO2; Test Result: 98 %; Comments: after given 10L NFM; Test Date: 20210725; Test Name: platelets; Result Unstructured Data: Test Result:95 x10 9/l; Comments: decreased; Test Date: 20210725; Test Name: RT-PCR test; Test Result: Positive ; Comments: RT-CPR, new infection, CT15
CDC Split Type: MTPFIZER INC202101005054

Write-up: Acute kidney injury; hypoxemia; dyspnea; Tachypnea; Diarrhea; positive for COvid-19 on RT-PCR test; COVID 19 pneumonia; positive for COvid-19 on RT-PCR test; This is a spontaneous report from a contactable physician. A 95-year-old male patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot Number: EJ6136), via intramuscular route of administration on 25Feb2021, as dose 2, single in left arm; and received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot Number: EJ6134), via intramuscular route of administration on 04Feb2021, as dose 1, single for COVID-19 immunization. The patient''s medical history included hypertension, diabetes, benign prostatic hyperplasia, hypothyroidism, and patient was a non-tobacco user. Concomitant medication included doxazosin 4 mg, daily; amlodipine 5 mg, daily; levothyroxine sodium (ELTROXIN) 100 mg, daily; gliclazide 40 mg, daily; and tamsulosin hydrochloride (OMNIC) 0.4 mg, daily; all taken for unspecified indications, start and stop date were not reported. On 25Jul2021, 5 months after the second dose of vaccine, the patient was tested positive for COVID-19 on RT-PCR test, indicating vaccination failure. On 28Jul2021, 5 months and 3 days after the second dose, the patient experienced COVID-19 pneumonia. Events COVID-19 and COVID-19 pneumonia were reported as fatal. On an unspecified date, after the second dose of vaccine, the patient experienced acute kidney injury, hypoxemia, dyspnea, tachypnea and diarrhea; which led to hospitalization on 25Jul2021 up to an unspecified date. The patient receives additional therapies for COVID-19 that included: Remdesivir on 25Jul2021 and 6mg dexamethasone daily on 25Jul2021. The patient was not admitted to an Intensive Care Unit. No pre-existing diseases worsened during the SARS-CoV2 infection. The patient has not been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. The patient underwent lab tests and procedures which included body temperature: 37.1; SpO2: 83% on air which improved to 98% on 10L NFM, desaturation to about 85% with minimal exertion, moving to edge of bed; chest x-ray: confluent air space shadowing at periphery of the right upper lobe, patchy consolidation at periphery of left middle to lower lung zones, findings suggestive of COVID pneumonia; SARS-CoV-2 test: positive (RT-CPR, new infection, CT15); fibrin d dimer (normal range 0 - 500 ng/ml): 880 raised; haemoglobin (normal range: 14.1 - 17.2 g/dl): 13.3 decreased; haematocrit (normal range: 40.4 - 50.4 %): 38; platelet count (normal range: 146 - 302x10^9/L): 95 decreased; lymphocyte count (normal range: 1.30 - 3.60 x 10^9/L): 0.66 decreased; Eosinophils (normal range: 0.10 - 0.70x10^9/L): 0; Red cell count (normal range: 4.60 - 5.90 x 10^12/L): 4.37; blood creatinine (normal range: 59-104 umol/l): 130 raised; glomerular filtration rate: 47 raised; C-reactive protein (normal range: 0-5 mg/L): 60.6 raised; and sodium (normal range: 136-145mmol/l): 134. The patient died on 28Jul2021. An autopsy was not performed. Primary cause of death was reported as COVID-19 pneumonia. The clinical outcome of events COVID-19 pneumonia, COVID-19, and vaccination failure was fatal. The clinical outcome of all other events was unknown. Follow-up activities completed. No further information expected.; Sender''s Comments: Based on plausible temporal relationship, a possible causal association between the all the reported events and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: covid-19 pneumonia


VAERS ID: 1554835 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-19
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary fibrosis, Respiratory disorder
SMQs:, Interstitial lung disease (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZPFIZER INC202101007835

Write-up: pulmonary fibrosis; Respiratory disorder; This is a spontaneous report from a contactable physician from a regulatory authority. A 78-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 06Jul2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced respiratory disorder on 19Jul2021, pulmonary fibrosis on unspecified date. The patient died on 19Jul2021. It was not reported if an autopsy was performed. The events were reported as unrelated to vaccine. The outcome of events was fatal. Reporters description of AEFI: CARM report onset date is death date and onset time unknown. The patient had covid vaccine 06Jul2021. Died on 19Jul2021 - of pulmonary fibrosis (Report states death as 18Jul2021 but NHI date used). Death not unexpected but thought should report as just had vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the information currently available, the events respiratory disorder and pulmonary fibrosis most likely represented the intercurrent /underlying medical conditions and were unrelated to Bnt162b2 vaccine. Case will be re-assessed upon the additional information provided.; Reported Cause(s) of Death: pulmonary fibrosis; Respiratory disorder


VAERS ID: 1554836 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-23
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Myocardial infarction
SMQs:, Anaphylactic reaction (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZPFIZER INC202101007888

Write-up: Myocardial infarction; Chest discomfort; Dizziness; Dyspnoea; This is a spontaneous report from a contactable consumer received from the regulatory authority. Regulatory authority report number is AEFI-A-008000. A patient of unspecified age and gender received BNT162B2 (COMIRNATY), via an unspecified route of administration on 18Jul2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced chest discomfort, dizziness, dyspnoea and myocardial infarction on 23Jul2021. The events were considered serious due to death. The events were considered unrelated to the vaccine. The patient died on an unspecified date. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on plausible temporal relationship, a possible causal association between the all the reported events and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Chest discomfort; Dizziness; Dyspnoea; Myocardial infarction


VAERS ID: 1554837 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-06-03
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Agitation, Angioedema, Anxiety, Bronchospasm, Chest discomfort, Dizziness, Feeling of body temperature change, Headache, Mouth ulceration, Pyrexia, Rash, Urticaria, Vaccination site pain, Vomiting
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (narrow), Dementia (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZPFIZER INC202101007905

Write-up: Agitation; Angioedema; Anxiety; Bronchospasm; Chest discomfort; Dizziness; Feeling of body temperature change; Headache; Injection site pain; Mouth ulceration; Pyrexia; Rash; Urticaria; Vomiting; This is a spontaneous report from a contactable consumer from the Medsafe. Regulatory authority report number is AEFI-A-008036. A 66-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 28May2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. Historical Vaccine included Comirnaty (Dose1, single) for COVID-19 immunization and experienced Ulcers. Also ulcers Had a lot of this after 1st jab but worsened after 2nd. Events: Agitation, Angioedema, Anxiety, Bronchospasm, Chest discomfort, Dizziness, Feeling of body temperature change, Headache, Injection site pain, Mouth ulceration, Pyrexia, Rash, Urticaria, Vomiting on 03Jun2021. Seriousness was provided as died. The event outcome was Died-unclassifiable. The patient died in 2021. 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: Agitation; Angioedema; Anxiety; Bronchospasm; Chest discomfort; Dizziness; Feeling of body temperature change; Headache; Injection site pain; Mouth ulceration; Pyrexia; Urticaria; Vomiting; Rash


VAERS ID: 1554876 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-26
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FB5996 / UNK - / OT

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: 2021-07-26
   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: PHPFIZER INC202101007720

Write-up: Cough; Fever; Difficulty breathing; 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-300094757. A 76-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 02Jul2021 (Batch/Lot Number: FB5996) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced cough and fever, difficulty breathing on 26Jul2021. The patient died on 26Jul2021. The outcome of all events was fatal. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: Cough; Fever; Difficulty breathing


VAERS ID: 1555437 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-03-15
   Days after vaccination:45
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: COVID-19 PCR TEST; Test Result: Positive ; Comments: Variant PCR based: B.1.1.7
CDC Split Type: ATPFIZER INC202101016126

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory authority number AT-BASGAGES-2021-39202. An 85-year-old male patient received bnt162b2 (COMIRNATY, Formulation: solution for injection), dose 2 via an unspecified route of administration on 29Jan2021 (Lot Number: EJ6134; Expiration Date: 30Apr2021) as DOSE 2, SINGLE and dose 1 via an unspecified route of administration on 08Jan2021 (Lot Number: EJ6796; Expiration Date: 30Apr2021) as DOSE 1, SINGLE for covid-19 immunisation. The patient had no relevant medical history and concurrent conditions. No concomitant medications were reported. On 15Mar2021, the patient experienced sars-cov-2 infection and vaccination failure. The patient underwent lab tests and procedures on an unspecified date in 2021 included sars-cov-2 test: positive for Variant PCR based: B.1.1.7. The patient died on an unspecified date.It was not reported if an autopsy was performed or not. Conclusion: The investigation included reviewing the involved batch records, deviation investigation, evaluation of reference samples, 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 EJ6796. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality, regulatory, validation and stability. PGS Puurs concludes that the reported defect was not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that a regulatory notification was required. The reported defect could not be confirmed on the evaluation of reference samples. No root cause or CAPA were identified as the complaint was not confirmed. 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 EJ6134. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality, regulatory, validation and stability. PGS Puurs concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that 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.; Reported Cause(s) of Death: SARS-CoV-2 infection


VAERS ID: 1555438 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-06-07
   Days after vaccination:117
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210607; Test Name: SARS-CoV-2 test PCR; Test Result: Positive
CDC Split Type: ATPFIZER INC202101016173

Write-up: SARS-CoV-2 infection/ Variant PCR based: B.1.1.7; N501Y positive; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-39210. A 98-year-old female patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: EJ6136), via an unspecified route of administration on 10Feb2021 as dose 2, single dose and first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: EJ6796), via an unspecified route of administration on 20Jan2021 as dose 1, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 07Jun2021, patient experienced SARS-CoV-2 infection, variant PCR based: B.1.1.7; N501Y positive. Physician reported as serious. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 07Jun2021. The patient died on an unspecified date. It was not reported if an autopsy was performed. Outcome of the event vaccination failure was unknown and SARS-CoV-2 infection was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: SARS-CoV-2 infection


VAERS ID: 1555439 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-03-12
   Days after vaccination:38
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 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 Date: 2021; Test Name: Sars-cov-2 test; Result Unstructured Data: Test Result:variant sequenced: B.1.1.7; N501Y positive
CDC Split Type: ATPFIZER INC202101016151

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Authority number AT-BASGAGES-2021-39211. An 81-year-old female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection), second dose via an unspecified route of administration on 02Feb2021 (Batch/Lot Number: EJ6797) as a single dose and first dose via an unspecified route of administration on 12Jan2021 (Batch/Lot Number: EJ6796) as a single dose for COVID-19 immunisation. No medical history and concomitant medications were reported. On 12Mar2021, the patient had sars-cov-2 infection, vaccination failure. The patient underwent lab tests and procedures which included sars-cov-2 test: variant sequenced: b.1.1.7; n501y positive on an unspecified date in 2021. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: SARS-CoV-2 infection


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